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Sample records for medical drug compliance

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

    PubMed

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

    2013-12-01

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

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

    PubMed

    Doyle, Kelly; Strathmann, Frederick G

    2017-02-01

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

  3. Maximizing drug compliance in the elderly. Tips for staying on top of your patients' medication use.

    PubMed

    Ennis, K J; Reichard, R A

    1997-09-01

    The old joke goes, "I finally got it all together, but now I forget where I put it. "So it is for many older patients facing complicated disease management plans. They think they understand, but then the instructions blur or they forget if they took the medications or they become concerned that the drugs cost too much and decide to cut back. Taking care of themselves is suddenly just too complicated. Drs Ennis and Reichard look at the issues and present some strategies to improve compliance among the elderly.

  4. Evaluation of drug use and medication compliance in adolescents admitted to a psychiatric facility from the pediatric emergency department.

    PubMed

    Wang, George Sam; Roosevelt, Genie; Becker, Amy; Brou, Lina; Galinkin, Jeffrey L

    2017-05-01

    Knowledge of drug use and medication compliance during mental health evaluation can help guide evaluation and treatment. The objective was to evaluate drug use and medication compliance in a pediatric emergency department (PED) psychiatric population by comparing medical history, standard urine drug screen (EIA), and expanded urine drug screen (HPLC-MS/MS). A prospective cohort study of admitted psychiatric patients ≥13years and ≤18years in a tertiary-care children's hospital psychiatric ED from January 31, 2013 through April 16, 2014. 100 patients in our PED were enrolled. Marijuana was the most commonly admitted and detected substance; 43% had co-ingestions. HPLC-MS/MS revealed 36 additional substance exposures than identified by history. All substances detected by EIA were also detected by HPLC-MS/MS. Combination of history and HPLC-MS/MS revealed the most substances used. HPLC-MS/MS identified antidepressants in 76% of patients prescribed a detectable antidepressant. Marijuana use was greater than nicotine use and was associated with concomitant polysubstance abuse. A combination of history and HPLC-MS/MS was the most thorough in obtaining history of drug use. Almost a quarter of patients did not have their prescribed antidepressant detected by HPLC-MS/MS. A rapid, affordable expanded drug screen should replace the more standard limited drug screen particularly for patients who are refractory to treatment. Copyright © 2017 Elsevier Inc. All rights reserved.

  5. Immunoassay-Based Drug Tests Are Inadequately Sensitive for Medication Compliance Monitoring in Patients Treated for Chronic Pain.

    PubMed

    Snyder, Marion L; Fantz, Corrine R; Melanson, Stacy

    2017-02-01

    Enzyme immunoassays (EIA) have notable limitations for monitoring therapeutic compliance in pain management. Chromatography coupled with mass spectrometry provides definitive results and superior sensitivity and specificity over traditional EIA testing. To analyze and compare the sensitivity of EIA results together with known prescriptions to liquid chromatography-tandem mass spectrometry (LC-MS/MS) for monitoring drug use (and abuse) in patients treated for chronic pain. A total of 530 urine samples from patients being treated for chronic pain were studied. Pain management clinic in the United States. The samples were tested for a profile of chronic pain medications and illicit drugs with commercially available EIA kits followed by analysis with Agilent LC-MS/MS system. The EIAs exhibited poor sensitivity and high rates of false negative results in the pain management setting. For example, 21% of EIA for opiates show false negative results. Mass spectrometry methods were more sensitive, detected a broader range of drugs and metabolites, and could detect non-prescribed drug use and simulations in compliance. Patients do not always accurately report drug use information, and some drugs do not have EIA methods available for comparative purposes. Mass spectrometry is a more robust and reliable method for detection of drugs used in the pain management setting. Due to the extent of undisclosed use and abuse of medications and illicit drugs, LC-MS/MS testing is necessary for adequate and accurate drug detection. In addition, LC-MS/MS methods are superior in terms of sensitivity and number of compounds that can be screened, making this a better method for use in pain management. Key words: Pain management, enzyme immunoassays, mass spectrometry, urine drug testing, prescription status, compliance.

  6. 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.

  7. Significant cost savings achieved by in-sourcing urine drug testing for monitoring medication compliance in pain management.

    PubMed

    Melanson, Stacy E F; Tanasijevic, Milenko J; Snyder, Marion L; Darragh, Alicia; Quade, Cathleen; Jarolim, Petr

    2013-06-25

    Reference laboratory testing can represent a significant component of the laboratory budget. Therefore, most laboratories continually reassess the feasibility of in-sourcing various tests. We describe the transfer of urine drug testing performed for monitoring medication compliance in pain management from a reference laboratory into an academic clinical laboratory. The process of implementing of both screening immunoassays and confirmatory LC-MS/MS testing and the associated cost savings is outlined. The initial proposal for in-sourcing this testing, which included the tests to be in-sourced, resources required, estimated cost savings and timeline for implementation, was approved in January 2009. All proposed testing was implemented by March 2011. Keys to the successful implementation included budgeting adequate resources and developing a realistic timeline, incorporating the changes with the highest budget impact first. We were able to in-source testing in 27 months and save the laboratory approximately $1 million in the first 3 year. Copyright © 2013 Elsevier B.V. All rights reserved.

  8. Patient compliance with antihypertensive medication.

    PubMed Central

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

    1980-01-01

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

  9. 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

  10. 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.

  11. Medication/Drug Allergy

    MedlinePlus

    ... Science Education & Training Home Conditions Medication/Drug Allergy Medication/Drug Allergy Make an Appointment Find a Doctor ... immediate or delayed. What Is an Allergy to Medication/Drugs? Allergies to drugs/medications are complicated, because ...

  12. 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

  13. Utility of oral fluid in compliance monitoring of opioid medications.

    PubMed

    Conermann, Till; Gosalia, Ankur R; Kabazie, Abraham Jack; Moore, Christina; Miller, Kathy; Fetsch, Madalene; Irvan, Dwain

    2014-01-01

    Prescription drug abuse is the fastest growing drug problem in the United States, and the increase in unintentional drug overdose deaths has been driven by the increase in opioid analgesic use. Given the epidemic of non-medical prescription pain reliever use and the current medico-legal climate, it is increasingly important for the prescriber to monitor for medication compliance. The purpose of this IRB approved study is to compare the results of oral fluid (OF) and routine urinalysis for monitoring compliance in a single academic pain management program in an urban setting in order to evaluate the utility of OF analysis in compliance monitoring when prescribing opioid medications. Outcomes analysis of prospective, consecutive, paired comparison study with clinical implications. Single academic interventional pain management center in the United States. Paired OF and urine specimens were collected for each patient with signed informed consent, at the Institute for Pain Medicine, Western Pennsylvania Hospital, from patients who routinely donated urine on a random basis for compliance testing. A total of 153 paired specimens were analyzed. Demographic and prescription data were made available. Specimens were screened using immunoassay and presumptive positive findings were confirmed with liquid-chromatography and mass spectrometry. Although both matrices were tested for a wider range of medications, the data presented here are representative of analgesic opioids and benzodiazepine drug classes only. Following exclusion criteria, of the 132 remaining specimen pairs that were positive for opioids or benzodiazepines in at least one matrix, 101 pairs showed exact drug class matches (76.5%). In an additional 21 pairs, at least one drug class was positive in both matrices (15.9%), giving an overall agreement of 92.4%. Overall, 191 positive results were found in urine averaging 1.4 drugs per specimen; 176 positives were detected using OF for an average of 1.3 drugs per

  14. Patient Compliance and Medication Perception.

    ERIC Educational Resources Information Center

    Buckalew, L. W.; Sallis, R. E.

    1986-01-01

    Addresses problem of patient noncompliance with regimens of prescribed medication, with attention to incidence and illogical nature of this behavior. Psychological theory of cognitive dissonance is suggested as appropriate to understanding some aspects of noncompliance because medicinal preparations represent stimuli that are not necessarily…

  15. 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

  16. 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

  17. 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.

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

    PubMed Central

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

    2015-01-01

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

  19. [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

  20. 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.

  1. 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

  2. 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

  3. 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.

  4. 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

  5. Compliance of medications prescribed from a pediatric emergency department.

    PubMed

    Sammons, Nicole Willis; Yin, Han

    2015-06-01

    Studies regarding compliance of medications prescribed from emergency departments (EDs) have primarily been adult-based or based on self-reported data. Most pediatric studies have shown that patients with private insurance tend to be more compliant. This study aims to determine the rate of medication compliance from a pediatric ED, which medications are most likely to be filled, if there are differences in compliance based on insurance status and age, and if noncompliant patients are more likely to have unintended return visits to the ED. In this retrospective chart review, a sample of consecutive pediatric patients discharged from the ED was obtained. Pharmacies were contacted to ensure prescriptions were filled. Medication compliance was inferred if a prescription was filled. The 152 patients included had a total of 229 prescriptions that were used for data analysis. The overall medication compliance rate was 72.5%. There was no statistically significant difference in medication compliance between age (P = 0.9), diagnosis (P = 0.26), insurance status (P = 0.3), or type of medication (P = 0.3). No difference was demonstrated for unintended return visits based on compliance (P = 0.79). Over a quarter of patients prescribed medications were noncompliant. However, there was no statistically significant difference in compliance between age, diagnosis, insurance status, or type of medication. Unlike most previous studies, privately insured patients were just as unlikely to fill their medications as publicly insured patients, and cost did not appear to be a contributing factor to noncompliance. Therefore efforts to educate patients and their families should be widespread and unbiased.

  6. 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…

  7. 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.

  8. 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.

  9. 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?

  10. 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

  11. Intravenous Smart Pump Drug Library Compliance: A Descriptive Study of 44 Hospitals.

    PubMed

    Giuliano, Karen K; Su, Wan-Ting; Degnan, Daniel D; Fitzgerald, Kristy; Zink, Richard J; DeLaurentis, Poching

    2017-06-01

    Although intravenous (IV) smart pumps with built-in dose-error reduction systems (DERS) can reduce IV medication administration error, most serious adverse events still occur during IV medication administration. Sources of error include overriding DERS and manually bypassing drug libraries and the DERS. Our purpose was to use the Regenstrief National Center for Medical Device Informatics data set to better understand IV smart pump drug library and DERS compliance. Our sample consisted of 12 months of data from 7 hospital systems, 44 individual hospitals, and descriptive data from the American Hospital Directory (AHD) for 2015. The aims of the study were (1) to determine whether there are differences in IV smart pump drug library compliance between hospital systems and (2) to provide a broad descriptive overview of relevant trends related to IV smart pump compliance. For aim 1, we found 3 significant relationships among the 7 hospital systems: systems 3 (P < 0.001), 6 (P = 0.003), and 7 (P = 0.002) had significantly higher IV smart compliance as compared with system 4. For aim 2, the number of drug library profiles was positively correlated (P = 0.029) with IV smart pump compliance and the IV smart pump type used was significantly correlated (P = 0.013) with IV smart pump compliance. Our findings support that there are differences in IV smart pump compliance both within and between hospital systems and that IV smart pump type and the number of drug library profiles may be influencing factors. Further research is required to more accurately identify the impact of these factors in this very important area of patient safety.

  12. [Compliance and knowledge about prescribed medication among elderly home-care recipients by method of providing medications].

    PubMed

    Okuno, J; Yanagi, H; Tomura, S

    2001-09-01

    After long-term care insurance commenced in April 2000, various types of in-home care began, including delivery of prescriptions medicines to the elderly. However, the effects of in-home care workers on patient drug compliance are unclear as yet. In this study, we examined the characteristics of the care workers who delivered prescription medicines to the elderly, and analyzed the effects on patient drug compliance and knowledge about medication. The subjects included 163 homecare recipients aged 60 and older, who were taking more than one prescribed drug, who ranked worse than J-2 who were physically disabled, and cognitively normal. The rate of good compliance was 71.1% when pharmacists provided the prescribed drugs and counseled the patients at home, which rate was significantly higher than that of self-supply by the patient (35.0%), caregiver supply (44.7%), and home-helper supply (0.0%). The difference in compliance may be explained by the possibility that when caregivers and home-helpers provided prescribed medications, thorough and accurate information about the drugs were not clearly imparted to the elderly, whereas when pharmacists provided prescribed medications, a pharmacological examination was performed and thorough and accurate information was communicated to the elderly. In the group counseled by pharmacists, knowledge about the effects and purpose of medication positively correlated with drug compliance. However, in the group provided drugs by caregivers, knowledge about the effects and purpose of medication inversely correlated with drug compliance. These findings suggested that the elderly in the latter group chose, to some degree, not to comply. Many elderly people had difficulty getting to hospital, and 23.1% of the patients in this study had not consulted the doctor for more than 2 months. Our data suggest that drugs provided by pharmacists and the availability of pharmacist counseling play an important role in preventing drug noncompliance and

  13. Allergies in India: a study on medication compliance.

    PubMed

    Shaikh, Wiqar A; Shaikh, Shifa Wiqar

    2009-07-01

    There are no studies in Indian literature on compliance to various medications for allergic diseases such as nasal sprays, inhalers, immunotherapy and antihistamines. This study was initiated to cover this lacuna. Eighty young patients suffering from asthma with rhinitis or urticaria between the age group of 10 and 40 years were included in this study. Compliance to medications was carefully observed using dose diaries for a period of one year. The data obtained revealed the highest compliance for sublingual immunotherapy (84.19%) and the lowest for a nasal spray (62.32%). The compliance for a dry powder inhaler was 69.31% and for fexofenadine tablets it was 71.78%. These figures are surprisingly low, especially since this study was conducted in a private clinic.

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

    PubMed

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

    2014-11-01

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

  15. Compliance with medication in patients with heart failure in Zimbabwe.

    PubMed

    Bhagat, K; Mazayi-Mupanemunda, M

    2001-01-01

    To determine the extent of adherence to prescribed medication in patients with chronic heart failure and to determine to what extent patients recall information given regarding their medication. Compliance and knowledge of prescribed medication was studied in 22 heart failure patients [mean age 45 +/- 4 (range 40-67); 14 (64%) male], using in-depth interviews performed 30 days after having been prescribed medication. All patients received standardised verbal and written information regarding their medication. Patients attending four general practices in the private sector (in Harare, Zimbabwe) for at least six months prior to enrolling were in included in the study. Only 12 (55%) patients could correctly name what medication had been prescribed, 11 (50%) were unable to state the prescribed doses and 14 (64%) could not account for when the medication was to be taken, that is to say, at what time of day and when in relation to meals the medication was to be taken. In the overall assessment six (27%) patients were found non-compliant and 16 (73%) patients were considered as possibly being compliant with their prescribed medication. Non-compliance was common in heart failure patients, as were shortcomings in patients' knowledge regarding prescribed medication, despite efforts to give adequate information. There exists a need for alternative strategies to improve compliance in these patients.

  16. Anti-retroviral drugs compliance in intravenous and non intravenous drug abusers.

    PubMed

    Daud, Muhammad Yousuf; Qazi, Rizwan Aziz; Bashir, Naila

    2014-01-01

    Intravenous drug abuse is often associated with poor adherence to anti-retroviral drugs in HIV/AIDS. Very few studies in Pakistan have determined implications of intravenous drug abuse on anti-retroviral drug compliance in HIV/AIDS patients. The objectives of the study were to assess and compare the adherence to anti-retroviral drugs in intravenous drug users (IDUs) and non-intravenous drug users (NIDUs) and to determine various factors influencing the adherence to anti-retroviral (ARV) drugs in HIV positive IDUs in HIV treatment centre Pakistan Institute of Medical Sciences (PIMS), Islamabad. This descriptive observational study was carried out at HIV/AIDS treatment and care centre PIMS, Islamabad. A total of 162 HIV positive male (81 IDU and 81 NIDU) were enrolled in this study. They were followed over a period of five years from 2008-2012. ARV drug compliance and anti-tuberculosis treatment (ATT) outcome in IDUs and NIDUs were assessed using standard outcome parameters. Among IDUs Hepatitis C was positive in 63 (77.77%) cases and negative in 18 (22.22%) cases. In NIDUs hepatitis C was positive in 5 (6.17%) and negative in 76 (93.82%) (p=0.000). In IDUs Pulmonary tuberculosis was present in 61 (75.30%) patients and in NIDUs it was present in 52 (64.19%) (p=0.171). Regarding ATT outcome, amongst IDUs 41 (50.61%) lost to follow up, 16 (19.75%) were compliant to treatment and 4 (4.93%) were transferred out. In NIDUs, 2 (2.46%) patients were lost to follow-up, 38 (46.91%) remained compliant to treatment and 6 (7.40%) were transferred out (p=0.000). Regarding end status of ARVs, in IDUs, 48 (59.25%) were lost to follow-up, 1 (1.23%) was defaulter, 16 (19.75%) were compliant to treatment, 8 (9.87%) were transferred out and 8 (9.87%) expired. In NIDUs, 73 (90.12%) were compliant to treatment, 5 (6.17%) expired, 2 (2.46%) were lost to follow-up. Due to various socioeconomic and clinical factors, compliance to ARVs in IDUs is poorer as compared to NIDUs. The factors

  17. Drug advertising in medical journals

    PubMed Central

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

    1976-01-01

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

  18. 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. ...

  19. [Influence of substitution of brand name for generic drugs on therapeutic compliance in hypertension and dyslipidemia].

    PubMed

    Mainar, Antoni Sicras; Artieda, Ruth Navarro

    2010-01-01

    To determine therapeutic compliance when brand name amlodipine and simvastatin are substituted for generic drugs, and to determine patients' and physicians' opinions of this substitution. We performed an observational study with a control group, based on a review of the medical records in six primary care centers. Participants consisted of patients ≥ 40 years old initiating treatment with a brand name drug (initial period), which was later substituted by a generic drug (final period). The study subgroups consisted of patients with hypertension (amlodipine) or dyslipidemia (simvastatin). The main measures were comorbidity, compliance, treatment length, biochemistry determinations, and patients' and physicians' opinions (interviews). All patients received a brand name drug for a minimum of 1 year followed by a generic drug for a minimum of 1 year (minimum continuation/patient: 24 months). There were 1,252 patients (groups: 49.5% amlodipine; 50.5% simvastatin). Patients treated with amlodipine (period comparison) showed better compliance (65.8 vs. 61.3%; p=0.037) and blood pressure control (48.5 vs. 45.8%; p=0.039) with the brand name drug. The percentages with simvastatin were 62.8 vs. 58.4% (p=0.041), respectively. A total of 73.6% of the physicians interviewed prescribed generic drugs and 59.2% believed that both types of drug had the same efficacy. Most of the patients interviewed (79.8%; CI: 74.3-85.3%) accepted the substitution; 55.3% (CI: 48.5-62.1%) received the appropriate information but 61.5% were confused by the different products. Lack of compliance was reported by 18.2%. In patients receiving amlodipine or simvastatin, compliance decreased with time, independently of the change from a band name to a generic drug. Copyright © 2010 SESPAS. Published by Elsevier Espana. All rights reserved.

  20. 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.

  1. The effectiveness of compliance therapy on drug attitude among schizophrenic patients: a systematic review.

    PubMed

    Chang, Ying-Tzu; Lee, Ling-Ling

    2015-08-14

    Schizophrenia is one of the most severe mental illnesses. Studies have found that 25% to 80% of all schizophrenic patients are non-compliant in medication-taking. Non-compliance of medication-taking is associated with higher readmission rates that result from relapses. Compliance therapy has been developed to modify negative beliefs toward medication and aims to improve drug attitude toward medication-taking. However, the effect of compliance therapy on drug attitude among schizophrenic patients is unclear. The objective of this review was to systematically review the available evidence with regards to the effect of compliance therapy on improving attitudes toward medication among schizophrenic patients. People diagnosed with schizophrenia, schizophrenia-form disorder, delusion disorder, schizo-affective disorder. TYPES OF INTERVENTION(S): The review considered studies that evaluated any form of compliance therapy. The comparator was standard care. TYPES OF STUDIES: The review considered randomized controlled trials. TYPES OF OUTCOMES: Drug attitude measured by the Drug Attitude Inventory. Database searches included MEDLINE, CINAHL, EMBASE, Science Direct, SocIndex, PsycINFO, ERIC, the Web of Science, the National Central Library and the Chinese Electronic Periodical Services databases. Searches were limited to English and Chinese. Search was limited to articles published from 1983 to 2013. Two reviewers independently appraised the studies using the standardized critical appraisal checklist for randomized control trial and pseudo-randomized trails designed by Joanna Briggs Institute. Disagreements were resolved through discussion. A standardized data extraction tool from the Joanna Briggs Institute was used. Data were extracted by two reviewers independently. Due to the concern of heterogeneity, meta-analysis was not considered as an appropriate approach to synthesize data in the current review. A narrative summary was therefore carried out. Three randomized

  2. 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

  3. 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.

  4. 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.

  5. 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…

  6. 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…

  7. 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...

  8. 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...

  9. 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...

  10. 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.

  11. [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.

  12. OSHA lead in construction compliance directive: Medical surveillance program

    SciTech Connect

    Vernon, L.S.

    1994-11-01

    This article is part of a series that reviews the Occupational Health and Safety Administration (OSHA) Instruction CPL 2-2.58, a compliance directive for 29 CFR 1926.62, Lead Exposure in Construction. The OSHA document is intended to provide guidance to those charged with field enforcement of the lead regulation; however, it also provides vital information to those in industry who must comply with the regulation. This month, the requirements for employer medical surveillance programs are discussed.

  13. 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.

  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, Persistence, and Preferences Regarding Osteoporosis Treatment During Active Therapy or Drug Holiday.

    PubMed

    Eliasaf, Alona; Amitai, Alina; Maram Edry, Mira; Yosselson Superstine, Shimona; Rotman Pikielny, Pnina

    2016-11-01

    Osteoporosis treatments reduce the risk of fractures by 30%-50%, but adherence after 1 year is only about 50%. Drug holiday, a period with no active treatment, is part of routine management. The objective of this study was to determine compliance and persistence with osteoporosis therapy among postmenopausal women and to assess attitudes regarding treatment resumption among patients on drug holiday. This was a prospective observational study of patients followed at a dedicated metabolic bone clinic September 2013-February 2014. Compliance was assessed by medication possession ratio (MPR; number of doses dispensed relative to the number prescribed). Persistence was defined as continuation of treatment without a >30-day gap in prescription refills. Of 150 patients (70.1 ± 8.1 years), 57% were prescribed a medication: 64% oral, mostly bisphosphonates. MPR ≥ 80% was found in 80% and <50% in 12%; it was 100% for zoledronic acid and denosumab and 97%, 85%, 83%, and 70% for raloxifene, teriparatide, oral bisphosphonates, and strontium ranelate, respectively. Of 39 patients prescribed oral bisphosphonates, 77% persisted with treatment, and 89% took them as directed. Of 64 patients on a drug holiday, 59% expressed confidence in their physician's future treatment choice, whereas 19% expressed concerns about resuming treatment. Compliance among patients attending a dedicated bone clinic was higher than that reported in the literature. High persistence and compliance may be specific to patients followed in this type of setting. This study provides new information about attitudes of patients on a drug holiday. Most were not concerned about resuming treatment and did not have a preferred medication. © 2016, The American College of Clinical Pharmacology.

