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Sample records for medical drug compliance

  1. Ensuring compliance with drug regimens.

    PubMed

    Clarence, M

    This article explores the difficulties patients encounter in complying with prescribed drug regimens, and describes some of the compliance aids which are commonly available. A sensitive understanding of patients' individual difficulties by health care staff is an essential precursor to successful compliance behaviour.

  2. Compliance with inhaled asthma medication in preschool children.

    PubMed Central

    Gibson, N. A.; Ferguson, A. E.; Aitchison, T. C.; Paton, J. Y.

    1995-01-01

    BACKGROUND--Previous studies have shown poor compliance with regular drug therapy in children and adults with asthma. In preschool children the parents supervise and are responsible for drug administration, but little is known of compliance in this group. In addition, there are few data on the patterns of drug use of inhaled prophylactic asthma therapy or of the relation between compliance and symptom control. A study was undertaken to address these issues with the hypothesis that parental supervision would result in good compliance. METHODS--The subjects were 29 asthmatic children aged 15 months to five years already established on inhaled prophylactic medication delivered through a large volume spacer. The prescribed drug regimens varied between subjects. This was an observational study using an electronic inhaler timer device to record the date and time of each actuation of the aerosol canister. Diary cards were used for parallel recording of symptoms and parentally reported compliance with a drug regimen. RESULTS--Variable and generally poor compliance was demonstrated with a median of 50% of study days with full compliance (subject range 0-94%) and an overall median of 77% of prescribed doses of therapy taken during the study period. No relation was found between frequency of prescribed regimen and good compliance. Day care was associated with poorer compliance. No relation between good compliance and low symptom scores was found. CONCLUSION--Compliance with inhaled prophylactic therapy is poor in preschool children with asthma whose medication is administered under parental supervision. Images PMID:8553301

  3. 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.

  4. 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

  5. Medical Waste Act. Requires physician compliance.

    PubMed

    Chadzynki, L

    1991-07-01

    In Michigan, the medical care community has a long history of carefully managing infectious medical wastes within their facilities to control communicable diseases. Never the less, concerns have surfaced about health risks posed by medical waste because of the notoriety of reported incidents of improperly disposed medical waste that led to the promulgation of emergency rules and now permanent statutes. As the environment reemerges as a national issue, the proper disposal of medical waste remains, at the very least, a highly visible and volatile part of this nation's solid waste crisis. To better develop appropriate controls for dealing with regulated medical waste, we will need to work together. Journal articles such as this provide an important opportunity to share and more forward our understanding of this problem so that we may all enjoy a safer and better environment. Proper handling and disposal of medical waste will remain a public issue as long as wastes believed to be of medical origin are found on beaches or at unauthorized storage or disposal locations. Hence, compliance with the regulations for the handling, storing, treating, transporting and ultimate disposal of regulated medical waste by providers of health care in Michigan must be observed.

  6. 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

  7. 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

  8. 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.

  9. [Drug compliance and health locus of control in schizophrenia].

    PubMed

    Combes, C; Feral, F

    2011-05-01

    Schizophrenia is a frequent disorder since it affects about 1% of the general population. Drug compliance, that is to say patients' adherence to their treatment, remains rather poor concerning this disease with, on an average, one patient out of two not complying with his/her medication. Among the factors influencing drug compliance, we focused on patients' beliefs in terms of health control, a concept known as health locus of control. This is a concept that originated from social psychology and derived from the Rotters' original concept of locus of control: it corresponds to the type of connexion established by an individual between subsequent events in the history of his/her disease and internal (personal abilities) or external factors (chance, powerful others). Nowadays, the tridimensional structure of this concept is commonly admitted as being in three dimensions: internality, chance externality and powerful others externality, the latter group being divided between doctors and others. We have assumed that there is a correlation between the degree of drug compliance and the internal and/or doctors' external health locus of control. For this purpose, we have determined the quality of drug compliance by using the Medical Adherence Rating Scale (MARS) and the type of health locus of control by using the Multidimensional Health Locus of Control (MHLC) scale among 65 schizophrenic patients. We have also considered it was important to evaluate patients' insight by using the Amador's scale (Scale of Unawareness of Mental Disorder) because many researchers have established a strong correlation between insight and drug compliance in schizophrenia. Associations between the four dimensions of health locus of control ("internal", "chance external", "others external" and "doctors' external") and drug compliance were assessed by estimating Spearman's rank correlation coefficient (r) and its degree of significance (p). These associations were judged significant at an alpha

  10. Improving the Prediction of Medication Compliance: The Example of Bisphosphonates for Osteoporosis

    PubMed Central

    Curtis, Jeffrey R; Xi, Juan; Westfall, Andrew O; Cheng, Hong; Lyles, Kenneth; Saag, Kenneth G; Delzell, Elizabeth

    2009-01-01

    Introduction Administrative claims data have a limited ability to identify persons with high compliance to oral bisphosphonates. We tested whether adding information on compliance with other drugs used to treat chronic, asymptomatic conditions would improve the predictive ability of administrative data to identify adherent individuals. Methods Using data from a large, U.S. healthcare organization, we identified new bisphosphonate users and their 1 year compliance to oral bisphosphonates, quantified by the Medication Possession Ratio (MPR). Multivariable logistic regression models evaluated the relationship between high bisphosphonate compliance (MPR >= 80%) and patient demographics, comorbidities, and health services utilization. To these logistic regression models, we evaluated the incremental change in the area under the receiver operator curve (AUC) after adding information regarding compliance with other drug classes. These included anti-hyperlipidemics (statins), anti-hypertensives, anti-depressants, oral diabetes agents, and glaucoma medications. Results from the logistic regression models were evaluated in parallel using recursive partitioning trees with 10-fold cross-validation. Results Among 101,038 new bisphosphonate users, administrative data identified numerous non-medication factors (e.g. age, gender, use of preventive services) significantly associated with high bisphosphonate compliance at 1 year. However, all these factors in aggregate had low discriminant ability to identify persons highly adherent with bisphosphonates (AUC = 0.62). For persons who were new users of ≥ 1 of the other asymptomatic condition drugs, MPR data on the other drugs substantially improved the prediction of high bisphosphonate compliance. The impact on prediction was largest for concomitant statin users (AUC = 0.70). Conclusions Information on compliance with drugs used to treat chronic asymptomatic conditions improves the prediction of compliance with oral bisphosphonates

  11. Medications and Drug Allergic Reactions

    MedlinePlus

    ... Library ▸ Medications and drug allergic reactions TTR Share | Medications and Drug Allergic Reactions This article has been ... by Thanai Pongdee, MD, FAAAAI Everyone reacts to medications differently. One person may develop a rash while ...

  12. Introduction of a Self-report Version of the Prescription Drug Use Questionnaire and Relationship to Medication Agreement Non-Compliance

    PubMed Central

    Compton, Peggy A.; Wu, Stephen M.; Schieffer, Beatrix; Pham, Quynh; Naliboff, Bruce D.

    2008-01-01

    The Prescription Drug Use Questionnaire (PDUQ) is one of several published tools developed to help clinicians better identify the presence of opioid abuse or dependence in patients with chronic pain. This paper introduces a patient version of the PDUQ (PDUQp), a 31-item questionnaire derived from the items of the original tool designed for self-administration, and describes evidence for its validity and reliability in a sample of patients with chronic nonmalignant pain and on opioid therapy. Further, this study examines instances of discontinuation from opioid medication treatment related to violation of the medication agreement (MAVRD) in this population, and the relationship of these with problematic opioid misuse behaviors, PDUQ and PDUQp scores. A sample of 135 consecutive patients with chronic nonmalignant pain was recruited from a multidisciplinary Veterans Affairs chronic pain clinic, and prospectively followed over one year of opioid therapy. Utilizing the PDUQ as a criterion measure, moderate to good concurrent and predictive validity data for the PDUQp are presented, as well as item-by-item comparison of the two formats. Reliability data indicate moderate test stability over time. Of those patients whose opioid treatment was discontinued due to MAVRD (n = 38 or 28% of sample), 40% of these (n = 11) were due to specific problematic opioid misuse behaviors. Based upon specificity and sensitivity analyses, a suggested cut-off PDUQp score for predicting MAVRD is provided. This study supports the PDUQp as a useful tool for assessing and predicting problematic opioid medication use in a chronic pain patient sample. PMID:18508231

  13. 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

  14. How parental drug use and drug treatment compliance relate to family reunification.

    PubMed

    Smith, Brenda D

    2003-01-01

    This study uses Cox regression to assess the relationships among parental drug use, drug treatment compliance, and reunification from substitute care. The study finds that drug treatment compliance is associated with faster reunification, even when accounting for ongoing drug use and three parenting measures. The findings are consistent with a conceptual framework suggesting that certain client actions, such as drug treatment compliance, may serve as markers that substantially affect client outcomes.

  15. Indicators of medication compliance in first-episode psychosis.

    PubMed

    Kampman, Olli; Laippala, Pekka; Väänänen, Juha; Koivisto, Elina; Kiviniemi, Päivi; Kilkku, Nina; Lehtinen, Klaus

    2002-05-15

    Compliance behaviour is a multi-factorial phenomenon. In psychotic patients, it includes patient-related, medication-related, and environmental components. Compliance is a crucial factor in relation to outcome. The aim of this study was to explore indicators of compliance in a sample of 59 patients with a first-onset psychosis during their initial phase of treatment. Dependent variables in the logistic regression analysis included predictions made by the patients about their compliance in the initial phase and the observed compliance during the first 3 months according to patient record data. Explanatory variables comprised age, sex, living situation, education and social activities, Positive and Negative Syndrome Scale (PANSS) score, Hamilton Depression Scale score, Global Assessment of Functioning Scale score, Strauss-Carpenter Outcome Scale score, self-rated side effects, and insight and treatment-related variables. Predictions made by the patients about their compliance were determined by their self-rated attitude and insight measures. Determinants of observed non-compliance included experienced harmful side effects, male sex, lack of social activities, low score on PANSS positive symptoms, high PANSS total score and young age. The duration of untreated psychosis was not associated with compliance. Indicators of compliance in first-episode psychosis resemble those in the overall psychotic population. During the acute phase of psychosis, insight and attitudes toward treatment are the sole determinants of the patients' prediction of compliance.

  16. Predictors of medication compliance among older heart failure patients.

    PubMed

    Cholowski, Krystyna; Cantwell, Robert

    2007-12-01

    Aim.  To examine relationships between psycho-social and patho-physiological measures in explaining medication compliance in older heart failure (HF) patients. Background.  Self-efficacy is a predictor not only of medication compliance, but also health recovery. How older HF patients conceptualize and manage this life-threatening event is central to ongoing rehabilitation. Regulating ongoing medical and lifestyle changes in the rehabilitation process requires that any underlying negative affect be productively managed by the use of appropriate coping strategies. Method.  Using an exploratory correlational design, 51 older HF patients were asked to complete the Beck Depression Inventory, Beliefs about Medication and Diet Questionnaire, Reactions to Daily Events Questionnaire and Self-regulation scale. A self-report measure of medication compliance was obtained as part of a semi-structured interview. The study was conducted in 2003-2004. Results.  Using descriptive statistics, patho-physiological and psychosocial characteristics were given. Independent t-tests were used to assess the gender effects. Pairwise correlations were used to examine the relationships between presenting circumstances, psychosocial characteristics, medication compliance beliefs and self-reported medication compliance behaviours. All positive coping strategies and self-regulation were associated with positive intentions in medication compliance. Males were more inclined towards proactive coping and self-regulatory strategies than were females. Increased depressive symptoms were linked to carelessness in compliance. A belief in medication compliance was associated with a reduced likelihood of carelessness Conclusion.  Bandura's three conditions for agency in rehabilitation, self-efficacy and goal-directed intention appeared to be important even in the early phase of the programme. Positive coping strategies and self-regulation suggests a positive basis for medication compliance and more

  17. How Parental Drug Use and Drug Treatment Compliance Relate to Family Reunification.

    ERIC Educational Resources Information Center

    Smith, Brenda D.

    2003-01-01

    Cox regression was used to assess the relationships among parental drug use, drug treatment compliance, and reunification from substitute care. Findings indicated that drug treatment compliance was associated with faster reunification, even when accounting for ongoing drug use and three parenting measures. Findings were consistent with a…

  18. Compliance spectrum as a drug fingerprint of drug intake and drug disposition.

    PubMed

    Barrière, Olivier; Li, Jun; Nekka, Fahima

    2013-02-01

    Since drug related variability arises from different origins, particularly driven by the behaviour or physiology of the patient, the problems of drug intake and drug disposition are separately presented in general. To overcome the potential drawbacks of this artificial split, we propose in this paper a combined illustrative approach, named compliance spectrum, such that these two subprocesses can be equitably studied and visualized. We construct the compliance spectrum based on the Bayesian decision method we previously developed for the inverse problem of patient compliance within the framework of Population-PK. This spectrum provides an intuitive and interactive way to evaluate the relationship between drug intake and drug disposition along with their consequences on PK profile. As well, it opens a new direction for model quality diagnostic.

  19. Pharmacoeconomic consequences of variable patient compliance with prescribed drug regimens.

    PubMed

    Urquhart, J

    1999-03-01

    Variable compliance with prescribed drug regimens is a leading source of variability in drug response. Specifics differ by drug and disease. The role of variable compliance was clearly defined in 2 trials of lipid-lowering agents, cholestyramine and gemfibrozil, in which exceptionally careful measurements of compliance were made, which has not been done in later trials. Economic consequences of variable compliance are estimated by converting dose-dependent changes in absolute risk of incident coronary disease into the unicohort format, which designates how many patients must be treated to prevent, in a given time, a defined 'coronary event'. Two strong influences on the costs of treatment are: (i) the shape of the relation between drug intake and risk reduction; and (ii) the strength of the linkage between intake and prescription refills. The intake-effect relation for cholestyramine is linear, making compliance-neutral the cost to prevent 1 coronary event, provided that refills match intake. If refills exceed intake, treatment costs rise. The intake-effect relation for gemfibrozil is more typically nonlinear, so poorer compliers purchase and take the drug in amounts that have little benefit, increasing the cost to prevent 1 coronary event. If refills run at a higher rate than intake, costs increase still further. A key question for future study is: do policies that encourage timely refills increase compliance enough to offset their potential to waste money in the purchasing of an untaken drug?

  20. Medication/Drug Allergy

    MedlinePlus

    ... every time after the offending medication is taken. Penicillin and other antibiotics are the medication that most commonly cause allergic reactions. Women appear to have an increased risk for adverse reactions to medications. Facts about Allergies The tendency to develop allergies may be inherited. ...

  1. Factors influencing mothers' compliance with a medication regimen for asthmatic children.

    PubMed

    Radius, S M; Becker, M H; Rosenstock, I M; Drachman, R H; Schuberth, K C; Teets, K C

    1978-04-01

    This study lends support to the utility of a compliance-adapted health belief framework for exploring mothers' differential adherence to medication regiments prescribed for their asthmatic children. Most of the Model components behaved as hypothesized in predicting mothers' drug administration. The findings offer empirical evidence which can be applied to the purposes of identifying potential noncompliers and designating those specific, health-related orientations of the mother which are related to poor cooperation with therapy. Based on an educational diagnosis, the clinician may thus intervene to alter inappropriate health beliefs in order to enhance the likelihood of compliance for the asthmatic patient.

  2. 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…

  3. 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

  4. 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

  5. Cultural factors and medication compliance in Chinese immigrants who are taking antihypertensive medications: instrument development.

    PubMed

    Li, Wen-Wen; Stewart, Anita L; Stotts, Nancy A; Froelicher, Erika Sivarajan

    2005-01-01

    Chinese immigrants in the United States have a moderate to high prevalence of hypertension, but little is known about antihypertensive medication compliance in Chinese immigrants. This study presents some first-generation measures of antihypertensive medication compliance in a sample of Chinese immigrants. A literature review and two qualitative pilot studies were conducted to generate culturally sensitive instruments. Items were developed to assess cultural factors and medication compliance in Chinese immigrants receiving antihypertensive medications. Cultural factors included measures of cultural health perception of hypertension, health perceptions of Chinese herbs, health perceptions of Western medications, beneficial self-care behaviors, and social support. Four medication compliance scales were developed. The applicability of these scales was tested in a Chinese immigrant population (n=200). Cronbach's alpha for the cultural factors scales ranged from .57 to .91. Two of the medication compliance scales had Cronbach's alphas above .60. Results showed that most of the scales are applicable and acceptable in a Chinese immigrant population and had good reliability. However, further testing with a larger sample in other regions of the country is indicated.

  6. Migraine medication attributes are important for patient compliance.

    PubMed

    Massiou, Hélène

    2003-01-01

    The determinant of patient compliance with an anti-migraine drug is a complex alchemy. Studies of patient needs consistently show that pain freedom, speed of onset and no headache recurrence are important features of an anti-migraine product. Adverse events are important in migraine management, and concerns about them may significantly affect patient compliance. A high efficacy/tolerance ratio is definitely an essential factor, but irrational factors, such as the patient's expectations, knowledge, prejudices and concerns about the drug, may also interfere. Patients' worries about such events may instigate avoidance of prescription medicine that leads to increased intensity and duration of pain, an increased need to rest, reduced productivity and cancellation of social and work-related activities.

  7. [The influence of drug packaging on the drug-taking compliance of older patients living on their own].

    PubMed

    Schoberberger, Rudolf; Klik, Katharina; Korab, Tassilo; Kunze, Michael

    2007-01-01

    The present study is concerned with compliance and the possible influence thereon of drug packaging. Since most medications are prescribed for older persons, our target group was that of the over 70-year-olds otherwise usually excluded from participating as probands in clinical trials. Our method chose a study design that includes both the experience of a selected group of experts as well as the results of a field study. In the field study, 70 persons (18 male and 61 female), and 70-to-95 years of age participated in a face-to-face interview as well as in a test dealing with the handling of drug packaging. While the subjective patient responses provide a positive result with respect to compliance -- over 80% say that they take their medications regularly -- the data that were determined objectively within the framework of the test with selected medications showed deficiencies. The "medication test" carried out here shows impressively that child-proof packaging is also "age-proof" and, when used in the target group of older persons, can represent a considerable barrier to compliance.

  8. FDA/CVM's Compliance Policy Guide on compounding of drugs.

    PubMed

    1996-12-15

    As a veterinary practitioner, do you combine drug agents for anesthesia? Create antidotes? Dilute liquids for administration to small, young, or exotic species? Such efforts are examples of compounding. The FDA/CVM's new Compliance Policy Guide (CPG), which regulates the compounding of drugs by veterinarians and pharmacists for use in animals appears here, as originally published in the Compliance Policy Guide Manual. The CPG provides guidance to FDA's field and headquarters staff and serves as a source of useful information to veterinarians. The CPG for Compounding of Drugs for Use in Animals reflects the efforts of a task force made up of a diverse group of veterinarians, pharmacists, and regulators whose conclusions were published in the Symposium of Compounding in JAVMA, July 15, 1994, pp 189-303.

  9. 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), V1/F=15.3L, Q/F=0.61Lh(-1), and V2/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.

  10. 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…

  11. 49 CFR 1.50 - Office of Drug & Alcohol Policy & Compliance.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 49 Transportation 1 2014-10-01 2014-10-01 false Office of Drug & Alcohol Policy & Compliance. 1.50... POWERS AND DUTIES Office of the Secretary Ost Officials § 1.50 Office of Drug & Alcohol Policy & Compliance. The Office of Drug & Alcohol Policy & Compliance advises the Secretary on national...

  12. 49 CFR 1.50 - Office of Drug & Alcohol Policy & Compliance.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 49 Transportation 1 2012-10-01 2012-10-01 false Office of Drug & Alcohol Policy & Compliance. 1.50... POWERS AND DUTIES Office of the Secretary Ost Officials § 1.50 Office of Drug & Alcohol Policy & Compliance. The Office of Drug & Alcohol Policy & Compliance advises the Secretary on national...

  13. 49 CFR 1.50 - Office of Drug & Alcohol Policy & Compliance.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 49 Transportation 1 2013-10-01 2013-10-01 false Office of Drug & Alcohol Policy & Compliance. 1.50... POWERS AND DUTIES Office of the Secretary Ost Officials § 1.50 Office of Drug & Alcohol Policy & Compliance. The Office of Drug & Alcohol Policy & Compliance advises the Secretary on national...

  14. Compliance of psychotropic drug prescription with clinical practice guidelines in older inpatients.

    PubMed

    Etchepare, Fanny; Pambrun, Elodie; Bégaud, Bernard; Verdoux, Hélène; Tournier, Marie

    2016-02-01

    Several practice guidelines were published by French regulatory agencies between 2006 and 2009 to improve psychotropic drug use in older patients. The objectives of the study were to assess compliance with these guidelines in older patients hospitalized in psychiatric units and to identify characteristics associated with compliance. A cross-sectional study was conducted in 117 patients aged 65 years and older hospitalized in two psychiatric departments of a public hospital, at three dates randomly chosen between January and May 2014. Medical and sociodemographic characteristics were collected from electronic medical records. In all, 8% of psychotropic prescriptions were compliant with guidelines. A total of 98% of antidepressant prescriptions complied with guidelines for product selection (no tricyclics) and 72% for initial dosage (half of that recommended for younger adults). Regarding benzodiazepines, short half-life drugs were chosen in 73% of treatments, low maintenance dosage was found in 64% of treatments, and a discontinuous administration rhythm was noted in 33% of treatments. Regarding antipsychotics, initial dosage was a quarter of the allowed initial dosage for younger adults in 39% of prescriptions and metabolic blood testing was performed in 17% of prescriptions. Neurological and cognitive tolerance was monitored in 41% and 61% of prescriptions, respectively. Few clinical factors were found to be associated with compliance or noncompliance with guidelines in older psychiatric inpatients. Practice guidelines on psychotropic drug prescription were partially respected in older inpatients. Practitioners should take into account the risks associated with non-recommended patterns of psychotropic drug use in this vulnerable population.

  15. 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…

  16. Ensuring safe and quality medication use in nuclear medicine: a collaborative team achieves compliance with medication management standards.

    PubMed

    Beach, Trent A; Griffith, Karen; Dam, Hung Q; Manzone, Timothy A

    2012-03-01

    As hospital nuclear medicine departments were established in the 1960s and 1970s, each department developed detailed policies and procedures to meet the specialized and specific handling requirements of radiopharmaceuticals. In many health systems, radiopharmaceuticals are still unique as the only drugs not under the control of the health system pharmacy; however, the clear trend--and now an accreditation requirement--is to merge radiopharmaceutical management with the overall health system medication management system. Accomplishing this can be a challenge for both nuclear medicine and pharmacy because each lacks knowledge of the specifics and needs of the other field. In this paper we will first describe medication management standards, what they cover, and how they are enforced. We will describe how we created a nuclear medicine and pharmacy team to achieve compliance, and we will present the results of their work. We will examine several specific issues raised by incorporating radiopharmaceuticals in the medication management process and describe how our team addressed those issues. Finally, we will look at how the medication management process helps ensure ongoing quality and safety to patients through multiple periodic reviews. The reader will gain an understanding of medication management standards and how they apply to nuclear medicine, learn how a nuclear medicine and pharmacy team can effectively merge nuclear medicine and pharmacy processes, and gain the ability to achieve compliance at the reader's own institution.

  17. 75 FR 14448 - Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-25

    ... HUMAN SERVICES Food and Drug Administration 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. SUMMARY: The Food and Drug Administration (FDA) Los...

  18. 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

    ... drugs, devices, and biologics; as well as inspections of clinical investigators, IRBs, and research... HUMAN SERVICES Food and Drug Administration Food and Drug Administration Clinical Trial Requirements, Compliance, and Good Clinical Practice; Public Workshop AGENCY: Food and Drug Administration, HHS....

  19. 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

    ... HUMAN SERVICES Food and Drug Administration 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 and Drug Administration (FDA), Baltimore District Office,...

  20. Initial evaluation of low-dose phenobarbital as an indicator of compliance with antimalarial drug treatment.

    PubMed Central

    Karbwang, J.; Fungladda, W.; Pickard, C. E.; Shires, S.; Hay, A.; Feely, M.

    1998-01-01

    Since poor compliance with antimalarial therapy is often suspected but difficult to prove, this study attempted to establish a model for predicting the plasma concentration of phenobarbital (given in low doses in conjunction with the drug) as an indicator of compliance. Phenobarbital was chosen because its value had been demonstrated as a marker of compliance in long-course therapies, any significant departure from steady-state concentrations (achieved with full compliance) indicating one or more missed doses. Therapy for uncomplicated malaria varies from 5 days with artesunate to 7 days with quinine + tetracycline. Volunteers with confirmed falciparum malaria were randomized into 5 groups and given malaria therapy as well as phenobarbital daily for 3-7 days. Plasma samples for determination of phenobarbital concentrations were taken just prior to the daily dose of phenobarbital. Although there was a clear and predictable individual pattern of blood concentrations following each dose of phenobarbital, inter-individual variation in blood levels was significant and reduced their predictive value beyond the second day's dose. The cause of the variations is not clear; it could be attributable to different sources of the drug, previous intake of phenobarbital by the patient, or differences in drug absorption and disposition in malaria patients. Results for the 5-day artesunate regimen suggest that phenobarbital may be useful as a marker of compliance if the patient stops medication after 3 days; clear differences were evident at the end of the course of treatment between plasma phenobarbital concentrations in individuals completing the 5-day course and those who stopped after 3 days. For the quinine-tetracycline regimen, results suggest that it may be possible to discriminate between subjects where there is a 3-day difference in treatment. Phenobarbital is a better discriminant when dosing is every 24 hours as with artesunate, rather than the 8-hourly regimen for

  1. 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…

  2. Evaluation of a computer-assisted medication refill reminder system for improving patient compliance.

    PubMed

    Heard, C; Blackburn, J L; Thompson, M S; Wallace, S M

    1984-10-01

    Computer-generated refill reminder notices were mailed to patients receiving continual medication for cardiovascular diseases to measure improved compliance and to discover whether a computer-assisted program was economically viable. Guidelines were established to define compliance. A computer-assisted compliance intervention program did not significantly improve the rate at which patients had their prescriptions filled "on time" and the mean compliance rate for both experimental and control groups was greater than 79%. Also discussed were cost and compliance strategy implications and the receptiveness of patients to the reminder program.

  3. Patient compliance with crucial drug regimens: implications for prostate cancer.

    PubMed

    Urquhart, J

    1996-01-01

    Understanding of patient compliance with crucial drug regimens has improved markedly since 1986, based on data from two objective methods for monitoring drug dosing by ambulatory patients. Electronic monitoring records times and dates of drug package use, and chemical markers, incorporated into drug dosage forms, are assayed in plasma. These methods remove the camouflage that masks many poor compliers. In contrast, other methods (returned tablet counts, interviews, questionnaires) allow patients easily to censor evidence for delayed or omitted doses. The new methods show many more and larger errors of omission in both trials and practice than previously believed. One patient in about six is punctually compliant, but a modest majority of patients make errors probably too small to attenuate or otherwise modify the actions of all but the most unforgiving medicines. About a third of patients delay or omit many prescribed doses, thus attenuating or otherwise modifying the actions of all but the most forgiving drugs. One patient in about six takes little medicine, though camouflaged as a good complier. Similar patterns of delayed and omitted does prevail, essentially independent of drug, disease, prognosis, or symptoms. In summary, patients take the prescribed dose at intervals longer than prescribed--often by hours, sometimes by days, occasionally by weeks. The clinical and economic consequences of these lapses in dosing are unique to the treatment situation and the severity of disease and comorbidity. The new methods have not yet been applied to androgen-blocking agents, but if the findings resemble those with, e.g. tamoxifen in breast cancer, it will doubtless trigger some rethinking about failed treatment, trial design, and clinical management.

  4. Predictors of medication compliance after hospital discharge in adolescent psychiatric patients.

    PubMed

    Lloyd, A; Horan, W; Borgaro, S R; Stokes, J M; Pogge, D L; Harvey, P D

    1998-01-01

    Failure in medication compliance in adult psychiatric patients is often found to be due to side effects or associated with unawareness of illness. Little research has been conducted on medication compliance in adolescent psychiatric patients. In this study, 97 adolescent psychiatric patients, including 46 with substance abuse, were followed up an average of 14 months after their discharge from inpatient psychiatric care. Compliance with prescribed medications was examined and the association between several potential predictors and compliance was examined. The overall rate of medication compliance was only 38% at 14-month follow-up, whereas the rate of patients stopping their medications because of side effects was only 23%. Significant predictors of compliance failures were general noncompliance with the discharge plan, followed by postdischarge substance abuse. Side effects did not contribute any additional variance when these factors were considered. These data suggest that medication compliance may be adversely impacted by general tendencies toward noncompliance with treatment, which may be mediated by several possible factors. Interventions to increase awareness of the need for psychotropic medications as well as careful monitoring for substance abuse relapse in this population are suggested.

  5. Development of a structural model explaining medication compliance of persons with schizophrenia.

    PubMed

    Seo, Mi A; Min, Sung Kil

    2005-06-30

    The purpose of this study was to develop and test a structural model explaining medication compliance of schizophrenia. From a review of the literature, a hypothetical model was developed based on the conceptual framework of the Health Belief Model with medication knowledge, symptom severity and social support as the exogenous variables, and perceived benefits, perceived barriers, substance use and medication compliance as the endogenous variables. Data was collected at various mental health facilities, including psychiatric outpatient clinics of general hospitals and community mental health centers, between March and May, 2001. A structured questionnaire was used by one- on- one interviews to collect data on 208 schizophrenic patients. Well established measurement instruments, with confirmed reliability, were used to assess each method variable. As a result of covariance structural analysis, the hypothetical model was found not to fit the empirical data well, so a parsimonious model was adopted after modifying the model. The final model was able to explain the 33 % medication compliance. Medication knowledge, social support and perceived benefits had significant effects on medication compliance. The findings of this study address the importance of medication education and social support to promote medication compliance. It is also suggested that various education programs and support groups are needed to enhance medication compliance.

  6. Monitoring one-year compliance to antihypertension medication in the Seychelles.

    PubMed Central

    Bovet, Pascal; Burnier, Michel; Madeleine, George; Waeber, Bernard; Paccaud, Fred

    2002-01-01

    OBJECTIVE: To examine the compliance to medication among newly diagnosed hypertensive patients screened from the general population of the Seychelles, a rapidly developing country. METHODS: Among the 1067 participants to a population-based survey for cardiovascular risk factors, hypertension was discovered in 50 (previously unaware of having hypertension and having blood pressure > or = 160/95 mmHg over 3 visits). These 50 patients were placed on a daily one-pill regimen of medication (bendrofluazide, atenolol, or a combination of hydrochlorothiazide and atenolol) and compliance to the regimen was assessed over 12 months using electronic pill containers. Satisfactory compliance was defined as taking the medication on 6 or 7 days a week on average (which corresponds to a mean compliance level of > or = 86%). FINDINGS: In the first month, fewer than half (46%) of the new hypertension patients achieved satisfactory compliance, and only about one-quarter (26%) achieved this level by the twelfth month. Compliance was better among the 23 participants who regularly attended medical follow-up, with nearly three-quarters of these patients (74%) achieving satisfactory compliance during the first month and over one-half (55%) by the twelfth month. There was a direct association between mean 12-month compliance level and having a highly skilled occupation; having good health awareness; and regularly attending medical appointments. In contrast, there was an inverse relationship between mean compliance level and heavy drinking. CONCLUSION: The low proportion of people selected from the general population who were capable of sustaining satisfactory compliance to antihypertension medication may correspond to the maximum effectiveness of medication interventions based on a screening and treatment strategy in the general population. The results stress the need for both high-risk and population approaches to improve hypertension control. PMID:11884971

  7. 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.

  8. 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…

  9. 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.…

  10. 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

  11. Medical imaging in new drug clinical development.

    PubMed

    Wang, Yi-Xiang; Deng, Min

    2010-12-01

    Medical imaging can help answer key questions that arise during the drug development process. The role of medical imaging in new drug clinical trials includes identification of likely responders; detection and diagnosis of lesions and evaluation of their severity; and therapy monitoring and follow-up. Nuclear imaging techniques such as PET can be used to monitor drug pharmacokinetics and distribution and study specific molecular endpoints. In assessing drug efficacy, imaging biomarkers and imaging surrogate endpoints can be more objective and faster to measure than clinical outcomes, and allow small group sizes, quick results and good statistical power. Imaging also has important role in drug safety monitoring, particularly when there is no other suitable biomarkers available. Despite the long history of radiological sciences, its application to the drug development process is relatively recent. This review highlights the processes, opportunities, and challenges of medical imaging in new drug development.

  12. Medical Consequences of Drug Abuse

    MedlinePlus

    ... Trends and Alerts Alcohol Club Drugs Cocaine Hallucinogens Heroin Inhalants Marijuana MDMA (Ecstasy/Molly) Methamphetamine Opioids Prescription ... Public Health What Can We Do About the Heroin Overdose Epidemic? NIDA's Publication Series Brain Power DrugFacts ...

  13. Potential Drug - Drug Interactions among Medications Prescribed to Hypertensive Patients

    PubMed Central

    Ganguly, Barna

    2014-01-01

    Context: Drug-drug interactions(DDIs) are significant but avoidable causes of iatrogenic morbidity and hospital admission. Aim: To detect potential drug-drug interactions among medications received by hypertensive patients. Materials and Methods: Patients of both sex and all adult age groups, who were attending medicine out -patient department (OPD) of a tertiary care teaching rural hospital since last six months and were being prescribed antihypertensive drug/s for essential hypertension, were selected for the study. Hypertensive patient with co-morbities diabetes mellitus, ischemic heart diseases, congestive heart failure, and chronic renal diseases were also included in the study. Potential drug drug interactions were checked with medscape drug interaction software. Results: With the help of medscape drug interaction software, 71.50% prescriptions were identified having atleast one drug-drug interaction. Total 918 DDIs were found in between 58 drug pairs. 55.23% DDIs were pharmacodynamic, 4.79% pharmacokinetic type of DDIs. 32.24% DDIs were found affecting serum potassium level. 95.42% DDIs were found significant type of DDIs. Drug drug interaction between atenolol & amlodipine was the most common DDI (136) followed by metoprolol and amlodine (88) in this study. Atenolol and amlodipine ( 25.92%) was the most common drugs to cause DDIs in our study. Conclusion: We detected a significant number of drug drug interaction in hypertensive patients. These interactions were between antihypertensive agents or between hypertensive and drug for co-morbid condition. PMID:25584241

  14. [Treatment with tuberculostatic drugs: compliance at a general hospital].

    PubMed

    Polo Friz, H; Kremer, L; Acosta, H; Abdala, O; Canova, S; Rojo, S; Roca, G; Daín, A

    1997-01-01

    The purpose of this study was to assess the compliance with tuberculostatic drugs treatment in a public hospital from Córdoba City and to establish the causes of noncompliance. All the patients to which treatment with tuberculostatic drugs was indicated from January 1991 up to December 1994 were included. 45 patients were included: 18 females (40%) and 29 males. Sixteen (35.6%) did not complete the time of treatment indicated. Nine (56.3%) abandoned the treatment 2 months after having initiated it. In the group that did not complete the treatment there was a higher percentage of female patients (62.5%) than in the group that did complete it (27.6%), p = 0.02. There were not statistically significant differences in age, percentages of pulmonar and extrapulmonar tuberculosis and months of treatment indicated between both groups. Thirty-six percent of the patients who abandoned the treatment referred having interrupted it due to their own negligency, knowing the risk of such behavior; 36% suffered side effects and did not come back to hospital; 21% referred having consulted another physician who indicated to interrupt the treatment without performing other tests; and 7% misunderstood the indications. It is concluded that in a general hospital from Córdoba City, the percentage of patients who abandoned tuberculostatic treatment is high. In most cases the cause was related to failures in the conduct of patients, physicians or both.

  15. 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.)

  16. ESTABLISHING COMPLIANCE WITH LIQUID MEDICATION ADMINISTRATION IN A CHILD WITH AUTISM

    PubMed Central

    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. PMID:21709797

  17. Compliance with antihypertensive medication in Chinese immigrants: cultural specific issues and theoretical application.

    PubMed

    Li, Wen-Wen; Stotts, Nancy A; Froelicher, Erika Sivarajan

    2007-01-01

    This paper presents a theoretical framework to study medication compliance in Chinese immigrants with hypertension (HTN). The framework was developed from (a) literature review of medication compliance and Chinese cultural belief/practices and (b) critique of major models of health behaviors in persons with chronic illness. Four constructs shape the model: motivation, cultural health perceptions, modifying factors, and cultural health care activities. Among these constructs, cultural health perceptions and health care activities are especially important because these address how Chinese immigrants perceive HTN and antihypertensive treatments and how they manage HTN. Using a culturally sensitive model is important to guide studies of medication compliance in this population and to assist health care providers to support compliance with antihypertensive treatments for Chinese immigrants.

  18. 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

  19. 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.

  20. Determination of clozapine in serum of patients with schizophrenia as a measurement of medication compliance.

    PubMed

    Mennickent, S; Sobarzo, A; Vega, M; de Diego, M; Godoy, G; Rioseco, P; Saavedra, L

    2010-03-01

    Abstract Although antipsychotic drugs have been effective in reducing symptoms of schizophrenia, issues with adherence to these agents continue to be a barrier to the implementation and delivery of a successful treatment plan. An estimated 25% of patients with schizophrenia are partially adherent or non-adherent within 7-10 days of beginning therapy. There are some ways to evaluate the pharmacotherapy adherence of the patients: evaluation of the disease symptoms and/or the side effects of the drugs, questionnaires to evaluate quality of life, patient attitude toward his (her) drugs and pill counts. Although these methods represent a good option, they are subjective; for example, if the patients lie this leads to false results. Drug monitoring of patients' biological fluids can be a useful tool to evaluate adherence by relating the serum or plasma levels of drugs with pharmacotherapy compliance. The aim of this study was to determine if serum clozapine levels are a suitable method for evaluating patient adherence to clozapine therapy. Clozapine concentration was determined in serum of 26 volunteer patients who were using this drug as pharmacotheraphy for 6 months to 5 years (steady state conditions at 7-10 days of treatment with the drug). The analysis was done for 6 months, with three samples taken for each patient during this time, relating clozapine serum concentration of lower than therapeutic range with pharmacotherapy non-adherence of patients. Moreover, we compared the evaluation of the pharmacotherapy adherence from serum levels of the drug, with the evaluation of the pharmacotherapy adherence from an indirect tool to evaluate symptoms of disease. Twelve patients were found non-adherent by clozapine serum concentration (46.15%), whereas eight patients were found non-adherent using clinician questionnaire (30.76%). After to evaluate some factors (cigarettes, co-medication, inter-individual variability) that could give different results of adherence from

  1. Medication compliance and serum lipid changes in the Helsinki Heart Study.

    PubMed Central

    Mäenpää, H; Heinonen, O P; Manninen, V

    1991-01-01

    1. To control the bias caused by poor medication compliance in the Helsinki Heart Study three methods were used to measure medication compliance during the total 5 years follow up time: continuous capsule counting, semi-annual urine gemfibrozil analysis and a new method, the digoxin marker at the end of the third and fifth study years. 2. The serum lipid responses to gemfibrozil treatment varied linearly with the level of medication compliance, e.g. the mean change in serum total cholesterol was -11.4% among those whose apparent capsule consumption was greater than or equal to 90% of the scheduled dosage, -11.2% among those who had greater than or equal to 90% positive gemfibrozil analyses and -11.4% among those with good compliance according to both digoxin marker measurements. In contrast the mean serum cholesterol change was only -0.02% if the mean daily capsule count was less than 50%, -1.7% with fewer than 50% positive gemfibrozil analyses and -1.1% if the result was poor in both digoxin marker measurements. 3. Combining the different method findings revealed that the cholesterol changes tended to be small in those groups who had poor compliance classification measured by any of the methods, even if the other results showed good compliance. PMID:1958432

  2. Medical Management of Drug-Resistant Tuberculosis.

    PubMed

    Jeon, Doosoo

    2015-07-01

    Drug-resistant tuberculosis (TB) is still a major threat worldwide. However, recent scientific advances in diagnostic and therapeutic tools have improved the management of drug-resistant TB. The development of rapid molecular testing methods allows for the early detection of drug resistance and prompt initiation of an appropriate treatment. In addition, there has been growing supportive evidence for shorter treatment regimens in multidrug-resistant TB; and for the first time in over 50 years, new anti-TB drugs have been developed. The World Health Organization has recently revised their guidelines, primarily based on evidence from a meta-analysis of individual patient data (n=9,153) derived from 32 observational studies, and outlined the recommended combination and correct use of available anti-TB drugs. This review summarizes the updated guidelines with a focus on the medical management of drug-resistant TB.

  3. A cross-sectional study on compliance with topical glaucoma medication and its associated socioeconomic burden for a Chinese population

    PubMed Central

    Lui, Man-Hin; Lam, Jason Chun Ho; Kwong, Yi Lee; Wong, Tak Siu; Cheung, Pak Long; Lai, Sherri Shun Yan; Yuen, Pak Lun; Lam, Wai Yiu; Chan, Ho Yan; Wong, Yiu Fai; Lai, Jimmy Shiu Ming; Shih, Kendrick Co

    2017-01-01

    AIM To estimate the overall drug compliance for local Chinese glaucoma patients on long-term topical treatment. METHODS This was a retrospective cross-sectional study. Fifty-seven primary glaucoma patients from the subspecialty clinic of a publicly-funded tertiary care hospital in Hong Kong completed a questionnaire on compliance with topical glaucoma medication, attitude towards glaucoma and therapy and vision related quality of life. Noncompliance was defined as reporting missing more than or equal to 10% of the prescribed topical glaucoma medication during the 2wk immediately prior to the consultation. Relationships between noncompliance and demographics, attitude, disease and treatment status was studied. Cost was estimated with quality of life and direct medical cost involved with noncompliance. Multivariable logistic regression on noncompliance was performed on selected factors. RESULTS Compliance was calculated as 75% (95% CI: 64%-87%) among 57 subjects (mean age 69y, female 51%). No statistical significant relationship was established between noncompliance and any single factors or outcomes. Age (P=0.048) and forgetfulness (P=0.064) were found to be marginally significant predictive factors on noncompliance in multivariable logistic regression. Noncompliance might be related (P=0.130) to poorer self-rated vision-associated quality of life. The societal cost of noncompliance was estimated to be over 2510 life-years and US$ 3.7 million territory-wide. CONCLUSION The compliance of Chinese glaucoma patients in Hong Kong is comparable to other parts in the world, and carries detrimental impacts on individual and societal levels. Age and forgetfulness are two possible independent predictors for noncompliance. PMID:28251091

  4. Use of home blood pressure monitoring and exercise, diet and medication compliance in Japan.

    PubMed

    Saito, Ikuo; Nomura, Motoko; Hirose, Hiroshi; Kawabe, Hiroshi

    2010-07-01

    Little is known about the attitudes of doctors and patients to the use of home blood pressure monitoring (HBPM) and its relationship with compliance to exercise, diet, and antihypertensive medication and blood pressure (BP) control. We conducted a cross-sectional internet survey in treated patients with hypertension in Japan. Overall, 500 questionnaires were returned; 292 respondents (58.4%) reported that their doctor had recommended HBPM and among them 106 (36.3%) reported satisfactory adherence to HBPM. Compared to patients with poor adherence to HBPM, patients with satisfactory adherence to HBPM were more likely to have satisfactory compliance with exercise, diet and medication but no significant difference in BP control.

  5. Medical devices; reconditioners, rebuilders of medical devices; revocation of compliance policy guide; request for comments--FDA. Notice.

    PubMed

    1998-12-04

    The Food and Drug Administration (FDA) is revoking Compliance Policy Guide (CPG) 7124.28 because application of current good manufacturing practice (CGMP) requirements to "reconditioners/rebuilders" of used medical devices does not comport with definitions in the quality system (QS) regulation or guidance in the final rule that applies CGMP requirements to "manufacturers" and "remanufacturers." Because "reconditioners/rebuilders" are specifically excluded from the definition of "manufacturer" or "remanufacturer" in the QS regulation, guidance in the CPG on the applicability of registration, listing, and other statutory and regulatory requirements to "reconditioners/rebuilders" does not represent current agency thinking. In the advance notice of proposed rulemaking (ANPRM), published in the December 23, 1997, Federal Register, FDA announced its intention to consider identifying the used device market, for regulatory purposes, in terms of "refurbishers," "as-is remarketers," and "servicers" whose activities do not significantly change the safety, performance, or use of a device, and to examine alternative approaches for regulating these firms. Pending the issuance of a rule or guidance setting forth FDA's current position, CPG 7124.28 is being revoked to eliminate obsolete guidance and reduce industry burdens.

  6. 77 FR 18830 - Small Entity Compliance Guide: Further Amendments to General Regulations of the Food and Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-28

    ... HUMAN SERVICES Food and Drug Administration Small Entity Compliance Guide: Further Amendments to General Regulations of the Food and Drug Administration To Incorporate Tobacco Products; Availability AGENCY: Food and... the Food and Drug Administration to Incorporate Tobacco Products--Small Entity Compliance Guide''...

  7. 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.

  8. DRUG-DRUG INTERACTION PROFILES OF MEDICATION REGIMENS EXTRACTED FROM A DE-IDENTIFIED ELECTRONIC MEDICAL RECORDS SYSTEM

    PubMed Central

    Butkiewicz, Mariusz; Restrepo, Nicole A.; Haines, Jonathan L.; Crawford, Dana C.

    2016-01-01

    With age, the number of prescribed medications increases and subsequently raises the risk for adverse drug-drug interactions. These adverse effects lower quality of life and increase health care costs. Quantifying the potential burden of adverse effects before prescribing medications can be a valuable contribution to health care. This study evaluated medication lists extracted from a subset of the Vanderbilt de-identified electronic medical record system. Reported drugs were cross-referenced with the Kyoto Encyclopedia of Genes and Genomes DRUG database to identify known drug-drug interactions. On average, a medication regimen contained 6.58 medications and 2.68 drug-drug interactions. Here, we quantify the burden of potential adverse events from drug-drug interactions through drug-drug interaction profiles and include a number of alternative medications as provided by the Anatomical Therapeutic Chemical Classification System. PMID:27570646

  9. Potential barriers in adoption of a medication compliance neckwear by elderly population.

    PubMed

    Choi, Young Mi; Olubanjo, Temiloluwa; Farajidavar, Aydin; Ghovanloo, Maysam

    2013-01-01

    This paper presents results of a study to understand potential barriers of geriatric population with chronic illnesses towards adoption of a wireless wearable medication compliance system in the form of a neckwear. The neck being a critical part of the body can serve as a good source to collect a range of health related information on an individual. The primary research question we investigate here is this: for individuals with chronic illnesses especially amongst the elderly population how willing are they to adopt a neckwear system if it can monitor and mitigate health complications? Elderly patients deal with constant prescription changes over time and this further degrades medication compliance and thereby complicates an already wavering health status. A semi-structured interview was conducted to better understand medication adherence, regimen and issues encountered using reminder devices with the goal of informing the design of a new compliance monitoring system. Results show that preserving health is one of the primary concerns of people living with chronic illnesses therefore there is a promising potential for seamless adoption of a neckwear medication compliance system with additional capabilities to monitor general health status.

