Sample records for medical drug compliance

  1. Optimizing urine drug testing for monitoring medication compliance in pain management.

    PubMed

    Melanson, Stacy E F; Ptolemy, Adam S; Wasan, Ajay D

    2013-12-01

    It can be challenging to successfully monitor medication compliance in pain management. Clinicians and laboratorians need to collaborate to optimize patient care and maximize operational efficiency. The test menu, assay cutoffs, and testing algorithms utilized in the urine drug testing panels should be periodically reviewed and tailored to the patient population to effectively assess compliance and avoid unnecessary testing and cost to the patient. Pain management and pathology collaborated on an important quality improvement initiative to optimize urine drug testing for monitoring medication compliance in pain management. We retrospectively reviewed 18 months of data from our pain management center. We gathered data on test volumes, positivity rates, and the frequency of false positive results. We also reviewed the clinical utility of our testing algorithms, assay cutoffs, and adulterant panel. In addition, the cost of each component was calculated. The positivity rate for ethanol and 3,4-methylenedioxymethamphetamine were <1% so we eliminated this testing from our panel. We also lowered the screening cutoff for cocaine to meet the clinical needs of the pain management center. In addition, we changed our testing algorithm for 6-acetylmorphine, benzodiazepines, and methadone. For example, due the high rate of false negative results using our immunoassay-based benzodiazepine screen, we removed the screening portion of the algorithm and now perform benzodiazepine confirmation up front in all specimens by liquid chromatography-tandem mass spectrometry. Conducting an interdisciplinary quality improvement project allowed us to optimize our testing panel for monitoring medication compliance in pain management and reduce cost. Wiley Periodicals, Inc.

  2. [Drug compliance of patients on anticoagulant treatment].

    PubMed

    Gadó, Klára; Kocsis, Eszter; Zelkó, Romána; Hankó, Balázs; Kovácsné Balogh, Judit; Forczig, Mónika; Domján, Gyula

    2015-08-09

    Despite several therapeutic possibilities the morbidity and mortality of thromboembolic disorders remain high. Improving drug compliance - i. e. keeping up the doctor's prescriptions - may be an effective tool to reach better results. To improve patients' compliance, the risk factors of non-compliance should be recognized. Among these patients' fear of adverse effects of drugs, their lack of knowledge about their illness and medication, forgetfulness, and other social, economic factors may be the most important. Furthermore, adherence may be worsened when the patient feels that the decision has been made over his/her head. Sustained medical adherence is important because anticoagulation may be a life-long treatment. The new oral anticoagulants make the matter of compliance to be current. These new type of drugs do not need regular laboratory monitoring and, therefore, compliance cannot be strictly followed. There are several studies concerning drug compliance to anticoagulant medications. Improvement of adherence is based on regular patient education after reviewing the factors of non-compliance, which needs teamwork with important roles of doctors, pharmacists, dietetics and nurses. Careful and accurate work of the participants of primary care might be complemented by the activity of anticoagulant clinics.

  3. Cost and Efficacy Assessment of an Alternative Medication Compliance Urine Drug Testing Strategy.

    PubMed

    Doyle, Kelly; Strathmann, Frederick G

    2017-02-01

    This study investigates the frequency at which quantitative results provide additional clinical benefit compared to qualitative results alone. A comparison between alternative urine drug screens and conventional screens including the assessment of cost-to-payer differences, accuracy of prescription compliance or polypharmacy/substance abuse was also included. In a reference laboratory evaluation of urine specimens from across the United States, 213 urine specimens with provided prescription medication information (302 prescriptions) were analyzed by two testing algorithms: 1) conventional immunoassay screen with subsequent reflexive testing of positive results by quantitative mass spectrometry; and 2) a combined immunoassay/qualitative mass-spectrometry screen that substantially reduced the need for subsequent testing. The qualitative screen was superior to immunoassay with reflex to mass spectrometry in confirming compliance per prescription (226/302 vs 205/302), and identifying non-prescription abuse (97 vs 71). Pharmaceutical impurities and inconsistent drug metabolite patterns were detected in only 3.8% of specimens, suggesting that quantitative results have limited benefit. The percentage difference between the conventional testing algorithm and the alternative screen was projected to be 55%, and a 2-year evaluation of test utilization as a measure of test order volume follows an exponential trend for alternative screen test orders over conventional immunoassay screens that require subsequent confirmation testing. Alternative, qualitative urine drug screens provide a less expensive, faster, and more comprehensive evaluation of patient medication compliance and drug abuse. The vast majority of results were interpretable with qualitative results alone indicating a reduced need to automatically reflex to quantitation or provide quantitation for the majority of patients. This strategy highlights a successful approach using an alternative strategy for both the

  4. Drug Brand Response and Its Impact on Compliance and Efficacy in Depression Patients

    PubMed Central

    Li, Mingming; Cai, Jian; Zhang, Ping; Fei, Chunhua; Xu, Feng

    2017-01-01

    Introduction: Patient's response to drug brand is a comprehensive physiological and psychological effect which might impact the compliance and efficacy of drugs. Whether the therapeutic outcome altered on patients with brand response after they experience drug switch is not clear. Methods: 459 outpatients with mild-to-moderate depression were divided into the imported (joint venture) drug group and the domestic drug group according to their current drug application. Two groups of patients were assessed by drug brand preference questionnaire and medication compliance questionnaire. Patients with brand preference in imported (joint venture) drugs group received rational use of limited medical resource and pharmacoeconomics education, and then switched with domestic drug for 8 weeks. Safety and efficacy were evaluated both before and after the drug switch. Results: Overall, there were 27% of patients in imported drug group and 35% of patients in domestic drug group have brand response, respectively. About 2/3 patients in both groups showed low or no brand response. The compliance was similar in both groups with no significant difference (6.04 ± 2.08 vs. 4.74 ± 2.13, respectively, P > 0.05). The efficacy of imported drug group was significantly better than of the domestic drug group. Correlation analysis showed that in imported (joint venture) drugs group, medication compliance was closely related with brand response, but negatively correlated with age and duration. In domestic drugs group, medication compliance was independent of brand response, but closely related with education, age, and duration. After drug switch with domestic drug on patients with brand response, patients continued to maintain good antidepressant effect, and no severe adverse reaction occurred. Conclusion: The results suggested that domestic drugs switch might be feasible for patients using imported drugs with brand response, while providing patients with rational use of drug education and

  5. Drug Brand Response and Its Impact on Compliance and Efficacy in Depression Patients.

    PubMed

    Li, Mingming; Cai, Jian; Zhang, Ping; Fei, Chunhua; Xu, Feng

    2016-01-01

    Introduction: Patient's response to drug brand is a comprehensive physiological and psychological effect which might impact the compliance and efficacy of drugs. Whether the therapeutic outcome altered on patients with brand response after they experience drug switch is not clear. Methods: 459 outpatients with mild-to-moderate depression were divided into the imported (joint venture) drug group and the domestic drug group according to their current drug application. Two groups of patients were assessed by drug brand preference questionnaire and medication compliance questionnaire. Patients with brand preference in imported (joint venture) drugs group received rational use of limited medical resource and pharmacoeconomics education, and then switched with domestic drug for 8 weeks. Safety and efficacy were evaluated both before and after the drug switch. Results: Overall, there were 27% of patients in imported drug group and 35% of patients in domestic drug group have brand response, respectively. About 2/3 patients in both groups showed low or no brand response. The compliance was similar in both groups with no significant difference (6.04 ± 2.08 vs. 4.74 ± 2.13, respectively, P > 0.05). The efficacy of imported drug group was significantly better than of the domestic drug group. Correlation analysis showed that in imported (joint venture) drugs group, medication compliance was closely related with brand response, but negatively correlated with age and duration. In domestic drugs group, medication compliance was independent of brand response, but closely related with education, age, and duration. After drug switch with domestic drug on patients with brand response, patients continued to maintain good antidepressant effect, and no severe adverse reaction occurred. Conclusion: The results suggested that domestic drugs switch might be feasible for patients using imported drugs with brand response, while providing patients with rational use of drug education and

  6. Factors that interfere the medication compliance in hypertensive patients

    PubMed Central

    Daniel, Ana Carolina Queiroz Godoy; Veiga, Eugenia Velludo

    2013-01-01

    ABSTRACT Objective: To characterize the factors that interfere in drug treatment compliance in a group of individuals with arterial hypertension. Methods: A non-experimental descriptive study that analyzed a sample of 80 patients diagnosed with arterial hypertension, who underwent medical treatment and were admitted to a university hospital during the period from March to May 2009. To collect data, the Instrument for Evaluation of Attitudes Regarding Taking Medication was applied. Results: In the studied population, 45.1% had sufficient degree of compliance to drug therapy. Individuals with controlled blood pressure, females, white, single, married or widowed, retired, aged between 40 and 59 years, and those aged above 80 years were the interviewees who answered positively regarding compliance and follow-up of drug therapy. Conclusion: Despite the fact that the number of factors that facilitate the process of compliance to drug treatment is greater than the number of complicating factors, we found that more than half of the patients surveyed had an insufficient degree of compliance with drug treatment for high blood pressure, which demonstrates the need to develop studies aimed to identify these factors and their contribution to the promotion of patient autonomy, acceptance, awareness and adaptation regarding their illness. PMID:24136760

  7. Medication apprehension and compliance among dialysis patients--a comprehensive guidance attitude.

    PubMed

    Katzir, Ze'ev; Boaz, Mona; Backshi, Irena; Cernes, Relu; Barnea, Zvi; Biro, Alexander

    2010-01-01

    Compliance with treatment regimens is a continuing challenge for chronic dialysis patients and their medical caregivers. Poor patient adherence to prescribed medications can adversely affect treatment outcome. In this pre- versus post-intervention study, 89 chronic dialysis patients [75 hemodialysis (HD), 14 continuous ambulatory peritoneal dialysis (CAPD); mean age 62.7 +/- 12.39 years, 34 females] responded to a written questionnaire designed to assess knowledge about and compliance with 5 groups of prescribed medications: metabolic drugs, antihypertensives, cardiac-supporting agents, peptic disease therapy and hematological replacement therapy. Mode of intake, storage, means of supply and source of information for each class of drug were also assessed. Patients then received both oral and written instructions regarding their prescribed medications (intervention). This information was repeated 3 months later. Six months after the intervention, patients were re-administered the questionnaires. Response to the questionnaires and laboratory data were compared prior to and following the intervention. Overall, compliance with prescribed medications significantly improved following the intervention, from 89 to 95.7%, p = 0.0007. This relative improvement was greater in HD than CAPD patients (27 vs. 2%, p < 0.0001). Improvement in compliance was associated with lower initial scores, fewer years of education, and longer dialysis vintage. Compared to baseline values, post-intervention blood hemoglobin, hematocrit, mean corpuscular volume, ferritin and Ca levels were significantly improved. Dialysis patients appear to benefit from receiving comprehensive guidance about medications, in terms of compliance with medications and blood chemistry and hematology measures. (c) 2009 S. Karger AG, Basel.

  8. The use of medication compliance devices by district nursing services.

    PubMed

    McGraw, C; Drennan, V

    2000-07-01

    This article presents a critical review of the literature relating to medication compliance devices and the findings of a survey that examined the use of such devices by district nursing services. The UKCC (1992) does not regard the loading of compliance devices by nurses as safe practice; however, compliance devices continue to be used by district nurses. The evidence base concerning the value and use of medication compliance devices is examined and significant gaps in the literature relating to the use of such devices are identified. There is an absence of studies that focus on the effect of compliance devices on adherence among older patients and the nature and frequency of drug administration errors involving these devices. The survey findings show that nurse-loaded compliance devices are used in over one-third of the sample. Further research is necessary to assess the clinical effectiveness of, and clinical risk attached to, compliance devices for older patients in the community. It is suggested that this is an issue of serious concern for primary care groups considering the principles of clinical governance.

  9. Evaluation of Patients' Compliance with Medical Practitioners' Prescriptions: University Health Center Experience.

    ERIC Educational Resources Information Center

    Parsons, Robert J.; And Others

    1980-01-01

    This research report examines the characteristics of patients and their compliance with drug prescriptions and suggests that there is a need for education among patients receiving medication so that they do not prematurely terminate the medication process. (JN)

  10. Nonlinear Pricing in Drug Benefits and Medication Use: The Case of Statin Compliance in Medicare Part D

    PubMed Central

    Jung, Kyoungrae; Feldman, Roger; McBean, A Marshall

    2014-01-01

    Objective To examine how enrollees' statin compliance responds to expected prices in Medicare Part D, which features a nonlinear price schedule due to a coverage gap. Data Sources/Study Setting Prescription Drug Event data for a 5 percent random sample of Medicare Advantage Prescription Drug Plan enrollees in 2008 who did not receive a low-income subsidy. Study Design We analyze statin compliance prior to the coverage gap, where the “effective price” is higher than the actual copayment for drugs because consumers anticipate that more spending will make them more likely to reach the gap. We construct each enrollee's effective price as her expected price at the end of the year, which is the weighted average between pre-gap and in-gap copayments with the weight being the predicted probability of hitting the gap. Compliance is defined as at least 80 percent of days covered. Principal Findings Part D enrollees' pre-gap statin compliance decreases by 3.7–4.7 percentage points for a $10 increase in the effective price. Conclusion The presence of a coverage gap decreases statin compliance prior to the gap, suggesting that incorporating expected future prices is important to assess the full impact of cost sharing on drug compliance under nonlinear price schedules. PMID:24354765

  11. Compliance assessed by the Medication Event Monitoring System.

    PubMed Central

    Olivieri, N F; Matsui, D; Hermann, C; Koren, G

    1991-01-01

    The accurate assessment of patient compliance is especially crucial in evaluating the efficacy of a new treatment. Because of the problems associated with parenteral desferrioxamine, the development of a safe, effective, and convenient iron chelator is of high priority. The high morbidity and mortality associated with iron overload requires careful evaluation of the ability of any new agent to promote long term effective iron chelation. Patients' compliance with an orally available chelating agent, 1,2,-dimethyl-3-hydroxypyrid-4-one (L1), that has been demonstrated to induce in vivo iron excretion equivalent to that of desferrioxamine during supervised short term administration, was examined. Compliance was assessed in seven patients by patient interview, by daily diaries reviewed monthly with each patient, and with the use of the Medication Event Monitoring System (MEMS) standard pill bottles with microprocessors in the cap that record the timing and frequency of bottle openings. L1 was dispensed in MEMS containers to the patients, who, unaware of their significance, recorded compliance using a daily diary. Overall compliance rate (% of prescribed doses taken) measured by MEMS was 88.7 +/- 6.8%. When 'doubling of doses' was accounted for, significantly poorer compliance with L1 was noted by MEMS (91.7 +/- 7.4%) than by patients' diaries (95.7 +/- 5.2%). There was no significant difference in patient compliance recorded between the first and last 30 day period of drug administration. MEMS can eliminate the confounding variable of erratic patient compliance in the evaluation of a new drug's efficacy. As MEMS cannot distinguish a missed dose from one doubled at the next bottle opening, the use of patient diaries is a useful adjunct to the accurate assessment of compliance and should be combined with the use of MEMS. PMID:1776885

  12. NON-COMPLIANCE TO ANTI-HYPERTENSIVE MEDICATION AND ITS ASSOCIATED FACTORS AMONG HYPERTENSIVES.

    PubMed

    Bilal, Arshia; Riaz, Mehwish; Shafiq, Noor-ulain; Ahmed, Mariam; Sheikh, Sadaf; Rasheed, Sobia

    2015-01-01

    Non-compliance to anti-hypertensive drugs can have negative impact on cardiovascular outcome. Various studies have been conducted on the issue but the factors are not yet explored properly, particularly in Pakistan. This study was conducted to determine the frequency and factors associated with non-compliance to anti-hypertensive medications in Karachi. This descriptive cross sectional study was conducted on 113 indoor hypertensive patients included by purposive sampling, aged 30 years and above diagnosed at least 6 months back in public sector tertiary care institutes of Karachi from March to October 2011. Data was collected through a questionnaire in Urdu. Demographic data, hypertension diagnosis, medical co-morbidity, current number of anti-hypertensive medicines, frequency of missing prescribed antihypertensive therapy and other factors affecting compliance pertaining to medicines, patient, physician and health care centre were included in the questionnaire. This study revealed that 68.14% patients were non-compliant. Non-compliance was found to be associated with gender and socioeconomic status. Duration of hypertension, duration between follow up visits to physician, number of drugs, careless attitude, role of physician and limiting access to health care center are found to be important factors in non-compliance. Multiple factors including patients, medicine and health care system related, which can be prevented with simple measures, were found responsible for higher prevalence of non-compliance against anti-hvnertensive medicines.

  13. 75 FR 76015 - Compliance Policy Guide Sec. 393.200 Laser(s) as Medical Devices for Facelift, Wrinkle Removal...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-07

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0551] Compliance Policy Guide Sec. 393.200 Laser(s) as Medical Devices for Facelift, Wrinkle Removal, Acupuncture... Compliance Policy Guide Sec. 393.200 Laser(s) as Medical Devices for Facelift, Wrinkle Removal, Acupuncture...

  14. Patient compliance with antihypertensive medication.

    PubMed Central

    Hershey, J C; Morton, B G; Davis, J B; Reichgott, M J

    1980-01-01

    Self-reported medication taking compliance behavior of 132 high blood pressure patients was analyzed using an expanded version of the health belief model. Subjects were selected through random sampling procedures from regular hypertension program sessions at a large urban hospital. A questionnaire was constructed to measure the model components, and interviews were conducted with each patient. Bivariate analysis showed that control over health matters, dependence on providers, perceived barriers, duration of treatment, and others' nonconfirming experience were significantly related to compliance (p < .05). Log-linear multivariate analysis revealed that three of these five variables--control over health matters, perceived barriers, and duration of treatment--contributed independently to patient compliance. Self-reported medication taking was significantly related to blood pressure control (p < .02). These data provide the basis for developing interventions for providers to facilitate the medication taking behavior of clinic patients. PMID:7416325

  15. Teaching Medical Students about Treatment Compliance

    ERIC Educational Resources Information Center

    Blackwell, Barry; And Others

    1978-01-01

    To demonstrate poor patient compliance, medical students who preregistered for a conference on patient compliance were asked to adopt the role of "patient" and to take "medication" (Vitamin C) for one week, to observe certain dietary restrictions, and to complete an attitude and health beliefs questionnaire. Student attitudes resembled those of…

  16. Identification of factors involved in medication compliance: incorrect inhaler technique of asthma treatment leads to poor compliance

    PubMed Central

    Darbà, Josep; Ramírez, Gabriela; Sicras, Antoni; García-Bujalance, Laura; Torvinen, Saku; Sánchez-de la Rosa, Rainel

    2016-01-01

    Objective To identify the impact of delivery device of inhaled corticosteroids and long-acting β2-agonist (ICS/LABA) on asthma medication compliance, and investigate other factors associated with compliance. Materials and methods We conducted a retrospective and multicenter study based on a review of medical registries of asthmatic patients treated with ICS/LABA combinations (n=2,213) whose medical devices were either dry powder inhalers (DPIs, such as Accuhaler®, Turbuhaler®, and NEXThaler®) or pressurized metered-dose inhalers (pMDI). Medication compliance included persistence outcomes through 18 months and medication possession ratios. Data on potential confounders of treatment compliance such as asthma exacerbations, comorbidities, demographic characteristics, and health care resource utilization were also explored. Results The probability of asthma medication compliance in case of DPIs was lower compared to pMDIs, which suggests that inhaler devices influence inhalation therapies. There were additional confounding factors that were considered as explanatory variables of compliance. A worse measure of airflow obstruction (forced expiration volume in 1 second), comorbidities and general practitioner (GP) consultations more than once per month decreased the probability of compliance. Within comorbidities, alcoholism was positively associated with compliance. Patients of 29–39, 40–50, and 51–61 age groups or suffering from more than two exacerbations during the study period were more likely to comply with their medication regime. The effects of DPIs toward compliance varied with the different DPIs. For instance, Accuhaler® had a greater negative effect on compliance compared to Turbuhaler® and Nexthaler® in cases of patients who suffered exacerbations. We found that GP consultations reduced the probability of medication compliance for patients treated with formoterol/budesonide combination. For retired patients, visiting the GP increased the

  17. A Study of Medication Compliance in Geriatric Patients with Chronic Illnesses at a Tertiary Care Hospital

    PubMed Central

    Shruthi, R.; Pundarikaksha, H.P.; Nagesh, G.N.; Tushar, T.J.

    2016-01-01

    Introduction Geriatric population is more prone for various chronic and recurrent illnesses like diabetes mellitus, hypertension, IHD, arthritic, neurodegenerative, gastrointestinal, ocular, genitourinary, respiratory disorders etc., which may require chronic medication with multiple drugs. Poor compliance in this age group accounts for medication wastage with increased cost of healthcare and substantial worsening of the disease with disability or death. Most of the human and economic costs associated with non adherence can be avoided by improving medication adherence. Aim To assess the level of medication compliance in elderly patients with chronic illnesses and to analyse the factors influencing medication compliance. Materials and Methods The study subjects were assessed by using twenty item structured questionnaires as per modified Morisky Medication Adherence Scale (MMAS). Results A total of 251 subjects of geriatric age group with chronic illnesses were assessed for the level of compliance for long term medications. The average number of medications 2.96±1.42 per subject and most of the subjects were receiving FDCs. The compliance level was assessed by way of interview using a twenty item structured pretested questionnaire as per modified MMAS. The level of compliance was good in 45.41%, moderate in 35.45% and poor in 19.12% of the study subjects. Conclusion The level of compliance positively correlated with the educational status of the study subjects and their awareness about the diseases and prescribed medications. The overall level of compliance was higher in subjects living with spouse or families, subjects without any functional impairment, subjects who were regular for the follow-up visits and also in subjects who did not experience any adverse events. PMID:28208878

  18. Medicated chewing gum, a novel drug delivery system

    PubMed Central

    Aslani, Abolfazl; Rostami, Farnaz

    2015-01-01

    New formulations and technologies have been developed through oral drug delivery systems’ researches. Such researches display significance of oral route amongst patients. We’ve reviewed all the features associated with medicated chewing gum as a modern drug delivery by introducing the history, advantages and disadvantages, methods of manufacturing, composition differences, evaluation tests and examples of varieties of medicated chewing gums. Acceptance of medicated chewing gum has been augmented through years. The advantages and therapeutic benefits of chewing gum support its development as we can see new formulations with new drugs contained have been produced from past and are going to find a place in market by formulation of new medicated chewing gums. Potential applications of medicated chewing gums are highly widespread as they will be recognized in future. Nowadays standards for qualifying chewing gums are the same as tablets. Patient-centered studies include medicated chewing gums as a delivery system too which creates compliance for patients. PMID:26109999

  19. [Patient compliance with inhaled medication approach in community pharmacy].

    PubMed

    Maesschalck, J; Duquet, N

    2012-03-01

    Non compliance with chronic administration of inhaled medication is a great pitfall. Pharmacists have an important task in optimizing patient compliance since they hold several advantages for that purpose: they possess an overview of the patient's medication, even prescription free medication such as cough medicines. Moreover, the pharmacist is capable of explaining the role of the medication in therapy and he enjoys the patient's confidence to do so. This article highlights some strategies to measure patient compliance and seeks to understand the underlying reasons for non-compliance. The appropriate pharmacist's action will depend on that reason.

  20. Multi-compartment medication devices and patient compliance.

    PubMed

    McGraw, Caroline

    2004-07-01

    Multi-compartment medication compliance devices are widely used in primary care. The aim of this review is to reveal whether they are effective in promoting adherence among non-adherent adults living at home. Searches were undertaken using two electronic databases (Medline (1966-2003) and International Pharmaceutical Abstracts (1970-2002)). Only randomized controlled trials (including crossover studies) were included in the review. Participants had to be non-institutionalized adults receiving one or more prescription medicines each day and displaying problems with adherence. Studies had to compare multi-compartment medication compliance devices to standard packaging and outcome measures and to include either pill counts, biological assays and/or clinical response. Articles were selected if they described a follow up period of at least three months and demonstrated that over 80% of participants had completed the trial. Two studies were identified that met the criteria, reporting data on a total of 148 patients. The findings from the first study found diabetic patients receiving medication in a compliance device demonstrated better glucose control than patients receiving medication in standard packaging. The second study found compliance devices had no impact on blood pressure control in hypertensive patients. Further research needs to be conducted to assess the effectiveness of multi-compartment medication compliance devices in promoting adherence among non-adherent adults living at home.

  1. Patient compliance with drug therapy in schizophrenia. Economic and clinical issues.

    PubMed

    Lindström, E; Bingefors, K

    2000-08-01

    The effectiveness of drug treatment in clinical practice is considerably lower than the efficacy shown in controlled studies. The lower effectiveness in practice presumably leads to lower cost effectiveness of drug treatment in real-life situations compared with that demonstrated by studies based on results from controlled trials. Improved cost effectiveness in routine clinical practice would be a significant advantage in the treatment of schizophrenia, one of the most costly diseases in society. The aetiology of schizophrenia is unknown, and there is no cure. The main aims of therapy with antipsychotic medication include the effective relief of symptoms without the introduction of adverse effects or serious adverse events, improved quality of life, cost effectiveness and a positive long term outcome. The older classical antipsychotic drugs do not always meet these requirements because of their well-known limitations, such as a lack of response in a subgroup of individuals with schizophrenia and intolerable adverse effects. There has long been a need for new antipsychotics that can ameliorate more symptoms and have no or few adverse effects. Some of the recently introduced antipsychotics have been shown to be more effective in certain clinical situations and to have a more favourable adverse effect profile than the classical antipsychotics. A major factor contributing to the lower effectiveness of drug treatment is noncompliance, which may be very high in schizophrenia. There are several factors influencing compliance, including drug type and formulation, patient, disease status, physician, health care system, community care and family. There have been very few studies of compliance improvement strategies in schizophrenia or, indeed, in medicine in general. Current methods are relatively complex and there are differing opinions on their effectiveness. There are several ways to increase compliance in schizophrenia--the evidence is strongest for psychoeducative

  2. Role of illness perceptions and medication beliefs on medication compliance of elderly hypertensive cohorts.

    PubMed

    Rajpura, Jigar R; Nayak, Rajesh

    2014-02-01

    Poor compliance with antihypertensive medications is one possible reason why its success in clinical trials has not been translated into everyday practice. In addition, medication noncompliance in elderly leads to increased hospitalizations, physician visits, and higher health care costs. The study assessed influence of illness perceptions and medications beliefs on medication compliance of elderly hypertensive cohorts. A cross-sectional survey research design, utilizing self-administered health surveys, was adapted to address key study objectives. Conceptualized associations among the study variables were explored to assess their individual as well as their collective impact on the medication compliance. A total of 78 (66%) study samples were found to be noncompliant with their medications. Analysis revealed that perceptions about illness and beliefs about medication jointly played a significant role in the prediction of medication compliance (F = 5.966, P < .05; R (2) = .212). Significant bivariate correlations were observed between Morisky's test score versus Brief Illness Perception Questionnaire measure (r = .332, P = .001), Beliefs of Medication Questionnaire (BMQ) differential score (r = .301, P = .001), and BMQ components, such as specific necessity (r = .250, P = .008), specific concern (r = -.231, P = .001), and general overuse (r = -.342, P = .001). The findings provide practical basis for designing interventions and programs aimed at compliance building in elderly populations having hypertension by incorporating the value and importance of patient perceptions of illness and medications in order to achieve desired patient outcomes.

  3. Improving admission medication reconciliation compliance using the electronic tool in admitted medical patients.

    PubMed

    Taha, Haytham; Abdulhay, Dana; Luqman, Neama; Ellahham, Samer

    2016-01-01

    Sheikh Khalifa Medical City (SKMC) in Abu Dhabi is the main tertiary care referral hospital in the United Arab Emirates (UAE) with 560 bed capacity that is fully occupied most of the time. SKMC senior management has made a commitment to make quality and patient safety a top priority. Our governing body Abu Dhabi Health Services Company has identified medication reconciliation as a critical patient safety measure and key performance indicator (KPI). The medication reconciliation electronic form a computerized decision support tool was introduced to improve medication reconciliation compliance on transition of care at admission, transfer and discharge of patients both in the inpatient and outpatient settings. In order to improve medication reconciliation compliance a multidisciplinary task force team was formed and led this quality improvement project. The purpose of this publication is to indicate the quality improvement interventions implemented to enhance compliance with admission medication reconciliation and the outcomes of those interventions. We chose to conduct the pilot study in general medicine as it is the busiest department in the hospital, with an average of 390 patients admitted per month during the study period. The study period was from April 2014 till October 2015 and a total of 8576 patients were evaluated. The lessons learned were disseminated throughout the hospital. Our aim was to improve admission medication reconciliation compliance using the electronic form in order to ensure patient safety and reduce preventable harm in terms of medication errors. Admission medication reconciliation compliance improved in general medicine from 40% to above 85%, and this improvement was sustained for the last four months of the study period.

  4. Disease management and medication compliance.

    PubMed

    Cohen, Joshua; Christensen, Kathyrn; Feldman, Lanna

    2012-02-01

    Lack of medication compliance is harmful to health care systems from both a clinical and economic perspective. This study examines the methods that disease management organizations employ to identify nonadherent patients and to measure effectiveness of compliance programs for patients with diabetes, hyperlipidemia, and cystic fibrosis. In addition, this study investigates the degree to which disease managers assume risk in their contracts, and whether compliance strategies are being coordinated with payers' use of value-based insurance design, in which patient cost sharing is a function of the relative value of pharmaceuticals. This study's findings suggest that disease management may be falling short in terms of: (a) comprehensive commitment to expert-recommended at-home devices used to self-diagnose and measure health indicators; (b) early adoption of expert-recommended new technologies to measure and improve compliance; (c) intensity of use of standard tests in outpatient clinics; (d) coordination of compliance strategies with payers' use of value-based insurance design; and (e) the proportion of risk assumed in disease management contracts.

  5. Therapeutic drug monitoring of psychotropic medications

    PubMed Central

    Mitchell, Philip B

    2000-01-01

    Therapeutic drug monitoring (TDM) of a number of psychotropic medications has proven to be of value, enabling minimization of the limitations of considerable genetic variability in their metabolism and the high rates of poor compliance with many psychiatric disorders. Therapeutic ranges have been established for lithium, some of the tricyclic antidepressants, and clozapine. TDM has also been shown to be useful in avoiding toxicity (as many psychotropics have narrow therapeutic indices), particularly that due to interactions with other compounds. PMID:10759685

  6. Systematic Evaluation of “Compliance” to Prescribed Treatment Medications and “Abstinence” from Psychoactive Drug Abuse in Chemical Dependence Programs: Data from the Comprehensive Analysis of Reported Drugs

    PubMed Central

    2014-01-01

    This is the first quantitative analysis of data from urine drug tests for compliance to treatment medications and abstinence from drug abuse across “levels of care” in six eastern states of America. Comprehensive Analysis of Reported Drugs (CARD) data was used in this post-hoc retrospective observational study from 10,570 patients, filtered to include a total of 2,919 patients prescribed at least one treatment medication during 2010 and 2011. The first and last urine samples (5,838 specimens) were analyzed; compliance to treatment medications and abstinence from drugs of abuse supported treatment effectiveness for many. Compared to non-compliant patients, compliant patients were marginally less likely to abuse opioids, cannabinoids, and ethanol during treatment although more likely to abuse benzodiazepines. Almost 17% of the non-abstinent patients used benzodiazepines, 15% used opiates, and 10% used cocaine during treatment. Compliance was significantly higher in residential than in the non-residential treatment facilities. Independent of level of care, 67.2% of the patients (n = 1963; P<.001) had every treatment medication found in both first and last urine specimens (compliance). In addition, 39.2% of the patients (n = 1143; P<.001) had no substance of abuse detected in either the first or last urine samples (abstinence). Moreover, in 2010, 16.9% of the patients (n = 57) were abstinent at first but not at last urine (deteriorating abstinence), the percentage dropped to 13.3% (n = 174) in 2011; this improvement over years was statistically significant. A longitudinal analysis for abstinence and compliance was studied in a randomized subset from 2011, (n = 511) representing 17.5% of the total cohort. A statistically significant upward trend (p = 2.353×10−8) of abstinence rates as well as a similar but stronger trend for compliance ((p = 2.200×10−16) was found. Being cognizant of the trend toward drug urine testing being linked

  7. [Knowledge, attitudes, and behaviour of the population of the Czech Republic to self-medication. III: behaviour in the area of drugs and self-medication].

    PubMed

    Drhová, L

    2005-09-01

    A large survey carried out from June to September 2002 in the territory of the Czech Republic found and analyzed the knowledge of the population of the Czech Republic in relation to self-medication and o-t-c drugs and revealed the main problematic areas from the viewpoint of the public. The survey was particularly focused on the behaviour of people in relation to packaging of OTC drugs and drug information sheets, expiration period of medicaments-advertisements for OTC drugs in the media, most frequently selected indications for self-medication, self-medication in small children, financial participation in self-medication and the resultant compliance or non-compliance, and the price of the OTC drug and dosage. The results show that 68% of respondents are able to take a medicine after its expiration period. An o-t-c drug would be bought just on the basis of television advertising by 7% of respondents, and more than a half of the respondents (57%) stated they would first consult their physician or pharmacist. In the case of a sudden ailment of a one-year-old child, 80% of respondents stated that they would contact the physician, 8% opted for self-medication. Under the assumption that an OTC drug is covered by health insurance, 27% of respondents would go to the physician, though they could buy it themselves.

  8. Using Candy to Teach Counselors to Teach Clients about Medication Compliance

    ERIC Educational Resources Information Center

    Shaffer, Tammy

    2009-01-01

    Schizophrenia and other serious mental illness hinder medication compliance. Clinicians are often challenged to increase clients' medication compliance, but lack the tools to enhance consistent treatment compliance. Counselor educators enhance their course instruction by offering a specific counseling tool to students. Those working directly with…

  9. Medicated chewing gum--a potential drug delivery system.

    PubMed

    Chaudhary, Shivang A; Shahiwala, Aliasgar F

    2010-07-01

    Over the years, patient convenience and patient compliance-orientated research in the field of drug delivery has resulted in bringing out potential innovative drug delivery options. Out of which, medicated chewing gum (MCG) offers a highly convenient patient-compliant way of dosing medications, not only for special population groups with swallowing difficulties such as children and the elderly, but also for the general population, including the young generation. In this review, various formulation ingredients, different manufacturing processes, and assessment of in vivo and in vitro drug release from MCG are thoroughly discussed along with the therapeutic potential and limitations of MCG. Readers will gain knowledge about the rationale and prominent formulation and performance evaluation strategies behind chewing gum as a drug delivery system. The availability of directly compressible co-processed gum material enables rapid, safe and low-cost development of MCG as a drug delivery option. By MCG formulation, revitalization of old products and reformulation of new patented products is possible, to differentiate them from upcoming generics competition in the market.

  10. Teachers' Drug Reference: A Guide to Medical Conditions and Drugs Commonly Used in School-Aged Children.

    ERIC Educational Resources Information Center

    Agins, Alan P.

    This book provides a guide to approximately 175 drugs used with children. An introduction precedes the three major sections of the guide. Section 1 provides an overview of pharmacology and therapeutics in chapters on the basics of pharmacology, the language of pharmacology and therapeutics, compliance, side effects, and medications in school.…

  11. Parent & Educators' Drug Reference: A Guide to Common Medical Conditions & Drugs Used in School-Aged Children.

    ERIC Educational Resources Information Center

    Agins, Alan P.

    This book provides a guide to more than 180 drugs used for children. An introduction precedes the four major sections of the guide. Section 1 provides an overview of pharmacology and therapeutics in chapters on the basics of pharmacology, the language of pharmacology and therapeutics, compliance, side effects, medications in school, and drug…

  12. Evidence for compliance with long-term medication: a systematic review of randomised controlled trials.

    PubMed

    King, Michelle A; Pryce, Rebecca L

    2014-02-01

    Pharmacists play a pivotal role in optimising medication use which often includes actions to maximise compliance with long-term medication. The best evidence to support medication use is derived from randomised controlled trials (RCTs). It is often assumed that 100 % compliance is required to obtain the outcomes identified in the trial. This assumption needs to be examined. To systematically review the reporting of compliance in RCTs of long-term medications. RCTs published in the New England Journal of Medicine, Journal of the American Medical Association, Lancet and BMJ in 2012, were reviewed to identify trials of medications for long-term use in adults. These trials were examined to evaluate the reporting of compliance. The proportion of trials reporting compliance data, the methods used, and the proportion of trials using more than one method to determine compliance. Of the 289 RCTs published in 2012, 25 assessed long-term medications in adults. Compliance was reported in 12 (48 %) studies and only 2 (8 %) studies used more than one method to measure compliance. Pill count was the most commonly reported method for measuring compliance, with patient reports and blood levels also being used. The reporting of compliance in RCTs is poor and the methodology inconsistent. The methods used overestimate compliance. If compliance in a clinical trial is low, the evidence for the effectiveness and most importantly safety of the medication(s) is questionable. Two or more methods, one of which is standardised, should be used to measure compliance in clinical trials. The requirement to report compliance should be included in publication guidelines.

  13. Population pharmacokinetic model of lithium and drug compliance assessment.

    PubMed

    Pérez-Castelló, Isabel; Mangas-Sanjuan, Víctor; González-García, Ignacio; Gonzalez-Alvarez, Isabel; Bermejo, Marival; Marco-Garbayo, Jose Luis; Trocóniz, Iñaki F

    2016-12-01

    Population pharmacokinetic analysis of lithium during therapeutic drug monitoring and drug compliance assessment was performed in 54 patients and 246 plasma concentrations levels were included in this study. Patients received several treatment cycles (1-9) and one plasma concentration measurement for each patient was obtained always before starting next cycle (pre-dose) at steady state. Data were analysed using the population approach with NONMEM version 7.2. Lithium measurements were described using a two-compartment model (CL/F=0.41Lh -1 , V 1 /F=15.3L, Q/F=0.61Lh -1 , and V 2 /F = 15.8L) and the most significant covariate on lithium CL was found to be creatinine clearance (reference model). Lithium compliance was analysed using inter-occasion variability or Markovian features (previous lithium measurement as ordered categorical covariate) on bioavailability parameter. Markov-type model predicted the lithium compliance in the next cycle with higher success rate (79.8%) compared to IOV model (65.2%) and reference model (43.2%). This model becomes an efficient tool, not only being able to adequately describe the observed outcome, but also to predict the individual drug compliance in the next cycle. Therefore, Bipolar disorder patients can be classified regarding their probability to become extensive or poor compliers in the next cycle and then, individual probabilities lower than 0.5 highlight the need of intensive monitoring, as well as other pharmaceutical care measurements that might be applied to enhance drug compliance for a better and safer lithium treatment. Copyright © 2016 Elsevier B.V. and ECNP. All rights reserved.

  14. 27 CFR 17.136 - Compliance with Food and Drug Administration requirements.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 1 2010-04-01 2010-04-01 false Compliance with Food and Drug Administration requirements. 17.136 Section 17.136 Alcohol, Tobacco Products and Firearms ALCOHOL... Compliance with Food and Drug Administration requirements. A product is not a medicine, medicinal preparation...

  15. Pharmaceutic factors affecting pediatric compliance.

    PubMed

    Mattar, M E; Markello, J; Yaffe, S J

    1975-01-01

    Evaluation of treatment given at home was studied in children with otitis media who were seen in an outpatient clinic. Full compliance was present in only 5% of the initial 100 patients (Study A). Practical factors limiting their compliance included inadequate dispensing of medication at drug stores, 15%; incorrect therapy schedule, 36%; early termination, 37%; spilled medicine, 7%; therapy shared, 5%. Because of these findings, a plan was implemented (Study B) in which hospital pharmacy personnel gave patient families verbal and written instructions for administering medications that were dispensed, together with a calibrated measuring device and a calendar to record doses taken. Full compliance was raised to 51% in this pilot group (of 33 patients) as compared with 8.5% in 20 concurrent controls who went to neighborhood drug stores. The importance of detailed therapy instructions is stressed. The potential role of the pharmacist in improving compliance is demonstrated.

  16. Compliance with medical regimens during adolescence.

    PubMed

    Litt, I F; Cuskey, W R

    1980-02-01

    In summary, compliance behavior among adolescents is complex and imcompletely understood. Although the study of compliance is important for understanding the adolescent's stage of psychological development, relationships with authority figures, and the beginning of the youngster's career as a consumer of health care, its ultimate importance lies in the prospect of improving the likelihood that medication will be utilized appropriately. The first step in the process involves systematic monitoring of compliance rather than doing so only when noncompliance is clinically suspected. When compliance is found to be problematic for an adolescent, resorting to "scare" techniques or re-education is rarely effective. A more positive outcome may be achieved by determining the circumstances under which the youngster was successful in complying and attempting to tailor-make the regimen accordingly. Barriers to compliance, such as the presence of side effects, previous negative experience with the medicine, and lack of conviction about the diagnosis of appropriateness of therapy, should always be explored. Other potential intervention strategies for improving compliance have been discussed. In the final analysis, however, as Jonson has noted, all strategies aimed at improving compliance must provide the patient with insight into his own situation and himself, as well as his capability of doing something other than conforming when he judges it best.

  17. Increased medication compliance of liver transplant patients switched from a twice-daily to a once-daily tacrolimus-based immunosuppressive regimen.

    PubMed

    Eberlin, M; Otto, G; Krämer, I

    2013-01-01

    Compliance with immunosuppressive therapy plays a major role in the long-term success of liver transplantation. Thus, the development of strategies to promote compliance of liver transplant patients and its evaluation over time are of particular interest. The main objective of this study was to compare medication compliance rates among liver transplant patients over time after transplantation where switched from a twice- to once-daily tacrolimus-based regimen. Sixty-five liver transplant patients being administered tacrolimus-based therapy were classified into three subgroups with regard to time posttransplantation. Medication compliance with tacrolimus-based therapy was measured using an electronic medication event monitoring system over a 12-month period: for 6 months tacrolimus was administered twice-daily and for 6 months, once-daily. Dosing, taking, and timing compliance as well as drug holidays were compared intra-individually between twice- and once-daily intake and among the three subgroups. In addition, patient compliance and quality of life were evaluated using questionnaires. A per protocol analysis of electronically obtained data showed 63 patients to be eligible. The resulting dosing, taking, and timing compliance rates of the patients were higher during the once-daily dosing period. No significant differences in compliance rates with tacrolimus therapy were observed among three subgroups independent of the dosing regimen. More patients failed the correct timing of the evening compared to the morning dose. Missing doses occurred particularly during weekends. Compliance variables measured by questionnaires (Morisky score, self-report, Medication Experience Scale for Immunosuppressants (MESI) score) and the Hospital Anxiety and Depression Scale score were similar in the two dosing periods. The short-form health survey (SF-36) score was higher with once-daily intake. The high measured compliance rates did not vary significantly dependent upon the time

  18. Medical management of primary open-angle glaucoma: Best practices associated with enhanced patient compliance and persistency.

    PubMed

    Kulkarni, Sadhana V; Damji, Karim F; Buys, Yvonne M

    2008-02-02

    Primary open angle glaucoma is a chronic optic neuropathy often requiring lifelong treatment. Patient compliance, adherence and persistence with therapy play a vital role in improved outcomes by reducing morbidity and the economic consequences that are associated with disease progression. A literature review including searches of The Cochrane Library, MEDLINE, PubMed, conference proceedings, and bibliographies of identified articles reveals the enormous public health burden in various populations due to the impact of glaucoma associated visual impairment on the overall quality of life eg, fear of blindness, inability to work in certain occupations, driving restrictions, motor vehicle accidents, falls, and general health status. Providing specific definitions for the frequently misunderstood terms "compliance, persistence and adherence" with reference to medication use is central not only for monitoring patients' drug dosing histories and clinical outcomes but also for subsequent research. In this review article, a summary of the advantages/disadvantages including cost-effectiveness of various medical approaches to glaucoma treatment, techniques employed for measuring patient compliance and actual patient preferences for therapy are outlined. We conclude by identifying the key barriers to ongoing treatment and suggest some best practices to enhance compliance and persistence.

  19. Medical management of primary open-angle glaucoma: Best practices associated with enhanced patient compliance and persistency

    PubMed Central

    Kulkarni, Sadhana V; Damji, Karim F; Buys, Yvonne M

    2008-01-01

    Primary open angle glaucoma is a chronic optic neuropathy often requiring lifelong treatment. Patient compliance, adherence and persistence with therapy play a vital role in improved outcomes by reducing morbidity and the economic consequences that are associated with disease progression. A literature review including searches of The Cochrane Library, MEDLINE, PubMed, conference proceedings, and bibliographies of identified articles reveals the enormous public health burden in various populations due to the impact of glaucoma associated visual impairment on the overall quality of life eg, fear of blindness, inability to work in certain occupations, driving restrictions, motor vehicle accidents, falls, and general health status. Providing specific definitions for the frequently misunderstood terms “compliance, persistence and adherence” with reference to medication use is central not only for monitoring patients’ drug dosing histories and clinical outcomes but also for subsequent research. In this review article, a summary of the advantages/disadvantages including cost-effectiveness of various medical approaches to glaucoma treatment, techniques employed for measuring patient compliance and actual patient preferences for therapy are outlined. We conclude by identifying the key barriers to ongoing treatment and suggest some best practices to enhance compliance and persistence. PMID:19920977

  20. Non-compliance with pharmacotherapy of depression is associated with a sensation seeking personality.

    PubMed

    Ekselius, L; Bengtsson, F; von Knorring, L

    2000-09-01

    Inadequate compliance of drug intake is an important cause of ineffective pharmacotherapy and has been associated with therapeutic failure. We hypothesized that sensation seeking personality traits would affect compliance with long-term antidepressant medication. Three hundred and eight depressed patients participating in a randomized double-blind study of sertraline and citalopram were included. Personality traits were assessed using the Karolinska Scales of Personality. Compliance to medication was determined in two ways, by means of tablet counting and by measurement concentration of drug in serum. Tablet non-compliance was defined as less than 80% or more than 100% intake of the prescribed drug during weeks 20-24. Serum drug non-compliance was defined as undetectable amounts of either drug and main metabolite in the serum samples at week 24. Two virtually not overlapping groups of non-compliant patients were identified, where those regarded as non-compliant due to the interpretation of the serum drug levels were in majority. The group of serum drug non-compliant patients were recognized by significantly higher scores on the Monotony Avoidance scale and the Impulsive Sensation Seeking Psychopathy factor. The need for better methods than tablet counting and patient questioning to ascertain compliance is emphasized.

  1. Medical compliance to evidence-based clinical guidelines on secondary prevention of coronary heart disease in a hospital from Lima, Peru: a retrospective study.

    PubMed

    Castañeda-Amado, Zaira; Calixto-Aguilar, Lesly; Loza Munarriz, César; Medina Palomino, Félix A

    2017-06-29

    Cardiovascular disease is the leading cause of mortality worldwide. When an acute myocardial infarction occurs, it is necessary to establish secondary prevention measures, which can reduce mortality by 50%. Clinical guidelines state that the optimal medical treatment is based upon four groups of drugs: antiplatelet drugs, statins, beta-blockers and angiotensin-converting-enzyme inhibitor or angiotensin II receptor antagonist. To determine physician compliance to evidence-based clinical practice guidelines on secondary prevention of coronary heart disease. Retrospective, observational study in Hospital Cayetano Heredia in Lima, Peru. The study included patients with confirmed acute coronary syndrome from February 2011 to February 2013. Medical records, laboratory results and medical therapy at discharge were collected and were compared to the American Heart Association type I, evidence level A recommendations. In addition, patient follow-up visits to the outpatient cardiology clinic at 1, 3 and 6 months after discharge were analyzed. The study population included 143 patients. Eighty-nine (89) patients were admitted with the diagnosis of unstable angina and non-ST-segment elevation (62.2%) and 54 had ST-segment elevation myocardial infarction (37.8%). Forty patients (28%) received all four recommended medications at discharge, which decreased at 1, 3 and 6 months after discharge to 12.6%, 7% and 3.5% respectively. The results showed a significant reduction in patient compliance to follow-up visits with a 48% reduction at the first visit to 10% on the last visit. Medical compliance to guidelines recommendations in secondary cardiovascular prevention is suboptimal with a compliance score under 50%.

  2. The need of adequate information to achieve total compliance of mass drug administration in Pekalongan

    NASA Astrophysics Data System (ADS)

    Ginandjar, Praba; Saraswati, Lintang Dian; Taufik, Opik; Nurjazuli; Widjanarko, Bagoes

    2017-02-01

    World Health Organization (WHO) initiated The Global Program to Eliminate Lymphatic Filariasis (LF) through mass drug administration (MDA). Pekalongan started MDA in 2011. Yet the LF prevalence in 2015 remained exceed the threshold (1%). This study aimed to describe the inhibiting factors related to the compliance of MDA in community level. This was a rapid survey with cross sectional approach. A two-stages random sampling was used in this study. In the first stage, 25 clusters were randomly selected from 27 villages with proportionate to population size (PPS) methods (C-Survey). In the second stage, 10 subjects were randomly selected from each cluster. Subject consisted of 250 respondents from 25 selected clusters. Variables consisted of MDA coverage, practice of taking medication during MDA, enabling and inhibiting factors to MDA in community level. The results showed most respondents had poor knowledge on filariasis, which influence awareness of the disease. Health-illness perception, did not receive the drugs, lactation, side effect, and size of the drugs were dominant factors of non-compliance to MDA. MDA information and community empowerment were needed to improve MDA coverage. Further study to explore the appropriate model of socialization will support the success of MDA program

  3. Lower Cutoffs for LC-MS/MS Urine Drug Testing Indicates Better Patient Compliance.

    PubMed

    Krock, Kevin; Pesce, Amadeo; Ritz, Dennis; Thomas, Richard; Cua, Agnes; Rogers, Ryan; Lipnick, Phil; Kilbourn, Kristen

    2017-11-01

    Urine drug testing is used by health care providers to determine a patient's compliance to their prescribed regimen and to detect non-prescribed medications and illicit drugs. However, the cutoff levels used by clinical labs are often arbitrarily set and may not reflect the urine drug concentrations of compliant patients. Our aim was to test the hypothesis that commonly used cutoffs for many prescribed and illicit drugs were set too high, and methods using these cutoffs may yield a considerable number of false-negative results. The goals of this study were to outline the way to analyze patient results and estimate a more appropriate cutoff, develop and validate a high sensitivity analytical method capable of quantitating drugs and metabolites at lower than the commonly used cutoffs, and determine the number of true positive results that would have been missed when using the common cutoffs. This was a retrospective study of urine specimens submitted for urine drug testing as part of the monitoring of prescription drug compliance described in chronic opioid therapy treatment guidelines. The study was set in a clinical toxicology laboratory, using specimens submitted for routine analysis by health care providers in the normal course of business. Lognormal distributions of test results were generated and fitted with a trendline to estimate the required cutoff level necessary to capture the normal distributions of each drug for the patient population study. A validated laboratory derived liquid chromatography tandem mass spectrometry (LC-MS/MS) analysis capable of achieving the required cutoff levels was developed for each drug and/or metabolite. The study shows that a lognormal distribution of patient urine test results fitted with a trendline is appropriate for estimating the required cutoff levels needed to assess medication adherence. The study showed a wide variation in the false-negative rate, ranging from 1.5% to 94.3% across a range of prescribed and illicit

  4. Medication/Drug Allergy

    MedlinePlus

    ... Training Home Conditions Medication/Drug Allergy Medication/Drug Allergy Make an Appointment Find a Doctor Ask a ... risk for adverse reactions to medications. Facts about Allergies The tendency to develop allergies may be inherited. ...

  5. Serum potassium monitoring for users of ethinyl estradiol/drospirenone taking medications predisposing to hyperkalemia: physician compliance and survey of knowledge and attitudes.

    PubMed

    Mona Eng, Patricia; Seeger, John D; Loughlin, Jeanne; Oh, Kelly; Walker, Alexander M

    2007-02-01

    Yasmin-28 [ethinyl estradiol 0.03 mg/drospirenone 3 mg (EE/DRSP)] contains drospirenone, a progestin component that possesses antimineralocorticoid activity with a potassium-sparing diuretic effect similar to that in spironolactone. Product labeling recommends potassium monitoring in the first month of use for women concurrently receiving medication that may increase serum potassium. We evaluated compliance with this recommendation by measuring monitoring around the date of oral contraceptive (OC) initiation in women who received EE/DRSP while being treated with medications predisposing to hyperkalemia and in similar women who received other OCs. Because preliminary analyses indicated incomplete compliance, we surveyed physicians who prescribed EE/DRSP to women receiving drugs predisposing to hyperkalemia on their knowledge and attitudes with regard to the recommendation. We conducted this study using data from the Ingenix Research Datamart, which includes insurance claims for reimbursement for medical services and prescription medications for approximately 8,000,000 members of a large nationally dispersed health plan. We used claims for pharmacy dispensings of prescription medications to identify all women aged 10-59 years old who initiated EE/DRSP or other OCs during the first 3 years of EE/DRSP availability (July 2001 to June 2004). The frequency of potassium monitoring was measured by identifying claims for serum potassium tests. We conducted a telephone survey of 58 physicians who had prescribed EE/DRSP up to June 2003 to women who received concomitant hyperkalemic drugs. Although potassium monitoring was generally more frequent among EE/DRSP initiators receiving concomitant hyperkalemic drugs than among other OC initiators receiving similar medications, only 40% of 466 EE/DRSP initiators with concurrent hyperkalemic treatment had potassium tests. More than 98% of surveyed physicians were aware of the potassium-sparing property of EE/DRSP. Compared with

  6. Development and Application of Direct Data Capture for Monitoring Medication Compliance in Clinical Trials.

    PubMed

    Kim, Eun-Young

    2017-10-01

    The monitoring of medication compliance in clinical trials is important but labor intensive. To check medication compliance in clinical trials, a system was developed, and its technical feasibility evaluated. The system consisted of three parts: a management part (clinical trial center database and a developed program), clinical trial investigator part (monitoring), and clinical trial participant part (personal digital assistant [PDA] with a barcode scanner). The system was tested with 20 participants for 2 weeks, and compliance was evaluated. This study developed a medication compliance monitoring system that used a PDA with a barcode scanner, which sent reminder/warning messages, logged medication barcode data, and provided compliance information to investigators. Registered participants received short message service (SMS) reminder/warning messages on their PDA and sent barcode data at the dosing time. The age range of the participants was 29 to 73 years. Five participants were <50 years old and 8 were ≥65 years old. The total mean compliance rate was 82.3%. The mean compliance rate was 83.1% in participants <65 years old and 81.1% in those ≥65 years old. The system was feasible, usable, and effective, even with elderly participants, for monitoring medication compliance in clinical trials using a PDA with a barcode scanner, and may improve the quality of clinical trials.

  7. A comparison of medication administration errors from original medication packaging and multi-compartment compliance aids in care homes: A prospective observational study.

    PubMed

    Gilmartin-Thomas, Julia Fiona-Maree; Smith, Felicity; Wolfe, Rory; Jani, Yogini

    2017-07-01

    No published study has been specifically designed to compare medication administration errors between original medication packaging and multi-compartment compliance aids in care homes, using direct observation. Compare the effect of original medication packaging and multi-compartment compliance aids on medication administration accuracy. Prospective observational. Ten Greater London care homes. Nurses and carers administering medications. Between October 2014 and June 2015, a pharmacist researcher directly observed solid, orally administered medications in tablet or capsule form at ten purposively sampled care homes (five only used original medication packaging and five used both multi-compartment compliance aids and original medication packaging). The medication administration error rate was calculated as the number of observed doses administered (or omitted) in error according to medication administration records, compared to the opportunities for error (total number of observed doses plus omitted doses). Over 108.4h, 41 different staff (35 nurses, 6 carers) were observed to administer medications to 823 residents during 90 medication administration rounds. A total of 2452 medication doses were observed (1385 from original medication packaging, 1067 from multi-compartment compliance aids). One hundred and seventy eight medication administration errors were identified from 2493 opportunities for error (7.1% overall medication administration error rate). A greater medication administration error rate was seen for original medication packaging than multi-compartment compliance aids (9.3% and 3.1% respectively, risk ratio (RR)=3.9, 95% confidence interval (CI) 2.4 to 6.1, p<0.001). Similar differences existed when comparing medication administration error rates between original medication packaging (from original medication packaging-only care homes) and multi-compartment compliance aids (RR=2.3, 95%CI 1.1 to 4.9, p=0.03), and between original medication packaging

  8. [Drug advertising and promotion: regulations and extent of compliance in five Latin American countries].

    PubMed

    Vacca, Claudia; Vargas, Claudia; Cañás, Martín; Reveiz, Ludovic

    2011-02-01

    To analyze differing regulations regarding drug promotion, and the extent of compliance as seen in samples of advertising directed to the public in Argentina, Colombia, Ecuador, Nicaragua, and Peru. A total of 683 pieces of promotional material on display in health facilities, pharmacies, and on the street were collected, 132 of which were randomly selected for analysis. The regulations governing pharmaceutical advertising, taken from official websites and interviews with regulatory officials and Ministry of Health staff in the five countries covered, were reviewed, along with their adherence to the ethical criteria of the World Health Organization (WHO). The contents of the materials in the sample were evaluated to determine their degree of compliance with national regulations and WHO recommendations on drug promotion. The countries have regulations incorporating WHO ethical criteria. Over 80% of the material analyzed included the indications for the drug, while over 70% omitted information on adverse effects. Fifty percent of the advertisements for over-the-counter (OTC) drugs on display in pharmacies listed indications not approved by the relevant health authority. In advertising in pharmacies, the risks from inadequate information were not found to differ significantly for OTC or prescription medications. Compared with materials provided in health facilities, the relative risk of the absence of information on dosage in the material distributed in pharmacies was 2.08 (confidence interval 95% 1.32-3.39). Although regulations on drug promotion and advertising in the five countries studied generally incorporate the WHO recommendations, promotional materials often fail to reflect the fact.

  9. Compliance and Cognitive Function: A Methodological Approach to Measuring Unintentional Errors in Medication Compliance in the Elderly.

    ERIC Educational Resources Information Center

    Isaac, Lisa M.; And Others

    1993-01-01

    Assessed multiple aspects of cognitive performance, medication planning ability, and medication compliance in 20 elderly outpatients. Findings suggest that aspects of attention/concentration, visual and verbal memory, and motor function which are untapped by simple mental status assessment are related to medication access, planning, and compliance…

  10. The Effect of Compliance on the Impact of Mass Drug Administration for Elimination of Lymphatic Filariasis in Egypt

    PubMed Central

    El-Setouhy, Maged; Abd Elaziz, Khaled M.; Helmy, Hanan; Farid, Hoda A.; Kamal, Hussein A.; Ramzy, Reda M. R.; Shannon, William D.; Weil, Gary J.

    2008-01-01

    We studied effects of compliance on the impact of mass drug administration (MDA) with diethylcarbamazine and albendazole for lymphatic filariasis (LF) in an Egyptian village. Baseline microfilaremia (mf) and filarial antigenemia rates were 11.5% and 19.0%, respectively. The MDA compliance rates were excellent (> 85%). However, individual compliance was highly variable; 7.4% of those surveyed after five rounds of MDA denied having ever taken the medications and 52.4% reported that they had taken all five doses. The mf and antigenemia rates were 0.2% and 2.7% in those who reported five doses of MDA and 8.3% and 13.8% in those who reported zero doses. There was no significant difference in residual infection rates among those who had taken two or more doses. These results underscore the importance of compliance for LF elimination programs based on MDA and suggest that two ingested doses of MDA are as effective as five doses for reducing filariasis infection rates. PMID:18165524

  11. Drug use--problem in pregnancy.

    PubMed

    Durisova, A; Magulova, L

    2004-01-01

    The consumption of drugs during pregnancy considered as a specific medical problem. Drug consumption and drug compliance in pregnancy were analysed in our study. Structured questionnaire and data from mothers were used as principal sources for analysis. Consumption of drugs and compliance with therapy were evaluated in 331 pregnant women, 60% city and 40% rural population, of Region Nitra, Slovakia, after their child birth. Drug's use was confirmed in 75% of pregnant women. The consumption was significantly higher in the first and second pregnancy when compared to the females by in their third or further pregnancies. Medical prescription was the reason of drug use in 89% pregnant women. The number of prescribed drugs similarly as the total consumption was higher in the first and second pregnancies. We noted medical prescribing drug compliance in 70% pregnant women. 16% of pregnant women used anagetic drugs, out of whom 57% on the basis of medical prescription. Adverse drug reactions (gastrointestinal problems and)headache were reported by 15% of pregnant women. In the observed group 6% of women gave birth premature infants (once gemini, once trimini). Two newborns overcomed sepsis. One baby suffered from cheilognatopalatoschisis and two newborns from vitium cordis congenitum. We do not suppose any correlation between child abnormalities and drug consumption during pregnacy. (Tab. 1, Ref. 9.).

  12. A prototype home robot with an ambient facial interface to improve drug compliance.

    PubMed

    Takacs, Barnabas; Hanak, David

    2008-01-01

    We have developed a prototype home robot to improve drug compliance. The robot is a small mobile device, capable of autonomous behaviour, as well as remotely controlled operation via a wireless datalink. The robot is capable of face detection and also has a display screen to provide facial feedback to help motivate patients and thus increase their level of compliance. An RFID reader can identify tags attached to different objects, such as bottles, for fluid intake monitoring. A tablet dispenser allows drug compliance monitoring. Despite some limitations, experience with the prototype suggests that simple and low-cost robots may soon become feasible for care of people living alone or in isolation.

  13. Self-assessment of treatment compliance with antimuscarinic drugs and lower urinary tract condition among women with urinary incontinence.

    PubMed

    Kosilov, Kirill; Loparev, Sergey; Kuzina, Irina; Shakirova, Olga; Zhuravskaya, Natalya; Lobodenko, Alexandra

    2017-11-01

    Our aim was to determine the efficiency of the Medication Compliance Self-Report Inventory (MASRI) in self-reporting antimuscarinic drug treatment compliance among women with urinary incontinence (UI). The study assessed 347 women aged 18-65 (averaging 49.7) years with more than one urinary incontinence (UI) episode per day. Treatment compliance was tested at the beginning and at weeks 4, 8, and 12 using the MASRI, the Brief Medication Questionnaire (BMQ), and visual pill counts. The MASRI's constructive, concurrent, and discriminate validity was studied in comparison with an external standard that uses the chi-square and Spearman coefficient. Receiver operating characteristic (ROC) analysis was performed to identify optimum MASRI cutoffs that would predict noncompliance. Furthermore, the functional condition of the lower urinary tract was tested using voiding diaries, uroflowmetry, and cystometry. The correlation between the percentage of noncompliant women according to the MASRI, and individuals with a belief barrier with respect to the BMQ screen was r = 0.81 (p ≤0.05), r = 0.84 (p ≤0.05), and r = 0.79 (p ≤0.05). The correlation between the percentage of noncompliant women according to the MASRI and of women who missed >20% of their doses according to the Regimen Screen of the BMQ was r = 0.79, p ≤0.05, r = 0.82, p ≤0.01, r = 0.77, and p ≤0.05 at the control points. Finally, the percentage of noncompliant patients who self-reported correctly according to the MASRI data compared with the BMQ was 95.6%, 95.7%, and 96.6% at the control points. The MASRI entails acceptable validity for accurately predicting treatment compliance with antimuscarinic drugs among women who have had UI for >3 months.

  14. What role does measuring medication compliance play in evaluating the efficacy of naltrexone?

    PubMed

    Baros, Alicia M; Latham, Patricia K; Moak, Darlene H; Voronin, Konstantin; Anton, Raymond F

    2007-04-01

    Compliance with medication in pharmacotherapy trials of alcoholism has been shown to be equal to, or more, important than in other areas of medicine. Research has suggested that naltrexone's effectiveness can be greatly influenced by the compliance of participants in clinical trials. Presently, we compare 2 compliance measurement methods [urine riboflavin and medication event monitoring system (MEMS)] used simultaneously to evaluate naltrexone's efficacy and the impact of compliance on the size of observable treatment effects. One hundred and thirty-seven of 160 randomized alcoholic patients completed 12-weeks (84 days) of naltrexone or placebo and cognitive behavioral therapy (CBT) or motivational enhancement therapy (MET). Urine riboflavin was determined during study weeks 2, 6, and 12. The MEMS provided a detailed computerized record of when a participant opened their medication bottle throughout the trial. Baseline predictors of MEMS (80% openings) and urine riboflavin (>or=1,500 ng/mL by fluorimetry) compliance were examined. The effects of the treatments in the compliant participants defined by one, the other, or both methods were compared and contrasted with a previously reported intent-to-treat analysis where compliance was not taken into account. Age was predictive of compliance. 105 participants were deemed compliant via urine riboflavin criteria, 87 via MEMS, and 77 when both criteria were met, with no significant differences between treatment groups. The most compliant participants showed a significant medication by therapy interaction. Those treated with naltrexone/CBT showed more abstinence days (p<0.03), less heavy drinking days (p<0.03) and less total drinks (p<0.03) than the other groups. The effect size of this interaction increased from about 0.2 in the intent-to-treat analysis, to about 0.4 to 0.5 in the compliant group analyses, with little difference between compliance measurement methods. Compliance measurement does appear to influence the

  15. Impact of prepackaging antimalarial drugs on cost to patients and compliance with treatment.

    PubMed Central

    Yeboah-Antwi, K.; Gyapong, J. O.; Asare, I. K.; Barnish, G.; Evans, D. B.; Adjei, S.

    2001-01-01

    OBJECTIVE: To examine the extent to which district health teams could reduce the burden of malaria, a continuing major cause of mortality and morbidity, in a situation where severe resource constraints existed and integrated care was provided. METHODS: Antimalarial drugs were prepackaged into unit doses in an attempt to improve compliance with full courses of chemotherapy. FINDINGS: Compliance improved by approximately 20% in both adults and children. There were 50% reductions in cost to patients, waiting time at dispensaries and drug wastage at facilities. The intervention, which tended to improve both case and drug management at facilities, was well accepted by health staff and did not involve them in additional working time. CONCLUSION: The prepackaging of antimalarials at the district level offers the prospect of improved compliance and a reduction in the spread of resistance. PMID:11417034

  16. Compliance with the Use of Medical and Cloth Masks Among Healthcare Workers in Vietnam.

    PubMed

    Chughtai, Abrar Ahmad; Seale, Holly; Dung, Tham Chi; Hayen, Andrew; Rahman, Bayzidur; Raina MacIntyre, C

    2016-06-01

    Masks are often worn in healthcare settings to prevent the spread of infection from healthcare workers (HCWs) to patients. Masks are also used to protect the employee from patient-generated infectious organisms but poor compliance can reduce efficacy. The aim of this study was to examine the factors influencing compliance with the use of medical and cloth masks amongst hospital HCWs. HCWs compliance with the use of medical and cloth masks was measured over a 4-week period in a randomized controlled trial in Vietnam. HCWs were instructed to record their daily activities in diary cards. Demographic, clinical, and diary card data were used to determine the predictors of compliance and the relationship of compliance with infection outcomes. Compliance rates for both medical and cloth masks decreased during the 4 weeks: medical mask use decreased from 77 to 68% (P < 0.001) and cloth masks from 78 to 69% (P < 0.001). The presence of adverse events (adjusted RR 0.90, 95% CI 0.85-0.95), and performing aerosol-generating procedures (adjusted RR 0.78, 95% CI 0.73-0.82) were negatively associated with compliance, while contact with febrile respiratory illness patients was positively associated (adjusted RR 1.14, 95% CI 1.07-1.20). Being compliant with medical or cloth masks use (average use ≥70% of working time) was not associated with clinical respiratory illness, influenza-like illness, and laboratory-confirmed viral infection. Understanding the factors that affect compliance is important for the occupational health and safety of HCWs. New strategies and tools should be developed to increase compliance of HCWs. The presence of adverse events such as discomfort and breathing problems may be the main reasons for the low compliance with mask use and further studies should be conducted to improve the design/material of masks to improve comfort for the wearer. © The Author 2016. Published by Oxford University Press on behalf of the British Occupational Hygiene Society.

  17. Pathology consultation on urine compliance testing and drug abuse screening.

    PubMed

    Ward, Michael B; Hackenmueller, Sarah A; Strathmann, Frederick G

    2014-11-01

    Compliance testing in pain management requires a distinct approach compared with classic clinical toxicology testing. Differences in the patient populations and clinical expectations require modifications to established reporting cutoffs, assay performance expectations, and critical review of how best to apply the available testing methods. Although other approaches to testing are emerging, immunoassay screening followed by mass spectrometry confirmation remains the most common testing workflow for pain management compliance and drug abuse testing. A case-based approach was used to illustrate the complexities inherent to and uniqueness of pain management compliance testing for both clinicians and laboratories. A basic understanding of the inherent strengths and weaknesses of immunoassays and mass spectrometry provides the clinician a better understanding of how best to approach pain management compliance testing. Pain management compliance testing is a textbook example of an emerging field requiring open communication between physician and performing laboratory to fully optimize patient care. Copyright© by the American Society for Clinical Pathology.

  18. Establishing Compliance with Liquid Medication Administration in a Child with Autism

    ERIC Educational Resources Information Center

    Schiff, Averil; Tarbox, Jonathan; Lanagan, Taira; Farag, Peter

    2011-01-01

    Children with autism often display difficulty with swallowing pills and liquid medications. In the current study, stimulus fading and positive reinforcement established compliance with liquid medication administration in a young boy with autism. The boy's mother eventually administered liquid medication on her own. (Contains 1 figure.)

  19. A Study to Determine the Correlation between Continuity of Care and Patient Medication Compliance

    DTIC Science & Technology

    1984-08-01

    U (III FILE ’Y TO DETERMINE THE CORRELATION BETWEEN CONTINUITY OF CARE AND PATIENT MEDICATION COMPLIANCE IA Graduate Research Project Submitted to...43 APPENDIX A. PATIENT MEDICATION COMPLIANCE QUESTIONNAIRE . . . . . 45 B. COMPUTER CODED INPUT FORMAT . . . . . . . ...... 48 C. RESEARCH DATA...and that adhered to by the patient . This failure to comply with medical recommendations results in a waste of health resources, frustration to the

  20. Direct medical costs and medication compliance among fibromyalgia patients: duloxetine initiators vs. pregabalin initiators.

    PubMed

    Sun, Peter; Peng, Xiaomei; Sun, Steve; Novick, Diego; Faries, Douglas E; Andrews, Jeffrey S; Wohlreich, Madelaine M; Wu, Andrew

    2014-01-01

    To assess and compare direct medical costs and medication compliance between patients with fibromyalgia who initiated duloxetine and patients with fibromyalgia who initiated pregabalin in 2008. A retrospective cohort study design was used based on a large US national commercial claims database (2006 to 2009). Patients with fibromyalgia aged 18 to 64 who initiated duloxetine or pregabalin in 2008 and who had continuous health insurance 1 year preceding and 1 year following the initiation were selected into duloxetine cohort or pregabalin cohort based on their initiated agent. Medication compliance was measured by total supply days, medication possession ratio (MPR), and proportion of patients with MPR ≥ 0.8. Direct medical costs were measured by annual costs per patient and compared between the cohorts in the year following the initiation. Propensity score stratification and bootstrapping methods were used to adjust for distribution bias, as well as cross-cohort differences in demographic, clinical and economic characteristics, and medication history prior to the initiation. Both the duloxetine (n = 3,033) and pregabalin (n = 4,838) cohorts had a mean initiation age around 49 years, 89% were women. During the postindex year, compared to the pregabalin cohort, the duloxetine cohort had higher totally annual supply days (273.5 vs. 176.6, P < 0.05), higher MPR (0.7 vs. 0.5, P < 0.05), and more patients with MPR ≥ 0.8 (45.1% vs. 29.4%, P < 0.05). Further, relative to pregabalin cohort, duloxetine cohort had lower inpatient costs ($2,994.9 vs. $4,949.6, P < 0.05), lower outpatient costs ($8,259.6 vs. $10,312.2, P < 0.05), similar medication costs ($5,214.6 vs. $5,290.8, P > 0.05), and lower total medical costs ($16,469.1 vs. $20,552.6, P < 0.05) in the postinitiation year. In a real-world setting, patients with fibromyalgia who initiated duloxetine in 2008 had better medication compliance and consumed less inpatient, outpatient, and total

  1. The role of personal opinions and experiences in compliance with mass drug administration for lymphatic filariasis elimination in Kenya.

    PubMed

    Njomo, Doris W; Amuyunzu-Nyamongo, Mary; Magambo, Japheth K; Njenga, Sammy M

    2012-01-01

    The main strategy adopted for Lymphatic Filariasis (LF) elimination globally is annual mass drug administration (MDA) for 4 to 6 rounds. At least 65% of the population at risk should be treated in each round for LF elimination to occur. In Kenya, MDA using diethylcarbamazine citrate (DEC) and albendazole data shows declining compliance (proportion of eligible populations who receive and swallow the drugs) levels (85%-62.8%). The present study's aim was to determine the role of personal opinions and experiences in compliance with MDA. This was a retrospective cross-sectional study conducted between January and September 2009 in two districts based on December 2008 MDA round. In each district, one location with high and one with low compliance was selected. Through systematic sampling, nine villages were selected and interviewer-based questionnaires administered to 965 household heads or adult representatives also systematically sampled. The qualitative data were generated from opinion leaders, LF patients with clinical signs and community drug distributors (CDDs) all purposively selected and interviewed. Sixteen focus group discussions (FGDs) were also conducted with single-sex adult and youth male and female groups. Chi square test was used to assess the statistical significance of differences in compliance with treatment based on the records reviewed. The house-to-house method of drug distribution influenced compliance. Over one-quarter (27%) in low compared to 15% in high compliance villages disliked this method. Problems related to size, number and taste of the drugs were more common in low (16.4%) than in high (14.4%) compliance villages. Reasons for failure to take the drugs were associated with compliance (p<0.001). The reasons given included: feeling that the drugs were not necessary, CDD not visiting to issue the drugs, being absent and thinking that the drugs were meant for only the patients with LF clinical signs. A dislike for modern medicine prevailed

  2. Quality of drug stores: Storage practices & Regulatory compliance in Karachi, Pakistan

    PubMed Central

    Shah, Syed Shaukat Ali Muttaqi; Naqvi, Baqar Shyum; Fatima, Mashhad; Khaliq, Asif; Sheikh, Abdul Latif; Baqar, Muhammad

    2016-01-01

    Objective: To assess and evaluate the drug storage quality and regulatory compliance among privately operated drug stores of Karachi Pakistan. Methods: A cross-sectional survey of drug stores located in Karachi was conducted from May to December 2013. A total of 1003 drug stores that were involved in the sales, purchase and dispensing of pharmaceutical products were approached by non-probability purposive sampling technique, and the information was collected using a close ended, structured questionnaire. Results: Out of 1003 drug stores inspected only 4.1%(n=41) were found compliant to regulatory requirements. Most of the stores 74.9%(n=752) were selling general items along with the drugs. Only 12%(n=124) stores were having qualified person working on the store, out of which 33% were pharmacist. 47.4%(n=400) of the stores had drug sales license displayed in the premises and 33.4%(n=282) of the stores had expired drug sales license. 11.4%(n=94) stores were found selling vaccines without proper refrigerator and only 11.7% stores had the power backup for the refrigerator. Only 40.2%(n=403) of stores were protected from direct sunlight and 5.4%(n=54) having air conditioning in the premises. Conclusion: The regulatory compliance of majority of the drug stores operated privately in different areas of Karachi is below standard. Only a few drugs stores have adequate facilities to protect the drugs from extreme temperature, sunlight and provision of refrigeration. Very few of the drug stores carry out drug sales under the supervision of qualified pharmacist. There is a dire need to improve the storage practices in the drug stores by complying with the regulatory standards/laws as specified by the Drug Regulatory Authority of Pakistan. PMID:27881996

  3. Understanding medication compliance and persistence from an economics perspective.

    PubMed

    Elliott, Rachel A; Shinogle, Judith A; Peele, Pamela; Bhosle, Monali; Hughes, Dyfrig A

    2008-01-01

    An increased understanding of the reasons for noncompliance and lack of persistence with prescribed medication is an important step to improve treatment effectiveness, and thus patient health. Explanations have been attempted from epidemiological, sociological, and psychological perspectives. Economic models (utility maximization, time preferences, health capital, bilateral bargaining, stated preference, and prospect theory) may contribute to the understanding of medication-taking behavior. Economic models are applied to medication noncompliance. Traditional consumer choice models under a budget constraint do apply to medication-taking behavior in that increased prices cause decreased utilization. Nevertheless, empiric evidence suggests that budget constraints are not the only factor affecting consumer choice around medicines. Examination of time preference models suggests that the intuitive association between time preference and medication compliance has not been investigated extensively, and has not been proven empirically. The health capital model has theoretical relevance, but has not been applied to compliance. Bilateral bargaining may present an alternative model to concordance of the patient-prescriber relationship, taking account of game-playing by either party. Nevertheless, there is limited empiric evidence to test its usefulness. Stated preference methods have been applied most extensively to medicines use. Evidence suggests that patients' preferences are consistently affected by side effects, and that preferences change over time, with age and experience. Prospect theory attempts to explain how new information changes risk perceptions and associated behavior but has not been applied empirically to medication use. Economic models of behavior may contribute to the understanding of medication use, but more empiric work is needed to assess their applicability.