  16. 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

  17. The Interaction of Patient Perception of Overmedication with Drug Compliance and Side Effects

    PubMed Central

    Fincke, Benjamin Graeme; Miller, Donald R; Spiro, Avron

    1998-01-01

    OBJECTIVE Little is known about the significance of patient-perceived overmedication. We sought to determine its prevalence and relation to medication compliance, adverse drug reactions, health-related quality of life (HRQOL), and burden of illness. DESIGN Analysis of self-reported questionnaire data. PATIENTS/PARTICIPANT There were 1,648 participants in a longitudinal study of male veterans. INTERVENTION Participants listed each of their medications with indication, missed doses, adverse reactions, and whether their amount of medication was “too much, the right amount, or too little.” The survey included questions about medication adherence, “problems with medications,” common symptoms, and screening questions for a number of chronic conditions. We assessed HRQOL with the Multiple Outcomes Study 36-Item Short Form Health Study (SF-36). MEASUREMENTS AND MAIN RESULTS Of the 1,256 respondents, 1,007 (80%) had taken medication within 4 weeks. Forty (4%) thought they were taking too much. They reported a 1.6-fold increase in prescription medications, a 5-8 fold increase in adverse effects, a 1.5-2 fold decrease in compliance, an increase in each of seven measured symptoms, and a decrease in six of eight SF-36 domains (p < .05 for all comparisons), the exceptions being the mental health and role-emotional scales. There was also a slight increase in the report of any chronic illness (95% vs 86%, p >.05). CONCLUSIONS Patient perception of overmedication correlates with self-report of decreased compliance, adverse drug reactions, decreased HRQOL, and an increase in symptomatology that is compatible with unrecognized side effects of medication. Such patients warrant careful evaluation. PMID:9541375

  18. 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…

  19. 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…

  20. [Development of a risk calculator for drug compliance in treated hypertensives: The FLAHS Compliance Calculator].

    PubMed

    Girerd, X; Hanon, O; Pannier, B; Vaïsse, B

    2017-06-01

    To investigate the determinants of non-compliance with antihypertensive treatments among participants in the FLAHS 2015 survey and to develop a risk calculator for drug compliance in a hypertensive population. The FLAHS surveys are carried out by self-questionnaire sent by mail to individuals from the TNS SOFRES (representative panel of the population living in metropolitan France) sampling frame. In 2015, FLAHS was performed in subjects aged 55years and older. Using the Girerd questionnaire, the "perfect observance" was determined for a score of 0 and "nonobservance" for a score of 1 or higher. A Poisson regression was conducted in univariate and multivariate to estimate risk ratios for each determinant. A non-compliance risk calculator is constructed from multivariate analysis. A Poisson regression was performed in univariate and multivariate to estimate risk ratios. For each sex, a probability table is produced from the equation of the multivariate analysis and then the calculation of a nonobservance probability ratio (PR) using the profile with the best probability as a reference. Each subject is then classified into one of the three classes of risk of non-compliance: low (PR <1.5), high (PR>=2) and intermediate (PR>=1.5 and <2). The survey included 6379 subjects and analysis based on 2370 treated hypertensives. The onset of treatment was less than 2years in 7% of subjects and the median follow-up duration of treatment was 10years. Perfect compliance was observed in 64% of subjects. Independent determinants of non-compliance are: male sex, young age, number of antihypertensive tablet, treatment for a metabolic disease (diabetes, dyslipidemia), presence of other chronic illness, secondary prevention of cardiovascular disease. To get the risk class of nonobservance a web page is available at http://www.comitehta.org/flahs-observance-hta/. The development of the FLAHS Compliance Test is a tool whose use is possible during an office visit. Its free availability for

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

    PubMed

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

    2008-01-01

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

  2. Communication, compliance, and concordance between physicians and patients with prescribed medications.

    PubMed

    Hulka, B S; Cassel, J C; Kupper, L L; Burdette, J A

    1976-09-01

    Forty-six practicing physicians and 357 patients with diabetes mellitus or congestive heart failure were the subjects for this study, which focuses on the impact of medication regimen and doctor-patient communication in affecting patient medication-taking behavior and physician awareness of these behaviors. Four types of medication errors were defined: omissions, commissions, scheduling misconceptions and scheduling non-compliance. The average error rates were 19 per cent, 19 per cent, 17 per cent and 3 per cent, respectively. The combined average error was 58 per cent; scheduline non-compliance on the part of the patient was a minor component. Specific aspects of the medication regimen were associated with increased errors: (1) the more drugs involved between the doctor-patient pair, the greater the errors of omission and commission; and (2) the greater the complexity of the scheduling, the greater the errors of commission and scheduling misconceptions. If the patient did not know the function of all his drugs, errors of commission and scheduling misconception increased. Neither characteristics of patients nor the severity of disease were influential in determining the extent of medication errors. For patients with congestive heart failure, good communication of instructions and information from physician to patient was associated with low levels of all types of errors.

  3. 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

  4. 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…

  5. Drug related admissions to medical wards

    PubMed Central

    Hallas, Jesper; Gram, Lars F.; Grodum, Ellen; Damsbo, Niels; Brøsen, Kim; Haghfelt, Torben; Harvald, Bent; Beck-Nielsen, Jørgen; Worm, Jørgen; Birger Jensen, Kurt; Davidsen, Otto; Frandsen, Niels E.; Hagen, Claus; Andersen, Morten; Frølund, Flemming; Kromann-Andersen, Hans; Schou, Jens

    1992-01-01

    1 In total 1999 consecutive admissions to six medical wards were subjected to a prospective high-intensity drug event monitoring scheme to assess the extent and pattern of admissions caused by adverse drug reactions (ADRs) or dose related therapeutic failures (TF), in a population-based design. The wards were sub-specialised in general medicine, geriatrics, endocrinology, cardiology, respiratory medicine and gastroenterology. 2 Considering definite, probable and possible drug events, the prevalence of drug related hospital admissions was 11.4% of which 8.4% were caused by ADRs and 3.0% by TFs. There were large inter-department differences. 3 The six classes of drugs most frequently involved in admissions caused by ADRs were anti-rheumatics and analgesics (27%), cardiovascular drugs (23%), psychotropic drugs (14%), anti-diabetics (12%), antibiotics (7%), and corticosteroids (5%). Non-compliance accounted for 66% of the TFs with diuretics and anti-asthmatics most frequently involved. 4 The pattern of drugs involved in ADRs was compared with the regional drug sales statistics. Drugs with a particularly high rate of ADR related admissions per unit dispensed were nitrofurantoin and insulin (617 and 182 admissions per 1,000,000 defined daily doses), while low rates were seen for diuretics and benzodiazepines (10 and 7 admissions per 1,000,000 defined daily doses). Confidence intervals were wide. 5 Patients who had their therapy prescribed by a hospital doctor had a slightly higher prevalence of drug events than those who were treated by a general practitioner (12.6% vs 11.8%). The reverse applied for drug events assessed as avoidable (3.3% vs 4.6%). Although these differences were not statistically significant, it may suggest general practitioners as the appropriate target for interventive measures. 6 Only one ADR was reported to The Danish Committee on Adverse Drug Reactions, indicating a severe under-reporting and a potential for gross selectivity. The data collection

  6. 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.

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

    PubMed

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

    2011-02-01

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

  8. [Medical students and drug marketing].

    PubMed

    Calderón Larrañaga, Sara; Rabanaque Hernández, María José

    2014-03-01

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

  9. Medication Interactions: Food, Supplements and Other Drugs

    MedlinePlus

    ... you are prescribed a new medication. Ask about food, beverages, dietary supplements and other drugs. Check with your ... it with other drugs? Should I avoid certain foods, beverages or other products? What are possible drug interaction ...

  10. 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.

  11. 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.

  12. Medication compliance in renal transplant patients during the Great East Japan Earthquake.

    PubMed

    Kadowaki, M; Saito, M; Amada, N; Haga, I; Nakamura, A; Tokodai, K

    2014-01-01

    Oral immunosuppressant suspension induces renal graft dysfunction in renal transplant patients. After the Great East Japan Earthquake, not only were drugs lost in the tsunami, but visiting hospitals became difficult owing to information and transportation network disruption. We investigated medication compliance in renal transplant patients and actions taken immediately after the earthquake. We included 315 patients who were visiting our outpatient department as of March 11, 2011, from June to August 2011. Information was collected from questionnaires, medical records, and outpatient diaries. The questionnaire collection rate was 93%, with valid replies from 296 patients. One hundred eighty-five patients (62%) had stockpiled oral medications before the earthquake; of these, 131 (44%) always carried medications with them. Forty-five patients (16%) had difficulties with continuing oral immunosuppressants after the earthquake (supply delay, 29 patients; drugs lost in tsunami, 9; others, 10). Of these 48, oral medication was suspended in 18 for 3 days at maximum. As to outpatient prescriptions, out-of-hospital prescriptions were sent by fax to 17 patients, prescription drugs were sent from our hospital by mail or home delivery services to 11, and prescriptions were given to 13 who visited other hospitals. Because of the difficulty in requesting prescriptions from disaster base hospitals, drugs prescribed at our hospital were delivered to 3 severely damaged institutions for patients living in surrounding areas. After the earthquake, our usual self-management guidance proved effective. Further examination of the infrastructure for communicating with patients and supplying drugs is needed. Copyright © 2014 Elsevier Inc. All rights reserved.

  13. 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.

  14. 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…

  15. 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

  16. [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.

  17. Drug Delivery Innovations to Address Global Health Challenges for Pediatric and Geriatric Populations (Through Improvements in Patient Compliance).

    PubMed

    Boateng, Joshua

    2017-07-20

    Despite significant advances in pharmaceutical and biotechnological drug discovery, the global population is plagued with many challenging diseases. These are further compounded by anticipated explosion in an ageing population, which presents several problems such as polypharmacy, dysphagia, and neurologic conditions, resulting in noncompliance and disease complications. For antibiotics, poor compliance, can result in development of drug-resistant infections which can be fatal. Furthermore, children, especially, in developing countries die unnecessarily from easily treatable diseases (e.g., malaria), due to poor compliance arising from bitter taste and inability to swallow currently available medication. Although some of these challenges require the discovery of new drug compounds, a significant number can be resolved by employing pharmaceutics approaches to reduce the incidence of poor patient compliance. Such solutions are expected to make swallowing easier and reduce the need to swallow several solid medications, which is difficult for vulnerable pediatric and geriatric patients. This commentary will explore the current state of the art in the use of drug delivery innovations to overcome some of these challenges, taking cues from relevant regulatory agencies such as the Food and Drug Administration, the European Medicines Agency, World Health Organization, and the peer-reviewed scientific and clinical literature. Copyright © 2017 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.

  18. Medication adherence to oral anticancer drugs: systematic review.

    PubMed

    Huang, Wen-Chuan; Chen, Chung-Yu; Lin, Shun-Jin; Chang, Chao-Sung

    2016-01-01

    Many studies have demonstrated that non-adherence to oral anticancer drugs (OACDs) has challenged treatment efficacy. Otherwise, few validated tools exist to measure patients' adherence to medication regimen in clinical practice. To synthesize previous studies on adherence by cancer patients taking OACDs, especially in targeted therapy, a systematic search of several electronic databases was conducted. We analyzed existing scales' contents for various cancer patients and outcomes of studies assessing adherence. However, a well-validated scale designed particularly for OACD adherence is still lacking. Most adherence scales used in the studies reviewed contain items focused on measuring patients' medication-taking behavior more than their barriers to medication compliance and beliefs. However, non-adherence to OACDs is a complex phenomenon, and drug-taking barriers and patient beliefs significantly affect patients' non-adherence. To understand the key drivers and predisposing factors for non-adherence, we need to develop a well-validated, multidimensional scale.

  19. 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.

  20. 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.

  1. 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

  2. 76 FR 30727 - Food and Drug Administration Food Safety Modernization Act: Focus on Inspections and Compliance

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-26

    ... HUMAN SERVICES Food and Drug Administration Food and Drug Administration Food Safety Modernization Act: Focus on Inspections and Compliance AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public meeting; request for comments. SUMMARY: The Food and Drug Administration (FDA) is announcing a public...

  3. 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 Angeles...

  4. 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.…

  5. 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…

  6. 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.…

  7. 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…

  8. Compliance with safe handling guidelines of antineoplastic drugs in Jordanian hospitals.

    PubMed

    Al-Azzam, Sayer I; Awawdeh, Banan T; Alzoubi, Karem H; Khader, Yousef S; Alkafajei, Ahmed M

    2015-02-01

    To evaluate the compliance of healthcare workers with standard safety guidelines during the preparation and administrations of antineoplastic medications. A cross-sectional survey study. All hospitals in Jordan where healthcare workers are involved in preparation and administration of antineoplastic medications. All healthcare workers who are involved in preparation and administration of antineoplastic medications in Jordanian hospitals. A questionnaire that covered information about work place, healthcare workers, and use of personal protective equipments during handling of antineoplastic medications was self-filled by each participant. Compliance rates with workplace requirements, healthcare workers, and use of personnel protective equipments. Majority of participants (74.2%), representing nine out of 15 (60%) hospitals, reported full compliance of workplace with all requirements of the guidelines. Items with full compliance in all hospitals were availability of policies and procedures for safe handling of antineoplastic agents, availability of reporting system, and availability of sharp containers. Concerning healthcare workers' guidelines, worker with full compliance were 46.4% of participants. Items with least compliance rate were working inside biological safety cabinet (65.1%) and having training program on handling chemotherapy medications (66.7%). Finally, concerning items-related personal protective equipments, only 10.7% of participants reported full compliance. Items with least compliance rates were wearing goggles (eye protection), shoe cover, and hair cover. Results of this study showed the levels of compliance with guidelines pertaining to work place and workers who prepare and administer antineoplastic medications. Among other points, compliance with guidelines pertaining to wearing personnel protective equipments was limited and required further improvement. © The Author(s) 2014 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav.

  9. 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

  10. 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.)

  11. 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 ...

  12. 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.

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

    PubMed

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

    2015-04-01

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

  15. 76 FR 17138 - Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-28

    ... nursing education by the Pennsylvania State Nurses Association (PSNA), an accredited approver by the...? Possible FDA Compliance Actions; (13) Ethical Issues in Subject Enrollment; (14) Medical Device Aspects of...

  16. 75 FR 51824 - Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-23

    ...] [FR Doc No: 2010-20834] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good Clinical Practice; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION...

  17. 76 FR 51040 - Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-17

    ... Continuing Medical Education to provide continuing medical education for physicians. CNE for Nurses: SoCRA is...: Why, When, and How; (9) Investigator Initiated Research; (10) Medical Device Aspects of Clinical...--What Happens Next? Possible FDA Compliance Actions; (13) Ethical Issues in Subject Enrollment; (14...

  18. 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.

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

    PubMed Central

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

    2008-01-01

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

  20. What determines the duration of patient medication compliance in patients with chronic disease: are we looking in the wrong place?

    PubMed Central

    Sencan, Nazli Muzeyyen; Wertheimer, Albert; Levine, Chadd Brandon

    2011-01-01

    Objectives: The objective of this study was to do a pilot inquiry, to determine whether physicians with similar practices in the same neighborhood demonstrated any difference in the duration of compliance among their patients. Methods: Through a cooperating urban community pharmacy, patients with prescriptions for hypertension and type II diabetes were identified for this pilot study. Patients refill medication records were searched to determine the average number of months of drug regimen compliance. The patient data of the four local physicians were separated and compared. Results: One physician was able to generate refill durations nearly double that of the average duration of medication refills seen in the patients consulting the several other nearby physicians. Conclusion: In this pilot study, it was determined that there are differences in the compliance behavior of patients attending different physicians. We can conclude that some communication or personality characteristics of some physicians appear to be more successful in achieving higher compliance. Subsequent studies should identify those which may be at least partially responsible for this finding. PMID:23093889

  1. Knowledge and Practice Related to Compliance with Mass Drug Administration during the Egyptian National Filariasis Elimination Program

    PubMed Central

    Abd Elaziz, Khaled M.; El-Setouhy, Maged; Bradley, Mark H.; Ramzy, Reda M. R.; Weil, Gary J.

    2013-01-01

    Lymphatic filariasis (LF) has been targeted for global elimination by 2020. The primary tool for the program is mass drug administration (MDA) with antifilarial medications to reduce the source of microfilariae required for mosquito transmission of the parasite. This strategy requires high MDA compliance rates. Egypt initiated a national filariasis elimination program in 2000 that targeted approximately 2.7 million persons in 181 disease-endemic localities. This study assessed factors associated with MDA compliance in year three of the Egyptian LF elimination program. 2,859 subjects were interviewed in six villages. The surveyed compliance rate for MDA in these villages was 85.3% (95% confidence interval = 83.9–86.5%). Compliance with MDA was positively associated with LF knowledge scores, male sex, and older age. Adverse events reported by 18.4% of participants were mild and more common in females. This study has provided new information on factors associated with MDA compliance during Egypt's successful LF elimination program. PMID:23751402

  2. Deuterium oxide as a tracer for measurement of compliance in pediatric clinical drug trials

    SciTech Connect

    Rodewald, L.E.; Maiman, L.A.; Foye, H.R.; Borch, R.F.; Forbes, G.B.

    1989-05-01

    We tested the hypothesis that a deuterium oxide (D/sub 2/O) tracer could discriminate among patterns of clinically significant, imperfect compliance during drug trials. A model was developed to predict deuterium concentration during multiple dose regimens. After developing a regression equation to predict one of the model parameters for children, we selected healthy children (N = 20) at random to receive one of five 10-day D/sub 2/O regimens. Five urine samples were obtained from each child during 15 days and analyzed for deuterium level by mass spectrometry. Each child's height, weight, age, and the first four urinary deuterium levels were used to estimate the amount and timing of deuterium administration. These estimates were compared with the five regimens to determine the closest match between estimate and regimen. The closest matching regimen was the regimen actually administered to 19 (95%) of the 20 children. Two of these children had D/sub 2/O administration estimates that could be confused with another regimen. The correlation between the model's predicted levels and the measured levels of all urine samples was 0.96. We conclude that a D/sub 2/O tracer shows excellent promise as a quantitative method of assessing compliance with liquid medications under specified conditions.

  3. Drugs, medications and periodontal disease.

    PubMed

    Heasman, P A; Hughes, F J

    2014-10-01

    This paper reviews the effects that drugs may have on the gingival and periodontal tissues. Drug-induced gingival overgrowth has been recognised for over 70 years but is becoming a more prevalent occurrence with wider use of antihypertensive and immunosuppressant drugs. The anti-inflammatory steroids, non-steroidal drugs and anti-TNF-α agents might all be expected to exert a dampening effect on chronic periodontitis although the evidence is somewhat equivocal and none of these drugs has emerged as potentially valuable adjuncts to treat periodontal disease. Desquamative gingivitis is a clinical appearance of aggressive gingival inflammation with which a number of drugs have been associated and the oral contraceptives have also been implicated in the development of gingival inflammation. Patients who are prescribed bisphosphonates and anti-platelet drugs are at risk of serious side effects following more invasive dental procedures including extractions and surgical treatments although timely, conventional management of periodontal disease may be undertaken to reduce periodontal inflammation, prevent disease progression and ultimately the need for extractions.

  4. Mining FDA drug labels for medical conditions

    PubMed Central

    2013-01-01

    Background Cincinnati Children’s Hospital Medical Center (CCHMC) has built the initial Natural Language Processing (NLP) component to extract medications with their corresponding medical conditions (Indications, Contraindications, Overdosage, and Adverse Reactions) as triples of medication-related information ([(1) drug name]-[(2) medical condition]-[(3) LOINC section header]) for an intelligent database system, in order to improve patient safety and the quality of health care. The Food and Drug Administration’s (FDA) drug labels are used to demonstrate the feasibility of building the triples as an intelligent database system task. Methods This paper discusses a hybrid NLP system, called AutoMCExtractor, to collect medical conditions (including disease/disorder and sign/symptom) from drug labels published by the FDA. Altogether, 6,611 medical conditions in a manually-annotated gold standard were used for the system evaluation. The pre-processing step extracted the plain text from XML file and detected eight related LOINC sections (e.g. Adverse Reactions, Warnings and Precautions) for medical condition extraction. Conditional Random Fields (CRF) classifiers, trained on token, linguistic, and semantic features, were then used for medical condition extraction. Lastly, dictionary-based post-processing corrected boundary-detection errors of the CRF step. We evaluated the AutoMCExtractor on manually-annotated FDA drug labels and report the results on both token and span levels. Results Precision, recall, and F-measure were 0.90, 0.81, and 0.85, respectively, for the span level exact match; for the token-level evaluation, precision, recall, and F-measure were 0.92, 0.73, and 0.82, respectively. Conclusions The results demonstrate that (1) medical conditions can be extracted from FDA drug labels with high performance; and (2) it is feasible to develop a framework for an intelligent database system. PMID:23617267

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

    PubMed

    Chaudhary, Shivang A; Shahiwala, Aliasgar F

    2010-07-01

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

  6. College Students' Use of Compliance-Gaining Strategies to Obtain Prescription Stimulant Medications for Illicit Use

    ERIC Educational Resources Information Center

    Checton, Maria G.; Greene, Kathryn

    2011-01-01

    Objective: To examine college students' illicit use of prescription stimulant medications and compliance-gaining strategies that they would use to obtain a stimulant medication. Design: A questionnaire-based study. Setting: Seven hundred and twenty undergraduate college students at a large, northeastern university in the United States were…

  7. Medical utilization associated with palivizumab compliance in a commercial and managed medicaid health plan.

    PubMed

    Diehl, Jocelyn L; Daw, Jessica R; Coley, Kim C; Rayburg, Renee

    2010-01-01

    palivizumab during the 2006-2007 RSV season were compliant with dosing recommendations. Compliance was associated with a lower proportion of infants with at least 1 respiratory-related ER visit but not with any other study outcome, including the proportion of infants with at least 1 hospital admission or physician visit or any measure of RSV-related use. Median palivizumab per patient costs were higher for the compliant group, but there was no significant between-group difference in total median per patient cost (palivizumab drug plus respiratory-related medical cost).

  8. 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.

  9. Drug shortages: Implications for medical toxicology.

    PubMed

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

    2015-07-01

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

  10. 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

  11. 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

  12. The case for regulatory compliance of electronic medical records about human tissue intended for transplantation.

    PubMed

    Carrier, Robert

    2004-01-01

    It is vital that patients receiving human tissue by transplantation be able to trust in the suitability of the product. In short, patient safety must be ensured to the highest degree possible. To this end, firms operating tissue banks and those providing tissue donor coordination services are inspected by the U.S. Food and Drug Administration (FDA). The suitability of tissue for transplantation is objectively documented at all phases, beginning with donor screening. This process often involves the use of custom software applications that produce electronic medical records (EMRs) and databases that store the results. When a firm elects to keep the medical records relevant to human tissue products in electronic form, the record system must comply with applicable codified regulations. Unfortunately for the patient, many firms have yet to achieve regulatory compliance, and FDA enforcement is only beginning to approach the intensity appropriate to regulate this fast-growing industry. This article discusses current FDA trends in enforcement and rule-making related to human tissue intended for transplantation, as well as expectations the FDA has during an inspection.

