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Sample records for medical drug compliance

  1. FDA (Food and Drug Administration) Compliance Program Guidance Manual. Section 4. Medical and radiological devices. Basic section. (FY-89)

    SciTech Connect

    Not Available

    1989-01-01

    The Food and Drug Administration (FDA) Compliance Program Guidance Manual provides a system for issuing and filing program plans and instructions directed to the Food and Drug Administration Field operations for project implementation. Section IV provides those chapters of the Compliance Program Guidance Manual which pertain to the areas of medical and radiological devices. Some of the areas of coverage include laser and sunlamp standards inspections, compliance testing of various radiation-emitting products such as television receivers and microwave ovens, emergency response planning and policy, premarket approval and device manufacturers inspections, device problem reporting, sterilization of devices, and consumer education programs on medical and radiological devices.

  2. FDA (Food and Drug Administration) compliance program guidance manual (FY 87). Section 4. Medical and radiological devices

    SciTech Connect

    Not Available

    1987-01-01

    The FDA Compliance Program Guidance Manual provides a system for issuing and filing program plans and instructions directed to Food and Drug Administration Field operations for project implementation. Section IV provides those chapters of the Compliance Program Guidance Manual which pertain to the areas of medical and radiological devices. Some of the areas of coverage include laser and sunlamp standards inspections, compliance testing of various radiation-emitting products such as television receivers and microwave ovens, emergency response planning and policy, premarket approval and device manufacturers inspections, device problem reporting, sterilization of devices, and consumer education programs on medical and radiological devices.

  3. FDA (Food and Drug Administration) Compliance Program Guidance Manual. Section 4. Medical and radiological devices. Irregular report

    SciTech Connect

    Not Available

    1989-01-01

    The FDA Compliance Program Guidance Manual provides a system for issuing and filing program plans and instructions directed to Food and Drug Administration Field operations for project implementation. Section IV provides those chapters of the Compliance Program Guidance Manual which pertain to the areas of medical and radiological devices. Some of the areas of coverage include laser and sunlamp standards inspections, compliance testing of various radiation-emitting products such as television receivers and microwave ovens, emergency response planning and policy, premarket approval and device manufacturers inspections, device problem reporting, sterilization of devices, and consumer education programs on medical and radiological devices.

  4. FDA (Food and Drug Administration) Compliance Program Guidance Manual (FY 88). Section 4. Medical and radiological devices

    SciTech Connect

    Not Available

    1988-01-01

    The FDA Compliance Program Guidance Manual provides a system for issuing and filing program plans and instructions directed to Food and Drug Administration Field operations for project implementation. Section IV provides those chapters of the Compliance Program Guidance Manual which pertain to the areas of medical and radiological devices. Some of the areas of coverage include laser and sunlamp standards inspections, compliance testing of various radiation-emitting products such as television receivers and microwave ovens, emergency response planning and policy, premarket approval and device manufacturers inspections, device problem reporting, sterilization of devices, and consumer education programs on medical and radiological devices.

  5. FDA (Food and Drug Administration) Compliance Program Guidance Manual (FY 85). Section 4. Medical and radiological devices

    SciTech Connect

    Not Available

    1985-01-01

    The FDA Compliance Program Guidance Manual provides a system for issuing and filing program plans and instructions directed to Food and Drug Administration Field operations for project implementation. Section IV provides those chapters of the Compliance Program Guidance Manual which pertain to the areas of medical and radiological devices. Some of the areas of coverage include laser and sunlamp standards inspections, compliance testing of various radiation-emitting products such as television receivers and microwave ovens, emergency response planning and policy, premarket approval and device manufacturers inspections, device problem reporting, sterilization of devices, and consumer education programs on medical and radiological devices.

  6. FDA (Food and Drug Administration) compliance program guidance manual and updates (FY 86). Section 4. Medical and radiological devices. Irregular report

    SciTech Connect

    Not Available

    1986-01-01

    The FDA Compliance Program Guidance Manual provides a system for issuing and filing program plans and instructions directed to Food and Drug Administration Field operations for project implementation. Section IV provides those chapters of the Compliance Program Guidance Manual which pertain to the areas of medical and radiological devices. Some of the areas of coverage include laser and sunlamp standards inspections, compliance testing of various radiation-emitting products such as television receivers and microwave ovens, emergency response planning and policy, premarket approval and device manufacturers inspections, device problem reporting, sterilization of devices, and consumer education programs on medical and radiological devices.

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

    PubMed Central

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

    2014-01-01

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

  8. Medication compliance in hyperactive children.

    PubMed

    Kauffman, R E; Smith-Wright, D; Reese, C A; Simpson, R; Jones, F

    1981-01-01

    Medication compliance was studied over an 18-week period in 12 male children, ages 6 to 12 years, who were receiving medication for "hyperactivity." Subjects were randomly assigned to receive placebo (PB), d-amphetamine (AMP), and methylphenidate (MPH) for 6 weeks each in a triple-blind, crossover design. Urine samples were obtained weekly and assayed for MPH and AMP to assess compliance. Individual patient compliance varied from 0.00% to 100% (x = 67%) while taking MPH and from 20% to 83% (x = 60%) while taking AMP. The percent of patients compliant for a given week varied from 55% to 80% (x = 67%) when taking MPH and from 25% to 83% (x = 61%) when taking AMP. Significant positive noncompliance also occurred; ie, MPH was found in urine during the PB period in five of 12 individuals. Poor compliance in taking medication may explain, in part, the variable and conflicting results reported in many studies of the effect of medication on improving the behavior of hyperactive children. PMID:7346742

  9. 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.

  10. Teaching Medical Students about Treatment Compliance

    ERIC Educational Resources Information Center

    Blackwell, Barry; And Others

    1978-01-01

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

  11. 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

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

    ERIC Educational Resources Information Center

    Parsons, Robert J.; And Others

    1980-01-01

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

  13. Pediatric psychotropic medication compliance: a literature review and research-based suggestions for improving treatment compliance.

    PubMed

    Hack, S; Chow, B

    2001-01-01

    Without good compliance the best psychiatric treatment is ineffective. This article reviews what is known or can be inferred about compliance with psychiatric medications in the pediatric population. The review includes discussions of assessment techniques, risk and protective factors, the relevant research literature, and research-based practical techniques to improve compliance. A Medline search surveying the years from 1966 to August 2000 yielded only seven peer-reviewed papers reporting on compliance with pediatric psychopharmacology. All seven studies looked at stimulant compliance among children with attention deficit hyperactivity disorder. Reported levels of compliance range from 56% to 75%. These rates, although low, are likely to be overestimates of actual compliance. We review two related areas of research for which there are small but significant bodies of knowledge: pharmacological compliance studies among adult psychiatric populations and pediatric medical populations. This literature supports the idea that medication compliance is a significant obstacle to the effective treatment of patients. Because compliance rates are lower for children as compared to adults and psychiatric patients as compared to medical patients, we suspect that children with psychiatric illness may be at great risk for poor medication compliance. Fortunately, the research literature demonstrates several simple techniques that clinicians can use to improve medication compliance among their patients. The treatment alliance; education; and medication duration, dosing, palatability, and cost can all be tailored to improve medication compliance.

  14. Blood pressure control. Improving medication compliance among ESRD patients.

    PubMed

    Krevolin, Larry; Ilagan, Justin

    2015-08-01

    Medication compliance among individuals with hypertension symbolizes a growing concern within the medical community. It is said that roughly 50% of hypertensive patients in the United States do not comply with their medication regimen. Uncontrolled hypertension in turn can lead to kidney failure and other complications. Because compliance to medication regimens is complex and difficult to ascertain, solutions to this problem must be multifactorial.

  15. [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

  16. Does drug compliance change in asthmatic patients during pregnancy?

    PubMed Central

    2013-01-01

    Background Pregnant women with asthma are recommended to maintain optimal therapeutic management during pregnancy. Uncontrolled, symptomatic asthma may increase the risk of adverse peri-natal outcomes; thus adequate regular anti-asthmatic treatment must be given to provide optimal asthma control during pregnancy. However, doubts about the safety of asthmatic drugs can affect pregnant asthmatic patients’ drug compliance. The aim of this study was to assess behavioral differences in drug compliance among pregnant asthmatic patients. Methods Thirty two asthmatic and 121 healthy pregnant women were enrolled in the study. Structured face-to-face interviews were conducted after delivery. The interviews included disease characteristics, drug compliance and patients’ own perspective for asthma status prior to and during pregnancy. In addition, medical and pregnancy history, pregnancy complications and outcomes, and newborn characteristics were recorded. Results In our study group the rates of hospitalization, emergency room visits and systemic steroid use in the year before pregnancy were 13%, 46.9% and 18.8%, respectively. The rate of regular asthma medication use was only 32% at that period and increased to 44% during pregnancy. However, hospitalization, emergency room visits, systemic steroid usage rates remained unchanged and according to patients’ own evaluations, 44% of asthmatics pointed out that their asthma had worsened during pregnancy. No statistically significant difference was detected in terms of pregnancy/labour complication between asthmatic and non-asthmatics. Conclusions Contrary to some previous studies, in our study regular use of asthma drugs increased during pregnancy. The uncontrolled condition of their asthma before and during pregnancy and the idea that their asthma worsened during pregnancy might force the patients to use medication more regularly. PMID:23759108

  17. 75 FR 76015 - Compliance Policy Guide Sec. 393.200 Laser(s) as Medical Devices for Facelift, Wrinkle Removal...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-07

    ... the Federal Register of August 9, 2010 (75 FR 48180 at 48233), FDA included the Compliance Policy... HUMAN SERVICES Food and Drug Administration Compliance Policy Guide Sec. 393.200 Laser(s) as Medical... Administration (FDA) is announcing the withdrawal of Compliance Policy Guide Sec. 393.200 Laser(s) as...

  18. Therapeutic drug monitoring of psychotropic medications

    PubMed Central

    Mitchell, Philip B

    2001-01-01

    Therapeutic drug monitoring (TDM) of a number of psychotropic medications has proven to be of value, enabling minimization of the limitations of considerable genetic variability in their metabolism and the high rates of poor compliance with many psychiatric disorders. Therapeutic ranges have been established for lithium, some of the tricyclic antidepressants, and clozapine. TDM has also been shown to be useful in avoiding toxicity (as many psychotropics have narrow therapeutic indices), particularly that due to interactions with other compounds. PMID:11564052

  19. Medications and Drug Allergic Reactions

    MedlinePlus

    ... Drug Guide Conditions Dictionary Just for Kids Library School Tools Videos Virtual Allergist Education & Training Careers in ... reaction to a medication. These include: genetics, body chemistry, frequent drug exposure or the presence of an ...

  20. 77 FR 20025 - Draft Guidance for Industry on Compliance Policy for Reporting Drug Sample Distribution...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-03

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Compliance Policy for... guidance for industry entitled ``Compliance Policy on Reporting Drug Sample Distribution Information Under... availability of a draft guidance for industry entitled ``Compliance Policy on Reporting Drug...

  1. Perceived compliance with AZT dosing among a sample of African-American drug users.

    PubMed

    Williams, M; Bowen, A; Ross, M; Freeman, R; Elwood, W

    2000-01-01

    The purpose of this report was to present findings from a pilot study conducted to explore the associations between sociodemographic, drug use, and health belief factors and perceived compliance with zidovudine (AZT) among African-American drug users. Data were collected in Washington, DC, USA from individuals who were African-American; were recent or current drug injectors or crack smokers; were HIV-seropositive, and were receiving treatment for HIV infection. Participants were recruited through local organizations that provide services to HIV-infected persons. Participants were interviewed using a questionnaire that solicited sociodemographic, lifetime and current drug use, current sexual behaviours, health status, HIV and drug treatment history, and health belief data. Analyses were limited to individuals currently using an illicit substance and who had received AZT during their medical treatment. Parametric (Pearson's r) and nonparametric (Spearman's rho) statistics were used to assess correlations between perceived compliance with AZT dosing and independent variables. As the study was intended to be both descriptive and exploratory, the level of statistical significance was set at 0.10, rather than the customary 0.05. Antiretroviral medications recognized and recalled by participants are presented. The most commonly recalled medication was AZT. Slightly less than one-third of participants reported being completely compliant with an AZT regimen. Perceived compliance was found to be negatively associated with 5 variables: age, homelessness, number of injections in the previous 30 days, trading sex for drugs, and the perception that AIDS is no longer a serious disease since the development of new antiretroviral medications. Intensity of feelings of joy, fear, and the belief that taking more anti-HIV medications would result in better health were found to be positively correlated. Bivariate associations between perceived compliance and sociodemographic, drug use

  2. DigiSpenser--a GSM-based drug management and compliance monitoring system.

    PubMed

    Schukat, M; Rudroju, B

    2011-01-01

    Approximately one-third of all independently living elderly people are not compliant with their drug therapy. This lack of medication management results either in undermedication or overmedication, causing unnecessary and often serious health risks. This problem will worsen in the future with the change of demographics and cost constraints in the health sector. Therefore there is a need for (cost-) effective reliable approaches to compliance monitoring. To date numerous care schemes, retrospective assessment procedures and compliance supports tools have been introduced, but none of them has fully solved the problem of medication non-compliance yet. This paper will address some of the factors that need to be considered when designing such systems and will showcase DigiSpenser, a recently developed compliance monitoring and drug management system. PMID:22255537

  3. [Using King's Goal Attainment Theory to facilitate drug compliance in a psychiatric patient].

    PubMed

    Cheng, Mei-Ying

    2006-06-01

    This paper describes a schizophrenic patient who failed to comply with his drug regimen and was repeatedly admitted to hospital. Using King's Goal Attainment Theory as guidance, it was found that the patient's main problem was medication noncompliance. We developed an individual nursing care plan that met the patient's needs, including helping him to understand the importance of medication compliance, the relationship between disease and medication-control, and the symptoms of disease recurrence. The result showed that King's Goal Attainment Theory benefited both patients and families when it was applied to drug therapy and medication compliance. From this experience, we are able to demonstrate that using King's Goal Attainment Theory to design nursing care plans and interventions for schizophrenic patients who are repeatedly admitted to hospital because of medication noncompliance is very effective. In addition, it can also assist patients to control their conditions, decrease frequency of the disease recurrence and hospital readmission, and maintain their socialized functions. PMID:16767629

  4. 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…

  5. Design a compliance plan for the medical office.

    PubMed

    Bloink, Jacqueline Nash

    2013-01-01

    The Affordable Care Act has mandated that all physician offices will need to have a compliance plan and compliance point of contact. Although the Office of Inspector General has not yet set the date, now is the time to get ready and design a compliance plan for your medical office. Fraud, waste, and abuse are at an all-time high. The government and taxpayers want to plug the holes where valuable healthcare dollars are being inappropriately used. Be proactive and take the time to design your compliance plan now. Read on to learn how to remove the question of "who, what, and I don't know" from your vocabulary when it comes to the topic of compliance! PMID:24765731

  6. Teratogenic mechanisms of medical drugs.

    PubMed

    van Gelder, Marleen M H J; van Rooij, Iris A L M; Miller, Richard K; Zielhuis, Gerhard A; de Jong-van den Berg, Lolkje T W; Roeleveld, Nel

    2010-01-01

    BACKGROUND Although prescription drug use is common during pregnancy, the human teratogenic risks are undetermined for more than 90% of drug treatments approved in the USA during the past decades. A particular birth defect may have its origins through multiple mechanisms and possible exposures, including medications. A specific pathogenic process may result in different outcomes depending upon factors such as embryonic age at which a drug is administered, duration and dose of exposure and genetic susceptibility. This review focuses on the teratogenic mechanisms associated with a number of medications. METHODS We used three methods to identify the teratogenic mechanisms of medications: the MEDLINE and EMBASE databases, two recent books on teratogenic agents and a list of drugs classified as U.S. Food and Drug Administration class D or X. Mechanisms were included only if they are associated with major structural birth defects and medications that are used relatively frequently by women of reproductive age. RESULTS We identified six teratogenic mechanisms associated with medication use: folate antagonism, neural crest cell disruption, endocrine disruption, oxidative stress, vascular disruption and specific receptor- or enzyme-mediated teratogenesis. Many medications classified as class X are associated with at least one of these mechanisms. CONCLUSIONS Identifying teratogenic mechanisms may not only be relevant for etiologic and post-marketing research, but may also have implications for drug development and prescribing behavior for women of reproductive age, especially since combinations of seemingly unrelated prescription and over the counter medications may utilize similar teratogenic mechanisms with a resultant increased risk of birth defects. PMID:20061329

  7. Patient compliance with inhaled medication: does combining beta-agonists with corticosteroids improve compliance?

    PubMed

    Bosley, C M; Parry, D T; Cochrane, G M

    1994-03-01

    Patient compliance with an inhaled corticosteroid may be greater if it is combined with a beta-agonist. This study compared compliance with an inhaled corticosteroid (budesonide), and a short-acting inhaled beta-agonist (terbutaline sulphate), and a Turbuhaler inhaler containing a combination of the two drugs. In an open, multicentre, parallel group study 102 asthmatic patients were randomly divided into two groups, either receiving the two drugs in separate Turbuhalers or combined into one Turbuhaler. A twice daily regimen was prescribed and a preweighed metered-dose inhaler (MDI) of salbutamol was provided for rescue use. Compliance was measured using the Turbuhaler Inhalation Computer (TIC), which recorded the time and date of each inhalation over a 12 week period. Forced expiratory volume in one second (FEV1) and forced vital capacity (FVC) measurements were carried out at week 0, 6 and 12. Results from 72 patients were analysed. The average compliance was 60-70%. Treatment was taken as prescribed on 30-40% of the study days, and over-usage occurred on less than 10% of days. Only 15% of patients took the drugs as prescribed for more than 80% of the days. Compliance was no greater in patients using the combined inhalers. Other ways of improving patient self-management need further investigation. PMID:8013609

  8. 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

  9. Medicated chewing gum, a novel drug delivery system.

    PubMed

    Aslani, Abolfazl; Rostami, Farnaz

    2015-04-01

    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

  10. Drug-eluting medical implants.

    PubMed

    Zilberman, Meital; Kraitzer, Amir; Grinberg, Orly; Elsner, Jonathan J

    2010-01-01

    Drug-eluting medical implants are actually active implants that induce healing effects, in addition to their regular task of support. This effect is achieved by controlled release of active pharmaceutical ingredients (API) into the surrounding tissue. In this chapter we focus on three types of drug-eluting devices: drug-eluting vascular stents, drug-eluting wound dressings and protein-eluting scaffolds for tissue regeneration, thus describing both internal and external implants. Each of these drug-eluting devices also presents an approach for solving the drug release issue. Most drug-eluting vascular stents are loaded with water-insoluble antiproliferative agents, and their diffusion from the device to the surrounding tissue is relatively slow. In contrast, most drug-eluting wound dressings are loaded with highly water-soluble antibacterial agents and the issue of fast release must therefore be addressed. Growth factor release from scaffolds for tissue regeneration offers a new approach of incorporating high-molecular-weight bioactive agents which are very sensitive to process conditions and preserve their activity during the preparation stage. The drug-eluting medical implants are described here in terms of matrix formats and polymers, incorporated drugs and their release profiles from the implants, and implant functioning. Basic elements, such as new composite core/shell fibers and structured films, can be used to build new antibiotic-eluting devices. As presented in this chapter, the effect of the processing parameters on the microstructure and the resulting drug release profiles, mechanical and physical properties, and other relevant properties, must be elucidated in order to achieve the desired properties. Newly developed implants and novel modifications of previously developed approaches have enhanced the tools available for creating clinically important biomedical applications.

  11. Compliance with buprenorphine medication-assisted treatment and relapse to opioid use.

    PubMed

    Tkacz, Joseph; Severt, Jamie; Cacciola, John; Ruetsch, Charles

    2012-01-01

    Opioid dependence (OD), often characterized as a chronic relapsing disorder, affects millions of people worldwide. The purpose of this study was to examine the effect of compliance with buprenorphine on reducing relapse among a sample of patients in treatment for OD. Patients new to buprenorphine (N = 703) completed the Addiction Severity Index (ASI) at baseline, and at 1, 2, and 3 months postbaseline. The ASI is a semistructured interview designed to measure problem severity in seven functional areas known to be affected by alcohol and drug dependence. Compliance was defined as taking buprenorphine medication on at least 22 of the past 28 days (80%), while relapse classification was based on resumed use of opioids during the follow-up period (months 2 and 3). Relapse was regressed onto demographic indicators, baseline ASI composite scores, and compliance with buprenorphine. Noncompliant patients were over 10 times more likely to relapse than those who were compliant (exp β= 10.55; p < .001). Neither demographics nor baseline ASI composite scores were predictive of relapse (p's > .05). Compliance with medication-assisted treatment supports abstinence, essential for patient recovery. Understanding the factors that drive treatment compliance and noncompliance may assist providers in supporting patient compliance and recovery. 

  12. [Compliance enhancement in drug therapy : opportunities and limitations].

    PubMed

    Krolop, L; Jaehde, U

    2012-01-01

    In the execution of their pharmacotherapy, many patients deviate from the prescribed treatment regimen. Reasons for noncompliance can be diverse and range from forgetfulness of the patient to attributes of the health care system. Besides increased health care costs, poor compliance causes both an endangerment to the patient and poor health outcomes. Therefore, it is crucial that compliance enhancement receives high priority. In the beginning of this process, noncompliance must be detected in daily practice. Moreover, various methods can provide valuable information about medication-taking behavior, time patterns, and reasons for noncompliance. Based on this assessment, appropriate measures to enhance compliance can be taken. In this article, the opportunities and limitations of compliance enhancement are discussed. PMID:22119908

  13. Compliance issues in manufacturing of drugs.

    PubMed

    Kaufman, Brian; Novack, Gary D

    2003-04-01

    The therapeutic process relies on the assumption that the prescription written by the clinician is what is dispensed to the patient. In this article, we review the many factors involved in the manufacture of pharmaceutical products so that they consistently meet quality standards as approved by regulatory agencies. Industry and government agencies have developed procedures and laws to assure quality in Chemistry, Manufacturing and Controls (CMC) for pharmaceuticals, addressing conditions that may be harmful to patient health. This includes procedures for receipt of materials, production, packaging, labeling, quality control, release, storage and distribution, known as current Good Manufacturing Practice. Special control considerations for ophthalmic products include foreign particulate matter control, preservative effectiveness tests, sterility and leaching of chemicals from the packaging into the product. We also describe the "form, fill and seal" manufacture process as used in unit-dose, non-preserved ophthalmic products; product expiration dates; stages of drug development; and financial considerations for pharmaceutical companies. PMID:17075636

  14. 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…

  15. 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…

  16. 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…

  17. Medication Interactions: Food, Supplements and Other Drugs

    MedlinePlus

    ... Pressure High Blood Pressure Tools & Resources Stroke More Medication Interactions: Food, Supplements and Other Drugs Updated:Oct 15,2014 ... celebrations when eating habits tend to change. Common Medication Interactions Drugs with Food and Beverages Food and drinks don’t mix ...

  18. Alcohol-medical drug interactions.

    PubMed

    Johnson, Bankole A; Seneviratne, Chamindi

    2014-01-01

    Concomitant use of alcohol and medications may lead to potentially serious medical conditions. Increasing prescription medication abuse in today's society necessitates a deeper understanding of the mechanisms involved in alcohol-medication interactions in order to help prevent adverse events. Interactions of medications with alcohol result in altered bioavailability of the medication or alcohol (pharmacokinetic interactions) or modification of the effects at receptor or ion channel sites to alter behavioral or physical outcome (pharmacodynamic interactions). The nature of pharmacokinetic or pharmacodynamic interactions involved in alcohol-medication interactions may differ between acute and chronic alcohol use and be influenced by race, gender, or environmental or genetic factors. This review focuses on the mechanisms underlying pharmacokinetic and pharmacodynamic interactions between alcohol and medications and provides examples for such interactions from replicated research studies. In conclusion, further translational research is needed to address several gaps in our current knowledge of alcohol-medication interactions, including those under various pathologic conditions.

  19. 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 ...

  20. 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

  1. 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.…

  2. 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…

  3. [Medical drug abuse and aging].

    PubMed

    Nubukpo, Philippe; Clément, Jean-Pierre

    2013-09-01

    Drug addiction is often underestimated among the aged. Opiate drugs (mostly pain killers) are the most frequently implicated in drug addiction after benzodiazepines (BZD) in the aged. The subjects aged of 65 years or more are the most represented among the BZD users in France. Frequency of BZD use varies according to various studies from 39 to 55% in this age group. Leading a lonely life is associated with the use of psychotropic drugs among retired people (OR=1.7). Vulnerability at this age must take into account not only polypathology, but also the faster aging of a minority of the population under opiate drugs substitution treatment (OST), more subjects to drugs interaction. Drug addiction among elderly often reflects the drift of "lawful" doctor's instructions that leads to an increase in drugs use. The difficulty has to do with a lack of specificity of diagnosis of addiction at this age, but perhaps also with physicans'instructions in the aged. Some authors suggest that continued and prolonged use should be considered the main criterion for BZD addiction at this age, with or without increase in doses and failed attempt at cessation. Besides, the prescription of BZD increases after retirement and loneliness.

  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. 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

  6. 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...

  7. Establishing compliance with liquid medication administration in a child with autism.

    PubMed

    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

  8. 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.)

  9. Medical Management of Drug-Resistant Tuberculosis

    PubMed Central

    2015-01-01

    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. PMID:26175768

  10. Compliance with medication among outpatients with uncontrolled hypertension in the Seychelles.

    PubMed Central

    Hungerbuhler, P.; Bovet, P.; Shamlaye, C.; Burnand, B.; Waeber, B.

    1995-01-01

    Owing to increasing rates of hypertension and cardiovascular-related diseases in developing countries, compliance with antihypertensive medication is major public health importance. Few studies have reported on compliance in developing countries. We determined the compliance of 187 patients with uncontrolled hypertension in the Seychelles (Indian Ocean), by assessing the presence of a biologic marker (riboflavin) in the urine. The urine tested positive in 56% of the cases. Compliance varied from one physician to another (highest 72% versus lowest 33%, P = 0.003), improved with the level of literacy (62% versus 45%, P = 0.024), and depended on the presence absence of diuretics in the medication (respectively, 45% versus 66%, P = 0.005). The ability of patients to report correctly the number of antihypertensive pills to be taken daily was a predictor of compliance (62% of the patients who gave appropriate answers had positive urine for the marker versus 31% for those giving inappropriate answers). PMID:7554014

  11. FDA (food and drug administration) compliance program guidance manual (fy 84). Section 6. Radiological health

    SciTech Connect

    Not Available

    1983-10-01

    The FDA Compliance Program Guidance Manual provides a system for issuing and filing written program plans and instructions directed to Food and Drug Administration Field operations for project implementation. Section VI provides those chapters of the Compliance Program Guidance Manual which pertain to the area of radiological health. Some of the areas of coverage include laser standards; compliance testing of x-ray equipment, ultrasonic therapy devices, mercury vapor lamps, television receivers, and microwave ovens; radiation policy; and imported electronic products.

  12. 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

    ... Drugs; Compliance Policy Guide Sec. 440.100; Marketed New Drugs Without Approved NDAs or ANDAs... ``Marketed Unapproved Drugs--Compliance Policy Guide Sec. 440.100, Marketed New Drugs Without Approved NDAs... exercise of enforcement discretion discussed in the CPG apply only to unapproved new drug products that...

  13. 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. PMID:12165187

  14. 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.

  15. 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

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

    PubMed

    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

  17. 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…

  18. Compliance, medical records, and the FBI: preventing fraud and abuse.

    PubMed

    Vincze, L S

    1998-01-01

    The possibility of an investigation related to fraud and abuse is the last thing most people want to think about, but it's important to be prepared, just in case. The author gives some advice on how to react if your facility is the target of an investigation and points out some important steps to take to ensure compliance.

  19. Drug treatment program compliance and resistance activities during implementation of California's Proposition 36.

    PubMed

    Reynolds, Grace

    2009-01-01

    The Substance Abuse and Crime Prevention Act (SACPA), also known as Proposition 36, was implemented statewide in 2001 in California. This legislation remands non-violent drug offenders to drug treatment rather than prison or jail. Structured telephone interviews were conducted with a purposive sample of 72 drug treatment programs from six Southern California counties concerning compliance and resistance activities during implementation. A linear regression model was developed that used a dependent variable capturing overall experience with Proposition 36 and compliance and resistance activities as independent variables. The final model included three compliance variables (sharing problems and solutions with other treatment providers, hiring new staff, acquiring additional space through rental or purchase) that were most predictive of the programs' overall experience with Proposition 36. The implications of these findings in the context of organizational compliance and resistance activities are discussed.

  20. 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... announcing a public workshop entitled ``FDA Clinical Trial Requirements, Regulations, Compliance, and Good... representatives. The program will focus on the relationships among the FDA and clinical trial staff,...