  4. Randomised clinical trial of strategies for improving medication compliance in primary hypertension.

    PubMed

    Sackett, D L; Haynes, R B; Gibson, E S; Hackett, B C; Taylor, D W; Roberts, R S; Johnson, A L

    1975-05-31

    230 Canadian steelworkers with hypertension took part in a randomised trial to see if compliance with antihypertensive drug regimens could be improved. For care and follow-up these men were randomly allocated to see either their own family doctors outside working-hours or industrial physicians during work shifts; the same men were randomly allocated to receive or not receive an educational programme aimed at instructing them about hypertension and its treatment. Surprisingly, the convenience of follow-up at work had no effect upon these men's compliance with antihypertensive drug regimens. Similarly, although men receiving health education learned a lot about hypertension, they were not more likely to take their medicine.

  5. 76 FR 78933 - Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-20

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good Clinical Practice; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. The...

  6. 76 FR 17138 - Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-28

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good Clinical Practice; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. The...

  7. 75 FR 14448 - Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-25

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good Clinical Practices; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop...

  8. Compliance with referrals to medical specialist care: patient and general practice determinants: a cross-sectional study.

    PubMed

    van Dijk, Christel E; de Jong, Judith D; Verheij, Robert A; Jansen, Tessa; Korevaar, Joke C; de Bakker, Dinny H

    2016-02-01

    In a gatekeeper system, primary care physicians and patients jointly decide whether or not medical specialist care is needed. However, it is the patient who decides to actually use the referral. Referral non-compliance could delay diagnosis and treatment. The objective of this study was to assess patient compliance with a referral to medical specialist care and identify patient and practice characteristics that are associated with it. Observational study using data on 48,784 referrals to medical specialist care derived from electronic medical records of 58 general practices for the period 2008-2010. Referral compliance was based on claims data of medical specialist care. Logistic multilevel regression analyses were conducted to determine associations between patient and general practice characteristics and referral compliance. In 86.6% of the referrals, patients complied. Patient and not practice characteristics were significantly associated with compliance. Patients from deprived urban areas and patients aged 18-44 years were less likely to comply, whereas patients aged 65 years and older were more likely to comply. About 1 in 8 patients do not use their referral. These patients may not receive adequate care. Demographic and socio-economic factors appear to affect compliance. The results of this study may be used to make general practitioners more aware that some patients are more likely to be noncompliant with referrals.

  9. Hybrid dendrimer hydrogel/poly(lactic-co-glycolic acid) nanoparticle platform: an advanced vehicle for topical delivery of antiglaucoma drugs and a likely solution to improving compliance and adherence in glaucoma management.

    PubMed

    Yang, Hu; Leffler, Christopher T

    2013-03-01

    Glaucoma therapy typically begins with topical medications, of which there are 4 major classes in common use in the United States: beta-adrenergic antagonists, alpha-agonists, carbonic anhydrase inhibitors, and prostaglandin analogs. Unfortunately, all 4 classes require at least daily dosing, and 3 of the 4 classes are approved to be administered 2 or 3 times daily. This need for frequent dosing with multiple medications makes compliance difficult. Longer-acting formulations and combinations that require less frequent administration might improve compliance and therefore medication effectiveness. Recently, we developed an ocular drug delivery system, a hybrid dendrimer hydrogel/poly(lactic-co-glycolic acid) nanoparticle platform for delivering glaucoma therapeutics topically. This platform is designed to deliver glaucoma drugs to the eye efficiently and release the drug in a slow fashion. Furthermore, this delivery platform is designed to be compatible with many of the glaucoma drugs that are currently approved for use. In this article, we review this new delivery system with in-depth discussion of its structural features, properties, and preclinical application in glaucoma treatment. In addition, future directions and translational efforts for marketing this technology are elaborated.

  10. Microprocessor controlled compliance monitor for eye drop medication.

    PubMed

    Hermann, M M; Diestelhorst, M

    2006-07-01

    The effectiveness of a self administered eye drop medication can only be assessed if the compliance is known. The authors studied the specificity and sensitivity of a new microprocessor controlled monitoring device. The monitoring system was conducted by an 8 bit microcontroller for data acquisition and storage with sensors measuring applied pressure to the bottle, temperature, and vertical position. 10 devices were mounted under commercial 10 ml eye drops. Test subjects had to note down each application manually. A total of 15 applications each within 3 days was intended. Manual reports confirmed 15 applications for each of the 10 bottles. The monitoring devices detected a total of 149 events; one was missed; comprising a sensitivity of 99%. Two devices registered three applications, which did not appear in the manual protocols, indicating a specificity of about 98%. Refrigerated bottles were correctly identified. The battery lifetime exceeded 60 days. The new monitoring device demonstrated a high reliability of the collected compliance data. The important, yet often unknown, influence of compliance in patient care and clinical trials shall be illuminated by the new device. This may lead to a better adapted patient care. Studies will profit from a higher credibility and results will be less influenced by non-compliance.

  11. A study of promotional advertisements of drugs in a medical journal: an ethics perspective.

    PubMed

    Nath, Sarmila; Bhowmick, Subhrojyoti; Dutta, Trayambak; Chowrasia, V R; Bhattacharya, Shipra; Chatterjee, R N; Sarkar, Manjula; Ram, A K; Mukherjee, P K

    2014-01-01

    The study assessed 54 advertisements of 145 different drugs, published over one year (from December 2011 to November 2012) in an Indian medical journal, circulated widely mainly among general practitioners (GPs). The ethical guidelines of the World Health Organization (WHO) and Organisation of Pharmaceutical Producers of India (OPPI) for medicinal drug promotion were applied. The brand name was mentioned in all advertisements (100% compliance both with the WHO and OPPI criteria) and the names of the active ingredients were also mentioned in 128 (90.14%) advertisements. However, major adverse drug reactions were mentioned in only two advertisements (1.37%); precautions, contraindications and warnings in only two (1.37%); and major interactions in only one (0.68%). Only three advertisements (2.06%) were well substantiated with references. To ensure the ethical promotionof drugs among GPs, journals must introduce compulsory review and appraisal of promotional advertisements by a dedicated review board, including at least one member trained in pharmacology and one representative from the medical division of a pharmaceutical company.

  12. [Resistant hypertension by unadvertised non-compliance detected by psychiatric expertise and drug dosages].

    PubMed

    Didier, R; Gilard, M; Denolle, T

    2018-06-01

    The management of patients with resistant hypertension remains a major challenge in daily clinical practice in order to limit macro and microvascular impact. However, lack of compliance often remains one of the main etiologies of resistant hypertension. Through a clinical case of complex therapeutic non-compliance, we will detail the frequency, the screening and the management of therapeutic non-compliance. Finally, we will specify the contribution of drug dosages and psychological expertise in screening non-observant patients with presumed resistant hypertension. Copyright © 2018 Elsevier Masson SAS. All rights reserved.

  13. Clinical trial registration, reporting, publication and FDAAA compliance: a cross-sectional analysis and ranking of new drugs approved by the FDA in 2012

    PubMed Central

    Miller, Jennifer E; Korn, David; Ross, Joseph S

    2015-01-01

    Objective To evaluate clinical trial registration, reporting and publication rates for new drugs by: (1) legal requirements and (2) the ethical standard that all human subjects research should be publicly accessible to contribute to generalisable knowledge. Design Cross-sectional analysis of all clinical trials submitted to the Food and Drug Administration (FDA) for drugs approved in 2012, sponsored by large biopharmaceutical companies. Data sources Information from Drugs@FDA, ClinicalTrials.gov, MEDLINE-indexed journals and drug company communications. Main outcome measures Clinical trial registration and results reporting in ClinicalTrials.gov, publication in the medical literature, and compliance with the 2007 FDA Amendments Acts (FDAAA), analysed on the drug level. Results The FDA approved 15 drugs sponsored by 10 large companies in 2012. We identified 318 relevant trials involving 99 599 research participants. Per drug, a median of 57% (IQR 32–83%) of trials were registered, 20% (IQR 12–28%) reported results in ClinicalTrials.gov, 56% (IQR 41–83%) were published, and 65% (IQR 41–83%) were either published or reported results. Almost half of all reviewed drugs had at least one undisclosed phase II or III trial. Per drug, a median of 17% (IQR 8–20%) of trials supporting FDA approvals were subject to FDAAA mandated public disclosure; of these, a median of 67% (IQR 0–100%) were FDAAA-compliant. 68% of research participants (67 629 of 99 599) participated in FDAAA-subject trials, with 51% (33 405 of 67 629) enrolled in non-compliant trials. Transparency varied widely among companies. Conclusions Trial disclosures for new drugs remain below legal and ethics standards, with wide variation in practices among drugs and their sponsors. Best practices are emerging. 2 of our 10 reviewed companies disclosed all trials and complied with legal disclosure requirements for their 2012 approved drugs. Ranking new drugs on transparency criteria may improve

  14. Microprocessor controlled compliance monitor for eye drop medication

    PubMed Central

    Hermann, M M; Diestelhorst, M

    2006-01-01

    Background/aims The effectiveness of a self administered eye drop medication can only be assessed if the compliance is known. The authors studied the specificity and sensitivity of a new microprocessor controlled monitoring device. Methods The monitoring system was conducted by an 8 bit microcontroller for data acquisition and storage with sensors measuring applied pressure to the bottle, temperature, and vertical position. 10 devices were mounted under commercial 10 ml eye drops. Test subjects had to note down each application manually. A total of 15 applications each within 3 days was intended. Results Manual reports confirmed 15 applications for each of the 10 bottles. The monitoring devices detected a total of 149 events; one was missed; comprising a sensitivity of 99%. Two devices registered three applications, which did not appear in the manual protocols, indicating a specificity of about 98%. Refrigerated bottles were correctly identified. The battery lifetime exceeded 60 days. Conclusion The new monitoring device demonstrated a high reliability of the collected compliance data. The important, yet often unknown, influence of compliance in patient care and clinical trials shall be illuminated by the new device. This may lead to a better adapted patient care. Studies will profit from a higher credibility and results will be less influenced by non‐compliance. PMID:16540488

  15. 77 FR 49449 - Food and Drug Administration Clinical Trial Requirements, Compliance, and Good Clinical Practice...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-16

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Food and Drug Administration Clinical Trial Requirements, Compliance, and Good Clinical Practice; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. The Food...

  16. 77 FR 49448 - Food and Drug Administration Clinical Trial Requirements, Compliance, and Good Clinical Practice...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-16

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Food and Drug Administration Clinical Trial Requirements, Compliance, and Good Clinical Practice; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. The Food...

  17. A Perfect Platform: Combining Contingency Management with Medications for Drug Abuse

    PubMed Central

    Carroll, Kathleen M.; Rounsaville, Bruce J.

    2008-01-01

    Contingency management (CM) procedures, which provide concrete reinforcers or rewards contingent on verification of discrete targeted behaviors, such as drug-free urines, have been demonstrated to be effective in a number of clinical trials. However, to date there have been only a few that have capitalized on the unique strengths and capabilities of CM as an ideal platform to improve response to or address weaknesses of many pharmacotherapies used in the treatment of drug abuse. In this review, we describe the multiple potential uses of CM as a platform for pharmacotherapy, including reducing illicit drug use in the context of agonist therapies; fostering medication compliance with antagonists, aversive agents and HIV medications; fostering a period of abstinence prior to initiation of agents used to treat comorbid psychiatric conditions or in the context of vaccines to foster adequate periods of abstinence while titer levels are building; and to enhance the effectiveness of anticraving agents through additive or synergistic effects. Although its multiple strengths render it an almost perfect platform, CM does have some weaknesses that have limited its use to date, including cost, the short-term nature of its effects, and need for training. Future treatment development of CM as a medication platform needs to counter these issues by focusing on CM applications with large potential benefit, developing simple or automated methods for CM delivery and placing greater emphasis on the process of transitioning away from formal CM treatment. PMID:17613963

  18. Depot-medication compliance for patients with psychotic disorders: the importance of illness insight and treatment motivation.

    PubMed

    Noordraven, Ernst L; Wierdsma, André I; Blanken, Peter; Bloemendaal, Anthony Ft; Mulder, Cornelis L

    2016-01-01

    Noncompliance is a major problem for patients with a psychotic disorder. Two important risk factors for noncompliance that have a severe negative impact on treatment outcomes are impaired illness insight and lack of motivation. Our cross-sectional study explored how they are related to each other and their compliance with depot medication. Interviews were conducted in 169 outpatients with a psychotic disorder taking depot medication. Four patient groups were defined based on low or high illness insight and on low or high motivation. The associations between depot-medication compliance, motivation, and insight were illustrated using generalized linear models. Generalized linear model showed a significant interaction effect between motivation and insight. Patients with poor insight and high motivation for treatment were more compliant (94%) (95% confidence interval [CI]: 1.821, 3.489) with their depot medication than patients with poor insight and low motivation (61%) (95% CI: 0.288, 0.615). Patients with both insight and high motivation for treatment were less compliant (73%) (95% CI: 0.719, 1.315) than those with poor insight and high motivation. Motivation for treatment was more strongly associated with depot-medication compliance than with illness insight. Being motivated to take medication, whether to get better or for other reasons, may be a more important factor than having illness insight in terms of improving depot-medication compliance. Possible implications for clinical practice are discussed.

  19. Experience with the use of the Codonics Safe Label System(™) to improve labelling compliance of anaesthesia drugs.

    PubMed

    Ang, S B L; Hing, W C; Tung, S Y; Park, T

    2014-07-01

    The Codonics Safe Labeling System(™) (http://www.codonics.com/Products/SLS/flash/) is a piece of equipment that is able to barcode scan medications, read aloud the medication and the concentration and print a label of the appropriate concentration in the appropriate colour code. We decided to test this system in our facility to identify risks, benefits and usability. Our project comprised a baseline survey (25 anaesthesia cases during which 212 syringes were prepared from 223 drugs), an observational study (47 cases with 330 syringes prepared) and a user acceptability survey. The baseline compliance with all labelling requirements was 58%. In the observational study the compliance using the Codonics system was 98.6% versus 63.8% with conventional labelling. In the user acceptability survey the majority agreed the Codonics machine was easy to use, more legible and adhered with better security than the conventional preprinted label. However, most were neutral when asked about the likelihood of flexibility and customisation and were dissatisfied with the increased workload. Our findings suggest that the Codonics labelling machine is user-friendly and it improved syringe labelling compliance in our study. However, staff need to be willing to follow proper labelling workflow rather than batch label during preparation. Future syringe labelling equipment developers need to concentrate on user interface issues to reduce human factor and workflow problems. Support logistics are also an important consideration prior to implementation of any new labelling system.

  20. The impact of cognitive insight, self-stigma, and medication compliance on the quality of life in patients with schizophrenia.

    PubMed

    Lien, Yin-Ju; Chang, Hsin-An; Kao, Yu-Chen; Tzeng, Nian-Sheng; Lu, Chien-Wen; Loh, Ching-Hui

    2018-02-01

    Impaired quality of life (QoL) is a common and clinically relevant feature of schizophrenia. In the present study, we attempted to formulate a model of QoL in the chronic stage of schizophrenia by including key variables-namely cognitive insight, self-stigma, insight into treatment, and medication compliance-that were proposed as its significant predictors in previous studies. We employed structural equation modeling (SEM) to simultaneously test the associations between these variables. A total of 170 community-dwelling patients with schizophrenia participated in this study. Cognitive insight, self-stigma, insight into treatment, medication compliance, and QoL were assessed through self-reporting. Symptoms were rated by interviewers. The influences of cognitive insight, stigma, insight into treatment, and medication compliance on QoL were supported using SEM. Our findings indicated that cognitive insight had a significant, positive, and direct effect on both self-stigma and insight into treatment; in contrast, it had a negative and direct effect on medication compliance. Notably, no evidence indicated a direct effect of cognitive insight on QoL. Thus, individuals with high cognitive insight reported low QoL because of stigma, low medication compliance, and their increased insight into treatment. In contrast, cognitive insight might indirectly ameliorate QoL mediated by the effect of insight into treatment on medication compliance. The findings provide additional support of the links between cognitive and clinical insight, self-stigma, medication compliance, and QoL in those with schizophrenia and suggest the need for screening and intervention services appropriate for this high-risk population.

  1. Emergency Telemedicine: Achieving and Maintaining Compliance with the Emergency Medical Treatment and Labor Act.

    PubMed

    Rockwell, Kimberly Lovett; Gilroy, Alexis

    2018-03-12

    Telemedicine is a growing and important platform for medical delivery in the emergency department. Emergency telemedicine outlays often confront and conflict with important federal healthcare regulations. Because of this, academic medical centers, critical access hospitals, and other providers interested in implementing emergency telemedicine have often delayed or forgone such services due to reasonable fears of falling out of compliance with regulatory restrictions imposed by the Emergency Medical Treatment and Labor Act ("EMTALA"). This article offers insights into methods for implementing emergency telemedicine services while maintaining EMTALA compliance. Critical analysis of EMTALA and its attendant regulations. The primary means of ensuring EMTALA compliance while implementing emergency telemedicine programs include incorporating critical clinical details into the services contracts and implementing robust written policies that anticipate division of labor issues, the need for backup coverage, triaging, patient transfer protocols, and credentialing issues. With adequate up-front due diligence and meaningful contracting, hospitals and telemedicine providers can avoid common EMTALA liability pitfalls.

  2. Effects of electronic prescribing on formulary compliance and generic drug utilization in the ambulatory care setting: a retrospective analysis of administrative claims data.

    PubMed

    Ross, S Michael; Papshev, Diana; Murphy, Erin L; Sternberg, David J; Taylor, Jeffrey; Barg, Ronald

    2005-06-01

    Electronic prescribing (e-prescribing) provides formulary information at the point of care. The objective of this study was to assess the effects of e-prescribing on formulary compliance and generic utilization. This was a retrospective analysis of pharmacy claims data from a large national managed care organization. A sample of 95 providers using predominantly e-prescribing was randomly selected (e-prescriber group). A matched sample of 95 traditional prescribers was selected (traditional prescriber group), matched to the e-prescriber group by zip code and medical specialty. A total of 110,975 paid pharmacy claims, for the 12 months from August 1, 2001, through July 31, 2002, were analyzed to assess the effect of e-prescribing on formulary compliance and generic utilization. All paid pharmacy claims were examined for each group; for the e-prescriber group, this included all claims, not just those prescribed using an e-prescribing device. A written qualitative survey was distributed to physicians and office managers to assess e-prescribing usage, sources of formulary information, and effects of e-prescribing on office resources. Both predominantly e-prescribers and traditional prescribers demonstrated high levels of formulary compliance, 83.2% versus 82.8%, respectively (P=0.32). Formulary compliance for these groups did not differ from the overall prescriber population (82.0%). There was not a difference in generic drug utilization rates between e-prescribers and traditional prescribers (absolute rates 37.3% versus 36.9%, P=0.18). Qualitative survey responses supported previously reported research indicating reductions in calls both to and from pharmacies for prescription orders. An examination of paid pharmacy claims from a large, national managed care organization demonstrated no differences between predominantly e-prescribers and traditional prescribers in measures of formulary compliance or generic drug utilization. Future studies should examine keystroke data

  3. Economic impact of compliance to treatment with antidiabetes medication in type 2 diabetes mellitus: a review paper.

    PubMed

    Breitscheidel, L; Stamenitis, S; Dippel, F-W; Schöffski, O

    2010-03-01

    Suboptimal compliance and failure to persist with antidiabetes therapies are of potential economic significance. The present research aims to describe the impact of poor compliance and persistence with antidiabetes medications on the cost of healthcare or its components for patients with type 2 diabetes mellitus (T2DM). Literature search was conducted in PubMed for relevant articles published in the period between 1 January 2000 and 30 April 2009. Thus, it is possible that relevant articles not listed in PubMed, but available in other databases are not included in the current review. Studies describing economic consequence of compliance and/or persistence with pharmaceutical antidiabetes treatment were identified. The variability in the studies reviewed was high, making it extremely difficult to make a comparison between them. Of 449 articles corresponding to the primary search algorithm, 12 studies (all conducted in USA) fulfilled the inclusion criteria regarding the economic impact of compliance and/or persistence with treatment on the overall cost of T2DM care or its components. Compliance was assessed via medication possession ratio (MPR) in ten studies, where it ranged from 0.52 to 0.93 depending on regimen. Persistence was assessed in one study. Mean total annual costs per T2DM patient varied between the studies, ranging from $4570 to $17338. In seven studies, medication compliance was inversely associated with total healthcare costs, while in four other studies inverse associations between medication compliance and hospitalisation costs were reported. In one study increased adherence did not change overall healthcare costs. Improved compliance may lead to reductions of the total healthcare costs in T2DM, Further research is needed in countries other than the US to assess impact of compliance and persistence to pharmacotherapy on T2DM costs in country-specific settings.

  4. Depot-medication compliance for patients with psychotic disorders: the importance of illness insight and treatment motivation

    PubMed Central

    Noordraven, Ernst L; Wierdsma, André I; Blanken, Peter; Bloemendaal, Anthony FT; Mulder, Cornelis L

    2016-01-01

    Background Noncompliance is a major problem for patients with a psychotic disorder. Two important risk factors for noncompliance that have a severe negative impact on treatment outcomes are impaired illness insight and lack of motivation. Our cross-sectional study explored how they are related to each other and their compliance with depot medication. Methods Interviews were conducted in 169 outpatients with a psychotic disorder taking depot medication. Four patient groups were defined based on low or high illness insight and on low or high motivation. The associations between depot-medication compliance, motivation, and insight were illustrated using generalized linear models. Results Generalized linear model showed a significant interaction effect between motivation and insight. Patients with poor insight and high motivation for treatment were more compliant (94%) (95% confidence interval [CI]: 1.821, 3.489) with their depot medication than patients with poor insight and low motivation (61%) (95% CI: 0.288, 0.615). Patients with both insight and high motivation for treatment were less compliant (73%) (95% CI: 0.719, 1.315) than those with poor insight and high motivation. Conclusion Motivation for treatment was more strongly associated with depot-medication compliance than with illness insight. Being motivated to take medication, whether to get better or for other reasons, may be a more important factor than having illness insight in terms of improving depot-medication compliance. Possible implications for clinical practice are discussed. PMID:26893565

  5. 76 FR 30727 - Food and Drug Administration Food Safety Modernization Act: Focus on Inspections and Compliance

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-26

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0366] Food and Drug Administration Food Safety Modernization Act: Focus on Inspections and Compliance AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public meeting; request for comments. SUMMARY: The...

  6. Medical Marijuana Users are More Likely to Use Prescription Drugs Medically and Nonmedically.

    PubMed

    Caputi, Theodore L; Humphreys, Keith

    2018-04-17

    Previous studies have found a negative population-level correlation between medical marijuana availability in US states, and trends in medical and nonmedical prescription drug use. These studies have been interpreted as evidence that use of medical marijuana reduces medical and nonmedical prescription drug use. This study evaluates whether medical marijuana use is a risk or protective factor for medical and nonmedical prescription drug use. Simulations based upon logistic regression analyses of data from the 2015 National Survey on Drug Use and Health were used to compute associations between medical marijuana use, and medical and nonmedical prescription drug use. Adjusted risk ratios (RRs) were computed with controls added for age, sex, race, health status, family income, and living in a state with legalized medical marijuana. Medical marijuana users were significantly more likely (RR 1.62, 95% confidence interval [CI] 1.50-1.74) to report medical use of prescription drugs in the past 12 months. Individuals who used medical marijuana were also significantly more likely to report nonmedical use in the past 12 months of any prescription drug (RR 2.12, 95% CI 1.67-2.62), with elevated risks for pain relievers (RR 1.95, 95% CI 1.41-2.62), stimulants (RR 1.86, 95% CI 1.09-3.02), and tranquilizers (RR 2.18, 95% CI 1.45-3.16). Our findings disconfirm the hypothesis that a population-level negative correlation between medical marijuana use and prescription drug harms occurs because medical marijuana users are less likely to use prescription drugs, either medically or nonmedically. Medical marijuana users should be a target population in efforts to combat nonmedical prescription drug use.

  7. Drug advertising in medical journals

    PubMed Central

    Morgan, A. H.; Jeffers, T. A.; Petrie, J. C.; Walker, W.

    1976-01-01

    1 One hundred different drug advertisements from each of seven leading medical journals have been assessed. 2 Information about drug interactions, adverse reactions, mode of action, absorption, distribution, metabolism, excretion and cost was seldom provided in UK journals. 3 A requirement should exist that drug advertisements include such clinically important information. Only a few pharmaceutical companies are attempting to educate doctors through their marketing and promotional material in advertisements in medical journals. PMID:22216530

  8. 76 FR 12743 - Medical Device Reporting; Malfunction Reporting Frequency

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-08

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0097] Medical Device Reporting; Malfunction Reporting Frequency AGENCY: Food and Drug Administration, HHS... compliance with FDA's Medical Device Reporting regulation, pending future FDA notice under the Federal Food...

  9. Application of drug testing using exhaled breath for compliance monitoring of drug addicts in treatment.

    PubMed

    Carlsson, Sten; Olsson, Robert; Lindkvist, Irene; Beck, Olof

    2015-04-01

    Exhaled breath has recently been identified as a possible matrix for drug testing. This study explored the potential of this new method for compliance monitoring of patients being treated for dependence disorders. Outpatients in treatment programs were recruited for this study. Urine was collected as part of clinical routine and a breath sample was collected in parallel together with a questionnaire about their views of the testing procedure. Urine was analyzed for amphetamines, benzodiazepines, cannabis, cocaine, buprenorphine, methadone and opiates using CEDIA immunochemical screening and mass spectrometry confirmation. The exhaled breath was collected using the SensAbues device and analyzed by mass spectrometry for amphetamine, methamphetamine, diazepam, oxazepam, tetrahydrocannabinol, cocaine, benzoylecgonine, buprenorphine, methadone, morphine, codeine and 6-acetylmorphine. A total of 122 cases with parallel urine and breath samples were collected; 34 of these were negative both in urine and breath. Out of 88 cases with positive urine samples 51 (58%) were also positive in breath. Among the patients on methadone treatment, all were positive for methadone in urine and 83% were positive in breath. Among patients in treatment with buprenorphine, 92% were positive in urine and among those 80% were also positive in breath. The questionnaire response documented that in general, patients accepted drug testing well and that the breath sampling procedure was preferred. Compliance testing for the intake of prescribed and unprescribed drugs among patients in treatment for dependence disorders using the exhaled breath sampling technique is a viable method and deserves future attention.

  10. A conceptual framework for achieving performance enhancing drug compliance in sport.

    PubMed

    Donovan, Robert J; Egger, Garry; Kapernick, Vicki; Mendoza, John

    2002-01-01

    There has been, and continues to be, widespread international concern about athletes' use of banned performance enhancing drugs (PEDs). This concern culminated in the formation of the World Anti-Doping Agency (WADA) in November 1999. To date, the main focus on controlling the use of PEDs has been on testing athletes and the development of tests to detect usage. Although athletes' beliefs and values are known to influence whether or not an athlete will use drugs, little is known about athletes' beliefs and attitudes, and the limited empirical literature shows little use of behavioural science frameworks to guide research methodology, results interpretation, and intervention implications. Mindful of this in preparing its anti-doping strategy for the 2000 Olympics, the Australian Sports Drug Agency (ASDA) in 1997 commissioned a study to assess the extent to which models of attitude-behaviour change in the public health/injury prevention literature had useful implications for compliance campaigns in the sport drug area. A preliminary compliance model was developed from three behavioural science frameworks: social cognition models; threat (or fear) appeals; and instrumental and normative approaches. A subsequent review of the performance enhancing drug literature confirmed that the overall framework was consistent with known empirical data, and therefore had at least face validity if not construct validity. The overall model showed six major inputs to an athlete's attitudes and intentions with respect to performance enhancing drug usage: personality factors, threat appraisal, benefit appraisal, reference group influences, personal morality and legitimacy. The model demonstrated that a comprehensive, fully integrated programme is necessary for maximal effect, and provides anti-doping agencies with a structured framework for strategic planning and implementing interventions. Programmes can be developed in each of the six major areas, with allocation of resources to each

  11. A logistic regression analysis of factors related to the treatment compliance of infertile patients with polycystic ovary syndrome.

    PubMed

    Li, Saijiao; He, Aiyan; Yang, Jing; Yin, TaiLang; Xu, Wangming

    2011-01-01

    To investigate factors that can affect compliance with treatment of polycystic ovary syndrome (PCOS) in infertile patients and to provide a basis for clinical treatment, specialist consultation and health education. Patient compliance was assessed via a questionnaire based on the Morisky-Green test and the treatment principles of PCOS. Then interviews were conducted with 99 infertile patients diagnosed with PCOS at Renmin Hospital of Wuhan University in China, from March to September 2009. Finally, these data were analyzed using logistic regression analysis. Logistic regression analysis revealed that a total of 23 (25.6%) of the participants showed good compliance. Factors that significantly (p < 0.05) affected compliance with treatment were the patient's body mass index, convenience of medical treatment and concerns about adverse drug reactions. Patients who are obese, experience inconvenient medical treatment or are concerned about adverse drug reactions are more likely to exhibit noncompliance. Treatment education and intervention aimed at these patients should be strengthened in the clinic to improve treatment compliance. Further research is needed to better elucidate the compliance behavior of patients with PCOS.

  12. Oral anticancer agent medication adherence by outpatients.

    PubMed

    Kimura, Michio; Usami, Eiseki; Iwai, Mina; Nakao, Toshiya; Yoshimura, Tomoaki; Mori, Hiromi; Sugiyama, Tadashi; Teramachi, Hitomi

    2014-11-01

    In the present study, medication adherence and factors affecting adherence were examined in patients taking oral anticancer agents. In June 2013, 172 outpatients who had been prescribed oral anticancer agents by Ogaki Municipal Hospital (Ogaki, Gifu, Japan) completed a questionnaire survey, with answers rated on a five-point Likert scale. The factors that affect medication adherence were evaluated using a customer satisfaction (CS) analysis. For patients with good and insufficient adherence to medication, the median ages were 66 years (range, 21-85 years) and 73 years (range, 30-90 years), respectively (P=0.0004), while the median dosing time was 131 days (range, 3-3,585 days) and 219 days (24-3,465 days), respectively (P=0.0447). In 36.0% (62 out of 172) of the cases, there was insufficient medication adherence; 64.5% of those cases (40 out of 62) showed good medication compliance (4-5 point rating score). However, these patients did not fully understand the effects or side-effects of the drugs, giving a score of three points or less. The percentage of patients with good medication compliance was 87.2% (150 out of 172). Through the CS analysis, three items, the interest in the drug, the desire to consult about the drug and the condition of the patient, were extracted as items for improvement. Overall, the medication compliance of the patients taking the oral anticancer agents was good, but the medication adherence was insufficient. To improve medication adherence, a better understanding of the effectiveness and necessity of drugs and their side-effects is required. In addition, the interest of patients in their medication should be encouraged and intervention should be tailored to the condition of the patient. These steps should lead to improved medication adherence.

  13. 19 CFR 147.23 - Compliance with Plant Quarantine Act and Federal Food, Drug, and Cosmetic Act.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... the plant quarantine regulations. (b) Federal Food, Drug, and Cosmetic Act. The entry of food products... Food, Drug, and Cosmetic Act. 147.23 Section 147.23 Customs Duties U.S. CUSTOMS AND BORDER PROTECTION... Laws § 147.23 Compliance with Plant Quarantine Act and Federal Food, Drug, and Cosmetic Act. (a) Plant...

  14. 19 CFR 147.23 - Compliance with Plant Quarantine Act and Federal Food, Drug, and Cosmetic Act.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... the plant quarantine regulations. (b) Federal Food, Drug, and Cosmetic Act. The entry of food products... Food, Drug, and Cosmetic Act. 147.23 Section 147.23 Customs Duties U.S. CUSTOMS AND BORDER PROTECTION... Laws § 147.23 Compliance with Plant Quarantine Act and Federal Food, Drug, and Cosmetic Act. (a) Plant...

  15. 19 CFR 147.23 - Compliance with Plant Quarantine Act and Federal Food, Drug, and Cosmetic Act.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... Food, Drug, and Cosmetic Act. 147.23 Section 147.23 Customs Duties U.S. CUSTOMS AND BORDER PROTECTION... Laws § 147.23 Compliance with Plant Quarantine Act and Federal Food, Drug, and Cosmetic Act. (a) Plant... the plant quarantine regulations. (b) Federal Food, Drug, and Cosmetic Act. The entry of food products...

  16. 19 CFR 147.23 - Compliance with Plant Quarantine Act and Federal Food, Drug, and Cosmetic Act.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... Food, Drug, and Cosmetic Act. 147.23 Section 147.23 Customs Duties U.S. CUSTOMS AND BORDER PROTECTION... Laws § 147.23 Compliance with Plant Quarantine Act and Federal Food, Drug, and Cosmetic Act. (a) Plant... the plant quarantine regulations. (b) Federal Food, Drug, and Cosmetic Act. The entry of food products...

  17. 19 CFR 147.23 - Compliance with Plant Quarantine Act and Federal Food, Drug, and Cosmetic Act.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... Food, Drug, and Cosmetic Act. 147.23 Section 147.23 Customs Duties U.S. CUSTOMS AND BORDER PROTECTION... Laws § 147.23 Compliance with Plant Quarantine Act and Federal Food, Drug, and Cosmetic Act. (a) Plant... the plant quarantine regulations. (b) Federal Food, Drug, and Cosmetic Act. The entry of food products...

  18. Herb-drug, food-drug, nutrient-drug, and drug-drug interactions: mechanisms involved and their medical implications.

    PubMed

    Sørensen, Janina Maria

    2002-06-01

    Adverse drug reactions (ADRs) and iatrogenic diseases have been identified as significant factors responsible for patient morbidity and mortality. Significant studies on drug metabolism in humans have been published during the last few years, offering a deeper comprehension of the mechanisms underlying adverse drug reactions and interactions. More understanding of these mechanisms, and of recent advances in laboratory technology, can help to evaluate potential drug interactions when drugs are prescribed concurrently. Increasing knowledge of interindividual variation in drug breakdown capacity and recent findings concerning the influence of environment, diet, nutrients, and herbal products can be used to reduce ADRs and iatrogenic diseases. Reviewed data suggest that drug treatment should be increasingly custom tailored to suit the individual patient and that appropriately co-prescribed diet and herbal remedies, could increase drug efficacy and lessen drug toxicity. This review focuses mainly on recently published research material. The cytochrome p450 enzymes, their role in metabolism, and their mechanisms of action are reviewed, and their role in drug-drug interactions are discussed. Drug-food and drug-herb interactions have garnered attention. Interdisciplinary communication among medical herbalists, medical doctors, and dietetic experts needs to be improved and encouraged. Internet resources for obtaining current information regarding drug-drug, drug-herb, and drug-nutrient interactions are provided.

  19. Noncompliance and Drug Toxicity in Black, Poor, and Aged Patients

    PubMed Central

    Miller, Russell L.; Algee, John

    1978-01-01

    Drug toxicity is a common medical problem. Continued increases in drug toxicity are related to the extensive, indiscriminate use of drugs. This is a national health problem which is caused partly by gaps in pharmacology as a basic and clinical science and partly by the rapid proliferation of drugs (the drug explosion) in the past 30 years. Socioeconomically disadvantaged (black, poor, and aged) patients are particularly vulnerable to compliance problems and drug toxicity. In this presentation we discuss the basis for this increased vulnerability and suggest strategies that practicing physicians can use to minimize both compliance problems and drug toxicity. PMID:712862

  20. Noncompliance and drug toxicity in black, poor, and aged patients.

    PubMed

    Miller, R L; Algee, J

    1978-10-01

    Drug toxicity is a common medical problem. Continued increases in drug toxicity are related to the extensive, indiscriminate use of drugs. This is a national health problem which is caused partly by gaps in pharmacology as a basic and clinical science and partly by the rapid proliferation of drugs (the drug explosion) in the past 30 years. Socioeconomically disadvantaged (black, poor, and aged) patients are particularly vulnerable to compliance problems and drug toxicity. In this presentation we discuss the basis for this increased vulnerability and suggest strategies that practicing physicians can use to minimize both compliance problems and drug toxicity.

  1. Monitoring universal protocol compliance through real-time clandestine observation by medical students results in performance improvement.

    PubMed

    Logan, Catherine A; Cressey, Brienne D; Wu, Roger Y; Janicki, Adam J; Chen, Cyril X; Bolourchi, Meena L; Hodnett, Jessica L; Stratigis, John D; Mackey, William C; Fairchild, David G

    2012-01-01

    To measure universal protocol compliance through real-time, clandestine observation by medical students compared with chart audit reviews, and to enable medical students the opportunity to become conscious of the importance of medical errors and safety initiatives. With endorsement from Tufts Medical Center's (TMC's) Chief Medical Officer and Surgeon-in-Chief, 8 medical students performed clandestine observation audits of 98 cases from April to August 2009. A compliance checklist was based on TMC's presurgical checklist. Our initial results led to interventions to improve our universal protocol procedures, including modifications to the operating room white board and presurgical checklist, and specific feedback to surgical departments. One year later, 6 medical students performed observations of 100 cases from June to August 2010. Tufts Medical Center, Boston, Massachusetts, which is an academic medical center and the principal teaching hospital for Tufts University School of Medicine. An operating room coordinator placed the medical students into 1 of our 25 operating rooms with students entering under the premise of observing the anesthesiologist for clinical education. The observations were performed Monday to Friday between 7 am and 4 pm. Although observations were not randomized, no single service or type of surgery was targeted for observation. A broad range of departments was observed. In 8.2% of cases, the surgical site was unmarked. A Time Out occurred in 89.7% of cases. The entire surgical team was attentive during the time out in 82% of cases. The presurgical checklist was incomplete before incision in 13 cases. Images were displayed in 82% of cases. The operating room "white board" was filled out completely in 49% of cases. Team introductions occurred in 13 cases. One year later, compliance increased in all Universal Protocol dimensions. Direct, real-time observation by medical students provides an accurate and granular assessment of compliance with

  2. [Pilot study of dementia medication compliance conducted among pharmacists providing home visits which evaluates the degree of drug compliance, as defined by numerous attributes, between patients at home and patients in a medical facility].

    PubMed

    Nanaumi, Yoko; Matoba, Shunya; Onda, Mitsuko; Tanaka, Rie; Tsubota, Kenichi; Mukai, Yusuke; Sakurai, Hidehiko; Hayase, Yukitoshi; Arakawa, Yukio

    2012-01-01

    A survey was conducted among pharmacists providing "home-visit guidance on drug management" to patients taking medication for dementia. Factors related to medication adherence among patients and pharmacists' acquisition of patient information were then verified. The survey items were: (1) patient attributes (degree of care received, bed-ridden, family composition, and living environment); (2) the person controlling medications; (3) drug storage method and location; (4) dispensing method; (5) patient management of visiting nurses; (6) patient management of visiting physician; (7) details of pharmacist's home-visit guidance; (8) medication adherence; (9) five items related to cognitive function (short-term memory, autonomous judgment, fluctuations in level of consciousness, excitation and loss of orientation, understanding); and (10) ten items related of ADL (mobility in bed, transferring, mobility within the home or outdoors, dressing upper/lower body, eating, toilet use, individual hygiene, bathing). The t test was used to verify the number of items of patient information concerning cognitive function and physical function that pharmacists could acquire at a visit. It was suggested that pharmacists were able to acquire more patient information (①cognitive function and ②ADL) when they visited patients cared for at home, compared to facility residents (①p=0.008, ② p=0.006). Thus, it was suggested that there is a latent risk concerning the pharmacist's ability to discover problems with administration of medications among facility residents. These findings demonstrate that it is essential for pharmacists to be more proactive about providing home-visit guidance.

  3. Role of health education and self-action plan in improving the drug compliance in bronchial asthma.

    PubMed

    Gaude, Gajanan S; Hattiholi, Jyothi; Chaudhury, Alisha

    2014-01-01

    Considering the prevalence and associated burden of disease due to bronchial asthma, it is mandatory to obtain an optimal control of the disease and to improve outcomes for these patients. But it has been observed that there is very poor adherence to the inhalational therapy which leads to the suboptimal control of the disease. To study the adherence for aerosol therapy in bronchial asthma patients and to assess the impact of health education and self-action plan in improving the compliance to the therapy. A prospective study was done in a total of 500 bronchial asthma patients over a period of 2 years. Once included in the study, the patients were followed-up for a total of 12 weeks for calculation of nonadherence to the aerosol therapy. In nonadherent patients, we employed various health education strategies to improve the compliance in these cases. A total of 500 patients of bronchial asthma who were started on aerosol therapy over duration of 2 years were included in the study. At the end of 12 weeks, it was observed that, only 193 patients (38.6%) had regular compliance and 307 patients (61.4%) were noncompliant to aerosol therapy as prescribed for bronchial asthma. Factors that were associated with poor compliance were: Lower educational level status, poor socioeconomic status, cumbersome regimens, dislike of medication, and distant pharmacies. Nondrug factors that reduced the compliance were: Fears about side effects, anger about condition or its treatment, forgetfulness or complacency, and patient's ill attitudes toward health. After employing the various strategies for improving the compliance in these patients, the compliance increased in 176 patients (57.3%) among the earlier defaulted patients, while the remaining 131 patients (42.7%) were found to be noncompliant even after various educational techniques. Noncompliance in asthma management is a fact of life and no single compliance improving strategy probably will be as effective as a good physician

  4. [Hypertension therapy and patient compliance].

    PubMed

    Rapi, Judit

    2002-08-25

    In the treatment of chronic disease like hypertension it is very important to achieve good patient compliance. One third of the patients however takes his medicament irregularly. The failure of the treatment is usually caused by the patient, who is not aware of his illness, he feels healthy that's why he does not go to see the doctor or he stops taking the medicine. The cause of bad compliance can also be the doctor who does not spend enough time and energy on his patients. Rarely the therapy is broken off because of the side effects of the medication. In the last year 100 patients with hypertension were asked with help of a questionnaire about their drug-taking habits and their knowledge about hypertension. From the answers we found out that one third of the patients takes his drugs irregularly. Less than half of the patients reaches the normotension. Most of the patients who have been treated for many years do not know the goal blood pressure, the possible complications of hypertension, the goal of the treatment. Often they do not even know the name of their medicine. Compliance is a complicated problem. Improvement could be reached by regular teaching of the patients, by teaching the patients how to measure blood pressure at home, by increasing the number of educational publications, by regular training of the doctors, by keeping the rules of the treatment, by using modern and long-term effective drugs. It would be important to start with teaching the healthy way of living already at a young age.

  5. Alcohol and Drug Abuse in Medical Education.

    ERIC Educational Resources Information Center

    Galanter, Marc, Ed.

    This book presents the state of the art of American medical education in alcohol and drug abuse, and is the culmination of a four-year collaborative effort among the medical school faculty of the Career Teacher Program in Alcohol and Drug Abuse. The first part contains reports, curricula, and survey data prepared for the medical education…

  6. Positive recognition program increases compliance with medication reconciliation by resident physicians in an outpatient clinic.

    PubMed

    Neufeld, Nathan J; González Fernández, Marlís; Christo, Paul J; Williams, Kayode A

    2013-01-01

    The purpose of this study was to determine if well-understood, positive reinforcement performance improvement models can successfully improve compliance by resident physicians with medication reconciliation in an outpatient clinical setting. During the preintervention phase, 36 anesthesiology residents who rotate in an outpatient pain clinic were instructed in the medication reconciliation process. During the postintervention phase, instruction was given, and then improvement was recognized publicly. Data on physician compliance were collected monthly. The authors performed a secondary analysis of the audit database, which contained 1733 patient charts. The data were divided into preintervention and postintervention phases for comparison. A 4-fold increase in compliance was found. When logistic regression was used to adjust for adaptation of resident physicians over time and year, the odds of reconciling were 82% higher postintervention. By the consistent application of this effective tool, the authors have demonstrated that sustained performance of a tedious but important task can be achieved.

  7. Oral antidiabetic therapy in a large Italian sample: drug supply and compliance for different therapeutic regimens.

    PubMed

    Vittorino Gaddi, A; Benedetto, D; Capello, F; Di Pietro, C; Cinconze, E; Rossi, E; De Sando, V; Cevenini, M; D'Alò, G

    2014-01-01

    To define the main features of patients treated with oral antidiabetics, evaluating monotherapy (MT), loose-dose combination therapy (LDCT) and fixed-dose combination therapy (FDCT); to describe medication adherence to the different therapies; and to evaluate the differences in compliance with the prescribed therapy regimen among prevalent and incident patient cohorts. This study was a retrospective cohort analysis based on the ARNO database, a national record that tracks reimbursable prescription claims submitted from selected pharmacies to the Italian national health system. In total, 169,375 subjects, from an overall population of 4,040,624 were included in this study. The patients represented 12 different local health units. Each patient had at least one oral antidiabetic prescription claim (A10B ATC code). Patients were divided into four groups according to their treatment regimen during the recruitment period (1 January 2008-31 December 2008): MT, FDCT, LDCT and switching therapy. A timespan of 5 years was considered, from 4 years before to 1 year after the index date (i.e. date of the prescription selected in the recruitment period). A medication possession ratio (MPR) with a cut-off value of 80% was used to measure medication adherence. Descriptive statistics and multiple logistic regression were used to define the objectives, while P < 0.05 was considered to indicate significance. The median age of patients (n = 169,375, prevalence 4.2%) was 70 years [interquartile range (IQR) 17], and 49.1% were females. Considering the entire sample, the median MPRs for the treatment regimens were: MT, 0.73 (IQR 0.53; 43.9% compliant); FDCT, 1 (IQR 0.29, 68,5% compliant); and LDCT, 0.89 (IQR 0.33, 60.3% compliant). FDCT and LDCT were significantly correlated with MPR. Compliance was 48.9% in the prevalent patient cohort (i.e. patients prescribed oral antidiabetic therapy in both prerecruitment and recruitment periods); median MPRs for the treatment regimens were: MT, 0

  8. Year 2000 (Y2K) computer compliance guide; guidance for FDA personnel. Food and Drug Administration. Notice.

    PubMed

    1999-05-14

    The Food and Drug Administration (FDA) is announcing the availability of a new compliance policy guide (CPG) entitled "Year 2000 (Y2K) Computer Compliance" (section 160-800). This guidance document represents the agency's current thinking on the manufacturing and distribution of domestic and imported products regulated by FDA using computer systems that may not perform properly before, or during, the transition to the year 2000 (Y2K). The text of the CPG is included in this notice. This compliance guidance document is an update to the Compliance Policy Guides Manual (August 1996 edition). It is a new CPG, and it will be included in the next printing of the Compliance Policy Guides Manual. This CPG is intended for FDA personnel, and it is available electronically to the public.

  9. A Review of Factors That Influence Individual Compliance with Mass Drug Administration for Elimination of Lymphatic Filariasis

    PubMed Central

    Krentel, Alison; Fischer, Peter U.; Weil, Gary J.

    2013-01-01

    Background The success of programs to eliminate lymphatic filariasis (LF) depends in large part on their ability to achieve and sustain high levels of compliance with mass drug administration (MDA). This paper reports results from a comprehensive review of factors that affect compliance with MDA. Methodology/Principal Findings Papers published between 2000 and 2012 were considered, and 79 publications were included in the final dataset for analysis after two rounds of selection. While results varied in different settings, some common features were associated with successful programs and with compliance by individuals. Training and motivation of drug distributors is critically important, because these people directly interact with target populations, and their actions can affect MDA compliance decisions by families and individuals. Other important programmatic issues include thorough preparation of personnel, supplies, and logistics for implementation and preparation of the population for MDA. Demographic factors (age, sex, income level, and area of residence) are often associated with compliance by individuals, but compliance decisions are also affected by perceptions of the potential benefits of participation versus the risk of adverse events. Trust and information can sometimes offset fear of the unknown. While no single formula can ensure success MDA in all settings, five key ingredients were identified: engender trust, tailor programs to local conditions, take actions to minimize the impact of adverse events, promote the broader benefits of the MDA program, and directly address the issue of systematic non-compliance, which harms communities by prolonging their exposure to LF. Conclusions/Significance This review has identified factors that promote coverage and compliance with MDA for LF elimination across countries. This information may be helpful for explaining results that do not meet expectations and for developing remedies for ailing MDA programs. Our

  10. Social, Economic, and Medical Factors Associated With Solifenacin Therapy Compliance Among Workers Who Suffer From Lower Urinary Tract Symptoms.

    PubMed

    Kosilov, Kirill Vladimirovich; Alexandrovich, Loparev Sergay; Gennadyevna, Kuzina Irina; Viktorovna, Shakirova Olga; Sergeevna, Zhuravskaya Natalia; Ivanovich, Ankudinov Ivan

    2016-09-01

    The prevalence of hyperactive-type lower urinary tract symptoms is 45.2%, with shares of overactive bladder (OAB) and urge incontinence (UI) symptoms of 10.7% and 8.2%, respectively. We investigated the possible impact of a wide range of social, economic, and medical factors on compliance with solifenacin treatment in the working population. Social, economic, and medical factors as well as the Overactive Bladder questionnaire - the OAB-q Short Form (OAB-q SF), bladder diaries, and uroflowmetry of 1,038 people who were administered solifenacin for a year were gathered from employer documentation. Among the subjects, 32% maintained their compliance with solifenacin treatment throughout the year. Only 65% of the patients had compliance exceeding 80%, and 17% of patients had compliance of ≥50%, yet less than 80% were still taking solifenacin 12 months after the beginning of this experiment. Working people whose compliance level was, at least, 80% had reliably higher (P≤0.01) average age, annual salary, and treatment efficacy, and a greater treatment satisfaction level, as well as a lack of satisfaction with other antimuscarinic treatments and higher rate of urge UI diagnosis. The same cohort also featured a lower level (P≤0.01) of caffeine abuse and lower share of salary spent purchasing solifenacin. This study has shown that compliance with solifenacin treatment is associated with a number of significant medical, social, and economic factors. The medical factors included the type of urination disorder, severity of incontinence symptoms, presence of side effects, treatment efficacy and patients' satisfaction with it, and experience using other antimuscarinic treatments. Among the social and economic factors, those with the strongest correlation to compliance were patient age, employment in medicine and education, annual income level, percentage of solifenacin purchase expenditures, and caffeine abuse. Factors with a weaker, but still significant, association were

  11. Medical Readings on Drug Abuse.

    ERIC Educational Resources Information Center

    Byrd, Oliver E.

    Summaries are presented of over 150 articles in the recent medical and psychiatric literature. Topics covered are: effects of drugs, tobacco, alcohol, drugs used in medicine, vapor sniffing, marijuana, barbiturates, tranquilizers, amphetamines, methamphetamine, lysergic acid diethylamide, other hallucinogens, heroin and the opiates, psychiatric…

  12. Association Between Loyalty to Community Pharmacy and Medication Persistence and Compliance, and the Use of Guidelines-Recommended Drugs in Type 2 Diabetes

    PubMed Central

    Dossa, Anara Richi; Grégoire, Jean-Pierre; Lauzier, Sophie; Guénette, Line; Sirois, Caroline; Moisan, Jocelyne

    2015-01-01

    Abstract Pharmacists record data on all drugs claimed and may build a personal relationship with their clients. We hypothesized that loyalty to a single pharmacy could be associated with a better quality of drug use. To assess the association between pharmacy loyalty and quality of drug use among individuals treated with oral antidiabetes drugs (OADs). This is a cohort study using Quebec Health Insurance Board data. Associations were assessed using multivariable logistic regression. New OAD users, aged ≥18 years. Individuals who filled all their prescription drugs in the same pharmacy during the first year of treatment were considered loyal. During year 2 of treatment we assessed 4 quality indicators of drug use: persistence with antidiabetes treatment, compliance with antidiabetes treatment among those considered persistent, use of an angiotensin-converting enzyme inhibitor or of an angiotensin II receptor blocker (ACEi/ARB), and use of a lipid-lowering drug. Of 124,009 individuals, 59.75% were identified as loyal. Nonloyal individuals were less likely to persist with their antidiabetes treatment (adjusted odds ratio = 0.89; 95% CI: 0.86–0.91), to comply with their antidiabetes treatment (0.82; 0.79–0.84), to use an ACEi/ARB (0.85; 0.83–0.88) and to use a lipid-lowering drug (0.83; 0.80–0.85). Quality of drug use decreased as the number of different pharmacies increased (linear contrast tests <0.001). Results underscore the important role pharmacists could play in helping their clients with chronic diseases to better manage their drug treatments. Further research is needed to determine to what extent the positive effects associated with pharmacy loyalty are specifically due to pharmacists. PMID:26166087

  13. Patterns of medical drug use - a community focus.

    PubMed Central

    Chaiton, A.; Spitzer, W. O.; Roberts, R. S.; Delmore, T.

    1976-01-01

    The pattern and extent of medical use of drugs was examined by survey in a rural Ontario community (Smithville) and a suburban (Burlington) family practice. Changes in established patterns of drug use that occur after the introduction of a nurse practitioner were also examined in the suburban practice. In both surveys 60% of respondents were using at least one medication and 30% were taking at least one medication prescribed or suggested by a doctor. There were consistently high rates of use of nonprescribed drugs at all ages, especially among females. Vitamins and tonics were the most commonly used drugs, and were taken by 25 to 28% of the respondents, 40% of whom used them on the advice of a physician. From 8.8 to 10.5% of respondents used sedatives or tranquillizers, and reduction in the prescribed use of these drugs was found among patients managed by the nurse practitioners. Self-medication is apparently unrelated to the frequency of medical consultation. PMID:1253030

  14. Compliance revisited: pharmaceutical drug trials in the era of the contract research organization.

    PubMed

    Jonvallen, Petra

    2009-12-01

    Over the past decade, the management of clinical trials of pharmaceuticals has become a veritable industry, as evidenced by the emergence and proliferation of contract research organizations (CROs) that co-ordinate and monitor trials. This article focuses on work performed by one CRO involved in the introduction of new software, modelled on industrial production processes, into clinical trial practices. It investigates how this new management technique relates to the work performed in the clinic to ensure that trial participants comply with the protocol. Using an analytical distinction between 'classical' management work and invisible work, the article contextualizes the meaning of compliance in the clinic and suggests that the work involved in producing compliance should be taken into consideration by those concerned with validity of trials, as clinical trials are put under private industrial management. The article builds on participant observation at a Swedish university hospital and interviews the nurses, dieticians, doctors and a software engineer, all part of a team involved in pharmaceutical drug trials on a potential obesity drug.

  15. The Laboratory’s Role in Opioid Pain Medication Monitoring

    PubMed Central

    2012-01-01

    Opioid analgesics are the most potent pain medications therefore they are often used for the treatment of chronic malignant and non-malignant pain. Their strong addictive potential requires close monitoring of patients on opioid therapy for possible non-compliance with prescriptions, for drug diversion, and for proof of avoidance of non-prescribed or illicit opioids. Monitoring can be performed by urine drug screens or qualitative or quantitative drug confirmation assays. Natural, semi-synthetic and synthetic opioids have dissimilar chemical structures and they undergo extensive metabolism. Phase one metabolic reactions of opioids can produce other opioids with similar structures to other, non-prescribed medications. Only detailed and concurrent analysis of parent drugs and metabolites can provide accurate clinical information regarding patient compliance. Traditional immunoassays, often used for urine drug screening, react with only a small number of opioids or only with a single medication and they exhibit variable cross reactivity with their phase two metabolites. Additionally the limit of detection of these immunoassays may not be sufficient for medical purposes, therefore clinical interpretation of immunoassay test results can be challenging. Recently liquid chromatography, mass spectrometry (LCMSMS) based assays have been adapted by many clinical laboratories. These LCMSMS tests can provide information about the presence of several opioids and their metabolites in a single sample at clinically meaningful detection limits, allowing accurate assessment of patient compliance. This review article will investigate in details the various opioids, their metabolism and the challenges the testing laboratories and ordering clinicians face. PMID:27683413

  16. Perceived treatment effectiveness, medication compliance, and complementary and alternative medicine use among veterans with bipolar disorder.

    PubMed

    Jarman, Christopher N; Perron, Brian E; Kilbourne, Amy M; Teh, Carrie Farmer

    2010-03-01

    Recent research shows a high rate of complementary and alternative medicine (CAM) use among persons with mental disorders, although correlates and patterns of CAM use are relatively unknown. This study tested whether CAM use is associated with perceived effectiveness of conventional treatment (i.e., psychotropic medication and psychotherapy) and medication compliance among persons with bipolar disorder. Patients with bipolar disorder (n = 435) were included as part of a naturalistic cohort study. Measures of CAM utilization, medication compliance, and perceptions of the effectiveness of psychotropic medications and psychotherapy were based on previously established questionnaires. Associations were tested using bivariate and multivariate analyses. Bivariate analyses showed that patients who did not perceive psychotherapy as effective at improving social, family, or job functioning reported greater CAM use. However, medication compliance was not significantly associated with use of CAM. Patients who used oral (e.g., herbal therapies) or cognitive (e.g., meditation) CAM were more likely to report that their medications were not effective at relieving manic or depressive symptoms. Users of cognitive CAM were more likely to report that their medications did not help with social, job, or family functioning, and that they did not prevent recurrences of manic or depressive episodes. None of the bivariate associations remained significant in multivariate analyses. Prior research has suggested that persons who are dissatisfied with treatment for medical conditions are more likely to use CAM therapies. However, the results of this study do not show CAM therapies to be associated with perceived effectiveness of treatments for mental health problems among this sample of persons with serious mental illnesses. This suggests that motivations for CAM use may vary by population and condition. Because few correlates of CAM use among persons with serious mental illnesses are known

  17. Patterns of Prescription Medication Diversion among Drug Dealers

    ERIC Educational Resources Information Center

    Rigg, Khary K.; Kurtz, Steven P.; Surratt, Hilary L.

    2012-01-01

    This research examined the following questions: (1) how do drug dealers acquire their inventories of prescription medications? and (2) which types of prescription medications do dealers most commonly sell? Data are drawn from a National Institute on Drug Abuse-funded research study that examined prescription drug diversion and abuse in South…

  18. Drug shortages: Implications for medical toxicology.

    PubMed

    Mazer-Amirshahi, Maryann; Hawley, Kristy L; Zocchi, Mark; Fox, Erin; Pines, Jesse M; Nelson, Lewis S

    2015-07-01

    Drug shortages have significantly increased over the past decade. There are limited data describing how shortages impact medical toxicology of drugs. To characterize drug shortages affecting the management of poisoned patients. Drug shortage data from January 2001 to December 2013 were obtained from the University of Utah Drug Information Service. Shortage data for agents used to treat poisonings were analyzed. Information on drug type, formulation, reason for shortage, shortage duration, marketing, and whether the drug was available from a single source was collected. The availability of a substitute therapy and whether substitutes were in shortage during the study period were also investigated. Of 1,751 shortages, 141 (8.1%) impacted drugs used to treat poisoned patients, and as of December 2013, 21 (14.9%) remained unresolved. New toxicology shortages increased steadily from the mid-2000s, reaching a high of 26 in 2011. Median shortage duration was 164 days (interquartile range: 76-434). Generic drugs were involved in 85.1% of shortages and 41.1% were single-source products. Parenteral formulations were often involved in shortages (89.4%). The most common medications in shortage were sedative/hypnotics (15.6%). An alternative agent was available for 121 (85.8%) drugs; however, 88 (72.7%) alternatives were also affected by shortages at some point during the study period. When present, the most common reasons reported were manufacturing delays (22.0%) and supply/demand issues (17.0%). Shortage reason was not reported for 48.2% of drugs. Toxicology drug shortages are becoming increasingly prevalent, which can result in both suboptimal treatment and medication errors from using less familiar alternatives. Drug shortages affected a substantial number of critical agents used in the management of poisoned patients. Shortages were often of long duration and for drugs without alternatives. Providers caring for poisoned patients should be aware of current shortages and

  19. Self-reported responsiveness to direct-to-consumer drug advertising and medication use: results of a national survey.

    PubMed

    Dieringer, Nicholas J; Kukkamma, Lisa; Somes, Grant W; Shorr, Ronald I

    2011-09-23

    ABSTRACT: BACKGROUND: Direct-to-consumer (DTC) marketing of pharmaceuticals is controversial, yet effective. Little is known relating patterns of medication use to patient responsiveness to DTC. METHODS: We conducted a secondary analysis of data collected in national telephone survey on knowledge of and attitudes toward DTC advertisements. The survey of 1081 U.S. adults (response rate = 65%) was conducted by the Food and Drug Administration (FDA). Responsiveness to DTC was defined as an affirmative response to the item: "Has an advertisement for a prescription drug ever caused you to ask a doctor about a medical condition or illness of your own that you had not talked to a doctor about before?" Patients reported number of prescription and over-the-counter (OTC) medicines taken as well as demographic and personal health information. RESULTS: Of 771 respondents who met study criteria, 195 (25%) were responsive to DTC. Only 7% respondents taking no prescription were responsive, whereas 45% of respondents taking 5 or more prescription medications were responsive. This trend remained significant (p trend .0009) even when controlling for age, gender, race, educational attainment, income, self-reported health status, and whether respondents "liked" DTC advertising. There was no relationship between the number of OTC medications taken and the propensity to discuss health-related problems in response to DTC advertisements (p = .4). CONCLUSION: There is a strong cross-sectional relationship between the number of prescription, but not OTC, drugs used and responsiveness to DTC advertising. Although this relationship could be explained by physician compliance with patient requests for medications, it is also plausible that DTC advertisements have a particular appeal to patients prone to taking multiple medications. Outpatients motivated to discuss medical conditions based on their exposure to DTC advertising may require a careful medication history to evaluate for therapeutic

  20. 76 FR 50741 - 2011 Parenteral Drug Association/Food and Drug Administration Joint Public Conference; Quality...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-16

    ... Compliance in Today's Regulatory Enforcement Environment AGENCY: Food and Drug Administration, HHS. ACTION... Regulatory Enforcement Environment.'' The conference will span 2\\1/2\\ days and cover current issues affecting... facilitate the development and continuous improvement of safe and effective medical products. The conference...

  1. 5-ASA in ulcerative colitis: improving treatment compliance.

    PubMed

    Prantera, Cosimo; Rizzi, Marina

    2009-09-21

    5-Aminosalicylic acid (5-ASA) compounds are a highly effective treatment for ulcerative colitis (UC). While UC patient compliance in clinical studies is over 90%, only 40% of patients in every day life take their prescribed therapy. Adherence to medication has been emphasized recently by a Cochrane meta-analysis that has suggested that future trials of 5-ASA in UC should look at patient compliance rather than drug efficacy. Better compliance can be obtained by reducing the number of tablets and times of administration. Given that the 5-ASA formulations have different delivery systems that split the active moiety in various regions of the intestine, it is particularly important that an adequate dose of the drug arrives at the inflamed part of the colon. 5-ASA Multi matrix (MMx) is a novel, high strength (1.2 g), oral formulation designed for once-daily dosing. It releases the active moiety throughout the colon. Different studies with this compound have shown that it is as effective as 5-ASA enema in the treatment of mild-to-moderate, left-sided UC, and is comparable to a pH-dependent, delayed release 5-ASA (Asacol), even if given once daily. Recently, the effectiveness in the acute phase of UC has been confirmed also in maintenance. In conclusion, at present, 5-ASA MMx seems theoretically the best agent for maintaining patient compliance, and consequently, treatment effectiveness.

  2. Urine drug testing results and paired oral fluid comparison from patients enrolled in long-term medication-assisted treatment in Tennessee.

    PubMed

    Miller, Katie L; Puet, Brandi L; Roberts, Ali; Hild, Cheryl; Carter, Jason; Black, David L

    2017-05-01

    Urine drug testing is recommended for individuals receiving medication-assisted treatment. It provides objective information for practitioners to consider and may serve as a protective factor against drug-related mortality. The primary objective of our study was to describe urine drug testing results for patients undergoing long-term medication-assisted treatment (≥6months). The secondary objective was to provide further evidence to establish oral fluid as a reliable alternative to urine. All subjects (n=639) included in the study were enrolled in one of five treatment centers in the state of Tennessee, and all urine specimens were positive for either methadone or buprenorphine. Nicotine (87%), caffeine (70%), marijuana (15%), alcohol (14%) and gabapentin (10%) were the most prevalent substances identified through urine drug testing. The presence of non-maintenance opioids (prescription and/or heroin) may represent relapse; these drugs were present in 10% of specimens tested. Evidence of illicit drug use (cocaine, heroin, marijuana and/or methamphetamine) was detected in 19% specimens. For 126 of the 639 subjects included in the study, paired oral fluid and urine test results were compared for agreement. Of the total paired urine and oral fluid tests, approximately 7% were positive for a drug in both specimen types and 91% were negative in both, resulting in an overall agreement of 98%. The study demonstrates continued use of illicit and commercially available medications in a medication-assisted treatment population undergoing long-term treatment. The results affirm the reliability of oral fluid as an alternative specimen type for compliance testing in this population. Copyright © 2017 Elsevier Inc. All rights reserved.

  3. Quality and correlates of medical record documentation in the ambulatory care setting

    PubMed Central

    Soto, Carlos M; Kleinman, Kenneth P; Simon, Steven R

    2002-01-01

    Background Documentation in the medical record facilitates the diagnosis and treatment of patients. Few studies have assessed the quality of outpatient medical record documentation, and to the authors' knowledge, none has conclusively determined the correlates of chart documentation. We therefore undertook the present study to measure the rates of documentation of quality of care measures in an outpatient primary care practice setting that utilizes an electronic medical record. Methods We reviewed electronic medical records from 834 patients receiving care from 167 physicians (117 internists and 50 pediatricians) at 14 sites of a multi-specialty medical group in Massachusetts. We abstracted information for five measures of medical record documentation quality: smoking history, medications, drug allergies, compliance with screening guidelines, and immunizations. From other sources we determined physicians' specialty, gender, year of medical school graduation, and self-reported time spent teaching and in patient care. Results Among internists, unadjusted rates of documentation were 96.2% for immunizations, 91.6% for medications, 88% for compliance with screening guidelines, 61.6% for drug allergies, 37.8% for smoking history. Among pediatricians, rates were 100% for immunizations, 84.8% for medications, 90.8% for compliance with screening guidelines, 50.4% for drug allergies, and 20.4% for smoking history. While certain physician and patient characteristics correlated with some measures of documentation quality, documentation varied depending on the measure. For example, female internists were more likely than male internists to document smoking history (odds ratio [OR], 1.90; 95% confidence interval [CI], 1.27 – 2.83) but were less likely to document drug allergies (OR, 0.51; 95% CI, 0.35 – 0.75). Conclusions Medical record documentation varied depending on the measure, with room for improvement in most domains. A variety of characteristics correlated with

  4. Case outsourcing medical device reprocessing.

    PubMed

    Haley, Deborah

    2004-04-01

    IN THE INTEREST OF SAVING MONEY, many hospitals are considering extending the life of some single-use medical devices by using medical device reprocessing programs. FACILITIES OFTEN LACK the resources required to meet the US Food and Drug Administration's tough quality assurance standards. BY OUTSOURCING, hospitals can reap the benefits of medical device reprocessing without assuming additional staffing and compliance burdens. OUTSOURCING enables hospitals to implement a medical device reprocessing program quickly, with no capital investment and minimal effort.

  5. eDrug: a dynamic interactive electronic drug formulary for medical students

    PubMed Central

    Maxwell, Simon R J; McQueen, Daniel S; Ellaway, Rachel

    2006-01-01

    What is already known about this subject Delivering education about an ever-increasing number of prescribable drugs to medical students represents a major challenge. Drug names are generally not logical or intuitive, and many students find learning them akin to learning a foreign language. Pharmacology and therapeutics teaching is struggling for visibility in some integrated medical curricula. What this study adds Development of electronic tools allowing web delivery of a restricted student formulary facilitates dynamic access to core learning materials, improves the profile of this aspect of the curriculum and is highly appreciated by students. Aims Prescribing drugs is a key responsibility of a doctor and requires a solid grounding in the relevant scientific disciplines of pharmacology and therapeutics (PT). The move away from basic science disciplines towards a more system-based and integrated undergraduate curriculum has created difficulties in the delivery of PT teaching in some medical schools. We aimed to develop a web-based strategy to overcome these problems and improve the PT learning experience. Methods We designed and introduced ‘eDrug’, a dynamic interactive web-based student formulary, as an aid to teaching and learning of PT throughout a 5-year integrated medical curriculum in a UK medical school of 1300 students. This was followed by a prospective observational study of student-reported views about its impact on their PT learning experience. Results eDrug was rated highly by students and staff, with the main benefits being increased visibility of PT in the curriculum, clear identification of core drugs, regular sourcing of drug information via direct links to accredited sources including the British National Formulary, prioritization of learning, immediate access and responsiveness. It has also served as a focus of discussion concerning core PT learning objectives amongst staff and students. Conclusions Web-based delivery of PT learning

  6. Opinions of community pharmacists on the value of a cardiovascular polypill as a means of improving medication compliance.

    PubMed

    Burns, Kharis; Turnbull, Fiona; Patel, Anushka; Peiris, David

    2012-06-01

    Cardiovascular disease is a major public health problem despite established treatment guidelines and significant healthcare expenditure worldwide. Poor medication compliance accounts in part for some of the observed evidence/practice gaps. Trials of fixed-dose combination pills are currently underway, but the attitudes of relevant health professionals to the routine use of a cardiovascular polypill are generally unknown. Pharmacists are a group of providers who play an important role in patient compliance with long-term medications. The objective was to identify the main perceived barriers to compliance and to investigate pharmacists' opinions regarding the routine use of a cardiovascular polypill. The setting was community pharmacies in the metropolitan and greater areas of New South Wales, Australia. Structured questionnaires were administered to a random sample of community pharmacists and peer-to-peer, semi-structured interviews were conducted with a sub-sample. Quantitative data were analysed using SPSS V16.0 and interviews were analysed thematically. Questionnaires were completed by 72 of the 250 pharmacists invited to participate. The major barrier to cardiovascular medication compliance identified by respondents was polypharmacy. Other barriers included patient disinterest, time constraints and costs. Most pharmacists agreed that a cardiovascular polypill could be one potential solution to poor compliance by simplifying the treatment regimen (73.6% agreed) and reducing patient costs (79.2% agreed). Inability to tailor treatment and to ascribe side effects was among some of the identified concerns. The use of a cardiovascular polypill as a means of increasing patient compliance with long-term cardiovascular preventive therapies is seen as potentially valuable by community pharmacists. © 2011 The Authors. IJPP © 2011 Royal Pharmaceutical Society.

  7. Using the costs of drug therapy to screen patients for a community pharmacy-based medication review program.

    PubMed

    Krähenbühl, Jean-Marc; Decollogny, Anne; Bugnon, Olivier

    2008-12-01

    To measure the positive predictive value (PPV) of the cost of drug therapy (threshold = 2000 Swiss francs [CHF], US$1440, 1360) as a screening criterion for identifying patients who may benefit from medication review (MR). To describe identified drug-related problems (DRPs) and expense problems (EPs), and to estimate potential savings if all recommendations were accepted. Five voluntary Swiss community pharmacies. Of 12,680 patients, 592 (4.7%) had drug therapy costs exceeding 2000 CHF over a six-month period from July 1 to December 31, 2002. This threshold limit was set to identify high-risk patients for DRPs and EPs. Three pharmacists consecutively conducted a medication review based on the pharmaceutical charts of 125 sampled patients who met the inclusion criterion. The PPV of a threshold of 2000 CHF for identifying patients who might benefit from a MR: true positives were patients with at least one DRP, while false positives were patients with no DRP. The selection based on this criterion had a PPV of 86% for detecting patients with at least one DRP and 95% if EPs were also considered. There was a mean of 2.64 (SD = 2.20) DRPs per patient and a mean of 2.14 (SD = 1.39) EPs per patient. Of these patients, 90% were over 65 years old or were treated with at least five chronic medications, two common criteria for identifying patients at risk of DRPs. The main types of DRPs were drug-drug interactions, compliance problems and duplicate drugs. Mean daily drug cost per patient was CHF 14.87 (US$10.70, 10.10). A potential savings of CHF 1.67 (US$1.20, 1.14) per day (11%) was estimated if all recommendations to solve DRPs and EPs suggested herein were implemented. Further studies should investigate whether the potential benefit of medication reviews in preventing DRPs and containing costs in this patient group can be confirmed in a real practice environment.

  8. Coverage and Awareness of and Compliance with Mass Drug Administration for Elimination of Lymphatic Filariasis in Burdwan District, West Bengal, India

    PubMed Central

    Sarkar, Aditya Prasad; Misra, Raghunath; Chakroborty, Amitava; Mondal, Tusar Kanti; Bag, Kanad

    2013-01-01

    India adopted WHO's strategy of repeated rounds of mass drug administration (MDA) with diethylcarbamazine to eliminate lymphatic filariasis. The present study attempted to assess the coverage and awareness of and compliance with MDA for elimination of lymphatic filariasis in Burdwan district of India, following MDA round in July 2010. A cross-sectional study was conducted among the four randomly-selected clusters in the district of Burdwan, West Bengal, India, covering 603 individuals from 154 households, using a predesigned pretested schedule. The drug distribution coverage, compliance, and effective coverage were 48.76 %, 70.07%, and 34.16% respectively. Only 41.4% of the study population was aware of the MDA activity. This evaluation study noted that MDA is restricted to tablet distribution only. There is an urgent need to improve compliance with drug intake through strengthening of the awareness programme involving both government health workers and community volunteers. PMID:23930334

  9. Medical students' medication communication skills regarding drug prescription-a qualitative analysis of simulated physician-patient consultations.

    PubMed

    Hauser, Katarina; Matthes, Jan

    2017-04-01

    Poor medication communication of physicians to patients is detrimental, e.g. for medication adherence. Reasons for physicians' deficits in medication communication may be unfavourable conditions in daily practice or already insufficient training during their (undergraduate) medical studies. We explored medical students' communication on new medications in simulated physician-patient conversations to identify actual deficits indicating apparent educational needs. Fifth year medical students attending a mandatory course at the University of Cologne had simulated physician-patient consultations aiming at drug prescription. In 2015, 21 consultations were recorded, transcribed and subjected to qualitative content analysis based on the method of inductive coding. Even essential information on drug therapy was often lacking (e.g. adverse effects, drug administration). Some aspects were addressed more frequently than others. This seemed to differ depending on the diagnosis underlying the particular treatment (acute event vs. chronic disease). The extent of information on drug treatments given in simulated physician-patient consultations varied significantly between students. Fifth year medical students showed appreciable deficits in communicating drug prescriptions to patients though there were remarkable inter-individual differences. Our findings suggest that communication on drug therapy to patients is no self-evolving skill. Thus, there is obviously a need for emphasizing medication communication in the training of medical students. Communication aids specifically aiming at medication communication might facilitate learning of adequate medication communication skills.

  10. TU-AB-204-02: Device Adverse Events and Compliance

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Gonzales, S.