  13. Teaching medication compliance to psychiatric residents: placing an orphan topic into a training curriculum.

    PubMed

    Weiden, Peter J; Rao, Nyapati

    2005-01-01

    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 about this vagueness among academic psychiatrists and to offer a suggested curriculum to facilitate implementation. The authors present a curriculum covering major aspects of the theory and practice of compliance. The proposed curriculum is divided into five core components that can be used together or separately. These components are: 1) definition of compliance and noncompliance; 2) understanding how compliance depends on efficacy; 3) assessment of compliance and noncompliance; 4) the importance of the therapeutic alliance; and 5) pharmacological and psychosocial strategies to improve compliance. These five sections can be modified into specific lectures that are added to ongoing psychopharmacology, psychiatric interviewing, or psychotherapy courses. A careful review of the American Board of Psychiatry and Neurology (ABPN) core curriculum found no mention of medication compliance/adherence as a specific training goal, and our residency program, like many others, did not have a specific course that focused on this issue. To address this omission, the authors designed and taught a five-session course for PGY-III and PGY-IV psychiatry residents that specifically addressed assessment and management of noncompliance. It was piloted in the 2003-2004 academic year. The course was very well received and formed the basis of this material presented in this review and discussion. The principles of understanding, assessing, and managing medication compliance should be a part of the core curriculum for every psychiatric residency training program.

  14. How useful is riboflavin as a tracer of medication compliance?

    PubMed

    Babiker, I E; Cooke, P R; Gillett, M G

    1989-02-01

    A quantitative spectrofluorometer assay of urinary riboflavin is described. Using the method, levels produced by prescribed riboflavin are reliably distinguished from normal background levels without requiring dietary restrictions. The method is successfully used to verify the intake of a single 50-mg dose of riboflavin. However, when more frequent dosage is used, verification becomes unreliable because of a "spillover" effect produced by the slow rate of elimination of the substance. This seriously limits the utility of riboflavin as a tracer, as does its tendency to change the appearance of therapeutic compounds into which it is incorporated. The need for further work on validating combined measures of compliance is stressed.

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

    PubMed Central

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

    2008-01-01

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

  16. 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

  17. 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.

  18. 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

  19. 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.

  20. 21 CFR 898.13 - Compliance dates.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Compliance dates. 898.13 Section 898.13 Food and 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...

  1. 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.

  2. [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.

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

    PubMed

    Sørensen, Janina Maria

    2002-06-01

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

  4. 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.

  5. 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…

  6. 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…

  7. 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.

  8. 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.…

  9. 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.…

  10. 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...

  11. 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.

  12. 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

  13. 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

  14. 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.

  15. 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

  16. 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.

  17. 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 the...

  18. Improvements in compliance with medical force protection measures by simplification of the anti-malarial chemoprophylaxis regime.

    PubMed

    Sellers, E L; Ross, D A; Green, A D

    2011-06-01

    Medical Force Protection (MFP) is important in keeping service personnel "fit to fight." It is particularly important for overseas deployment, where personnel are exposed to a range of infectious diseases. We report a full audit cycle assessing compliance with medical force protection measures, on an exercise in Belize. An anonymous questionnaire was administered to personnel four weeks after returning from an Infantry Overseas Training Exercise (OTX) in Belize in two successive years (OTX 1 & 2). Compliance with physical MFP measures (mosquito nets, insecticide soak of kit and personal insect repellent usage) was excellent on both exercises. Antimalarial chemoprophylaxis compliance with a regime of weekly chloroquine and daily proguanil was poor (30%) during OTX 1. Revision of the regime to weekly chloroquine alone following review of antimalarial policies increased compliance on OTX 2 to 67%. Simplification of dosage regimes, consistency of information provided between different medical briefs and emphasis of the threat from malaria in Belize significantly improved compliance with antimalarial chemoprophylaxis.

  19. 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...

  20. 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...

  1. 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...

  2. 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

  3. [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.

  4. 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

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

    PubMed

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

    2017-06-29

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

  6. Drug persistence and compliance affect patient-reported outcomes in overactive bladder syndrome.

    PubMed

    Kim, Tae Heon; Choo, Myung-Soo; Kim, Young-Joo; Koh, Hyein; Lee, Kyu-Sung

    2016-08-01

    To evaluate persistence and compliance for patients receiving antimuscarinics for overactive bladder (OAB), and to assess patient-reported outcomes (PROs) according to persistence and compliance. This was a 24-week, multicenter, prospective, observational study that included 952 OAB patients who had newly started antimuscarinics. Patients aged ≥18 years with a total OAB Symptom Score (OABSS) ≥3 and an urgency score of OABSS ≥2 were eligible for the study. Drug persistence and compliance were evaluated at 4, 12, and 24 weeks. Changes in scores on PROs were compared between groups (persistence vs. non-persistence and compliance vs. non-compliance) after 24 weeks. Factors contributing to persistence were examined using multivariate logistic regression. After 24 weeks, 56.8 % of patients remained on treatment. The persistence rates were 85.6 and 71.4 % after 4 and 12 weeks, respectively. The compliance rates were 75.6, 53.8, and 34.3 % after 4, 12, and 24 weeks, respectively. Patients who were persistent in taking antimuscarinics resulted in significant improvements in OABSS and OAB questionnaire short form score compared with those who were non-persistent (all p < 0.05). Changes from baseline in OABSS (p = 0.735) and the EuroQoL five-dimensions score (p = 0.384) were not significantly different between compliant and non-compliant groups. Predictors of high persistence included older age (OR 1.017, p = 0.007) and dry OAB (OR 1.422, p = 0.013). Patients who were persistent with antimuscarinics showed significant improvements in PROs compared to those who were non-persistent.

  7. Effect of drug information request templates on pharmacy student compliance with the modified systematic approach to answering drug information questions.

    PubMed

    Lavsa, Stacey M; Corman, Shelby L; Verrico, Margaret M; Pummer, Tara L

    2009-11-01

    The modified systematic approach to answering drug information questions is a technique used in drug information practice and in teaching pharmacy students to effectively provide drug information. Drug information request templates were developed to prompt students and other trainees to ask appropriate background questions and perform an effective search. An evaluation was conducted to determine whether use of drug information templates by fourth-year pharmacy students during their drug information experiential rotation improved compliance with the modified systematic approach. Fifty documented drug information requests, including 25 prior to template implementation (August 2005-August 2006) and 25 after template implementation (August 2007-August 2008), were randomly selected for evaluation. Each question was evaluated for completeness of background information obtained, categorization and identification of the ultimate question, completeness of references searched, and formulation of a concise response and an evidence-based recommendation. Background information was complete in 16% of pre-template questions and 92% of post-template questions (p < 0.001). Eighty-four percent of pre-template questions and 96% of post-template questions were appropriately categorized (p = 0.349). The requestor's ultimate question was clearly identified in 68% of pretemplate questions and 92% of post-template questions (p = 0.074). All necessary references were searched in 36% of pre-template questions and 88% of post-template questions (p < 0.001). A concise response was documented in 80% of pretemplate questions and 92% of post-template questions (p = 0.417). In questions determined to require a specific recommendation among the pre-template (n = 20) and post-template groups (n = 14), a clear and evidence-based recommendation was described in 40% (p = 0.038) and 79% (p = 0.038), respectively. Use of drug information request templates improves students' compliance with the modified

  8. 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...

  9. 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...

  10. 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...

  11. 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...

  12. 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.

  13. 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.

  14. 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

  15. 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…

  16. 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…

  17. 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.

  18. Automating Quality Metrics in the Era of Electronic Medical Records: Digital Signatures for Ventilator Bundle Compliance

    PubMed Central

    Lan, Haitao; Thongprayoon, Charat; Ahmed, Adil; Herasevich, Vitaly; Sampathkumar, Priya; Gajic, Ognjen; O'Horo, John C.

    2015-01-01

    Ventilator-associated events (VAEs) are associated with increased risk of poor outcomes, including death. Bundle practices including thromboembolism prophylaxis, stress ulcer prophylaxis, oral care, and daily sedation breaks and spontaneous breathing trials aim to reduce rates of VAEs and are endorsed as quality metrics in the intensive care units. We sought to create electronic search algorithms (digital signatures) to evaluate compliance with ventilator bundle components as the first step in a larger project evaluating the ventilator bundle effect on VAE. We developed digital signatures of bundle compliance using a retrospective cohort of 542 ICU patients from 2010 for derivation and validation and testing of signature accuracy from a cohort of random 100 patients from 2012. Accuracy was evaluated against manual chart review. Overall, digital signatures performed well, with median sensitivity of 100% (range, 94.4%–100%) and median specificity of 100% (range, 100%–99.8%). Automated ascertainment from electronic medical records accurately assesses ventilator bundle compliance and can be used for quality reporting and research in VAE. PMID:26167484

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

    PubMed

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

    2017-07-01

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

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

    PubMed

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

    2002-01-01

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

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

    PubMed

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

    2016-07-01

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

  2. 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.

  3. Medical and nonmedical users of prescription drugs among college students.

    PubMed

    Rozenbroek, Katelyn; Rothstein, William G

    2011-01-01

    To examine medical and nonmedical users of prescription opioids, central nervous system depressants, and stimulants taken individually and in combination. Undergraduates at an urban mid-Atlantic university with 12,000 students. A questionnaire administered in classes provided 413 responses, with a usable response rate of 94%. Nonmedical users obtained prescription drugs from friends and took them with friends. More nonmedical users than medical users took combinations of drugs. Nonmedical users did not show strong preferences for particular drugs. Nonmedical users compared to medical users who took only 1 drug were more likely to take stimulants and less likely to take opioids. The nonmedical use of prescription drugs by college students is a social activity that involves sharing drugs and taking combinations of drugs with friends. Discouraging nonmedical use must focus on the dangers of combining drugs, sharing drugs, and using social gatherings to consume drugs.

  4. 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.

  5. 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

    ... HUMAN SERVICES Food and Drug Administration Drug and Medical Device Forum on Food and Drug Administration Drug and Device Requirements and Supplier Controls; Public Educational Forum AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public educational forum. SUMMARY: The Food and Drug Administration...

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. Bibliometric Analysis of Medication Errors and Adverse Drug Events Studies.

    PubMed

    Huang, Hung-Chi; Wang, Cheng-Hua; Chen, Pi-Ching; Lee, Yen-Der

    2015-07-31

    Medication errors and adverse drug events are a key concern of the health-care industry. The objectives of this study were to map the intellectual structure of the studies of medication errors and adverse drug events and to investigate the developing path of this literature and interrelationships among the main topics. The Web of Science database was searched for documentation of medication errors and adverse drug events from 1961 to 2013. The most cited articles and references were profiled and analyzed using HistCite software to draw a historiograph and Ucinet software to draw a sociogram. The database search revealed 3343 medication errors and 3342 adverse drug event documents. The most cited articles on medication errors focused on 3 key themes from 1961 to 2013, namely, medication errors in adult inpatients, computerized physician order entry in medication error studies, and medication errors in pediatric inpatients. The developing path for the most cited articles about adverse drug events from 1987 to 2013 was as follows: detection, analysis, effect, and prevention from adult inpatient to pediatric inpatient settings and from hospitalized care to ambulatory care. In addition, social network analysis based on the most cited references revealed a close relationship between medication errors and adverse drug events. The mapping results provide a valuable tool for researchers to access the literature in this field and can be used to help identify the direction of medication errors and adverse drug events research.

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

    PubMed

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

    2014-10-01

    Increasing the adoption of electronic health records (EHRs) with integrated clinical decision support (CDS) is a key initiative of the current US healthcare administration. High over-ride rates of CDS alerts strongly limit these potential benefits. As a result, EHR designers aspire to improve alert design to achieve better acceptance rates. In this study, we evaluated drug-drug interaction (DDI) alerts generated in EHRs and compared them for compliance with human factors principles. We utilized a previously validated questionnaire, the I-MeDeSA, to assess compliance with nine human factors principles of DDI alerts generated in 14 EHRs. Two reviewers independently assigned scores evaluating the human factors characteristics of each EHR. Rankings were assigned based on these scores and recommendations for appropriate alert design were derived. The 14 EHRs evaluated in this study received scores ranging from 8 to 18.33, with a maximum possible score of 26. Cohen's κ (κ=0.86) reflected excellent agreement among reviewers. The six vendor products tied for second and third place rankings, while the top system and bottom five systems were home-grown products. The most common weaknesses included the absence of characteristics such as alert prioritization, clear and concise alert messages indicating interacting drugs, actions for clinical management, and a statement indicating the consequences of over-riding the alert. We provided detailed analyses of the human factors principles which were assessed and described our recommendations for effective alert design. Future studies should assess whether adherence to these recommendations can improve alert acceptance. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  13. 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.

  14. 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

  15. 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…

  16. Improved Hand Hygiene Compliance is Associated with the Change of Perception toward Hand Hygiene among Medical Personnel

    PubMed Central

    Park, Se Jeong; Chung, Moon Joo; Lee, Ju Hee; Kang, Hyun Joo; Lee, Jeong-a; Kim, Yong Kyun

    2014-01-01

    Background Hand hygiene compliance has improved significantly through hand hygiene promotion programs that have included poster campaign, monitoring and performance feedback, and education with special attentions to perceived subjective norms. We investigated factors associated with improved hand hygiene compliance, focusing on whether the improvement of hand hygiene compliance is associated with changed perception toward hand hygiene among medical personnel. Materials and Methods Hand hygiene compliance and perceptions toward hand hygiene among medical personnel were compared between the second quarter of 2009 (before the start of a hand hygiene promotion program) and the second quarter of 2012. We assessed adherence to hand hygiene among medical personnel quarterly according to the WHO recommended method for direct observation. Also, we used a modified self-report questionnaire to collect perception data. Results Hand hygiene compliance among physicians and nurses improved significantly from 19.0% in 2009 to 74.5% in 2012 (P < 0001), and from 52.3% to 91.2% (P < 0.001), respectively. These improvements were observed in all professional status or all medical specialties that were compared between two periods, regardless of the level of the risk for cross-transmission. Hand hygiene compliance among the medical personnel continued to improve, with a slight decline in 2013. Perceptions toward hand hygiene improved significantly between 2009 and 2012. Specifically, improvements were evident in intention to adhere to hand hygiene, knowledge about hand hygiene methods, knowledge about hand hygiene indications including care of a dirty and a clean body site on the same patient, perceived behavioral and subjective norms, positive attitude toward hand hygiene promotion campaign, perception of difficulty in adhering to hand hygiene, and motivation to improve adherence to hand hygiene. Conclusions The examined hand hygiene promotion program resulted in improved hand hygiene

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

    PubMed Central

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

    2012-01-01

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

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

    PubMed

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

    2015-11-12

    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. 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. Information from Drugs@FDA, ClinicalTrials.gov, MEDLINE-indexed journals and drug company communications. 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. 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. 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 compliance with legal and ethics standards and the quality of medical knowledge. Published by

  19. 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

  20. 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.

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

    PubMed

    McNulty, Judy; Donnelly, Eileen; Iorio, Kris

    2009-01-01

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

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

    PubMed Central

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

    2014-01-01

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

  3. Maternal medication, drug use, and breastfeeding.

    PubMed

    Rowe, Hilary; Baker, Teresa; Hale, Thomas W

    2015-01-01

    This article reviews the necessary skills required for clinicians to make informed decisions about the use of medications in breastfeeding women. Even without specific data on certain medications, this review of kinetic principles, mechanisms of medication entry into breast milk, and important infant factors can aid in clinical decision making. In addition, the article reviews common medical conditions (eg, depression, hypertension, infections) in breastfeeding women and their appropriate treatment. Copyright © 2015 Elsevier Inc. All rights reserved.

  4. 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.

  5. 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

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

    PubMed Central

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

    2013-01-01

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

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

    DTIC Science & Technology

    2009-06-02

    leaders increase their involvement in promoting compliance and accuracy, ensure users have adequate education regarding DMHRSi, and use an organizational ... change model to improve user compliance and accuracy throughout the organization.

  8. 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.

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

    PubMed

    Novello, Mayra Faria; Rosa, Maria Luiza Garcia; Ferreira, Ranier Tagarro; Nunes, Icaro Gusmão; Jorge, Antonio José Lagoeiro; Correia, Dayse Mary da Silva; Martins, Wolney de Andrade; Mesquita, Evandro Tinoco

    2017-02-01

    Hypertension is the most prevalent risk factor for cardiovascular disease, and its proper control can prevent the high morbidity and mortality associated with this disease. To assess the degree of compliance of antihypertensive prescriptions with the VI Brazilian Guidelines on Hypertension and the blood pressure control rate in primary care. Cross-sectional study conducted between August 2011 and November 2012, including 332 adults ≥ 45 years registered in the Family Doctor Program in Niteroi and selected randomly. The analysis included the prescribed antihypertensive classes, doses, and frequencies, as well as the blood pressure (BP) of the individuals. The rate of prescription compliance was 80%. Diuretics were the most prescribed medications, and dual therapy was the most used treatment. The most common non-compliances were underdosing and underfrequencies. The BP goal in all cases was < 140/90 mmHg, except for diabetic patients, in whom the goal was set at < 130/80 mmHg. Control rates according to these goals were 44.9% and 38.6%, respectively. There was no correlation between prescription compliance and BP control. The degree of compliance was considered satisfactory. The achievement of the targets was consistent with national and international studies, suggesting that the family health model is effective in BP management, although it still needs improvement. A hipertensão arterial é o fator de risco mais prevalente para a doença cardiovascular e seu controle adequado pode prevenir a elevada morbi-mortalidade associada a esta doença. Avaliar o grau de conformidade das prescrições de anti-hipertensivos com as VI Diretrizes Brasileiras de Hipertensão e a taxa de controle pressórico na atenção básica. Estudo transversal conduzido entre agosto de 2011 e novembro de 2012, incluindo 332 adultos ≥ 45 anos cadastrados no Programa Médico de Família de Niterói e selecionados aleatoriamente. Foram analisadas as classes de anti-hipertensivos prescritos

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

    PubMed

    Novello, Mayra Faria; Rosa, Maria Luiza Garcia; Ferreira, Ranier Tagarro; Nunes, Icaro Gusmão; Jorge, Antonio José Lagoeiro; Correia, Dayse Mary da Silva; Martins, Wolney de Andrade; Mesquita, Evandro Tinoco

    2017-02-13

    Hypertension is the most prevalent risk factor for cardiovascular disease, and its proper control can prevent the high morbidity and mortality associated with this disease. To assess the degree of compliance of antihypertensive prescriptions with the VI Brazilian Guidelines on Hypertension and the blood pressure control rate in primary care. Cross-sectional study conducted between August 2011 and November 2012, including 332 adults ≥ 45 years registered in the Family Doctor Program in Niteroi and selected randomly. The analysis included the prescribed antihypertensive classes, doses, and frequencies, as well as the blood pressure (BP) of the individuals. The rate of prescription compliance was 80%. Diuretics were the most prescribed medications, and dual therapy was the most used treatment. The most common non-compliances were underdosing and underfrequencies. The BP goal in all cases was < 140/90 mmHg, except for diabetic patients, in whom the goal was set at < 130/80 mmHg. Control rates according to these goals were 44.9% and 38.6%, respectively. There was no correlation between prescription compliance and BP control. The degree of compliance was considered satisfactory. The achievement of the targets was consistent with national and international studies, suggesting that the family health model is effective in BP management, although it still needs improvement. A hipertensão arterial é o fator de risco mais prevalente para a doença cardiovascular e seu controle adequado pode prevenir a elevada morbi-mortalidade associada a esta doença. Avaliar o grau de conformidade das prescrições de anti-hipertensivos com as VI Diretrizes Brasileiras de Hipertensão e a taxa de controle pressórico na atenção básica. Estudo transversal conduzido entre agosto de 2011 e novembro de 2012, incluindo 332 adultos ≥ 45 anos cadastrados no Programa Médico de Família de Niterói e selecionados aleatoriamente. Foram analisadas as classes de anti-hipertensivos prescritos

  12. 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

    ... 19 Customs Duties 2 2010-04-01 2010-04-01 false Compliance with Plant Quarantine Act and Federal Food, Drug, and Cosmetic Act. 147.23 Section 147.23 Customs Duties U.S. CUSTOMS AND BORDER PROTECTION, DEPARTMENT OF HOMELAND SECURITY; DEPARTMENT OF THE TREASURY (CONTINUED) TRADE FAIRS Requirements of Other...

  13. 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.

  14. 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.

  15. Medications and Characteristics of Drugs Causing Ototoxicity.

    ERIC Educational Resources Information Center

    Pappas, Dennis G.; Pappas, Dennis G., Jr.

    1997-01-01

    This article discusses medications which, by entering the confines of the inner ear, can be toxic and destroy the structures of hearing. Medications that may produce ototoxicity are explained and include aminoglycosides, quinine, salycilates, and diuretics. Factors that should be considered relating to ototoxicity are provided. Contains…

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

    PubMed

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

    2010-06-01

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

  18. 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.

  19. 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...

  20. 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...

  1. Psychostimulant drug abuse and personality factors in medical students.

    PubMed

    Bucher, Joshua T; Vu, Duc M; Hojat, Mohammadreza

    2013-01-01

    Psychostimulants have a high abuse potential and are appealing to college students for enhancing their examination performance. This study was designed to examine the prevalence of psychostimulant drug abuse among medical students and to test the hypothesis that medical students who use psychostimulant drugs for non-medical reasons are characterized by a sensation seeking and aggressive-hostility personality and exhibit lower empathy. The Zuckerman-Kuhlman personality questionnaire and the Jefferson scale of empathy were completed anonymously on-line by 321 medical students in 2010-2011 academic year. A total of 45 students (14%) reported that they had abused psychostimulant medications either before or during medical school. RESULTS of multivariate analysis of variance provided support for one of our research hypothesis: students who reported using psychostimulant compared to the rest, obtained a significantly higher average score on the aggressive-hostility personality factor. No other significant differences were observed. Further research is needed to confirm the rate of psychostimulant drug abusers among medical students in other medical schools. In particular, it is desirable to examine if such psychostimulant drug abusers are likely to abuse other substances in medical school and later in their professional career.

  2. Relationships between medical students and drug companies in New Zealand.

    PubMed

    Wyber, Rosemary; Fancourt, Nicholas; Stone, Bradley

    2011-08-26

    The relationships between doctors and drug companies have generated considerable global debate. Medical students are unique stakeholders in this discussion, although they are underrepresented in descriptive data. This article reviews international literature on the effects of drug company promotion, the effect on students, the New Zealand context and explores implications for New Zealand medical students. Creating an influence free environment to inform and involve students in the debate is a strong precursor to delivering gold standard patient care in the future.

  3. 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

  4. Knowledge of dietary restrictions and the medical consequences of noncompliance by patients on hemodialysis are not predictive of dietary compliance.

    PubMed

    Durose, Claire Louise; Holdsworth, Michelle; Watson, Vicki; Przygrodzka, Frances

    2004-01-01

    To investigate whether knowledge of the diet and medical consequences of noncompliance influences dietary compliance among patients on hemodialysis. An interviewer-administered questionnaire assessed patients' knowledge of foods restricted in their diet (four separate scores for knowledge of foods restricted for: potassium, phosphorus, sodium, and fluid); overall knowledge of restricted foods (one composite knowledge score); and knowledge of medical complications of dietary noncompliance (one composite knowledge score). Patients' mean monthly serum phosphorus and potassium and weight charts provided an estimate of dietary compliance. Seventy-one of the eligible 82 patients on hemodialysis at Nottingham City Hospital, Nottingham, UK, participated in the study (87% response rate). Chi(2) tests determined associations between dietary compliance and knowledge scores. More than one third of patients were noncompliant with at least one dietary restriction. Phosphorus dietary restrictions were the most commonly abused and potassium the least. Patients' knowledge of the medical consequences of noncompliance was poorer than knowledge of renal dietary restrictions (mean scores 29.4%; 74.7%). There was no association between compliance with potassium or sodium/fluid restrictions and knowledge of these dietary restrictions. However, patients with better knowledge about phosphorus were less likely to be compliant (P=.03). Patients with better knowledge about the medical complications of noncompliance were less likely to be compliant for phosphorus (P=.002) and sodium/fluid (P=.008) restrictions. These findings question the value of current dietary education techniques in motivating patients to comply with dietary restrictions. Instead of the more traditional approach of information-giving, effective educational methods that focus on motivating patients to comply with dietary restrictions are needed to improve compliance.