  1. 49 CFR 1.50 - Office of Drug & Alcohol Policy & Compliance.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... the Office of the General Counsel, publishes and provides interpretations of rules related to 49 CFR... 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...

  2. 49 CFR 1.50 - Office of Drug & Alcohol Policy & Compliance.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... the Office of the General Counsel, publishes and provides interpretations of rules related to 49 CFR... 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...

  3. 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.

  4. An evaluation of drug promotional literatures published in scientific medical journals

    PubMed Central

    Vachhani, Pooja M.; Solanki, Manish N.; Desai, Mira K.

    2016-01-01

    Objectives: Evaluation and comparison of ethical standards of published drug promotional literatures (DPLs) between different Indian and non-Indian scientific medical journals regarding compliance to the World Health Organization (WHO) and International Federation of Pharmaceutical Manufacturers and Associations (IFPMAs) guidelines. Materials and Methods: A cross-sectional, observational study was carried out at pharmacology department. DPLs published in Indian and non-Indian scientific medical journals available at central library of medical college during the period of 6 months were collected according to selection criteria. DPLs were evaluated and compared for compliance to ethical standards of drug promotion laid by the WHO and IFPMA. Data were analyzed using Fisher's exact test. Results: Out of total 178 DPLs, 103 DPLs were from Indian journals and 75 DPLs were from non-Indian journals. When compared regarding compliance to all the 11 ethical criteria of WHO, no significant difference was found between DPLs published in Indian and non-Indian journals. However, DPLs from indian journals contained significantly less information regarding dosage regimen (P = 0.0096), adverse drug reactions (P = 0.0028), warnings (P = 0.0104) and major drug interactions (P < 0.0001) as compared to non-Indian journals. Compliance to all the five IFPMA criteria was significantly higher in DPLs of non-Indian journals (88%) than Indian journals (39%) (P < 0.0001). Conclusion: Noncompliance to ethical standards of WHO and IFPMA guidelines is more common in DPLs of Indian journals as compared to non-Indian journals. Thus strict implementation of regulatory measures regarding DPLs published in Indian medical journals is recommended. PMID:27413355

  5. 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

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

    PubMed

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

    2014-07-01

    The Codonics Safe Labeling System(™) (http://www.codonics.com/Products/SLS/flash/) is a piece of equipment that is able to barcode scan medications, read aloud the medication and the concentration and print a label of the appropriate concentration in the appropriate colour code. We decided to test this system in our facility to identify risks, benefits and usability. Our project comprised a baseline survey (25 anaesthesia cases during which 212 syringes were prepared from 223 drugs), an observational study (47 cases with 330 syringes prepared) and a user acceptability survey. The baseline compliance with all labelling requirements was 58%. In the observational study the compliance using the Codonics system was 98.6% versus 63.8% with conventional labelling. In the user acceptability survey the majority agreed the Codonics machine was easy to use, more legible and adhered with better security than the conventional preprinted label. However, most were neutral when asked about the likelihood of flexibility and customisation and were dissatisfied with the increased workload. Our findings suggest that the Codonics labelling machine is user-friendly and it improved syringe labelling compliance in our study. However, staff need to be willing to follow proper labelling workflow rather than batch label during preparation. Future syringe labelling equipment developers need to concentrate on user interface issues to reduce human factor and workflow problems. Support logistics are also an important consideration prior to implementation of any new labelling system. PMID:24967766

  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. PMID:26736514

  8. Persistence and compliance with medication management in the treatment of overactive bladder

    PubMed Central

    Kim, Tae Heon

    2016-01-01

    Overactive bladder (OAB) is a common and chronic condition that impacts patients' daily activities and quality of life. Pharmaco-therapy for OAB is a mainstay of treatment. Antimuscarinics and β3-adrenoceptor agonists are the two major classes of oral pharmacotherapy and have similar efficacy for treating the symptoms of OAB. Owing to the chronic nature of OAB, long-term use of medication is essential for OAB symptom control and positive health outcomes. However, many patients elect to stop their medications during the treatment period. Unmet expectations of treatment and side effects seem to be the major factors for discontinuing OAB pharmacotherapy. Furthermore, the short- and long-term persistence and compliance with medication management are markedly worse in OAB than in other chronic medical conditions. Improvement in persistence and compliance with OAB pharmacotherapy is a hot topic in OAB treatment and should be an important goal in the treatment of OAB. Effective strategies should be identified to improve persistence and compliance. In this review, we outline what is known about persistence and compliance and the factors affecting persistence with pharmacotherapy in patients with OAB. PMID:26981589

  9. 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…

  10. [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.

  11. 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.…

  12. The role of matrix compliance on cell responses to drugs and toxins: towards predictive drug screening platforms.

    PubMed

    Zustiak, Silviya Petrova

    2015-05-01

    Since the birth of tissue engineering, it has been redefined to include not only the development of tissues for clinical use, but also in vitro models for the study of tissue physiology and pathology. Great strides have been accomplished in the design of in vitro tissue models, yet one area in which they are underrepresented, but where they can have an immediate impact, is the development of platforms for drug screening. By providing more in vivo-like cell environments, such models could address the growing concerns about drug failures due to lack of efficacy or unexpected side effects. This review aims to address the interface between substrate compliance and cell responsiveness to toxins and drugs since compliance has been established as a major determinate of overall cell fate. Here, results from 2D substrates and 3D matrices are discussed. Additionally, examples of biomaterial-based high-throughput stiffness assays in drug screening are presented.

  13. 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…

  14. 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.

  15. Predicting parental anticonvulsant medication compliance using the theory of reasoned action.

    PubMed

    Austin, J K

    1989-04-01

    One approach to better understanding compliance behavior is the use of the theory of reasoned action. In this article, the theory of reasoned action is used to predict the compliance behavior of 29 parents of children with epilespy. In support of the theory, behavioral intention was found to significantly predict (p less than 0.01) parental medicine-giving behavior. Contrary to the results predicted by the theory, parents' attitudes toward giving the medication correlated with a significant amount of variance in medicine-giving behavior beyond that accounted for by behavioral intention.

  16. 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

    ... Specifications and New Drug Application Supplements; Withdrawal of Guidance AGENCY: Food and Drug Administration... withdrawal of Compliance Policy Guide (CPG) Sec. 420.300 Changes in Compendial Specifications and New Drug.... Ouderkirk, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire...

  17. 27 CFR 17.136 - Compliance with Food and Drug Administration requirements.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 1 2010-04-01 2010-04-01 false Compliance with Food and Drug Administration requirements. 17.136 Section 17.136 Alcohol, Tobacco Products and Firearms ALCOHOL AND TOBACCO TAX AND TRADE BUREAU, DEPARTMENT OF THE TREASURY LIQUORS DRAWBACK ON TAXPAID DISTILLED SPIRITS USED IN MANUFACTURING...

  18. 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.

  19. 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...

  20. Computing the compliance of physician drug orders with guidelines using an OWL2 reasoner and standard drug resources.

    PubMed

    Noussa Yao, Joseph; Séroussi, Brigitte; Bouaud, Jacques

    2011-01-01

    Assessing the conformity of a physician's prescription to a given recommended prescription is not obvious since both prescriptions are expressed at different levels of abstraction and may concern only a subpart of the whole order. Recent formalisms (OWL2) and tools (reasoners) from the semantic web technologies are becoming available to represent defined concepts and to handle classification services. We propose a generic framework based on such technologies, using available standardized drug resources, to compute the compliance of a given drug order to a recommended prescription, such that the subsumption relationship yields the conformity relationship between the order and the recommendation. The ATC drug classification has been used as a local ontology. The method has been successfully implemented for arterial hypertension management for which we had a sample of antihypertensive orders. However, supplemental standardized drug knowledge is needed to correctly compare drug orders to recommended orders.

  1. 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…

  2. Co-Medication of Statins with Contraindicated Drugs

    PubMed Central

    Yang, Bo Ram; Seong, Jong-Mi; Choi, Nam-Kyong; Shin, Ju-Young; Lee, Joongyub; Kim, Ye-Jee; Kim, Mi-Sook; Park, Soyoung; Song, Hong Ji; Park, Byung-Joo

    2015-01-01

    Background The concomitant use of cytochrome P450 3A4 (CYP3A4) metabolized statins (simvastatin, lovastatin, and atorvastatin) with CYP3A4 inhibitors has been shown to increase the rate of adverse events. Objective This study was performed to describe the co-medication prevalence of CYP3A4-metabolized statins with contraindicated drugs. Methods The patients aged 40 or older receiving CYP3A4-metabolized statin prescriptions in 2009 were identified using the national patient sample from a Korea Health Insurance Review and Assessment Service database. Contraindicated co-medication was defined as prescription periods of statins and contraindicated drugs overlapping by at least one day. Co-medication patterns were classified into 3 categories as follows: co-medication in the same prescription, co-medication by the same medical institution, and co-medication by different medical institutions. The proportion of co-medication was analyzed by age, gender, co-morbidities, and the statin’s generic name. Results A total of 2,119,401 patients received CYP3A4-metabolized statins and 60,254 (2.84%) patients were co-medicated with contraindicated drugs. The proportion of co-medication was 4.6%, 2.2%, and 1.8% in simvastatin, lovastatin, and atorvastatin users, respectively. The most frequent combination was atorvastatin-itraconazole, followed by simvastatin-clarithromycin and simvastatin-itraconazole. Among the co-medicated patients, 85.3% were prescribed two drugs by different medical institutions. Conclusion The proportion of co-medication of statins with contraindicated drugs was relatively lower than that of previous studies; however, the co-medication occurring by different medical institutions was not managed appropriately. There is a need to develop an effective system and to conduct outcomes research confirming the association between co-medication and the risk of unfavorable clinical outcomes. PMID:25932626

  3. Encouraging patient adherence: primary care physicians' use of verbal compliance-gaining strategies in medical interviews.

    PubMed

    Smith, Valerie A; DeVellis, Brenda M; Kalet, Adina; Roberts, Joanne C; DeVellis, Robert F

    2005-04-01

    Compliance-gaining strategies refer to subtle differences in ways people use language when their goal is to influence someone else's behavior. This stands in contrast to other kinds of persuasion aimed only at influencing others beliefs and attitudes. We have developed a new method of coding what physicians say when they are trying to influence patients' behaviors. This method applies theory and methods from the fields of interpersonal influence, linguistics and social psychology. We tested the reliability of this new method by randomly selecting 37 audiotaped medical interviews collected for an unrelated study [J. Gen. Int. Med., 9 (1994) 402] and having three coders independently identify physician compliance-gaining utterances and then independently apply one of 57 codes to each utterance. These codes also were categorized on two underlying dimensions reflecting whether the physician (1) framed the compliance-gaining utterance in a direct or indirect way, and (2) did or did not give a justification for that direct or indirect request. Reliability among coders and coders agreement with the final utterance identification and coding decisions, measured as per cent agreement among coders and/or, where appropriate, by Cohen's kappa were good to excellent. Most physicians' strategies were indirect and incomplete. For female patients, physicians used significantly more strategies, including more indirect strategies, complete strategies, "prescriptions" and "demands". For male patients, physicians used a greater percent of direct strategies, including "procedural demands". This method provides a reliable and promising new technique for observing naturally occurring physician compliance-gaining speech.

  4. 76 FR 12743 - Medical Device Reporting; Malfunction Reporting Frequency

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-08

    ... HUMAN SERVICES Food and Drug Administration Medical Device Reporting; Malfunction Reporting Frequency AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA... continue to submit malfunction reports in full compliance with FDA's Medical Device Reporting...

  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. Effectiveness of antidepressant pharmacotherapy: the impact of medication compliance and patient education.

    PubMed

    Mundt, J C; Clarke, G N; Burroughs, D; Brenneman, D O; Griest, J H

    2001-01-01

    This study was designed to investigate the impact of a time-phased patient education program (RHYTHMS) on medication compliance and treatment outcomes of primary care patients diagnosed with major depression and started on antidepressant pharmacotherapy. Two hundred forty-six depressed patients, diagnosed and treated at one of three outpatient clinics affiliated with the Kaiser-Permanente Northwest Region (KPNW) healthcare system, were randomly assigned to either receive or not receive (usual care) the educational materials by mail. Depression severity and functional impairment affecting patients' quality of life were assessed at baseline and 4, 12, and 30 weeks later. Self-reported impressions of improvement and patient satisfaction with treatment were also assessed at follow-up. Clinical assessment data were obtained using an interactive voice response (IVR) system. Study subjects were compensated $5, $10, $15, and $25 for completing each assessment (Baseline to Week 30, respectively). Upon study completion, prescription fill data of the subjects were extracted from the KPNW Pharmacy System for analysis of medication compliance. Most of the study subjects (63.5%) responded to the pharmacotherapy treatment by study end-point. Few statistically significant differences in either treatment outcomes or duration of medication compliance were found between the treatment groups, and significant differences found were of fairly small magnitude. Patients not receiving the educational materials initially exhibited a more positive response to treatment (Week 4), but this difference did not persist at later follow-ups and was associated with significantly higher relapse rates. A strong time-dose relationship was evident between the duration of the initial treatment episode and treatment outcomes at follow-up, but randomized treatment assignment did not influence the duration of initial medication compliance. Educational programs designed to encourage depressed patients to

  7. 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

  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, 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...

  10. 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...

  11. 19 CFR 147.23 - Compliance with Plant Quarantine Act and Federal Food, Drug, and Cosmetic Act.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

  12. 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...

  13. 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.

  14. 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…

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

    PubMed

    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

  16. 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

  17. A Study of Color Preferences for Drugs and Implications for Compliance and Drug-taking.

    ERIC Educational Resources Information Center

    Coffield, K. E.; Buckalew, L. W.

    1988-01-01

    Examined medication capsule color preferences of male and female college students, both on and not on medication. Sex and medication status were insignificant in preference rankings. Blacks, grays, tans, and browns were clearly rejected colors while blues and some reds and yellows were preferred. Findings have relevance for patient compliance…

  18. 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...

  19. 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.

  20. 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. PMID:26827465

  1. 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.

  2. 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

  3. 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.

  4. 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.

  5. 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. PMID:25278321

  6. 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

  7. 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

  8. An electronic medication reminder, supported by a monitoring service, to improve medication compliance for elderly people living independently.

    PubMed

    Parker, Roger; Frampton, Christopher; Blackwood, Angela; Shannon, Ady; Moore, Graeme

    2012-04-01

    We conducted a pilot study of a personal medication reminder unit, supported by a monitoring service. A total of 31 elderly residents were offered the reminder service for a period of eight weeks (1736 person-days of service). A telephone call from the monitoring service was made after four weeks to check that each participant was happy with the service and keen to continue. No one opted out and users of the service found it easy to manage, helpful and acceptable. There was a significant improvement (P = 0.012) in the rate of self-assessed medication compliance, from pre (52%) to post (81%) service introduction. There was a significant improvement in people's perceived ability to look after themselves at home (self-care ability) (P = 0.001). The percentage of participants rating their ability to look after themselves at home as excellent increased from 42% to 68%. Health-related quality of life measures, such as physical and mental health, showed positive improvement, but the changes were not significant. The service has the potential to improve health and well-being outcomes for people on multiple medications living independently in the community. PMID:22362828

  9. [Drug utilization in renal transplant patients: medication practices and representations].

    PubMed

    de Arruda, Guilherme Oliveira; Renovato, Rogério Dias

    2012-12-01

    Qualitative research approach, descriptive and exploratory with objective of to know the practices and representations of medication on the use of drugs by people transplanted kidney. 18 people participated in the Dourados (MS), through semistructured interview. The theoretical contributions of medication practices were Peter Conrad and representation of Stuart Hall. The definition of the categories of theoretical analysis was Michel Foucault. Respondents had a mean age of 53.5 years, 13 males and 5 females, with median time to transplant eight years. The medications predominantly used were immunosuppresssive. We developed three categories of analysis: the drug as part of everyday life, the central role of the drug and correlation with rejection, and medicine and the autonomy of the transplanted kidney. The drugs are part of everyday life and the representations of autonomy and quality enhance your daily use.

  10. Characteristics of medication errors with parenteral cytotoxic drugs.

    PubMed

    Fyhr, A; Akselsson, R

    2012-09-01

    Errors involving cytotoxic drugs have the potential of being fatal and should therefore be prevented. The objective of this article is to identify the characteristics of medication errors involving parenteral cytotoxic drugs in Sweden. A total of 60 cases reported to the national error reporting systems from 1996 to 2008 were reviewed. Classification was made to identify cytotoxic drugs involved, type of error, where the error occurred, error detection mechanism, and consequences for the patient. The most commonly involved cytotoxic drugs were fluorouracil, carboplatin, cytarabine and doxorubicin. The platinum-containing drugs often caused serious consequences for the patients. The most common error type were too high doses (45%) followed by wrong drug (30%). Twenty-five of the medication errors (42%) occurred when doctors were prescribing. All of the preparations were delivered to the patient causing temporary or life-threatening harm. Another 25 of the medication errors (42%) started with preparation at the pharmacies. The remaining 10 medication errors (16%) were due to errors during preparation by nurses (5/60) and administration by nurses to the wrong patient (5/60). It is of utmost importance to minimise the potential for errors in the prescribing stage. The identification of drugs and patients should also be improved.

  11. 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. PMID:25650538

  12. 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.

  13. 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

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

    PubMed Central

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

    2012-01-01

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

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

    PubMed Central

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

    2015-01-01

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

  16. 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.

  17. Compliance towards dispensed medication labelling standards: a cross-sectional study in the state of Penang, Malaysia.

    PubMed

    Neoh, Chin Fen; Hassali, Mohamed Azmi; Shafie, Asrul Akmal; Awaisu, Ahmed; Tambyappa, Jayabalan

    2009-09-01

    Good medicine labelling practice is vital to ensure safe use of medicines. Non-compliance to labelling standards is a potential source of medication errors. This study was intended to evaluate and compare compliance towards labelling standard for dispensed medications between community pharmacists and general practitioners in Penang, Malaysia. A total of 128 community pharmacies and 26 general practitioners' clinics were visited. Using 'Simulated Client Method' (SCM), data were collected on the medications dispensed upon presentation of hypothetical common cold symptoms. The medications dispensed were evaluated for labelling adequacy. Result revealed that majority of the dispensed medications obtained were not labelled according to regulatory requirements. However, general practitioners complied better than community pharmacists in terms of labelling for: name of patient (p<0.001), details of supplier (p<0.001), dosage of medication (p=0.023), frequency to take medication (p=0.023), patient's reference number (p<0.001), date of supply (p<0.001), special instructions for medication (p=0.008), storage requirements (p=0.002), and indication for medication (p<0.001). Conversely, community pharmacists labelled dispensed medications with the words "Controlled Medicine" more often than did general practitioners (p<0.001). Although laws for labelling dispensed medicines are in place, most community pharmacists and general practitioners did not comply accordingly, thereby putting patients' safety at risks of medication errors.

  18. Medical databases in studies of drug teratogenicity: methodological issues.

    PubMed

    Ehrenstein, Vera; Sørensen, Henrik T; Bakketeig, Leiv S; Pedersen, Lars

    2010-01-01

    More than half of all pregnant women take prescription medications, raising concerns about fetal safety. Medical databases routinely collecting data from large populations are potentially valuable resources for cohort studies addressing teratogenicity of drugs. These include electronic medical records, administrative databases, population health registries, and teratogenicity information services. Medical databases allow estimation of prevalences of birth defects with enhanced precision, but systematic error remains a potentially serious problem. In this review, we first provide a brief description of types of North American and European medical databases suitable for studying teratogenicity of drugs and then discuss manifestation of systematic errors in teratogenicity studies based on such databases. Selection bias stems primarily from the inability to ascertain all reproductive outcomes. Information bias (misclassification) may be caused by paucity of recorded clinical details or incomplete documentation of medication use. Confounding, particularly confounding by indication, can rarely be ruled out. Bias that either masks teratogenicity or creates false appearance thereof, may have adverse consequences for the health of the child and the mother. Biases should be quantified and their potential impact on the study results should be assessed. Both theory and software are available for such estimation. Provided that methodological problems are understood and effectively handled, computerized medical databases are a valuable source of data for studies of teratogenicity of drugs.

  19. Compliance with the law and appropriate medical standards during interhospital transfers.

    PubMed

    Bullard, M J; Liaw, S J; Chen, J C; Hu, P M

    1998-11-01

    Interhospital transfer patients constitute a significant proportion of medical center emergency department (ED) patients in Taiwan. Many such transfers are poorly planned and put the patient at risk. We wished to evaluate the safety and compliance with the Taiwan Medical Law among patients transferred to the Linkou Chang Gung Memorial Hospital ED from other health care centers. We performed a prospective, cross-sectional, observational study on 1,056 patients transferred from August 15 to September 30, 1997. Of these patients, 357 were critically ill or injured and only 160 received adequate pretransfer stabilization. The major omissions included: 1) failure to intubate in 121 (55%) of the 220 patients in severe respiratory distress or unprotected patent airways; 2) no intravenous line in 74 (20.7%) of the 357; and 3) inadequate IV lines in 36 (63.2%) of the 57 severely hypotensive patients. Overall, 894 patients were sent with transfer notes, but few indicated whether the referral was to the ED or outpatient department. This added an unnecessary burden for patients with stable longstanding problems who claimed they had been referred to the ED. While the majority of patients (49.4%) were transferred at the request of physicians for further treatment, 28% of the critically ill patients were transferred because of family requests. Physicians accompanied these patients only on seven occasions and nurses on 84 occasions. Despite the 1993 Department of Health policy of pretransfer phone contact with the receiving hospital for critically ill patients, such contact occurred only 10.6% of the time. While the Taiwan emergency medical system, Emergency Medicine, and Critical Care Medicine are all in their developmental stages, a medical and legal noncompliance rate of above 55% for critically ill transfer patients is unacceptably high. The appropriate medical societies and the Department of Health should work in concert to upgrade existing transfer practices.

  20. 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.

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

    PubMed

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

    2014-01-01

    The study assessed 54 advertisements of 145 different drugs, published over one year (from December 2011 to November 2012) in an Indian medical journal, circulated widely mainly among general practitioners (GPs). The ethical guidelines of the World Health Organization (WHO) and Organisation of Pharmaceutical Producers of India (OPPI) for medicinal drug promotion were applied. The brand name was mentioned in all advertisements (100% compliance both with the WHO and OPPI criteria) and the names of the active ingredients were also mentioned in 128 (90.14%) advertisements. However, major adverse drug reactions were mentioned in only two advertisements (1.37%); precautions, contraindications and warnings in only two (1.37%); and major interactions in only one (0.68%). Only three advertisements (2.06%) were well substantiated with references. To ensure the ethical promotionof drugs among GPs, journals must introduce compulsory review and appraisal of promotional advertisements by a dedicated review board, including at least one member trained in pharmacology and one representative from the medical division of a pharmaceutical company. PMID:25377037

  2. 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...

  3. 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.

  4. 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

  5. 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

  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. 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...

  8. 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...

  9. 76 FR 45402 - Advisory Committee; Medical Imaging Drugs Advisory Committee; Re-Establishment

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-29

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Part 14 Advisory Committee; Medical Imaging Drugs.... SUMMARY: The Food and Drug Administration (FDA) is announcing the re- establishment of the Medical Imaging... language for the Medical Imaging Drugs Advisory Committee in the Agency's list of standing...

  10. Adolescent drug misuse treatment and use of medical care services.

    PubMed

    Freeborn, D K; Polen, M R; Mullooly, J P

    1995-05-01

    Research on adults has documented that use of medical services decreases after initiation of treatment for alcohol problems, but little is known about this relationship among adolescents. We studied utilization and costs of care following participation in the Adolescent Chemical Health Program (ACHP) of Kaiser Permanente, Northwest Region, in 1986-88. Three groups of adolescents (and their parents) were identified: adolescents who were assessed and initiated treatment in ACHP (n = 561), adolescents who were assessed and recommended for treatment but did not return for treatment (n = 278), and adolescents with no known substance use problems (n = 381). Medical records were reviewed for 1 year pre- and 1.5 years postassessment. After adjusting for preassessment medical visits, severity of alcohol and drug use, gender, and age, analyses suggested that substance user treatment was not associated with reduced use of medical services or costs by either adolescents or parents. PMID:7558471

  11. 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.

  12. Solicitation of information and recommendations for developing OIG compliance program guidance for the durable medical equipment industry--HHS. Notice.

    PubMed

    1998-08-01

    This Federal Register notice seeks the input and recommendations of interested parties into the OIG's development of a compliance program guidance for the durable medical equipment (DME) industry, its providers and suppliers. Many providers and provider organizations have expressed an interest in better protecting their operations from fraud and abuse. Previously, the OIG has developed compliance program guidances for hospitals, clinical laboratories and home health agencies. In order to provide clear and meaningful guidance to those segments of the health care industry involved in the supply and distribution of DME, we are soliciting comments, recommendations and other suggestions from concerned parties and organizations on how best to develop compliance program guidance and reduce fraud and abuse within the DME industry.

  13. 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.

  14. The medical and surgical treatment of drug-resistant tuberculosis

    PubMed Central

    Calligaro, Gregory L.; Moodley, Loven; Symons, Greg

    2014-01-01

    Multi drug-resistant tuberculosis (MDR-TB) and extensively drug-resistant TB (XDR-TB) are burgeoning global problems with high mortality which threaten to destabilise TB control programs in several parts of the world. Of alarming concern is the emergence, in large numbers, of patients with resistance beyond XDR-TB (totally drug-resistant TB; TDR-TB or extremely drug resistant TB; XXDR-TB). Given the burgeoning global phenomenon of MDR-TB, XDR-TB and TDR-TB, and increasing international migration and travel, healthcare workers, researchers, and policy makers in TB endemic and non-endemic countries should familiarise themselves with issues relevant to the management of these patients. Given the lack of novel TB drugs and limited access to existing drugs such as linezolid and bedaquiline in TB endemic countries, significant numbers of therapeutic failures are emerging from the ranks of those with XDR-TB. Given the lack of appropriate facilities in resource-limited settings, such patients are being discharged back into the community where there is likely ongoing disease spread. In the absence of effective drug regimens, in appropriate patients, surgery is a critical part of management. Here we review the diagnosis, medical and surgical management of MDR-TB and XDR-TB. PMID:24624282

  15. 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

  16. Use of differential reinforcement to treat medical non-compliance in a paediatric patient with leukocyte adhesion deficiency.

    PubMed

    Gorski, Jo Anne B; Westbrook, Alana C

    2002-01-01

    Leukocyte Adhesion Deficiency (LAD) is a rare immuno-deficiency disorder which results in chronic infections, such as gingivitis, necrotic skin infections and gastrointestinal ulcers. This case describes an 18-year-old male who was non-compliant during an inpatient hospitalization with several aspects of his complex medical regimen, particularly his wound care, physical therapy and use of his crutches. The patient's dressing change protocol was task analysed in order to create a structured, predictable routine by having the subject complete small, discrete steps. A differential reinforcement programme was implemented to provide the patient with tangible reinforcement for general compliance with his treatment, including compliance with dressing changes and physical therapy. Over a 1-month period, the subject's overall compliance with his medical regimen achieved an average of approximately 87%. His compliance with physical therapy and dressing changes both improved to 87 and 80%, respectively, by the end of his hospitalization. During the last week of his hospitalization, the use of his crutches was task analysed and included in his reinforcement programme using a changing criterion design. His average use of his crutches also improved to 80%.

  17. 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

  18. Medication compliance and comorbid substance abuse in schizophrenia: impact on community survival 4 years after a relapse.

    PubMed

    Hunt, Glenn E; Bergen, Jenny; Bashir, Marie

    2002-04-01

    This prospective study examined the effect of medication compliance and substance abuse on 4 year outcome in 99 patients following a relapse of schizophrenia. Univariate survival analysis revealed longer community tenure in patients if they were over the age of 35 years, not admitted 2 years prior to the index episode, remained medication compliant and did not abuse substances during the follow-up interval. Comparisons between patients grouped according to medication compliance and current substance abuse indicated that those patients who regularly took their medication but also abused substances were readmitted to hospital sooner (median survival, 10 months) compared to compliant patients who did not use substances (37 months). For noncompliant patients, time to first readmission was shorter for patients with a dual diagnosis (5 months) compared to patients with a singular diagnosis of schizophrenia (10 months). Over the 4 year period, noncompliant patients with a dual diagnosis (n=28) accounted for 57% of all hospital readmissions for the cohort and averaged 1.5 admissions per patient year. These data indicate that much of the benefit that antipsychotic medication has on increasing community survival is reduced by substance abuse. This interval is further reduced in patients who are both substance abusers and noncompliant with medication resulting in a revolving door situation of frequent hospital admissions. Integrated treatment programs which address these issues are likely to reduce the need for hospital readmission in patients with a dual diagnosis. PMID:11950550

  19. 76 FR 25357 - Advisory Committee; Medical Imaging Drugs Advisory Committee; Reestablishment

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-04

    ... HUMAN SERVICES Food and Drug Administration Advisory Committee; Medical Imaging Drugs Advisory Committee... Administration (FDA) is announcing the ] reestablishment of the Medical Imaging Drugs Advisory Committee in the.... 101-635); and 21 CFR 14.40(b), FDA is announcing the reestablishment of the Medical Imaging...