    The responsibilities of the Food and Drug Administration (FDA) have increased since the inception of the Food and Drugs Act in 1906. Medical devices first came under comprehensive regulation with the passage of the 1938 Food, Drug, and Cosmetic Act. In 1971 FDA also took on the responsibility for consumer protection against unnecessary exposure to radiation-emitting devices for home and occupational use. However it was not until 1976, under the Medical Device Regulation Act, that the FDA was responsible for the safety and effectiveness of medical devices. This session will be presented by the Division of Radiological Health (DRH) andmore » the Division of Imaging, Diagnostics, and Software Reliability (DIDSR) from the Center for Devices and Radiological Health (CDRH) at the FDA. The symposium will discuss on how we protect and promote public health with a focus on medical physics applications organized into four areas: pre-market device review, post-market surveillance, device compliance, current regulatory research efforts and partnerships with other organizations. The pre-market session will summarize the pathways FDA uses to regulate the investigational use and commercialization of diagnostic imaging and radiation therapy medical devices in the US, highlighting resources available to assist investigators and manufacturers. The post-market session will explain the post-market surveillance and compliance activities FDA performs to monitor the safety and effectiveness of devices on the market. The third session will describe research efforts that support the regulatory mission of the Agency. An overview of our regulatory research portfolio to advance our understanding of medical physics and imaging technologies and approaches to their evaluation will be discussed. Lastly, mechanisms that FDA uses to seek public input and promote collaborations with professional, government, and international organizations, such as AAPM, International Electrotechnical Commission

  11. Self-medication practices and rational drug use habits among university students: a cross-sectional study from Kahramanmaraş, Turkey.

    PubMed

    Okyay, Ramazan Azim; Erdoğan, Ayşegül

    2017-01-01

    Self-medication refers to the use of medicines to treat self-diagnosed diseases without consulting any healthcare professionals. Irrational drug use and self-medication have serious negative consequences both on health and economy. Therefore, the aim of this study is to assess the habits related to rational use of drugs (RUD) and to estimate the prevalence of self-medication practices among university students. This cross-sectional study was conducted on university students in Kahramanmaraş. From May 2017 to June 2017 a total of 960 students filled a "Rational Use of Drugs Questionnaire". The prevalence of practicing self-medication in students was 63.4%. The most common medicines that the students had consumed without prescription were analgesics by 39.5%, antibiotics by 36.9% and cold remedies by 24.0%. The rate of students who declared that they were familiar with RUD and "rational use of antibiotics" (RUA) was 45.9%. Reading/checking the instructions in the prospectus (OR = 1.529, 95% CI [1.176-1.990]), understanding the context of the prospectus (OR = 1.893, 95% CI [1.387-2.584]), compliance with the duration of antibiotic treatment (OR = 1.597, 95% CI [1.231-2.071]) and consulting a physician in case of a side effect (OR = 1.350, 95% CI [1.037-1.757]) were significantly higher among students who were familiar with RUD as compared to who were not. Since the awareness of RUD among university students was found to be inadequate, it has critical importance to hold educational activities with the cooperation of physicians, health organizations, universities, non-governmental organizations and media to avoid negative consequences of irrational drug use and self-medication.

  12. Medication Compliance and the Aged: An Educational Challenge.

    ERIC Educational Resources Information Center

    Skolnick, Bruce D.; And Others

    1984-01-01

    Discusses physiological changes and multiple prescription regimens, which, coupled with an increased incidence of chronic disease, increase the likelihood of adverse drug reactions in the elderly. Outlines some of the research related to noncompliance of prescription medication and identifies some educational interventions guidelines for health…

  13. When to Compound Medications for Veterinary Patients.

    PubMed

    Forsythe, Lauren Eichstadt

    2017-01-01

    This article serves as a brief discussion about some of the restrictions applicable to compounding medications for veterinary patients based on U. S. Food and Drug Administration compliance policy guidelines and provides a brief summary of when it is appropriate to compound medications for veterinary patients. Copyright© by International Journal of Pharmaceutical Compounding, Inc.

  14. Examining the Relationships between Family Drug Court Program Compliance and Child Welfare Outcomes.

    PubMed

    Child, Holly; McIntyre, Dara

    2015-01-01

    Although the evidence is accumulating to substantiate the successes of Family Drug Courts (FDC), there is little research on the relationship between parent compliance and successful reunification of children with their parent(s). This study looked at data from 206 families participating in a FDC in Sacramento County, California. Four compliance measures were examined individually and collectively, after controlling for participant characteristics, using logistic regression models to determine how FDC participation benchmarks impact child reunification. This study found the best predictors of reunification was participation in support group meetings and negative tests for substance use. These findings indicate that initiatives designed to address the needs of families affected by child maltreatment and substance use should take into account and support engagement in informal, community-based activities as well as formal, clinically focused interventions.

  15. Organizational safety culture/climate and worker compliance with hazardous drug guidelines: lessons from the blood-borne pathogen experience.

    PubMed

    McDiarmid, Melissa A; Condon, Marian

    2005-07-01

    The health risks posed to health care workers (HCW) handling antineoplastic and other hazardous drugs (HDs) are well established. However, despite nearly 20 years of professional practice standards, compliance with safe handling procedures is poor. We present documentation of undercompliance with recommended safety procedures for HDs. Then, we examine a similar problem, HCW compliance with blood-borne pathogen universal precautions (UP) and its partial solution tied to the strength of a facility's safety culture. Lessons learned here may be applicable to the HD issue. It is proposed that analyzing a facility's safety culture may enlarge our understanding of the barriers contributing to HD under-compliance and suggest strategies to improve it. The Safety Culture paradigm offers many targets for intervention to enhance and promote worker compliance with safe HD handling practices thus mitigating internal exposure.

  16. Safety and compliance-related hazards in the medical practice: Part one.

    PubMed

    Calway, R C

    2001-01-01

    Safety and risk management hazards are a fact of life for the medical practice, and the costs of these incidents can place the group at significant risk of liability. Good compliance and risk management programs help minimize these incidents, improve staff morale, increase a practice's visibility in the community, and positively affect the practice's financial and operational bottom line performance. Medical practices that implement effective safety and risk management programs can realize savings in staffing costs, operational efficiency, morale, insurance premiums, and improved third-party relationships while at the same time avoiding embarrassing risks, fines, and liability. This article outlines some of the most common safety and risk management-related deficiencies seen in medical practices today. The author explains how to remedy these deficiencies and provides a self-test tool to enable the reader to assess areas within his or her own practice in need of attention.

  17. Non-Medical Prescription Drug Use among University Students

    ERIC Educational Resources Information Center

    Vidourek, Rebecca A.; King, Keith A.; Knopf, Ellen E.

    2010-01-01

    Background: Non-medical prescription drug use is an increasing problem among university students. Purpose: The present study investigated university students' involvement in non-medical prescription drug (NMPD) use and associations between use and other risky behaviors. Methods: A sample of 363 university students completed a four page survey…

  18. Drug therapy in spinal tuberculosis.

    PubMed

    Rajasekaran, S; Khandelwal, Gaurav

    2013-06-01

    Although the discovery of effective anti-tuberculosis drugs has made uncomplicated spinal tuberculosis a medical disease, the advent of multi-drug-resistant Mycobacterium tuberculosis and the co-infection of HIV with tuberculosis have led to a resurgence of the disease recently. The principles of drug treatment of spinal tuberculosis are derived from our experience in treating pulmonary tuberculosis. Spinal tuberculosis is classified to be a severe form of extrapulmonary tuberculosis and hence is included in Category I of the WHO classification. The tuberculosis bacilli isolated from patients are of four different types with different growth kinetics and metabolic characteristics. Hence multiple drugs, which act on the different groups of the mycobacteria, are included in each anti-tuberculosis drug regimen. Prolonged and uninterrupted chemotherapy (which may be 'short course' and 'intermittent' but preferably 'directly observed') is effective in controlling the infection. Spinal Multi-drug-resistant TB and spinal TB in HIV-positive patients present unique problems in management and have much poorer prognosis. Failure of chemotherapy and emergence of drug resistance are frequent due to the failure of compliance hence all efforts must be made to improve patient compliance to the prescribed drug regimen.

  19. A Prospective Randomized Trial on the Effect of Using an Electronic Monitoring Drug Dispensing Device to Improve Adherence and Compliance.

    PubMed

    Henriksson, Jarmo; Tydén, Gunnar; Höijer, Jonas; Wadström, Jonas

    2016-01-01

    Outcome after renal transplantation depends on patient compliance and adherence for early detection of complications and identification of intervention opportunities. Compliance describes the degree to which patients follow medical advice and take their medications. Adherence has been defined as the extent to which a patients' behavior coincides with clinical prescriptions. Patients were randomized 7 to 14 days after transplantation into groups with (n = 40) and without (n = 40) an electronic medication dispenser (EMD). The EMD, which was used for the 1-year study period, recorded the date and time the patient took their medications and was monitored via a web-based application. Patients were monitored for 1 year regarding outpatient follow-up visits, emergency hospitalizations, renal biopsies, rejection episodes, renal function, and blood concentration of medications. Compliance in the intervention group was 97.8% (the control group was not assessed). Number of missed doses varied significantly by weekday (P = 0.033); patients were most likely to miss doses on Saturdays and Thursdays. Patients missed a total of 11 follow-up visits. During the study, 92 biopsies were performed on 55 patients (intervention group: 32 [17]; control group, 60 [38]). Biopsy-verified rejection was three times more common among controls (13 patients vs. 4; P = 0.054, not significant). Average P-creatinine level was slightly lower in the intervention group than the control group (131 vs. 150 μmol/L, not significant), whereas mean tacrolimus was similar (7.32 vs. 7.22 ng/mL, n.s.). The EMD is associated with high compliance, and there are also indications of a lower rejection rate.

  20. Pharmacy Malpractice: The rate and prevalence of dispensing high-risk prescription-only medications at community pharmacies in Saudi Arabia.

    PubMed

    Alshammari, Thamir M; Alhindi, Salman A; Alrashdi, Ahmed M; Benmerzouga, Imaan; Aljofan, Mohamad

    2017-07-01

    To assess the compliance of community pharmacies with the regulations that prohibit the dispensing of prescription-only medications in the absence of a physician prescription in Saudi Arabia. A cross-sectional study was conducted in the period between October 2014 and January 2015. A list of 10 prescription-only medications were selected to be studied. 150 community pharmacies were visited across 6 major regions in Saudi Arabia to assess the prevalence of non-compliance among community pharmacies. Pharmacies were selected in random and researchers (disguised as patients) requested to purchase prescription-only medications in the absence of a prescription. Not all medications were purchased at once. Data were recorded per pharmacy, where pharmacies that approved dispense of the selected drug were scored as non-compliant and the pharmacies that rejected dispense of the selected drug were scored as compliant. Compliance rate was calculated per region per drug. Pharmacies based in governmental hospitals were visited in parallel. A total of 20 were visited. Data and statistical analysis were performed using Statistical Analyses Software (SAS 9.3). A total of 150 pharmacies were visited over a period of 3 months. On average, the percent approved dispense of prescription-only drugs across 6 regions in Saudi Arabia is 63% and the percent rejected dispense is 37% representing a significant non-compliance rate regarding the selected list of medications in this study. The frequency of dispense per medication across 6 major regions in Saudi Arabia is as follows: Isosorbide dinitrate (86%), Enoxaparin (82%), nitroglycerin (74%), Propranolol (73%), Verapamil (70%), Warfarin (65%), Methyldopa (64%), Ciprofloxacin (57%) and Codeine (4%). Non-compliance of community pharmacies with the law of pharmaceutical practice is at an alarming rate in the Kingdom of Saudi Arabia and authoritative figures must intervene to impede and combat such activities .

  1. Antibiotic drug advertising in medical journals.

    PubMed

    Gilad, Jacob; Moran, Lia; Schlaeffer, Francisc; Borer, Abraham

    2005-01-01

    Advertising is a leading strategy for drug promotion. We analysed 779 advertisements in 24 medical journals, 25% of which featured antibiotics. Antibiotic advertisements showed differences compared to those of other drugs. None addressed the issue of antibiotic resistance. Efforts to prevent antibiotic resistance should take antibiotic advertising into consideration.

  2. Teaching Medication Compliance to Psychiatric Residents: Placing an Orphan Topic into a Training Curriculum

    ERIC Educational Resources Information Center

    Weiden, Peter J.; Rao, Nyapati

    2005-01-01

    OBJECTIVE: Medication compliance is an orphan topic. Training in the understanding and management of noncompliance does not neatly fall within the domain of psychopharmacology, nor does it clearly fit into other core curricula areas, such as clinical interviewing or psychotherapy training. The objective of this article is to increase awareness…

  3. Association Between Loyalty to Community Pharmacy and Medication Persistence and Compliance, and the Use of Guidelines-Recommended Drugs in Type 2 Diabetes: A Cohort Study.

    PubMed

    Dossa, Anara Richi; Grégoire, Jean-Pierre; Lauzier, Sophie; Guénette, Line; Sirois, Caroline; Moisan, Jocelyne

    2015-07-01

    Pharmacists record data on all drugs claimed and may build a personal relationship with their clients. We hypothesized that loyalty to a single pharmacy could be associated with a better quality of drug use.To assess the association between pharmacy loyalty and quality of drug use among individuals treated with oral antidiabetes drugs (OADs).This is a cohort study using Quebec Health Insurance Board data. Associations were assessed using multivariable logistic regression.New OAD users, aged ≥18 years.Individuals who filled all their prescription drugs in the same pharmacy during the first year of treatment were considered loyal. During year 2 of treatment we assessed 4 quality indicators of drug use: persistence with antidiabetes treatment, compliance with antidiabetes treatment among those considered persistent, use of an angiotensin-converting enzyme inhibitor or of an angiotensin II receptor blocker (ACEi/ARB), and use of a lipid-lowering drug.Of 124,009 individuals, 59.75% were identified as loyal. Nonloyal individuals were less likely to persist with their antidiabetes treatment (adjusted odds ratio = 0.89; 95% CI: 0.86-0.91), to comply with their antidiabetes treatment (0.82; 0.79-0.84), to use an ACEi/ARB (0.85; 0.83-0.88) and to use a lipid-lowering drug (0.83; 0.80-0.85). Quality of drug use decreased as the number of different pharmacies increased (linear contrast tests <0.001).Results underscore the important role pharmacists could play in helping their clients with chronic diseases to better manage their drug treatments. Further research is needed to determine to what extent the positive effects associated with pharmacy loyalty are specifically due to pharmacists.

  4. 21 CFR 107.270 - Compliance with this subpart.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 2 2010-04-01 2010-04-01 false Compliance with this subpart. 107.270 Section 107.270 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION INFANT FORMULA Infant Formula Recalls § 107.270 Compliance with this subpart...

  5. 21 CFR 107.270 - Compliance with this subpart.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 2 2011-04-01 2011-04-01 false Compliance with this subpart. 107.270 Section 107.270 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION INFANT FORMULA Infant Formula Recalls § 107.270 Compliance with this subpart...

  6. Additional mailing phase for FIT after a medical offer phase: The best way to improve compliance with colorectal cancer screening in France.

    PubMed

    Piette, Christine; Durand, Gérard; Bretagne, Jean-François; Faivre, Jean

    2017-03-01

    Compliance with colorectal cancer screening is critical to its effectiveness. The organisation of the mass screening programme in France has recently been modified with no evaluation of the consequences. To evaluate the impact of the way the screening test is delivered on compliance. During the first six months of the screening campaign (Ille-Vilaine, Brittany), general practitioners were asked to propose a faecal immunochemical test (FIT), OC-Sensor, to individuals at average risk for colorectal cancer (n=152,097). A subset of non-participants in the medical phase (n=13,071) was randomly chosen to receive a reminder that included the screening test or a simple postal reminder without the screening test. Compliance was 31% if the screening test was proposed during a medical consultation. In non-participants during the medical phase, it was 45% in those receiving both a reminder and the screening test and 28% amongst those receiving a simple reminder. An estimated overall participation rate of 54% can be expected if non-participants in the medical phase are sent a reminder together with the screening test. In France, a compliance rate above the minimum uptake rate of 45% recommended by European Union experts can be achieved if the FIT is mailed to non-participants after the medical free-offer phase. Copyright © 2016. Published by Elsevier Ltd.

  7. Is the treatment worse than the cure? Attitudes toward medications among persons with severe mental illness.

    PubMed

    Van Dongen, C J

    1997-03-01

    1. Patients' attitudes toward taking long-term psychotropic medications and factors that may influence drug attitudes are important factors in compliance. 2. Patients in this study had generally positive drug attitudes and perceived their medications as important in preventing relapse. 3. Attitudes toward psychotropic medications may be more positive than has been assumed by mental health professionals, as patients seem to realize that the advantages of medications outweight side effects.

  8. 75 FR 18219 - Drug and Medical Device Forum on Food and Drug Administration Drug and Device Requirements and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-09

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0142] Drug and Medical Device Forum on Food and Drug Administration Drug and Device Requirements and Supplier Controls; Public Educational Forum AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public...

  9. Year 2000 compliance issues.

    PubMed

    1999-03-01

    This month, we continue our coverage of the year 2000 (Y2K) problem as it affects healthcare facilities and the professionals who work in them. We present the following articles: "Checking PCs for Y2K Compliance"--In this article, we describe the probable sources of Y2K-related errors in PCs and present simple procedures for testing the Y2K compliance of PCs and application software. "Y2K Assessment Equipment Expectations"--In this article, we review the Y2K compliance data from a small sampling of hospitals to help answer the question "What percentage of medical equipment will likely be susceptible to Y2K problems?" "Y2K Labeling of Medical Devices"--In this article, we discuss the pros and cons of instituting a program to label each medical device with its Y2K status. Also in this section, we present an updated list of organizations that support ECRI's Position Statement on the testing of medical devices for Y2K compliance, which we published in the December 1998 issue of Health Devices (27[12]). And we remind readers of the services ECRI can offer to help healthcare institutions cope with the Y2K problem.

  10. Compliance to follow up and adherence to medication in hypertensive patients in an urban informal settlement in Kenya: comparison of three models of care.

    PubMed

    Kuria, Ng'endo; Reid, Anthony; Owiti, Philip; Tweya, Hannock; Kibet, Caleb Kipkurui; Mbau, Lilian; Manzi, Marcel; Murunga, Victor; Namusonge, Tecla; Kibachio, Joseph

    2018-05-19

    To determine and compare, among three models of care, compliance to scheduled clinic appointments and adherence to anti-hypertensive medication of patients in an informal settlement of Kibera, Kenya. Routinely collected patient data were used from three health facilities, six walkway clinics and one weekend/church clinic. Patients were eligible if they had received hypertension care for more than six months. Compliance with clinic appointments and self-reported adherence to medication were determined from clinic records and compared using the Chi-square test. Univariate and multivariate logistic regression models estimated the odds of overall adherence to medication. 785 patients received hypertension treatment eligible for analysis, of whom two-thirds were women. Between them, there were 5879 clinic visits with an overall compliance to appointments of 63%. Compliance was high in the health facilities and walkway clinics but men were more likely to attend the weekend/church clinics. Self-reported adherence to medication by those complying with scheduled clinic visits was 94%. Patients in the walkway clinics were two times more likely to adhere to anti-hypertensive medication than patients at the health facility (OR 1.97, 95%CI 1.25-3.10). Walkway clinics outperformed health facilities and weekend clinics. Use of multiple sites for the management of hypertensive patients led to good compliance with scheduled clinic visits and very good self-reported adherence to medication in a low-resource setting. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

  11. Antiprogestin drugs: ethical, legal and medical issues.

    PubMed

    Cook, R J; Grimes, D A

    1992-01-01

    RU 486 allows women the choice of a medical rather than a surgical abortion, and, for most women, the choice is one of procedure, not of whether to have an abortion. Issues surrounding RU 486 were explored in an American Society of Law and Medicine conference in December 1991 entitled "Antiprogestin Drugs: Ethical, Legal and Medical Issues." An introduction to 14 conference papers provides an overview of the proceedings. Baulieu, the father of RU 486, described updated developments in its use and the medically supervised method of abortion. Bygdeman and Swahn presented their work in Sweden on combining RU 486 with a prostaglandin to make abortion more effective. They suggested that the drug may be an attractive postovulation contraceptive. Greenslad et al. discussed service delivery aspects of the use of RU 486. Holt considered the implications of use of the drug in low-resource settings. A survey of obstetricians and gynecologists, presented by Heilig, indicates that 22% more physicians would perform a medical abortion. Patient perspectives were addressed by David, who stated that measuring acceptability of an abortion technique is difficult; women have historically used whatever method is available. A collaborative research project in India and Cuba on why women chose certain methods was reported by Winikoff et al. (90% of women would choose medical abortion if faced with the choice again). Berer analyzed French data on women's perspectives on medical vs. surgical abortion. The question of adolescent use of the drug was considered by Senderowitz, who lamented the lack of data on the subject and described what is known about adolescent pregnancy. Macklin proposed a framework for ethical analysis and used facts to address ethical questions. Weinstein provided another ethical framework, to analyze whether pharmacists have a right to refuse to provide abortifacient drugs. Buc approached the subject from a legal point of view and concluded that, whereas legal problems

  12. Impact of a pharmaceutical care program on liver transplant patients' compliance with immunosuppressive medication: a prospective, randomized, controlled trial using electronic monitoring.

    PubMed

    Klein, Anja; Otto, Gerd; Krämer, Irene

    2009-03-27

    Compliance with immunosuppressive therapy plays a major role in the long-term success of organ transplantation. Thus, strategies to promote compliance in posttransplant care are of particular interest. At the pharmacy department of the University Hospital Mainz, a program for pharmaceutical care of organ transplant patients has been developed for the first time ever. The main objective of the presented study was to examine the influence of this program on liver transplant patients' compliance with immunosuppressive therapy. To measure compliance, medication event monitoring systems were used. Dosing compliance (DC) was calculated for each patient and the mean DC was compared between the two groups. Further direct and indirect methods of measuring compliance served to confirm the electronic compliance data. Pharmaceutical care of liver transplant patients led to a significant increase in compliance with the immunosuppressive therapy. The mean DC of the intervention group was 90%+/-6% compared with 81%+/-12% in the control group (P=0.015). Only two patients (10%) in the intervention group and nine patients (43%) in the control group showed a DC less than 80% (P=0.032). Furthermore, patients in the intervention group were more likely to achieve target blood levels. Patients who received pharmaceutical care with traditional patient care showed significantly better compliance with their immunosuppressive medication than patients who received only traditional patient care. Pharmaceutical care proved to be an effective intervention that should be implemented in posttransplant care.

  13. Polypharmacy, drug-drug interactions, and potentially inappropriate medications in older adults with human immunodeficiency virus infection.

    PubMed

    Greene, Meredith; Steinman, Michael A; McNicholl, Ian R; Valcour, Victor

    2014-03-01

    To describe the frequency of medication-related problems in older adults with human immunodeficiency virus (HIV) infection. Retrospective chart review. Community. HIV-positive individuals aged 60 and older and age- and sex-matched HIV-negative individuals. Total number of medications, potentially inappropriate medications (PIMs) according to the modified Beers Criteria, anticholinergic drug burden according to the Anticholinergic Risk Scale (ARS), and drug-drug interactions using the Lexi-Interact online drug interactions database. Of 89 HIV-positive participants, most were Caucasian (91%) and male (94%), with a median age of 64 (range 60-82). Common comorbidities included hyperlipidemia, hypertension, and depression. Participants were taking a median of 13 medications (range 2-38), of which only a median of four were antiretrovirals. At least one PIM was prescribed in 46 participants (52%). Sixty-two (70%) participants had at least one Category D (consider therapy modification) drug-drug interaction, and 10 (11%) had a Category X (avoid combination) interaction. One-third of these interactions were between two nonantiretroviral medications. Fifteen participants (17%) had an ARS score of 3 or greater. In contrast, HIV-negative participants were taking a median of six medications, 29% had at least one PIM, and 4% had an ARS score of 3 or greater (P < .05 for each comparison, except P = .07 for anticholinergic burden). HIV-positive older adults have a high frequency of medication-related problems, of which a large portion is due to medications used to treat comorbid diseases. These medication issues were substantially higher than HIV-negative participants. Attention to the principles of geriatric prescribing is needed as this population ages in order to minimize complications from multiple medication use. © Published 2014. This article is a U.S. Government work and is in the public domain in the U.S.A.

  14. Stability Testing of Herbal Drugs: Challenges, Regulatory Compliance and Perspectives.

    PubMed

    Bansal, Gulshan; Suthar, Nancy; Kaur, Jasmeen; Jain, Astha

    2016-07-01

    Stability testing is an important component of herbal drugs and products (HDPs) development process. Drugs regulatory agencies across the globe have recommended guidelines for the conduct of stability studies on HDPs, which require that stability data should be included in the product registration dossier. From the scientific viewpoint, numerous chemical constituents in an herbal drug are liable to varied chemical reactions under the influence of different conditions during its shelf life. These reactions can lead to altered chemical composition of HDP and consequently altered therapeutic profile. Many reports on stability testing of HDPs have appeared in literature since the last 10 years. A review of these reports reveals that there is wide variability in temperature (-80 to 100 °C), humidity (0-100%) and duration (a few hours-36 months) for stability assessment of HDPs. Of these, only 1% studies are conducted in compliance with the regulatory guidelines for stability testing. The present review is aimed at compiling all stability testing reports, understanding key challenges in stability testing of HDPs and suggesting possible solutions for these. The key challenges are classified as chemical complexity and biochemical composition variability in raw material, selection of marker(s) and influences of enzymes. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

  15. A study of reasons of non-compliance of psychiatric treatment and patients' attitudes towards illness and treatment in Qatar.

    PubMed

    Bener, Abdulbari; Dafeeah, Elnour E; Salem, Mohamad O

    2013-04-01

    The aim of this study was to examine the extent of psychiatric patients' compliance and non-compliance with treatment and examine the factors that affect compliance. Patients were recruited who were between 16 and 60 years of age and who were hospitalized with a psychiatric disorder and treated in the outpatient clinics of the psychiatry department. A total of 689 patients were approached and 564 patients agreed to participate in the study, a response rate of 81.8%. Participants were asked to complete a questionnaire that asked about socio-demographic characteristics (e.g., age, gender, nationality, level of education, occupation, marital status, and life style habits); medication(s) prescribed and the participant's response; the degree of social supervision (rated subjectively by the patient as "poor," "good," or "very good"); data also were obtained from clinical records. Data analyses explored significant associations between compliance and non-compliance and a group of relevant variables. Of the 564 patients studied, 328 (58.2%) were compliant with treatment and 236 (41.8%) were non-compliant. There was no significant difference between compliance and non-compliance in terms of gender (p = 0.471). Patients between 21-30 years of age were significantly more compliant with drug treatment than not. Non-compliance was more common among patients diagnosed with schizophrenia (28.4%), followed by depression (14.4%), and bipolar affective disorder (12.7%) (p = 0.001). Only 25% of compliant patients and 26.3% of non-compliant patients used non-psychotropic medication. Social supervision (40%) was very poor in non-compliant patients whereas 49.4% of compliant patients had very good family support. Notable reasons for non-compliance were irregular attendance to clinic (55.5%), ignorance about side effects of medication (61%), free medicine (45.8%), and a lack of education about medication (58.1%). This study revealed that non-compliance rates among psychiatry patients

  16. Drug utilization and medication costs at the end of life.

    PubMed

    Pont, Lisa; Jansen, Kristian; Schaufel, Margrete Aase; Haugen, Dagny Faksvåg; Ruths, Sabine

    2016-01-01

    In the end stages of life, drug treatment goals shift to symptom control and quality of life and as such changes in drug utilization are expected. The aim of this paper is to review the extent to which costs are considered in drug utilization research at the end of life, with a particular focus on the outcome measures being used. This systematic review identified seven studies across varied settings studies reporting both drug utilization and medication cost outcome measures. The main factors identified that impacted medication use and cost were the time period considered and the provision of specialist palliative care services. Combining drug utilization and medication cost outcomes is critical for the allocation of healthcare resources and the development of a sound health policy.

  17. Conversational pursuit of medication compliance in a Therapeutic Community for persons diagnosed with mental disorders*

    PubMed Central

    Mortari, Luigina

    2014-01-01

    Purpose In this article, we contribute to the debate on medication compliance by exploring the conversational “technologies” entailed in the process of promoting clients’ adherence to psychopharmacological prescriptions. Using a case study approach, we explore how medication-related problems are dealt with in conversational interaction between the staff members and the clients of a mental health Therapeutic Community (TC) in Italy. Method Four meetings between two staff members (Barbara and Massimo) and the clients of the TC were audio-recorded. The data were transcribed and analyzed using the method of Conversation Analysis. Results Barbara and Massimo recur to practices of topic articulation to promote talk that references the clients’ failure to take the medications. Through these practices they deal with the practical problem of mobilizing the clients’ cooperation in courses of action that fit into the institutional agenda of fostering medication adherence. Conclusions Barbara and Massimo’s conversational practices appear to reflect the assumption that medication-related problems can be reduced to compliance problems. This assumption works to make the clients accountable for their failure to take the medications while shaping a conversational environment that is unreceptive to their complaints about side effects. Implications for the understanding of mental health rehabilitation practice in TCs are discussed. Implications of RehabilitationTherapeutic community staff members should be aware of the challenges and blocks in communicating with their clients.Therapeutic communities can promote staff members’ awareness of communication challenges through reflective workshops in which they can jointly view and comment on interaction with their clients.Reflective workshops can be used to raise awareness of the presuppositions underlying therapeutic community staff members’ communication practices. PMID:24053481

  18. Understanding patient compliance and persistence with osteoporosis therapy.

    PubMed

    Gold, Deborah T

    2011-04-01

    Chronic non-terminal diseases, including postmenopausal osteoporosis, are associated with poor treatment compliance and persistence. The longer a patient with osteoporosis complies and persists with treatment, the lower the risk of fracture. Retrospective studies with emphasis on real-world data have led to a greater understanding of the factors affecting medication compliance and persistence, and their association with improved treatment outcomes. However, these data do not contain information about patient choices of medication or patient commitment to particular medication regimens. Patient preferences can affect compliance and persistence behaviours. While recent evidence questions the importance of dosing regimen in patient preferences, other recent data show that medication efficacy and safety remain the most important determinants of patient preference. Informed patient decision making about treatment options, adverse effects and outcomes can have a beneficial impact on medication-taking behaviour. Healthcare professionals play a crucial role in the management of factors associated with poor compliance and persistence with osteoporosis therapies. Education about disease consequences and differences among treatment options, as well as treatment monitoring and positive reinforcement, are crucial to improving medication compliance and persistence in osteoporotic patients.

  19. Economic messages in prescription drug advertisements in medical journals.

    PubMed

    Neumann, Peter J; Zivin Bambauer, Kara; Ramakrishnan, Vijay; Stewart, Kate A; Bell, Chaim M

    2002-09-01

    The extent to which pharmaceutical companies promote the economic advantages of their products in advertisements in medical journals, and whether such claims are supported by evidence, has not been quantified. Our objectives were to examine how often prescription drug advertisements in leading medical journals contain economic messages, and to determine the types of promotional claims made and whether supporting evidence is provided. All prescription drug advertisements appearing in six leading general medical and specialty journals in 3 selected months annually from 1990 to 1999 were reviewed. Using a standard data collection form, two reviewers examined each ad for economic content-including mention of the drug's price, value, cost saving, or cost-effectiveness. Economic messages appeared in 237 (11.1%) of the 2144 advertisements examined. Proportion of ads with economic content has increased over time (P = 0.003). Most frequently, economic ads contained statements that drugs were "less expensive" or "cost less" than alternative treatments (50.6% of economic ads). Supporting evidence for economic claims was clearly reported in 63.7% of cases, and typically referred to published drug prices rather than more detailed economic analysis. Ads for calcium channel blocking agents and ACE inhibitors frequently contained economic messages. Economic messages about prescription drugs are used in advertisements in leading medical journals and their frequency may be rising. Physicians should be aware of this phenomenon, and its potential impact on their prescribing decisions. More scrutiny of the supporting evidence underlying economic claims by the medical community and regulators may be needed.

  20. Using Social Cognitive Theory to Predict Medication Compliance Behavior in Patients with Depression in Southern United States in 2016 in a Cross-Sectional Study.

    PubMed

    Bennett, Britney; Sharma, Manoj; Bennett, Russell; Mawson, Anthony R; Buxbaum, Sarah G; Sung, Jung Hye

    2018-03-01

    Introduction: Depression is a major public health issue. One of the concerns in depression research and practice pertains to non-compliance to prescribed medications. The purpose of the study was to predict compliance with medication use for patients with depression using social cognitive theory (SCT). Based on this study it was envisaged that recommendations for interventions to enhance compliance for medication use could be developed for patients with depression. Methods: The study was conducted using cross sectional design (n=148) in southern United States with a convenience sample of clinic-based depression patients with a 37-item valid and reliable questionnaire. Sample size was calculated to be 148 using G*Power (five predictors with a 0.80 power at the 0.05 alpha level and an estimated effect size of 0.10 with an inflation by 10% for missing data). Social cognitive theory constructs of expectations, self-efficacy and self-efficacy in overcoming barriers, self-control, and environment were reified. Data were analyzed using multiple linear regression and multiple logistic regression analyses. Results: Self-control for taking medication for depression (P=0.04), expectations for taking medication for depression (P=0.025), age (P<0.0001) and race (P=0.04) were significantly related to intent for taking medication for depression (Adjusted R 2 = 0.183). In race, Blacks had lower intent to take medication for depression. Conclusion: Social cognitive theory is weakly predictive with low explained variance for taking medication for depression. It needs to be bolstered by newer theories like integrative model or multi-theory model of health behavior change for designing educational interventions aimed at enhancing compliance to medication for depression.

  1. Relationships between drug company representatives and medical students: medical school policies and attitudes of student affairs deans and third-year medical students.

    PubMed

    Sierles, Frederick; Brodkey, Amy; Cleary, Lynn; McCurdy, Frederick A; Mintz, Matthew; Frank, Julia; Lynn, Deborah Joanne; Chao, Jason; Morgenstern, Bruce; Shore, William; Woodard, John

    2009-01-01

    The authors sought to ascertain the details of medical school policies about relationships between drug companies and medical students as well as student affairs deans' attitudes about these interactions. In 2005, the authors surveyed deans and student affairs deans at all U.S. medical schools and asked whether their schools had a policy about relationships between drug companies and medical students. They asked deans at schools with policies to summarize them, queried student affairs deans regarding their attitudes about gifts, and compared their attitudes with those of students who were studied previously. Independently of each other, 114 out of 126 deans (90.5%) and 114 out of 126 student affairs deans (90.5%) responded (identical numbers are not misprints). Ten schools had a policy regarding relationships between medical students and drug company representatives. Student affairs deans were much more likely than students to perceive that gifts were inappropriate. These 2005 policies show trends meriting review by current medical schools in considering how to comply with the 2008 Association of American Medical Colleges recommendations about relationships between drug companies and medical students or physicians.

  2. Long term telemedicine study of compliance in paranoid schizophrenia.

    PubMed

    Krzystanek, Marek; Krzeszowski, Dariusz; Jagoda, Karolina; Krysta, Krzysztof

    2015-09-01

    Low compliance is one of the crucial problems of contemporary psychiatry. Relapses, deterioration of cognitive functioning, negative symptoms, neuroleptic resistance are the examples of many consequences of noncompliance in schizophrenia The study was designed to assess the compliance in the 200 patients diagnosed with paranoid schizophrenia, all in the state of symptomatic remission and on the stable neuroleptic treatment. The compliance was assessed using a telepsychiatric system, sending reminders: 1 hour before the planned dose to remind them that drug intake is approaching, and at the moment of intake to check if they took the drug. The confirmed drug intakes were counted by the telepsychiatric system. 158 patients completed the study period. The compliance in the first month of the treatment was 44.6% and decreased over the rest of the period to the level of 33.4%. 50% of the schizophrenic patients were compliant at a level lower than 37%. This group was considered the low compliance group, and in this group the compliance increased after 6 months from 9.3% to 10.3% (p<0.0001). The compliance in the group of schizophrenic patients in remission is very low. The telemedicine system improves the compliance in the patients with the worst compliance.

  3. Electronic compliance monitoring of topical treatment after ophthalmic surgery.

    PubMed

    Hermann, Manuel Marcel; Ustündag, Can; Diestelhorst, Michael

    2010-08-01

    The success of many medical treatments is built on compliance. Electronic monitoring is the most accurate tool to quantify compliance by measuring adherence. In order to assess the efficiency of a recently introduced miniature monitoring device for eye drop application, we evaluated adherence in ophthalmic patients undergoing post-operative short-term topical treatment. This pilot study enrolled 30 outpatients (mean age 61.8 +/- 18.5 years) after cataract (n = 24) and glaucoma filtration surgery (n = 6) applying fixed-combination eye drops containing prednisolone and gentamicin five times daily for 2 weeks. Patients received eye drops in conventional bottles each equipped with a miniature monitoring device recording events of application. Two patients failed to bring back the monitoring device; therefore data collected from only 28 patients could be examined. Data showed highly variable results with a mean dose compliance of 50.2%. Dose compliance was below 25% in approximately one out of five patients. Four cataract patients, but no glaucoma patient, discontinued therapy prematurely. The observed mean dosage interval was calculated for each patient and ranged 4.6-19.7 h. Thirty percent of analysed dosage intervals exceeded 12.0 h. Different patterns of compliance behaviour-like early non-persistence, drug holiday and low treatment frequency could be identified and illustrated using electronic data. Age or gender did not significantly influence compliance rates. Our pilot study demonstrates successful electronic compliance monitoring using a technology capable of continuous data recording over weeks of treatment. The low compliance rate for a relevant part of the patients demonstrates the necessity to study and improve compliance in ophthalmology. In future, new application methods and electronic application devices may improve treatment response in eye care.

  4. Illicit drug use is increasing among non-medical users of prescription drugs-Results from population-based surveys 2002-2014.

    PubMed

    Karjalainen, Karoliina; Lintonen, Tomi; Hakkarainen, Pekka

    2017-09-01

    Non-medical use of prescription drugs (NMUPD) is known to be associated with illicit drug use, but less is known about how illicit drug use has changed in NMUPD. We examined (1) the changes in illicit drug use among Finnish non-medical users of prescription drugs during the 2000s and (2) whether the trends of illicit drug use differ by non-medical use of prescription drugs in the general population. Data were derived from population-based (aged 15-69) Drug Surveys conducted in Finland in 2002, 2006, 2010 and 2014. The response rates varied between 63% and 48%. NMUPD during the last year was measured (n=252). Past-year illicit drug use among non-medical users of prescription drugs and the reference population not reporting NMUPD (n=10,967) was compared. Logistic regression was used to estimate the p-values for trends. Illicit drug use has increased notably among Finnish non-medical users of prescription drugs (from 21% to 70%, p for trend<0.001). This was not explained by the respondents' gender, age, employment status or alcohol use. Among the reference population, illicit drug use also increased statistically significantly, but much more moderately (from 2.5% to 5.4%). The difference between the trends was confirmed by an interaction test (p=0.022). NMUPD seems to be increasingly merging with illicit drug use. This indicates an increasing prevalence of polydrug use among non-medical users of prescription drugs, which may bring about more severe harms and worse health outcomes for users and more challenges in regard to treatment. Copyright © 2017 Elsevier B.V. All rights reserved.

  5. A review of compliance to treatment in Alzheimer's disease: potential benefits of a transdermal patch.

    PubMed

    Small, Gary; Dubois, Bruno

    2007-11-01

    Following prescribed medication regimens is essential for the effective treatment of any medical condition. Unfortunately, patients often fail to follow recommendations, and treatment non-compliance represents a widespread, often underestimated problem, placing tremendous burden on the healthcare system. Compliance in Alzheimer's disease (AD), a chronic neurodegenerative disease typically afflicting older adults, is especially challenging. To review factors contributing to poor treatment compliance in AD, considering the prominent role care givers often play in treatment management; and acknowledging strategic approaches, particularly modern transdermal patches, to improve compliance in this particularly susceptible population. Articles were identified by searching MEDLINE in November 2006 (search limits: 1987-2007) using the terms: compliance; Alzheimer's; treatment; and transdermal. Additional resources included bibliographies of identified articles. Strategic approaches to improving treatment compliance include: simplifying treatment regimens, using reminder packaging, and developing more patient- or caregiver-friendly modes of administration. To date, AD therapies have been administered orally. However, recent developments in alternative modes of drug delivery, such as transdermal patches, may offer effective, well-tolerated treatment options with the potential to enhance compliance. A patch containing rivastigmine (Exelon), an established cholinesterase inhibitor, has been developed and demonstrated to have good efficacy and tolerability in patients with AD. In addition, initial caregiver experience suggests preference for the patch over oral administration. Transdermal patches may be an effective way to optimize treatment compliance for AD, as well as an increasing number of other chronic conditions that typically afflict the older population, offering the possibility of more sustained clinical benefits.

  6. Integrating technology to improve medication administration.

    PubMed

    Prusch, Amanda E; Suess, Tina M; Paoletti, Richard D; Olin, Stephen T; Watts, Starann D

    2011-05-01

    The development, implementation, and evaluation of an i.v. interoperability program to advance medication safety at the bedside are described. I.V. interoperability integrates intelligent infusion devices (IIDs), the bar-code-assisted medication administration system, and the electronic medication administration record system into a bar-code-driven workflow that populates provider-ordered, pharmacist-validated infusion parameters on IIDs. The purpose of this project was to improve medication safety through the integration of these technologies and decrease the potential for error during i.v. medication administration. Four key phases were essential to developing and implementing i.v. interoperability: (a) preparation, (b) i.v. interoperability pilot, (c) preliminary validation, and (d) expansion. The establishment of pharmacy involvement in i.v. interoperability resulted in two additional safety checks: pharmacist infusion rate oversight and nurse independent validation of the autoprogrammed rate. After instituting i.v. interoperability, monthly compliance to the telemetry drug library increased to a mean ± S.D. of 72.1% ± 2.1% from 56.5% ± 1.5%, and the medical-surgical nursing unit's drug library monthly compliance rate increased to 58.6% ± 2.9% from 34.1% ± 2.6% (p < 0.001 for both comparisons). The number of manual pump edits decreased with both telemetry and medical-surgical drug libraries, demonstrating a reduction from 56.9 ± 12.8 to 14.2 ± 3.9 and from 61.2 ± 15.4 to 14.7 ± 3.8, respectively (p < 0.001 for both comparisons). Through the integration and incorporation of pharmacist oversight for rate changes, the telemetry and medical-surgical patient care areas demonstrated a 32% reduction in reported monthly errors involving i.v. administration of heparin. By integrating two stand-alone technologies, i.v. interoperability was implemented to improve medication administration. Medication errors were reduced, nursing workflow was simplified, and

  7. [Quality assessment of drug use in the elderly].

    PubMed

    Mosegui, G B; Rozenfeld, S; Veras, R P; Vianna, C M

    1999-10-01

    The objective is to evaluate the quality of medication utilization through the analysis of the pattern of usage, the degree of compliance to essential drug lists, therapeutic value and by drug interactions found among women over 60 years of age. Six hundred thirty-four women enrolled at the Open University of the Third Age were studied. Data was collected through pattern-oriented, tested questionnaires. The variables examined were related to drugs and to drug utilization. The units of analysis used were the drugs and the individual. Of 634 women that participated in the study, 9,1% did not use drugs. The number of medications taken vary from 1 to 17. The average is 4,0 drugs/woman. Among the 2.510 pharmaceutical specialties mentioned by the interviewed, 538 different substances were identified. About 26% of the medications were in agreement with the recommendations of the World Health Organization and 17% with recommendations of the "Relação Nacional de Medicamentos Essenciais". Seventeen percent of the drugs are inappropriate for use in seniors; 14,1% of the women may suffer consequences for taking drugs of the same therapeutic class, and 15, 5% are exposed to interactions. The data suggest that the pattern of the medication utilization is considerably influenced by the medical prescription and that their quality is harmed by the low selectiveness of the pharmaceutical market

  8. Relationship between compliance and persistence with osteoporosis medications and fracture risk in primary health care in France: a retrospective case-control analysis.

    PubMed

    Cotté, François-Emery; Mercier, Florence; De Pouvourville, Gérard

    2008-12-01

    Nonadherence to treatment is an important determinant of long-term outcomes in women with osteoporosis. This study was conducted to investigate the association between adherence and osteoporotic fracture risk and to identify optimal thresholds for good compliance and persistence. A secondary objective was to perform a preliminary evaluation of the cost consequences of adherence. This was a retrospective case-control analysis. Data were derived from the Thales prescription database, which contains information on >1.6 million patients in the primary health care setting in France. Cases were women aged >or=50 years who had an osteoporosis-related fracture in 2006. For each case, 5 matched controls were randomly selected. Both compliance and persistence aspects of treatment adherence were examined. Compliance was estimated based on the medication possession ratio (MPR). Persistence was calculated as the time from the initial filling of a prescription for osteoporosis medication until its discontinuation. The mean (SD) MPR was lower in cases compared with controls (58.8% [34.7%] vs 72.1% [28.8%], respectively; P < 0.001). Cases were more likely than controls to discontinue osteoporosis treatment (50.0% vs 25.3%; P < 0.001), yielding a significantly lower proportion of patients who were still persistent at 1 year (34.1% vs 40.9%; P < 0.001). MPR was the best predictor of fracture risk, with an area under the receiver-operating-characteristic curve that was higher than that for persistence (0.59 vs 0.55). The optimal MPR threshold for predicting fracture risk was >or=68.0%. Compared with less-compliant women, women who achieved this threshold had a 51% reduction in fracture risk. The difference in annual drug expenditure between women achieving this threshold and those who did not was approximately euro300. The optimal threshold for persistence with therapy was at least 6 months. Attaining this threshold was associated with a 28% reduction in fracture risk compared with

  9. A pharmaco-economic analysis of patients with schizophrenia switching to generic risperidone involving a possible compliance loss.

    PubMed

    Treur, Maarten; Heeg, Bart; Möller, Hans-Jürgen; Schmeding, Annette; van Hout, Ben

    2009-02-18

    As schizophrenia patients are typically suspicious of, or are hostile to changes they may be reluctant to accept generic substitution, possibly affecting compliance. This may counteract drug costs savings due to less symptom control and increased hospitalization risk. Although compliance losses following generic substitution have not been quantified so far, one can estimate the possible health-economic consequences. The current study aims to do so by considering the case of risperidone in Germany. An existing DES model was adapted to compare staying on branded risperidone with generic substitution. Differences include the probability of non-compliance and medication costs. Incremental probability of non-compliance after generic substitution was varied between 2.5% and 10%, while generic medication costs were assumed to be 40% lower. Effect of medication price was assessed as well as the effect of applying compliance losses to all treatment settings. The probability of staying on branded risperidone being cost-effective was calculated for various outcomes of a hypothetical study that would investigate non-compliance following generic substitution of risperidone. If the incremental probability of non-compliance after generic substitution is 2.5%, 5.0%, 7.5% and 10% respectively, incremental effects of staying on branded risperidone are 0.004, 0.007, 0.011 and 0.015 Quality Adjusted Life Years (QALYs). Incremental costs are euro757, euro343, -euro123 and -euro554 respectively. Benefits of staying on branded risperidone include improved symptom control and fewer hospitalizations. If generic substitution results in a 5.2% higher probability of non-compliance, the model predicts staying on branded risperidone to be cost-effective (NICE threshold of 30,000 per QALY gained). Compliance losses of more than 6.9% makes branded risperidone the dominant alternative. Results are sensitive to the locations at which compliance loss is applied and the price of generic risperidone

  10. Topical rosacea therapy: the importance of vehicles for efficacy, tolerability and compliance.

    PubMed

    Jackson, J Mark; Pelle, Michelle

    2011-06-01

    Many topical medications are available for the treatment of papulopustular rosacea. While treatments contain metronidazole, azelaic acid, or sodium sulfacetamide-sulfur as the active ingredient, the composition of the vehicle formulations varies widely. These vehicles come in gels, creams, lotions and foams; some ingredients are common to many vehicles, while some vehicles contain unique ingredients designed to optimize skin penetration and delivery of the active drug to its target. Vehicles can also influence tolerability, which is always a concern in patients with heightened skin sensitivity, and compliance, which is typically lower for topical treatments than oral treatments. Ideally, the vehicle of any rosacea treatment should enhance drug delivery, be nonirritating and be easy to use. Ingredients that help repair barrier function are also desirable. This review will focus on the key components of the vehicles from the most commonly used topical therapies for papulopustular rosacea and how vehicle formulations influence the delivery of active ingredient, skin barrier repair, tolerability and compliance.

  11. Continuing Medical Education Improves Gastroenterologists' Compliance with Inflammatory Bowel Disease Quality Measures.

    PubMed

    Sapir, Tamar; Moreo, Kathleen; Carter, Jeffrey D; Greene, Laurence; Patel, Barry; Higgins, Peter D R

    2016-07-01

    Low rates of compliance with quality measures for inflammatory bowel disease (IBD) have been reported for US gastroenterologists. We assessed the influence of quality improvement (QI) education on compliance with physician quality reporting system (PQRS) measures for IBD and measures related to National Quality Strategy (NQS) priorities. Forty community-based gastroenterologists participated in the QI study; 20 were assigned to educational intervention and control groups, respectively. At baseline, randomly selected charts of patients with moderate-to-severe ulcerative colitis were retrospectively reviewed for the gastroenterologists' performance of 8 PQRS IBD measures and 4 NQS-related measures. The intervention group participated in a series of accredited continuing medical education (CME) activities focusing on QI. Follow-up chart reviews were conducted 6 months after the CME activities. Independent t tests were conducted to compare between-group differences in baseline-to-follow-up rates of documented compliance with each measure. The analysis included 299 baseline charts and 300 follow-up charts. The intervention group had significantly greater magnitudes of improvement than the control group for the following measures: assessment of IBD type, location, and activity (+14 %, p = 0.009); influenza vaccination (+13 %, p = 0.025); pneumococcal vaccination (+20 %, p = 0.003); testing for latent tuberculosis before anti-TNF-α therapy (+10 %, p = 0.028); assessment of hepatitis B virus status before anti-TNF-α therapy (+9 %, p = 0.010); assessment of side effects (+17 %, p = 0.048), and counseling patients about cancer risks (+13 %, p = 0.013). QI-focused CME improves community-based gastroenterologists' compliance with IBD quality measures and measures aligned with NQS priorities.

  12. A quality improvement programme to increase compliance with an anti-infective prescribing policy

    PubMed Central

    Thakkar, Kandarp; Gilchrist, Mark; Dickinson, Edward; Benn, Jonathan; Franklin, Bryony Dean; Jacklin, Ann; Adeniran, Shola; Ali, Alisha; Brannigan, Eimear; Bamford, Kathy; Lam-Chong, Kelly; Dickinson, Edward; Gilchrist, Mark; Jacklin, Ann; Lawson, Wendy; Mehta, Roopal; Newsholme, William; Rana, Ambreen; Reynolds, Sarah; Sanderson, Frances; Wei Tan, Xin; Thakkar, Kandarp; Bracey, Gemma

    2011-01-01

    Objectives The UK Department of Health has made recommendations on safe and appropriate prescribing of anti-infectives. In response, we reviewed our anti-infective policies to ensure they were in line with best practice. As a result, a new adult anti-infective policy was launched. To help facilitate its implementation, a quality improvement programme was established, with the aim of achieving >90% compliance with the new policy. Methods Patients under the care of the medical admissions teams who had been prescribed one or more systemic anti-infectives between January and November 2008 were included in the study. Study pharmacists collected data daily on all patients, including the anti-infective(s) prescribed and indication(s) documented on either the patient's drug prescription chart or health records. A definition of compliance was developed, which required documented indication(s) and associated anti-infectives to match the anti-infective policy. A baseline compliance level was established; we then implemented a series of interventions using the plan-do-study-act (‘PDSA’) approach to monitor and improve compliance. Three overlapping intervention phases were retrospectively identified: raising awareness; education; and weekly feedback of results in the form of run charts distributed to medical teams. Results Over the 11 month study period, compliance with the policy increased from 30% to 71%. Since 2008, we have seen the average compliance increase year-on-year to over 90% in 2010 using a sustainable once weekly data collection model. Conclusions This study shows that it is possible to use quality improvement methodology to support antimicrobial stewardship within existing resources and suggests that an improvement in policy compliance can be both achieved and sustained. PMID:21642650

  13. Non-medical use of prescription drugs in Bangalore, India.

    PubMed

    Nattala, Prasanthi; Murthy, Pratima; Kandavel, Thennarasu; Cottler, Linda B

    2015-01-01

    Non-medical prescription drug use is an ongoing problem in India; however, there is paucity of literature in the Indian population. The objective of the present study is to explore the non-medical use of prescription medicines in urban Bangalore, South India (N = 717). Participants were recruited using a mall-intercept approach, wherein they were intercepted in 5 randomly selected shopping malls, and interviewed on their use of prescription medicines. The mean age of the participants was 28 years (S.D. 5). The non-medical use of different prescription medicine classes over the past 12 months was as follows: anti-inflammatories and analgesics (26%), opioids (17%), antibiotics (13%), and sedatives (12%). The majority reported "use without prescription," while "use in ways other than as prescribed" was also reported. In all cases, chemist shops were the main source of obtaining the drugs non-medically. In multivariate logistic regression analyses, non-medical use was found to be significantly associated with participants' baseline characteristics like gender, education, current employment status, and marital status. Sixty-five percent stated that although "doctor's prescription is not required for common complaints, we can decide ourselves," while 60% stated, "it's okay to deviate from a prescription as needed." One hundred percent said that "using prescription medicines is more socially acceptable, and safer, compared to alcohol or illicit drugs." These findings underscore the need for considering various contextual factors in tailoring preventive interventions for reducing non-medical use of prescription drugs.

  14. Drug Holidays From ADHD Medication: International Experience Over the Past Four Decades.

    PubMed

    Ibrahim, Kinda; Donyai, Parastou

    2015-07-01

    ADHD is managed by stimulants that are effective but can cause growth retardation. Prescribers should ideally monitor children and trial a "drug holiday" to enable catch-up growth. Our aim was to map the experience of drug holidays from ADHD medication in children and adolescents. A comprehensive search of the literature identified 22 studies published during the period 1972 to 2013. Drug holidays are prevalent in 25% to 70% of families and are more likely to be exercised during school holidays. They test whether medication is still needed and are also considered for managing medication side effects and drug tolerance. The impact of drug holidays was reported in terms of side effects and ADHD symptoms. There was evidence of a positive impact on child growth with longer breaks from medication, and shorter breaks could reduce insomnia and improve appetite. Drug holidays from ADHD medication could be a useful tool with multiple purposes: assessment, management, prevention, and negotiation. © 2014 SAGE Publications.

  15. Drug safety: withdrawn medications are only part of the picture.

    PubMed

    Rawson, Nigel S B

    2016-02-13

    In a research article published in BMC Medicine, Onakpoya and colleagues provide a historical review of withdrawals of medications for safety reasons. However, withdrawn medications are only one part of the picture about how regulatory agencies manage drug risks. Moreover, medications introduced before the increased pre-marketing regulations and post-marketing monitoring systems instituted after the thalidomide tragedy have little relevance when considering the present drug safety picture because the circumstances under which they were introduced were completely different. To more fully understand drug safety management and regulatory agency actions, withdrawals should be evaluated within the setting and timeframe in which the medications are approved, which requires information about approvals and safety warnings. Studies are needed that provide a more comprehensive current picture of the identification and evaluation of drug safety risks as well as how regulatory agencies deal with them. Please see related research article: http://bmcmedicine.biomedcentral.com/articles/10.1186/s12916-016-0553-2.

  16. Pill-poppers and dopers: a comparison of non-medical prescription drug use and illicit/street drug use among college students.

    PubMed

    Ford, Jason A; Arrastia, Meagan C

    2008-07-01

    Data from the 2001 College Alcohol Study, a national sample of U.S. college students, were used to conduct multinomial logistic regression analysis examining correlates of substance use. Students were divided into three groups based on their lifetime substance use: non-users, non-medical prescription drug use only, and illicit/street drug use only. The purpose of this analytic strategy was to examine the similarities/differences in the correlates of non-medical prescription drug use and illicit/street drug use. Findings indicate that race, age, G.P.A., sexual activity, health, binge drinking, marijuana use, social bonding and social learning measures are correlates of non-medical prescription drug use. Correlates of illicit/street drug use include gender, Hispanic ethnicity, sexual activity, binge drinking, marijuana use, social bonding and social learning measures. Finally, the focus of the paper is a comparison of students who report only non-medical prescription drug use to students who report only illicit/street drug use. Findings indicate that gender, race, marital status, sexual activity, marijuana use, and social bonding measures significantly distinguish illicit/street drug use from non-medical prescription drug use. Important implications, limitations, and future research needs were discussed.

  17. [Impulsivity: What are the consequences on compliance to rehabilitation?].

    PubMed

    Cancel, A; Naudet, F; Rousseau, P F; Millet, B; Drapier, D

    2016-08-01

    Impulsivity is a transnosographical dimension with major consequences on medical care with which psychiatrists are frequently confronted. Furthermore, compliance is a major variable that can affect the efficiency of therapeutics and hospitalizations in psychiatry. A study was carried out in three drug and alcohol rehabilitation hospitalization units to find out if impulsivity can have consequences on compliance. The studied population was composed of 85 patients aged from 18 to 70, hospitalized for one or more addiction disorders in a psychometric hospital in Vannes (France). Impulsivity was measured for all patients with the BIS-11 at the beginning of the rehabilitation program. Because no tool to evaluate a total rehab program compliance existed, a scale, used at the end of the hospitalization, was created to measure patient compliance. This score was composed of two simple numeric scales (one used by the nurses and one used by the patient's psychiatrist) and a coefficient of hospitalization duration that was the ratio of completed to planned days of hospitalization. Correlations were made between the different dimensions: impulsivity and compliance, impulsivity and hospitalization conditions, compliance and hospitalization conditions (voluntary or involuntary, planned by a psychiatrist or not, etc.). The main statistically significant result of the study was a negative correlation existing between the motor dimension of impulsivity and compliance (r=-0.37 and P=0.001). The other dimensions of impulsivity showed no significant correlation with compliance score. The study revealed that the different hospitalization conditions showed no link with compliance or impulsivity. These original results show that motor impulsive patients need an adaptation of the rehabilitation programs. Shorter programs might be more efficient. Copyright © 2015 L’Encéphale, Paris. Published by Elsevier Masson SAS. All rights reserved.

  18. FDA plan for statutory compliance. Notice of availability.

    PubMed

    1998-11-24

    The Food and Drug Administration (FDA) is announcing the availability of a document entitled "FDA Plan for Statutory Compliance" (the plan). This document is the agency's response to section 406(b) of the Food and Drug Administration Modernization Act of 1997 (FDAMA), which requires the Secretary of the Department of Health and Human Services (the Secretary) to develop a plan bringing the agency into compliance with the requirements of the Federal Food, Drug, and Cosmetic Act (the act).

  19. 76 FR 19373 - The 14th Annual Food and Drug Administration-Orange County Regulatory Affairs Educational...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-07

    ... (OCRA). The conference is intended to provide the drug, device, biologics, and dietary supplement... will be product approval, compliance, and risk management in the three medical product areas. Industry...

  20. 77 FR 24721 - The 15th Annual Food and Drug Administration-Orange County Regulatory Affairs Educational...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-25

    ... Group (OCRA). The conference is intended to provide the drug, device, biologics, and dietary supplement... product approval, compliance, and risk management in the three medical product areas. Industry speakers...

  1. Improving Coverage and Compliance in Mass Drug Administration for the Elimination of LF in Two ‘Endgame’ Districts in Indonesia Using Micronarrative Surveys

    PubMed Central

    Krentel, Alison; Damayanti, Rita; Titaley, Christiana Rialine; Suharno, Nugroho; Bradley, Mark; Lynam, Timothy

    2016-01-01

    Background As the Global Programme to Eliminate Lymphatic Filariasis (LF) approaches its 2020 goal, an increasing number of districts will enter the endgame phase where drug coverage rates from mass drug administration (MDA) are used to assess whether MDA can be stopped. As reported, the gap between reported and actual drug coverage in some contexts has overestimated the true rates, thus causing premature administration of transmission assessment surveys (TAS) that detect ongoing LF transmission. In these cases, districts must continue with additional rounds of MDA. Two districts in Indonesia (Agam District, Depok City) fit this criteria—one had not met the pre-TAS criteria and the other, had not passed the TAS criteria. In both cases, the district health teams needed insight into their drug delivery programs in order to improve drug coverage in the subsequent MDA rounds. Methodology/Principal Findings To inform the subsequent MDA round, a micronarrative survey tool was developed to capture community members’ experience with MDA and the social realm where drug delivery and compliance occur. A baseline survey was implemented after the 2013 MDA in endemic communities in both districts using the EPI sampling criteria (n = 806). Compliance in the last MDA was associated with perceived importance of the LF drugs for health (p<0.001); perceived safety of the LF drugs (p<0.001) and knowing someone in the household has complied (p<0.001). Results indicated that specialized messages were needed to reach women and younger men. Both districts used these recommendations to implement changes to their MDA without additional financial support. An endline survey was performed after the 2014 MDA using the same sampling criteria (n = 811). Reported compliance in the last MDA improved in both districts from 57% to 77% (p<0.05). Those who reported having ever taken the LF drug rose from 79% to 90% (p<0.001) in both sites. Conclusions/Significance Micronarrative surveys were shown

  2. Drug therapy problems and medication discrepancies during care transitions in super-utilizers.

    PubMed

    Surbhi, Satya; Munshi, Kiraat D; Bell, Paula C; Bailey, James E

    First, to investigate the prevalence and types of drug therapy problems and medication discrepancies among super-utilizers, and associated patient characteristics. Second, to examine the outcomes of pharmacist recommendations and estimated cost avoidance through care transitions support focused on medication management. Retrospective analysis of the pharmacist-led interventions as part of the SafeMed Program. A large nonprofit health care system serving the major medically underserved areas in Memphis, Tennessee. Three hundred seventy-four super-utilizing SafeMed participants with multiple chronic conditions and polypharmacy. Comprehensive medication review, medication therapy management, enhanced discharge planning, home visits, telephone follow-up, postdischarge medication reconciliation, and care coordination with physicians. Types of drug therapy problems, outcomes of pharmacist recommendations, estimated cost avoided, medication discrepancies, and self-reported medication adherence. Prevalence of drug therapy problems and postdischarge medication discrepancies was 80.7% and 75.4%, respectively. The most frequently occurring drug therapy problems were enrollee not receiving needed medications (33.4%), underuse of medications (16.9%), and insufficient dose or duration (11.2%). Overall 50.8% of the pharmacist recommendations were accepted by physicians and patients, resulting in an estimated cost avoidance of $293.30 per drug therapy problem identified. Multivariate analysis indicated that participants with a higher number of comorbidities were more likely to have medication discrepancies (odds ratio 1.23 [95% CI 1.05-1.44]). Additional contributors to postdischarge medication discrepancies were difficulty picking up and paying for medications and not being given necessary prescriptions before discharge. Drug therapy problems and medication discrepancies are common in super-utilizers with multiple chronic conditions and polypharmacy during transitions of care

  3. Management of Older Inpatients Who Refuse Nonpsychiatric Medication Within Birmingham and Solihull Mental Health NHS Foundation Trust

    PubMed Central

    Umotong, Eno

    2016-01-01

    Abstract The effects of poor medication compliance are well documented and include increased morbidity, early mortality, and financial costs to the society. According to national guidelines, when a competent patient refuses medication, the doctor on duty has a responsibility to ensure the patient understands their proposed course of action. The aims of this audit were to evaluate whether this consultation was taking place within older in-patient units across Birmingham and Solihull Mental Health NHS Foundation Trust when patients refuse nonpsychiatric medicines. Poor compliance was defined as more than five refusals of a nonpsychiatric medication over a 4-week period. A discussion with the duty doctor occurred in 75% of cases (27/36), which resulted in a change in prescription or compliance in 59% (16/27 patients). After patient refusal of medication, a consultation with the duty doctor is likely to improve compliance and uncover salient issues particularly in regards to capacity and drug suitability. PMID:27893528

  4. Optimizing medicines management: From compliance to concordance

    PubMed Central

    Cushing, Annie; Metcalfe, Richard

    2007-01-01

    Medication prescribed but not consumed represents a huge loss in drug and prescribing costs and an enormous waste of expensive medical time. In this article we discuss what is known about compliance and adherence, explore the concept of concordance and demonstrate its fundamental difference from both. Not all patients are ready or suitable for shared decision making in management of their condition, some still preferring a doctor-led decision but an increasing number want a partnership approach. By opening up and rebalancing the discussion about medication, we can expect a consultation which is more satisfying for both parties and flowing from this, more effective, focused prescribing of medication which is more likely to be adhered to by the patient. We examine the extent to which doctor and patient behaviors are currently compatible with this change of concept and practice, look at available consultation models which might be useful to the reflective practitioner and consider what actions on the part of the doctor and the healthcare system could promote medicine prescription and utilization in line with this new approach based on partnership. PMID:18516274

  5. Developing drug formularies for the "National Medical Holding" JSC.

    PubMed

    Akhmadyar, N S; Khairulin, B E; Amangeldy-Kyzy, S; Ospanov, M A

    2015-01-01

    One of the main problems of drug provision of multidisciplinary hospitals is the necessity to improve the efficiency of budget spending. Despite the efforts undertaken in Kazakhstan for improving the mechanism of drug distribution (creation of the Kazakhstan National Formulary, Unified National Health System, the handbook of medicines (drugs) costs in the electronic register of inpatients (ERI), having a single distributor), the number of unresolved issues still remain."National Medical Holding" JSC (NMH) was established in 2008 and unites 6 innovational healthcare facilities with up to 1431 beds (700 children and 731 adults), located in the medical cluster - which are "National Research Center for Maternal and Child Health" JSC (NRCMC), "Republic Children's Rehabilitation Center" JSC (RCRC), "Republican Diagnostic Center" JSC (RDC), "National Centre for Neurosurgery" JSC (NCN), "National Research Center for Oncology and Transplantation" JSC (NRCOT) and "National Research Cardiac Surgery Center" JSC (NRCSC). The main purpose of NMH is to create an internationally competitive "Hospital of the Future", which will provide the citizens of Kazakhstan and others with a wide range of medical services based on advanced medical technology, modern hospital management, international quality and safety standards. These services include emergency care, outpatient diagnostic services, obstetrics and gynecology, neonatal care, internal medicine, neurosurgery, cardiac surgery, transplantation, cancer care for children and adults, as well as rehabilitation treatment. To create a program of development of a drug formulary of NMH and its subsidiaries. In order to create drug formularies of NMH, analytical, software and statistical methods were used.AII subsidiary organizations of NMH (5 out of 6) except for the NRCOT have been accredited by Joint Commission International (JCI) standards, which ensure the safety of patients and clinical staff, by improving the technological

  6. Update on medical and regulatory issues pertaining to compounded and FDA-approved drugs, including hormone therapy

    PubMed Central

    Pinkerton, JoAnn V.; Pickar, James H.

    2016-01-01

    Abstract Objective: We review the historical regulation of drug compounding, concerns about widespread use of non-Food and Drug Admiistration (FDA)-approved compounded bioidentical hormone therapies (CBHTs), which do not have proper labeling and warnings, and anticipated impact of the 2013 Drug Quality and Security Act (DQSA) on compounding. Methods: US government websites were searched for documents concerning drug compounding regulation and oversight from 1938 (passage of Federal Food, Drug, and Cosmetic Act [FDCA]) through 2014, including chronologies, Congressional testimony, FDA guidelines and enforcements, and reports. The FDCA and DQSA were reviewed. PubMed and Google were searched for articles on compounded drugs, including CBHT. Results: Congress explicitly granted the FDA limited oversight of compounded drugs in a 1997 amendment to the FDCA, but the FDA has encountered obstacles in exercising that authority. After 64 patient deaths and 750 adversely affected patients from the 2012 meningitis outbreak due to contaminated compounded steroid injections, Congress passed the DQSA, authorizing the FDA to create a voluntary registration for facilities that manufacture and distribute sterile compounded drugs in bulk and reinforcing FDCA regulations for traditional compounding. Given history and current environment, concerns remain about CBHT product regulation and their lack of safety and efficacy data. Conclusions: The DQSA and its reinforcement of §503A of the FDCA solidifies FDA authority to enforce FDCA provisions against compounders of CBHT. The new law may improve compliance and accreditation by the compounding industry; support state and FDA oversight; and prevent the distribution of misbranded, adulterated, or inconsistently compounded medications, and false and misleading claims, thus reducing public health risk. PMID:26418479

  7. The teaching of drug development to medical students: collaboration between the pharmaceutical industry and medical school

    PubMed Central

    Stanley, A G; Jackson, D; Barnett, D B

    2005-01-01

    Collaboration between the medical school at Leicester and a local pharmaceutical company, AstraZeneca, led to the design and implementation of an optional third year special science skills module teaching medical students about drug discovery and development. The module includes didactic teaching about the complexities of the drug discovery process leading to development of candidate drugs for clinical investigation as well as practical experience of the processes involved in drug evaluation preclinically and clinically. It highlights the major ethical and regulatory issues concerned with the production and testing of novel therapies in industry and the NHS. In addition it helps to reinforce other areas of the medical school curriculum, particularly the understanding of clinical study design and critical appraisal. The module is assessed on the basis of a written dissertation and the critical appraisal of a drug advertisement. This paper describes the objectives of the module and its content. In addition we outline the results of an initial student evaluation of the module and an assessment of its impact on student knowledge and the opinion of the pharmaceutical industry partner. This module has proven to be popular with medical students, who acquire a greater understanding of the work required for drug development and therefore reflect more favourably on the role of pharmaceutical companies in the UK. PMID:15801942

  8. Adverse Drug Events and Medication Errors in African Hospitals: A Systematic Review.

    PubMed

    Mekonnen, Alemayehu B; Alhawassi, Tariq M; McLachlan, Andrew J; Brien, Jo-Anne E

    2018-03-01

    Medication errors and adverse drug events are universal problems contributing to patient harm but the magnitude of these problems in Africa remains unclear. The objective of this study was to systematically investigate the literature on the extent of medication errors and adverse drug events, and the factors contributing to medication errors in African hospitals. We searched PubMed, MEDLINE, EMBASE, Web of Science and Global Health databases from inception to 31 August, 2017 and hand searched the reference lists of included studies. Original research studies of any design published in English that investigated adverse drug events and/or medication errors in any patient population in the hospital setting in Africa were included. Descriptive statistics including median and interquartile range were presented. Fifty-one studies were included; of these, 33 focused on medication errors, 15 on adverse drug events, and three studies focused on medication errors and adverse drug events. These studies were conducted in nine (of the 54) African countries. In any patient population, the median (interquartile range) percentage of patients reported to have experienced any suspected adverse drug event at hospital admission was 8.4% (4.5-20.1%), while adverse drug events causing admission were reported in 2.8% (0.7-6.4%) of patients but it was reported that a median of 43.5% (20.0-47.0%) of the adverse drug events were deemed preventable. Similarly, the median mortality rate attributed to adverse drug events was reported to be 0.1% (interquartile range 0.0-0.3%). The most commonly reported types of medication errors were prescribing errors, occurring in a median of 57.4% (interquartile range 22.8-72.8%) of all prescriptions and a median of 15.5% (interquartile range 7.5-50.6%) of the prescriptions evaluated had dosing problems. Major contributing factors for medication errors reported in these studies were individual practitioner factors (e.g. fatigue and inadequate knowledge

  9. Medical consequences of drug abuse and co-occurring infections: research at the National Institute on Drug Abuse.

    PubMed

    Khalsa, Jag H; Treisman, Glenn; McCance-Katz, Elinore; Tedaldi, Ellen

    2008-01-01

    Substance abuse still remains one of the major problems in the world today, with millions of people abusing legal and illegal drugs. In addition, a billion people may also be infected with one or more infections. Both drugs of abuse and infections are associated with enormous burden of social, economic, and health consequences. This article briefly discusses a few medical consequences of drugs of abuse and infections such as human immunodeficiency virus, hepatitis C virus, psychiatric complications in hepatitis C infection, pharmacokinetic drug-drug interactions among medications used in the treatment of addiction and infections, and new drugs in development for the treatment of infections. Research is encouraged to study interactions between infections, drugs of abuse, and underlying pathophysiologic and molecular/genetic mechanisms of these interactions.

  10. Improve compliance and financial performance at the same time.

    PubMed

    Sinaiko, Jeff

    2002-01-01

    Contrary to conventional wisdom, which holds that compliance is often a net negative to a practice's financial performance, the fact is that compliance, operations, and the financial performance of a medical practice can all be simultaneously improved. This article will illustrate that the basic drivers of effective compliance are often the same fundamental business principles that lead to outstanding operations and enhanced financial performance. The lesson for medical practice managers is that if you improve compliance, you should actually improve your bottom line, not harm it.

  11. Medicalized addiction, self-medication, or nonmedical prescription drug use? How trust figures into incarcerated women's conceptualization of illicit prescription drug use.

    PubMed

    Smirnova, Michelle; Owens, Jennifer Gatewood

    2017-06-01

    Trust is crucial to optimal care. When trust is compromised, patients, doctors, and others involved in the provision of health care may not act in patients' best interests, particularly when dealing with prescription (Rx) drugs. Patients must trust that doctors are giving them the proper treatment, including access to Rx drugs only when medically necessary. They must also trust themselves to use these drugs properly. Likewise, doctors must trust the patient's ability to use medications appropriately. Given the recent rise in illicit Rx drug use in the U.S., we seek to understand how women articulate levels of trust in doctors and themselves and if different combinations of trust and distrust impact how they acquire, use, and articulate their experiences with Rx drugs. To this end, we identified and interviewed 40 women incarcerated in the U.S., who were deeply entrenched in illicit Rx drug use prior to prison. Based upon this research, we argue that illicit Rx drug use may be tied to different combinations of trust and distrust in individual doctors (interpersonal trust), the field of medicine (institutional trust), and the users themselves (self trust). How these women acquire Rx drugs: through doctors, friends, family, or the street market are influenced by combinations of interpersonal, institutional, and self trust. Copyright © 2017 Elsevier Ltd. All rights reserved.

  12. Comparison of clonazepam compliance by measurement of urinary concentration by immunoassay and LC-MS/MS in pain management population.

    PubMed

    West, Robert; Pesce, Amadeo; West, Cameron; Crews, Bridgit; Mikel, Charles; Almazan, Perla; Rosenthal, Murray; Latyshev, Sergey

    2010-01-01

    Physicians determine patient compliance with their medications by use of urine drug testing. It is known that measurement of benzodiazepines is limited by immunoassay specificity and cutoff limits and therefore does not offer physicians an accurate picture of their patients' compliance with these medications. A few studies have used lower cutoffs to demonstrate patient compliance. To define more appropriate cutoffs for compliance monitoring of patients prescribed clonazepam as determined using immunoassay and liquid chromatography-tandem mass spectrometry (LC-MS/MS). A diagnostic accuracy study of the urinary excretion of clonazepam. Millennium Laboratories performed measurements on the urinary excretion of pain patients prescribed clonazepam as the indicator test. This benzodiazepine was chosen because it forms one major metabolite, 7-aminoclonazepam which is specific for that drug. Patients whose only benzodiazepine medication was clonazepam were selected as the test population. The Millennium Laboratories test database was filtered first to select patients on clonazepam, then a second filter was used to eliminate patients with any other listed benzodiazepine medications. Samples were tested using the Microgenics DRI benzodiazepine assay with a 200 ng/mL cutoff. The same samples were quantitatively assessed for 7-aminoclonazepam by LC-MS/MS with a cutoff of 40 ng/mL. The results from the immunoassay were scored as positive or negative while the quantitative results from the LC-MS/MS were also scored as positive or negative depending upon their concentration. Samples from 180 patients met these medication criteria. The positivity rates were 21% (38 samples) by immunoassay. The positivity rate was 70% (126 samples) if the LC-MS/MS cutoff was set at 200 ng/mL. However, the positivity rate was 87% (157 samples) if the LC-MS/MS was set at 40 ng/mL. Concentration distributions revealed a significant fraction (7%) in the 40 - 100 ng/mL range. A limitation of the study

  13. Management of Older Inpatients Who Refuse Nonpsychiatric Medication Within Birmingham and Solihull Mental Health NHS Foundation Trust: Audit.