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

    PubMed

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

    2012-01-01

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

  6. 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

  7. 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…

  8. 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

  9. Medical cost offsets from prescription drug utilization among Medicare beneficiaries.

    PubMed

    Roebuck, M Christopher

    2014-10-01

    This brief commentary extends earlier work on the value of adherence to derive medical cost offset estimates from prescription drug utilization. Among seniors with chronic vascular disease, 1% increases in condition-specific medication use were associated with significant (P  less than  0.001) reductions in gross nonpharmacy medical costs in the amounts of 0.63% for dyslipidemia, 0.77% for congestive heart failure, 0.83% for diabetes, and 1.17% for hypertension.

  10. Medical resident choices of electronic drug information resources.

    PubMed

    Hughes, Gregory J; Patel, Priti; Mason, Christopher

    2015-06-01

    To determine medical residents' day-to-day use of drug information resources since their choices of these resources, when faced with common questions, are unknown. An online survey including simulated drug information questions was administered to 146 medical residents in the Department of General Internal Medicine during July 2012. Residents were given a wide range of choices in drug information resources to answer these questions and were instructed to select what they would choose in actual practice. A score was assigned to each resource corresponding to a "best," "intermediate," or "not good" choice. Seventy-three respondents completed the survey and results were analyzed for statistical significance. Fifty-seven percent of respondents reported receiving no formal training regarding drug information. Statistical analyses revealed there were no significant differences in performance based on postgraduate year (P = .43) or extent of prior training (P = .45). Individual question responses revealed a generally infrequent selection of "best" choices. Less than 10% of the respondents chose the "best" answer for drug information questions related to drug interactions, herbal supplements, adverse events, and medication identification. Further training in drug information resource selection is warranted in the medical residency program to increase the frequency of use of higher quality resources. © The Author(s) 2014.

  11. Increasing Compliance with Mass Drug Administration Programs for Lymphatic Filariasis in India through Education and Lymphedema Management Programs

    PubMed Central

    Cantey, Paul T.; Rout, Jonathan; Rao, Grace; Williamson, John; Fox, LeAnne M.

    2010-01-01

    Background Nearly 45% of people living at risk for lymphatic filariasis (LF) worldwide live in India. India has faced challenges obtaining the needed levels of compliance with its mass drug administration (MDA) program to interrupt LF transmission, which utilizes diethylcarbamazine (DEC) or DEC plus albendazole. Previously identified predictors of and barriers to compliance with the MDA program were used to refine a pre-MDA educational campaign. The objectives of this study were to assess the impact of these refinements and of a lymphedema morbidity management program on MDA compliance. Methods/Principal Findings A randomized, 30-cluster survey was performed in each of 3 areas: the community-based pre-MDA education plus community-based lymphedema management education (Com-MDA+LM) area, the community-based pre-MDA education (Com-MDA) area, and the Indian standard pre-MDA education (MDA-only) area. Compliance with the MDA program was 90.2% in Com-MDA+LM, 75.0% in Com-MDA, and 52.9% in the MDA-only areas (p<0.0001). Identified barriers to adherence included: 1) fear of side effects and 2) lack of recognition of one's personal benefit from adherence. Multivariable predictors of adherence amenable to educational intervention were: 1) knowing about the MDA in advance of its occurrence, 2) knowing everyone is at risk for LF, 3) knowing that the MDA was for LF, and 4) knowing at least one component of the lymphedema management techniques taught in the lymphedema management program. Conclusions/Significance This study confirmed previously identified predictors of and barriers to compliance with India's MDA program for LF. More importantly, it showed that targeting these predictors and barriers in a timely and clear pre-MDA educational campaign can increase compliance with MDA programs, and it demonstrated, for the first time, that lymphedema management programs may also increase compliance with MDA programs. PMID:20628595

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

    PubMed Central

    Carroll, Kathleen M.; Rounsaville, Bruce J.

    2008-01-01

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

  13. Drug advertisements published in Indian Medical Journals: Are they ethical?

    PubMed

    Charan, Jaykaran; Yadav, Preeti; Saxena, Deepak; Kantharia, N D

    2011-07-01

    It is observed in studies done for western medical journals that insufficient information related to drug is usually provided in the drug advertisements published in them. As data for advertisements published in Indian Medical Journals were lacking, this study was designed with the aim of evaluating drug advertisements published in Indian Medical Journals for adequacy of information on drug and references given to support the claim made in the advertisements. Cross-sectional survey. All medical journals related to clinical practice subscribed by the Central Library of Government Medical College, Surat, (Indian Journal of Pediatrics [IJP], Indian Pediatrics [IP], Journal of the Association of Physicians of India [JAPI], Journal of Indian Medical Association [JIMA], Indian Journal of Critical Care Medicine [IJCCM], Indian Journal of Medical and Pediatric Oncology [IJMPO], Indian Journal of Gastroenterology [IJG], Indian Journal of Ophthalmology [IJO], and Journal of Obstetrics and Gynecology of India [JOGI] were evaluated for adequacy of reporting of various parameters in drug advertisements published in these journals on the basis of "World Heath Organization (WHO)" criteria. References mentioned to support claims were also evaluated. Descriptive statistics was used to describe data as frequencies, percentages, and 95% confidence interval around the percentage. Generic name was mentioned in 90% advertisements. Indications were mentioned in 84% advertisements. Dose, precautions, and contraindications were mentioned in 24%, 17%, and 16% advertisements, respectively. Adverse effects and postal address of pharmaceutical company was mentioned in 19% and 74% advertisements, respectively. Price was mentioned in only 5% advertisements. Only 28% claims were supported by references. Most common references were Journal articles (75%). Drug advertisements published in Indian Medical Journals are poor in reporting various parameters according to WHO criteria.

  14. Discrimination Between Drug Abuse and Medical Therapy

    PubMed Central

    Akhgari, Maryam; Jokar, Farzaneh; Etemadi-Aleagha, Afshar; Ghasemi, Ali

    2017-01-01

    Tranylcypromine is an effective antidepressant from the class of monoamine oxidase inhibitors and is structurally related to amphetamine. However, reports differ regarding the potential metabolism of tranylcypromine to amphetamine and methamphetamine within the human body. We report a 25-year-old woman with severe depression who died due to a fatal tranylcypromine overdose in 2016. She had been prescribed tranylcypromine one day previously and had no history of previous suicide attempts or substance abuse. The body was transferred to a forensic medicine department in Tehran, Iran for the autopsy. A urine sample was positive for tranylcypromine, amphetamine and methamphetamine using gas chromatography/mass spectrometry after derivatisation with heptafluorobutyric acid. As amphetamines were present in the urine sample, it was assumed that the tranylcypromine had been converted to amphetamines metabolically. As such, it is possible that the legitimate use of certain prescription drugs may complicate the interpretation of test results for illegal drugs. PMID:28690895

  15. 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.

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

    PubMed

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

    2016-01-01

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

  17. Social mobilisation, drug coverage and compliance and adverse reactions in a Mass Drug Administration (MDA) Programme for the Elimination of Lymphatic Filariasis in Sri Lanka

    PubMed Central

    Weerasooriya, Mirani V; Yahathugoda, Channa T; Wickramasinghe, Darshana; Gunawardena, Kithsiri N; Dharmadasa, Rohan A; Vidanapathirana, Kanchana K; Weerasekara, Saman H; Samarawickrema, Wilfred A

    2007-01-01

    Background In Sri Lanka filariasis is endemic in Southern, Western and North Western provinces covering eight districts designated as implementation units in the Programme for the Elimination of Lymphatic Filariasis (PELF). Despite control activities over sixty years including multidose diethylcarbamazine, 6 mg/kg treatment microfilaria rates had persisted at low levels. Following systematic social mobilisation the first MDA with DEC albendazole combination was conducted in 2002. Methods We investigated the extent social mobilisation had reached the people, their drug compliance and adverse reactions. Three localities were selected from each district to pick target population samples for pre-tested questionnaire. Three teams each with six people visited one district each day. One team worked from three starting points in one locality. A member applied eight part questionnaire to one family member totalling 150–160 people from one locality. Questions included social mobilisation, drug compliance and adverse reactions. Results Information was disseminated by television, radio, banners and leaflets, to a lesser extent by people. Information reached more people in the periphery than in Colombo. 35.2% from Colombo municipality were unaware of the MDA. Drug coverage was 79.6%, home delivery 71.7% and delivery centres 7.9%. 35.6% in Colombo district and 53.4% from Colombo municipality did not receive drugs. Drugs were consumed by 71.4%. 28.6% who did not comply included 20.4% who did not receive them. 91.4% showed no adverse reactions, 7.5% were mild, 1.1% recovered with home remedies. Conclusion Drug compliance showed significant positive correlation with awareness of the MDA. Door to door delivery was more successful than delivery from centres. More delivery centres conveniently located would have rectified this disparity. Poor awareness and compliance in Colombo and urban areas could be rectified with separate strategy for urban areas. More time for MDA and trained

  18. Estimation of Severe Drug-Drug Interaction Warnings by Medical Specialist Groups for Austrian Nationwide eMedication

    PubMed Central

    Sauter, S. K.; Neuhofer, L. M.; Edlinger, D.; Grossmann, W.; Wolzt, M.; Endel, G.; Gall, W.

    2014-01-01

    Summary Objective The objective of this study is to estimate the amount of severe drug-drug interaction warnings per medical specialist group triggered by prescribed drugs of a patient before and after the introduction of a nationwide eMedication system in Austria planned for 2015. Methods The estimations of interaction warnings are based on patients’ prescriptions of a single health care professional per patient, as well as all patients’ prescriptions from all visited health care professionals. We used a research database of the Main Association of Austrian Social Security Organizations that contains health claims data of the years 2006 and 2007. Results The study cohort consists of about 1 million patients, with 26.4 million prescribed drugs from about 3,400 different health care professionals. The estimation of interaction warnings show a heterogeneous pattern of severe drug-drug-interaction warnings across medical specialist groups. Conclusion During an eMedication implementation it must be taken into consideration that different medical specialist groups require customized support. PMID:25298801

  19. Estimation of severe drug-drug interaction warnings by medical specialist groups for Austrian nationwide eMedication.

    PubMed

    Rinner, C; Sauter, S K; Neuhofer, L M; Edlinger, D; Grossmann, W; Wolzt, M; Endel, G; Gall, W

    2014-01-01

    The objective of this study is to estimate the amount of severe drug-drug interaction warnings per medical specialist group triggered by prescribed drugs of a patient before and after the introduction of a nationwide eMedication system in Austria planned for 2015. The estimations of interaction warnings are based on patients' prescriptions of a single health care professional per patient, as well as all patients' prescriptions from all visited health care professionals. We used a research database of the Main Association of Austrian Social Security Organizations that contains health claims data of the years 2006 and 2007. The study cohort consists of about 1 million patients, with 26.4 million prescribed drugs from about 3,400 different health care professionals. The estimation of interaction warnings show a heterogeneous pattern of severe drug-drug-interaction warnings across medical specialist groups. During an eMedication implementation it must be taken into consideration that different medical specialist groups require customized support.

  20. 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.

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

    PubMed Central

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

    1976-01-01

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

  2. [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

  3. Drug consumption by medical students in Tegucigalpa, Honduras.

    PubMed

    Buchanan, Juana Carolina; Pillon, Sandra Cristina

    2008-01-01

    The use of drugs, in Honduras, involves 25% of college students. The most used substances include legal and recreational drugs, such as alcohol. This study aimed to identify the use of drugs and socio-demographic factors in a sample of 260 medical students. Average age of 20 years old, unemployed and religious women, single, with no children. Alcohol was the most consumed drug in the last six months for recreational purposes. The following stimulants were frequently consumed: caffeine, mate herb tea, energetic drinks and Coke. Drugs like marijuana, cocaine, valium and sedatives were used in smaller proportions. The reasons reported by women were: to alleviate tiredness and improve their academic performance. The men's reasons were recreation and to alleviate psychological tension. This research has implications for the development of drugs prevention programs in universities.

  4. Formulation development and evaluation of medicated chewing gum of anti-emetic drug

    PubMed Central

    Paradkar, Mansi; Gajra, Balaram; Patel, Bhautik

    2015-01-01

    Context: Medicated chewing gum (MCG) of Domperidone Maleate (DM) was developed by direct compression method with the goal to achieve quick onset of action and to improve patient compliance. Objective: Formulation development of MCG of DM and optimization of the formulation by screening of different excipients. Material and methods: MCG containing DM was prepared by screening different concentrations of sweeteners, flavouring agents, softening agents, lubricants and anti-adherents by changing one variable at a time. Performance evaluation was carried out by evaluating size, shape, thickness, taste, scanning electron microscopy, texture analysis, in vivo drug release study, ex vivo buccal permeation study and by studying statistical analysis for quality. Results and discussion: The statistical analysis showed significant improvement in organoleptic properties such as chewable mass, product taste, product consistency, product softness, total flavour lasting time and pharmaceutical properties like micromeritic properties after incorporation of appropriate excipients in an optimum amount in final optimized MCG formulation. In vivo drug release study showed 97% DM release whereas ex vivo buccal permeation study through goat buccal mucosa exhibited 11.27% DM permeation within 15 min indicating its potential for increasing bioavailability by decreasing time of onset. The optimized formulation showed good surface properties and the peak load required for drug release was found to be acceptable for crumbling action. Conclusion: The developed formulation of medicated chewing gum can be a better alternative to mouth dissolving and conventional tablet formulation. It may be proved as a promising approach to improve the bioavailability as well as to improve patient compliance. PMID:27013908

  5. 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

  6. Prescriber compliance with black box warnings in older adult patients.

    PubMed

    Ricci, Judith R; Coulen, Charmaine; Berger, Jan E; Moore, Marsha C; McQueen, Angela; Jan, Saira A

    2009-11-01

    Patients prescribed medications with US Food and Drug Administration-issued black box warnings (BBWs) warrant additional vigilance by prescribers because these drugs can cause serious adverse drug events. Seniors are at greater risk for adverse drug events due to increased medication burden and greater health vulnerability. To improve our understanding of the prescribing and patient-monitoring practices of physicians prescribing medications with a BBW to patients age >or=65 years in an ambulatory care setting. A retrospective cohort study of administrative pharmacy and medical claims identified 58,190 patients age >or=65 years in the Horizon Blue Cross Blue Shield of New Jersey beneficiary population with >or=1 claim for >or=1 of the 8 targeted medications between January 1, 2005, and December 31, 2005. Medications included carbamazepine, amiodarone, ketoconazole, loop diuretics, methotrexate, cyclosporine, metformin and combinations, and cilostazol. Patients were followed 12 months from the index prescription date to evaluate prescriber compliance with BBWs using operationalized definitions of compliance. Patients prescribed drugs with a drug-laboratory warning had lower rates of prescriber BBW compliance (0.7%-24.9%) than patients prescribed drugs with a drug-disease warning (84.7%-90.2%). Administrative claims analysis identified low rates of prescriber compliance with BBWs in managing patients age >or=65 years. Claims analysis may be a cost-effective strategy to monitor prescriber compliance with BBWs in older patients at higher risk.

  7. 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.

  8. [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.

  9. [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.

  10. [Quality recording of information in the health centre medical records on the use of analgesic and anti-inflammatory drugs].

    PubMed

    González-Navarro, M D; Gómez-Zapata, M; Pérez-Cárceles, M D; Poveda-Siles, S; Luna-Maldonado, A

    2012-01-01

    To examine medical records within a health centre to determine whether there are data in the information process on the secondary effects and interactions of analgesic and anti-inflammatory drugs, and to determine the patient profile as regards whether or not this information is recorded in their medical records. Descriptive, cross-sectional study based on electronic medical records in the Mariano Yago Primary Care Centre in Yecla (Murcia), Spain. A systematic random sample of 232 electronic medical records was reviewed. All the 232 patients, of legal age, gave their consent to review of their electronic medical records for the purposes of the study. The percentage of doctors who recorded the fact that they had provided information regarding secondary effects and non-compatibilities of the prescription of analgesic and antiinflammatory drugs was 21.6%. The factors involved in the non- recording of this information in the medical record were the type of prescription, the type of analgesic and anti-inflammatory drug prescribed, glomerular filtration, and adequate gastrointestinal protection. The degree of compliance to patients rights to information about treatment with analgesic and anti-inflammatory drugs is low.

  11. 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

    ... Committee; Medical Imaging Drugs Advisory Committee AGENCY: Food and Drug Administration, HHS. ACTION... on the Medical Imaging Drugs Advisory Committee in the Center for Drug Evaluation and Research. FDA... requesting nominations for voting members on the Medical Imaging Drugs Advisory Committee (the Committee...

  12. 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

  13. Prescription Drug Labeling Medication Errors: A Big Deal for Pharmacists

    PubMed Central

    Jeetu, G; Girish, T

    2010-01-01

    Today, in the health care profession, all types of medication errors including missed dose, wrong dosage forms, wrong time interval, wrong route, etc., are a big deal for better patient care. Today, problems related to medications are common in the healthcare profession, and are responsible for significant morbidity, mortality, and cost. Several recent studies have demonstrated that patients frequently have difficulty in reading and understanding medication labels. According to the Institute of Medicine report, “Preventing Medication Errors”, cited poor labeling as a central cause for medication errors in the USA. Evidence suggests that specific content and format of prescription drug labels facilitate communication with and comprehension by patients. Efforts to improve the labels should be guided by such evidence, although an additional study assessing the influence of label design on medication-taking behavior and health outcomes is needed. Several policy options exist to require minimal standards to optimize medical therapy, particularly in light of the new Medicare prescription drug benefit. PMID:21331202

  14. 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

    ... maximum of 13.3 Continuing Education (CE) credits for SoCRA CE and Nurse continuing nursing education (CNE...--What Happens Next? Possible FDA Compliance Actions; (13) Ethical Issues in Subject Enrollment; (14...

  15. 77 FR 8886 - Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-15

    .... CNE for Nurses: SoCRA is an approved provider of continuing nursing education by the Pennsylvania... Inspection is Over--What Happens Next? Possible FDA Compliance Actions; (13) Ethical Issues in Subject...

  16. Suicide and Drug Abuse in the Medical Community

    ERIC Educational Resources Information Center

    Bressler, Bernard

    1976-01-01

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

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

    PubMed

    Yang, Hu; Leffler, Christopher T

    2013-03-01

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

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

    PubMed Central

    Carson, Brittany; Moller, Helene; Hill, Suzanne

    2010-01-01

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

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

    PubMed

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

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

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

    PubMed

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

    2005-04-01

    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.

  1. 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

  2. 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.

  3. 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.

  4. 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…

  5. 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…

  6. 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....

  7. Medication takeovers: Covert druggings and behavioral control in Alzheimer's.

    PubMed

    Berry, Brandon; Apesoa-Varano, Ester Carolina

    2017-09-01

    Older adults consume the most prescription medication in the U.S. For those who develop Alzheimer's disease, risk of medication misuse increases with the progression of the disease. Family members commonly intervene to lessen risks by taking over the management and administering of a medication regimen. Despite the potential for grave harm around the misuse of powerful drugs, few studies provide insight into the household social context of medication use for this disease. Drawing on 60 in-depth interviews conducted in four waves over 2.5 years, this study investigates how family members administered prescription and over-the-counter medications to elders with Alzheimer's. The findings detail how family members initially created and enacted the role of proxy-administrator to avoid self-administration errors and then expanded the role to manage disruptive behaviors. During this process, family members perceived themselves as working in partnership with doctors, especially in the effort to craft a regimen that controlled the affected individual's mood and sleep/wake cycle. The paper concludes by discussing the implications that family members used medications to improve conformity to a preferred household social order. The study offers conceptual advances in understanding 1) the process of proxy-administration in Alzheimer's care and 2) the role of proxy-administrators in the medicalization of deviant behavior. Copyright © 2017 Elsevier Ltd. All rights reserved.

  8. Medical management and antiepileptic drugs in hypothalamic hamartoma.

    PubMed

    Helen Cross, J; Spoudeas, Helen

    2017-06-01

    Hypothalamic hamartoma may present with epilepsy, specifically gelastic or dacrystic seizures, or endocrine dysfunction, commonly precocious puberty. The epilepsy in many patients is drug resistant, and has a high association with progressive cognitive, learning and behavioral difficulty. Medical treatment of seizures remains problematic, with many resistant to drug treatment. Surgical resection, or disconnection of the hamartoma provides the optimal chance of seizure control but with a relatively high risk of endocrine dysfunction, the result of interference with the hypothalamic-pituitary axis in many. Careful assessment and monitoring by specialist centers with discussion of optimal intervention is required for individual cases. Wiley Periodicals, Inc. © 2017 International League Against Epilepsy.

  9. Drug advertisements and the medicalization of unipolar depression in women.

    PubMed

    Nikelly, A G

    1995-01-01

    Unipolar depression occurs twice as frequently among women as among men, and the pharmacological industry maintains a massive advertising campaign that encourages psychiatric professionals to rely on antidepressant medication as the solution to this problem. The pictorial content of drug advertisements shows women as victims of depression. The social problems and situational stresses associated with unipolar depression are never shown, and depression is assumed to be a personal and biological illness, its etiology decontextualized. In these advertisements, women are not offered a choice between medical and nonmedical treatment and are not empowered to become more active participants in their health decisions. Therapists are urged to become alert to this oversimplification.

  10. [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

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

    PubMed

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

    2015-01-01

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

  12. 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

  13. Overview: medications development for the treatment of drug abuse.

    PubMed

    Vocci, F; Chiang, C N; Cummings, L; Hawks, R

    1995-01-01

    Drug abuse is of great public concern, and effective treatment strategies for opiate and cocaine dependence are urgently needed for the general addict population as well as for pregnant women and their infants. NIDA's effort to develop new pharmacotherapies as an adjunct to the treatment of opiate addiction has already led to the approval of LAAM and an NDA development program for buprenorphine. The momentum achieved by the new Medications Development Program's success with opiate addiction treatment must now be applied to the development of new treatments for cocaine addiction. With recent advances in neuroscience, imaging techniques, and pharmaceutical technology, the development of medications for significantly improving drug abuse treatment in a variety of directions holds real promise.

  14. 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

  15. 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

  16. 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.

  17. 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.

  18. 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.

  19. 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.

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

    PubMed Central

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

    2006-01-01

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

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

    PubMed

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

    2017-10-01

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

  2. The costs of compliance.

    PubMed

    Leeman, Eve

    2007-01-01

    While the many costs of noncompliance have frequently been reviewed, this article addresses some of the costs of compliance, to the detriment of patients, doctors, and the doctor-patient relationship, and to the benefit of the pharmaceutical companies. Some psychiatric history is reviewed to analyze why psychiatric practice has become so focused on making specific diagnoses and treating those with specific medicines, even as fewer than 50% of patients follow medical advice. Some evidence for specific drug treatments is presented, and the powerful effects of nonspecific therapies, usually dismissed as confounders, are explored. Lastly, an argument for collaboration rather than compliance is made, imploring physicians to tailor individual treatment to each patient, and encouraging patients to be active in their own care.