  10. 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…

  11. Developing medical device software in compliance with regulations.

    PubMed

    Zema, M; Rosati, S; Gioia, V; Knaflitz, M; Balestra, G

    2015-08-01

    In the last decade, the use of information technology (IT) in healthcare has taken a growing role. In fact, the adoption of an increasing number of computer tools has led to several benefits related to the process of patient care and allowed easier access to social and health care resources. At the same time this trend gave rise to new challenges related to the implementation of these new technologies. Software used in healthcare can be classified as medical devices depending on the way they are used and on their functional characteristics. If they are classified as medical devices they must satisfy specific regulations. The aim of this work is to present a software development framework that can allow the production of safe and high quality medical device software and to highlight the correspondence between each software development phase and the appropriate standard and/or regulation.

  12. 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

  13. Physician and Patient Perceptions of Cultural Competency and Medical Compliance

    ERIC Educational Resources Information Center

    Ohana, S.; Mash, R.

    2015-01-01

    To examine the relationship between the different perceptions of medical teams and their patients of the cultural competence of physicians, and the influence of this relationship on the conflict between them. Physicians' cultural competence (Noble A. Linguistic and cultural mediation of social services. Cultural competence of health care.…

  14. [An alarming threat to secondary prevention: low compliance (lifestyle) and poor adherence (drugs)].

    PubMed

    Fuster, Valentín

    2012-07-01

    The deteriorating health of the general population and the increasing prevalence of chronic disease combine to present a problem of global proportions whose causes are both multifactorial and complex. The consumer society we live in does not encourage healthy living, and the consequences are even most devastating when social inequalities, the economic situation and the population explosion in recent decades are taken into account. The growth of poor eating habits, obesity, and hypertension are relentlessly contributing to the development of an epidemic of cardiovascular disease. In this context, the ability of national and international bodies and regulatory agencies to have an effect on commercial interests is very limited and alternative ways of reducing the disease burden are needed. Recent studies on patient compliance with lifestyle changes and on adherence to prescribed medication have produced alarming findings. Over 50% of patients, on average, choose to abandon the treatment they have been prescribed, and the percentage that achieve the targets proposed for improving habitual behaviors (e.g. quitting smoking, losing weight or increasing physical activity) is similar or lower. It is essential that solutions to these problems are found because, in addition to their implications for the health of the individual, poor compliance and adherence threaten to undermine the relevance of clinical study findings and are associated with substantial economic costs, given that they result in the failure to achieve therapeutic goals and increase rates of hospitalization and death. Improved communication between doctors and patients, the active participation of other health professionals and the development of combination drug formulations (e.g. the polypill) appear to be the most promising strategies for improving patient adherence to treatment and reducing the economic burden.

  15. Compliance and concordance during domiciliary medication review involving pharmacists and older people.

    PubMed

    Salter, Charlotte

    2010-01-01

    Medication review is an advanced service registered pharmacists can now offer patients in the UK. This in-depth study of pharmacist-older patient communication during domiciliary medication review encounters examines how the interactions are constructed by participants and the influence of the compliance paradigm on the interaction. Twenty-nine observed, taped and transcribed consultations were analysed using discourse analysis. Ethnographic-style interviews in the field with pharmacists, follow-up interviews with patients and feedback workshops with pharmacists allowed interpretations to be tested and strengthened. The findings presented here use discourse analysis to look at the task-driven nature of the medication review encounters. The analysis explores the interactional format of three over-lapping phases of the consultations: (i) introductions and agenda setting; (ii) screening and testing patients' ability to comply; and, (iii) investigating over-the-counter medicines. Analysis suggests that a dominant compliance paradigm encourages pharmacist-led encounters with patients failing to engage in the medication review process. Little evidence of two-way reciprocated discussion or concordance was evident. The strategic nature of the discourse of compliance heard in these medication review encounters and its effect on older patients are discussed. The paper concludes with a consideration of the implications for pharmacy practice and policy development.

  16. [Medication error due to drug packaging: a case report].

    PubMed

    Hélène', Ginestet; David, Breton; Sophie, Spadoni; Vincent, Jandard; Michel, Paillet; Xavier, Bohand

    2009-12-01

    Nowadays, occurrence of medication errors is a public health concern at hospital. Drug packaging represent one of the important causes of medication errors. The authors report a medication error associated with an erroneous interpretation of drug packaging information. This error was detected during the pharmaceutical review of the medical prescription. The nursing staff in charge of drug administering must thus be particularly aware of this risk. The potential clinical significance of this type of medication error may be important.

  17. 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

  18. Improving medication compliance of a patient with schizophrenia through collaborative behavioral therapy.

    PubMed

    Heinssen, Robert K

    2002-03-01

    Introduction by the column editors: Numerous factors influence a patient's decision to accept or reject prescribed medications, including the patient's personal values, environmental conditions, and the quality of the patient-physician relationship (1). Guidelines for evaluating and managing noncompliance with medication regimens by patients with schizophrenia take this multidimensional perspective into account, emphasizing functional assessment of nonadherence behaviors and individualized behavior-change strategies to secure and maintain the patient's cooperation (2). Moreover, a collaborative approach to planning pharmacotherapy is required to ensure medication compliance, with a particular emphasis on linking the positive effects of medications with the patient's personal goals and desires for better functioning and quality of life (3). The following case study illustrates the application of principles for enhancing medication compliance in the treatment of a woman diagnosed as having schizophrenia, paranoid type. Strategies presented by Dr. Heinssen include collaborative treatment contracts, analysis of adherence behaviors, and techniques for boosting medication cues and reinforcers in the patient's home. The therapy described was provided in the Life Skills partial hospitalization and psychiatric rehabilitation program, a multidisciplinary, multilevel outpatient service of the now-closed Chestnut Lodge Hospital in Rockville, Maryland. The program integrated medical, social-learning, and cognitive-behavioral interventions for psychosis within a psychiatric rehabilitation framework.

  19. Compliance with the Prescription of Antihypertensive Medications and Blood Pressure Control in Primary Care

    PubMed Central

    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

    2017-01-01

    Background 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. Objective 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. Methods 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. Results 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. Conclusions 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. PMID:28327875

  20. Strategies for improving patient compliance.

    PubMed

    Strand, J

    1994-01-01

    Achieving patient compliance in taking prescribed medications is a formidable challenge for all clinicians. As PAs, we have daily opportunities to communicate with patients and improve their compliance. An office-based compliance program, combining patient education and behavior-modification components, can be beneficial in this regard. Strategies for improving compliance include giving clear, concise, and logical instructions in familiar language, adapting drug regimens to daily routines, eliciting patient participation through self-monitoring, and providing educational materials that promote overall good health in connection with medical treatment.

  1. 27 CFR 17.136 - Compliance with Food and Drug Administration requirements.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... products manufactured solely for export or for uses other than internal human consumption (e.g. tobacco... 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...

  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. 21 CFR 898.13 - Compliance dates.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PERFORMANCE STANDARD FOR ELECTRODE LEAD WIRES AND PATIENT CABLES § 898.13 Compliance dates. The dates for compliance with the standard set forth in § 898.12(a) shall be as follows: (a) For electrode lead wires...

  4. 21 CFR 898.13 - Compliance dates.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PERFORMANCE STANDARD FOR ELECTRODE LEAD WIRES AND PATIENT CABLES § 898.13 Compliance dates. The dates for compliance with the standard set forth in § 898.12(a) shall be as follows: (a) For electrode lead wires...

  5. 21 CFR 898.13 - Compliance dates.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PERFORMANCE STANDARD FOR ELECTRODE LEAD WIRES AND PATIENT CABLES § 898.13 Compliance dates. The dates for compliance with the standard set forth in § 898.12(a) shall be as follows: (a) For electrode lead wires...

  6. 77 FR 52741 - Compliance Policy Guide Sec. 420.300 Changes in Compendial Specifications and New Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-30

    ... HUMAN SERVICES Food and Drug Administration Compliance Policy Guide Sec. 420.300 Changes in Compendial Specifications and New Drug Application Supplements; Withdrawal of Guidance AGENCY: Food and Drug Administration, HHS. ACTION: Notice; withdrawal. SUMMARY: The Food and Drug Administration (FDA) is announcing...

  7. 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…

  8. The Role of Personal Opinions and Experiences in Compliance with Mass Drug Administration for Lymphatic Filariasis Elimination in Kenya

    PubMed Central

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

    2012-01-01

    Background 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. Methods/Findings 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

  9. Medication monitoring and drug testing ethics project.

    PubMed

    Payne, Richard; Moe, Jeffrey L; Sevier, Catherine Harvey; Sevier, David; Waitzkin, Michael

    2015-01-01

    In 2012, Duke University initiated a research project, funded by an unrestricted research grant from Millennium Laboratories, a drug testing company. The project focused on assessing the frequency and nature of questionable, unethical, and illegal business practices in the clinical drug testing industry and assessing the potential for establishing a business code of ethics. Laboratory leaders, clinicians, industry attorneys, ethicists, and consultants participated in the survey, were interviewed, and attended two face-to-face meetings to discuss a way forward. The study demonstrated broad acknowledgment of variations in the legal and regulatory environment, resulting in inconsistent enforcement of industry practices. Study participants expressed agreement that overtly illegal practices sometimes exist, particularly when laboratory representatives and clinicians discuss reimbursement, extent of testing, and potential business incentives with medical practitioners. Most respondents reported directly observing probable violations involving marketing materials, contracts, or, in the case of some individuals, directly soliciting people with offers of clinical supplies and other "freebies." While many study respondents were skeptical that voluntary standards alone would eliminate questionable business practices, most viewed ethics codes and credentialing as an important first step that could potentially mitigate uneven enforcement, while improving quality of care and facilitating preferred payment options for credentialed parties. Many were willing to participate in future discussions and industry-wide initiatives to improve the environment.

  10. 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

  11. When drugs don't work: economic assessment of enhancing compliance with interventions supported by electronic monitoring devices.

    PubMed

    Hughes, Dyfrig

    2007-01-01

    Non-compliance with prescribed regimens poses a significant problem in clinical therapeutics - patients who do not take their medications according to the labelling instructions are at higher risk of treatment failure, and this may have adverse effects on health outcome and healthcare costs. There is increasing evidence on strategies aimed at improving compliance, but most studies do not implement an unbiased technique for measuring compliance. Patients and clinicians alike are notoriously unreliable in assessing compliance; the use of electronic compliance-monitoring devices (ECMDs) is one of the most robust ways to identify non-compliance and assess the effectiveness of interventions aimed at promoting compliance. ECMDs may also form a part of the intervention, by allowing the health professional to provide feedback to the patient on his/her dosing history. This approach has been referred to as a 'measurement-guided medication management (MGMM) programme'.This article reviews the evidence on the effectiveness of MGMM programmes based on ECMDs, and sets out a framework for assessing their economic value. Existing studies focus primarily on the impact of MGMM programmes on compliance. However, to generalise to other settings, including routine practice, further evidence is required on their clinical and cost effectiveness. Specifically, more studies are required to assess whether the observed improvements in compliance translate to improvements in health outcomes, and whether these may be achieved in a cost-effective manner.

  12. 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.

  13. 76 FR 58398 - Revised Guidance on Marketed Unapproved Drugs; Compliance Policy Guide Sec. 440.100; Marketed New...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-21

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Chapter I Revised Guidance on Marketed Unapproved...; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of compliance policy guide. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a revised guidance...

  14. 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...

  15. 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

    ... 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...

  16. 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

    ... 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...

  17. 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...

  18. 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...

  19. Integrated data acquisition system for medical device testing and physiology research in compliance with good laboratory practices.

    PubMed

    Koenig, Steven C; Woolard, Cary; Drew, Guy; Unger, Lauren; Gillars, Kevin; Ewert, Dan; Gray, Laman; Pantalos, George

    2004-01-01

    In seeking approval from the US Food and Drug Administration (FDA) for clinical trial evaluation of an experimental medical device, a sponsor is required to submit experimental findings and support documentation to demonstrate device safety and efficacy that are in compliance with Good Laboratory Practices (GLP). The objective of this project was to develop an integrated data acquisition (DAQ) system and documentation strategy for monitoring and recording physiological data when testing medical devices in accordance with GLP guidelines mandated by the FDA. Data aquisition systems were developed as stand-alone instrumentation racks containing transducer amplifiers and signal processors, analog-to-digital converters for data storage, visual display and graphical user-interfaces, power conditioners, and test measurement devices. Engineering standard operating procedures (SOP) were developed to provide a written step-by-step process for calibrating, validating, and certifying each individual instrumentation unit and the integrated DAQ system. Engineering staff received GLP and SOP training and then completed the calibration, validation, and certification process for the individual instrumentation components and integrated DAQ system. Eight integrated DAQ systems have been successfully developed that were inspected by regulatory affairs consultants and determined to meet GLP guidelines. Two of these DAQ systems were used to support 40 of the pre-clinical animal studies evaluating the AbiCor artificial heart (ABIOMED, Danvers, MA). Based in part on these pre-clinical animal data, the AbioCor clinical trials began in July 2001. The process of developing integrated DAQ systems, SOP, and the validation and certification methods used to ensure GLP compliance are presented in this article.

  20. 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…

  1. Influence of signal colored hand disinfectant dispensers on hand hygiene compliance at a medical intensive care unit.

    PubMed

    Scheithauer, Simone; Häfner, Helga; Schröder, Jörg; Nowicki, Katharina; Lemmen, Sebastian

    2014-08-01

    To assess the influence of signal colors on hand disinfectant dispenser activities, health care workers (HCWs) at a medical intensive care unit were analyzed for a total of 20 weeks with 8 weeks before and 12 weeks after exchange to signal color. No significant increase in hand rubs (HRs) per patient day (PD) was observed (about 40 HRs/PD); however, HCW-adjusted compliance showed a 6% increase with signal colored devices. Therefore, colored devices may help to improve hand hygiene compliance.

  2. Expectant Israeli fathers and the medicalized pregnancy: ambivalent compliance and critical pragmatism.

    PubMed

    Ivry, Tsipy; Teman, Elly

    2008-09-01

    This article addresses the medicalization of pregnancy in Israel and its effects on the experiences of Jewish-Israeli men who participated in various stages of their female partners' prenatal care. The highly medicalized arena of Israeli prenatal care, with its strong emphasis on prenatal diagnostic testing, provided the context in which the men's accounts of their interactions with reproductive biomedical authority, practitioners and knowledge were understood. It is suggested that the anthropological scholarship on reproduction assumes that men benefit from the medicalization of pregnancy and birth and comply with medicalization. Women, on the other hand, are often depicted as being subjected to harmful medical surveillance and responding to it in degrees, ranging from compliance to resistance, and mediated by pragmatism. Data derived from participant observation in multiple arenas and from 16 in-depth interviews with Israeli men whose female partners were pregnant or had recently given birth suggest that although some Israeli men regard the biomedicalization of pregnancy positively, most tend toward varying degrees of criticism. It is suggested that men's responses to reproductive biomedicine are far more complex than portrayed to date in the existing scholarship and that men's responses to biomedicalization reveal complex power negotiations.

  3. Six-month compliance with antidepressant medication in the treatment of major depressive disorder.

    PubMed

    Demyttenaere, Koen; Adelin, Albert; Patrick, Mesters; Walthère, Dewé; Katrien, De Bruyckere; Michèle, Sangeleer

    2008-01-01

    The investigation of compliance in patients with major depressive disorder (in drop-outs versus completers and in first episode versus recurrent episode patients). A total of 85 outpatients with major depressive disorder were followed for 6 months. Different dimensions of compliance were investigated: drop-outs versus completers and their medication adherence (with electronic monitoring). General linear mixed models were applied to examine the time courses of adherence. Drop-out rates were higher in younger patients and in patients with a lower initial depression severity. The adherence during 6 months of treatment with selective serotonin reuptake inhibitors was above 80 in 70% of the patients. The adherence decreased by 2.5% per month and decreased more than three times more rapidly in drop-outs (from baseline to time of drop-out). A medical visit resulted in a temporary increase in pill intake. General linear mixed model analysis showed that the predicted outcome was worse in drop-outs than in completers and worse in recurrent episode patients than in first episode patients (the former showing a higher adherence). Adherence decreases with time during 6 months of treatment with antidepressants and is influenced by demographic and clinical variables. Completers show a higher adherence than drop-outs. The outcome was worse in recurrent episode patients than first episode patients although they had a higher adherence.

  4. 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.

  5. No payments, copayments and faux payments: are medical practitioners adequately equipped to manage Medicare claiming and compliance?

    PubMed

    Faux, M A; Wardle, J L; Adams, J

    2015-02-01

    The complexity of Medicare claiming means it is often beyond the comprehension of many, including medical practitioners who are required to interpret and apply Medicare every day. A single Medicare service can be the subject of 30 different payment rates, multiple claiming methods and a myriad of rules, with severe penalties for non-compliance, yet the administrative infrastructure and specialised human resourcing of Medicare may have decreased over time. As a result, medical practitioners experience difficulties accessing reliable information and support concerning their claiming and compliance obligations. Some commentators overlook the complexity of Medicare and suggest that deliberate misuse of the system by medical practitioners is a significant contributor to rising healthcare costs, although there is currently no empirical evidence to support this view. Quantifying the precise amount of leakage caused by inappropriate claiming has proven an impossible task, although current estimates are $1-3 billion annually. The current government's proposed copayment plan may cause increases in non-compliance and incorrect Medicare claiming, and a causal link has been demonstrated between medical practitioner access to Medicare education and significant costs savings. Medicare claiming is a component of almost every medical interaction in Australia, yet most education in this area currently occurs on an ad hoc basis. Research examining medical practitioner experiences and understanding regarding Medicare claiming and compliance is urgently required to adapt medicine responsibly to our rapidly changing healthcare environment.

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

    PubMed Central

    2016-01-01

    Purpose 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. Methods 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. Results 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. Conclusions 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

  7. Drug interactions between prescribed and over-the-counter medication.

    PubMed

    Honig, P K; Gillespie, B K

    1995-11-01

    The use and availability of over-the-counter (OTC) medication is increasing. Although regulatory agencies take care to assure than nonprescription medications are safe and effective, these drugs still have the potential to have clinically significant interactions with prescription medicines. The major classes of OTC medication to be considered in this light include antacids, histamine H2 receptor antagonists, NSAIDs, cough and cold preparations and the antiasthma products. Healthcare providers and patients/consumers should be educated regarding possible drug interactions, patient drug regimens should be simplified where possible, and all therapeutic failures and adverse reactions should be investigated with regard to the potential contribution of OTC drug products. Regulatory agencies and pharmaceutical manufacturers should ensure that nonprescription drug labelling is complete and intelligible to meet these objectives. Consideration should be given to improving the postmarketing surveillance of OTC medications.

  8. General Medical Drugs Associated with Depression

    PubMed Central

    2008-01-01

    Drug-induced depression has been the focus of intense scrutiny by the US Food and Drug Administration and has serious clinical and medicolegal implications. “Gold standard” studies of drug-induced depression—involving randomized, placebo-controlled design and direct assessment of depressive symptoms—are lacking. Based on the available literature, our review suggests that only a few types of drugs are strongly linked with induction of depression. However, the potential for idiosyncratic reactions—not necessarily detected in large-scale studies—suggests that particular caution and careful monitoring are warranted with several types of drugs, including isotretinoin, rimonabant, and alpha interferons. PMID:19724774

  9. Drugs on the Internet, part II: antidepressant medication web sites.

    PubMed

    Morgan, Melissa; Montagne, Michael

    2011-01-01

    Antidepressant medications have been the fastest growing category of use of pharmaceutical products over the past decade. Selected Internet web sites providing information on antidepressant medications were identified and assessed using code of conduct criteria for posting health information on the Internet as developed by the Health on the Internet Foundation. Thirteen representative web sites were evaluated. Degree of compliance with each of the eight criterion varied by site, though all 13 sites met the criterion for legality of content and conduct on their web site. WebMD and FamilyDoctor.org met most of the criteria, while pharmaceutical company sites tended to meet the fewest criteria.

  10. Physical activity and better medication compliance improve mini-mental state examination scores in the elderly.

    PubMed

    Guimarães, Fabiana Costa; Amorim, Paulo Roberto dos Santos; Reis, Fernando Fonseca dos; Bonoto, Robson Teixeira; Oliveira, Wederson Candido de; Moura, Tiago Augusto da Silva; Assis, Cláudia Loures de; Palotás, András; Lima, Luciana Moreira

    2015-01-01

    In addition to hypertension, dyslipidemia, atherosclerosis, and diabetes, a sedentary lifestyle plays a pivotal role in cerebro- and cardiovascular disease and progressive cognitive decline, including vascular dementia and Alzheimer's disease. The present study investigated whether controlling the key risks and participating in physical activity have a beneficial impact on these disorders. Elderly volunteers were enrolled in a 3-month program that consisted of structured exercise three times per week. The daily routine, medical treatment, and vital parameters were evaluated and correlated with the subjects' neuropsychiatric status. High blood pressure was found in 40% of the participants, with no significant differences between the sexes. A higher proportion of females (55%) than males (18%) forgot to take their medication during the observation period. Significant negative correlations were found between Mini-Mental State Examination (MMSE) scores and age, lack of a caregiver, and increased pulse rate before or after exercise. These results suggest that the presence of home assistance and subsequent improvement in medication compliance, vital parameter optimization, and regular physical activity may yield better MMSE results and a lower risk for cerebro- and cardiovascular disease.

  11. Are we nearly there yet? Coverage and compliance of mass drug administration for lymphatic filariasis elimination.

    PubMed

    Alexander, Neal D E

    2015-03-01

    Lymphatic filariasis has been targeted for elimination by 2020, and a threshold of 65% coverage of mass drug administration (MDA) has been adopted by the Global Programme to Eliminate Lymphatic Filariasis (GPELF). A recent review by Babu and Babu of 36 studies of MDA for lymphatic filariasis in India found that coverage, defined as receipt of tablets, ranged from 48.8 to 98.8%, while compliance, defined as actual ingestion of tablets, was 22% lower on average. Moreover, the denominator for these coverage figures is the eligible, rather than total, population. By contrast, the 65% threshold, in the original modelling study, refers to ingestion of tablets in the total population. This corresponds to GPELF's use of 'epidemiological drug coverage' as a trigger for the Transmission Assessment Surveys (TAS), which indicate whether to proceed to post-MDA surveillance. The existence of less strict definitions of 'coverage' should not lead to premature TAS that could impair MDA's sustainability.

  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. 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.

  14. The psychology of compliance.

    PubMed

    Condor, B

    1997-01-01

    There is no single personality trait, psychological condition, socioeconomic factor or stage of disease that can reliably be used to predict drug compliance. Missing doses of protease inhibitors can lead to drug resistance, so complying with a treatment regimen is critical. One major issue is the timing of medication; some drugs need to be taken with foods, some without, and many complex treatment regimens specify rigid times at which the drugs should be taken. Patients are encouraged to keep a written record of their care, and are more likely to comply if they know the reasons why it is necessary and are prepared to expect some physical discomfort.

  15. 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

  16. Polypathology, polypharmacy, medication regimen complexity and drug therapy appropriateness.

    PubMed

    Gómez Aguirre, N; Caudevilla Martínez, A; Bellostas Muñoz, L; Crespo Avellana, M; Velilla Marco, J; Díez-Manglano, J

    2017-02-16

    Polypathological patients are usually elderly and take numerous drugs. Polypharmacy affects 85% of these individuals and is not associated with greater survival. On the contrary, polypharmacy exposes these individuals to more adverse effects, such as weight loss, falls, functional and cognitive impairment and hospitalisations. The complexity of a drug regimen covers more aspects than the simple number of drugs consumed. The galenic form, the dosage and the method for preparing the drug can impede the understanding of and compliance with prescriptions. Both polypharmacy and therapeutic complexity are associated with poorer adherence by patients. To prevent polypharmacy, reduce complexity and improve adherence, the appropriate use of drugs is needed. Proper prescribing consists of selecting drugs that have clear evidence for their use in the indication, which are appropriate for the patient's circumstances, are well tolerated and cost-effective and whose benefits outweigh the risks. To improve the drug prescription, periodic reviews of the drugs need to be conducted, especially when the patient changes doctor and during healthcare transitions. The Beers and STOPP/START (Screening Tool of Older Person's potentially inappropriate Prescriptions/Screening Tool to Alert doctors to the Right Treatment) criteria are effective tools for this improvement. Deprescription for polymedicated polypathological patients that considers their clinical circumstances, prognosis and preferences can contribute to a more appropriate use of drugs.

  17. Patterns of prescription medication diversion among drug dealers

    PubMed Central

    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 Florida. In-depth semi-structured interviews (n = 50) were conducted with an ethnically diverse sample of prescription drug dealers from a variety of milieus to assess patterns of diversion. Audiotapes of the interviews were transcribed, coded, and thematically analysed using the NVivo 8 software program. Dealers relied on a wide array of diversion methods including visiting multiple pain clinics, working with pharmacy employees to steal medications from pharmacies, and purchasing medications from indigent patients. The type of medication most commonly sold by dealers was prescription opioid analgesics, and to a lesser extent benzodiazepines such as alprazolam. These findings inform public health policy makers, criminal justice officials, the pharmaceutical industry and government regulatory agencies in their efforts to reduce the availability of diverted prescription drugs in the illicit market. Specifically, these data support the need for statewide prescription drug monitoring programs and increased training for healthcare workers who have access to controlled medications. PMID:22665955

  18. MEDIC: An Approach to Student Responsibility in Drug Usage

    ERIC Educational Resources Information Center

    Coppoc, Gordon L.; Stuckey, William J.

    1977-01-01

    The Minimum Essential Drug Information Checklist (MEDIC) was designed at Purdue University in response to a need for more structure in the approach to drug education in veterinary medicine. It covers: therapeutic goal, routes given, dose form, dose interval, duration of therapy, withdrawal time, cost, precautions, reactions, antidote, and therapy…

  19. Business process improvement: an electronic system to monitor compliance with medical resident work hours.

    PubMed

    Landesman, Linda Young; Markowitz, Forest; Conde, Nelson

    2010-01-01

    The limitation of medical intern and resident work hours, known as the Bell 405 regulations, was initiated in New York State in 1989 with a modification to the state hospital code. The Bell 405 regulations were strengthened in 2000, and facilities would now be fined for noncompliance. Monitoring systems in place at that time were insufficient to provide an adequate level of review for the New York City Health and Hospitals Corporation (HHC) with more than 7,000 medical residents whose training is based at or who rotate through these public hospitals. A "simple to use," yet comprehensive, method of monitoring compliance needed to be developed to ensure that residents and interns complied with laws regulating working hours. The subsequent development of national accreditation standards increased the stakes for reliable scrutiny. HHC developed and implemented a Web-based Structured Query Language (SQL) application that facilitated easy access to work hour surveys captured through electronic time sheets. The time sheet data automatically entered a database that provided instant analysis of conformance to state law. The development of an electronic on-line application accessible from anywhere allowed HHC to efficiently identify nonconformance and pinpoint corrective action. Since the inception of the application and its expansion allowing access through the intranet, 26,000 individual time sheets have been submitted for evaluation. With the national movement regulating work hours, other hospitals still at the pencil and manual computation stage would greatly benefit by developing a similar application.

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

    PubMed

    Foo, Jong Yong Abdiel; Tan, Xin Ji Alan

    2016-11-28

    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.

  1. 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.

  2. 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.

  3. 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.

  4. [Regulatory Science in the Review of Drugs and Medical Devices].

    PubMed

    Koide, Akihiro

    2016-01-01

    The review of drugs and medical devices is an integral part of regulatory science. The Pharmaceuticals and Medical Devices Agency (PMDA) evaluates the efficacy, safety, and quality of drugs and medical devices after applications are submitted for regulatory approval. The products are approved when their benefits exceed their risks, i.e., an application is approved if the efficacy of the product in patients was demonstrated and the safety of the product is acceptable in view of its observed benefits. However, drugs and medical devices for which efficacy was not clearly demonstrated in clinical trials makes the decision to approve a difficult process. Under those circumstances, the approval process is based on the totality of information, such as the reason why clinical trials did not succeed and medical needs in Japan. The Wingspan stent system, which was approved for the treatment of intracranial arterial stenosis, is an example of a product with a use different from that intended by the US Food and Drug Administration and PMDA.

  5. [Medical economics evaluation of 5-HT3 receptor antagonist drugs].

    PubMed

    Utsunomiya, Junpei; Hirano, Shigeki; Fukui, Aiko; Funabashi, Kazuaki; Deguchi, Yuko; Yamada, Susumu; Naito, Kazuyuki

    2010-10-01

    At Komaki City Hospital, the drug cost in connection with cancer chemotherapy was re-examined as part of improved management along with the introduction of DPC in July 2008. With due attention to the 5-HT3 receptor antagonists, both the change from injections to oral drugs and the change from brand-name drugs to generic drugs were tried between July 2008 and June 2009. After that, in order to examine the economic impact of these changes, we investigated and analyzed the number of medications, the cost of medicine purchased, and the average drug cost per medication of the 5-HT3 receptor antagonists between April 2008 and September 2009. As a result, the cost of 5-HT3 receptor antagonists purchased decreased greatly, and the impact of the improvement was mainly due to the change to oral drugs, and partially to the change to generic drugs. Therefore, from the viewpoint of hospital economic improvement in DPC, it was thought that the change to oral drugs(5-HT3 receptor antagonists)is given top priority.

  6. 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

  7. Medication Repurposing in Pediatric Patients: Teaching Old Drugs New Tricks

    PubMed Central

    2016-01-01

    OBJECTIVES: Gaps in pediatric therapeutics often result in off-label use and specifically, novel uses for existing medications, termed “drug repurposing.” Drug Information (DI) queries to a Pediatric Medication Resource Center of a large metropolitan pediatric hospital in New York and inherent difficulties in retrieving evidence-based information prompted a review of current medication repurposing for pediatric patients. The objective included characterization of innovative off-label use of medications Food and Drug Administration (FDA)-approved for 1 or more indications to treat a totally different disorder or indication in pediatric patients. METHODS: A systematic literature review was conducted to retrieve publications describing repurposed medications in pediatric patients. Excluded was FDA-approved indications used off-label in pediatric patients (e.g., different dose), preclinical data, adult use only, and experimental use. Evidence quality was classified using a modified American Academy of Neurology Level of Evidence. Results were analyzed using χ2 at p < 0.05. RESULTS: Over 2000 references were retrieved and reviewed. A total of 101 medications repurposed for novel off-label uses for pediatric patients were identified: 38 for neonates, 74 for children, and 52 for adolescents. Neonates and infants were least likely to receive a medication for a repurposed use. Strong or intermediate evidence existed in 80.2% of cases. The evidence was weak in 19.8%. No significant relationship was observed between the pediatric age group and strength of the literature. Most repurposed uses pertained to generic or widely used medications. Less than 5% of medications were first marketed after 2011. CONCLUSIONS: While not exhaustive, the present study represents the most comprehensive listing of novel uses exclusive to pediatric patients. Further research is needed to identify the frequency of repurposed uses. The valuable DI role of pharmacists in assessing repurposed

  8. Are we nearly there yet? Coverage and compliance of mass drug administration for lymphatic filariasis elimination

    PubMed Central

    Alexander, Neal D. E.

    2015-01-01

    Lymphatic filariasis has been targeted for elimination by 2020, and a threshold of 65% coverage of mass drug administration (MDA) has been adopted by the Global Programme to Eliminate Lymphatic Filariasis (GPELF). A recent review by Babu and Babu of 36 studies of MDA for lymphatic filariasis in India found that coverage, defined as receipt of tablets, ranged from 48.8 to 98.8%, while compliance, defined as actual ingestion of tablets, was 22% lower on average. Moreover, the denominator for these coverage figures is the eligible, rather than total, population. By contrast, the 65% threshold, in the original modelling study, refers to ingestion of tablets in the total population. This corresponds to GPELF's use of ‘epidemiological drug coverage’ as a trigger for the Transmission Assessment Surveys (TAS), which indicate whether to proceed to post-MDA surveillance. The existence of less strict definitions of ‘coverage’ should not lead to premature TAS that could impair MDA's sustainability. PMID:25575555

  9. 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.…

  10. Attaining resident duty hours compliance: the acute care nurse practitioners program at Olive View-UCLA Medical Center.

    PubMed

    Lundberg, Scott; Wali, Soma; Thomas, Peggy; Cope, Dennis

    2006-12-01

    The institution of resident duty hours limits by the Accreditation Council for Graduate Medical Education (ACGME) has made it difficult for some programs to cover inpatient teaching services. The medical literature is replete with editorials criticizing the hour limits and the resulting problems but is nearly silent on the topic of constructive solutions to compliance. In this article, the authors describe a new program, initiated in 2003 at the Olive View-UCLA Medical Center, of using acute care nurse practitioners to allow for compliance with the "24 + 6" continuous duty hours limit, as well as the 80-hour workweek limit. Each post-call team is assigned a nurse practitioner for the day, allowing residents to sign out by 2 pm while ensuring quality care for patients. Nurse practitioners participate in evaluation of residents and, in turn, are evaluated by them. Using this system, the authors report 99% compliance with ACGME work-hour restrictions, with average work hours for inpatient ward residents decreasing from 84 to 76 hours per week. Physician satisfaction with the new system is high; anonymous evaluation by residents and faculty returned average scores of 8.8 out of 9 possible points. The authors report that using nurse practitioners on post-call days provides excellent, continuous patient care without impinging on scheduling and without sacrificing responsibility, continuity, or education for the residents. This system has several potential advantages over previously described work-hour solutions. Addition of a nurse practitioner to the post-call team is an effective solution to the problem of compliance with resident duty hours limitations.

  11. 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

  12. Effects of an educational compliance enhancement programme and therapeutic drug monitoring on treatment adherence in depressed patients managed by general practitioners.

    PubMed

    Akerblad, Ann-Charlotte; Bengtsson, Finn; Ekselius, Lisa; von Knorring, Lars

    2003-11-01

    Medication non-adherence is a major obstacle in the treatment of affective disorders. The primary objective of this study was to evaluate two different interventions to improve adherence to antidepressant drugs. Secondary objectives included response to treatment, relation between adherence and response, patient satisfaction and tolerability. A randomized controlled design was used to assess the effect of a patient educational compliance enhancing programme (CP) and therapeutic drug monitoring in 1031 major depressed patients treated with sertraline for 24 weeks and managed by their general practitioner. Adherence was measured by questioning, measurable serum levels of sertraline and desmethylsertraline, appointments kept and a composite index including all three methods. Treatment adherence was found in 37-70% of patients, depending on the method used. Neither of the interventions resulted in a significant increase in adherence rate. However, significantly more patients in the CP group had responded at week 24 compared to patients in the control group. Overall, significantly more adherent patients responded to treatment compared to non-adherent patients, regardless of method used to determine adherence. This large study demonstrates that treatment response increases when using an educational compliance programme and that a strong relationship between treatment adherence and response exists.

  13. 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

    ... related to the production and marketing of drugs and/or devices. Topics for discussion include the following: Regulating Medical Products in the Global Environment FDA Revitalization Efforts--Top 10 Drug... Case Studies--Supplier Controls Supplier Quality in a Global Economy--Consensus Standards...

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

    DTIC Science & Technology

    1984-08-01

    prescribe new medication d. take you off medication _e. other (describe) 17. The medications were prescribed by: a. my primary physician b. my...ailment: yes no 21. FOUPVIS - If "yes", did the physician: a. prescribe the same medication b. increase current medication c. prescribe new medication d

  15. 77 FR 10537 - Food and Drug Administration/Xavier University Global Medical Device Conference

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-22

    ... HUMAN SERVICES Food and Drug Administration 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) Cincinnati District, in cosponsorship with...

  16. Handling chemotherapy drugs-Do medical gloves really protect?

    PubMed

    Landeck, Lilla; Gonzalez, Ernesto; Koch, Olaf Manfred

    2015-10-15

    Due to their potential mutagenic, carcinogenic and teratogenic effects occupational exposure to chemotherapy drugs should be kept to a minimum. Utilization of personnel protective devices, especially the use of protective medical gloves, is a mainstay to avoid skin contact. The choice of appropriate gloves is of outstanding importance. For optimal protection in the oncology setting it is essential to establish general guidelines evaluating appropriate materials and defining quality standards. Establishing these guidelines can facilitate better handling and avoid potential hazards and late sequelae. In Europe there are no specific requirements or test methodologies for medical gloves used in the oncology environment. The implementation of uniform standards for gloves used while handling chemotherapy drugs would be desirable. In contrast, in the US medical gloves used to handle chemotherapy drugs have to fulfill requirements according to the ASTM International (American Society of Testing and Materials) standard D 6978-05. Nitrile or natural rubber latex is a preferred basic glove material, while vinyl is considered inappropriate because of its generally increased permeability. For extended exposure to chemotherapy drugs, double gloving, the use of thicker gloves and the frequent change of gloves increases their protective power.

  17. Drug delivery systems improve pharmaceutical profile and facilitate medication adherence.

    PubMed

    Wertheimer, Albert I; Santella, Thomas M; Finestone, Albert J; Levy, Richard A

    2005-01-01

    Innovations in dosage forms and dose delivery systems across a wide range of medications offer substantial clinical advantages, including reduced dosing frequency and improved patient adherence; minimized fluctuation of drug concentrations and maintenance of blood levels within a desired range; localized drug delivery; and the potential for reduced adverse effects and increased safety. The advent of new large-molecule drugs for previously untreatable or only partially treatable diseases is stimulating the development of suitable delivery systems for these agents. Although advanced formulations may be more expensive than conventional dosage forms, they often have a more favorable pharmacologic profile and can be cost-effective. Inclusion of these dosage forms on drug formulary lists may help patients remain on therapy and reduce the economic and social burden of care.

  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. Post-market safety warnings for drugs approved in Canada under the Notice of Compliance with conditions policy

    PubMed Central

    Lexchin, Joel

    2015-01-01

    Aims Health Canada has developed a pathway to approve drugs that have limited efficacy and safety data, the Notice of Compliance with conditions (NOC/c) policy. Increased safety reporting is required for these drugs but there has not been any systematic review of their post-market safety. This study compares safety warnings for NOC/c drugs with drugs with a priority and a standard review. Methods A list of drugs approved between January 1 1998 and March 31 2013 was developed and serious safety warnings for these drugs were identified. Drugs were put into one of three groups based on the way that they were approved. Kaplan−Meier curves were generated to examine the likelihood of NOC/c drugs receiving a serious safety warning compared with drugs with a priority and a standard review. The time spent in the review process for each of the groups was also measured. Results Compared with drugs with a priority review, NOC/c drugs were not more likely to receive a serious safety warning (P = 0.5940) but were more likely than drugs with a standard review (P = 0.0113). NOC/c drugs spent less time in the review process compared with drugs with a standard review. Conclusions Possible reasons for the increase likelihood of a serious safety warning are the limited knowledge of the safety of NOC/c drugs when they are approved and the length of time that they spend in the review process. Health Canada should consider spending longer reviewing these drugs and monitor their post-market safety more closely. PMID:25393960

  20. 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

  1. Glutamatergic medications for the treatment of drug and behavioral addictions

    PubMed Central

    Olive, M. Foster; Cleva, Richard M.; Kalivas, Peter W.; Malcolm, Robert J.

    2011-01-01

    Historically, most pharmacological approaches to the treatment of addictive disorders have utilized either substitution-based methods (i.e., nicotine replacement or opioid maintenance) or have targeted monoaminergic or endogenous opioidergic neurotransmitter systems. However, substantial evidence has accumulated indicating that ligands acting on glutamatergic transmission are also of potential utility in the treatment of drug addiction, as well as various behavioral addictions such as pathological gambling. The purpose of this review is to summarize the pharmacological mechanisms of action and general clinical efficacy of glutamatergic medications that are currently approved or are being investigated for approval for the treatment of addictive disorders. Medications with effects on glutamatergic transmission that will be discussed include acamprosate, N-acetylcysteine, D-cycloserine, gabapentin, lamotrigine, memantine, modafinil, and topiramate. We conclude that manipulation of glutamatergic neurotransmission is relatively young but promising avenue for the development of improved therapeutic agents for the treatment of drug and behavioral addictions. PMID:21536062

  2. Medical emergencies and drugs: an online study guide.

    PubMed

    2008-05-01

    The Editorial Board of the Journal of Endodontics has developed a literature-based study guide of topical areas related to endodontics. This study guide is intended to give the reader a focused review of the essential endodontic literature and does not cite all possible articles related to each topic. Although citing all articles would be comprehensive, it would defeat the idea of a study guide. This section will cover medical emergencies and drugs.

  3. Software process improvement for the medical industry.

    PubMed

    McCaffery, Fergal; Donnelly, Peter; McFall, Donald; Wilkie, Frederick George

    2005-01-01

    This chapter describes a software process improvement framework, structured to ensure regulatory compliance for the software developed in medical devices. Software is becoming an increasingly important aspect of medical devices and medical device regulation. Medical devices can only be marketed if compliance and approval from the appropriate regulatory bodies of the Food and Drug Administration (US requirement), and the European Commission under its Medical Device Directives (CE marking requirement) is achieved.

  4. Adverse drug events and medication errors: detection and classification methods.

    PubMed

    Morimoto, T; Gandhi, T K; Seger, A C; Hsieh, T C; Bates, D W

    2004-08-01

    Investigating the incidence, type, and preventability of adverse drug events (ADEs) and medication errors is crucial to improving the quality of health care delivery. ADEs, potential ADEs, and medication errors can be collected by extraction from practice data, solicitation of incidents from health professionals, and patient surveys. Practice data include charts, laboratory, prescription data, and administrative databases, and can be reviewed manually or screened by computer systems to identify signals. Research nurses, pharmacists, or research assistants review these signals, and those that are likely to represent an ADE or medication error are presented to reviewers who independently categorize them into ADEs, potential ADEs, medication errors, or exclusions. These incidents are also classified according to preventability, ameliorability, disability, severity, stage, and responsible person. These classifications, as well as the initial selection of incidents, have been evaluated for agreement between reviewers and the level of agreement found ranged from satisfactory to excellent (kappa = 0.32-0.98). The method of ADE and medication error detection and classification described is feasible and has good reliability. It can be used in various clinical settings to measure and improve medication safety.

  5. Suicide and drug abuse in the medical community.

    PubMed

    Bressler, B

    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% to 30% are associated with drug abuse and 40% with alcoholism. Various problem areas are considered. Role strain, leading to excessive drug use in an attempt to increase work efficiency, is coupled with a denial of the physician's own dependency needs and gratification. The problem of identity occurs in relation to the exaggerated sense of duty and obligation the physician feels in attending to the demands of the patients and their families. Medicine as magical thinking is also discussed, revealing the physician's belief in his own immunity, which is strenuously tested when he actually sets up in practice. The community's high regard for the physician further complicates the situation. Too little has been done about working with emotional problems of medical students during their training and after they begin to practice. Unfortunately, physicians feel uncomfortable in turning to colleagues for help; rather, they tend to isolate themselves, resorting to alcohol and drugs. One should question the selection of medical students and their overall training, not only in terms of academic learning but also with more consideration for the stresses and strains of the future career.

  6. Behavioral Management of Medical Compliance: Its Role in the History of Group Psychotherapy.

    ERIC Educational Resources Information Center

    Harris, Ben; Lightner, Jean

    Most histories of psychology and psychiatry attribute the first group psychotherapy to Joseph Pratt's 1905 class for tuberculosis patients. Pratt's actual treatment procedures are examined. They are shown to have consisted primarily of operant and social-learning techniques, aimed at increasing patient compliance with a demanding therapeutic…

  7. 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

  8. 78 FR 16679 - Center for Drug Evaluation and Research Medical Policy Council; Request for Comments

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-18

    ... HUMAN SERVICES Food and Drug Administration Center for Drug Evaluation and Research Medical Policy... interested organizations, on medical policy issues that may be considered by the CDER Medical Policy Council (Council) in FDA's Center for Drug Evaluation and Research (CDER). These comments will help the...

  9. [Compliance in schizophrenia: predictive factors, therapeutical considerations and research implications].

    PubMed

    Misdrahi, D; Llorca, P M; Lançon, C; Bayle, F J

    2002-01-01

    Compliance has been defined as the extent to which a person's behavior coincides with the medical advice given. Medication compliance is one of the foremost problems affecting neuroleptic efficacy in psychiatric patients. Since chlorpromazine introduction in 1952, antipsychotics are the principal element of schizophrenia treatment. Actually progress links to the use of new antipsychotics are conditioned by quality of compliance. The problem of nonadherence to medication could concern 50% of prescription. The reported incidence of non-compliance with antipsychotic medication ranges from 11 to 80%. In a two thirds of case rehospitalization is the result of complete or partial noncompliance. After one year of first hospitalisation, 40% of relapse results from non adherence to medication. Medication adherence problems increase hospitalisation, morbidity and mortality. Social consequences, professional problems and family troubles linked to hospitalisations lead to low quality of life for patients and high cost for society. There are three main methods of measuring compliance. These include patient and clinical self-report, pill counts, and biological measures. Self-report methods are generally the most cost-effective and time-efficient way of obtaining an indication of compliance. In psychiatric research, the most commonly used self-report measure of compliance is the Drug Attitude Inventory (DAI) originally devised by Hogan et al. On the basis of criticism concerning DAI reliability, a new questionnaire of medication compliance was proposed: the Medication Adherence Rating scale (MARS). The main goal of compliance evaluation is to quantify this phenomenon with accuracy and to find predictive factors of medication nonadherence. Three types of factors influencing compliance are identified: factors due to medications, factors linked to patients and factors depending on the therapeutic relation with the clinician. Tolerance is considered as the principal reason explaining

  10. 77 FR 125 - Draft Guidance for Industry and Food and Drug Administration Staff; Medical Device Classification...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-03

    ... Staff; Medical Device Classification Product Codes; Availability AGENCY: Food and Drug Administration... of the draft guidance entitled ``Medical Device Classification Product Codes.'' The purpose of the... classification product codes for medical devices regulated by the Center for Devices and Radiological...