    PubMed

    Umotong, Eno

    2016-12-01

    The effects of poor medication compliance are well documented and include increased morbidity, early mortality, and financial costs to the society. According to national guidelines, when a competent patient refuses medication, the doctor on duty has a responsibility to ensure the patient understands their proposed course of action. The aims of this audit were to evaluate whether this consultation was taking place within older in-patient units across Birmingham and Solihull Mental Health NHS Foundation Trust when patients refuse nonpsychiatric medicines. Poor compliance was defined as more than five refusals of a nonpsychiatric medication over a 4-week period. A discussion with the duty doctor occurred in 75% of cases (27/36), which resulted in a change in prescription or compliance in 59% (16/27 patients). After patient refusal of medication, a consultation with the duty doctor is likely to improve compliance and uncover salient issues particularly in regards to capacity and drug suitability.

  14. Review of the 2015 Drug Supply Chain Security Act

    PubMed Central

    Brechtelsbauer, Erich D.; Pennell, Benjamin; Durham, Mary; Hertig, John B.; Weber, Robert J.

    2016-01-01

    The integrity of the pharmaceutical supply chain is threatened by medication counterfeiting, importation of unapproved and substandard drugs, and grey markets – all of which have the potential to distribute drug products with the potential for serious harm. On November 27, 2013, President Obama signed into law Title II of the Drug Quality and Security Act, now known as the Drug Supply Chain Security Act (DSCSA). Over the next 10 years, the DSCSA will require the pharmaceutical supply chain to implement medication tracking and tracing; serialization, verification, and detection of suspicious products; and strict guidelines for wholesaler licensing and reporting. This article reviews the important aspects of the DSCSA and outlines the role of health-system pharmacy leaders in ensuring compliance to the DSCSA. By verifying that medication supplies are free from adulteration and tampering, the DSCSA serves as a foundational law to ensure quality in providing patient-centered pharmacy services. PMID:27354753

  15. The practitioner, the patient and resistance to change: recent ideas on compliance.

    PubMed Central

    Butler, C; Rollnick, S; Stott, N

    1996-01-01

    Despite the explosion of research into the effect of medical advice on patient behaviour, only about 50% of patients comply with long-term drug regimens. And when it comes to changes in lifestyle, the percentage of patients who comply with medical advice often falls to single figures. Review articles on compliance have traditionally concentrated on factors that make it easier for patients to adhere to medical advice. However, recent articles urge clinicians to be more understanding of the wider implications of compliance in their patients' lives. This article focuses on how clinicians' consulting methods can affect patients' behaviour. Specifically, the authors consider the patient-centred clinical method as well as insights from and consulting techniques pioneered in the addictions field that can help to bring ambivalent patients closer to decisions about change. Instead of seeing resistance to change as rooted entirely in the patient, the authors view it as stemming partly from the way clinicians talk to patients. An advice-giving approach is usually inadequate to motivate people to embark on major lifestyle changes. Instead, the authors propose a negotiation-based framework that harnesses patients' intrinsic motivation to make their own decisions. This approach also promotes clinicians' acceptance of patients' decisions, even if these decisions run counter to current medical wisdom. PMID:8616739

  16. [Medical students and drug marketing].

    PubMed

    Calderón Larrañaga, Sara; Rabanaque Hernández, María José

    2014-03-01

    To determine the exposure of medical students to the marketing activities of the pharmaceutical industry, and identify their opinions and attitudes, and also the possible effects this exposure on their training and future professional practice. Descriptive cross-sectional. University of Zaragoza Faculty of Medicine. Third, fourth, fifth and sixth year medical students. The information was obtained using a previously adapted, self-report questionnaire on the exposure, attitudes and perceived suitability of drug marketing activities. Percentages were calculated for the categorical variables, applying the chi squared test for the comparison between the groups. A logistic regression was performed to determine the factors associated with their attitudes towards these activities. A total of 369 questionnaires were returned (93% of those attending classes). The exposure to marketing activities is high, particularly in the clinical stage (78.6% said to have received a gift non-educational gift). The students recognised the possible biases and repercussions in professional practice, although with ambiguity and contradictions. The most accepted activities are those associated with training, and the most critical attitudes appear in the clinical stage, particularly in the sixth year. Exposure to drug marketing by medical students and its possible training and professional effects is frequent and significant. The training environment is particularly open to promotional activities. The differences observed in the later years suggest the need for a specific curriculum subject and development of reflective attitudes by the students themselves. Copyright © 2013 Elsevier España, S.L. All rights reserved.

  17. In-home drug storage and utilization habits: a Sudanese study.

    PubMed

    Yousif, M A

    2002-01-01

    Community drug-use habits were studied in 469 household units in different areas of Sudan. About 97.7% of the investigated families had at least one drug product stored at home. The study revealed a high rate of self-medication (46.9%), repeated use of unfinished stored drugs (55.0%), a high rate of drug exchange among families (59.3%) and poor compliance (71.2%). In Sudan there is still a great need to educate and to motivate the general public regarding the principles of rational drug use in order to safeguard health and avoid economic losses.

  18. Modification of Tamoxifen Effectiveness by Gene Polymorphisms and Other Drugs

    DTIC Science & Technology

    2010-05-01

    study) Mr. Ahern’s three dissertation studies utilize the nationwide medical registries of Denmark to evaluate associations between prescription drugs...K Antagonists and Cancer Risk” component of the SOW. This study utilizes heart valve transplant as a proxy for treatment with a VKA, since actual...after a medication has been paid for and dispensed, we expect prescription compliance to be high. An earlier validation study of hor- mone replacement

  19. Assessment of nurse attitudes on psychiatric patient compliance with pharmacotherapy.

    PubMed

    Gajski, Anita; Karlović, Dalibor

    2008-09-01

    The aim of the study was to assess the opinion of nurses employed at a psychiatry department about compliance with pharmacotherapy in patients they provide care for on a daily basis, i.e. assessment of the nurse's role in patient compliance with prescribed medication and how much the nurse can contribute to better patient compliance with pharmacotherapy. Thirty-nine nurses, i.e. 2/3 of nurses employed at University Department of Psychiatry, Sestre milosrdnice University Hospital, participated in the study Data were collected through a structured survey/questionnaire for nurses, which is used to assess the nurses' opinion of patient compliance with pharmacotherapy. Study results confirmed the belief that nurses recognize the importance of patient compliance in daily work and are aware that this compliance depends on the patient himself, his diagnosis, the medicine he receives, his family and medical professionals involved in his medical care.

  20. 78 FR 42526 - Compliance Policy Guide Sec. 690.800 Salmonella

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-16

    ... withdrawal of ``Compliance Policy Guide Sec. 690.700 Salmonella Contamination of Dry Dog Food.'' The... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0378] Compliance Policy Guide Sec. 690.800 Salmonella in Food for Animals; Availability AGENCY: Food and Drug...

  1. Compliance, persistence, costs and quality of life in young patients treated with antipsychotic drugs: results from the COMETA study

    PubMed Central

    2013-01-01

    Background Little data is available on the real-world socio-economic burden and outcomes in schizophrenia. This study aimed to assess persistence, compliance, costs and Health-Related Quality-of-Life (HRQoL) in young patients undergoing antipsychotic treatment according to clinical practice. Methods A naturalistic, longitudinal, multicentre cohort study was conducted: we involved 637 patients aged 18–40 years, with schizophrenia or schizophreniform disorder diagnosed ≤10 years before, enrolled in 86 Italian Mental Health Centres and followed-up for 1 year. Comparisons were conducted between naïve (i.e., patients visiting the centre for the first time and starting a new treatment regimen) and non naïve patients. Results At enrolment, 84% of patients were taking atypical drugs, 3.7% typical, 10% a combination of the two classes, and 2% were untreated. During follow-up, 23% of patients switched at least once to a different class of treatment, a combination or no treatment. The mean Drug-Attitude-Inventory score was 43.4, with 94.3% of the patients considered compliant by the clinicians. On average, medical costs at baseline were 390.93€/patient-month, mostly for drug treatment (29.5%), psychotherapy (29.2%), and hospitalizations (27.1%). Patients and caregivers lost 3.5 days/patient-month of productivity. During follow-up, attitude toward treatment remained fairly similar, medical costs were generally stable, while productivity, clinical statusand HRQoL significantly improved. While no significantly different overall direct costs trends were found between naïve and non naïve patients, naïve patients showed generally a significant mean higher improvement of clinical outcomes, HRQoL and indirect costs, compared to the others. Conclusions Our results suggest how tailoring the treatment strategy according to the complex and specific patient needs make it possible to achieve benefits and to allocate more efficiently resources. This study can also provide

  2. Factors responsible for coverage and compliance in mass drug administration during the programme to eliminate lymphatic filariasis in the East Godavari District, South India.

    PubMed

    Babu, B V; Satyanarayana, K

    2003-04-01

    The paper attempts to report the factors responsible for the coverage and compliance of mass diethylcarbamazine citrate (DEC) administration, during the programme to eliminate lymphatic filariasis in the East Godavari District of Andhra Pradesh, India. The evaluation survey indicates that single dose DEC was received by 77% and taken by 64% of eligible people. Reasons for non-reception and non-consumption of the drug at household level were identified. The factors that influenced the coverage and compliance of treatment are broadly categorized as health services related, community related and drug related factors. The study identified some key factors to be followed for the success of the programme.

  3. 40 CFR 60.39e - Compliance times.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 40 Protection of Environment 6 2011-07-01 2011-07-01 false Compliance times. 60.39e Section 60.39e... PERFORMANCE FOR NEW STATIONARY SOURCES Emission Guidelines and Compliance Times for Hospital/Medical/Infectious Waste Incinerators § 60.39e Compliance times. (a) Each State in which a designated facility is...

  4. 40 CFR 60.39e - Compliance times.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 40 Protection of Environment 7 2012-07-01 2012-07-01 false Compliance times. 60.39e Section 60.39e... PERFORMANCE FOR NEW STATIONARY SOURCES Emission Guidelines and Compliance Times for Hospital/Medical/Infectious Waste Incinerators § 60.39e Compliance times. (a) Each State in which a designated facility is...

  5. A survey of attitudes, practices, and knowledge regarding drug-drug interactions among medical residents in Iran.

    PubMed

    Nabovati, Ehsan; Vakili-Arki, Hasan; Taherzadeh, Zhila; Saberi, Mohammad Reza; Abu-Hanna, Ameen; Eslami, Saeid

    2017-06-01

    Background When prescribing medications, physicians should recognize clinically relevant potential drug-drug interactions (DDIs). To improve medication safety, it is important to understand prescribers' knowledge and opinions pertaining to DDIs. Objective To determine the current DDI information sources used by medical residents, their knowledge of DDIs, their opinions about performance feedback on co-prescription of interacting drugs. Setting Academic hospitals of Mashhad University of Medical Sciences (MUMS) in Iran. Methods A questionnaire containing questions regarding demographic and practice characteristics, DDI information sources, ability to recognize DDIs, and opinions about performance feedback was distributed to medical residents of 22 specialties in eight academic hospitals in Iran. We analyzed their perception pertaining to DDIs, their performance on classifying drug pairs, and we used a linear regression model to assess the association of potential determinants on their DDI knowledge. Main Outcome Measure prescribers' knowledge and opinions pertaining to DDIs. Results The overall response rate and completion rate for 315 distributed questionnaires were 90% (n = 295) and 86% (n = 281), respectively. Among DDI information sources, books, software on mobile phone or tablet, and Internet were the most commonly-used references. Residents could correctly classify only 41% (5.7/14) of the drug pairs. The regression model showed no significant association between residents' characteristics and their DDI knowledge. An overwhelming majority of the respondents (n = 268, 95.4%) wished to receive performance feedback on co-prescription of interacting drugs in their prescriptions. They mostly selected information technology-based tools (i.e. short text message and email) as their preferred method of receiving feedback. Conclusion Our findings indicate that prescribers may have poor ability to prevent clinically relevant potential DDI occurrence, and they

  6. Electronic compliance monitoring in resistant hypertension: the basis for rational therapeutic decisions.

    PubMed

    Burnier, M; Schneider, M P; Chioléro, A; Stubi, C L; Brunner, H R

    2001-02-01

    Incomplete compliance is one of several possible causes of uncontrolled hypertension. Yet, non-compliance remains largely unrecognized and is falsely interpreted as treatment resistance, because it is difficult to confirm or exclude objectively. The goal of this study was to evaluate the potential benefits of electronic monitoring of drug compliance in the management of patients with resistant hypertension. Forty-one hypertensive patients resistant to a three-drug regimen (average blood pressure 156/ 106 +/- 23/11 mmHg, mean +/- SD) were studied prospectively. They were informed that for the next 2 months, their presently prescribed drugs would be provided in electronic monitors, without any change in treatment, so as to provide the treating physician with a measure of their compliance. Thereafter, patients were offered the possibility of prolonging the monitoring of compliance for another 2 month period, during which treatment was adapted if necessary. Monitoring of compliance alone was associated with a significant improvement of blood pressure at 2 months (145/97 +/- 20/15 mmHg, P < 0.01). During monitoring, blood pressure was normalized (systolic < 140 mmHg or diastolic < 90 mmHg) in one-third of the patients and insufficient compliance was unmasked in another 20%. When analysed according to tertiles of compliance, patients with the lowest compliance exhibited significantly higher achieved diastolic blood pressures (P = 0.04). In 30 patients, compliance was monitored up to 4 months and drug therapy was adapted whenever necessary. In these patients, a further significant decrease in blood pressure was obtained (from 150/100 +/- 18/15 to 143/94 +/- 22/11 mmHg, P = 0.04/0.02). These results suggest that objective monitoring of compliance using electronic devices may be a useful step in the management of patients with refractory hypertension, as it enables physicians to take rational decisions based on reliable and objective data of drug compliance and hence to

  7. Medication Interactions: Food, Supplements and Other Drugs

    MedlinePlus

    ... for Heart.org CPR & ECC for Heart.org Shop for Heart.org Causes for Heart.org Advocate ... Aneurysm More Medication Interactions: Food, Supplements and Other Drugs Updated:Oct 15,2014 Some foods — even healthy ...

  8. 21 CFR 1005.21 - Application for permission to bring product into compliance.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Application for permission to bring product into compliance. 1005.21 Section 1005.21 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND... Procedures § 1005.21 Application for permission to bring product into compliance. Application for permission...

  9. Satisfaction, compliance and communication.

    PubMed

    Ley, P

    1982-11-01

    The literature on communication, compliance, and patient satisfaction is selectively reviewed. As in earlier reviews, it is concluded that dissatisfaction with communication remains widespread, as does lack of compliance with medical advice. Related factors include poor transmission of information from patient to doctor, low understandability of communications addressed to the patient, and low levels of recall of information by patients. There does not appear to be any evidence that provision of additional information leads to adverse reactions by patients. Theoretical approaches to communication and compliance are described, and it is concluded that these should be used to direct future research.

  10. Coverage of, and compliance with, mass drug administration under the programme to eliminate lymphatic filariasis in India: a systematic review.

    PubMed

    Babu, Bontha V; Babu, Gopalan R

    2014-09-01

    India's mass drug administration (MDA) programme to eliminate lymphatic filariasis (PELF) covers all 250 endemic districts, but compliance with treatment is not adequate for the programme to succeed in eradicating this neglected tropical disease. The objective of our study was to systematically review published studies on the coverage of and compliance with MDA under the PELF in India. We searched several databases-PubMed/Medline, Google Scholar, CINAHL/EBSCO, Web of Knowledge (including Web of Science) and OVID-and by applying selection criteria identified a total of 36 papers to include in the review. Overall MDA coverage rates varied between 48.8% and 98.8%, while compliance rates ranged from 20.8% to 93.7%. The coverage-compliance gap is large in many MDA programmes. The effective level of compliance, ≥65%, was reported in only 10 of a total of 31 MDAs (5 of 20 MDAs in rural areas and 2 of 12 MDAs in urban areas). The review has identified a gap between coverage and compliance, and potentially correctable causes of this gap. These causes need to be addressed if the Indian programme is to advance towards elimination of lymphatic filariasis. © The Author 2014. Published by Oxford University Press on behalf of Royal Society of Tropical Medicine and Hygiene. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  11. Physician Verbal Compliance-Gaining Strategies and Patient Satisfaction

    ERIC Educational Resources Information Center

    Olynick, Janna; Iliopulos, Alexandra; Li, Han Z.

    2017-01-01

    Purpose: The patient healthcare experience is a complex phenomenon, as is encouraging patient compliance with medical advice. To address this multifaceted relationship, the purpose of this paper is to explore the ways resident physicians verbally encourage patient compliance and the relationship between these compliance-seeking strategies and…

  12. Robotic Assistance in Medication Management: Development and Evaluation of a Prototype.

    PubMed

    Schweitzer, Marco; Hoerbst, Alexander

    2016-01-01

    An increasing number of elderly people and the prevalence of multimorbid conditions often lead to age-related problems for patients in handling their common polypharmaceutical, domestic everyday medication. Ambient Assisted Living therefore provides means to support an elderly's everyday life. In the present paper we investigated the viability of using a commercial mass-produced humanoid robot system to support the domestic medication of an elderly person. A prototypical software application based on the NAO-robot platform was implemented to remind the patient for drug intakes, check for drug-drug-interactions, document the compliance and assist through the complete process of individual medication. A technical and functional evaluation of the system in a laboratory setting revealed versatile and viable results, though further investigations are needed to examine the practical use in an applied field.

  13. Combining naltrexone and prazosin in a single oral medication decreases alcohol drinking more effectively than does either drug alone.

    PubMed

    Froehlich, Janice C; Hausauer, Brett J; Rasmussen, Dennis D

    2013-10-01

    Naltrexone (NTX) is underutilized in clinical treatment settings because its efficacy is modest, and it is not effective for all alcoholics and, when it is effective, a significant number of alcoholics fail to maintain initial treatment gains and subsequently relapse to heavy drinking. This has slowed acceptance of NTX by the treatment community, and there is a clear need for additional treatments for alcoholism and alcohol use disorders. Given that NTX and prazosin can each reduce alcohol drinking in rats selectively bred for alcohol preference and high voluntary alcohol drinking (alcohol-preferring "P" rats), we tested whether a combination of NTX + prazosin is more effective in decreasing alcohol drinking than is either drug alone. P rats were given access to a 15% (v/v) alcohol solution for 2 hours daily. Rats were fed NTX and prazosin, alone or in combination, prior to onset of the daily 2-hour alcohol access period for 4 weeks and the effect of drug treatment on alcohol and water intake was assessed. During the first week of treatment, neither a low dose of NTX, nor prazosin, was effective in decreasing alcohol intake when each drug was administered alone, but combining the 2 drugs in a single medication significantly reduced alcohol intake. The combination was as effective as was a higher dose of NTX. Using a low dose of NTX in combination with prazosin may reduce the potential for undesirable side effects early in treatment which, in turn, may improve patient compliance and result in a more successful outcome when NTX is used for treating alcoholism and alcohol use disorders. Combining low-dose NTX and prazosin in a single medication may be more useful than is either drug alone for treating both inpatient and outpatient alcoholics and heavy drinkers early in the treatment process. Copyright © 2013 by the Research Society on Alcoholism.

  14. Turkish Final Year Medical Students’ Exposure to and Attitudes Concerning Drug Company Interactions: A Perspective from a Minimally Regulated Environment for Medical Students

    PubMed Central

    Beyhun, Nazim Ercument; Kolayli, Cevriye Ceyda; Can, Gamze; Topbas, Murat

    2016-01-01

    Interactions between drug companies and medical students may affect evidence-based medical practice and patient safety. The aim of this study was to assess drug company–medical student interactions in a medical faculty where limited specific national or institutional regulations apply between drug companies and medical students. The objectives of the study were to determine the exposure and attitudes of final year medical students in terms of drug company–medical student and physician interactions, to identify factors affecting those attitudes and to provide data for policymakers working on the regulation of interactions between drug companies and medical students. This anonymous questionnaire-based study of 154 medical final year medical students at the Karadeniz Technical University Medical Faculty, Trabzon, Turkey, in April and May 2015 attracted a response rate of 92.2% (n/N, 154/164). Exposure to interaction with a pharmaceutical representative was reported by 90.3% (139/154) of students, and 68.8% (106/154) reported experiencing such interaction alongside a resident. In addition, 83.7% (128/153) of students reported an interaction during internship. Furthermore, 69.9% (107/153) of students agreed that interactions influence physicians’ prescription preferences, while 33.1% (51/154) thought that a medical student should never accept a gift from a drug company and 24.7% (38/154) agreed with the proposition that “drug companies should not hold activities in medical faculties”. Students with rational prescription training expressed greater agreement with the statement “I am skeptical concerning the information provided by drug companies during interactions” than those who had not received such training, and this finding was supported by logistic regression [O.R.(C.I), p -3.7(1.2–11.5), p = 0.022]. Acceptance of advertisement brochures was found to significantly reduce the level of agreement with the proposition that “A physician should not

  15. Turkish Final Year Medical Students' Exposure to and Attitudes Concerning Drug Company Interactions: A Perspective from a Minimally Regulated Environment for Medical Students.

    PubMed

    Beyhun, Nazim Ercument; Kolayli, Cevriye Ceyda; Can, Gamze; Topbas, Murat

    2016-01-01

    Interactions between drug companies and medical students may affect evidence-based medical practice and patient safety. The aim of this study was to assess drug company-medical student interactions in a medical faculty where limited specific national or institutional regulations apply between drug companies and medical students. The objectives of the study were to determine the exposure and attitudes of final year medical students in terms of drug company-medical student and physician interactions, to identify factors affecting those attitudes and to provide data for policymakers working on the regulation of interactions between drug companies and medical students. This anonymous questionnaire-based study of 154 medical final year medical students at the Karadeniz Technical University Medical Faculty, Trabzon, Turkey, in April and May 2015 attracted a response rate of 92.2% (n/N, 154/164). Exposure to interaction with a pharmaceutical representative was reported by 90.3% (139/154) of students, and 68.8% (106/154) reported experiencing such interaction alongside a resident. In addition, 83.7% (128/153) of students reported an interaction during internship. Furthermore, 69.9% (107/153) of students agreed that interactions influence physicians' prescription preferences, while 33.1% (51/154) thought that a medical student should never accept a gift from a drug company and 24.7% (38/154) agreed with the proposition that "drug companies should not hold activities in medical faculties". Students with rational prescription training expressed greater agreement with the statement "I am skeptical concerning the information provided by drug companies during interactions" than those who had not received such training, and this finding was supported by logistic regression [O.R.(C.I), p -3.7(1.2-11.5), p = 0.022]. Acceptance of advertisement brochures was found to significantly reduce the level of agreement with the proposition that "A physician should not accept any gift from a

  16. Determinants of compliance with malaria chemoprophylaxis among French soldiers during missions in inter-tropical Africa

    PubMed Central

    2010-01-01

    Background The effectiveness of malaria chemoprophylaxis is limited by the lack of compliance whose determinants are not well known. Methods The compliance with malaria chemoprophylaxis has been estimated and analysed by validated questionnaires administered before and after the short-term missions (about four months) in five tropical African countries of 2,093 French soldiers from 19 military companies involved in a prospective cohort study. "Correct compliance" was defined as "no missed doses" of daily drug intake during the entire mission and was analysed using multiple mixed-effect logistic regression model. Results The averaged prevalence rate of correct compliance was 46.2%, ranging from 9.6%to 76.6% according to the companies. Incorrect compliance was significantly associated with eveningness (p = 0.028), a medical history of clinical malaria (p < 0.001) and a perceived mosquito attractiveness inferior or superior to the others (p < 0.007). Correct compliance was significantly associated with the systematic use of protective measures against mosquito bites (p < 0.001), the type of military operations (combat vs. training activities, p < 0.001) and other individual factors (p < 0.05). Conclusions The identification of circumstances and profiles of persons at higher risk of lack of compliance would pave the way to specifically targeted strategies aimed to improve compliance with malaria chemoprophylaxis and, therefore, its effectiveness. PMID:20128921

  17. Wireless Technologies, Ubiquitous Computing and Mobile Health: Application to Drug Abuse Treatment and Compliance with HIV Therapies.

    PubMed

    Boyer, Edward W; Smelson, David; Fletcher, Richard; Ziedonis, Douglas; Picard, Rosalind W

    2010-06-01

    Beneficial advances in the treatment of substance abuse and compliance with medical therapies, including HAART, are possible with new mobile technologies related to personal physiological sensing and computational methods. When incorporated into mobile platforms that allow for ubiquitous computing, these technologies have great potential for extending the reach of behavioral interventions from clinical settings where they are learned into natural environments.

  18. Denial of pain medication by health care providers predicts in-hospital illicit drug use among individuals who use illicit drugs.

    PubMed

    Ti, Lianping; Voon, Pauline; Dobrer, Sabina; Montaner, Julio; Wood, Evan; Kerr, Thomas

    2015-01-01

    Undertreated pain is common among people who use illicit drugs (PWUD), and can often reflect the reluctance of health care providers to provide pain medication to individuals with substance use disorders. To investigate the relationship between having ever been denied pain medication by a health care provider and having ever reported using illicit drugs in hospital. Data were derived from participants enrolled in two Canadian prospective cohort studies between December 2012 and May 2013. Using bivariable and multivariable logistic regression analyses, the relationship between having ever been denied pain medication by a health care provider and having ever reported using illicit drugs in hospital was examined. Among 1053 PWUD who had experienced ≥ 1 hospitalization, 452 (44%) reported having ever used illicit drugs while in hospital and 491(48%) reported having ever been denied pain medication. In a multivariable model adjusted for confounders, having been denied pain medication was positively associated with having used illicit drugs in hospital (adjusted OR 1.46 [95% CI 1.14 to 1.88]). The results of the present study suggest that the denial of pain medication is associated with the use of illicit drugs while hospitalized. These findings raise questions about how to appropriately manage addiction and pain among PWUD and indicate the potential role that harm reduction programs may play in hospital settings.

  19. Denial of pain medication by health care providers predicts in-hospital illicit drug use among individuals who use illicit drugs

    PubMed Central

    Ti, Lianping; Voon, Pauline; Dobrer, Sabina; Montaner, Julio; Wood, Evan; Kerr, Thomas

    2015-01-01

    BACKGROUND: Undertreated pain is common among people who use illicit drugs (PWUD), and can often reflect the reluctance of health care providers to provide pain medication to individuals with substance use disorders. OBJECTIVE: To investigate the relationship between having ever been denied pain medication by a health care provider and having ever reported using illicit drugs in hospital. METHODS: Data were derived from participants enrolled in two Canadian prospective cohort studies between December 2012 and May 2013. Using bivariable and multivariable logistic regression analyses, the relationship between having ever been denied pain medication by a health care provider and having ever reported using illicit drugs in hospital was examined. RESULTS: Among 1053 PWUD who had experienced ≥1 hospitalization, 452 (44%) reported having ever used illicit drugs while in hospital and 491 (48%) reported having ever been denied pain medication. In a multivariable model adjusted for confounders, having been denied pain medication was positively associated with having used illicit drugs in hospital (adjusted OR 1.46 [95% CI 1.14 to 1.88]). CONCLUSIONS: The results of the present study suggest that the denial of pain medication is associated with the use of illicit drugs while hospitalized. These findings raise questions about how to appropriately manage addiction and pain among PWUD and indicate the potential role that harm reduction programs may play in hospital settings. PMID:25562839

  20. Evaluation of medication alerts in electronic health records for compliance with human factors principles

    PubMed Central

    Phansalkar, Shobha; Zachariah, Marianne; Seidling, Hanna M; Mendes, Chantal; Volk, Lynn; Bates, David W

    2014-01-01

    Introduction Increasing the adoption of electronic health records (EHRs) with integrated clinical decision support (CDS) is a key initiative of the current US healthcare administration. High over-ride rates of CDS alerts strongly limit these potential benefits. As a result, EHR designers aspire to improve alert design to achieve better acceptance rates. In this study, we evaluated drug–drug interaction (DDI) alerts generated in EHRs and compared them for compliance with human factors principles. Methods We utilized a previously validated questionnaire, the I-MeDeSA, to assess compliance with nine human factors principles of DDI alerts generated in 14 EHRs. Two reviewers independently assigned scores evaluating the human factors characteristics of each EHR. Rankings were assigned based on these scores and recommendations for appropriate alert design were derived. Results The 14 EHRs evaluated in this study received scores ranging from 8 to 18.33, with a maximum possible score of 26. Cohen's κ (κ=0.86) reflected excellent agreement among reviewers. The six vendor products tied for second and third place rankings, while the top system and bottom five systems were home-grown products. The most common weaknesses included the absence of characteristics such as alert prioritization, clear and concise alert messages indicating interacting drugs, actions for clinical management, and a statement indicating the consequences of over-riding the alert. Conclusions We provided detailed analyses of the human factors principles which were assessed and described our recommendations for effective alert design. Future studies should assess whether adherence to these recommendations can improve alert acceptance. PMID:24780721

  1. Questionnaire on the awareness of generic drugs among outpatients and medical staff.

    PubMed

    Hoshi, S; Kimura, H

    2008-06-01

    Generic drugs are not as widely used in Japan as they are in the West. The objective of this study was to survey the awareness of generic drugs among outpatients and medical staff and propose methods of promoting the use of generic drugs. Our survey showed that 86.7% of respondents were aware of generic drugs. This is a higher awareness rate than that in a survey of other groups conducted last year. One reason to explain this higher awareness is the recent increase in generic drug advertisements both in newspapers and on television. However, a point of note is that generic drug usage has not increased. Our survey also showed that generic drug awareness was differed widely among age groups, as younger respondents were much more aware of generic drugs than older respondents. Still, about 40% of respondents who were aware of generic drugs did not realize that they were less expensive than name-brand drugs ? including 30% of medical staff. In addition to continuing advertisement of generic drugs in the media, medical doctors and pharmacists should also be encouraged to endorse the use of generic drugs. Furthermore a new system allowing for substitution prescriptions started in April 2008 and consequently pharmacists can now play an important role in promoting the use of generic drugs.

  2. 10 CFR 707.13 - Medical review of results of tests for illegal drug use.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 4 2010-01-01 2010-01-01 false Medical review of results of tests for illegal drug use... Procedures § 707.13 Medical review of results of tests for illegal drug use. (a) All test results shall be submitted for medical review by the MRO. A confirmed positive test for drugs shall consist of an initial...

  3. Motivations for Non-Medical Prescription Drug Use: A Mixed Methods Analysis

    PubMed Central

    Rigg, Khary K.; Ibañez, Gladys E.

    2010-01-01

    Despite a dramatic increase in the non-medical use of prescription drugs among illicit drug users, their motives for abusing prescription drugs are still largely unknown. The objective of this study was to 1) determine the motivations for engaging in the non-medical use of prescription opioids and sedatives among street-based illicit drug users, methadone maintenance patients, and residential drug treatment clients, 2) examine associations between prescription drug abuse motivations and gender, age, race/ethnicity, and user group, and 3) examine associations between specific motivations and prescription drug abuse patterns. Quantitative surveys (n = 684) and in-depth interviews (n = 45) were conducted with a diverse sample of prescription drug abusers in South Florida between March 2008 and November 2009. The three most common motivations reported were “to get high”, “to sleep”, and “for anxiety/stress”. There were age, race/ethnicity, and gender differences by motives. Prescription drug abuse patterns were also found to be associated with specific motivations. While additional research is needed, these findings serve to inform appropriate prevention and treatment initiatives for prescription drug abusers. PMID:20667680

  4. Handwashing compliance.

    PubMed

    Antoniak, Jeannie

    2004-09-01

    Undeniably, handwashing remains the single most effective and cost-efficient method for preventing and reducing the transmission of nosocomial infections. Yet the rates and outbreaks of nosocomial infections in Canadian and international healthcare institutions continue to increase. Shaikh Khalifa Medical Center developed and implemented a multidisciplinary approach to address the challenges of handwashing compliance among nurses and healthcare workers in its workplace setting. Supported by evidence-based research, the approach consisted of three components: collaboration, implementation and evaluation. The use of the alcohol-based hand rub sanitizer or "solution" was integral to the multidisciplinary approach. Ongoing education, communication and a committed leadership were essential to promote and sustain handwashing compliance.

  5. Adverse Drug Events caused by Serious Medication Administration Errors

    PubMed Central

    Sawarkar, Abhivyakti; Keohane, Carol A.; Maviglia, Saverio; Gandhi, Tejal K; Poon, Eric G

    2013-01-01

    OBJECTIVE To determine how often serious or life-threatening medication administration errors with the potential to cause patient harm (or potential adverse drug events) result in actual patient harm (or adverse drug events (ADEs)) in the hospital setting. DESIGN Retrospective chart review of clinical events that transpired following observed medication administration errors. BACKGROUND Medication errors are common at the medication administration stage for hospitalized patients. While many of these errors are considered capable of causing patient harm, it is not clear how often patients are actually harmed by these errors. METHODS In a previous study where 14,041 medication administrations in an acute-care hospital were directly observed, investigators discovered 1271 medication administration errors, of which 133 had the potential to cause serious or life-threatening harm to patients and were considered serious or life-threatening potential ADEs. In the current study, clinical reviewers conducted detailed chart reviews of cases where a serious or life-threatening potential ADE occurred to determine if an actual ADE developed following the potential ADE. Reviewers further assessed the severity of the ADE and attribution to the administration error. RESULTS Ten (7.5% [95% C.I. 6.98, 8.01]) actual adverse drug events or ADEs resulted from the 133 serious and life-threatening potential ADEs, of which 6 resulted in significant, three in serious, and one life threatening injury. Therefore 4 (3% [95% C.I. 2.12, 3.6]) serious and life threatening potential ADEs led to serious or life threatening ADEs. Half of the ten actual ADEs were caused by dosage or monitoring errors for anti-hypertensives. The life threatening ADE was caused by an error that was both a transcription and a timing error. CONCLUSION Potential ADEs at the medication administration stage can cause serious patient harm. Given previous estimates of serious or life-threatening potential ADE of 1.33 per 100

  6. The roles of safety and compliance in determining effectiveness of topical therapy for psoriasis.

    PubMed

    Stein Gold, Linda; Corvari, Linda

    2007-01-01

    Topical therapies are the mainstays of treatment for most patients with psoriasis because they relieve symptoms and reduce the size and severity of lesions. The effectiveness of a therapeutic intervention is a function of drug efficacy (determined by randomized clinical trial results) and patient safety and compliance. Alterations in any parameter can have a substantial influence on clinical outcomes. However, topical agents can be associated with unwanted and potentially toxic side effects that make physicians reluctant to prescribe them, and patients intentionally discontinue treatment with these topical agents. To maximize effectiveness and improve patient safety, physicians may prescribe medications in combination, sequential, or rotational therapeutic regimens. This treatment strategy has the potential to improve the overall efficacy and safety of topical therapy; however, the effectiveness of this method may be compromised because the complexity of the therapeutic regimen may decrease patient compliance. Newer topical therapies that have a convenient once-daily dosing schedule are needed and will have important implications for patient compliance.

  7. Determinants of compliance behaviours among patients undergoing hemodialysis in Malaysia.

    PubMed

    Chan, Yoke Mun; Zalilah, Mohd Shariff; Hii, Sing Ziunn

    2012-01-01

    Patients with end stage renal disease often fail to follow prescribed dietary and fluid regimen, leading to undesirable outcomes. This study aimed to examine and identify factors influencing dietary, fluid, medication and dialysis compliance behaviours in patients undergoing hemodialysis. This was a cross-sectional study which employed purposive sampling design. A total of 188 respondents were recruited from 14 dialysis centres in Malaysia between 2008-2011. Self-reported compliance behaviours and biochemical measurements were used as evaluation tools. Compliance rates of dietary, fluid, medication and dialysis were 27.7%, 24.5%, 66.5% and 91.0%, respectively. Younger, male, working patients and those with longer duration on hemodialysis were found more likely to be non-compliant. Lacks of adequate knowledge, inadequate self-efficacy skills, forgetfulness and financial constraints were the major perceived barriers towards better compliance to fluid, dietary, medication and dialysis, respectively. Healthcare professionals should recognise the factors hindering compliance from the patients' perspective while assisting them with appropriate skills in making necessary changes possible.

  8. Personal digital assistant-based drug information sources: potential to improve medication safety.

    PubMed

    Galt, Kimberly A; Rule, Ann M; Houghton, Bruce; Young, Daniel O; Remington, Gina

    2005-04-01

    This study compared the potential for personal digital assistant (PDA)-based drug information sources to minimize potential medication errors dependent on accurate and complete drug information at the point of care. A quality and safety framework for drug information resources was developed to evaluate 11 PDA-based drug information sources. Three drug information sources met the criteria of the framework: Eprocrates Rx Pro, Lexi-Drugs, and mobileMICROMEDEX. Medication error types related to drug information at the point of care were then determined. Forty-seven questions were developed to test the potential of the sources to prevent these error types. Pharmacists and physician experts from Creighton University created these questions based on the most common types of questions asked by primary care providers. Three physicians evaluated the drug information sources, rating the source for each question: 1=no information available, 2=some information available, or 3 = adequate amount of information available. The mean ratings for the drug information sources were: 2.0 (Eprocrates Rx Pro), 2.5 (Lexi-Drugs), and 2.03 (mobileMICROMEDEX). Lexi-Drugs was significantly better (mobileMICROMEDEX t test; P=0.05; Eprocrates Rx Pro t test; P=0.01). Lexi-Drugs was found to be the most specific and complete PDA resource available to optimize medication safety by reducing potential errors associated with drug information. No resource was sufficient to address the patient safety information needs for all cases.

  9. Estimation of the clinical and economic consequences of non-compliance with antimicrobial treatment of canine skin infections.

    PubMed

    Van Vlaenderen, Ilse; Nautrup, Barbara Poulsen; Gasper, Sabina M

    2011-05-01

    The goal of this study was to estimate the health and economic consequences of non-compliance with oral antimicrobial treatment in dogs with superficial pyoderma, wounds or abscesses in the US. A mathematical model (Markov model) which simulated treatment with long-term injectable cefovecin versus oral amoxicillin/clavulanic acid was developed and accounted for the effect of non-compliance on clinical outcomes and mean total treatment costs per patient. Efficacy parameters considered in the model were derived from clinical studies. Treatment failure due to oral antimicrobial treatment non-compliance was approximated from published data at 13.6%. US cost data for 2009 were derived from public sources. When non-compliance was considered as a cause of treatment failure with oral medication, the long-term injectable antibiotic was more effective than oral comparator (162 versus 158 days without clinical signs). Mean total treatment costs were lower with cefovecin (USD 376.74) versus amoxicillin/clavulanic acid (USD 382.34) in dogs of 25 kg; and cefovecin remained cost-saving up to a body weight of 31 kg. In large dogs, cefovecin was more costly; however, total therapy costs were less than 6% greater than with amoxicillin/clavulanic acid. Accordingly the higher drug and administration costs of the long-term injectable antibiotic were totally or substantially offset when non-compliance was considered as reason for treatment failure with oral medication. The model also allowed for the estimation of the impact of various non-compliance scenarios. Copyright © 2011 Elsevier B.V. All rights reserved.

  10. An Institutional Program to Increase Compliance with Clinicaltrials.gov Requirements.

    PubMed

    Kelly-Pumarol, Issis; Andrews, Joseph E

    2018-01-01

    Recent National Institutes of Health policy changes have expanded the number of research studies that must be registered in clinicaltrials.gov beyond the requirements of the Food and Drug Administration Amendments Act of 2007. The International Committee of Medical Journal Editors has also adopted a policy that requires registration of research in a public database. The goal was to increase the transparency of research by reporting the original endpoints of a study, and to discern whether primary endpoints were excluded in subsequent publications. Efforts to increase openness and accountability in clinical trials are likely to strengthen public trust. However, first investigators and study staff must be educated about the requirements, and staff must be prepared to offer support to researchers in navigating the clinicaltrials.gov system. For academic institutions, maintaining compliance requires continuous oversight so that problems can be identified centrally and addressed with investigators. At Wake Forest University Health Sciences, because researchers often did not realize they were out of compliance, we implemented a program to assist them and provide oversight. We introduced standard operating procedures, provided education and assistance to investigators, and engaged leadership about consequences of compliance, resulting in increased budget support for a full-time employee in this role. As a result of these changes, compliance increased from 22% to 92% over 4 months. These approaches may help other institutions become compliant with registration requirements more quickly.

  11. Prescription drug advertising: is it a driving force on drug pricing?

    PubMed

    Millstein, Lloyd G

    2003-01-01

    It has been shown that drug companies will sell more drugs when they use DTC advertising, but it is also true that many consumers who are suffering--unaware there is help for their symptoms--will learn from these ads that help is available. Advertising to consumers, like advertising to professionals, will continue to be one of the best methods of providing information. Of course, healthcare professionals also have the sales representatives, their colleagues, medical journals, and medical conventions as additional options for needed information. The consumer may or may not use other methods, such as the Internet, the library or friends or family, but the advertising is a starting point for a dialogue. If the DTC ad provides consumers with "information," which is different from "advertising," the drug company will be providing a worthwhile service to consumers and potential patients. No doubt consumers will begin demanding higher quality information from DTC ads and will frown upon the ads that are blatantly trying just to sell a drug. It will also reap the benefits of improved consumer awareness and patient compliance. A DTC ad that is consumer-friendly, does not use fear appeal, is educational in tone, and downplays the "hard sell" and hype will go a long way in offering important information to the casual observer. Oversight by the FDA will ensure the information meets the requirements they have set down for prescription drug advertising. That is, advertising will be truthful and fairly balanced and will meet what the government, consumers and, no doubt, the medical community wants. Attempting to control drug costs, by controlling advertising, will not be an easy task. This has an implication across all product areas, not just drugs. DTC advertising has become a lightening rod for cost containment issues, but is it alone driving demand for prescription products? I don't think so.

  12. A randomized controlled trial to assess the effect of a medication plan containing drug administration recommendations on patients' drug knowledge after 2 months.

    PubMed

    Send, A F J; Peters-Klimm, F; Bruckner, T; Haefeli, W E; Seidling, H M

    2017-02-01

    Patients' drug administration errors are often promoted by poor drug knowledge resulting from inadequate oral or written information. It has previously been shown that a medication plan enhanced with graphical and textual information on drug handling (enhanced medication plan) proved to immediately increase patients' drug knowledge. This study aimed to evaluate the effect of the enhanced medication plan on drug knowledge in outpatients after 2 months (intervention group) compared to patients with a simple medication plan with standard information (control group). We recruited patients using ≥5 drugs in four family practices in Germany. After inclusion, patients' knowledge on handling of their drugs was assessed using three questions from a standardized catalog. Thereafter, patients were randomized to the intervention or control group. After 2 months, drug knowledge was reassessed with three different questions from the same standardized catalog. Of 120 enrolled patients, 75% of participants in the control group (42/60 patients) and 78% of participants in the intervention group (46/60; P = 0·71) completed the study. Baseline drug knowledge was similar in both groups (43·7% vs. 40·6% correct answers). After 2 months, patients' drug knowledge showed an absolute increase of 23·2% in the intervention group (P < 0·01) and was unchanged in the control group (46·0%; P = 0·70). The enhanced medication plan outperformed the effect of a simple medication plan and persistently increased the fraction of correct answers of polypharmacy patients. This demonstrates that the enhanced medication plan may be a useful tool in promoting drug knowledge. © 2016 John Wiley & Sons Ltd.

  13. Drugs and Medical Devices: Adverse Events and the Impact on Women's Health.

    PubMed

    Carey, Jennifer L; Nader, Nathalie; Chai, Peter R; Carreiro, Stephanie; Griswold, Matthew K; Boyle, Katherine L

    2017-01-01

    A large number of medications and medical devices removed from the market by the US Food and Drug Administration over the past 4 decades specifically posed greater health risks to women. This article reviews the historical background of sex and gender in clinical research policy and describes several approved drugs and devices targeted for use in women that have caused major morbidity and mortality. The intended population for the medications and devices, population affected, approval process, and the basic and legal actions taken against the medication/drug company are also discussed. It is recognized that women are still at risk for harm from unsafe medications and devices, and continued improvements in legislation that promotes inclusion of sex and gender into the design and analysis of research will improve safety for both men and women. Copyright © 2017 Elsevier HS Journals, Inc. All rights reserved.

  14. Medical problems related to recreational drug use at nocturnal dance parties.

    PubMed

    Van Sassenbroeck, Diederik K; Calle, Paul A; Rousseau, Filip M; Verstraete, Alain G; Belpaire, Frans M; Monsieurs, Koenraad G; Haentjens, Raoul; Allonsius, Jacques; Van Brantegem, Jean; Haenen, Wim; Buylaert, Walter A

    2003-12-01

    During 'I love techno' (edition 2001), an indoor rave party attended by 37 000 people, data about medical problems (especially drug-related problems) were collected. To place these data in a wider perspective, a similar registration was done during 'De Nacht', a traditional New Year's Eve dance party held at the same location and attended by 12 000 people. Furthermore, a prospective study on the time course of the level of consciousness (Glasgow Coma Score) and blood concentrations of illicit drugs, especially gamma-hydroxybutyrate was set up. The results revealed that during 'I love techno' the incidence of medical problems was high (66.5/10 000 attendees), but not higher than during 'De Nacht' (70.0/10 000 attendees). At 'I love techno', however, mainly illicit drugs were used, more frequently leading to severe drug-related medical problems. The observations in patients with a drug-related medical problem who had taken gamma-hydroxybutyrate showed that for a given level of consciousness the gamma-hydroxybutyrate concentrations may show important differences, that the transition from coma (Glasgow Coma Score < or =7) to full recovery (Glasgow Coma Score 15) takes only 30-60 min (and only a small decrease in gamma-hydroxybutyrate concentrations), and that the time it takes before a comatose patient reaches the above-mentioned 'transition area' may be a few hours.

  15. Causal chain mapping: a novel method to analyse treatment compliance decisions relating to lymphatic filariasis elimination in Alor, Indonesia.

    PubMed

    Krentel, Alison; Aunger, Robert

    2012-08-01

    Many public health programmes require individuals to comply with particular behaviours that are novel to them, for example, acquiring new eating habits, accepting immunizations or taking a new medication. In particular, mass drug administration programmes only work to reduce the prevalence of a disease if significant proportions of the target population take the drug in question. In such cases, knowledge of the factors most likely to lead to high levels of compliance is crucial to the programme's success. Existing models of compliance tend to either address interpersonal, organizational or psychological causes independently. Here, the authors present a formal method for analysing relevant factors in the situational context of the compliant behaviour, identifying how these factors may interact within the individual. This method was developed from semantic network analysis, augmented to include environmental and demographic variables to show causal linkages-hence the name 'causal chain mapping'. The ability of this method to provide significant insight into the actual behaviour of individuals is demonstrated with examples from a mass drug administration for lymphatic filariasis in Alor District, Indonesia. The use of this method is likely to help identify key components influencing compliance, and thus make any public health programme reliant on the adoption of novel behaviours more effective.

  16. Herb-drug interactions. Interactions between saw palmetto and prescription medications.

    PubMed

    Bressler, Rubin

    2005-11-01

    Patients over age 50 typically present with one chronic disease per decade. Each chronic disease typically requires long-term drug therapy, meaning most older patients require several drugs to maintain health. Simultaneously, use of complementary and alternative medicine (CAM) has increased in the United States in the last 20 years, reaching 36% in 2002; herbal medicine use accounts for approximately 22% of all CAM use. Older adults often add herbal medicines to prescription medications, yet do not always inform their physicians. The drug metabolizing enzyme systems process all compounds foreign to the body, including prescription and herbal medications. Therefore use of both medicinals simultaneously has a potential for adverse interactions. This review, which discusses saw palmetto, is the last in a series covering the documented interactions among the top 5 efficacious herbal medicines and prescription drugs.

  17. Compliance with eye care in glaucoma patients with comorbid depression.

    PubMed

    Weiss, Guy A; Goldich, Yakov; Bartov, Elisha; Burgansky-Eliash, Zvia

    2011-12-01

    Comorbid depression may play an important role in non-compliance with medical treatment among patients with chronic illnesses. Glaucoma is a potentially blinding chronic disease requiring life-long commitment to medical therapy. Failure to adhere to anti-glaucoma treatment may lead to disease progression and visual loss. To assess the prevalence of depressive symptoms in glaucoma patients and the association between these symptoms and non-compliance with anti-glaucoma therapy. In this cross-sectional observational study, compliance with pharmacotherapy was assessed with the Morisky Medication Adherence questionnaire (eight items). Screening for depression was performed by means of the CES-D (Center for Epidemiologic Studies Depression scale). The association between depression and compliance rates was analyzed. The study group comprised 76 glaucoma patients; 19.7% of the subjects were classified as non-compliant (Morisky cutoff 10) and 21.1% suffered from depression (CES-D cutoff > or = 16). We found a similar level of non-compliance when comparing depressed with non-depressed glaucoma patients. However, a correlation was observed between the level of depression and the level of non-compliance (P = 0.04). Our study revealed a similar rate of depression in glaucoma patients and the general israeli population. The presence of depression was not associated with the presence of non-compliance, yet the level of depression was associated with the level of non-compliance.

  18. Compliance and schizophrenia: the predictive potential of insight into illness, symptoms, and side effects.

    PubMed

    Kao, Yu-Cheng; Liu, Yia-Ping

    2010-01-01

    Personal beliefs about medication compliance have been reliably associated with emotional and behavioral response to mental health problems and health outcomes. This notion has been extensively explored in relation to mental illness. In the current study, a questionnaire designed to assess beliefs about medication compliance (the medication adherence rating scale [MARS]) was translated into Taiwanese to explore beliefs about compliance in schizophrenic patients. In this cross-sectional study, 104 patients who met Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, criteria for schizophrenic disorders were recruited and independently interviewed. We first determined the psychometric properties of the translated MARS, including internal consistency, test-retest reliability, and construct validity. In addition, we investigated the relationships between medication compliance and clinical variables through correlation and regression analyses. We found that the translated MARS was a simple and reliable self-reported compliance scale. Furthermore, in this exploratory study, we found that patients with better medication compliance had better insight into mental illness, less severe psychopathologic condition, and less negative subjective response to side effects of antipsychotics. Additional research focusing on these patient outcomes will be of great interest and value in elucidating the role of medication compliance in management of schizophrenic patients. Copyright © 2010 Elsevier Inc. All rights reserved.

  19. Does Medical Cannabis Use Increase or Decrease the Use of Opioid Analgesics and Other Prescription Drugs?

    PubMed

    Bachhuber, Marcus A; Arnsten, Julia H; Cunningham, Chinazo O; Sohler, Nancy

    2018-04-17

    : In observational and retrospective studies, people who use cannabis are more likely than people who do not use cannabis to also use other drugs. People who take medical cannabis are also more likely to report medical and non-medical use of opioid analgesics, stimulants, and tranquilizers. Given that people who take medical cannabis and those who do not are likely to have different underlying morbidity, it is possible that medical cannabis use reduces prescription drug use yet prescription drug use remains relatively high. Studies comparing people who take medical cannabis with people who do not take it cannot draw conclusions about the effect of medical cannabis on drug use. To fully understand the effect of medical cannabis on the use of other drugs, prospective longitudinal studies randomizing individuals to cannabis versus other treatments are urgently needed.

  20. A novel Web-based graduate medical education management system including ACGME compliance algorithms.

    PubMed

    Gauger, Paul G; Davis, Janice W; Orr, Peter J

    2002-09-01

    Administration of graduate medical education programs has become more difficult as compliance with ACGME work guidelines has assumed increased importance. These guidelines have caused many changes in the resident work environment, including the emergence of complicated cross-cover arrangements. Many participating residents (each with his or her own individual scheduling requirements) usually generate these schedules. Accordingly, schedules are often not submitted in a timely fashion and they may not be in compliance with the ACGME guidelines for maximum on-call assignments and mandatory days off. Our objective was the establishment of a Web-based system that guides residents in creating on-call schedules that follow ACGME guidelines while still allowing maximum flexibility -- thus allowing each resident to maintain an internal locus of control. A versatile and scalable system with password-protected user (resident) and administrator interfaces was created. An entire academic year is included, and past months and years are automatically archived. The residents log on within the first 15 days of the preceding month and choose their positions in a schedule template. They then make adjustments while receiving immediate summary feedback on compliance with ACGME guidelines. The schedule is electronically submitted to the educational administrator for final approval. If a cross-cover system is required, the program automatically generates an optimal schedule using both of the approved participating service schedules. The residents then have an additional five-day period to make adjustments in the cross-cover schedule while still receiving compliance feedback. The administrator again provides final approval electronically. The communication interface automatically pages or e-mails the residents when schedules are updated or approved. Since the information exists in a relational database, simple reporting tools are included to extract the information necessary to generate

  1. The effect of a health communication campaign on compliance with mass drug administration for schistosomiasis control in western Kenya--the SCORE project.

    PubMed

    Omedo, Martin; Ogutu, Michael; Awiti, Alphonce; Musuva, Rosemary; Muchiri, Geoffrey; Montgomery, Susan P; Secor, W Evan; Mwinzi, Pauline

    2014-11-01

    Compliance with mass drug administration (MDA) can be affected by rumors and mistrust about the drug. Communication campaigns are an effective way to influence attitudes and health behaviors in diverse public health contexts, but there is very little documentation about experiences using health communications in schistosomiasis control programs. A qualitative study was conducted with community health workers (CHWs) as informants to explore the effect of a health communication campaign on their experiences during subsequent praziquantel MDA for schistosomiasis. Discussions were audio-recorded, transcribed verbatim, translated into English where applicable, and analyzed thematically using ATLAS.ti software. According to the CHWs, exposure to mass media messages improved awareness of the MDA, which in turn, led to better treatment compliance. Our findings suggest that communication campaigns influence health behaviors and create awareness of schistosomiasis control interventions, which may ultimately improve praziquantel MDA. © The American Society of Tropical Medicine and Hygiene.

  2. To give is better than to receive: compliance with WHO guidelines for drug donations during 2000-2008.

    PubMed

    Bero, Lisa; Carson, Brittany; Moller, Helene; Hill, Suzanne

    2010-12-01

    to assess drug donations in terms of their adherence to the drug donation guidelines put forth by the World Health Organization (WHO). in 2009 we searched the academic and lay literature - journal articles, media articles and industry and donor web sites - to identify reports about drug donations made from 2000 to 2008. Publications focusing on molecular mechanisms of drug action, general descriptions of guidelines or specific one-time drug donations before 2000 were excluded. For cases with sufficient information, we assessed compliance with each of the 12 articles of WHO's guidelines. we found 95 articles describing 96 incidents of drug donations between 2000 and 2008. Of these, 50 were made in response to disaster situations, 43 involved the long-term donation of a drug to treat a specific disease and 3 were drug recycling cases. Disaster-related donations were less likely to comply with the guidelines, particularly in terms of meeting the recipient's needs, quality assurance and shelf-life, packaging and labelling, and information management. Recipient countries were burdened with the costs of destroying the drugs received through inappropriate donations. Although long-term donations were more likely to comply with WHO guidelines related to quality assurance and labelling, they did not consistently meet the needs of the recipients. Furthermore, they discouraged local drug production and development. drug donations can do more harm than good for the recipient countries. Strengthening the structures and systems for coordinating and monitoring drug donations and ensuring that these are driven by recipient needs will improve adherence to the drug donation guidelines set forth by WHO.

  3. The assemblage of compliance in psychiatric case management.

    PubMed

    Brodwin, Paul

    2010-08-01

    In the post-asylum era, case managers perform much of the face-to-face work of pharmaceutical compliance for people with severe and persistent mental illness. Their work demands careful orchestration of the assemblage of compliance, including the actual medications, the ideology of biopsychiatry, the division of professional labor, and certain mundane tools. Ethnographic vignettes from an Assertive Community Treatment (ACT) team show how case managers use this assemblage in their everyday routines, but also how it undercuts key elements of the original ACT mission. Reflecting its roots in the deinstitutionalization movement, the ACT model gives case managers limitless responsibilities for clients' lives, but then narrowly defines their role as the prosthetic extension of psychiatric authority. To produce compliance, case managers depend on the medication cassette, analyzed here as a human/non-human hybrid woven into their ordinary work. The medication cassette has pre-scripted uses that enlist clinicians in biopsychiatric thinking and also silently impose compliant behavior on clients. The elements in the assemblage of compliance depend on each other, but they do not form a seamless whole, as evidenced by the dilemmas and micropolitics of the clinical front-line. Theoretical notions of assemblages and technologies of compliance, drawn from science and technology studies, illuminate a core conundrum of practice in psychiatric case management.

  4. Development of drug-loaded polymer microcapsules for treatment of epilepsy.

    PubMed

    Chen, Yu; Gu, Qi; Yue, Zhilian; Crook, Jeremy M; Moulton, Simon E; Cook, Mark J; Wallace, Gordon G

    2017-09-26

    Despite significant progress in developing new drugs for seizure control, epilepsy still affects 1% of the global population and is drug-resistant in more than 30% of cases. To improve the therapeutic efficacy of epilepsy medication, a promising approach is to deliver anti-epilepsy drugs directly to affected brain areas using local drug delivery systems. The drug delivery systems must meet a number of criteria, including high drug loading efficiency, biodegradability, neuro-cytocompatibility and predictable drug release profiles. Here we report the development of fibre- and sphere-based microcapsules that exhibit controllable uniform morphologies and drug release profiles as predicted by mathematical modelling. Importantly, both forms of fabricated microcapsules are compatible with human brain derived neural stem cells and differentiated neurons and neuroglia, indicating clinical compliance for neural implantation and therapeutic drug delivery.

  5. Can oral fluid cannabinoid testing monitor medication compliance and/or cannabis smoking during oral THC and oromucosal Sativex administration?

    PubMed

    Lee, Dayong; Karschner, Erin L; Milman, Garry; Barnes, Allan J; Goodwin, Robert S; Huestis, Marilyn A

    2013-06-01

    We characterize cannabinoid disposition in oral fluid (OF) after dronabinol, synthetic oral Δ(9)-tetrahydrocannabinol (THC), and Sativex, a cannabis-extract oromucosal spray, and evaluate whether smoked cannabis relapse or Sativex compliance can be identified with OF cannabinoid monitoring. 5 and 15 mg synthetic oral THC, low (5.4 mg THC, 5.0 mg cannabidiol (CBD)) and high (16.2 mg THC, 15.0 mg CBD) dose Sativex, and placebo were administered in random order (n=14). Oral fluid specimens were collected for 10.5 h after dosing and analyzed for THC, CBD, cannabinol (CBN), and 11-nor-9-carboxy-THC (THCCOOH). After oral THC, OF THC concentrations decreased over time from baseline, reflecting residual THC excretion from previously self-administered smoked cannabis. CBD and CBN also were rarely detected. After Sativex, THC, CBD and CBN increased greatly, peaking at 0.25-1 h. Median CBD/THC and CBN/THC ratios were 0.82-1.34 and 0.04-0.06, respectively, reflecting cannabinoids' composition in Sativex. THCCOOH/THC ratios within 4.5 h post Sativex were ≤ 1.6 pg/ng, always lower than after oral THC and placebo. THCCOOH/THC ratios increased throughout each dosing session. Lack of measurable THC, CBD and CBN in OF following oral THC, and high OF CBD/THC ratios after Sativex distinguish oral and sublingual drug delivery routes from cannabis smoking. Low THCCOOH/THC ratios suggest recent Sativex and smoked cannabis exposure. These data indicate that OF cannabinoid monitoring can document compliance with Sativex pharmacotherapy, and identify relapse to smoked cannabis during oral THC medication but not Sativex treatment, unless samples were collected shortly after smoking. Published by Elsevier Ireland Ltd.

  6. Adequacy of pharmacological information provided in pharmaceutical drug advertisements in African medical journals

    PubMed Central

    Oshikoya, Kazeem A.; Senbanjo, Idowu O.; Soipe, Ayo

    2008-01-01

    Pharmaceutical advertisement of drugs is a means of advocating drug use and their selling but not a substitute for drug formulary to guide physicians in safe prescribing. Objectives: To evaluate drug advertisements in Nigerian and other African medical journals for their adequacy of pharmacological information. Methods: Twenty four issues from each of West African Journal of Medicine (WAJM), East African Medical Journal (EAMJ), South African Medical Journal (SAMJ), Nigerian Medical Practitioner (NMP), Nigerian Quarterly Journal of Hospital Medicine (NQJHM) and Nigerian Postgraduate Medical Journal (NPMJ) were reviewed. While EAMJ, SAMJ and NMP are published monthly, the WAJM, NQJHM and NPMJ are published quarterly. The monthly journals were reviewed between January 2005 and December 2006, and the quarterly journals between January 2001 and December 2006. The drug information with regards to brand/non-proprietary name, pharmacological data, clinical information, pharmaceutical information and legal aspects was evaluated as per World Health Organisation (WHO) criteria. Counts in all categories were collated for each advertiser. Results: Forty one pharmaceutical companies made 192 advertisements. 112 (58.3%) of these advertisements were made in the African medical journals. Pfizer (20.3%) and Swipha (12.5%) topped the list of the advertising companies. Four (2.1%) adverts mentioned generic names only, 157 (81.8%) mentioned clinical indications. Adults and children dosage (39.6%), use in special situations such as pregnancy and renal or liver problems (36.5%), adverse effects (30.2%), average duration of treatment (26.0%), and potential for interaction with other drugs (18.7%) were less discussed. Pharmaceutical information such as available dosage forms and product and package information {summary of the generic and proprietary names, the formulation strength, active ingredient, route of administration, batch number, manufactured and expiry dates, and the manufacturer

  7. New rules for physicians implement sample drug bill.

    PubMed

    1990-06-01

    Record keeping requirements for dangerous drugs, including samples, has been a source of confusion for physicians and often has lead to misinterpretation of the law. To clarify this issue and to assist in implementing Senate Bill 788 (the sample drug bill), the Texas State Board of Medical Examiners recently has adopted rules for record keeping for dangerous drugs and controlled substances. A dangerous drug is any drug or device that is not listed in the Controlled Substances Act and thus is not safe for self-medication, or bears the legend, "Caution: Federal law prohibits dispensing without a prescription." The Dangerous Drugs Act requires a physician to maintain records for 2 years after the date of the acquisition or disposal of the dangerous drug. The new TSBME rules provide a presumption of compliance by a physician for record keeping for dangerous drug samples if he or she (1) retains a copy of the signed request form required by the Prescription Drug Marketing Act of 1987 for 2 years and (2) makes appropriate entries in a patient's medical records when a dangerous drug sample is supplied to the patient. Generally, a drug company representative provides a copy of the request as a receipt at the time the physician receives the samples. For dangerous drugs that the physician acquires other than as samples, the physician needs to retain a copy of the invoice or receiving order or other form of documentation of receipt or acquisition for 2 years. Once again, the physician should make appropriate entries in patients' records.(ABSTRACT TRUNCATED AT 250 WORDS)

  8. Drug packaging in 2014: authorities should direct more efforts towards medication safety.

    PubMed

    2015-05-01

    In 2014, Prescrire examined the packaging quality of about 250 drugs. A few advances stand out, mainly involving recent drugs, but on the whole, the situation is worrisome in terms of medication safety. Although pharmaceutical companies and drug regulatory agencies seem to be taking more account of the risk of accidental poisoning in children, the level of protection remains low overall in the absence of stringent measures on the part of the authorities. New drugs too often have poor-quality or even dangerous packaging at the time of their market introduction. And the packaging quality of older drugs is disturbing. Pharmaceutical companies no longer invest in the packaging of these products, and agencies often fail to take advantage of the opportunities provided by their reassessment to improve the situation. The inappropriate labelling of certain injectable drugs remains a source of medication errors, sometimes resulting in very serious consequences. In 2014, signs of progress in the packaging of several drugs show that its role in medication safety is better appreciated. But the persistence of dangers in the pharmaceuticals market, created by "unfinished", overly complex or poor-quality packaging, raises the question of the responsibility of pharmaceutical companies and agencies for past and present accidents.

  9. Drugs and Medical Devices: Adverse Events and the Impact on Women’s Health

    PubMed Central

    Carey, Jennifer L.; Nader, Nathalie; Chai, Peter R.; Carreiro, Stephanie; Griswold, Matthew K.; Boyle, Katherine L.

    2018-01-01

    A large number of medications and medical devices removed from the market by the US Food and Drug Administration over the past 4 decades specifically posed greater health risks to women. This article reviews the historical background of sex and gender in clinical research policy and describes several approved drugs and devices targeted for use in women that have caused major morbidity and mortality. The intended population for the medications and devices, population affected, approval process, and the basic and legal actions taken against the medication/drug company are also discussed. It is recognized that women are still at risk for harm from unsafe medications and devices, and continued improvements in legislation that promotes inclusion of sex and gender into the design and analysis of research will improve safety for both men and women. PMID:28069260

  10. Outsourcing your medical practice call center: how to choose a vendor to ensure regulatory compliance.

    PubMed

    Johnson, Bill

    2014-01-01

    Medical practices receive hundreds if not thousands of calls every week from patients, payers, pharmacies, and others. Outsourcing call centers can be a smart move to improve efficiency, lower costs, improve customer care, ensure proper payer management, and ensure regulatory compliance. This article discusses how to know when it's time to move to an outsourced call center, the benefits of making the move, how to choose the right call center, and how to make the transition. It also provides tips on how to manage the call center to ensure the objectives are being met.

  11. Do national drug control laws ensure the availability of opioids for medical and scientific purposes?

    PubMed Central

    Brown, Marty Skemp; Maurer, Martha A

    2014-01-01

    Abstract Objective To determine whether national drug control laws ensure that opioid drugs are available for medical and scientific purposes, as intended by the 1972 Protocol amendment to the 1961 Single Convention on Narcotic Drugs. Methods The authors examined whether the text of a convenience sample of drug laws from 15 countries: (i) acknowledged that opioid drugs are indispensable for the relief of pain and suffering; (ii) recognized that government was responsible for ensuring the adequate provision of such drugs for medical and scientific purposes; (iii) designated an administrative body for implementing international drug control conventions; and (iv) acknowledged a government’s intention to implement international conventions, including the Single Convention. Findings Most national laws were found not to contain measures that ensured adequate provision of opioid drugs for medical and scientific purposes. Moreover, the model legislation provided by the United Nations Office on Drugs and Crime did not establish an obligation on national governments to ensure the availability of these drugs for medical use. Conclusion To achieve consistency with the Single Convention, as well as with associated resolutions and recommendations of international bodies, national drug control laws and model policies should be updated to include measures that ensure drug availability to balance the restrictions imposed by the existing drug control measures needed to prevent the diversion and nonmedical use of such drugs. PMID:24623904

  12. Information on actual medication use and drug-related problems in older patients: questionnaire or interview?

    PubMed

    Willeboordse, Floor; Grundeken, Lucienne H; van den Eijkel, Lisanne P; Schellevis, François G; Elders, Petra J M; Hugtenburg, Jacqueline G

    2016-04-01

    Information on medication use and drug-related problems is important in the preparation of clinical medication reviews. Critical information can only be provided by patients themselves, but interviewing patients is time-consuming. Alternatively, patient information could be obtained with a questionnaire. In this study the agreement between patient information on medication use and drug-related problems in older patients obtained with a questionnaire was compared with information obtained during an interview. General practice in The Netherlands. A questionnaire was developed to obtain information on actual medication use and drug-related problems. Two patient groups ≥65 years were selected based on general practitioner electronic medical records in nine practices; I. polypharmacy and II. ≥1 predefined general geriatric problems. Eligible patients were asked to complete the questionnaire and were interviewed afterwards. Agreement on information on medication use and drug-related problems collected with the questionnaire and interview was calculated. Ninety-seven patients participated. Of all medications used, 87.6 % (95 % CI 84.7-90.5) was reported identically in the questionnaire and interview. Agreement for the complete medication list was found for 45.4 % (95 % CI 35.8-55.3) of the patients. On drug-related problem level, agreement between questionnaire and interview was 75 %. Agreement tended to be lower in vulnerable patients characterized by ≥4 chronic diseases, ≥10 medications used and low health literacy. Information from a questionnaire showed reasonable agreement compared with interviewing. The patients reported more medications and drug-related problems in the interview than the questionnaire. Taking the limitations into account, a questionnaire seems a suitable tool for medication reviews that may replace an interview for most patients.

  13. Better knowledge improves adherence to lifestyle changes and medication in patients with coronary heart disease.

    PubMed

    Alm-Roijer, Carin; Stagmo, Martin; Udén, Giggi; Erhardt, Leif

    2004-12-01

    Many patients with coronary heart disease (CHD) are not managed adequately, and we often fail to reach treatment targets. To investigate if knowledge of risk factors for CHD, measured by a questionnaire, would show any relation to advice to compliance to lifestyle changes to attain treatment goals and adherence to drug therapy. Men and women <71 years who had had a cardiac event were screened consecutively (509) from the medical records. Responders (392) were interviewed, examined and received a questionnaire. Three hundred and forty-seven patients answered the questionnaire regarding their general knowledge of risk factors for CHD, compliance to lifestyle changes to attain treatment goals and adherence to drug therapy. There were statistically significant correlations between general knowledge about risk factors for CHD and compliance to certain lifestyle changes: weight, physical activity, stress management, diet, attainment of lipid level goals and the likelihood of taking prescribed blood pressure-lowering drugs. General knowledge of risk factors had no correlation to blood glucose or blood pressure levels nor on smoking habits or treatment patterns for prescribed lipid- and blood glucose-lowering drugs. Knowledge correlates to patient behaviour with respect to some risk factors, which should be recognised in preventive programs.

  14. Mining drug-disease relationships as a complement to medical genetics-based drug repositioning: Where a recommendation system meets genome-wide association studies.

    PubMed

    Wang, H; Gu, Q; Wei, J; Cao, Z; Liu, Q

    2015-05-01

    A novel recommendation-based drug repositioning strategy is presented to simultaneously determine novel drug indications and side effects in one integrated framework. This strategy provides a complementary method to medical genetics-based drug repositioning, which reduces the occurrence of false positives in medical genetics-based drug repositioning, resulting in a ranked list of new candidate indications and/or side effects with different confidence levels. Several new drug indications and side effects are reported with high prediction confidences. © 2015 American Society for Clinical Pharmacology and Therapeutics.

  15. [Continuous drug infusion in terminal cancer].

    PubMed

    Ottesen, S; Manger, A T; Monrad, L

    1992-05-30

    Today's technology provides portable pumps which facilitate continuous infusion of drugs to relieve suffering in terminal disease. Subcutaneous and epidural infusion is now frequently used in our hospital. The most common indications are gastrointestinal obstruction, impaired absorption of drugs, refractory side effects of oral medication or poor compliance because good pain relief is no longer possible orally. During the last days of life, this method may be the only possible approach to good comfort and relief from terminal agitation and anxiety. Of the patients referred to the advisory group for seriously ill and dying in 1990, 64% received subcutaneous infusions and 15% epidural infusions during the last days or weeks of life. Continuous infusion of drugs from portable pumps has become an almost indispensible method of treatment in an ordinary clinic.

  16. 42 CFR 124.516 - Charitable facility compliance alternative.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 42 Public Health 1 2010-10-01 2010-10-01 false Charitable facility compliance alternative. 124.516... RESOURCES DEVELOPMENT MEDICAL FACILITY CONSTRUCTION AND MODERNIZATION Reasonable Volume of Uncompensated Services to Persons Unable To Pay § 124.516 Charitable facility compliance alternative. (a) Effect of...

  17. [Management of adverse drug effects].

    PubMed

    Schlienger, R G

    2000-09-01

    Adverse drug reactions (ADRs) are still considered one of the main problems of drug therapy. ADRs are associated with considerable morbidity, mortality, decreased compliance and therapeutic success as well as high direct and indirect medical costs. Several considerations have to come into play when managing a potential ADR. It is critical to establish an accurate clinical diagnosis of the adverse event. Combining information about drug exposure together with considering other possible causes of the reaction is crucial to establish a causal relationship between the reaction and the suspected drug. Identification of the underlying pathogenesis of an ADR together with the severity of the reaction will have profound implications on continuation of drug therapy after an ADR. Since spontaneous reports about ADRs are a key stone of a functioning post-marketing surveillance system and therefore play a key role in improving drug safety, health care professionals are highly encouraged to report ADRs to a local or national organization. However, because the majority of ADRs is dose-dependent and therefore preventable, individualization of pharmacotherapy may have a major impact on reducing such events.

  18. 21 CFR 118.12 - Enforcement and compliance.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD... compliance. (a) Authority. This part is established under authority of the Public Health Service Act (the PHS...) A statement that these eggs must not be sold, distributed, or otherwise disposed of or moved except...

  19. 21 CFR 118.12 - Enforcement and compliance.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD... compliance. (a) Authority. This part is established under authority of the Public Health Service Act (the PHS...) A statement that these eggs must not be sold, distributed, or otherwise disposed of or moved except...

  20. Measuring Compliance with Tobacco-Free Campus Policy

    ERIC Educational Resources Information Center

    Fallin, Amanda; Murrey, Megan; Johnson, Andrew O.; Riker, Carol A.; Rayens, Mary Kay; Hahn, Ellen J.

    2012-01-01

    Objective: The purpose is to describe psychometric testing and feasibility of the Tobacco-Free Compliance Assessment Tool (TF-CAT) to measure tobacco-free policy compliance at a public university and medical center. The aims are to (1) investigate concurrent validity by comparing the number of cigarette butts in areas covered by the policy with…

  1. 12-Step participation reduces medical use costs among adolescents with a history of alcohol and other drug treatment.

    PubMed

    Mundt, Marlon P; Parthasarathy, Sujaya; Chi, Felicia W; Sterling, Stacy; Campbell, Cynthia I

    2012-11-01

    Adolescents who attend 12-step groups following alcohol and other drug (AOD) treatment are more likely to remain abstinent and to avoid relapse post-treatment. We examined whether 12-step attendance is also associated with a corresponding reduction in health care use and costs. We used difference-in-difference analysis to compare changes in seven-year follow-up health care use and costs by changes in 12-step participation. Four Kaiser Permanente Northern California AOD treatment programs enrolled 403 adolescents, 13-18-years old, into a longitudinal cohort study upon AOD treatment entry. Participants self-reported 12-step meeting attendance at six-month, one-year, three-year, and five-year follow-up. Outcomes included counts of hospital inpatient days, emergency room (ER) visits, primary care visits, psychiatric visits, AOD treatment costs and total medical care costs. Each additional 12-step meeting attended was associated with an incremental medical cost reduction of 4.7% during seven-year follow-up. The medical cost offset was largely due to reductions in hospital inpatient days, psychiatric visits, and AOD treatment costs. We estimate total medical use cost savings at $145 per year (in 2010 U.S. dollars) per additional 12-step meeting attended. The findings suggest that 12-step participation conveys medical cost offsets for youth who undergo AOD treatment. Reduced costs may be related to improved AOD outcomes due to 12-step participation, improved general health due to changes in social network following 12-step participation, or better compliance to both AOD treatment and 12-step meetings. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

  2. Exploring the usage of a mobile phone application in transplanted patients to encourage medication compliance and education.

    PubMed

    Zanetti-Yabur, Alana; Rizzo, Amanda; Hayde, Nicole; Watkins, Anthony C; Rocca, Juan P; Graham, Jay A

    2017-10-01

    Medication non-adherence in transplant patients is a grave problem that results in increased rejection episodes, graft loss and significant morbidity. The efficacy of users and non-users of a mobile phone application (mobile app) in promoting medication adherence was investigated. The Beliefs about Medicine Questionnaire (BMQ) and Morisky Medication Adherence Scale (MMAS-8) were used in these cohorts to assess the predilection for poor adherence. Serum tacrolimus, creatinine levels, and rejection episodes were also recorded. Lastly, the patients were tested on their recall of their immunosuppression. Overall, patients had extremely negative beliefs about medication reflected in their tendency toward higher predicted rates of non-adherence. Interestingly, though not significant, app users had higher rates of medication recollection. The high-risk nature of this population demands efforts to abrogate non-adherence. Caregivers are charged with the responsibility to offer patients a feasible option to safeguard treatment compliance. Mobile apps are a potentially powerful tool, which can be used to decrease non-adherence. Copyright © 2017 Elsevier Inc. All rights reserved.

  3. Identification of patients at risk of non-adherence to oral antirheumatic drugs in rheumatoid arthritis using the Compliance Questionnaire in Rheumatology: an ARCO sub-study.