  3. 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.

  4. Choice of Initial Antiepileptic Drug for Older Veterans: Possible Pharmacokinetic Drug Interactions With Existing Medications

    PubMed Central

    Pugh, Mary Jo V.; VanCott, Anne C.; Steinman, Michael A.; Mortensen, Eric M.; Amuan, Megan E.; Wang, Chen-Pin; Knoefel, Janice E.; Berlowitz, Dan R.

    2014-01-01

    Objectives Identify clinically-meaningful potential drug-drug interactions with antiepileptic drugs (AED-PDI), the AEDs and co-administered drugs commonly associated with AED-PDI, and characteristics of patients with increased likelihood of AED-PDI exposure. Design Five-year retrospective cohort study of veterans with new-onset epilepsy. Setting National VA and Medicare databases. Participants Veterans age 66 years and older with a new diagnosis of epilepsy between October 1, 1999-September 30, 2004 (N=9,682). Measurements We restricted AED-PDI to clinically-meaningful potential drug interactions identified by prior literature review. AED-PDI were identified using participants' date of initial AED prescription and overlapping concomitant medications. Logistic regression analysis identified factors associated with AED-PDI including demographic characteristics, chronic disease states and diagnostic setting. Results AED-PDI exposure was found in 45.5% (4,406/9,682); phenytoin, a drug with many potential drug interactions, was the most commonly prescribed AED. Cardiovascular drugs, lipid-lowering medications and psychotropic agents were the most commonly co-administered AED-PDI medications. Individuals at higher likelihood of AED-PDI exposure had 1) hypertension (OR=1.46, 99% CI 1.24-1.82), 2) hypercholesterolemia (OR=1.40, 99% CI 1.24-1.57) and 3) were diagnosed in emergency or primary care vs. Neurology settings (emergency OR: 1.30 99% CI=1.08-1.58; primary care OR: 1.29 99% CI 1.12-1.49). Conclusion Exposure to AED-PDI was substantial, but less common in epilepsy patients diagnosed in a neurology setting. Because potential outcomes associated with AED-PDI include stroke and myocardial infarction in a population already at elevated risk, clinicians should closely monitor blood pressure, coagulation, and lipid measures to minimize adverse effects of AED-PDI. Interventions to reduce AED-PDI may improve patient outcomes. PMID:20398114

  5. 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.

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

    PubMed

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

    2017-07-01

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

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

    PubMed

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

    2006-12-01

    Prescribing drugs is a key responsibility of a doctor and requires a solid grounding in the relevant scientific disciplines of pharmacology and therapeutics (PT). The move away from basic science disciplines towards a more system-based and integrated undergraduate curriculum has created difficulties in the delivery of PT teaching in some medical schools. We aimed to develop a web-based strategy to overcome these problems and improve the PT learning experience. We designed and introduced 'eDrug', a dynamic interactive web-based student formulary, as an aid to teaching and learning of PT throughout a 5-year integrated medical curriculum in a UK medical school of 1300 students. This was followed by a prospective observational study of student-reported views about its impact on their PT learning experience. eDrug was rated highly by students and staff, with the main benefits being increased visibility of PT in the curriculum, clear identification of core drugs, regular sourcing of drug information via direct links to accredited sources including the British National Formulary, prioritization of learning, immediate access and responsiveness. It has also served as a focus of discussion concerning core PT learning objectives amongst staff and students. Web-based delivery of PT learning objectives actively supports learning within an integrated curriculum.

  8. Interventions do not enhance medication persistence and compliance in patients with overactive bladder: a 24 weeks, randomised, open-label, multi-center trial.

    PubMed

    Sung, H H; Han, D H; Kim, T H; Lee, Y-S; Lee, H N; Seo, J T; Choo, M-S; Lee, K-S

    2015-11-01

    Anticholinergics are currently the mainstay for the management of overactive bladder (OAB). However, low drug adherence has been noted with these medications. The aim of this study was to determine whether a health education intervention (HEI) could improve drug persistence with anticholinergics in OAB patients. We enrolled 682 OAB patients who were randomly distributed into either the HEI plus fesoterodine (HEI) group or the fesoterodine alone (control) group. The HEI consists of four education sections: understanding OAB disease, dietary control, bladder training and understanding anticholinergics. The primary end-point was the difference in drug persistence between the HEI and control groups at 24 weeks. Persistence was defined as a gap ≤ 30 days between successive prescription pills. Among the 682 patients, 210 (30.8%) completed 24 weeks of study. Persistence of the HEI group at 6 months was not statistically higher than that of the control group (40.4% vs. 34.9%, p = 0.181). Compliance at 6 months was also similar between the two groups (38.5% vs. 32.5%, p = 0.128). Using OAB symptom score questionnaire, the efficacy of the two groups was not different at each follow-up (p > 0.05). The global response was similar between the two groups. However, the HEI group was more satisfied with treatment than the control group (p = 0.034). The most common reason for discontinuation was satisfaction with the treatment so that they did not need to follow-up, followed by inadequate efficacy in both groups. Adverse events were reported in 12.3% of patients. The health education intervention was not effective to increase drug persistence in OAB patients on anticholinergics. © 2015 John Wiley & Sons Ltd.

  9. 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

  10. 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

  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. 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...

  14. Teaching exercise of drug utilization by medical students.

    PubMed

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

    2005-01-01

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

  15. Effectiveness of adverse effects search filters: drugs versus medical devices

    PubMed Central

    Farrah, Kelly; Mierzwinski-Urban, Monika; Cimon, Karen

    2016-01-01

    Objective The study tested the performance of adverse effects search filters when searching for safety information on medical devices, procedures, and diagnostic tests in MEDLINE and Embase. Methods The sensitivity of 3 filters was determined using a sample of 631 references from 131 rapid reviews related to the safety of health technologies. The references were divided into 2 sets by type of intervention: drugs and nondrug health technologies. Keyword and indexing analysis were performed on references from the nondrug testing set that 1 or more of the filters did not retrieve. Results For all 3 filters, sensitivity was lower for nondrug health technologies (ranging from 53%–87%) than for drugs (88%–93%) in both databases. When tested on the nondrug health technologies set, sensitivity was lower in Embase (ranging from 53%–81%) than in MEDLINE (67%–87%) for all filters. Of the nondrug records that 1 or more of the filters missed, 39% of the missed MEDLINE records and 18% of the missed Embase records did not contain any indexing terms related to adverse events. Analyzing the titles and abstracts of nondrug records that were missed by any 1 filter, the most commonly used keywords related to adverse effects were: risk, complications, mortality, contamination, hemorrhage, and failure. Conclusions In this study, adverse effects filters were less effective at finding information about the safety of medical devices, procedures, and tests compared to information about the safety of drugs. PMID:27366123

  16. Effectiveness of adverse effects search filters: drugs versus medical devices.

    PubMed

    Farrah, Kelly; Mierzwinski-Urban, Monika; Cimon, Karen

    2016-07-01

    The study tested the performance of adverse effects search filters when searching for safety information on medical devices, procedures, and diagnostic tests in MEDLINE and Embase. The sensitivity of 3 filters was determined using a sample of 631 references from 131 rapid reviews related to the safety of health technologies. The references were divided into 2 sets by type of intervention: drugs and nondrug health technologies. Keyword and indexing analysis were performed on references from the nondrug testing set that 1 or more of the filters did not retrieve. For all 3 filters, sensitivity was lower for nondrug health technologies (ranging from 53%-87%) than for drugs (88%-93%) in both databases. When tested on the nondrug health technologies set, sensitivity was lower in Embase (ranging from 53%-81%) than in MEDLINE (67%-87%) for all filters. Of the nondrug records that 1 or more of the filters missed, 39% of the missed MEDLINE records and 18% of the missed Embase records did not contain any indexing terms related to adverse events. Analyzing the titles and abstracts of nondrug records that were missed by any 1 filter, the most commonly used keywords related to adverse effects were: risk, complications, mortality, contamination, hemorrhage, and failure. In this study, adverse effects filters were less effective at finding information about the safety of medical devices, procedures, and tests compared to information about the safety of drugs.

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

    PubMed

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

    2010-01-01

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

  18. Medication dyes as a source of drug allergy.

    PubMed

    Swerlick, Robert A; Campbell, Caren F

    2013-01-01

    Excipients are defined as inert substances added to a drug or food to confer a suitable consistency, appearance, or form. They may be added for bulk, to change dissolution or the kinetics of absorption, to improve stability, to influence palatability, or to create a distinctive appearance. The last function may depend heavily on the use of coloring agents, especially when there are multiple dosages (such as with warfarin), and dose confusion may result in profound complications. While described as inert, excipients have been associated with triggering immunological reactions, although this is almost never considered in common practice when patients have reactions to medications, even when they appear to react to many different and distinct drugs. We have found a cohort of 11 patients with chronic, unexplained pruritic skin disorders that have responded to medication changes centered around avoidance of coloring agents, particularly FD&C Blue No. 1 (bright blue) and Blue No. 2 (indigo carmine). We believe that reactions to agents that color medications and foods may be more common than previously appreciated and that recognition of this phenomenon may provide therapeutic alternatives to patients with intractable pruritic disorders.

  19. 75 FR 47604 - Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices; Neurological...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-06

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices; Neurological and Physical Medicine Device Guidance Document; Reopening of Comment Period; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Notice; correction. SUMMARY...

  20. 78 FR 12762 - Joint Meeting of the Medical Imaging Drugs Advisory Committee and the Oncologic Drugs Advisory...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-25

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Joint Meeting of the Medical Imaging Drugs Advisory Committee and the Oncologic Drugs Advisory Committee; Notice of Meeting. AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a...

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

    PubMed

    Hauser, Katarina; Matthes, Jan

    2017-04-01

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

  2. Factors influencing compliance to hygiene routines in community care - the viewpoint of medically responsible nurses in Sweden.

    PubMed

    Lindh, Marianne; Kihlgren, Annica; Perseius, Kent-Inge

    2013-06-01

    The aim of the study was to describe factors influencing compliance to hygiene routines in community care in Swedish municipalities from the perspective of medically responsible nurses (MRN). A web-based questionnaire was sent to all MRNs in Swedish municipalities, N = 268. Beside demographical background data, the questionnaire contained two core open-ended questions generating free text data. Data were analysed with descriptive statistics and qualitative content analysis. Four categories of factors were found: resources, management, staff and external factors. All four categories contained subcategories. To some extent, the challenges to uphold adequate compliance to hygiene routines seem different in community care than in hospitals. Resources regarding equipment and supplies seem as an uncertain asset and uneven distributed among municipalities. Home likeness was seen as a major obstacle for upholding adequate hygiene routines. To uphold sufficient hygiene routines in a person's home or in a home-like environment might be one of the major challenges for community health care in the future. The MRN's narratives suggest that Registered Nurses have a key role in upholding sufficient hygiene in community care. This report might contribute in providing them with more knowledge to take on this urgent task. © 2012 Nordic College of Caring Science.

  3. The Americans with Disabilities Act: II. Implications and Suggestions for Compliance for Medical Schools.

    ERIC Educational Resources Information Center

    Essex-Sorlie, Diane

    1994-01-01

    A discussion of the Americans with Disabilities Act (1990) looks at the legislation's implications for the relationships between medical schools, applicants, and students. Issues examined include impact on the application/admissions process and accommodation of student disabilities. Fifteen steps for medical schools to take to comply with the act…

  4. Equipment for drug release testing of medicated chewing gums.

    PubMed

    Kvist, L C; Andersson, S B; Berglund, J; Wennergren, B; Fors, S M

    2000-04-01

    An apparatus was specially designed and constructed for release testing of medicated chewing gums. The adjustable instrumental settings such as temperature, chewing frequency, chewing time, volume of test medium, distance between the jaws and twisting angle increased the versatility of the apparatus. Selection of the test medium was also an important parameter. Each sample was kneaded mechanically in separate test chambers and the drug release was followed by sampling and HPLC analysis. Different gum formulations were tested and the obtained results demonstrated satisfactory release curves for a variety of formulations and active ingredients. The tested gum formulations comprised nicotine, meclizine, dimenhydrinate and xylitol. The apparatus proved to be suitable in product control of commercial batches but also a useful tool in the research and development of medicated gum formulations.

  5. 76 FR 12743 - Medical Device Reporting; Malfunction Reporting Frequency

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-08

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Medical Device Reporting; Malfunction Reporting Frequency... continue to submit malfunction reports in full compliance with FDA's Medical Device Reporting regulation...

  6. 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

  7. Medicating the mind: a Kantian analysis of overprescribing psychoactive drugs.

    PubMed

    Manninen, B A

    2006-02-01

    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.

  8. 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.

  9. Perception of Nigerian medical students on adverse drug reaction reporting.

    PubMed

    Abubakar, Abdullahi Rabiu; Chedi, Bashir A Z; Mohammed, Khalid Garba; Haque, Mainul

    2015-01-01

    Spontaneous reporting (SPR) and intensive monitoring are the conventional systems used for detecting, recording, and reporting adverse drug reactions (ADRs). Using spontaneous reporting a lot of successes has been made as existing ADRs were identified and new ones prevented through this methods. The aim of this appraisal was to evaluate the knowledge, attitude, and the practice of medical students with regards to ADRs reporting and to see if differences exist between the level of study and genders. The questionnaire was adopted, modified, and validated from previous studies. It comprised of 25 questions. It was administered year-IV and V medical students of Bayero University Kano, Nigeria. The data collected were coded and analyzed using the Statistical Package for the Social Sciences (SPSS) version 20, currently known as IBM SPSS Statistics. The response rate was 74%. Among the 108 participants, 80% got the definition of ADRs correct; 63% of them knew the precise functions of pharmacovigilance (PV). In addition, 82% strongly agreed that ADR reporting is health care workers responsibility; 82% also said PV should be taught in detail. Meanwhile, 99% have noticed patient experiencing ADRs; 67% said even mild ADRs should be reported. The outcome of this study showed good knowledge and attitude with respect to ADRs and PV among the medical students surveyed. Unfortunately, the practice of medical students was found to be unsatisfactory. There is a need to upgrade the students teaching the curriculum with respect to ADRs monitoring.

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

    PubMed

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

    2017-03-01

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

  11. 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.

  12. A Multicenter Evaluation of Off-Label Medication Use and Associated Adverse Drug Reactions in Adult Medical ICUs.

    PubMed

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

    2015-08-01

    Prior research indicates that off-label use is common in the ICU; however, the safety of off-label use has not been assessed. The study objective was to determine the prevalence of adverse drug reactions associated with off-label use and evaluate off-label use as a risk factor for the development of adverse drug reactions in an adult ICU population. Multicenter, observational study : Medical ICUs at three academic medical centers. Adult patients (age ≥ 18 yr old) receiving medication therapy. All administered medications were evaluated for Food and Drug Administration-approved or off-label use. Patients were assessed daily for the development of an adverse drug reaction through active surveillance. Three adverse drug reaction assessment instruments were used to determine the probability of an adverse drug reaction resulting from drug therapy. Severity and harm of the adverse drug reaction were also assessed. Cox proportional hazard regression was used to identify a set of covariates that influenced the rate of adverse drug reactions. Overall, 1,654 patient-days (327 patients) and 16,391 medications were evaluated, with 43% of medications being used off-label. One hundred and sixteen adverse drug reactions were categorized dichotomously (Food and Drug Administration or off-label), with 56% and 44% being associated with Food and Drug Administration-approved and off-label use, respectively. The number of adverse drug reactions for medications administered and the number of harmful and severe adverse drug reactions did not differ for medications used for Food and Drug Administration-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 adverse drug reactions increases by 8% for every one additional off-label medication

  13. Population dynamics of tuberculosis treatment: mathematical models of the roles of non-compliance and bacterial heterogeneity in the evolution of drug resistance.

    PubMed

    Lipsitch, M; Levin, B R

    1998-03-01

    Patient non-compliance and/or spatial heterogeneity in drug concentration or effectiveness may contribute to the emergence of drug resistance during multiple-drug chemotherapy of tuberculosis. Using mathematical models of mycobacterial population dynamics under antimicrobial treatment, to assess the effects of non-compliance, heterogeneity and other factors on the success of treatment. A mathematical model is used to generate predictions about the ascent of drug resistance in treated hosts with non-compliance and/or a 'protected compartment' of bacteria where only one drug is active; simulations of a more realistic version of this model take into account random mutation, and different assumptions about the size of, and growth rate of bacteria in, the protected compartment. The existence of a protected compartment can increase the likelihood of resistance to the single drug active in that compartment, but only if bacteria resistant to that drug can grow in the protected compartment or if the host is non-adherent to the treatment regimen. However, the protected compartment may also slow the ascent of bacteria resistant to drugs not active in it (e.g. isoniazid) by providing a reservoir of non-selected mycobacteria. The model predicts that relative rates of killing are more important than mutation rates in determining the order in which resistant mutants ascend. Model predictions, in combination with data about drug resistance patterns, suggest that non-compliance, but not heterogeneity, is an important cause of treatment failure. Patterns of acquired drug resistance may be used to infer processes of selection during treatment; mathematical models can aid in generating predictions about the relative impacts of treatment parameters in the evolution of resistance, and eventually in suggesting improved treatment protocols.

  14. 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...

  15. 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...

  16. 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...

  17. 76 FR 78933 - Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-20

    ... HUMAN SERVICES Food and Drug Administration Food and Drug Administration Clinical Trial Requirements... to receive the hotel room rate of $145.00 plus applicable taxes (available until February 14, 2012... of Health and Human Services' and FDA's important mission to protect the public health. The public...

  18. 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...: The public workshop will be held at the Radisson Plaza Lord Baltimore Hotel, 20 West Baltimore St... SoCRA to receive the hotel room rate of $129.00 plus applicable taxes (available until October 13...

  19. 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

  20. [The advertising message of drugs advertisements in Spanish medical journals].

    PubMed

    Riera, Eusebi J Castaño; de la Fuente, David Oterino; Rodrígueza, Rosa M Rodríguez

    2007-01-01

    To describe the characteristics of advertising in Spanish medical journals and to analyze the advertising message in drug advertisements. Six issues of 4 Spanish medical journals published in 2001 were reviewed to identify the number of advertisements and their characteristics. The journals selected were Atención Primaria, Anales Españoles de Pediatría, Medicina Clínica and Gaceta Sanitaria. The advertising message was analyzed by evaluating 5 factors: communication aim, sales argument, communication treatment, and use of text and image. 609 advertisements were found. Drug advertisements were the most numerous (69.9%). Advertising pressure was highest in Atención Primaria (36%), followed by Anales Españoles de Pediatría (22%), Medicina Clínica (12%) and Gaceta Sanitaria (4%). Of the 195 drug advertisements analyzed, the aim of the advertising message was mostly to present or remind readers of an existing product (70.8%). The sales argument was rational in 86.5%. The communication treatment was advertising in 72.6%. The text of the advertisement contained a headline in 82.4% or a slogan in 50.8%. The advertisement image was a photograph in 74.7% and the aim of the image was to present the product (48.7%), to promise a benefit (45.1%), or to argue its qualities (31.1%). In the journals aimed at prescribing physicians advertising pressure was higher and advertisements were intercalated in article text. Advertising concerned already existing products, used rational arguments, and the communication treatment was advertising.

  1. Medication Adherence and the Use of Generic Drug Therapies

    PubMed Central

    Briesacher, Becky A.; Andrade, Susan E.; Fouayzi, Hassan; Chan, K. Arnold

    2010-01-01

    Objective to assess if the lower copayments often charged for generic drugs explains the improved drug adherence associated with use of generic drugs. Methods We analyzed 2001–2004 healthcare claims data from 45 large employers. Study subjects were aged 18 years +, had 1 or more of 5 study conditions (hypercholesterolemia, hypertension, hypothyroidism, seizure disorders, and type 2 diabetes), and new use of generic-only or brand-only drug therapy for that condition. We measured adherence as the medication possession ratio (MPR), and adequate adherence as MPR >= 80%. Logistic regressions were conducted to assess adequate adherence adjusting for copayments. Results We identified 327,629 new users of drug therapy for the study conditions. Proportion of individuals starting generic therapies ranged from 9% in hypothyroidism to 45% in hypertension. After 1 year of therapy, 66.2% of individuals with hypothyroidism achieved MPR >= 80% compared to 53.4% with hypertension, 53.2% with hypercholesterolemia, 52.0% with diabetes, and 42.2% with seizure disorders. Logistic regressions of adequate adherence showed generics were associated with higher adherence relative to brands in 2 conditions (hypercholesterolemia AOR 1.52, 95% CI: 1.44–1.60; diabetes AOR 1.06, 95% CI: 1.01–1.12, p<.05), with lower adherence in 2 conditions (hypertension AOR 0.75, 95% CI:.73-.77; hypothyroidism AOR 0.86, 95% CI:.78-.94, p<.05), and no difference in seizure disorders. In comparison, the likelihood of achieving MPR >= 80% with $0 copayments relative to $1-$9 ranged from AOR 1.32 for seizure disorders (95% CI: 1.41–1.43) to AOR 1.45 for hypothyroidism (95% CI: 1.43–1.48). Conclusion Generic prescribing was associated with improved medication adherence in 2 of 5 study conditions, and the effect was modest. Copayments of $0 were associated with improved adherence across all study conditions. PMID:19589012

  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. DMEPOS (Durable Medical Equipment, Prosthetics, Orthotics and Supply) model compliance program: does the OIG have it right?

    PubMed

    Parver, C; O'Connor, B

    1999-06-01

    Companies of every size and structure can and should develop an ethical culture of compliance in which prevention, detection, and resolution of abusive practices are "core values." OIG has released a draft Compliance Guideline that includes a seven-element plan to which all agencies must comply. Yet, compliance programs simply are not a "one-size-fits-all" item.

  4. Effectiveness of a challenge-and-respond checklist in ensuring safety behavior compliance by medical team members at a rotor-wing air medical program.

    PubMed

    Frakes, Michael A; Van Voorhis, Samantha

    2007-01-01

    Checklists are a frequently recommended strategy for minimizing human error in both the aviation and medical industries, yet checklist noncompliance is sometimes cited as a factor in untoward incidents. We evaluate the use of a challenge-and-respond checklist designed to ensure compliance with basic pre-departure safety preparations by medical personnel at a helicopter air medical program. The studied helicopter air medical transport program uses an interactive, challenge-and-respond checklist prior to departure to verify completion of four operational safety items. This is a prospective, convenience sample evaluation of 33 observations in which a checklist violation was created artificially and detection of that violation by the transport team was measured by direct observation. Characteristics of the transport by time, site of origin, and patient acuity were also recorded. Undetected violations were corrected by the investigator prior to departure, ensuring operational safety. Seven of the violations (21.2%) were detected by the transport team during routine completion of the checklist. Team members with less than 3 years of experience in the program had a 10% detection rate (95% confidence interval [CI], 1.5-23.1), whereas those with greater than 3 years experience in the program had a 38.5% detection rate (95% CI, 12.0-65.0). In this sample, no other observed variable suggested an association with detection rates. Routine completion of an interactive challenge-and-respond checklist by medical personnel had a low rate of detecting operational safety omissions in the studied helicopter critical care transport program. There was some difference in results by crew tenure.