  20. [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

  1. [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

  2. 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

  3. 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

  4. 77 FR 125 - Draft Guidance for Industry and Food and Drug Administration Staff; Medical Device Classification...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-03

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

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

    PubMed

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

    2011-01-01

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

  7. 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. PMID:10766358

  8. 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. PMID:26605155

  9. 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. PMID:16446415

  10. 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

  11. 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

  12. 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…

  13. Issues in Medication Compliance among Children and Families Affected by Attention Deficit Hyperactivity Disorder (ADHD)

    ERIC Educational Resources Information Center

    Terneus, Sandra K.; Wheeler, John J.

    2005-01-01

    The use of medication therapy for the treatment of ADHD in children has been cited as the most frequent course of treatment for children diagnosed with this condition with an estimated 3% of school-aged children being prescribed stimulant medication (Kirk, 1999). One issue that is frequently cited when using medication to treat this condition is…

  14. 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,…

  15. Use of anti-anxiety drugs in the medically ill.

    PubMed

    Wheatley, D

    1988-01-01

    being developed, i.e. zolpidem and zopiclone. These drugs are relatively short-acting and of equivalent potency to the BZD without problems of dependence etc. Anxiety, as either cause or effect, accompanies many medical illnesses and the use of anti-anxiety drugs as concomitant therapy can both reduce morbidity and improve prognosis. PMID:2905817

  16. Adverse Drug Reactions Causing Admission to Medical Wards

    PubMed Central

    Mouton, Johannes P.; Njuguna, Christine; Kramer, Nicole; Stewart, Annemie; Mehta, Ushma; Blockman, Marc; Fortuin-De Smidt, Melony; De Waal, Reneé; Parrish, Andy G.; Wilson, Douglas P.K.; Igumbor, Ehimario U.; Aynalem, Getahun; Dheda, Mukesh; Maartens, Gary; Cohen, Karen

    2016-01-01

    Abstract Limited data exist on the burden of serious adverse drug reactions (ADRs) in sub-Saharan Africa, which has high HIV and tuberculosis prevalence. We determined the proportion of adult admissions attributable to ADRs at 4 hospitals in South Africa. We characterized drugs implicated in, risk factors for, and the preventability of ADR-related admissions. We prospectively followed patients admitted to 4 hospitals’ medical wards over sequential 30-day periods in 2013 and identified suspected ADRs with the aid of a trigger tool. A multidisciplinary team performed causality, preventability, and severity assessment using published criteria. We categorized an admission as ADR-related if the ADR was the primary reason for admission. There were 1951 admissions involving 1904 patients: median age was 50 years (interquartile range 34–65), 1057 of 1904 (56%) were female, 559 of 1904 (29%) were HIV-infected, and 183 of 1904 (10%) were on antituberculosis therapy (ATT). There were 164 of 1951 (8.4%) ADR-related admissions. After adjustment for age and ATT, ADR-related admission was independently associated (P ≤ 0.02) with female sex (adjusted odds ratio [aOR] 1.51, 95% confidence interval [95% CI] 1.06–2.14), increasing drug count (aOR 1.14 per additional drug, 95% CI 1.09–1.20), increasing comorbidity score (aOR 1.23 per additional point, 95% CI 1.07–1.41), and use of antiretroviral therapy (ART) if HIV-infected (aOR 1.92 compared with HIV-negative/unknown, 95% CI 1.17–3.14). The most common ADRs were renal impairment, hypoglycemia, liver injury, and hemorrhage. Tenofovir disoproxil fumarate, insulin, rifampicin, and warfarin were most commonly implicated, respectively, in these 4 ADRs. ART, ATT, and/or co-trimoxazole were implicated in 56 of 164 (34%) ADR-related admissions. Seventy-three of 164 (45%) ADRs were assessed as preventable. In our survey, approximately 1 in 12 admissions was because of an ADR. The range of ADRs and implicated drugs reflect

  17. [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

  18. 78 FR 59038 - Mobile Medical Applications; Guidance for Industry and Food and Drug Administration Staff...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-25

    ... HUMAN SERVICES Food and Drug Administration Mobile Medical Applications; Guidance for Industry 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 availability of the guidance...

  19. 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 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open...

  20. 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...

  1. Medical X-Rays

    MedlinePlus

    ... Diagnostic X-Ray Equipment Compliance Program Guidance Manual CP 7386.003 Field Compliance Testing of Diagnostic (Medical) ... and Exporting Electronic Products Compliance Program Guidance Manual CP 7386.003 Field Compliance Testing of Diagnostic (Medical) ...

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

    PubMed

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

    2008-01-01

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

  4. 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.

  5. 42 CFR 418.106 - Condition of participation: Drugs and biologicals, medical supplies, and durable medical equipment.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... this chapter; and drugs and biologicals related to the palliation and management of the terminal... drug management as defined in hospice policies and procedures and State law, who is an employee of or... provided pharmacist services must include evaluation of a patient's response to medication...

  6. 42 CFR 418.106 - Condition of participation: Drugs and biologicals, medical supplies, and durable medical equipment.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... this chapter; and drugs and biologicals related to the palliation and management of the terminal... drug management as defined in hospice policies and procedures and State law, who is an employee of or... provided pharmacist services must include evaluation of a patient's response to medication...

  7. 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

  8. 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...

  9. 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…

  10. 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...

  11. 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...

  12. 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...

  13. 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...

  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. 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

  16. 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

  17. 76 FR 17138 - Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-28

    ... HUMAN SERVICES Food and Drug Administration Food and Drug Administration Clinical Trial Requirements... public workshop on FDA's clinical trial requirements is designed to aid the clinical research... interaction with FDA representatives. The program will focus on the relationships among FDA and clinical...

  18. 77 FR 8886 - Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-15

    ... HUMAN SERVICES Food and Drug Administration Food and Drug Administration Clinical Trial Requirements... public workshop on FDA's clinical trial requirements is designed to aid the clinical research... interaction with FDA representatives. The program will focus on the relationships among FDA and clinical...

  19. 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... workshop. The public workshop on FDA's clinical trial requirements is designed to aid the clinical research... interaction with FDA representatives. The program will focus on the relationships among FDA and clinical...

  20. 76 FR 51040 - Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-17

    ... HUMAN SERVICES Food and Drug Administration Food and Drug Administration Clinical Trial Requirements... workshop. The public workshop on FDA's clinical trial requirements is designed to aid the clinical research... interaction with FDA representatives. The program will focus on the relationships among FDA and clinical...

  1. 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

    ... HUMAN SERVICES Food and Drug Administration Food and Drug Administration Clinical Trial Requirements... announcing a public workshop. The public workshop on FDA's clinical trial requirements is designed to aid the... FDA and clinical trial staff, investigators, and institutional review boards (IRBs). Individual...

  2. 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... public workshop on FDA's clinical trial requirements is designed to aid the clinical research... interaction with FDA representatives. The program will focus on the relationships among FDA and clinical...

  3. 75 FR 51824 - Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-23

    ... HUMAN SERVICES Food and Drug Administration Food and Drug Administration Clinical Trial Requirements... workshop. The public workshop on FDA's clinical trial requirements is designed to aid the clinical research... interaction with FDA representatives. The program will focus on the relationships among FDA and clinical...

  4. 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...

  5. 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...

  6. 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...

  7. 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. PMID:22504572

  8. 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.

  9. 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

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

    PubMed

    Meier, Brian P; Lappas, Courtney M

    2016-11-01

    Research indicates that there is a preference for natural v. synthetic products, but the influence of this preference on drug choice in the medical domain is largely unknown. We present 5 studies in which participants were asked to consider a hypothetical situation in which they had a medical issue requiring pharmacological therapy. Participants ( N = 1223) were asked to select a natural, plant-derived, or synthetic drug. In studies 1a and 1b, approximately 79% of participants selected the natural v. synthetic drug, even though the safety and efficacy of the drugs were identical. Furthermore, participants rated the natural drug as safer than the synthetic drug, and as that difference increased, the odds of choosing the natural over synthetic drug increased. In studies 2 and 3, approximately 20% of participants selected the natural drug even when they were informed that it was less safe (study 2) or less effective (study 3) than the synthetic drug. Finally, in study 4, approximately 65% of participants chose a natural over synthetic drug regardless of the severity of a specific medical condition (mild v. severe hypertension), and this choice was predicted by perceived safety and efficacy differences. Overall, these data indicate that there is a bias for natural over synthetic drugs. This bias could have implications for drug choice and usage. PMID:26683247

  11. Teaching older adults to self-manage medications: preventing adverse drug reactions.

    PubMed

    Curry, Linda Cox; Walker, Charles; Hogstel, Mildred O; Burns, Paulette

    2005-04-01

    Older adults use more prescription and OTC medications than any other age group. Because their medication regimens often are complicated by many medications and different doses, times, and administration methods, older adults are at high risk for medication mismanagement. The most common errors associated with medication mismanagement include mixing OTC and prescription medications, discontinuing prescriptions, taking wrong dosages, using incorrect techniques, and consuming inappropriate foods with specific medications. Both human and environmental factors contribute to medication mismanagement among older adults. Human factors include faulty communication between the health care provider and the patient; the patient's lack of knowledge; ADRs; alcohol-drug interactions; use of OTC medications and herbal products; cognitive, sensory, and motor impairments; and polypharmacy. Environmental factors include high cost of prescribed medications, improper medication storage, and absence of clearly marked expiration dates. Nurses need to take advantage of both formal and informal teaching opportunities in all settings to prepare a patient for medication self-management. Teaching should be individualized and based on a thorough assessment of the patient's abilities to administer medication safely and the specific medication regimen. By involving older adults as active partners in their health care, many errors and medication-related health problems can be prevented. New technologies and devices have the potential for improving the patient's self-management of medications. The role of nurses in educating older adults and their families about proper medication management is vital. PMID:15839523

  12. [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. PMID:11802515

  13. [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.

  14. 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)

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

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... flavors or animal feed flavors) in accordance with laws and regulations administered by FDA. Under § 17... violate a ban or restriction of the U.S. Food and Drug Administration (FDA) pertaining to such products. If FDA bans or restricts the use of any ingredient in such a way that further manufacture of...

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

    PubMed

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

    2015-05-01

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

  18. 42 CFR 418.106 - Condition of participation: Drugs and biologicals, medical supplies, and durable medical equipment.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... chapter; and drugs and biologicals related to the palliation and management of the terminal illness and... management as defined in hospice policies and procedures and State law, who is an employee of or under... provided pharmacist services must include evaluation of a patient's response to medication...

  19. 42 CFR 418.106 - Condition of participation: Drugs and biologicals, medical supplies, and durable medical equipment.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... chapter; and drugs and biologicals related to the palliation and management of the terminal illness and... management as defined in hospice policies and procedures and State law, who is an employee of or under... provided pharmacist services must include evaluation of a patient's response to medication...

  20. 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. PMID:24447983

  1. 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.

  2. 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

  3. Drug utilization study in medical emergency unit of a tertiary care hospital in north India.

    PubMed

    Kaur, Sharonjeet; Rajagopalan, Sujit; Kaur, Navjot; Shafiq, Nusrat; Bhalla, Ashish; Pandhi, Promila; Malhotra, Samir

    2014-01-01

    Objective. To generate data on the drug utilization pattern and cost of drug treatment and to determine the rationality of prescriptions. Methods. A retrospective cross-sectional drug utilization study was conducted in the medical emergency unit of our hospital. Patient case records were reviewed to extract data on the pattern of drug use. Cost of drug treatment for the emergency visit was calculated by referring to the cost mentioned in Monthly Index of Medical Specialties and the rationality of prescriptions was evaluated using WHO core indicators of drug utilization. Results. 1100 case records were reviewed. Majority of patients received proton pump inhibitors followed by multivitamins. The median cost per prescription was 119.23$ (7.32$-7663.46$). Majority (49.9%) of drug cost was driven by antibiotics alone. An average of 4.9 drugs was prescribed per prescription. There were 14.89% encounters with antibiotics. 75.17% of the drugs were given as injectables and only 29.27% of the drugs were prescribed as generics. Conclusion. There is need to rationalize the drug therapy in terms of increasing prescribing of drugs by generic name and to avoid overuse of PPIs and multivitamins in emergency unit. Also the hospital pharmacy should be encouraged to procure more cost effective alternative antibiotics in future. PMID:24883208

  4. New medications for drug addiction hiding in glutamatergic neuroplasticity.

    PubMed

    Kalivas, P W; Volkow, N D

    2011-10-01

    The repeated use of drugs that directly or indirectly stimulate dopamine transmission carry addiction liability and produce enduring pathological changes in the brain circuitry that normally regulates adaptive behavioral responding to a changing environment. This circuitry is rich in glutamatergic projections, and addiction-related behaviors in animal models have been linked to impairments in excitatory synaptic plasticity. Among the best-characterized glutamatergic projection in this circuit is the prefrontal efferent to the nucleus accumbens. A variety of molecular adaptations have been identified in the prefrontal glutamate synapses in the accumbens, many of which are induced by different classes of addictive drugs. Based largely on work with cocaine, we hypothesize that the drug-induced adaptations impair synaptic plasticity in the cortico-accumbens projection, and thereby dysregulate the ability of addicts to control their drug-taking habits. Accordingly, we go on to describe the literature implicating the drug-induced changes in protein content or function that impinge upon synaptic plasticity and have been targeted in preclinical models of relapse and, in some cases, in pilot clinical trials. Based upon modeling drug-induced impairments in neuroplasticity in the cortico-accumbens pathway, we argue for a concerted effort to clinically evaluate the hypothesis that targeting glial and neuronal proteins regulating excitatory synaptic plasticity may prove beneficial in treating addiction. PMID:21519339

  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. An Evaluation of Coverage and Compliance of Mass Drug Administration 2006 for Elimination of Lymphatic Filariasis in Endemic Areas of Gujarat

    PubMed Central

    Kumar, Pradeep; Prajapati, PB; Saxena, Deepak; Kavishwar, Abhay B; Kurian, George

    2008-01-01

    Background: Mass drug administration (MDA) means once-in-a-year administration of diethyl carbamazine (DEC) tablet to all people (excluding children under 2 years, pregnant women and severely ill persons) in identified endemic areas. It aims at cessation of transmission of lymphatic filariasis. Objective: What has been the coverage and compliance of MDA in Gujarat during the campaign in December 2006? Study Design: Cross-sectional population based house-to-house visit. Setting: Urban and rural areas in Gujarat identified as endemic for filariasis where MDA 2006 was undertaken. Study Variables: Exploratory - Rural and urban districts; Outcome - coverage, compliance, actual coverage, side effects. Analysis: Percentage and proportions. Results: Twenty-six clusters, each comprising 32 households from six endemic districts, yielded an eligible population of 4164. The coverage rate was 85.2% with variation across different areas. The compliance with drug ingestion was 89% with a gap of 11% to be targeted by intensive IEC. The effective coverage (75.8%) was much below the target (85%). Side effects of DEC were minimum, transient and drug-specific. Overall coverage was marginally better in rural areas. The causes of poor coverage and compliance have been discussed and relevant suggestions have been made. PMID:19966995

  7. 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.…

  8. 42 CFR 423.153 - Drug utilization management, quality assurance, and medication therapy management programs (MTMPs).

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ...-utilization and under-utilization of prescribed medications; and (3) Provides CMS with information concerning... examination of claims data and other records, through computerized drug claims processing and information retrieval systems, in order to identify patterns of inappropriate or medically unnecessary care...

  9. 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.

  10. Medication and drug abuse in relation to road traffic safety.

    PubMed

    Lesch, O M; Lentner, S; Mader, R; Musalek, M; Nimmerrichter, A; Walter, H

    1989-01-01

    Apart from alcohol, various other substances with a psychotropic effect have been discussed recently in relation to their association with road traffic safety. There has been a general lack of hard facts, however, on how much drug use and abuse influence this. In the absence of data on the frequency of such effects, a representative random sample (approx. 8000 persons) of the Austrian population was interviewed and questioned on their drug intake. A smaller sample (2007 persons) was also questioned as to their behaviour regarding road traffic participation. The results showed that those drugs taken most frequently belong to the 'analgesic' group, whilst the frequency in use of substances to which greater importance is attached currently regarding road safety is relatively low (tranquillizers by 4%; strictly 'psychotropic' drugs by 0.3% to 0.6% of the population). These findings are similar to those reported in English-speaking countries. Data analysis showed that socio-cultural factors (age, sex, marital status and profession) influence the frequency and type of drug intake. The definition of drug abuse and addiction used (increase of dosage, inappropriate use, effect changes) proved somewhat unreliable and called into question the criteria used for diagnosis and categorization of persons at risk. In view of the results of previous studies and the importance attached by critics, an unexpected finding of this survey was the minor influence exerted by tranquillizers on road traffic safety. However, the number of cases for individual drug classes was relatively small and there is a need for more broadly based studies of a similar design before reaching firm conclusions. PMID:2748692

  11. 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.

  12. 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.

  13. NON-MEDICAL DRUG USE AMONG INTERNS AND HOUSE-OFFICERS

    PubMed Central

    Choudhary, R. K.; Singh, Rajpal; Avasthi, Ajit; Gupta, Rajeev

    1980-01-01

    SUMMARY Self-administered questionnaire was given to a sample of 105 interns and house officers working in Govt. Medical College, Jammu. Questionnaire was designed to obtain information about socio-demographic characteristics, the frequency of non-medical drug use during the last one year and to enquire about “reasons” for drug intake. It was found that drugs commonly used were alcohol, tobacco, tranquillizers, amphetamines, cannabis. Most of the subjects used the same for ‘company’, festivity or curiosity. PMID:22058486

  14. 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.

  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. 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.

  17. 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

  18. 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. PMID:26237982

  19. 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…

  20. Description of medication errors detected at a drug information centre in Southern Brazil

    PubMed Central

    Dos Santos, Luciana; Winkler, Natália; Dos Santos, Marlise A.; Martinbiancho, Jacqueline K.

    2014-01-01

    Objective: To identify and describe actual or potential medication errors related to drug information inquiries made by staff members of a teaching hospital to a Drug Information Centre from January 2012 to December 2013. Methods: Data were collected from the records of inquiries made by health care professionals to the Drug Information Centre throughout this period. Results: During the study period, the Drug Information Centre received 3,500 inquiries. Of these, 114 inquiries had medication errors. Most errors were related to prescribing, preparation, and administration and were classified according to severity as category B (57%) (potential errors) and categories C (26.3%) and D (15.8%) (actual errors that did not result in harm to the patient). Error causes included overdose (13.2%), wrong route of administration (11.4%), inadequate drug storage (11.4%), and wrong dosage form (8.8%). The drugs most frequently involved in errors were vitamin K (4.4%), vancomycin (3.5%), and meropenem (3.5%). Conclusion: In this study, it was not possible to measure the reduction in error rate involving medication use because of the lack of previous data on this process in the institution. However, our findings indicate that the Drug Information Centre may be used as a strategy to seek improvements in processes involving medication use. PMID:25883691

  1. 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

  2. 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

  3. Medical drugs of limited commercial interest: profit alone is a bitter pill.

    PubMed

    Asbury, C H

    1981-01-01

    Medical drugs of limited commercial interest frequently are unavailable to the public even though their therapeutic efficacy is well established. At present, availability of a particular drug is unpredictable, and determined largely by pharmaceutical industry willingness to produce the drug potentially at no profit. Anticipated profitability also profoundly guides drug development decisions by industry. Federal efforts by both the executive and legislative branches to develop policy aimed at facilitating development and distribution of medical drugs of limited commercial interest have intensified. Thorough analysis of the problems and of proposed plans for their amelioration is necessary to effect a policy which takes into account the social, political, and scientific factors, as well as the profit motive. PMID:7298256

  4. FDA (food and drug administration) compliance program guidance manual (fy 84). Section 6. Radiological health. Updates. Irregular repts

    SciTech Connect

    Not Available

    1984-01-01

    The standing order allows one to obtain updates to Section VI of the Compliance Program Guidance Manual which provides plans and instructions to Field operatons which are surveillance and/or compliance oriented and provide needed direction from Headquarters Offices and Bureaus in accomplishing FDA's regulatory obligations for those products monitored for radiation. This section also includes the concept to the Manual and miscellaneous material relating to compliance functions.

  5. 77 FR 22328 - Guidance for Industry on the Judicious Use of Medically Important Antimicrobial Drugs in Food...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-13

    ... Important Antimicrobial Drugs in Food-Producing Animals; Availability AGENCY: Food and Drug Administration... a guidance for industry (GFI 209) entitled ``The Judicious Use of Medically Important Antimicrobial... thinking on the use of medically important antimicrobial drugs in animal agriculture. DATES: Submit...

  6. Quality improvement in breast cancer project: compliance with antiresorptive agents and changing patterns of drug use.

    PubMed

    Borden, Charles P; Shapiro, Charles L; Ramirez, Maria Teresa; Kotur, Linda; Farrar, William

    2014-02-01

    The Ohio State University Comprehensive Cancer Center - James Cancer Hospital and Solove Research Institute participated in NCCN's Quality Improvement in Breast Cancer initiative. The Opportunities for Improvement (OFI) team elected to improve concordance with the NCCN Clinical Practice Guidelines in Oncology for Breast Cancer recommendation that all patients diagnosed with skeletal metastases receive bisphosphonates. Assembling a multidisciplinary team of clinicians, researchers, and administrative stakeholders, the OFI team followed Six Sigma's approach to problem-solving known as DMAIC (define, measure, analyze, improve, and control). Baseline concordance was 79%, which was below the recommended target range. Initial analysis quickly revealed that 5 cases were concordant, resulting in a new baseline of 89%. The key root cause identified for the remaining gap was lack of documentation. The solution included education regarding documentation for existing staff, in addition to hard-wiring the material into new physician orientation, discussion of all patients with bone disease at tumor board meetings, and improved consistency with use of the new electronic medical record system. After implementation, the reported concordance was 92%, and the lack of documentation problem decreased from 11% in the baseline study to 6%. The team concluded that use of the NCCN Oncology Outcomes Database as an opportunity for clinical quality improvement initiatives not only is possible but also should be an essential element of any clinical program looking to continuously improve. PMID:24614050

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

    PubMed Central

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

    2014-01-01

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

  8. 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. PMID:25246690

  9. 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. PMID:20402543

  10. An Evaluation of Mass Drug Administration Compliance Against Filariasis of Tikamgarh District of Madhya Pradesh-A Household-Based Community Study

    PubMed Central

    Singh, Sandeep; Patel, Meena; Kushwah, Sugriv Singh

    2013-01-01

    Background: Mass drug administration (MDA) means once-in-a-year administration of diethyl carbamazine (DEC) tablet to all people (excluding children under 2 years, pregnant women and severely ill persons) in identified endemic areas. It aims at cessation of transmission of lymphatic filariasis. Objective: To study the coverage and compliance of MDA in Tikamgarh district during the campaign in April 2010. Materials and Methods: The activities under MDA involved administration of DEC tablets to eligible population from endemic area by health staff and Integrated Child Development Scheme (ICDS) functionaries referred as drug distributors (DD) make house-to-house visits on select dates in 2010. DEC was administered to all people (excluding children under 2 years, pregnant women and severely ill persons) with the instruction to ingest the tablet preferably on the spot. Study Design: Cross-sectional population based house-to-house visit. Setting: Urban and rural areas in Tikamgarh district identified as endemic for filariasis where MDA 2010 was undertaken. Study Variables: Exploratory - Rural and urban clusters of Tikamgarh district; Outcome - coverage, compliance, actual coverage, side effects. Analysis: Percentage and proportions. Results: Four clusters, each comprising 30 households from Tikamgarh endemic district, yielded an eligible population of 641. The coverage rate was 607 (94.6% of eligible) with variation across different areas. The compliance with drug ingestion was 89.9% with a gap of 10.1% to be targeted by intensive IEC. The effective coverage (85.2%) was just above the target (85%). Side effects of DEC were minimum, transient and drug-specific. Overall coverage was marginally better in rural areas. The causes of poor coverage and compliance have been discussed and relevant suggestions have been made. PMID:24479075

  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. Handwashing compliance.

    PubMed

    Antoniak, Jeannie

    2004-09-01

    Undeniably, handwashing remains the single most effective and cost-efficient method for preventing and reducing the transmission of nosocomial infections. Yet the rates and outbreaks of nosocomial infections in Canadian and international healthcare institutions continue to increase. Shaikh Khalifa Medical Center developed and implemented a multidisciplinary approach to address the challenges of handwashing compliance among nurses and healthcare workers in its workplace setting. Supported by evidence-based research, the approach consisted of three components: collaboration, implementation and evaluation. The use of the alcohol-based hand rub sanitizer or "solution" was integral to the multidisciplinary approach. Ongoing education, communication and a committed leadership were essential to promote and sustain handwashing compliance. PMID:15510782

  13. 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.

  14. 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. PMID:26881768

  15. Indication Alerts Intercept Drug Name Confusion Errors during Computerized Entry of Medication Orders

    PubMed Central

    Galanter, William L.; Bryson, Michelle L.; Falck, Suzanne; Rosenfield, Rachel; Laragh, Marci; Shrestha, Neeha; Schiff, Gordon D.; Lambert, Bruce L.

    2014-01-01

    Background Confusion between similar drug names is a common cause of potentially harmful medication errors. Interventions to prevent these errors at the point of prescribing have had limited success. The purpose of this study is to measure whether indication alerts at the time of computerized physician order entry (CPOE) can intercept drug name confusion errors. Methods and Findings A retrospective observational study of alerts provided to prescribers in a public, tertiary hospital and ambulatory practice with medication orders placed using CPOE. Consecutive patients seen from April 2006 through February 2012 were eligible if a clinician received an indication alert during ordering. A total of 54,499 unique patients were included. The computerized decision support system prompted prescribers to enter indications when certain medications were ordered without a coded indication in the electronic problem list. Alerts required prescribers either to ignore them by clicking OK, to place a problem in the problem list, or to cancel the order. Main outcome was the proportion of indication alerts resulting in the interception of drug name confusion errors. Error interception was determined using an algorithm to identify instances in which an alert triggered, the initial medication order was not completed, and the same prescriber ordered a similar-sounding medication on the same patient within 5 minutes. Similarity was defined using standard text similarity measures. Two clinicians performed chart review of all cases to determine whether the first, non-completed medication order had a documented or non-documented, plausible indication for use. If either reviewer found a plausible indication, the case was not considered an error. We analyzed 127,458 alerts and identified 176 intercepted drug name confusion errors, an interception rate of 0.14±.01%. Conclusions Indication alerts intercepted 1.4 drug name confusion errors per 1000 alerts. Institutions with CPOE should consider

  16. [Pattern of drug consumption without medical prescription in the city of Porto Alegre, RS].

    PubMed

    Vitor, Ricardo Sozo; Lopes, Caroline Panone; Menezes, Honório Sampaio; Kerkhoff, Carlos Eduardo

    2008-04-01

    Self-medication is a very common practice not only in Brazil but also in other countries. It is defined as medication of oneself without medical advice, the patient himself deciding which drug to use. The overall objective of this study is to describe the pattern of drug consumption without medical prescription in the city of Porto Alegre between January and February 2007. It was an observational, transversal, descriptive and prospective study. Seven hundred and forty two individuals of both sexes, aged between 18 and 70 years and resident in Porto Alegre where interviewed between January and February 2007 after self-medication had been confirmed. With respect to sex, there was a predominance of self-medicating women (57.54%) in the studied sample. As refers to media influence, the majority (76.28%) was not influenced by the media in the choice of a medicament. In relation to the variable medical consultations during the last twelve months the majority (26.81%) had seen the doctor twice. The data here presented confirm the importance of studying the practice of self-medication and support the hypothesis of a naive and excessive belief of our society in the power of medicines.

  17. 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.