  11. 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

  12. Drug Attitude and Adherence to Anti-Glaucoma Medication

    PubMed Central

    Hong, Samin; Kang, Sung Yong; Yoon, Jong Uk; Kang, Uicheon; Seong, Gong Je

    2010-01-01

    Purpose The purpose of this study is to assess patient attitudes towards anti-glaucoma medication and their association with adherence, visual quality of life, and personality traits. Materials and Methods One hundred and forty-seven glaucoma patients were enrolled this study. The participants were divided into 'pharmacophobic' and 'pharmacophilic' groups according to their scores on the Modified Glaucoma Drug Attitude Inventory (MG-DAI). To establish a correlation with patient drug attitude, each group had their subjective drug adherence, visual quality of life, and personality traits examined. For personality traits, the Myers-Briggs Type Indicator (MBTI) was used to sub-classify each group. Results Among the patients analyzed, 91 (72.80%) patients showed a 'pharmacophobic' attitude and 34 (27.20%) patients showed a 'pharmacophilic' attitude. The pharmacophobic group tended to have worse adherence than the pharmacophilic group. Personality dichotomies from the MBTI also showed different patterns for each group. Conclusion In glaucoma patients, pharmacological adherence was influenced by their attitude towards drugs; an association might exist between drug attitude and underlying personality traits. PMID:20191020

  13. 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

  14. Silicone surface with drug nanodepots for medical devices.

    PubMed

    Mokkaphan, Jiratchaya; Banlunara, Wijit; Palaga, Tanapat; Sombuntham, Premsuda; Wanichwecharungruang, Supason

    2014-11-26

    An ideal surface of poly(dimethylsiloxane) (PDMS) medical devices requires sustained drug release to combat various tissue responses and infection. At present, a noncovalent surface coating with drug molecules using binders possesses a detachment problem, while covalently linking drug molecules to the surface provides no releasable drug. Here, a platform that allows the deposition of diverse drugs onto the PDMS surface in an adequate quantity with reliable attachment and a sustained-release character is demonstrated. First, a PDMS surface with carboxyl functionality (PDMS-COOH) is generated by subjecting a PDMS piece to an oxygen plasma treatment to obtain silanol moieties on its surface, then condensing the silanols with (3-aminopropyl)triethoxysilane molecules to generate amino groups, and finally reacting the amino groups with succinic anhydride. The drug-loaded carriers with hydroxyl groups on their surface can then be esterified to PDMS-COOH, resulting in a PDMS surface covalently grafted with drug-filled nanocarriers so that the drugs inside the securely grafted carriers can be released. Demonstrated here is the covalent linking of the surface of a PDMS endotracheal tube with budesonide-loaded ethylcellulose nanoparticles. A secure and high drug accumulation at the surface of the tubes (0.025 mg/cm2) can be achieved without changes in its bulk property such as hardness (Shore-A), and sustained release of budesonide with a high release flux during the first week followed by a reduced release flux over the subsequent 3 weeks can be obtained. In addition, the grafted tube possesses more hydrophilic surface and thus is more tissue-compatible. The grafted PDMS pieces show a reduced in vitro inflammation in cell culture and a lower level of in vivo tissue responses, including a reduced level of inflammation, compared to the unmodified PDMS pieces, when implanted in rats. Although demonstrated with budesonide and a PDMS endotracheal tube, this platform of grafting a

  15. Single-item vs multiple-item measures of stage of change in compliance with prescribed medications.

    PubMed

    Cook, Christopher L; Perri, Matthew

    2004-02-01

    The Stage of Change construct from the Transtheoretical Model of behavioral change has been widely utilized in the assessment of various health behaviors. The majority of these tests measure the Stage of Change construct using the single-item. multiple-choice format. This study validated the use of a single-item measure in measuring readiness to comply with taking a prescribed medication. A sample of 161 subjects tested the multiple-item Stage of Change measure, then a refined multiple-item survey was tested with 59 subjects. With the latter survey, discriminating subjects at the differing stages of change dimensions was difficult. A correlation of .91 was found for stage classifications between ratings on the single-item and multiple-item scales. The use of the single-item measure seems reasonable when assessing stage of change in compliance with prescribed medication.

  16. Defense Medical Human Resources System-internet (DMHRSi): A Case Study on Compliance and Accuracy

    DTIC Science & Technology

    2009-06-02

    further education focusing on the importance of DMHRSi. In a recent study, intensive care nurses increased physicians’ adherence to following...promoting compliance and accuracy, ensure users have adequate education regarding DMHRSi, and use an organizational change model to improve user... Education Technician 19b. TELEPHONE NUMBER (Include area code) (210)221-6443 Standard Form 298 (Rev. 8/98) Proscribed by ANSI Std. Z39.18 Defense

  17. Development of copper based drugs, radiopharmaceuticals and medical materials.

    PubMed

    Szymański, Paweł; Frączek, Tomasz; Markowicz, Magdalena; Mikiciuk-Olasik, Elżbieta

    2012-12-01

    Copper is one of the most interesting elements for various biomedical applications. Copper compounds show vast array of biological actions, including anti-inflammatory, anti-proliferative, biocidal and other. It also offers a selection of radioisotopes, suitable for nuclear imaging and radiotherapy. Quick progress in nanotechnology opened new possibilities for design of copper based drugs and medical materials. To date, copper has not found many uses in medicine, but number of ongoing research, as well as preclinical and clinical studies, will most likely lead to many novel applications of copper in the near future.

  18. Unsolicited post-prescription antibiotic review in surgical and medical wards: factors associated with counselling and physicians' compliance.

    PubMed

    Lesprit, P; Landelle, C; Brun-Buisson, C

    2013-02-01

    The purpose of this investigation was to describe the impact of an early review of antibiotic prescriptions in a hospital using unsolicited infectious disease physician (IDP) counselling, identify areas for improvement and examine factors associated with physicians' non-compliance. The prescriptions of 15 selected antibiotics from surgical or medical wards were screened daily and reviewed between days 3 and 5 by a single IDP during an 8-month period to identify those likely needing counselling. Improved antibiotic use was sought by encouraging ward physicians to withdraw or de-escalate therapy, promoting oral switch or reducing the duration of therapy whenever appropriate. Variables potentially associated with IDP counselling and physicians' non-compliance were tested using bivariate analysis and then entered in a logistic regression model. Among 857 prescriptions analysed, 54.6 % prompted unsolicited counselling, mostly for stopping therapy (18.8 %), reducing its duration (18.0 %) or de-escalation (13.0 %). Variables independently associated with IDP counselling included antibiotic combination (adjusted odds ratio [aOR], 5.27 [95 % confidence interval (CI), 1.80-15.45]; p = 0.002), non-clinically documented infection (aOR, 4.98 [95 % CI, 2.81-8.82]; p < 0.001) and microbiologically documented infection (aOR, 2.04 [95 % CI, 1.51-2.75]; p < 0.001). The physicians' compliance rate was 77.3 %. Variables independently associated with physicians' non-compliance to the IDP recommendation were the surgical speciality of the ward physician (aOR, 1.91 [95 % CI, 1.17-3.12]; p = 0.009) and advice to reduce the duration of therapy (aOR, 1.88 [95 % CI, 1.12-3.15]; p = 0.017). An unsolicited post-prescription antibiotic review can be successfully implemented with a high rate of physicians' compliance. Areas for targeting improvement measures include prescriptions in surgical wards and shortening the duration of therapy.

  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. 77 FR 20025 - Draft Guidance for Industry on Compliance Policy for Reporting Drug Sample Distribution...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-03

    ... Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New..., 10903 New Hampshire Ave., Bldg. 51, Rm. 4288, Silver Spring, MD 20993-0002, 301- 796-0584; Paul Loebach, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg....

  1. Evaluation of Perioperative Medication Errors and Adverse Drug Events

    PubMed Central

    Nanji, Karen C.; Patel, Amit; Shaikh, Sofia; Seger, Diane L.; Bates, David W.

    2015-01-01

    Background The purpose of this study is to assess the rates of perioperative medication errors (MEs) and adverse drug events (ADEs) as percentages of medication administrations, evaluate their root causes, and formulate targeted solutions to prevent them. Methods In this prospective observational study, anesthesia-trained study staff (anesthesiologists/nurse anesthetists) observed randomly selected operations at a 1,046 bed tertiary care academic medical center to identify MEs and ADEs over eight months. Retrospective chart abstraction was performed to flag events that were missed by observation. All events subsequently underwent review by two independent reviewers. Primary outcomes were the incidence of MEs and ADEs. Results A total of 277 operations were observed with 3,671 medication administrations of which 193 (5.3%, 95% CI 4.5 to 6.0) involved a ME and/or ADE. Of these, 153 (79.3%) were preventable and 40 (20.7%) were non-preventable. The events included 153 (79.3%) errors and 91 (47.2%) ADEs. While 32 (20.9%) of the errors had little potential for harm, 51 (33.3%) led to an observed ADE and an additional 70 (45.8%) had the potential for patient harm. Of the 153 errors, 99 (64.7%) were serious, 51 (33.3%) were significant and 3 (2.0%) were life-threatening. Conclusions One in twenty perioperative medication administrations included an ME and/or ADE. More than one third of the MEs led to observed ADEs, and the remaining two thirds had the potential for harm. These rates are markedly higher than those reported by retrospective surveys. Specific solutions exist which have the potential to decrease the incidence of perioperative MEs. PMID:26501385

  2. Collaborative drug therapy management and comprehensive medication management-2015.

    PubMed

    McBane, Sarah E; Dopp, Anna L; Abe, Andrew; Benavides, Sandra; Chester, Elizabeth A; Dixon, Dave L; Dunn, Michaelia; Johnson, Melissa D; Nigro, Sarah J; Rothrock-Christian, Tracie; Schwartz, Amy H; Thrasher, Kim; Walker, Scot

    2015-04-01

    The American College of Clinical Pharmacy (ACCP) previously published position statements on collaborative drug therapy management (CDTM) in 1997 and 2003. Since 2003, significant federal and state legislation addressing CDTM has evolved and expanded throughout the United States. CDTM is well suited to facilitate the delivery of comprehensive medication management (CMM) by clinical pharmacists. CMM, defined by ACCP as a core component of the standards of practice for clinical pharmacists, is designed to optimize medication-related outcomes in collaborative practice environments. New models of care delivery emphasize patient-centered, team-based care and increasingly link payment to the achievement of positive economic, clinical, and humanistic outcomes. Hence clinical pharmacists practicing under CDTM agreements or through other privileging processes are well positioned to provide CMM. The economic value of clinical pharmacists in team-based settings is well documented. However, patient access to CMM remains limited due to lack of payer recognition of the value of clinical pharmacists in collaborative care settings and current health care payment policy. Therefore, the clinical pharmacy discipline must continue to establish and expand its use of CDTM agreements and other collaborative privileging mechanisms to provide CMM. Continued growth in the provision of CMM by appropriately qualified clinical pharmacists in collaborative practice settings will enhance recognition of their positive impact on medication-related outcomes.

  3. The "Next Dose" dosage spoon circa 1927 as an aid for proper dose measurement and enhancement of medication compliance.

    PubMed

    Fincham, Jack E

    2007-01-01

    These "Next Dose" spoons were marketed until the 1960s in the United States. Unfortunately, the further paths crossed by Messieurs Morgan and Bushey cannot be further elucidated. Nor can further information be identified for the eventual marketer of the "Next Dose" spoon. What we can surmise is that the use of specialized devices to administer and remind patients about dosing is not new. There is scant mention of compliance in the literature too years ago, but pharmacies and patients no doubt found these devices to be useful. For the pharmacist, advertising on the spoon provided a reminder of their services, and for the patient, a reminder was present on the body of the spoon to remind them of the next dosing time. Most medications during this time were in liquid form, and a device to help accurately measure liquid, elixir, tonic, suspensions was a highly sought-after item welcomed by patients and/or caregivers.

  4. Medication assisted treatment in the treatment of drug abuse and dependence in HIV/AIDS infected drug users.

    PubMed

    Kresina, Thomas F; Bruce, R Douglas; McCance-Katz, Elinore F

    2009-07-01

    Drug use and HIV/AIDS are global public health issues. The World Health Organization (WHO) estimates that up to 30% of HIV infections are related to drug use and associated behaviors. The intersection, of the twin epidemics of HIV and drug/alcohol use, results in difficult medical management issues for the health care providers and researchers who work in the expanding global HIV prevention and treatment fields. Access to care and treatment, medication adherence to multiple therapeutic regimens, and concomitant drug -drug interactions of prescribed treatments are difficult barriers for drug users to overcome without directed interventions. Injection drug users are frequently disenfranchised from medical care and suffer sigma and discrimination creating additional barriers to care and treatment for their drug abuse and dependence as well as HIV infection. In an increasing number of studies, medication assisted treatment of drug abuse and dependence has been shown to be an important HIV prevention intervention. Controlling the global transmission of HIV will require further investment in evidence-based interventions and programs to enhance access to care and treatment of individuals who abuse illicit drugs and alcohol. In this review, we present the cumulative evidence of the importance of medication assisted treatment in the prevention, care, and treatment of HIV infected individuals who also abuse drugs and alcohol.

  5. Medical Use, Illicit Use, and Diversion of Abusable Prescription Drugs

    ERIC Educational Resources Information Center

    McCabe, Sean Esteban; Teter, Christian J.; Boyd, Carol J.

    2006-01-01

    The authors investigated the medical use, illicit use, and diversion of 4 distinct classes of abusable prescription medication (sleeping medication, sedative or anxiety medication, stimulant medication, and pain medication) in a random sample of undergraduate students. In spring 2003, 9,161 undergraduate students attending a large, public,…

  6. Relationships between Drug Company Representatives and Medical Students: Medical School Policies and Attitudes of Student Affairs Deans and Third-Year Medical Students

    ERIC Educational Resources Information Center

    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

    Objectives: 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. Methods: In 2005, the authors surveyed deans and student affairs deans at all U.S. medical schools and asked whether their schools…

  7. Compliance with and attitudes towards the management of medical emergencies in general dental practice.

    PubMed

    Johnson, T M; Kurt-Gabel, C

    2014-02-01

    Patient safety and risk management are increasing priorities in dental practice today. Ensuring that members of the dental team are prepared and equipped to adequately manage the common medical emergencies that might occur is an expectation of the public and increasingly demanded by the inspecting and regulatory bodies in healthcare.

  8. 76 FR 45578 - Request for Nominations for Members on a Public Advisory Committee; Medical Imaging Drugs...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-29

    ... HUMAN SERVICES Food and Drug Administration Request for Nominations for Members on a Public Advisory Committee; Medical Imaging Drugs Advisory Committee AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is requesting nominations for 12 members to...

  9. 76 FR 43689 - Draft Guidance for Industry and Food and Drug Administration Staff; Mobile Medical Applications...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-21

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration Staff; Mobile Medical Applications; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the...

  10. Medication assisted treatment of drug abuse and dependence: global availability and utilization.

    PubMed

    Kresina, Thomas F

    2007-01-01

    Clinical trials and clinical studies, using patented drugs and drugs off patent, provide data that impact the best treatment practices for substance abuse and dependence. In the United States, medications have been approved for use in the treatment of both alcohol and opioid dependence. Medications are used in the detoxification from drug abuse and dependence in the symptomatic relief of withdrawal. For long term treatment or medical maintenance treatment, medications eliminate the physiological effects of drug use by blocking drug-receptor binding in the brain. Therefore, patented drugs showing interactions with neurotransmitters in the brain, are attractive candidates for treatment efficacy trials. An effective long term treatment paradigm for reducing drug dependence is the combinatorial use of medications that block the effects of drug use with behavior change counseling and psychotherapy. Medications used for the long term treatment of opioid dependence are methadone, buprenorphine, and naltrexone. Pharmacotherapies used in the treatment of alcohol dependence include acamprosate, antabuse and naltrexone. A reliable indicator for successful treatment of drug dependence is time in treatment. Patients remain in long term treatment when they perceive that their health care environment is supportive and non-stigmatizing and with a good patient-provider relationship where their needs are identified and met. Additional medications are needed for individual comprehensive substance abuse treatment plans, particularly for individuals who abuse stimulants. Patented drugs remain an important source of candidate pharmacotherapies comprising medication assistant treatment, part of a comprehensive treatment plan for drug dependence that addresses the medical, social, and psychological needs of the patient. Adapting this drug treatment paradigm globally requires identifying and testing new drug candidates while building and changing programs to patient centered treatment

  11. 49 CFR 242.115 - Substance abuse disorders and alcohol drug rules compliance.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 49 Transportation 4 2014-10-01 2014-10-01 false Substance abuse disorders and alcohol drug rules... CONDUCTORS Program and Eligibility Requirements § 242.115 Substance abuse disorders and alcohol drug rules... evaluated as not currently affected by a substance abuse disorder or that the person has been evaluated...

  12. 49 CFR 242.115 - Substance abuse disorders and alcohol drug rules compliance.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 49 Transportation 4 2012-10-01 2012-10-01 false Substance abuse disorders and alcohol drug rules... CONDUCTORS Program and Eligibility Requirements § 242.115 Substance abuse disorders and alcohol drug rules... evaluated as not currently affected by a substance abuse disorder or that the person has been evaluated...

  13. 49 CFR 242.115 - Substance abuse disorders and alcohol drug rules compliance.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 49 Transportation 4 2013-10-01 2013-10-01 false Substance abuse disorders and alcohol drug rules... CONDUCTORS Program and Eligibility Requirements § 242.115 Substance abuse disorders and alcohol drug rules... evaluated as not currently affected by a substance abuse disorder or that the person has been evaluated...

  14. 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

  15. Adverse drug reactions to self-medication: a study in a pharmacovigilance database.

    PubMed

    Berreni, Aurélia; Montastruc, François; Bondon-Guitton, Emmanuelle; Rousseau, Vanessa; Abadie, Delphine; Durrieu, Geneviève; Chebane, Leila; Giroud, Jean-Paul; Bagheri, Haleh; Montastruc, Jean-Louis

    2015-10-01

    Although self-medication is widely developed, there are few detailed data about its adverse drug reactions (ADRs). This study investigated the main characteristics of ADRs with self-medication recorded in the Midi-Pyrénées PharmacoVigilance between 2008 and 2014. Self-medication included first OTC drugs and second formerly prescribed drugs later used without medical advice (reuse of previously prescribed drugs). Among the 12 365 notifications recorded, 160 (1.3%) were related to SM with 186 drugs. Around three-forth of the ADRs were 'serious'. Mean age was 48.8 years with 56.3% females. The most frequent ADRs were gastrointestinal and neuropsychiatric and main drug classes involved NSAIDs, analgesics, and benzodiazepines. Phytotherapy-homeopathy accounted for 9.1% of drugs.

  16. Therapeutic Drug Monitoring of the Newer Anti-Epilepsy Medications

    PubMed Central

    Krasowski, Matthew D.

    2010-01-01

    In the past twenty years, 14 new antiepileptic drugs have been approved for use in the United States and/or Europe. These drugs are eslicarbazepine acetate, felbamate, gabapentin, lacosamide, lamotrigine, levetiracetam, oxcarbazepine, pregabalin, rufinamide, stiripentol, tiagabine, topiramate, vigabatrin and zonisamide. In general, the clinical utility of therapeutic drug monitoring has not been established in clinical trials for these new anticonvulsants, and clear guidelines for drug monitoring have yet to be defined. The antiepileptic drugs with the strongest justifications for drug monitoring are lamotrigine, oxcarbazepine, stiripentol, and zonisamide. Stiripentol and tiagabine are strongly protein bound and are candidates for free drug monitoring. Therapeutic drug monitoring has lower utility for gabapentin, pregabalin, and vigabatrin. Measurement of salivary drug concentrations has potential utility for therapeutic drug monitoring of lamotrigine, levetiracetam, and topiramate. Therapeutic drug monitoring of the new antiepileptic drugs will be discussed in managing patients with epilepsy. PMID:20640233

  17. 77 FR 43846 - Food and Drug Administration Pediatric Medical Devices Workshop; Notice of Workshop

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-26

    ... HUMAN SERVICES Food and Drug Administration Food and Drug Administration Pediatric Medical Devices... Administration's (FDA) Office of Orphan Products Development is announcing the following workshop: FDA Pediatric Medical Devices Workshop. This meeting is intended to focus on challenges in pediatric device...

  18. 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...

  19. 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...

  20. 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...

  1. 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...

  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. 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...

  3. 75 FR 52765 - Development and Distribution of Patient Medication Information for Prescription Drugs; Public...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-27

    ... HUMAN SERVICES Food and Drug Administration Development and Distribution of Patient Medication... patient medication information (PMI) to be provided to patients who are prescribed drug products. Under... determined that the current system is not adequate to ensure that patients receive the essential...

  4. Evaluating Alcoholism and Drug Abuse Knowledge in Medical Education: A Collaborative Project.

    ERIC Educational Resources Information Center

    Griffin, John B., Jr.

    1983-01-01

    Medical students performed less well on examinations about drug abuse problems and patient management than on traditional medical board examinations. The best knowledge was of pharmacology of drug abuse, Alcoholics Anonymous, and treatment of delirium tremens. Students knew less about metabolic and biochemical areas, emergency-room treatment, and…

  5. Predictors of compliance with a home-based exercise program added to usual medical care in preventing postmenopausal osteoporosis: an 18-month prospective study.

    PubMed

    Mayoux-Benhamou, M A; Roux, C; Perraud, A; Fermanian, J; Rahali-Kachlouf, H; Revel, M

    2005-03-01

    This prospective 18-month study was designed to assess long-term compliance with a program of exercise aimed to prevent osteoporosis after an educational intervention and to uncover determinants of compliance. A total of 135 postmenopausal women were recruited by flyers or instructed by their physicians to participate in an educational session added to usual medical care. After a baseline visit and dual-energy X-ray absorptiometry, volunteers participated in a 1-day educational session consisting of a lecture and discussion on guidelines for appropriate physical activity and training in a home-based exercise program taught by a physical therapist. Scheduled follow-up visits were 1, 6, and 18 months after the educational session. Compliance with the exercise program was defined as an exercise practice rate 50% or greater than the prescribed training. The 18-month compliance rate was 17.8% (24/135). The main reason for withdrawal from the program was lack of motivation. Two variables predicted compliance: contraindication for hormone replacement therapy (odds ratio [OR] = 0.13; 95% confidence interval [95% CI], 0.04 to 0.46) and general physical function scores from an SF-36 questionnaire (OR=1.26; 95% CI, 1.03 to 1.5). To a lesser extent, osteoporosis risk, defined as a femoral T-score < or =-2.5, predicted compliance (OR=0.34; 95% CI, 0.10 to 1.16). Despite the addition of an educational session to usual medical care to inform participants about the benefits of exercise, only a minority of postmenopausal women adhered to a home-based exercise program after 18 months.

  6. 78 FR 68459 - Medical Device Development Tools; Draft Guidance for Industry, Tool Developers, and Food and Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-14

    ... HUMAN SERVICES Food and Drug Administration Medical Device Development Tools; Draft Guidance for Industry, Tool Developers, and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing...

  7. Drug-related problems associated with self-medication and medication guided by prescription: A pharmacy-based survey

    PubMed Central

    Panda, Abinash; Pradhan, Supriya; Mohapatra, Gurukrushna; Mohapatra, Jigyansa

    2016-01-01

    Objectives: The objective of this study is to identify and compare the nature of the drug-related problems (DRPs) associated with self-medication and non-self-medication (drug use guided by a prescription). Materials and Methods: The cross-sectional, observational study was conducted on 1100 adult participants at a convenience sample of six retail private pharmacy counters. The data collection form was based on the Pharmaceutical Care Network Europe version 6.2 classification for DRPs. Descriptive statistics was used to represent the prevalence of DRPs. Chi-square test was used to find out the association between the type of medication and DRPs. Odds ratio (OR) with confidence interval (CI) was computed to find the factors determining the occurrence of DRPs. P < 0.05 was considered to be statistically significant. Data were analyzed using SPSS version 16.0. Results: The prevalence of self-medication was 18.72%. The prevalence of DRPs was 17.36%. In the self-medication group, the prevalence of DRPs was high (40.78%) as compared to the non-self-medication group (11.97%). DRP related to inappropriate drug dosing was observed in 44.83% and 40.45% subjects in self-medication and non-self-medication group, respectively (P < 0.001). The subjects in the self-medication group were about 5 times likely to have a DRP (OR: 5.06, CI: 3.59-7.14, P < 0.001). Conclusions: Self-medication is associated with a higher risk of various DRPs. Since retail pharmacy outlet is often the first point of contact between the patient and the health care system in a developing country, interventions like drug information activities at the retail pharmacy is likely to bring down the DRPs associated with self-medication. PMID:27721536

  8. 78 FR 21612 - Medical Device Classification Product Codes; Guidance for Industry and Food and Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-11

    ... HUMAN SERVICES Food and Drug Administration Medical Device Classification Product Codes; Guidance for... guidance entitled ``Medical Device Classification Product Codes.'' This document describes how device product codes are used in a variety of FDA program areas to regulate and track medical devices...

  9. 42 CFR 423.153 - Drug utilization management, quality assurance, and medication therapy management programs (MTMPs).

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 42 Public Health 3 2012-10-01 2012-10-01 false Drug utilization management, quality assurance, and... Drug utilization management, quality assurance, and medication therapy management programs (MTMPs). (a... D plan, a drug utilization management program, quality assurance measures and systems, and an...

  10. 42 CFR 423.153 - Drug utilization management, quality assurance, and medication therapy management programs (MTMPs).

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 42 Public Health 3 2013-10-01 2013-10-01 false Drug utilization management, quality assurance, and... Drug utilization management, quality assurance, and medication therapy management programs (MTMPs). (a... D plan, a drug utilization management program, quality assurance measures and systems, and an...

  11. 42 CFR 423.153 - Drug utilization management, quality assurance, and medication therapy management programs (MTMPs).

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 42 Public Health 3 2014-10-01 2014-10-01 false Drug utilization management, quality assurance, and... Drug utilization management, quality assurance, and medication therapy management programs (MTMPs). (a... D plan, a drug utilization management program, quality assurance measures and systems, and an...

  12. Subjective effects of antipsychotic drugs and their relevance for compliance and remission.

    PubMed

    Naber, Dieter

    2008-01-01

    Only recently, success criteria became more ambitious and include a more thorough consideration of negative symptoms and cognitive dysfunction. The most important change within the last decade is the long overdue consideration of the patient's perspective. His/her subjective well-being, often unchanged or even worsened by typical antipsychotics, was neglected for a long time. One reason was the prejudice that schizophrenic patients are not able to self-rate their quality of life. Another reason was the belief that such data are not necessary because the psychiatrists' perspective, "objective" psychopathology, includes these domains. Among other scales, a self-report instrument has been constructed to evaluate "subjective well-being under neuroleptics" (SWN). This scale was used in numerous open and controlled trials, indicating: a) patients, if no longer acutely psychotic or suffering from severe cognitive deficits, are able to reliably assess their subjective well-being, b) high SWN is correlated with high compliance, c) atypical antipsychotics increase SWN, and d) individual improvements of SWN and of PANSS are not strongly related. Moreover, several studies found that early improvement of subjective well-being is a major predictor for the chance of remission. All these data indicate that a better consideration of the patient's perspective is possible and necessary.

  13. 77 FR 8886 - Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-15

    ... of public workshop. SUMMARY: The Food and Drug Administration (FDA) Detroit District Office, in co... District Office, 300 River Pl., Suite 5900, Detroit, MI 48207, 313-393-8143, Fax: 313- 393-8139, email... 13.3 Continuing Education Credits for SoCRA CE and Nurse CNE. SoCRA designates this live activity...

  14. 76 FR 78933 - Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-20

    .... ACTION: Notice of public workshop. The Food and Drug Administration (FDA), Los Angeles District Office... continuing nurse education (CNE). SOCRA designates this educational activity for a maximum of 13.3 American.... SoCRA is an approved provider of CNE by the Pennsylvania State Nurses Association (PSNA),...

  15. 76 FR 51040 - Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-17

    .... ACTION: Notice of public workshop. The Food and Drug Administration (FDA) Philadelphia District Office..., Philadelphia District, 900 U.S. Customhouse, Second & Chestnut Streets, Philadelphia, PA 19106, 215-597-4390... Continuing Education Credits for SoCRA CE and Nurse CNE. SOCRA designates this live activity for a maximum...

  16. 76 FR 17138 - Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-28

    .... ACTION: Notice of public workshop. The Food and Drug Administration (FDA) Denver District Office, in co... activity for a maximum of 13.3 Continuing Education (CE) Credits for SoCRA CE and Nurse CNE. SoCRA... nursing education by the Pennsylvania State Nurses Association (PSNA), an accredited approver by...

  17. Hand contamination during routine care in medical wards: the role of hand hygiene compliance.

    PubMed

    Monistrol, Olga; López, M Liboria; Riera, Montserrat; Font, Roser; Nicolás, Carme; Escobar, Miguel Angel; Freixas, Núria; Garau, Javier; Calbo, Esther

    2013-04-01

    The hands of healthcare workers (HCWs) are the most common vehicle for the transmission of micro-organisms from patient to patient and within the healthcare environment. The aim of this study was to evaluate the impact of a multimodal campaign on the type and amount of resident and transient flora and the presence of potential risk factors for hand contamination during routine care. A before-after (PRE and POST periods) interventional study was carried out in medical wards of a tertiary care hospital. Eighty-nine samples were analysed. Samples were cultured immediately before patient contact using a glove-juice method. Data collected included socio-demographic and risk factors for hand contamination. Flora was measured as log10 c.f.u. ml(-1) and evaluated by comparing median values in the PRE and POST periods. Transient flora was isolated from the hands of 67.4 and 46.1 % of HCWs in the PRE and POST periods, respectively (P<0.001). Enterobacteriaceae, Pseudomonas spp. and meticillin-sensitive Staphylococcus aureus were the predominant contaminants. Resident flora was isolated from 92.1 % of HCWs in the PRE period and from 70.8 % in the POST period (P<0.001). The meticillin-resistant coagulase-negative staphylococci log10 c.f.u. count ml(-1) decreased from 1.96 ± 1.2 to 0.89 ± 1.2 (mean ± s d; P<0.001), and the global flora count decreased from 2.77 ± 1.1 to 1.56 ± 1.4 (P<0.001). In the POST period, the wearing of fewer rings (P<0.001), shorter fingernail length (P = 0.008), a shorter time since recent hand hygiene (HH) (P = 0.007) and an increased use of alcohol-based hand rub instead of soap (P<0.001) were documented. The HH multimodal strategy reduced the number of risk factors and the level of HCW hand contamination.

  18. 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.

  19. Tuberculosis screening and compliance with return for skin test reading among active drug users.

    PubMed Central

    Malotte, C K; Rhodes, F; Mais, K E

    1998-01-01

    OBJECTIVES: This study assessed the independent and combined effects of different levels of monetary incentives and a theory-based educational intervention on return for tuberculosis (TB) skin test reading in a sample of active injection drug and crack cocaine users. Prevalence of TB infection in this sample was also determined. METHODS: Active or recent drug users (n = 1004), recruited via street outreach techniques, were skin tested for TB. They were randomly assigned to 1 of 2 levels of monetary incentive ($5 and $10) provided at return for skin test reading, alone or in combination with a brief motivational education session. RESULTS: More than 90% of those who received $10 returned for skin test reading, in comparison with 85% of those who received $5 and 33% of those who received no monetary incentive. The education session had no impact on return for skin test reading. The prevalence of a positive tuberculin test was 18.3%. CONCLUSIONS: Monetary incentives dramatically increase the return rate for TB skin test reading among drug users who are at high risk of TB infection. PMID:9585747

  20. Investigation into the reasons for preventable drug related admissions to a medical admissions unit: observational study

    PubMed Central

    Howard, R; Avery, A; Howard, P; Partridge, M

    2003-01-01

    Objective: To describe the drugs and types of medicine management problems most frequently associated with preventable drug related admissions to an acute medical admissions unit. Design: Observation study. Setting: Medical admissions unit in a teaching hospital in Nottingham, UK. Participants: 4093 patients seen by pharmacists on the medical admissions unit between 1 January and 30 June 2001. Main outcome measures: Proportion of admissions that were drug related and preventable, classification of the underlying causes of preventable drug related admissions, and identification of drugs most commonly associated with preventable drug related admissions. Results: Of the admissions seen by pharmacists, 265 (6.5%) were judged to be drug related and 178 (67%) of these were judged to be preventable. Preventable admissions were mainly due to problems with prescribing (63 cases (35%)), monitoring (46 cases (26%)), and adherence to medication (53 cases (30%)). The drugs most commonly implicated were NSAIDs, antiplatelets, antiepileptics, hypoglycaemics, diuretics, inhaled corticosteroids, cardiac glycosides, and beta-blockers. Conclusions: Potentially preventable drug related morbidity was associated with 4.3% of admissions to a medical admissions unit. In 91% of cases these admissions were related to problems with either prescribing, monitoring, or adherence. PMID:12897361

  1. Medical education for alcohol and other drug abuse in the United States.

    PubMed Central

    Lewis, D C

    1990-01-01

    Initiatives by individuals, private foundations and government have led to improvements in the United States in medical education dealing with alcohol and drug-related problems. Progress has been made, particularly in the past 5 years, in developing new medical school curricula and in faculty development. Greater activity by national professional organizations has helped raise the priority of training in alcohol- and drug-related areas for undergraduate and postgraduate medical education. As an example, Project ADEPT (Alcohol and Drug Education for Physician Training in primary care) at Brown University in Providence, Rhode Island, is described. The importance of positive and motivated faculty role models and of skills training is emphasized. PMID:2224678

  2. [Evaluation of pharmacokinetic drug-drug-interactions. Critical considerations of the relevance of pharmacokinetic drug-drug interactions of proton pump inhibitors in self medication].

    PubMed

    Petersen, Karl-Uwe

    2011-08-01

    Mechanisms and evaluation of pharmacokinetic drug interactions are discussed in general, including mechanisms beyond the hepatic phase-I reactions, and especially for the example of proton pump inhibitors (PPI), preferentially omeprazole. Particular attention is paid to the use of PPI as self-prescribed drugs. The sequelae of pharmacokinetic drug interactions can be serious. However, only the evidence of clinical consequences will convert such an interaction from a laboratory finding into a possible adverse effect. Without this, interacting drugs can still be co-administered if the specific characteristics of the concerned drugs, quantitative aspects of the interaction, and especially severity and frequency of possible clinical correlates are taken into consideration. It is encouraging that the laboratory findings reported for the PPI--in vitro or ex vivo from volunteer studies--have hardly found equivalents in clinical consequences. As of today, this is also true of the widely discussed interaction with clopidogrel. Regarding the safety of use of PPI as self-prescribed drugs, it also needs to be emphasized that a sizable number of interactions reported for omeprazole and/or pantoprazole were observed at higher dose levels than the 20 mg licensed for self medication. In conjunction with the temporal limitation of PPI self-prescription (14 days), it can be expected that pharmacokinetic drug interactions will generally be no critical factor in the usage of PPI in self-medication. However clinically relevant interactions can occur, e.g. when PPI are combined with extracts from St. John's wort, methotrexat or some inhibitors of HIV-protease with pH-dependent absorption.

  3. Khantzian's 'self-medication hypothesis' of drug addiction and films by Martin Scorsese.

    PubMed

    Sivapalan, Haran

    2009-06-01

    The portrayal of self-medication and drug use was studied in three films by Martin Scorsese: Raging Bull (1980), Goodfellas (1990) and The Departed (2006). Self-medication using nicotine in Raging Bull, cocaine in Goodfellas and sedatives in The Departed, exhibit mixed portrayals of the self-medication hypothesis. The temporal aspects of the hypothesis and credibility of character psychopathology show variation between the films. Across all films, the selection of particular drugs of choice for certain symptom clusters is consonant with that detailed in the self-medication hypothesis put forward by Khantzian.

  4. [Drugs for young Mozart. Medical treatment of Wolfgang as a child by his father Leopold Mozart].

    PubMed

    Bankl, H C; Reiter, C; Bankl, H

    2001-12-17

    Leopold Mozart (1719-1787), father of Wolfgang Amadé, had profound medical knowledge and was a passionate medical dilettante. As long as the young Mozart lived with his father and travelled on his concert tours with him, Leopold cared for his son in medical matters. Doctors were only consulted occasionally. In the extensive correspondence of Mozart's father drugs and treatments used for Wolfgang Amadé are reported in detail. This represents a reliable description of the pharmacological therapies of the late 18th century. The mentioned drugs are, as far as possible, viewed from todays medical perspective.

  5. 78 FR 49529 - Radio Frequency Wireless Technology in Medical Devices; Guidance for Industry and Food and Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-14

    ... Technology in Medical Devices; Guidance for Industry and Food and Drug Administration Staff; Availability... ``Radio Frequency Wireless Technology in Medical Devices; Guidance for Industry and Food and Drug... Technology in Medical Devices; Guidance for Industry and Food and Drug Administration Staff,'' you may...

  6. Urine phenobarbital drug screening: potential use for compliance assessment in neonates.

    PubMed

    Guillet, Ronnie; Kwon, Jennifer M; Chen, Sixaio; McDermott, Michael P

    2012-02-01

    This study was done to determine if urine phenobarbital measurements provide a reliable indicator of presence of the drug in neonates. Urine was collected from neonates treated with phenobarbital for clinical indications within 4 to 6 hours of clinically indicated collection of serum phenobarbital levels. Urine samples were also collected from control neonates not treated with phenobarbital. One aliquot was assayed fresh, another frozen at -30°C and assayed 1 to 3 months later. Phenobarbital was assayed using the ONLINE TDM Roche/Hitachi automated clinical chemistry analyzer. Serum and urine concentrations were compared as were fresh and frozen urine measurements. Serum phenobarbital ranged from 5.6 to 52.7 μg/mL. Matched urine samples were 56.6 ± 12.5% of the serum level. Frozen samples were 98.3 ± 8.0% of the fresh samples. Urine phenobarbital concentrations, either fresh or frozen, can be used in neonates as a noninvasive estimate of drug levels.

  7. Drug-Exposed Infants: Understanding the Medical Risk.

    ERIC Educational Resources Information Center

    Zuckerman, Barry

    1991-01-01

    Reviews the effects of prenatal exposure to the following: (1) cigarettes; (2) alcohol; (3) heroin; (4) narcotics; (5) marijuana; and (6) cocaine. Also discussed are the effects of exposure to multiple drugs and research issues in assessing drug effects. The importance of environment in long-term outcome is emphasized. (SLD)

  8. Compliance with the new Food and Drug Administration regulations: an approach by industry.

    PubMed

    Ward, J W

    1981-09-01

    Good Laboratory Practice regulations became effective on June 20, 1979. The regulations provide guidance for the proper conduct and reporting of nonclinical laboratory studies on articles regulated by the United States Food and Drug Administration. A fundamental requirement of the regulations is the establishment of a quality assurance unit within each research facility to ensure the utilization and maintenance of good laboratory practices. A second significant feature is the requirement for an archival unit responsible for maintaining all raw data, documentation, protocols, specimens, and final reports. Experience with the regulations has been mixed. The quality of reports has been upgraded dramatically. Protocols contain more information than ever, data recording is more extensive and more carefully executed, and reports are prepared more carefully and edited more thoroughly. Conversely, there is no real evidence that quality of science has been improved, and costs have increased markedly.

  9. 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

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Medical Device Reporting for Manufacturers; Draft Guidance....115). The draft guidance, when finalized, will represent the Agency's current thinking on...

  10. 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.

  11. 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.

  12. Medical aspects of drug misuse during one year in a rehabilitation unit

    PubMed Central

    Scott, Robert T.A.

    1986-01-01

    The medical work in a voluntary drug rehabilitation unit near Glasgow was examined. During one year 174 residents were admitted of whom 103 (59%) developed illnesses which required medical treatment. The need for drug misusers to receive general medical services during and after drug misuse was confirmed. Although withdrawal from barbiturate misuse required the prescription of controlled drugs, opiate and other withdrawals were satisfactorily managed with psychological support and general care; substances which could be abused were not prescribed. Blood testing of 129 residents showed that 114 (88%) had evidence of previous hepatitis B infection, while only two had human immunodeficiency virus (HIV) antibody. The low prevalence of HIV antibody compared with the high prevalence that has been reported in Edinburgh suggests that the opportunity exists at the moment to limit the spread of acquired immune deficiency syndrome among Glasgow drug misusers. PMID:3656269

  13. Inside Maine's Medicine Cabinet: Findings From the Drug Enforcement Administration's Medication Take-Back Events.

    PubMed

    Stewart, Heather; Malinowski, Alexandra; Ochs, Leslie; Jaramillo, Jeanie; McCall, Kenneth; Sullivan, Meghan

    2015-01-01

    Objectives. We evaluated the quantity and type of medications obtained in unused-medications return programs and the proportion of medication waste. Methods. We analyzed data collected in 11 Maine cities in 2011 to 2013 during 6 Drug Enforcement Administration (DEA) national medication take-back events. Pharmacy doctoral student volunteers collected data under the supervision of law enforcement, independent of the DEA. Data entry into the Pharmaceutical Collection Monitoring System, through its interface with Micromedex, allowed for analysis of medication classification, controlled substance category, therapeutic class, and percentage of medication waste (units returned/units dispensed). Results. Medication take-back events resulted in return of 13 599 individual medications from 1049 participants. We cataloged 553 019 units (capsules, tablets, milliliters, patches, or grams), representing 69.7% medication waste. Noncontrolled prescription medications accounted for 56.4% of returns, followed by over-the-counter medications (31.4%) and controlled prescription medications (9.1%). Conclusions. The significant quantities of medications, including controlled substances, returned and high degree of medication waste emphasize the need for medication collection programs to further public health research and improve health in our communities.

  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. Medical Students' Knowledge about Alcohol and Drug Problems: Results of the Medical Council of Canada Examination

    ERIC Educational Resources Information Center

    Kahan, Meldon; Midmer, Deana; Wilson, Lynn; Borsoi, Diane

    2006-01-01

    Purpose: To determine knowledge of a national sample of medical students about substance withdrawal, screening and early intervention, medical and psychiatric complications of addiction, and treatment options. Methods: Based on learning objectives developed by medical faculty, twenty-two questions on addictions were included in the 1998 Canadian…

  16. 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

  17. Intentional Medication Non-Adherence Due to Interactive Toxicity Beliefs among HIV Positive Active Drug Users

    PubMed Central

    Kalichman, Seth C.; Kalichman, Moira O.; Cherry, Charsey; Hoyt, Ginger; Washington, Christopher; Grebler, Tamar; Merely, Cindy; Welles, Brandi

    2015-01-01

    Drug use poses significant challenges to medical management of HIV infection. While most research has focused on the influence of intoxication on unintentional adherence to HIV treatment, drug use may also lead to intentional non-adherence, particularly when individuals believe that mixing medications with drugs is harmful. This study examined whether interactive toxicity beliefs predict non-adherence to antiretroviral therapy (ART) over a prospective period of adherence monitoring. Men and women living with HIV who screened positive for drug use and were being treated with ART (N=530) completed computerized self-interviews, three prospective unannounced pill counts to measure ART adherence, provided urine specimens for drug screening, and HIV viral load results from medical records. Results showed that 189 (35%) participants indicated that they intentionally miss their ART when they are using drugs. These participants also reported common beliefs regarding the perceived hazards of mixing HIV medications with alcohol and other drugs. Multivariable models that controlled for demographic and health characteristics, as well as frequency of alcohol use, showed that intentional non-adherence predicted poorer ART adherence over the prospective month and also predicted poorer treatment outcomes as indexed by unsuppressed HIV viral load. These findings extend previous research to show that interactive toxicity beliefs and intentional non-adherence play a significant role in medication non-adherence for a substantial number of people living with HIV and should be actively addressed in HIV clinical care. PMID:26226250

  18. 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.

  19. 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.…

  20. Myasthenia Gravis Medication Information Card (Drugs to be Avoided or Used with Caution in Myasthenia Gravis)

    MedlinePlus

    MYASTHENIA GRAVIS MEDICATION INFORMATION CARD Drugs to be Avoided or Used with Caution in MG My Name _______________________________________________ Address ________________________________________________ ... the MGFA web site; reference document “Medications and Myasthenia Gravis (A Reference for Health Care Professionals.” www.myasthenia. ...

  1. A Multicenter Evaluation of Off-Label Medication Use and Associated Adverse Drug Reactions in Adult Medical Intensive Care Units

    PubMed Central

    Smithburger, Pamela L.; Buckley, Mitchell S.; Culver, Mark A.; Sokol, Sarah; Lat, Ishaq; Handler, Steven M.; Kirisci, Levent; Kane-Gill, Sandra L.

    2016-01-01

    Objective Prior research indicates off-label use is common in the intensive care unit (ICU); however the safety of off-label use has not been assessed. The study objective was to determine the incidence of adverse drug reactions (ADRs) associated with off-label use and evaluate off-label use as a risk factor for the development of ADRs in an adult ICU population. Setting Medical ICUs at three academic medical centers Patients Adult patients (age ≥ 18 years old) receiving medication therapy Interventions All administered medications were evaluated for Food and Drug Administration (FDA) approved or off-label use. Patients were assessed daily for the development of an ADR through active surveillance. Three ADR assessment instruments were used to determine the probability of an ADR resulting from drug therapy. Severity and harm of the ADR were also assessed. Cox proportional hazard regression was used to identify a set of covariates that influenced the rate of ADRs. Measurements and Main Results Overall, 1654 patient days (327 patients) and 16,391 medications were evaluated, with 43% of medications being used off-label. One hundred and sixteen ADRs were categorized dichotomously (FDA or off-label), with 56% and 44% being associated with FDA approved and off-label use, respectively. The number of ADRs for medications administered and number of harmful and severe ADRs did not differ for medications used for FDA approved or off-label use (0.74% vs 0.67%, p = 0.336; 33 vs. 31 events, p=0.567; 24 vs. 24 events, p = 0.276). Age, sex, number of high-risk medications, number of off-label medications, and severity of illness score were included in the Cox proportional hazard regression. It was found that the rate of ADRs increases by 8% for every one additional off-label medication (HR = 1.08; 95 % CI: 1.018–1.154). Conclusion While ADRs do not occur more frequently with off-label use, ADR risk increases with each additional off-label medication used. PMID:25855897

  2. Did the Olympics need more drugs? a doctor's reflection on providing medical care during Op OLYMPICS.

    PubMed

    Monteiro de Barros, James; Ross, D A

    2014-09-01

    This paper examines some of the medical problems arising from the successful deployment of Defence Medical Services personnel to Op OLYMPICS (mid-June 2012-September 2012). It does not aim to be all encompassing in its scope, but focuses on the most pressing issues affecting a junior military doctor's ability to work effectively under field conditions. This will entail a discussion about whether in a deployment such as Op OLYMPICS medical care should be based upon offering solely primary healthcare in medical centres or using Role 1 medical treatment facilities, which include primary healthcare and pre-hospital emergency care. The main recommendations arising from the deployment are: clinicians should deploy with a minimum of basic emergency drugs and equipment; a medical facility treating a large population at risk for a prolonged period should have a broad stock of medications available on site; and medical risk assessments must be performed on all Reservists during mobilisation.