  5. Spanish Compliance With Guidelines for Prescribing Four Drugs in the Intensive Phase of Standard Tuberculosis Treatment.

    PubMed

    García-García, José-María; Rodrigo, Teresa; Casals, Martí; Ruiz-Manzano, Juan; Pascual-Pascual, Teresa; Caylà, Joan A

    2016-05-01

    International and Spanish guidelines recommend a 4-drug regimen in the intensive treatment of tuberculosis (TB). The aim of our study was to determine if these recommendations are followed in Spain, and the factors associated with the use of 3 drugs (standard regimen without ethambutol). Observational, multicenter, retrospective analysis of data from patients diagnosed with TB in practically all Spanish Autonomous Communities between 2007 and 2102. Factors associated with the use of 3 drugs were analyzed using logistic regression, and odds ratios (OR) and corresponding 95% confidence intervals (CI) were calculated. A total of 3,189 patients were included, 1,413 (44.3%) of whom received 3 drugs. The percentage of 3-drug users among patients with positive sputum smear was 41.2%; among patients with resistance to at least 1 drug, 36.1%; among HIV-infected patients, 31.4%; and among immigrants, 24.8%. Factors associated with the use of 3 drugs were: female sex (OR=1.18; CI: 1.00-1.39); native Spanish (OR=3.09; CI: 2.58-3.70); retired (OR=1.42; CI: 1.14-1.77); homeless (OR=3.10; CI: 1.52-6.43); living alone (OR=1.62; CI: 1.11-2.36); living in a family (OR=1.97; CI: 1.48-2.65); seen by specialists in the region (OR=1.37; CI: 1.10;1.70); no HIV infection (OR=1.63; CI: 1.09-2.48); and negative sputum smear with positive culture (OR=1.59; CI: 1.25-2.02). A large proportion of TB patients receive intensive treatment with 3 drugs. TB treatment recommendations should be followed, both in routine clinical practice and by the National Plan for Prevention and Control of Tuberculosis in Spain. Copyright © 2015 SEPAR. Published by Elsevier Espana. All rights reserved.

  6. 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.

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

    PubMed

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

    2002-06-01

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

  8. 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.

  9. Development of nanotoxicology: implications for drug delivery and medical devices.

    PubMed

    Bhattacharjee, Sourav; Brayden, David J

    2015-07-01

    Current nanotoxicology research suffers from suboptimal in vitro models, lack of in vitro-in vivo correlations, variability within in vitro protocols, deficits in both material purity and physicochemical characterization. Reliable nanomaterial toxicity and mechanistic insights are required for health and toxicity risk assessments. Much in vitro toxicological data is inconclusive in designating whether nanomaterials for drug delivery and medical device implants are truly safe. A critique is presented to analyze the interface between toxicology and nanopharmaceuticals. Deficiencies of existing practices in toxicology are reviewed and useful emerging techniques (e.g., lab-on-a-chip, tissue engineering, atomic force microscopy, high-content analysis) are highlighted. Cross-fertilization between disciplines will aid development of biocompatible delivery and implant platforms while improvements are being suggested for better translation of nanotoxicology.

  10. 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.

  11. 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,…

  12. Applying the desiderata for controlled medical vocabularies to drug information databases.

    PubMed Central

    Lau, L. M.; Lam, S. H.

    1999-01-01

    Medication history has always been an integral part of the patient's medical record. With the advent of the computerized medical record and the longitudinal clinical data repository, having the medication history has enabled the development of clinical decision support system that alerts for drug to drug interactions and drug allergies. Furthermore, medication data is increasingly being analyzed from a utilization and clinical outcomes standpoint. For these activities to occur, a controlled pharmacy vocabulary akin to a controlled medical vocabulary is essential. Drug information databases are well-established sources of information for pharmacy-related data and products. However, do they measure up as a controlled vocabulary? Recent experience reviewing drug information databases and integrating pharmacy-related information into a data dictionary in real-time clinical use at multiple health care institutions have revealed several challenges and issues. These are discussed according to Cimino's desiderata for controlled medical vocabularies. PMID:10566328

  13. Modulation sensing of fluorophores in tissue: a new approach to drug compliance monitoring

    NASA Astrophysics Data System (ADS)

    Abugo, Omoefe O.; Gryczynski, Zygmunt; Lakowicz, Joseph R.

    1999-10-01

    We describe a method to detect the presence of fluorophores in scattering media, including intralipid suspensions and chicken muscle covered with skin. The fluorophores were rhodamine 800 (Rb800) and indocyanine green (IcG), both of which can be excited at long wavelengths where there is minimal absorption by tissues. These fluorophores were dissolved in intralipid or in chicken muscle under skin. A method to approximate the fluorophore concentration in such samples was developed using a long lifetime reference fluorophores in a polymer film placed immediately on the illuminated surface of the sample. Because of the long lifetime of the reference film, the modulation of its emission at low frequencies near 2 MHz is near zero. Since the lifetime of Rh800 and IcG are below 2 ns the modulation of the combined emission is a measure of the intensity of the fluorophore (Rh800 or IcG) relative to the long lifetime reference. Using this method we were able to measure the concentration-dependent intensities of Rh800 and IcG in an intralipid suspension. Additionally, micromolar concentrations of these probes could be detected in chicken muscles, even when the muscle was covered with a layer of chicken skin. The presence of an India ink absorber in the intralipid had only a moderate effect on the modulation values. We suggest the use of this transdermal detection of long-wavelength fluorophores as a noninvasive method to monitor patient compliance when taking medicines used for treatment of chronic diseases such as AIDS or tuberculosis.

  14. 75 FR 52765 - Development and Distribution of Patient Medication Information for Prescription Drugs; Public...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-27

    ... the current system, patients may receive several different types of information, developed by... products is an important component of medical product safety. Currently, patients receive multiple types of... and comprehension. The types of written prescription drug information include: Consumer Medication...

  15. 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 Medical Device Conference AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public conference. SUMMARY: The Food and Drug Administration (FDA) Cincinnati District, in co-sponsorship with Xavier...

  16. 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 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 Xavier...

  17. 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 Xavier...

  18. 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

  19. 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.

  20. 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

  1. 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

  2. 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…

  3. 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.

  4. Medical cost impact of intrathecal drug delivery for noncancer pain.

    PubMed

    Guillemette, Scott; Witzke, Susan; Leier, Jacqueline; Hinnenthal, Jennifer; Prager, Joshua P

    2013-04-01

    As healthcare budgets continue to contract, there is increased payer scrutiny on the use of implantable intrathecal drug-infusion devices. This study utilizes claims data to evaluate the economic effects of intrathecal drug delivery (IDD) based on health services utilization and costs of care before and after implantation. We performed a retrospective database study involving 555 noncancer pain patients that received an IDD system implant within a 3-year service period (1/2006-1/2009). IDD patient costs were temporally aligned to implant month and repriced to a standardized, national pricing schedule over a 6-year episode cycle (3 years preimplant, implant month, and 3 years postimplant). Additionally, we made an actuarial projection of postimplant experience, in the absence of IDD intervention, simulating a conventional pain therapy (CPT) protocol by assuming the same slope in costs prior to implantation at standardized, national price levels. Cost projections were produced over a 30-year time horizon at various reimplantation rates. IDD therapy was less costly than the CPT protocol over our baseline implantation cycle. Costs in the month of IDD implantation, and in the year following, are cumulatively $17,317 more than the CPT protocol; however, IDD financial break-even occurs soon after the second year postimplant. The lifetime analysis indicates that IDD per patient per year savings is $3,111 compared with CPT. The authors found that patients receiving an implantable IDD system may experience reduced cumulative future medical costs relative to anticipated costs in the absence of receiving IDD. This finding complements published literature on the cost-effectiveness of IDD. Wiley Periodicals, Inc.

  5. Drug utilization in a hospital general medical outpatient clinic with particular reference to antihypertensive and antidiabetic drugs.

    PubMed

    Yuen, Y H; Chang, S; Chong, C K; Lee, S C; Critchley, J A; Chan, J C

    1998-08-01

    To examine the prescribing patterns, particularly antihypertensive and antidiabetic drugs, in a hospital outpatient clinic and to evaluate the expenditure incurred. Prescriptions from a general medical outpatient clinic in a teaching hospital were collected for 4 weeks. Drug expenditures were calculated. A total of 622 prescriptions containing 1903 items were collected. Antihypertensive and antidiabetic drugs accounted for 25.9 and 9.1% usage, respectively. Calcium channel blocking agents, angiotensin converting enzyme inhibitors and beta-blocking agents were the most popular antihypertensive drugs used. Sulphonylureas were the most frequently prescribed antidiabetic agents. Amlodipine, doxazosin and sotalol accounted for 4.5% of all prescription items but 27.8% of the total drug expenditure. The use of antihypertensive and antidiabetic drugs accounted for most of the drug usage in this study. Use of newer and more expensive agents has further increased drug expenditure. Monitoring drug usage and their correlations with clinical outcomes are warranted.

  6. 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.

  7. 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.

  8. A review of pharmacokinetic drug-drug interactions with the anthelmintic medications albendazole and mebendazole.

    PubMed

    Pawluk, Shane Ashley; Roels, Craig Allan; Wilby, Kyle John; Ensom, Mary H H

    2015-04-01

    Medications indicated for helminthes and other parasitic infections are frequently being used in mass populations in endemic areas. Currently, there is a lack of guidance for clinicians on how to appropriately manage drug interactions when faced with patients requiring short-term anthelmintic therapy with albendazole or mebendazole while concurrently taking other agents. The objective of this review was to systematically summarize and evaluate published literature on the pharmacokinetics of albendazole or mebendazole when taken with other interacting medications. A search of MEDLINE (1946 to October 2014), EMBASE (1974 to October 2014), International Pharmaceutical Abstracts (1970 to October 2014), Google, and Google Scholar was conducted for articles describing the pharmacokinetics of albendazole or mebendazole when given with other medications (and supplemented by a bibliographic review of all relevant articles). Altogether, 17 articles were included in the review. Studies reported data on pharmacokinetic parameters for albendazole or mebendazole when taken with cimetidine, dexamethasone, ritonavir, phenytoin, carbamazepine, phenobarbital, ivermectin, praziquantel, diethylcarbamazine, azithromycin, and levamisole. Cimetidine increased the elimination half-life of albendazole and maximum concentration (Cmax) of mebendazole; dexamethasone increased the area under the plasma concentration-time curve (AUC) of albendazole; levamisole decreased the Cmax of albendazole; anticonvulsants (phenytoin, phenobarbital, carbamazepine) decreased the AUC of albendazole; praziquantel increased the AUC of albendazole; and ritonavir decreased the AUC of both albendazole and mebendazole. No major interactions were found with ivermectin, azithromycin, or diethylcarbamazine. Future research is required to clarify the clinical relevance of the interactions observed.

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

    PubMed Central

    Brown, Marty Skemp; Maurer, Martha A

    2014-01-01

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

  10. Electrospun medicated shellac nanofibers for colon-targeted drug delivery.

    PubMed

    Wang, Xia; Yu, Deng-Guang; Li, Xiao-Yan; Bligh, S W Annie; Williams, Gareth R

    2015-07-25

    Medicated shellac nanofibers providing colon-specific sustained release were fabricated using coaxial electrospinning. A solution of 7.5 g shellac and 1.5 g of ferulic acid (FA) in 10 mL ethanol was used as the core fluid, and a mixture of ethanol and N,N-dimethylformamide (8/10 v/v) as the shell. The presence of the shell fluid was required to prevent frequent clogging of the spinneret. The diameters of the fibers (D) can be manipulated by varying the ratio of shell to core flow rates (F), according to the equation D=0.52 F(-0.19). Scanning electron microscopy images revealed that fibers prepared with F values of 0.1 and 0.25 had linear morphologies with smooth surfaces, but when the shell fluid flow rate was increased to 0.5 the fiber integrity was compromised. FA was found to be amorphously distributed in the fibers on the basis of X-ray diffraction and differential scanning calorimetry results. This can be attributed to good compatibility between the drug and carrier: IR spectra indicated the presence of hydrogen bonds between the two. In vitro dissolution tests demonstrated that there was minimal FA release at pH 2.0, and sustained release in a neutral dissolution medium. The latter occurred through an erosion mechanism. During the dissolution processes, the shellac fibers were gradually converted into nanoparticles as the FA was freed into solution, and ultimately completely dissolved.

  11. 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.

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

    PubMed

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

    2013-10-01

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

  13. 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...

  14. 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...

  15. 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...

  16. 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...

  17. 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...

  18. 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…

  19. 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…

  20. 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...

  1. The Effect of a Health Communication Campaign on Compliance with Mass Drug Administration for Schistosomiasis Control in Western Kenya—The SCORE Project

    PubMed Central

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

    2014-01-01

    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. PMID:25246690

  2. 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.

  3. Improving compliance with surgical antibiotic prophylaxis guidelines: A multicenter evaluation.

    PubMed

    Schmitt, Cristiane; Lacerda, Rubia Aparecida; Turrini, Ruth Natalia Teresa; Padoveze, Maria Clara

    2017-06-16

    Improving surgical antibiotic prophylaxis (SAP) use is an important element in the control of antimicrobial resistance. However, compliance with SAP guidelines is unsatisfactory. This study investigated the level of compliance with SAP guidelines in neurosurgery, and institutional characteristics associated with compliance. This study assessed surgeries in 9 Brazilian hospitals. Medical record reviews and a structured questionnaire were used to assess compliance and to describe institutional characteristics. Six attributes of compliance with SAP guidelines were evaluated; full compliance was defined whenever all these attributes were met. Logistic and linear regressions were used to investigate the association between compliance, patients, and hospital characteristics. Full compliance was 10% and was associated with weekly hours of infection control personnel per intensive care unit bed (95% CI, 0.2-0.1), hospital-wide dissemination of SAP guidelines (95% CI, 1.2-25.1), monitoring (95% CI, 1.2-25.1), and feedback of compliance rates (95% CI, 3.8-25.2). Daytime procedures had greater compliance regarding drug dose (odds ratio [OR], 3.38; 95% confidence interval [CI], 1.72-6.65) and initial time (OR, 2.30; 95% CI, 1.24-4.25). Spinal procedures achieved greater compliance with initial time (OR, 1.83; 95% CI, 1.12-3.01) and duration (OR, 1.59; 95% CI, 1.7-2.16). A low level of compliance was identified, which pointed out the need for an innovative stewardship approach to improve adherence to SAP guidelines. Targeted training programs need to be developed to ensure dissemination of guidelines among surgeons. Monitoring, feedback, and closer interaction between the infection control personnel and the surgical team are key factors for better compliance rates of SAP. Copyright © 2017 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Elsevier Inc. All rights reserved.

  4. 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

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

    PubMed

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

    2016-11-01

    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. 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. Micronarrative surveys were shown to be a valid and effective tool to detect operational issues within

  6. 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

  7. Compliance with hand hygiene on surgical, medical, and neurologic intensive care units: direct observation versus calculated disinfectant usage.

    PubMed

    Scheithauer, Simone; Haefner, Helga; Schwanz, Thomas; Schulze-Steinen, Henna; Schiefer, Johannes; Koch, Alexander; Engels, Astrid; Lemmen, Sebastian W

    2009-12-01

    Hand hygiene (HH) is considered the single most effective measure to prevent and control health care-associated infections (HAIs). Although there have been several reports on compliance rates (CRs) to HH recommendations, data for intensive care units (ICUs) in general and for shift- and indication-specific opportunities in particular are scarce. The aim of this study was to collect data on ICU-, shift-, and indication-specific opportunities, activities and CRs at a surgical ICU (SICU), a medical ICU (MICU), and a neurologic ICU (NICU) at the University Hospital Aachen based on direct observation (DO) and calculated disinfectant usage (DU). Opportunities for HH recorded over a 24-hour period were significantly higher for the SICU (188 per patient day [PD]) and MICU (163 per PD) than for the NICU (124 per PD). Directly observed CRs were 39% (73/188) in the SICU, 72% (117/163) in the MICU, and 73% (90/124) in the NICU. However, CRs calculated as a measure of DU were considerably lower: 16% (29/188) in the SICU, 21% (34/163) in the MICU, and 25% (31/124) in the NICU. Notably, CRs calculated from DO were lowest before aseptic tasks and before patient contact. To the best of our knowledge, this study provides the first data picturing a complete day, including shift- and indication-specific analyses, and comparing directly observed CRs with those calculated based on DU, the latter of which revealed a 2.75-fold difference. Worrisomely, CRs were very low, especially concerning indications of greatest impact in preventing HAIs, such as before aseptic task. Thus, the gathering of additional data on CRs and the reasons for noncompliance is warranted.

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

    PubMed Central

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

    2002-01-01

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

  9. Drug-related problems among medical ward patients in Jimma university specialized hospital, Southwest Ethiopia

    PubMed Central

    Tigabu, Bereket Molla; Daba, Daniel; Habte, Belete

    2014-01-01

    Objective: The increasing number of available drugs and drug users, as well as more complex drug regimens led to more side effects and drug interactions and complicates follow-up. The objective of this study was to assess drug-related problems (DRPs) and associated factors in hospitalized patients. Methods: A hospital-based cross-sectional study design was employed. The study was conducted in Jimma University Specialized Hospital, Jimma, located in the south west of Addis Ababa. All patients who were admitted to the medical ward from February 2011 to March 2011 were included in the study. Data on sociodemographic variables, past medical history, drug history, current diagnosis, current medications, vital signs, and relevant laboratory data were collected using semi-structured questionnaire and data collection forms which were filling through patient interview and card review. Data were analyzed using SPSS version 16 for windows. Descriptive statistics, cross-tabs, Chi-square, and logistic regression were utilized. Findings: Out of 257 study participants, 189 (73.5%) had DRPs and a total of 316 DRPs were identified. From the six classes of DRPs studied, 103 (32.6%) cases related to untreated indication or need additional drug therapy, and 49 (15.5%) cases related to high medication dosage. Unnecessary drug therapy in 49 (15.5%) cases, low medication dosage in 44 (13.9%) cases, and ineffective drug therapy in 42 (13.3%) cases were the other classes of problems identified. Noncompliance in 31 (9.8%) cases was the least prevalent DRP. Independent factors which predicted the occurrence of DRPs in the study population were sex, age, polypharmacy, and clinically significant potential drug-drug interactions. The prevalence of DRPs was substantially high (73.5%). Conclusion: Drug-related problems are common among medical ward patients. Indication-related problems, untreated indication and unnecessary drug therapy were the most common types of DRPs among patients of our

  10. 75 FR 44267 - Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices; Neurological...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-28

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices; Neurological and Physical Medicine Device Guidance Document; Reopening of Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Notice; reopening of comment period...

  11. 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

    ... educate regulated industry and FDA Staff on how, when, and why to use classification product codes for... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration Staff; Medical Device Classification Product Codes; Availability AGENCY: Food and Drug Administration...

  12. 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...

  13. 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...

  14. 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...

  15. [Prescription and drug expenditure in gynecology and obstetrics in Northwest medical units from IMSS].

    PubMed

    Torres Gómez, Luis Guillermo; Canales Muñoz, José Luis

    2006-08-01

    Drug prescription is the most frequent medical intervention in Gynecology and Obstetrics; however, studies of prescription profile are limited. In this study, we analyzed differences of expense by drug prescription for gynecologic and obstetrics health problems. It was performed a cross sectional study for one year analysis in each medical area that shape IMSS western district. We calculated spending and consumption coefficients for each drug and therapeutic groups. User coefficients were ordered to compare consumption differences. Besides the statistical ratio of consumption between drugs groups, we described the differences found and analyzed the prescription profile among medical regions. Data related to the expenses in each one of the regions show important differences in each one of the drugs and therapeutic groups. The most common expense for drugs is related to the treatment of osteoporosis, menopause and fertility problems. We also found differences in prescription drug preferences in each therapeutic subgroup. Drug prescription studies are useful as a basis for further specific studies in each pharmacologic subgroup. There are few studies that analyze the drug prescription profile on Gynecology and Obstetrics. In this study it is possible to suppose that medical prescription was not based on known medical evidences; therefore, we must reconsider the need of a permanent actualization and systematic medical evaluation.

  16. 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.

  17. 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.

  18. [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.

  19. The influence of medical student gender and drug use on the detection of addiction in patients.

    PubMed

    Roncero, Carlos; Rodríguez-Cintas, Laia; Egido, Angel; Barral, Carmen; Pérez-Pazos, Jesús; Collazos, Francisco; Grau-López, Lara; Casas, Miquel

    2014-01-01

    Little is known about medical students' interest in their training on drug addiction, their personal experience of consumption, and whether these aspects influence the detection of addiction in patients. Eighty-eight and one half percent considered that drug dependence issues are important to their professional future. The students report consuming alcohol (69%), cigarettes (19.5%), and illegal drugs (15.8%). Female students consumed fewer illegal drugs than the men (p =.022). Male students consumed more illegal drugs more frequently (p =.005), knew more consumers (p =.023), and those who drink alcohol consumed more illegal drugs than women who drink alcohol (p <.005). Drug and alcohol consumption among medical students may serve to normalize consumption and thus, may prevent the detection of addicts. It is important to educate and raise awareness about drugs and alcohol use, as this may influence detection. The focus should be particularly on the male group.

  20. How Does This Happen? Part I: Mechanisms of Adverse Drug Reactions Associated with Psychotropic Medications

    PubMed Central

    Elbe, Dean; Savage, Robert

    2010-01-01

    Objective: To review the background and mechanisms behind how certain psychotropic medications cause adverse drug reactions. Methods: A literature review pertaining to several interesting and unusual adverse drug reactions attributed to selected psychotropic medications was conducted. These include: 1) QTc interval prolongation secondary to ziprasidone, pimozide, and other antipsychotic agents. 2) Nephrogenic diabetes insipidus and hypernatremia secondary to lithium. 3) Hypothyroidism secondary to lithium. 4) Erectile dysfunction secondary to selective serotonin and serotonin/norepinephrine reuptake inhibitors (SSRIs/SNRIs). Results: Biochemical mechanisms of how certain psychotropic medications cause adverse drug reactions were reviewed. Specific interventions and monitoring recommendations to prevent or reduce the impact of these adverse reactions are discussed briefly. Conclusion: Knowledge of risk factors and mechanisms of adverse drug reactions with psychotropic medications can help to guide medication prescribing, monitoring and interventions to prevent or mitigate these reactions. PMID:20119566

  1. 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.

  2. 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

  3. Medication adherence and knowledge of older patients with and without multidose drug dispensing.

    PubMed

    Kwint, Henk-Frans; Stolk, Glenn; Faber, Adrianne; Gussekloo, Jacobijn; Bouvy, Marcel L

    2013-09-01

    we compared the self-reported medication adherence and knowledge of older patients receiving their drugs via multidose drug dispensing (MDD users) with patients receiving manually dispensed drugs (non-MDD users). MDD users (≥ 65 years, ≥ 5 oral chronic drugs) were randomly selected from eight Dutch community pharmacies. Non-MDD users (≥ 5 oral chronic drugs) were matched on age and gender. Medication adherence was assessed by using the Medication Adherence Reporting Scale (MARS) and medication knowledge by asking the indication of drugs. Cognitive function was measured with Mini-Mental State Examination (MMSE) for a sub selection of patients. the percentage of patients being adherent to all drugs was higher for MDD users (n = 119, 81%) compared with non-MDD users (n = 96, 58%, P < 0.001).The percentage of patients with adequate knowledge was lower for MDD users (40%) compared with non-MDD users (79%, P < 0.001). The differences in adherence were independent of knowledge and MMSE scores. this study shows that older patients receiving their drugs via MDD reported a higher medication adherence compared with patients receiving manually dispensed drugs, despite a lower knowledge and lower cognitive function among patients receiving MDD.