  18. Adverse Drug Reaction Reporting Program of the Ontario Medical Association: the first 3 years.

    PubMed Central

    Gowdey, C W; Brennan, M

    1985-01-01

    This paper describes the Adverse Drug Reaction Reporting Program developed and operated by the Committee on Drugs and Pharmaco-therapy of the Ontario Medical Association. Analyses were done to demonstrate some of the trends derived from the reports. Some of the clinical observations based on the reports, which are published quarterly and circulated to physicians and to pharmacy, nursing and hospital organizations, are also reviewed. PMID:3871167

  19. 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. PMID:26940870

  20. Direct drug analysis from oral fluid using medical swab touch spray mass spectrometry.

    PubMed

    Pirro, Valentina; Jarmusch, Alan K; Vincenti, Marco; Cooks, R Graham

    2015-02-25

    Fourteen common drugs of abuse were identified in spiked oral fluid (ng mL(-1) levels), analyzed directly from medical swabs using touch spray mass spectrometry (TS-MS), exemplifying a rapid test for drug detection. Multiple stages of mass analysis (MS(2) and MS(3)) provided identification and detection limits sought by international forensic and toxicological societies, Δ(9)-THC and buprenorphine excluded. The measurements were made using a medical swab as both the sampling probe and means of ionization. The adaptation of medical swabs for TS-MS analysis allows non-invasive and direct sampling of neat oral fluid. Data acquisition was rapid, seconds per drug, and MS(3) ensured reliable identification of illicit drugs. The reported data were acquired to investigate (i) ionization of common drugs from commercial swabs, (ii) ion intensity over spray duration, and (iii) dynamic range, all as initial steps in development of a quantitative method. The approach outlined is intended for point-of-care drug testing using oral fluid in clinical applications as well as in situ settings, viz. in forensic applications. The proof-of-concept results presented will require extension to other controlled substances and refinement in analytical procedures to meet clinical/legal requirements. PMID:25702273

  1. Direct drug analysis from oral fluid using medical swab touch spray mass spectrometry.

    PubMed

    Pirro, Valentina; Jarmusch, Alan K; Vincenti, Marco; Cooks, R Graham

    2015-02-25

    Fourteen common drugs of abuse were identified in spiked oral fluid (ng mL(-1) levels), analyzed directly from medical swabs using touch spray mass spectrometry (TS-MS), exemplifying a rapid test for drug detection. Multiple stages of mass analysis (MS(2) and MS(3)) provided identification and detection limits sought by international forensic and toxicological societies, Δ(9)-THC and buprenorphine excluded. The measurements were made using a medical swab as both the sampling probe and means of ionization. The adaptation of medical swabs for TS-MS analysis allows non-invasive and direct sampling of neat oral fluid. Data acquisition was rapid, seconds per drug, and MS(3) ensured reliable identification of illicit drugs. The reported data were acquired to investigate (i) ionization of common drugs from commercial swabs, (ii) ion intensity over spray duration, and (iii) dynamic range, all as initial steps in development of a quantitative method. The approach outlined is intended for point-of-care drug testing using oral fluid in clinical applications as well as in situ settings, viz. in forensic applications. The proof-of-concept results presented will require extension to other controlled substances and refinement in analytical procedures to meet clinical/legal requirements.

  2. 77 FR 63837 - Draft Guidance for Industry and Food and Drug Administration Staff; eCopy Program for Medical...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-17

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

  3. 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...

  4. 77 FR 70166 - Provisions of the Food and Drug Administration Safety and Innovation Act Related to Medical Gases...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-23

    ... HUMAN SERVICES Food and Drug Administration Provisions of the Food and Drug Administration Safety and Innovation Act Related to Medical Gases; Establishment of a Public Docket AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is establishing a...

  5. [The scope of expert competence for the evaluation of non-compliance with the requirements of the departmental normative legal acts in the course of forensic medical panel examinations concerning "medical practice" in the criminal legal procedures].

    PubMed

    Kovalev, A V; Pletianova, I V; Fetisov, V A

    2014-01-01

    This article is devoted to the analysis of the problem of expert competence for the evaluation of non-compliance with the requirements of the departmental normative legal acts in the course of forensic medical panel examinations concerning "medical practice" in the criminal legal procedures. The approaches to the solution of his problem are exemplified by forensic medical expertise of selected cases from obstetric and gynecological practice. It is demonstrated that investigations into non-compliance events arising in the work of medical facilities must include the analysis of the departmental normative legal acts that govern the organizational and diagnostic processes. These documents should be regarded as pertaining to an additional direct object and considered to be one of the constituent elements of.the offence to be identified during forensic medical expertise. Such documents are very specific in terms of their content and can not be properly interpreted by independent specialists possessing juristic knowledge alone. Therefore, the expert judgments concerning these issues must include well-reasoned arguments and solidly established evidence of normative legal character.

  6. 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

  7. [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. PMID:1523604

  8. [Evaluation of the medical value of a drug. A necessity for the Transparency Commission].

    PubMed

    Avouac, B

    1992-01-01

    The marketing approval (AMM) is based on criteria of pharmaceutical quality, efficacy and safety of use. Before marketing, the data are collected by means of double-blind, randomized, prospective clinical trials that compare the study product to a reference product. A post-AMM assessment is needed to define the increase of the medical benefit (ASMR) and the therapeutic value of the new drugs. The quantification of the ASMR is essential for registration on the list of drugs reimbursable for those who benefit from Social Security. The evaluation of the therapeutic value and the nature of the affection treated are the criteria upon which the reimbursement ratio is chosen. After marketing, the reevaluation of the medical benefit and the drugs' usefulness may be compared to the treatment's net medical cost (direct + indirect cost--avoided cost) in cost/utility or cost/benefit studies. The Transparency Commission has worked out a scale of assessment of the ASMR which will orient recommendation, or non-recommendation, of registration on the list of reimbursable drugs as well as price fixing proposals. In the future, the Transparency Commission is to strengthen its position regarding the good use of the drug through a better prescriber information system. Thanks to the pharmaco-epidemiology and the pharmaco-vigilance data, the Transparency Commission will be able to guarantee the post-marketing follow-up of the drugs. The examination of the products' conditions of use, the reevaluation of the treatment's advantages based on the utility studies and the epidemiological surveys, and the cost-benefit studies will contribute to a medical control of health spending linked to drug consumption.

  9. Cognitive Factors Related to Drug Abuse Among a Sample of Iranian Male Medical College Students

    PubMed Central

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

    2015-01-01

    Backgrounds: Drug abuse is one of the most serious social problems in many countries. College students, particularly at their first year of education, are considered as one of the at risk groups for drug abuse. The present study aimed to determine cognitive factors related to drug abuse among a sample of Iranian male medical college students based on the social cognitive theory (SCT). Method: This cross-sectional study was carried out on 425 Iranian male medical college students who were randomly selected to participate voluntarily in the study. The participants filled out a self-administered questionnaire. Data were analyzed by the SPSS software (ver. 21.0) using bivariate correlations, logistic and linear regression at 95% significant level. Results: Attitude, outcome expectation, outcome expectancies, subjective norms, and self-control were cognitive factors that accounted for 49% of the variation in the outcome measure of the intention to abuse drugs. Logistic regression showed that attitude (OR=1.062), outcome expectancies (OR=1.115), and subjective norms (OR=1.269) were the most influential predictors for drug abuse. Conclusions: The findings suggest that designing and implementation of educational programs may be useful to increase negative attitude, outcome expectancies, and subjective norms towards drug abuse for college students in order to prevent drug abuse. PMID:26156919

  10. Is the efficacy of psychopharmacological drugs comparable to the efficacy of general medicine medication?

    PubMed Central

    2012-01-01

    There is an ongoing debate concerning the risk benefit ratio of psychopharmacologic compounds. With respect to the benefit, recent reports and meta-analyses note only small effect sizes with comparably high placebo response rates in the psychiatric field. These reports together with others lead to a wider, general critique on psychotropic drugs in the scientific community and in the lay press. In a recently published article, Leucht and his colleagues compare the efficacy of psychotropic drugs with the efficacy of common general medicine drugs in different indications according to results from reviewed meta-analyses. The authors conclude that, overall, the psychiatric drugs were generally not less effective than most other medical drugs. This article will highlight some of the results of this systematic review and discuss the limitations and the impact of this important approach on the above mentioned debate. PMID:22335858

  11. 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.

  12. 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. PMID:22106646

  13. eDrugCalc: an online self-assessment package to enhance medical students' drug dose calculation skills

    PubMed Central

    McQueen, Daniel S; Begg, Michael J; Maxwell, Simon R J

    2010-01-01

    AIMS Dose calculation errors can cause serious life-threatening clinical incidents. We designed eDrugCalc as an online self-assessment tool to develop and evaluate calculation skills among medical students. METHODS We undertook a prospective uncontrolled study involving 1727 medical students in years 1–5 at the University of Edinburgh. Students had continuous access to eDrugCalc and were encouraged to practise. Voluntary self-assessment was undertaken by answering the 20 questions on six occasions over 30 months. Questions remained fixed but numerical variables changed so each visit required a fresh calculation. Feedback was provided following each answer. RESULTS Final-year students had a significantly higher mean score in test 6 compared with test 1 [16.6, 95% confidence interval (CI) 16.2, 17.0 vs. 12.6, 95% CI 11.9, 13.4; n = 173, P < 0.0001 Wilcoxon matched pairs test] and made a median of three vs. seven errors. Performance was highly variable in all tests with 2.7% of final-year students scoring < 10/20 in test 6. Graduating students in 2009 (30 months' exposure) achieved significantly better scores than those in 2007 (only 6 months): mean 16.5, 95% CI 16.0, 17.0, n = 184 vs. 15.1, 95% CI 14.5, 15.6, n = 187; P < 0.0001, Mann–Whitney test. Calculations based on percentage concentrations and infusion rates were poorly performed. Feedback showed that eDrugCalc increased confidence in calculating doses and was highly rated as a learning tool. CONCLUSIONS Medical student performance of dose calculations improved significantly after repeated exposure to an online formative dose-calculation package and encouragement to develop their numeracy. Further research is required to establish whether eDrugCalc reduces calculation errors made in clinical practice. PMID:20840441

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

    PubMed Central

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

    2011-01-01

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

  15. 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)

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

    PubMed Central

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

    2015-01-01

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

  17. Carry-over of veterinary drugs from medicated to non-medicated feeds in commercial feed manufacturing plants.

    PubMed

    Stolker, A A M; Manti, V; Zuidema, T; van Egmond, H; Deckers, E R; Herbes, R; Hooglugt, J; Olde Heuvel, E; de Jong, J

    2013-01-01

    Different compound feeds have to be manufactured in the same production line. As a consequence, traces of the first produced feed may remain in the production and get mixed with the next feed batches. This "carry-over" is unavoidable, and so non-medicated feed can be contaminated with veterinary drugs like antibiotics added to the previous batch of medicated feed. To monitor the carry-over of antibiotics in the Netherlands, 21 feed mills were visited and 140 samples of flushing feeds were collected and analysed for containing residues of antibiotics. Results show that 87% of all samples contain concentrations of antibiotics in the range of 0.1-154 mg/kg. It is expected that these levels - which are in the same range as previously found for the nowadays banned antimicrobial growth promoters (AMGPs) - have an effect on the occurrence of microbial resistance. Analysis of a second set of samples collected at four different feed mills directly after the production of oxytetracycline-medicated feed demonstrated that the first part of a flushing feed has much higher contamination than the last part of the batch. Furthermore, it was demonstrated that the carry-over percentage shows no correlation with the carry-over determined by one of the standard GMP+ procedures. These observations, unavoidable carry-over, inhomogeneous batches of feed with antibiotics and difficulties to predict the carry-over levels, together with the awareness of the increasing problem of microbial resistance, motivated the NEVEDI, association of Dutch Feed Producers, to announce that they will voluntarily stop the production of medicated feed in 2011. The alternatives for medicated feed are for example water or milk medication or the use of top-dressings at the farm. The consequences and possible new risks of carry-over at the farm are not completely clear yet. PMID:23742236

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

    PubMed Central

    2014-01-01

    Background This was a systematic review of the literature in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. Evidence mapping was used to reveal the effect of drug reminder packaging on medication adherence, to identify research gaps and to make suggestions for future research. Methods PubMed, Embase, CINAHL and PsycINFO were searched with an end date of September 2013 using the Medical Subject Headings (MeSH) term ‘medication adherence’ and 20 different search terms for ‘drug reminder packaging’, limited to the English and German languages. Additional references were identified through cross-referencing. All prospective controlled trials with an intervention using drug reminder packaging for patients taking at least one medication without the assistance of a health-care professional were included in the evidence mapping of the effect of drug reminder packaging on adherence and outcomes according to the Economic, Clinical and Humanistic Outcomes (ECHO) model. Results A total of 30 studies met the inclusion criteria: 10 randomized controlled trials, 19 controlled clinical trials and 1 cohort study. Drug reminder packaging had a significant effect on at least one adherence parameter in 17 studies (57%). The methodological quality was strong in five studies. Two studies provided complete information. Clear research gaps emerged. Conclusions Overall, the studies showed a positive effect of drug reminder packaging on adherence and clinical outcomes. However, poor reporting and important gaps like missing humanistic and economic outcomes and neglected safety issues limit the drawing of firm conclusions. Suggestions are made for future research. PMID:24661495

  19. 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.

  20. Competence of medical students in communicating drug therapy: Value of role-play demonstrations

    PubMed Central

    Tayem, Yasin I.; Altabtabaei, Abdulaziz S.; Mohamed, Mohamed W.; Arrfedi, Mansour M.; Aljawder, Hasan S.; Aldebous, Fahad A.; James, Henry; Al Khaja, Khalid A. J.; Sequeira, Reginald P.

    2016-01-01

    Objectives: This study used role-play demonstrations to train medical students to communicate drug therapy and evaluated the perceptions on this instructional approach. Materials and Methods: The second-year medical students who attended a prescription writing session (n = 133), participated in this study. Prescription communication was introduced by using role-play demonstrations. Participant's perceptions were explored by a self-administered questionnaire and focus group discussion. The academic achievement of attendees and nonattendees was compared with an objective structured performance evaluation (OSPE) station that tested students’ competence in this skill. Results: Most attendees responded to the questionnaire (81.2%). Almost all respondents expressed their desire to have similar demonstrations in other units. A large proportion of participants reported that role-play demonstrations helped them develop their communication skills, in general, confidence to communicate drug-related information in a prescription, and the ability to explain the aim of drug therapy to patients. Most trainees thought also that they developed skills to communicate instructions on drug use including drug dose, frequency of administration, duration of therapy, adverse drug reactions, and warnings. During the focus group interviews, students thought that role-play was useful but would be more beneficial if conducted frequently in small group as part of the curriculum implementation. The majority of students also reported improved competence in writing a complete prescription. Analysis of attendees and nonattendees grades in the OSPE showed that the former scored higher than the latter group (P = 0.016). Conclusions: Role-play demonstrations were well accepted by medical students and led to the development of their competence in communicating drug therapy to patients. PMID:26997720

  1. Cannabis: a self-medication drug for weight management? The never ending story.

    PubMed

    Bersani, Francesco Saverio; Santacroce, Rita; Coviello, Marialuce; Imperatori, Claudio; Francesconi, Marta; Vicinanza, Roberto; Minichino, Amedeo; Corazza, Ornella

    2016-02-01

    In a society highly focused on physical appearance, people are increasingly using the so-called performance and image-enhancing drugs (PIEDs) or life-style drugs as an easy way to control weight. Preliminary data from online sources (e.g. websites, drug forums, e-newsletters) suggest an increased use of cannabis amongst the general population as a PIED due to its putative weight-loss properties. The use of cannabis and/or cannabis-related products to lose weight may represent a new substance-use trend that should be carefully monitored and adequately investigated, especially in light of the well-known adverse psychiatric and somatic effects of cannabis, its possible interaction with other medications/drugs and the unknown and potentially dangerous composition of synthetic cannabimimetics preparations.

  2. Apparatus for studying in vitro drug release from medicated chewing gums.

    PubMed

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

    1999-10-28

    An apparatus for in vitro drug release testing of medicated chewing gums has been developed and is described in detail. The effects on the drug release when varying critical instrumental settings such as the chewing stroke frequency, the distance between the chewing surfaces, the twisting movements of these surfaces and the temperature of the test medium have been thoroughly investigated. It has been shown that the drug release can be tuned to obtain suitable drug release profiles for a number of products: Nicorette((R)) and Nicotinell((R)) (active substance nicotine), Travvell((R)) (dimenhydrinate), V6((R)) (xylitol) and an experimental formulation containing meclizine. The main usage of the present apparatus should be within quality control but the present study has also shown that it may be employed within development pharmaceutics since useful in vivo/in vitro relationships may be obtained due to the versatile settings of the critical instrumental parameters. PMID:10518685

  3. Drug Abuse Among Medical Students at a Nigerian University: Part 1. Prevalence and Pattern of Use

    PubMed Central

    Ihezue, U. H.

    1988-01-01

    Using a structured pro forma, 728 out of 775 medical undergraduates at a Nigerian university were surveyed for the prevalence and pattern of drug use. An operational definition of substance abuse was made, and 28 percent of students fell within that criterion. Male abusers (81 percent) exceeded female abusers (19 percent). Substances most commonly abused were alcohol (60 percent), minor tranquilizers (48 percent), tobacco (35 percent), and narcotics (29 percent), particularly codeine. Only 11 percent abused cannabis. While most students were polydrug users, there was a low frequency of daily drug use. A general lifetime (occasional use) prevalence of substance use of 56 percent was found. Drugs consumed on a daily basis were alcohol (2 percent) and tobacco (6 percent). The prevalence of drug use was highest among the fourth and final year students. The majority of students were occasional abusers; there was no evidence of physical dependence. PMID:3257527

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

    PubMed

    Brooks, Eleanor; Geyer, Robert

    2016-04-01

    Innovation in the development of new drugs has to balance the needs of health actors and administrators, the pharmaceutical industry and patients. Differing perspectives on what constitutes an innovation, where research and development should be directed and how new drugs should be evaluated and priced cause ongoing tensions within the regulatory framework. In the current climate, where Europe's health systems face rising demand for health services and increasingly restricted resources, the efficiency of pharmaceutical regulation and drug development is under even greater scrutiny. How can regulation foster innovation and industry growth while also serving the public health needs of society, and what is the EU's role in pursuing this objective? Drawing on a provision which formerly existed in Norwegian pharmaceutical legislation, this article explores the potential of a medical need clause (MNC) in addressing these issues. In restricting market authorisations to those drugs that offer an added therapeutic value, might a MNC foster innovation and spending efficiency in Europe's health systems? PMID:26333920

  5. Drug abuse among medical students at a Nigerian university: Part 1. Prevalence and pattern of use.

    PubMed

    Ihezue, U H

    1988-01-01

    Using a structured pro forma, 728 out of 775 medical undergraduates at a Nigerian university were surveyed for the prevalence and pattern of drug use. An operational definition of substance abuse was made, and 28 percent of students fell within that criterion. Male abusers (81 percent) exceeded female abusers (19 percent). Substances most commonly abused were alcohol (60 percent), minor tranquilizers (48 percent), tobacco (35 percent), and narcotics (29 percent), particularly codeine. Only 11 percent abused cannabis. While most students were polydrug users, there was a low frequency of daily drug use. A general lifetime (occasional use) prevalence of substance use of 56 percent was found. Drugs consumed on a daily basis were alcohol (2 percent) and tobacco (6 percent). The prevalence of drug use was highest among the fourth and final year students. The majority of students were occasional abusers; there was no evidence of physical dependence. PMID:3257527

  6. Friendship Intimacy, Close Friend Drug Use, and Self-Medication in Adolescence

    PubMed Central

    Shadur, Julia; Hussong, Andrea

    2014-01-01

    The current study examined between- and within-person processes related to friendship intimacy, close-friend substance use, negative affect, and self-medication. We tested between-person hypotheses that global negative affect, friendship intimacy, and close-friend drug use predict increased substance use, and the within-person hypothesis that friendship intimacy and close-friend substance use moderate the temporal relationship between daily negative affect and subsequent substance use (i.e., self-medication). Experience sampling methodology (ESM) was employed to capture daily variations in mood and substance use, and multilevel modeling techniques were used to parse between- versus within-person differences in risk for use. Findings supported between-person hypotheses that higher levels of negative affect and lower levels of friendship intimacy predicted greater substance use, and a consistent trend indicated that friendship intimacy and close-friend drug use interact to predict substance use more generally (though not for self-medication). Risk and protective mechanisms emerged from this interaction such that the effect of friendship intimacy on adolescent use depends on the degree of close-friend drug use. More specific reformulations of the risk processes involving friendships and self-medication among younger youth are indicated. PMID:25473144

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

    PubMed

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

    2010-01-01

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

  8. Drug allergies

    MedlinePlus

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

  9. Comparative study on drug safety surveillance between medical students of Malaysia and Nigeria

    PubMed Central

    Abubakar, Abdullahi Rabiu; Ismail, Salwani; Rahman, Nor Iza A; Haque, Mainul

    2015-01-01

    Background Internationally, there is a remarkable achievement in the areas of drug discovery, drug design, and clinical trials. New and efficient drug formulation techniques are widely available which have led to success in treatment of several diseases. Despite these achievements, large number of patients continue to experience adverse drug reactions (ADRs), and majority of them are yet to be on record. Objectives The purpose of this survey is to compare knowledge, attitude, and practice with respect to ADRs and pharmacovigilance (PV) between medical students of Malaysia and Nigeria and to determine if there is a relationship between their knowledge and practice. Method A cross-sectional, questionnaire-based survey involving year IV and year V medical students of the Department of Medicine, Universiti Sultan Zainal Abidin and Bayero University Kano was carried out. The questionnaire which comprised 25 questions on knowledge, attitude, and practice was adopted, modified, validated, and administered to them. The response was analyzed using SPSS version 20. Results The response rate from each country was 74%. There was a statistically significant difference in mean knowledge and practice score on ADRs and PV between medical students of Malaysia and Nigeria, both at P<0.000. No significance difference in attitude was observed at P=0.389. Also, a statistically significant relationship was recorded between their knowledge and practice (r=0.229, P=0.001), although the relationship was weak. Conclusion Nigerian medical students have better knowledge and practice than those of Malaysia, although they need improvement. Imparting knowledge of ADRs and PV among medical students will upgrade their practice and enhance health care delivery services in the future. PMID:26170680

  10. The ideal compliance world: integrating physicians into the compliance program.

    PubMed

    Belton, P R; Roughton, S E

    1999-12-01

    Compliance officers are in a unique position to provide guidance to physicians and will succeed in gaining physician support and buy-in when appropriate steps are taken to integrate physicians into the compliance program. First and foremost, the compliance officer's primary responsibility is to apprise physicians of the seriousness nature of current compliance issues. When physicians are provided with clear information through a variety of media, they will understand that compliance program goals and objectives will resolve compliance-related issues dilemmas. Next, the compliance officer should expect no less than the ideal compliance world. Recruit physician champions who will actively participate in compliance program planning and development. Call upon medical staff members to get involved in implementation stages of compliance action plans and engage physician leaders to educate and train their physician peers on compliance-related issues. Most importantly, minimize individual physician liability by providing adequate education programs to physicians. Help them to master the art of coding and documentation and to mitigate any prospect of fraud and abuse or compliance-related concerns. Last, collaboration is the key--the compliance officer must provide guidance to the physician so that the physician may continue to fulfill the role of leader and healer. In turn, the physician must recognize that his or her actions and those of the hospital and system are inseparable and that they must actively participate in compliance program initiatives.

  11. 75 FR 37450 - Draft Guidance: The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-29

    ... Antimicrobial Drugs in Food-Producing Animals; Availability AGENCY: Food and Drug Administration, HHS. ACTION... Animals.'' This draft guidance is intended to inform the public of FDA's current thinking on the use of medically important antimicrobial drugs in food-producing animals. DATES: Although you can comment on...

  12. Medical device reporting: manufacturer reporting, importer reporting, user facility reporting, distributor reporting. Food and Drug Administration, HHS. Final rule.

    PubMed

    2000-01-26

    The Food and Drug Administration (FDA) is amending its regulations governing reporting by manufacturers, importers, distributors and health care (user) facilities of adverse events related to medical devices. Amendments are being made to implement revisions to the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Food and Drug Administration Modernization Act of 1997 (FDAMA).

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

    PubMed

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

    2008-01-01

    Infectious disease (ID) medication management is complex and clinical decision support tools (CDSTs) can provide valuable assistance. This study evaluated scope and completeness of ID drug information found in online databases by evaluating their ability to answer 147 question/answer pairs. Scope scores produced highest rankings (%) for: Micromedex (82.3), Lexi-Comp/American Hospital Formulary Service (81.0), and Medscape Drug Reference (81.0); lowest includes: Epocrates Online Premium (47.0), Johns Hopkins ABX Guide (45.6), and PEPID PDC (40.8). PMID:18999059

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

    PubMed

    Kishimoto, Keiko; Fukushima, Noriko

    2011-01-01

    In this study, we investigated the status of researching drug information online, and the type of Internet user who uses anonymous Web communities and websites. A Web-based cross-sectional survey of 10875 male and female Internet users aged 16 and over was conducted in March 2010. Of 10282 analyzed respondents, excluding medical professionals, about 47% reported that they had previously searched the Internet for drug information and had used online resources ranging from drug information search engines and pharmaceutical industry websites to social networking sites and Twitter. Respondents who had researched drug information online (n=4861) were analyzed by two multivariable logistic regressions. In Model 1, the use of anonymous websites associated with age (OR, 0.778; 95% CI, 0.742-0.816), referring to the reputation and the narrative of other Internet users on shopping (OR, 1.640; 95% CI, 1.450-1.855), taking a prescription drug (OR, 0.806; 95% CI, 0.705-0.922), and frequent consulting with non-professionals about medical care and health (OR, 1.613; 95% CI, 1.396-1.865). In Model 2, use of only anonymous websites was associated with age (OR, 0.753; 95% CI, 0.705-0.805), using the Internet daily (OR, 0.611; 95% CI, 0.462-0.808), taking a prescription drug (OR, 0.614; 95% CI, 0.505-0.747), and experience a side effect (OR, 0.526; 95% CI, 0.421-0.658). The analysis revealed the profiles of Internet users who researched drug information on social media sites where the information providers are anonymous and do not necessarily have adequate knowledge of medicine and online information literacy. PMID:21532265

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

    PubMed Central

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

    2015-01-01

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

  16. Antineoplastic drug contamination on the hands of employees working throughout the hospital medication system.

    PubMed

    Hon, Chun-Yip; Teschke, Kay; Demers, Paul A; Venners, Scott

    2014-07-01

    We previously reported that antineoplastic drug contamination is found on various work surfaces situated throughout the hospital medication system (process flow of drug within a facility from initial delivery to waste disposal). The presence of drug residual on surfaces suggests that healthcare workers involved in some capacity with the system may be exposed through dermal contact. The purpose of this paper was to determine the dermal contamination levels of healthcare employees working throughout a hospital and to identify factors that may influence dermal contamination. We selected participants from six hospitals and wiped the front and back of workers' hands. Wipe samples were analyzed for cyclophosphamide (CP), a commonly used antineoplastic drug, using high-performance liquid chromatography-tandem mass spectrometry. Participants were asked about their frequency of handling antineoplastic drugs, known contact with CP on their work shift, gender, job title, and safe drug handling training. In addition, participants were surveyed regarding their glove usage and hand washing practices prior to wipe sample collection. We collected a total of 225 wipe samples. Only 20% (N = 44) were above the limit of detection (LOD) of 0.36ng per wipe. The average concentration was 0.36ng per wipe, the geometric mean < LOD, the geometric standard deviation 1.98, and the range < LOD to 22.8ng per wipe. Hospital employees were classified into eight different job categories and all categories had some dermal contamination levels in excess of the LOD. The job category with the highest proportion of samples greater than the LOD were those workers in the drug administration unit who were not responsible for drug administration (volunteer, oncologist, ward aide, dietician). Of note, the highest recorded concentration was from a worker who had no known contact with CP on their work shift. Our results suggest that a broader range of healthcare workers than previously believed, including

  17. Harmonising adverse drug reaction terminology: the role of the Council for International Organizations of Medical Sciences.

    PubMed

    Venulet, J; Bankowski, Z

    1998-09-01

    Health professionals from different countries are known to differ considerably in their use of medical terminology, including the terminology used for adverse drug reactions (ADRs) and in the exact meanings attributed to terms. To remedy this situation, the Council for International Organizations of Medical Sciences (CIOMS) has attempted to provide definitions and basic requirements for proper use of ADR terms. The work has concentrated on terms liable to be misinterpreted and those used for serious and frequently reported ADRs. For every selected term a short monograph has been prepared. It consists of a preamble, definition, basic requirements for use of the term and additional comments, if any. In cooperation with medical experts, drug regulators and the pharmaceutical industry, 13 papers have been published so far. Approximately 160 terms have been defined and work on another 50 terms continues. The full collection of monographs will eventually appear in the form of a book and CD-ROM intended to help doctors fill in case reports, and regulatory agencies and the pharmaceutical industry assess reports. Pharmaceutical companies receive numerous reports of suspected ADRs from medical practitioners and other prescribing professionals. Each company is required to transmit these reports to the drug regulatory agency of the country, or countries, in which the drug is used. Therefore, in addition to receiving the correct name of the ADR, collecting and evaluating centres, regardless of whether they are part of a regulatory agency or a pharmaceutical company, need to be provided with sufficient supporting data to be convinced that what is reported was what was actually observed, and that the ADR term used represents the observed event.