    PubMed

    Marras, Carlos; Monteagudo, Indalecio; Salvador, Georgina; de Toro, Francisco J; Escudero, Alejandro; Alegre-Sancho, Juan J; Raya, Enrique; Ortiz, Ana; Carmona, Loreto; Mestre, Yvonne; Cea-Calvo, Luis; Calvo-Alén, Jaime

    2017-07-01

    The ARCO study (Study on Adherence of Rheumatoid Arthritis patients to SubCutaneous and Oral Drugs), a multicenter, non-interventional retrospective study, was primarily designed to assess the percentage of patients [aged ≥18 years with an established rheumatoid arthritis (RA) diagnosis] with non-adherence to prescribed subcutaneous biologicals. This paper reports data for the secondary objective from a subset of patients, namely to evaluate non-adherence to prescribed oral antirheumatic drugs in RA patients in Spain using the validated Compliance Questionnaire Rheumatology (CQR). Patients also completed the Morisky-Green Medication Adherence Questionnaire, Beliefs about Medicines Questionnaire, and a questionnaire (developed and validated in Spain) on patient satisfaction with RA treatment and preferences. A total of 271 patients (76.7% females; mean age 55.6 years) were being treated with oral drugs for RA, of which 234 completed the CQR questionnaire. Non-adherence was reported in 49/234 (20.9%) patients. The proportion of non-adherence in younger patients (aged ≤48 years; 37.5%) was double that recorded in patients aged >48 years (p = 0.006). Patients with a perception of lower efficacy also had a higher risk of non-adherence (p = 0.012). Multivariable analysis showed that younger age and male gender were independently associated with risk of non-adherence. There was only slight agreement between the CQR and Morisky-Green assessment tools (kappa coefficient = 0.186), possibly reflecting the fact that both questionnaires measure slightly different aspects of medication adherence. In conclusion, one out of five RA patients was identified as at risk for non-adherence with the CQR, and this was more frequent in younger patients and in males.

  4. 5 CFR 339.103 - Compliance with EEOC regulations.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 5 Administrative Personnel 1 2012-01-01 2012-01-01 false Compliance with EEOC regulations. 339.103 Section 339.103 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT CIVIL SERVICE REGULATIONS MEDICAL QUALIFICATION DETERMINATIONS General § 339.103 Compliance with EEOC regulations. Actions under this part must be...

  5. 5 CFR 339.103 - Compliance with EEOC regulations.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 5 Administrative Personnel 1 2010-01-01 2010-01-01 false Compliance with EEOC regulations. 339.103 Section 339.103 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT CIVIL SERVICE REGULATIONS MEDICAL QUALIFICATION DETERMINATIONS General § 339.103 Compliance with EEOC regulations. Actions under this part must be...

  6. 5 CFR 339.103 - Compliance with EEOC regulations.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 5 Administrative Personnel 1 2013-01-01 2013-01-01 false Compliance with EEOC regulations. 339.103 Section 339.103 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT CIVIL SERVICE REGULATIONS MEDICAL QUALIFICATION DETERMINATIONS General § 339.103 Compliance with EEOC regulations. Actions under this part must be...

  7. 5 CFR 339.103 - Compliance with EEOC regulations.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 5 Administrative Personnel 1 2011-01-01 2011-01-01 false Compliance with EEOC regulations. 339.103 Section 339.103 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT CIVIL SERVICE REGULATIONS MEDICAL QUALIFICATION DETERMINATIONS General § 339.103 Compliance with EEOC regulations. Actions under this part must be...

  8. 5 CFR 339.103 - Compliance with EEOC regulations.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 5 Administrative Personnel 1 2014-01-01 2014-01-01 false Compliance with EEOC regulations. 339.103 Section 339.103 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT CIVIL SERVICE REGULATIONS MEDICAL QUALIFICATION DETERMINATIONS General § 339.103 Compliance with EEOC regulations. Actions under this part must be...

  9. [Medical Treatment of Newly Arrived Refugees in Erlangen: A Study of Drug Prescription Rates Focused on Psychotropic Drugs].

    PubMed

    Kahl, Fabian; Frewer, Andreas

    2017-04-01

    Background: In 2015 the number of refugees who sought asylum in Germany has increased dramatically. Therefore, the medical care for these refugees faces huge challenges. The treatment of mental illness of refugees is a particular difficult topic. Objective of this study is the acquisition of the outpatient prescriptions of drugs for newly arrived refugees in Erlangen, focused on psychotropic drugs. Methods: Evaluation of all outpatient prescribed drugs (n=1 137), which were prescribed between 10/01/2014 and 09/30/2015 for asylum seekers living in the refugee center in Erlangen, a branch of the "Central Admission Institution" ("ZAE") Zirndorf. Funding organization of this treatment is the City of Erlangen. Settlement documents of the City of Erlangen were used for the analysis. Results: The prescribed drugs cover the spectrum of acute primary care. Big parts of the prescription rates are antiinfectives (ATC-Code: J), medication for the respiratory system (ATC: R), as well as non-steroidal anti-inflammatory drug (NSAID's: ibuprofen, paracetamol, metamizole). The prescription of psychotropic drugs is relatively underrepresented. © Georg Thieme Verlag KG Stuttgart · New York.

  10. SIMulation of Medication Error induced by Clinical Trial drug labeling: the SIMME-CT study.

    PubMed

    Dollinger, Cecile; Schwiertz, Vérane; Sarfati, Laura; Gourc-Berthod, Chloé; Guédat, Marie-Gabrielle; Alloux, Céline; Vantard, Nicolas; Gauthier, Noémie; He, Sophie; Kiouris, Elena; Caffin, Anne-Gaelle; Bernard, Delphine; Ranchon, Florence; Rioufol, Catherine

    2016-06-01

    To assess the impact of investigational drug labels on the risk of medication error in drug dispensing. A simulation-based learning program focusing on investigational drug dispensing was conducted. The study was undertaken in an Investigational Drugs Dispensing Unit of a University Hospital of Lyon, France. Sixty-three pharmacy workers (pharmacists, residents, technicians or students) were enrolled. Ten risk factors were selected concerning label information or the risk of confusion with another clinical trial. Each risk factor was scored independently out of 5: the higher the score, the greater the risk of error. From 400 labels analyzed, two groups were selected for the dispensing simulation: 27 labels with high risk (score ≥3) and 27 with low risk (score ≤2). Each question in the learning program was displayed as a simulated clinical trial prescription. Medication error was defined as at least one erroneous answer (i.e. error in drug dispensing). For each question, response times were collected. High-risk investigational drug labels correlated with medication error and slower response time. Error rates were significantly 5.5-fold higher for high-risk series. Error frequency was not significantly affected by occupational category or experience in clinical trials. SIMME-CT is the first simulation-based learning tool to focus on investigational drug labels as a risk factor for medication error. SIMME-CT was also used as a training tool for staff involved in clinical research, to develop medication error risk awareness and to validate competence in continuing medical education. © The Author 2016. Published by Oxford University Press in association with the International Society for Quality in Health Care; all rights reserved.

  11. Antenatal drug consumption: the burden of self-medication in a developing world setting.

    PubMed

    Adanikin, Abiodun Idowu; Awoleke, Jacob Olumuyiwa

    2017-07-01

    This institutional-based cross-sectional study examines the burden of self-medication during pregnancy in a middle-income country setting and the impact on fetal wellbeing. Using a blend of open-ended and indication-oriented questionnaires, 346 pregnant women at term were interviewed about their pregnancy complaints and drug intake. Inferential statistical data analysis was employed with level of significance (α) set at 0.05. Excluding routine supplements and vaccinations, 251 (72.5%) women used medicines, of whom 79 (31.5%) had self-medicated. Consuming drugs without prescription was associated with increased US Food & Drug Administration (FDA) risk category (χ 2  = 8.375; P = 0.015). There is therefore a need to scale up efforts towards educating women about the dangers of self-medication, while also introducing effective restrictive policies on over-the-counter drug sales.

  12. Relation between response to illness and compliance in haemodialysis patients.

    PubMed

    Saounatsou, M

    1999-01-01

    The treatment schedule of the haemodialysis patient has many restrictions and the long-term haemodialysis patient's response to illness is characterised by various emotional reactions. Compliance with their medical regimens remains a significant problem which influences the progress of health and by extension quality of life. The preconceived idea that a patient's response to illness may influence his adherence to medical regimen led to this study. The main variables examined were the relationship between the patient's response to illness and compliance and the relationship between compliance and age, education and the length of time on haemodialysis.

  13. The significance of compliance and persistence in the treatment of diabetes, hypertension and dyslipidaemia: a review

    PubMed Central

    Cramer, J A; Benedict, Á; Muszbek, N; Keskinaslan, A; Khan, Z M

    2008-01-01

    Objectives To review studies of patient compliance/persistence with cardiovascular or antidiabetic medication published since the year 2000; to compare the methods used to measure compliance/persistence across studies; to compare reported compliance/persistence rates across therapeutic classes and to assess whether compliance/persistence correlates with clinical outcomes. Methods English language papers published between January 2000 and November 2005 investigating patient compliance/persistence with cardiovascular or antidiabetic medication were identified through searches of the MEDLINE and EMBASE databases. Definitions and measurements of compliance/persistence were compared across therapeutic areas using contingency tables. Results Of the 139 studies analysed, 32% focused on hypertension, 27% on diabetes and 13% on dyslipidaemia. The remainder covered coronary heart disease and cardiovascular disease (CVD) in general. The most frequently reported measure of compliance was the 12-month medication possession ratio (MPR). The overall mean MPR was 72%, and the MPR did not differ significantly between treatment classes (range: 67–76%). The average proportion of patients with an MPR of > 80% was 59% overall, 64% for antihypertensives, 58% for oral antidiabetics, 51% for lipid-lowering agents and 69% in studies of multiple treatments, again with no significant difference between treatment classes. The average 12-month persistence rate was 63% and was similar across therapeutic classes. Good compliance had a positive effect on outcome in 73% of the studies examining clinical outcomes. Conclusions Non-compliance with cardiovascular and antidiabetic medication is a significant problem, with around 30% of days ‘on therapy’ not covered by medication and only 59% of patients taking medication for more than 80% of their days ‘on therapy’ in a year. Good compliance has a positive effect on clinical outcome, suggesting that the management of CVD may be improved by

  14. Can oral fluid cannabinoid testing monitor medication compliance and/or cannabis smoking during oral THC and oromucosal Sativex administration?

    PubMed Central

    Lee, Dayong; Karschner, Erin L.; Milman, Garry; Barnes, Allan J.; Goodwin, Robert S.; Huestis, Marilyn A.

    2012-01-01

    OBJECTIVES We characterize cannabinoid disposition in oral fluid (OF) after Dronabinol, synthetic oral Δ9-tetrahydrocannabinol (THC), and Sativex, a cannabis-extract oromucosal spray, and evaluate whether smoked cannabis relapse or Sativex compliance can be identified with OF cannabinoid monitoring. METHODS 5 and 15 mg synthetic oral THC, low (5.4 mg THC, 5.0 mg cannabidiol (CBD)) and high (16.2 mg THC, 15.0 mg CBD) dose Sativex, and placebo were administered in random order (n=14). Oral fluid specimens were collected for 10.5h after dosing and analyzed for THC, CBD, cannabinol (CBN), and 11-nor-9-carboxy-THC (THCCOOH). RESULTS After oral THC, OF THC concentrations decreased over time from baseline, reflecting residual THC excretion from previously self-administered smoked cannabis. CBD and CBN also were rarely detected. After Sativex, THC, CBD and CBN increased greatly, peaking at 0.25–1h. Median CBD/THC and CBN/THC ratios were 0.82–1.34 and 0.04–0.06, respectively, reflecting cannabinoids’ composition in Sativex. THCCOOH/THC ratios within 4.5h post Sativex were ≤1.6 pg/ng, always lower than after oral THC and placebo. THCCOOH/THC ratios increased throughout each dosing session. CONCLUSIONS Lack of measurable THC, CBD and CBN in OF following oral THC, and high OF CBD/THC ratios after Sativex distinguish oral and sublingual drug delivery routes from cannabis smoking. Low THCCOOH/THC ratios suggest recent Sativex and smoked cannabis exposure. These data indicate that OF cannabinoid monitoring can document compliance with Sativex pharmacotherapy, and identify relapse to smoked cannabis during oral THC medication but not Sativex treatment, unless samples were collected shortly after smoking. PMID:23146820

  15. TU-AB-204-03: Research Activities in Medical Physics

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Badano, A.

    The responsibilities of the Food and Drug Administration (FDA) have increased since the inception of the Food and Drugs Act in 1906. Medical devices first came under comprehensive regulation with the passage of the 1938 Food, Drug, and Cosmetic Act. In 1971 FDA also took on the responsibility for consumer protection against unnecessary exposure to radiation-emitting devices for home and occupational use. However it was not until 1976, under the Medical Device Regulation Act, that the FDA was responsible for the safety and effectiveness of medical devices. This session will be presented by the Division of Radiological Health (DRH) andmore » the Division of Imaging, Diagnostics, and Software Reliability (DIDSR) from the Center for Devices and Radiological Health (CDRH) at the FDA. The symposium will discuss on how we protect and promote public health with a focus on medical physics applications organized into four areas: pre-market device review, post-market surveillance, device compliance, current regulatory research efforts and partnerships with other organizations. The pre-market session will summarize the pathways FDA uses to regulate the investigational use and commercialization of diagnostic imaging and radiation therapy medical devices in the US, highlighting resources available to assist investigators and manufacturers. The post-market session will explain the post-market surveillance and compliance activities FDA performs to monitor the safety and effectiveness of devices on the market. The third session will describe research efforts that support the regulatory mission of the Agency. An overview of our regulatory research portfolio to advance our understanding of medical physics and imaging technologies and approaches to their evaluation will be discussed. Lastly, mechanisms that FDA uses to seek public input and promote collaborations with professional, government, and international organizations, such as AAPM, International Electrotechnical Commission

  16. Urine drug screening in the medical setting.

    PubMed

    Hammett-Stabler, Catherine A; Pesce, Amadeo J; Cannon, Donald J

    2002-01-01

    The term drug screen is a misnomer since it implies screening for all drugs, which is not possible. Current practice is to limit the testing to the examination of serum for several drugs such as ethanol, acetaminophen, salicylate, and of urine for several specific drugs or classes of drugs. In the emergency setting the screen should be performed in less than one hour. Controversies continue to exist regarding the value of urine drug testing in the medical setting. The reasons for these include the drugs involved, the sample, the methods utilized to perform the tests, and the level of understanding of the physician using the data, all of which are closely related to the other. Current automated methods provide rapid results demanded in emergency situations, but are often designed for, or adapted from, workplace testing and are not necessarily optimized for clinical applications. Furthermore, the use of these methods without consideration of the frequency in which the drugs are found in a given area is not cost-effective. The laboratory must understand the limitations of the assays used and provide this information to the physician. Additionally, the laboratory and the physicians using the data must cooperate to determine which drugs are appropriate and necessary to measure for their institution and clinical setting. In doing so it should be remembered that for many drugs, the sample, urine, contains the end product(s) of drug metabolism, not the parent drug. Furthermore, it is necessary to understand the pharmacokinetic parameters of the drug of interest when interpreting data. Finally, while testing for some drugs may not appear cost-effective, the prevention or reduction of morbidity and mortality may offset any laboratory costs. While the literature is replete with studies concerning new methods and a few regarding physician understanding, there are none that we could find that thoroughly, objectively, and fully addressed the issues of utility and cost-effectiveness.

  17. Methodologies for sustaining barcode medication administration compliance. A multi-disciplinary approach.

    PubMed

    McNulty, Judy; Donnelly, Eileen; Iorio, Kris

    2009-01-01

    Numerous recent studies have looked at how nursing workarounds and technology failures can undermine the patient safety benefits of barcode medication administration (BCMA) systems. This article will discuss how Solaris Health System in Edison, NJ, methodically addressed these challenges to achieve and sustain 95 percent compliance with BCMA, one of two major initiatives of the non-profit Solaris Patient Safety Institute, which was established to research best practices that could be shared with other organizations. Through meetings and interviews with frontline nurses and their managers, a multidisciplinary team (pharmacy, IT, nursing) identified 12 educational, technological and process-oriented issues, then developed concrete action plans to address each one (e.g., one-on-one software and device training, additional wireless access points, a "hard stop" to require scanning the patient's wristband). Key success factors included demonstrating executive dedication, creating a culture of ownership by engaging frontline nurses in solution design and providing a strong support system.

  18. First-line medications for alcohol use disorders among public drug plan beneficiaries in Ontario.

    PubMed

    Spithoff, Sheryl; Turner, Suzanne; Gomes, Tara; Martins, Diana; Singh, Samantha

    2017-05-01

    To examine use of first-line alcohol use disorder (AUD) medications (naltrexone and acamprosate) among public drug plan beneficiaries in the year following an AUD diagnosis. Retrospective population-based cohort study. Ontario. Individuals eligible for public drug plan benefits who had an AUD diagnosis at a hospital visit between April 1, 2011, and March 31, 2012. Number of AUD medications dispensed to public drug plan beneficiaries who had a recent hospital visit with an AUD diagnosis, and number of prescriptions dispensed per person. A total of 10 394 Ontarians between 18 and 65 years of age were identified who had a hospital visit with an AUD diagnosis and were eligible for public drug plan benefits. The rate of AUD medications dispensed in the subsequent year was 3.56 per 1000 population (95% CI 2.51 to 4.91; n = 37). This rate did not differ significantly by sex ( P = .83). Very few public drug plan beneficiaries are dispensed first-line AUD medications in the year following an AUD diagnosis. Copyright© the College of Family Physicians of Canada.

  19. Deeply discounted medications: Implications of generic prescription drug wars.

    PubMed

    Czechowski, Jessica L; Tjia, Jennifer; Triller, Darren M

    2010-01-01

    To describe the history of generic prescription pricing programs at major pharmacy chains and their potential implications on prescribing, quality of care, and patient safety. Publicly available generic prescription discount program drug lists as of May 1, 2009. Fierce competition among major pharmacy chains such as Walgreens, CVS, and Walmart has led to a generic prescription pricing war with unclear public health implications. Introduced in 2006, currently 7 of the 10 largest pharmacy chains advertise a version of a deeply discounted medication (DDM) program, accounting for more than 25,000 locations nationally. By early 2008, almost 70 million Americans had used these programs. Although DDM programs lower drug costs for many patients, DDM formularies include potentially ineffective or harmful medications, have the potential to influence physician prescribing behavior, and may impair pharmacists' ability to review complete drug-dispensing records. DDMs are widespread but have the potential for unintended consequences on patients, providers, and the health care system. A systematic review of DDMs needs to evaluate the clinical, economic, and system-level implications of such programs.

  20. A prospective three-step intervention study to prevent medication errors in drug handling in paediatric care.

    PubMed

    Niemann, Dorothee; Bertsche, Astrid; Meyrath, David; Koepf, Ellen D; Traiser, Carolin; Seebald, Katja; Schmitt, Claus P; Hoffmann, Georg F; Haefeli, Walter E; Bertsche, Thilo

    2015-01-01

    To prevent medication errors in drug handling in a paediatric ward. One in five preventable adverse drug events in hospitalised children is caused by medication errors. Errors in drug prescription have been studied frequently, but data regarding drug handling, including drug preparation and administration, are scarce. A three-step intervention study including monitoring procedure was used to detect and prevent medication errors in drug handling. After approval by the ethics committee, pharmacists monitored drug handling by nurses on an 18-bed paediatric ward in a university hospital prior to and following each intervention step. They also conducted a questionnaire survey aimed at identifying knowledge deficits. Each intervention step targeted different causes of errors. The handout mainly addressed knowledge deficits, the training course addressed errors caused by rule violations and slips, and the reference book addressed knowledge-, memory- and rule-based errors. The number of patients who were subjected to at least one medication error in drug handling decreased from 38/43 (88%) to 25/51 (49%) following the third intervention, and the overall frequency of errors decreased from 527 errors in 581 processes (91%) to 116/441 (26%). The issue of the handout reduced medication errors caused by knowledge deficits regarding, for instance, the correct 'volume of solvent for IV drugs' from 49-25%. Paediatric drug handling is prone to errors. A three-step intervention effectively decreased the high frequency of medication errors by addressing the diversity of their causes. Worldwide, nurses are in charge of drug handling, which constitutes an error-prone but often-neglected step in drug therapy. Detection and prevention of errors in daily routine is necessary for a safe and effective drug therapy. Our three-step intervention reduced errors and is suitable to be tested in other wards and settings. © 2014 John Wiley & Sons Ltd.

  1. Addressing medical coding and billing part II: a strategy for achieving compliance. A risk management approach for reducing coding and billing errors.

    PubMed Central

    Adams, Diane L.; Norman, Helen; Burroughs, Valentine J.

    2002-01-01

    Medical practice today, more than ever before, places greater demands on physicians to see more patients, provide more complex medical services and adhere to stricter regulatory rules, leaving little time for coding and billing. Yet, the need to adequately document medical records, appropriately apply billing codes and accurately charge insurers for medical services is essential to the medical practice's financial condition. Many physicians rely on office staff and billing companies to process their medical bills without ever reviewing the bills before they are submitted for payment. Some physicians may not be receiving the payment they deserve when they do not sufficiently oversee the medical practice's coding and billing patterns. This article emphasizes the importance of monitoring and auditing medical record documentation and coding application as a strategy for achieving compliance and reducing billing errors. When medical bills are submitted with missing and incorrect information, they may result in unpaid claims and loss of revenue to physicians. Addressing Medical Audits, Part I--A Strategy for Achieving Compliance--CMS, JCAHO, NCQA, published January 2002 in the Journal of the National Medical Association, stressed the importance of preparing the medical practice for audits. The article highlighted steps the medical practice can take to prepare for audits and presented examples of guidelines used by regulatory agencies to conduct both medical and financial audits. The Medicare Integrity Program was cited as an example of guidelines used by regulators to identify coding errors during an audit and deny payment to providers when improper billing occurs. For each denied claim, payments owed to the medical practice are are also denied. Health care is, no doubt, a costly endeavor for health care providers, consumers and insurers. The potential risk to physicians for improper billing may include loss of revenue, fraud investigations, financial sanction

  2. 75 FR 15439 - Food and Drug Administration/Xavier University Global Medical Device Conference

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-29

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Food and Drug Administration/Xavier University Global Medical Device Conference AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public conference. SUMMARY: The Food and Drug Administration (FDA...

  3. 78 FR 15957 - Food and Drug Administration/Xavier University Global Medical Device Conference

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-13

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Food and Drug Administration/Xavier University Global Medical Device Conference AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public conference. SUMMARY: The Food and Drug Administration (FDA...

  4. 77 FR 10537 - Food and Drug Administration/Xavier University Global Medical Device Conference

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-22

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Food and Drug Administration/Xavier University Global Medical Device Conference AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public conference. SUMMARY: The Food and Drug Administration (FDA...

  5. Accuracy and completeness of drug information in Wikipedia medication monographs.

    PubMed

    Reilly, Timothy; Jackson, William; Berger, Victoria; Candelario, Danielle

    The primary objective of this study was to determine the accuracy and completeness of drug information on Wikipedia and Micromedex compared with U.S. Food and Drug Administration-approved U.S. product inserts. The top 10 brand and top 10 generic medications from the 2012 Institute for Health Informatics' list of top 200 drugs were selected for evaluation. Wikipedia medication information was evaluated and compared with Micromedex in 7 sections of drug information; the U.S. product inserts were used as the standard comparator. Wikipedia demonstrated significantly lower completeness and accuracy scores compared with Micromedex (mean composite scores 18.55 vs. 38.4, respectively; P <0.01). No difference was found between the mean composite scores for brand versus generic drugs in either reference (17.8 vs. 19.3, respectively [P = 0.62], for Wikipedia; 39.2 vs. 37.6, [P = 0.06] for Micromedex). Limitations to these results include the speed with which information is edited on Wikipedia, that there was no evaluation of off-label information, and the limited number of drugs that were evaluated. Wikipedia lacks the accuracy and completeness of standard clinical references and should not be a routine part of clinical decision making. More research should be conducted to evaluate the rationale for health care providers' use of Wikipedia. Copyright © 2016 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.

  6. To give is better than to receive: compliance with WHO guidelines for drug donations during 2000–2008

    PubMed Central

    Carson, Brittany; Moller, Helene; Hill, Suzanne

    2010-01-01

    Abstract Objective To assess drug donations in terms of their adherence to the drug donation guidelines put forth by the World Health Organization (WHO). Methods In 2009 we searched the academic and lay literature – journal articles, media articles and industry and donor web sites – to identify reports about drug donations made from 2000 to 2008. Publications focusing on molecular mechanisms of drug action, general descriptions of guidelines or specific one-time drug donations before 2000 were excluded. For cases with sufficient information, we assessed compliance with each of the 12 articles of WHO‘s guidelines. Findings We found 95 articles describing 96 incidents of drug donations between 2000 and 2008. Of these, 50 were made in response to disaster situations, 43 involved the long-term donation of a drug to treat a specific disease and 3 were drug recycling cases. Disaster-related donations were less likely to comply with the guidelines, particularly in terms of meeting the recipient’s needs, quality assurance and shelf-life, packaging and labelling, and information management. Recipient countries were burdened with the costs of destroying the drugs received through inappropriate donations. Although long-term donations were more likely to comply with WHO guidelines related to quality assurance and labelling, they did not consistently meet the needs of the recipients. Furthermore, they discouraged local drug production and development. Conclusion Drug donations can do more harm than good for the recipient countries. Strengthening the structures and systems for coordinating and monitoring drug donations and ensuring that these are driven by recipient needs will improve adherence to the drug donation guidelines set forth by WHO. PMID:21124717

  7. Borderline personality symptomatology and compliance with general health care among internal medicine outpatients.

    PubMed

    Sansone, Randy A; Bohinc, R Jordan; Wiederman, Michael W

    2015-06-01

    The extant literature on borderline personality disorder (BPD) and compliance with mental health treatment contains conflicting findings. However, among those individuals with this type of personality dysfunction, reduced compliance with mental health treatment appears to be the predominant theme. To our knowledge, the relationship between BPD and compliance with general health care has not been studied. In addition, there is no prior study in this area examining a primary care population. Using a cross-sectional survey methodology among a sample of internal medicine outpatients (N = 261), we assessed borderline personality symptoms with two self-report measures and general health care compliance or adherence with four self-report measures. With the exception of on-time arrival for doctor appointments, the remaining compliance variables demonstrated statistically significant relationships at the p < 0.01-0.001 levels, with borderline personality symptoms predicting reduced compliance (i.e., conscientiousness with medical treatment, regular dental check-ups, timely completion of laboratory work, following doctor's exercise and nutrition instructions, remembering to take medications, and Medical Outcomes Study General Adherence Score). Compared with participants without borderline personality symptoms, those participants with such symptoms in this study evidenced lower general health care compliance.

  8. Adverse drug events and medication problems in "Hospital at Home" patients.

    PubMed

    Mann, Elizabeth; Zepeda, Orlando; Soones, Tacara; Federman, Alex; Leff, Bruce; Siu, Albert; Boockvar, Kenneth

    2018-03-26

    "Hospital at Home(HaH)" programs provide an alternative to traditional hospitalization. However, the incidence of adverse drug events in these programs is unknown. This study describes adverse drug events and potential adverse drug events in a new HaH program. We examined the charts of the first 50 patients admitted. We found 45 potential adverse drug events and 14 adverse drug events from admission to 30 days after HaH discharge. None of the adverse drug events were severe. Some events, like problems with medication administration, may be unique to the hospital at home setting. Monitoring for adverse drug events is feasible and important for hospital at home programs.

  9. 23 CFR 192.7 - Apportionment of withheld funds after compliance.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 23 Highways 1 2014-04-01 2014-04-01 false Apportionment of withheld funds after compliance. 192.7 Section 192.7 Highways FEDERAL HIGHWAY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION PAYMENT PROCEDURES DRUG OFFENDER'S DRIVER'S LICENSE SUSPENSION § 192.7 Apportionment of withheld funds after compliance...

  10. 23 CFR 192.7 - Apportionment of withheld funds after compliance.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 23 Highways 1 2013-04-01 2013-04-01 false Apportionment of withheld funds after compliance. 192.7 Section 192.7 Highways FEDERAL HIGHWAY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION PAYMENT PROCEDURES DRUG OFFENDER'S DRIVER'S LICENSE SUSPENSION § 192.7 Apportionment of withheld funds after compliance...

  11. 23 CFR 192.7 - Apportionment of withheld funds after compliance.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 23 Highways 1 2010-04-01 2010-04-01 false Apportionment of withheld funds after compliance. 192.7 Section 192.7 Highways FEDERAL HIGHWAY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION PAYMENT PROCEDURES DRUG OFFENDER'S DRIVER'S LICENSE SUSPENSION § 192.7 Apportionment of withheld funds after compliance...

  12. 23 CFR 192.7 - Apportionment of withheld funds after compliance.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 23 Highways 1 2011-04-01 2011-04-01 false Apportionment of withheld funds after compliance. 192.7 Section 192.7 Highways FEDERAL HIGHWAY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION PAYMENT PROCEDURES DRUG OFFENDER'S DRIVER'S LICENSE SUSPENSION § 192.7 Apportionment of withheld funds after compliance...

  13. Influence of social competence of physicians on patient compliance with osteoporosis medications--a study on Polish postmenopausal women.

    PubMed

    Bryl, Nadia; Horst-Sikorska, Wanda; Ignaszak-Szczepaniak, Magdalena; Marcinkowska, Michalina; Michalak, Michał; Sewerynek, Ewa

    2012-07-01

    The aim of the study was to examine the impact of social competence of physicians on the effectiveness of patient compliance and persistence with therapy. The study included physicians and their patients, previously diagnosed with osteoporosis, and eligible to receive pharmacological treatment. The physicians were evaluated with the social competence questionnaire involving three dimensions: social exposure, intimacy and assertiveness, as well as in the combined scale. All patients in the study group were prescribed the same medication: alendronate once a week. Compliance and persistence of the patients were juxtaposed with social interaction skills of physicians during 7 scheduled appointments at 2-month intervals. Doctor's effectiveness in situations demanding close interpersonal contact was higher in the group with good compliance--group A (p < 0.001), as well as in the situations of social exposure, (p < 0.001). On the other hand, their assertiveness was higher in the group with poor compliance--group B (p < 0.001). Co-morbid conditions (group A: 76%, group B: 74%), as well as earlier fractures (40.43% vs. 36.78%) were comparable in both groups. Disease acceptance and suggested methods of treatment were more often accepted by patients from group A than group B (56% vs. 33%, respectively). (1) Disease acceptance is essential for effective treatment. (2) Social skills of physicians influence patient adherence to therapy recommendations. (3) Close interpersonal contact between physicians and their patients eliminates the feeling of fear and

  14. 42 CFR 35.2 - Compliance with hospital rules.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 42 Public Health 1 2011-10-01 2011-10-01 false Compliance with hospital rules. 35.2 Section 35.2 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES MEDICAL CARE AND EXAMINATIONS HOSPITAL AND STATION MANAGEMENT General § 35.2 Compliance with hospital rules. All patients and...

  15. 42 CFR 35.2 - Compliance with hospital rules.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 42 Public Health 1 2014-10-01 2014-10-01 false Compliance with hospital rules. 35.2 Section 35.2 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES MEDICAL CARE AND EXAMINATIONS HOSPITAL AND STATION MANAGEMENT General § 35.2 Compliance with hospital rules. All patients and...

  16. 42 CFR 35.2 - Compliance with hospital rules.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 42 Public Health 1 2012-10-01 2012-10-01 false Compliance with hospital rules. 35.2 Section 35.2 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES MEDICAL CARE AND EXAMINATIONS HOSPITAL AND STATION MANAGEMENT General § 35.2 Compliance with hospital rules. All patients and...

  17. 42 CFR 35.2 - Compliance with hospital rules.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 42 Public Health 1 2013-10-01 2013-10-01 false Compliance with hospital rules. 35.2 Section 35.2 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES MEDICAL CARE AND EXAMINATIONS HOSPITAL AND STATION MANAGEMENT General § 35.2 Compliance with hospital rules. All patients and...

  18. Drug-Related-Problem Outcomes and Program Satisfaction from a Comprehensive Brown Bag Medication Review.

    PubMed

    O'Connell, Mary Beth; Chang, Feng; Tocco, Ashley; Mills, Megan E; Hwang, Jamie M; Garwood, Candice L; Khreizat, Hanan S; Gupta, Nishi S

    2015-09-01

    To classify and quantify drug-related problems (DRPs), determine acceptance of DRP recommendations, and assess medication review satisfaction. Comprehensive brown bag medication reviews. Six senior centers and three senior high-rises. Individuals aged 60 and older (mean age 75.9 ± 8.5) taking five or more medications (n = 85). Two investigators independently classified DRPs using modified Pharmaceutical Care Network Europe classification scheme and severity of medication error and value of service scales. Two other investigators adjudicated classification differences. Satisfaction surveys were administered immediately and 3 months after review. A DRP recommendation implementation survey was completed at least 3 months after the review. Participants had a mean of 4.3 ± 2.8 DRPs (range 0-10). DRPs were classified as adverse reactions (30%), treatment effectiveness (28%), treatment costs (13%), information need (8%), and other (21%). Causes included drug selection (40%), wrong dosage (23%), participant problems (e.g., adherence, lack of medication knowledge, 16%), drug use process problems (12%), drug formulation (0.5%), treatment duration (0.5%), and other (7%). Interventions required drug changes (44%), prescriber input (37%), individual counseling (18%), or other (1%). DRP severities were significant (59%) or minor (35%). Participants expressed satisfaction with the program because they were able to ask questions, trusted the answers, and knew more about their medications. After 3 months, they had implemented 63% of the DRP recommendations. Older adults found the medication review helpful and implemented 63% of the DRP recommendations. © 2015, Copyright the Authors Journal compilation © 2015, The American Geriatrics Society.

  19. The demand for statin: the effect of copay on utilization and compliance.

    PubMed

    Thiebaud, Patrick; Patel, Bimal V; Nichol, Michael B

    2008-01-01

    Increasing drug costs in the US have prompted employers and insurers alike to turn to higher drug copays for cost containment. The effect of rising copays on compliance with statins (HMG-CoA reductase inhibitors) treatment has received surprisingly little attention in the applied literature. This paper uses pharmacy claims data from a commercially insured adult population to determine the effect of copay change on compliance at the individual level. Fixed effect logit and Poisson regressions estimate the effect of copays on monthly likelihood of high compliance and average monthly days of supply respectively. Higher copays reduce compliance among statin users, with less compliant patients responding more strongly to copay change than compliant patients. These results suggest that specific financial incentives given to less compliant patients could improve compliance with statin treatment at a relatively low cost. Copyright (c) 2007 John Wiley & Sons, Ltd.

  20. Medical Advice from Lawyers: A Content Analysis of Advertising for Drug Injury Lawsuits.

    PubMed

    Tippett, Elizabeth

    2015-01-01

    This study examined the medical information contained in a sample of television ads soliciting consumers for lawsuits against drug and medical device manufactures. Almost all such ads involved drugs or devices that have not been recalled and remain on the market. These ads raise important public health questions because they may influence the prospective medical decisions of viewers. The ads contained extensive descriptions of serious adverse events associated with the drugs or devices but almost uniformly failed to disclose information relating to the likelihood of such events. They also failed to effectively advise viewers to consult a doctor. Results also identified a subset of ads that mimicked public service announcements, claiming to be. a "medical alert" "consumer alert" or "FDA warning" at the start of the ad. Most such ads did not disclose the attorney source of the advertising until the final few seconds.

  1. Efficacy of telephone and mail intervention in patient compliance with antihypertensive drugs in hypertension. ETECUM-HTA study.

    PubMed

    Márquez Contreras, Emilio; Vegazo García, Onofre; Martel Claros, Nieves; Gil Guillén, Vicente; de la Figuera von Wichmann, Mariano; Casado Martínez, José Joaquín; Fernández, Raúl

    2005-01-01

    To study the efficacy of telephone and mail intervention in therapeutic compliance among patients with mild to moderate hypertension. A prospective controlled multicenter clinical trial. Eighty-five primary care centers in Spain, with a duration of 6 months. A total of 636 patients with newly diagnosed or uncontrolled hypertension were included. Interventions. The patients were randomized and distributed between the following groups: (i) control (CG) - under routine clinical management; (ii) mail intervention (MIG) - received a mailed message reinforcing compliance and reminding of the visits (15 days, 2 and 4 months); (iii) telephone intervention (TIG) - received a telephone call at 15 days, then at 7 and 15 weeks. Five visits were scheduled, with the measurement of blood pressure and counting of tablets. Compliers were defined as subjects showing 80-110% drug consumption. Calculations were made of mean percentage compliance (MPC) and compliers, mean blood pressure and percentage controlled subjects. Five hundred and thirty-eight patients completed the study (261 males); 85.5% were compliers (CI = 82.5-88.5; n = 460). The MPC was 95.1+/-19.6% (CI = 93.28-96.92). The CG consisted of 182 individuals, MIG = 172 and TIG = 184. Compliers represented 69.2% of the CG (CI 62.5-75.9%), 91.3% (CI = 87.1-95.5) of the MIG (p = 0.0001) and 96.2% of the TIG (CI 93.5-98.9%); the final MPC was 89.6%+/-15 in CG, 96.6%+/-12 in MIG and 99.1+/-26.8 in TIG (p = 0.0001). The percentage of controlled subjects was 47.2% in CG (CI = 40-54.4), 61.3% in MIG (CI = 54.1-68.5%) and 63.3% in TIG (CI = 56.4-70.2%) (p<0.05). TIG and MIG are effective measures for improving patient compliance in hypertension.

  2. Severe drug interactions and potentially inappropriate medication usage in elderly cancer patients.

    PubMed

    Alkan, Ali; Yaşar, Arzu; Karcı, Ebru; Köksoy, Elif Berna; Ürün, Muslih; Şenler, Filiz Çay; Ürün, Yüksel; Tuncay, Gülseren; Ergün, Hakan; Akbulut, Hakan

    2017-01-01

    Due to more comorbidities, polypharmacy is common in elderly patients and drug interactions are inevitable. It is also challenging to treat an elderly patient with a diagnosis of cancer. Prevalence and clinical impacts of drug interactions and using potentially inappropriate medications (PIMs) have been studied in geriatric patients. However, these are not well defined in oncology practice. The purpose of this study is to define the prevalence of PIMs and severe drug interactions (SDIs) in elderly cancer patients and investigate the factors associated with them. Patients more than 65 years of age in both inpatient and outpatient clinics were evaluated. Patient, disease characteristics, and medications used were collected by self reports and medical records. Drug interactions were checked with Lexicomp® and PIM was defined with 2012 update of Beers criteria. Severe drug interactions are defined with category D or X DIs. Logistic regression was used to compute odds ratios (ORs) and 95 % confidence intervals (CIs) for the association between SDIs, PIMs, and clinical parameters. Four hundered and forty-five elderly patients (286 outpatient, 159 inpatient), with a median age of 70 (65-89) were evaluated. SDIs were present in 156 (35.1 %) of patients, 81 (28.3 %), and 75 (47.2 %) for outpatient and inpatients, respectively (p < 0.001). PIMs were present in 117 (26.6 %) of the patients, 40 (14.2 %), and 77(48.4 %) for outpatient and inpatients, respectively (p < 0.001). In multivariate analysis; polypharmacy (≥5 drugs), inpatient status and diagnosis of lung cancer were associated with severe DIs. Polypharmacy, inpatient status, and bad performance score (ECOG 3-4) were associated with PIMs. Nearly one third of the elderly cancer patients are exposed to severe drug interactions and PIMs. Clinicians dealing with elderly cancer patients should be more cautious when prescribing/ planning drugs to this group of patients. More strategies should be developed in

  3. Evaluation of discharge medication orders following automatic therapeutic substitution of commonly exchanged drug classes.

    PubMed

    Glaholt, Sarah; Hayes, Genevieve L; Wisniewski, Christopher S

    2014-04-01

    Automatic therapeutic substitution (ATS) is a mechanism that, upon patient hospitalization, prompts the pharmacist to exchange an equivalent formulary drug for a nonformulary medication, typically without prescriber contact. In facilities utilizing ATS, there is the possibility that physicians and patients may be unaware of the substitution, potentially leading to drug-drug interactions, therapeutic duplication, and/or increased patient expense following discharge should the original regimen not be resumed. The purpose of this study was to determine the frequency with which hospitalized patients subjected to an ATS protocol were not returned to outpatient drug therapy. A retrospective chart review of adult patients admitted to an academic medical center between January 1 and June 30, 2011, was conducted. Patients were included if they were admitted on angiotensin-converting enzyme (ACE) inhibitors, antidepressants, nonsedating antihistamines, histamine (H2) receptor antagonists, or proton pump inhibitors (PPIs), and were then prescribed a different agent via ATS. Admission and discharge medication reconciliation documents, dictated discharge summaries, and patient education documentation reports were reviewed for drug therapies and doses, as well as medication counseling evidence. The primary endpoint was the percentage of patients not returned to original outpatient therapy following ATS. Secondary endpoints included prescribing events in patients not returned to original therapy, the rate and source of drug therapy counseling at discharge, and the number of patients discharged on a potentially cost-prohibitive drug, defined as any drug available only as a branded product during the study period. A total of 317 interventions were identified through review of pharmacy records. Of these, 47 patients (15%) were not returned to original outpatient therapy. Within this subsection, 15 patients (32%) were discharged on the substituted drug, eight patients (17%) resumed

  4. Use of Preclinical Drug vs. Food Choice Procedures to Evaluate Candidate Medications for Cocaine Addiction.

    PubMed

    Banks, Matthew L; Hutsell, Blake A; Schwienteck, Kathryn L; Negus, S Stevens

    2015-06-01

    Drug addiction is a disease that manifests as an inappropriate allocation of behavior towards the procurement and use of the abused substance and away from other behaviors that produce more adaptive reinforcers (e.g. exercise, work, family and social relationships). The goal of treating drug addiction is not only to decrease drug-maintained behaviors, but also to promote a reallocation of behavior towards alternative, nondrug reinforcers. Experimental procedures that offer concurrent access to both a drug reinforcer and an alternative, nondrug reinforcer provide a research tool for assessment of medication effects on drug choice and behavioral allocation. Choice procedures are currently the standard in human laboratory research on medications development. Preclinical choice procedures have been utilized in biomedical research since the early 1940's, and during the last 10-15 years, their use for evaluation of medications to treat drug addiction has increased. We propose here that parallel use of choice procedures in preclinical and clinical studies will facilitate translational research on development of medications to treat cocaine addiction. In support of this proposition, a review of the literature suggests strong concordance between preclinical effectiveness of candidate medications to modify cocaine choice in nonhuman primates and rodents and clinical effectiveness of these medications to modify either cocaine choice in human laboratory studies or metrics of cocaine abuse in patients with cocaine use disorder. The strongest evidence for medication effectiveness in preclinical choice studies has been obtained with maintenance on the monoamine releaser d -amphetamine, a candidate agonist medication for cocaine use analogous to use of methadone to treat heroin abuse or nicotine formulations to treat tobacco dependence.

  5. Use of Preclinical Drug vs. Food Choice Procedures to Evaluate Candidate Medications for Cocaine Addiction

    PubMed Central

    Banks, Matthew L; Hutsell, Blake A; Schwienteck, Kathryn L; Negus, S. Stevens

    2015-01-01

    Opinion Statement Drug addiction is a disease that manifests as an inappropriate allocation of behavior towards the procurement and use of the abused substance and away from other behaviors that produce more adaptive reinforcers (e.g. exercise, work, family and social relationships). The goal of treating drug addiction is not only to decrease drug-maintained behaviors, but also to promote a reallocation of behavior towards alternative, nondrug reinforcers. Experimental procedures that offer concurrent access to both a drug reinforcer and an alternative, nondrug reinforcer provide a research tool for assessment of medication effects on drug choice and behavioral allocation. Choice procedures are currently the standard in human laboratory research on medications development. Preclinical choice procedures have been utilized in biomedical research since the early 1940’s, and during the last 10–15 years, their use for evaluation of medications to treat drug addiction has increased. We propose here that parallel use of choice procedures in preclinical and clinical studies will facilitate translational research on development of medications to treat cocaine addiction. In support of this proposition, a review of the literature suggests strong concordance between preclinical effectiveness of candidate medications to modify cocaine choice in nonhuman primates and rodents and clinical effectiveness of these medications to modify either cocaine choice in human laboratory studies or metrics of cocaine abuse in patients with cocaine use disorder. The strongest evidence for medication effectiveness in preclinical choice studies has been obtained with maintenance on the monoamine releaser d-amphetamine, a candidate agonist medication for cocaine use analogous to use of methadone to treat heroin abuse or nicotine formulations to treat tobacco dependence. PMID:26009706

  6. Teaching exercise of drug utilization by medical students.

    PubMed

    Das, B P; Sethi, A; Nutan, K; Gunjan

    2005-01-01

    The prescription is a vital written document communicating between the physician, the patient and the pharmacist. The audit of prescribing pattern is a component of medical audit, which seeks monitoring, evaluation and necessary modifications in the prescribing practices of prescribers to achieve rational and cost effective medical care for the patients, The present drug utilization study was conducted by fourth year MBBs students during their research posting in the department of Pharmacology at B.P. Koirala Institute of Health Sciences (BPKIHS), Dharan. The prescriptions were randomly collected from BPKIHS pharmacy over a period of 3 weeks. The auditing was done in the form of a semi structured performa containing the patients particulars with regard to age, sex, and residence, the details of the illness and prescribed drug information. The data was analyzed at the end of the study. The study points out that the maximum (27.5%) prescriptions were from General Outpatient Department (GOPD) followed by ENT (16.5%), Internal medicine (15.5%) and General surgery (10%). This indicates the distribution of patient load in hospital and the dominant areas to be targeted for intervention. Further, the proportion of antimicrobial agents (AMAs) i.e. 26.03% use was low and was prescribed empirically in most of the cases. There was use of expensive AMAs and irrational prescribing of combinations of AMAs in some prescriptions. Other prevailing drugs which were prescribed were analgesics. The usage of nimesulide and rofecoxib. withdrawn by FDA were used recurrently in this setup. There was greater use of dubious drugs of unproven benefit like vitamins, calcium etc. The diagnosis of the disease were not mentioned in 32.5% of prescriptions, The dose, frequency and duration of drugs were unascertained in majority of prescriptions that might lead to health hazards. This exercise might change the behavior of existing prescribers and also of the future doctors.

  7. Methods Development for Blood Borne Macrophage Carriage of Nanoformulated Antiretroviral Drugs

    PubMed Central

    Roy, Upal; Martinez-Skinner, Andrea; McMillan, JoEllyn; Gendelman, Howard E.

    2010-01-01

    Nanoformulated drugs can improve pharmacodynamics and bioavailability while serving also to reduce drug toxicities for antiretroviral (ART) medicines. To this end, our laboratory has applied the principles of nanomedicine to simplify ART regimens and as such reduce toxicities while improving compliance and drug pharmacokinetics. Simple and reliable methods for manufacturing nanoformulated ART (nanoART) are shown. Particles of pure drug are encapsulated by a thin layer of surfactant lipid coating and produced by fractionating larger drug crystals into smaller ones by either wet milling or high-pressure homogenization. In an alternative method free drug is suspended in a droplet of a polymer. Herein, drug is dissolved within a polymer then agitated by ultrasonication until individual nanosized droplets are formed. Dynamic light scattering and microscopic examination characterize the physical properties of the particles (particle size, charge and shape). Their biologic properties (cell uptake and retention, cytotoxicity and antiretroviral efficacy) are determined with human monocyte-derived macrophages (MDM). MDM are derived from human peripheral blood monocytes isolated from leukopacks using centrifugal elutriation for purification. Such blood-borne macrophages may be used as cellular transporters for nanoART distribution to human immunodeficiency virus (HIV) infected organs. We posit that the repackaging of clinically available antiretroviral medications into nanoparticles for HIV-1 treatments may improve compliance and positively affect disease outcomes. PMID:21178968

  8. Biocompatible medical implant materials with binding sites for a biodegradable drug-delivery system

    PubMed Central

    Al-Dubai, Haifa; Pittner, Gisela; Pittner, Fritz; Gabor, Franz

    2011-01-01

    Feasibility studies have been carried out for development of a biocompatible coating of medical implant materials allowing the binding of biodegradable drug-delivery systems in a way that their reloading might be possible. These novel coatings, able to bind biodegradable nanoparticles, may serve in the long run as drug carriers to mediate local pharmacological activity. After biodegradation of the nanoparticles, the binding sites could be reloaded with fresh drug-delivering particles. As a suitable receptor system for the nanoparticles, antibodies are anchored. The design of the receptor is of great importance as any bio- or chemorecognitive interaction with other components circulating in the blood has to be avoided. Furthermore, the binding between receptor and the particles has to be strong enough to keep them tightly bound during their lifetime, but on the other hand allow reloading after final degradation of the particles. The nanoparticles suggested as a drug-delivery system for medical implants can be loaded with different pharmaceuticals such as antibiotics, growth factors, or immunosuppressives. This concept may enable the changing of medication, even after implantation of the medical device, if afforded by patients’ needs. PMID:24198488

  9. Factors associated with compliance with viscosity-modified diet among dysphagic patients.

    PubMed

    Shim, Jae Seong; Oh, Byung-Mo; Han, Tai Ryoon

    2013-10-01

    To investigate compliance with a viscosity-modified diet among Korean dysphagic patients and to determine which factors are associated with compliance. We retrospectively reviewed medical records of patients who had been recommended to use thickeners in the previous videofluoroscopic swallowing study (VFSS). Among 68 patients, 6 were excluded because tube feeding was required due to deterioration in their medical condition. Finally, 62 patients were included in the study. Patient compliance was assessed using their medical records by checking whether he or she had maintained thickener use until the next VFSS. To determine which factors affect compliance, the relationship between thickener use and patient characteristics, such as sex, age, inpatient/outpatient status, severity of dysphagia, aspiration symptoms, follow-up interval of VFSS, and current swallowing therapy status were assessed. For noncompliers, reasons for not using thickeners were investigated by telephone interview. Among 62 patients, 35 (56.5%) were compliers, and 27 (43.5%) were noncompliers. Eighteen (90%) of 20 inpatients had followed previous recommendations; however, only 17 (40.5%) of 42 outpatients had been using thickeners. Of patient characteristics, only admission status was significantly correlated with compliance. When asked about the reason why they had not used thickeners, noncompliers complained about dissatisfaction with texture and taste, greater difficulty in swallowing, and inconvenience of preparing meals. Among Korean dysphagic patients, compliance with a viscosity-modified liquid diet was only about 50%. Betterments of texture and taste along with patient education might be necessary to improve compliance with thickener use.

  10. How many people in Canada use prescription opioids non-medically in general and street drug using populations?

    PubMed

    Popova, Svetlana; Patra, Jayadeep; Mohapatra, Satya; Fischer, Benedikt; Rehm, Jürgen

    2009-01-01

    Medical prescriptions for opioids as well as their non-medical use have increased in Canada in recent years. This study aimed to estimate the number of non-medical prescription opioid (PO) users in the general and street drug using populations in Canada. The number of non-medical PO users among the general population and the number of non-medical PO users, heroin users, or both among the street drug using population was estimated for Canada and for the most populous Canadian provinces. Different estimation methods were used: 1) the number of non-medical PO users in the Canadian general population was estimated based on Canadian availability data, and the ratio of US availability to non-medical PO use from US survey data; 2) numbers within the street drug using population were indirectly estimated based on overdose death data, and a key informants survey. Distribution and trends by usage of opioids were determined by using the multi-site Canadian OPICAN cohort data. Between 321,000 to 914,000 non-medical PO users were estimated to exist among the general population in Canada in 2003. The estimated number of non-medical PO users, heroin users, or both among the street drug using population was about 72,000, with more individuals using nonmedical PO than heroin in 2003. Based on data from the OPICAN survey, in 2005 the majority of the street drug using population in main Canadian cities was non-medical PO users, with the exception of Vancouver and Montreal. A relative increase of 24% was observed from 2002 to 2005 in the proportion of the street drug using population who used non-medical POs only. There is an urgent need to further assess the extent and patterns of non-medical prescription opioid use, related problems and drug distribution channels in Canada.

  11. Limited Awareness of the Essences of Certification or Compliance Markings on Medical Devices.

    PubMed

    Foo, Jong Yong Abdiel; Tan, Xin Ji Alan

    2017-06-01

    Medical devices have been long used for odiagnostic, therapeutic or rehabilitation purposes. Currently, they can range from a low-cost portable device that is often used for personal health monitoring to high-end sophisticated equipment that can only be operated by trained professionals. Depending on the functional purposes, there are different certification or compliance markings on the device when it is sold. One common certification marking is the Conformité Européenne affixation but this has a range of certification mark numbering for a variety of functional purposes. While the regulators and medical device manufacturers understand the associated significance and clinical implications, these may not be apparent to the professionals (using or maintaining the device) and the general public. With portable healthcare devices and mobile applications gaining popularity, better awareness of certification marking will be needed. Particularly, there are differences in the allowed functional purposes and the associated cost derivations of devices with a seemingly similar nature. A preferred approach such as an easy-to-understand notation next to any certification marking on a device can aid in differentiation without the need to digest mountainous regulatory details.

  12. Non-medical use of psychoactive drugs in relation to suicide tendencies among Chinese adolescents.

    PubMed

    Juan, Wang; Jian-Xiong, Deng; Lan, Guo; Yuan, He; Xue, Gao; Jing-Hui, Huang; Guo-Liang, Huang; Ci-Yong, Lu

    2015-12-01

    To investigate the prevalence of non-medical use of psychoactive prescription drug (NMUPD) among adolescents and to explore the associations between non-medical psychoactive prescription drug use and depressive symptoms, poor sleep quality, deliberate self-harm, and suicide. A two-stage stratified cluster sample design produced a representative sample of 12-19-year-old students in grades 1-6 who attended public middle schools in Guangdong province. Prevalence estimates (SE) of non-medical psychoactive prescription drug use were calculated, and logistic regression was used to examine its association with depressive symptoms, poor sleep quality, deliberate self-harm, and suicide. Overall, 7.5% of adolescents reported non-medical use of opioids, and 4.8% of adolescents reported non-medical use of sedatives. Lifetime, last-year, and last-month non-medical use of opioids and sedatives were positively associated with depressive symptoms, poor sleep quality, deliberate self-harm, suicidal ideation, and suicidal attempts among different gender and age-group adolescents. Those who reported last month non-medical use of opioids and sedatives had the greatest odds of reporting depressive symptoms, poor sleep quality, deliberate self-harm, suicidal ideation, and suicidal attempts. Males who were last month non-medical users of opioids or sedative had 8.9 or 10.7 times greater odds of reporting a suicidal attempt, and 8.8 or 9.8 times greater odds of reporting a suicidal attempt were observed among adolescents aged 16-19 who were last-month non-medical users of opioids or sedatives. These findings provide evidence for improving adolescents' suicide prevention strategy by targeting supervision on high risk current non-medical users of psychoactive drug. Copyright © 2015 Elsevier Ltd. All rights reserved.

  13. Trends in Non-prescription Drug Recalls in Japan.

    PubMed

    Yamamoto, Chikoto; Ishida, Takuya; Osawa, Takashi; Naito, Takafumi; Kawakami, Junichi

    2016-01-01

    Recalls of non-prescription drugs can contribute to preventing harm to human health, however, they also interrupt the supply of medicines to the market. The aim of the present study was to investigate the trends in non-prescription drug recalls in Japan. Class I, II, and III recalls reported from April 2009 to March 2014 were obtained from the websites of the Ministry of Health, Labour and Welfare and the Pharmaceuticals and Medical Devices Agency. Each drug recall was classified according to year, dosage form, therapeutic category, and reasons for the recall. The trends over the 5 year period were assessed for each class. A total of 220 recalls were reported in the 5-year study period. The numbers of drug recalls were 21, 16, 80, 58, and 45 in 2009, 2010, 2011, 2012, and 2013, respectively. The drugs recalled consisted of 177 internal medications, 35 topical agents, and 8 others. Drug recalls were observed in 12 therapeutic categories of drug effects. The largest number of recalls was for Chinese herbal medicines and crude drugs. Of all the drug recalls in 2011, Chinese herbal medicines and crude drugs produced by one manufacturer accounted for 84%. Slightly more than half (54%) of drug recalls were due to a violation of the regulations. One manufacturer recalled many drugs because of non-compliance with the standard regulations for manufacturing drugs after 2011. In conclusion, non-prescription drug recalls can occur for any drug regardless of the dosage form and therapeutic category.

  14. Prescription copay reduction program for diabetic employees: impact on medication compliance and healthcare costs and utilization.

    PubMed

    Nair, Kavita V; Miller, Kerri; Saseen, Joseph; Wolfe, Pamela; Allen, Richard Read; Park, Jinhee

    2009-01-01

    To examine the impact of a value-based benefit design on utilization and expenditures. This benefit design involved all diabetes-related drugs and testing supplies placed on the lowest copay tier for 1 employer group. The sample of diabetic members were enrolled from a 9-month preperiod and for 2 years after the benefit design was implemented. Measured outcomes included prescription drug utilization for diabetes and medical utilization. Generalized measures were used to estimate differences between years 1 and 2 and the preperiod adjusting for age, gender, and comorbidity risk. Diabetes prescription drug use increased by 9.5% in year 1 and by 5.5% in year 2, and mean adherence increased by 7% to 8% in year 1 and fell slightly in year 2 compared with the preperiod. Pharmacy expenditures increased by 47% and 53% and expenditures for diabetes services increased by 16% and 32% in years 1 and 2, respectively. Increases in adherence and use of diabetes medications were observed. There were no compensatory cost-savings for the employer through lower utilization of medical expenditures in the first 2 years. Adherent patients had fewer emergency department visits than nonadherent patients after the implementation of this benefit design.

  15. Generic antiepileptic drugs and associated medical resource utilization in the United States.

    PubMed

    Labiner, D M; Paradis, P E; Manjunath, R; Duh, M S; Lafeuille, M-H; Latrémouille-Viau, D; Lefebvre, P; Helmers, S L

    2010-05-18

    To evaluate whether generic substitution was associated with any difference in medical resource utilization for 5 widely used antiepileptic drugs (AEDs) in the United States. Health insurance claims from PharMetrics Database, representing over 90 health plans between January 2000 and October 2007, were analyzed. Adult patients with epilepsy, continuously treated with carbamazepine, gabapentin, phenytoin, primidone, or zonisamide, were selected. An open-cohort design was used to classify patients into mutually exclusive periods of brand vs generic use of AEDs. Pharmacy and medical utilization were compared between the 2 periods with multivariate regression analyses. Results were stratified into epilepsy-related medical services, and stable (< or = 2 outpatient visits per year and no emergency room visit) vs unstable epilepsy. Time-to-event analyses were also performed for all services and epilepsy-related endpoints. A total of 18,125 patients were observed in the stable group and 15,500 patients in the unstable group. After adjustment of covariates, periods of generic AED treatment were associated with increased use of all prescription drugs (incidence rate ratio [IRR] [95% confidence interval (CI)] = 1.13 [1.13-1.14]) and higher epilepsy-related medical utilization rates (hospitalizations: IRR [95% CI] = 1.24 [1.19-1.30]; outpatient visits: IRR [95% CI] = 1.14 [1.13-1.16]; lengths of hospital stays: IRR [95% CI] = 1.29 [1.27-1.32]). Generic-use periods were associated with increased utilization rates in stable and unstable patients and with 20% increased risk of injury, compared to periods with brand use of AEDs. Generic antiepileptic drug use was associated with significantly greater medical utilization and risk of epilepsy-related medical events, compared to brand use. This relationship was observed even in patients characterized as stable. AED = antiepileptic drug; CI = confidence interval; ER = emergency room; HR = hazard ratio; ICD = International

  16. Suicide and Drug Abuse in the Medical Community

    ERIC Educational Resources Information Center

    Bressler, Bernard

    1976-01-01

    In the United States each year the equivalent of an average-size medical school graduating class commits suicide, with the highest incidence occurring in the decade following the completion of training. Of these suicides, 20 percent to 30 percent are associated with drug abuse and 40 percent with alcoholism. Various problem areas are considered.…

  17. Russia and the Medical Drug Trade in the Seventeenth Century

    PubMed Central

    Griffin, Clare

    2018-01-01

    Summary This article deals with the trade in medicines into Russia in the seventeenth century. Both the early modern medical drug trade, and Russian medicine, have previously received substantial attention, but no work has thus far been undertaken on the Russian angle of the drug trade. Drawing on previously unused documents, this article traces the kinds of drugs acquired by the Moscow court. In contrast to the dominant view of official Russian medicine as divorced from native healing practices and fundamentally reliant upon Western European trends, these documents reveal that drugs were sourced as locally as Moscow markets, and from as far afield as East Asia and the Americas, but that not all drugs were accepted. As many of these imports came through Western European markets, this article also sheds further light on what drugs were available there, demonstrating the great diversity of drugs traded in early modern Europe. PMID:29713122

  18. Precursor medications as a source of methamphetamine and/or amphetamine positive drug testing results.

    PubMed

    Cody, John T

    2002-05-01

    Medical Review Officer interpretation of laboratory results is an important component of drug testing programs. The clinical evaluation of laboratory results to assess the possibility of appropriate medical use of a drug is a task with many different facets, depending on the drug class considered. This intercession prevents the reporting of positive results unless it is apparent that drugs were used illicitly. In addition to the commonly encountered prescribed drugs that yield positive drug testing results, other sources of positive results must be considered. This review describes a series of compounds referred to as "precursor" drugs that are metabolized by the body to amphetamine and/or methamphetamine. These compounds lead to positive results for amphetamines even though neither amphetamine nor methamphetamine were used, a possibility that must be considered in the review of laboratory results. Description of the drugs, their clinical indications, and results seen following administration are provided. This information allows for the informed evaluation of results with regard to the potential involvement of these drugs.

  19. Compliance With Electronic Medical Records Privacy Policy: An Empirical Investigation of Hospital Information Technology Staff

    PubMed Central

    Sher, Ming-Ling; Talley, Paul C.; Yang, Ching-Wen; Kuo, Kuang-Ming

    2017-01-01

    The employment of Electronic Medical Records is expected to better enhance health care quality and to relieve increased financial pressure. Electronic Medical Records are, however, potentially vulnerable to security breaches that may result in a rise of patients’ privacy concerns. The purpose of our study was to explore the factors that motivate hospital information technology staff’s compliance with Electronic Medical Records privacy policy from the theoretical lenses of protection motivation theory and the theory of reasoned action. The study collected data using survey methodology. A total of 310 responses from information technology staff of 7 medical centers in Taiwan was analyzed using the Structural Equation Modeling technique. The results revealed that perceived vulnerability and perceived severity of threats from Electronic Medical Records breaches may be used to predict the information technology staff’s fear arousal level. And factors including fear arousal, response efficacy, self-efficacy, and subjective norm, in their turn, significantly predicted IT staff’s behavioral intention to comply with privacy policy. Response cost was not found to have any relationship with behavioral intention. Based on the findings, we suggest that hospitals could plan and design effective strategies such as initiating privacy-protection awareness and skills training programs to improve information technology staff member’s adherence to privacy policy. Furthermore, enhancing the privacy-protection climate in hospitals is also a viable means to the end. Further practical and research implications are also discussed.

  20. Evaluating the effectiveness of self-administration of medication (SAM) schemes in the hospital setting: a systematic review of the literature.

    PubMed

    Richardson, Suzanna J; Brooks, Hannah L; Bramley, George; Coleman, Jamie J

    2014-01-01

    Self-administration of medicines is believed to increase patients' understanding about their medication and to promote their independence and autonomy in the hospital setting. The effect of inpatient self-administration of medication (SAM) schemes on patients, staff and institutions is currently unclear. To systematically review the literature relating to the effect of SAM schemes on the following outcomes: patient knowledge, patient compliance/medication errors, success in self-administration, patient satisfaction, staff satisfaction, staff workload, and costs. Keyword and text word searches of online databases were performed between January and March 2013. Included articles described and evaluated inpatient SAM schemes. Case studies and anecdotal studies were excluded. 43 papers were included for final analysis. Due to the heterogeneity of results and unclear findings it was not possible to perform a quantitative synthesis of results. Participation in SAM schemes often led to increased knowledge about drugs and drug regimens, but not side effects. However, the effect of SAM schemes on patient compliance/medication errors was inconclusive. Patients and staff were highly satisfied with their involvement in SAM schemes. SAM schemes appear to provide some benefits (e.g. increased patient knowledge), but their effect on other outcomes (e.g. compliance) is unclear. Few studies of high methodological quality using validated outcome measures exist. Inconsistencies in both measuring and reporting outcomes across studies make it challenging to compare results and draw substantive conclusions about the effectiveness of SAM schemes.

  1. A Systematic, Intensive Statistical Investigation of Data from the Comprehensive Analysis of Reported Drugs (CARD) for Compliance and Illicit Opioid Abstinence in Substance Addiction Treatment with Buprenorphine/naloxone.

    PubMed

    Blum, Kenneth; Han, David; Modestino, Edward J; Saunders, Scott; Roy, A Kennison; Jacobs, W; Inaba, Darryl S; Baron, David; Oscar-Berman, Marlene; Hauser, Mary; Badgaiyan, Rajendra D; Smith, David E; Femino, John; Gold, Mark S

    2018-01-28

    Buprenorphine and naloxone (bup/nal), a combination partial mu receptor agonist and low-dose delta mu antagonist, is presently recommended and used to treat opioid-use disorder. However, a literature review revealed a paucity of research involving data from urine drug tests that looked at compliance and abstinence in one sample. Statistical analysis of data from the Comprehensive Analysis of Reported Drugs (CARD) was used to assess compliance and abstinence during treatment in a large cohort of bup/nal patients attending chemical-dependency programs from eastern USA in 2010 and 2011. Part 1: Bup/nal was present in 93.4% of first (n = 1,282; p <.0001) and 92.4% of last (n = 1,268; p <.0001) urine samples. Concomitantly, unreported illicit drugs were present in 47.7% (n = 655, p =.0261) of samples. Patients who were compliant to the bup/nal prescription were more likely than noncompliant patients to be abstinent during treatment (p =.0012; odds ratio = 1.69 with 95% confidence interval (1.210, 2.354). Part 2: An analysis of all samples collected in 2011 revealed a significant improvement in both compliance (p < 2.2 × 10 -16 ) and abstinence (p < 2.2 × 10 -16 ) during treatment. Conclusion/Importance: While significant use of illicit opioids during treatment with bup/nal is present, improvements in abstinence and high compliance during maintenance-assisted therapy programs may ameliorate fears of diversion in comprehensive programs. Expanded clinical datasets, the treatment modality, location, and year of sampling are important covariates, for further studies. The potential for long-term antireward effects from bup/nal use requires consideration in future investigations.

  2. 10 CFR 707.13 - Medical review of results of tests for illegal drug use.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 4 2012-01-01 2012-01-01 false Medical review of results of tests for illegal drug use. 707.13 Section 707.13 Energy DEPARTMENT OF ENERGY WORKPLACE SUBSTANCE ABUSE PROGRAMS AT DOE SITES Procedures § 707.13 Medical review of results of tests for illegal drug use. (a) All test results shall be...

  3. 10 CFR 707.13 - Medical review of results of tests for illegal drug use.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 4 2011-01-01 2011-01-01 false Medical review of results of tests for illegal drug use. 707.13 Section 707.13 Energy DEPARTMENT OF ENERGY WORKPLACE SUBSTANCE ABUSE PROGRAMS AT DOE SITES Procedures § 707.13 Medical review of results of tests for illegal drug use. (a) All test results shall be...

  4. 10 CFR 707.13 - Medical review of results of tests for illegal drug use.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 4 2013-01-01 2013-01-01 false Medical review of results of tests for illegal drug use. 707.13 Section 707.13 Energy DEPARTMENT OF ENERGY WORKPLACE SUBSTANCE ABUSE PROGRAMS AT DOE SITES Procedures § 707.13 Medical review of results of tests for illegal drug use. (a) All test results shall be...

  5. 10 CFR 707.13 - Medical review of results of tests for illegal drug use.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 10 Energy 4 2014-01-01 2014-01-01 false Medical review of results of tests for illegal drug use. 707.13 Section 707.13 Energy DEPARTMENT OF ENERGY WORKPLACE SUBSTANCE ABUSE PROGRAMS AT DOE SITES Procedures § 707.13 Medical review of results of tests for illegal drug use. (a) All test results shall be...

  6. The Influence of Safety, Efficacy, and Medical Condition Severity on Natural versus Synthetic Drug Preference.

    PubMed

    Meier, Brian P; Lappas, Courtney M

    2016-11-01

    Research indicates that there is a preference for natural v. synthetic products, but the influence of this preference on drug choice in the medical domain is largely unknown. We present 5 studies in which participants were asked to consider a hypothetical situation in which they had a medical issue requiring pharmacological therapy. Participants ( N = 1223) were asked to select a natural, plant-derived, or synthetic drug. In studies 1a and 1b, approximately 79% of participants selected the natural v. synthetic drug, even though the safety and efficacy of the drugs were identical. Furthermore, participants rated the natural drug as safer than the synthetic drug, and as that difference increased, the odds of choosing the natural over synthetic drug increased. In studies 2 and 3, approximately 20% of participants selected the natural drug even when they were informed that it was less safe (study 2) or less effective (study 3) than the synthetic drug. Finally, in study 4, approximately 65% of participants chose a natural over synthetic drug regardless of the severity of a specific medical condition (mild v. severe hypertension), and this choice was predicted by perceived safety and efficacy differences. Overall, these data indicate that there is a bias for natural over synthetic drugs. This bias could have implications for drug choice and usage. © The Author(s) 2015.

  7. Federalizing Medical Campaigns against Alcoholism and Drug Abuse

    PubMed Central

    Metlay, Grischa

    2013-01-01

    Context The formation of the National Institute on Alcohol Abuse and Alcoholism (NIAAA) and the Special Action Office for Drug Abuse Prevention (SAODAP) in the early 1970s dramatically expanded scientific and medical efforts to control alcoholism and drug abuse in the United States. Methods Drawing on a variety of primary, secondary, and archival sources, this article describes the creation and early years of these agencies. Findings I show that while the agencies appeared at roughly the same time, their creation involved separate sets of issues and actors. In addition, I show that SAODAP received more money and resources, even though advocates for alcoholics mobilized a stronger lobbying campaign. Conclusions Two factors explain this discrepancy in money and resources: (1) alcoholism was framed as a public health problem, whereas drug abuse was drawn into broader debates about crime and social decline; and (2) alcohol programs relied on congressional support, whereas drug programs found champions at high levels of the Nixon administration. These political and cultural factors help explain why current programs for illegal drugs receive more federal support, despite alcohol's greater public health burden. PMID:23488713

  8. MEDICATION DISPOSAL AS A SOURCE FOR DRUGS AS ...

    EPA Pesticide Factsheets

    The major routes by which pharmaceuticals enter the environment are excretion, bathing, anddisposal of leftover, unwanted medications. Pharmaceuticals designed for humans and animalsoften remain unused. Leftover, accumulated drugs represent potentially environmentallyunsound disposal and suboptimal delivery of health care. They also can pose acute exposurerisks for humans and wildlife. Active pharmaceutical ingredients (APIs) directly enter theenvironment primarily via sewage. Among the three routes of entry, the relative contributions ofeach are poorly understood. In contrast to excretion, which as a source comprises continual lowlevelcontributions from multitudes of people, drug disposal comprises acute but transient andepisodic contributions from fewer people. The only route that is subject most easily to pollutionprevention or source control measures is disposal.A major unknown with respect to drugs as pollutants is what fractions of drug residues occurringin the ambient environment result from discarding leftover drugs. No studies exist that provideobjective data from well-defined populations to support any type of conclusion. Given theimportance of environmental stewardship to sustainability, a means for assessing the relativecontributions of APIs resulting from disposal would be useful in justifying the resources thatmight be devoted to controlling this source - - for example, by way of consumer

  9. Federalizing medical campaigns against alcoholism and drug abuse.

    PubMed

    Metlay, Grischa

    2013-03-01

    The formation of the National Institute on Alcohol Abuse and Alcoholism (NIAAA) and the Special Action Office for Drug Abuse Prevention (SAODAP) in the early 1970s dramatically expanded scientific and medical efforts to control alcoholism and drug abuse in the United States. Drawing on a variety of primary, secondary, and archival sources, this article describes the creation and early years of these agencies. I show that while the agencies appeared at roughly the same time, their creation involved separate sets of issues and actors. In addition, I show that SAODAP received more money and resources, even though advocates for alcoholics mobilized a stronger lobbying campaign. Two factors explain this discrepancy in money and resources: (1) alcoholism was framed as a public health problem, whereas drug abuse was drawn into broader debates about crime and social decline; and (2) alcohol programs relied on congressional support, whereas drug programs found champions at high levels of the Nixon administration. These political and cultural factors help explain why current programs for illegal drugs receive more federal support, despite alcohol's greater public health burden. © 2013 Milbank Memorial Fund.

  10. [Compliance to treatment in heart failure patients in Lomé].

    PubMed

    Yayehd, K; Damorou, F; N'cho Mottoh, M P; Tchérou, T; Johnson, A; Pessinaba, S; Tété, Y; Diziwiè, A M

    2013-02-01

    The incidence and prevalence rates of the heart failure in the world approach epidemic proportions. The evaluation of the follow-up of the treatment of heart failure can allow the setting up of strategies to reduce the frequency of decompensations and improve the quality of life of these patients. To estimate the compliance to treatment and factors liable to influence it in Togolese patients suffering from heart failure. This study was carried out from January 1st, 2008 to June 30th, 2009 in the department of cardiology of the university teaching hospital Campus in Lomé and included prospectively, patients with chronic heart failure hospitalized for acute decompensation and of which the heart failure was diagnosed and treated for at least 3 months. Questionnaires were filled to estimate the compliance to medication, to diet, as well as knowledge of the patients on their disease and their relationship with their doctor and their family. In the 103 patients included, we noticed no good compliance to medication; there were 74.7% of bad compliance to medication, 47.3% of good compliance to diet; 62.1% of patients had enough knowledge on their disease, 29.1% considered that their doctor did not grant them enough time; 57.3% estimated to have no necessary support of their family. Bad compliance to treatment was correlated to the existence or not of a health care insurance (OR=115.5; 95% CI=21.51-620.08; P<0.0001); this difference persisted after adjusting for age, sex and monthly income (OR=99.65; 95% CI=18.87-587.21; P=0.001). Bad compliance was not associated with monthly income (OR=0.93; 95% CI=0.37-2.28; P=0.944); it was neither influenced by traditional therapy (OR=1.58 95% CI=0.64-3.91; P=0.43), nor recovery prayers (OR=1.6; 95% CI=0.62-4.13; P=0.45), nor frequency of tablets intake (≥3 intake day), OR=0.169; 95% CI=0.05-0.49; P=0.43. The compliance to medication in Togolese heart failure patients was very low and essentially correlated to the absence of health

  11. Baseline Antihypertensive Drug Count and Patient Response to Hypertension Medication Management.

    PubMed

    Crowley, Matthew J; Olsen, Maren K; Woolson, Sandra L; King, Heather A; Oddone, Eugene Z; Bosworth, Hayden B

    2016-04-01

    Telemedicine-based medication management improves hypertension control, but has been evaluated primarily in patients with low antihypertensive drug counts. Its impact on patients taking three or more antihypertensive agents is not well-established. To address this evidence gap, the authors conducted an exploratory analysis of an 18-month, 591-patient trial of telemedicine-based hypertension medication management. Using general linear models, the effect of medication management on blood pressure for patients taking two or fewer antihypertensive agents at study baseline vs those taking three or more was compared. While patients taking two or fewer antihypertensive agents had a significant reduction in systolic blood pressure with medication management, those taking three or more had no such response. The between-subgroup effect difference was statistically significant at 6 months (-6.4 mm Hg [95% confidence interval, -12.2 to -0.6]) and near significant at 18 months (-6.0 mm Hg [95% confidence interval, -12.2 to 0.2]). These findings suggest that baseline antihypertensive drug count may impact how patients respond to hypertension medication management and emphasize the need to study management strategies specifically in patients taking three or more antihypertensive medications. Published 2015. This article is a U.S. Government work and is in the public domain in the USA.