  3. Drug-related problems in medical wards of Tikur Anbessa specialized hospital, Ethiopia

    PubMed Central

    Ayalew, Mohammed Biset; Megersa, Teshome Nedi; Mengistu, Yewondwossen Taddese

    2015-01-01

    Objective: This study was aimed to determine the prevalence of drug-related problems (DRPs), identify the most common drugs, and drug classes involved in DRPs as well as associated factors with the occurrence of DRPs. Methods: A prospective cross-sectional study was conducted on 225 patients admitted to medical wards of Tikur Anbessa Specialized Hospital, Addis Ababa from March to June 2014. Data regarding patient characteristics, medications, diagnosis, length of hospitalization, investigation, and laboratory results were collected using data abstraction forms through review of patients’ medical card and medication charts. Identified DRPs were recorded and classified using DRP registration forms. The possible intervention measures for the identified DRPs were proposed and communicated to either the physician or the patient. Data were entered into Epi Info 7 and analyzed using SPSS version 21 (IBM Corp. Released 2012, Armonk, NY: IBM Corp). Findings: DRPs were found in 52% of study subjects. A drug-drug interaction (48% of all DRPs) was the most common DRP followed by adverse drug reaction (23%). Anti-infectives and gastrointestinal medicines were commonly involved in DRPs. Drugs with the highest drug risk ratio were gentamycin, warfarin, nifedipine, and cimetidine. The number of drugs taken by the patient per day is an important risk factor for DRPs. Conclusion: DRPs are common among medical ward patients. Polypharmacy has a significant association with the occurrence of DRP. Drugs such as gentamycin, warfarin, nifedipine, and cimetidine have the highest probability of causing DRP. So, patients who are taking either of these drugs or polypharmacy should be closely assessed for identification and timely correction of DRPs. PMID:26645029

  4. Non-medical prescription drug and illicit street drug use among young Swiss men and associated mental health issues.

    PubMed

    Baggio, Stéphanie; Studer, Joseph; Mohler-Kuo, Meichun; Daeppen, Jean-Bernard; Gmel, Gerhard

    2014-01-01

    Non-medical use of prescription drugs (NMUPD) is increasing among the general population, particularly among teenagers and young adults. Although prescription drugs are considered safer than illicit street drugs, NMUPD can lead to detrimental consequences. The aim of the present study was to investigate the relationship between drug use (NMUPD on the one side, illicit street drugs on the other side) with mental health issues and then compare these associations. A representative sample of 5719 young Swiss men aged around 20 years filled in a questionnaire as part of the ongoing baseline Cohort Study on Substance Use Risk Factors (C-SURF). Drug use (16 illicit street drugs and 5 NMUPDs, including sleeping pills, sedatives, pain killers, antidepressants, stimulants) and mental health issues (depression, SF12) were assessed. Simple and multiple linear regressions were employed. In simple regressions, all illicit and prescription drugs were associated with poorer mental health. In multiple regressions, most of the NMUPDs, except for stimulants, were significantly associated with poorer mental health and with depression. On the contrary, the only associations that remained significant between illicit street drugs and mental health involved cannabis. NMUPD is of growing concern not only because of its increasing occurrence, but also because of its association with depression and mental health problems, which is stronger than the association observed between these problems and illicit street drug use, excepted for cannabis. Therefore, NMUPD must be considered in screening for substance use prevention purposes.

  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

    2017-04-05

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-29

    ... HUMAN SERVICES Food and Drug Administration Food and Drug Administration/Xavier University Global... University, is announcing a public conference entitled ``FDA/Xavier University Global Medical Device... public conference will be held on the campus of Xavier University, 3800 Victory Pkwy., Cincinnati,...

  7. 78 FR 15957 - Food and Drug Administration/Xavier University Global Medical Device Conference

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-13

    ... HUMAN SERVICES Food and Drug Administration Food and Drug Administration/Xavier University Global... University, is announcing a public conference entitled ``FDA/Xavier University Global Medical Device... public conference will be held on the campus of Xavier University, 3800 Victory Pkwy., Cincinnati,...

  8. The Food and Drug Administration and pragmatic clinical trials of marketed medical products.

    PubMed

    Anderson, Monique L; Griffin, Joseph; Goldkind, Sara F; Zeitler, Emily P; Wing, Liz; Al-Khatib, Sana M; Sherman, Rachel E

    2015-10-01

    Pragmatic clinical trials can help answer questions of comparative effectiveness for interventions routinely used in medical practice. Pragmatic clinical trials may examine outcomes of one or more marketed medical products, and they are heterogeneous in design and risk. The Food and Drug Administration is charged with protecting the rights, safety, and welfare of individuals enrolled in clinical investigations, as well as assuring the integrity of the data upon which approval of medical products is made. The Food and Drug Administration 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 Food and Drug Administration regulations. While many pragmatic clinical trials will meet the criteria for an exemption from the requirements for an investigational new drug application or investigational device exemption, in general, all clinical investigations of medical products that fall under Food and Drug Administration jurisdiction must adhere to regulations for informed consent and review by an institutional review board. We are concerned that current Food and Drug Administration requirements for obtaining individual informed consent may deter or delay the conduct of pragmatic clinical trials intended to develop reliable evidence of comparative safety and effectiveness of approved medical products that are regulated by the Food and Drug Administration. 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 pragmatic clinical trials. We recommend that the Food and Drug Administration establish a risk-based approach to obtaining informed consent in pragmatic clinical trials that would facilitate the conduct of pragmatic clinical trials without compromising the protection of enrolled individuals or the integrity of the resulting data.

  9. The opioid receptors as targets for drug abuse medication.

    PubMed

    Noble, Florence; Lenoir, Magalie; Marie, Nicolas

    2015-08-01

    The endogenous opioid system is largely expressed in the brain, and both endogenous opioid peptides and receptors are present in areas associated with reward and motivation. It is well known that this endogenous system plays a key role in many aspects of addictive behaviours. The present review summarizes the modifications of the opioid system induced by chronic treatment with drugs of abuse reported in preclinical and clinical studies, as well as the action of opioid antagonists and agonists on the reinforcing effects of drugs of abuse, with therapeutic perspectives. We have focused on the effects of chronic psychostimulants, alcohol and nicotine exposure. Taken together, the changes in both opioid peptides and opioid receptors in different brain structures following acute or chronic exposure to these drugs of abuse clearly identify the opioid system as a potential target for the development of effective pharmacotherapy for the treatment of addiction and the prevention of relapse.

  10. The opioid receptors as targets for drug abuse medication

    PubMed Central

    Noble, Florence; Lenoir, Magalie; Marie, Nicolas

    2015-01-01

    The endogenous opioid system is largely expressed in the brain, and both endogenous opioid peptides and receptors are present in areas associated with reward and motivation. It is well known that this endogenous system plays a key role in many aspects of addictive behaviours. The present review summarizes the modifications of the opioid system induced by chronic treatment with drugs of abuse reported in preclinical and clinical studies, as well as the action of opioid antagonists and agonists on the reinforcing effects of drugs of abuse, with therapeutic perspectives. We have focused on the effects of chronic psychostimulants, alcohol and nicotine exposure. Taken together, the changes in both opioid peptides and opioid receptors in different brain structures following acute or chronic exposure to these drugs of abuse clearly identify the opioid system as a potential target for the development of effective pharmacotherapy for the treatment of addiction and the prevention of relapse. PMID:25988826

  11. Herbal medication: potential for adverse interactions with analgesic drugs.

    PubMed

    Abebe, W

    2002-12-01

    The use of herbal supplements in the US has increased dramatically in recent years. These products are not regulated by the Food and Drug Administration (FDA) with the same scrutiny as conventional drugs. Patients who use herbal supplements often do so in conjunction with conventional drugs. This article is a review of potential adverse interactions between some of the commonly used herbal supplements and analgesic drugs. Non-steroidal anti-inflammatory drugs (NSAIDs), particularly aspirin, have the potential to interact with herbal supplements that are known to possess antiplatelet activity (ginkgo, garlic, ginger, bilberry, dong quai, feverfew, ginseng, turmeric, meadowsweet and willow), with those containing coumarin (chamomile, motherworth, horse chestnut, fenugreek and red clover) and with tamarind, enhancing the risk of bleeding. Acetaminophen may also interact with ginkgo and possibly with at least some of the above herbs to increase the risk of bleeding. Further, the incidences of hepatotoxicity and nephrotoxicity may be augmented by acetaminophen when concomitantly used with the potentially hepatotoxic herbs Echinacea and kava, and with herbs containing salicylate (willow, meadowsweet), respectively. The concomitant use of opioid analgesics with the sedative herbal supplements, valerian, kava and chamomile, may lead to increased central nervous system (CNS) depression. The analgesic effect of opioids may also be inhibited by ginseng. It is suggested that health-care professionals should be more aware of the potential adverse interactions between herbal supplements and analgesic drugs, and take appropriate precautionary measures to avoid their possible occurrences. However, as most of the interaction information available is based on individual case reports, animal studies and in vitro data, further research is needed to confirm and assess the clinical significance of these potential interactions.

  12. Effect of medical, drug abuse, and mental health care on receipt of dental care by drug users.

    PubMed

    Turner, Barbara J; Laine, Christine; Cohen, Abigail; Hauck, Walter W

    2002-10-01

    We examined the association of patterns of health care in 1996 with subsequent dental care in 1997 or 1998 for 47,260 drug users enrolled in New York State Medicaid. From Medicaid files, we identified psychiatric care, prescribed antidepressants, a regular source of medical care, regular drug treatment (6+ contiguous months), and clinical conditions. Of this cohort, 58% received dental care. The adjusted odds ratios (AOR) of dental care were increased for drug users receiving psychiatric care and antidepressants (1.66 [1.55, 1.77]), psychiatric care alone (1.48 [1.41, 1.56]), or only antidepressants (1.18 [1.10, 1.27]), vs. neither. AORs of dental care were also higher for those with a regular source of medical care alone (1.27 [1.23, 1.35]) or with regular drug treatment (1.33 [CI 1.25, 1.41]) vs. neither. Mental health care and, to a lesser extent, a regular source of medical care and regular drug treatment may promote dental care in this vulnerable population.

  13. 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.

  14. 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.

  15. Popular Medical Concepts in Jamaica and Their Impact on Drug Use

    PubMed Central

    Mitchell, M. Faith

    1983-01-01

    Universally, popular medical concepts form the basis of lay understanding of health, disease and cure. In Jamaica these concepts first developed in association with traditional herbal medicine. Now they are applied to the most common forms of primary care: over-the-counter and prescribed drugs. Research findings suggest that where there is disagreement between popular and professional medical models, as is the case in Jamaica, the effect of popular concepts is to increase self-medication and reduce adherence to prescribed medical regimens. To ameliorate this situation and the attendant potential risks for drug consumers, methods for providing needed drug information and improving physician-patient communication are suggested. These suggestions apply not only to Jamaicans living in Jamaica and the United States, but also to members of any group whose ethnomedical concepts differ from the biomedical training of physicians. PMID:6364573

  16. Medical and Nonmedical Users of Prescription Drugs among College Students

    ERIC Educational Resources Information Center

    Rozenbroek, Katelyn; Rothstein, William G.

    2011-01-01

    Objectives: To examine medical and nonmedical users of prescription opioids, central nervous system depressants, and stimulants taken individually and in combination. Participants: Undergraduates at an urban mid-Atlantic university with 12,000 students. Methods: A questionnaire administered in classes provided 413 responses, with a usable response…

  17. Conceptual framework for drug usage review, medical audit and other patient care review procedures.

    PubMed

    Stolar, M H

    1977-02-01

    The following concepts are discussed: (1) quality assurance programs, (2) drug usage review, (3) utilization review, (4) peer review, (5) medical audit, (6) patient care audit and (7) medical care evaluation studies. A framework within which all types of hospital quality assurance mechanisms can be constructed is proposed and their interrelationships are described. The pharmacist's particpiation in the hospital's overall quality assurance program is stressed in two main areas-drug usage review, performed jointly with the medical staff, and quality assurance of pharmaceutical services, a peer review function of the pharmacy profession. These services are primarily drug distribution and control, drug information, clinical pharmacy, continuing education, and other pharmacy and pharmacist functions. Both functions may be viewed as parts of the pharmacy audit, one of several patient care audits within the facility. Pharmacists in skilled nursing facilities have quality assurance responsibilities similar to those of hospital-based pharmacists.

  18. Industry practices and compliance with U.S. Food and Drug Administration guidelines among California sprout firms.

    PubMed

    Thomas, Jennifer L; Palumbo, Mary S; Farrar, Jeff A; Farver, Thomas B; Cliver, Dean O

    2003-07-01

    Since 1995, raw vegetable sprouts have been implicated as the vehicle of infection in 15 foodborne outbreaks involving Salmonella and 2 foodborne outbreaks involving Escherichia coli O157:H7. To reduce the numbers of sprout-related outbreaks, the U.S. Food and Drug Administration (FDA) published Guidance for Industry: Reducing Microbial Food Safety Hazards for Sprouting Seeds in 1999. Between October 2000 and April 2001, 61.5% (16 of 26) of the known commercial sprout firms in California were enrolled in a survey to evaluate the industry practices of California sprouting operations and to determine compliance with FDA guidelines. A standardized questionnaire was used to collect data on firm demographics and seed disinfection practices. Additionally, free chlorine levels in seed disinfection solutions were measured, and 48-h spent irrigation water samples were collected from each firm. The irrigation water was screened for Salmonella and E. coli O157:H7 with FDA-recommended test kits. Free chlorine levels in the treatment solutions ranged from 50 to 35,000 mg/liter (ppm), with a median of 14,000 mg/liter (ppm). Free chlorine levels were higher for firms producing alfalfa sprouts than for those producing only mung bean or soybean sprouts (P=0.03). Levels of free chlorine tended to be higher for firms using a calcium hypochlorite treatment solution than for firms using a sodium hypochlorite treatment solution (P=0.067). All 32 irrigation water samples screened for Salmonella tested negative. Of the irrigation water samples tested for E. coil O157:H7, 75% (24 of 32) tested negative, and 25% (8 of 32) tested presumptive positive. The eight presumptive positive samples were found to be negative after further testing. These results indicate that producers of alfalfa sprouts are generally achieving the FDA-recommended calcium hypochlorite level of 20,000 mg/liter (ppm), whereas mung bean sprout producers are not.

  19. 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.

  20. 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

  1. 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

  2. Economic content in medical journal advertisements for medical devices and prescription drugs.

    PubMed

    Ackerly, D Clay; Glickman, Seth W; Schulman, Kevin A

    2010-01-01

    Previous studies of economic content in medical journal advertisements have not examined all types of economic content and have not included advertisements for medical devices. To examine trends in the economic content of medical device and pharmaceutical advertisements in medical journals. Three reviewers examined pharmaceutical and medical device advertisements in six leading medical journals from 1997 through 2006. Product characteristics, economic claims and evidence to support those claims were evaluated. Economic content appeared in 23.5% (561/2389) of pharmaceutical and device advertisements; 11.9% made market share claims and 12.7% made other economic claims. From 1997 through 2006, the percentage of medical device advertisements containing economic content declined from 26.7% to 6.7% (p = 0.02), whereas the percentage of pharmaceutical advertisements containing economic content remained stable (21.6-22.0%; p = 0.99). For pharmaceuticals, price claims declined significantly (15.7-4.2%; p < 0.01) and market share claims increased (2.8-11.5%; p = 0.09), and both consistently presented evidence (83% and 98%, respectively) while other types did not (e.g. 13.5% of formulary claims). Medical device economic claims differed from pharmaceutical economic claims; they made fewer market share claims (1.1% vs 12.8%) but more cost-effectiveness (6.5% vs 0.6%) and reimbursement (4.9% vs 0.8%) claims. Fewer than 2% of device advertisements with economic claims provided supporting evidence. The prevalence and type of economic content in pharmaceutical and device advertisements changed between 1997 and 2006, which may reflect evolving market dynamics, such as changes in reimbursement systems. Furthermore, the lack of supporting evidence in medical device advertisements and pharmaceutical formulary claims are potential areas of concern that require additional scrutiny by regulators and journal editors.

  3. 77 FR 38177 - TRICARE; Off-Label Uses of Devices; Partial List of Examples of Unproven Drugs, Devices, Medical...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-27

    ... Examples of Unproven Drugs, Devices, Medical Treatments, or Procedures AGENCY: Office of the Secretary... rule to revise the definition of ``unlabeled or off-label drug'' to ``off-label use of a drug or device... demonstrations from medical literature, national organizations, or technology assessment bodies that the...

  4. Medical need, scientific opportunity and the drive for antimalarial drugs.

    PubMed

    Ridley, Robert G

    2002-02-07

    Continued and sustainable improvements in antimalarial medicines through focused research and development are essential for the world's future ability to treat and control malaria. Unfortunately, malaria is a disease of poverty, and despite a wealth of scientific knowledge there is insufficient market incentive to generate the competitive, business-driven industrial antimalarial drug research and development that is normally needed to deliver new products. Mechanisms of partnering with industry have been established to overcome this obstacle and to open up and build on scientific opportunities for improved chemotherapy in the future.

  5. 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.

  6. The Changing Drug Culture: Medical and Recreational Marijuana.

    PubMed

    Albertson, Timothy E; Chenoweth, James A; Colby, Daniel K; Sutter, Mark E

    2016-02-01

    The major psychoactive compounds in marijuana (cannabis) are cannabinoids, the most significant of which is delta-9-tetrahydrocannabinol. There are also two synthetic pharmaceutical cannabinoids, nabilone and dronabinol, available by prescription in the United States. The use of marijuana has increased in the United States with passage of medical marijuana laws in many states and legalization of recreational marijuana use in several states. In addition, the potency of marijuana has increased in recent years. Marijuana has been used for a variety of medical purposes, including management of nausea and vomiting, appetite and immunologic stimulation in patients with HIV infection and AIDS, glaucoma, neurologic disorders, and pain relief. Studies on the benefits of marijuana as a treatment for various conditions have been inconsistent, except for those on pain management. Marijuana has adverse effects, and has been associated with driving impairment, psychosis, dependence and withdrawal syndromes, hyperemesis, acute cardiac events, some cancers, and impaired lung function. As with studies on the benefits of marijuana, studies of adverse effects have yielded inconsistent results. Except for impaired driving and the occurrence of dependence and withdrawal syndromes, the adverse effects of marijuana use have not been fully studied.

  7. 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.

  8. Surgical hemostatic agents: assessment of drugs and medical devices.

    PubMed

    Aubourg, R; Putzolu, J; Bouche, S; Galmiche, H; Denis, C; d'Andon, A; Maitrot, D; Partensky, C

    2011-12-01

    Surgical hemostatic agents are indicated to improve hemostasis when conventional techniques (compression, sutures or electrocoagulation) are inadequate. The National French Authority for Health (Haute Autorité de santé [HAS]) set out to assess these products (medical devices and agents) to determine their optimal utility. This evaluation included one class of products containing some form of human fibrinogen and thrombin and eight classes of medical devices and automated devices to prepare autologous fibrin. The assessment was based on a systematic review of the literature and expert opinion of health care professionals. The main measures of effectiveness of hemostatic agents were the success rate as expressed in terms of the time necessary to obtain adequate hemostasis, the volume of intra and/or postoperative blood loss, the need for blood transfusions, complication rate, duration of operations and hospital stay. A meta-analysis and 52 controlled randomized studies were selected involving cardiac or vascular surgery (19), ENT surgery (11), gastrointestinal surgery (5), urology (4), orthopedic surgery (4). Approximately half of the studies retained in this analysis evaluated blood derived agents (fibrin sealants) while the other half evaluated medical devices. The working group considered that there is not any evidence that these surgical hemostatic agents decrease the rates of transfusion, complications, reoperation, mortality, duration of operation and/or hospital stay. The working group considered that the use of surgical hemostatic agents to improve the safety of hemostasis in the absence of identified bleeding as an alternative to adequate conventional hemostasis was not justified. Surgical hemostatic agents can be used in ad hoc settings, as a complement to conventional methods to control persistent bleeding after conventional hemostatic techniques, or when abundant bleeding has led to biologic hemostatic disorders. The working group also distinguished

  9. Towards a cyber-medical system for drug assisting devices

    NASA Astrophysics Data System (ADS)

    Copot, Dana; De Keyser, Robin; Kovacs, Levente; Ionescu, Clara

    2017-01-01

    The purpose of this paper is to describe the role of non-integer models in healthcare pathways and how these tools provide a breakthrough in our understanding of drug delivery protocols. Two examples will be given as being typical of such applications: modeling glucose levels in diabetic type I patients and modeling pain transmission in patients suffering from (post operative) chronic pain. A wide range of tools to model these pathways and their role for use in healthcare delivery for optimal treatment and patient well-being are discussed. Individualized patient healthcare is nowadays top priority in European research framework for health and these modeling tools are primary aids in meeting these challenges.

  10. 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.

  11. 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

  12. The Food and Drug Administration's initiative for safe design and effective use of home medical equipment.

    PubMed

    Weick-Brady, Mary; Singh, Simran

    2014-06-01

    Although home-use medical devices provide significant benefits, including improved quality of life and cost savings, they are associated with unique risks. These risks result from interactions among the user, the use environment, and the device, and they can greatly impact user and patient safety. This article describes measures being taken by the Food and Drug Administration to address safe use of medical equipment by trained and untrained people outside of clinical facilities.

  13. Medical treatment of the adolescent drug abuser. An opportunity for rehabilitative intervention.

    PubMed

    Schonberg, S K

    1976-03-01

    Illnesses related to both the pharmacologic properties of abused substances and their methods of administration often bring the teenager to medical attention and may provide sufficient motivation for the adolescent to seek help beyond the acute problem. Successful treatment of an overdose reaction, an abstinence syndrome, or any other medical complication of drug abuse may give the physician a unique opportunity to begine further evalution for future care.

  14. Identifying medical-surgical nursing staff perceptions of the drug-abusing patient.

    PubMed

    Nilsen, Stacy L; Stone, Wendy L; Burleson, Stephanie L

    2013-01-01

    Nurses report a negative, stereotypical, and moralistic view of substance-abusing patients. Unaddressed bias may impede delivery of quality care. There is limited research of the needs specific to medical-surgical nursing staff interacting with substance-abusing patients. Nursing therapeutic commitment refers to the degree the nurse feels prepared with an adequate knowledge base, professional support, and personal ownership of a patient condition. Low therapeutic commitment correlates with job dissatisfaction. The Drug and Drug Problems Perceptions Questionnaire assesses healthcare provider attitude and therapeutic commitment to patients using or abusing medication or illicit substances. This therapeutic commitment survey serves as a staff needs assessment for a targeted educational innovation. The results show that the medical and surgical nursing staff has a constructive attitude and a moderately high degree of therapeutic commitment to the drug-abusing patient population, similar to more specialized multidisciplinary, mental healthcare workers. This study showed that medical-surgical nurses feel professionally responsible and clinically supported with patients with primary or comorbid drug abuse. Consistent with established results, focused and ongoing education on the risk factors, outcomes, and physical and psychological effects of illicit substances is necessary to improve therapeutic commitment to drug-dependent patients.

  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 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

  16. 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

  17. Two Models of Integrating Buprenorphine Treatment and Medical Staff within Formerly "Drug-Free" Outpatient Programs.

    PubMed

    Monico, Laura; Schwartz, Robert P; Gryczynski, Jan; O'Grady, Kevin E; Mitchell, Shannon Gwin

    2016-01-01

    "Drug-free" outpatient programs deliver treatment to the largest number of patients of all treatment modalities in the U.S., providing a significant opportunity to expand access to medication treatments for substance use disorders. This analysis examined staff perceptions of organizational dynamics associated with the delivery of buprenorphine maintenance within three formerly "drug-free" outpatient treatment programs. Semi-structured interviews (N = 15) were conducted with counseling and medical staff, and respondents were predominantly African American (n = 11) and female (n = 12). Themes and concepts related to medical staff integration emerged through an inductive and iterative coding process using Atlas.ti qualitative analysis software. Two treatment clinics incorporated buprenorphine maintenance into their programs using a co-located model of care. Their staff generally reported greater intra-organizational discord regarding the best ways to combine medication and counseling compared to the clinic using an integrated model of care. Co-located program staff reported less communication between medical and clinical staff, which contributed to some uncertainty about proper dosing and concerns about the potential for medication diversion. Clinics that shift from "drug-free" to incorporating buprenorphine maintenance should consider which model of care they wish to adapt and how to train staff and structure staff communication.

  18. Compliance assessment of ambulatory Alzheimer patients to aid therapeutic decisions by healthcare professionals

    PubMed Central

    2010-01-01

    Background Compliance represents a major determinant for the effectiveness of pharmacotherapy. Compliance reports summarising electronically compiled compliance data qualify healthcare needs and can be utilised as part of a compliance enhancing intervention. Nevertheless, evidence-based information on a sufficient level of compliance is scarce complicating the interpretation of compliance reports. The purpose of our pilot study was to determine the compliance of ambulatory Alzheimer patients to antidementia drugs under routine therapeutic use using electronic monitoring. In addition, the forgiveness of donepezil (i.e. its ability to sustain adequate pharmacological response despite suboptimal compliance) was characterised and evidence-based guidance for the interpretation of compliance reports was intended to be developed. Methods We determined the compliance of four different antidementia drugs by electronic monitoring in 31 patients over six months. All patients were recruited from the gerontopsychiatric clinic of a university hospital as part of a pilot study. The so called medication event monitoring system (MEMS) was employed, consisting of a vial with a microprocessor in the lid which records the time (date, hour, minute) of every opening. Daily compliance served as primary outcome measure, defined as percentage of days with correctly administered doses of medication. In addition, pharmacokinetics and pharmacodynamics of donepezil were simulated to systematically assess therapeutic undersupply also incorporating study compliance patterns. Statistical analyses were performed with SPSS and Microsoft Excel. Results Median daily compliance was 94% (range 48%-99%). Ten patients (32%) were non-compliant at least for one month. One-sixth of patients taking donepezil displayed periods of therapeutic undersupply. For 10 mg and 5 mg donepezil once-daily dosing, the estimated forgiveness of donepezil was 80% and 90% daily compliance or two and one dosage omissions at

  19. 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

    ... HUMAN SERVICES Food and Drug Administration 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 Administration (FDA) is announcing the availability of...

  20. 78 FR 38058 - Guidance for Industry on Heparin for Drug and Medical Device Use: Monitoring Crude Heparin for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-25

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Heparin for Drug and Medical Device Use: Monitoring Crude Heparin for Quality; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of...

  1. 77 FR 63837 - Draft Guidance for Industry and Food and Drug Administration Staff; eCopy Program for Medical...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-17

    ... HUMAN SERVICES Food and Drug Administration Draft 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 Administration (FDA) is announcing the availability...

  2. Potential drug-drug interactions in medical intensive care unit of a tertiary care hospital in Pakistan.

    PubMed

    Ismail, Mohammad; Khan, Farmanullah; Noor, Sidra; Haider, Iqbal; Haq, Inam-Ul; Ali, Zahid; Shah, Zahir; Hassam, Mohsin

    2016-10-01

    Background Patients admitted to intensive care unit (ICU) present with severe and life-threatening illnesses. Most of them suffer from various comorbidities. They usually receive complex pharmacotherapy with large number of medicines which increase the risk of drug-drug interactions (DDIs). Objective The present report aimed to investigate prevalence and levels of potential DDIs (pDDIs) in medical ICU. Methods Medications profiles of 416 patients were checked for pDDIs using Micromedex Drug-Reax(®). Prevalence, levels of severity and levels of documentation were reported. Results Of total 416 patients, 310 were exposed to pDDIs (overall prevalence = 74.5 %). Likewise, a prevalence rate of 13.9 % was recorded for contraindicated pDDIs, 52.2 % for major pDDI and 58.4 % for moderate pDDI. This study reported 740 interacting drug pairs that were presented in total 1686 pDDIs. Of 1686 pDDIs, 4.3 % were of contraindicated severity, 33.8 % of major severity and 49.6 % of moderate severity, whereas 45.5 % were of fair scientific evidence and 41.4 % of good scientific evidence. Conclusion In this study, pDDIs were found highly prevalent in ICU patients at a rate of 74.5 %. Most of the pDDIs had moderate severity; however, substantial number of interactions (38.1 %) had major and contraindicated severity.

  3. Comparative analysis of pharmacovigilance methods in the detection of adverse drug reactions using electronic medical records

    PubMed Central

    Liu, Mei; McPeek Hinz, Eugenia Renne; Matheny, Michael Edwin; Denny, Joshua C; Schildcrout, Jonathan Scott; Miller, Randolph A; Xu, Hua

    2013-01-01

    Objective Medication  safety requires that each drug be monitored throughout its market life as early detection of adverse drug reactions (ADRs) can lead to alerts that prevent patient harm. Recently, electronic medical records (EMRs) have emerged as a valuable resource for pharmacovigilance. This study examines the use of retrospective medication orders and inpatient laboratory results documented in the EMR to identify ADRs. Methods Using 12 years of EMR data from Vanderbilt University Medical Center (VUMC), we designed a study to correlate abnormal laboratory results with specific drug administrations by comparing the outcomes of a drug-exposed group and a matched unexposed group. We assessed the relative merits of six pharmacovigilance measures used in spontaneous reporting systems (SRSs): proportional reporting ratio (PRR), reporting OR (ROR), Yule's Q (YULE), the χ2 test (CHI), Bayesian confidence propagation neural networks (BCPNN), and a gamma Poisson shrinker (GPS). Results We systematically evaluated the methods on two independently constructed reference standard datasets of drug–event pairs. The dataset of Yoon et al contained 470 drug–event pairs (10 drugs and 47 laboratory abnormalities). Using VUMC's EMR, we created another dataset of 378 drug–event pairs (nine drugs and 42 laboratory abnormalities). Evaluation on our reference standard showed that CHI, ROR, PRR, and YULE all had the same F score (62%). When the reference standard of Yoon et al was used, ROR had the best F score of 68%, with 77% precision and 61% recall. Conclusions Results suggest that EMR-derived laboratory measurements and medication orders can help to validate previously reported ADRs, and detect new ADRs. PMID:23161894

  4. Therapeutic drug monitoring (TDM) of antifungal agents: guidelines from the British Society for Medical Mycology.

    PubMed

    Ashbee, H Ruth; Barnes, Rosemary A; Johnson, Elizabeth M; Richardson, Malcolm D; Gorton, Rebecca; Hope, William W

    2014-05-01

    The burden of human disease related to medically important fungal pathogens is substantial. An improved understanding of antifungal pharmacology and antifungal pharmacokinetics-pharmacodynamics has resulted in therapeutic drug monitoring (TDM) becoming a valuable adjunct to the routine administration of some antifungal agents. TDM may increase the probability of a successful outcome, prevent drug-related toxicity and potentially prevent the emergence of antifungal drug resistance. Much of the evidence that supports TDM is circumstantial. This document reviews the available literature and provides a series of recommendations for TDM of antifungal agents.

  5. Therapeutic drug monitoring (TDM) of antifungal agents: guidelines from the British Society for Medical Mycology

    PubMed Central

    Ashbee, H. Ruth; Barnes, Rosemary A.; Johnson, Elizabeth M.; Richardson, Malcolm D.; Gorton, Rebecca; Hope, William W.

    2014-01-01

    The burden of human disease related to medically important fungal pathogens is substantial. An improved understanding of antifungal pharmacology and antifungal pharmacokinetics–pharmacodynamics has resulted in therapeutic drug monitoring (TDM) becoming a valuable adjunct to the routine administration of some antifungal agents. TDM may increase the probability of a successful outcome, prevent drug-related toxicity and potentially prevent the emergence of antifungal drug resistance. Much of the evidence that supports TDM is circumstantial. This document reviews the available literature and provides a series of recommendations for TDM of antifungal agents. PMID:24379304

  6. [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.

  7. Medication reconciliation: a tool to prevent adverse drug events in geriatrics medicine.

    PubMed

    Berthe, Anaïs; Fronteau, Clémentine; Le Fur, Éloïse; Morin, Caroline; Huon, Jean-François; Rouiller-Furic, Isabelle; Berlioz-Thibal, Marielle; Berrut, Gilles; Lepelletier, Aline

    2017-03-01

    Iatrogenic effects represent a large part of emergency admissions among elderly people. Throughout the care pathway of a patient, whether he is at home or hospitalized, many different health professionals are involved regarding the patient's medication. Medication reconciliation is one way to prevent adverse drug events at all care transitions for every patient by eliminating undocumented intentional discrepancies and unintentional discrepancies in the patient's medication. The aim of this article is to present the different activities of clinical pharmacy developed since 2011 in a follow up and rehabilitation geriatric care service, including medication reconciliation activity. Monitoring of this activity started in March 2014, indicators show that almost 90% of patients were reconciled at admission and discharge from the geriatric unit. Physicians and pharmacists play an active role in reviewing, managing and monitoring a patient's medication. Care coordination and communication among the many members of the medical care team have become one of the greatest challenges healthcare professionals face. At the time of discharge, the patient also plays a key role in medication reconciliation and should be educated when it's possible on the importance of managing medication information. Finally, the hospital pharmacist's role is to keep the primary care physicians and community pharmacists informed about medication changes.

  8. 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

  9. 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

  10. Treatment by medical compression stockings among 144 consecutive patients with non-complicated primary varicose veins: results on compliance.

    PubMed

    Rastel, D

    2014-12-01

    Compression stockings are the major long-term treatment of non-complicated primary varicose veins recommended by international consensus. Nevertheless there are few data concerning the patient compliance to treatment. Hundred and forty-four patients with varicose veins of primary origin were prospectively recruited and questioned about their compression therapy: 29.2% patients are wearing compression stockings, and for 10.4% on a daily basis; 32.6% do not wear their compression mainly because it is not well tolerated; 38.2% do not have compression treatment because it is not recommended or not prescribed by the physician.

  11. Is the Accreditation Council for Graduate Medical Education (ACGME) Resident/Fellow survey, a valid tool to assess general surgery residency programs compliance with work hours regulations?

    PubMed

    Sticca, Robert P; Macgregor, Jay M; Szlabick, Randolph E

    2010-01-01

    The Accreditation Council for Graduate Medical Education (ACGME) uses the resident/fellow survey to assess residency programs compliance with ACGME work hours regulations. Survey results can have significant consequences for residency programs including ACGME letters of warning, shortened program accreditation cycle, immediate full program and institutional site visits, or administrative withdrawal of a program's accreditation. Survey validity was assessed by direct query of general surgery residents who answer the survey each year. A multiple-choice survey was created to assess all US general surgery residents' interpretation and understanding of the ACGME survey. The survey was distributed to all surgery residency program directors in the US in 2009. Responses were compiled via an online survey program. Statistical analysis was performed in aggregate and between junior and senior residents. Nine hundred sixty-five (13.2%) general surgical residents responded with 961 (99.6%) completing all questions. All responding residents had taken the ACGME survey at least once with 634 (66%) having taken it more than once. Nineteen percent of residents had difficulty understanding the questions with senior residents (23%) reporting difficulty more than junior residents (14%), p < 0.001. Thirty-five percent of residents had discussed the survey with their faculty or program director prior to taking it, while 17% were instructed on how to answer the survey. One hundred thirty-three residents (14%) admitted to not answering the questions truthfully while 352 (37%) of residents felt that the survey did not provide an accurate evaluation of their work hours in residency training. An evaluation tool in which 1 in 7 residents admit to answering the questions falsely and 1 in 5 residents had difficulty interpreting the questions may not be a valid method to evaluate compliance with work hours regulations. Evaluation of work hours regulations compliance should be based on actual work

  12. 42 CFR 423.153 - Drug utilization management, quality assurance, and medication therapy management programs (MTMPs).

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 42 Public Health 3 2011-10-01 2011-10-01 false Drug utilization management, quality assurance, and... management, quality assurance, and medication therapy management programs (MTMPs). (a) General rule. Each... utilization management program, quality assurance measures and systems, and an MTMP as described in...

  13. 42 CFR 423.153 - Drug utilization management, quality assurance, and medication therapy management programs (MTMPs).

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 42 Public Health 3 2010-10-01 2010-10-01 false Drug utilization management, quality assurance, and... management, quality assurance, and medication therapy management programs (MTMPs). (a) General rule. Each... utilization management program, quality assurance measures and systems, and an MTMP as described in...

  14. Drug Abuse and Alcoholism Teaching in U.S. Medical and Osteopathic Schools

    ERIC Educational Resources Information Center

    Pokorny, Alex; And Others

    1978-01-01

    Findings from a national survey show that required teaching activities during all four years of medical school averaged 25.7 hours, with a range from 0 to 126. Schools differed widely in the number and type of electives offered in drug abuse and alcoholism, as well as in the number of clinical assignments available. (Author/LBH)

  15. Development of a standardized knowledge base to generate individualized medication plans automatically with drug administration recommendations

    PubMed Central

    Send, Alexander F J; Al-Ayyash, Adel; Schecher, Sabrina; Rudofsky, Gottfried; Klein, Ulrike; Schaier, Matthias; Pruszydlo, Markus G; Witticke, Diana; Lohmann, Kristina; Kaltschmidt, Jens; Haefeli, Walter E; Seidling, Hanna M

    2013-01-01

    Aims We aimed to develop a generic knowledge base with drug administration recommendations which allows the generation of a dynamic and comprehensive medication plan and to evaluate its comprehensibility and potential benefit in a qualitative pilot study with patients and physicians. Methods Based on a literature search and previously published medication plans, a prototype was developed and iteratively refined through qualitative evaluation (interviews with patients and focus group discussions with physicians). To develop the recommendations for safe administration of specific drugs we screened the summary of product characteristics (SmPC) of different exemplary brands, allocated the generated advice to groups with brands potentially requiring the same advice, and reviewed these allocations regarding applicability and appropriateness of the recommendations. Results For the recommendations, 411 SmPCs of 140 different active ingredients including all available galenic formulations, routes of administrations except infusions, and administration devices were screened. Finally, 515 distinct administration recommendations were included in the database. In 926 different generic groups, 29 879 allocations of brands to general advice, food advice, indications, step-by-step instructions, or combinations thereof were made. Thereby, 27 216 of the preselected allocations (91.1%) were confirmed as appropriate. In total, one third of the German drug market was labelled with information. Conclusions Generic grouping of brands according to their active ingredient and other drug characteristics and allocation of standardized administration recommendations is feasible for a large drug market and can be integrated in a medication plan. PMID:24007451

  16. Using Temporal Patterns in Medical Records to Discern Adverse Drug Events from Indications

    PubMed Central

    Liu, Yi; LePendu, Paea; Iyer, Srinivasan; Shah, Nigam H.

    2012-01-01

    Researchers estimate that electronic health record systems record roughly 2-million ambulatory adverse drug events and that patients suffer from adverse drug events in roughly 30% of hospital stays. Some have used structured databases of patient medical records and health insurance claims recently—going beyond the current paradigm of using spontaneous reporting systems like AERS—to detect drug-safety signals. However, most efforts do not use the free-text from clinical notes in monitoring for drug-safety signals. We hypothesize that drug–disease co-occurrences, extracted from ontology-based annotations of the clinical notes, can be examined for statistical enrichment and used for drug safety surveillance. When analyzing such co-occurrences of drugs and diseases, one major challenge is to differentiate whether the disease in a drug–disease pair represents an indication or an adverse event. We demonstrate that it is possible to make this distinction by combining the frequency distribution of the drug, the disease, and the drug-disease pair as well as the temporal ordering of the drugs and diseases in each pair across more than one million patients. PMID:22779050

  17. Staff Report to the Senior Department Official on Recognition Compliance Issues. Recommendation Page: Council on Naturopathic Medical Education

    ERIC Educational Resources Information Center

    US Department of Education, 2010

    2010-01-01

    The Council on Naturopathic Medical Education (CNME) is a programmatic accrediting agency. CNME's current scope of recognition is the accreditation and preaccreditation throughout the United States of graduate level, four-year naturopathic medical education programs leading to the Doctor of Naturopathic Medicine (N.M.D.) or Doctor of Naturopathy…

  18. Recent Literature on Medication Errors and Adverse Drug Events in Older Adults

    PubMed Central

    Naples, Jennifer G.; Hanlon, Joseph T.; Schmader, Kenneth E.; Semla, Todd P.

    2015-01-01

    Medication errors and adverse drug events are common in older adults, but locating literature addressing these issues is often challenging. The objective of this article was to summarize recent studies addressing medication errors and adverse drug events in a single location to improve accessibility for individuals working with older adults. The authors conducted a comprehensive literature search for studies published in 2014 and identified 51 potential articles. After critical review, 17 studies were selected for inclusion based on innovation, rigorous observational or experimental study designs, and use of reliable, valid measures. Four articles characterizing potentially inappropriate prescribing and interventions to optimize medication regimens were annotated and critiqued in detail. We hope that health policy makers and clinicians find this information helpful in improving the quality of care for older adults. PMID:26804210

  19. Perivascular medical devices and drug delivery systems: Making the right choices.

    PubMed

    Mylonaki, Ioanna; Allémann, Éric; Saucy, François; Haefliger, Jacques-Antoine; Delie, Florence; Jordan, Olivier

    2017-02-28

    Perivascular medical devices and perivascular drug delivery systems are conceived for local application around a blood vessel during open vascular surgery. These systems provide mechanical support and/or pharmacological activity for the prevention of intimal hyperplasia following vessel injury. Despite abundant reports in the literature and numerous clinical trials, no efficient perivascular treatment is available. In this review, the existing perivascular medical devices and perivascular drug delivery systems, such as polymeric gels, meshes, sheaths, wraps, matrices, and metal meshes, are jointly evaluated. The key criteria for the design of an ideal perivascular system are identified. Perivascular treatments should have mechanical specifications that ensure system localization, prolonged retention and adequate vascular constriction. From the data gathered, it appears that a drug is necessary to increase the efficacy of these systems. As such, the release kinetics of pharmacological agents should match the development of the pathology. A successful perivascular system must combine these optimized pharmacological and mechanical properties to be efficient.

  20. Oral targeted therapies: managing drug interactions, enhancing adherence and optimizing medication safety in lymphoma patients.

    PubMed

    Liewer, Susanne; Huddleston, Ashley N

    2015-04-01

    The advent of newer, targeted oral chemotherapy medications such as small molecule kinase inhibitors, ibrutinib and idelalisib, has created additional options for the treatment of lymphoma. The targeted nature of these agents offers many patient-identified advantages over older, intravenously administered chemotherapy regimens such as ease of self-administration and an increased sense of independence. However, newer oral agents also present unique challenges not previously experienced with older therapies that may affect safety, efficacy and patient adherence. In this article, we review oral agents for the treatment of lymphoma, how to evaluate and manage drug-drug and drug-food interactions with concomitant oral medications, and issues with patient adherence as well as methods to determine adherence for oral chemotherapy.

  1. 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

  2. Alcohol and other drugs: the response of the political and medical institutions.

    PubMed

    Pittman, D J; Staudenmeier, W J; Kaplan, A

    1991-08-01

    Formal and informal social control in shaping individual behaviors toward the use of alcohol and other drugs is discussed. Emphasis is placed on formal social control as it occurs in two major institutions. The state, which embodies the political and legal structures of the society is discussed in terms of the social control of some of the consequences of drinking, such as public drunkenness, alcoholism, operating vehicles with specific blood alcohol levels, and crime and alcohol use. The medical institution's involvement in alcohol and drug control is discussed in terms of the physician's role in diagnosing alcohol and drug dependent individuals. Two contemporary cases, those of pregnant addicts and alcohol-related organ transplant patients, illustrate the significant interactions between the responses of the political and medical institutions, and the broader influences that help shape these responses.

  3. 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.

  4. 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

  5. Cobicistat versus ritonavir boosting and differences in the drug-drug interaction profiles with co-medications.

    PubMed

    Marzolini, Catia; Gibbons, Sara; Khoo, Saye; Back, David

    2016-07-01

    Nearly all HIV PIs and the integrase inhibitor elvitegravir require a pharmacokinetic enhancer in order to achieve therapeutic plasma concentrations at the desired dose and frequency. Whereas ritonavir has been the only available pharmacokinetic enhancer for more than a decade, cobicistat has recently emerged as an alternative boosting agent. Cobicistat and ritonavir are equally strong inhibitors of cytochrome P450 (CYP) 3A4 and consequently were shown to be equivalent pharmacokinetic enhancers for elvitegravir and for the PIs atazanavir and darunavir. Since cobicistat is a more selective CYP inhibitor than ritonavir and is devoid of enzyme-inducing properties, differences are expected in their interaction profiles with some co-medications. Drugs whose exposure might be altered by ritonavir but unaltered by cobicistat are drugs primarily metabolized by CYP1A2, CYP2B6, CYP2C8, CYP2C9 and CYP2C19 or drugs undergoing mainly glucuronidation. Thus, co-medications should be systematically reviewed when switching the pharmacokinetic enhancer to anticipate potential dosage adjustments.

  6. Pivotal clinical trials of novel ophthalmic drugs and medical devices: retrospective observational study, 2002–2012

    PubMed Central

    Hwang, Jenny; Ciolino, Joseph B

    2015-01-01

    Objectives Novel therapeutics are an important part of ophthalmologists’ armamentarium, and the risks and benefits of these therapies must be carefully evaluated. We sought to quantify the characteristics of the pivotal clinical trials supporting the regulatory approval of new ophthalmic drugs and medical devices. Design Retrospective observational study. Setting and data source Medical review dossiers for new ophthalmic drug and high-risk device approvals released publicly by the US Food and Drug Administration (FDA). Main outcome measures Proportion of pivotal trials with randomisation, masking, active or placebo controls and subgroup analyses; total and median number of trial enrollees; and the number of drugs and devices approved with required postapproval studies. Results From 2002 to 2012, the FDA approved 11 ophthalmic drugs and 25 devices. The pivotal trials underlying the approvals of ophthalmic drugs in our study cohort enrolled a median of 809 patients. Virtually all drug trials were randomised and masked (91%), of which 7 (70%) used a placebo control. Pivotal trials for ophthalmic devices enrolled 324 patients on average, and significantly fewer trials for ophthalmic devices versus drugs were randomised (16% vs 91%; p<0.001) or masked (12% vs 91%; p<0.001). 8 (32%) ophthalmic devices and 6 (55%) ophthalmic drugs were approved with required postapproval studies. Conclusions Ophthalmic therapeutics were approved based on varying levels of evidence. Postapproval studies could be used to confirm or refute early indications of safety and effectiveness of these therapeutics, with the study results accessible to patients and clinicians who need to make informed treatment decisions. PMID:26044760

  7. Drugs involved in drug-facilitated crimes--part II: Drugs of abuse, prescription and over-the-counter medications. A review.

    PubMed

    Shbair, M K S; Eljabour, S; Bassyoni, I; Lhermitte, M

    2010-11-01

    In recent years, there has been a notable increase in the number of reports of drug-facilitated crimes. Usually, individuals report that they were robbed or assaulted while incapacitated by drugs. Most often, these cases have involved drugs that have the ability to produce an effect that leaves the victim in a semiconscious or unconscious state. It is reasonable to assume that the purpose of drug-induced incapacitation is probably largely unchanged with time. This covers the full range of property offences (particularly theft) and crimes against the person (often sexual assault). What have changed are the drugs themselves: the number; type; their accessibility; effects and detection. This review describes the different aspects related to the involvement and use of drugs of abuse, as well as prescription and over-the counter medications in drug-facilitated crimes, which may help people working in this field to expand their knowledge in order to better understand the nature of these crimes or offences.