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

    PubMed

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

    2015-04-01

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

  19. Relationship Between Characteristics of Medications and Drug-Induced Liver Disease Phenotype and Outcome

    PubMed Central

    Vuppalanchi, Raj; Gotur, Raghavender; Reddy, K. Rajender; Fontana, Robert J.; Ghabril, Marwan; Kosinski, Andrzej S.; Gu, Jiezhun; Serrano, Jose; Chalasani, Naga

    2014-01-01

    Background & Aims: It is not known if specific characteristics of medication are associated with type of drug-induced liver injury (DILI) or outcome. We examined the relationships among select characteristics of medications and DILI phenotype and outcome. Methods: We analyzed 383 cases of DILI caused by a single orally administered prescription agent from the DILI Network Prospective Study with causalities of definite, highly likely, or probable. Relationship of daily dosage (≥ 50 mg vs. ≤ 49 mg), preponderance of hepatic metabolism (≥50% vs <50%), or Biopharmaceutics Drug Disposition Classification System (BDDCS) class (1–4, based on solubility and metabolism of the drug) were compared with clinical characteristics and outcomes. Results: Compared to cases of DILI in the <50 mg/day group, those associated with daily dosages ≥50 mg had shorter latency (median 38 days vs 56 days; P=.03) and a different biochemical pattern of liver injury (P=.04); no differences in pattern of injury, recovery, severity, or outcome were observed. Patients with DILI caused by medications with or without preponderant hepatic metabolism did not differ in clinical characteristics or outcomes. Compared to other classes of BDDCS, DILI caused by BDDCS class 1 medications had significantly longer latency (P<.001) and greater proportion of hepatocellular injury (P=.001). However, peak liver biochemical values and patients’ time to recovery, disease severity, and outcomes did not differ among the 4 BDDCS classes. Conclusions: Characteristics of medications (dosage, hepatic metabolism, and solubility) are associated with features of DILI such as latency and pattern of liver injury, but not with recovery, severity, or outcome. PMID:24362054

  20. Non-compliance--or how many aunts has Matilda?

    PubMed

    Wright, E C

    1993-10-01

    The compliance of patients with medication prescribed for them is a challenge. It seems that one-third of patients comply adequately, one-third more-or-less, and one-third are non-compliant, so that compliance rates hover around 50%. This can be improved upon, but not by treating failure to comply as a deplorably aberrant behaviour. First we need to know more about compliance and non-compliance, and that means standardising methods of study and measuring, by questioning the patient, counting tablets, or looking at drug metabolites or markers in faeces, blood or urine. Doctors' prejudices and patients' perceptions alike have to be taken into account since strategies for improvement must include both educating the prescriber and counselling the patient.

  1. Consumers devise drug cost-cutting measures: medical and legal issues to consider.

    PubMed

    Ganguli, Gouranga

    2003-01-01

    Health care costs in general, and prescription drug costs in particular, are rapidly rising. Between 1996 and 2007 the average annual per capita health care cost is projected to increase from dollar 3,781 to dollar 7,100. [AQ1] The single leading component of health care cost is the cost of prescription drugs (currently 10% of total health care spending, projected to become 18% in 2008). The average cost per drug increased 40% during the 1993-1998 period. Forty-one million Americans have no health insurance, and those who have, have inadequate prescription drug coverage. [AQ2] To cope with this situation, many consumers are trying to economize by doing without the prescriptions or the appropriate doses, buying generics or medicines from Canada or Mexico, or splitting pills of higher doses to take advantage of the pricing policy of drug manufacturers. Some of these approaches are medically and/or legally acceptable, while some are dubious. Most adversely affected are the seniors and poor; for certain groups of seniors prescription drugs account for 30% of their health care spending. The problem must receive prompt concerted attention from consumers, insurers, pharmaceutical companies, and lawmakers before it gets out of hand.

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

    PubMed

    Shimazawa, Rumiko; Ikeda, Masayuki

    2015-01-01

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

  3. Medication safety program reduces adverse drug events in a community hospital

    PubMed Central

    Cohen, M; Kimmel, N; Benage, M; Cox, M; Sanders, N; Spence, D; Chen, J

    2005-01-01

    Background: There is widespread interest in improving medication safety, particularly in the hospital setting. Numerous suggestions have been made as to how this should be done, but there is a paucity of data demonstrating the effectiveness of any of the interventions that have been proposed. Objectives: To assess the impact of a wide ranging, community hospital based patient safety program on patient harm as measured by the rate of adverse drug events. Design: An audit of discharged hospital patients was conducted from January 2001 to December 2003. Baseline data were collected for the first 6 months and multiple drug protocols and other interventions were instituted on the nursing units and in the pharmacy department over the subsequent 9 months (transition period). These interventions were largely based on information about medication risks acquired from internal medication event reporting. Each month of the study adverse drug events (ADE) were sought from a random sample of inpatient charts. A trigger tool was used to detect clues to ADEs, the presence of which was confirmed or excluded by detailed manual chart review. The severity of these events was categorized using the classification system of the National Coordinating Council for Medication Error and Reporting and Prevention. Main outcome measures and results: Median ADEs per 1000 doses of medication dispensed declined significantly from 2.04 to 0.65 (p<0.001). Median ADEs per 100 patient days declined significantly from 5.07 to 1.30 (p<0.001). The proportion of inpatients with one or more ADE in the baseline period was 31% and declined threefold (p<0.001). The severity of reported medication events also declined. The number of ADEs associated conclusively with patient harm was 1.67 per total doses delivered in the baseline period and declined eightfold (p<0.001). Conclusion: The implementation of a carefully planned series of low cost interventions focused on high risk medications, driven by information

  4. 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…

  5. 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.

  6. The use of erection enhancing medication and party drugs among men living with HIV in Europe.

    PubMed

    De Ryck, Iris; Van Laeken, David; Noestlinger, Christiana; Platteau, Tom; Colebunders, Robert

    2013-08-01

    Studies have shown more erectile dysfunction (ED) in men living with HIV (MLHIV), relative to age matched HIV-negative men. Erection enhancing medication (EEM) is more frequently used by HIV-positive men than in the general male population. Increased sexually transmitted infection has been described in HIV-positive men with ED using EEM. This study investigated the use of EEM and party drugs (methyleendioxymethamfetamine (XTC), gammahydroxybutyrate (GHB) "fluid XTC" and alkyl nitrites "poppers") among MLHIV. Self-administered questionnaires were distributed consecutively to all patients attending 17 European HIV treatment centers. The sample included 1118 HIV-positive men, among whom 74.5% men having sex with men (MSM). The use of EEM was more frequent in MSM than in heterosexual men (odds ratio (OR) 3.33, p<0.001) and was associated with increased sexual risk behavior (OR 3.27, p<0.001). Nonmedically indicated use of EEM was linked to increased use of party drugs (OR 2.30, p=0.01). Physicians taking care of MLHIV need to be aware of the high prevalence of (nonmedical) use of EEM and party drugs. Medical provision of EEM should be combined with a discussion on safer sex behavior and the risk related to concomitant use of party drugs and illegal EEM.

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

    PubMed

    Massó, Paloma

    2015-09-01

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

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

    PubMed

    Massó, Paloma

    2015-09-01

    This article traces a map of the social control of drugs through the politics of space, according to the Foucaultian concept of "heterotopia." Firstly, a brief genealogy of the use of psychotropic substances in different times and cultures is described, up to the introduction of the prohibitionist paradigm. Attention is paid to the way in which power has marked, separated and enclosed certain rituals and uses of pleasure in physical and symbolic sites. The itinerary is focused on the Spanish context to establish a dialogue between the various policies of space that have come into being and have overlapped in the construction and management of a problem which has been rendered an object to the gazes, mechanics and discourses of the medical, legal, and social fields. In this way, the intersections between the liminal spaces of drug use and the harm reduction paradigm are analyzed, including therapeutic strategies with prescribed drugs, from methadone programs to the new heroin programs. PMID:26418094

  9. Interactions between Medical Residents and Drug Companies: A National Survey after the Mediator® Affair

    PubMed Central

    Montastruc, François; Moulis, Guillaume; Palmaro, Aurore; Gardette, Virginie; Durrieu, Geneviève; Montastruc, Jean-Louis

    2014-01-01

    Background The present study aimed to describe exposure and attitudes of French medical residents towards pharmaceutical industry. The study was performed shortly after the Mediator affair which revealed several serious conflicts of interest inside the French health system. Methods and Findings A cross-sectional study was implemented among residents from 6 French medical faculties. Independent education in pharmacology, attitudes towards the practices of pharmaceutical sales representatives, opinions concerning the pharmaceutical industry, quality of information provided by the pharmaceutical industry, and opinions about pharmaceutical company sponsorship were investigated through a web-based questionnaire. We also assessed potential changes in resident attitudes following the Mediator affair. The mean value of exposure to drug companies was 1.9 times per month. Global opinions towards drug company information were negative for 42.7% of the residents and positive for only 8.2%. Surprisingly, 81.6% of residents claimed that they had not changed their practices regarding drug information since the Mediator affair. Multivariate analyses found that residents in anesthesiology were less likely to be exposed than others (OR = 0.17 CI95% [0.05–0.61]), exposure was significantly higher at the beginning of residence (p<0.001) and residents who had a more positive opinion were more frequently exposed to drug companies (OR = 2.12 CI95% [1.07–4.22]). Conclusions Resident exposure to drug companies is around 1 contact every 2 weeks. Global opinion towards drug information provided by pharmaceutical companies was negative for around 1 out of 2 residents. In contrast, residents tend to consider the influences of the Mediator affair on their practice as relatively low. This survey enabled us to identify profiles of residents who are obviously less exposed to pharmaceutical industry. Current regulatory provisions are not sufficient, indicating that further efforts are

  10. Drugs and adverse reactions: an economic view of a medical problem.

    PubMed

    Pedroni, G

    1984-01-01

    This monograph attempts to show how patient, physician and drug producer should assess the value and risks of a drug from the economic point of view. The value of a drug lies in its efficacy against disease and pain; the risks are the various side effects. A hypothetical example illustrates the evaluation from the point of view of an individual patient. A distinction must be made here between diseases which may prove fatal and those of a less serious nature. This means that a distinction must also be made in evaluating the risks attached to a drug and the individual attitude to side effects. For the physician, the task of recognizing an adverse drug reaction (ADR) is an extremely complex one. A 11-step flow chart for decision making is presented as a benchmark procedure. Several empirical studies on the incidence of ADRs in ambulatory and hospitalized patients are shown to use shortcuts, which are entirely justified in daily medical practice, but questionable in a scientific analysis. For various reasons the drug manufacturer too is anxious to recognize ADRs at an early stage and to avoid them whenever possible. Prolonged clinical trials, however, produce a steep rise in costs and delay the launching of the product, while the additional information obtained is not always comprehensive and exhaustive. Moreover, the mere fact of recognizing an ADR does not mean that it can be prevented. The producer is therefore forced to consider the risks and costs involved in speeding up or delaying the introduction of a product. The fact that the drug has been approved for sale does not automatically release introduction of a product. The fact that the drug has been approved for sale does not automatically release him from the obligation to carry out further intensive monitoring for the entire period that it is on the market.

  11. 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. PMID:27476300

  12. 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.

  13. Medical and psychosocial services in drug abuse treatment: do stronger linkages promote client utilization?

    PubMed Central

    Friedmann, P D; D'Aunno, T A; Jin, L; Alexander, J A

    2000-01-01

    OBJECTIVE: To examine the extent to which linkage mechanisms (on-site delivery, external arrangements, case management, and transportation assistance) are associated with increased utilization of medical and psychosocial services in outpatient drug abuse treatment units. DATA SOURCES: Survey of administrative directors and clinical supervisors from a nationally representative sample of 597 outpatient drug abuse treatment units in 1995. STUDY DESIGN: We generated separate two-stage multivariate generalized linear models to evaluate the correlation of on-site service delivery, formal external arrangements (joint program/venture or contract), referral agreements, case management, and transportation with the percentage of clients reported to have utilized eight services: physical examinations, routine medical care, tuberculosis screening, HIV treatment, mental health care, employment counseling, housing assistance, and financial counseling services. PRINCIPAL FINDINGS: On-site service delivery and transportation assistance were significantly associated with higher levels of client utilization of ancillary services. Referral agreements and formal external arrangements had no detectable relationship to most service utilization. On-site case management was related to increased clients' use of routine medical care, financial counseling, and housing assistance, but off-site case management was not correlated with utilization of most services. CONCLUSIONS: On-site service delivery appears to be the most reliable mechanism to link drug abuse treatment clients to ancillary services, while referral agreements and formal external mechanisms offer little detectable advantage over ad hoc referral. On-site case management might facilitate utilization of some services, but transportation seems a more important linkage mechanism overall. These findings imply that initiatives and policies to promote linkage of such clients to medical and psychosocial services should emphasize on

  14. Beyond the prescription: medication monitoring and adverse drug events in older adults

    PubMed Central

    Steinman, Michael A.; Handler, Steven M.; Gurwitz, Jerry H.; Schiff, Gordon D.; Covinsky, Kenneth E.

    2014-01-01

    Whether a given patient will suffer harm from a medication or how severe that harm will be is difficult to precisely predict. As a result, many adverse drug events (ADEs) occur in patients in whom it was reasonable to believe that the drug's benefits exceeded its risks. Improving safety and reducing the burden of ADEs in older adults requires addressing this uncertainty by focusing not only on the appropriateness of the initial prescribing decision but also on detecting and mitigating adverse events once they have started to occur. Such enhanced monitoring of signs, symptoms, and laboratory parameters can determine whether an adverse event has only mild and short-term impacts or major long-term effects on morbidity and mortality. While current medication monitoring practices are often suboptimal, several strategies can be leveraged to improve the quality and outcomes of monitoring. These strategies include using health information technology to link pharmacy and laboratory data, prospective delineation of risk, and patient outreach and activation, all within a framework of team-based approaches to patient management. While many of these strategies are theoretically possible now, they are poorly utilized and will be difficult to implement without a significant restructuring of medical practice. An enhanced focus on medication monitoring will also require a new conceptual framework to re-engineer the prescribing process. In this approach, prescribing quality hinges not on static attributes of the initial prescribing decision, but entails a dynamic process in which the benefits and harms of drugs are actively monitored, managed, and reassessed over time. PMID:21797831

  15. Compliance and chronic disease.

    PubMed

    German, P S

    1988-03-01

    The shifting demographics of the population and increasing skill in treatment of chronic disease in this country have combined to make compliance a topic of greater salience than ever before. General issues of compliance are a necessary background to specific issues of compliance with regimens for single diseases such as hypertension. The definition of compliance continues to be modified, and examination of past work reveals certain consistencies in studies of compliance. Non-compliance is higher in chronic conditions, in activities requiring change in life-style, and in clinician-initiated visits. Noncomprehension of instructions is held to be the most frequent cause of noncompliance. Noncompliance is a threat to the course of treatment, increases unnecessary diagnostic procedures, and confounds evaluation of effectiveness. Factors related to compliance have been identified with regard to certain patient and disease characteristics, amount of support in the immediate environment, and the nature of the doctor-patient relationship. Older patients are often at greater risk in understanding regimens because clinicians educate this group less often, because symptoms are misunderstood by both patient and provider, and because of greater complexity in both conditions that are being treated and number of drugs and other aspects of treatment required. Methods of improving the doctor-patient relationship have been urged most recently as a means through which compliance can be increased.

  16. The role of physicians as medical review officers in workplace drug testing programs. In pursuit of the last nanogram.

    PubMed Central

    Clark, H W

    1990-01-01

    In discussing the role of physicians in workplace drug testing programs, I focus on the recent Department of Transportation regulations that require drug testing in such regulated industries as interstate trucking, air transportation, mass transit, and the railroads. These regulations require that applicable drug testing programs employ physicians as medical review officers to evaluate positive tests that have been screened and confirmed by different techniques to determine if there is a legal medical explanation for the result. The drug testing program tests for the presence of amphetamine, cocaine, tetrahydrocannabinol, opiates, and phencyclidine. If an employee testing positive has an acceptable medical explanation, the result is to be reported as negative. Little practical advice exists for medical review officers, and they must be aware of key elements of the regulations and potential trouble spots. PMID:2190419

  17. Medicare program; medical loss ratio requirements for the Medicare Advantage and the Medicare Prescription Drug Benefit Programs.

    PubMed

    2013-05-23

    This final rule implements new medical loss ratio (MLR) requirements for the Medicare Advantage Program and the Medicare Prescription Drug Benefit Program established under the Patient Protection and Affordable Care Act.

  18. A stewardship intervention program for safe medication management and use of antidiabetic drugs

    PubMed Central

    Zhao, Rui-yi; He, Xiao-wen; Shan, Yan-min; Zhu, Ling-ling; Zhou, Quan

    2015-01-01

    Background Diabetes patients are complex due to considerations of polypharmacy, multimorbidities, medication adherence, dietary habits, health literacy, socioeconomic status, and cultural factors. Meanwhile, insulin and oral hypoglycemic agents are high-alert medications. Therefore it is necessary to require a multidisciplinary team’s integrated endeavors to enhance safe medication management and use of antidiabetic drugs. Methods A 5-year stewardship intervention program, including organizational measures and quality improvement activities in storage, prescription, dispensing, administration, and monitoring, was performed in the Second Affiliated Hospital of Zhejiang University, People’s Republic of China, a 3,200-bed hospital with 3.5 million outpatient visits annually. Results The Second Affiliated Hospital of Zhejiang University has obtained a 100% implementation rate of standard storage of antidiabetic drugs in the Pharmacy and wards since August 2012. A zero occurrence of dispensing errors related to highly “look-alike” and “sound-alike” NovoMix 30® (biphasic insulin aspart) and NovoRapid® (insulin aspart) has been achieved since October 2011. Insulin injection accuracy among ward nurses significantly increased from 82% (first quarter 2011) to 96% (fourth quarter 2011) (P<0.05). The number of medication administration errors related to insulin continuously decreased from 20 (2011) to six (2014). The occurrence rate of hypoglycemia in non–endocrinology ward diabetes inpatients during 2011–2013 was significantly less than that in 2010 (5.03%–5.53% versus 8.27%) (P<0.01). Percentage of correct management of hypoglycemia by nurses increased from 41.5% (April 2014) to 67.2% (August 2014) (P<0.01). The percentage of outpatient diabetes patients receiving standard insulin injection education increased from 80% (April 2012) to 95.2% (October 2012) (P<0.05). Insulin injection techniques among diabetes outpatients who started to receive insulin were

  19. Graphic Mining of High-Order Drug Interactions and Their Directional Effects on Myopathy Using Electronic Medical Records.

    PubMed

    Du, L; Chakraborty, A; Chiang, C-W; Cheng, L; Quinney, S K; Wu, H; Zhang, P; Li, L; Shen, L

    2015-08-01

    We propose to study a novel pharmacovigilance problem for mining directional effects of high-order drug interactions on an adverse drug event (ADE). Our goal is to estimate each individual risk of adding a new drug to an existing drug combination. In this proof-of-concept study, we analyzed a large electronic medical records database and extracted myopathy-relevant case control drug co-occurrence data. We applied frequent itemset mining to discover frequent drug combinations within the extracted data, evaluated directional drug interactions related to these combinations, and identified directional drug interactions with large effect sizes. Furthermore, we developed a novel visualization method to organize multiple directional drug interaction effects depicted as a tree, to generate an intuitive graphical and visual representation of our data-mining results. This translational bioinformatics approach yields promising results, adds valuable and complementary information to the existing pharmacovigilance literature, and has the potential to impact clinical practice. PMID:26380157

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

    PubMed

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

    2016-01-01

    The 2015 Varsity Medical Ethics debate convened upon the motion: "This house believes nootropic drugs should be available under prescription". This annual debate between students from the Universities of Oxford and Cambridge, now in its seventh year, provided the starting point for arguments on the subject. The present article brings together and extends many of the arguments put forward during the debate. We explore the current usage of nootropic drugs, their safety and whether it would be beneficial to individuals and society as a whole for them to be available under prescription. The Varsity Medical Debate was first held in 2008 with the aim of allowing students to engage in discussion about ethics and policy within healthcare. The event is held annually and it is hoped that this will allow future leaders to voice a perspective on the arguments behind topics that will feature heavily in future healthcare and science policy. This year the Oxford University Medical Society at the Oxford Union hosted the debate. PMID:27624701

  1. Considerations in the Evaluation of Potential Efficacy of Medications for Alcohol and Drug Use Disorders: An Editorial.

    PubMed

    Egli, M; White, D A; Acri, J B

    2016-01-01

    The societal burden created by alcohol and drug use disorders is estimated to be on the order of hundreds of billions of dollars, creating a need for effective medications to reduce use and prevent relapse. While there are FDA-approved medications to facilitate abstinence and prevent relapse for some indications including, alcohol, tobacco, and opiate use disorders, there are no approved treatments for other abused substances, including cocaine, methamphetamine, and cannabis, leaving these critical medical needs unmet. The development of such medications has fallen largely to the government with efforts spearheaded by the National Institute on Drug Abuse and the National Institute on Alcoholism and Alcohol Abuse. Both agencies have medication development programs with preclinical components that include the standardized evaluation of compounds using animal models. This chapter describes the rationale and considerations involved in the use of such models, including reinstatement of drug self-administration. PMID:27055609

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

    NASA Astrophysics Data System (ADS)

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

    2013-05-01

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

  3. Soft hydrogels interpenetrating silicone--A polymer network for drug-releasing medical devices.

    PubMed

    Steffensen, Søren L; Vestergaard, Merete H; Møller, Eva H; Groenning, Minna; Alm, Martin; Franzyk, Henrik; Nielsen, Hanne M

    2016-02-01

    Materials for the next generation of medical devices will require not only the mechanical stability of current devices, but must also possess other properties such as sustained release of drugs in a controlled manner over a prolonged period of time. This work focuses on creating such a sophisticated material by forming an interpenetrating polymer network (IPN) material through modification of silicone elastomers with a poly(2-hydroxyethyl methacrylate) (PHEMA)-based hydrogel. IPN materials with a PHEMA content in the range of 13%-38% (w/w) were synthesized by using carbon dioxide-based solvent mixtures under high pressure. These IPNs were characterized with regard to microstructure as well as ability of the hydrogel to form a surface-connected hydrophilic carrier network inside the silicone. A critical limit for hydrogel connectivity was found both via simulation and by visualization of water uptake in approximately 25% (w/w) PHEMA, indicating that entrapment of gel occurs at low gel concentrations. The optimized IPN material was loaded with the antibiotic ciprofloxacin, and the resulting drug release was shown to inhibit bacterial growth when placed on agar, thus demonstrating the potential of this IPN material for future applications in drug-releasing medical devices.

  4. 77 FR 14706 - Medical Diagnostic Equipment Accessibility Standards

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-13

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

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

    PubMed Central

    Babalola, EO; Akinhanmi, A; Ogunwale, A

    2014-01-01

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

  6. Life table methods applied to use of medical care and of prescription drugs in early childhood.

    PubMed

    Rasmussen, F; Smedby, B

    1989-06-01

    Life table methods were applied to analyses of longitudinal data on the use of medical care during the first 5 years of life among all 1701 children born in a Swedish semirural municipality. Cumulative proportions of the children who had used particular types of medical care or prescription drugs at least once by certain ages were estimated. By the fifth birthday, 98% had made at least one visit to any physician and 82% at least one visit to a paediatrician. By the fifth birthday at least one prescription for antibiotics had been purchased at a pharmacy by 82%; and 33% had been admitted to inpatient hospital care at least once (excluding immediate postnatal care). Acute conditions and more chronic diseases were also studied using these methods. At least one visit to a physician at a primary health care centre had been made for acute otitis media in 65% of 5 year olds and for atopic dermatitis in 8%.

  7. [Legal regulation of clinical drug trials for the use in military-medical organisations].

    PubMed

    Ivchenko, E V; Ivanov, V S; Shustov, S B

    2015-06-01

    The authors identified problematic issues of legal regulation of clinical drug trials for medical use, and proposed possible solutions. It has been established that the conduction of clinical trials, of medicinal products is based on the norms of various branches of law embodied in the Constitution of the Russian Federation, the norms of international law, the Civil Code of the Russian Federation and federal laws and subordinate legislations regulating health and pharmaceutical activity. According to the authors, the norms of bioethics can be attributed to the sources of legal doctrine. It is proposed to oblige executives of clinical trials to make a report about effectiveness and safety of drugs and pass the results to the customer, in his/her turn the customer is obliged to accept the results of these trials and pay for them. PMID:26442317

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

    PubMed

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

    2015-06-09

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

  9. 78 FR 38058 - Guidance for Industry on Heparin for Drug and Medical Device Use: Monitoring Crude Heparin for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-25

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Heparin for Drug and Medical Device... confirm the species origin of crude heparin in each lot of every shipment before use in the manufacture or... testing crude heparin and for the identification of species origin. The method should be based on...

  10. 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

    ... guidance to FDA staff, industry, healthcare providers, researchers, and patient and consumer groups on a... 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...

  11. The impact of the code drugs: cardioactive medications in cardiac arrest resuscitation.

    PubMed

    Williamson, Kelly; Breed, Meghan; Alibertis, Kostas; Brady, William J

    2012-02-01

    The goal of treating patients who present with cardiac arrest is to intervene as quickly as possible to affect the best possible outcome. The mainstays of these interventions, including early activation of the emergency response team, early initiation of cardiopulmonary resuscitation, and early defibrillation, are essential components with demonstrated positive impact on resuscitation outcomes. Conversely, the use of the code drugs as a component of advanced life support has not benefited these patients to the same extent as the basic interventions in a general. Although short-term outcomes are improved as a function of these medications, the final outcome has not been altered significantly in most instances. PMID:22107975

  12. Drug discovery and development for Huntington's disease - an orphan indication with high medical need.

    PubMed

    Heitz, Freddy; La Rosa, Salvatore; Gonzalez-Couto, Eduardo; Gaviraghi, Giovanni; Terstappen, Georg C

    2008-09-01

    Huntington's disease (HD) is a rare neurodegenerative disorder that progressively destroys the mental capacity and motor control of patients. This loss of motor control results in abnormal body movements (chorea) - the hallmark of HD. Given that no disease-modifying therapy for HD exists and that available symptomatic treatments are not highly efficacious, the medical need for this 'orphan' disease remains high. The number of compounds that are undergoing discovery and development for the treatment of HD has increased significantly in recent years, spurred by legislative incentives for orphan drug development and by support from non-profit foundations. Thus, hope exists for patients with HD that efficacious medicines will become available.

  13. Methodology for evaluating Insite: Canada's first medically supervised safer injection facility for injection drug users

    PubMed Central

    Wood, Evan; Kerr, Thomas; Lloyd-Smith, Elisa; Buchner, Chris; Marsh, David C; Montaner, Julio SG; Tyndall, Mark W

    2004-01-01

    Many Canadian cities are experiencing ongoing infectious disease and overdose epidemics among injection drug users (IDUs). In particular, Human Immunodeficiency Virus (HIV) and hepatitis C Virus (HCV) have become endemic in many settings and bacterial and viral infections, such as endocarditis and cellulitis, have become extremely common among this population. In an effort to reduce these public health concerns and the public order problems associated with public injection drug use, in September 2003, Vancouver, Canada opened a pilot medically supervised safer injecting facility (SIF), where IDUs can inject pre-obtained illicit drugs under the supervision of medical staff. The SIF was granted a legal exemption to operate on the condition that its impacts be rigorously evaluated. In order to ensure that the evaluation is appropriately open to scrutiny among the public health community, the present article was prepared to outline the methodology for evaluating the SIF and report on some preliminary observations. The evaluation is primarily structured around a prospective cohort of SIF users, that will examine risk behavior, blood-borne infection transmission, overdose, and health service use. These analyses will be augmented with process data from within the SIF, as well as survey's of local residents and qualitative interviews with users, staff, and key stakeholders, and standardised evaluations of public order changes. Preliminary observations suggest that the site has been successful in attracting IDUs into its programs and in turn helped to reduce public drug use. However, each of the indicators described above is the subject of a rigorous scientific evaluation that is attempting to quantify the overall impacts of the site and identify both benefits and potentially harmful consequences and it will take several years before the SIF's impacts can be appropriately examined. PMID:15535885

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

    PubMed Central

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

    2015-01-01

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

  15. Monitoring compliance to therapy during addiction treatments by means of hair analysis for drugs and drug metabolites using capillary zone electrophoresis coupled to time-of-flight mass spectrometry.