  12. Clinical trial transparency: a reassessment of industry compliance with clinical trial registration and reporting requirements in the United States

    PubMed Central

    Lassman, Scott M; Shopshear, Olivia M; Jazic, Ina; Ulrich, Jocelyn; Francer, Jeffrey

    2017-01-01

    Objective To evaluate the accuracy of a 2015 cross-sectional analysis published in the BMJ Open which reported that pharmaceutical industry compliance with clinical trial registration and results reporting requirements under US law was suboptimal and varied widely among companies. Design We performed a reassessment of the data reported in Miller et al to evaluate whether statutory compliance analyses and conclusions were valid. Data sources Information from the Dryad Digital Repository, ClinicalTrials.gov, Drugs@FDA and direct communications with sponsors. Main outcome measures Compliance with the clinical trial registration and results reporting requirements under the Food and Drug Administration Amendments Act (FDAAA). Results Industry compliance with FDAAA disclosure requirements was notably higher than reported by Miller et al. Among trials subject to FDAAA, Miller et al reported that, per drug, a median of 67% (middle 50% range: 0%–100%) of trials fully complied with registration and results reporting requirements. On reanalysis of the data, we found that a median of 100% (middle 50% range: 93%–100%) of clinical trials for a particular drug fully complied with the law. When looking at overall compliance at the trial level, our reassessment yields 94% timely registration and 90% timely results reporting among the 49 eligible trials, and an overall FDAAA compliance rate of 86%. Conclusions The claim by Miller et al that industry compliance is below legal standards is based on an analysis that relies on an incomplete dataset and an interpretation of FDAAA that requires disclosure of study results for drugs that have not yet been approved for any indication. On reanalysis using a different interpretation of FDAAA that focuses on whether results were disclosed within 30 days of drug approval, we found that industry compliance with US statutory disclosure requirements for the 15 reviewed drugs was consistently high. PMID:28942418

  13. Inappropriate drug donations: what has happened since the 1999 WHO guidelines?

    PubMed

    van Dijk, D P; Dinant, G; Jacobs, J A

    2011-08-01

    Drug donations to developing countries may be part of medical relief operations in acute emergencies, development aid in non-emergency situations, or a corporate donations programme. After a number of documented inappropriate drug donations, the World Health Organization developed the 'Guidelines for Drug Donations', with the second and final version published in 1999. We reviewed the medical literature on drug donations since the Guidelines publication in 1999. Literature was retrieved from PubMed and other on-line databases as well as from relevant websites providing medical literature for use in developing countries. We considered the following donations to be inappropriate: (i) essential drugs in excessive quantities; (ii) mixed unused drugs (unsorted medicines and free samples); and (iii) drug dumping (large quantities of useless medicines). We retrieved 25 publications dated after 1999, including 20 and 5 from the scientific literature and 'grey' literature (technical reports, working papers), respectively. New information concerned emergencies in East Timor, Mozambique, El Salvador, Gujarat State (India), Aceh (Indonesia) and Sri Lanka. Except for East Timor and Gujarat, inappropriate donations still occurred, accounting for 85%, 37%, 70% and 80% of donations in Mozambique, El Salvador, Aceh and Sri Lanka, respectively. Very little information was found on drug donations in non-emergency situations. There are few recent reports on the compliance of drug donations with the World Health Organization guidelines. For emergency situations, there is still room for improvement. Drug donations in non-emergency situations need to be evaluated. A reform of drug donations policy is needed.

  14. Towards iconic language for patient records, drug monographs, guidelines and medical search engines.

    PubMed

    Lamy, Jean-Baptiste; Duclos, Catherine; Hamek, Saliha; Beuscart-Zéphir, Marie-Catherine; Kerdelhué, Gaetan; Darmoni, Stefan; Favre, Madeleine; Falcoff, Hector; Simon, Christian; Pereira, Suzanne; Serrot, Elisabeth; Mitouard, Thierry; Hardouin, Etienne; Kergosien, Yannick; Venot, Alain

    2010-01-01

    Practicing physicians have limited time for consulting medical knowledge and records. We have previously shown that using icons instead of text to present drug monographs may allow contraindications and adverse effects to be identified more rapidly and more accurately. These findings were based on the use of an iconic language designed for drug knowledge, providing icons for many medical concepts, including diseases, antecedents, drug classes and tests. In this paper, we describe a new project aimed at extending this iconic language, and exploring the possible applications of these icons in medicine. Based on evaluators' comments, focus groups of physicians and opinions of academic, industrial and associative partners, we propose iconic applications related to patient records, for example summarizing patient conditions, searching for specific clinical documents and helping to code structured data. Other applications involve the presentation of clinical practice guidelines and improving the interface of medical search engines. These new applications could use the same iconic language that was designed for drug knowledge, with a few additional items that respect the logic of the language.

  15. Drug consumption among medical students in São Paulo, Brazil: influences of gender and academic year.

    PubMed

    Oliveira, Lucio Garcia de; Barroso, Lucia Pereira; Wagner, Gabriela Arantes; Ponce, Julio de Carvalho; Malbergier, André; Stempliuk, Vladimir de Andrade; Andrade, Arthur Guerra de

    2009-09-01

    To analyze alcohol, tobacco and other drug use among medical students. Over a five-year period (1996-2001), we evaluated 457 students at the Universidade de São Paulo School of Medicine, located in São Paulo, Brazil. The students participated by filling out an anonymous questionnaire on drug use (lifetime, previous 12 months and previous 30 days). The influence that gender and academic year have on drug use was also analyzed. During the study period, there was an increase in the use of illicit drugs, especially inhalants and amphetamines, among the medical students evaluated. Drug use (except that of marijuana and inhalants) was comparable between the genders, and academic year was an important influencing factor. Increased inhalant use was observed among the medical students, especially among males and students in the early undergraduate years. This is suggestive of a specific behavioral pattern among medical students. Our findings corroborate those of previous studies. Inhalant use is on the rise among medical students at the Universidade de São Paulo School of Medicine. Because of the negative health effects of illicit drug use, further studies are needed in order to deepen the understanding of this phenomenon and to facilitate the development of preventive measures.

  16. 48 CFR 2823.107 - Compliance responsibilities.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... SOCIOECONOMIC PROGRAMS ENVIRONMENT, CONSERVATION, OCCUPATIONAL SAFETY, AND DRUG-FREE WORKPLACE Pollution Control and Clean Air and Water 2823.107 Compliance responsibilities. If a contracting officer becomes aware of noncompliance with clean air, water or other affected media standards in facilities used in...

  17. 48 CFR 2823.107 - Compliance responsibilities.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... Programs ENVIRONMENT, CONSERVATION, OCCUPATIONAL SAFETY, AND DRUG-FREE WORKPLACE Pollution Control and Clean Air and Water 2823.107 Compliance responsibilities. If a contracting officer becomes aware of noncompliance with clean air, water or other affected media standards in facilities used in performing nonexempt...

  18. Physicians’ influence on breast cancer patient compliance

    PubMed Central

    Kostev, Karel; Waehlert, Lilia; Jockwig, Achim; Jockwig, Barbara; Hadji, Peyman

    2014-01-01

    In recent years there have been major advances in the treatment of breast cancer. However, taking the prescribed medication for a sufficient period of time is crucial to the success of any therapy. Thus far, no database-based studies have been published in German-speaking countries empirically examining the influence of the physician on the compliance of patients. The aim of this study is to investigate, quantify, and critically discuss the effect treating physicians have on the compliance of their breast cancer patients. Patients with a confirmed breast cancer diagnosis who started therapy (tamoxifen or aromatase inhibitors) between January 2001 and December 2011 were selected from the representative IMS Disease Analyzer database and analyzed with regard to their compliance. Practices were grouped into two categories concerning the compliance of all treated patients. A regression model showed that a breast cancer patient who is treated in a practice with a trend toward poor compliance has a nearly 60% higher risk for treatment discontinuation than would be the case in a practice with good compliance. It shows how important it is to motivate physicians to strive toward good compliance rates. PMID:24454275

  19. Prescription Factors Associated with Medication Non-adherence in Japan Assessed from Leftover Drugs in the SETSUYAKU-BAG Campaign: Focus on Oral Antidiabetic Drugs.

    PubMed

    Koyanagi, Kaori; Kubota, Toshio; Kobayashi, Daisuke; Kihara, Taro; Yoshida, Takeo; Miisho, Takamasa; Miura, Tomoko; Sakamoto, Yoshiko; Takaki, Junichi; Seo, Takashi; Shimazoe, Takao

    2016-01-01

    Medication adherence has an important influence on health outcomes in patients with chronic diseases. However, few studies have been performed in Japan to determine factors related to medication non-adherence. The aim of this study was to identify prescription factors related to medication non-adherence by investigating patient characteristics, all prescriptions, and prescriptions for oral antidiabetic drugs (OADs). A retrospective cross-sectional survey of prescription data about implementation of dosing regimen was performed at community pharmacies engaged in appropriate use of leftover drugs. We evaluated the amount of drugs originally prescribed and the reduced amount after use of leftover drugs, and then calculated prescription reduction ratio (PRR). We analyzed prescription factors contributing to non-adherence based on the PRR. Prescription information for 1207 patients was reviewed, revealing that patients were non-adherent to 58% of prescriptions. Lack of a drug copayment, fewer concurrent drugs, and drugs not in single-dose packaging were associated with non-adherence. Among the 1207 patients, 234 prescriptions for diabetes and 452 OAD formulations were included. Forty-seven percent of prescriptions and 29% of the formulations were non-adherent. A higher dosing frequency and preprandial administration were associated with non-adherence. Among the OADs, adherence was lower for α-glucosidase inhibitors and biguanides than for sulfonylureas. Several factors related to patient characteristics, general drug prescriptions, and OAD prescriptions were associated with non-adherence. Further consideration will be needed to improve adherence to medication in Japan. Health care providers should perform more careful monitoring of adherence in patients with the factors identified by this study.

  20. Near-perfect compliance with SCIP Inf-9 had no effect on catheter utilization or urinary tract infections at an academic medical center.

    PubMed

    Kaplan, Jennifer A; Carter, Jonathan T

    2018-01-01

    The Joint Commission's SCIP Inf-9 mandated early removal of indwelling urinary catheters (IUCs), but the impact of compliance on catheter-associated urinary tract infection (CAUTI) and postoperative urinary retention (POUR) are unknown. Retrospective pre- and post-intervention study at a single tertiary academic medical center of all patients undergoing general surgery procedures with an IUC placed at the time of surgery who were admitted for at least two days before and after a Best Practice Advisory was put in place to improve compliance with SCIP Inf-9. A total of 1036 patients were included (468 pre-intervention; 568 post-intervention). POUR occurred in 13% of patients and CAUTI in 0.8%. There was no change in POUR, CAUTI, or catheter utilization after the Best Practice Advisory was initiated. Both POUR and CAUTI predicted longer lengths of stay. Near-perfect SCIP Inf-9 compliance had no effect on the CAUTI rate at our institution. Copyright © 2017 Elsevier Inc. All rights reserved.

  1. Medications for Arrhythmia

    MedlinePlus

    ... including over-the-counter medications and vitamins (and holistic type supplements). Many rhythm disorders, especially tachycardias, respond ... child about this before the doctor visit. Medicine Management What is compliance? Compliance simply means following the ...

  2. 75 FR 45130 - Draft Compliance Policy Guide Sec. 690.800 Salmonella

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-02

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0378] Draft Compliance Policy Guide Sec. 690.800 Salmonella in Animal Feed; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the...

  3. Simple heuristics in over-the-counter drug choices: a new hint for medical education and practice.

    PubMed

    Riva, Silvia; Monti, Marco; Antonietti, Alessandro

    2011-01-01

    Over-the-counter (OTC) drugs are widely available and often purchased by consumers without advice from a health care provider. Many people rely on self-management of medications to treat common medical conditions. Although OTC medications are regulated by the National and the International Health and Drug Administration, many people are unaware of proper dosing, side effects, adverse drug reactions, and possible medication interactions. This study examined how subjects make their decisions to select an OTC drug, evaluating the role of cognitive heuristics which are simple and adaptive rules that help the decision-making process of people in everyday contexts. By analyzing 70 subjects' information-search and decision-making behavior when selecting OTC drugs, we examined the heuristics they applied in order to assess whether simple decision-making processes were also accurate and relevant. Subjects were tested with a sequence of two experimental tests based on a computerized Java system devised to analyze participants' choices in a virtual environment. We found that subjects' information-search behavior reflected the use of fast and frugal heuristics. In addition, although the heuristics which correctly predicted subjects' decisions implied significantly fewer cues on average than the subjects did in the information-search task, they were accurate in describing order of information search. A simple combination of a fast and frugal tree and a tallying rule predicted more than 78% of subjects' decisions. The current emphasis in health care is to shift some responsibility onto the consumer through expansion of self medication. To know which cognitive mechanisms are behind the choice of OTC drugs is becoming a relevant purpose of current medical education. These findings have implications both for the validity of simple heuristics describing information searches in the field of OTC drug choices and for current medical education, which has to prepare competent health

  4. Effect of medication burden on persistent use of lipid-lowering drugs among patients with hypertension.

    PubMed

    Robertson, Teisha A; Cooke, Catherine E; Wang, Jingshu; Shaya, Fadia T; Lee, Helen Y

    2008-11-01

    To determine the effect of medication burden on persistent use of newly added lipid-lowering (LL) drugs among patients with hypertension. This retrospective database study used medical and pharmacy claims from a mid-Atlantic managed care organization. The cohort was obtained from continuous member enrollment in pharmacy and medical benefits from January 1, 2003, to December 31, 2005. Prescription claims were obtained for 18 months following the date of the first filled LL prescription (ie, index date). Patients were stratified into patients who changed LL drug or strength (group 1) and patients who did not change LL drug or strength (group 2). The primary outcome measure was persistence to newly added LL therapy. Persistence was defined by the length of time a member remained on therapy following the index date. The secondary outcome measure was the medication possession ratio (MPR). The MPR was calculated as the ratio of the sum of the days' supply of prescription filled divided by the number of days filled, plus the days' supply for the final prescription fill. Associations between the daily medication burden, defined as the number of unique drug products, and the outcome measures were analyzed. In the cohort of 3058 patients, the mean medication burden was 2.9 medications. Medication burden was positively associated with persistence and MPR through 18 months. Patients who had greater medication burden had longer persistence (P <.001). Likewise, patients who had greater medication burden had higher MPRs and were more likely to be considered adherent (MPR, >80%) (P < .001 for both). Patients with higher medication burden had greater adherence to newly added LL therapy. Medication burden should not deter clinicians from adding LL therapy. Among patients with added LL therapy, more attention should focus on patients who have changes to their LL regimen compared with patients who continue on the same LL prescription.

  5. Progress and Compliance in Alcohol Abuse Treatment*

    PubMed Central

    Lien, Hsien-Ming; Lu, Mingshan; Ma, Ching-To Albert; McGuire, Thomas G.

    2009-01-01

    Improving patient compliance with physicians’ treatment or prescription recommendations is an important goal in medical practice. We examine the relationship between treatment progress and patient compliance. We hypothesize that patients balance expected benefits and costs during a treatment episode when deciding on compliance; a patient is more likely to comply if doing so results in an expected gain in health benefit. We use a unique data set of outpatient alcohol abuse treatment to identify a relationship between treatment progress and compliance. Treatment progress is measured by the clinician’s comments after each attended visit. Compliance is measured by a client attending a scheduled appointment, and continuing with treatment. We find that a patient who is making progress is less likely to drop out of treatment. We find no evidence that treatment progress raises the likelihood of a patient attending the next scheduled visit. Our results are robust to unobserved patient heterogeneity. PMID:20031241

  6. Pricing of multiple dosage prescription medications: an analysis of the Ontario Drug Benefit Formulary.

    PubMed

    Lexchin, Joel

    2009-07-01

    This paper investigates the pricing strategy (perfect flat pricing, perfect monotonic pricing, intermediate) used for multiple dosage medications listed in the Ontario Drug Benefit Formulary. All multiple dosage solid medications containing a single active ingredient newly listed in the Ontario Drug Benefit Formulary between 1996 and 2005 were identified. The relationship between price and dosage was calculated using a previously developed method. Seventy-three multiple dosage medications were introduced. Where medications were equivalent to existing ones in most cases companies followed the pricing strategy used by therapeutically equivalent drugs already in the formulary. Where there were no equivalent products companies did not adopt any particular pricing strategy. There was no difference in the way that companies priced scored tablets versus unscored tablets and capsules or in the way that they priced drugs that had objective measurements of efficacy/effectiveness, for example blood pressure, versus those that did not have these measurements. When Monotonic pricing is used it leads to higher expenditures whereas flat pricing results in lower expenditures and offers more predictability in expenditures. Provincial governments should consider requiring flat pricing in return for formulary listing.

  7. Impact of Multiple Pharmacy Use on Medication Adherence and Drug-drug Interactions in Older Adults with Medicare Part D

    PubMed Central

    Marcum, Zachary A.; Driessen, Julia; Thorpe, Carolyn T.; Gellad, Walid F.; Donohue, Julie M.

    2014-01-01

    Objective To assess the association between multiple pharmacy use and medication adherence and potential drug-drug interactions (DDIs) among older adults. Design, Setting, and Participants Cross-sectional propensity score-weighted analysis of 2009 claims data from a nationally representative sample of 926,956 Medicare Part D beneficiaries aged >65 continuously enrolled in fee-for-service Medicare and Part D that year, and filled >1 prescription at a community/retail or mail order pharmacy. Multiple pharmacy use was defined as concurrent (overlapping time periods) or sequential use (non-overlapping time periods) of >2 pharmacies in the year. Measurements Medication adherence was calculated using a proportion of days covered ≥0.80 for eight therapeutic categories (β-blockers, renin angiotensin system antagonists, calcium channel blockers, statins, sulfonylureas, biguanides [i.e., metformin], thiazolidinediones, and dipeptidyl peptidase-IV inhibitors). Potential DDIs arising from use of certain drugs across a broad set of classes were defined as the concurrent filling of two interacting drugs. Results Overall, 38.1% of the sample used multiple pharmacies. Those using multiple pharmacies (both concurrently and sequentially) consistently had higher adjusted odds of non-adherence (ranging from 1.10 to 1.31, p<0.001) across all chronic medication classes assessed after controlling for socio-demographic, health status and access to care factors, compared to single pharmacy users. The adjusted predicted probability of exposure to a DDI was also slightly higher for those using multiple pharmacies concurrently (3.6%) compared to single pharmacy users (3.2%, AOR 1.11, 95% CI 1.08–1.15) but lower in individuals using multiple pharmacies sequentially (2.8%, AOR 0.85, 95% CI 0.81–0.91). Conclusions Filling prescriptions at multiple pharmacies was associated with lower medication adherence across multiple chronic medications, and a small but statistically significant

  8. [Evaluation of the medical value of a drug. A necessity for the Transparency Commission].

    PubMed

    Avouac, B

    1992-01-01

    The marketing approval (AMM) is based on criteria of pharmaceutical quality, efficacy and safety of use. Before marketing, the data are collected by means of double-blind, randomized, prospective clinical trials that compare the study product to a reference product. A post-AMM assessment is needed to define the increase of the medical benefit (ASMR) and the therapeutic value of the new drugs. The quantification of the ASMR is essential for registration on the list of drugs reimbursable for those who benefit from Social Security. The evaluation of the therapeutic value and the nature of the affection treated are the criteria upon which the reimbursement ratio is chosen. After marketing, the reevaluation of the medical benefit and the drugs' usefulness may be compared to the treatment's net medical cost (direct + indirect cost--avoided cost) in cost/utility or cost/benefit studies. The Transparency Commission has worked out a scale of assessment of the ASMR which will orient recommendation, or non-recommendation, of registration on the list of reimbursable drugs as well as price fixing proposals. In the future, the Transparency Commission is to strengthen its position regarding the good use of the drug through a better prescriber information system. Thanks to the pharmaco-epidemiology and the pharmaco-vigilance data, the Transparency Commission will be able to guarantee the post-marketing follow-up of the drugs. The examination of the products' conditions of use, the reevaluation of the treatment's advantages based on the utility studies and the epidemiological surveys, and the cost-benefit studies will contribute to a medical control of health spending linked to drug consumption.

  9. Comprehensive Assessment of Compliance with Antimuscarinic Drug Treatment in the Case of Urge Urinary Incontinence of Older Patients.

    PubMed

    Kosilov, Kirill V; Loparev, Sergey A; Kuzina, Irina G; Shakirova, Olga V; Zhuravskaya, Natalya S; Lobodenko, Alexandra

    2017-01-01

    To investigate the heterogeneous factors affecting the stability of patients older than 60 years in the UI treatment with Antimuscarinics. The prevalence of Urge Incontinence (UI) in older persons reaches 29.3%. The symptoms of urinary incontinence in older people reduce the health related life quality. In 1257 patients over 60 years (857 (68.2%) women - average age 67.8, 400 (31.8%) men - 71.4), who received AM for one year, demographic, socio-economic and health parameters were studied. OABq-SF questionnaires, MOS SF-36, urination diaries, uroflowmetry, income information from the tax offices and outpatient records were used. The compliance to AM treatment within 6 months was retained in 44.2%, and within the year - 26.8% of older patients. At least 40% of the total number of patients refused to continue the treatment for medical reasons. The persons taking Solifenacin (p≤ 0.01), Trospium (p≤ 0.05), or Darifenacin (p≤ 0.05), suffering from severe UI symptoms (p≤ 0.01), and experiencing minor side effects (p≤ 0.01), well-informed about UI treatment methods (p≤ 0.01) prevailed among the treatment compliant patients. At least 20.4% of the patients discontinued their treatment due to economic reasons. The persons with significantly larger annual income (p≤ 0.05) and annual medical cost (p≤ 0.01) prevailed among the treatment compliant patients. About 12.2% of the patients stopped their treatment for reasons related to the social background and psychological status. In this experiment, we found that AM treatment compliance in older patients, in addition to medical parameters and health conditions, is largely affected by the economic as well as social, demographic and psychological factors. The study results can be claimed by practitioners involved in correcting UI symptoms in older people. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

  10. Medical management of oral motor disorders: dystonia, dyskinesia and drug-induced dystonic extrapyramidal reactions.

    PubMed

    Clark, Glenn T

    2006-08-01

    This article reviews three of the involuntary hyperkinetic motor disorders that affect the orofacial region, namely orofacial dystonia, oromandibular dyskinesia, as well as medication-induced extrapyramidal syndrome-dystonic reactions. Specifically, it discusses and contrasts the clinical features and management strategies for spontaneous primary and drug-induced motor disorders in the orofacial region. The article provides a list of medications reported to cause drug-related extrapyramidal motor activity above and beyond the more commonly known antipsychotics medications. It provides a needed update because the number and use of medications causing involuntary jaw muscle activity are increasing. For example, selective serotonin reuptake inhibitors (SSRI), stimulant medications and illegal drugs have all been reported to induce an orofacial motor activation as adverse reactions. This article also discusses briefly the genetic and traumatic events associated with spontaneous dystonia. Finally, this article presents an approach for management of the orofacial motor disorders that involves the following three steps: (1) collect a full clinical history and examination, including magnetic resonance imaging of the brain; (2) after ruling out CNS disease, adverse medications reactions and local pathology, try one or more of the motor-suppressive medications that may be helpful in these cases (e.g., cholinergic receptor antagonizers or blockers, and GABA-ergic including benzodiazepines); and (3) if the disorder is severe enough and focal enough to consider, and motor-suppressive medications are not adequate, then consider botulinum toxin injections. The contraindications, side effects, and usual approach for these medications and injections are discussed.

  11. Competence of medical students in communicating drug therapy: Value of role-play demonstrations.

    PubMed

    Tayem, Yasin I; Altabtabaei, Abdulaziz S; Mohamed, Mohamed W; Arrfedi, Mansour M; Aljawder, Hasan S; Aldebous, Fahad A; James, Henry; Al Khaja, Khalid A J; Sequeira, Reginald P

    2016-01-01

    This study used role-play demonstrations to train medical students to communicate drug therapy and evaluated the perceptions on this instructional approach. The second-year medical students who attended a prescription writing session (n = 133), participated in this study. Prescription communication was introduced by using role-play demonstrations. Participant's perceptions were explored by a self-administered questionnaire and focus group discussion. The academic achievement of attendees and nonattendees was compared with an objective structured performance evaluation (OSPE) station that tested students' competence in this skill. Most attendees responded to the questionnaire (81.2%). Almost all respondents expressed their desire to have similar demonstrations in other units. A large proportion of participants reported that role-play demonstrations helped them develop their communication skills, in general, confidence to communicate drug-related information in a prescription, and the ability to explain the aim of drug therapy to patients. Most trainees thought also that they developed skills to communicate instructions on drug use including drug dose, frequency of administration, duration of therapy, adverse drug reactions, and warnings. During the focus group interviews, students thought that role-play was useful but would be more beneficial if conducted frequently in small group as part of the curriculum implementation. The majority of students also reported improved competence in writing a complete prescription. Analysis of attendees and nonattendees grades in the OSPE showed that the former scored higher than the latter group (P = 0.016). Role-play demonstrations were well accepted by medical students and led to the development of their competence in communicating drug therapy to patients.

  12. MEDICATION DISPOSAL AS A SOURCE FOR DRUGS AS ENVIRONMENTAL CONTAMINANTS

    EPA Science Inventory

    The major routes by which pharmaceuticals enter the environment are excretion, bathing, and

    disposal of leftover, unwanted medications. Pharmaceuticals designed for humans and animals

    often remain unused. Leftover, accumulated drugs represent potentially environment...

  13. Duty Hour Compliance: A Survey of U.S. Military Medical Interns and Residents.

    PubMed

    Blitz, Jason B; Rogers, Amy E; Polmear, Michael M; Owings, Alfred J

    2017-11-01

    In 2011, the Accreditation Council for Graduate Medical Education (ACGME) modified its duty hour standards for interns and residents. This was done, in part, because of a belief that increased compliance with these standards was needed to positively impact resident fatigue, resident quality of life, and patient safety. However, several studies indicate that duty hour noncompliance and false reporting by interns and residents remains a significant concern for residency program directors. This study examined the compliance of interns and residents with ACGME duty hour standards at a large military graduate medical education (GME) training program. We conducted a survey of 535 trainees assigned to 24 GME programs within the National Capital Consortium (NCC). Statistical analysis for descriptive parameters used a standard error of measure on the basis of sample and target population sizes to calculate two-sided 95% confidence intervals (CIs). A χ 2 analysis was performed to compare response differences for particular survey questions. A Cronbach α coefficient was calculated to compare the internal consistency of responses for questions in which individual responses were expected to correlate. This study was reviewed by the Offices of Research at the Walter Reed National Military Medical Center and the Uniformed Services University and adjudicated as "Not Research." Overall, 41.3% (N = 221) of those contacted completed all survey questions. From the available responses, 31.6% (95% CI, 26.9-36.2) reported at least one occurrence of implicit pressure to alter duty hour reporting, and 32.0% (95% CI, 27.3-36.7) reported at least one occurrence of altering reported duty hours. In addition, 37.2 (95% CI, 32.5-41.9) reported being unable to always follow duty hour limits and 58.1% (95% CI, 53.1-63.1) felt time working at home on residency requirements should be included in reported duty hours. Our results indicate that a significant portion of interns and residents within

  14. eDrugCalc: an online self-assessment package to enhance medical students' drug dose calculation skills.

    PubMed

    McQueen, Daniel S; Begg, Michael J; Maxwell, Simon R J

    2010-10-01

    Dose calculation errors can cause serious life-threatening clinical incidents. We designed eDrugCalc as an online self-assessment tool to develop and evaluate calculation skills among medical students. We undertook a prospective uncontrolled study involving 1727 medical students in years 1-5 at the University of Edinburgh. Students had continuous access to eDrugCalc and were encouraged to practise. Voluntary self-assessment was undertaken by answering the 20 questions on six occasions over 30 months. Questions remained fixed but numerical variables changed so each visit required a fresh calculation. Feedback was provided following each answer. Final-year students had a significantly higher mean score in test 6 compared with test 1 [16.6, 95% confidence interval (CI) 16.2, 17.0 vs. 12.6, 95% CI 11.9, 13.4; n= 173, P < 0.0001 Wilcoxon matched pairs test] and made a median of three vs. seven errors. Performance was highly variable in all tests with 2.7% of final-year students scoring < 10/20 in test 6. Graduating students in 2009 (30 months' exposure) achieved significantly better scores than those in 2007 (only 6 months): mean 16.5, 95% CI 16.0, 17.0, n= 184 vs. 15.1, 95% CI 14.5, 15.6, n= 187; P < 0.0001, Mann-Whitney test. Calculations based on percentage concentrations and infusion rates were poorly performed. Feedback showed that eDrugCalc increased confidence in calculating doses and was highly rated as a learning tool. Medical student performance of dose calculations improved significantly after repeated exposure to an online formative dose-calculation package and encouragement to develop their numeracy. Further research is required to establish whether eDrugCalc reduces calculation errors made in clinical practice. © 2010 The Authors. British Journal of Clinical Pharmacology © 2010 The British Pharmacological Society.

  15. Sedative Drug Use among King Saud University Medical Students: A Cross-Sectional Sampling Study.

    PubMed

    Al-Sayed, Ahmed A; Al-Rashoudi, Abdualltef H; Al-Eisa, Abdulrhman A; Addar, Abdullah M; Al-Hargan, Abdullah H; Al-Jerian, Albaraa A; Al-Omair, Abdullah A; Al-Sheddi, Ahmed I; Al-Nowaiser, Hussam I; Al-Kathiri, Omar A; Al-Hassan, Abdullah H

    2014-01-01

    Introduction. Medical students experience significant psychological stress and are therefore at higher risk of using sedatives. There are currently no studies describing the prevalence of sedative drug use among medical students in Saudi Arabia. The aim of this study was to evaluate the prevalence and factors associated with sedative drug use among medical students in Saudi Arabia. Materials and Methods. A cross-sectional convenience sampling study gathered data by anonymous questionnaire from students enrolled at the King Saud University College of Medicine in 2011. The questionnaires collected data regarding social and demographic variables, sleep patterns, and the use of stimulant and sedative drugs since enrollment. Sedatives were defined as any pharmaceutical preparations that induce sleep. Results and Discussion. Of the 729 students who returned questionnaires, 17.0% reported sedative drug use at some time since enrollment. Higher academic year, lower grade point average, regular exercise, fewer hours of sleep per day, poorer quality of sleep, and the presence of sleeping disorders were found to be significantly associated with sedative drug use. Conclusions. Further study is required to increase our understanding of sedative drug use patterns in this relatively high-risk group, as such understanding will help in the development of early intervention programs.

  16. Sedative Drug Use among King Saud University Medical Students: A Cross-Sectional Sampling Study

    PubMed Central

    Al-Sayed, Ahmed A.; Al-Rashoudi, Abdualltef H.; Al-Eisa, Abdulrhman A.; Addar, Abdullah M.; Al-Hargan, Abdullah H.; Al-Jerian, Albaraa A.; Al-Omair, Abdullah A.; Al-Sheddi, Ahmed I.; Al-Nowaiser, Hussam I.; Al-Kathiri, Omar A.; Al-Hassan, Abdullah H.

    2014-01-01

    Introduction. Medical students experience significant psychological stress and are therefore at higher risk of using sedatives. There are currently no studies describing the prevalence of sedative drug use among medical students in Saudi Arabia. The aim of this study was to evaluate the prevalence and factors associated with sedative drug use among medical students in Saudi Arabia. Materials and Methods. A cross-sectional convenience sampling study gathered data by anonymous questionnaire from students enrolled at the King Saud University College of Medicine in 2011. The questionnaires collected data regarding social and demographic variables, sleep patterns, and the use of stimulant and sedative drugs since enrollment. Sedatives were defined as any pharmaceutical preparations that induce sleep. Results and Discussion. Of the 729 students who returned questionnaires, 17.0% reported sedative drug use at some time since enrollment. Higher academic year, lower grade point average, regular exercise, fewer hours of sleep per day, poorer quality of sleep, and the presence of sleeping disorders were found to be significantly associated with sedative drug use. Conclusions. Further study is required to increase our understanding of sedative drug use patterns in this relatively high-risk group, as such understanding will help in the development of early intervention programs. PMID:24551449

  17. Improving compliance with diabetes clinical practice guidelines in military medical treatment facilities.

    PubMed

    McCraw, Wendy M; Kelley, Patricia Watts; Righero, Anna M; Latimer, Renee

    2010-01-01

    A multidisciplinary, multifaceted approach to disease management that incorporates the health system, the provider, and the patient is supported in the literature. There was a need to improve patient outcomes to meet or to exceed the Health Plan Employer Data and Information Set (HEDIS) benchmarks for the management of patients with diabetes. The purpose of this study was to implement a process improvement effort using practice guidelines on the basis of an evidence-based practice model for the management of type II diabetes mellitus at two primary care clinics at two military medical facilities in Hawaii. A retrospective review of charts, electronic records, and system data revealed that the clinics used as project sites were not compliant with established guidelines for diabetes management. After a literature review and an analysis of the current processes, a multidisciplinary care delivery model was developed and implemented to identify spheres of influence involving all members of the diabetes management team and the tasks that influenced patient outcomes. Improvements were seen for more than 6 months of initial practice change, including compliance with annual glycosylated hemoglobin (HbA1c), lipid, blood pressure, and foot checks. At Site 1, HEDIS measures increased for adequately controlled HbA1c and low-density lipoprotein (LDL) from 80% to 85% and from 49% to 58%, respectively. Site 2 showed an increase in adequate control of HbA1c from 77% to 79% at 6 months. After a steady increase in compliance, the percentage for adequately controlled LDL dropped to 56% at 9 months. At Site 1, HEDIS measures decreased slightly to 82% for HbA1c control and to 54% for LDL control at the 9-month mark. Inconsistent delivery of care and lack of staff and patient involvement influenced process outcomes. There were challenges with database accuracy, adequate staffing, computer software upgrades, and overseas site locations. Annual foot examinations showed the largest

  18. Compliance/adherence and care management in HIV disease.

    PubMed

    Crespo-Fierro, M

    1997-01-01

    With the changing perspectives of the HIV epidemic and the introduction of protease inhibitors to treat human immunodeficiency virus (HIV) disease, the issue of compliance has gained considerable interest among health care providers. The idea that clients with HIV disease should succumb to a patriarchal system of medical care has been challenged by AIDS activists since the beginning of the epidemic. The concept that there is only one explanation for "noncompliance" is outdated. The reasons for noncompliance are multifaceted in nature and include psychosocial factors, complex medication and treatment regimens, ethnocultural concerns, and in many instances substance use. Therefore, the notion that there is one intervention to resolve noncompliance is at best archaic. Interventions to enhance compliance include supervised therapy, improving the nurse-client relationship, and patient education, all of which should be combined with ethnocultural interventions. Plans to enhance compliance must incorporate person-specific variables and should be tailored to individualized needs.

  19. Better adherence to antithyroid drug is associated with decreased risk of stroke in hyperthyroidism patients.

    PubMed

    Tsai, M-S; Chuang, P-Y; Huang, C-H; Shih, S-R; Chang, W-T; Chen, N-C; Yu, P-H; Cheng, H-J; Tang, C-H; Chen, W-J

    2015-12-01

    An increased risk for ischaemic stroke has been reported in young hyperthyroidism patients independent of atrial fibrillation (AF). However, whether the use of antithyroid drugs in hyperthyroidism patients can reduce the occurrence of ischaemic stroke remains unclear. A total of 36,510 newly diagnosed hyperthyroidism patients during 2003-2006 were identified from the Taiwan National Health Insurance Research database. Each patient was individually tracked for 5 years from their index date (beginning the antithyroid drugs) to identify those who suffered from new episode of ischaemic stroke. Medication possession ratio (MPR) was used to represent the antithyroid drug compliance. The association between the MPR and the risk of stroke was examined. The stroke incidence rates for hyperthyroidism patients with age < 45 years and age ≥ 45 years were 0.42 and 3.76 per 1000 person-years, respectively. The patients aged < 45 years with MPR < 0.2 (adjusted hazard ratio, HR, 2.30; 95% CI, 1.13-4.70; p = 0.02) and 0.2 ≤ MPR < 0.4 (adjusted HR, 2.24; 95% CI, 1.06-4.72; p = 0.035) had a significantly increased risk of ischaemic stroke as compared to those with ≥ 0.6. In patients of the age ≥ 45 years, only the patients with MPR < 0.2 (adjusted HR, 1.44; 95% CI, 1.03-2.01; p = 0.036) had a significantly higher risk of ischaemic stroke as compared to those with MPR ≥ 0.6. In hyperthyroidism patients without AF, good antithyroid drugs compliance also reduced the incidence of stroke significantly (adjusted HR, range: 1.52-1.61; p = 0.02); but not in hyperthyroidism with AF. Hyperthyroidism patients with good antithyroid drug compliance had a lower risk of ischaemic stroke than patients with poor compliance. © 2015 John Wiley & Sons Ltd.

  20. Effect of drug reminder packaging on medication adherence: a systematic review revealing research gaps

    PubMed Central

    2014-01-01

    Background This was a systematic review of the literature in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. Evidence mapping was used to reveal the effect of drug reminder packaging on medication adherence, to identify research gaps and to make suggestions for future research. Methods PubMed, Embase, CINAHL and PsycINFO were searched with an end date of September 2013 using the Medical Subject Headings (MeSH) term ‘medication adherence’ and 20 different search terms for ‘drug reminder packaging’, limited to the English and German languages. Additional references were identified through cross-referencing. All prospective controlled trials with an intervention using drug reminder packaging for patients taking at least one medication without the assistance of a health-care professional were included in the evidence mapping of the effect of drug reminder packaging on adherence and outcomes according to the Economic, Clinical and Humanistic Outcomes (ECHO) model. Results A total of 30 studies met the inclusion criteria: 10 randomized controlled trials, 19 controlled clinical trials and 1 cohort study. Drug reminder packaging had a significant effect on at least one adherence parameter in 17 studies (57%). The methodological quality was strong in five studies. Two studies provided complete information. Clear research gaps emerged. Conclusions Overall, the studies showed a positive effect of drug reminder packaging on adherence and clinical outcomes. However, poor reporting and important gaps like missing humanistic and economic outcomes and neglected safety issues limit the drawing of firm conclusions. Suggestions are made for future research. PMID:24661495

  1. Comparative cost evaluation of brand name and generic ophthalmology medications in Ontario.

    PubMed

    Popovic, Marko; Chan, Clara; Lattanzio, Nisha; El-Defrawy, Sherif; Schlenker, Matthew B

    2018-04-01

    Medication cost for the same indication can vary considerably and can affect patient compliance. In this comparative cost analysis of commonly prescribed ophthalmology medications, the differences in cost between generic and brand name medications as well as different medications within an individual drug class were evaluated. Eye preparations from the Ontario Drug Benefit Formulary were identified, and further agents commonly prescribed by ophthalmologists were included. The standardized prescription drug cost, which includes the cost of the medication, mark-up, and dispensing cost, was provided by Ontario Shoppers Drug Mart stores in July 2016 for 103 common medications using typical dosages and durations. Based on medication class, the highest and lowest cost medications were antiallergy agents (Zaditor [ketotifen], Vasocon [naphazoline]), antibiotic ophthalmic solutions (Vigamox [moxifloxacin], generic ciprofloxacin), oral antibiotics (Cipro [ciprofloxacin], generic cephalexin), antibiotic ophthalmic ointments (generic erythromycin, Tobrex [tobramycin]), antiviral treatment (Valtrex [oral valacyclovir], Viroptic [topical trifluridine]), blepharitis treatment (Zithromax [oral azithromycin], generic oral tetracycline), beta-adrenergic inhibitors (Timoptic [topical timolol], generic topical timolol), topical prostaglandin analogues (Xalatan [latanoprost], generic travoprost), oral carbonic anhydrase inhibitors (methazolamide, acetazolamide), topical carbonic anhydrase solutions (Trusopt preservative-free [dorzolamide], Azopt [brinzolamide]), topical alpha-adrenergic agonists (Alphagan [brimonidine], generic brimonidine), topical muscarinic agonists (Isopto carpine [pilocarpine], Diocarpine [pilocarpine]), topical combination glaucoma agents (Cosopt [dorzolamide-timolol], generic dorzolamide-timolol), topical lubricants (Lacri-lube, Isopto tears), topical nonsteroidal anti-inflammatory drugs (Acuvail [ketorolac], Ilevro [nepafenac]), and steroids (Durezol

  2. [Kidney patients: aspects related to compliance with renal treatment].

    PubMed

    Caraballo Nazario, G L; Lebrón de avilés, C; Dávila Torres, R R; Burgos Calderón, R

    2001-12-01

    The Objective of this study was identify the aspects related with the adherence of medical treatment recommended to the patients that received hemodialysis in the tertiary public hospital. A non experimental transectional correlation design was utilized in this study. Fifty-three patients constituted the population study. A structure interview was utilized to gathered the data. Descriptive statistics and Chi-square tests were utilized to analysis. The response rate was 91.0%. The 75.0% of patients not compliance with the medical treatment. Significant association between compliance variable and educational level was encountered (p < or = 0.05). This study provides important findings to will develops educative intervention in the Renal Unit, directed to improve the adherence of the patient with medical treatment.

  3. Medication Incidents Involving Antiepileptic Drugs in Canadian Hospitals: A Multi-Incident Analysis.

    PubMed

    Cheng, Roger; Yang, Yu Daisy; Chan, Matthew; Patel, Tejal

    2017-01-01

    Medication errors involving antiepileptic drugs (AEDs) are not well studied but have the potential to cause significant harm. We investigated the occurrence of medication incidents in Canadian hospitals that involve AEDs, their severity and contributing factors by analyzing data from two national databases. Our multi-incident analysis revealed that while medication errors were rarely fatal, errors do occur of which some are serious. Medication incidents were most commonly caused by dose omissions, the dose or its frequency being incorrect and the wrong AED being given. Our analysis could augment quality-improvement initiatives by medication safety administrators to reduce AED medication incidents in hospitals.

  4. The role of the psychiatrist in improving patient compliance.

    PubMed

    Hotujac, Ljubomir

    2007-02-01

    Compliance, usually referring to how well the patient takes the medication as prescribed, is an important issue in clinical practice. However, many patients, especially those with a psychiatric illness, stop taking their medications despite physician advice to continue. This cessation can lead to a deterioration in the condition, a relapse, or a recurrence of the illness. In the literature, many different factors contributing to poor compliance have been described, but the doctor's role and responsibilities are hardly mentioned. These factors will be discussed here with special emphasis on what a doctor should do and what a doctor should avoid.

  5. Nature and frequency of exchanges on medications during primary care encounters.

    PubMed

    Richard, Claude; Lussier, Marie-Thérèse

    2006-12-01

    To describe the exchanges, related to discussion of all medications during primary care medical consultations. Descriptive study of audio recordings of 422 medical encounters. Coding was done with MEDICODE, a validated instrument developed to analyse verbal exchanges on medications. The unit of analysis is the medication. An average of 3.9 medications (S.D.=2.8; range 1-21) are discussed per interview and 4.2 themes are broached for each drug (S.D.=2.6; range 1-17). "Active Discussed", "Represcribed" and "Newly Prescribed" drugs account for 43.1, 16.3 and 10.6%, respectively of all medications discussed. Themes most often discussed are Name, Instructions, Observed Main Effect, Class, Reasons for Taking the Drug, General Use of the Medication, Expected Effect on Symptoms, Form of the Medication, Indications Another Consultation Needed, and Alternative Medication. The least often discussed themes include clinically significant ones such as Possible Adverse Effects, Observed Adverse Effects, Expression of Attitudes and Emotions with regard to the medication, Compliance and Warnings. The average number of themes discussed differed between medications that were prescribed during the encounter, either New prescriptions or Represcribed drugs, compared to medications that were only discussed during the encounter. Our results show that medication discussions are heterogeneous and vary with the status of the medication and the theme. Also, the nature and extent of the discussions about medications do not support the shared-decision making model. Though it is too soon to make specific recommendations about discussions on medications, it seems clear that information-sharing about medications during medical encounters is a process that extends beyond any single encounter. Although communication skills are now part of most medical curriculums, there is an obvious need to put forth the concept of patient medication knowledge-building over multiple physician-patient encounters and

  6. Immunotherapy for Drug Abuse

    PubMed Central

    Shen, Xiaoyun; Kosten, Thomas R.

    2013-01-01

    Substance use disorders continue to be major medical and social problems worldwide. Current medications for substance use disorders have many limitations such as cost, availability, medication compliance, dependence, diversion of some to illicit use and relapse to addiction after discontinuing their use. Immunotherapies using either passive monoclonal antibodies or active vaccines have distinctly different mechanisms and therapeutic utility from small molecule approaches to treatment. They have great potential to help the patient achieve and sustain abstinence and have fewer of the above limitations. This review covers the cocaine vaccine development in detail and provides an overview of directions for developing anti-addiction vaccines against the abuse of other substances. The notable success of the first placebo-controlled clinical trial of a cocaine vaccine, TA-CD, has led to an ongoing multi-site, Phase IIb clinical trial in 300 subjects. The results from these trials are encouarging further development of the cocaine vacine as one of the first anti-addiction vaccines to go forward to the U.S. Food and Drug Administration for review and approval for human use. PMID:22229313

  7. Immunotherapy for drug abuse.

    PubMed

    Shen, Xiaoyun; Kosten, Thomas R

    2011-12-01

    Substance use disorders continue to be major medical and social problems worldwide. Current medications for substance use disorders have many limitations such as cost, availability, medication compliance, dependence, diversion of some to illicit use and relapse to addiction after discontinuing their use. Immunotherapies using either passive monoclonal antibodies or active vaccines have distinctly different mechanisms and therapeutic utility from small molecule approaches to treatment. They have great potential to help the patient achieve and sustain abstinence and have fewer of the above limitations. This review covers the cocaine vaccine development in detail and provides an overview of directions for developing anti-addiction vaccines against the abuse of other substances. The notable success of the first placebo-controlled clinical trial of a cocaine vaccine, TA-CD, has led to an ongoing multi-site, Phase IIb clinical trial in 300 subjects. The results from these trials are encouarging further development of the cocaine vacine as one of the first anti-addiction vaccines to go forward to the U.S. Food and Drug Administration for review and approval for human use.

  8. Research monitoring by US medical institutions to protect human subjects: compliance or quality improvement?

    PubMed

    de Jong, Jean Philippe; van Zwieten, Myra C B; Willems, Dick L

    2013-04-01

    In recent years, to protect the rights and welfare of human subjects, institutions in the USA have begun to set up programmes to monitor ongoing medical research. These programmes provide routine, onsite oversight, and thus go beyond existing oversight such as investigating suspected misconduct or reviewing paperwork provided by investigators. However, because of a lack of guidelines and evidence, institutions have had little guidance in setting up their programmes. To help institutions make the right choices, we used interviews and document analysis to study how and why 11 US institutions have set up their monitoring programmes. Although these programmes varied considerably, we were able to distinguish two general types. 'Compliance' programmes on the one hand were part of the institutional review board office and set up to ensure compliance with regulations. Investigators' participation was mandatory. Monitors focused on documentation. Investigators could be disciplined, and could be obliged to take corrective actions. 'Quality-improvement' programmes on the other hand were part of a separate office. Investigators requested to be monitored. Monitors focused more on actual research conduct. Investigators and other parties received feedback on how to improve the research process. Although both types of programmes have their drawbacks and advantages, we argue that if institutions want to set up monitoring programmes, quality improvement is the better choice: it can help foster an atmosphere of trust between investigators and the institutional review board, and can help raise the standards for the protection of human subjects.

  9. [Therapeutic Drug Monitoring of Valproic Acid in Children: A Prospective Study of The Effect of The Compliance and The Economic Level on the Trough Plasmatic Concentrations and Epileptic Seizures].

    PubMed

    Charfi, Rim; Lakhal, Mohamed; Klouz, Anis; Trabelsi, Sameh; Salouage, Issam

    2015-01-01

    Valproic acid (VA) is a widely used antiepileptic drug. Because of its pharmacokinetic variability and the influence of intrinsic and extrinsic factors such as the treatment compliance, VA therapeutic drug monitoring (TDM) is recommended in children. The aim of this study is to evaluate the effect of treatment compliance and the economic level on VA tough plasmatic concentration (TPC) and epileptic rhythm in children. A one-year prospective study (August 2008-August 2009) concerning children (age≤5 years) regularly treated by VA who had a VA TDM. So, 276 plasmatic samples from 238 children were collected. The children were divided in two groups as following: the group 1 (G1) presenting a good compliance and a reliable questioning and the group 2 (G2) presenting a bad compliance and a non reliable questioning. We evaluated the interindividual variability by correlating the TPC to the dose. Then, we divided the hole group in function of their economic levels (low-medium-high). Sex ratio male/female was 1.3. Median age was 5 years+/-3,9. The mean TPC was 62 µg/mL [0.12-131 µg/mL]. VA TPC were in the therapeutic range (TR) in 62%. Adverse drug reactions were noted in 4.2% of the children. G1 represented 70% of the children and G2, 30%. The TPC were in the TR in 67% of G1 and 51% of G2 (p=0.02). There was a significant difference between the TPC in G1 and G2 (p=0.02).There was no significative difference in the TPC in function of the economic levels. There was no correlation between TPC and the administered doses. The epileptic seizures were more spaced in children with therapeutic TPC than those with TPC in the TR (p=0.002) and in G1 than in G2 (p=0.03). Compliance should be appropriate in order to optimize the TDM rule. A good compliance and a therapeutic TPC allow a better control of epileptic seizures. © 2015 Société Française de Pharmacologie et de Thérapeutique.

  10. Use and reimbursement costs of smoking cessation medication under the Quebec public drug insurance plan.

    PubMed

    Tremblay, Michèle; Payette, Yves; Montreuil, Annie

    2009-01-01

    Since October 2000, the nicotine patch, nicotine gum and bupropion have been reimbursed under Quebec's public drug insurance plan. The objective of this study is to describe use of these medications between October 2000 and December 2004 by smokers covered by the public plan, as well as the costs of reimbursing these medications. Data from the Régie de l'assurance maladie du Québec were used to analyze prescriptions for smoking cessation medication issued to persons insured under the public drug insurance plan. Between October 1, 2000, and December 31, 2004, more than 300,000 Quebeckers covered by the public drug insurance plan were reimbursed for smoking cessation medications. This corresponds to a yearly average of 14% of all smokers insured under the public plan. The proportion of employment assistance recipients who used these medications was higher than the proportion of seniors or "other" insurance plan participants. Nicotine patches were the treatment of choice for most users. A total of $55 million was reimbursed by the public drug insurance plan for the nicotine patch, nicotine gum and bupropion over this four-year period. The reimbursement provisions put in place in Quebec in 2000 were successful in reaching financially disadvantaged smokers, at a cost that was comparable with other effective smoking cessation services.

  11. Substituting cannabis for prescription drugs, alcohol and other substances among medical cannabis patients: The impact of contextual factors.

    PubMed

    Lucas, Philippe; Walsh, Zach; Crosby, Kim; Callaway, Robert; Belle-Isle, Lynne; Kay, Robert; Capler, Rielle; Holtzman, Susan

    2016-05-01

    Recent years have witnessed increased attention to how cannabis use impacts the use of other psychoactive substances. The present study examines the use of cannabis as a substitute for alcohol, illicit substances and prescription drugs among 473 adults who use cannabis for therapeutic purposes. The Cannabis Access for Medical Purposes Survey is a 414-question cross-sectional survey that was available to Canadian medical cannabis patients online and by hard copy in 2011 and 2012 to gather information on patient demographics, medical conditions and symptoms, patterns of medical cannabis use, cannabis substitution and barriers to access to medical cannabis. Substituting cannabis for one or more of alcohol, illicit drugs or prescription drugs was reported by 87% (n = 410) of respondents, with 80.3% reporting substitution for prescription drugs, 51.7% for alcohol, and 32.6% for illicit substances. Respondents who reported substituting cannabis for prescription drugs were more likely to report difficulty affording sufficient quantities of cannabis, and patients under 40 years of age were more likely to substitute cannabis for all three classes of substance than older patients. The finding that cannabis was substituted for all three classes of substances suggests that the medical use of cannabis may play a harm reduction role in the context of use of these substances, and may have implications for abstinence-based substance use treatment approaches. Further research should seek to differentiate between biomedical substitution for prescription pharmaceuticals and psychoactive drug substitution, and to elucidate the mechanisms behind both. [Lucas P, Walsh Z, Crosby K, Callaway R, Belle-Isle L, Kay B, Capler R, Holtzman S. Substituting cannabis for prescription drugs, alcohol, and other substances among medical cannabis patients: The impact of contextual factors. Drug Alcohol Rev 2016;35:326-333]. © 2015 Australasian Professional Society on Alcohol and other Drugs.

  12. Simple heuristics in over-the-counter drug choices: a new hint for medical education and practice

    PubMed Central

    Riva, Silvia; Monti, Marco; Antonietti, Alessandro

    2011-01-01

    Introduction Over-the-counter (OTC) drugs are widely available and often purchased by consumers without advice from a health care provider. Many people rely on self-management of medications to treat common medical conditions. Although OTC medications are regulated by the National and the International Health and Drug Administration, many people are unaware of proper dosing, side effects, adverse drug reactions, and possible medication interactions. Purpose This study examined how subjects make their decisions to select an OTC drug, evaluating the role of cognitive heuristics which are simple and adaptive rules that help the decision-making process of people in everyday contexts. Subjects and methods By analyzing 70 subjects’ information-search and decision-making behavior when selecting OTC drugs, we examined the heuristics they applied in order to assess whether simple decision-making processes were also accurate and relevant. Subjects were tested with a sequence of two experimental tests based on a computerized Java system devised to analyze participants’ choices in a virtual environment. Results We found that subjects’ information-search behavior reflected the use of fast and frugal heuristics. In addition, although the heuristics which correctly predicted subjects’ decisions implied significantly fewer cues on average than the subjects did in the information-search task, they were accurate in describing order of information search. A simple combination of a fast and frugal tree and a tallying rule predicted more than 78% of subjects’ decisions. Conclusion The current emphasis in health care is to shift some responsibility onto the consumer through expansion of self medication. To know which cognitive mechanisms are behind the choice of OTC drugs is becoming a relevant purpose of current medical education. These findings have implications both for the validity of simple heuristics describing information searches in the field of OTC drug choices and

  13. Comparative study on drug safety surveillance between medical students of Malaysia and Nigeria.

    PubMed

    Abubakar, Abdullahi Rabiu; Ismail, Salwani; Rahman, Nor Iza A; Haque, Mainul

    2015-01-01

    Internationally, there is a remarkable achievement in the areas of drug discovery, drug design, and clinical trials. New and efficient drug formulation techniques are widely available which have led to success in treatment of several diseases. Despite these achievements, large number of patients continue to experience adverse drug reactions (ADRs), and majority of them are yet to be on record. The purpose of this survey is to compare knowledge, attitude, and practice with respect to ADRs and pharmacovigilance (PV) between medical students of Malaysia and Nigeria and to determine if there is a relationship between their knowledge and practice. A cross-sectional, questionnaire-based survey involving year IV and year V medical students of the Department of Medicine, Universiti Sultan Zainal Abidin and Bayero University Kano was carried out. The questionnaire which comprised 25 questions on knowledge, attitude, and practice was adopted, modified, validated, and administered to them. The response was analyzed using SPSS version 20. The response rate from each country was 74%. There was a statistically significant difference in mean knowledge and practice score on ADRs and PV between medical students of Malaysia and Nigeria, both at P<0.000. No significance difference in attitude was observed at P=0.389. Also, a statistically significant relationship was recorded between their knowledge and practice (r=0.229, P=0.001), although the relationship was weak. Nigerian medical students have better knowledge and practice than those of Malaysia, although they need improvement. Imparting knowledge of ADRs and PV among medical students will upgrade their practice and enhance health care delivery services in the future.

  14. Comparative study on drug safety surveillance between medical students of Malaysia and Nigeria

    PubMed Central

    Abubakar, Abdullahi Rabiu; Ismail, Salwani; Rahman, Nor Iza A; Haque, Mainul

    2015-01-01

    Background Internationally, there is a remarkable achievement in the areas of drug discovery, drug design, and clinical trials. New and efficient drug formulation techniques are widely available which have led to success in treatment of several diseases. Despite these achievements, large number of patients continue to experience adverse drug reactions (ADRs), and majority of them are yet to be on record. Objectives The purpose of this survey is to compare knowledge, attitude, and practice with respect to ADRs and pharmacovigilance (PV) between medical students of Malaysia and Nigeria and to determine if there is a relationship between their knowledge and practice. Method A cross-sectional, questionnaire-based survey involving year IV and year V medical students of the Department of Medicine, Universiti Sultan Zainal Abidin and Bayero University Kano was carried out. The questionnaire which comprised 25 questions on knowledge, attitude, and practice was adopted, modified, validated, and administered to them. The response was analyzed using SPSS version 20. Results The response rate from each country was 74%. There was a statistically significant difference in mean knowledge and practice score on ADRs and PV between medical students of Malaysia and Nigeria, both at P<0.000. No significance difference in attitude was observed at P=0.389. Also, a statistically significant relationship was recorded between their knowledge and practice (r=0.229, P=0.001), although the relationship was weak. Conclusion Nigerian medical students have better knowledge and practice than those of Malaysia, although they need improvement. Imparting knowledge of ADRs and PV among medical students will upgrade their practice and enhance health care delivery services in the future. PMID:26170680

  15. Associations between medical cannabis and other drug use among unstably housed women.

    PubMed

    Meacham, Meredith C; Ramo, Danielle E; Kral, Alex H; Riley, Elise D

    2018-02-01

    Several studies suggest that U.S. state-level legalization of cannabis for medical purposes may be associated with reductions in opioid use; yet its relationship with stimulant use, particularly in high-risk populations like unstably housed women, has received less attention. The purpose of this study was to estimate independent associations between medical and non-medical use of cannabis and use of stimulants and opioids among unstably housed women. Cross-sectional data were analyzed from 245 women in the SHADOW study, a community based cohort in San Francisco, CA, in which HIV+ women were oversampled (126 HIV+ and 119 HIV-). Compared to no cannabis use in the past 6 months (51%), non-medical cannabis use (28%) was associated with a higher adjusted odds of using stimulants (Adjusted Odds Ratio [AOR]=4.34, 95% confidence interval [CI]: 2.17-8.70) and opioids (AOR=3.81, 95% CI: 1.78-8.15). Compared to no cannabis use, medical cannabis use (21%) was not significantly associated with stimulant or opioid use. Compared to non-medical cannabis use, however, medical cannabis use was associated with lower adjusted odds of using stimulants (AOR=0.42, 95% CI: 0.18-0.96). These associations were not modified by HIV status. Associations between use of cannabis and "street drugs" depend on whether the cannabis is obtained through a medical context. Interventions, research, and policy considering the influence of cannabis on the use of other drugs may benefit by distinguishing between medical and non-medical cannabis use. Copyright © 2017. Published by Elsevier B.V.

  16. [Compliance in the treatment of schizophrenia -- results of an expert survey in Saxony and Saxony-Anhalt].

    PubMed

    Giessler, Anne; Born, Anja; Helm, Hedda; Puschner, Bernd; Becker, Thomas

    2005-10-01

    To report attitudes of psychiatrists and neurologists towards compliance with regard to medication-taking behaviour of patients suffering from schizophrenia. A questionnaire was sent to psychiatrists and neurologists practising in Saxony and Saxony-Anhalt. Out of a total of 120, 54 completed questionnaires were returned. Most of the experts defined compliance as the degree of fidelity to treatment recommendations and patient cooperation. In the experts' view, a positive attitude towards treatment, insight into illness, and accurate perception of the symptoms correlate strongly with compliance, whereas the association between sociodemographic characteristics and compliance was seen as moderate. A majority of experts considered there were changes in compliance over time. With regard to the improvement of compliance, the importance of the doctor-patient-relationship is supported by the results of our study. As ratings of doctors suggest, compliance is a broadly determined behaviour which is variable over time. Future research on medication-related compliance in patients suffering from schizophrenia should take into account these findings.

  17. Comparison of the pattern, efficacy, and tolerability of self-medicated drugs in primary dysmenorrhea: a questionnaire based survey.

    PubMed

    Sugumar, Ramya; Krishnaiah, Vasundara; Channaveera, Gokul Shetty; Mruthyunjaya, Shilpa

    2013-01-01

    To compare the pattern, efficacy, and tolerability of self-medicated drugs and to assess the adequacy of their dose in primary dysmenorrhea (PD). A survey using a self-developed, validated, objective, and structured questionnaire as a tool was conducted among subjects with PD. Statistical analysis was carried out using Chi-square test and ANOVA with post-hoc Tuckey's test. Out of 641 respondents, 42% were self-medicated. The pattern of drugs used was: Dicyclomine, an unknown drug, mefenamic acid, mefenamic acid + dicyclomine, and metamizole by 35%, 29%, 26%, 9%, and 1% of respondents, respectively. Mefenamic acid + dicyclomine, the combination was the most efficacious in comparison to other drugs in moderate to severe dysmenorrhea. There was better tolerability with mefenamic acid + dicyclomine group compared to other drugs. Sub-therapeutic doses were used by 86% of self-medicating respondents. The prevailing self-medication practices were inappropriate in a substantial proportion of women with inadequate knowledge regarding appropriate drug choice, therapeutic doses, and their associated side effects.

  18. The role of human drug self-administration procedures in the development of medications

    PubMed Central

    Comer, SD; Ashworth, JB; Foltin, RW; Johanson, CE; Zacny, JP; Walsh, SL

    2008-01-01

    The purpose of this review is to illustrate the utility and value of employing human self-administration procedures in medication development, including abuse liability assessments of novel medications and evaluation of potential pharmacotherapies for substance use disorders. Traditionally, human abuse liability testing has relied primarily on subjective reports describing drug action by use of questionnaires; similarly, drug interactions between putative treatment agents and the drugs of abuse have relied on these measures. Subjective reports are highly valued because they provide qualitative and quantitative information about the characteristics of central and peripheral pharmacodynamic effects as well as safety and tolerability. However, self-administration procedures directly examine the behavior of interest – that is, drug taking. The present paper 1) reviews the most commonly used human self-administration procedures, 2) discusses the concordance of subjective reports and self-administration within the context of medications development for substance use disorders, focusing primarily on illustrative examples from development efforts with opioid and cocaine dependence, and 3) explores the utility of applying self-administration procedures to assess the abuse liability of novel compounds, including “abuse deterrent” formulations (ADFs). The review will focus on opioid and cocaine dependence because a rich database from both clinical laboratory and clinical trial research exists for these two drug classes. The data reviewed suggest that drug-induced changes in self-administration and subjective effects are not always concordant. Therefore, assessment of self-administration in combination with subjective effects provides a more comprehensive picture that may have improved predictive validity for translating to the clinical setting. PMID:18436394

  19. Hand hygiene compliance in patients under contact precautions and in the general hospital population.

    PubMed

    Almaguer-Leyva, Martín; Mendoza-Flores, Lidia; Medina-Torres, Ana Gabriela; Salinas-Caballero, Ana Gabriela; Vidaña-Amaro, Jose Antonio; Garza-Gonzalez, Elvira; Camacho-Ortiz, Adrián

    2013-11-01

    Hand hygiene (HH) is the single most important intervention for preventing hospital-acquired infections. Contact precautions are a series of actions that infection control units take to reduce the transmission of nosocomial pathogens. We conducted an observational study of HH compliance. Observations were stratified as opportunities in patients under contact precautions and in the general hospital population. Trained infection control personnel performed all direct evaluations. A total of 3,270 opportunities were recorded. HH compliance was statistically higher in patients on contact precautions than in the overall population (70.3% vs 60.4%; P = .0001). Critical care areas had higher HH compliance when patients were isolated by contact precautions. Medical wards were statistically lower in HH when patients were under contact precautions. Respiratory technicians had the highest HH compliance in both overall performance and in patients under contact precautions. Medical students had a lower HH compliance in both evaluations (P < .001). We noted greater compliance with HH practices when patients were under contact precaution in comparison with the overall hospital population. The difference was stronger in intensive care areas and lower among medical students. Copyright © 2013 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Mosby, Inc. All rights reserved.

  20. Effects of drug pharmacokinetic/pharmacodynamic properties, characteristics of medication use, and relevant pharmacological interventions on fall risk in elderly patients.

    PubMed

    Chen, Ying; Zhu, Ling-Ling; Zhou, Quan

    2014-01-01

    Falls among the elderly are an issue internationally and a public health problem that brings substantial economic and quality-of-life burdens to individuals and society. Falls prevention is an important measure of nursing quality and patient safety. Numerous studies have evaluated the association of medication use with fall risk in elderly patients. However, an up-to-date review has not been available to summarize the multifaceted pharmaceutical concerns in the prevention of medication-related falls. Relevant literature was identified by performing searches in PubMed, Web of Science, and the Cochrane Library, covering the period until February 2014. We included studies that described an association between medications and falls, and effects of drug pharmacokinetic/pharmacodynamic properties, characteristics of medication use, and pharmacological interventions on fall risk in elderly patients. The full text of each included article was critically reviewed, and data interpretation was performed. Fall-risk-increasing drugs (FRIDs) include central nervous system-acting agents, cough preparations, nonsteroidal anti-inflammatory drugs, anti-Alzheimer's agents, antiplatelet agents, calcium antagonists, diuretics, α-blockers, digoxin, hypoglycemic drugs, neurotoxic chemotherapeutic agents, nasal preparations, and antiglaucoma ophthalmic preparations. The degree of medication-related fall risk was dependent on one or some of the following factors: drug pharmacokinetic/pharmacodynamic properties (eg, elimination half-life, metabolic pathway, genetic polymorphism, risk rating of medications despite belonging to the same therapeutic class) and/or characteristics of medication use (eg, number of medications and drug-drug interactions, dose strength, duration of medication use and time since stopping, medication change, prescribing appropriateness, and medication adherence). Pharmacological interventions, including withdrawal of FRIDs, pharmacist-conducted clinical medication

  1. Attitudes and practices of primary healthcare center patients about drug use in Turkey.

    PubMed

    Arslan, Leyla Sündüs; Semin, Semih

    2006-08-01

    Noncompliance is considered as a widespread but often neglected problem all over the world. In order to promote compliance, it is essential to first know the current drug use situation. Therefore, this study aims to investigate the level of drug compliance in patients of a primary healthcare centre and identify factors which affect the patients' drug compliance in Turkey. The cross-sectional study was executed in 2003 in Ilica Health Centre; a total of 280 patients took part in the study. The patients were visited at home and a questionnaire was applied in order to obtain information on compliance. Overall 204 (72.8%) of patients were compliant and 76 (27.2%) were noncompliant. According to patients, the main reason for primary noncompliance was poverty. Compliance with prescription is needed to get favourable results in treatments. The results show that even in urban areas drug compliance is still an important problem in Turkey. The findings of this study may contribute to develop programmes to improve patient compliance in Turkey. The aims of these programs should include reducing the barriers, such as lack of social security, which prevent access to the prescribed drugs.

  2. Predictors of long-term compliance in attending a worksite hypertension programme.

    PubMed

    Landers, R; Riccobene, A; Beyreuther, M; Neusy, A J

    1993-12-01

    Variables such as patient's anxiety, knowledge, number of medication changes, medication-induced side-effects and programme-derived benefits and conveniences have been reported or theorised to be important determinants of patient's attendance at worksite hypertension programmes. This study investigates whether these variables have predictive value in differentiating compliers from noncompliers attending a union-sponsored worksite hypertension programme for at least five years. Scores were created from a questionnaire distributed to 243 patients with a response rate of 98%. Compliance was defined as missing < or = 25% of scheduled clinic appointments. By discriminant statistical analysis scores for patient's anxiety, knowledge, number of medication changes, medication side-effects, perceived benefits and conveniences failed to show any predictive value for patient's compliance with appointment keeping.

  3. [Medical treatment of patients with clinical peripheral arterial disease at hospital discharge: compliance with the French guidelines and changing practices (COPART I registry)].

    PubMed

    Béraut, E; Cambou, J P; Guilhem, J M; Vaysse, N; Labro, S; Séverac, D; Boccalon, H; Bura-Rivière, A

    2008-02-01

    Peripheral arterial disease (PAD) is a frequent and serious condition with a risk of mortality comparable to that of certain cancers. However, in France, the literature on this medical condition is scarce and data on management, incidence of complications and prognosis are lacking. The COPART I registry, set up in June 2004, in the Vascular Medicine Department of the University Hospital of Toulouse, France, constitutes an observational database on hospitalized patients with PAD, in order to evaluate management, follow-up and prognosis of the patients. The aim of the present work is to compare medical prescriptions at hospital discharge, with the recent guidelines of the French High Authority of Health. All consecutive patients with PAD, hospitalized in the Vascular Medicine Department of the University of Toulouse, between June 1, 2004 and July 31, 2006 were included. Only surviving patients were analysed. Four hundred patients were included in the study. As expected, the majority were male (70%). Common cardiovascular risk factors were: arterial hypertension (66.7%), dyslipidemia (58.9%), diabetes (42.9%), and smoking (27.4%). Three patients out of 10 had claudication intermittens, nearly two out of 10 patients complained of persistent pain, and four out of 10 patients had Leriche and Fontaine stage IV arteriopathy. At hospital discharge, 86.9% of the patients were taking at least one antiplatelet treatment, 71.2% a statin, 54% a renin-angiotensin-system inhibitor. Nearly 66% of the patients (65.8%) received at least one antiplatelet agent and a statin. Nearly 50% of the patients (49.4%) had the three drugs recommended by the French High Authority of Health. We observed a change in prescription practices for statins (+30%), as well as for prescription of evidence-based tri-therapy (+29%) between 2004 and 2006. Treatments prescribed at hospital discharge of patient with PAD included in the COPART I registry are in compliance with the French High Authority of Health

  4. Evaluation of the ASCO Value Framework for Anticancer Drugs at an Academic Medical Center.

    PubMed

    Wilson, Leslie; Lin, Tracy; Wang, Ling; Patel, Tanuja; Tran, Denise; Kim, Sarah; Dacey, Katie; Yuen, Courtney; Kroon, Lisa; Brodowy, Bret; Rodondi, Kevin

    2017-02-01

    Anticancer drug prices have increased by an average of 12% each year from 1996 to 2014. A major concern is that the increasing cost and responsibility of evaluating treatment options are being shifted to patients. This research compared 2 value-based pricing models that were being considered for use at the University of California, San Francisco (UCSF) Medical Center to address the growing burden of high-cost cancer drugs while improving patient-centered care. The Medication Outcomes Center (MOC) in the Department of Clinical Pharmacy, University of California, San Francisco (UCSF), School of Pharmacy focuses on assessing the value of medication-related health care interventions and disseminating findings to the UCSF Medical Center. The High Cost Oncology Drug Initiative at the MOC aims to assess and adopt tools for the critical assessment and amelioration of high-cost cancer drugs. The American Society of Clinical Oncology (ASCO) Value Framework (2016 update) and a cost-effectiveness analysis (CEA) framework were identified as potential tools for adoption. To assess 1 prominent value framework, the study investigators (a) asked 8 clinicians to complete the ASCO Value Framework for 11 anticancer medications selected by the MOC; (b) reviewed CEAs assessing the drugs; (c) generated descriptive statistics; and (d) analyzed inter-rater reliability, convergence validity, and ranking consistency. On the scale of -20 to 180, the mean ASCO net health benefit (NHB) total score across 11 drugs ranged from 7.6 (SD = 7.8) to 53 (SD = 9.8). The Kappa coefficient (κ) for NHB scores across raters was 0.11, which is categorized as "slightly reliable." The combined κ score was 0.22, which is interpreted as low to fair inter-rater reliability. Convergent validity indicates that the correlation between NHB scores and CEA-based incremental cost-effectiveness ratios (ICERs) was low (-0.215). Ranking of ICERs, ASCO scores, and wholesale acquisition costs indicated different results

  5. Synergistic Effects of Food Insecurity and Drug Use on Medication Adherence among People Living with HIV Infection

    PubMed Central

    Chen, Yiyun; Kalichman, Seth C.

    2014-01-01

    Food insecurity and drug use are closely connected in the context of poverty, and both have been suggested to interfere with HIV medication adherence among people living with HIV/AIDS (PLWH). Yet the potential interaction between the two factors on adherence has not been examined. For this study we collected longitudinal data on HIV medication adherence among PLWH in Atlanta, GA, to assess a possible synergistic effect between the two factors on HIV medication adherence. People informed about the study came to the research site and completed an audio computer-assisted self-interview and instructions for pill counting. Over the next five weeks participants received three unscheduled follow-up phone assessments conducted two weeks apart to collect pill counts of their HIV medication. The prevalence of food insecurity was 60% (488) and that of drug use was 33% (274) in the sample of 809 participants. Among 770 participants who completed follow-up phone assessments, both food insecurity and drug use were associated with HIV medication adherence after adjusting for socio-demographic characteristics. The negative association between drug use and adherence persisted after further adjusting for health-related characteristics. Moreover, drug use appeared to moderate the effect of food insufficiency on adherence, with drug users who were food insufficient being the least likely to achieve 85% adherence. Results from the current study demonstrate a synergism between food insecurity and drug use that may impede adherence among PLWH. The findings imply that the disruptive effects of food insecurity and drug use on adherence are likely to be intensified with the presence of each other, and encourage interventions to address the problem of HIV medication adherence from a multi-faceted perspective that takes into account detrimental combination of problem factors. PMID:25533641

  6. Synergistic effects of food insecurity and drug use on medication adherence among people living with HIV infection.

    PubMed

    Chen, Yiyun; Kalichman, Seth C

    2015-06-01

    Food insecurity and drug use are closely connected in the context of poverty, and both have been suggested to interfere with HIV medication adherence among people living with HIV/AIDS (PLWH). Yet the potential interaction between the two factors on adherence has not been examined. For this study we collected longitudinal data on HIV medication adherence among PLWH in Atlanta, GA, to assess a possible synergistic effect between the two factors on HIV medication adherence. People informed about the study came to the research site and completed an audio computer-assisted self-interview and instructions for pill counting. Over the next 5 weeks participants received three unscheduled follow-up phone assessments conducted 2 weeks apart to collect pill counts of their HIV medication. The prevalence of food insecurity was 60 % (488) and that of drug use was 33 % (274) in the sample of 809 participants. Among 770 participants who completed follow-up phone assessments, both food insecurity and drug use were associated with HIV medication adherence after adjusting for socio-demographic characteristics. The negative association between drug use and adherence persisted after further adjusting for health-related characteristics. Moreover, drug use appeared to moderate the effect of food insufficiency on adherence, with drug users who were food insufficient being the least likely to achieve 85 % adherence. Results from the current study demonstrate a synergism between food insecurity and drug use that may impede adherence among PLWH. The findings imply that the disruptive effects of food insecurity and drug use on adherence are likely to be intensified with the presence of each other, and encourage interventions to address the problem of HIV medication adherence from a multi-faceted perspective that takes into account detrimental combination of problem factors.