  8. Development of an Alert System to Detect Drug Interactions with Herbal Supplements using Medical Record Data

    PubMed Central

    Archer, Melissa; Proulx, Joshua; Shane-McWhorter, Laura; Bray, Bruce E.; Zeng-Treitler, Qing

    2014-01-01

    While potential medication-to-medication interaction alerting engines exist in many clinical applications, few systems exist to automatically alert on potential medication to herbal supplement interactions. We have developed a preliminary knowledge base and rules alerting engine that detects 259 potential interactions between 9 supplements, 62 cardiac medications, and 19 drug classes. The rules engine takes into consideration 12 patient risk factors and 30 interaction warning signs to help determine which of three different alert levels to categorize each potential interaction. A formative evaluation was conducted with two clinicians to set initial thresholds for each alert level. Additional work is planned add more supplement interactions, risk factors, and warning signs as well as to continue to set and adjust the inputs and thresholds for each potential interaction. PMID:25954326

  9. Reliability and validity of a new Medication Adherence Rating Scale (MARS) for the psychoses.

    PubMed

    Thompson, K; Kulkarni, J; Sergejew, A A

    2000-05-05

    Medication compliance is one of the foremost problems affecting neuroleptic efficacy in psychiatric patients. To date, compliancy has most commonly been assessed with the Drug Attitude Inventory (DAI) developed by Hogan et al. (Hogan, T.P., Awad, A.G., Eastwood, R., 1983. A self-report scale predictive of drug compliance in schizophrenics: reliability and discriminative validity. Psychol. Med. 13, 177-183). The present study identified several deficiencies in the DAI. Using the partial credit version of the Item Response Theory measurement model, the DAI was refined with the aim of greater validity and clinical utility. The new inventory was administered to 66 patients, the majority of whom were diagnosed with schizophrenia. When available, lithium levels and carer ratings of compliance were also recorded and used to verify compliancy. The new inventory appears to be a valid and reliable measure of compliancy for psychoactive medications.

  10. 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.

  11. Can a medical need clause help manage the growing costs of prescription drugs in the EU?

    PubMed

    Brooks, Eleanor; Geyer, Robert

    2016-04-01

    Innovation in the development of new drugs has to balance the needs of health actors and administrators, the pharmaceutical industry and patients. Differing perspectives on what constitutes an innovation, where research and development should be directed and how new drugs should be evaluated and priced cause ongoing tensions within the regulatory framework. In the current climate, where Europe's health systems face rising demand for health services and increasingly restricted resources, the efficiency of pharmaceutical regulation and drug development is under even greater scrutiny. How can regulation foster innovation and industry growth while also serving the public health needs of society, and what is the EU's role in pursuing this objective? Drawing on a provision which formerly existed in Norwegian pharmaceutical legislation, this article explores the potential of a medical need clause (MNC) in addressing these issues. In restricting market authorisations to those drugs that offer an added therapeutic value, might a MNC foster innovation and spending efficiency in Europe's health systems?

  12. 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.

  13. 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

  14. ASSESSMENT OF PRACTICE AT RETAIL PHARMACIES IN PAKISTAN: EXTENT OF COMPLIANCE WITH THE PREVAILING DRUG LAW OF PAKISTAN.

    PubMed

    Ullah, Hanif; Zada, Wahid; Khan, Muhammad Sona; Iqbal, Muhammad; Chohan, Osaam; Raza, Naeem; Khawaja, Naeem Raza; Abid, Syed Mobasher Ali; Murtazai, Ghulam

    2016-01-01

    The main objective of this study was to assess the practice at retail pharmacies in Pakistan and to compare the same in rural and urban areas. The maintenance of pharmacy and drug inspectors' visit was also assessed. This cross sectional study was conducted in Abbottabad, Pakistan during October-November, 2012. A sample of 215 drug sellers or drug stores was selected by employing convenient sampling method. With a response rate of 91.6%, 197 drug sellers participated in this study. All the drug sellers were male. Overall, 35% (n = 197) of the drug sellers did not have any professional qualification. A majority of the drug sellers were involved in various malpractices like selling of medicines without prescription (80.7%), prescribing practice (60.9%), prescription intervention (62.4%) and selling of controlled substances (66%) without a license for selling it. These malpractices were significantly higher in rural area than that in urban area.

  15. Teaching of medical pharmacology: the need to nurture the early development of desired attitudes for safe and rational drug prescribing.

    PubMed

    Gwee, Matthew C E

    2009-09-01

    Pharmacology, as a basic medical science discipline, provides the scientific basis of therapeutics, i.e. the scientific foundation for safe and rational prescribing of drugs. The public, lay media, and the medical profession have raised serious concerns over the high incidence of errors of drug prescribing which compromise patient safety, including death of some patients, attributed mainly to inadequate teaching of medical pharmacology and, consequently, to medical graduates lacking skills in safe and effective drug prescribing. There is also overwhelming evidence that the pervasive and prevalent doctor-drug industry relationships have a strong influence over the prescribing habits and drug education of doctors. The British Pharmacological Society and American Association of Medical Colleges have crafted some insightful guidelines, including the learning of desired attitudes, for designing a medical pharmacology curriculum aimed at enhancing patient safety. This article will critically review the major issues relating to errors of drug prescribing, including the need to nurture the early development of desired attitudes which foster safe and rational drug prescribing. A simple educational approach, using a task analysis of drug prescribing, is applied to identify desired attitudes which should be incorporated into a basic pharmacology course for medical students in the twenty-first century.

  16. The role of human drug self-administration procedures in the development of medications.

    PubMed

    Comer, S D; Ashworth, J B; Foltin, R W; Johanson, C E; Zacny, J P; Walsh, S L

    2008-07-01

    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.

  17. 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

  18. Social support networks and medical service use among HIV-positive injection drug users: implications to intervention.

    PubMed

    Knowlton, A R; Hua, W; Latkin, C

    2005-05-01

    The study used network analysis to identify forms and sources of social support associated with a medical services use among a medically underserved population living with HIV/AIDS. Participants were African American former or current injection drug users (n=295; 34% female, 45% current drug users and 17% AIDS diagnosed). Outcomes were access to the same medical provider, use of outpatient services and emergency room (ER) use with or without subsequent hospitalization. Controlling for AIDS diagnosis, insurance, current drug use and gender, access to the same medical care provider was associated with more females in one's support network and more network sources of emotional support, financial support and instrumental assistance. Adjusting for confounders, outpatient service use was associated with more female support network members and more sources of emotional support. Controlling for participants' drug use and insurance, sub-optimal emergency department use was associated with greater number of active drug users in one's support network. Contrary to other study findings, having a supportive sex partner was associated with lower access to medical care, and kin support was not associated with medical service use. Results indicate that specific sources and forms of social support had differential influences on the sample's utilization of medical services. The findings suggest that promoting HIV-positive African American injection drug users' support network functioning may help improve HIV medical services utilization among this medically underserved population.

  19. Drug allergies

    MedlinePlus

    Allergic reaction - drug (medication); Drug hypersensitivity; Medication hypersensitivity ... A drug allergy involves an immune response in the body that produces an allergic reaction to a medicine. The ...

  20. 78 FR 17611 - Provisions of the Food and Drug Administration Safety and Innovation Act Related to Medical Gases...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-22

    ... On July 9, 2012, President Obama signed the Food and Drug Safety and Innovation Act (FDASIA) (Pub. L... HUMAN SERVICES Food and Drug Administration 21 CFR Part Chapter 1 Provisions of the Food and Drug Administration Safety and Innovation Act Related to Medical Gases; Request for Comments Regarding...

  1. 78 FR 3005 - Creating an Alternative Approval Pathway for Certain Drugs Intended to Address Unmet Medical Need...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-15

    ... HUMAN SERVICES Food and Drug Administration Creating an Alternative Approval Pathway for Certain Drugs Intended to Address Unmet Medical Need; Public Hearing; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public hearing; request for comments. SUMMARY: The Food and...

  2. Performance of online drug information databases as clinical decision support tools in infectious disease medication management.

    PubMed

    Polen, Hyla H; Zapantis, Antonia; Clauson, Kevin A; Clauson, Kevin Alan; Jebrock, Jennifer; Paris, Mark

    2008-11-06

    Infectious disease (ID) medication management is complex and clinical decision support tools (CDSTs) can provide valuable assistance. This study evaluated scope and completeness of ID drug information found in online databases by evaluating their ability to answer 147 question/answer pairs. Scope scores produced highest rankings (%) for: Micromedex (82.3), Lexi-Comp/American Hospital Formulary Service (81.0), and Medscape Drug Reference (81.0); lowest includes: Epocrates Online Premium (47.0), Johns Hopkins ABX Guide (45.6), and PEPID PDC (40.8).

  3. Managing a new medication administration process.

    PubMed

    Englebright, Jane D; Franklin, Michelle

    2005-09-01

    The national focus on medication errors has stimulated rapid adoption of medication administration technologies with bar code verification. The effectiveness of these technologies in preventing errors is directly related to how consistently practitioners use the technology to verify both patient identity and drug identity with each administration. The authors discuss management strategies that have proven effective at increasing staff compliance with using bar code-enabled medication systems.

  4. Use of anonymous Web communities and websites by medical consumers in Japan to research drug information.

    PubMed

    Kishimoto, Keiko; Fukushima, Noriko

    2011-01-01

    In this study, we investigated the status of researching drug information online, and the type of Internet user who uses anonymous Web communities and websites. A Web-based cross-sectional survey of 10875 male and female Internet users aged 16 and over was conducted in March 2010. Of 10282 analyzed respondents, excluding medical professionals, about 47% reported that they had previously searched the Internet for drug information and had used online resources ranging from drug information search engines and pharmaceutical industry websites to social networking sites and Twitter. Respondents who had researched drug information online (n=4861) were analyzed by two multivariable logistic regressions. In Model 1, the use of anonymous websites associated with age (OR, 0.778; 95% CI, 0.742-0.816), referring to the reputation and the narrative of other Internet users on shopping (OR, 1.640; 95% CI, 1.450-1.855), taking a prescription drug (OR, 0.806; 95% CI, 0.705-0.922), and frequent consulting with non-professionals about medical care and health (OR, 1.613; 95% CI, 1.396-1.865). In Model 2, use of only anonymous websites was associated with age (OR, 0.753; 95% CI, 0.705-0.805), using the Internet daily (OR, 0.611; 95% CI, 0.462-0.808), taking a prescription drug (OR, 0.614; 95% CI, 0.505-0.747), and experience a side effect (OR, 0.526; 95% CI, 0.421-0.658). The analysis revealed the profiles of Internet users who researched drug information on social media sites where the information providers are anonymous and do not necessarily have adequate knowledge of medicine and online information literacy.

  5. Gaps in Drug Dosing for Obese Children: A Systematic Review of Commonly Prescribed Acute Care Medications

    PubMed Central

    Rowe, Stevie; Siegel, David; Benjamin, Daniel K.

    2015-01-01

    Purpose Approximately 1 out of 6 children in the United States is obese. This has important implications for drug dosing and safety, as pharmacokinetic (PK) changes are known to occur in obesity due to altered body composition and physiology. Inappropriate drug dosing can limit therapeutic efficacy and increase drug-related toxicity for obese children. Few systematic reviews examining PK and drug dosing in obese children have been performed. Methods We identified 25 acute care drugs from the Strategic National Stockpile and Acute Care Supportive Drugs List and performed a systematic review for each drug in 3 study populations: obese children (2–18 years of age), normal weight children, and obese adults. For each study population, we first reviewed a drug’s Food and Drug Administration (FDA) label, followed by a systematic literature review. From the literature, we extracted drug PK data, biochemical properties, and dosing information. We then reviewed data in 3 age subpopulations (2–7 years, 8–12 years, and 13–18 years) for obese and normal weight children and by route of drug administration (intramuscular, intravenous, by mouth, and inhaled). If sufficient PK data were not available by age/route of administration, a data gap was identified. Findings Only 2/25 acute care drugs (8%) contained dosing information on the FDA label for each obese children and adults compared with 22/25 (88%) for normal weight children. We found no sufficient PK data in the literature for any of the acute care drugs in obese children. Sufficient PK data were found for 7/25 acute care drugs (28%) in normal weight children and 3/25 (12%) in obese adults. Implications Insufficient information exists to guide dosing in obese children for any of the acute care drugs reviewed. This knowledge gap is alarming, given the known PK changes that occur in the setting of obesity. Future clinical trials examining the PK of acute care medications in obese children should be prioritized. PMID

  6. Self-medication with drugs and complementary and alternative medicines in Alexandria, Egypt: prevalence, patterns and determinants.

    PubMed

    El-Nimr, N A; Wahdan, I M H; Wahdan, A M H; Kotb, R E

    2015-06-09

    This study aimed to describe the prevalence, pattern and reasons for self-medication among adults in Alexandria, Egypt. In a community-based survey during 2012, a representative sample of 1100 adults completed a predesigned interview questionnaire on self-medication practices by drugs and complementary or alternative medicines (CAM). A majority of them practised self-medication (86.4%), mostly using both drugs and CAM (77.5%). The most commonly used drugs were analgesics (96.7%), and cough and cold preparations (81.9%), but 53.9% of respondents reported self-medication with antibiotics. The most frequently used CAM were herbs (91.6%), followed by spiritual healing (9.4%) and cupping and acupuncture (6.4%). CAM improved the condition according to 95.2% of users. Logistic regression analysis revealed that age, occupation and the presence of chronic conditions were the independent factors significantly affecting the practice of self-medication with drugs.

  7. 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

  8. 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)

  9. 77 FR 14706 - Medical Diagnostic Equipment Accessibility Standards

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-13

    ... TRANSPORTATION BARRIERS COMPLIANCE BOARD 36 CFR Part 1195 RIN 3014-AA40 Medical Diagnostic Equipment... the Federal Register, 77 FR 6916, on accessibility standards for medical diagnostic equipment and... equipment, in consultation with the Commissioner of the Food and Drug Administration. The Access...

  10. ["It's free, therefore they abuse...". Study of answers of medical students concerning drug consumption].

    PubMed

    Cao, M M; Deschamps, J P

    1997-06-01

    In 1994, during a public health examination, in Nancy, a question was asked to students in their 6th year of medical studies: "why do the patients who benefit of a total reimbursement of the drug's cost (that is patients that receive free medical care because they have a serious illness), consume obviously more than the others?". The aim of this study is to analyse the student's answers: 57 students gave the correct answer (serious illness explains high consumption), 44 gave several answers (included free care explains high consumption); for 71 students, it is only an abusive consumption. Although the time to complete the test is limited, it is a good indication of the student's attitudes. Many of them do not make a difference between high consumption in a case of serious illness and abusive consumption as a result of free medical care. Then the student's attitude towards the patients is frequently negative.

  11. Early adoption of new drug treatments: the role of continuing medical education and physician adaptivity.

    PubMed

    Mascarenhas, Desmond; Singh, Baljit K; Singh, Amoolya H; Veer, Sally Vander

    2007-03-01

    The influence of continuing medical education (CME) on the adoption of new treatments is widely regarded as self-evident. Less well understood is how the dynamics of dissemination of new healthcare practices are influenced by the intersection of education with the adaptive characteristics of providers. We developed and validated a 43-item online instrument (eSAIL) for measuring adaptive style and used it to investigate the interplay of physician adaptivity with key components of effective medical education. Satisfactory Cronbach alpha and test-retest reliability coefficients were observed for all primary psychometric scales and a composite adaptivity scale. Discriminant, convergent, and predictive validities of eSAIL scales were consistent across all cohorts. Using an online medical education program for which data on physician behavioral change are available, we show that the rate of adoption of new drugs is driven by both psychological (adaptivity) and environmental (educational) inputs. We show for the first time that topic eminence, length of reinforcement period and physician adaptive score in the eSAIL are each proportional to early-adoption-related behavioral change. Using a simple forced-choice question, a cohort of 208 physicians was segmented into "A" (adaptive) and "C" (conservative) segments based on their eSAIL adaptivity z scores (+0.170 versus -0.234 respectively; P < 0.01). Early adoption of new drug treatments by similarly segmented physician cohorts was driven almost entirely by A-segment physicians, but only when those physicians were additionally exposed to effective medical education.

  12. Development of drug-approval regulations for medical countermeasures against CBRN agents in Japan.

    PubMed

    Shimazawa, Rumiko; Ikeda, Masayuki

    2015-01-01

    To develop approval regulations for drugs against chemical, biological, radiological, or nuclear (CBRN) agents in Japan, and to help inform arguments about the development of anti-CBRN agents, we analyzed documentation describing approval processes and data for drugs against CBRN agents. Sixteen countermeasure products against 10 CBRN agents have been approved in Japan. Approval schemes were grouped into 3 categories: application for off-label uses, expedited review for antiterrorism measures, and expedited review. Ten drug applications were designated "priority reviews," and the median review time was 4.4 months. No application relied exclusively on clinical trials to expose patients to CBRN threats. Clinical experience with drugs in victims of unexpected exposure was not necessarily important for approval. The United States is the most advanced country in terms of developing medical countermeasure products against CBRN agents. Japan has similarities with the US in approved products and application packages, but there were 3 unapproved products or indications that were approved under the Animal Rule in the US. The Animal Rule might encourage development of a novel product by providing efficacy evaluation in animal studies. The US also has regulations that do not exist in Japan that authorize administration of an investigational drug outside a clinical trial for patients. Introduction of the Animal Rule and expanded access of investigational drugs could contribute to development and approvals of novel countermeasure products and improve an emergency response in a crisis in Japan.

  13. Advances in drug delivery and medical imaging using colloidal lyotropic liquid crystalline dispersions.

    PubMed

    Mulet, Xavier; Boyd, Ben J; Drummond, Calum J

    2013-03-01

    The overarching goal of this feature article is to review the recent developments in the field of drug delivery specifically involving colloidal lyotropic liquid crystalline dispersions. The development of advanced particles for drug delivery applications is regarded as the next necessary step in the advancement of nanomedicine. An outline of the state of the art in preparation and application of self-assembled nanoparticles to drug delivery and medical imaging is presented. The basic concepts for controlling the nature of the internal structure of particles by tuning the self-assembly properties of small molecule amphiphiles is covered. Theranostics is an exciting emerging area for this colloidal material class, and the types of therapeutic compounds and medical imaging agents that can be incorporated as well as their methods of preparation are described. The stabilisation and biocompatibility of the colloidal dispersions are also discussed. Finally an overview of lesion-specific active and passive targeting is presented. Exploiting such a multi-functional drug delivery platform is essential to not only the next generation delivery of bioactive molecules but also in the creation of new diagnostic tools.

  14. [Cartography of psychoactive heterotopias: a look at the medical, legal and social discourses regarding drug use].

    PubMed

    Massó, Paloma

    2015-09-01

    This article traces a map of the social control of drugs through the politics of space, according to the Foucaultian concept of "heterotopia." Firstly, a brief genealogy of the use of psychotropic substances in different times and cultures is described, up to the introduction of the prohibitionist paradigm. Attention is paid to the way in which power has marked, separated and enclosed certain rituals and uses of pleasure in physical and symbolic sites. The itinerary is focused on the Spanish context to establish a dialogue between the various policies of space that have come into being and have overlapped in the construction and management of a problem which has been rendered an object to the gazes, mechanics and discourses of the medical, legal, and social fields. In this way, the intersections between the liminal spaces of drug use and the harm reduction paradigm are analyzed, including therapeutic strategies with prescribed drugs, from methadone programs to the new heroin programs.

  15. Governmental oversight of prescribing medications: history of the US Food and Drug Administration and prescriptive authority.

    PubMed

    Plank, Linda S

    2011-01-01

    The evolution of drug regulation and awarding of prescriptive authority is a complex and sometimes convoluted process that can be confusing for health care providers. A review of the history of how drugs have been manufactured and dispensed helps explain why this process has been so laborious and complicated. Because the federal and state governments have the responsibility for protecting the public, most regulations have been passed with the intentions of ensuring consumer safety. The current system of laws and regulations is the result of many years of using the legal system to correct drug marketing that had adverse health consequences. Government oversight will continue as prescribing medications transitions to an electronic form and as health care professionals in addition to physicians seek to gain prescriptive authority.

  16. Medication Assisted Treatment in US Drug Courts: Results from a Nationwide Survey of Availability, Barriers and Attitudes

    PubMed Central

    Matusow, Harlan; Dickman, Samuel L.; Rich, Josiah D.; Fong, Chunki; Dumont, Dora M.; Hardin, Carolyn; Marlowe, Douglas; Rosenblum, Andrew

    2012-01-01

    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, 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. PMID:23217610

  17. 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.

  18. 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.

  19. Compliance status

    SciTech Connect

    Black, D.G.

    1995-06-01

    This section of the 1994 Hanford Site Environmental Report summarizes the activities conducted to ensure that the Hanford Site is in compliance with federal environmental protection statutes and related Washington State and local environmental protection regulations and the status of Hanford`s compliance with these requirements. Environmental permits required under the environmental protection regulations are discussed under the applicable statute.

  20. An active one-lobe pulmonary simulator with compliance control for medical training in neonatal mechanical ventilation.

    PubMed

    Baldoli, Ilaria; Tognarelli, Selene; Cecchi, Francesca; Scaramuzzo, Rosa Teresa; Ciantelli, Massimiliano; Gentile, Marzia; Cuttano, Armando; Laschi, Cecilia; Menciassi, Arianna; Boldrini, Antonio; Dario, Paolo

    2014-06-01

    Mechanical ventilation is a current support therapy for newborns affected by respiratory diseases. However, several side effects have been observed after treatment, making it mandatory for physicians to determine more suitable approaches. High fidelity simulation is an efficient educational technique that recreates clinical experience. The aim of the present study is the design of an innovative and versatile neonatal respiratory simulator which could be useful in training courses for physicians and nurses as for mechanical ventilation. A single chamber prototype, reproducing a pulmonary lobe both in size and function, was designed and assembled. Volume and pressure within the chamber can be tuned by the operator through the device control system, in order to simulate both spontaneous and assisted breathing. An innovative software-based simulator for training neonatologists and nurses within the continuing medical education program on respiratory disease management was validated. Following the clinical needs, three friendly graphic user interfaces were implemented for simulating three different clinical scenarios (spontaneous breathing, controlled breathing and triggered/assisted ventilation modalities) thus providing physicians with an active experience. The proposed pulmonary simulator has the potential to be included in the range of computer-driven technologies used in medical training, adding novel functions and improving simulation results.

  1. 77 FR 22328 - Guidance for Industry on the Judicious Use of Medically Important Antimicrobial Drugs in Food...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-13

    ... thinking on the use of medically important antimicrobial drugs in animal agriculture. DATES: Submit either... the Agency's current thinking on the topic. It does not create or confer any rights for or on...

  2. 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

  3. Varsity Medical Ethics Debate 2015: should nootropic drugs be available under prescription on the NHS?

    PubMed

    Thorley, Emma; Kang, Isaac; D'Costa, Stephanie; Vlazaki, Myrto; Ayeko, Olaoluwa; Arbe-Barnes, Edward H; Swerner, Casey B

    2016-09-13

    The 2015 Varsity Medical Ethics debate convened upon the motion: "This house believes nootropic drugs should be available under prescription". This annual debate between students from the Universities of Oxford and Cambridge, now in its seventh year, provided the starting point for arguments on the subject. The present article brings together and extends many of the arguments put forward during the debate. We explore the current usage of nootropic drugs, their safety and whether it would be beneficial to individuals and society as a whole for them to be available under prescription. The Varsity Medical Debate was first held in 2008 with the aim of allowing students to engage in discussion about ethics and policy within healthcare. The event is held annually and it is hoped that this will allow future leaders to voice a perspective on the arguments behind topics that will feature heavily in future healthcare and science policy. This year the Oxford University Medical Society at the Oxford Union hosted the debate.

  4. Optical sensors for therapeutic drug monitoring of antidepressants for a better medication adjustment

    NASA Astrophysics Data System (ADS)

    Krieg, Anne K.; Hess, Stefan; Gauglitz, Günter

    2013-05-01

    Therapeutic drug monitoring provides the attending physicians with detailed information on a patient's individual serum level especially during long-term medication. Due to the fact that each patient tolerates drugs or their metabolites differently a medication adjustment can reduce the number and intensity of noticeable side-effects. In particular, psychotropic drugs can cause unpleasant side-effects that affect a patient's life almost as much as the mental disease itself. The tricyclic antidepressants amitriptyline is commonly used for treatment of depressions and was selected for the development of an immunoassay using the direct optical sensor technique Reflectometric Interference Spectroscopy (RIfS). RIfS is a simple, robust and label-free method for direct monitoring of binding events on glass surfaces. Binding to the surface causes a shift of the interference spectrum by a change of the refractive index or physical thickness. This technique can be used for time-resolved observation of association and dissociation of amitriptyline (antigen) and a specific antibody using the binding inhibition test format. An amitriptyline derivative is immobilized on the sensor surface and a specific amount of antibodies can bind to the surface unless the binding is inhibited by free amitriptyline in a sample. No fluorescent label is needed making the whole assay less expensive than label-based methods. With this recently developed immunoassay amitriptyline concentrations in buffer (PBS) can easily be detected down to 500 ng/L.

  5. Export of pharmaceuticals and medical devices under the federal Food, Drug & Cosmetic Act: FDA's striking change in interpretation post-Shelhigh.

    PubMed

    Basile, Edward M; Tolomeo, Deborah; Gluck, Elizabeth

    2009-01-01

    With no communication to industry except court filings in United States v. Undetermined Quantities of Boxes of Articles of Device (Shelhigh) and a draft guidance document, the Food and Drug Administration (FDA) has articulated new policies regarding export of pharmaceutical products and medical devices. FDA's departure from its historic interpretation of the export provisions of the Federal Food, Drug, and Cosmetic Act (FDCA) significantly limits the ability of manufacturers to export misbranded drugs and medical devices that FDA deems "adulterated," contrary to the plain language and legislative intent of the FDCA. To further exacerbate the issue, FDA has begun to implement these policies without the notice-and-comment rulemaking required by the Administrative Procedures Act (APA), but rather through an enforcement proceeding brought in the United States District Court for the District of New Jersey. In a letter opinion, the District Court prevented the export of Current Good Manufacturing Practices (CGMP) --adulterated medical devices that complied with FDCA Section 801(e)(1), at least as historically interpreted by FDA. The purpose of this article is to review the history of FDA's export policies for pharmaceuticals and medical devices, particularly those aspects of the export policies that are affected by FDA's recent change in position. Three changes in FDA's interpretation of the export provisions of the FDCA will be addressed: 1) unapproved devices that a manufacturer reasonably believes are eligible for Section 510(k) clearance may no longer be exported under Section 801(e) and now must be exported under Section 802, in substantial compliance with Current CGMP; 2) adulterated devices and misbranded drugs can only be exported if the foreign purchaser's specifications cause the product to be adulterated; and 3) an article may not be exported if a like article has ever been sold or offered for sale in domestic commerce. FDA's new interpretations of FDCA

  6. Inside Maine’s Medicine Cabinet: Findings From the Drug Enforcement Administration's Medication Take-Back Events

    PubMed Central

    Malinowski, Alexandra; Ochs, Leslie; Jaramillo, Jeanie; McCall, Kenneth; Sullivan, Meghan

    2015-01-01

    Objectives. We evaluated the quantity and type of medications obtained in unused-medications return programs and the proportion of medication waste. Methods. We analyzed data collected in 11 Maine cities in 2011 to 2013 during 6 Drug Enforcement Administration (DEA) national medication take-back events. Pharmacy doctoral student volunteers collected data under the supervision of law enforcement, independent of the DEA. Data entry into the Pharmaceutical Collection Monitoring System, through its interface with Micromedex, allowed for analysis of medication classification, controlled substance category, therapeutic class, and percentage of medication waste (units returned/units dispensed). Results. Medication take-back events resulted in return of 13 599 individual medications from 1049 participants. We cataloged 553 019 units (capsules, tablets, milliliters, patches, or grams), representing 69.7% medication waste. Noncontrolled prescription medications accounted for 56.4% of returns, followed by over-the-counter medications (31.4%) and controlled prescription medications (9.1%). Conclusions. The significant quantities of medications, including controlled substances, returned and high degree of medication waste emphasize the need for medication collection programs to further public health research and improve health in our communities. PMID:25393189

  7. Factors related to compliance to anti-malarial drug combination: example of amodiaquine/sulphadoxine-pyrimethamine among children in rural Senegal

    PubMed Central

    Souares, Aurélia; Lalou, Richard; Sene, Ibra; Sow, Diarietou; Le Hesran, Jean-Yves

    2009-01-01

    Background The introduction of new anti-malarial treatment that is effective, but more expensive, raises questions about whether the high level of effectiveness observed in clinical trials can be found in a context of family use. The objective of this study was to determine the factors related to adherence, when using the amodiaquine/sulphadoxine-pyrimethamine (AQ/SP) association, a transitory strategy before ACT implementation in Senegal. Methods The study was conducted in five rural dispensaries. Children, between two and 10 years of age, who presented mild malaria were recruited at the time of the consultation and were prescribed AQ/SP. The child's primary caretaker was questioned at home on D3 about treatment compliance and factors that could have influenced his or her adherence to treatment. A logistic regression model was used for the analyses. Results The study sample included 289 children. The adherence rate was 64.7%. Two risks factors for non-adherence were identified: the children's age (8–10 years) (ORa = 3.07 [1.49–6.29]; p = 0.004); and the profession of the head of household (retailer/employee versus farmer) (ORa = 2.71 [1.34–5.48]; p = 0.006). Previously seeking care (ORa = 0.28 [0.105–0.736], p=0.001] satisfaction with received information (ORa = 0.45 [0.24–0.84]; p = 0.013), and the quality of history taking (ORa = 0.38 [0.21–0.69]; p = 0.001) were significantly associated with good compliance. Conclusion The results of the study show the importance of information and communication between caregivers and health center staff. The experience gained from this therapeutic transition emphasizes the importance of information given to the patients at the time of the consultation and drug delivery in order to improve drug use and thus prevent the emergence of rapid drug resistance. PMID:19497103

  8. Poor compliance with antifungal drug use guidelines by transplant physicians: a framework for educational guidelines and an international consensus on patient safety.

    PubMed

    Muñoz, Patricia; Rojas, Loreto; Cervera, Carlos; Garrido, Gregorio; Fariñas, Maria Carmen; Valerio, Maricela; Giannella, Maddalena; Bouza, Emilio

    2012-01-01

    The rate of compliance with antifungal drug use guidelines by transplant physicians is mostly unknown. We performed a nationwide electronic survey to assess antifungal use by different types of transplant physicians. Sixty-one percent (53/87) of the transplant programs responded (accounting for 85% of heart transplant procedures, 65% of kidney transplantations, and 71.5% of liver transplantations). Antifungal prophylaxis was used in 41.5% programs (liver 93.3%, heart 30.8%, and kidney 16%). Prophylaxis was universal in 32% of the programs and targeted only to selected patients in 68%, mainly indicated after re-transplantation (73.3%), re-intervention (66.7%) and hemodialysis (60%). Main drugs for universal prophylaxis were fluconazole and itraconazole (42.9% each), while fluconazole (60%), L-amphotericin B (AMB), and caspofungin (13.4% each) were preferred for targeted prophylaxis. Overall, 84.9% of the programs used galactomannan for the diagnosis of invasive aspergillosis (only 34% in BAL) and 66.6% used voriconazole as first-line monotherapy. Combination first-line therapy for invasive aspergillosis was used by 31.3%, mainly with voriconazole with caspofungin (40%) or anidulafungin (26.7%) or L-AMB-caspofungin (26.7%). Adherence of transplant physicians to current recommendations on antifungal treatment and prophylaxis is poor. An international consensus that responds to differences in patients and centers and emphasizes patient safety is clearly needed.

  9. Who Guards the Guards: Drug Use Pattern Among Medical Students in a Nigerian University

    PubMed Central

    Babalola, EO; Akinhanmi, A; Ogunwale, A

    2014-01-01

    Background: Several studies have examined the prevalence and pattern of substance use among medical students in Nigeria. Few of these studies have specifically examined the relationship between the psychological distress and psychoactive substance use among these students. Yet, evidence world-wide suggests that substance use among medical students might be on the rise and may be related to the level of stress among them. Aim: The present study is the first study aimed to determine the prevalence, pattern and factors associated with psychoactive substance use among medical students of Olabisi Onabanjo University, Ogun State, Nigeria. Subjects and Methods: The World Health Organization student drug use questionnaire was used to evaluate for substance use among 246 clinical medical students between September and October 2011. General health questionnaire (GHQ) 12 was used to assess for psychological distress among these students. Statistical analysis was performed using the SPSS version 16. (Chicago, USA). Proportions were compared using the Chi-square test while a value of P < 0.05 was considered statistically significant. Fisher exact test was used instead of Chi-square when the number in the cell is less than 5. Results: Lifetime prevalence of substance use among medical students was 65% (165/246). It was found that the most commonly used substances were alcohol 63.4% (156/246), mild stimulants 15.6% (38/246), tobacco 15% (37/246) and sedatives 6.1% (15/246). Substance use was associated with gender, frequency of participation in religious activities and GHQ scores. Conclusion: Psychoactive substance use is a major problem among medical students. Psychological well-being plays a significant role in substance use among these students. There is a need for adequate screening and assessment for substance use disorders among these students and incorporating stress management strategies in their curriculum. PMID:24971216

  10. Sex, drugs and the medical role: A case report of a man prescribed Alprazolam following stroke.

    PubMed

    Hamam, Natalie

    2011-01-01

    It is well-known that sexual dysfunction can result from many classes of drugs including sedatives, anti-hypertensives and anti-depressants. Untreated sexual dysfunction can lead to patient distress.A 64-year-old man with a history of a left cerebrovascular accident participated in a qualitative research study on sex after stroke. He had been experiencing sexual dysfunction for four years.Discussions with the patient were difficult due to his expressive dysphasia. The researcher asked him to re-visit his general practitioner (GP) who reviewed his medications and changed the prescribed sleeping tablet. Sexual function returned within a week. This case report highlights the contribution of medication to sexual dysfunction and the need for doctors to initiate conversations about sexual concerns.

  11. Alcohol and Drug Abuse Teaching Methodology Guide for Medical Faculty. Medicine 1. Health Professions Education Curriculum Resource Series.

    ERIC Educational Resources Information Center

    Hostetler, Jeptha R.

    This guide, one of a series of publications written for medical faculty to use in designing substance abuse instruction, focuses on the teaching of alcohol and drug abuse intervention in medical and osteopathic schools. Following a brief introducton to the booklet, the career teacher program, which is supported by federal grants, is explained.…

  12. Designing a national combined reporting form for adverse drug reactions and medication errors.

    PubMed

    Tanti, A; Serracino-Inglott, A; Borg, J J

    2015-06-09

    The Maltese Medicines Authority was tasked with developing a reporting form that captures high-quality case information on adverse drug reactions (ADRs) and medication errors in order to fulfil its public-health obligations set by the European Union (EU) legislation on pharmacovigilance. This paper describes the process of introducing the first combined ADR/medication error reporting form in the EU for health-care professionals, the analysis of reports generated by it and the promotion of the system. A review of existing ADR forms was carried out and recommendations from the European Medicines Agency and World Health Organization audits integrated. A new, combined ADR/medication error reporting form was developed and pilot tested based on case studies. The Authority's quality system (ISO 9001 certified) was redesigned and a promotion strategy was deployed. The process used in Malta can be useful for countries that need to develop systems relative to ADR/medication error reporting and to improve the quality of data capture within their systems.

  13. 49 CFR 240.119 - Criteria for consideration of data on substance abuse disorders and alcohol/drug rules compliance.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... Process § 240.119 Criteria for consideration of data on substance abuse disorders and alcohol/drug rules.... (b) Fitness requirement. (1) A person who has an active substance abuse disorder shall not be... certified engineer who is determined to have an active substance abuse disorder shall be suspended...

  14. 49 CFR 240.119 - Criteria for consideration of data on substance abuse disorders and alcohol/drug rules compliance.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... Process § 240.119 Criteria for consideration of data on substance abuse disorders and alcohol/drug rules.... (b) Fitness requirement. (1) A person who has an active substance abuse disorder shall not be... certified engineer who is determined to have an active substance abuse disorder shall be suspended...

  15. 49 CFR 240.119 - Criteria for consideration of data on substance abuse disorders and alcohol/drug rules compliance.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... Process § 240.119 Criteria for consideration of data on substance abuse disorders and alcohol/drug rules.... (b) Fitness requirement. (1) A person who has an active substance abuse disorder shall not be... certified engineer who is determined to have an active substance abuse disorder shall be suspended...

  16. 49 CFR 240.119 - Criteria for consideration of data on substance abuse disorders and alcohol/drug rules compliance.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... Process § 240.119 Criteria for consideration of data on substance abuse disorders and alcohol/drug rules.... (b) Fitness requirement. (1) A person who has an active substance abuse disorder shall not be... certified engineer who is determined to have an active substance abuse disorder shall be suspended...

  17. Use of Prescription Pain Medications Among Medical Cannabis Patients: Comparisons of Pain Levels, Functioning, and Patterns of Alcohol and Other Drug Use

    PubMed Central

    Perron, Brian E.; Bohnert, Kipling; Perone, Angela K.; Bonn-Miller, Marcel O.; Ilgen, Mark

    2015-01-01

    Objective: Management of chronic pain is one of the most common reasons given by individuals seeking medical cannabis. However, very little information exists about the concurrent use of cannabis and prescription pain medication (PPM). This study fills this gap in knowledge by systematically comparing medical cannabis users who use or do not use PPM, with an emphasis on understanding whether concurrent use of cannabis and PPM is associated with more serious forms of alcohol and other drug involvement. Method: Data from this study were collected from a medical cannabis clinic in southwestern Michigan (N = 273). Systematic comparisons were made on measures of sociodemographics, reasons for substance use, pain, functioning, and perceptions of PPM and medical cannabis efficacy. Results: PPM users tended to be older and reported higher levels of pain and lower levels of functioning. The overall sample exhibited higher lifetime and past-3-month rates of alcohol and other noncannabis drug use than did the general population. Approximately 40% of subjects reported combining cannabis with alcohol, but no significant difference was observed between PPM users and nonusers. PPM users and nonusers did not exhibit any difference in either lifetime or past-3-month use of other drugs, including cocaine, sedatives, street opioids, and amphetamines. PPM users rated the efficacy of cannabis higher than PPM for pain management and indicated a strong desire to reduce PPM usage. Conclusions: Use of PPM among medical cannabis users was not identified as a correlate for more serious forms of alcohol and other drug involvement. However, longitudinal study designs are needed to better understand the trajectories of alcohol and other drug involvement over time among medical cannabis users. PMID:25978826

  18. Use of Naloxone by Emergency Medical Services during Opioid Drug Overdose Resuscitation Efforts.

    PubMed

    Sumner, Steven Allan; Mercado-Crespo, Melissa C; Spelke, M Bridget; Paulozzi, Leonard; Sugerman, David E; Hillis, Susan D; Stanley, Christina

    2016-01-01

    Naloxone administration is an important component of resuscitation attempts by emergency medical services (EMS) for opioid drug overdoses. However, EMS providers must first recognize the possibility of opioid overdose in clinical encounters. As part of a public health response to an outbreak of opioid overdoses in Rhode Island, we examined missed opportunities for naloxone administration and factors potentially influencing EMS providers' decision to administer naloxone. We reviewed medical examiner files on all individuals who died of an opioid-related drug overdose in Rhode Island from January 1, 2012 through March 31, 2014, underwent attempted resuscitation by EMS providers, and had records available to assess for naloxone administration. We evaluated whether these individuals received naloxone as part of their resuscitation efforts and compared patient and scene characteristics of those who received naloxone to those who did not receive naloxone via chi-square, t-test, and logistic regression analyses. One hundred and twenty-four individuals who underwent attempted EMS resuscitation died due to opioid overdose. Naloxone was administered during EMS resuscitation attempts in 82 (66.1%) of cases. Females were nearly three-fold as likely not to receive naloxone as males (OR 2.9; 95% CI 1.2-7.0; p-value 0.02). Additionally, patients without signs of potential drug abuse also had a greater than three-fold odds of not receiving naloxone (OR 3.3; 95% CI 1.2-9.2; p-value 0.02). Older individuals, particularly those over age 50, were more likely not to receive naloxone than victims younger than age 30 (OR 4.8; 95% CI 1.3-17.4; p-value 0.02). Women, older individuals, and those patients without clear signs of illicit drug abuse, were less likely to receive naloxone in EMS resuscitation attempts. Heightened clinical suspicion for opioid overdose is important given the recent increase in overdoses among patients due to prescription opioids.

  19. 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

  20. [Role of pharmacists in medical team on HIV infection].

    PubMed

    Ido, Keiko

    2006-06-01

    Medical staff, including physicians, nurses, pharmacists, nutritionists, laboratory medical technologists, social workers, and case managers, should act as a team to support patients with human immunodeficiency virus (HIV) infection. The therapeutic purpose of a potent cocktail of anti-HIV drugs is to maintain undetectable plasma levels of HIV over the long term. To achieve this, it is necessary to maintain treatment compliance. However, noncompliance frequently occurs because of a poor understanding of HIV therapy or difficulty in taking anti-HIV drugs. Thus pharmacists should contribute as HIV medical team members by providing medication counseling to ensure treatment compliance or delivering drug information to achieve successful HIV therapy. We describe the roles of pharmacists on HIV medical teams at Ehime University Hospital in examples of nutritional disorder or pregnant women with HIV.

  1. Survey of Aviation Medical Examiners: Information and Attitudes about the Pre-Employment and Pre-Appointment Drug Testing Program

    DTIC Science & Technology

    1992-03-01

    urine specimens fbr pre - employment or pre -appointment drug testing for FAA employees’? A...Federal guidelines for the FAA pre - employment / pre -appointment drug testing program. A B C D E A3 SOME AMES HAVE EXPERIENCED PROBLEMS WITH LAB ...COMMENTS BY ITEM 1. ARE YOU AN AVIATION MEDICAL EXAMINER WHO COLLECTS URINE SPECIMENS FOR PRE - EMPLOYMENT OR PRE -APPOINTMENT DRUG TESTING FOR FAA

  2. Survey of Aviation Medical Examiners: Information and Attitudes about the Pre-Employment and Pre-Appointment Drug Testing Program

    DTIC Science & Technology

    1992-03-01

    urine specimens for pre - employment or pre -appointment drug testing for FAA...BY ITEM 1. ARE YOU AN AVIATION MEDICAL EXAMINER WHO COLLECTS URINE SPECIMENS FOR PRE - EMPLOYMENT OR PRE -APPOINTMENT DRUG TESTING FOR FAA EMPLOYEES? I...believe I have done more than one pre - employment in the past year. My comments are of little or no value to your survey. We have done so few drug screening

  3. [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

  4. Medication noncompliance--a thriving problem.

    PubMed

    Aziz, A M; Ibrahim, M I

    1999-06-01

    A study was conducted among out-patients attending the Melaka Tengah Health Clinic to determine their compliance status towards antihypertensive, antidiabetic and antiasthmatic drugs. A total of 585 patients were enrolled in this study. Assessment of compliance was carried out using pill-counting and house-to-house interviews 14 days from the date of medication dispensed at the counter. The noncompliance rate among the 464 successfully interviewed patients was 56%. The mean noncompliance percentage was 78.0 +/- 43.1% (range: -10.0-314.3%). Among the four variables of compliance studied, race was not seen as a determinant of compliance. The older age group and those taking two or more drugs were statistically significant to be a noncomplier. Females were highly likely not to comply with drug therapy. Patients who conform to their refill dates were not really drug compliers. Forgetting to take their drugs and inability to read instructions on drug labels were the main reasons given. Underdosing was more common than overdosing, with an estimated cost of RM20,261.00 of unused medications per year.

  5. Unapproved prescription cough, cold, and allergy drug products: recent US Food and Drug Administration regulatory action on unapproved cough, cold, and allergy medications.

    PubMed

    Ostroff, Craig; Lee, Charles E; McMeekin, Judith

    2011-08-01

    The US Food and Drug Administration (FDA) drug approval and over-the-counter drug monograph processes play an essential role in ensuring that all drugs are both safe and effective for their intended uses. Manufacturers of drugs that lack required approval have not provided the FDA with evidence demonstrating that their products are safe and effective. Some of these prescription drugs have been marketed for many years and have remained on the market despite changes to the Federal Food, Drug, and Cosmetic Act, which requires approval for safety and efficacy purposes. Many health-care providers may be unaware that unapproved drugs exist because the product labels of these drugs do not disclose that they lack FDA approval. The FDA recently took action against unapproved prescription oral cough, cold, and allergy drug products because of concerns about the potential risks of these products, particularly some extended-release formulations that have not been reviewed for quality. There is a potential for medication errors because product names and labeling have not been reviewed for potential confusion, with some products inappropriately labeled for use in children aged ≤ 2 years. FDA-approved prescription drugs or drugs appropriately marketed as over the counter remain available for treatment of cough, cold, and allergy symptoms. Such products are of known efficacy, safety, identity, quality, and purity. Removing unapproved drugs from the marketplace and encouraging manufacturers of unapproved products to seek FDA review and approval is a top priority for the FDA. Since the initiation of the Unapproved Drugs Initiative in 2006, the FDA has removed ~1,500 unapproved products from the market and has worked with firms to bring other unapproved drugs into the approval process. The FDA remains committed to its mission of ensuring that safe and effective drugs are available to American consumers.

  6. Managing hypertension: drugs, life-style manipulation or benign neglect? Medical, ethical and economic considerations.

    PubMed

    Simpson, F O

    1990-10-01

    Antihypertensive drugs have been of major benefit to people with moderate or severe hypertension and have contributed enormously to fundamental physiological knowledge. Antihypertensive therapy in milder hypertension reduces the incidence of stroke by 40% or more, may reduce myocardial infarction and prevents progression to more severe hypertension or heart failure but is being criticised as not cost-effective. Much of this criticism is based on deductions from inappropriate data. Nevertheless, it is likely that money is in some cases being wasted on the treatment of people who were not truly hypertensive in the first place. It is also likely that drug dosage is often unnecessarily high. Clearly it is vital that treatment is delivered as economically as possible. A reduction in the prevalence of hypertension would be the best way to reduce costs. Obesity and a high alcohol intake are associated with a higher blood pressure at any age. A high salt intake throughout life appears to be associated with a rise in blood pressure in the second half of life and may well be the main factor in hypertension. A radical rethinking of the method of pricing of medical care should be considered, so as to provide incentives to people to adopt life-style measures that lead to avoidance of hypertension (and other cardiovascular risk factors) or, in established hypertension, to a reduction in the need for medication.