    PubMed

    Gottardo, Rossella; Fanigliulo, Ameriga; Sorio, Daniela; Liotta, Eloisa; Bortolotti, Federica; Tagliaro, Franco

    2012-03-10

    Capillary electrophoresis coupled to time-of-flight mass spectrometry was used in the present work for the determination of therapeutic and abused drugs and their metabolites in the hair of subjects undergoing addiction treatments, in order to monitor their compliance to therapy. For this purpose a rapid, qualitative drug screening method was adopted based on capillary electrophoresis hyphenated with time-of-flight mass spectrometry, which had earlier been developed and validated for the forensic-toxicological analysis of hair, limitedly to illicit/abused drugs [1]. Sampling of hair was carried out in order to refer to a time window of about two months from the date of sampling (i.e. 2cm ca. from cortex). A single extraction procedure was applied, allowing the determination in the hair matrix of "drugs of abuse" referred to the past abuses, and therapeutic drugs prescribed in the detoxification program as well as their metabolites. Analyte identification was based on accurate mass measurements and comparison of isotope patterns, providing the most likely matching between accurate mass value and elemental formula. Small molecules (<500Da) of forensic and toxicological interest could be identified unambiguously using mass spectrometric conditions tailored to meet a mass accuracy ≤5ppm. In the present study, the proposed approach proved suitable for the rapid broad spectrum screening of hair samples, although needing further confirmation of results by using fragmentation mass spectrometry.

  16. [Drug advertising as communication between the pharmaceutical industry and the physician: advertisements for psychotropic drugs in the Dutch medical journal, Nederlands Tijdschrift voor Geneeskunde, 1900-1940].

    PubMed

    van der Hoogte, Arjo Roersch; Pieters, Toine

    2010-01-01

    In this article we explore the historical development of drug advertisements for psychotropic drugs in the leading Dutch medical journal from 1900 to 1940. The advertisements for hypnotics and sedatives, in The Nederlands Tijdschrift voor Geneeskunde (Dutch medical journal) reflected the changes in the vocabulary and image promoted by the pharmaceutical companies. In the first two decades, the advertisements were sober and to the point, and included the trademark, company name, molecular formula and therapeutic properties of the medication. The emphasis was on creating a scientific image of reliable symptom control for the therapeutic drug. In doing so, the ethical drug companies tried (successfully) to distinguish themselves from the producers of patent medicines. Once scientific credibility was established, the form and content of the advertisements changed significantly. In the late 1920s and 1930s drug companies embraced modern advertising techniques, developing a figurative language to address the changing beliefs and practices of Dutch physicians. Instead of promoting therapeutic drugs as safe and scientific, the emphasis was on their effectiveness in comparison to similar drugs. In the process, scientific information was reduced to an indispensable standardized minimum, whereby therapeutic drugs were advertised according to the latest pharmacological taxonomy rather than molecular formulas. The image-making of 'ethical marketing' began during the interwar years when marketers applied modern advertising techniques and infotainment strategies. The scanty black and white informational bulletins transitioned into colourful advertisements. The pharmaceutical companies employed the same medical language as used by physicians, so that one word or image in an advertisement would suffice for the physician to recognize a drug and its therapeutic properties. These developments show the changing relationship between the modern ethical pharmaceutical industry and Dutch

  17. [Drug advertising as communication between the pharmaceutical industry and the physician: advertisements for psychotropic drugs in the Dutch medical journal, Nederlands Tijdschrift voor Geneeskunde, 1900-1940].

    PubMed

    van der Hoogte, Arjo Roersch; Pieters, Toine

    2010-01-01

    In this article we explore the historical development of drug advertisements for psychotropic drugs in the leading Dutch medical journal from 1900 to 1940. The advertisements for hypnotics and sedatives, in The Nederlands Tijdschrift voor Geneeskunde (Dutch medical journal) reflected the changes in the vocabulary and image promoted by the pharmaceutical companies. In the first two decades, the advertisements were sober and to the point, and included the trademark, company name, molecular formula and therapeutic properties of the medication. The emphasis was on creating a scientific image of reliable symptom control for the therapeutic drug. In doing so, the ethical drug companies tried (successfully) to distinguish themselves from the producers of patent medicines. Once scientific credibility was established, the form and content of the advertisements changed significantly. In the late 1920s and 1930s drug companies embraced modern advertising techniques, developing a figurative language to address the changing beliefs and practices of Dutch physicians. Instead of promoting therapeutic drugs as safe and scientific, the emphasis was on their effectiveness in comparison to similar drugs. In the process, scientific information was reduced to an indispensable standardized minimum, whereby therapeutic drugs were advertised according to the latest pharmacological taxonomy rather than molecular formulas. The image-making of 'ethical marketing' began during the interwar years when marketers applied modern advertising techniques and infotainment strategies. The scanty black and white informational bulletins transitioned into colourful advertisements. The pharmaceutical companies employed the same medical language as used by physicians, so that one word or image in an advertisement would suffice for the physician to recognize a drug and its therapeutic properties. These developments show the changing relationship between the modern ethical pharmaceutical industry and Dutch

  18. Philadelphia's community based drug abuse program: broader medical and social concepts.

    PubMed

    Schut, J

    1975-06-01

    The rehabilitation of drug dependent people has undergone drastic changes since first attempts were made to curb the abuse of illegal drugs. The isolated law-enforcement model proved to be of no use in this area. So, too, the medical model, the psychological model and the public health model proved disappointingly low in their results. During the last ten years, a so-called "metabolic replacement model" has had its upsurge, creating a controversy still under discussion. The Drug Abuse Rehabilitation Programs of the West Philadelphia Community Mental Health Consortium, Inc. have been in the forefront with its treatment models. Established in 1968 as a purely methadone maintenance program, it has evolved into becoming a model, applying community mental health principles. This paper will explore this model further, describing the mechanics of its changes. From a municipal hospital-based methadone dispensing station, the program has developed into a multi-modality project. Three decentralized drug-free outpatient services are located in the midst of the community where the drug abuse problem is more accute. Outreach is emphasized and case-funding is applied. A possibly unique river-front motel was just acquired for the development of a community-based treatment modality. The 94 rooms were converted into a first-floor alcoholism program which also has a "highway safety program" and an intermediate care facility for alcoholics. The second floor of this facility contains outpatient services for the treatment of drug addicts, including a methadone maintenance program, counselling, family therapy and group therapy. The place where most of the emphasis has been placed is the Work Rehabilitation Center (a novel approach whereby patients will spend up to six hours in "partial hospitalization"). Clients will be tested for vocational aptitude and four workshops will be developed on the premises - carpentry, automotive, electricity and clerical. A huge cafeteria with a semi

  19. Evaluation of adherence to immunosuppressive drugs in kidney transplantation by control of medication dispensing.

    PubMed

    Brahm, M M T; Manfro, R C; Mello, D; Cioato, S; Gonçalves, L F S

    2012-10-01

    Nonadherence to immunosuppressive medications represents a burden to organ transplantation being associated with rejection episodes and graft loss. In this cross-sectional study we evaluated the prevalence and risk factors for nonadherence in kidney transplant patients by measuring the retrieval of the immunosuppressive drugs in the registry kept by the state Rio Grande do Sul public health system. We considered nonadherence the failure to retrieval of medication at least one time over a 1-year period of evaluation. In 288 patients evaluated, the frequency of failure to retrieve was 58.7%. Being fully employed (66.4% × 33.6%, P = .008) and younger age at transplantation (39 ± 13 × 46 ± 11, P = .011) were associated with nonadherence. Multivariate analysis showed a greater prevalence ratio (PR) of non- adherence in patients using tacrolimus. Estimated glomerular filtration rate was significantly lower in the nonadherence groups as compared with adherent groups (45.3 ± 21.6 × 51.3 ± 19.4, P = .016). In conclusion, we found a high prevalence of nonadherence to immunosuppressive drugs with association to active working situation and use of tacrolimus. Importantly, glomerular filtration rate was found to be lower in nonadherent patients.

  20. Distress, coping, and drug law enforcement in a series of patients using medical cannabis.

    PubMed

    Aggarwal, Sunil Kumar; Carter, Gregory; Sullivan, Mark; Morrill, Richard; Zumbrunnen, Craig; Mayer, Jonathan

    2013-04-01

    Patients using medical cannabis in the United States inhabit a conflicting medicolegal space. This study presents data from a dispensary-based survey of patients using medical cannabis in the state of Washington regarding cannabis-specific health behaviors, levels of psychological distress, stress regarding marijuana criminality, past experiences with drug law enforcement, and coping behaviors. Thirty-seven subjects were enrolled in this study, and all but three completed survey materials. The median index of psychological distress, as measured by the Behavioral Symptom Inventory, was nearly 2.5 times higher than that found in a general population sample but one third less than that found in an outpatient sample. The subjects reported a moderate amount of stress related to the criminality of marijuana, with 76% reporting previous exposure to 119 separate drug law enforcement tactics in total. The subjects reported a wide range of coping methods, and their responses to a modified standardized survey showed the confounding influence of legality in assessing substance-related disorders.

  1. Distress, coping, and drug law enforcement in a series of patients using medical cannabis.

    PubMed

    Aggarwal, Sunil Kumar; Carter, Gregory; Sullivan, Mark; Morrill, Richard; Zumbrunnen, Craig; Mayer, Jonathan

    2013-04-01

    Patients using medical cannabis in the United States inhabit a conflicting medicolegal space. This study presents data from a dispensary-based survey of patients using medical cannabis in the state of Washington regarding cannabis-specific health behaviors, levels of psychological distress, stress regarding marijuana criminality, past experiences with drug law enforcement, and coping behaviors. Thirty-seven subjects were enrolled in this study, and all but three completed survey materials. The median index of psychological distress, as measured by the Behavioral Symptom Inventory, was nearly 2.5 times higher than that found in a general population sample but one third less than that found in an outpatient sample. The subjects reported a moderate amount of stress related to the criminality of marijuana, with 76% reporting previous exposure to 119 separate drug law enforcement tactics in total. The subjects reported a wide range of coping methods, and their responses to a modified standardized survey showed the confounding influence of legality in assessing substance-related disorders. PMID:23538974

  2. Drug reps and the academic medical center: a case for management rather than prohibition.

    PubMed

    Huddle, Thomas S

    2008-01-01

    Abstract:Academic physicians and bioethicists are increasingly voicing objections to "drug rep" detailing. Leaders in academic medical centers are considering proposals to ban the small gifts of detailing within their walls. Such bans would be a mistake, as the small gifts are unlikely to act as bribes and do not create unacceptable conflicts of interest for physicians. Drug rep detailing does influence physician behavior, but this influence has not been shown to be harmful. Calls for a ban are premised on empirical evidence for harm that is inconclusive at best, and emerging literature in economics suggests that detailing may well be socially beneficial. A preponderance of harm over benefit is not, however, the primary source of the animus against detailing, which stems from moral considerations that are independent of its social consequences. However, pharmaceutical advertising, including detailing, is a morally legitimate aspect of the world of medical practice that we in academic medicine ought to be preparing our trainees to encounter and properly sift. PMID:18453729

  3. A Review of the Toxicity of HIV Medications II: Interactions with Drugs and Complementary and Alternative Medicine Products.

    PubMed

    Stolbach, Andrew; Paziana, Karolina; Heverling, Harry; Pham, Paul

    2015-09-01

    For many patients today, HIV has become a chronic disease. For those patients who have access to and adhere to lifelong antiretroviral (ARV) therapy, the potential for drug-drug interactions has become a real and life-threatening concern. It is known that most ARV drug interactions occur through the cytochrome P450 (CYP) pathway. Medications for comorbid medical conditions, holistic supplements, and illicit drugs can be affected by CYP inhibitors and inducers and have the potential to cause harm and toxicity. Protease inhibitors (PIs) tend to inhibit CYP3A4, while most non-nucleoside reverse transcriptase inhibitors (NNRTIs) tend to induce the enzyme. As such, failure to adjust the dose of co-administered medications, such as statins and steroids, may lead to serious complications including rhabdomyolysis and hypercortisolism, respectively. Similarly, gastric acid blockers can decrease several ARV absorption, and warfarin doses may need to be adjusted to maintain therapeutic concentrations. Illicit drugs such as methylenedioxymethamphetamine (MDMA, "ecstasy") in combination with PIs lead to increased toxicity, while the concomitant administration of sedative drugs such as midazolam and alprazolam in patients taking PIs can result in prolonged sedation, delayed recovery, and increased length of stay. Even supplements like St. John's Wort can alter PI concentrations. In theory, any drug that is metabolized by CYP has potential for a pharmacokinetic drug-drug interaction with all PIs, cobicistat, and most NNRTIs. When adding a new medication to an ARV regimen, use of a drug-drug interaction software and/or consultation with a clinical pharmacist/pharmacologist or HIV specialist is recommended. PMID:26036354

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

    PubMed Central

    Riva, Silvia; Monti, Marco; Antonietti, Alessandro

    2011-01-01

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

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

    PubMed Central

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

    2014-01-01

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

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

    PubMed Central

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

    2016-01-01

    Background: Medication adherence has an important influence on health outcomes in patients with chronic diseases. However, few studies have been performed in Japan to determine factors related to medication non-adherence. Objective: The aim of this study was to identify prescription factors related to medication non-adherence by investigating patient characteristics, all prescriptions, and prescriptions for oral antidiabetic drugs (OADs). Methods: A retrospective cross-sectional survey of prescription data about implementation of dosing regimen was performed at community pharmacies engaged in appropriate use of leftover drugs. We evaluated the amount of drugs originally prescribed and the reduced amount after use of leftover drugs, and then calculated prescription reduction ratio (PRR). We analyzed prescription factors contributing to non-adherence based on the PRR. Results: Prescription information for 1207 patients was reviewed, revealing that patients were non-adherent to 58% of prescriptions. Lack of a drug copayment, fewer concurrent drugs, and drugs not in single-dose packaging were associated with non-adherence. Among the 1207 patients, 234 prescriptions for diabetes and 452 OAD formulations were included. Forty-seven percent of prescriptions and 29% of the formulations were non-adherent. A higher dosing frequency and preprandial administration were associated with non-adherence. Among the OADs, adherence was lower for α-glucosidase inhibitors and biguanides than for sulfonylureas. Conclusions: Several factors related to patient characteristics, general drug prescriptions, and OAD prescriptions were associated with non-adherence. Further consideration will be needed to improve adherence to medication in Japan. Health care providers should perform more careful monitoring of adherence in patients with the factors identified by this study. PMID:27489544

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

    PubMed

    Xu, Shuai; Kesselheim, Aaron S

    2014-01-01

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

  8. Incidence, severity and factors related to drug-induced keratoepitheliopathy with glaucoma medications

    PubMed Central

    Fukuchi, Takeo; Wakai, Kimiko; Suda, Kieko; Nakatsue, Tomoko; Sawada, Hideko; Hara, Hiroaki; Ueda, Jun; Tanaka, Takayuki; Yamada, Akiko; Abe, Haruki

    2010-01-01

    Purpose To evaluate the incidence, severity, and factors related to drug-induced keratoepitheliopathy in eyes using antiglaucoma eye drops. Patients and methods In a cross-sectional study, 749 eyes from 427 patients who had used one or more antiglaucoma eye drops were examined at Niigata University Medical and Dental Hospital or related facilities. The incidence and severity of superficial punctate keratitis (SPK), patient gender and age, type of glaucoma, and type of eye drops were recorded. SPK was graded according to the AD (A, area; D, density) classification. The severity score (SS) was calculated from A × D. Results SPK was observed in 382 (51.0%) of 749 eyes that had received any type of antiglaucoma eye drops. While 254 eyes (33.9%) were classified as A1D1 (SS 1), 34 eyes (4.6%) had severe SPK with SS 4 or more. The number of eye drops and the total dosing frequency per day were significantly greater in SPK-positive eyes than in eyes without SPK. The number of eye drops was proportional to the frequency and severity of SPK. Among eyes that were treated with three or more eye drops, SPK was more severe and more frequent in older patients (≥71 years). In addition, a considerable difference was detected for each type of glaucoma. Conclusion Drug-induced keratoepitheliopathy is often observed in eyes that have received recent antiglaucoma eye drops. The number of eye drops, the total dose frequency per day, patient age, and type of glaucoma may affect this condition. We have to consider not only the effects on intraocular pressure but also the incidence and severity of drug-induced keratoepitheliopathy as a frequent side effect of glaucoma medications. PMID:20463785

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

    PubMed

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

    2015-06-01

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

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

    PubMed

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

    2015-06-01

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

  11. Successful introduction of a daily checklist to enhance compliance with accepted standards of care in the medical intensive care unit.

    PubMed

    Nama, A; Sviri, S; Abutbul, A; Stav, I; van Heerden, P V

    2016-07-01

    We introduced a simple checklist to act as an aid to memory for our junior medical staff to ensure that every patient in the intensive care unit (ICU) received every appropriate element of a bundle of care every day. The checklist was developed in consultation with our junior doctors and was designed to be completed every morning for every patient by the junior doctor reviewing the patient. The completed checklist was then checked again by the attending intensivist on the main daily ward round to ensure all the appropriate elements of the checklist had been applied to the patient. It was also noted each day which of the elements of the checklist had been forgotten and was therefore prompted to be completed by use of the checklist. Of the 75 patients surveyed there were 99 occasions, in 48 patients, when the checklist detected a forgotten element of the bundle of care (i.e. in 64% of patients). There was a decrease in the incidence of missed elements of the bundle of care the longer the patient stayed in the ICU. Types of missed elements varied with the duration of the ICU stay. We found that the introduction of a simple checklist, developed in collaboration with the junior medical staff who would be using the checklist every day in the ICU, resulted in the detection and correction of missed elements of a bundle of care we had previously introduced in the ICU.

  12. Successful introduction of a daily checklist to enhance compliance with accepted standards of care in the medical intensive care unit.

    PubMed

    Nama, A; Sviri, S; Abutbul, A; Stav, I; van Heerden, P V

    2016-07-01

    We introduced a simple checklist to act as an aid to memory for our junior medical staff to ensure that every patient in the intensive care unit (ICU) received every appropriate element of a bundle of care every day. The checklist was developed in consultation with our junior doctors and was designed to be completed every morning for every patient by the junior doctor reviewing the patient. The completed checklist was then checked again by the attending intensivist on the main daily ward round to ensure all the appropriate elements of the checklist had been applied to the patient. It was also noted each day which of the elements of the checklist had been forgotten and was therefore prompted to be completed by use of the checklist. Of the 75 patients surveyed there were 99 occasions, in 48 patients, when the checklist detected a forgotten element of the bundle of care (i.e. in 64% of patients). There was a decrease in the incidence of missed elements of the bundle of care the longer the patient stayed in the ICU. Types of missed elements varied with the duration of the ICU stay. We found that the introduction of a simple checklist, developed in collaboration with the junior medical staff who would be using the checklist every day in the ICU, resulted in the detection and correction of missed elements of a bundle of care we had previously introduced in the ICU. PMID:27456181

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

    Code of Federal Regulations, 2014 CFR

    2014-10-01

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

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

    Code of Federal Regulations, 2013 CFR

    2013-10-01

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

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

    Code of Federal Regulations, 2012 CFR

    2012-10-01

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

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

    Code of Federal Regulations, 2011 CFR

    2011-10-01

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

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

    PubMed Central

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

    2009-01-01

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

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

    PubMed Central

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

    2015-01-01

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

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

    PubMed Central

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

    2014-01-01

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

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

    PubMed

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

    2006-07-01

    The purpose of this study was to determine whether specialty alcohol and other drug (AOD) treatment is associated with reduced subsequent medical care costs. AOD treatment costs and medical costs in a group model health maintenance organization (HMO) were collected for up to 6 years on 1,472 HMO members who were recommended for specialty AOD treatment, and on 738 members without AOD diagnoses or treatment. Addiction Severity Index measures were also obtained from a sample of 293 of those recommended for treatment. Changes in medical costs did not differ between treatment and comparison groups. Nor did individuals with improved treatment outcomes have greater reductions in medical costs. AOD treatment costs were not inversely related to subsequent medical costs, except for a subgroup with recent AOD treatment. In the interviewed sample, better treatment outcomes did not predict lower subsequent medical costs. Multiple treatment episodes may hold promise for producing cost-offsets. PMID:16752110

  1. From the stretcher to the pharmacy's shelf: drug leads from medically important brazilian venomous arachnid species.

    PubMed

    Rates, Breno; Verano-Braga, Thiago; Santos, Daniel Moreira; Nunes, Kênia Pedrosa; Pimenta, Adriano M C; De Lima, Maria Elena

    2011-10-01

    Accidents involving venomous animals have always caught the attention of mankind due to their lethality and other clinical implications. However, since the molecules obtained from animal venoms have been the product of millions of years of evolutionary process, toxins could be used to probe physiological mechanisms and could serve as leads for drug development. The present work reviews the state of the art pertaining to venom molecules from Brazilian medically important arachnid species bearing potential biotechnological applications. Special focus is given to toxins isolated from the scorpion Tityus serrulatus and the spiders Phoneutria nigriventer and Lycosa erythrognatha, whose venoms possess molecules acting as erectile function modulators and as antihypertensive, analgesic, neuroprotective and antimicrobial agents. PMID:21824079

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

    PubMed

    1999-11-24

    The Food and Drug Administration (FDA) is issuing a final rule to revoke a regulation requiring a cardiac pacemaker registry. The registry, which was mandated by the Deficit Reduction Act of 1984, requires any physician and any provider of services who requests or receives Medicare payment for an implantation, removal, or replacement of permanent cardiac pacemaker devices and pacemaker leads to submit certain information to the registry. The information is used by FDA to track the performance of permanent cardiac pacemakers and pacemaker leads and by the Health Care Finance Administration (HCFA) to administer its Medicare payment program for these devices. This action is being taken to implement an act to Repeal An Unnecessary Medical Device Reporting Requirement passed by Congress in 1996 to remove the cardiac pacemaker registry to eliminate duplicative and unnecessary reporting. PMID:11010690

  3. From the stretcher to the pharmacy's shelf: drug leads from medically important brazilian venomous arachnid species.

    PubMed

    Rates, Breno; Verano-Braga, Thiago; Santos, Daniel Moreira; Nunes, Kênia Pedrosa; Pimenta, Adriano M C; De Lima, Maria Elena

    2011-10-01

    Accidents involving venomous animals have always caught the attention of mankind due to their lethality and other clinical implications. However, since the molecules obtained from animal venoms have been the product of millions of years of evolutionary process, toxins could be used to probe physiological mechanisms and could serve as leads for drug development. The present work reviews the state of the art pertaining to venom molecules from Brazilian medically important arachnid species bearing potential biotechnological applications. Special focus is given to toxins isolated from the scorpion Tityus serrulatus and the spiders Phoneutria nigriventer and Lycosa erythrognatha, whose venoms possess molecules acting as erectile function modulators and as antihypertensive, analgesic, neuroprotective and antimicrobial agents.

  4. Drug discovery and development for Huntington's disease - an orphan indication with high medical need.

    PubMed

    Heitz, Freddy; La Rosa, Salvatore; Gonzalez-Couto, Eduardo; Gaviraghi, Giovanni; Terstappen, Georg C

    2008-09-01

    Huntington's disease (HD) is a rare neurodegenerative disorder that progressively destroys the mental capacity and motor control of patients. This loss of motor control results in abnormal body movements (chorea) - the hallmark of HD. Given that no disease-modifying therapy for HD exists and that available symptomatic treatments are not highly efficacious, the medical need for this 'orphan' disease remains high. The number of compounds that are undergoing discovery and development for the treatment of HD has increased significantly in recent years, spurred by legislative incentives for orphan drug development and by support from non-profit foundations. Thus, hope exists for patients with HD that efficacious medicines will become available. PMID:18763216

  5. A needle-free reconstitution and transfer system for compounded sterile intravenous drug solutions in compliance with United States Pharmacopeia Chapter <797> standards.

    PubMed

    Marks, Zach

    2014-01-01

    Today's health-system pharmacists and those in independent practice face risks, including exposure to potent cytotoxic drugs via needlesticks, that are associated with preparing intravenous compounded sterile preparations for immediate use. Healthcare givers who administer such medications also risk exposure to needlesticks. Those hazards can be minimized when the pharmacist thoroughly understands and complies with current standard operating procedures for preparing intravenous compounded sterile preparations and the healthcare giver uses a needle-free system for drug reconstitution and administration. The components of an overall needlestick risk-reduction strategy to ensure safety in the preparation (and eventual administration) of intravenous compounded sterile preparations should therefore include the use of needle-free connection and administration devices as well as hand-hygiene training, aseptic technique competency evaluation and training, and the maximum use of commercially available or ready-to-use dosage forms. This article, which focuses on the pharmacist's use of a needle-free reconstitution and transfer system for compounded sterile intravenous drug solutions, uses as an example the Vial2Bag (Medimop Medical Projects, Ltd., [a subsidiary of West Pharmaceutical Services, Inc., Exton, Pennsylvania], Ra'anana, Israel), which complies with United States Pharmacopeia Chapter <797> standards. Features of that system are summarized for easy reference. PMID:24881111

  6. A needle-free reconstitution and transfer system for compounded sterile intravenous drug solutions in compliance with United States Pharmacopeia Chapter <797> standards.

    PubMed

    Marks, Zach

    2014-01-01

    Today's health-system pharmacists and those in independent practice face risks, including exposure to potent cytotoxic drugs via needlesticks, that are associated with preparing intravenous compounded sterile preparations for immediate use. Healthcare givers who administer such medications also risk exposure to needlesticks. Those hazards can be minimized when the pharmacist thoroughly understands and complies with current standard operating procedures for preparing intravenous compounded sterile preparations and the healthcare giver uses a needle-free system for drug reconstitution and administration. The components of an overall needlestick risk-reduction strategy to ensure safety in the preparation (and eventual administration) of intravenous compounded sterile preparations should therefore include the use of needle-free connection and administration devices as well as hand-hygiene training, aseptic technique competency evaluation and training, and the maximum use of commercially available or ready-to-use dosage forms. This article, which focuses on the pharmacist's use of a needle-free reconstitution and transfer system for compounded sterile intravenous drug solutions, uses as an example the Vial2Bag (Medimop Medical Projects, Ltd., [a subsidiary of West Pharmaceutical Services, Inc., Exton, Pennsylvania], Ra'anana, Israel), which complies with United States Pharmacopeia Chapter <797> standards. Features of that system are summarized for easy reference.

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

    PubMed Central

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

    2015-01-01

    Background Despite well-established negative consequences, high rates of substance use and related disorders continue to be reported. Physicians in training are not immune from this, or the associated risks to their health and careers, while impaired physicians are a threat to patient safety. Objective We surveyed family medicine residency programs' practices relating to drug testing of medical students and incoming residents. The survey asked about the extent to which residency programs are confronted with trainees testing positive for prohibited substances, and how they respond. Methods The survey was sent to the directors of family medicine residency programs. A total of 205 directors (47.2%) completed the survey. Results A majority of the responding programs required drug testing for incoming residents (143, 68.9%). Most programs did not require testing of medical students (161, 81.7%). Few programs reported positive drug tests among incoming residents (9, 6.5%), and there was only 1 reported instance of a positive result among medical students (1, 3.3%). Respondents reported a range of responses to positive results, with few reporting that they would keep open training spots or offer supportive services for a medical student who tested positive. Conclusions Changing laws legalizing certain drugs may require corresponding changes in the focus on drug testing and associated issues in medical training; however, many residency program directors were not aware of their institution's current policies. Programs will need to reexamine drug testing policies as new generations of physicians, growing up under altered legal circumstances concerning drug use, progress to clinical training. PMID:26217424

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

    PubMed

    Sattler, Sebastian; Schunck, Reinhard

    2015-01-01

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

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

    PubMed Central

    Sattler, Sebastian; Schunck, Reinhard

    2016-01-01

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

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

    PubMed

    Sattler, Sebastian; Schunck, Reinhard

    2015-01-01

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

  11. Compliance status

    SciTech Connect

    Black, D.G.

    1995-06-01

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

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

    PubMed

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

    2015-04-01

    This study aimed to describe the prevalence, pattern and reasons for self-medication among adults in Alexandria, Egypt. In a community-based survey during 2012, a representative sample of 1100 adults completed a predesigned interview questionnaire on self-medication practices by drugs and complementary or alternative medicines (CAM). A majority of them practised self-medication (86.4%), mostly using both drugs and CAM (77.5%). The most commonly used drugs were analgesics (96.7%), and cough and cold preparations (81.9%), but 53.9% of respondents reported self-medication with antibiotics. The most frequently used CAM were herbs (91.6%), followed by spiritual healing (9.4%) and cupping and acupuncture (6.4%). CAM improved the condition according to 95.2% of users. Logistic regression analysis revealed that age, occupation and the presence of chronic conditions were the independent factors significantly affecting the practice of self-medication with drugs. PMID:26077520

  13. Life cycle of medical product rules issued by the US Food and Drug Administration.

    PubMed

    Hwang, Thomas J; Avorn, Jerry; Kesselheim, Aaron S

    2014-08-01

    The US Food and Drug Administration (FDA) uses rulemaking as one of its primary tools to protect the public health and implement laws enacted by Congress and the president. Because of the many effects that these rules have on social welfare and the economy, the FDA and other executive agencies receive input from the executive branch, the public, and in some cases, the courts, during the process of rulemaking. In this article, we examine the life cycle of FDA regulations concerning medical products and review notable features of the rulemaking process. The current system grants substantial opportunities for diverse stakeholders to participate in and influence how rules are written and implemented. However, the duration, complexity, and adversarial qualities of the rulemaking process can hinder the FDA's ability to achieve its policy and public health goals. There is considerable variation in the level of transparency at different stages in the process, ranging from freely accessible public comments to undisclosed internal agency deliberations. In addition, significant medical product rules are associated with lengthy times to finalization, in some cases for unclear reasons. We conclude by identifying potential areas for reform on the basis of transparency and efficiency.