  7. Compliance with the Prescription of Antihypertensive Medications and Blood Pressure Control in Primary Care.

    PubMed

    Novello, Mayra Faria; Rosa, Maria Luiza Garcia; Ferreira, Ranier Tagarro; Nunes, Icaro Gusmão; Jorge, Antonio José Lagoeiro; Correia, Dayse Mary da Silva; Martins, Wolney de Andrade; Mesquita, Evandro Tinoco

    2017-02-01

    Hypertension is the most prevalent risk factor for cardiovascular disease, and its proper control can prevent the high morbidity and mortality associated with this disease. To assess the degree of compliance of antihypertensive prescriptions with the VI Brazilian Guidelines on Hypertension and the blood pressure control rate in primary care. Cross-sectional study conducted between August 2011 and November 2012, including 332 adults ≥ 45 years registered in the Family Doctor Program in Niteroi and selected randomly. The analysis included the prescribed antihypertensive classes, doses, and frequencies, as well as the blood pressure (BP) of the individuals. The rate of prescription compliance was 80%. Diuretics were the most prescribed medications, and dual therapy was the most used treatment. The most common non-compliances were underdosing and underfrequencies. The BP goal in all cases was < 140/90 mmHg, except for diabetic patients, in whom the goal was set at < 130/80 mmHg. Control rates according to these goals were 44.9% and 38.6%, respectively. There was no correlation between prescription compliance and BP control. The degree of compliance was considered satisfactory. The achievement of the targets was consistent with national and international studies, suggesting that the family health model is effective in BP management, although it still needs improvement. A hipertensão arterial é o fator de risco mais prevalente para a doença cardiovascular e seu controle adequado pode prevenir a elevada morbi-mortalidade associada a esta doença. Avaliar o grau de conformidade das prescrições de anti-hipertensivos com as VI Diretrizes Brasileiras de Hipertensão e a taxa de controle pressórico na atenção básica. Estudo transversal conduzido entre agosto de 2011 e novembro de 2012, incluindo 332 adultos ≥ 45 anos cadastrados no Programa Médico de Família de Niterói e selecionados aleatoriamente. Foram analisadas as classes de anti-hipertensivos prescritos

  8. Patient compliance in hypertension: role of illness perceptions and treatment beliefs.

    PubMed

    Ross, S; Walker, A; MacLeod, M J

    2004-09-01

    Despite many years of study, questions remain about why patients do or do not take medicines and what can be done to change their behaviour. Hypertension is poorly controlled in the UK and poor compliance is one possible reason for this. Recent questionnaires based on the self-regulatory model have been successfully used to assess illness perceptions and beliefs about medicines. This study was designed to describe hypertensive patients' beliefs about their illness and medication using the self-regulatory model and investigate whether these beliefs influence compliance with antihypertensive medication. We recruited 514 patients from our secondary care population. These patients were asked to complete a questionnaire that included the Beliefs about Medicines and Illness Perception Questionnaires. A case note review was also undertaken. Analysis shows that patients who believe in the necessity of medication are more likely to be compliant (odds ratio (OR)) 3.06 (95% CI 1.74-5.38), P<0.001). Other important predictive factors in this population are age (OR 4.82 (2.85-8.15), P<0.001), emotional response to illness (OR 0.65 (0.47-0.90), P=0.01) and belief in personal ability to control illness (OR 0.59 (0.40-0.89), P=0.01). Beliefs about illness and about medicines are interconnected; aspects that are not directly related to compliance influence it indirectly. The self-regulatory model is useful in assessing patients health beliefs. Beliefs about specific medications and about hypertension are predictive of compliance. Information about health beliefs is important in achieving concordance and may be a target for intervention to improve compliance.

  9. Campania Preventability Assessment Committee (Italy): A Focus on the Preventability of Non-steroidal Anti-inflammatory Drugs' Adverse Drug Reactions.

    PubMed

    Sessa, Maurizio; Sportiello, Liberata; Mascolo, Annamaria; Scavone, Cristina; Gallipoli, Silvia; di Mauro, Gabriella; Cimmaruta, Daniela; Rafaniello, Concetta; Capuano, Annalisa

    2017-01-01

    Purpose: This study aims to investigate preventability criteria of adverse drug reactions (ADRs) involving non-steroidal anti-inflammatory drugs (NSAIDs) by analyzing individual case safety reports (ICSRs) sent through Campania region (Italy) spontaneous reporting system from July 2012 to October 2016. Methods: For all the ICSRs that reported NSAIDs as suspected drug, a trained multidisciplinary team of Campania Pharmacovigilance Regional Centre composed of clinical pharmacologists and pharmacists with pluriannual experience in Pharmacovigilance assessed preventability by using the P-method. Results: In all 19,039 ICSRs were sent to Campania Pharmacovigilance Regional Centre, of which 550 reported NSAIDs as suspected drug. In total, 94 cases (17.1%) out of 550 ICSRs were preventable. In the 94 preventable cases, 201 critical criteria were detected of which 182/201 (90.5%) related to healthcare professionals' practices, 0/201 (0.0%) to drug quality, and 19/201 (9.5%) to patient behavior. The most detected critical criteria were the necessary medication not given (52/182; 28.6%), labeled drug-drug interaction (36/182; 19.7%), incorrect drug administration duration (31/182; 16.9%), wrong indication (26/182; 14.2%), therapeutic duplication (18/182; 10.0%), and documented hypersensitivity to administered drug or drug class (10/182; 5.6%). In seventeen (18.1%) preventable cases, there were 19 critical criteria involving non-compliance (15/19 critical criteria; 78.9%) and self-medication with the non-over-the-counter drugs (4/19 critical criteria; 21.1%). In all, 17 out 94 (18.1%) preventable cases involved over-the-counter drugs. Conclusion: A call for action for Campania Pharmacovigilance Regional Centre is necessary in order to promote initiatives to increase the awareness of healthcare professionals and citizens on the risk associated with inappropriate use of NSAIDs.

  10. Exploring medical identity theft.

    PubMed

    Mancilla, Desla; Moczygemba, Jackie

    2009-09-16

    The crime of medical identity theft is a growing concern in healthcare institutions. A mixed-method study design including a two-stage electronic survey, telephone survey follow-up, and on-site observations was used to evaluate current practices in admitting and registration departments to reduce the occurrence of medical identity theft. Survey participants were chief compliance officers in acute healthcare organizations and members of the Health Care Compliance Association. Study results indicate variance in whether or how patient identity is confirmed in healthcare settings. The findings of this study suggest that information systems need to be designed for more efficient identity management. Admitting and registration staff must be trained, and compliance with medical identity theft policies and procedures must be monitored. Finally, biometric identity management solutions should be considered for stronger patient identification verification.

  11. Longitudinal medical records as a complement to routine drug safety signal analysis†

    PubMed Central

    Watson, Sarah; Sandberg, Lovisa; Johansson, Jeanette; Edwards, I. Ralph

    2015-01-01

    Abstract Purpose To explore whether and how longitudinal medical records could be used as a source of reference in the early phases of signal detection and analysis of novel adverse drug reactions (ADRs) in a global pharmacovigilance database. Methods Drug and ADR combinations from the routine signal detection process of VigiBase® in 2011 were matched to combinations in The Health Improvement Network (THIN). The number and type of drugs and ADRs from the data sets were investigated. For unlabelled combinations, graphical display of longitudinal event patterns (chronographs) in THIN was inspected to determine if the pattern supported the VigiBase combination. Results Of 458 combinations in the VigiBase data set, 190 matched to corresponding combinations in THIN (after excluding drugs with less than 100 prescriptions in THIN). Eighteen percent of the VigiBase and 9% of the matched THIN combinations referred to new drugs reported with serious reactions. Of the 112 unlabelled combinations matched to THIN, 52 chronographs were inconclusive mainly because of lack of data; 34 lacked any outstanding pattern around the time of prescription; 24 had an elevation of events in the pre‐prescription period, hence weakened the suspicion of a drug relationship; two had an elevated pattern of events exclusively in the post‐prescription period that, after review of individual patient histories, did not support an association. Conclusions Longitudinal medical records were useful in understanding the clinical context around a drug and suspected ADR combination and the probability of a causal relationship. A drawback was the paucity of data for newly marketed drugs with serious reactions. © 2015 The Authors. Pharmacoepidemiology and Drug Safety published by John Wiley & Sons, Ltd. PMID:25623045

  12. Medication adherence, healthcare costs and utilization associated with acne drugs in Medicaid enrollees with acne vulgaris.

    PubMed

    Tan, Xi; Al-Dabagh, Amir; Davis, Scott A; Lin, Hsien-Chang; Balkrishnan, Rajesh; Chang, Jongwha; Feldman, Steven R

    2013-06-01

    Acne vulgaris is a common chronic disease that may require long-term treatment. Medication adherence is critical to acne management; non-adherence is a common reason for treatment failure and can lead to poor quality of life. The aim of the study was to examine medication adherence, healthcare costs, and utilization associated with acne drugs among acne patients in the USA. This was a retrospective cohort study from January 2004 to December 2007 using the Marketscan Medicaid Database, a national healthcare claims database. The study followed acne patients aged 0-64 years for 90 days after the first acne drug prescription to measure acne medication adherence, acne-related outpatient visits, and total acne-related healthcare costs. Adherence was measured among different acne drug classes using medication possession ratio (MPR). Multivariate regression analyses were conducted to assess the outcomes. The study included 24,438 eligible patients, of whom 89.39 % were under 18 years old. The average adherence rate to acne drugs (MPR) was 0.34, and only 11.74 % of the patients were adherent (MPR ≥0.80). Patients with drug refills had a higher adherence rate (MPR = 0.74) than who those without refills (MPR = 0.27). Factors significantly associated with adherence were age, comorbidity, gender, number of drug refills and number of drug classes used. Patients were more adherent to oral retinoids than any other acne drug classes (MPR = 0.78, 57 % adherent). Patients were less adherent to oral antibiotics (MPR = 0.21) and topical retinoids (MPR = 0.31). After controlling for medication use behavior, the use of oral antibiotics decreased the number of acne-related outpatient visits by 50.9 % (p < 0.001) and lowered acne-related total costs by 51.7 % (p < 0.001). Medication non-adherence is generally prevalent among young acne patients enrolled in Medicaid. The combination of a topical retinoid and an antibiotic agent may be a good choice given their associated healthcare

  13. The Food and Drug Administration and pragmatic clinical trials of marketed medical products

    PubMed Central

    Anderson, Monique L; Griffin, Joseph; Goldkind, Sara F; Zeitler, Emily P; Wing, Liz; Al-Khatib, Sana M; Sherman, Rachel E

    2015-01-01

    Pragmatic clinical trials (PCTs) can help answer questions of comparative effectiveness for interventions routinely used in medical practice. PCTs may examine outcomes of one or more marketed medical products, and they are heterogeneous in design and risk. The Food and Drug Administration (FDA) is charged with protecting the rights, safety, and welfare of individuals enrolled in clinical investigations, as well as assuring the integrity upon which approval of medical products are made. The FDA has broad jurisdiction over drugs and medical devices (whether or not they are approved for marketing), and as such, clinical investigations of these products are subject to applicable FDA regulations. While many PCTs will meet the criteria for an exemption from the requirements for an investigational new drug application (IND) or investigational device exemption (IDE), in general all clinical investigations of medical products that fall under FDA jurisdiction must adhere to regulations for informed consent and review by an institutional review board (IRB). We are concerned that current FDA requirements for obtaining individual informed consent may deter or delay the conduct of PCTs intended to develop reliable evidence of comparative safety and effectiveness of approved medical products that are regulated by the FDA. Under current regulations, there are no described mechanisms to alter or waive informed consent to make it less burdensome or more practicable for low-risk PCTs. We recommend that the FDA establish a risk-based approach to obtaining informed consent in PCTs that would facilitate the conduct of PCTs without compromising the protection of enrolled individuals or the integrity of the resulting data. PMID:26374684

  14. Drug interactions of clinical importance among the opioids, methadone and buprenorphine, and other frequently prescribed medications: a review.

    PubMed

    McCance-Katz, Elinore F; Sullivan, Lynn E; Nallani, Srikanth

    2010-01-01

    Drug interactions are a leading cause of morbidity and mortality. Methadone and buprenorphine are frequently prescribed for the treatment of opioid addiction. Patients needing treatment with these medications often have co-occurring medical and mental illnesses that require medication treatment. The abuse of illicit substances is also common in opioid-addicted individuals. These clinical realities place patients being treated with methadone and buprenorphine at risk for potentially toxic drug interactions. A substantial literature has accumulated on drug interactions between either methadone or buprenorphine with other medications when ingested concomitantly by humans. This review summarizes current literature in this area.

  15. Drug Interactions of Clinical Importance among the Opioids, Methadone and Buprenorphine, and other Frequently Prescribed Medications: A Review

    PubMed Central

    McCance-Katz, Elinore F.; Sullivan, Lynn; Nallani, Srikanth

    2012-01-01

    Drug interactions are a leading cause of morbidity and mortality. Methadone and buprenorphine are frequently prescribed for the treatment of opioid addiction. Patients needing treatment with these medications often have co-occurring medical and mental illnesses that require medication treatment. The abuse of illicit substances is also common in opioid-addicted individuals. These clinical realities place patients being treated with methadone and buprenorphine at risk for potentially toxic drug interactions. A substantial literature has accumulated on drug interactions between either methadone or buprenorphine with other medications when ingested concomitantly by humans. This review summarizes current literature in this area. PMID:20132117

  16. Automated drug dispensing system reduces medication errors in an intensive care setting.

    PubMed

    Chapuis, Claire; Roustit, Matthieu; Bal, Gaëlle; Schwebel, Carole; Pansu, Pascal; David-Tchouda, Sandra; Foroni, Luc; Calop, Jean; Timsit, Jean-François; Allenet, Benoît; Bosson, Jean-Luc; Bedouch, Pierrick

    2010-12-01

    We aimed to assess the impact of an automated dispensing system on the incidence of medication errors related to picking, preparation, and administration of drugs in a medical intensive care unit. We also evaluated the clinical significance of such errors and user satisfaction. Preintervention and postintervention study involving a control and an intervention medical intensive care unit. Two medical intensive care units in the same department of a 2,000-bed university hospital. Adult medical intensive care patients. After a 2-month observation period, we implemented an automated dispensing system in one of the units (study unit) chosen randomly, with the other unit being the control. The overall error rate was expressed as a percentage of total opportunities for error. The severity of errors was classified according to National Coordinating Council for Medication Error Reporting and Prevention categories by an expert committee. User satisfaction was assessed through self-administered questionnaires completed by nurses. A total of 1,476 medications for 115 patients were observed. After automated dispensing system implementation, we observed a reduced percentage of total opportunities for error in the study compared to the control unit (13.5% and 18.6%, respectively; p<.05); however, no significant difference was observed before automated dispensing system implementation (20.4% and 19.3%, respectively; not significant). Before-and-after comparisons in the study unit also showed a significantly reduced percentage of total opportunities for error (20.4% and 13.5%; p<.01). An analysis of detailed opportunities for error showed a significant impact of the automated dispensing system in reducing preparation errors (p<.05). Most errors caused no harm (National Coordinating Council for Medication Error Reporting and Prevention category C). The automated dispensing system did not reduce errors causing harm. Finally, the mean for working conditions improved from 1.0±0.8 to 2

  17. Campania Preventability Assessment Committee (Italy): A Focus on the Preventability of Non-steroidal Anti-inflammatory Drugs' Adverse Drug Reactions

    PubMed Central

    Sessa, Maurizio; Sportiello, Liberata; Mascolo, Annamaria; Scavone, Cristina; Gallipoli, Silvia; di Mauro, Gabriella; Cimmaruta, Daniela; Rafaniello, Concetta; Capuano, Annalisa

    2017-01-01

    Purpose: This study aims to investigate preventability criteria of adverse drug reactions (ADRs) involving non-steroidal anti-inflammatory drugs (NSAIDs) by analyzing individual case safety reports (ICSRs) sent through Campania region (Italy) spontaneous reporting system from July 2012 to October 2016. Methods: For all the ICSRs that reported NSAIDs as suspected drug, a trained multidisciplinary team of Campania Pharmacovigilance Regional Centre composed of clinical pharmacologists and pharmacists with pluriannual experience in Pharmacovigilance assessed preventability by using the P-method. Results: In all 19,039 ICSRs were sent to Campania Pharmacovigilance Regional Centre, of which 550 reported NSAIDs as suspected drug. In total, 94 cases (17.1%) out of 550 ICSRs were preventable. In the 94 preventable cases, 201 critical criteria were detected of which 182/201 (90.5%) related to healthcare professionals' practices, 0/201 (0.0%) to drug quality, and 19/201 (9.5%) to patient behavior. The most detected critical criteria were the necessary medication not given (52/182; 28.6%), labeled drug–drug interaction (36/182; 19.7%), incorrect drug administration duration (31/182; 16.9%), wrong indication (26/182; 14.2%), therapeutic duplication (18/182; 10.0%), and documented hypersensitivity to administered drug or drug class (10/182; 5.6%). In seventeen (18.1%) preventable cases, there were 19 critical criteria involving non-compliance (15/19 critical criteria; 78.9%) and self-medication with the non-over-the-counter drugs (4/19 critical criteria; 21.1%). In all, 17 out 94 (18.1%) preventable cases involved over-the-counter drugs. Conclusion: A call for action for Campania Pharmacovigilance Regional Centre is necessary in order to promote initiatives to increase the awareness of healthcare professionals and citizens on the risk associated with inappropriate use of NSAIDs. PMID:28603499

  18. Patient compliance based on genetic medicine: a literature review.

    PubMed

    Schneider, Kai Insa; Schmidtke, Jörg

    2014-01-01

    For this literature review, medical literature data bases were searched for studies on patient compliance after genetic risk assessment. The review focused on conditions where secondary or tertiary preventive options exist, namely cancer syndromes (BRCA-related cancer, HNPCC/colon cancer), hemochromatosis, thrombophilia, smoking cessation, and obesity. As a counterpart, patient compliance was assessed regarding medication adherence and medical advice in some of the most epidemiologically important conditions (including high blood pressure, metabolic syndrome, and coronary heart disease) after receiving medical advice based on nongenetic risk information or a combination of genetic and nongenetic risk information. In the majority of studies based on genetic risk assessments, patients were confronted with predictive rather than diagnostic genetic profiles. Most of the studies started from a knowledge base around 10 years ago when DNA testing was at an early stage, limited in scope and specificity, and costly. The major result is that overall compliance of patients after receiving a high-risk estimate from genetic testing for a given condition is high. However, significant behavior change does not take place just because the analyte is "genetic." Many more factors play a role in the complex process of behavioral tuning. Without adequate counseling and guidance, patients may interpret risk estimates of predictive genetic testing with an increase in fear and anxiety.

  19. Medical marijuana laws and adolescent use of marijuana and other substances: Alcohol, cigarettes, prescription drugs, and other illicit drugs.

    PubMed

    Cerdá, Magdalena; Sarvet, Aaron L; Wall, Melanie; Feng, Tianshu; Keyes, Katherine M; Galea, Sandro; Hasin, Deborah S

    2018-02-01

    Historical shifts have taken place in the last twenty years in marijuana policy. The impact of medical marijuana laws (MML) on use of substances other than marijuana is not well understood. We examined the relationship between state MML and use of marijuana, cigarettes, illicit drugs, nonmedical use of prescription opioids, amphetamines, and tranquilizers, as well as binge drinking. Pre-post MML difference-in-difference analyses were performed on a nationally representative sample of adolescents in 48 contiguous U.S. states. Participants were 1,179,372U.S. 8th, 10th, and 12th graders in the national Monitoring the Future annual surveys conducted in 1991-2015. Measurements were any self-reported past-30-day use of marijuana, cigarettes, non-medical use of opioids, amphetamines and tranquilizers, other illicit substances, and any past-two-week binge drinking (5+ drinks per occasion). Among 8th graders, the prevalence of marijuana, binge drinking, cigarette use, non-medical use of opioids, amphetamines and tranquilizers, and any non-marijuana illicit drug use decreased after MML enactment (0.2-2.4% decrease; p-values:<0.0001-0.0293). Among 10th graders, the prevalence of substance use did not change after MML enactment (p-values: 0.177-0.938). Among 12th graders, non-medical prescription opioid and cigarette use increased after MML enactment (0.9-2.7% increase; p-values: <0.0001-0.0026). MML enactment is associated with decreases in marijuana and other drugs in early adolescence in those states. Mechanisms that explain the increase in non-medical prescription opioid and cigarette use among 12th graders following MML enactment deserve further study. Copyright © 2017 Elsevier B.V. All rights reserved.

  20. Analysis of the drug formulary and the purchasing process at a Moroccan university medical center.

    PubMed

    Lachhab, Z; Serragui, S; Hassar, M; Cherrah, Y; Errougani, A; Ahid, S

    2018-05-31

    To give an overview of the pharmaceutical policy in the largest medical center in Morocco, a developing country in socio-economic transition. This is an analytical descriptive study of the drug formulary and the purchasing process carried out at the Ibn Sina University Medical Center. Our formulary included 830 drugs belonging to 14 classes according to the Anatomical, Therapeutic and Chemical (ATC) Classification System. There was a respective predominance of class N (21.8%), class B (13.5%), and class J (12.6%). Injectable route was dominant (46%). Drugs had a significant actual benefit in 70% (according to the French Data), reimbursable in 42.8%, essential in 29.2% according to World Health Organization (WHO) list, and in 36.9% according to the Moroccan list. The calls for tenders included 542 drugs representing 65% of the formulary, and the attribution rate was 71%. The main reason for non-attribution was the lack of offers. Generics accounted for 45% by volume and 26.5% by value. With this first study, we were able to identify key indicators on drugs used in the largest medical center in Morocco. The current challenge is to introduce pharmacoeconomics in decision making concerning the updates of the drug formulary.

  1. Inventory of Drug Samples in a Health Care Institution

    PubMed Central

    Soucy, Geneviève; Bussières, Jean-François; Tardif, Lyne; Bailey, Benoît

    2009-01-01

    Background: Few data exist on the presence of drug samples in health care facilities. Although the use of drug samples has potential benefits, this practice is also controversial, as it can contribute to non-optimal drug use. The objective of this study was to evaluate the inventory of drug samples in a health care institution and to determine compliance with existing policies and procedures. Methods: This descriptive observational study was conducted in a university hospital centre from October 18 to November 1, 2007. A standardized data collection form was used for a physical inventory, which was intended to identify all drug samples available in the institution. The following information was recorded: number of locations where drug samples were found, primary patient care activity performed at each location, number of storage areas in the location, type of storage, presence of a lock, location of the key (if a lock was present), medical specialty, number of physicians and nurses likely to use the samples, reasons given for handing out samples, presence of a designated person to manage the samples, physical inventory (i.e., various details for each distribution unit), and declaration of samples to the pharmacy department. The inventory was conducted by 2 research assistants during day shifts. Results: A total of 84 locations were included in the inventory, and drug samples were found in 21 locations (with a total of 31 storage areas). All of the locations were intended for ambulatory patients (outpatient clinics and day centres). No drug samples were found in inpatient care units. The drug samples, which came from 62 different pharmaceutical companies, represented a total of 159 generic entities and 266 different brands. Of the distribution units for drug samples that were identified during this inventory, 59% were not on the hospital’s local formulary. Furthermore, only 3.5% of the distribution units had been declared to the pharmacy department, in accordance

  2. Medication assisted treatment in US drug courts: results from a nationwide survey of availability, barriers and attitudes.

    PubMed

    Matusow, Harlan; Dickman, Samuel L; Rich, Josiah D; Fong, Chunki; Dumont, Dora M; Hardin, Carolyn; Marlowe, Douglas; Rosenblum, Andrew

    2013-01-01

    Drug treatment courts are an increasingly important tool in reducing the census of those incarcerated for non-violent drug offenses; medication assisted treatment (MAT) is proven to be an effective treatment for opioid addiction. However, little is known about the availability of and barriers to MAT provision for opioid-addicted people under drug court jurisdiction. Using an online survey, we assessed availability, barriers, and need for MAT (especially agonist medication) for opioid addiction in drug courts. Ninety-eight percent reported opioid-addicted participants, and 47% offered agonist medication (56% for all MAT including naltrexone). Barriers included cost and court policy. Responses revealed significant uncertainty, especially among non-MAT providing courts. Political, judicial and administrative opposition appear to affect MAT's inconsistent use and availability in drug court settings. These data suggest that a substantial, targeted educational initiative is needed to increase awareness of the treatment and criminal justice benefits of MAT in the drug courts. Copyright © 2013 Elsevier Inc. All rights reserved.

  3. Unidentified drugs in traditional medications causing toxic epidermal necrolysis: a developing country experience.

    PubMed

    Kumar Das, Kishore; Khondokar, Sazzad; Rahman, Ashrafur; Chakraborty, Anjana

    2014-04-01

    Drugs are by far the most common cause of toxic epidermal necrolysis (TEN), but unidentified drugs and chemicals present in herbal and traditional medications may also be responsible for this reaction, which manifests as widespread epidermal detachment of the skin and mucous membrane. In contexts in which a subject has used an herbal or traditional medication, it is very difficult to diagnose the condition, identify the offending agent, and prevent the disease from recurring. This prospective study was conducted at a tertiary burn center between July 2004 and October 2012. All patients were referred to this unit by the local department of medicine at least one week after the eruption of vesicles. On arrival, all patients demonstrated a severe form of disease with features of sepsis and electrolyte imbalance (SCORTEN scores of ≥4). All non-fatal cases were followed to observe long-term sequelae and recurrences. About 34% of patients had developed the condition after ingesting traditional herbal medications and were unable to identify the responsible drug by name. Nineteen (66%) of the 29 patients referred to the unit with TEN died within the first week after being transferred. Nine patients achieved complete recovery, and one developed corneal haziness and alopecia. One patient experienced recurrence within three months but recovered. Illiteracy and financial vulnerability were major factors in driving patients towards the use of traditional medications, which were often prepared and preserved improperly. Mortality and other complications could be reduced by the prompt recognition of the condition, immediate withdrawal of the culprit drug, and quick referral to proper care.

  4. Psychotropic Drug Use among College Students: Patterns of Use, Misuse, and Medical Monitoring

    ERIC Educational Resources Information Center

    Oberleitner, Lindsay M. S.; Tzilos, Golfo K.; Zumberg, Kathryn M.; Grekin, Emily R.

    2011-01-01

    Objective: To assess whether college students who use psychotropic drugs are (1) aware of potential side effects, (2) appropriately monitored by prescribing physicians, and (3) taking medications as prescribed. Participants: Fifty-five college students, currently taking psychotropic medications, were recruited between Summer 2008 and Fall 2009.…

  5. Canada's Patented Medicines (Notice of Compliance) Proceedings and Intellectual Property.

    PubMed

    Bian, Henry; McCourt, Conor

    2015-01-08

    Canada's Patent Register is a tool created by the Patented Medicines (Notice of Compliance) Regulations to help innovators protect their inventions relating to pharmaceuticals. This tool exists at the intersection between the intellectual property and drug approval regimes. By listing a patent on the Patent Register, an innovator can prevent a generic manufacturer from entering the marketplace rather than having to wait for his or her patent to be infringed. This article provides information on the requirements for listing a patent on the Patent Register and an overview of how the Patent Medicines (Notice of Compliance) Regulations affect the drug approval process. Copyright © 2015 Cold Spring Harbor Laboratory Press; all rights reserved.

  6. Comparison of the pattern, efficacy, and tolerability of self-medicated drugs in primary dysmenorrhea: A questionnaire based survey

    PubMed Central

    Sugumar, Ramya; Krishnaiah, Vasundara; Channaveera, Gokul Shetty; Mruthyunjaya, Shilpa

    2013-01-01

    Objective: To compare the pattern, efficacy, and tolerability of self-medicated drugs and to assess the adequacy of their dose in primary dysmenorrhea (PD). Materials and Methods: A survey using a self-developed, validated, objective, and structured questionnaire as a tool was conducted among subjects with PD. Statistical analysis was carried out using Chi-square test and ANOVA with post-hoc Tuckey's test. Results: Out of 641 respondents, 42% were self-medicated. The pattern of drugs used was: Dicyclomine, an unknown drug, mefenamic acid, mefenamic acid + dicyclomine, and metamizole by 35%, 29%, 26%, 9%, and 1% of respondents, respectively. Mefenamic acid + dicyclomine, the combination was the most efficacious in comparison to other drugs in moderate to severe dysmenorrhea. There was better tolerability with mefenamic acid + dicyclomine group compared to other drugs. Sub-therapeutic doses were used by 86% of self-medicating respondents. Conclusions: The prevailing self-medication practices were inappropriate in a substantial proportion of women with inadequate knowledge regarding appropriate drug choice, therapeutic doses, and their associated side effects. PMID:23716896

  7. Cold atmospheric pressure plasma for treatment of chronic wounds: drug or medical device?

    PubMed

    Kramer, A; Conway, B R; Meissner, K; Scholz, F; Rauch, B H; Moroder, A; Ehlers, A; Meixner, A J; Heidecke, C-D; Partecke, L I; Kietzmann, M; Assadian, O

    2017-08-02

    The use of cold atmospheric pressure plasma (CAPP) as a new therapeutic option to aid the healing of chronic wounds appears promising. Currently, uncertainty exists regarding their classification as medical device or medical drug. Because the classification of CAPP has medical, legal, and economic consequences as well as implications for the level of preclinical and clinical testing, the correct classification is not an academic exercise, but an ethical need. A multidisciplinary team of physicians, surgeons, pharmacists, physicists and lawyers has analysed the physical and technical characteristics as well as legal conditions of the biological action of CAPP. It was concluded that the mode of action of the locally generated CAPP, with its main active components being different radicals, is pharmacological and not physical in nature. Depending on the intended use, CAPP should be classified as a drug, which is generated by use of a medical device directly at the point of therapeutic application.

  8. Interns' compliance with accreditation council for graduate medical education work-hour limits.

    PubMed

    Landrigan, Christopher P; Barger, Laura K; Cade, Brian E; Ayas, Najib T; Czeisler, Charles A

    2006-09-06

    Sleep deprivation is associated with increased risk of serious medical errors and motor vehicle crashes among interns. The Accreditation Council for Graduate Medical Education (ACGME) introduced duty-hour standards in 2003 to reduce work hours. To estimate compliance with the ACGME duty-hour standards among interns. National prospective cohort study with monthly Web-based survey assessment of intern work and sleep hours using a validated instrument, conducted preimplementation (July 2002 through May 2003) and postimplementation (July 2003 through May 2004) of ACGME standards. Participants were 4015 of the approximately 37 253 interns in US residency programs in all specialties during this time; they completed 29 477 reports of their work and sleep hours. Overall and monthly rates of compliance with the ACGME standards. Postimplementation, 1068 (83.6%; 95% confidence interval [CI], 81.4%-85.5%) of 1278 of interns reported work hours in violation of the standards during 1 or more months. Working shifts greater than 30 consecutive hours was reported by 67.4% (95% CI, 64.8%-70.0%). Averaged over 4 weeks, 43.0% (95% CI, 40.3%-45.7%) reported working more than 80 hours weekly, and 43.7% (95% CI, 41.0%-46.5%) reported not having 1 day in 7 off work duties. Violations were reported during 3765 (44.0%; 95% CI, 43.0%-45.1%) of the 8553 intern-months assessed postimplementation (including vacation and ambulatory rotations), and during 2660 (61.5%; 95% CI, 60.0%-62.9%) of 4327 intern-months during which interns worked exclusively in inpatient settings. Postimplementation, 29.0% (95% CI, 28.7%-29.7%) of reported work weeks were more than 80 hours per week, 12.1% (95% CI, 11.8%-12.6%) were 90 or more hours per week, and 3.9% (95% CI, 3.7%-4.2%) were 100 or more hours per week. Comparing preimplementation to postimplementation responses, reported mean work duration decreased 5.8% from 70.7 (95% CI, 70.5-70.9) hours to 66.6 (95% CI, 66.3-66.9) hours per week (P<.001), and reported

  9. Hand hygiene compliance rates: Fact or fiction?

    PubMed

    McLaws, Mary-Louise; Kwok, Yen Lee Angela

    2018-05-16

    The mandatory national hand hygiene program requires Australian public hospitals to use direct human auditing to establish compliance rates. To establish the magnitude of the Hawthorne effect, we compared direct human audit rates with concurrent automated surveillance rates. A large tertiary Australian teaching hospital previously trialed automated surveillance while simultaneously performing mandatory human audits for 20 minutes daily on a medical and a surgical ward. Subtracting automated surveillance rates from human audit rates provided differences in percentage points (PPs) for each of the 3 quarterly reporting periods for 2014 and 2015. Direct human audit rates for the medical ward were inflated by an average of 55 PPs in 2014 and 64 PPs in 2015, 2.8-3.1 times higher than automated surveillance rates. The rates for the surgical ward were inflated by an average of 32 PPs in 2014 and 31 PPs in 2015, 1.6 times higher than automated surveillance rates. Over the 6 mandatory reporting quarters, human audits collected an average of 255 opportunities, whereas automation collected 578 times more data, averaging 147,308 opportunities per quarter. The magnitude of the Hawthorne effect on direct human auditing was not trivial and produced highly inflated compliance rates. Mandatory compliance necessitates accuracy that only automated surveillance can achieve, whereas daily hand hygiene ambassadors or reminder technology could harness clinicians' ability to hyperrespond to produce habitual compliance. Crown Copyright © 2018. Published by Elsevier Inc. All rights reserved.

  10. Exploring Medical Identity Theft

    PubMed Central

    Mancilla, Desla; Moczygemba, Jackie

    2009-01-01

    The crime of medical identity theft is a growing concern in healthcare institutions. A mixed-method study design including a two-stage electronic survey, telephone survey follow-up, and on-site observations was used to evaluate current practices in admitting and registration departments to reduce the occurrence of medical identity theft. Survey participants were chief compliance officers in acute healthcare organizations and members of the Health Care Compliance Association. Study results indicate variance in whether or how patient identity is confirmed in healthcare settings. The findings of this study suggest that information systems need to be designed for more efficient identity management. Admitting and registration staff must be trained, and compliance with medical identity theft policies and procedures must be monitored. Finally, biometric identity management solutions should be considered for stronger patient identification verification. PMID:20169017

  11. The regulation of mobile medical applications.

    PubMed

    Yetisen, Ali Kemal; Martinez-Hurtado, J L; da Cruz Vasconcellos, Fernando; Simsekler, M C Emre; Akram, Muhammad Safwan; Lowe, Christopher R

    2014-03-07

    The rapidly expanding number of mobile medical applications have the potential to transform the patient-healthcare provider relationship by improving the turnaround time and reducing costs. In September 2013, the U.S. Food and Drug Administration (FDA) issued guidance to regulate these applications and protect consumers by minimising the risks associated with their unintended use. This guidance distinguishes between the subset of mobile medical apps which may be subject to regulation and those that are not. The marketing claims of the application determine the intent. Areas of concern include compliance with regular updates of the operating systems and of the mobile medical apps themselves. In this article, we explain the essence of this FDA guidance by providing examples and evaluating the impact on academia, industry and other key stakeholders, such as patients and clinicians. Our assessment indicates that awareness and incorporation of the guidelines into product development can hasten the commercialisation and market entry process. Furthermore, potential obstacles have been discussed and directions for future development suggested.

  12. The Role of Parent-Adolescent Concordance in Compliance with Cancer Chemotherapy.

    ERIC Educational Resources Information Center

    Tebbi, Cameron K.; And Others

    1988-01-01

    Studied 16 parent/adolescent cancer patient pairs on their knowledge and understanding of illness, medications and treatments, and their medication compliance. Found that adolescent responses closely matched those of their parents on all topics. Age was positively correlated with agreement for medication instructions. Findings have implications…

  13. [A role of motivation for treatment in the structure of compliance in psychopharmacologically treated patients].

    PubMed

    Sorokin, M Yu; Lutova, N B; Wied, V D

    2016-01-01

    To reveal an impact of specific motivation structures on the compliance in psychiatric inpatients. The Treatment Motivation Questionnaire and the Medication Compliance Scale have been administered to 104 patients, including 67 patients with schizophrenia and schizophrenia-spectrum disorders, 15 with affective disorders, 13 with personality and neurotic disorders and 9 with organic disorders, of the department of integrative pharmaco- and psychotherapy. A motivational mechanism based on the subjective suffering from disease plays a key role in the formation of overall score of compliance. Amotivation syndrome has a negative impact on the compliance. "Passive agreement" attitude to treatment corresponds to a deficiency in both patient and physician compliance subsystems along with a reduction in insight and cognitive functions in the patient's subsystem. Extreme external motivation for treatment correlates with insufficiently constructive support on the part of significant others in patient's environment subsystem resulting in the delay of internal motivation development. Extremely low scores based on understanding of disease character leads to the deficiency of medication compliance subsystem.

  14. Degradation of the chemotherapy drug 5-fluorouracil on medical-grade silver surfaces

    NASA Astrophysics Data System (ADS)

    Risinggård, Helene Kjær; Cooil, Simon; Mazzola, Federico; Hu, Di; Kjærvik, Marit; Østli, Elise Ramleth; Patil, Nilesh; Preobrajenski, Alexei; Andrew Evans, D.; Breiby, Dag W.; Trinh, Thuat T.; Wells, Justin W.

    2018-03-01

    The degradation of the chemotherapy drug 5-fluorouracil by a non-pristine metal surfaces is studied. Using density functional theory, X-ray photoelectron spectroscopy and X-ray absorption spectroscopy we show that the drug is entirely degraded by medical-grade silver surfaces, already at body temperature, and that all of the fluorine has left the molecule, presumably as HF. Remarkably, this degradation is even more severe than that reported previously for 5-fluorouracil on a pristine monocrystalline silver surface (in which case 80% of the drug reacted at body temperature) [1]. We conclude that the observed reaction is due to a reaction pathway, driven by H to F attraction between molecules on the surface, which results in the direct formation of HF; a pathway which is favoured when competing pathways involving reactive Ag surface sites are made unavailable by environmental contamination. Our measurements indicate that realistically cleaned, non-pristine silver alloys, which are typically used in medical applications, can result in severe degradation of 5-fluorouracil, with the release of HF - a finding which may have important implications for the handling of chemotherapy drugs.

  15. Canada’s Patented Medicines (Notice of Compliance) Proceedings and Intellectual Property

    PubMed Central

    Bian, Henry; McCourt, Conor

    2015-01-01

    Canada’s Patent Register is a tool created by the Patented Medicines (Notice of Compliance) Regulations to help innovators protect their inventions relating to pharmaceuticals. This tool exists at the intersection between the intellectual property and drug approval regimes. By listing a patent on the Patent Register, an innovator can prevent a generic manufacturer from entering the marketplace rather than having to wait for his or her patent to be infringed. This article provides information on the requirements for listing a patent on the Patent Register and an overview of how the Patent Medicines (Notice of Compliance) Regulations affect the drug approval process. PMID:25573772

  16. 42 CFR 423.153 - Drug utilization management, quality assurance, and medication therapy management programs (MTMPs).

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... PRESCRIPTION DRUG BENEFIT Cost Control and Quality Improvement Requirements § 423.153 Drug utilization... 42 Public Health 3 2010-10-01 2010-10-01 false Drug utilization management, quality assurance, and medication therapy management programs (MTMPs). 423.153 Section 423.153 Public Health CENTERS FOR MEDICARE...

  17. Relationship between medication use and cardiovascular disease health outcomes in the Jackson Heart Study.

    PubMed

    Addison, Clifton C; Jenkins, Brenda W; Sarpong, Daniel; Wilson, Gregory; Champion, Cora; Sims, Jeraline; White, Monique S

    2011-06-01

    Even though some medications have the potential to slow the progress of atherosclerosis and development of CVD, there are many at-risk individuals who continue to resist the benefits that are available by not following the advice of medical professionals. Non-adherence to prescribed drug regimens is a pervasive medical problem that negatively affects treatment outcomes. Information from standardized interviews of 5301 African Americans participating in the Jackson Heart Study was examined to determine the association between demographic parameters, behavior including adherence to prescribed medical regimens, and health outcomes. Data were also collected at Annual Follow-Up and Surveillance visits. During the two weeks prior to the examination visit, almost 52% of the participants reported taking blood pressure medication, 14% took cholesterol medication, 16% took medication for diabetes, and 19% took blood thinning medication. Of those who did not take the prescribed medications, the reasons given were the following: 47% were in a hurry, too busy, or forgot to take medications; 23% were trying to do without medications; 18% had no money to purchase medications; 19% indicated that the medications made them feel bad; 17% felt that they could not carry out daily functions when taking medications. The African American population can benefit from heightened awareness of the risk factors that are associated with CVD and the benefits of following a prescribed treatment regimen. Unacceptable secondary effects of prescribed medication comprised an important cause of non-compliance. Encouragement of this population to communicate with their healthcare providers to ensure that medication regimens are better tolerated could increase compliance and improve health outcomes.

  18. Association between participation and compliance with Continuing Medical Education and care production by physicians: a cross-sectional study

    PubMed Central

    Carrera, Renato Melli; Cendoroglo, Miguel; Gonçales, Paulo David Scatena; Marques, Flavio Rocha Brito; Sardenberg, Camila; Glezer, Milton; dos Santos, Oscar Fernando Pavão; Rizzo, Luiz Vicente; Lottenberg, Claudio Luiz; Schvartsman, Cláudio

    2015-01-01

    Objective Physician participation in Continuing Medical Education programs may be influenced by a number of factors. To evaluate the factors associated with compliance with the Continuing Medical Education requirements at a private hospital, we investigated whether physicians’ activity, measured by volumes of admissions and procedures, was associated with obtaining 40 Continuing Medical Education credits (40 hours of activities) in a 12-month cycle. Methods In an exclusive and non-mandatory Continuing Medical Education program, we collected physicians’ numbers of hospital admissions and numbers of surgical procedures performed. We also analyzed data on physicians’ time since graduation, age, and gender. Results A total of 3,809 credentialed, free-standing, private practice physicians were evaluated. Univariate analysis showed that the Continuing Medical Education requirements were more likely to be achieved by male physicians (odds ratio 1.251; p=0.009) and who had a higher number of hospital admissions (odds ratio 1.022; p<0.001). Multivariate analysis showed that age and number of hospital admissions were associated with achievement of the Continuing Medical Education requirements. Each hospital admission increased the chance of achieving the requirements by 0.4%. Among physicians who performed surgical procedures, multivariate analysis showed that male physicians were 1.3 time more likely to achieve the Continuing Medical Education requirements than female physicians. Each surgical procedure performed increased the chance of achieving the requirements by 1.4%. Conclusion The numbers of admissions and number of surgical procedures performed by physicians at our hospital were associated with the likelihood of meeting the Continuing Medical Education requirements. These findings help to shed new light on our Continuing Medical Education program. PMID:25807247

  19. Integration of Biosensors and Drug Delivery Technologies for Early Detection and Chronic Management of Illness

    PubMed Central

    Ngoepe, Mpho; Choonara, Yahya E.; Tyagi, Charu; Tomar, Lomas Kumar; du Toit, Lisa C.; Kumar, Pradeep; Ndesendo, Valence M. K.; Pillay, Viness

    2013-01-01

    Recent advances in biosensor design and sensing efficacy need to be amalgamated with research in responsive drug delivery systems for building superior health or illness regimes and ensuring good patient compliance. A variety of illnesses require continuous monitoring in order to have efficient illness intervention. Physicochemical changes in the body can signify the occurrence of an illness before it manifests. Even with the usage of sensors that allow diagnosis and prognosis of the illness, medical intervention still has its downfalls. Late detection of illness can reduce the efficacy of therapeutics. Furthermore, the conventional modes of treatment can cause side-effects such as tissue damage (chemotherapy and rhabdomyolysis) and induce other forms of illness (hepatotoxicity). The use of drug delivery systems enables the lowering of side-effects with subsequent improvement in patient compliance. Chronic illnesses require continuous monitoring and medical intervention for efficient treatment to be achieved. Therefore, designing a responsive system that will reciprocate to the physicochemical changes may offer superior therapeutic activity. In this respect, integration of biosensors and drug delivery is a proficient approach and requires designing an implantable system that has a closed loop system. This offers regulation of the changes by means of releasing a therapeutic agent whenever illness biomarkers prevail. Proper selection of biomarkers is vital as this is key for diagnosis and a stimulation factor for responsive drug delivery. By detecting an illness before it manifests by means of biomarkers levels, therapeutic dosing would relate to the severity of such changes. In this review various biosensors and drug delivery systems are discussed in order to assess the challenges and future perspectives of integrating biosensors and drug delivery systems for detection and management of chronic illness. PMID:23771157

  20. A Review of the Toxicity of HIV Medications II: Interactions with Drugs and Complementary and Alternative Medicine Products.

    PubMed

    Stolbach, Andrew; Paziana, Karolina; Heverling, Harry; Pham, Paul

    2015-09-01

    For many patients today, HIV has become a chronic disease. For those patients who have access to and adhere to lifelong antiretroviral (ARV) therapy, the potential for drug-drug interactions has become a real and life-threatening concern. It is known that most ARV drug interactions occur through the cytochrome P450 (CYP) pathway. Medications for comorbid medical conditions, holistic supplements, and illicit drugs can be affected by CYP inhibitors and inducers and have the potential to cause harm and toxicity. Protease inhibitors (PIs) tend to inhibit CYP3A4, while most non-nucleoside reverse transcriptase inhibitors (NNRTIs) tend to induce the enzyme. As such, failure to adjust the dose of co-administered medications, such as statins and steroids, may lead to serious complications including rhabdomyolysis and hypercortisolism, respectively. Similarly, gastric acid blockers can decrease several ARV absorption, and warfarin doses may need to be adjusted to maintain therapeutic concentrations. Illicit drugs such as methylenedioxymethamphetamine (MDMA, "ecstasy") in combination with PIs lead to increased toxicity, while the concomitant administration of sedative drugs such as midazolam and alprazolam in patients taking PIs can result in prolonged sedation, delayed recovery, and increased length of stay. Even supplements like St. John's Wort can alter PI concentrations. In theory, any drug that is metabolized by CYP has potential for a pharmacokinetic drug-drug interaction with all PIs, cobicistat, and most NNRTIs. When adding a new medication to an ARV regimen, use of a drug-drug interaction software and/or consultation with a clinical pharmacist/pharmacologist or HIV specialist is recommended.

  1. [Treatment side effects and compliance in patients with depression].

    PubMed

    Petrova, N N; Kucher, E O

    2012-01-01

    The impact of treatment side-effects on the compliance was studied in 85 depressive patients with different mental disorders - recurrent depressive disorder, postschizophrenic depression and organic affective disorder. The comparison of objective and subjective evaluations of compliance and a comparative analysis of the level of compliance, with its dependence on the treatment specifics, in different diseases were done. A significant role of efficacy and treatment side-effects was identified. The levels of "mental" and "autonomous" side-effects were highest in the treatment of depression: patients with postschizophrenic depression had the highest risk in respect of maintenance treatment; patients with recurrent depressive disorder and organic (affective) disorder were more tolerant to the treatment side-effects and their treatment, including the maintenance therapy, was rather effective. The compliance of all patients with depression was negatively correlated with the severity of side-effects of pharmacotherapy. The greatest side-effects and the lowest level of compliance were observed in the complex treatment with antidepressants and atypical neuroleptics. The effect of side-effects on the compliance was dependent on their severity and subjective tolerability and, to a lesser extent, on the amount of drugs.

  2. A Bivariate Genetic Analysis of Drug Abuse ascertained through medical and criminal registries in Swedish Twins, Siblings and Half-Siblings

    PubMed Central

    Maes, Hermine H.; Neale, Michael C.; Ohlsson, Henrik; Zahery, Mahsa; Lichtenstein, Paul; Sundquist, Kristina; Sundquist, Jan; Kendler, Kenneth S.

    2016-01-01

    Objective Using Swedish nationwide registry data, the authors investigated the correlation of genetic and environmental risk factors in the etiology of drug abuse as ascertained from medical and criminal registries by modeling twin and sibling data. Methods Medical drug abuse was defined using public inpatient and outpatient records, while criminal drug abuse was ascertained through legal records. Twin, full and half sibling pairs were obtained from the national twin and genealogical registers. Information about sibling pair residence within the same household was obtained from Statistics Sweden. Standard bivariate genetic structural equation modeling was applied to the population-based data on drug abuse ascertained through medical and crime registries, using OpenMx. Results Analyses of all possible pairs of twins (MZ: N=4,482; DZ: N=9,838 pairs), full- (N=1,278,086) and half-siblings (paternal: N=7,767; maternal N=70,553) who grew up together suggested that factors explaining familial resemblance for drug abuse as defined through medical or criminal registries were mostly the same. Results showed substantial heritability and moderate contributions of shared environmental factors to drug abuse; both were higher in males versus females, and higher for drug abuse ascertained through criminal than medical records. Because of the low prevalence of both assessments of drug abuse, having access to population data was crucial to obtain stable estimates. Conclusions Using objective registry data, the authors found that drug abuse - whether ascertained through medical versus criminal records - was highly heritable. Furthermore, shared environmental factors contributed significantly to the liability of drug abuse. Genetic and shared environmental risk factors for these two forms of drug abuse were highly correlated. PMID:27480873

  3. A Bivariate Genetic Analysis of Drug Abuse Ascertained Through Medical and Criminal Registries in Swedish Twins, Siblings and Half-Siblings.

    PubMed

    Maes, Hermine H; Neale, Michael C; Ohlsson, Henrik; Zahery, Mahsa; Lichtenstein, Paul; Sundquist, Kristina; Sundquist, Jan; Kendler, Kenneth S

    2016-11-01

    Using Swedish nationwide registry data, the authors investigated the correlation of genetic and environmental risk factors in the etiology of drug abuse as ascertained from medical and criminal registries by modeling twin and sibling data. Medical drug abuse was defined using public inpatient and outpatient records, while criminal drug abuse was ascertained through legal records. Twin, full and half sibling pairs were obtained from the national twin and genealogical registers. Information about sibling pair residence within the same household was obtained from Statistics Sweden. Standard bivariate genetic structural equation modeling was applied to the population-based data on drug abuse ascertained through medical and crime registries, using OpenMx. Analyses of all possible pairs of twins (MZ: N = 4482; DZ: N = 9838 pairs), full- (N = 1,278,086) and half-siblings (paternal: N = 7767; maternal N = 70,553) who grew up together suggested that factors explaining familial resemblance for drug abuse as defined through medical or criminal registries were mostly the same. Results showed substantial heritability and moderate contributions of shared environmental factors to drug abuse; both were higher in males versus females, and higher for drug abuse ascertained through criminal than medical records. Because of the low prevalence of both assessments of drug abuse, having access to population data was crucial to obtain stable estimates. Using objective registry data, the authors found that drug abuse-whether ascertained through medical versus criminal records-was highly heritable. Furthermore, shared environmental factors contributed significantly to the liability of drug abuse. Genetic and shared environmental risk factors for these two forms of drug abuse were highly correlated.

  4. The demise of Oregon's Medically Needy program: effects of losing prescription drug coverage.

    PubMed

    Zerzan, Judy; Edlund, Tina; Krois, Lisa; Smith, Jeanene

    2007-06-01

    In January 2003, people covered by Oregon's Medically Needy program lost benefits owing to state budget shortfalls. The Medically Needy program is a federally matched optional Medicaid program. In Oregon, this program mainly provided prescription drug benefits. To describe the Medically Needy population and determine how benefit loss affected this population's health and prescription use. A 49-question telephone survey instrument created by the research team and administered by a research contractor. A random sample of 1,269 eligible enrollees in Oregon's Medically Needy Program. Response rate was 35% with 439 individuals, ages 21-91 and 64% women, completing the survey. Demographics, health information, and medication use at the time of the survey obtained from the interview. Medication use during the program obtained from administrative data. In the 6 months after the Medically Needy program ended, 75% had skipped or stopped medications. Sixty percent of the respondents had cut back on their food budget, 47% had borrowed money, and 49% had skipped paying other bills to pay for medications. By self-report, there was no significant difference in emergency department visits, but a significant decrease in hospitalizations comparing 6 months before and after losing the program. Two-thirds of respondents rated their current health as poor or fair. The Medically Needy program provided coverage for a low-income, chronically ill population. Since its termination, enrollees have decreased prescription drug use and increased financial burden. As states make program changes and Medicare Part D evolves, effects on vulnerable populations must be considered.

  5. Effects of drug pharmacokinetic/pharmacodynamic properties, characteristics of medication use, and relevant pharmacological interventions on fall risk in elderly patients

    PubMed Central

    Chen, Ying; Zhu, Ling-Ling; Zhou, Quan

    2014-01-01

    Background Falls among the elderly are an issue internationally and a public health problem that brings substantial economic and quality-of-life burdens to individuals and society. Falls prevention is an important measure of nursing quality and patient safety. Numerous studies have evaluated the association of medication use with fall risk in elderly patients. However, an up-to-date review has not been available to summarize the multifaceted pharmaceutical concerns in the prevention of medication-related falls. Materials and methods Relevant literature was identified by performing searches in PubMed, Web of Science, and the Cochrane Library, covering the period until February 2014. We included studies that described an association between medications and falls, and effects of drug pharmacokinetic/pharmacodynamic properties, characteristics of medication use, and pharmacological interventions on fall risk in elderly patients. The full text of each included article was critically reviewed, and data interpretation was performed. Results Fall-risk-increasing drugs (FRIDs) include central nervous system-acting agents, cough preparations, nonsteroidal anti-inflammatory drugs, anti-Alzheimer’s agents, antiplatelet agents, calcium antagonists, diuretics, α-blockers, digoxin, hypoglycemic drugs, neurotoxic chemotherapeutic agents, nasal preparations, and antiglaucoma ophthalmic preparations. The degree of medication-related fall risk was dependent on one or some of the following factors: drug pharmacokinetic/pharmacodynamic properties (eg, elimination half-life, metabolic pathway, genetic polymorphism, risk rating of medications despite belonging to the same therapeutic class) and/or characteristics of medication use (eg, number of medications and drug–drug interactions, dose strength, duration of medication use and time since stopping, medication change, prescribing appropriateness, and medication adherence). Pharmacological interventions, including withdrawal of

  6. Medicare prescription drug plan coverage of pharmacotherapies for opioid and alcohol dependence in WA.

    PubMed

    Kennedy, Jae; Dipzinski, Aaron; Roll, John; Coyne, Joseph; Blodgett, Elizabeth

    2011-04-01

    Pharmacotherapeutic treatments for drug addiction offer new options, but only if they are affordable for patients. The objective of this study is to assess the current availability and cost of five common antiaddiction medications in the largest federal medication insurance program in the US, Medicare Part D. In early 2010, we collected coverage and cost data from 41 Medicare Part D prescription drug plans (PDPs) and 45 Medicare Advantage Plans (MAPs) in Washington State. The great majority of Medicare plans (82-100%) covered common pharmacotherapeutic treatments for drug addiction. These Medicare plans typically placed patent protected medications on their highest formulary tiers, leading to relatively high patient co-payments during the initial Part D coverage period. For example, median monthly co-payments for buprenorphine (Suboxone®) were about $46 for PDPs, and about $56 for MAPs. While Medicare prescription plans usually cover pharmacotherapeutic treatments for drug addiction, high co-payments can limit access. For example, beneficiaries without supplemental coverage who use Vivitrol® would exceed their initial coverage cap in 7-8 months, reaching the "doughnut hole" in their Part D coverage and becoming responsible for the full cost of the medication (over $900 per month). The 2010 Patient Protection and Affordable Care Act will gradually eliminate this coverage gap, and loss of patent protection for other antiaddiction medications (Suboxone® and Campral®) should also drive down patient costs, improving access and compliance. Copyright © 2010 Elsevier Ireland Ltd. All rights reserved.

  7. Monitoring compliance to therapy during addiction treatments by means of hair analysis for drugs and drug metabolites using capillary zone electrophoresis coupled to time-of-flight mass spectrometry.

    PubMed

    Gottardo, Rossella; Fanigliulo, Ameriga; Sorio, Daniela; Liotta, Eloisa; Bortolotti, Federica; Tagliaro, Franco

    2012-03-10

    Capillary electrophoresis coupled to time-of-flight mass spectrometry was used in the present work for the determination of therapeutic and abused drugs and their metabolites in the hair of subjects undergoing addiction treatments, in order to monitor their compliance to therapy. For this purpose a rapid, qualitative drug screening method was adopted based on capillary electrophoresis hyphenated with time-of-flight mass spectrometry, which had earlier been developed and validated for the forensic-toxicological analysis of hair, limitedly to illicit/abused drugs [1]. Sampling of hair was carried out in order to refer to a time window of about two months from the date of sampling (i.e. 2cm ca. from cortex). A single extraction procedure was applied, allowing the determination in the hair matrix of "drugs of abuse" referred to the past abuses, and therapeutic drugs prescribed in the detoxification program as well as their metabolites. Analyte identification was based on accurate mass measurements and comparison of isotope patterns, providing the most likely matching between accurate mass value and elemental formula. Small molecules (<500Da) of forensic and toxicological interest could be identified unambiguously using mass spectrometric conditions tailored to meet a mass accuracy ≤5ppm. In the present study, the proposed approach proved suitable for the rapid broad spectrum screening of hair samples, although needing further confirmation of results by using fragmentation mass spectrometry. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

  8. 75 FR 14607 - Small Entity Compliance Guide: Bottled Water: Total Coliform and E. coli

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-26

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0141] Small Entity Compliance Guide: Bottled Water: Total Coliform and E. coli; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing...

  9. Transdermal Delivery of Drugs with Microneedles—Potential and Challenges

    PubMed Central

    Ita, Kevin

    2015-01-01

    Transdermal drug delivery offers a number of advantages including improved patient compliance, sustained release, avoidance of gastric irritation, as well as elimination of pre-systemic first-pass effect. However, only few medications can be delivered through the transdermal route in therapeutic amounts. Microneedles can be used to enhance transdermal drug delivery. In this review, different types of microneedles are described and their methods of fabrication highlighted. Microneedles can be fabricated in different forms: hollow, solid, and dissolving. There are also hydrogel-forming microneedles. A special attention is paid to hydrogel-forming microneedles. These are innovative microneedles which do not contain drugs but imbibe interstitial fluid to form continuous conduits between dermal microcirculation and an attached patch-type reservoir. Several microneedles approved by regulatory authorities for clinical use are also examined. The last part of this review discusses concerns and challenges regarding microneedle use. PMID:26131647

  10. Nanotechnology-based drug delivery systems for Alzheimer's disease management: Technical, industrial, and clinical challenges.

    PubMed

    Wen, Ming Ming; El-Salamouni, Noha S; El-Refaie, Wessam M; Hazzah, Heba A; Ali, Mai M; Tosi, Giovanni; Farid, Ragwa M; Blanco-Prieto, Maria J; Billa, Nashiru; Hanafy, Amira S

    2017-01-10

    Alzheimer's disease (AD) is a neurodegenerative disease with high prevalence in the rapidly growing elderly population in the developing world. The currently FDA approved drugs for the management of symptomatology of AD are marketed mainly as conventional oral medications. Due to their gastrointestinal side effects and lack of brain targeting, these drugs and dosage regiments hinder patient compliance and lead to treatment discontinuation. Nanotechnology-based drug delivery systems (NTDDS) administered by different routes can be considered as promising tools to improve patient compliance and achieve better therapeutic outcomes. Despite extensive research, literature screening revealed that clinical activities involving NTDDS application in research for AD are lagging compared to NTDDS for other diseases such as cancers. The industrial perspectives, processability, and cost/benefit ratio of using NTDDS for AD treatment are usually overlooked. Moreover, active and passive immunization against AD are by far the mostly studied alternative AD therapies because conventional oral drug therapy is not yielding satisfactorily results. NTDDS of approved drugs appear promising to transform this research from 'paper to clinic' and raise hope for AD sufferers and their caretakers. This review summarizes the recent studies conducted on NTDDS for AD treatment, with a primary focus on the industrial perspectives and processability. Additionally, it highlights the ongoing clinical trials for AD management. Copyright © 2016 Elsevier B.V. All rights reserved.

  11. Controlling release from 3D printed medical devices using CLIP and drug-loaded liquid resins.

    PubMed

    Bloomquist, Cameron J; Mecham, Michael B; Paradzinsky, Mark D; Janusziewicz, Rima; Warner, Samuel B; Luft, J Christopher; Mecham, Sue J; Wang, Andrew Z; DeSimone, Joseph M

    2018-05-28

    Mass customization along with the ability to generate designs using medical imaging data makes 3D printing an attractive method for the fabrication of patient-tailored drug and medical devices. Herein we describe the application of Continuous Liquid Interface Production (CLIP) as a method to fabricate biocompatible and drug-loaded devices with controlled release properties, using liquid resins containing active pharmaceutical ingredients (API). In this work, we characterize how the release kinetics of a model small molecule, rhodamine B-base (RhB), are affected by device geometry, network crosslink density, and the polymer composition of polycaprolactone- and poly (ethylene glycol)-based networks. To demonstrate the applicability of using API-loaded liquid resins with CLIP, the UV stability was evaluated for a panel of clinically-relevant small molecule drugs. Finally, select formulations were tested for biocompatibility, degradation and encapsulation of docetaxel (DTXL) and dexamethasone-acetate (DexAc). Formulations were shown to be biocompatible over the course of 175 days of in vitro degradation and the clinically-relevant drugs could be encapsulated and released in a controlled fashion. This study reveals the potential of the CLIP manufacturing platform to serve as a method for the fabrication of patient-specific medical and drug-delivery devices for personalized medicine. Copyright © 2018. Published by Elsevier B.V.

  12. Intended and unintended impacts of price changes for drugs and medical services: Evidence from China.

    PubMed

    Fu, Hongqiao; Li, Ling; Yip, Winnie

    2018-06-18

    In 2012, the Chinese government launched a nationwide reform of county-level public hospitals with the goal of controlling the rapid growth of healthcare expenditure. The key components of the reform were the zero markup drug policy (ZMDP), which removed the previously allowed 15% markup for drug sales at public hospitals, and associated increases in fees for medical services. By exploiting the temporal and cross-sectional variations in the policy implementation and using a unique, nationally representative hospital-level dataset in 1880 counties between 2009 and 2014, we find that the policy change led to a reduction in drug expenditures, a rise in expenditures for medical services, and no measurable changes in total health expenditures. However, we also find an increase in expenditures for diagnostic tests/medical consumables at hospitals that had a greater reliance on drug revenues before the reform, which is unintended by policymakers. Further analysis shows that these results were more likely to be driven by the supply side, suggesting that hospitals offset the reductions in drug revenues by increasing the provision of services and products with higher price-cost margins. These findings hold lessons for cost containment policies in both developed and developing countries. Copyright © 2018 Elsevier Ltd. All rights reserved.

  13. Treatment compliance of working persons to high-dose antimuscarinic therapies: a randomized trial.

    PubMed

    Kosilov, Kirill Vladimirovich; Loparev, Sergey; Kuzina, Irina; Shakirova, Olga; Zhuravskaya, Nataliya; Lobodenko, Alexandra

    2016-08-01

    The aim of this work was to study the factors affecting the stability of working patients in antimuscarinic (AM) drug treatment. The prevalence of urge urinary incontinence (UUI) is an average of between 8.2% and 16.0% of the population. UUI is a condition that adversely affects the health-related quality of life. The first-line therapy in managing UUI is AM treatment. In 1006 patients between 18 and 60 years old (627 women, 379 men, mean age 69.4) who received AM treatment for one year, the possible demographic, socioeconomic and health factors influencing compliance were studied. Also, the functional state of the lower urinary tract (LUT) was studied in this randomized, prospective survey. The study instruments were the documents of employers, tax offices, outpatient records, OABq-SF (overactive bladder - short form) questionnaires, MOS SF-36 (Medical Outcomes Study short form-36), voiding charts, and uroflowmetry data. The compliance to AM treatment within 6 months was retained in 49.5% patients; during the year, in 32.3% of patients. The average time for reaching the 30-day break in taking trospium was 194 days. In the course of the experiment it was revealed that compliance to AM treatment was significantly higher in patients taking solifenacin and trospium in high dosages ( p ⩽ 0.01, p ⩽ 0.05), suffering from severe symptoms of urgency ( p ⩽ 0.01), and having a low level of side effects ( p ⩽ 0.01). A satisfactory level of compliance is characteristic of patients with a high level of monthly and annual income ( p ⩽ 0.01, p ⩽ 0.01), a low percentage of expenses to AM ( p ⩽ 0.05), and rarely changing employers ( p ⩽ 0.05). In addition, the compliance to treatment is higher in older adults ( p ⩽ 0.05), living in the urban district ( p ⩽ 0.01), and working in educational ( p ⩽ 0.05) and health ( p ⩽ 0.01) institutions, having a high level of the indices of Social Functioning ( p ⩽ 0.05), Role-Emotional ( p ⩽ 0.05), and Mental Health

  14. [Cooperation with the electronic medical record and accounting system of an actual dose of drug given by a radiology information system].

    PubMed

    Yamamoto, Hideo; Yoneda, Tarou; Satou, Shuji; Ishikawa, Toru; Hara, Misako

    2009-12-20

    By input of the actual dose of a drug given into a radiology information system, the system converting with an accounting system into a cost of the drug from the actual dose in the electronic medical record was built. In the drug master, the first unit was set as the cost of the drug, and we set the second unit as the actual dose. The second unit in the radiology information system was received by the accounting system through electronic medical record. In the accounting system, the actual dose was changed into the cost of the drug using the dose of conversion to the first unit. The actual dose was recorded on a radiology information system and electronic medical record. The actual dose was indicated on the accounting system, and the cost for the drug was calculated. About the actual dose of drug, cooperation of the information in a radiology information system and electronic medical record were completed. It was possible to decide the volume of drug from the correct dose of drug at the previous inspection. If it is necessary for the patient to have another treatment of medicine, it is important to know the actual dose of drug given. Moreover, authenticity of electronic medical record based on a statute has also improved.

  15. FDA 2011 process validation guidance: lifecycle compliance model.

    PubMed

    Campbell, Cliff

    2014-01-01

    This article has been written as a contribution to the industry's efforts in migrating from a document-driven to a data-driven compliance mindset. A combination of target product profile, control engineering, and general sum principle techniques is presented as the basis of a simple but scalable lifecycle compliance model in support of modernized process validation. Unit operations and significant variables occupy pole position within the model, documentation requirements being treated as a derivative or consequence of the modeling process. The quality system is repositioned as a subordinate of system quality, this being defined as the integral of related "system qualities". The article represents a structured interpretation of the U.S. Food and Drug Administration's 2011 Guidance for Industry on Process Validation and is based on the author's educational background and his manufacturing/consulting experience in the validation field. The U.S. Food and Drug Administration's Guidance for Industry on Process Validation (2011) provides a wide-ranging and rigorous outline of compliant drug manufacturing requirements relative to its 20(th) century predecessor (1987). Its declared focus is patient safety, and it identifies three inter-related (and obvious) stages of the compliance lifecycle. Firstly, processes must be designed, both from a technical and quality perspective. Secondly, processes must be qualified, providing evidence that the manufacturing facility is fully "roadworthy" and fit for its intended purpose. Thirdly, processes must be verified, meaning that commercial batches must be monitored to ensure that processes remain in a state of control throughout their lifetime.

  16. Medication competency of nurses according to theoretical and drug calculation online exams: A descriptive correlational study.

    PubMed

    Sneck, Sami; Saarnio, Reetta; Isola, Arja; Boigu, Risto

    2016-01-01

    Medication administration is an important task of registered nurses. According to previous studies, nurses lack theoretical knowledge and drug calculation skills and knowledge-based mistakes do occur in clinical practice. Finnish health care organizations started to develop a systematic verification processes for medication competence at the end of the last decade. No studies have yet been made of nurses' theoretical knowledge and drug calculation skills according to these online exams. The aim of this study was to describe the medication competence of Finnish nurses according to theoretical and drug calculation exams. A descriptive correlation design was adopted. Participants and settings All nurses who participated in the online exam in three Finnish hospitals between 1.1.2009 and 31.05.2014 were selected to the study (n=2479). Quantitative methods like Pearson's chi-squared tests, analysis of variance (ANOVA) with post hoc Tukey tests and Pearson's correlation coefficient were used to test the existence of relationships between dependent and independent variables. The majority of nurses mastered the theoretical knowledge needed in medication administration, but 5% of the nurses struggled with passing the drug calculation exam. Theoretical knowledge and drug calculation skills were better in acute care units than in the other units and younger nurses achieved better results in both exams than their older colleagues. The differences found in this study were statistically significant, but not high. Nevertheless, even the tiniest deficiency in theoretical knowledge and drug calculation skills should be focused on. It is important to identify the nurses who struggle in the exams and to plan targeted educational interventions for supporting them. The next step is to study if verification of medication competence has an effect on patient safety. Copyright © 2015 Elsevier Ltd. All rights reserved.

  17. Medication taking behavior of students attending a private university in Bangladesh.

    PubMed

    Chowdhury, Nishat; Matin, Fatema; Chowdhury, Sk Feroz Uddin Ahmed

    2009-01-01

    The objective of this study was to investigate the patterns of self-reported medication use, including both prescription and OTC drugs, and to assess the possible predictors of self-medication and medication non-compliance (non-adherence), for 929 non-medical undergraduate students of the American International University, a private university situated in Dhaka city, Bangladesh. Although a high proportion (69%, n = 644) of students of this university had fallen sick in the last six months before the study, the rate of visiting qualified health practitioners was much lower (53%). A good proportion of the sick students were reported to have practiced self-medication (16%, n = 100) and medication non-adherence (15%, n = 98). The average treatment cost involved in self medication was much lower than that offered by a qualified physician (Tk 463 vs Tk 2546 per case). Those students living with parents were more likely to have visited qualified health practitioners (56%, p < .05), and students whose families kept a well-stocked medicine cabinet at home were more likely to have completed the full course (39%, p < .05) of prescribed medicine. No significant difference was found in the rates of self medication and medication compliance incidence for variables like age groups, gender, residence status, financial level, engagement in part-time jobs etc. The study also showed that antimicrobials are widely available (170 incidents) in the home medicine cabinets of the Dhaka City population. The storage of leftover antibiotics in the home constitutes an alternative potential source of self-medication that can have untoward consequences. Further elaborate studies are required to reveal the true pattern of antibiotic usage in Bangladesh.

  18. Quality beyond compliance.

    PubMed

    Centanni, N; Monroe, M; White, L; Larson, R

    1999-01-01

    The service sector within the biopharmaceutical industry has experienced phenomenal growth over the past decade. In the highly regulated Good Laboratory Practices environment, the need for timely, high-quality service, accurate results, and on-time deliverables becomes paramount for the success and profitability of biopharmaceutical companies. The quality assurance process is a vital component of this drug product-development cycle and ensures compliance to the highest domestic and international regulatory standards. Quality-assurance professionals historically have held the role of independent auditors of the processes, who certify that results meet current standards of practice. Covance, a contract research organization that includes Good Laboratory Practices laboratories, reorganized and expanded the functional responsibilities of its quality assurance team in 1997. Auditors and quality assurance professionals have assumed roles beyond traditional compliance auditing and are forging new leadership and mentoring roles as process-improvement specialists. The results have been tangible, measurable benefits for clients and the Covance organization. This article provides an overview of this cultural change and the processes put in place to improve efficiency, productivity, and customer and employee satisfaction.

  19. Polypharmacy in the oldest old (≥80 years of age) patients in China: a cross-sectional study.

    PubMed

    Lai, Xiaoxing; Zhu, Hongwei; Huo, Xiaopeng; Li, Zheng

    2018-03-02

    The oldest old generally have worse health and more comorbidities than the general population of older adults, and they are more likely to be exposed to polypharmacy. Reliable investigation of polypharmacy among the oldest old (≥80 years of age) in China are lacking. So this study aims to describe the polypharmacy status of oldest old patients ≥80 years of age and to assess the factors influencing medication compliance. This was a cross-sectional study of 258 oldest old patients ≥ 80 years of age and hospitalized at a tertiary hospital in Beijing between December 1, 2014 and June 30, 2015. They completed three validated questionnaires to assess their pre-admission status (general demographics, medication knowledge, and medication adherence). Potentially inappropriate medications (PIM) use was evaluated by physicians. The majority of the patients (55.4%) took < 10 types of drugs. The numbers of drugs taken ranged from 8 to 60 drugs (median of 22.9). Patients taking 11-20 drugs accounted for 46.1% of the patients. Subjects with a history of adverse drug reactions accounted for 40.3%. The proportion of PIMs was 27.1%. Compliance was only 32.6% among the oldest old patients with polypharmacy. Age and medication classes were independently negatively associated with compliance, and medication knowledge was independently positively associated with compliance. Oldest old patients (≥ 80 years of age) had a poor medication knowledge. Age, medication classes, and medication knowledge were independently associated with medication compliance.

  20. Medical Treatment for Postthrombotic Syndrome

    PubMed Central

    Palacios, Federico Silva; Rathbun, Suman Wasan

    2017-01-01

    Deep vein thrombosis (DVT) is a prevalent disease. About 20 to 30% of patients with DVT will develop postthrombotic syndrome (PTS) within months after the initial diagnosis of DVT. There is no gold standard for diagnosis of PTS, but clinical signs include pitting edema, hyperpigmentation, phlebectatic crown, venous eczema, and varicose veins. Several scoring systems have been developed for diagnostic evaluation. Conservative treatment includes compression therapy, medications, lifestyle modification, and exercise. Compression therapy, the mainstay and most proven noninvasive therapy for patients with PTS, can be prescribed as compression stockings, bandaging, adjustable compression wrap devices, and intermittent pneumatic compression. Medications may be used to both prevent and treat PTS and include anticoagulation, anti-inflammatories, vasoactive drugs, antibiotics, and diuretics. Exercise, weight loss, smoking cessation, and leg elevation are also recommended. Areas of further research include the duration, compliance, and strength of compression stockings in the prevention of PTS after DVT; the use of intermittent compression devices; the optimal medical anticoagulant regimen after endovascular therapy; and the role of newer anticoagulants as anti-inflammatory agents. PMID:28265131

  1. [Drug advertising as communication between the pharmaceutical industry and the physician: advertisements for psychotropic drugs in the Dutch medical journal, Nederlands Tijdschrift voor Geneeskunde, 1900-1940].

    PubMed

    van der Hoogte, Arjo Roersch; Pieters, Toine

    2010-01-01

    In this article we explore the historical development of drug advertisements for psychotropic drugs in the leading Dutch medical journal from 1900 to 1940. The advertisements for hypnotics and sedatives, in The Nederlands Tijdschrift voor Geneeskunde (Dutch medical journal) reflected the changes in the vocabulary and image promoted by the pharmaceutical companies. In the first two decades, the advertisements were sober and to the point, and included the trademark, company name, molecular formula and therapeutic properties of the medication. The emphasis was on creating a scientific image of reliable symptom control for the therapeutic drug. In doing so, the ethical drug companies tried (successfully) to distinguish themselves from the producers of patent medicines. Once scientific credibility was established, the form and content of the advertisements changed significantly. In the late 1920s and 1930s drug companies embraced modern advertising techniques, developing a figurative language to address the changing beliefs and practices of Dutch physicians. Instead of promoting therapeutic drugs as safe and scientific, the emphasis was on their effectiveness in comparison to similar drugs. In the process, scientific information was reduced to an indispensable standardized minimum, whereby therapeutic drugs were advertised according to the latest pharmacological taxonomy rather than molecular formulas. The image-making of 'ethical marketing' began during the interwar years when marketers applied modern advertising techniques and infotainment strategies. The scanty black and white informational bulletins transitioned into colourful advertisements. The pharmaceutical companies employed the same medical language as used by physicians, so that one word or image in an advertisement would suffice for the physician to recognize a drug and its therapeutic properties. These developments show the changing relationship between the modern ethical pharmaceutical industry and Dutch

  2. Experience with a pharmacy technician medication history program.

    PubMed

    Cooper, Julie B; Lilliston, Michelle; Brooks, DeAnne; Swords, Bruce

    2014-09-15

    The implementation and outcomes of a pharmacy technician medication history program are described. An interprofessional medication reconciliation team, led by a clinical pharmacist and a clinical nurse specialist, was charged with implementing a new electronic medication reconciliation system to improve compliance with medication reconciliation at discharge and capture compliance-linked reimbursement. The team recommended that the pharmacy department be allocated new pharmacy technician full-time-equivalent positions to assume ownership of the medication history process. Concurrent with the implementation of this program, a medication history standard was developed to define rules for documentation of what a patient reports he or she is actually taking. The standard requires a structured interview with the patient or caregiver and validation with outside sources as indicated to determine which medications to document in the medication history. The standard is based on four medication administration category rules: scheduled, as-needed, short-term, and discontinued medications. The medication history standard forms the core of the medication history technician training and accountability program. Pharmacy technicians are supervised by pharmacists, using a defined accountability plan based on a set of medical staff approved rules for what medications comprise a best possible medication history. Medication history accuracy and completeness rates have been consistently over 90% and rates of provider compliance with medication reconciliation rose from under 20% to 100% since program implementation. A defined medication history based on a medication history standard served as an effective foundation for a pharmacy technician medication history program, which helped improve provider compliance with discharge medication reconciliation. Copyright © 2014 by the American Society of Health-System Pharmacists, Inc. All rights reserved.