  4. 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

  5. Injury prevention strategies, coach compliance and player adherence of 33 of the UEFA Elite Club Injury Study teams: a survey of teams' head medical officers.

    PubMed

    McCall, Alan; Dupont, Gregory; Ekstrand, Jan

    2016-06-01

    (1) To quantify current practice at the most elite level of professional club football in Europe with regard to injury prevention strategy; (2) to describe player adherence and coach compliance to the overall injury prevention programme. A structured online survey was administered to the Head medical officers of 34 elite European teams currently participating in the UEFA Elite Club Injury Study. The survey had 4 sections; (1) risk factors for injury, (2) assessment and monitoring of injury risk, (3) prevention strategies and (4) coach compliance and player adherence to the injury prevention process. 33 (97%) Medical officers of the teams responded. The most important perceived injury risk factor was previous injury. Four of the top 6 risk factors-physical fitness, accumulated fatigue, reduced recovery time between matches and training load-were related to player workload. The top 3 preventative exercises were eccentric, balance/proprioception and core training. Regarding monitoring, the top 3 tools implemented were measurement of workload, subjective wellness and a general medical screen. The subjectively rated level of coach compliance in UEFA teams was perceived as 'high', while the player adherence varied from none at all to perfect. Medical officers place importance on workload-related variables as risk factors for injury in elite European football players. A lack of consistently high player adherence may limit the effects of contemporary injury prevention programmes in elite European footballers. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  6. [An analysis of drug advertising in non-specialty medical journals].

    PubMed

    López Valpuesta, F J; Hevia Alonso, A; Vázquez Díaz, J A; Fernández López, J A; Fernández Alonso, A

    1993-02-01

    It has been evaluated drug advertisement in four medical journals during 1989. A questionnaire allows us to evaluate pharmacological and advertising data. The main results obtained are the following: amoxicillin + clavulanic acid was the more advertising drug; the ratio publicity/pharmacological information was 3:1; 60% of the advertising products were new drugs, and only a 6% were essentials drugs according to WHO; slogans were acceptable; generally, aspects such as dosage and toxicology are referred. However, it is necessary to improve information about drug use in elderly patients, patients with impaired renal functional, as well as the necessary information in adverse drug reactions.

  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. 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)

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

    PubMed

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

    2017-05-01

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

  10. [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.

  11. 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.

  12. 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 either...

  13. Do emergency physicians attribute drug-related emergency department visits to medication-related problems?

    PubMed

    Hohl, Corinne M; Zed, Peter J; Brubacher, Jeffrey R; Abu-Laban, Riyad B; Loewen, Peter S; Purssell, Roy A

    2010-06-01

    Adverse drug events represent the most common cause of preventable nonsurgical adverse events in medicine but may remain undetected. Our objective is to determine the proportion of drug-related visits emergency physicians attribute to medication-related problems. This prospective observational study enrolled adults presenting to a tertiary care emergency department (ED) during 12 weeks. Drug-related visits were defined as ED visits caused by adverse drug events. The definition of adverse drug event was varied to examine both narrow and broad adverse drug event classification systems. Clinical pharmacists evaluated all patients for drug-related visits, using standardized assessment algorithms, and then followed patients until hospital discharge. Interrater agreement for the clinical pharmacist diagnosis of drug-related visit was assessed. Emergency physicians, blinded to the clinical pharmacist opinion, were interviewed at the end of each shift to determine whether they attributed the visit to a medication-related problem. An independent committee reviewed and adjudicated all cases in which the emergency physicians' and clinical pharmacists' assessments were discordant, or either the emergency physician or clinical pharmacist was uncertain. The primary outcome was the proportion of drug-related visits attributed to a medication-related problem by emergency physicians. Nine hundred forty-four patients were enrolled, of whom 44 patients received a diagnosis of the narrowest definition of an adverse drug event, an adverse drug reaction (4.7%; 95% confidence interval [CI] 3.5% to 6.2%). Twenty-seven of these were categorized as medication-related by emergency physicians (61.4%; 95% CI 46.5% to 74.3%), 10 were categorized as uncertain (22.7%; 95% CI 12.9% to 37.1%), and 7 categorized as a non-medication-related problem (15.9%; 95% CI 8.0% to 29.5%). Seventy-eight patients (8.3%; 95% CI 6.7% to 10.2%) received a diagnosis of an adverse drug event caused by an adverse drug

  14. 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.

  15. 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

  16. 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.

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

    PubMed

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

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

  18. 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

  19. 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

  20. 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

  1. Impact of a medically supervised safer injecting facility on drug dealing and other drug-related crime

    PubMed Central

    Wood, Evan; Tyndall, Mark W; Lai, Calvin; Montaner, Julio SG; Kerr, Thomas

    2006-01-01

    North America's first medically supervised safer injecting facility (SIF) recently opened in Vancouver, Canada. One of the concerns prior to the SIF's opening was that the facility might lead to a migration of drug activity and an increase in drug-related crime. Therefore, we examined crime rates in the neighborhood where the SIF is located in the year before versus the year after the SIF opened. No increases were seen with respect to drug trafficking (124 vs. 116) or assaults/robbery (174 vs. 180), although a decline in vehicle break-ins/vehicle theft was observed (302 vs. 227). The SIF was not associated with increased drug trafficking or crimes commonly linked to drug use. PMID:16722550

  2. 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.

  3. Distinguishing Drug Toxicity Syndromes From Medical Diseases: A QMR Computer-Based Approach

    PubMed Central

    Mabry, Michael E.; Miller, Randolph A.

    1990-01-01

    Drug effects can mimic a wide variety of diseases. Experts note that adverse drug reactions (ADRs) have become the “greatest imitator” of disease in clinical medicine. Quick Medical Reference (QMR) is a decision support system providing diagnostic data about more than 600 medical diseases. Currently QMR contains only limited drug information. Just as physicians have difficulty diagnosing ADRs, QMR has similar problems in differentiating natural disease manifestations from drug toxicity syndromes. To remedy this problem, two prototype Drug Syndromes (DS), Carbamazepine Toxicity and Penicillin Toxicity, were incorporated into the QMR Knowledge Base (KB). Using detailed case reports, we demonstrated that a DS-augmented version of QMR was successful in discriminating these DS from the other diseases in QMR's KB. The addition of DS significantly improves QMR's diagnostic performance in cases in which some of the pathologic features are the consequence of drugs.

  4. 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…

  5. 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…

  6. 78 FR 734 - Medical Imaging Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-04

    ... HUMAN SERVICES Food and Drug Administration Medical Imaging Drugs Advisory Committee; Notice of Meeting... resonance imaging in brain (intracranial), spine, and associated tissues in adults and pediatric patients (from neonates to 17 years of age) to detect and visualize areas with disruption of the blood...

  7. 76 FR 15986 - Food and Drug Administration/Xavier University Global Medical Device Conference

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-22

    ... 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... Products Panel. Update on Quality System Regulations. Warning Letter and Enforcement Action Trends. MDUFMA...

  8. Improving the quality of adverse drug reaction reporting by 4th-year medical students.

    PubMed

    Rosebraugh, Curtis J; Tsong, Yi; Zhou, Feng; Chen, Min; Mackey, Ann Corken; Flowers, Charlene; Toyer, Denise; Flockhart, David A; Honig, Peter K

    2003-03-01

    Evaluate whether a 15-minute lecture intervention will improve adverse drug reaction reporting quality on standard MedWatch forms. Seventy-eight 4th-year medical students were randomized to intervention 'Group-A' or non-intervention 'Group-B' on the first day of a required five-day clinical pharmacology rotation. Group-A participants attended a 15-minute lecture on completing a MedWatch form with quality information considered by the Food and Drug Administration as critical to adequate adverse drug reaction reporting. Group-B participants did not attend this lecture. Both groups then watched a standardized patient interview of a recognizable adverse drug reaction and completed MedWatch forms. Four Safety Evaluators from the Food and Drug Administration (FDA) rated student responses in a blinded fashion for the primary efficacy variable of Overall Impression and six informational domins using a standardized data quality analysis form that was developed within the Office of Postmarketing Drug Risk Assessment of the FDA. Seventy-eight MedWatch forms were evaluated (Group-A = 40, Group B = 38). Overall MedWatch information quality scores for the intervention group were significantly higher than the non-intervention group (p < 0.004). As little as a 15-minute intervention can significantly improve the quality of adverse drug reaction reporting by 4th-year medical students. Academic medical centers should consider incorporating adverse drug reaction reporting curriculum into the clinical training of medical students.

  9. 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

  10. National burden of preventable adverse drug events associated with inpatient injectable medications: healthcare and medical professional liability costs.

    PubMed

    Lahue, Betsy J; Pyenson, Bruce; Iwasaki, Kosuke; Blumen, Helen E; Forray, Susan; Rothschild, Jeffrey M

    2012-11-01

    Harmful medication errors, or preventable adverse drug events (ADEs), are a prominent quality and cost issue in healthcare. Injectable medications are important therapeutic agents, but they are associated with a greater potential for serious harm than oral medications. The national burden of preventable ADEs associated with inpatient injectable medications and the associated medical professional liability (MPL) costs have not been previously described in the literature. To quantify the economic burden of preventable ADEs related to inpatient injectable medications in the United States. Medical error data (MedMarx 2009-2011) were utilized to derive the distribution of errors by injectable medication types. Hospital data (Premier 2010-2011) identified the numbers and the types of injections per hospitalization. US payer claims (2009-2010 MarketScan Commercial and Medicare 5% Sample) were used to calculate the incremental cost of ADEs by payer and by diagnosis-related group (DRG). The incremental cost of ADEs was defined as inclusive of the time of inpatient admission and the following 4 months. Actuarial calculations, assumptions based on published literature, and DRG proportions from 17 state discharge databases were used to derive the probability of preventable ADEs per hospitalization and their annual costs. MPL costs were assessed from state- and national-level industry reports, premium rates, and from closed claims databases between 1990 and 2011. The 2010 American Hospital Association database was used for hospital-level statistics. All costs were adjusted to 2013 dollars. Based on this medication-level analysis of reported harmful errors and the frequency of inpatient administrations with actuarial projections, we estimate that preventable ADEs associated with injectable medications impact 1.2 million hospitalizations annually. Using a matched cohort analysis of healthcare claims as a basis for evaluating incremental costs, we estimate that inpatient

  11. 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.…

  12. 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. ...

  13. 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.…

  14. 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.

  15. 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

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. MEADERS: Medication Errors and Adverse Drug Event Reporting system.

    PubMed

    Zafar, Atif

    2007-10-11

    The Agency for Healthcare Research and Quality (AHRQ) recently funded the PBRN Resource Center to develop a system for reporting ambulatory medication errors. Our goal was to develop a usable system that practices could use internally to track errors. We initially performed a comprehensive literature review of what is currently available. Then, using a combination of expert panel meetings and iterative development we designed an instrument for ambulatory medication error reporting and createad a reporting system based both in MS Access 2003 and on the web using MS ASP.NET 2.0 technologies.

  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. 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

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND... a final rule published in the Federal Register of February 2, 2012. This small entity compliance guide (SECG) is intended to set forth in plain language the requirements of the regulation and to help...

  3. 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…

  4. 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…

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

    PubMed

    Kahl, Fabian; Frewer, Andreas

    2017-04-01

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

  6. [The medical drugs at Divanü Lügat-it Türk].

    PubMed

    Altintaş, A

    2001-01-01

    Divanü Lügat-It Türk is a great encyclopaedical work written by Kaşgarli Mahmud in the 11th century. This masterpiece gives us detailed information on the Turkish culture of the time. This paper is constituted of five parts and covers all medical drugs mentioned in the book. On the first part, information is given about the physicians and pharmacists charged in drug preparation. The medical drugs of the 11th century have been listed alphabetically in the second part. This list comprises 190 medical drugs each of which has been shown by their counterparts in the Divan up to its volumes and pages in the original text.

  7. 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.

  8. 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.

  9. 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

  10. Medicaid prescription drug policies and medication access and continuity: findings from ten states.

    PubMed

    West, Joyce C; Wilk, Joshua E; Rae, Donald S; Muszynski, Irvin S; Stipec, Maritza Rubio; Alter, Carol L; Sanders, Karen E; Crystal, Stephen; Regier, Darrel A

    2009-05-01

    The aims of this study were to compare medication access problems among psychiatric patients in ten state Medicaid programs, assess adverse events associated with medication access problems, and determine whether prescription drug utilization management is associated with access problems and adverse events. Psychiatrists from the American Medical Association's Masterfile were randomly selected (N=4,866). Sixty-two percent responded; 32% treated Medicaid patients and were randomly assigned a start day and time to report on two Medicaid patients (N=1,625 patients). A medication access problem in the past year was reported for a mean+/-SE of 48.3%+/-2.0% of the patients, with a 37.6% absolute difference between states with the lowest and highest rates (p<.001). The most common access problems were not being able to access clinically indicated medication refills or new prescriptions because Medicaid would not cover or approve them (34.0%+/-1.9%), prescribing a medication not clinically preferred because clinically indicated or preferred medications were not covered or approved (29.4%+/-1.8%), and discontinuing medications as a result of prescription drug coverage or management issues (25.8%+/-1.6%). With patient case mix adjusted to control for sociodemographic and clinical confounders, patients with medication access problems had 3.6 times greater likelihood of adverse events (p<.001), including emergency visits, hospitalizations, homelessness, suicidal ideation or behavior, or incarceration. Also, all prescription drug management features were significantly associated with increased medication access problems and adverse events (p<.001). States with more access problems had significantly higher adverse event rates (p<.001). These associations indicate that more effective Medicaid prescription drug management and financing practices are needed to promote medication continuity and improve treatment outcomes.

  11. Functional Limitations, Medication Support, and Responses to Drug Costs among Medicare Beneficiaries.

    PubMed

    Whaley, Christopher; Reed, Mary; Hsu, John; Fung, Vicki

    2015-01-01

    Standard Medicare Part D prescription drug benefits include substantial and complex cost-sharing. Many beneficiaries also have functional limitations that could affect self-care capabilities, including managing medications, but also have varying levels of social support to help with these activities. We examined the associations between drug cost responses, functional limitations, and social support. We conducted telephone interviews in a stratified random sample of community-dwelling Medicare Advantage beneficiaries (N = 1,201, response rate = 70.0%). Participants reported their functional status (i.e., difficulty with activities of daily living) and social support (i.e., receiving help with medications). Drug cost responses included cost-reducing behaviors, cost-related non-adherence, and financial stress. We used multivariate logistic regression to assess associations among functional status, help with medications, and drug cost responses, adjusting for patient characteristics. Respondents with multiple limitations who did not receive help with their medications were more likely to report cost-related non-adherence (OR = 3.2, 95% CI: 1.2-8.5) and financial stress (OR = 2.4, 95% CI: 1.3-4.5) compared to subjects with fewer limitations and no help; however, those with multiple limitations and with medication help had similar odds of unfavorable cost responses as those with fewer limitations. The majority of beneficiaries with functional limitations did not receive help with medications. Support with medication management for beneficiaries who have functional limitations could improve adherence and outcomes.

  12. Frequency and Severity of Adverse Drug Events by Medication Classes: The JADE Study.

    PubMed

    Sakuma, Mio; Kanemoto, Yuko; Furuse, Akari; Bates, David W; Morimoto, Takeshi

    2015-08-13

    Adverse drug events (ADEs) are a significant concern in daily practice; however, the profile of high-risk drugs remains unclear. Our objective was to categorize high-risk medication classes according to frequency and severity of ADEs. The JADE study is a prospective cohort study of 3459 hospitalized adult patients. We investigated the ADEs and medications prescribed to the patients. The rate of ADEs for each medication class was calculated by dividing the number of ADEs by the number of patients who received each medication class on admission. Overall, 14,435 medications were ordered on admission for patients (median 4; interquartile range, 2-6). Electrolytes and fluids were most frequently prescribed (1876 patients, 54%). Sedatives, antibiotics, peptic ulcer drugs, and analgesics were also commonly prescribed. The frequency was similar in both elderly and younger patients. Among 1010 identified ADEs, antibiotics were most frequently associated with ADEs (31 ADEs per 100 prescribed patients on admission). In patients 65 years and older, corticosteroids, anticonvulsants, laxatives, nonsteroidal anti-inflammatory drugs, and antipsychotics were the 5 most frequent medication classes causing ADEs following antibiotics. In patients younger than 65 years, antibiotics were also the most frequent cause of ADEs, followed by laxatives, lipid-lowering agents, anticonvulsants, and corticosteroids. Among cardiovascular agent-associated ADEs, 46% were fatal or life threatening in elderly patients, whereas antihypertensives were most often associated with fatal or life-threatening ADEs (25%) in younger patients. The medication classes frequently associated with ADEs did not necessarily induce severe ADEs.

  13. 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

  14. 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.

  15. 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

  16. 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

  17. [Children and medications: educational software on drug administration in pediatrics].

    PubMed

    Zem-Mascarenhas, S H; Cassiani, S H

    2000-01-01

    The purpose of this study is the development and evaluation of an educational software on the administration of pediatric medicaments called "Children and medication". The pedagogical framework of Robert M. Gagné and the Three Stages Model, proposed by Price (1991) to develop CAI programs, were used. The software utilizes multimedia resources and is composed of four topics: the child, the medicament, the person who administers it and the administering of the medication. After the development of the program, it went through an evaluation process which was divided in three phases and had the participation of system analyst professionals and the target population to which the software was designed. Data analysis of the software showed that most of the items received excellent approval by the evaluators. It was observed that the software was accepted by the users and that it contributed for the nursing teaching of pediatric medicament administering through a new resource.

  18. Orexin Receptor Targets for Anti-Relapse Medication Development in Drug Addiction.

    PubMed

    Zhou, Luyi; Sun, Wei-Lun; See, Ronald E

    2011-06-14

    Drug addiction is a chronic illness characterized by high rates of relapse. Relapse to drug use can be triggered by re-exposure to drug-associated cues, stressful events, or the drug itself after a period of abstinence. Pharmacological intervention to reduce the impact of relapse-instigating factors offers a promising target for addiction treatment. Growing evidence has implicated an important role of the orexin/hypocretin system in drug reward and drug-seeking, including animal models of relapse. Here, we review the evidence for the role of orexins in modulating reward and drug-seeking in animal models of addiction and the potential for orexin receptors as specific targets for anti-relapse medication approaches.

  19. Non-prescription Drugs and Self-medication: Features and Subjects in Pharmaceutical Education.

    PubMed

    Watanabe, Kinzo

    2016-01-01

    At the time of consultation with a patient regarding OTC drugs, a pharmacist goes through the following five steps. In Step 1 information is collected, including the patient's gender, age, health condition, living situation, etc. In Step 2, upon analyzing and evaluating this collected information, the pharmacist decides whether to recommend that the patient see a medical doctor or whether an OTC drug is sufficient. In Step 3, when an OTC drug is required, the pharmacist suggests the most suitable OTC drug. In Step 4, the pharmacist provides the patient recommendations and information about the selected OTC. In Step 5, sales record entry and aftercare are performed. In these five steps, the pharmacist is making a decision on whether the consultation recommendation is required or optional; the step of making an optimal selection of an OTC drug is distinct from prescription dispensing. In many cases, at the time of OTC drug consultation, since the patient is not consulting a medical doctor, a pharmacist becomes a "first access" health professional. In this instance, the advice of a pharmacist may have a great influence on a patient's prognosis regarding the particular health challenge. Therefore, pharmacists who perform patient consultations regarding OTC drugs are required to have broad medical knowledge and communication skills. The features of consultation and information dissemination about OTC drugs by a pharmacist, and the practice and study of this subject in present-day pharmaceutical education, are described herein.

  20. Determinants and associated factors influencing medication adherence and persistence to oral anticancer drugs: a systematic review.

    PubMed

    Verbrugghe, M; Verhaeghe, S; Lauwaert, K; Beeckman, D; Van Hecke, A

    2013-10-01

    The use of oral anticancer drugs has increased in modern oncology treatment. The move from intravenous treatments towards oral anticancer drugs has increased the patients' own responsibility to take oral anticancer drugs as being prescribed. High rates of non-adherence to oral anticancer drugs have been reported. A systematic literature review was conducted to gain insight into determinants and associated factors of non-adherence and non-persistence in patients taking oral anticancer therapy. PubMed, Cochrane, Web of Science and Cinahl were systematically searched for studies focusing on determinants and associated factors of medication non-adherence and non-persistence to oral anticancer drugs. The methodological quality of the included studies was assessed by two independent reviewers. No studies were excluded based on the quality assessment. Twenty-five studies were included and systematically reviewed. The quality of the studies was moderate. Associated factors influencing medication non-adherence and non-persistence to oral anticancer drugs are multifactorial and interrelated. Older and younger age, and the influence of therapy related side effects were found to be predominant factors. Non-adherence and non-persistence to oral anticancer drug therapy are complex phenomena. More qualitative research is needed to facilitate the development of patient tailored complex interventions by exploring patients' needs and underlying processes influencing medication non-adherence and non-persistence to oral anticancer drugs. Copyright © 2013 Elsevier Ltd. All rights reserved.

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

    PubMed

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

    2015-12-01

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

  2. Impact of Multiple Pharmacy Use on Medication Adherence and Drug-drug Interactions in Older Adults with Medicare Part D

    PubMed Central

    Marcum, Zachary A.; Driessen, Julia; Thorpe, Carolyn T.; Gellad, Walid F.; Donohue, Julie M.