  14. Treatment of medical, psychiatric, and substance-use comorbidities in people infected with HIV who use drugs

    PubMed Central

    Altice, Frederick L; Kamarulzaman, Adeeba; Soriano, Vincent V; Schechter, Mauro; Friedland, Gerald H

    2016-01-01

    HIV-infected drug users have increased age-matched morbidity and mortality compared with HIV-infected people who do not use drugs. Substance-use disorders negatively affect the health of HIV-infected drug users, who also have frequent medical and psychiatric comorbidities that complicate HIV treatment and prevention. Evidence-based treatments are available for the management of substance-use disorders, mental illness, HIV and other infectious complications such as viral hepatitis and tuberculosis, and many non-HIV-associated comorbidities. Tuberculosis co-infection in HIV-infected drug users, including disease caused by drug-resistant strains, is acquired and transmitted as a consequence of inadequate prescription of antiretroviral therapy, poor adherence, and repeated interfaces with congregate settings such as prisons. Medication-assisted therapies provide the strongest evidence for HIV treatment and prevention efforts, yet are often not available where they are needed most. Antiretroviral therapy, when prescribed and adherence is at an optimum, improves health-related outcomes for HIV infection and many of its comorbidities, including tuberculosis, viral hepatitis, and renal and cardiovascular disease. Simultaneous clinical management of multiple comorbidities in HIV-infected drug users might result in complex pharmacokinetic drug interactions that must be adequately addressed. Moreover, interventions to improve adherence to treatment, including integration of health services delivery, are needed. Multifaceted, interdisciplinary approaches are urgently needed to achieve parity in health outcomes in HIV-infected drug users. PMID:20650518

  15. Antiepileptic drug utilization in Bangladesh: experience from Dhaka Medical College Hospital

    PubMed Central

    2013-01-01

    Background Epilepsy is a common health problem which carries a huge medical social psychological and economic impact for a developing country. The aim of this hospital-based study was to get an insight into the effectiveness and tolerability of low cost antiepileptic drugs (AEDs) in Bangladeshi people with epilepsy. Methods This retrospective chart review was done from hospital records in weekly Epilepsy outdoor clinic of Department of Neurology, Dhaka Medical College Hospital (DMCH) from October 1998 to February 2013. A total of 854 epilepsy patients met the eligibility criteria (had a complete record of two years of follow up data) from hospital database. A checklist was used to take demographics (age and gender), epilepsy treatment and adverse event related data. At least two years of follow up data were considered for analysis. Results Out of 854 patients selected, majority of the patients attending outdoor clinic were >11-30 years age group (55.2%) with a mean age of 20.3 ± 9 years and with a male (53%) predominance. Focal epilepsy were more common (53%), among whom secondary generalized epilepsy was the most frequent diagnosis (67%) followed by complex partial seizure (21%). Among those with Idiopathic Generalized Epilepsy (46%), generalized tonic clonic seizure was encountered in 74% and absence seizure was observed in 13%. The number of patients on monotherapy and dual AED therapy were 67% and 24% respectively and polytherapy (i.e. >3 AEDs) was used only in 9%. CBZ (67%) was the most frequently prescribed AED, followed by VPA (43%), PHB (17%), and PHT (8%). CBZ was prescribed in 37% patients as monotherapy followed by VPA in 21% and PHB in 8% patients. Newer generation drugs eg lemotrigine and topiramate were used only as add on therapy in combination with CBZ and VPA in only 2% patients. The treatment retention rates over the follow up period for the AEDs in monotherapy varied between 86 and 91% and were highest for CBZ, followed by VPA. Most of the

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

    PubMed

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

    2010-01-01

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

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

    PubMed

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

    2010-01-01

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

  18. Drug-dependence behaviour and outcome of medication-overuse headache after treatment.

    PubMed

    Corbelli, Ilenia; Caproni, Stefano; Eusebi, Paolo; Sarchielli, Paola

    2012-11-01

    This study aimed at determining the causes of failure of the different proposed strategies to ensure improvement of medication-overuse headache (MOH) patients, since they have not been investigated so far, especially with regard to aspects related to cognitive and behavioural aspects of symptomatic drugs overused by them. One hundred and twenty in-patients, 82 females (68.3 %), median age 49 (42-56) years, affected by MOH were admitted to the study and treated with abrupt discontinuation of the medication overused, a 6-day in-patient detoxification regimen and an immediate start of personalized prophylactic treatment, then followed for 1 year. Leeds Dependence Questionnaire (LDQ), among all the clinical variables, was administered at baseline and at 1-year follow-up visit to assess substance dependence. Of the 120 patients enrolled, 68 (56.7 %) were successfully detoxified (Responder-group), while 52 (43.3 %) were not (Non-Responder-group). At baseline, the mean LDQ total score was slightly higher in the Non-Responder group than in the Responder group (12.08 ± 2.14 vs. 11.94 ± 1.98). Although this difference was not significant at baseline (p > 0.05), the LDQ total score was significantly different (p < 0.001) at the 1-year follow-up visit between the responder group (7.8 ± 2.3) and the Non-Responder group (12.1 ± 2.1). Moreover, the pattern of the responses of the patients in the responder group differed from that of the Non-Responder-group in the items relating to the compulsion to start, compulsion to continue, primacy of effect, constancy of state and cognitive set. The results showed that patients of the Non-Responder group showed a drug dependence pattern similar to that previously described in addicts. Conversely, in patients who positively responded to the procedure, drug-abuse behaviour seemed to be a consequence of chronic headache, reflecting the need for daily analgesic use to cope with everyday life.

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

    PubMed Central

    Graham, Hillary T.; Rotroff, Daniel M.; Marvel, Skylar W.; Buse, John B.; Havener, Tammy M.; Wilson, Alyson G.; Wagner, Michael J.; Motsinger-Reif, Alison A.; Friedewald, W.T.

    2016-01-01

    Given the high costs of conducting a drug-response trial, researchers are now aiming to use retrospective analyses to conduct genome-wide association studies (GWAS) to identify underlying genetic contributions to drug-response variation. To prevent confounding results from a GWAS to investigate drug response, it is necessary to account for concomitant medications, defined as any medication taken concurrently with the primary medication being investigated. We use data from the Action to Control Cardiovascular Disease (ACCORD) trial in order to implement a novel scoring procedure for incorporating concomitant medication information into a linear regression model in preparation for GWAS. In order to accomplish this, two primary medications were selected: thiazolidinediones and metformin because of the wide-spread use of these medications and large sample sizes available within the ACCORD trial. A third medication, fenofibrate, along with a known confounding medication, statin, were chosen as a proof-of-principle for the scoring procedure. Previous studies have identified SNP rs7412 as being associated with statin response. Here we hypothesize that including the score for statin as a covariate in the GWAS model will correct for confounding of statin and yield a change in association at rs7412. The response of the confounded signal was successfully diminished from p = 3.19 × 10−7 to p = 1.76 × 10−5, by accounting for statin using the scoring procedure presented here. This approach provides the ability for researchers to account for concomitant medications in complex trial designs where monotherapy treatment regimens are not available.

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

    PubMed

    Graham, Hillary T; Rotroff, Daniel M; Marvel, Skylar W; Buse, John B; Havener, Tammy M; Wilson, Alyson G; Wagner, Michael J; Motsinger-Reif, Alison A

    2016-01-01

    Given the high costs of conducting a drug-response trial, researchers are now aiming to use retrospective analyses to conduct genome-wide association studies (GWAS) to identify underlying genetic contributions to drug-response variation. To prevent confounding results from a GWAS to investigate drug response, it is necessary to account for concomitant medications, defined as any medication taken concurrently with the primary medication being investigated. We use data from the Action to Control Cardiovascular Disease (ACCORD) trial in order to implement a novel scoring procedure for incorporating concomitant medication information into a linear regression model in preparation for GWAS. In order to accomplish this, two primary medications were selected: thiazolidinediones and metformin because of the wide-spread use of these medications and large sample sizes available within the ACCORD trial. A third medication, fenofibrate, along with a known confounding medication, statin, were chosen as a proof-of-principle for the scoring procedure. Previous studies have identified SNP rs7412 as being associated with statin response. Here we hypothesize that including the score for statin as a covariate in the GWAS model will correct for confounding of statin and yield a change in association at rs7412. The response of the confounded signal was successfully diminished from p = 3.19 × 10(-7) to p = 1.76 × 10(-5), by accounting for statin using the scoring procedure presented here. This approach provides the ability for researchers to account for concomitant medications in complex trial designs where monotherapy treatment regimens are not available.

  1. EMPADE Study: Evaluation of Medical Prescriptions and Adverse Drug Events in COPD Patients Admitted to Intensive Care Unit

    PubMed Central

    Khan, M. Amer; Khan, M. Nematullah; Sultan, Ihtisham; Khan, M. Aamer; Ali, S. Amir; Farooqui, Afroze

    2015-01-01

    Introduction Inappropriate drug usage may preclude ideal benefit due to increased medical cost, antimicrobial resistance, adverse effects and mortality. Therefore drug utilization studies have become a plausible means in evaluating the healthcare systems. COPD management usually involves more than one drug which may escalate the risk of ADEs (adverse drug events). Aim The present study was aimed at assessing the current drug practice and ADEs in COPD management in ICU. Materials and Methods A total of 1,044 patients admitted for the treatment of COPD were included in the study. Their prescriptions were recorded for evaluation of drug utilization and patients were counseled for assessing ADEs. Results were evaluated by Chi-square test and percentages. Result All-embracing 15,360 drugs were prescribed at an average of 14.71 drugs per patient, wherein β2-agonists were extensively prescribed agents followed by inhaled-corticosteroids and anti-cholinergics. 372 ADEs were reported in 252 patients, wherein restlessness was the most frequent ADE and theophylline was found to be associated with highest cases of ADEs. Conclusion Practitioners should prescribe least number of drugs to mitigate the likelihood of adverse outcomes in patients due to numerous drugs usage, which may be achieved by following GOLD guidelines. The present work may help in improving the current management of COPD by rectifying the flaws delineated in this article. PMID:26675667

  2. 42 CFR 418.106 - Condition of participation: Drugs and biologicals, medical supplies, and durable medical equipment.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

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

  3. RATE OF ADHERENCE TO AND FACTORS ASSOCIATED WITH METHADONE MAINTENANCE TREATMENT PROGRAM (MMTP) COMPLIANCE AMONG INJECTING DRUG USE PATIENTS IN NEPAL.

    PubMed

    Sharma, Vikas; Chamroonswasdi, Kanittha; Srisorrachatr, Suwat

    2016-03-01

    We conducted a survey to determine the rate of adherence to and factors associated with compliance with a methadone maintenance treatment program (MMTP) among injecting drug users in Nepal. We conducted face-to-face structured interviews with 165 methadone treatment patients aged 20-54 years during 5-20 April 2015. Data analysis included percentages, means, standard deviations, chi-square tests and multiple logistic regression analysis. Seventy-two point one percent of respondents had good adherence to a MMTP. Multiple logistic regression with 81.8% prediction showed respondents without a previous history of relapse were 2.7 times more likely to adhere to the MMTP than those with a history of relapse [Adjusted OR = 2.772; 95% Confidence interval (CI): 1.163-6.605]. Respondents with a good knowledge of the MMTP 9.4 times more likely to be adherent to the MMTP than those with a poor to fair knowledge of the MMTP (Adjusted OR = 9.464; 95% CI: 3.873-23.126). The likelihood of MMTP adherence was 4.5 times more likely when methadone treatment services were available than those where the availability of methadone treatment services were low to moderate (Adjusted OR = 4.553; 95% CI: 1.883-11.008). Knowledge and availability of MMTP need to be improved in the study area in Nepal.

  4. RATE OF ADHERENCE TO AND FACTORS ASSOCIATED WITH METHADONE MAINTENANCE TREATMENT PROGRAM (MMTP) COMPLIANCE AMONG INJECTING DRUG USE PATIENTS IN NEPAL.

    PubMed

    Sharma, Vikas; Chamroonswasdi, Kanittha; Srisorrachatr, Suwat

    2016-03-01

    We conducted a survey to determine the rate of adherence to and factors associated with compliance with a methadone maintenance treatment program (MMTP) among injecting drug users in Nepal. We conducted face-to-face structured interviews with 165 methadone treatment patients aged 20-54 years during 5-20 April 2015. Data analysis included percentages, means, standard deviations, chi-square tests and multiple logistic regression analysis. Seventy-two point one percent of respondents had good adherence to a MMTP. Multiple logistic regression with 81.8% prediction showed respondents without a previous history of relapse were 2.7 times more likely to adhere to the MMTP than those with a history of relapse [Adjusted OR = 2.772; 95% Confidence interval (CI): 1.163-6.605]. Respondents with a good knowledge of the MMTP 9.4 times more likely to be adherent to the MMTP than those with a poor to fair knowledge of the MMTP (Adjusted OR = 9.464; 95% CI: 3.873-23.126). The likelihood of MMTP adherence was 4.5 times more likely when methadone treatment services were available than those where the availability of methadone treatment services were low to moderate (Adjusted OR = 4.553; 95% CI: 1.883-11.008). Knowledge and availability of MMTP need to be improved in the study area in Nepal. PMID:27244967

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

    ERIC Educational Resources Information Center

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

    2011-01-01

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

  6. Emergency Victim Care. A Training Manual for Emergency Medical Technicians. Module 8--Crisis Intervention, Drug-Related Problems. Revised.

    ERIC Educational Resources Information Center

    Ohio State Dept. of Education, Columbus. Div. of Vocational Education.

    This training manual for emergency medical technicians, one of 14 modules that comprise the Emergency Victim Care textbook, covers crisis intervention and drug related problems. Objectives stated for the two chapters are for the student to be able to describe: treating common mental disturbances, relating to those suffering a crisis in a…

  7. The Conceptual Adequacy of the Drug Attitude Inventory for Measuring Youth Attitudes toward Psychotropic Medications: A Mixed Methods Evaluation

    ERIC Educational Resources Information Center

    Townsend, Lisa; Floersch, Jerry; Findling, Robert L.

    2010-01-01

    Adolescents are routinely treated with psychiatric medications; however, little is known about their attitudes toward pharmacological intervention. The authors used a concurrent triangulation, mixed methods design to assess whether the Drug Attitude Inventory (DAI), developed for adults, is suitable for measuring adolescent attitudes toward…

  8. P-glycoprotein alters blood–brain barrier penetration of antiepileptic drugs in rats with medically intractable epilepsy

    PubMed Central

    Ma, Aimei; Wang, Cuicui; Chen, Yinghui; Yuan, Weien

    2013-01-01

    P-glycoprotein is one of the earliest known multidrug transporters and plays an important role in resistance to chemotherapeutic drugs. In this study, we detected levels of P-glycoprotein and its mRNA expression in a rat brain model of medically intractable epilepsy established by amygdala kindling and drug selection. We investigated whether inhibition of P-glycoprotein affects the concentration of antiepileptic drugs in cortical extracellular fluid. We found that levels of P-glycoprotein and its mRNA expression were upregulated in epileptic cerebral tissue compared with cerebral tissue from normal rats. The concentrations of two antiepileptic drugs, carbamazepine and phenytoin, were very low in the cortical extracellular fluid of rats with medically intractable epilepsy, and were restored after blockade of P-glycoprotein by verapamil. These results show that increased P-glycoprotein levels alter the ability of carbamazepine and phenytoin to penetrate the blood–brain barrier and reduce the concentrations of these agents in extracellular cortical fluid. High P-glycoprotein levels may be involved in resistance to antiepileptic drugs in medically intractable epilepsy. PMID:24348021

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

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ...) Screening for potential drug therapy problems due to therapeutic duplication. (ii) Age/gender-related... dosage or duration of drug therapy. (vi) Drug-allergy contraindications. (vii) Clinical abuse/misuse....

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

    SciTech Connect

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

    2012-04-01

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

  11. Medical Appointments

    MedlinePlus

    ... trouble concentrating, stomach problems or emotional issues like anxiety. New or increasing side effects or reactions to your medications. Again, for how long? How serious are they? Medication compliance: How well you’ve been taking your medications. Have you missed doses? If so, ...

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

    PubMed

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

    2007-03-22

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

  13. ABC-VED Analysis of a Drug Store in the Department of Community Medicine of a Medical College in Delhi.

    PubMed

    Anand, T; Ingle, G K; Kishore, J; Kumar, R

    2013-01-01

    A matrix based on coupling of cost (always, better and control) analysis and criticality (vital, essential and desirable) analysis was employed for drug inventory containing 129 items of drug store in the Department of Community Medicine of a Medical College in Delhi. The annual drug expenditure incurred on 129 drug items for the year 2010-2011 was found to be Rs. 4,35,847.85. On always, better and control analysis, 18.6, 24.0 and 57.4% drugs were found to be always, better and control category items, respectively, amounting for 69.1, 20.8 and 10.1% of annual drug expenditure. About 13.2 (17), 38.8 (50) and 48.0% (62) items were found to be vital, essential and desirable category items, respectively, amounting for 18.7, 49.5 and 31.8% of annual drug expenditure. Based on always, better and control-vital, essential and desirable matrix analysis there were 37 (28.68%) items in category I, 53 (41.09%) items in category II and 39 (30.23%) items in category III, amounting for 73.0, 22.2 and 4.8% of annual drug expenditure, respectively. To conclude, scientific inventory management tools are needed to be applied in routine for efficient management of the pharmacy stores as it contributes to not only in improvement in patient care but also judicious use of resources as well. PMID:23901172

  14. 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

    ... HUMAN SERVICES Food and Drug Administration Supplemental Funding Under the Food and Drug Administration... Supplemental Application AGENCY: Food and Drug Administration, HHS. ACTION: Notice of intent. SUMMARY: The Food and Drug Administration (FDA) is announcing a program expansion of its Conference...

  15. Benchmarking HIPAA compliance.

    PubMed

    Wagner, James R; Thoman, Deborah J; Anumalasetty, Karthikeyan; Hardre, Pat; Ross-Lazarov, Tsvetomir

    2002-01-01

    One of the nation's largest academic medical centers is benchmarking its operations using internally developed software to improve privacy/confidentiality of protected health information (PHI) and to enhance data security to comply with HIPAA regulations. It is also coordinating the development of a web-based interactive product that can help hospitals, physician practices, and managed care organizations measure their compliance with HIPAA regulations.

  16. Prevalence, nature and potential preventability of adverse drug events – a population-based medical record study of 4970 adults

    PubMed Central

    Hakkarainen, Katja M; Gyllensten, Hanna; Jönsson, Anna K; Andersson Sundell, Karolina; Petzold, Max; Hägg, Staffan

    2014-01-01

    Aims To estimate the 3 month prevalence of adverse drug events (ADEs), categories of ADEs and preventable ADEs, and the preventability of ADEs among adults in Sweden. Further, to identify drug classes and organ systems associated with ADEs and estimate their seriousness. Methods A random sample of 5025 adults in a Swedish county council in 2008 was drawn from the Total Population Register. All their medical records in 29 inpatient care departments in three hospitals, 110 specialized outpatient clinics and 51 primary care units were reviewed retrospectively in a stepwise manner, and complemented with register data on dispensed drugs. ADEs, including adverse drug reactions (ADRs), sub-therapeutic effects of drug therapy (STEs), drug dependence and abuse, drug intoxications from overdose, and morbidities due to drug-related untreated indication, were detected during a 3 month study period, and assessed for preventability. Results Among 4970 included individuals, the prevalence of ADEs was 12.0% (95% confidence interval (CI) 11.1, 12.9%), and preventable ADEs 5.6% (95% CI 5.0, 6.2%). ADRs (6.9%; 95% CI 6.2, 7.6%) and STEs (6.4%; 95% CI 5.8, 7.1%) were more prevalent than the other ADEs. Of the ADEs, 38.8% (95% CI 35.8–41.9%) was preventable, varying by ADE category and seriousness. ADEs were frequently associated with nervous system and cardiovascular drugs, but the associated drugs and affected organs varied by ADE category. Conclusions The considerable burden of ADEs and preventable ADEs from commonly used drugs across care settings warrants large-scale efforts to redesign safer, higher quality healthcare systems. The heterogeneous nature of the ADE categories should be considered in research and clinical practice for preventing, detecting and mitigating ADEs. PMID:24372506

  17. Barriers in the quest for quality drug information: salutary lessons from TGA-approved sources for thyroid-related medications.

    PubMed

    Stockigt, Jim R

    2007-01-15

    Product information (PI) for thyroid-related medications endorsed by the Therapeutic Goods Administration, as reproduced in the commonly used compilation publications June 2006 MIMS (Monthly index of medical specialties) annual, MIMS Online and the Australian prescription products guide 2006, was evaluated to see whether it reflects contemporary therapeutic practice. Compared with current medical literature, these PI-based sources provide inadequate, inaccurate or outdated therapeutic directives. Examples include: Incorrect advice that thyroxine therapy should always begin at very low dosage. Failure to recommend increased thyroxine dosage early in pregnancy (thus placing the offspring of women being treated for hypothyroidism at risk of impaired fetal brain development). Incorrect and potentially unsafe advice to treat thyrotoxicosis with stable iodide in late pregnancy. Failure to advise serial adjustment of antithyroid drug dosage until after a patient becomes euthyroid (this can result in iatrogenic thyroid dysfunction). Outdated advice that antithyroid drugs are not compatible with breastfeeding. Recent initiatives to upgrade consumer medicine information (CMI) appear to accept PI-based sources as a reliable benchmark for CMI. That inference is not warranted for thyroid-related medications. Accountability for the updating of clinical information in PI needs to be defined, and the process for updating PI may need to be modified. Quality drug information, both PI and CMI, depends on fluent, evidence-based collaboration between suppliers, regulators, prescribers, specialist clinicians and consumers.

  18. The drug thief at Georgetown University Medical Center: anatomy of a $2 billion class-action lawsuit.

    PubMed

    2000-08-01

    Separate lawsuits filed on behalf of plaintiff patients at Georgetown University Medical Center, Washington, DC, have been consolidated under a District of Columbia judge who is scheduled to rule soon on whether to certify them as a class-action suit against the medical center. The case involves a drug-abusing worker in the interventional radiology unit at Georgetown University Hospital who may have exposed up to 500 patients to HIV, hepatitis, and other viruses during his period of employment from September 8, 1999 to February 2, 2000. The lawsuits allege that the med center failed to protect patients by not adopting American Hospital Association guidelines that call for universal pre-employment drug screening. The hospital currently is in the final stages of being sold to Medstar Health, Columbia, MD, which may eventually change the drug-screening policy. The episode not only has been embarrassing for the prestigious medical center, but also has focused attention on the potential consequences for hospitals that do not screen employees for drug use.

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

    NASA Astrophysics Data System (ADS)

    Serbezov, Valery; Sotirov, Sotir; Serbezov, Svetlin

    2013-03-01

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

  20. [Medical devices. Regulatory framework and contribution of the German Federal Institute for Drugs and Medical Devices (BfArM) to the safe application].

    PubMed

    Lauer, Wolfgang; Stößlein, E; Brinker, A; Broich, K

    2014-12-01

    Medical devices are of great importance for the prevention, diagnosis and treatment of many diseases. With their broad range and interdisciplinarity, they represent both a very dynamic field of innovation and a significant sector of the economy. The European and thus the German Medical Devices Act aim in this context to make new medical devices for patients and users rapidly available while ensuring safety and performance at the same time. The main responsibility for this lies with the manufacturer. In addition, others are involved in a complex collaboration in the conformity assessment and also later in the marketing phase for the early identification, assessment and minimization of potential risks. This paper presents the legal framework for medical devices and the related roles and responsibilities of various stakeholders, especially the two federal agencies the German Federal Institute for Drugs and Medical Devices (BfArM) and the Paul Ehrlich Institute (PEI). From the perspective of the BfArM the procedure and criteria for risk assessment of incident reports are explained and the experiences and wishes from regulatory practice are described. The active engagement of the BfArM to contribute knowledge from the incident report assessment within the relevant standards organisations and the medical profession is described using examples of medical devices from the field of out-of-hospital ventilation. The paper concludes with a look at future challenges, e.g. in combination products, IT networks and automatization, as well as on current developments to improve risk identification and assessment in a European context.

  1. Non-medical use of prescription drugs and HIV risk behaviour in transgender women in the Mid-Atlantic region of the United States.

    PubMed

    Benotsch, Eric G; Zimmerman, Rick S; Cathers, Laurie; Pierce, Juan; McNulty, Shawn; Heck, Ted; Perrin, Paul B; Snipes, Daniel J

    2016-08-01

    Male-to-female transgender women (TGW) experience high rates of substance use and HIV. A recent substance use trend is the use of prescription medication without a doctor's consent. No research to date has examined the associations between this non-medical use of prescription drugs and HIV risk behaviour in TGW. In the present study, TGW recruited from community venues (N = 104) in the Mid-Atlantic region of the United States completed surveys assessing demographic information, non-medical use of prescription drugs, other substance use, injection practices and sexual risk behaviour. Twenty-four per cent of the sample reported lifetime non-medical use of prescription drugs across the following categories: analgesics (21.2%), anxiolytics (14.4%), stimulants (12.5%) and sedatives (8.7%). Participants reporting non-medical use of prescription drugs were more likely to report other substance use, needle use to inject drugs, injecting silicone and sharing needles. In multivariable analyses, non-medical use of prescription drugs was associated with unprotected sex, sex after engaging in substance use, and commercial sex work, after controlling for demographic factors. Self-esteem and social support from family served as protective factors for non-medical use of prescription drugs. HIV-prevention programmes focused on TGW in the United States may wish to expand their assessment of substance use to include the use of prescription medications without a physician's consent.

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

    PubMed

    Gispen, Marie Elske C

    2013-11-01

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

  3. The Regulation of Medical Computer Software as a “Device” under the Food, Drug, and Cosmetic Act

    PubMed Central

    Brannigan, Vincent

    1986-01-01

    Recent developments in computer software have raised the possibility that federal regulators may claim to control medical computer software as a “device” under the Food, Drug and Cosmetic Act. The purpose of this paper is to analyze the FDCA to determine whether computer software is included in the statutory scheme, examine constitutional arguments relating to computer software, and discuss regulatory principles that should be taken into account when deciding appropriate regulation. This paper is limited to computer program output used by humans in deciding appropriate medical therapy for a patient.

  4. Self-Medication Patterns and Drug Use Behavior in Housewives Belonging to the Middle Income Group in a City in Northern India

    PubMed Central

    Kaushal, Jyoti; Gupta, Mahesh C; Jindal, Pooja; Verma, Savita

    2012-01-01

    Objectives: The objective was to assess the self-medication patterns and drug use behavior in housewives belonging to the middle income group in a city of Haryana State in Northern India. Materials and Methods: A detailed questionnaire designed to assess the self-medication patterns and drug use behavior and interview technique was used to elicit the requisite information. One hundred housewives of the middle income group were interviewed in Rohtak. Results: Most of the housewives were in the habit of keeping the medicines though only 73% of them were in the habit of using it without any prescription. Also it was seen that those housewives who were taking self-medication were better educated than those not indulged in self-medication. All of them were using allopathic drugs on a regular basis while other modes of medications were less used. The self-medication was most commonly based on the previous prescriptions issued by the doctors followed by the suggestions from friends, advertisement on the television, and newspapers. For most of them the reasons for self-medication were financial restraints and lack of time to go to the medical practitioner. Conclusions: The study delineates the difference in the self-medication patterns and drug use behavior in housewives in a city of Northern India. The results emphasize the need for comprehensive measures for intervention strategies to promote rational drug therapy by improving prescribing patterns and influencing self-medication. PMID:22529534

  5. Cable compliance

    NASA Technical Reports Server (NTRS)

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

    1992-01-01

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

  6. [Cooperation with the electronic medical record and accounting system of an actual dose of drug given by a radiology information system].