  7. Over-the-Counter Drugs and Complementary Medications Use among Children in Southern Italy.

    PubMed

    Pileggi, Claudia; Mascaro, Valentina; Bianco, Aida; Pavia, Maria

    2015-01-01

    The use of nonprescription medicines (NPDs) for children illnesses without a doctor's suggestion can lead to unnecessary medication use and is not free of risks. The aim of our study was to examine attitudes and practice of parents towards NPDs use for their children. We also investigated the conditions that may predict NPDs use. A cross-sectional survey was conducted on parents of children attending Community Based Pediatrician (CBP) consultation and data were collected through structured interviews. Positive attitude on NPDs use was reported by 71.4% of parents, and 61.5% of them had administered NPDs in the previous 6 months. Antipyretic drugs were the most frequently used medication class without the supervision of the CBP. A positive attitude towards NPDs was significantly more frequent in parents who did not use the CBP as the sole source of information about drugs. The study demonstrated a widespread use of NPDs in children in our context, supported by a substantial positive attitude towards their safety. However, considering potential harms related to some NPDs and the finding that most parents rely on CBP advice, role of CBP on appropriate use of NPDs by parents should be emphasized.

  8. 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

  9. Types of Nasal Delivery Drugs and Medications in Iranian Traditional Medicine to Treatment of Headache

    PubMed Central

    Ghorbanifar, Zahra; Delavar Kasmaei, Hosein; Minaei, Bagher; Rezaeizadeh, Hossein; Zayeri, Farid

    2014-01-01

    Context: Headache is a common symptom throughout the world. The main purpose of patient-centered approaches is the utilization of useful and simple treatment. Nowadays, there is a rising propensity toward herbal remedies. Nasal route is one of the ancient and topical prescriptions used in headache. In Iranian traditional medicine, physicians such as Avicenna were prescribing herbal drugs through the nose to treat a variety of central nervous system diseases like headache. In this review paper, authors have attempted to introduce different types of nasal administrations which were used in Iranian traditional medicine for the treatment of headaches. Evidence Acquisition: Initially, we studied two different types of Canon and separated all herbs used in the treatment of headache. Next, all plants were classified according to the method of prescription. Then, we pick out all the plants which were nasally utilized in the treatment of headache and divided them based on the method of administration. In order to find scientific names of herbs, we used two different botany references. Moreover, we conducted various researches in scientific databases with the aim of finding results concerning the analgesic and antinociceptive effects of herbs. Throughout the research, key terms were “analgesic” and “antinociceptive “with the scientific names of all herbs separately. The databases searched included PubMed, Scopus, Cochrane library and SID. Results: 35 plants were prescribed for the treatment of headaches, which were all nasally used. These plants took either the form of powder, liquid or gas (steam). They were divided in to six categories according to the method of prescription. The Percentage of usage for each method was as follows: 62% Saoot (nasal drop), 25% Shamoom (smell), 17% Inkabab (vapor), 11% Nafookh (snuff), 11% Nashooq (inhaling) and 2% Bokhoor (smoke). Conclusions: Medications that are used via nasal delivery have greater effect than oral medications

  10. 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.

  11. 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

  12. Medical innovation then and now: perspectives of innovators responsible for transformative drugs.

    PubMed

    Xu, Shuai; Kesselheim, Aaron S

    2014-01-01

    Effective medical innovation is a common goal of policymakers, physicians, researchers, and patients both in the private and public sectors. With the recent slowdown in approval of new transformative prescription drugs, many have looked back to the "golden years" of the 1980s and 1990s when numerous breakthrough products emerged. We conducted a qualitative study of innovators (n=127) directly involved in creation of groundbreaking drugs during that era to determine what made their work successful and how the process of conducting medical innovation has changed over the past 3 decades. Transcripts were analyzed using standard coding techniques and the constant comparative method of qualitative data analysis to identify the positive features of and challenges posed by the past and present therapeutic innovation environments (70 of the 127 interviewees explicitly addressed these issues). Interviewees emphasized the continued central role played by individuals and the institutions they were a part of in driving innovation. In addition, respondents discussed the importance of collaboration between individuals and institutions to share resources and expertise. Strong underlying basic science was also cited to be a major contributing factor to the success of an innovation. The climate for modern-day medical innovation involves a greater emphasis on patenting in academia, difficulty negotiating the technology transfer process, and funding constraints. Regulatory demands or reimbursement concerns were not commonly cited as factors that influenced transformative innovation. This study suggests that generating future transformative innovation will require a simplification of the current technology transfer process, continued commitment to basic science research, and policy changes that promote meaningful collaboration between individuals from disparate institutions.

  13. Further evidence of self-medication: personality factors influencing drug choice in substance use disorders.

    PubMed

    McKernan, Lindsey Colman; Nash, Michael R; Gottdiener, William H; Anderson, Scott E; Lambert, Warren E; Carr, Erika R

    2015-06-01

    According to Khantzian's (2003) self-medication hypothesis (SMH), substance dependence is a compensatory means to modulate affects and self-soothe in response to distressing psychological states. Khantzian asserts: (1) Drugs become addicting because they have the power to alleviate, remove, or change human psychological suffering, and (2) There is a considerable degree of specificity in a person's choice of drugs because of unique psychological and physiological effects. The SMH has received criticism for its variable empirical support, particularly in terms of the drug-specificity aspect of Khantzian's hypothesis. We posit that previous empirical examinations of the SMH have been compromised by methodological limitations. Also, more recent findings supporting the SMH have yet to be replicated. Addressing previous limitations to the research, this project tested this theory in a treatment sample of treatment-seeking individuals with substance dependence (N = 304), using more heterogeneous, personality-driven measures that are theory-congruent. Using an algorithm based on medical records, individuals were reliably classified as being addicted to a depressant, stimulant, or opiate by two independent raters. Theory-based a priori predictions were that the three groups would exhibit differences in personality characteristics and emotional-regulation strategies. Specifically, our hypotheses entailed that when compared against each other: (1) Individuals with a central nervous system (CNS) depressant as drug of choice (DOC) will exhibit defenses of repression, over-controlling anger, and emotional inhibition to avoid acknowledging their depression; (2) Individuals with an opiate as DOC will exhibit higher levels of aggression, hostility, depression, and trauma, greater deficits in ego functioning, and externalizing/antisocial behavior connected to their use; and (3) Individuals with a stimulant as DOC will experience anhedonia, paranoia, have a propensity to mania, and

  14. Good Medical Practice for Drugs. Definition, Guidelines, References, Field of Action and Applications.

    PubMed

    Bergmann, Jean-François

    2008-01-01

    Proper use of drugs can be defined as the use of the right product, in a correct dosage, during an adequate length of time, for a given patient and provided he has no serious side effects. It is virtually impossible, with such a number of drugs, such a number of clinical situations to prescribe adequately without using references or guidelines. References may lead to a unique choice, when the diagnosis is certain and the drug to be given is unique. With a good initial and continuous medical education, doctors can take easily this type of decision. The Summary of Products Characteristics (SPC) helps them; by sticking to this fundamental reference, prescription might be more precise and safe. In a lot of clinical situations the choice between a large numbers of therapeutic strategies necessitates use of a guideline based on scientific knowledge. Finally, a given therapeutic strategy can be as effective as and considerably less expensive than another. In such cases, payers can drive doctors to the prescription of the less expensive strategy. Some difficulties are common to all references and guidelines.

  15. Caffeine, tobacco, alcohol and drug consumption among medical students in Barcelona.

    PubMed

    Laporte, J R; Cami, J; Gutiérrez, R; Laporte, J

    1977-07-19

    A survey of medical students was conducted at the Universitat Autònoma de Barcelona in 1974. Out of 1029 students, 808 present at lectures (78.5%) returned properly completed questionnaires. These showed that mean caffeine consumption was 8.3 g per month and increased with the length of stay at the university. Tobacco consumption (general mean, 190 cigarettes per month, 216 for males and 150 for females) and alcohol consumption (8.8 litres/year for males and 4.1 litres/year for females) also increased with time spent at university. Alcohol consumption was not as high as in the general population. Amphetamine consumption was very high (22% of students had taken amphetamines on more than one occasion in the six months prior to the survey). Marihuana and hashish were by far the most commonly used drugs (9.6%), the use of these drugs being much less common than at other European universities. The use of "harder" drugs was very limited. Appraisal of alcohol, tobacco and amphetamine abuse is necessary, since the authorities have not employed adequate measures to stop or limit them.

  16. 42 CFR 418.106 - Condition of participation: Drugs and biologicals, medical supplies, and durable medical equipment.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... provided pharmacist services must include evaluation of a patient's response to medication therapy... own facility may only be administered medications by the following individuals: (i) A licensed nurse...) An employee who has completed a State-approved training program in medication administration;...

  17. Compliance therapy: an intervention to improve inpatients' attitudes toward treatment.

    PubMed

    Tay, Sim-Eng Clara

    2007-06-01

    Nonadherence to prescription medication is the leading cause of relapse or recurrence of psychotic illness. Literature has shown that compliance therapy, a brief intervention based on motivational interviewing and cognitive approaches, can lead to improved attitudes, adherence to treatment, and insight. This descriptive study aimed to examine the effectiveness of compliance therapy on treatment adherence. The 69 participants were patients of the same ward, either referred for patient education by the psychiatrist or selected from a convenience sample of patients on the clinical pathway of relapsed schizophrenia or major depression. Compliance therapy was conducted individually or in small groups of 2 to 3 patients. The shortened version of the Drug Attitude Inventory (DAI-10), along with a rating scale adapted from another study, was used to measure attitude and the rate of adherence before and after therapy. Patients in both individual and group sessions showed significant improvements in attitude. Those with six or more admissions had slightly less significant improvement, and those with personality disorder or substance abuse showed no significant improvement. Compliance therapy benefits patients and improves their attitude toward treatment. Psychiatric nurses could be trained in this clinical intervention to enable them to conduct compliance therapy in the hospital or in the community.

  18. Adverse drug reactions reported by consumers for nervous system medications in Europe 2007 to 2011

    PubMed Central

    2013-01-01

    Background Reporting of adverse drug reactions (ADRs) has traditionally been the sole province of healthcare professionals. In the European Union, more countries have allowed consumers to report ADRs directly to the regulatory agencies. The aim of this study was to characterize ADRs reported by European consumer for nervous system medications. Methods ADRs reported by consumers for nervous system medications (ATC group N) from 2007 to 2011 and located in the European ADR database, EudraVigilance, were analysed. Data were categorized with respect to age and sex, category and seriousness of reported ADRs and medications. The unit of analysis was one ADR. Results We located 4766 ADRs reported for nervous system medications, and one half of these were serious including 19 deaths. Less than 5% of ADRs were reported in children. Totally, 58% of ADRs were reported for women, 42% for men. The majority of reported ADRs were of the types “nervous system disorders” (18% of total ADRs) followed by “psychiatric disorders” (18% of total ADRs) and “general disorders” (15% of total ADRs) which also were the system organ classes in which the majority of serious ADRs were found. ADR reports encompassed medicines from the therapeutic groups: antiepileptics (ATC group N03) (36% of total ADRs), parasympathomimetics (ATC group N07) (22% of total ADRs) and antidepressants ATC group N06A (9% of total ADRs). Antiepileptics were the therapeutic group with the highest share of serious ADRs (60%) followed by antidepressants (15%). Many serious ADRs were reported for pregabalin and varenicline. Conclusions The majority of ADRs from nervous system mediations reported by consumers that were identified from the EudraVigilance database were serious. The value of consumer reports in pharmacovigilance still remains unclarified. PMID:23763896

  19. Nonmedical Use of Prescription Medication Among Adolescents Using Drugs in Quebec

    PubMed Central

    Roy, Élise; Nolin, Marc-Antoine; Traoré, Issouf; Leclerc, Pascale; Vasiliadis, Helen-Maria

    2015-01-01

    Objective: To determine the prevalence and factors associated with nonmedical use of prescription medication (NMUPM) among adolescents who use drugs (ages 12 to 17 years) in Quebec. Method: Secondary data analyses were carried out with data from a 6-month study, namely, the 2010–2011 Quebec Health Survey of High School Students—a large-scale survey that sought to gain a better understanding of the health and well-being of young Quebecers in high school. Bivariate and multivariate logistic regression analyses were conducted to study NMUPM among adolescents who use drugs, according to sociodemographic characteristics, peer characteristics, health indicators (anxiety, depression, or attention-deficit disorder [ADD] with or without hyperactivity), self-competency, family environment, and substance use (alcohol and drug use) factors. Results: Among adolescents who had used drugs in the previous 12 months, 5.4% (95% CI 4.9% to 6.0%) reported NMUPM. Based on multivariate analyses, having an ADD (adjusted odds ratio [AOR] 1.47; 95% CI 1.13 to 1.91), anxiety disorder (AOR 2.14; 95% CI 1.57 to 2.92), low self-esteem (AOR 1.62; 95% CI 1.26 to 2.08), low self-control (AOR 1.95; 95% CI 1.55 to 2.45), low parental supervision (AOR 1.43; 95% CI 1.11 to 1.83), regular alcohol use (AOR 1.72; 95% CI 1.36 to 2.16), and polysubstance use (AOR 4.09; 95% CI 3.06 to 5.48) were associated with increased odds of reporting NMUPM. Conclusions: The observed prevalence of NMUPM was lower than expected. However, the associations noted with certain mental health disorders and regular or heavy use of other psychoactive substances are troubling. Clinical implications are discussed. PMID:26720824

  20. Medication Use and Medical Comorbidity in Patients with Chronic Hepatitis C from a U.S. Commercial Claims Database: High Utilization of Drugs with Interaction Potential

    PubMed Central

    Lauffenburger, Julie C.; Mayer, Christina L.; Hawke, Roy L.; Brouwer, Kim L. R.; Fried, Michael W.; Farley, Joel F.

    2014-01-01

    Background With the advent of the direct-acting antiviral agents (DAAs), significant drug-drug interaction (DDI) potential now exists for patients treated for chronic hepatitis C virus (HCV) infection. However, little is known about how often patients with HCV use medications that may interact with newer HCV treatments, especially those with CYP3A DDI potential. Methods Using a large United States commercial insurance database, medication use and comorbidity burden was examined among adult patients with a chronic HCV diagnosis from 2006-2010. Medications were examined by total number of prescription claims, proportion of patients exposed, and DDI potential with prototypical CYP3A DAAs, boceprevir and telaprevir, for which data were available. Results Patient comorbidity burden was high and increased over the study period. Medication use was investigated in 53,461 patients with chronic HCV. Twenty-one (53%) of the top 40 most utilized medications were classified as having interaction potential, with 62% of patients received at least one of the top 22 interacting medications by exposure. Of these, 59% and 41% were listed in a common DDI resource but not in medication prescribing information, 77% and 77% had not been investigated in DDI studies, 32% and 27% did not have clear recommendations for DDI management, and only 14% and 23% carried a recommendation to avoid coadministration for boceprevir and telaprevir, respectively. Conclusion Practitioners may expect a medication with CYP3A DDI potential in two-thirds of patients with HCV and almost one-half of the most frequently used medications. However, DDI potential may not be reflected in prescribing information. PMID:25014625

  1. The Medication Information Line for the Elderly. A consumer/health care professional-oriented drug information service.

    PubMed

    Grymonpré, R E; Steele, J W; Schultz, B R

    1987-05-01

    The experiences of a drug information telephone service aimed at older adults, their care providers, and health care professionals are presented. The Medication Information Line for the Elderly received 1,561 telephone calls over the 12 months since its opening. The majority of callers (73%) were female and 723 (46%) of the 1,561 calls came from people in the 65 to 79 age group. Nearly one-third of all enquiries were about suspected drug-related adverse drug reactions. The drugs most commonly causing concern (as classified by the American Hospital Formulary Service) were nonsteroidal anti-inflammatory drugs, cardiac drugs, and benzodiazepines; a list comparable to the most frequently prescribed drugs in older adults. The pharmacist was able to respond to 853 (27%) of the 3,172 enquiries without reference material. The most frequently used sources of information were the USP Drug information, Volumes I & II, and the Compendium of Pharmaceuticals and Specialties. Follow-up calls on certain consumer enquiries indicated that 89% of the recommendations were adhered to, suggesting a beneficial influence of this type of drug information service on medication use.

  2. Medical cost-offset following treatment referral for alcohol and other drug use disorders in a group model HMO.

    PubMed

    Polen, Michael R; Freeborn, Donald K; Lynch, Frances L; Mullooly, John P; Dickinson, Daniel M

    2006-07-01

    The purpose of this study was to determine whether specialty alcohol and other drug (AOD) treatment is associated with reduced subsequent medical care costs. AOD treatment costs and medical costs in a group model health maintenance organization (HMO) were collected for up to 6 years on 1,472 HMO members who were recommended for specialty AOD treatment, and on 738 members without AOD diagnoses or treatment. Addiction Severity Index measures were also obtained from a sample of 293 of those recommended for treatment. Changes in medical costs did not differ between treatment and comparison groups. Nor did individuals with improved treatment outcomes have greater reductions in medical costs. AOD treatment costs were not inversely related to subsequent medical costs, except for a subgroup with recent AOD treatment. In the interviewed sample, better treatment outcomes did not predict lower subsequent medical costs. Multiple treatment episodes may hold promise for producing cost-offsets.

  3. Cable compliance

    NASA Technical Reports Server (NTRS)

    Kerley, J.; Eklund, W.; Burkhardt, R.; Rossoni, P.

    1992-01-01

    The object of the investigation was to solve mechanical problems using cable-in-bending and cable-in-torsion. These problems included robotic contacts, targets, and controls using cable compliance. Studies continued in the use of cable compliance for the handicapped and the elderly. These included work stations, walkers, prosthetic knee joints, elbow joints, and wrist joints. More than half of these objects were met, and models were made and studies completed on most of the others. It was concluded that the many different and versatile solutions obtained only opened the door to many future challenges.

  4. Medical devices; revocation of cardiac pacemaker registry. Food and Drug Administration, HHS. Final rule.

    PubMed

    1999-11-24

    The Food and Drug Administration (FDA) is issuing a final rule to revoke a regulation requiring a cardiac pacemaker registry. The registry, which was mandated by the Deficit Reduction Act of 1984, requires any physician and any provider of services who requests or receives Medicare payment for an implantation, removal, or replacement of permanent cardiac pacemaker devices and pacemaker leads to submit certain information to the registry. The information is used by FDA to track the performance of permanent cardiac pacemakers and pacemaker leads and by the Health Care Finance Administration (HCFA) to administer its Medicare payment program for these devices. This action is being taken to implement an act to Repeal An Unnecessary Medical Device Reporting Requirement passed by Congress in 1996 to remove the cardiac pacemaker registry to eliminate duplicative and unnecessary reporting.

  5. An example of US Food and Drug Administration device regulation: medical devices indicated for use in acute ischemic stroke.

    PubMed

    Peña, Carlos; Li, Khan; Felten, Richard; Ogden, Neil; Melkerson, Mark

    2007-06-01

    The Food and Drug Administration has established requirements for protecting the public health by assuring the safety and effectiveness of a variety of medical products including drugs, devices, and biological products, and for promoting public health by expediting the approval of treatments that are safe and effective. The Center for Devices and Radiological Health is the center within the agency that is responsible for pre- and postmarket regulation of medical devices. In this article, we review current regulation of medical devices, research and development programs, pre- and postmarket perspectives, and future considerations of medical devices, particularly as they relate to devices targeting acute ischemic stroke as an example of the process. We also review the Center for Devices and Radiological Health's historical perspective of acute ischemic stroke trials and clinical trial design considerations used in prior studies that have led to US market clearance as they are related to currently marketed devices indicated for acute ischemic stroke.

  6. Drug Testing Incoming Residents and Medical Students in Family Medicine Training: A Survey of Program Policies and Practices

    PubMed Central

    Bell, Paul F.; Semelka, Michael W.; Bigdeli, Laleh

    2015-01-01

    Background 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. Objective 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. Methods The survey was sent to the directors of family medicine residency programs. A total of 205 directors (47.2%) completed the survey. Results 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. Conclusions 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. PMID:26217424

  7. Development of medicated foams that combine incompatible hydrophilic and lipophilic drugs for psoriasis treatment.

    PubMed

    Mirtič, Janja; Papathanasiou, Foteini; Rakuša, Žane Temova; Matjaž, Mirjam Gosenca; Roškar, Robert; Kristl, Julijana

    2017-03-27

    The focus was on the development of medicated foam for incorporation of two incompatible active agents for psoriasis treatment; i.e., lipophilic cholecalciferol, and hydrophilic salicylic acid. Emphasis was given to formulation of a propellant-free foam, with sufficient foaming properties, physical and chemical stability, and low irritancy potential to maintain relevance for later translation into clinical practice. Various excipients and concentrations were examined to achieve suitable foam stability parameters, viscoelasticity, and bubble-size, which relate to foamability and spreadability. The major positive impact on these properties was through a combination of surfactants, and by inclusion of a viscosity-modifying polymer. Incorporation of the incompatible drugs was then examined, noting the instability of cholecalciferol in an acidic environment, with the design aim to separate the drug distributions among the different foam phases. Cholecalciferol was stabilized in the emulsion-based foam, with at least a 30-fold lower degradation rate constant compared to its aqueous solution. The composition of the emulsion-based foam itself protected cholecalciferol from degradation, as well as the addition of the radical-scavenging antioxidant tocopheryl acetate to the oil phase. With the patient in mind, the irritancy potential was also examined, which was below the set limit that defines a non-irritant dermal product.

  8. Associations Between the Big Five Personality Traits and the Non-Medical Use of Prescription Drugs for Cognitive Enhancement.

    PubMed

    Sattler, Sebastian; Schunck, Reinhard

    2015-01-01

    While the number of studies of the non-medical use of prescription drugs to augment cognitive functions is growing steadily, psychological factors that can potentially help explain variance in such pharmaceutical cognitive enhancement (CE) behavior are often neglected in research. This study investigates the association between the Big Five personality traits and a retrospective (prior CE-drug use) as well as a prospective (willingness to use CE drugs) measure of taking prescription drugs with the purpose of augmenting one's cognitive functions (e.g., concentration, memory, or vigilance) without medical necessity. We use data from a large representative survey of German employees (N = 6454, response rate = 29.8%). The Five Factor Model (FFM) of Personality was measured with a short version of the Big Five Personality Traits Inventory (BFI-S), which includes: openness to experience, conscientiousness, extraversion, agreeableness, and neuroticism. Together with this, demographic variables such as gender, age, education, and income were used as potential confounders in multiple logistic regression models. Our results show a 2.96% lifetime prevalence of CE-drug use and a 10.45% willingness to (re)use such drugs in the future. We found that less conscientious and more neurotic respondents have a higher probability of prior CE-drug use and a greater willingness to use CE drugs in the future. No significant effects were found for openness, extraversion, or agreeableness. Prior CE-drug use was strongly associated with a greater willingness to take such drugs in the future. This study shows that specific personality traits are not only associated with prior enhancement behavior, but also affect the willingness to (re)use such drugs. It helps increase understanding of the risk factors of CE-drug use, which is a health-related behavior that can entail severe side-effects for consumers. The knowledge gathered can thus help improve interventions aimed at minimizing health

  9. Associations Between the Big Five Personality Traits and the Non-Medical Use of Prescription Drugs for Cognitive Enhancement

    PubMed Central

    Sattler, Sebastian; Schunck, Reinhard

    2016-01-01

    While the number of studies of the non-medical use of prescription drugs to augment cognitive functions is growing steadily, psychological factors that can potentially help explain variance in such pharmaceutical cognitive enhancement (CE) behavior are often neglected in research. This study investigates the association between the Big Five personality traits and a retrospective (prior CE-drug use) as well as a prospective (willingness to use CE drugs) measure of taking prescription drugs with the purpose of augmenting one's cognitive functions (e.g., concentration, memory, or vigilance) without medical necessity. We use data from a large representative survey of German employees (N = 6454, response rate = 29.8%). The Five Factor Model (FFM) of Personality was measured with a short version of the Big Five Personality Traits Inventory (BFI-S), which includes: openness to experience, conscientiousness, extraversion, agreeableness, and neuroticism. Together with this, demographic variables such as gender, age, education, and income were used as potential confounders in multiple logistic regression models. Our results show a 2.96% lifetime prevalence of CE-drug use and a 10.45% willingness to (re)use such drugs in the future. We found that less conscientious and more neurotic respondents have a higher probability of prior CE-drug use and a greater willingness to use CE drugs in the future. No significant effects were found for openness, extraversion, or agreeableness. Prior CE-drug use was strongly associated with a greater willingness to take such drugs in the future. This study shows that specific personality traits are not only associated with prior enhancement behavior, but also affect the willingness to (re)use such drugs. It helps increase understanding of the risk factors of CE-drug use, which is a health-related behavior that can entail severe side-effects for consumers. The knowledge gathered can thus help improve interventions aimed at minimizing health

  10. Assessing cancer drugs for reimbursement: methodology, relationship between effect size and medical need.

    PubMed

    de Sahb-Berkovitch, Rima; Woronoff-Lemsi, Marie-Christine; Molimard, Mathieu

    2010-01-01

    Reimbursement is assessed by the Transparency Commission from the Health Authority (HAS) using a medical benefit (SMR) score that gives access to reimbursement, an "improvement of medical service rendered" (ASMR) that determines the added therapeutic value, and the target population. Assessing cancer drugs for reimbursement raises the same issues as other therapeutic classes, with some key differences. Overall survival (OS) is considered by the Transparency Commission as the endpoint for assessing clinical benefit, and yet it is not an applicable primary endpoint in all types of cancer. Later lines of treatment, particularly during the development process, may make it difficult to interpret OS as the primary endpoint. Therefore, progression-free survival (PFS) for metastatic situations and disease-free survival (DFS) in adjuvant situations are wholly relevant endpoints for decisions on the reimbursement of a new cancer drug. Effect size is assessed using actuarial survival curves of the product versus the comparator, and it is difficult to summarise them into one single parameter. Results are generally interpreted based on median survival, which is fragmented because it only measures one point of the curve. The hazard ratio measures the effect of treatment throughout the duration of survival and is therefore more comprehensive in quantifying clinical benefit. Determining an effect size threshold for granting reimbursement is difficult given the diversity of cancer settings and the level of medical need, which influences assessment of the clinical relevance of the observed difference. Rapid progress in comparators (700 molecules in development) and the identification of predictive factors of efficacy (biomarkers, histology, etc.) during development may lead to different ASMR scores per population, or to the restriction of the target population to a subgroup of the marketing authorisation (MA) population in which the expected effect size is greater. To address these

  11. Drugs and other product choices.

    PubMed

    Hyman, Paul M; Carvajal, Ricardo

    2009-01-01

    Dermatologists have at their disposal a wide range of products to recommend or prescribe to their patients, all of which are regulated in some way by the Food and Drug Administration (FDA). However, the degree to which FDA has confirmed the safety and efficacy of a dermatological product can vary widely. Most prescription and some over-the-counter drugs and medical devices are approved by the FDA based on scientific data. Most over-the-counter drugs are marketed in compliance with FDA regulations based on expert medical review. The FDA clears most medical devices based on their substantial equivalence to other legally marketed devices. Cosmetics, medical foods, and dietary supplements are subject only to general postmarket prohibitions against adulterated and misbranded products, although the FDA may review ingredient safety and specific claims for dietary supplements. Some product information is available on FDA's Web site, but the prudent physician should supplement that information by reviewing available scientific literature.

  12. [Good medical practice for drugs. Definition, guidelines, references, field of action and applications].

    PubMed

    2008-01-01

    Proper use of drugs can be defined as the use of the right product, in a correct dosage, during an adequate length of time, for a given patient and provided he has no serious side effects.It is virtually impossible, with such a number of drugs, such a number of clinical situations to prescribe adequately without using references or guidelines. References may lead to a unique choice, when the diagnosis is certain and the drug to be given is unique. With a good initial and continuous medical education, doctors can take easily this type of decision. The Summary of Products Characteristics (SPC) helps them; by sticking to this fundamental reference, prescription might be more precise and safe. In a lot of clinical situations the choice between a large numbers of therapeutic strategies necessitates use of a guideline based on scientific knowledge. Finally, a given therapeutic strategy can be as effective as and considerably less expensive than another. In such cases, payers can drive doctors to the prescription of the less expensive strategy.Some difficulties are common to all references and guidelines: 1. A lot of clinical situations are not covered by guidelines. 2. Guidelines should be updated each time there is a modification of knowledge: it is extremely difficult to do. 3. A great number of guidelines exist, issued by scientific community, health authorities or the payers. Sometime you can find a proposition in a guideline and the reverse in another guideline. It could be confusing. 4. Guidelines should be evaluated rigorously to know if they fulfil their goals. 5. Some of those guidelines simply cannot help doctors. They are too complex or do not take into account practical situations.We have made an inventory of those various guidelines and their weaknesses and we propose some solutions to increase their utility. We propose an analysis of the situation and some solutions to improve the quality and the relevance of the guidelines: to create groups of coordination

  13. Incorporating Concomitant Medications into Genome-Wide Analyses for the Study of Complex Disease and Drug Response

    PubMed Central

    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.; Friedewald, W.T.

    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. PMID:27775101

  14. 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.

  15. Compliance and oral contraceptives: a review.

    PubMed

    Rosenberg, M J; Burnhill, M S; Waugh, M S; Grimes, D A; Hillard, P J

    1995-09-01

    Compliance difficulties are more common among oral contraceptive (OC) users than generally appreciated by clinicians, in part because unintended pregnancy is a relatively infrequent consequence and in part because more common manifestations such as spotting and bleeding may not be recognized as resulting from poor compliance. While improving compliance is a shared responsibility of patients, clinicians, and manufacturers, the clinician is the focal point for these efforts. Counseling must be individualized, which requires knowledge of factors that predict compliance and an understanding of the patient's decision-making process as it relates to medications. Most OC compliance research has focused on adolescents, where predictors of poor compliance include multiple sex partners, low evaluation of personal health, degree of concern about pregnancy, and previous abortion. Good compliance has been linked with patient satisfaction with the clinician, the absence of certain side effects, establishing a regular daily routine to take OCs, and reading information distributed with OC packaging.

  16. Critical thinking about adverse drug effects: lessons from the psychology of risk and medical decision-making for clinical psychopharmacology.

    PubMed

    Nierenberg, Andrew A; Smoller, Jordan W; Eidelman, Polina; Wu, Yelena P; Tilley, Claire A

    2008-01-01

    Systematic biases in decision-making have been well characterized in medical and nonmedical fields but mostly ignored in clinical psychopharmacology. The purpose of this paper is to sensitize clinicians who prescribe psychiatric drugs to the issues of the psychology of risk, especially as they pertain to the risk of side effects. Specifically, the present analysis focuses on heuristic organization and framing effects that create cognitive biases in medical practice. Our purpose is to increase the awareness of how pharmaceutical companies may influence physicians by framing the risk of medication side effects to favor their products.

  17. 42 CFR 418.106 - Condition of participation: Drugs and biologicals, medical supplies, and durable medical equipment.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... licensed nurse, nurse practitioner (where appropriate), pharmacist, or physician; and (ii) The individual...: Ordering of drugs. (1) Only a physician as defined by section 1861(r)(1) of the Act, or a nurse practitioner in accordance with the plan of care and State law, may order drugs for the patient. (2) If...

  18. 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.

  19. Relationship between multiple drug resistance and biofilm formation in Staphylococcus aureus isolated from medical and non-medical personnel in Yaounde, Cameroon

    PubMed Central

    Eyoh, Agnes Bedie; Toukam, Michel; Atashili, Julius; Fokunang, Charles; Gonsu, Hortense; Lyonga, Emilia Enjema; Mandi, Henshaw; Ikomey, George; Mukwele, Bertha; Mesembe, Martha; Assoumou, Marie Claire Okomo

    2014-01-01

    Introduction Monitoring the prevalence of nasal carriage of multiple drug resistance (MDR) Staphylococcus aureus (SA) strains in hospital personnel is essential. These strains when transmitted from hospital personnel to patients with already weakened immune states or in-built medical devices, may limit the latter's treatment options. This study aimed at assessing the potential exposure of patients to these MDR SA in a resource-limited hospital setting by assessing the prevalence and relationship between antimicrobial susceptibility and biofilm forming capacity of SA isolates from hospital personnel. Methods A total of 59 bacteria isolates phenotypically identified as Staphylococcus aureus obtained from medical (39) and non-medical personnel (20) in Yaounde were used in the study. Multiple drug resistance defined as resistance to four or more of twelve locally used antibiotics were determined by Kirby Bauer disc diffusion technique whereas quantification of biofilm production was by the microtitre plate method. Results Among the 59 SA isolates, the prevalence of MDR was 50.9%. Among medical personnel 48.7% had MDR as against 55.9% for non-medical personnel (p-value=0.648). The overall percentage of weak biofilm producers was 35.6%. Although the prevalence of weak biofilm formers was higher in isolates from non-medical personnel (40%) than medical personnel (33.3%) the difference was not statistically significant (p-value= 0.246). Slightly less than half (42.9%) of the weak biofilm producers were MDR. Conclusion Considering the high rates of MDR and that slightly less than half of biofilm formers were MDR, these trends need to be monitored regularly among hospital personnel in Yaounde. PMID:25396012

  20. Time-dependent drug-drug interaction alerts in care provider order entry: software may inhibit medication error reductions.

    PubMed

    van der Sijs, Heleen; Lammers, Laureen; van den Tweel, Annemieke; Aarts, Jos; Berg, Marc; Vulto, Arnold; van Gelder, Teun

    2009-01-01

    Time-dependent drug-drug interactions (TDDIs) are drug combinations that result in a decreased drug effect due to coadministration of a second drug. Such interactions can be prevented by separately administering the drugs. This study attempted to reduce drug administration errors due to overridden TDDIs in a care provider order entry (CPOE) system. In four periods divided over two studies, logged TDDIs were investigated by reviewing the time intervals prescribed in the CPOE and recorded on the patient chart. The first study showed significant drug administration error reduction from 56.4 to 36.2% (p<0.05), whereas the second study was not successful (46.7 and 45.2%; p>0.05). Despite interventions, drug administration errors still occurred in more than one third of cases and prescribing errors in 79-87%. Probably the low alert specificity, the unclear alert information content, and the inability of the software to support safe and efficient TDDI alert handling all diminished correct prescribing, and consequently, insufficiently reduced drug administration errors.

  1. Sequential pattern of non-medical drug use in the drug career of opiate dependents in Nagpur, India.

    PubMed

    Wairagkar, N S; Wahab, S N; Kulkarni, H R

    1996-12-01

    A study was carried out in a group of opiate addicts who reported to various centers in Nagpur city, India, to know the sequential pattern of nonmedical drug use in the drug career of opiate dependents in Nagpur. The mean age of the study group was 28.2 years, the majority were males, educated up to 10th standard, employed in various occupations like petty business, vehicle driving, etc, with an average monthly income of Rs. 316. The average number of drugs ever used per person was 3.7 +/- 1.2, those recently used was 2.6 +/- 0.9 and currently used was 2.2 +/- 0.6. The study group experienced 13 drug types in their addict careers. Beedi¿cigarette was the first drug abused by the majority. Drug careers starting with beedi¿cigarette, progressing to alcohol and then to canabis and finally to heroin were observed in a majority of subjects. There appeared to be a shift from multidrug use to the singular combination of heroin and beedi¿cigarette currently. Use of all other drugs declined in favor of heroin as the career progressed. The study indicates that preventive programs should be directed at reducing the use of initial drugs like beedi¿cigarette and alcohol and also reducing the social acceptability of these drugs as measure for preventing progression to hard drugs like heroin.

  2. Drug Use and Misuse in the Mountains: A UIAA MedCom Consensus Guide for Medical Professionals.

    PubMed

    Donegani, Enrico; Paal, Peter; Küpper, Thomas; Hefti, Urs; Basnyat, Buddha; Carceller, Anna; Bouzat, Pierre; van der Spek, Rianne; Hillebrandt, David

    2016-09-01

    Donegani, Enrico, Peter Paal, Thomas Küpper, Urs Hefti, Buddha Basnyat, Anna Carceller, Pierre Bouzat, Rianne van der Spek, and David Hillebrandt. Drug use and misuse in the mountains: a UIAA MedCom consensus guide for medical professionals. High Alt Med Biol. 17:157-184, 2016.-Aims: The aim of this review is to inform mountaineers about drugs commonly used in mountains. For many years, drugs have been used to enhance performance in mountaineering. It is the UIAA (International Climbing and Mountaineering Federation-Union International des Associations d'Alpinisme) Medcom's duty to protect mountaineers from possible harm caused by uninformed drug use. The UIAA Medcom assessed relevant articles in scientific literature and peer-reviewed studies, trials, observational studies, and case series to provide information for physicians on drugs commonly used in the mountain environment. Recommendations were graded according to criteria set by the American College of Chest Physicians.

  3. 75 FR 17143 - Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices; Neurological...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-05

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration... AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA... six of them from the premarket notification requirements of the Federal Food, Drug, and Cosmetic...

  4. [Doctors and jurists who objected to the separation of drug dispensaries from the medical practice in the Taisho Era].

    PubMed

    Amano, Hiroshi

    2002-01-01

    Doctors were very nervous about the movements of pharmacists toward achievement of the separation of drug dispensaries in the medical practices and drug dispensation in 1914 and 1915. They specifically blamed one person, Professor Tokichiro Niwa of Tokyo Imperial University who strongly advocated the separation of dispensaries in the medical practices. Furthermore, they were also very anxious that the Japan Pharmacists Association had supported legislators who had stood by the separation of dispensaries from medical practice at the twelfth general election held on March 25, 1915. They were concerned that the domain of doctors' activities would be narrowed by such a separation. Professor Kunika Katayama of the Tokyo Imperial University School of Medicine published a thesis at his own cost advocating a modification of the doctor's law to prohibit the separation of dispensaries be legislation and insisting that the right prescribe a drug to a patient must remain with the doctor. Moreover, Professor Mitsue Ichimura of Kyoto Imperial University also insisted that a doctor has the right to give drugs to patients, and that as a jurist he disagreed with the separation of dispensaries from medical practice.

  5. Non-Medical Use of Prescription Drugs among Youth in an Appalachian Population: Prevalence, Predictors, and Implications for Prevention

    ERIC Educational Resources Information Center

    Collins, David; Abadi, Melissa Harris; Johnson, Knowlton; Shamblen, Steve; Thompson, Kirsten

    2011-01-01

    This article examines prevalence of non-medical use of prescription drugs (NMUPD) in a sample of elementary and high school students in an Appalachian Tennessee county. We found that lifetime prevalence of NMUPD (35%) was higher than prevalence of cigarette use (28%) and marijuana use (17%), but lower than lifetime prevalence of alcohol use (46%).…

  6. 40 CFR 60.37e - Compliance, performance testing, and monitoring guidelines.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... and Compliance Times for Hospital/Medical/Infectious Waste Incinerators § 60.37e Compliance... hospital waste and/or medical/infectious waste. (f) The owner or operator of a designated facility...

  7. 40 CFR 60.37e - Compliance, performance testing, and monitoring guidelines.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... and Compliance Times for Hospital/Medical/Infectious Waste Incinerators § 60.37e Compliance... hospital waste and/or medical/infectious waste. (f) The owner or operator of a designated facility...

  8. 40 CFR 60.37e - Compliance, performance testing, and monitoring guidelines.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... and Compliance Times for Hospital/Medical/Infectious Waste Incinerators § 60.37e Compliance... hospital waste and/or medical/infectious waste. (f) The owner or operator of a designated facility...

  9. Oral hygiene products, medications and drugs - hidden aetiological factors for dental erosion.

    PubMed

    Hellwig, Elmar; Lussi, Adrian

    2014-01-01

    Acidic or EDTA-containing oral hygiene products and acidic medicines have the potential to soften dental hard tissues. The low pH of oral care products increases the chemical stability of some fluoride compounds and favours the incorporation of fluoride ions in the lattice of hydroxyapatite and the precipitation of calcium fluoride on the tooth surface. This layer has some protective effect against an erosive attack. However, when the pH is too low or when no fluoride is present these protecting effects are replaced by direct softening of the tooth surface. Oral dryness can occur as a consequence of medication such as tranquilizers, antihistamines, antiemetics and antiparkinsonian medicaments or of salivary gland dysfunction. Above all, patients should be aware of the potential demineralization effects of oral hygiene products with low pH. Acetyl salicylic acid taken regularly in the form of multiple chewable tablets or in the form of headache powder, as well as chewing hydrochloric acids tablets for the treatment of stomach disorders, can cause erosion. There is most probably no direct association between asthmatic drugs and erosion on the population level. Consumers and health professionals should be aware of the potential of tooth damage not only by oral hygiene products and salivary substitutes but also by chewable and effervescent tablets. Several paediatric medications show a direct erosive potential in vitro. Clinical proof of the occurrence of erosion after use of these medicaments is still lacking. However, regular and prolonged use of these medicaments might bear the risk of causing erosion. Additionally, it can be assumed that patients suffering from xerostomia should be aware of the potential effects of oral hygiene products with low pH and high titratable acidity.

  10. Sexual Function and the Use of Medical Devices or Drugs to Optimize Potency After Prostate Brachytherapy

    SciTech Connect

    Whaley, J. Taylor; Levy, Lawrence B.; Swanson, David A.; Pugh, Thomas J.; Kudchadker, Rajat J.; Bruno, Teresa L.; Frank, Steven J.

    2012-04-01

    Purpose: Prospective evaluation of sexual outcomes after prostate brachytherapy with iodine-125 seeds as monotherapy at a tertiary cancer care center. Methods and Materials: Subjects were 129 men with prostate cancer with I-125 seed implants (prescribed dose, 145 Gy) without supplemental hormonal or external beam radiation therapy. Sexual function, potency, and bother were prospectively assessed at baseline and at 1, 4, 8, and 12 months using validated quality-of-life self-assessment surveys. Postimplant dosimetry values, including dose to 10% of the penile bulb (D10), D20, D33, D50, D75, D90, and penile volume receiving 100% of the prescribed dose (V100) were calculated. Results: At baseline, 56% of patients recorded having optimal erections; at 1 year, 62% of patients with baseline erectile function maintained optimal potency, 58% of whom with medically prescribed sexual aids or drugs. Variables associated with pretreatment-to-posttreatment decline in potency were time after implant (p = 0.04) and age (p = 0.01). Decline in urinary function may have been related to decline in potency. At 1 year, 69% of potent patients younger than 70 years maintained optimal potency, whereas 31% of patients older than 70 maintained optimal potency (p = 0.02). Diabetes was related to a decline in potency (p = 0.05), but neither smoking nor hypertension were. For patients with optimal potency at baseline, mean sexual bother scores had declined significantly at 1 year (p < 0.01). Sexual potency, sexual function, and sexual bother scores failed to correlate with any dosimetric variable tested. Conclusions: Erections firm enough for intercourse can be achieved at 1 year after treatment, but most men will require medical aids to optimize potency. Although younger men were better able to maintain erections firm enough for intercourse than older men, there was no correlation between potency, sexual function, or sexual bother and penile bulb dosimetry.

  11. Evaluating oversight of human drugs and medical devices: a case study of the FDA and implications for nanobiotechnology.

    PubMed

    Paradise, Jordan; Tisdale, Alison W; Hall, Ralph F; Kokkoli, Efrosini

    2009-01-01

    This article evaluates the oversight of drugs and medical devices by the U.S. Food and Drug Administration (FDA) using an integration of public policy, law, and bioethics approaches and employing multiple assessment criteria, including economic, social, safety, and technological. Criteria assessment and expert elicitation are combined with existing literature, case law, and regulations in an integrative historical case studies approach. We then use our findings as a tool to explore possibilities for effective oversight and regulatory mechanisms for nanobiotechnology. Section I describes oversight mechanisms for human drugs and medical devices and presents current nanotechnology products. Section II describes the results of expert elicitation research. Section III highlights key criteria and relates them to the literature and larger debate. We conclude with broad lessons for the oversight of nanobiotechnology informed by Sections I-III in order to provide useful analysis from multiple disciplines and perspectives to guide discussions regarding appropriate FDA oversight.

  12. 78 FR 59038 - Mobile Medical Applications; Guidance for Industry and Food and Drug Administration Staff...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-25

    ... and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice..., and other entities about how the FDA intends to apply its regulatory authorities to select...

  13. The effects of non-medically used psychoactive drugs on monoamine neurotransmission in rat brain.

    PubMed

    Nagai, Fumiko; Nonaka, Ryouichi; Satoh Hisashi Kamimura, Kanako

    2007-03-22

    We developed a reproducible, simple, and small-scale method for determining the re-uptake and release of monoamines (dopamine, serotonin (5-HT) and norepinephrine) using rat brain synaptosomes. These assays were then applied to study the effects of different kinds of non-medically used psychoactive drugs on monoamine re-uptake and release. The phenethylamine derivatives, 4-fluoroamphetamine, 2-methylamino-3,4-methylene-dioxy-propiophenone (methylone), 1-(1,3-benzodioxol-5-yl)-2-butanamine (BDB), and N-methyl-1-(1,3-benzodioxol-5-yl)-2-butanamine (MBDB), had strong inhibitory effects on the re-uptake of dopamine, 5-HT and norepinephrine. 4-Fluoroamphetamine, methylone and BDB also strongly increased the release of the three monoamines, but MBDB increased 5-HT and norepinephrine release, but had little effect on dopamine release. However, 2,5-dimethoxy-4-iodophenethylamine (2C-I), 2,5-dimethoxy-4-ethylphenethylamine (2C-E), 2,5-dimethoxy-4-chlorophenethylamine (2C-C), 2,4,5-trimethoxyamphetamine (TMA-2) and 2,4,6-trimethoxyamphetamine (TMA-6), which are methoxylated phenethylamine derivatives, slightly influenced the re-uptake and release of monoamines. Alpha-metyltryptamine (AMT), a tryptamine derivative, was one of the strongest re-uptake inhibitors and releasers of the three monoamines. The tryptamine derivative, 5-methoxy-alpha-methyltryptamine (5-MeO-AMT), also strongly inhibited re-uptake and increased the release of the three monoamines. N,N-dipropyltryptamine (DPT), 5-methoxy-N,N-diisopropyltryptamine (5-MeO-DIPT), 5-methoxy-N,N-methylisopropyltryptamine (5-MeO-MIPT), and 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) inhibited monoamine re-uptake, but had a few effects on monoamine release. 1-(3-Chlorophenyl)piperazine (3CPP) and 1-(methoxyphenyl)piperazine (4MPP), which are piperazine derivatives, inhibited monoamine re-uptake and accelerated their release. The results suggest that some designer drugs strongly act on the central nerve system to the same

  14. Optimum Methadone Compliance Testing

    PubMed Central

    2006-01-01

    ) system was used to evaluate the overall quality of the body of evidence (defined as 1 or more studies) supporting the research questions explored in this systematic review. A description of the GRADE system is reported in Appendix 1. Summary of Findings A total of 854 potential citations were retrieved. After reviewing titles and abstracts, 2 met the inclusion and exclusion criteria. Two other relevant studies were found after corresponding with the author of the 2 studies retrieved from the literature search. Therefore a total of 4 published studies are included in this analysis. All 4 studies carried out by the same investigator meet the definition of Medical Advisory Secretariat level III (not a-randomized controlled trial with contemporaneous controls) study design. In each of the studies, paired urine and oral fluid specimens where obtained from drug users. Urine collection was not observed in the studies however, laboratory tests for pH and creatinine were used to determine the reliability of the specimen. Urine specimens thought to be diluted and unreliable were removed from the evaluation. Urinalysis was used as the criterion measurement for which to determine the sensitivity and specificity of oral fluid testing by the Intercept oral fluid device for opiates, benzodiazepines, cocaine and marijuana. Alcohol was not tested in any of the 4 studies. From these 4 studies, the following conclusions were drawn: The evidence indicates that oral fluid testing with the Intercept oral fluid device has better specificity than sensitivity for opiates, benzodiazepines, cocaine and marijuana. The sensitivity of oral fluids testing with the Intercept oral fluid device seems to be from best to worst: cocaine > benzodiazepines >opiates> marijuana. The sensitivity and specificity for opiates of the Intercept oral fluid device ranges from 75 to 90% and 97- 100% respectively. The consequences of opiate false-negatives by oral fluid testing with the Intercept oral fluid device need

  15. 75 FR 78155 - Uniform Compliance Date for Food Labeling Regulations

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-15

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Part 101 Uniform Compliance Date for Food Labeling Regulations AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is establishing January 1, 2014, as the uniform compliance date for food...