    2014-01-01

    Objective To assess the association between multiple pharmacy use and medication adherence and potential drug-drug interactions (DDIs) among older adults. Design, Setting, and Participants Cross-sectional propensity score-weighted analysis of 2009 claims data from a nationally representative sample of 926,956 Medicare Part D beneficiaries aged >65 continuously enrolled in fee-for-service Medicare and Part D that year, and filled >1 prescription at a community/retail or mail order pharmacy. Multiple pharmacy use was defined as concurrent (overlapping time periods) or sequential use (non-overlapping time periods) of >2 pharmacies in the year. Measurements Medication adherence was calculated using a proportion of days covered ≥0.80 for eight therapeutic categories (β-blockers, renin angiotensin system antagonists, calcium channel blockers, statins, sulfonylureas, biguanides [i.e., metformin], thiazolidinediones, and dipeptidyl peptidase-IV inhibitors). Potential DDIs arising from use of certain drugs across a broad set of classes were defined as the concurrent filling of two interacting drugs. Results Overall, 38.1% of the sample used multiple pharmacies. Those using multiple pharmacies (both concurrently and sequentially) consistently had higher adjusted odds of non-adherence (ranging from 1.10 to 1.31, p<0.001) across all chronic medication classes assessed after controlling for socio-demographic, health status and access to care factors, compared to single pharmacy users. The adjusted predicted probability of exposure to a DDI was also slightly higher for those using multiple pharmacies concurrently (3.6%) compared to single pharmacy users (3.2%, AOR 1.11, 95% CI 1.08–1.15) but lower in individuals using multiple pharmacies sequentially (2.8%, AOR 0.85, 95% CI 0.81–0.91). Conclusions Filling prescriptions at multiple pharmacies was associated with lower medication adherence across multiple chronic medications, and a small but statistically significant

  3. Non-medical use of psychotropic prescription drugs among adolescents in substance use treatment.

    PubMed

    Apantaku-Olajide, Tunde; Smyth, Bobby P

    2013-01-01

    Little is known about the extent of non-medical use of prescription drugs among European adolescents with substance use disorders. This cross-sectional study examined non-medical use of seven categories of psychotropic prescription drugs (opioid analgesics, ADHD stimulant, sleeping, sedative/anxiolytic, antipsychotic, antidepressant, and anabolic steroid medications) in a clinical sample of Irish adolescents with substance use disorders. Of the 85 adolescents (aged 13-18 years) invited to participate, 65 adolescents (M = 16.3 years, SD = 1.3) took part (response: 74%). Among respondents, 68% reported lifetime non-medical use of any of the prescription drugs; sedative/anxiolytic (62%) and sleeping medications (43%) were more commonly abused. The most frequently reported motives for abuse were "seeking high or buzz" (79%), "having good time" (63%), and "relief from boredom" (56%). Sharing among friends and street-level drug markets were the most readily available sources. Innovative solutions of control measures and intervention are required to address the abuse of prescription drugs.

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

    PubMed

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

    2016-06-01

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

  6. Effect of drug reminder packaging on medication adherence: a systematic review revealing research gaps.

    PubMed

    Boeni, Fabienne; Spinatsch, Esther; Suter, Katja; Hersberger, Kurt E; Arnet, Isabelle

    2014-03-24

    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. 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. 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. 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.

  7. 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.

  8. 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.

  9. 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.

  10. Prevalence and patient awareness of selected potential drug interactions with self-medication.

    PubMed

    Indermitte, J; Reber, D; Beutler, M; Bruppacher, R; Hersberger, K E

    2007-04-01

    In community pharmacies potential drug interactions between prescription only medicines (POM) and over-the-counter (OTC) drugs purchased for self-medication arise mainly in two situations: (i) if an OTC drug is purchased by a passer-by customer whose prescribed drug therapy is not known; or (ii) if a POM or an OTC drug is requested by a regular customer whose prescribed drug therapy is usually recorded. With this study we aimed to assess the prevalence of potential drug interactions with selected POM and OTC drugs in passer-by and regular customers as well as their awareness of these potential drug interactions. Data were collected in 14 community pharmacies in the region of Basel, Switzerland by observation of customer contacts and interviews with passer-by customers purchasing selected OTC drugs, and telephone-interviews with regular customers treated with selected POMs identified in community pharmacies' databases. The selected POMs and OTC drugs are drugs which could lead to clinically relevant drug interactions of varying severity but manageable through different interventions such as adjustment of dose and its timing and/or monitoring of the therapy, and avoidance of the combination by choosing an alternative treatment. Of 1183 passer-by customers observed, 164 (14 x 4%) purchased at least one of the selected OTC drugs. One hundred and two (62 x 2%) of those subjects were interviewed. Forty-three (42 x 2%) mentioned taking prescribed drugs, and three of them were exposed to potential drug interactions of moderate severity. Out of 592 regular customers selected from the community pharmacy database, 434 (73 x 3%) could be interviewed. Sixty-nine (15 x 9%) of them were exposed to a potential drug interaction between purchased OTC drug for self-medication and their POM. Furthermore, 116 (26 x 7%) regular customers were exposed to potential drug interactions within their prescribed drugs and in 28 (6 x 5%) multiple (>or=2) potential drug interactions were found

  11. 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.

  12. 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.

  13. 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

  14. 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.

  15. Prescription drug use among elderly admitted to medical wards in a Malaysian government hospital.

    PubMed

    Hor, J Y

    2008-06-01

    A cross-sectional study was conducted to examine the use of prescription drugs among elderly patients (> or = 60 years old) admitted to medical wards in Hospital Kuala Lumpur, Malaysia. A total of 204 elderly (101 men and 103 women) were interviewed. Eighty two percent of the elderly were taking at least one prescription drug, with 39.2% taking > or = 5 drugs. Prescription drugs commonly used were antihypertensives (54.4%), antidiabetics (40.2%), drugs used in haemostasis (36.8%), nitrates (33.3%) and diuretics (32.4%). Factors associated with increased use of prescription drugs were: more number of chronic diseases, self-rated health status as poor, low Barthel score, and Chinese women.

  16. 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

  17. Ethylene vinyl acetate (EVA) as a new drug carrier for 3D printed medical drug delivery devices.

    PubMed

    Genina, Natalja; Holländer, Jenny; Jukarainen, Harri; Mäkilä, Ermei; Salonen, Jarno; Sandler, Niklas

    2016-07-30

    The main purpose of this work was to investigate the printability of different grades of ethylene vinyl acetate (EVA) copolymers as new feedstock material for fused-deposition modeling (FDM™)-based 3D printing technology in fabrication of custom-made T-shaped intrauterine systems (IUS) and subcutaneous rods (SR). The goal was to select an EVA grade with optimal properties, namely vinyl acetate content, melting index, flexural modulus, for 3D printing of implantable prototypes with the drug incorporated within the entire matrix of the medical devices. Indomethacin was used as a model drug in this study. Out of the twelve tested grades of the EVA five were printable. One of them showed superior print quality and was further investigated by printing drug-loaded filaments, containing 5% and 15% indomethacin. The feedstock filaments were fabricated by hot-melt extrusion (HME) below the melting point of the drug substance and the IUS and SR were successfully printed at the temperature above the melting point of the drug. As a result, the drug substance in the printed prototypes showed to be at least partly amorphous, while the drug in the corresponding HME filaments was crystalline. This difference affected the drug release profiles from the filaments and printed prototype products: faster release from the prototypes over 30days in the in vitro tests. To conclude, this study indicates that certain grades of EVA were applicable feedstock material for 3D printing to produce drug-loaded implantable prototypes. Copyright © 2015 Elsevier B.V. All rights reserved.

  18. 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.

  19. 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.

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

    PubMed

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

    2009-04-01

    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. To evaluate drug advertisements in Nigerian and other African medical journals for their adequacy of pharmacological information. 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. 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 on both the container and

  1. 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

  2. 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.

  3. 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…

  4. 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.

  5. 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.

  6. 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.

  7. Impact of telephone medication therapy management on medication and health-related problems, medication adherence, and Medicare Part D drug costs: a 6-month follow up.

    PubMed

    Moczygemba, Leticia R; Barner, Jamie C; Lawson, Kenneth A; Brown, Carolyn M; Gabrillo, Evelyn R; Godley, Paul; Johnsrud, Michael

    2011-10-01

    The Medicare Modernization Act of 2003 mandated the provision of medication therapy management (MTM) to eligible Part D beneficiaries to improve medication-related outcomes. As MTM programs evolve, evaluation is necessary to help inform MTM best practices. The objective of this study was to determine the impact of pharmacist-provided telephone MTM on: (1) medication and health-related problems (MHRPs); (2) medication adherence; and (3) Part D drug costs. This quasi-experimental study included Part D beneficiaries from a Texas health plan. Andersen's Behavioral Model of Health Services Use served as the study framework. MTM utilization was the health behavior. Age, gender, and race were predisposing factors, and number of medications, chronic diseases, and medication regimen complexity were need factors. Outcomes were pre-to-post changes in: (1) MHRPs; (2) medication adherence, using the medication possession ratio (MPR); and (3) total drug costs. Multiple regression was used to analyze group differences while controlling for predisposing and need factors. At baseline, the intervention (n = 60) and control (n = 60) groups were not statistically different regarding predisposing and need factors, with the exception of gender. The intervention group had significantly (P = 0.009) more men compared with the control group (51.7% vs 28.3%). There were 4.8 (2.7) and 9.2 (2.9) MHRPs identified at baseline and 2.5 (2.0) and 7.9 (3.0) MHRPs remained at the 6-month follow up in the intervention and control groups, respectively. The intervention group (vs control) had significantly more MHRPs resolved (P = 0.0003). There were no significant predictors of change in MPR or total drug costs from baseline to follow up, although total drug costs decreased by $158 in the intervention group compared with a $118 increase in the control group. A telephone MTM program resolved significantly more MHRPs compared with a control group, but there were no significant changes in adherence and

  8. Sedative Drug Use among King Saud University Medical Students: A Cross-Sectional Sampling Study.

    PubMed

    Al-Sayed, Ahmed A; Al-Rashoudi, Abdualltef H; Al-Eisa, Abdulrhman A; Addar, Abdullah M; Al-Hargan, Abdullah H; Al-Jerian, Albaraa A; Al-Omair, Abdullah A; Al-Sheddi, Ahmed I; Al-Nowaiser, Hussam I; Al-Kathiri, Omar A; Al-Hassan, Abdullah H

    2014-01-01

    Introduction. Medical students experience significant psychological stress and are therefore at higher risk of using sedatives. There are currently no studies describing the prevalence of sedative drug use among medical students in Saudi Arabia. The aim of this study was to evaluate the prevalence and factors associated with sedative drug use among medical students in Saudi Arabia. Materials and Methods. A cross-sectional convenience sampling study gathered data by anonymous questionnaire from students enrolled at the King Saud University College of Medicine in 2011. The questionnaires collected data regarding social and demographic variables, sleep patterns, and the use of stimulant and sedative drugs since enrollment. Sedatives were defined as any pharmaceutical preparations that induce sleep. Results and Discussion. Of the 729 students who returned questionnaires, 17.0% reported sedative drug use at some time since enrollment. Higher academic year, lower grade point average, regular exercise, fewer hours of sleep per day, poorer quality of sleep, and the presence of sleeping disorders were found to be significantly associated with sedative drug use. Conclusions. Further study is required to increase our understanding of sedative drug use patterns in this relatively high-risk group, as such understanding will help in the development of early intervention programs.

  9. 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.

  10. 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 the...

  11. 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 the...

  12. 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

  13. 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

  14. Alternative Medications for Medications in the Use of High-Risk Medications in the Elderly and Potentially Harmful Drug-Disease Interactions in the Elderly Quality Measures.

    PubMed

    Hanlon, Joseph T; Semla, Todd P; Schmader, Kenneth E

    2015-12-01

    The National Committee for Quality Assurance (NCQA) and the Pharmacy Quality Alliance (PQA) use the American Geriatrics Society (AGS) Beers Criteria to designate the quality measure Use of High-Risk Medications in the Elderly (HRM). The Centers for Medicare and Medicaid Services (CMS) use the HRM measure to monitor and evaluate the quality of care provided to Medicare beneficiaries. NCQA additionally uses the AGS Beers Criteria to designate the quality measure Potentially Harmful Drug-Disease Interactions in the Elderly. Medications included in these measures may be harmful to elderly adults and negatively affect a healthcare plan's quality ratings. Prescribers, pharmacists, patients, and healthcare plans may benefit from evidence-based alternative medication treatments to avoid these problems. Therefore the goal of this work was to develop a list of alternative medications to those included in the two measures. The authors conducted a comprehensive literature review from 2000 to 2015 and a search of their personal files. From the evidence, they prepared a list of drug-therapy alternatives with supporting references. A reference list of nonpharmacological approaches was also provided when appropriate. NCQA, PQA, the 2015 AGS Beers Criteria panel, and the Executive Committee of the AGS reviewed the drug therapy alternatives and nonpharmacological approaches. Recommendations by these groups were incorporated into the final list of alternatives. The final product of drug-therapy alternatives to medications included in the two quality measures and some nonpharmacological resources will be useful to health professionals, consumers, payers, and health systems that care for older adults. © 2015, Copyright the Authors Journal compilation © 2015, The American Geriatrics Society.

  15. 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.

  16. 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

  17. 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

  18. Medication competency of nurses according to theoretical and drug calculation online exams: A descriptive correlational study.

    PubMed

    Sneck, Sami; Saarnio, Reetta; Isola, Arja; Boigu, Risto

    2016-01-01

    Medication administration is an important task of registered nurses. According to previous studies, nurses lack theoretical knowledge and drug calculation skills and knowledge-based mistakes do occur in clinical practice. Finnish health care organizations started to develop a systematic verification processes for medication competence at the end of the last decade. No studies have yet been made of nurses' theoretical knowledge and drug calculation skills according to these online exams. The aim of this study was to describe the medication competence of Finnish nurses according to theoretical and drug calculation exams. A descriptive correlation design was adopted. Participants and settings All nurses who participated in the online exam in three Finnish hospitals between 1.1.2009 and 31.05.2014 were selected to the study (n=2479). Quantitative methods like Pearson's chi-squared tests, analysis of variance (ANOVA) with post hoc Tukey tests and Pearson's correlation coefficient were used to test the existence of relationships between dependent and independent variables. The majority of nurses mastered the theoretical knowledge needed in medication administration, but 5% of the nurses struggled with passing the drug calculation exam. Theoretical knowledge and drug calculation skills were better in acute care units than in the other units and younger nurses achieved better results in both exams than their older colleagues. The differences found in this study were statistically significant, but not high. Nevertheless, even the tiniest deficiency in theoretical knowledge and drug calculation skills should be focused on. It is important to identify the nurses who struggle in the exams and to plan targeted educational interventions for supporting them. The next step is to study if verification of medication competence has an effect on patient safety. Copyright © 2015 Elsevier Ltd. All rights reserved.

  19. Pharmaco-epidcemiology of drugs utilised for cataract surgery in a government medical college and hospital.

    PubMed

    Biswas, Supreeti; Mondal, Kanchan Kumar; Halder, Sujash; Sarkar, Sougat Sourendra; Maiti, Tamoghna; Lahiri, Saibendu Kumar; Haldar, Swaraj

    2010-12-01

    Prescription audit is a powerful tool for rational prescription. To evaluate pharmaco-epidemiology of drugs utilised for cataract surgery, a retrospective study was conducted in the department of pharmacology, RG Kar Medical College, Kolkata. Data from bed head tickets of one year, available in medical record section, were collected in case report forms and analysed. Utilisation pattern of drugs like dosage form, dose, route and frequency of administration and duration of therapy were audited. Drug prescription versus therapeutic indication was also evaluated. Price of the prescribed drugs was evaluated for rationality towards cost-effective prescription. For 848 cases of cataract surgery, drugs were prescribed pre-, per- and post-operatively. Different fluoroquinolone antibiotics, anti-inflammatory and mydriatic-cycloplegic agents were prescribed. High or low cost drugs were prescribed both in generic (52%) and brand (48%) names. Few Latin abbreviations were used in directions. Different parameters and study results were discussed from various aspects to explore their social impacts. Though prescription pattern was almost rational, some parts need improvement. Healthcare provider should be aware of cost-effectiveness of the prescribed drugs for the benefit of patients to provide a rational prescription.

  20. Cognitive factors related to drug abuse among a sample of Iranian male medical college students.

    PubMed

    Jalilian, Farzad; Ataee, Mari; Matin, Behzad Karami; Ahmadpanah, Mohammad; Jouybari, Touraj Ahmadi; Eslami, Ahmad Ali; Mahboubi, Mohammad; Alavijeh, Mehdi Mirzaei

    2015-02-24

    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). 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. 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. 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.

  1. 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

  2. [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.

  3. 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... for marketing. CPG 440.100 has been revised to state that the enforcement priorities and potential... more advantageous to extended marketing of illegal, unapproved drug products. The potential increase in...

  4. Supported and unsupported claims in medicinal drug advertisements in Indian medical journals.

    PubMed

    Dhanaraj, Ethiraj; Nigam, Aditi; Bagani, Sanjay; Singh, Himmat; Tiwari, Pramil

    2011-01-01

    The study assessed 292 supported and unsupported claims in 102 medicinal drug advertisements across 15 Indian medical journals published in 2009. WHO ethical criteria for medicinal drug promotion were applied. None of the advertisements satisfied all the WHO criteria. Safe prescribing information on major adverse drug reactions, contraindications and warnings was provided in only 19 advertisements. Of 292 drug claims, only 80 (27%) were supported with reference(s), of which only 7 (9%) claims were unambiguous, or well substantiated with references. 14 references quoted did not substantiate the claim and 15 constituted weak scientific evidence. Superlatives like "tested" "trusted" "guarantees success" and "matchless safety" were used without evidence to substantiate such claims. Stronger enforcement mechanisms are necessary to ensure reliable drug information in pharmaceutical advertisements.

  5. Drugs Are Not Enough: Some Principles of Psychopharmacology for General Medical Practice

    PubMed Central

    Ross, W. Donald

    1963-01-01

    There is no necessary antagonism between the judicious use of drugs and a psychotherapeutic approach to patients in general medical practice. A table is presented with a simple pragmatic classification of types of drugs for altering emotional and mental states. Three general principles are given for the use of such drugs, illustrated by examples of the use and misuse of tranquillizers. Some differentiation is made between sedatives and tranquillizers and between different types of tranquillizers, particularly with reference to the need to consider depressive features in patients. Suggestions are made for the use of drugs for mild depressions and for depressions accompanying organic disease. One may have to take an “experimental” approach to new drugs to determine which to them are of value in relation to the particular emotional states of one's own patients. ImagesFig. 1 PMID:14060167

  6. 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

  7. 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)

  8. Improved medication use in long-term care: building on the consultant pharmacist's drug regimen review.

    PubMed

    Harjivan, Chandresh; Lyles, Alan

    2002-04-01

    Elderly and long-term care (LTC) patients often require complex medication regimens that increase their risk of adverse drug events or suboptimal pharmacotherapy. Currently, oversight of medication use in LTC facilities consists of a federally mandated monthly audit, the drug regimen review (DRR), performed by a consultant pharmacist, and yearly onsite government surveys. Although the DRR's purpose is to improve drug use and to avoid adverse drug events, the Centers for Medicare and Medicaid Services's (CMS) current DRR guidelines focus on a limited selection of medications and indications rather than on patient outcomes. An expanded model building on CMS's survey guidelines and the American Society of Consultant Pharmacists' Fleetwood Model is proposed to improve oversight of medication use. The proposed model includes using consultant pharmacists with demonstrated geriatric pharmacotherapy expertise, direct patient assessments by the pharmacist, increased interaction among healthcare professionals, evidence-based practices, and explicit patient outcome assessments. It is both feasible and timely: (1) the LTC prospective payment system aligns financial incentives between payers and providers; and (2) the Institute of Medicine has made quality improvement and error reduction a priority.

  9. 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

    ... and Drug Administration (FDA) is announcing a program expansion of its Conference Cooperative.... Background This FOA, issued by FDA, announces a proposed program expansion of FDA's Conference Cooperative... learned from medical product surveillance, and engaging stakeholders, namely the health care community...

  10. 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...

  11. 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...

  12. How does complementary private prescription drug insurance coverage affect seniors' use of publicly funded medications?

    PubMed

    Allin, Sara; Law, Michael R; Laporte, Audrey

    2013-05-01

    Like in many other high-income jurisdictions, the public drug program in Ontario, Canada provides comprehensive coverage of prescription drugs to the 65 years and older population with some cost sharing. The objective of this study was to examine the marginal impact of holding private drug coverage on the use of publicly funded medicines among the senior population in Ontario. We drew on linked survey and administrative data sources to examine the impact of private drug coverage first on total spending and utilization of medications, and second, on clinically recommended medications for individuals with a diagnosis of diabetes. Approximately 27% of Ontario seniors reported having private prescription drug insurance from a current or prior employer. The population-level analysis of all seniors found that individuals with private insurance coverage, on average, took about a quarter of an additional drug and incurred 16% more in costs to the public program in a year compared to those without additional coverage. The disease-specific analysis of seniors with a diagnosis of diabetes found that private coverage was associated with two-fold higher odds of taking an anti-hypertensive drug, but it had no association with the use of statins or anti-diabetic medications. The results of this study provide some evidence that seniors in Ontario are sensitive to the price of drugs. These findings raise equity concerns relating to the cost sharing arrangements in the public system and our policy of allowing private plans to "top-up" the public plan. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

  13. 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

  14. 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.

  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. Should eligibility for medication therapy management be based on drug adherence?

    PubMed

    Stuart, Bruce; Loh, Ellen; Miller, Laura; Roberto, Pamela

    2014-01-01

    Medicare Part D prescription drug plans must offer medication therapy management (MTM) services to qualified enrollees. Eligibility criteria used by plan sponsors are restrictive, and fewer than 10% of Part D enrollees receive MTM services. The extent to which plan criteria identify beneficiaries most at risk for suboptimal medication use is unknown. To (a) evaluate potential underuse of and poor adherence to evidence-based medications used in the treatment of Medicare beneficiaries with diabetes, heart failure, and chronic obstructive pulmonary disease (COPD) over 3 years; (b) determine whether MTM eligibility criteria used by the modal Part D plan in 2011 (drug spending ≥ $3,000, ≥ 3 chronic conditions, ≥ 8 Part D medications) identified Part D enrollees at greatest risk for underuse of and poor adherence to these drugs; and (c) demonstrate how sensitive MTM eligibility is to variations in criteria levels. Study subjects were selected from a 5% random sample of Part D enrollees with 1 or more of these diseases in 2006 and followed through 2008 or death. Longitudinal patterns of exposure and adherence to angiotensin-converting-enzyme inhibitor/angiotensin receptor blockers, beta-blockers, and COPD controller drugs were tracked comparing patterns for enrollees meeting/not meeting the modal 2011 MTM eligibility criteria. Use of evidence-based medication was consistently suboptimal for every disease cohort studied. Higher rates of exposure and adherence were observed among those with high drug spending taking multiple Part D drugs. Current MTM criteria were found to target beneficiaries with above average utilization of evidence-based medication and to exclude those with more problematic utilization patterns. We estimate that lowering the maximum required drug count from 8 to 2 would increase the percentage of beneficiaries eligible for MTM by two thirds. Our findings suggest that MTM eligibility criteria are not optimally targeted to capture underuse of and

  17. 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.

  18. Adverse drug events and medication errors in psychiatry: methodological issues regarding identification and classification.

    PubMed

    Mann, Klaus; Rothschild, Jeffrey M; Keohane, Carol A; Chu, James A; Bates, David W

    2008-01-01

    Abstract Adverse drug events and medication errors have received extensive study recently in a variety of clinical populations, though compared to many other areas relatively little work has focused on this area in psychiatry, especially with respect to the contribution of error to harm. The goal of this paper is to discuss methodological issues around measurement of medication safety in psychiatric patients. Against the background of a systems approach, a modern perspective of error management is discussed, and a multidimensional procedure for detection and classification of incidents related to the medication process is presented. This method has proven successful in non-psychiatric settings yielding the current best estimate of error rates and providing insight into the underlying causes. While this general approach can be adapted to the psychiatric setting, a number of issues make measurement especially challenging in psychiatry. These include the fluctuating course of psychiatric disorders, reduced patient adherence to the medication process, adverse effects which are often similar to symptoms of the underlying disorder, the frequent use of wide dose intervals depending on the clinical situation, and the presence of many drug-drug interactions. Data collected by means of the presented approach provide a basis for the development of effective strategies to reduce the risk of medication errors and thus improve patient safety in psychiatric care.

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

    PubMed

    Small, Gary; Dubois, Bruno

    2007-11-01

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

  20. 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.

  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 a