  3. The role of physicians as medical review officers in workplace drug testing programs. In pursuit of the last nanogram.

    PubMed Central

    Clark, H W

    1990-01-01

    In discussing the role of physicians in workplace drug testing programs, I focus on the recent Department of Transportation regulations that require drug testing in such regulated industries as interstate trucking, air transportation, mass transit, and the railroads. These regulations require that applicable drug testing programs employ physicians as medical review officers to evaluate positive tests that have been screened and confirmed by different techniques to determine if there is a legal medical explanation for the result. The drug testing program tests for the presence of amphetamine, cocaine, tetrahydrocannabinol, opiates, and phencyclidine. If an employee testing positive has an acceptable medical explanation, the result is to be reported as negative. Little practical advice exists for medical review officers, and they must be aware of key elements of the regulations and potential trouble spots. PMID:2190419

  4. Going GLP: Conducting Toxicology Studies in Compliance with Good Laboratory Practices.

    PubMed

    Carroll, Erica Eggers

    2016-01-01

    Good laboratory practice standards are US federal regulations enacted as part of the Federal Insecticide, Fungicide, and Rodenticide Act (40 CFR Part 160), the Toxic Substance Control Act (40 CFR Part 792), and the Good Laboratory Practice for Nonclinical Laboratory Studies (21 CFR Part 58) to support protection of public health in the areas of pesticides, chemicals, and drug investigations in response to allegations of inaccurate data acquisition. Essentially, good laboratory practices (GLPs) are a system of management controls for nonclinical research studies involving animals to ensure the uniformity, consistency, reliability, reproducibility, quality, and integrity of data collected as part of chemical (including pharmaceuticals) tests, from in vitro through acute to chronic toxicity tests. The GLPs were established in the United States in 1978 as a result of the Industrial Bio-Test Laboratory scandal which led to congressional hearings and actions to prevent fraudulent data reporting and collection. Although the establishment of infrastructure for GLPs compliance is labor-intensive and time-consuming, achievement and maintenance of GLP compliance ensures the accuracy of the data collected from each study, which is critical for defending results, advancing science, and protecting human and animal health. This article describes how and why those in the US Army Medical Department responsible for protecting the public health of US Army and other military personnel made the policy decision to have its toxicology laboratory achieve complete compliance with GLP standards, the first such among US Army laboratories. The challenges faced and how they were overcome are detailed.

  5. Personality, lifestyles, alcohol and drug consumption in a sample of British medical students.

    PubMed

    Ashton, C H; Kamali, F

    1995-05-01

    Personality characteristics and lifestyle variables were assessed in two cohorts of second-year medical students at the University of Newcastle upon Tyne, UK as part of a psychopharmacology 'teach-in' in 1993 and 1994. The pooled sample included 186 students: 77 men, 109 women, mean age 20.4 +/- 1.8 years. Measures included the Eysenck Personality Questionnaire, the Hospital Anxiety Depression Scale, and a questionnaire concerning consumption of alcohol, tobacco, cannabis and other illicit drugs, and physical exercise. The results were compared, where possible, with a similar survey in Newcastle upon Tyne medical students in 1983 and 1984. Personality variables, prevalence of cigarette smoking, levels of caffeine consumption and participation in sports had not changed significantly over the decade. There appeared to be a modest overall increase in alcohol consumption and in the 1993 and 1994 cohorts of students, 25.5% of those who drank alcohol exceeded recommended low risk levels (comparable data not available for 1983 and 1984). Reported use of cannabis and other illicit drugs had more than doubled, and in the present survey 49.2% of students recorded using cannabis and 22% had tried other illicit drugs. Corresponding figures for 1983 and 1984 were 20.9% for cannabis and 3.3% for other illicit drugs. Anxiety levels were not measured in 1983 and 1984 but in the present survey 39.3% of the students had anxiety ratings within the clinically significant range. The high levels of alcohol consumption and illicit drug use, and the high anxiety ratings, in this sample of medical students are a cause for concern.(ABSTRACT TRUNCATED AT 250 WORDS)

  6. The elderly on dialysis: some considerations in compliance.

    PubMed

    McKevitt, P M; Jones, J F; Lane, D A; Marion, R R

    1990-10-01

    Compliance with scheduled treatments, dietary and fluid restrictions, and multiple medications is an important component in the care and well-being of end-stage renal disease (ESRD) patients. Given the rigorus and complex demands of dialysis, it is important to examine the issue of compliance, focusing on a large and ever-increasing segment of our patient population, the elderly. The ESRD literature reflects efforts to define and measure levels of compliance, identify factors that influence and predict compliance, and develop intervention strategies to improve adherence to treatment regimens. While limited attention has been focused specifically on the elderly, there are studies suggesting that age may be a factor associated with improved adherence and that social support may be a significant contributor to compliance in this patient group. In an effort to examine the current status and needs of the dialysis elderly, research is in progress at Chromalloy American Kidney Center, Washington University, which replicates a study of 5 years ago. Eighty-four patients age 60 and over, on dialysis for a minimum of 6 months, were identified. Sociodemographic, treatment, compliance, and functional capacity data were collected; additional mental and psychological testing was completed on patients willing and able to participate. Preliminary data suggest the current elderly population is larger and significantly older than that of 5 years ago. Other sociodemographic data indicate the population is increasingly female, black, and more socioeconomically disadvantaged. In regard to compliance, the vast majority of elderly demonstrate good compliance as measured by serum potassium, fair to good compliance with phosphorus, and fair to poor compliance with fluid restrictions.(ABSTRACT TRUNCATED AT 250 WORDS)

  7. Drug Testing Incoming Residents and Medical Students in Family Medicine Training: A Survey of Program Policies and Practices.

    PubMed

    Bell, Paul F; Semelka, Michael W; Bigdeli, Laleh

    2015-03-01

    Despite well-established negative consequences, high rates of substance use and related disorders continue to be reported. Physicians in training are not immune from this, or the associated risks to their health and careers, while impaired physicians are a threat to patient safety. We surveyed family medicine residency programs' practices relating to drug testing of medical students and incoming residents. The survey asked about the extent to which residency programs are confronted with trainees testing positive for prohibited substances, and how they respond. The survey was sent to the directors of family medicine residency programs. A total of 205 directors (47.2%) completed the survey. A majority of the responding programs required drug testing for incoming residents (143, 68.9%). Most programs did not require testing of medical students (161, 81.7%). Few programs reported positive drug tests among incoming residents (9, 6.5%), and there was only 1 reported instance of a positive result among medical students (1, 3.3%). Respondents reported a range of responses to positive results, with few reporting that they would keep open training spots or offer supportive services for a medical student who tested positive. Changing laws legalizing certain drugs may require corresponding changes in the focus on drug testing and associated issues in medical training; however, many residency program directors were not aware of their institution's current policies. Programs will need to reexamine drug testing policies as new generations of physicians, growing up under altered legal circumstances concerning drug use, progress to clinical training.

  8. 78 FR 41069 - Medical Device Reporting for Manufacturers; Draft Guidance for Industry and Food and Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-09

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-0743] Medical Device Reporting for Manufacturers; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...

  9. Health workers' compliance to rapid diagnostic tests (RDTs) to guide malaria treatment: a systematic review and meta-analysis.

    PubMed

    Kabaghe, Alinune N; Visser, Benjamin J; Spijker, Rene; Phiri, Kamija S; Grobusch, Martin P; van Vugt, Michèle

    2016-03-15

    The World Health Organization recommends malaria to be confirmed by either microscopy or a rapid diagnostic test (RDT) before treatment. The correct use of RDTs in resource-limited settings facilitates basing treatment onto a confirmed diagnosis; contributes to speeding up considering a correct alternative diagnosis, and prevents overprescription of anti-malarial drugs, reduces costs and avoids unnecessary exposure to adverse drug effects. This review aims to evaluate health workers' compliance to RDT results and factors contributing to compliance. A PROSPERO-registered systematic review was conducted to evaluate health workers' compliance to RDTs in sub-Saharan Africa, following Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Studies published up to November 2015 were searched without language restrictions in Medline/Ovid, Embase, Cochrane Central Register of Controlled Trials, Web of Science, LILACS, Biosis Previews and the African Index Medicus. The primary outcome was health workers treating patients according to the RDT results obtained. The literature search identified 474 reports; 14 studies were eligible and included in the quantitative analysis. From the meta-analysis, health workers' overall compliance in terms of initiating treatment or not in accordance with the respective RDT results was 83% (95% CI 80-86%). Compliance to positive and negative results was 97% (95% CI 94-99%) and 78% (95% CI 66-89%), respectively. Community health workers had higher compliance rates to negative test results than clinicians. Patient expectations, work experience, scepticism of results, health workers' cadres and perceived effectiveness of the test, influenced compliance. With regard to published data, compliance to RDT appears to be generally fair in sub-Saharan Africa; compliance to negative results will need to improve to prevent mismanagement of patients and overprescribing of anti-malarial drugs. Improving diagnostic capacity

  10. Legal suits: pharmaceutical industry strategies to introduce new drugs in the Brazilian public healthcare system.

    PubMed

    Chieffi, Ana Luiza; Barata, Rita de Cássia Barradas

    2010-06-01

    To assess the distribution rate of legal suits according to drug (manufacturer), prescribing physician, and attorney filing the lawsuit. A descriptive study was carried out to assess the lawsuits in the São Paulo State (Southeastern Brazil) courts registry in 2006, and amounts spent in complying with these lawsuits, and total costs with medication thus resulting. In 2006, the São Paulo State Administration spent 65 million Brazilian reais in compliance with court decisions to provide medication to approximately 3,600 individuals. The total cost of the medication was 1.2 billion Brazilian reais. In the period studied, 2,927 lawsuits were examined. These lawsuits were filed by 565 legal professionals, among which 549 were attorneys engaged by private individuals (97.17% of the total legal professionals). The drugs scope of the lawsuits had been prescribed by 878 different physicians. By assessing the number of lawsuits filed per attorney, it was found that 35% of them were brought before the courts by 1% of them. The data related to the lawsuits and to the medication classified according to manufacturer, show that a small number of attorneys is responsible for the largest number of lawsuits filed to obtain these drugs. The finding that more than 70% of the lawsuits filed for certain drugs are the responsibility of one single attorney, may suggest a close connection between this professional and the manufacturer.

  11. Evolving Patient Compliance Trends: Integrating Clinical, Insurance, and Extrapolated Socioeconomic Data

    PubMed Central

    Klobusicky, Joseph J.; Aryasomayajula, Arun; Marko, Nicholas

    2015-01-01

    Efforts toward improving patient compliance in medication focus on either identifying trends in patient features or studying changes through an intervention. Our study seeks to provide an important link between these two approaches through defining trends of evolving compliance. In addition to using clinical covariates provided through insurance claims and health records, we also extracted census based data to provide socioeconomic covariates such as income and population density. Through creating quadrants based on periods of medicine intake, we derive several novel definitions of compliance. These definitions revealed additional compliance trends through considering refill histories later in a patient’s length of therapy. These results suggested that the link between patient features and compliance includes a temporal component, and should be considered in policymaking when identifying compliant subgroups. PMID:26958212

  12. Compliance with oral antibiotic regimens and associated factors in Japan: compliance survey of multiple oral antibiotics (COSMOS).

    PubMed

    Yamamoto, Yoshihiro; Kadota, Junichi; Watanabe, Akira; Yamanaka, Noboru; Tateda, Kazuhiro; Mikamo, Hiroshige; Tomono, Kazunori; Niki, Yoshihito; Aoki, Nobuki; Sunakawa, Keisuke; Kohno, Shigeru

    2012-02-01

    To provide an overall picture of oral antibiotic use in Japan, we conducted a survey of patients who had been prescribed oral antibiotics. In addition, factors potentially associated with compliance were evaluated. General practitioners at 155 GP practices throughout Japan participated in the survey. Questionnaires were collected from 1068 subjects visiting those GP practices (676 females; median age 38 y), with a collection rate of 82.9%. According to this survey, the overall percentage of fully compliant subjects was 74.7%. Subgroup analyses showed that compliance tended to be higher with a shorter duration of prescription and fewer doses per day, and also with a greater ease of understanding of the explanation of treatment provided by the doctor. In multivariate analysis, age, pharyngitis, number of doses per day, duration of prescription, intention to return for follow-up, and ease of understanding the explanation of treatment given by the doctor showed a statistically significant association with compliance. Based on our survey results, prescribing drugs taken with a minimal number of daily doses in a shorter regimen appears to be an effective strategy for improving compliance. It appears that doctors also need to raise awareness of the importance of taking antibiotics properly by clearly explaining their purpose and significance.

  13. 77 FR 68132 - Compliance Guidance for Small Business Entities on Labeling for Bronchodilators: Cold, Cough...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-15

    ... compliance guide applies to OTC bronchodilator drug products used to treat asthma that are marketed without... Asthma Alert warning), and directions that are required in the labeling of OTC bronchodilator drug...

  14. [Combination drug therapy in patients with BPH].

    PubMed

    Kuzmenko, A V; Kuzmenko, V V; Gyaurgiev, T A

    2018-03-01

    Introuction. One of the risk factors for LUTS is an infravesical obstruction, which is most often caused by benign prostatic hyperplasia (BPH). BPH symptoms are formed due to three components: static (mechanical), dynamic, and impaired functional capacity of the bladder. Medical treatment with 1-blockers decreases the outflow obstruction. 5-alpha reductase inhibitors are used to inhibit the static component of BPH. To investigate the effectiveness of various modifications of medical therapy of BPH using -blockers and 5-reductase inhibitors and combinations thereof. The study comprised 90 BPH patients who were divided into three groups, with each group containing 30 people. Patients of group I, II and III received monotherapy with -blockers, a combination of 5-reductase and -blockers, and fixed-dose combination drug Duodart, respectively. Evaluation of the treatment effectiveness included filling out voiding diaries, completing the I-PSS and QL questionnaires, uroflowmetry, transrectal ultrasonography of the prostate and estimation of the incidence of adverse effects. Also, compliance with the treatment was evaluated, and the number of patients who had episodes of acute urinary retention and required surgical treatment during the 12 month treatment course was registered. Compared to monotherapy, combination therapy with -blockers and 5-reductase inhibitors more effectively reduces the LUTS, increases Qmax and prevents the disease progression, which manifests in a lower incidence of AUR and fewer surgical interventions in groups II and III. However, the combination therapy can be associated with some side effects. Patients who received fixed-dose combination drug Duodart had a greater compliance rate than patients on the combination of drugs, which, in our opinion, is associated with fewer cases of AUR and surgical interventions. The use of Duodart in patients with BPH effectively alleviates LUTS and reduces the risk of the disease progression, which manifests itself

  15. 75 FR 74063 - Supplemental Funding Under the Food and Drug Administration's Convener of Active Medical Product...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-30

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0576] Supplemental Funding Under the Food and Drug Administration's Convener of Active Medical Product Surveillance Discussions (U13) RFA- FD-09-012; Request for Supplemental Application AGENCY: Food and Drug Administration...

  16. Non-medical use of prescription drugs in a national sample of college women

    PubMed Central

    McCauley, Jenna L.; Amstadter, Ananda B.; Macdonald, Alexandra; Danielson, Carla Kmett; Ruggiero, Kenneth J.; Resnick, Heidi S.; Kilpatrick, Dean G.

    2015-01-01

    Non-medical use of prescription drugs (NMUPD) is one of the fastest growing forms of illicit drug use, with research indicating that college students represent a particularly high risk population. The current study examined demographic characteristics, health/mental health, substance misuse, and rape experiences as potential risk correlates of NMUPD among a national sample of college women (N=2000). Interviews were conducted via telephone using Computer-Assisted Telephone Interviewing technology. NMUPD was assessed by asking if, participants had used a prescription drug non-medically in the past year. NMUPD was endorsed by 7.8% of the sample (n=155). Although incapacitated and drug–alcohol facilitated rape were associated with NMUPD in the initial model, the final multivariable model showed that only lifetime major depression and other forms of substance use/abuse were significantly uniquely associated with an increased likelihood of NMUPD. Implications for primary and secondary prevention and subsequent research are addressed. PMID:21356576

  17. Do drug advertisements in Russian medical journals provide essential information for safe prescribing?

    PubMed Central

    Vlassov, Vasiliy; Mansfield, Peter; Lexchin, Joel; Vlassova, Anna

    2001-01-01

    Objective To examine pharmaceutical advertisements in medical journals for their adequacy of information. Methods We selected a convenience sample of 5 major Russian medical journals covering different fields of medicine and different types of publications. We evaluated all the ads in all the issues of the selected journals published during 1998. We counted the number of appearances of trade, chemical, and generic names; indication and contraindication; pharmacologic group; safety warnings; and references. Counts in all categories were aggregated for each advertiser. Results There were 397 placements of 207 distinct advertisements. Only 154 placements (40%) mentioned the generic name, 177 (45%) mentioned any indication, 42 (11%) mentioned safety warnings and contraindications, 21 (5%) warned about drug interactions, and 8 (2%) provided references. The 6 companies responsible for the most ads on average provided less information than the other companies. Conclusions Almost none of the drug ads published in Russian medical journals provide the basic information required for appropriate prescribing. This is despite the fact that in Russia, ads that omit essential information and that could lead consumers to misunderstandings about an advertised product are illegal. The arrival of drug advertising in Russia has brought little information and has been potentially damaging. PMID:11381003

  18. Relationship between Medication Use and Cardiovascular Disease Health Outcomes in the Jackson Heart Study

    PubMed Central

    Addison, Clifton C.; Jenkins, Brenda W.; Sarpong, Daniel; Wilson, Gregory; Champion, Cora; Sims, Jeraline; White, Monique S.

    2011-01-01

    Even though some medications have the potential to slow the progress of atherosclerosis and development of CVD, there are many at-risk individuals who continue to resist the benefits that are available by not following the advice of medical professionals. Non-adherence to prescribed drug regimens is a pervasive medical problem that negatively affects treatment outcomes. Information from standardized interviews of 5301 African Americans participating in the Jackson Heart Study was examined to determine the association between demographic parameters, behavior including adherence to prescribed medical regimens, and health outcomes. Data were also collected at Annual Follow-Up and Surveillance visits. During the two weeks prior to the examination visit, almost 52% of the participants reported taking blood pressure medication, 14% took cholesterol medication, 16% took medication for diabetes, and 19% took blood thinning medication. Of those who did not take the prescribed medications, the reasons given were the following: 47% were in a hurry, too busy, or forgot to take medications; 23% were trying to do without medications; 18% had no money to purchase medications; 19% indicated that the medications made them feel bad; 17% felt that they could not carry out daily functions when taking medications. The African American population can benefit from heightened awareness of the risk factors that are associated with CVD and the benefits of following a prescribed treatment regimen. Unacceptable secondary effects of prescribed medication comprised an important cause of non-compliance. Encouragement of this population to communicate with their healthcare providers to ensure that medication regimens are better tolerated could increase compliance and improve health outcomes. PMID:21776242

  19. Medicating the mind: a Kantian analysis of overprescribing psychoactive drugs

    PubMed Central

    Manninen, B A

    2006-01-01

    Psychoactive drugs are being prescribed to millions of Americans at an increasing rate. In many cases these drugs are necessary in order to overcome debilitating emotional problems. Yet in other instances, these drugs are used to supplant, not supplement, interpersonal therapy. The process of overcoming emotional obstacles by introspection and the attainment of self knowledge is gradually being eroded via the gratuitous use of psychoactive medication in order to rapidly attain a release from the common problems that life inevitably presents us with. In this paper, I argue that Kant's formula of humanity, which maintains that persons ought never to treat others or themselves soley as a means to an end, proscribes this. Moreover, Kant argues that we have an imperfect duty of self development, and I argue that we fail to adhere to such a duty whenever we seek to evade the process of introspection and self knowledge in favour of the expedient results that drugs may provide us with as we attempt to overcome the emotional hurdles in our lives. PMID:16446415

  20. Incorporating Concomitant Medications into Genome-Wide Analyses for the Study of Complex Disease and Drug Response.

    PubMed

    Graham, Hillary T; Rotroff, Daniel M; Marvel, Skylar W; Buse, John B; Havener, Tammy M; Wilson, Alyson G; Wagner, Michael J; Motsinger-Reif, Alison A

    2016-01-01

    Given the high costs of conducting a drug-response trial, researchers are now aiming to use retrospective analyses to conduct genome-wide association studies (GWAS) to identify underlying genetic contributions to drug-response variation. To prevent confounding results from a GWAS to investigate drug response, it is necessary to account for concomitant medications, defined as any medication taken concurrently with the primary medication being investigated. We use data from the Action to Control Cardiovascular Disease (ACCORD) trial in order to implement a novel scoring procedure for incorporating concomitant medication information into a linear regression model in preparation for GWAS. In order to accomplish this, two primary medications were selected: thiazolidinediones and metformin because of the wide-spread use of these medications and large sample sizes available within the ACCORD trial. A third medication, fenofibrate, along with a known confounding medication, statin, were chosen as a proof-of-principle for the scoring procedure. Previous studies have identified SNP rs7412 as being associated with statin response. Here we hypothesize that including the score for statin as a covariate in the GWAS model will correct for confounding of statin and yield a change in association at rs7412. The response of the confounded signal was successfully diminished from p = 3.19 × 10 -7 to p = 1.76 × 10 -5 , by accounting for statin using the scoring procedure presented here. This approach provides the ability for researchers to account for concomitant medications in complex trial designs where monotherapy treatment regimens are not available.

  1. 77 FR 72868 - Compliance Guidance for Small Business Entities on Labeling and Effectiveness Testing; Sunscreen...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-06

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-1086] Compliance Guidance for Small Business Entities on Labeling and Effectiveness Testing; Sunscreen Drug Products for Over-the-Counter Human Use; Notice of Availability AGENCY: Food and Drug Administration, HHS...

  2. Technology utilization to prevent medication errors.

    PubMed

    Forni, Allison; Chu, Hanh T; Fanikos, John

    2010-01-01

    Medication errors have been increasingly recognized as a major cause of iatrogenic illness and system-wide improvements have been the focus of prevention efforts. Critically ill patients are particularly vulnerable to injury resulting from medication errors because of the severity of illness, need for high risk medications with a narrow therapeutic index and frequent use of intravenous infusions. Health information technology has been identified as method to reduce medication errors as well as improve the efficiency and quality of care; however, few studies regarding the impact of health information technology have focused on patients in the intensive care unit. Computerized physician order entry and clinical decision support systems can play a crucial role in decreasing errors in the ordering stage of the medication use process through improving the completeness and legibility of orders, alerting physicians to medication allergies and drug interactions and providing a means for standardization of practice. Electronic surveillance, reminders and alerts identify patients susceptible to an adverse event, communicate critical changes in a patient's condition, and facilitate timely and appropriate treatment. Bar code technology, intravenous infusion safety systems, and electronic medication administration records can target prevention of errors in medication dispensing and administration where other technologies would not be able to intercept a preventable adverse event. Systems integration and compliance are vital components in the implementation of health information technology and achievement of a safe medication use process.

  3. Norwegian elderly patients' need for drug information and attitudes towards medication use reviews in community pharmacies.

    PubMed

    Mamen, Anette Vik; Håkonsen, Helle; Kjome, Reidun L S; Gustavsen-Krabbesund, Bjørn; Toverud, Else-Lydia

    2015-12-01

    Medication use review (MUR) is a community pharmacy service in several countries. Knowledge about what patients want from such a service is limited. The aim of this study was therefore to investigate Norwegian elderly patients' need for drug information and their attitudes towards MURs. In Norway's two largest cities, 162 patients (72% women; mean age: 78.9 years) who used at least one prescription drug were recruited from 18 senior centres. They were interviewed personally with a structured questionnaire (29 closed and 4 open-ended questions). The average number of prescription drugs used was 4.4. Seventy per cent also used over-the-counter drugs. The main source of drug information was the general practitioner (GP) followed by package inserts and pharmacy staff. For drug-related problems, 62% would contact the GP compared with 24% who preferred the pharmacist. Fifty per cent remembered no information when collecting prescriptions. However, 56% wanted to know more about their medication and 55% were interested in a MUR. The main topics they wished to address were effect/side effects and interactions. Lack of privacy was reported to be a major obstacle in the current situation. This study shows that community pharmacies in Norway play a minor role regarding drug information to elderly polypharmacy patients. The GP is both their main information source and whom they contact for drug-related problems. However, half of the patients would like to know more about their medication. More than half were positive towards taking part in a MUR. © 2015 Royal Pharmaceutical Society.

  4. Tribological investigation of a functional medical textile with lubricating drug-delivery finishing.

    PubMed

    Gerhardt, L-C; Lottenbach, R; Rossi, R M; Derler, S

    2013-08-01

    Textile-based drug delivery systems have a high potential for innovative medical and gerontechnological applications. In this study, the tribological behaviour and lubrication properties of a novel textile with drug delivery function/finishing was investigated by means of friction experiments that simulated cyclic dynamic contacts with skin under dry and wet conditions. The textile drug delivery system is based on a loadable biopolymer dressing on a polyester (PES) woven fabric. The fabrics were finished with low (LC) and highly cross-linked (HC) polysaccharide dressings and investigated in the unloaded condition as well as loaded with phytotherapeutic substances. The mechanical resistance and possible abrasion of the functional coatings on the textile substrate were assessed by friction measurements and scanning electron microscopical analyses. Under dry contact conditions, all investigated fabrics (PES substrate alone and textiles with loaded and unloaded dressings) showed generally low friction coefficients (0.20-0.26). Under wet conditions, the measured friction coefficients were typically higher (0.34-0.51) by a factor of 1.5-2. In the wet condition, both loaded drug delivery textiles exhibited 7-29% lower friction (0.34-0.41) than the PES fabric with unloaded dressings (0.42-0.51), indicating pronounced lubrication effects. The lubrication effects as well as the abrasion resistance of the studied textiles with drug delivery function depended on the degree of dilution of the phytotherapeutic substances. Lubricating formulations of textile-based drug delivery systems which reduce friction against the skin might be promising candidates for advanced medical textile finishes in connection with skin care and wound (decubitus ulcer) prevention. Copyright © 2013 Elsevier B.V. All rights reserved.

  5. Effectiveness of adverse effects search filters: drugs versus medical devices.

    PubMed

    Farrah, Kelly; Mierzwinski-Urban, Monika; Cimon, Karen

    2016-07-01

    The study tested the performance of adverse effects search filters when searching for safety information on medical devices, procedures, and diagnostic tests in MEDLINE and Embase. The sensitivity of 3 filters was determined using a sample of 631 references from 131 rapid reviews related to the safety of health technologies. The references were divided into 2 sets by type of intervention: drugs and nondrug health technologies. Keyword and indexing analysis were performed on references from the nondrug testing set that 1 or more of the filters did not retrieve. For all 3 filters, sensitivity was lower for nondrug health technologies (ranging from 53%-87%) than for drugs (88%-93%) in both databases. When tested on the nondrug health technologies set, sensitivity was lower in Embase (ranging from 53%-81%) than in MEDLINE (67%-87%) for all filters. Of the nondrug records that 1 or more of the filters missed, 39% of the missed MEDLINE records and 18% of the missed Embase records did not contain any indexing terms related to adverse events. Analyzing the titles and abstracts of nondrug records that were missed by any 1 filter, the most commonly used keywords related to adverse effects were: risk, complications, mortality, contamination, hemorrhage, and failure. In this study, adverse effects filters were less effective at finding information about the safety of medical devices, procedures, and tests compared to information about the safety of drugs.

  6. Evaluating a switch from meconium to umbilical cord tissue for newborn drug testing: A retrospective study at an academic medical center.

    PubMed

    Palmer, Kendra L; Wood, Kelly E; Krasowski, Matthew D

    2017-04-01

    The objective of this study was to compare detection rates of newborn drug exposure at an academic medical center transitioning from meconium to umbilical cord tissue toxicology testing. We performed an Institutional Review Board-approved retrospective chart review on all newborns (n=2072) for whom newborn drug testing was ordered at our academic medical center between June 2012 and August 2015 (in August 2013, umbilical cord tissue became the preferred specimen). Meconium toxicology testing was positive for at least one compound in 221 cases (21.3% of 1037 total specimens), with non-medical drug use identified in 85 cases (8.2%). Umbilical cord tissue toxicology testing was positive for at least one compound in 302 cases (29.2%), with non-medical drug use identified in 107 cases (10.3%). Of the cases involving non-medical drug use, the most common compounds detected were tetrahydrocannabinol and amphetamines. Non-medical drug use did not differ significantly between meconium and umbilical cord tissue, either as a total or for classes of drugs such as amphetamines, cannabinoids, and opiates. Maternal non-medical use of tramadol (not tested for in meconium) was identified in 5 cases (0.4%). There were significant differences in rate of detection of iatrogenic medications. Specifically, morphine, lorazepam, phenobarbital, and codeine were more commonly detected in meconium, while oxycodone was more commonly detected in umbilical cord tissue. Umbilical cord tissue toxicology testing yielded a similar detection rate compared to meconium testing. The use of umbilical cord tissue avoids detection of medications given to the neonate prior to meconium collection. Copyright © 2016 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

  7. Evidence of Drug-Nutrient Interactions with Chronic Use of Commonly Prescribed Medications: An Update.

    PubMed

    Mohn, Emily S; Kern, Hua J; Saltzman, Edward; Mitmesser, Susan H; McKay, Diane L

    2018-03-20

    The long-term use of prescription and over-the-counter drugs can induce subclinical and clinically relevant micronutrient deficiencies, which may develop gradually over months or even years. Given the large number of medications currently available, the number of research studies examining potential drug-nutrient interactions is quite limited. A comprehensive, updated review of the potential drug-nutrient interactions with chronic use of the most often prescribed medications for commonly diagnosed conditions among the general U.S. adult population is presented. For the majority of the interactions described in this paper, more high-quality intervention trials are needed to better understand their clinical importance and potential consequences. A number of these studies have identified potential risk factors that may make certain populations more susceptible, but guidelines on how to best manage and/or prevent drug-induced nutrient inadequacies are lacking. Although widespread supplementation is not currently recommended, it is important to ensure at-risk patients reach their recommended intakes for vitamins and minerals. In conjunction with an overall healthy diet, appropriate dietary supplementation may be a practical and efficacious way to maintain or improve micronutrient status in patients at risk of deficiencies, such as those taking medications known to compromise nutritional status. The summary evidence presented in this review will help inform future research efforts and, ultimately, guide recommendations for patient care.

  8. A case study in generic drug use: should there be risk adjustment in incentive payments for the use of generic medications?

    PubMed

    Walton, Surrey M; Rash, Christine; Lambert, Bruce L; Galanter, William L

    2014-11-01

    Encouraging generic drug use has reduced health care costs for payers and consumers, but the availability of therapeutically interchangeable medications or generic medications of choice is not equal across disease states. The extent to which systems of care are able to substitute with generics is not well understood.  To (a) define and measure the maximum generic rate (MGR) of currently prescribed drugs within an academic medical group in and (b) illustrate differences across drugs associated with selected underlying diseases.   Prescription claims data were examined from an academic medical group in Chicago, Illinois. Based on pharmacologic and therapeutic criteria, drugs were classified into 2 categories-potentially substitutable and not potentially substitutable-based on whether the drugs are branded forms of the same chemical entities that are available as generics or are therapeutically interchangeable with other medications that have different chemical compositions but the same mechanisms of action and potential efficacy. A medication was considered potentially substitutable if it (a) did not have a narrow therapeutic index as defined by the FDA; (b) did not belong to 1 of 6 protected classes of drugs in the Medicare D provisions; (c) was substitutable with a generic medication containing the same chemical entity; or (d) was therapeutically interchangeable with a therapeutically equivalent medication. MGR was defined as the percentage of prescriptions that could potentially be prescribed in generic form. This rate was examined overall and across drugs known to be associated with illustrative diseases including hypertension, diabetes mellitus, and obstructive lung diseases.   The MGR ranged from 100% for drugs used in hypertension to 26.7% for drugs used in obstructive lung diseases. The MGR was 83.6%.  Payers wishing to promote generic substitution should incorporate the potential for substitution of clinically appropriate generic medications as part of

  9. Patient Compliance and Medication Perception.

    ERIC Educational Resources Information Center

    Buckalew, L. W.; Sallis, R. E.

    1986-01-01

    Addresses problem of patient noncompliance with regimens of prescribed medication, with attention to incidence and illogical nature of this behavior. Psychological theory of cognitive dissonance is suggested as appropriate to understanding some aspects of noncompliance because medicinal preparations represent stimuli that are not necessarily…

  10. Use Of Psychoactive Drugs Among Medical Undergraduates In Abbottabad.

    PubMed

    Nawaz, Haq; Khan, Aftab Alam; Bukhari, Saima

    2017-01-01

    Psychoactive substance abuse is prevalent among medical undergraduates of Pakistan, India & Western countries which can adversely affect the physical & psychological grooming of a medical undergraduate thus threatening to compromise their role as future physicians & health-care providers in the society. The objective of the present cross-sectional study was to explore the prevalence and patterns of psychoactive substance/drug consumption among undergraduate students of a public sector medical college in Abbottabad. Seven hundred and eighty participants after informed consent were requested to fill a questionnaire seeking information about their demographics, patterns & behaviours regarding ten common psychoactive substances of abuse including (Cigarettes, Benzodiazepines, naswar, cannabis, alcohol, amphetamine, opium, cocaine, heroin & organic solvents). Overall students who responded were 698 (89.48%). One hundred and fifty (21.49%) admitted to the use of a psychoactive substance in past or at present. Majority users (71.33%) were males. Overall (81.33%) users were living in hostel or a rented apartment. Substance abuse was more prevalent among senior students, i.e., 30.06% & 24.24% in 4th year & final year MBBS respectively. Majority of the consumers, i.e., 93 (62%) were falling in an age group between 15-20 years. Main reasons behind substance abuse were: psychological stress (49.33%) and pleasure seeking (42.67%). Substances/drugs used by students in order of preference were Cigarettes 115 (76.67%), Benzodiazepines 48 (32%), naswar 42 (28%), Cannabis 41 (27.33%), Alcohol 24 (16%), Amphetamine 22 (14.67%), Opium 15 (10%), Cocaine 14 (9.33%), Heroin 11 (7.33%) & Organic solvents 05 (3.33%). Use of more than one substance was observed in 70 (46.67%) students. It is concluded that prevalence of cigarette smoking, naswar, benzodiazepines, cannabis & alcohol is high among medical undergraduates in Abbottabad which is a matter of concern. Efforts are needed to create

  11. Medical students' exposure to and attitudes about drug company interactions: a national survey.

    PubMed

    Sierles, Frederick S; Brodkey, Amy C; Cleary, Lynn M; McCurdy, Frederick A; Mintz, Matthew; Frank, Julia; Lynn, D Joanne; Chao, Jason; Morgenstern, Bruce Z; Shore, William; Woodard, John L

    2005-09-07

    While exposure to and attitudes about drug company interactions among residents have been studied extensively, relatively little is known about relationships between drug companies and medical students. To measure third-year medical students' exposure to and attitudes about drug company interactions. In 2003, we distributed a 64-item anonymous survey to 1143 third-year students at 8 US medical schools, exploring their exposure and response to drug company interactions. The schools' characteristics included a wide spectrum of ownership types, National Institutes of Health funding, and geographic locations. In 2005, we conducted a national survey of student affairs deans to measure the prevalence of school-wide policies on drug company-medical student interactions. Monthly frequency of students' exposure to various activities and gifts during clerkships, and attitudes about receiving gifts. Overall response rate was 826/1143 (72.3%), with range among schools of 30.9%-90.7%. Mean exposure for each student was 1 gift or sponsored activity per week. Of respondents, 762/818 (93.2%) were asked or required by a physician to attend at least 1 sponsored lunch. Regarding attitudes, 556/808 (68.8%) believed gifts would not influence their practices and 464/804 (57.7%) believed gifts would not affect colleagues' practices. Of the students, 553/604 (80.3%) believed that they were entitled to gifts. Of 183 students who thought a gift valued at less than $50 was inappropriate, 158 (86.3%) had accepted one. The number of students who simultaneously believed that sponsored grand rounds are educationally helpful and are likely to be biased was 452/758 (59.6%). Students at 1 school who had attended a seminar about drug company-physician relationships were no more likely than the nonattending classmates to show skepticism. Of the respondents, 704/822 (85.6%) did not know if their school had a policy on these relationships. In a national survey of student affairs deans, among the 99 who

  12. Impact of medication reconciliation and review and counselling, on adverse drug events and healthcare resource use.

    PubMed

    Al-Hashar, Amna; Al-Zakwani, Ibrahim; Eriksson, Tommy; Sarakbi, Alaa; Al-Zadjali, Badriya; Al Mubaihsi, Saif; Al Zaabi, Mohammed

    2018-05-12

    Background Adverse drug events from preventable medication errors can result in patient morbidity and mortality, and in cost to the healthcare system. Medication reconciliation can improve communication and reduce medication errors at transitions in care. Objective Evaluate the impact of medication reconciliation and counselling intervention delivered by a pharmacist for medical patients on clinical outcomes 30 days after discharge. Setting Sultan Qaboos University Hospital, Muscat, Oman. Methods A randomized controlled study comparing standard care with an intervention delivered by a pharmacist and comprising medication reconciliation on admission and discharge, a medication review, a bedside medication counselling, and a take-home medication list. Medication discrepancies during hospitalization were identified and reconciled. Clinical outcomes were evaluated by reviewing electronic health records and telephone interviews. Main outcome measures Rates of preventable adverse drug events as primary outcome and healthcare resource utilization as secondary outcome at 30 days post discharge. Results A total of 587 patients were recruited (56 ± 17 years, 57% female); 286 randomized to intervention; 301 in the standard care group. In intervention arm, 74 (26%) patients had at least one discrepancy on admission and 100 (35%) on discharge. Rates of preventable adverse drug events were significantly lower in intervention arm compared to standard care arm (9.1 vs. 16%, p = 0.009). No significant difference was found in healthcare resource use. Conclusion The implementation of an intervention comprising medication reconciliation and counselling by a pharmacist has significantly reduced the rate of preventable ADEs 30 days post discharge, compared to the standard care. The effect of the intervention on healthcare resource use was insignificant. Pharmacists should be included in decentralized, patient-centred roles. The findings should be interpreted in the context

  13. National burden of preventable adverse drug events associated with inpatient injectable medications: healthcare and medical professional liability costs.

    PubMed

    Lahue, Betsy J; Pyenson, Bruce; Iwasaki, Kosuke; Blumen, Helen E; Forray, Susan; Rothschild, Jeffrey M

    2012-11-01

    Harmful medication errors, or preventable adverse drug events (ADEs), are a prominent quality and cost issue in healthcare. Injectable medications are important therapeutic agents, but they are associated with a greater potential for serious harm than oral medications. The national burden of preventable ADEs associated with inpatient injectable medications and the associated medical professional liability (MPL) costs have not been previously described in the literature. To quantify the economic burden of preventable ADEs related to inpatient injectable medications in the United States. Medical error data (MedMarx 2009-2011) were utilized to derive the distribution of errors by injectable medication types. Hospital data (Premier 2010-2011) identified the numbers and the types of injections per hospitalization. US payer claims (2009-2010 MarketScan Commercial and Medicare 5% Sample) were used to calculate the incremental cost of ADEs by payer and by diagnosis-related group (DRG). The incremental cost of ADEs was defined as inclusive of the time of inpatient admission and the following 4 months. Actuarial calculations, assumptions based on published literature, and DRG proportions from 17 state discharge databases were used to derive the probability of preventable ADEs per hospitalization and their annual costs. MPL costs were assessed from state- and national-level industry reports, premium rates, and from closed claims databases between 1990 and 2011. The 2010 American Hospital Association database was used for hospital-level statistics. All costs were adjusted to 2013 dollars. Based on this medication-level analysis of reported harmful errors and the frequency of inpatient administrations with actuarial projections, we estimate that preventable ADEs associated with injectable medications impact 1.2 million hospitalizations annually. Using a matched cohort analysis of healthcare claims as a basis for evaluating incremental costs, we estimate that inpatient

  14. National Burden of Preventable Adverse Drug Events Associated with Inpatient Injectable Medications: Healthcare and Medical Professional Liability Costs

    PubMed Central

    Lahue, Betsy J.; Pyenson, Bruce; Iwasaki, Kosuke; Blumen, Helen E.; Forray, Susan; Rothschild, Jeffrey M.

    2012-01-01

    Background Harmful medication errors, or preventable adverse drug events (ADEs), are a prominent quality and cost issue in healthcare. Injectable medications are important therapeutic agents, but they are associated with a greater potential for serious harm than oral medications. The national burden of preventable ADEs associated with inpatient injectable medications and the associated medical professional liability (MPL) costs have not been previously described in the literature. Objective To quantify the economic burden of preventable ADEs related to inpatient injectable medications in the United States. Methods Medical error data (MedMarx 2009–2011) were utilized to derive the distribution of errors by injectable medication types. Hospital data (Premier 2010–2011) identified the numbers and the types of injections per hospitalization. US payer claims (2009–2010 MarketScan Commercial and Medicare 5% Sample) were used to calculate the incremental cost of ADEs by payer and by diagnosis-related group (DRG). The incremental cost of ADEs was defined as inclusive of the time of inpatient admission and the following 4 months. Actuarial calculations, assumptions based on published literature, and DRG proportions from 17 state discharge databases were used to derive the probability of preventable ADEs per hospitalization and their annual costs. MPL costs were assessed from state- and national-level industry reports, premium rates, and from closed claims databases between 1990 and 2011. The 2010 American Hospital Association database was used for hospital-level statistics. All costs were adjusted to 2013 dollars. Results Based on this medication-level analysis of reported harmful errors and the frequency of inpatient administrations with actuarial projections, we estimate that preventable ADEs associated with injectable medications impact 1.2 million hospitalizations annually. Using a matched cohort analysis of healthcare claims as a basis for evaluating incremental

  15. An ontological knowledge framework for adaptive medical workflow.

    PubMed

    Dang, Jiangbo; Hedayati, Amir; Hampel, Ken; Toklu, Candemir

    2008-10-01

    As emerging technologies, semantic Web and SOA (Service-Oriented Architecture) allow BPMS (Business Process Management System) to automate business processes that can be described as services, which in turn can be used to wrap existing enterprise applications. BPMS provides tools and methodologies to compose Web services that can be executed as business processes and monitored by BPM (Business Process Management) consoles. Ontologies are a formal declarative knowledge representation model. It provides a foundation upon which machine understandable knowledge can be obtained, and as a result, it makes machine intelligence possible. Healthcare systems can adopt these technologies to make them ubiquitous, adaptive, and intelligent, and then serve patients better. This paper presents an ontological knowledge framework that covers healthcare domains that a hospital encompasses-from the medical or administrative tasks, to hospital assets, medical insurances, patient records, drugs, and regulations. Therefore, our ontology makes our vision of personalized healthcare possible by capturing all necessary knowledge for a complex personalized healthcare scenario involving patient care, insurance policies, and drug prescriptions, and compliances. For example, our ontology facilitates a workflow management system to allow users, from physicians to administrative assistants, to manage, even create context-aware new medical workflows and execute them on-the-fly.

  16. Utilization of self-medication and prescription drugs among 15-year-old children from the German GINIplus birth cohort.

    PubMed

    Italia, Salvatore; Brand, Helmut; Heinrich, Joachim; Berdel, Dietrich; von Berg, Andrea; Wolfenstetter, Silke Britta

    2015-11-01

    The objective was to analyse paediatric drug utilization in relation to self-medication, prescription drugs, and the most reported therapeutic drug categories. Data were collected for 3013 children on their utilization of drugs (4-week prevalence) from a German birth cohort study (GINIplus, 15-year follow-up) using a self-administered questionnaire. The drugs were grouped into over-the-counter drugs and prescription drugs, and were classified according to the anatomical therapeutic chemical classification system. Predictors were analysed using a logistic regression model with four independent variables (gender, study area, maternal education, and parental income). Some 69% of the reported 2489 drugs were over-the-counter drugs, and 31% were prescription drugs. The 4-week prevalence for using any type of drug was 41.0%. Drug categories with high prevalence rates of use were antiinflammatory drugs (10.3%), analgesics (7.1%), and antiallergics (5.0%). Factors associated with higher use of over-the-counter drugs were female gender (OR = 1.56, p < 0.0001) and higher maternal education (OR = 1.60, p = 0.0021; university degree vs. secondary high school). Maternal education was correlated with the use of prescribed or self-medicated antiallergics (positive association) and contraceptives (negative association). The use of antibiotics, methylphenidate, and drugs for thyroid therapy was associated with lower parental income. The use of over-the-counter drugs in 15-year-old children from the GINIplus birth cohort is very common and is predicted by socioeconomic factors such as maternal education. This has to be considered by health care managers when deciding about the exclusion of over-the-counter drugs (normally used for self-medication) from reimbursement or the deregulation of drug sales. Copyright © 2015 John Wiley & Sons, Ltd.

  17. Association between addressing antiseizure drug side effects and patient-reported medication adherence in epilepsy

    PubMed Central

    Moura, Lidia M V R; Carneiro, Thiago S; Cole, Andrew J; Hsu, John; Vickrey, Barbara G; Hoch, Daniel B

    2016-01-01

    Background and aim Adherence to treatment is a critical component of epilepsy management. This study examines whether addressing antiepileptic drug (AED) side effects at every visit is associated with increased patient-reported medication adherence. Patients and methods This study identified 243 adults with epilepsy who were seen at two academic outpatient neurology settings and had at least two visits over a 3-year period. Demographic and clinical characteristics were abstracted. Evidence that AED side effects were addressed was measured through 1) phone interview (patient-reported) and 2) medical records abstraction (physician-documented). Medication adherence was assessed using the validated Morisky Medication Adherence Scale-4. Complete adherence was determined as answering “no” to all questions. Results Sixty-two (25%) patients completed the interviews. Participants and nonparticipants were comparable with respect to demographic and clinical characteristics; however, a smaller proportion of participants had a history of drug-resistant epilepsy than nonparticipants (17.7% vs 30.9%, P=0.04). Among the participants, evidence that AED side effects were addressed was present in 48 (77%) medical records and reported by 51 (82%) patients. Twenty-eight (45%) patients reported complete medication adherence. The most common reason for incomplete adherence was missed medication due to forgetfulness (n=31, 91%). There was no association between addressing AED side effects (neither physician-documented nor patient-reported) and complete medication adherence (P=0.22 and 0.20). Discussion and conclusion Among patients with epilepsy, addressing medication side effects at every visit does not appear to increase patient-reported medication adherence. PMID:27826186

  18. Cognitive Factors Related to Drug Abuse Among a Sample of Iranian Male Medical College Students

    PubMed Central

    Jalilian, Farzad; Ataee, Mari; Matin, Behzad Karami; Ahmadpanah, Mohammad; Jouybari, Touraj Ahmadi; Eslami, Ahmad Ali; Mahboubi, Mohammad; Alavijeh, Mehdi Mirzaei

    2015-01-01

    Backgrounds: Drug abuse is one of the most serious social problems in many countries. College students, particularly at their first year of education, are considered as one of the at risk groups for drug abuse. The present study aimed to determine cognitive factors related to drug abuse among a sample of Iranian male medical college students based on the social cognitive theory (SCT). Method: This cross-sectional study was carried out on 425 Iranian male medical college students who were randomly selected to participate voluntarily in the study. The participants filled out a self-administered questionnaire. Data were analyzed by the SPSS software (ver. 21.0) using bivariate correlations, logistic and linear regression at 95% significant level. Results: Attitude, outcome expectation, outcome expectancies, subjective norms, and self-control were cognitive factors that accounted for 49% of the variation in the outcome measure of the intention to abuse drugs. Logistic regression showed that attitude (OR=1.062), outcome expectancies (OR=1.115), and subjective norms (OR=1.269) were the most influential predictors for drug abuse. Conclusions: The findings suggest that designing and implementation of educational programs may be useful to increase negative attitude, outcome expectancies, and subjective norms towards drug abuse for college students in order to prevent drug abuse. PMID:26156919

  19. Cannabis: a self-medication drug for weight management? The never ending story.

    PubMed

    Bersani, Francesco Saverio; Santacroce, Rita; Coviello, Marialuce; Imperatori, Claudio; Francesconi, Marta; Vicinanza, Roberto; Minichino, Amedeo; Corazza, Ornella

    2016-02-01

    In a society highly focused on physical appearance, people are increasingly using the so-called performance and image-enhancing drugs (PIEDs) or life-style drugs as an easy way to control weight. Preliminary data from online sources (e.g. websites, drug forums, e-newsletters) suggest an increased use of cannabis amongst the general population as a PIED due to its putative weight-loss properties. The use of cannabis and/or cannabis-related products to lose weight may represent a new substance-use trend that should be carefully monitored and adequately investigated, especially in light of the well-known adverse psychiatric and somatic effects of cannabis, its possible interaction with other medications/drugs and the unknown and potentially dangerous composition of synthetic cannabimimetics preparations. Copyright © 2015 John Wiley & Sons, Ltd.

  20. Developing Core Competencies for the Prevention and Management of Prescription Drug Misuse: A Medical Education Collaboration in Massachusetts.

    PubMed

    Antman, Karen H; Berman, Harris A; Flotte, Terence R; Flier, Jeffrey; Dimitri, Dennis M; Bharel, Monica

    2016-10-01

    Drug overdose has become the leading cause of injury death in the United States. More than half of those deaths involve prescription drugs, specifically opioids. A key component of addressing this national epidemic is improving prescriber practices.A review of the curricula at the four medical schools in Massachusetts revealed that, although they taught components of addiction medicine, no uniform standard existed to ensure that all students were taught prevention and management strategies for prescription drug misuse. To fill this gap, the governor and the secretary of health and human services invited the deans of the state's four medical schools to convene to develop a common educational strategy for teaching safe and effective opioid-prescribing practices. With leadership from the Department of Public Health and Massachusetts Medical Society, the deans formed the Medical Education Working Group in 2015. This group reviewed the relevant literature and current standards for treating substance use disorders and defined 10 core competencies for the prevention and management of prescription drug misuse.The medical schools have incorporated these competencies into their curricula and have committed to assessing students' competence in these areas. The members of the Medical Education Working Group have agreed to continue to work together on key next steps, including connecting these competencies to those for residents, equipping interprofessional teams to address prescription drug misuse, and developing materials in pain management and opioid misuse for practicing physicians. This first-in-the-nation partnership has yielded cross-institutional competencies that aim to address a public health emergency in real time.

  1. Compliance aids and medicine stability: new evidence of quality assurance.

    PubMed

    Glass, Beverley Dawn; Haywood, Alison; Llewelyn, Victoria; Mangan, Martina

    2009-01-01

    Although increasing use of compliance aids is resulting in improved clinical outcomes for patients, the stability of some drugs being repackaged into these aids is being questioned. This is due to the fact that despite their widespread use, there is limited availability of relevant stability data. This review presents clinical evidence for repackaging into Dose Administration Aids (DAAs), the Australian Pharmaceutical Advisory Committee and other guidelines on general stability issues related to repackaging and a summary of evidence for stability studies conducted in the practice. For frusemide and prochlorperazine chosen as candidates for study because of their light sensitivity, while discoloration on light exposure rendered them unacceptable for patient use, precautions in repackaging and patient counselling can easily overcome this problem. In the case of sodium valproate however, hygroscopicity results in these tablets being unusable after exposure to accelerated storage conditions. In the absence of specific data on the stability of drug products repackaged into compliance aids, the guidelines, practical recommendations for repackaging and the management of compliance aids put forward in this article provide the pharmacist with the tools to make an informed decision on this process.

  2. 75 FR 53972 - Guidance for Industry; Small Entities Compliance Guide-The Index of Legally Marketed Unapproved...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-02

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0435] Guidance for Industry; Small Entities Compliance Guide--The Index of Legally Marketed Unapproved New Animal... industry 201 entitled ``Small Entities Compliance Guide--The Index of Legally Marketed Unapproved New...

  3. Characteristics of medication overdose presentations to the ED: how do they differ from illicit drug overdose and self-harm cases?

    PubMed

    Buykx, Penny; Dietze, Paul; Ritter, Alison; Loxley, Wendy

    2010-07-01

    Medication overdose accounts for >80% of hospital presentations for self-harm. Previous research has identified typical characteristics of medication overdose cases; however, these cases have not been well differentiated from other similar presentations, namely (1) illicit drug overdose and (2) self-harm by means other than overdose. A 12-month audit of medication overdose cases (both intentional and unintentional) attending the emergency department (ED) of a major metropolitan public hospital in Melbourne, Australia was conducted. Comparison was made with patients attending for illicit drug overdose or for self-harm by means other than overdose. Medication overdose cases (n=453) showed a broadly comparable profile with those found in earlier studies (predominantly female gender, aged in their 30s and referred for psychosocial assessment). A similar though not identical profile was noted for self-harm cases (n=545). In contrast, patients attending for illicit drug overdose (n=409) could be characterised as male, in their 20s and not referred for psychosocial assessment. Illicit drug overdose cases were more likely than either the medication overdose or self-harm cases to be triaged in the most urgent category (19.3, 3.8 and 3.9% respectively), suggesting a high level of acuity in this group. However, the illicit drug overdose group on average spent less time in the ED than medication overdose patients, and were less likely to require hospital admission. On both demographic and treatment variables, patients attending the ED following a medication overdose more closely resemble those attending for self-harm by means other than overdose than those attending for illicit drug overdose.

  4. Prescribing error at hospital discharge: a retrospective review of medication information in an Irish hospital.

    PubMed

    Michaelson, M; Walsh, E; Bradley, C P; McCague, P; Owens, R; Sahm, L J

    2017-08-01

    Prescribing error may result in adverse clinical outcomes leading to increased patient morbidity, mortality and increased economic burden. Many errors occur during transitional care as patients move between different stages and settings of care. To conduct a review of medication information and identify prescribing error among an adult population in an urban hospital. Retrospective review of medication information was conducted. Part 1: an audit of discharge prescriptions which assessed: legibility, compliance with legal requirements, therapeutic errors (strength, dose and frequency) and drug interactions. Part 2: A review of all sources of medication information (namely pre-admission medication list, drug Kardex, discharge prescription, discharge letter) for 15 inpatients to identify unintentional prescription discrepancies, defined as: "undocumented and/or unjustified medication alteration" throughout the hospital stay. Part 1: of the 5910 prescribed items; 53 (0.9%) were deemed illegible. Of the controlled drug prescriptions 11.1% (n = 167) met all the legal requirements. Therapeutic errors occurred in 41% of prescriptions (n = 479) More than 1 in 5 patients (21.9%) received a prescription containing a drug interaction. Part 2: 175 discrepancies were identified across all sources of medication information; of which 78 were deemed unintentional. Of these: 10.2% (n = 8) occurred at the point of admission, whereby 76.9% (n = 60) occurred at the point of discharge. The study identified the time of discharge as a point at which prescribing errors are likely to occur. This has implications for patient safety and provider work load in both primary and secondary care.

  5. Medical Emergencies Related to Ethanol and Illicit Drugs at an Annual, Nocturnal, Indoor, Electronic Dance Music Event.

    PubMed

    Calle, Paul; Sundahl, Nora; Maudens, Kristof; Wille, Sarah Mr; Van Sassenbroeck, Diederik; De Graeve, Koen; Gogaert, Stefan; De Paepe, Peter; Devriese, Dieter; Arno, Geert; Blanckaert, Peter

    2018-02-01

    Introduction Medical problems are frequently encountered during electronic dance music (EDM) events. Problem There are uncertainties about the frequencies and severity of intoxications with different types of recreational drugs: ethanol, "classical" illicit party drugs, and new psychoactive substances (NPS). Statistical data on the medical problems encountered during two editions of an indoor electronic dance event with around 30,000 attendants were retrieved from the Belgian Red Cross (Mechelen, Belgium) database. Data on drug use were prospectively collected from the patient (or a bystander), the clinical presentation, and/or toxicological screening. In the on-site medical station, 487 patients were treated (265 in 2013 and 222 in 2014). The most frequent reasons were trauma (n=171), headache (n=36), gastro-intestinal problems (n=44), and intoxication (n=160). Sixty-nine patients were transferred to a hospital, including 53 with severe drug-related symptoms. Analysis of blood samples from 106 intoxicated patients detected ethanol in 91.5%, 3,4-methylenedioxymethamphetamine (MDMA) in 34.0%, cannabis in 30.2%, cocaine in 7.5%, amphetamine in 2.8%, and gamma-hydroxybutyric acid (GHB) in 0.9% of patients (alone or in combination). In only six of the MDMA-positive cases, MDMA was the sole substance found. In 2014, the neuroleptic drug clozapine was found in three cases and ketamine in one. Additional analyses for NPS were performed in 20 cases. Only in one agitated patient, the psychedelic phenethylamines 25B-NBOMe and 25C-NBOMe were found. At this particular event, recreational drug abuse necessitated on-site medical treatment in one out of 350 attendants and a hospital transfer in one out of 1,000. Ethanol remains the most frequently abused (legal) drug, yet classical illicit recreational drugs are also frequently (co-) ingested. The most worrying observation was high-risk poly-drug use, especially among MDMA users. Regarding NPS, the number of cases was low and the

  6. Patient satisfaction with psychotropic drugs: sensitivity to change and relationship to clinical status, quality-of-life, compliance and effectiveness of treatment. Results from a nation-wide 6-month prospective study.

    PubMed

    Gasquet, Isabelle; Tcherny-Lessenot, Stéphanie; Lépine, Jean-Pierre; Falissard, Bruno

    2006-12-01

    To see if patient satisfaction with psychotropics (PSP) could be used as a patient-oriented outcome variable in the evaluation of PSP drugs in clinical epidemiological studies, relationships between PSP, clinical status, QoL, compliance and the type of antipsychotic were analyzed. Elements of validation of PSP were also assessed. In a 6-month prospective study, 933 schizophrenic outpatients with initiation or change to their antipsychotic treatment were enrolled. Psychiatrists completed five CGI-SCH scales (positive, negative, cognitive, depressive and global), hospitalization, compliance, and prescription variables. Patients completed PSP, EuroQoL scales, sexual function and compliance variables. A satisfactory structural equation model was obtained showing significant relationships PSP/compliance (coef.=0.16), QoL/PSP (coef.=0.37), clinical status/QoL (coef.=0.61), clinical status/compliance (coef.=0.09). Patients receiving olanzapine were more satisfied than patients receiving other atypicals (coef.=012) and had better clinical status than patients treated with typicals (coef.=0.08). Evolution of PSP was related to clinical status, QoL, and continuation of treatment (all P<001). Sensitivity to change of PSP was moderate (effect size=0.2). PSP produced consistent results in relation to validated outcome variables. However, a single-item measure was not sufficiently sensitive to change. Multi-item questionnaires evaluating different dimensions are needed.

  7. Ethylene vinyl acetate (EVA) as a new drug carrier for 3D printed medical drug delivery devices.

    PubMed

    Genina, Natalja; Holländer, Jenny; Jukarainen, Harri; Mäkilä, Ermei; Salonen, Jarno; Sandler, Niklas

    2016-07-30

    The main purpose of this work was to investigate the printability of different grades of ethylene vinyl acetate (EVA) copolymers as new feedstock material for fused-deposition modeling (FDM™)-based 3D printing technology in fabrication of custom-made T-shaped intrauterine systems (IUS) and subcutaneous rods (SR). The goal was to select an EVA grade with optimal properties, namely vinyl acetate content, melting index, flexural modulus, for 3D printing of implantable prototypes with the drug incorporated within the entire matrix of the medical devices. Indomethacin was used as a model drug in this study. Out of the twelve tested grades of the EVA five were printable. One of them showed superior print quality and was further investigated by printing drug-loaded filaments, containing 5% and 15% indomethacin. The feedstock filaments were fabricated by hot-melt extrusion (HME) below the melting point of the drug substance and the IUS and SR were successfully printed at the temperature above the melting point of the drug. As a result, the drug substance in the printed prototypes showed to be at least partly amorphous, while the drug in the corresponding HME filaments was crystalline. This difference affected the drug release profiles from the filaments and printed prototype products: faster release from the prototypes over 30days in the in vitro tests. To conclude, this study indicates that certain grades of EVA were applicable feedstock material for 3D printing to produce drug-loaded implantable prototypes. Copyright © 2015 Elsevier B.V. All rights reserved.

  8. Self-reported prevalence of hypersensitivity reactions against drugs among medical students: does awareness cause any difference?

    PubMed

    Bavbek, Sevim; Erkekol, Ferda Öner; Celik, Gülfem Elif; Gönüllü, Ipek; Misirligil, Zeynep

    2011-02-01

    True epidemiologic data on hypersensitivity reactions to drugs are scarce. More accurate data may be obtained in more specific clinical settings. Considering their educational background, medical students may be an appropriate target audience for evaluating prevalence of drug hypersensitivity. This study is designed to determine the prevalence of self-reported drug hypersensitivity alongside related factors among young adults. A structured questionnaire was administered to the students. A total of 1267 students (mean age: 21.71+1.90 years, F/M: 648/619) from all grades responded to the survey. The mean prevalence of self-reported drug hypersensitivity was 4.7% (60/1267). The most frequently involved drugs were beta-lactam antibiotics (55%) followed by non-steroidal anti-inflammatory drugs (28%). The most commonly reported clinical presentations were cutaneous (43.3%), followed by systemic (36.8%), cardiovascular (8.3%) and respiratory (8.3%) symptoms. Factors related with reported reactions were higher grades (p=0.015, OR: 2.09), female gender (p=0.006, OR: 2.13), personal history of allergic diseases (p=0.001, OR: 2.64), and family history of drug hypersensitivity (p<0.001, OR: 5.78). Half of the students sought medical help during the acute stage of their reaction. Only 3.2% of the cases have been referred to an allergist for further evaluation. This study, the first of its kind in Turkey, with medical students showed that self-reported hypersensitivity reactions to drugs is highly prevalent and its prevalence seems to be affected by awareness of the individuals in addition to previously reported risk factors. The education of both patients and physicians on the management of drug hypersensitivity seems to be necessary. Copyright © 2010 John Wiley & Sons, Ltd.

  9. Pricing and reimbursement of drugs and medical devices in Hungary.

    PubMed

    Gulácsi, L; Dávid, T; Dózsa, Cs

    2002-01-01

    Similarly to other countries of Central and Eastern Europe, Hungary has witnessed massive diffusion of healthcare technology such as drugs and medical devices since 1990. While substantial new pharmaceuticals, medical devices, and procedures have been liberalized, there has been no proper evaluation or training in their use. Healthcare providers have come to find themselves as entrepreneurs in private practice, while patients are acquiring an increasing awareness as customers of healthcare,demanding services in return for their taxes and contributions. This has led to extremely irrational patterns of investment in technology, with most an obvious waste of resources, while leaving basic needs unmet. Both the National Health Insurance Fund and the Ministry of Finance believe that the current pharmaceutical and medical device bill is too high. However, introducing a more transparent and flexible pricing and reimbursement framework may enable a more efficient allocation of the limited resources to be achieved.

  10. Objective assessment of compliance and persistence among patients treated for glaucoma and ocular hypertension: a systematic review

    PubMed Central

    Reardon, Gregory; Kotak, Sameer; Schwartz, Gail F

    2011-01-01

    Purpose This study summarizes findings from objective assessments of compliance (or adherence) and persistence with ocular hypotensive agents in patients with glaucoma and ocular hypertension. Design Systematic literature review. Methods A PubMed and reference list search was conducted across publication years 1970–2010, using these terms and variants: “compliance,” the equivalent term “adherence,” and “persistence” in patients with these conditions and therapies. Summaries of selected studies were stratified by measurement method (electronic monitor, prescription fills review, medical chart review). Measures of central tendency across studies were calculated for commonly-reported compliance or persistence measures. Results Fifty-eight articles met all inclusion/exclusion criteria: measurement of compliance–electronic monitoring (seven studies reported in 14 articles), measurement of compliance/ persistence–prescription records (36 studies in 38 articles), and measurement of persistence– medical chart review (six studies in six articles). From electronic monitoring, most therapy-experienced patients took medication consistently, but ≥20% met criteria for poor compliance. From prescription records, only 56% (range 37%–92%) of the days in the first therapy year could be dosed with the medication supply dispensed over this period. At 12 months from therapy start, only 31% (range 10%–68%) of new therapy users had not discontinued, and 40% (range 14%–67%) had not discontinued or changed the initial therapy. From medical chart review, only 67% (range 62%–78%) of patients remained persistent 12 months after starting therapy. Conclusions Evidence provided by this review suggests that poor compliance and persistence has been and remains a common problem for many glaucoma patients, and is especially problematic for patients new to therapy. The direction of empirical research should shift toward a greater emphasis on understanding of root causes

  11. 78 FR 102 - Guidance for Industry and Food and Drug Administration Staff; eCopy Program for Medical Device...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-02

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-1056] Guidance for Industry and Food and Drug Administration Staff; eCopy Program for Medical Device Submissions; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug...

  12. [The advertising message of drugs advertisements in Spanish medical journals].

    PubMed

    Riera, Eusebi J Castaño; de la Fuente, David Oterino; Rodrígueza, Rosa M Rodríguez

    2007-01-01

    To describe the characteristics of advertising in Spanish medical journals and to analyze the advertising message in drug advertisements. Six issues of 4 Spanish medical journals published in 2001 were reviewed to identify the number of advertisements and their characteristics. The journals selected were Atención Primaria, Anales Españoles de Pediatría, Medicina Clínica and Gaceta Sanitaria. The advertising message was analyzed by evaluating 5 factors: communication aim, sales argument, communication treatment, and use of text and image. 609 advertisements were found. Drug advertisements were the most numerous (69.9%). Advertising pressure was highest in Atención Primaria (36%), followed by Anales Españoles de Pediatría (22%), Medicina Clínica (12%) and Gaceta Sanitaria (4%). Of the 195 drug advertisements analyzed, the aim of the advertising message was mostly to present or remind readers of an existing product (70.8%). The sales argument was rational in 86.5%. The communication treatment was advertising in 72.6%. The text of the advertisement contained a headline in 82.4% or a slogan in 50.8%. The advertisement image was a photograph in 74.7% and the aim of the image was to present the product (48.7%), to promise a benefit (45.1%), or to argue its qualities (31.1%). In the journals aimed at prescribing physicians advertising pressure was higher and advertisements were intercalated in article text. Advertising concerned already existing products, used rational arguments, and the communication treatment was advertising.

  13. Medication Development of Ibogaine as a Pharmacotherapy for Drug Dependencea.

    PubMed

    Mash, Deborah C; Kovera, Craig A; Buck, Billy E; Norenberg, Michael D; Shapshak, Paul; Hearn, W Lee; Sanchez-Ramos, Juan

    1998-05-01

    The potential for deriving new psychotherapeutic medications from natural sources has led to renewed interest in rain forest plants as a source of lead compounds for the development of antiaddiction medications. Ibogaine is an indole alkaloid found in the roots of Tabernanthe iboga (Apocynaceae family), a rain forest shrub that is native to equatorial Africa. Ibogaine is used by indigenous peoples in low doses to combat fatigue, hunger and in higher doses as a sacrament in religious rituals. Members of American and European addict self-help groups have claimed that ibogaine promotes long-term drug abstinence from addictive substances, including psychostimulants and cocaine. Anecdotal reports attest that a single dose of ibogaine eliminates withdrawal symptoms and reduces drug cravings for extended periods of time. The purported antiaddictive properties of ibogaine require rigorous validation in humans. We have initiated a rising tolerance study using single administration to assess the safety of ibogaine for the treatment of cocaine dependency. The primary objectives of the study are to determine safety, pharmacokinetics and dose effects, and to identify relevant parameters of efficacy in cocaine-dependent patients. Pharmacokinetic and pharmacodynamic characteristics of ibogaine in humans are assessed by analyzing the concentration-time data of ibogaine and its desmethyl metabolite (noribogaine) from the Phase I trial, and by conducting in vitro experiments to elucidate the specific disposition processes involved in the metabolism of both parent drug and metabolite. The development of clinical safety studies of ibogaine in humans will help to determine whether there is a rationale for conducting efficacy trials in the future.

  14. Medication development of ibogaine as a pharmacotherapy for drug dependence.

    PubMed

    Mash, D C; Kovera, C A; Buck, B E; Norenberg, M D; Shapshak, P; Hearn, W L; Sanchez-Ramos, J

    1998-05-30

    The potential for deriving new psychotherapeutic medications from natural sources has led to renewal interest in rain forest plants as a source of lead compounds for the development of antiaddiction medications. Ibogaine is an indole alkaloid found in the roots of Tabernanthe iboga (Apocynaceae family), a rain forest shrub that is native to equatorial Africa. Ibogaine is used by indigenous peoples in low doses to combat fatigue, hunger and in higher doses as a sacrament in religious rituals. Members of American and European addict self-help groups have claimed that ibogaine promotes long-term drug abstinence from addictive substances, including psychostimulants and cocaine. Anecdotal reports attest that a single dose of ibogaine eliminates withdrawal symptoms and reduces drug cravings for extended periods of time. The purported antiaddictive properties of ibogaine require rigorous validation in humans. We have initiated a rising tolerance study using single administration to assess the safety of ibogaine for treatment of cocaine dependency. The primary objectives of the study are to determine safety, pharmacokinetics and dose effects, and to identify relevant parameters of efficacy in cocaine-dependent patients. Pharmacokinetic and pharmacodynamic characteristics of ibogaine in humans are assessed by analyzing the concentration-time data of ibogaine and its desmethyl metabolite (noribogaine) from the Phase I trial, and by conducting in vitro experiments to elucidate the specific disposition processes involved in the metabolism of both parent drug and metabolite. The development of clinical safety studies of ibogaine in humans will help to determine whether there is a rationale for conducting efficacy trials in the future.

  15. Attitudes toward medication-assisted treatment among fishermen in Kuantan, Malaysia, who inject drugs.

    PubMed

    Brown, Shan-Estelle; Wickersham, Jeffrey A; Pelletier, Alyssa R; Marcus, Ruthanne M; Erenrich, Rebecca; Kamarulzaman, Adeeba; Altice, Frederick L

    2017-01-01

    Fishermen who inject drugs represent an understudied group at high risk for HIV in Malaysia. This study describes fishing, drug use, and attitudes toward medication-assisted treatment (MAT) for opioid use disorders. Thirty-four male ethnic Malay fishermen completed semistructured interviews analyzed by content analysis. Analysis revealed four themes surrounding opioids, which they called ubat ("medicine"): (a) the fishing lifestyle facilitating substance use, (b) previous unsuccessful attempts to quit, (c) categorizing substances as haram or halal, and (d) attitudes toward MAT. Fishermen's environment permits substance use, including injecting drugs on boats. Fishermen expressed more positive attitudes toward methadone and negative attitudes toward buprenorphine.

  16. Association of medication errors with drug classifications, clinical units, and consequence of errors: Are they related?

    PubMed

    Muroi, Maki; Shen, Jay J; Angosta, Alona

    2017-02-01

    Registered nurses (RNs) play an important role in safe medication administration and patient safety. This study examined a total of 1276 medication error (ME) incident reports made by RNs in hospital inpatient settings in the southwestern region of the United States. The most common drug class associated with MEs was cardiovascular drugs (24.7%). Among this class, anticoagulants had the most errors (11.3%). The antimicrobials was the second most common drug class associated with errors (19.1%) and vancomycin was the most common antimicrobial that caused errors in this category (6.1%). MEs occurred more frequently in the medical-surgical and intensive care units than any other hospital units. Ten percent of MEs reached the patients with harm and 11% reached the patients with increased monitoring. Understanding the contributing factors related to MEs, addressing and eliminating risk of errors across hospital units, and providing education and resources for nurses may help reduce MEs. Copyright © 2016 Elsevier Inc. All rights reserved.

  17. [Main causes of non-compliance with pulmonary tuberculosis treatment].

    PubMed

    Manjarréz Morales, E M; Serrano Montes, V; Cano Pérez, G; Verduzco Guerrero, E; Escandón Romero, C; Escobedo de la Peña, J

    1993-01-01

    One hundred rural patient with pulmonary tuberculosis and 74 urban patients were included in the study in order to study the main causes of non-compliance. Crude cumulative incidencia was 42% (73/164). Those factors with the strongest association with non-compliance, independently of its association with other factors, were to live in rural areas (OR 0 10.4; p < 0.001), had not gone to school (analfabet) (OR = 4.5; p < 0.001), and last more than an hour to reach the medical care unit (protector) (OR = 0.40; p = 0.07). No association was found with socioeconomic factors, neither with the patient's knowledge of the disease. Identifying those factors related to non-compliance is important, since non-compliance occurs in the very firsts days of treatment, when the shortage of treatment or giving fewer pills do not work at all. To get a better medial control may be a good way to reach the expected control of the disease.

  18. [Autonomy attitudes in the treatment compliance of a cohort of subjects with continuous psychotropic drug administration].

    PubMed

    Baumann, M; Trincard, M

    2002-01-01

    Prescriptions for psychotropic drugs are part of a general practitioner's daily routine. As with all drugs, they need to be controlled by a phenomenon of observance. Respecting prescriptions is in fact a major public health concern. Our problematic is centred on the analysis of the association between observance and autonomy in order to gain a better understanding of the links between the drug, how it is to be taken, and how the patients adapt and control it. Identifying and comparing autonomous practices psychotrope users associated with attitudes put into play by those who claim to observe or not to observe their treatment is the aim of this project. The qualitative analysis of the speech is based on the categorial analysis of the contents of 46 transcriptions of 23 women et 23 men continuous (regular monthly intake for at least 5 years), aged between 50 and 65. The majority live in couples, have professional activities, and are executives. The psychotropes with the largest consumption are: anxiolytics and antidepressors. The average duration of their consumption is more than 17 years. Two types of attitude can be distinguished through the qualitative analyse. The attitudes of non-observers towards the psychotropic drug and dependence show controlled, autonomous acts. Autonomy is an influencing factor in their observation of the prescribed treatment, it is a major component of their non-observance regarding psychotropes; thus our hypothesis is confirmed. The strategy adopted around the medication arises from autonomy of action. Organising the treatment is seen as a sign of autonomy, as taking an initiative in relation to the medical prescription, and not as rebellious, or carefree behaviour, or as a sign of inconsistency. Non-observers seem more to be involved in a step towards self-regulation. Active taking verbs such as stop, diminish, increase , and success verbs succeed the I is greatly used, reinforced in some cases by myself ; this vocabulary situates the

  19. Tax Compliance Inventory: TAX-I Voluntary tax compliance, enforced tax compliance, tax avoidance, and tax evasion

    PubMed Central

    Kirchler, Erich; Wahl, Ingrid

    2010-01-01

    Surveys on tax compliance and non-compliance often rely on ad hoc formulated items which lack standardization and empirical validation. We present an inventory to assess tax compliance and distinguish between different forms of compliance and non-compliance: voluntary versus enforced compliance, tax avoidance, and tax evasion. First, items to measure voluntary and enforced compliance, avoidance, and evasion were drawn up (collected from past research and newly developed), and tested empirically with the aim of producing four validated scales with a clear factorial structure. Second, findings from the first analyses were replicated and extended to validation on the basis of motivational postures. A standardized inventory is provided which can be used in surveys in order to collect data which are comparable across research focusing on self-reports. The inventory can be used in either of two ways: either in its entirety, or by applying the single scales independently, allowing an economical and fast assessment of different facets of tax compliance. PMID:20502612

  20. Tax Compliance Inventory: TAX-I Voluntary tax compliance, enforced tax compliance, tax avoidance, and tax evasion.

    PubMed

    Kirchler, Erich; Wahl, Ingrid

    2010-06-01

    Surveys on tax compliance and non-compliance often rely on ad hoc formulated items which lack standardization and empirical validation. We present an inventory to assess tax compliance and distinguish between different forms of compliance and non-compliance: voluntary versus enforced compliance, tax avoidance, and tax evasion. First, items to measure voluntary and enforced compliance, avoidance, and evasion were drawn up (collected from past research and newly developed), and tested empirically with the aim of producing four validated scales with a clear factorial structure. Second, findings from the first analyses were replicated and extended to validation on the basis of motivational postures. A standardized inventory is provided which can be used in surveys in order to collect data which are comparable across research focusing on self-reports. The inventory can be used in either of two ways: either in its entirety, or by applying the single scales independently, allowing an economical and fast assessment of different facets of tax compliance.