  16. 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

  17. 42 CFR 418.106 - Condition of participation: Drugs and biologicals, medical supplies, and durable medical equipment.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... must ensure that the interdisciplinary group confers with an individual with education and training in... provided pharmacist services must include evaluation of a patient's response to medication therapy... biologicals. (1) The interdisciplinary group, as part of the review of the plan of care, must determine...

  18. 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...

  19. 40 CFR 60.39e - Compliance times.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 6 2010-07-01 2010-07-01 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...

  20. 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...

  1. Compounding of Veterinary Drugs for Equine Practitioners.

    PubMed

    Stanley, Scott D; Moffitt, Krysta; Wiebe, Valerie

    2017-04-01

    Equine practitioners should follow these recommendations when using compounded medications: (1) the decision must be veterinary driven, based on a valid veterinarian-client-patient relationship and on evidence-based medicine; (2) compliance with the Animal Medicinal Drug Use Clarification Act of 1994; and (3) use limited to (a) horses for which no other method or route of drug delivery is practical; (b) those drugs for which safety, efficacy, and stability have been demonstrated; or (c) disease conditions for which a quantifiable response to therapy or drug concentration can be monitored.

  2. Hybrid nanocomposite coatings from metal (Mg alloy)-drug deposited onto medical implant by laser adaptive ablation deposition technique

    NASA Astrophysics Data System (ADS)

    Serbezov, Valery; Sotirov, Sotir; Serbezov, Svetlin

    2013-03-01

    Drug-eluting medical implants are active implants whose function is to create healing effects. The current requirements for active medical coatings for Drug-eluting medical implants are to be biocompatible, biodegradable, polymer free, mechanically stable and enable a controlled release of one or more drugs and defined degradation. This brings hybrid nanocomposite coatings into focus especially in the field of cardiovascular implants. We studied the properties of Metal (Mg alloy)-Paclitaxel coatings obtained by novel Laser Adaptive Ablation Deposition Technique (LAAD) onto cardiovascular stents from 316 LVM stainless steel material. The morphology and topology of coatings were studied by Bright field / Fluorescence optical microscope and Scanning Electron Microscope (SEM). Comparative measurements were made of the morphology and topology of hybrid, polymer free nanocomposite coatings deposited by LAAD and polymerdrug coatings deposited by classical spray technique. The coatings obtained by LAAD are homogeneous without damages and cracks. Metal nanoparticles with sizes from 40 nm to 230 nm were obtained in drug matrixes. Energy Dispersive X-ray Spectroscopy (EDX) was used for identification of metal nanoparticles presence in hybrid nanocomposites coatings. The new technology opens up possibilities to obtain new hybrid nanocomposite coatings with applications in medicine, pharmacy and biochemistry.

  3. [Key Points for Design and Evaluation of Clinical Studies in Treating Children's Attention Deficit Hyperactivity Disorder by Chinese Medical New Drugs].

    PubMed

    Shen, Wen; Ma, Rong; Hu, Si-yuan

    2015-05-01

    Based on collecting data at home and abroad, we combined clinical practice of scientific researches. We also summarized key points for design and evaluation of clinical studies in treating children's attention deficit hyperactivity disorder by Chinese medical new drugs from objective and design, selection of diagnostic criteria, recruitment and dropping-out of subjects, effectiveness evaluation, safety evaluation, drug combination, and quality control, and so on. We hope to provide reference for design and evaluation of clinical studies by Chinese medical new drugs.

  4. A human rights view on access to controlled substances for medical purposes under the international drug control framework.

    PubMed

    Gispen, Marie Elske C

    2013-11-05

    The world is confronted with a major public health deficit caused by poor access to controlled essential medicines under the international drug control framework. This is affecting millions of patients on a daily basis and resulting in numerous human rights violations. The present review contextualises this deficit from a human rights perspective. Drug control efforts are informed by a twofold objective stemming from the double nature of scheduled substances: free access for medical purposes should be ensured, though non-medical use of substances such as opium should be restricted. The international drug control framework is, in theory, based on this twofold notion, however at the level of interpretation, monitoring, and implementation, a one-sided emphasis is demonstrated. By tracing a parallel between the obligations of states under the international drug control framework and those that derive from human rights law, the review shows that the two systems seem incoherent and conflicting in nature and flags the importance of cross-disciplinary research into drug control and human rights.

  5. Compliance Assurance Monitoring

    EPA Pesticide Factsheets

    Compliance assurance monitoring is intended to provide a reasonable assurance of compliance with applicable requirements under the Clean Air Act for large emission units that rely on pollution control device equipment to achieve compliance.

  6. [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.

  7. 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

  8. Medical devices; exemption from premarket notification and reserved devices; class I. Food and Drug Administration, HHS. Final rule.

    PubMed

    2000-01-14

    The Food and Drug Administration (FDA) is amending its classification regulations to designate class I devices that are exempt from the premarket notification requirements, subject to certain limitations, and to designate those class I devices that remain subject to premarket notification requirements under the new statutory criteria for premarket notification requirements. The devices FDA is designating as exempt do not include class I devices that have been previously exempted by regulation from the premarket notification requirements. This action is being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the 1976 amendments), the Safe Medical Devices Act of 1990 (SMDA), and the FDA Modernization Act of 1997 (FDAMA). FDA is taking this action in order to implement a requirement of FDAMA. Elsewhere in this issue of the Federal Register, FDA is announcing that it is withdrawing proposed rules to revoke existing exemptions from premarket notification for two devices.

  9. Psychiatric drug-induced Chronic Brain Impairment (CBI): implications for long-term treatment with psychiatric medication.

    PubMed

    Breggin, Peter R

    2011-01-01

    Understanding the hazards associated with long-term exposure to psychiatric drugs is very important but rarely emphasized in the scientific literature and clinical practice. Drawing on the scientific literature and clinical experience, the author describes the syndrome of Chronic Brain Impairment (CBI) which can be caused by any trauma to the brain including Traumatic Brain Injury (TBI), electroconvulsive therapy (ECT), and long-term exposure to psychiatric medications. Knowledge of the syndrome should enable clinicians to more easily identify long-term adverse effects caused by psychiatric drugs while enabling researchers to approach the problem with a more comprehensive understanding of the common elements of brain injury as they are manifested after long-term exposure to psychiatric medications. Treatment options are also discussed.

  10. Medications in patients treated with therapeutic plasma exchange: prescription dosage, timing, and drug overdose.

    PubMed

    Ibrahim, Rami B; Balogun, Rasheed A

    2012-01-01

    Therapeutic plasma exchange (TPE) is an extracorporeal process commonly used in clinical medicine for the treatment of a variety of neurological, renal, hematological, dermatological, and other diseases. Inherent to the procedure, patients' plasma removal may lead to the extraction of drugs they are concurrently receiving. This review discusses the published literature assessing TPE's influence on different drug classes' disposition and, when applicable, sets forth management recommendations in cases where the drugs are used at the usual doses and in cases of drug overdose.

  11. [A security protocol for the exchange of personal medical data via Internet: monitoring treatment and drug effects].

    PubMed

    Viviani, R; Fischer, J; Spitzer, M; Freudenmann, R W

    2004-04-01

    We present a security protocol for the exchange of medical data via the Internet, based on the type/domain model. We discuss two applications of the protocol: in a system for the exchange of data for quality assurance, and in an on-line database of adverse reactions to drug use. We state that a type/domain security protocol can successfully comply with the complex requirements for data privacy and accessibility typical of such applications.

  12. Non-healing tongue ulcer in a rheumatoid arthritis patient medicated with leflunomide. An adverse drug event?

    PubMed

    Kalogirou, Eleni-Marina; Katsoulas, Nikolaos; Tosios, Konstantinos I; Lazaris, Andreas C; Sklavounou, Alexandra

    2017-02-01

    Leflunomide is a member of the disease modifying anti-rheumatic drugs group used as a treatment modality in active rheumatoid and psoriatic arthritis. "Oral ulcers" are reported in 3-5% of leflunomide medicated rheumatoid arthritis patients with adverse events, but they are not described in detail in the literature. We present a case of an ulcer in the tongue of a rheumatoid arthritis patient managed with leflunomide and contemplate on its pathogenesis. Key words:Leflunomide, oral ulcer, DHODH.

  13. Altered serum levels of interleukin-3 in first-episode drug-naive and chronic medicated schizophrenia.

    PubMed

    Fu, Yin Yang; Zhang, Tong; Xiu, Mei Hong; Tang, Wei; Han, Mei; Yun, Long Tan; Chen, Da Chun; Chen, Song; Tan, Shu Ping; Soares, Jair C; Tang, Wen Jie; Zhang, Xiang Yang

    2016-10-01

    Elevated serum levels of Interleukin-3 (IL-3), a major component of the cytokines, have been observed in chronic and medicated patients with schizophrenia, but this elevation may reflect either or both medication and illness chronicity effects. Thus, we compared serum IL-3 levels in first-episode drug-naive (FEDN) to chronic medicated patients with schizophrenia and examined the association of IL-3 with their psychopathological symptoms. Serum IL-3 levels were assessed in 55 FEDN patients, 52 chronic medicated patients and 43 healthy controls. Schizophrenia symptomatology was assessed with the Positive and Negative Syndrome Scale (PANSS). Serum IL-3 levels were measured by sandwich enzyme-linked immunosorbent assay (ELISA). We found significantly lower IL-3 levels in FEDN patients than both chronic patients and healthy controls (both p<0.001), while IL-3 levels in chronic patients were markedly higher than in healthy controls. No significant association was observed between IL-3 and any clinical psychopathology in FEDN patients; however, we found a significant correlation between serum IL-3 levels and the PANSS general psychopathology subscore in chronic medicated patients (p<0.05). Decreased IL-3 levels in FEDN patients suggest that suppressed immune function may be associated with developing schizophrenia, but as the disease progresses IL-3 levels increase perhaps related to medication treatment or other factors that occur during chronic illness.

  14. [Preselection procedure for medical devices suppliers at the essential medicines and generic drugs purchasing central in Togo (CAMEG-Togo)].

    PubMed

    Babaley, M

    2006-12-01

    One of the main objectives of pharmaceutical policies in developing countries is to ensure accessibility and affordability of good quality medicines for the population. The Essential Medicines and Generic Drugs Purchasing Central (French acronym, CAMEG-Togo) is a not-for-profit association established in 1998 to ensure procurement for public and not-for-profit private public health facilities within the framework of recovery of costs. Although attention has been focused mainly on medicines, medical devices account for a growing part of the pharmaceutical products purchased by central stores, hospitals and health programs. Recognizing this need in 2002, CAMEG-Togo in collaboration with the French cooperation agency decided to upgrade its competency in evaluating the quality of medical devices. For that purpose the information sheet used to preselect suppliers for international tenders and the technical specifications sheet for medical devices was revised and pharmacists responsible for processing these files were given specific training. European directive N 93/42/CEE of 14 June 1993 is currently used by CAMEG-Togo as the regulatory basis for preselection of medical device suppliers. Referencing based on American regulatory requirements is now under way to widen the scope of suppliers eligible for preselection. The purpose of this article is first to describe the main guidelines of the European directive used by medical device manufacturers to obtain EC certification and second to present the procedures used by the CAMEG-Togo to preselect medical device suppliers, with special focus on the technical specifications sheet.

  15. Follow up of patients who start treatment with antidepressants: treatment satisfaction, treatment compliance, efficacy and safety

    PubMed Central

    2013-01-01

    Background Measuring satisfaction with treatment has proved useful to ascertain the treatment features that are most important to the patients, and to explain increased treatment compliance. However, there are few studies that relate satisfaction to other clinical or self-perceived health status indicators. Recent studies have shown the close relationship between satisfaction with treatment, treatment compliance, and effectiveness. This study attempts to design and validate a scale to evaluate satisfaction with antidepressant drug therapy, assess treatment compliance (self-reported, validated questionnaire, drug accountability and electronic monitorization system), assess efficacy in reducing depressive symptoms and safety in patients who initiate antidepressant drug therapy, as well as to establish predictors of satisfaction, compliance and effectiveness with these drugs. Methods/design This is an observational longitudinal study with a cohort of adults initiating treatment with antidepressant drugs. A multi-centre study will be performed in which 20 Primary Care practices from Castilla-La Mancha are expected to participate. An initial interview and follow-up visits at 15 days, 1, 3, 6, 9 and 12 months will be conducted with all study participants. 706 subjects will be studied (95% confidence interval, precision ± 3%, expected rate of non-compliance 50%, expected non-responders and lost to follow up rate 15%). The following measurements will be performed: development and validation of a scale of satisfaction with antidepressant therapy, participant and antidepressant characteristics, treatment compliance evaluation (Haynes-Sackett Test, Morisky-Green Test, drug accountability and Medication Event Monitoring System), depression symptom reduction (Hamilton Depression Rating Scale and Montgomery-Asberg Depression Rating Scale), observation of adverse effects, and beliefs about treatment (The Beliefs about Medicines Questionnaire). Discussion Antidepressant drugs are

  16. Can Utilizing a Computerized Provider Order Entry (CPOE) System Prevent Hospital Medical Errors and Adverse Drug Events?

    PubMed Central

    Charles, Krista; Cannon, Margaret; Hall, Robert; Coustasse, Alberto

    2014-01-01

    Computerized provider order entry (CPOE) systems allow physicians to prescribe patient services electronically. In hospitals, CPOE essentially eliminates the need for handwritten paper orders and achieves cost savings through increased efficiency. The purpose of this research study was to examine the benefits of and barriers to CPOE adoption in hospitals to determine the effects on medical errors and adverse drug events (ADEs) and examine cost and savings associated with the implementation of this newly mandated technology. This study followed a methodology using the basic principles of a systematic review and referenced 50 sources. CPOE systems in hospitals were found to be capable of reducing medical errors and ADEs, especially when CPOE systems are bundled with clinical decision support systems designed to alert physicians and other healthcare providers of pending lab or medical errors. However, CPOE systems face major barriers associated with adoption in a hospital system, mainly high implementation costs and physicians’ resistance to change. PMID:25593568

  17. Fomepizole (orphan medical).

    PubMed

    Hantson, P

    2001-06-01

    Orphan Medical has developed fomepizole as a potential treatment for both ethylene glycol and methanol poisoning. The drug was launched as Antizol in January 1998 for the treatment of ethylene glycol poisoning [273949] after US marketing approval was grantedin December 1997 [271563]. It has also received US approval for methanol poisoning [393217] and UK approval for ethylene glycol poisoning [329495]. In 1999, Orphan Medical's partner, Cambridge Laboratories, intended to pursue European approval under the mutual recognition procedure [329495]. However, by September 2000, Cambridge Laboratories had discontinued their involvement with fomepizole and IDIS World Medicines had licensed the rights to distribute the drug in the UK [412142]. In February 2000, the Canadian Therapeutic Products Programme (TPP) granted fomepizole Priority Review, provided that an NDA was submitted by March 14, 2000 [354665]. In August 2000, the TPP accepted this NDA and set a target date for approval in the fourth quarter of 2000 [379474]. The TPP granted fomepizole a Notice of Compliance permitting the sale of fomepizole in Canada in December 2000. The company's marketing partner in Canada, Paladin Labs had launched fomepizole by January 2001 [396953]. In June 2000, Tucker Anthony Cleary Gull stated that the Orphan Drug status which Orphan Medical had obtained for fomepizole would provide marketing exclusivity through December 2004. The analysts also stated that fomepizole had accounted for 40% of Orphan Medical's revenue in financial year 1999, although +/- 30% of sales were estimated to be due to stockpiling [409606].

  18. Pulmonary drug delivery. Part II: The role of inhalant delivery devices and drug formulations in therapeutic effectiveness of aerosolized medications

    PubMed Central

    Labiris, N R; Dolovich, M B

    2003-01-01

    Research in the area of pulmonary drug delivery has gathered momentum in the last several years, with increased interest in using the lung as a means of delivering drugs systemically. Advances in device technology have led to the development of more efficient delivery systems capable of delivering larger doses and finer particles into the lung. As more efficient pulmonary delivery devices and sophisticated formulations become available, physicians and health professionals will have a choice of a wide variety of device and formulation combinations that will target specific cells or regions of the lung, avoid the lung's clearance mechanisms and be retained within the lung for longer periods. It is now recognized that it is not enough just to have inhalation therapy available for prescribing; physicians and other healthcare providers need a basic understanding of aerosol science, inhaled formulations, delivery devices, and bioequivalence of products to prescribe these therapies optimally. PMID:14616419

  19. Accuracy of drug advertisements in medical journals under new law regulating the marketing of pharmaceutical products in Switzerland

    PubMed Central

    Santiago, Macarena Gonzalez; Bucher, Heiner C; Nordmann, Alain J

    2008-01-01

    Background New legal regulations for the marketing of pharmaceutical products were introduced in 2002 in Switzerland. We investigated whether claims in drug advertisements citing published scientific studies were justified by these studies after the introduction of these new regulations. Methods In this cross-sectional study, two independent reviewers screened all issues of six major Swiss medical journals published in the year 2005 to identify all drug advertisements for analgesic, gastrointestinal and psychopharmacologic drugs and evaluated all drug advertisements referring to at least one publication. The pharmaceutical claim was rated as being supported, being based on a potentially biased study or not to be supported by the cited study according to pre-specified criteria. We also explored factors likely to be associated with supported advertisement claims. Results Of 2068 advertisements 577 (28%) promoted analgesic, psychopharmacologic or gastrointestinal drugs. Among them were 323 (56%) advertisements citing at least one reference. After excluding multiple publications of the same drug advertisement and advertisements with non-informative references, there remained 29 unique advertisements with at least one reference to a scientific study. These 29 advertisements contained 78 distinct pairs of claims of analgesic, gastrointestinal and psychopharmacologic drugs and referenced studies. Thirty-seven (47%) claims were supported, 16 (21%) claims were not supported by the corresponding reference, and 25 (32%) claims were based on potentially biased evidence, with no relevant differences between drug groups. Studies with conflict of interest and studies stating industry funding were more likely to support the corresponding claim (RR 1.52, 95% CI 1.07–2.17 and RR 1.50, 95% CI 0.98–2.28) than studies without identified conflict of interest and studies without information on type of funding. Conclusion Following the introduction of new regulations for drug

  20. A New Data Representation Based on Training Data Characteristics to Extract Drug Name Entity in Medical Text

    PubMed Central

    Basaruddin, T.

    2016-01-01

    One essential task in information extraction from the medical corpus is drug name recognition. Compared with text sources come from other domains, the medical text mining poses more challenges, for example, more unstructured text, the fast growing of new terms addition, a wide range of name variation for the same drug, the lack of labeled dataset sources and external knowledge, and the multiple token representations for a single drug name. Although many approaches have been proposed to overwhelm the task, some problems remained with poor F-score performance (less than 0.75). This paper presents a new treatment in data representation techniques to overcome some of those challenges. We propose three data representation techniques based on the characteristics of word distribution and word similarities as a result of word embedding training. The first technique is evaluated with the standard NN model, that is, MLP. The second technique involves two deep network classifiers, that is, DBN and SAE. The third technique represents the sentence as a sequence that is evaluated with a recurrent NN model, that is, LSTM. In extracting the drug name entities, the third technique gives the best F-score performance compared to the state of the art, with its average F-score being 0.8645. PMID:27843447

  1. The changing landscape of expanded access to investigational drugs for patients with unmet medical needs: ethical implications.

    PubMed

    Bunnik, Eline M; Aarts, Nikkie; van de Vathorst, Suzanne

    2017-01-01

    When patients are told that standard medical treatment options have been exhausted, their treating physicians may start looking for promising new drugs that are not yet approved, and still under investigation. Some patients can be included in clinical trials, but others cannot. It is not widely known that these patients might still be eligible for trying investigational drugs, in a therapeutic context. Worldwide, public and private parties are seeking to change this by informing patients and physicians about opportunities for expanded access and/or by facilitating its processes. When expanded access becomes available to larger groups of patients, ethical issues gain prominence, including informed consent, funding issues, disparities in access, and potential adverse effects on clinical drug development. Physicians, patients and policy-makers should not shift the responsibility to address these issues to pharmaceutical companies, but work together to resolve them.

  2. Alcohol and Drug Taking Among Medical Students at a Nigerian University Campus: Part 2. Sociodemographic Factors of Etiologic Significance

    PubMed Central

    Ihezue, U. H.

    1988-01-01

    In a survey of Nigerian undergraduate medical students, alcohol and drug users were classified as frequent users, casual users, and nonusers. Place of residence during session and family structure recorded no significant contribution to the development of substance abuse. Male sex, poor performance on examinations, drug taking among close friends and peers, and a family background of lower socioeconomic status emerged as sociodemographic factors correlating positively with the presence of substance abuse. Health education, controlled distribution of drugs and alcohol, stringent regulatory provisions against their use, and a permanent Commission on Substance Abuse with full judicial powers are suggested as measures that may help control the abuse of psychoactive substances and the hazard they pose to public health. PMID:3241308

  3. 40 CFR 60.39e - Compliance times.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... include an evaluation of the option to transport the waste offsite to a commercial medical waste treatment... 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...

  4. 40 CFR 60.39e - Compliance times.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... include an evaluation of the option to transport the waste offsite to a commercial medical waste treatment... 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...

  5. [Strategies to improve medication adherence].

    PubMed

    Laufs, U; Böhm, M; Kroemer, H K; Schüssel, K; Griese, N; Schulz, M

    2011-08-01

    Up to 50 % of patients with chronic diseases do not take their medication regularly. Poor adherence to drug therapy is associated with higher morbidity and mortality. A selective literature search using the terms adherence, compliance, concordance, persistence, medication management, and pharmaceutical care was performed. Evidence for improving adherence has been provided for the following principles: individual counselling of patients and care givers, medication management including simplifying dosing and use of combination tablets as well as the use of individual unit doses, e. g. blister cards. The effectiveness has only been shown for the duration of the interventions. The improvement of medication adherence represents an area of research with high impact on outcomes and cost. Measures to improve adherence may be as important as the development of novel therapies. However, prospective clinical evaluations with clinical endpoints are missing especially for the German health care system in order to develop recommendations for clinical practice. Joint efforts of physicians and pharmacists are needed.

  6. Incorporation of tramadol drug into Li-fluorohectorite clay: A preliminary study of a medical nanofluid

    NASA Astrophysics Data System (ADS)

    Valdés, L.; Hernández, D.; de Ménorval, L. Ch.; Pérez, I.; Altshuler, E.; Fossum, J. O.; Rivera, A.

    2016-07-01

    During the last years, clays have been increasingly explored as hosts for drugs. In the present paper, we have been able to host the non-steroidal anti-inflammatory drug, Tramadol, into the clay Li-fluorohectorite (Li-Fh). We preliminary evaluate its incorporation by means of UV spectroscopy and X ray diffraction. Our results indicate that the clay hosts the drug molecule in its interlayer space. We suggest a set of parameters to guarantee an efficient incorporation process. Future studies will concentrate on the release of the drug from the clay nanofluid.

  7. Gas gangrene following intra-arterial injection of oral medication in a drug abuser.

    PubMed

    Haiart, D C; Andrade, B; Murie, J A

    1992-09-01

    We report a patient in whom intra-arterial injection of oral medication led to the development of fulminating gas gangrene and death, despite the initial clinical symptoms being minor. We believe that prophylactic antibiotics should be administered to patients following intra-arterial injection of oral medication especially if immunocompetence, such as from human immunodeficiency virus (HIV) infection, is likely.

  8. A nebulizer chronolog to monitor compliance with inhaler use.

    PubMed

    Tashkin, D P; Rand, C; Nides, M; Simmons, M; Wise, R; Coulson, A H; Li, V; Gong, H

    1991-10-21

    The Lung Health Study is a 10-center 5-year clinical trial sponsored by the National Heart, Lung, and Blood Institute to evaluate the effectiveness of early intervention in chronic obstructive pulmonary disease (COPD). The specific objectives of the trial are to determine whether the accelerated decline in lung function characteristic of COPD and morbidity due to COPD can be reduced by special intervention at a relatively early stage in the evolution of the disease. Special intervention consists of a smoking-cessation program and the use of an inhaled bronchodilator to suppress airway hyperreactivity. The use of the inhaler canister is monitored every 4 months by canister weighing and, at two of the 10 centers, by an electronic recording device, the Nebulizer Chronolog. Among trial participants assigned the latter device, results from the first 4 months of the study indicate that only 52% of trial participants who were uninformed as to the nature of the chronolog used their inhaler at least twice daily as measured by the chronolog, compared with 87% as determined by self-report. Satisfactory or good compliance was achieved by 52% of these subjects as measured by the chronolog compared with 85% as assessed by canister weighing. Eighteen percent of uninformed participants "dumped" their inhalers within a 3-hour time period, contributing to the inaccuracy of canister weights as an indicator of compliance. Feedback of information to the participants from the chronolog improved the level of compliance and eliminated the "dumping" phenomenon. We conclude that, when accurate determinations of compliance are important, as in a drug trial, objective medication monitors should be considered. Electronic monitoring of inhaler use can provide valuable feedback, which encourages improved compliance.

  9. Japan-China Joint Medical Workshop on Drug Discoveries and Therapeutics 2008: The need of Asian pharmaceutical researchers' cooperation.

    PubMed

    Nakata, M; Tang, W

    2008-10-01

    The Japan-China Joint Medical Workshop on Drug Discoveries and Therapeutics 2008 (JCMWDDT 2008) was held from September 29 to October 1, 2008 at The University of Tokyo, Tokyo, Japan. JCMWDDT is an international workshop that is mainly organized by Asian editorial members of Drug Discoveries & Therapeutics (http://www.ddtjournal.com/home) for the purpose of promoting research exchanges in the field of drug discovery and therapeutic. This year's JCMWDDT is the second workshop and focused particularly on novel development and technological innovation of anti-influenza agents. The workshop began with an announcement by the Japanese Co-chairperson, Dr. Sekimizu (Department of Microbiology, Graduate School of Pharmaceutical Sciences, The University of Tokyo, Japan; Editorin- Chief of Drug Discoveries & Therapeutics, DDT) followed by a speech by the Chinese Co-chairperson, Dr. Wenfang Xu (School of Pharmaceutical Sciences, Shandong University, Shandong, China; Editor in China Office of DDT), with additional speeches by Dr. Norio Matsuki (The University of Tokyo, Japan; Editor of DDT) and Dr. Guanhua Du (Chinese Academy of Medical Science, China; Editor of DDT). Fifty-nine titles were presented in 6 specialized sessions (Research Advances in Drug Discoveries and Therapeutics, Drug Synthesis/Clinical Therapeutics, Medicinal Chemistry/Natural Products, Anti-influenza Drugs, Anti-infection/antiviral Drugs, Biochemistry/Molecular Biology /Pharmacology) and a poster session (Drug Discov Ther 2008; 2, Suppl; available at http://www.ddtjournal.com/Announce/index.htm). An annual outbreak of avian influenza in Asian countries including China and Japan has sparked fears that the virus will mutate and then cause an epidemic in humans. Therefore, Asian researchers need to work together to control this infection. This year's JCMWDDT helped provide an

  10. 77 FR 62479 - Medical Diagnostic Equipment Accessibility Standards Advisory Committee

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-15

    ... TRANSPORTATION BARRIERS COMPLIANCE BOARD 36 CFR Part 1195 RIN 3014-AA40 Medical Diagnostic Equipment Accessibility Standards Advisory Committee AGENCY: Architectural and Transportation Barriers Compliance Board... and Transportation Barriers Compliance Board (Access Board) established an advisory committee to...

  11. 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.

  12. A Ten-Year Analysis of Non-Medical Drug Use Behavior At Five American Universities.

    ERIC Educational Resources Information Center

    Dezelsky, Thomas L.; And Others

    1981-01-01

    A study was conducted on nonmedical drug use among college undergraduates enrolled in selected health science classes. A questionnaire was administered to measure drug use in relation to age, sex, and grade point average. Areas covered by the questionnaire involved patterns of marijuana, cocaine, alcohol, and barbituate use. (JN)

  13. Medicated Hypertensive Patients' Views and Experience of Information and Communication Concerning Antihypertensive Drugs.

    ERIC Educational Resources Information Center

    Lisper, Lotta; Isacson, Dag; Sjoden, Per-Olow; Bingefors, Kerstin

    1997-01-01

    Hypertensive patients (N=21) were interviewed regarding their views and experience of information and communication with respect to antihypertensive medicines. Patients' attitudes toward hypertension and antihypertensive drugs, communication with pharmacist and physician, perceptions of drug information, and the information environment are…

  14. [An attempt to degradation of anticancer drug and odor in the medical environment by photocatalyst].

    PubMed

    Sato, Junya; Kudo, Kenzo; Hirano, Takahiro; Kuwashima, Takayuki; Yamada, Sonpei; Kijihana, Ichiro; Sato, Kazuhiko; Takahashi, Katsuo

    2012-01-01

    Currently, there is a need to reduce the occupational exposure of health care workers to anticancer drugs. Environmental contamination by anticancer drugs and subsequent exposure of health care workers are associated with vaporization of anticancer drugs. Furthermore, carcinomatous unpleasant odor is an additional problem to vaporized anticancer drugs in the field of clinical cancer therapy. We attempted to degrade vaporized anticancer drug and unpleasant odor using a photocatalyst. Cyclophosphamide or unpleasant odors (ammonia, formaldehyde, isovaleric acid, and butyric acid) were vaporized by heating in a closed chamber. Plates of photocatalyst coated with titanium dioxide were placed into the chamber and irradiated by light source. Vaporized cyclophosphamide in the chamber was recovered by bubbling the internal air through acetone and derivatized by trifluoroacetic anhydride for analysis by gas chromatographic-mass spectrometric assay. Vaporized odors were determined using a gas-detector tube, which changed color depending on the concentration. Following activation of the photocatalyst by a light source, the residual amounts of anticancer drug and unpleasant odor components were significantly decreased compared with when the photocatalyst was not activated without a light source. These results indicate that the photocatalysts can accelerate the degradation of vaporized anticancer drugs and odor components. Air-cleaning equipment using a photocatalyst is expected to be useful in improving the QOL of cancer patients experiencing carcinomatous unpleasant odor, and in reducing occupational exposure of health care workers to anticancer drugs.

  15. Addressing Unmet Medical Needs in Type 2 Diabetes: A Narrative Review of Drugs under Development

    PubMed Central

    Mittermayer, Friedrich; Caveney, Erica; Oliveira, Claudia De; Gourgiotis, Loukas; Puri, Mala; Tai, Li-Jung; J, Rick Turner

    2015-01-01

    The global burden of type 2 diabetes is increasing worldwide, and successful treatment of this disease needs constant provision of new drugs. Twelve classes of antidiabetic drugs are currently available, and many new drugs are under clinical development. These include compounds with known mechanisms of action but unique properties, such as once-weekly DPP4 inhibitors or oral insulin. They also include drugs with new mechanisms of action, the focus of this review. Most of these compounds are in Phase 1 and 2, with only a small number having made it to Phase 3 at this time. The new drug classes described include PPAR agonists/modulators, glucokinase activators, glucagon receptor antagonists, anti-inflammatory compounds, G-protein coupled receptor agonists, gastrointestinal peptide agonists other than GLP-1, apical sodium-dependent bile acid transporter (ASBT) inhibitors, SGLT1 and dual SGLT1/SGLT2 inhibitors, and 11beta-HSD1 inhibitors. PMID:25537454

  16. Addressing unmet medical needs in type 2 diabetes: a narrative review of drugs under development.

    PubMed

    Mittermayer, Friedrich; Caveney, Erica; De Oliveira, Claudia; Gourgiotis, Loukas; Puri, Mala; Tai, Li-Jung; Turner, J Rick

    2015-01-01

    The global burden of type 2 diabetes is increasing worldwide, and successful treatment of this disease needs constant provision of new drugs. Twelve classes of antidiabetic drugs are currently available, and many new drugs are under clinical development. These include compounds with known mechanisms of action but unique properties, such as once-weekly DPP4 inhibitors or oral insulin. They also include drugs with new mechanisms of action, the focus of this review. Most of these compounds are in Phase 1 and 2, with only a small number having made it to Phase 3 at this time. The new drug classes described include PPAR agonists/modulators, glucokinase activators, glucagon receptor antagonists, anti-inflammatory compounds, G-protein coupled receptor agonists, gastrointestinal peptide agonists other than GLP-1, apical sodium-dependent bile acid transporter (ASBT) inhibitors, SGLT1 and dual SGLT1/SGLT2 inhibitors, and 11beta- HSD1 inhibitors.

  17. [Degrading anticancer drugs in the medical environment using a visible light-driven photocatalyst].

    PubMed

    Sato, Junya; Kikuchi, Satomi; Kudo, Kenzo

    2014-01-01

      Occupational exposure to anticancer drugs is recognized as a risk for healthcare workers. Reducing anticancer drugs in the environment is important to prevent the exposure of individuals to anticancer drugs. However, there are currently no effective degrading agents for all anticancer drugs used in clinical settings. We previously reported the resolution of an anticancer drug with the use of a photocatalyst (TiO2), which acts by absorbing ultraviolet light to degrade organic compounds. In this study, we evaluated anticancer drug degradation using a visible light-driven photocatalyst (Cu/WO3). Anticancer drugs [cyclophosphamide (CPA), paclitaxel (PTX), methotrexate (MTX), irinotecan (CPT-11), cytarabine (Ara-C), and 5-fluorouracil (5-FU)], were experimentally deposited on a stainless steel plate. The visible light-driven photocatalytic agent (0.075% Cu/WO3 solution) was sprayed onto the plate, and the plate was then left under a fluorescent lamp for 12 h. The anticancer drugs remaining on the plate were assayed by high-performance liquid chromatography (HPLC). CPA, PTX, MTX, CPT-11, Ara-C, and 5-FU were found to be degraded by up to 37.7%, >99.0%, 57.1%, 54.6%, 69.5%, and 36.3%, respectively. The visible light-driven photocatalyst was therefore confirmed to degrade anticancer drugs under a fluorescent lamp. The ability of the visible light-driven photocatalyst to degrade multiple chemotherapeutic agents without the need for altering the light source could make it a useful tool for reducing anticancer drug pollution in clinical settings.

  18. Ethical Analysis for Physicians Considering the Provision of Life-Ending Medication in Compliance with the California End of Life Option Act

    PubMed Central

    Shaner, D Malcolm

    2016-01-01

    The End of Life Option Act in California, effective June 9, 2016, permits physicians to prescribe lethal medication to patients confirmed to be terminally ill and capable of independently making and carrying out a decision to ingest deadly medication. Medicine has traditionally excluded the provision of deadly medication from proper practice. Physicians reasonably may hold to that limit. However, honoring a repeated request from a capable, terminally ill patient to receive life-ending medication still can be considered to be a moral and permissible approach to relieve suffering. A physician choosing to expand his/her role within this narrowly defined context allows the patient to assume authority for a deeply personal decision that may belong to the patient more than to anyone else. PMID:27828774

  19. Drugs in the home: danger and waste.

    PubMed

    Kiyingi, K S; Lauwo, J A

    1993-01-01

    A study on the prevalence of orally-used household drugs was carried out in a village of 139 households in Papua New Guinea. Of the 176 preparations found, 153 were essential drugs, and 115 had been prescribed. Current use was reported for 111 of the items; the others had been partially used, and 26 of them were being kept with a view to further use in the future. There were numerous instances of inappropriate self-medication, poor compliance, and the use of drugs kept beyond their expiry dates. The authors discuss ways of tackling these problems.

  20. Two-photon absorption-induced drug delivery from polymers for medical applications

    NASA Astrophysics Data System (ADS)

    Kim, Hee-Cheol; Kreiling, Stefan; Haertner, Sebastian; Hesse, Lutz; Greiner, Andreas; Hampp, Norbert A.

    2004-06-01

    Novel polymeric materials carrying a drug depot have been developed which are suitable for fabrication of photochemically modulated drug delivery devices. In order to avoid uncontrolled drug release the drug is covalently attached to the polymer backbone using a photo-active linker. Controlled drug release from the polymer can be accomplished either via single-photon excitation or by two-photon absorption (TPA). In particular the second possibility is of interest for applications where exposure to day light or UV light may not be omitted. One example are polymeric intraocular lenses (IOL), which are implanted instead of the opaque natural lens during cataract surgery. Secondary cataract formation is quite often observed after implantation of polymeric IOLs. In this study the well known cell toxic agent 5-fluorouracil (5FU) attached to a methylmethacrylate-based polymer was investigated as an IOL which can upon photochemical excitation release 5FU in order to treat or to prevent secondary cataract formation. The photochemical cleavage of the linker molecule was analyzed with single- and two-photon excitation. UV/VIS spectroscopy and HPLC analysis confirmed the release of 5FU form the polymer backbone. The diffusion of the drug precursor out from the polymer as well as the hydrolysis of the drug precursor which leads to 5FU formation were investigated in vitro.

  1. 76 FR 45402 - Advisory Committee; Medical Imaging Drugs Advisory Committee; Re-Establishment

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-29

    ... used in diagnostic radiology and makes appropriate recommendations to the Commissioner. The Medical... the fields of nuclear medicine, radiology, epidemiology or statistics, and related specialties... using radioactive pharmaceuticals and contrast media used in diagnostic radiology. * * * * * Dated:...

  2. Misoprostol use in medical evacuation of spontaneous miscarriage: Pilot drug use evaluation study at the Women's Hospital in Qatar

    PubMed Central

    ElSalem, Samah A.; AlSaad, Doua T.; Abdulrouf, Palli V.; Ahmed, Afif A.; AlHail, Moza S.

    2016-01-01

    Background: Misoprostol is a synthetic prostaglandin E1 that induces cervical effacement and uterine contractions at all gestational ages, thus facilitating uterine evacuation and pregnancy termination. Successful medical evacuation of spontaneous miscarriage with minimal adverse effects can be performed using misoprostol-only regimen if given as indicated and if the administered dose, frequency of the dosage, and number of total doses are appropriate. Aim: To conduct a drug use evaluation by investigating indications, appropriateness of dosing, and clinical outcome of misoprostol-only regimen when used for medical evacuation of spontaneous miscarriage at the Women's Hospital in Doha, Qatar. Materials and methods: A retrospective descriptive drug use evaluation was conducted on women with spontaneous miscarriage who received misoprostol for medical evacuation during August 2013. The current practice at the Women's Hospital was compared with the recommendation from the World Health Organization (WHO). Patients were stratified into three groups based on weeks of amenorrhea. Results: A total of 107 patients received misoprostol during August 2013, of which 33 (31%) were included in the study. In these patients, the main indication for misoprostol use was missed miscarriage (54.5%). In the group of patients at ≤ 9 weeks of gestation, 80% received an initial dose of 800 μg, 80% received frequency within the WHO recommendation, and the majority had surgical evacuation (80%). In the group of patients at 10–12 weeks of gestation, more than 80% received an initial dose of 800 μg, 6% received frequency within the WHO recommendation, and more than 75% had successful medical evacuation. In the group of patients at 13–22 weeks of gestation, more than 80% received an initial dose of 400 μg, more than 80% received frequency within the WHO recommendation, and 54% had successful medical evacuation. Overall, more than 70% of the patients received ≤ 3 total doses of

  3. 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.

  4. Acute generalised exanthematous pustulosis and other severe drug eruptions from over the counter medications: A case report and review of the literature.

    PubMed

    Kline, Amy; Fischer, Gayle

    2016-05-01

    We present a case of acute generalised exanthematous pustulosis in an 11-year-old girl who used Duro-Tuss, an over-the-counter cough mixture containing pholcodine, and present a comprehensive review of the literature on severe drug reactions resulting from using non-prescription medications. This case reinforces the importance of taking a complete medication history.

  5. [Medical prescription and consumption of psychotropic drugs: questions on the differences between men and women].

    PubMed

    Baumann, M; Pommier, J; Deschamps, J P

    1996-01-01

    In health sociology and social epidemiology the gender-related differences in psychotropic drug consumption and prescription have not been throughly investigated. The objective of this review of literature is to analyze women's attitudes and behaviour in psychotropic drug consumption, the cultural influence of the patient's role in the doctor-female patient relation. The family, the society and the cultural aspects related to the role of the patient appear to be factors that strengthen the females' behaviour concerning psychotropic drugs. Results reflect that women consume more psychotropic drugs than men do; when they consult, they obtain them more frequently than men do; and doctors prescribe psychotropic drugs more often to women than to men. However many questions persist about the physicians' role: are the differences in prescriber's attitudes and practices related to their gender or to their patients' gender? Do women doctors prescribe more psychotropic drugs than male doctors? Do the former prescribe more to women than to men? If that is the case, what are the social and cultural reasons that account for this difference? Does a specific socialisation of the two genders account majoritarily for this difference?

  6. Addressing Unmet Medical Needs in Type 1 Diabetes: A Review of Drugs under Development.

    PubMed

    Mittermayer, Friedrich; Caveney, Erica; De Oliveira, Claudia; Alexander Fleming, G; Gourgiotis, Loukas; Puri, Mala; Tai, Li-Jung; Rick Turner, J

    2016-04-13

    The incidence of type 1 diabetes (T1D) is increasing worldwide and there is a very large need for effective therapies. Besides pramlintide, there are essentially no pharmacologic therapies other than insulin currently approved for the treatment of T1D. Drugs already in use for type 2 diabetes and many new drugs are under clinical development for T1D, including compounds with both established and new mechanisms of action. Most of the new compounds in clinical development are currently in Phase 1 and Phase 2. Drug classes discussed in this review include new insulins, SGLT inhibitors, GLP-1 agonists, immunomodulatory drugs including autoantigens and anti-cytokines, and agents that regenerate β-cells. In addition, considerations are provided with regard to the regulatory environment for the clinical development of drugs for T1D, with a focus on the United States Food and Drug Administration and the European Medicines Agency. Future opportunities, such as combination treatments of immunomodulatory and β-cell regenerating therapies, are also discussed.

  7. Non-healing tongue ulcer in a rheumatoid arthritis patient medicated with leflunomide. An adverse drug event?

    PubMed Central

    Kalogirou, Eleni-Marina; Tosios, Konstantinos I.; Lazaris, Andreas C.; Sklavounou, Alexandra

    2017-01-01

    Leflunomide is a member of the disease modifying anti-rheumatic drugs group used as a treatment modality in active rheumatoid and psoriatic arthritis. “Oral ulcers” are reported in 3-5% of leflunomide medicated rheumatoid arthritis patients with adverse events, but they are not described in detail in the literature. We present a case of an ulcer in the tongue of a rheumatoid arthritis patient managed with leflunomide and contemplate on its pathogenesis. Key words:Leflunomide, oral ulcer, DHODH. PMID:28210457

  8. Concurrent detection of heroin, fentanyl, and xylazine in seven drug-related deaths reported from the Philadelphia Medical Examiner's Office.

    PubMed

    Wong, Stella C; Curtis, John A; Wingert, William E

    2008-03-01

    Recreational drugs, such as cocaine and heroin, are often adulterated with other pharmacological agents to either enhance or diminish the drug effects. Between April 21, 2006 and August 8, 2006, the Philadelphia Medical Examiner's Office detected xylazine (a veterinary sedative) and fentanyl (a synthetic opioid) in specimens taken from seven cases. Initial immunoassay screening was performed on urine and blood for fentanyl, opiate, cocaine, phencyclidine (PCP), and benzodiazepines. All tests reported positive were confirmed by gas chromatography-mass spectrometry. All seven xylazine positive cases tested positive for fentanyl and six cases tested positive for 6-acetylmorphine (a metabolite and definitive marker for heroin). The seventh case was positive for morphine and had a history of heroin abuse. Xylazine was present in urine in all seven cases and blood levels were detected in three cases. The blood concentrations ranged from trace to 130 ng/mL. Fentanyl was present in the blood and urine in each case and blood concentrations ranged from 4.7 to 47 ng/mL. Adulteration of illicit drugs has become an epidemic health concern for drug users. Healthcare professionals need to be aware of this issue, so the patients can be treated in an effective, timely manner.

  9. Discovery by a proteomic approach of possible early biomarkers of drug-induced nephrotoxicity in medication-overuse headache

    PubMed Central

    2013-01-01

    Background Medication-overuse headache (MOH) is a chronic headache condition that results from the overuse of analgesics drugs, triptans, or other antimigraine compounds. The epidemiology of drug-induced disorders suggests that medication overuse could lead to nephrotoxicity, particularly in chronic patients. The aim of this work was to confirm and extend the results obtained from a previous study, in which we analyzed the urinary proteome of 3 MOH patients groups: non-steroidal anti-inflammatory drugs (NSAIDs), triptans and mixtures abusers, in comparison with non-abusers individuals (controls). Methods In the present work we employed specialized proteomic techniques, namely two-dimensional gel electrophoresis (2-DE) coupled with mass spectrometry (MS), and the innovative Surface-Enhanced Laser Desorption/Ionization Time-of-Flight mass spectrometry (SELDI-TOF-MS), to discover characteristic proteomic profiles associated with MOH condition. Results By 2-DE and MS analysis we identified 21 over-excreted proteins in MOH patients, particularly in NSAIDs abusers, and the majority of these proteins were involved in a variety of renal impairments, as resulted from a literature search. Urine protein profiles generated by SELDI-TOF-MS analysis showed different spectra among groups. Moreover, significantly higher number of total protein spots and protein peaks were detected in NSAIDs and mixtures abusers. Conclusions These findings confirm the presence of alterations in proteins excretion in MOH patients. Analysis of urinary proteins by powerful proteomic technologies could lead to the discovery of early candidate biomarkers, that might allow to identify MOH patients prone to develop potential drug overuse-induced nephrotoxicity. PMID:23565828

  10. Hospitals as a `risk environment: An ethno-epidemiological study of voluntary and involuntary discharge from hospital against medical advice among people who inject drugs

    PubMed Central

    McNeil, Ryan; Small, Will; Wood, Evan; Kerr, Thomas

    2014-01-01

    People who inject drugs (PWID) experience high levels of HIV/AIDS and hepatitis C (HCV) infection that, together with injection-related complications such as non-fatal overdose and injection-related infections, lead to frequent hospitalizations. However, injection drug-using populations are among those most likely to be discharged from hospital against medical advice, which significantly increases their likelihood of hospital readmission, longer overall hospital stays, and death. In spite of this, little research has been undertaken examining how social-structural forces operating within hospital settings shape the experiences of PWID in receiving care in hospitals and contribute to discharges against medical advice. This ethno-epidemiological study was undertaken in Vancouver, Canada to explore how the social-structural dynamics within hospitals function to produce discharges against medical advice among PWID. In-depth interviews were conducted with thirty PWID recruited from among participants in ongoing observational cohort studies of people who inject drugs who reported that they had been discharged from hospital against medical advice within the previous two years. Data were analyzed thematically, and by drawing on the `Risk Environment' framework and concepts of social violence. Our findings illustrate how intersecting social and structural factors led to inadequate pain and withdrawal management, which led to continued drug use in hospital settings. In turn, diverse forms of social control operating to regulate and prevent drug use in hospital settings amplified drug-related risks and increased the likelihood of discharge against medical advice. Given the significant morbidity and health care costs associated with discharge against medical advice among drug-using populations, there is an urgent need to reshape the social-structural contexts of hospital care for PWID by shifting emphasis toward evidence-based pain and drug treatment augmented by harm

  11. Sexual dysfunction in women with epilepsy: role of antiepileptic drugs and psychotropic medications.

    PubMed

    Gutierrez, Mary A; Mushtaq, Romila; Stimmel, Glen

    2008-01-01

    Sexual dysfunction is a frequently encountered comorbid disorder in patients with neurological and psychiatric disorders. Importantly, sexual dysfunction can also occur as a treatment emergent adverse effect of a number of commonly used psychotropic and antiepileptic medications, and can include decreased libido, erectile dysfunction, disordered arousal, delayed orgasm, and anorgasmia. These effects can occur in both men and women, and can be seen across age groups. Understanding the neurobiology of normal sexual response, as well as the pharmacologic mechanisms of these commonly used medications can enable the clinician to predict how medication use may impact different phases of sexual response. Discussion of the current treatment strategies for female sexual dysfunction is also elucidated in this chapter.

  12. Novel application of hydrophobin in medical science: a drug carrier for improving serum stability

    PubMed Central

    Zhao, Liqiang; Xu, Haijin; Li, Ying; Song, Dongmin; Wang, Xiangxiang; Qiao, Mingqiang; Gong, Min

    2016-01-01

    Multiple physiological properties of glucagon-like peptide-1 (GLP-1) ensure that it is a promising drug candidate for the treatment of type 2 diabetes. However, the in vivo half-life of GLP-1 is short because of rapid degradation by dipeptidyl peptidase-IV (DPP-IV) and renal clearance. The poor serum stability of GLP-1 has significantly limited its clinical utility, although many studies are focused on extending the serum stability of this molecule. Hydrophobin, a self-assembling protein, was first applied as drug carrier to stabilize GLP-1 against protease degradation by forming a cavity. The glucose tolerance test clarified that the complex retained blood glucose clearance activity for 72 hours suggesting that this complex might be utilized as a drug candidate administered every 2–3 days. Additionally, it was found that the mutagenesis of hydrophobin preferred a unique pH condition for self-assembly. These findings suggested that hydrophobin might be a powerful tool as a drug carrier or a pH sensitive drug-release compound. The novel pharmaceutical applications of hydrophobin might result in future widespread interest in hydrophobin. PMID:27212208

  13. How a Drug Shortage Contributed to a Medication Error Leading to Baclofen Toxicity in an Infant

    PubMed Central

    Khazanie, Uma; Rowe, Emily; Fauman, Karen

    2016-01-01

    We report the case of a 4-month-old girl who developed encephalopathy, seizures, and respiratory compromise as a result of baclofen toxicity. After some investigation, the accidental ingestion of baclofen was caused by an error in compounding the patient's prescribed omeprazole with baclofen rather than sodium bicarbonate at a retail pharmacy. This error occurred because these two drugs, which were available as powders, were located side by side on the pharmacy shelf. The pharmacist further reported that their normal practice was to use injectable sodium bicarbonate rather than powder to compound an omeprazole suspension; however, the injectable form was not available due to a national shortage. This report demonstrates how a drug shortage contributed to severe clinical consequences and intensive care hospitalization of a patient. It also highlights the need for system improvement to minimize drug shortages. PMID:28018156

  14. How a Drug Shortage Contributed to a Medication Error Leading to Baclofen Toxicity in an Infant.

    PubMed

    Lau, Bonnie; Khazanie, Uma; Rowe, Emily; Fauman, Karen

    2016-01-01

    We report the case of a 4-month-old girl who developed encephalopathy, seizures, and respiratory compromise as a result of baclofen toxicity. After some investigation, the accidental ingestion of baclofen was caused by an error in compounding the patient's prescribed omeprazole with baclofen rather than sodium bicarbonate at a retail pharmacy. This error occurred because these two drugs, which were available as powders, were located side by side on the pharmacy shelf. The pharmacist further reported that their normal practice was to use injectable sodium bicarbonate rather than powder to compound an omeprazole suspension; however, the injectable form was not available due to a national shortage. This report demonstrates how a drug shortage contributed to severe clinical consequences and intensive care hospitalization of a patient. It also highlights the need for system improvement to minimize drug shortages.

  15. When drugs disappear from the patient: elimination of intravenous medication by hemodiafiltration.

    PubMed

    Stricker, Kay H; Takala, Jukka; Hullin, Roger; Ganter, Christoph C

    2009-11-01

    Twenty-three hours after heart transplantation, life-threatening acute right heart failure was diagnosed in a patient requiring continuous venovenous hemodiafiltration (CVVHDF). Increasing doses of catecholamines, sedatives, and muscle relaxants administered through a central venous catheter were ineffective. However, a bolus of epinephrine injected through an alternative catheter provoked a hypertensive crisis. Thus, interference with the central venous infusion by the dialysis catheter was suspected. The catheters were changed, and hemodynamics stabilized at lower catecholamine doses. When the effects of IV drugs are inadequate in patients receiving CVVHDF, interference with adjacent catheters resulting in elimination of the drug by CVVHDF should be suspected.

  16. TRICARE; off-label uses of devices; partial list of examples of unproven drugs, devices, medical treatments or procedures. Final rule.

    PubMed

    2012-06-27

    The Department of Defense is publishing this final rule to revise the definition of ``unlabeled or off-label drug'' to ``off-label use of a drug or device.'' This provision codifies the coverage of those medically necessary indications for which there are demonstrations from medical literature, national organizations, or technology assessment bodies that the off-label use is safe and effective and in accordance with nationally accepted standards of practice in the medical community. Additionally, this rule removes the partial list of examples of unproven drugs, devices, and medical treatments or procedures proscribed in TRICARE regulations. We are removing the partial list from the regulation but will maintain the partial list in the TRICARE Policy Manual at www.tricare.mil.

  17. 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

    ... Agreement Program (U13), awarded to the Engelberg Center for Health Care Reform at the Brookings Institution... learned from medical product surveillance, and engaging stakeholders, namely the health care community... information is available to the public and health care practitioners who are interacting with patients...

  18. Adolescent Attitudes toward Psychiatric Medication: The Utility of the Drug Attitude Inventory

    ERIC Educational Resources Information Center

    Townsend, Lisa; Floersch, Jerry; Findling, Robert L.

    2009-01-01

    Background: Despite the effectiveness of psychotropic treatment for alleviating symptoms of psychiatric disorders, youth adherence to psychotropic medication regimens is low. Adolescent adherence rates range from 10-80% (Swanson, 2003; Cromer & Tarnowski, 1989; Lloyd et al., 1998; Brown, Borden, and Clingerman, 1985; Sleator, 1985) depending on…

  19. [Legal debate about the definition of medical device and of medicinal drug for human use].

    PubMed

    Ferge, Zsigmond

    2014-03-16

    On 3 October 2013 the European Court of Justice made a decision regarding the interpretation of definitions of medical devices (Directive 93/42/EC) and medicinal product for human use (Directive 2001/83/EC), based on the Article 267 TFEU preliminary ruling. Orv. Hetil., 2014, 155(11), 429-433.

  20. "Aristotle's Pharmacy": The Medical Rhetoric of a Clinical Protocol in the Drug Development Process.

    ERIC Educational Resources Information Center

    Bell, Heather D.; Walch, Kathleen A.; Katz, Steven B.

    2000-01-01

    Analyzes the clinical protocol within the rhetorical framework of the drug development and approval process, identifying the constraints under which the protocol is written and the rhetorical form, argumentative strategies, and style needed to improve and teach the writing of this document. (SC)

  1. Socio-Psychological Correlates of Non-Medical Use of Drugs Among University Students.

    ERIC Educational Resources Information Center

    Mehra, N.

    This study was designed to collect and analyze study reactions on a broad range of social, cultural and educational issues including the nonmedical use of drugs. Two questionnaires and a personality inventory were used in the collection of data that was obtained from a stratified random sample of 282 students of the University of Alberta. An…

  2. Rationale to evaluate medically supervised safer smoking facilities for non-injection illicit drug users.

    PubMed

    Collins, Courtney L C; Kerr, Thomas; Tyndall, Mark W; Marsh, David C; Kretz, Patricia S; Montaner, Julio S; Wood, Evan

    2005-01-01

    Many cities are experiencing ongoing infectious disease epidemics and substantial community harm as a result of illicit drug use. In an effort to reduce these public order and public health concerns, consideration has been given to the opening in Vancouver of a safer smoking facility (SSF). The present review was conducted to examine if there is a rationale to support the evaluation of a SSF in the Canadian context. Available evidence suggests that conventional drug control strategies are insufficient to address the health and community harms of non-injection drug use, and that the public order benefits of supervised injection facilities may be relevant to SSFs. In addition, there is persuasive evidence to suggest there is potential for blood-borne disease transmission through the sharing of smoking paraphernalia, and the potential for SSFs to address this concern is a pressing public health question. Also relevant to this topic are interventions to prevent transition into injection drug use, and SSFs may also be evaluated as a potential strategy to address this concern.

  3. 76 FR 66074 - Small Entity Compliance Guide: Required Warnings for Cigarette Packages and Advertisements...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-25

    ... Cigarette Packages and Advertisements; Availability AGENCY: Food and Drug Administration, HHS. ACTION... industry entitled ``Required Warnings for Cigarette Packages and Advertisements--Small Entity Compliance... entitled ``Required Warnings for Cigarette Packages and Advertisements--Small Entity Compliance Guide''...

  4. Article: Next Generation Compliance

    EPA Pesticide Factsheets

    The article Next Generation Compliance by Cynthia Giles, Assistant Administrator for OECA was published in The Environmental Forum, Sept-Oct 2013 explains EPA's strategy on using new technologies to improve compliance with environmental laws.

  5. Knowledge, attitude and perception/practices (KAP) of medical practitioners in India towards adverse drug reaction (ADR) reporting

    PubMed Central

    Kharkar, Mala; Bowalekar, Suresh

    2012-01-01

    Objective: The objective was to assess knowledge, attitude and perceptions/practices (KAP) of medical practitioners (MPs) in India towards Adverse Drug Reaction (ADR) reporting. Materials and Methods: A questionnaire was designed for assessment of KAP of medical practitioners in India toward ADR reporting. This questionnaire was administered to 2-3 medical practitioners from each zone prior to administering final questionnaire which was approved by Disha Independent Ethics Committee, Mumbai. 1200 medical practitioners (about 300 from each zone) from India were selected randomly. Results: 1000 medical practitioners out of 1200 (90%), selected at random were approached. A total of 870 provided responses to the questionnaire, giving a response rate of 73% of 1200 selected randomly. A total of 47.5% respondents reported that they were aware of Government ADR centers. A total of 59.2% reported that they are familiar with the procedure of reporting ADRs to Government centers. However, only 18.5% of MPs have reported the observed ADRs to Government ADR centers. As against this relatively large number of MPs (87.9%) have reported ADRs observed during their routine practice to medical representatives of pharmaceutical company and NGOs (non-Govt. Organizations). A total of 80.5% of respondents agreed that safety plays an important role and 96% reported that ADR centers are useful. However, only 55.6% of respondents have reported that there is a need for ADR centers. Conclusion: The study reveals that practitioners are aware of ADR reporting; their perception toward ADR reporting is right but it is not reflected when it comes to the act of reporting of ADRs. In our sample of 870 respondents only 18.5 % reported ADRs to some organizations. Only 5% of respondents recorded the details of ADR and reported to the manufacturer and 1% of respondents to government health ministry. Thus, medical practitioners in India appear to have a good knowledge about ADR reporting, the right

  6. Health Services Utilization and Payments in Patients With Cancer Pain: A Comparison of Intrathecal Drug Delivery vs. Conventional Medical Management

    PubMed Central

    Stearns, Lisa J.; Hammond, Krisstin; Berryman, Eric; Janjan, Nora A.

    2016-01-01

    Introduction To compare health services utilization and payments for cancer patients who received an implantable intrathecal drug delivery (IDD) system, consisting of a pump and catheter, vs. conventional medical management (CMM) for the treatment of cancer‐related pain. Methods This retrospective claims‐data analysis compared health services utilization and payments in a population of patients receiving either IDD or CMM for treatment of cancer pain. Patients were propensity score‐matched 1:1 based on characteristics including, but not limited to, age, gender, cancer type, comorbid conditions, and health care utilization and payments. Results From a sample of 142 IDD patients and 3188 CMM patients who met all inclusion/exclusion criteria, 73 matched pairs were obtained. In the year following implant, IDD patients had a consistent trend of lower medical utilization, and total payments that were $3195 lower compared to CMM. Conclusions Despite the high initial cost of IDD, this analysis suggests that patients with IDD incur lower medical utilization and payments over the first year post‐implant. Further analysis comprised of a larger, longitudinal sample would contribute to health economics and outcomes research, and assist with future practice guideline development. PMID:26816205

  7. Improving the effect of FDA-mandated drug safety alerts with Internet-based continuing medical education.

    PubMed

    Kraus, Carl N; Baldwin, Alan T; McAllister, R G

    2013-02-01

    The US Food and Drug Administration (FDA) requires risk communication as an element of Risk Evaluation and Mitigation Strategies (REMS) to alert and educate healthcare providers about severe toxicities associated with approved drugs. The educational effectiveness of this approach has not been evaluated. To support the communication plan element of the ipilimumab REMS, a Medscape Safe Use Alert (SUA) letter was distributed by Medscape via email and mobile device distribution to clinicians specified in the REMS. This alert contained the FDA-approved Dear Healthcare Provider (DHCP) letter mandated for distribution. A continuing medical education (CME) activity describing ipilimumab toxicities and the appropriate management was simultaneously posted on the website and distributed to Medscape members. Data were collected over a 6-month period regarding the handling of the letter and the responses to pre- and post-test questions for those who participated in the CME activity. Analysis of the answers to the pre- and posttest questions showed that participation in the CME activity resulted in an improvement in correct answer responses of 47%. Our experience shows that there are likely distinct information sources that are utilized by different HCP groups. The ready availability of a brief CME activity was utilized by 24,063 individuals, the majority of whom showed enhanced understanding of ipilimumab toxicity by improvement in post-test scores, educational data that are not available via implementation of standard safety alert communications. These results demonstrate that improvement in understanding of specific drug toxicities is enhanced by a CME intervention.

  8. Assessing the comparative effectiveness of newly marketed medications: methodological challenges and implications for drug development.

    PubMed

    Schneeweiss, S; Gagne, J J; Glynn, R J; Ruhl, M; Rassen, J A

    2011-12-01

    Comparative-effectiveness research (CER) aims to produce actionable evidence regarding the effectiveness and safety of medical products and interventions as they are used outside of controlled research settings. Although CER evidence regarding medications is particularly needed shortly after market approval, key methodological challenges include (i) potential bias due to channeling of patients to the newly marketed medication because of various patient-, physician-, and system-related factors; (ii) rapid changes in the characteristics of the user population during the early phase of marketing; and (iii) lack of timely data and the often small number of users in the first few months of marketing. We propose a mix of approaches to generate comparative-effectiveness data in the early marketing period, including sequential cohort monitoring with secondary health-care data and propensity score (PS) balancing, as well as extended follow-up of phase III and phase IV trials, indirect comparisons of placebo-controlled trials, and modeling and simulation of virtual trials.

  9. A self-medication hypothesis for increased vulnerability to drug abuse in prenatally restraint stressed rats.

    PubMed

    Reynaert, Marie-Line; Marrocco, Jordan; Gatta, Eleonora; Mairesse, Jérôme; Van Camp, Gilles; Fagioli, Francesca; Maccari, Stefania; Nicoletti, Ferdinando; Morley-Fletcher, Sara

    2015-01-01

    Stress-related events that occur in the perinatal period can permanently change brain and behavior of the developing individual and there is increasing evidence that early-life adversity is a contributing factor in the etiology of drug abuse and mood disorders. Neural adaptations resulting from early-life stress may mediate individual differences in novelty responsiveness and in turn contribute to drug abuse vulnerability. Prenatal restraint stress (PRS) in rats is a well-documented model of early stress known to induce long-lasting neurobiological and behavioral alterations including impaired feedback mechanisms of the HPA axis, enhanced novelty seeking, and increased sensitiveness to psychostimulants as well as anxiety/depression-like behavior. Together with the HPA axis, functional alterations of the mesolimbic dopamine system and of the metabotropic glutamate receptors system appear to be involved in the addiction-like profile of PRS rats.

  10. Improper Use of Medications

    MedlinePlus

    ... Prescription and Illicit Drug Abuse Improper Use of Medications Improper Use on the Rise Taking a prescription ... addictive drugs such as sleeping pills. Problems Taking Medications Many older adults take medications that play an ...

  11. Drugs.

    ERIC Educational Resources Information Center

    Hurst, Hunter, Ed.; And Others

    1984-01-01

    This document contains the third volume of "Today's Delinquent," an annual publication of the National Center for Juvenile Justice. This volume deals with the issue of drugs and includes articles by leading authorities in delinquency and substance abuse who share their views on causes and cures for the drug problem among youth in this country.…

  12. Should performance-enhancing drugs in sport be legalized under medical supervision?

    PubMed

    Wiesing, Urban

    2011-02-01

    This review examines the question of whether performance-enhancing drugs should be permitted in sport under the control of physicians, and evaluates the expected outcomes of such a scenario. Such a change in regulation would need to be tightly controlled because of the risks involved. The results of legalizing performance-enhancing drugs in competitive sport would be either unhelpful or negative, and the unwanted aspects of doping control would not disappear. Athletes, including children and adolescents who wanted to pursue competitive sports, would be forced to take additional, avoidable health risks. The 'natural lottery' of athletic talents would be compensated for only partially by use of performance-enhancing agents. It would also be complemented by another 'natural lottery' of variable responses to doping measures, combined with the inventiveness of doping doctors. There would be no gain in 'justice' (i.e. fairer results that reflected efforts made) for athletes as a result of legalizing doping. Legalization would not reduce restrictions on athletes' freedom; the control effort would remain the same, if not increased. Extremely complicated international regulations would have to be adopted. The game of the 'tortoise and the hare' between doping athletes and inspectors would remain because prohibited but not identifiable practices could still provide additional benefits from use of permissible drugs. Audience mistrust, particularly toward athletes who achieved outstanding feats, would remain because it would still be possible that these athletes were reliant on illegal doping practices. Doping entails exposing the athletes to avoidable risks that do not need to be taken to increase the appeal of a sport. Most importantly, the function of sport as a role model would definitely be damaged. It is not necessary to clarify the question of what constitutes the 'spirit of sport' and whether this may be changed. From a practical point of view, a legalization of

  13. Multiple Animal Studies for Medical Chemical Defense Program in Soldier/ Patient Decontamination and Drug Development

    DTIC Science & Technology

    1988-12-01

    Drug Development on TASK ORDER 84-8: ASSESSMENT OF SUBCUTANEOUS LETHALITY OF MUSTARD AND EFFICACY OF ENZYME INHIBITORS AGAINST MUSTARD LETHALITY3 IN THE...maintaining cellular viability. To test this hypothesis, the islfluence of three poly(ADP-ribose) enzyme inhibitors; 3-aminobenzamide (3AB...intraperitoneal doses of each enzyme inhibitor. Three different inhibitor dose levels were tested at different administration time combinations relative to

  14. Off-label drugs prescription in neonatology: a physician's duty or a medical hazardous attitude?

    PubMed

    d'Aloja, Ernesto; Paribello, Francesco; Demontis, Roberto; Müller, Mima

    2011-10-01

    The off-label and unlicensed use of drugs in neonatology is a widespread reality in all the NICUs. Several explanations may be given to justify the extension of this phenomenon and, among them, the lack of ad hoc clinical trials in neonatal subpopulation and the freedom to cure worldwide recognized to relatives and physicians. It is well known that adverse effects are more frequent, more serious and more underreported when medicines are used unauthorized or off-label, being physicians in theory responsible for the newborn physical damage. To avoid this responsibility, we believe that a shared legal framework may be helpful where the informative process on risks/benefits ratio for the newborn has a pivotal role. The National and International Scientific Societies should promote a common guidelines also for the informations on drug effects to be supplied to relatives. But at the same time EMA has to implement its strong policy towards the mandatory request on trials, for every new drug, on specific neonatal and pediatric subpopulations.

  15. Personalized prescribing: a new medical model for clinical implementation of psychotropic drugs

    PubMed Central

    Eap, Chin B.

    2016-01-01

    The use of pharmacogenetic tests was already being proposed in psychiatry in the early 2000s because genetic factors were known to influence drug pharmacokinetics and pharmacodynamics. However, sufficient levels of evidence to justify routine use have been achieved for only a few tests (eg, major histocompatibility complex, class I, B, allele 1502 [HLA-B*1502] for carbamazepine in epilepsy and bipolar disorders); many findings are too preliminary or, when replicated, of low clinical relevance because of a small effect size. Although drug selection and dose adaptation according to cytochrome P450 genotypes are sound, a large number of patients need to be genotyped in order to prevent one case of severe side effect and/or nonresponse. The decrease in cost for genetic analysis shifts the cost: benefit ratio toward increasing use of pharmacogenetic tests. However, they have to be combined with careful clinical evaluations and other tools (eg, therapeutic drug monitoring and phenotyping) to contribute to the general aim of providing the best care for psychiatric patients. PMID:27757065

  16. Personalized prescribing: a new medical model for clinical implementation of psychotropic drugs.

    PubMed

    Eap, Chin B

    2016-09-01

    The use of pharmacogenetic tests was already being proposed in psychiatry in the early 2000s because genetic factors were known to influence drug pharmacokinetics and pharmacodynamics. However, sufficient levels of evidence to justify routine use have been achieved for only a few tests (eg, major histocompatibility complex, class I, B, allele 1502 [HLA-B*1502] for carbamazepine in epilepsy and bipolar disorders); many findings are too preliminary or, when replicated, of low clinical relevance because of a small effect size. Although drug selection and dose adaptation according to cytochrome P450 genotypes are sound, a large number of patients need to be genotyped in order to prevent one case of severe side effect and/or nonresponse. The decrease in cost for genetic analysis shifts the cost: benefit ratio toward increasing use of pharmacogenetic tests. However, they have to be combined with careful clinical evaluations and other tools (eg, therapeutic drug monitoring and phenotyping) to contribute to the general aim of providing the best care for psychiatric patients.

  17. 21 CFR 118.12 - Enforcement and compliance.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... Act). Under the FFDCA, the Food and Drug Administration (FDA) can enforce the food adulteration... 21 Food and Drugs 2 2011-04-01 2011-04-01 false Enforcement and compliance. 118.12 Section 118.12 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)...

  18. 21 CFR 118.12 - Enforcement and compliance.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... Act). Under the FFDCA, the Food and Drug Administration (FDA) can enforce the food adulteration... 21 Food and Drugs 2 2012-04-01 2012-04-01 false Enforcement and compliance. 118.12 Section 118.12 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)...

  19. 21 CFR 118.12 - Enforcement and compliance.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... Act). Under the FFDCA, the Food and Drug Administration (FDA) can enforce the food adulteration... 21 Food and Drugs 2 2010-04-01 2010-04-01 false Enforcement and compliance. 118.12 Section 118.12 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)...

  20. 21 CFR 118.12 - Enforcement and compliance.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... Act). Under the FFDCA, the Food and Drug Administration (FDA) can enforce the food adulteration... 21 Food and Drugs 2 2014-04-01 2014-04-01 false Enforcement and compliance. 118.12 Section 118.12 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)...

  1. Patient compliance with new oral anticoagulants after major orthopaedic surgery: rivaroxaban and dabigatran compared with subcutaneous injection of fondaparinux

    PubMed Central

    DI BENEDETTO, PAOLO; VETRUGNO, LUIGI; DE FRANCESCHI, DANIA; GISONNI, RENATO; CAUSERO, ARALDO; ROCCA, GIORGIO DELLA

    2016-01-01

    Purpose the main purpose of our study was to compare patient compliance with the orally administered new oral anticoagulants (NOCs) dabigatran and rivaroxaban compared with subcutaneously injected fondaparinux after major orthopaedic surgery, and to assess patient preference for the oral vs subcutaneous administration route. Methods prophylactic antithrombotic drug therapy with dabigatran (group D; GD, n=32 patients), rivaroxaban (group R; GR, n=38 patients) or fondaparinux (group F; GF, n=30 patients), to prevent deep vein thrombosis, was started immediately after surgery in 100 patients submitted to total hip arthroplasty. Results the patients had a mean age of 68.7±11 years and 62% were female. In GD, 87.5% of patients indicated that they preferred oral intake of medications to subcutaneous injection (12.5%). In GR, 84.2% declared a preference for oral administration over subcutaneous injection (15.8%). In GF, a surprisingly high proportion of patients (73.3%; p < 0.001) declared that they preferred subcutaneous administration of medications over the oral route (26.7%). Overall, the rate of compliance with antithrombotic drug therapy was very high, at 99%. Conclusions intake of the NOAs dabigatran and rivaroxaban following hospital discharge is entirely the responsibility of the patient; a high level of patient compliance with these drugs must therefore be demonstrated in order for them to become well accepted within the medical community. The results of this study showed a very high level of compliance both with orally and subcutaneously administered drugs. Level of evidence Level I, randomized clinical study. PMID:28217657

  2. [Twenty-year History and Future Challenges in Transparency Enhancement of Review Process for Approval: Focus on Public Release of Review Reports regarding New Drugs and Medical Devices].

    PubMed

    Morimoto, Kazushige; Kawasaki, Satoko; Yoshida, Yasunori

    2015-01-01

    For 20 years, the Ministry of Health, Labour and Welfare (MHLW, formerly Ministry of Health and Welfare (MHW)) has been trying to increase transparency of the review process for approving reports in order to promote the rational use of newly approved drugs and medical devices. The first Summary Basis of Approval (SBA) was published by MHW in 1994. In 1999, evaluation reports were prepared by MHW and the Pharmaceuticals and Medical Devices Evaluation Center to make them available to the public. In 2005, a notice from the Chief Executive of the Pharmaceuticals and Medical Devices Agency (PMDA) made procedures for public release of information on reviewing applications for new drugs. In 2006, 90 review reports of newly approved drugs and eight medical devices were revealed on PMDA websites. The dissemination of information by the United States Food and Drug Administration (FDA) and that of the European Medicines Agency (EMA) were studied and compared with that of the MHLW and PMDA. While common technical documents (CTD) for new drugs and summary technical documents (STED) for new medical devices have been released by PMDA, such documents are not released by the FDA and EMA. The European Public Assessment Report (EAPR) summary for the public is an interesting questionnaire approach that uses the "What," "How" and "Why" format. Finally, future proposals for the next decade are also outlined.

  3. Non-Compliance and Related Factors in Patients With Bipolar I Disorder: A Six Month Follow-Up Study

    PubMed Central

    Azadforouz, Sanaz; Shabani, Amir; Nohesara, Shabnam; Ahmadzad-Asl, Masoud

    2016-01-01

    Background Medication treatment compliance among bipolar patients is quite widespread. Objectives Treatment compliance depends on multiple factors. The aim of this study was to evaluate the predicting factors of noncompliance in patients with bipolar I disorder admitted to an Iranian hospital during a six-month follow up period. Materials and Methods This cross-sectional study included 47 bipolar I disorder subjects who were admitted to the Iran psychiatric hospital and that were chosen using a non-randomized convenient sampling model. The patients were assessed at baseline, and at two and six months after admission. For evaluating the patients, we used the medication possession ratio (MPR), the drug attitude inventory (DIA-10), the young mania rating scale (Y-MRS) and the scale for the assessment of positive symptoms (SAPS). The data were analyzed using a general linear model by SPSS 16 software. Results The repeated measures analysis revealed that medication compliance increased successively (P = 0.045), and age, gender and symptom severity did not alter the pattern. Conclusions There is an increasing pattern in treatment compliance in bipolar I disorder patients, regardless of the known predicting factors for nonadherence. PMID:27803718

  4. Drug-Gene Interactions of Antihypertensive Medications and Risk of Incident Cardiovascular Disease: A Pharmacogenomics Study from the CHARGE Consortium

    PubMed Central

    Smith, Albert Vernon; Sun, Fangui; Evans, Daniel S.; Musani, Solomon K.; Li, Xiaohui; Trompet, Stella; Krijthe, Bouwe P.; Harris, Tamara B.; Quibrera, P. Miguel; Brody, Jennifer A.; Demissie, Serkalem; Davis, Barry R.; Wiggins, Kerri L.; Tranah, Gregory J.; Lange, Leslie A.; Sotoodehnia, Nona; Stott, David J.; Franco, Oscar H.; Launer, Lenore J.; Stürmer, Til; Taylor, Kent D.; Cupples, L. Adrienne; Eckfeldt, John H.; Smith, Nicholas L.; Liu, Yongmei; Wilson, James G.; Heckbert, Susan R.; Buckley, Brendan M.; Ikram, M. Arfan; Boerwinkle, Eric; Chen, Yii-Der Ida; de Craen, Anton J. M.; Uitterlinden, Andre G.; Rotter, Jerome I.; Ford, Ian; Hofman, Albert; Sattar, Naveed; Slagboom, P. Eline; Westendorp, Rudi G. J.; Gudnason, Vilmundur; Vasan, Ramachandran S.; Lumley, Thomas; Cummings, Steven R.; Taylor, Herman A.; Post, Wendy; Jukema, J. Wouter; Stricker, Bruno H.

    2015-01-01

    Background Hypertension is a major risk factor for a spectrum of cardiovascular diseases (CVD), including myocardial infarction, sudden death, and stroke. In the US, over 65 million people have high blood pressure and a large proportion of these individuals are prescribed antihypertensive medications. Although large long-term clinical trials conducted in the last several decades have identified a number of effective antihypertensive treatments that reduce the risk of future clinical complications, responses to therapy and protection from cardiovascular events vary among individuals. Methods Using a genome-wide association study among 21,267 participants with pharmaceutically treated hypertension, we explored the hypothesis that genetic variants might influence or modify the effectiveness of common antihypertensive therapies on the risk of major cardiovascular outcomes. The classes of drug treatments included angiotensin-converting enzyme inhibitors, beta-blockers, calcium channel blockers, and diuretics. In the setting of the Cohorts for Heart and Aging Research in Genomic Epidemiology (CHARGE) consortium, each study performed array-based genome-wide genotyping, imputed to HapMap Phase II reference panels, and used additive genetic models in proportional hazards or logistic regression models to evaluate drug-gene interactions for each of four therapeutic drug classes. We used meta-analysis to combine study-specific interaction estimates for approximately 2 million single nucleotide polymorphisms (SNPs) in a discovery analysis among 15,375 European Ancestry participants (3,527 CVD cases) with targeted follow-up in a case-only study of 1,751 European Ancestry GenHAT participants as well as among 4,141 African-Americans (1,267 CVD cases). Results Although drug-SNP interactions were biologically plausible, exposures and outcomes were well measured, and power was sufficient to detect modest interactions, we did not identify any statistically significant interactions

  5. Blood Donors on Medication – an Approach to Minimize Drug Burden for Recipients of Blood Products and to Limit Deferral of Donors

    PubMed Central

    Becker, Christian D.K.; Stichtenoth, Dirk O.; Wichmann, Michael G.; Schaefer, Christof; Szinicz, Ladislaus

    2009-01-01

    Summary Background Blood products derived from donors on medication can contain drugs which might pose a risk for the recipients or influence the quality of the product itself. Material and Methods To judge the eligibility of blood donors on medication, 4 drug classes have been formed with respect to their pharmacological properties, and blood products have been divided in accordance with their single-donor plasma contents. Results For drugs with dose-dependent pharmacodynamics, no deferral periods are necessary for donation of blood products containing less than 50 ml single-donor plasma for application to adults. Waiting periods of tmax + 5 t1/2 were calculated for the other blood products. Teratogenic drugs do not require special considerations (exception: retinoids, thalidomide and lenalidomide, dutasteride or finasteride with waiting periods for all blood products). A deferral period of tmax + 24 t1/2 is proposed for every blood product from blood donors on genotoxic drugs. Drugs without systemic effects can be neglected. Irreversible inhibitors of platelet function cause a 10-day waiting period if production of platelet concentrates is intended. Conclusion Donors on medication are allowed to donate blood for blood products containing less than 50 ml plasma of a single donor, like red blood cell concentrates, for the use in adults without deferral periods, except those taking retinoids, thalidomide, lenalidomide, dutasteride, finasteride, or genotoxic drugs. PMID:20823991

  6. The non-medical use of antibiotics and the risk of causing microbial drug-resistance*

    PubMed Central

    Manten, A.

    1963-01-01

    One of the hazards involved in the use of antibiotics in animal feeds is that it may lead to the development of bacterial drug-resistance. An analysis of the phenomenon shows that this possibility largely depends on the size of the bacterial populations involved and on the possibility of selective multiplication of the resistant mutants that may be present. Additional factors involved in the development of resistance are the type of drug applied and the time during which the bacteria are in contact with it. Animal experiments and general practical experience show that resistance, especially in E. coli, Salm. typhimurium and Staph. aureus, may considerably increase as higher doses are added to the feed. Therefore, the lowest effective level for growth promotion (5-20 p.p.m. of penicillin or tetracycline) is to be preferred over higher levels. As to the practice of food preservation by means of antibiotics, a dangerous situation may arise if two factors combine: emergence of bacterial resistance in Salmonella and perhaps other pathogenic bacteria in the animal as a result of the addition of a certain antibiotic to feeds, and subsequent use of the same substance for preservation of the meat. PMID:14058230

  7. Investigating clandestine drug laboratories: adverse medical effects in law enforcement personnel.

    PubMed

    Burgess, J L; Barnhart, S; Checkoway, H

    1996-10-01

    A retrospective cohort study was conducted among an international group of 46 law enforcement chemists and 13 Washington State clandestine drug laboratory investigation team members with more than 2,800 combined investigations. Each participant completed a questionnaire concerning previous drug laboratory investigations and adverse health effects during response activities. Methamphetamine laboratories accounted for 81-97% of all responses. Total illness incident rates varied between 0.75-3.4% of responses. Most exposures were through inhalation, and many occurred in the years prior to use of personal protective equipment. Symptoms were primarily those of headache and respiratory, mucous membrane, and skin irritation. Most illness episodes occurred during the processing phase of laboratory responses, and none occurred during the entry phase. A majority of illness episodes occurred in laboratories with leak/spills, fire/explosion, or uncontrolled reactions. Responding to an active laboratory was associated with a 7 to 15-fold risk of becoming ill as compared with setup, in-transit, or former (equipment removed) laboratory responses. No other laboratories characteristics were consistently associated with a significantly elevated relative risk of adverse health effects.

  8. Miracle drug, poison, or placebo: patients' experiences with antidepressant medications as described in postings on an online message board.

    PubMed

    Montagne, Michael

    2011-01-01

    Messages posted on the MSN Health message board in response to a news story reporting that antidepressant medications are placebos were examined. Over 37 days, 1,624 messages were posted by 1,238 unique authors. The sampling unit consisted of 960 authors who were users. Users' messages were gathered in real time and content analyzed. Few users explicitly responded to the question posed in the article: 2.5% of the users stated their antidepressant was a miracle drug, 2.0% stated it was a poison, and only 0.2% stated it was a placebo. Users reported positive experiences with antidepressants more than twice as often as they reported negative experiences.

  9. Geographical expansion and the reconfiguration of medical authority: Garcia de Orta's Colloquies on the simples and drugs of India (1563).

    PubMed

    da Costa, Palmira Fontes

    2012-03-01

    The Colloquies on the simples and drugs of India (1563) were conceived and published at a sensitive moment, both in terms of the history of print culture and of European geographical expansion. They represented the culmination of a life-time project for their author Garcia de Orta who had lived for almost thirty years in Portuguese Goa. Although the importance of the work in sixteenth-century natural history and medicine has been generally acknowledged in Portuguese and international historiography, there are very few recent, detailed studies of the book informed by new approaches. This paper presents an integrated analysis of Orta's Colloquies as a literary, medical and cultural text. It aims to reveal not only the rich and subtle dynamics of the work but also to contribute to a better understanding of Orta's legitimation strategies as an author in a sixteenth-century world reconfigured by the new opportunities of the printing press, geographical expansion and increased material and cultural mobility.

  10. Urine drug testing of chronic pain patients: licit and illicit drug patterns.

    PubMed

    Cone, Edward J; Caplan, Yale H; Black, David L; Robert, Timothy; Moser, Frank

    2008-10-01

    Chronic pain patients are frequently maintained on one or more powerful opioid medications in combination with other psychoactive medications. Urine tests provide objective information regarding patient compliance status. Little information is available on testing this unique population. The goal of this study was to characterize drug disposition patterns in urine specimens collected from a large population of pain patients. Confirmation data for 10,922 positive specimens were collated into 11 drug Classes. The number of drug/metabolites tested (#) and number of confirmed positive specimens were as follows: amphetamines (7), 160; barbiturates (5), 308; benzodiazepines (6), 2397; cannabinoids (1), 967; carisoprodol (2), 611; cocaine (1), 310; fentanyl (1), 458; meperidine (2), 58; methadone (2), 1209; opiates (7), 8996; and propoxyphene (2), 385. Subdivision into 19 distinct drug Groups allowed characterization of drug use patterns. Of the 10,922 positive specimens, 15,859 results were reported as positive in various drug Classes, and 27,197 drug/metabolites were measured by gas chromatography-mass spectrometry. The frequency of illicit drug use (cannabis, cocaine, ecstasy) was 10.8%. Being the first study of this type, these data present a large array of information on licit and illicit drug use, drug detection frequencies, drug/metabolite patterns, and multi-drug use combinations in pain patients.

  11. Impact of weight-loss medications on the cardiovascular system: focus on current and future anti-obesity drugs.

    PubMed

    Drolet, Benoit; Simard, Chantale; Poirier, Paul

    2007-01-01

    Overweight and obesity have been rising dramatically worldwide and are associated with numerous co-morbidities such as cardiovascular disease (CVD), type 2 diabetes mellitus, hypertension, certain cancers, and sleep apnea. In fact, obesity is an independent risk factor for CVD and CVD risks have also been documented in obese children. The majority of overweight and obese patients who achieve a significant short-term weight loss do not maintain their lower bodyweight in the long term. This may be due to a lack of intensive counseling and support from a facilitating environment including dedicated healthcare professionals such as nutritionists, kinesiologists, and behavior specialists. As a result, there has been a considerable focus on the role of adjunctive therapy such as pharmacotherapy for long-term weight loss and weight maintenance. Beyond an unfavorable risk factor profile, overweight and obesity also impact upon heart structure and function. Since the beginning, the quest for weight loss drugs has encountered warnings from regulatory agencies and the withdrawal from the market of efficient but unsafe medications. Fenfluramine was withdrawn from the market because of unacceptable pulmonary and cardiac adverse effects. Nevertheless, there is extensive research directed at the development of new anti-obesity compounds. The effect of these molecules on CVD risk factors has been studied and reported but information regarding their impact on the cardiovascular system is sparse. Thus, instead of looking at the benefit of weight loss on metabolism and risk factor management, this article discusses the impact of weight loss medications on the cardiovascular system. The potential interaction of available and potential new weight loss drugs with heart function and structure is reviewed.

  12. 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...

  13. 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...

  14. 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...

  15. 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…

  16. The male heart and the female mind: a study in the gendering of antidepressants and cardiovascular drugs in advertisements in Irish medical publication.

    PubMed

    Curry, Phillip; O'Brien, Marita

    2006-04-01

    Stereotypes which suggest that cardiovascular disease and depression are related to gender can have consequences for the mental and physical health outcomes of both men and women. This study examines how these stereotypes may be reinforced by medical publications advertising for cardiovascular and antidepressant medication. A random sample of 61 (with no repeats) advertisements which appeared in Irish medical publications between July 2001 and December 2002 were analysed using both content and semiotic analysis. Results indicate that the meanings created by advertisers for cardiovascular drugs and antidepressants did in fact gender these products. Women were depicted as the predominant users of antidepressants and men as the main users of cardiovascular drugs. The images used identified two stereotyped patients: the 'male' heart patient and the depressed 'female' patient. Furthermore, the imagery and language used to promote the two categories of medication tended to strengthen gendered associations.

  17. Adverse Drug Effects and Preoperative Medication Factors Related to Perioperative Low-Dose Ketamine Infusions.

    PubMed

    Schwenk, Eric S; Goldberg, Stephen F; Patel, Ronak D; Zhou, Jon; Adams, Douglas R; Baratta, Jaime L; Viscusi, Eugene R; Epstein, Richard H

    2016-01-01

    High-dose opioid administration is associated with significant adverse events. Evidence suggests that low-dose ketamine infusions improve perioperative analgesia over conventional opioid management, but usage is highly variable. Ketamine's adverse drug effects (ADEs) are well known, but their prevalence during low-dose infusions in a clinical setting and how often they lead to infusion discontinuation are unknown. The purposes of this study were 3-fold: (1) to identify patient factors associated with initiation of ketamine infusions during spine surgery, (2) to identify specific spine procedures in which ketamine has been used most frequently, and (3) to identify ADEs associated with postoperative ketamine infusions and which ADEs most frequently led to discontinuation. Spine surgery was chosen because of its association with moderate to severe pain and a relatively high use of ketamine infusions in this population at our hospital.

  18. Hey Mister Tambourine Man, Play a Drug for Me: Music as Medication.

    PubMed

    Howland, Robert H

    2016-12-01

    Listening to music may be thought of as noninvasive and nonpharmacological, but music should be considered a drug therapy. Music exposure has measurable neurobiological effects that are linked to systems regulating reward, motivation, and pleasure; stress and arousal; and immunity. Functional neuroimaging and lesion studies demonstrate that music-evoked emotions are associated with modulation of linked limbic and paralimbic brain regions. Some of these regions are involved in reward, motivation, and pleasure, and there are additional projections to brain structures regulating autonomic, emotional, and cognitive function. Controlled clinical studies have found significant benefits with the use of music for depression and anxiety, pain relief, stroke recovery, schizophrenia, and behavioral and psychological symptoms of dementia. Because music is not associated with significant adverse effects, it is a viable adjunctive treatment option for patients in many different clinical settings. [Journal of Psychosocial Nursing and Mental Health Services, 54(12), 23-27.].

  19. Thymoquinone: an emerging natural drug with a wide range of medical applications

    PubMed Central

    Khader, Mohannad; Eckl, Peter M

    2014-01-01

    Nigella sativa has attracted healers in ancient civilizations and researchers in recent times. Traditionally, it has been used in different forms to treat many diseases including asthma, hypertension, diabetes, inflammation, cough, bronchitis, headache, eczema, fever, dizziness and influenza. Experimentally, it has been demonstrated that N. sativa extracts and the main constituent of their volatile oil, thymoquinone, possess antioxidant, anti-inflammatory and hepatoprotective properties. In this review we aimed at summarizing the most recent investigations related to a few and most important effects of thymoquinone. It is concluded that thymoquinone has evidently proved its activity as hepatoprotective, anti-inflammatory, antioxidant, cytotoxic and anti-cancer chemical, with specific mechanisms of action, which provide support to consider this compound as an emerging drug. Further research is required to make thymoquinone a pharmaceutical preparation ready for clinical trials. PMID:25859298

  20. e-Monitoring of Asthma Therapy to Improve Compliance in children using a real-time medication monitoring system (RTMM): the e-MATIC study protocol

    PubMed Central

    2013-01-01

    Background Many children with asthma do not have sufficient asthma control, which leads to increased healthcare costs and productivity loss of parents. One of the causative factors are adherence problems. Effective interventions improving medication adherence may therefore improve asthma control and reduce costs. A promising solution is sending real time text-messages via the mobile phone network, when a medicine is about to be forgotten. As the effect of real time text-messages in children with asthma is unknown, the primary aim of this study is to determine the effect of a Real Time Medication Monitoring system (RTMM) with text-messages on adherence to inhaled corticosteroids (ICS). The secondary objective is to study the effects of RTMM on asthma control, quality of life and cost-effectiveness of treatment. Methods A multicenter, randomized controlled trial involving 220 children (4–11 years) using ICS for asthma. All children receive an RTMM-device for one year, which registers time and date of ICS doses. Children in the intervention group also receive tailored text-messages, sent only when a dose is at risk of omission. Primary outcome measure is the proportion of ICS dosages taken within the individually predefined time-interval. Secondary outcome measures include asthma control (monthly Asthma Control Tests), asthma exacerbations, healthcare use (collected from hospital records, patient reports and pharmacy record data), and disease-specific quality of life (PAQLQ questionnaire). Parental and children’s acceptance of RTMM is evaluated with online focus groups and patient questionnaires. An economic evaluation is performed adopting a societal perspective, including relevant healthcare costs and parental productivity loss. Furthermore, a decision-analytic model is developed in which different levels of adherence are associated with clinical and financial outcomes. Also, sensitivity analyses are carried out on different price levels for RTMM. Discussion