    PubMed

    Yamamoto, Hideo; Yoneda, Tarou; Satou, Shuji; Ishikawa, Toru; Hara, Misako

    2009-12-20

    By input of the actual dose of a drug given into a radiology information system, the system converting with an accounting system into a cost of the drug from the actual dose in the electronic medical record was built. In the drug master, the first unit was set as the cost of the drug, and we set the second unit as the actual dose. The second unit in the radiology information system was received by the accounting system through electronic medical record. In the accounting system, the actual dose was changed into the cost of the drug using the dose of conversion to the first unit. The actual dose was recorded on a radiology information system and electronic medical record. The actual dose was indicated on the accounting system, and the cost for the drug was calculated. About the actual dose of drug, cooperation of the information in a radiology information system and electronic medical record were completed. It was possible to decide the volume of drug from the correct dose of drug at the previous inspection. If it is necessary for the patient to have another treatment of medicine, it is important to know the actual dose of drug given. Moreover, authenticity of electronic medical record based on a statute has also improved.

  7. Therapeutic drug monitoring of mexiletine at a large academic medical center

    PubMed Central

    Nei, Scott D; Danelich, Ilya M; Lose, Jennifer M; Leung, Lydia Yuk Ting; Asirvatham, Samuel J; McLeod, Christopher J

    2016-01-01

    Introduction: The therapeutic trough range for mexiletine (0.8–2 mcg/mL) was largely established in the setting of arrhythmia prophylaxis following myocardial infarction. Objective: Describe the usage patterns of serum mexiletine concentrations and the impact of these concentrations on mexiletine dosing in modern practice for ventricular arrhythmia treatment. Methods: A single-center, retrospective analysis was conducted using the electronic medical record to identify serum mexiletine concentrations drawn between December 2004 and December 2014. The primary endpoint was the incidence of mexiletine concentrations drawn as troughs. Secondary outcomes included the incidence of mexiletine concentrations that prompted a dose change, association between adverse events and elevated concentrations, and association between baseline characteristics and mexiletine concentrations. Results: A total of 237 individual concentrations were included for analysis with 109 (46.0%) drawn appropriately as trough concentrations. Only 31 (13.1%) of the 237 concentrations drawn prompted a dose change. Mexiletine was primarily used for the treatment of ventricular arrhythmias (96.2%), and 108 (45.6%) concentrations were drawn in an effort to assess efficacy. The median concentration was statistically different between patients with and without an adverse event (0.8 vs 0.7 mcg/mL, respectively; p = 0.017), but may not represent a clinical significance. Patients with hepatic dysfunction had higher median concentrations compared to those without hepatic dysfunction (1.30 vs 1.07 mcg/mL; p = 0.01). Conclusion: Mexiletine concentrations are often drawn at inappropriate times and seldom influence a dose change. This study suggests that routine monitoring of mexiletine concentrations may not be necessary; however, therapeutic drug monitoring may be considered in patients with hepatic dysfunction or to confirm mexiletine absorption in patients where this represents a concern. PMID

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

    PubMed

    2000-01-14

    The Food and Drug Administration (FDA) is amending its classification regulations to designate class I devices that are exempt from the premarket notification requirements, subject to certain limitations, and to designate those class I devices that remain subject to premarket notification requirements under the new statutory criteria for premarket notification requirements. The devices FDA is designating as exempt do not include class I devices that have been previously exempted by regulation from the premarket notification requirements. This action is being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the 1976 amendments), the Safe Medical Devices Act of 1990 (SMDA), and the FDA Modernization Act of 1997 (FDAMA). FDA is taking this action in order to implement a requirement of FDAMA. Elsewhere in this issue of the Federal Register, FDA is announcing that it is withdrawing proposed rules to revoke existing exemptions from premarket notification for two devices. PMID:11010655

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

    PubMed

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

    2004-04-01

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

  10. Disparity in Naloxone Administration by Emergency Medical Service Providers and the Burden of Drug Overdose in US Rural Communities

    PubMed Central

    Dailey, Michael W.; Sugerman, David E.; Sasser, Scott M.; Levy, Benjamin; Paulozzi, Len J.

    2015-01-01

    Objectives. We determined the factors that affect naloxone (Narcan) administration in drug overdoses, including the certification level of emergency medical technicians (EMTs). Methods. In 2012, 42 states contributed all or a portion of their ambulatory data to the National Emergency Medical Services Information System. We used a logistic regression model to measure the association between naloxone administration and emergency medical services certification level, age, gender, geographic location, and patient primary symptom. Results. The odds of naloxone administration were much higher among EMT-intermediates than among EMT-basics (adjusted odds ratio [AOR] = 5.4; 95% confidence interval [CI] = 4.5, 6.5). Naloxone use was higher in suburban areas than in urban areas (AOR = 1.41; 95% CI = 1.3, 1.5), followed by rural areas (AOR = 1.23; 95% CI = 1.1, 1.3). Although the odds of naloxone administration were 23% higher in rural areas than in urban areas, the opioid drug overdose rate is 45% higher in rural communities. Conclusions. Naloxone is less often administered by EMT-basics, who are more common in rural areas. In most states, the scope-of-practice model prohibits naloxone administration by basic EMTs. Reducing this barrier could help prevent drug overdose death. PMID:25905856

  11. Medical marijuana

    MedlinePlus

    ... people who have not had relief from other treatments. Unlike medical marijuana, the active ingredient in these drugs can be ... American Academy of Neurology. Medical Marijuana in Certain Medical Disorders. ... . Accessed August 24, 2015. ...

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

    PubMed Central

    Labiris, N R; Dolovich, M B

    2003-01-01

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

  13. Can utilizing a computerized provider order entry (CPOE) system prevent hospital medical errors and adverse drug events?

    PubMed

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

    2014-01-01

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

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

    PubMed Central

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

    2014-01-01

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

  15. What's new in medical management strategies for raised intra-abdominal pressure: evacuating intra-abdominal contents, improving abdominal wall compliance, pharmacotherapy, and continuous negative extra-abdominal pressure.

    PubMed

    De Keulenaer, Bart; Regli, Adrian; De Laet, Inneke; Roberts, Derek; Malbrain, Manu L N G

    2015-01-01

    In the future, medical management may play an increasingly important role in the prevention and management of intra-abdominal hypertension (IAH). A review of different databases was used (PubMed, MEDLINE and EMBASE) with the search terms 'Intra-abdominal Pressure' (IAP), 'IAH', ' Abdominal Compartment Syndrome' (ACS), 'medical management' and 'non-surgical management'. We also reviewed all papers with the search terms 'IAH', 'IAP' and 'ACS' over the last three years, only extracting those papers which showed a novel approach in the non-surgical management of IAH and ACS.IAH and ACS are associated with increased morbidity and mortality. Non-surgical management is an important treatment option in critically ill patients with raised IAP. There are five medical treatment options to be considered to reduce IAP: 1) improvement of abdominal wall compliance; 2) evacuation of intra-luminal contents; 3) evacuation of abdominal fluid collections; 4) optimisation of fluid administration; and 5) optimisation of systemic and regional perfusion. This paper will review the first three treatment arms of the WSACS algorithm: abdominal wall compliance; evacuation of intra-luminal contents and evacuation of abdominal fluid collections. Emerging medical treatments will be analysed and finally some alternative specific treatments will be assessed. Other treatment options with regard to optimising fluid administration and systemic and regional perfusion will be described elsewhere, and are beyond the scope of this review. Medical management of critically ill patients with raised IAP should be instigated early to prevent further organ dysfunction and to avoid progression to ACS. Many treatment options are available and are often part of routine daily management in the ICU (nasogastric, rectal tube, prokinetics, enema, sedation, body position). Some of the newer treatments are very promising options in specific patient populations with raised IAP. Future studies are warranted to confirm

  16. Adherence to Antiretroviral Medications among Persons who Inject Drugs in Transitional, Low and Middle Income Countries: An International Systematic Review

    PubMed Central

    Feelemyer, Jonathan; Jarlais, Don Des; Arasteh, Kamyar; Uuskula, Anneli

    2014-01-01

    Adherence to antiretroviral (ART) medication is vital to reducing morbidity and mortality among HIV positive persons. People who inject drugs (PWID) are at high risk for HIV infection in transitional/low/middle income countries (TLMIC). We conducted a systematic review of studies reporting adherence to ARTs among persons with active injection drug use and/or histories of injection drug use in TLMIC. Meta-regression was performed to examine relationships between location, adherence measurements, and follow-up period. Fifteen studies were included from seven countries. Adherence levels ranged from 33% to 97%; mean weighted adherence was 72%. ART adherence was associated with different methods of measuring adherence and studies conducted in Eastern Europe and East Asia. The great heterogeneity observed precludes generalization to TLMIC as a whole. Given the critical importance of ART adherence more research is needed on ART adherence among PWID in TLMIC, including the use of standardized methods for reporting adherence to ARTs. PMID:25331268

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

    PubMed Central

    Ihezue, U. H.

    1988-01-01

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

  18. [Analysis about characteristics of drug used in clinical for ischemic stroke patients based on hospital electronic medical database].

    PubMed

    Wang, Jia; Xie, Yan-Ming; Yang, Wei; Wang, Yong-Yan; Zhao, Wei; Zhuang, Yan

    2014-09-01

    There are many different kinds of drugs which can treat ischemic stroke. This study aims to analyze the clinical treatment of ischemic stroke using Chinese and western medicines and their combination scheme. Data abstracted from 15 national 3a grad hospitals' hospital information system (HIS) databases were collected, then were used frequencies to find the common used drug and type, and were used association rules to anylizs the common combined medication scheme of Chinese and western medicines. It was found that the Shuxuetong (9 015 cases, 22.66%), Danhong (7 369 cases,18.53%) and Xueshuaitong (5 302 cases,13.33%) injections were the most frequently used drugs, and blood-activating and stasis-dissolving prescription (30 384 cases, 76.39%), resuscitative prescription (6 850 cases,17.22%) and tonic prescription (5 997 cases,15.08%) were the most commonly used types of Chinese medicine. The oral dose of aspirin (20 924 cases, 52.60%), Guangxi pp injection (10 771 cases, 27.08%) and insulin injection (10 599 cases, 26.65%) were frequently used. And the types of antiplatelet agents (23 049 cases, 57.95%), vasodilator (19 608 cases, 59.29%) and antihypertensive drug (15 475 cases, 39.90%) were commonly used. The drug combination of aspirin, twenty five pearl pill, Danhong and Xueshuaitong injection were the most frequently used group and its confidence coefficient is 97.5%. The type combination of blood-activating and stasis-dissolving prescription, thrombolytic drug, insulin and vasodilator was the most commonly used group and its confidence coefficient is 97.424%. This study concludes that the drug combination of aspirin, twenty five pearl pill, Danhong and Xueshuaitong injection and the type combination of blood-activating and stasis-dissolving prescription, thrombolytic drug, insulin and vasodilator were commonly used in clinical.

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

    NASA Astrophysics Data System (ADS)

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

    2016-07-01

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

  20. Mortality from adverse drug reactions in adult medical inpatients at four hospitals in South Africa: a cross-sectional survey

    PubMed Central

    Mouton, Johannes P; Mehta, Ushma; Parrish, Andy G; Wilson, Douglas P K; Stewart, Annemie; Njuguna, Christine W; Kramer, Nicole; Maartens, Gary; Blockman, Marc; Cohen, Karen

    2015-01-01

    Aims Fatal adverse drug reactions (ADRs) are important causes of death, but data from resource-limited settings are scarce. We determined the proportion of deaths in South African medical inpatients attributable to ADRs, and their preventability, stratified by human immunodeficiency virus (HIV) status. Methods We reviewed the folders of all patients who died over a 30 day period in the medical wards of four hospitals. We identified ADR-related deaths (deaths where an ADR was ‘possible’, ‘probable’ or ‘certain’ using WHO-UMC criteria and where the ADR contributed to death). We determined preventability according to previously published criteria. Results ADRs contributed to the death of 2.9% of medical admissions and 56 of 357 deaths (16%) were ADR-related. Tenofovir, rifampicin and co-trimoxazole were the most commonly implicated drugs. 43% of ADRs were considered preventable. The following factors were independently associated with ADR-related death: HIV-infected patients on antiretroviral therapy (adjusted odds ratio (aOR) 4.4, 95% confidence interval (CI) 1.6, 12), exposure to more than seven drugs (aOR 2.5, 95% CI 1.3, 4.8) and increasing comorbidity score (aOR 1.3, 95% CI 1.1, 1.7). Conclusions In our setting, where HIV and tuberculosis are highly prevalent, fatal in-hospital ADRs were more common than reported in high income settings. Most deaths were attributed to drugs used in managing HIV and tuberculosis. A large proportion of the ADRs were preventable, highlighting the need to strengthen systems for health care worker training and support. PMID:25475751

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

    PubMed

    Nakata, M; Tang, W

    2008-10-01

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

  2. 40 CFR 60.37e - Compliance, performance testing, and monitoring guidelines.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

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

  3. 77 FR 50113 - ASTM International-Food and Drug Administration Workshop on Absorbable Medical Devices: Lessons...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-20

    ... Absorbable Medical Devices: Lessons Learned From Correlations of Bench Testing and Clinical Performance... ``ASTM International-FDA Workshop on Absorbable Medical Devices: Lessons Learned From Correlations of... interested in attending this public workshop must register online by November 13, 2012. Early registration...

  4. Training compliance

    SciTech Connect

    Clarke, A.N. )

    1989-02-01

    Legally mandated training to effect compliance with environmental regulations came into prominence with RCRA. Training and its associated recordkeeping requirements were to be in place by May 18, 1981, but, for the most part, this deadline went unnoticed. Whether the lack of response reflected that fact that the RCRA regulations were extremely confusing or that the training requirements were not taken seriously is hard to determine. Ironically, while RCRA facilities were frequently deficient in meeting the training requirements, it was this specific aspect of the regulations that inexperienced inspectors often targeted and cited. Over the years, through a combination of citations and, more importantly, an increasing appreciation of the benefits of training, the attitude toward regulatory compliance training slowly improved. This paper reflects the attitudes of both management and the workers receiving the training.

  5. 47 CFR 18.212 - Compliance information.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 47 Telecommunication 1 2010-10-01 2010-10-01 false Compliance information. 18.212 Section 18.212 Telecommunication FEDERAL COMMUNICATIONS COMMISSION GENERAL INDUSTRIAL, SCIENTIFIC, AND MEDICAL EQUIPMENT Applications and Authorizations § 18.212 Compliance information. (a) Equipment authorized under the...

  6. 47 CFR 18.212 - Compliance information.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 47 Telecommunication 1 2014-10-01 2014-10-01 false Compliance information. 18.212 Section 18.212 Telecommunication FEDERAL COMMUNICATIONS COMMISSION GENERAL INDUSTRIAL, SCIENTIFIC, AND MEDICAL EQUIPMENT Applications and Authorizations § 18.212 Compliance information. (a) Equipment authorized under the...

  7. 47 CFR 18.212 - Compliance information.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 47 Telecommunication 1 2011-10-01 2011-10-01 false Compliance information. 18.212 Section 18.212 Telecommunication FEDERAL COMMUNICATIONS COMMISSION GENERAL INDUSTRIAL, SCIENTIFIC, AND MEDICAL EQUIPMENT Applications and Authorizations § 18.212 Compliance information. (a) Equipment authorized under the...

  8. 47 CFR 18.212 - Compliance information.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 47 Telecommunication 1 2013-10-01 2013-10-01 false Compliance information. 18.212 Section 18.212 Telecommunication FEDERAL COMMUNICATIONS COMMISSION GENERAL INDUSTRIAL, SCIENTIFIC, AND MEDICAL EQUIPMENT Applications and Authorizations § 18.212 Compliance information. (a) Equipment authorized under the...

  9. 47 CFR 18.212 - Compliance information.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 47 Telecommunication 1 2012-10-01 2012-10-01 false Compliance information. 18.212 Section 18.212 Telecommunication FEDERAL COMMUNICATIONS COMMISSION GENERAL INDUSTRIAL, SCIENTIFIC, AND MEDICAL EQUIPMENT Applications and Authorizations § 18.212 Compliance information. (a) Equipment authorized under the...

  10. 78 FR 41069 - Medical Device Reporting for Manufacturers; Draft Guidance for Industry and Food and Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-09

    ... Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4613, Silver Spring... and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2312... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH...

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

    ERIC Educational Resources Information Center

    Dezelsky, Thomas L.; And Others

    1981-01-01

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

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

    PubMed Central

    2012-01-01

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

  13. Optimizing medicines management: From compliance to concordance

    PubMed Central

    Cushing, Annie; Metcalfe, Richard

    2007-01-01

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

  14. 21 CFR 107.270 - Compliance with this subpart.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

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

    PubMed Central

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

    2015-01-01

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

  16. Environmental health and safety issues related to the use of low-level radioactive waste (LLRW) at hospitals and medical research institutions and compliance determination with the Clean Air Act standards

    SciTech Connect

    Kasinathan, R.; Kanchan, A.

    1995-12-31

    Currently, the United States Nuclear Regulatory Commission (NRC) has standards for procedures, performance activities and technical specifications on storage of Low-Level Radioactive Waste (LLRW) under 10 CFR Part 20. The United States Environmental Protection Agency (EPA) is proposing environmental standards for the management, storage and disposal of LLRW. The proposed standards, which will become 40 CFR part 193 when finalized, limits the committed effective dose to members of the public from the management and storage of LLRW, committed effective doses resulting from LLRW disposal and levels of radiological contamination of underground sources of drinking water as a result of the activities subject to management, storage and disposal of LLRW. Further, under Title III of the Clean Air Act Amendments, radionuclides are required to be inventoried for all generators. For hospitals and medical research institutions, quantities of LLRW are often below the concentrations required under reporting and record keeping requirements of 10 CFR 20. However, in many instances, the facility may require NRC permits and compliance with air quality dispersion modeling requirements. This paper presents the typical radionuclides used in hospitals and medical research institutions, and strategies to evaluate their usage and steps to achieve compliance. Air quality dispersion modeling by use of the COMPLY model is demonstrated to evaluate the fate of radionuclides released from on-site incineration of LLRW. The paper concludes that no significant threat is posed from the incineration of LLRW.

  17. Fomepizole (orphan medical).

    PubMed

    Hantson, P

    2001-06-01

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

  18. Fomepizole (orphan medical).

    PubMed

    Hantson, P

    2001-06-01

    Orphan Medical has developed fomepizole as a potential treatment for both ethylene glycol and methanol poisoning. The drug was launched as Antizol in January 1998 for the treatment of ethylene glycol poisoning [273949] after US marketing approval was grantedin December 1997 [271563]. It has also received US approval for methanol poisoning [393217] and UK approval for ethylene glycol poisoning [329495]. In 1999, Orphan Medical's partner, Cambridge Laboratories, intended to pursue European approval under the mutual recognition procedure [329495]. However, by September 2000, Cambridge Laboratories had discontinued their involvement with fomepizole and IDIS World Medicines had licensed the rights to distribute the drug in the UK [412142]. In February 2000, the Canadian Therapeutic Products Programme (TPP) granted fomepizole Priority Review, provided that an NDA was submitted by March 14, 2000 [354665]. In August 2000, the TPP accepted this NDA and set a target date for approval in the fourth quarter of 2000 [379474]. The TPP granted fomepizole a Notice of Compliance permitting the sale of fomepizole in Canada in December 2000. The company's marketing partner in Canada, Paladin Labs had launched fomepizole by January 2001 [396953]. In June 2000, Tucker Anthony Cleary Gull stated that the Orphan Drug status which Orphan Medical had obtained for fomepizole would provide marketing exclusivity through December 2004. The analysts also stated that fomepizole had accounted for 40% of Orphan Medical's revenue in financial year 1999, although +/- 30% of sales were estimated to be due to stockpiling [409606]. PMID:16001315

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

    PubMed

    Sato, Junya; Kikuchi, Satomi; Kudo, Kenzo

    2014-01-01

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

  20. Attitude of Iranian Medical Oncologists Toward Economic Aspects, and Policy-making in Relation to New Cancer Drugs

    PubMed Central

    Daroudi, Rajabali; Mirzania, Mehrzad; Zendehdel, Kazem

    2016-01-01

    Background: Although medical oncologists can have an important role in controlling the cost of cancer treatment, there is little information about their attitudes toward the cost of cancer treatment and the impact of cost on their treatment recommendations, especially in low- and middle-income countries (LMICs). In this study, we assessed the attitude of Iranian medical oncologists toward some economic aspects of new cancer drugs. Methods: We translated a questionnaire that was used in similar studies in the United States and Canada into Persian and modified it according to the local setting in Iran. The face and content validity of the questionnaire were assessed by oncologists before being used in the survey. We distributed the questionnaire and collected the data from 80 oncologists who participated in the 13th Annual Congress of the Iranian Society of Medical Oncology and Hematology (ISMOH). Results: Fifty-two oncologists participated in our study (a response rate of 65%). The majority of oncologists stated that drug costs and patient out-of-pocket (OOP) costs influence their treatment recommendations (92% and 94%, respectively). Most oncologists (70%) felt that they are ready enough to use cost-effectiveness information in their treatment decisions, and 74% believed that patients should only have access to cancer treatments that are cost-effective. Most oncologists agree that the government should have control over drug prices, and more use of cost‐effectiveness data is required for decision-making about cancer drug coverage. Ninety-one percent of oncologists said that they always or frequently discuss cancer treatment costs with their patients. Oncologists believed that academic groups (research centers and scientific societies) (81%) and the Ministry of Health (MoH) (43%) are the most eligible groups for determining whether a drug provides good value. Conclusion: Iranian medical oncologists are ready to participate in the health technology assessment and

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

    NASA Astrophysics Data System (ADS)

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

    2004-06-01

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

  2. [Therapeutic non-compliance: a major problem in the prevention of cardiovascular diseases].

    PubMed

    Scheen, A J

    1999-12-01

    The prevention of cardiovascular diseases relies upon the correction of risk factors and, more particularly, the optimal management of various metabolic abnormalities such as obesity, dyslipidaemias, diabetes mellitus and arterial hypertension. Such an approach first requires the adherence to life-style habits (healthy diet, physical activity and no smoking) and, in case of failure, the use of lipid-lowering drugs, antidiabetic agents and/or antihypertensive medications. Sometimes, a monotherapy may be sufficient but, in most cases, a drug combination is mandatory because of the need to reach tight therapeutic targets and of the presence of a polypathology, especially within the frame of the metabolic syndrome. Unfortunately, all surveys indicate that therapeutic compliance to non-pharmacological advice and even to drug prescriptions is far from being excellent. Such a non-compliance limits the efficacy of the prevention strategies and contributes to markedly increase the cost of metabolic diseases and associated complications.

  3. Abstinence-Conflict Model: Toward an Optimal Animal Model for Screening Medications Promoting Drug Abstinence.

    PubMed

    Peck, J A

    2016-01-01

    Drug addiction is a significant health and societal problem for which there is no highly effective long-term behavioral or pharmacological treatment. A rising concern are the use of illegal opiate drugs such as heroin and the misuse of legally available pain relievers that have led to serious deleterious health effects or even death. Therefore, treatment strategies that prolong opiate abstinence should be the primary focus of opiate treatment. Further, because the factors that support abstinence in humans and laboratory animals are similar, several animal models of abstinence and relapse have been developed. Here, we review a few animal models of abstinence and relapse and evaluate their validity and utility in addressing human behavior that leads to long-term drug abstinence. Then, a novel abstinence "conflict" model that more closely mimics human drug-seeking episodes by incorporating negative consequences for drug seeking (as are typical in humans, eg, incarceration and job loss) and while the drug remains readily available is discussed. Additionally, recent research investigating both cocaine and heroin seeking in rats using the animal conflict model is presented and the implications for heroin treatments are examined. Finally, it is argued that the use of animal abstinence/relapse models that more closely approximate human drug addiction, such as the abstinence-conflict model, could lead to a better understanding of the neurobiological and environmental factors that support long-term drug abstinence. In turn, this will lead to the development of more effective environmental and pharmacotherapeutic interventions to treat opiate addiction and addiction to other drugs of abuse. PMID:27055619

  4. 76 FR 43689 - Draft Guidance for Industry and Food and Drug Administration Staff; Mobile Medical Applications...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-21

    ... example, such an accessory would be similar to an infusion pump stand, which is currently classified as a class I device because it supports the intended use of an infusion pump (class II medical device)....

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

    PubMed Central

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

    2016-01-01

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

  6. A Retrospective Analysis of Direct Medical Cost and Cost of Drug Therapy in Hospitalized Patients at Private Hospital in Western India

    PubMed Central

    Kumbar, Shivaprasad Kalakappa

    2015-01-01

    Background Pharmacoeconomics is analytical tool to know cost of hospitalization and its effect on health care system and society. In India, apart from the government health services, private sector also play big role to provide health care services. Objective To study the direct medical cost and cost of drug therapy in hospitalized patients at private hospital. Materials and Methods A retrospective study was conducted at private hospital in a metro city of Western India. Total 400 patients’ billing records were selected randomly for a period from 01/01/2013 to 31/12/2014. Data were collected from medical record of hospital with permission of medical director of hospital. Patients’ demographic profile age, sex, diagnosis and various costs like ICU charge, ventilator charge, diagnostic charge, etc. were noted in previously formed case record form. Data were analysed by Z, x2 and unpaired t-test. Result Patients were divided into less than 45 years and more than 45 year age group. They were divided into medical and surgical patients according to their admission in medical or surgical ward. Mortality, Intensive Care Unit (ICU) admission, patients on ventilator were significantly (p<0.05) higher in medical patients. Direct medical cost, ward bed charge, ICU bed charge, ventilator charge and cost of drug therapy per patient were significantly (p<0.05) higher in medical patients while operation theatre and procedural charge were significantly (p<0.05) higher in surgical patients. Cost of fibrinolytics, anticoagulants, cardiovascular drugs were significantly (p<0.05) higher in medical patients. Cost of antimicrobials, proton pump inhibitors (PPIs), antiemetics, analgesics, were significantly (p<0.05) higher in surgical patients. Conclusion Ward bed charge, ICU bed charge, ventilator charge accounted more than one third cost of direct medical cost in all the patients. Cost of drug therapy was one fourth of direct medical cost. Antimicrobials cost accounted 33% of cost

  7. Medication huddles slash adverse drug events (ADE), promote safety culture across all hospital units, including the ED.

    PubMed

    2014-03-01

    To make a big dent in adverse drug events (ADE), Nationwide Children's Hospital devised medication huddles: a process that takes place after every reported ADE. A core huddle team meets with clinicians from the specific unit involved to discuss why the ADE occurred, and what can be done to prevent future events. In three years, the approach has reduced ADEs by 74%, and the rate of ADEs per 1,000 dispensed doses has decreased by 85%. * Administrators say a safety culture that encourages error reporting is key to making the process work. * To facilitate the huddle discussions, developers created a data collection tool that prompts huddle participants to describe the ADE, what factors were involved, and potential solutions. * While the medication huddles were first implemented in the hospital's critical care units, the process has since been expanded to include all areas of the hospital, including the ED. PMID:24640292

  8. Physicians medication prescribing in primary care in Riyadh City, Saudi Arabia. Literature review, part 1: variations in drug prescribing.

    PubMed

    Neyaz, Y; Qureshi, N A; Khoja, T; Magzoub, M A; Haycox, A; Walley, T

    2011-02-01

    Rational prescribing is associated with improved safety in drug use, better quality of life for patients and cost-effective care. Medication prescribing is a relatively unexplored area of research in Saudi Arabia and until now most studies have been in the secondary and tertiary health care system. This paper is the first of 3 review articles that form the background for a series of 5 interconnected studies of prescribing patterns and medication errors in the public and private primary health care sectors of Saudi Arabia. A MEDLINE search was conducted to identify papers published in peer-reviewed journals over the previous 3 decades. The paper reviews variations in prescribing patterns and influences on physicians' prescribing behaviour worldwide and in Saudi Arabia. PMID:21735947

  9. Punctal plug: a medical device to treat dry eye syndrome and for sustained drug delivery to the eye.

    PubMed

    Yellepeddi, Venkata K; Sheshala, Ravi; McMillan, Hannah; Gujral, Chirag; Jones, David; Raghu Raj Singh, Thakur

    2015-07-01

    Punctal plugs (PPs) are miniature medical implants that were initially developed for the treatment of dry eyes. Since their introduction in 1975, many PPs made from different materials and designs have been developed. PPs, albeit generally successful, suffer from drawbacks such as epiphora and suppurative canaliculitis. To overcome these issues intelligent designs of PPs were proposed (e.g. SmartPLUG™ and Form Fit™). PPs are also gaining interest among pharmaceutical scientists for sustaining drug delivery to the eye. This review aims to provide an overview of PPs for dry eye treatment and drug delivery to treat a range of ocular diseases. It also discusses current challenges in using PPs for ocular diseases. PMID:25668579

  10. 40 CFR 60.56c - Compliance and performance testing.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... compliance with the visible emissions limits for fugitive emissions from flyash/bottom ash storage and... Reference Method 22 of appendix A-7 of this part shall be used to determine compliance with the fugitive ash... Sources: Hospital/Medical/Infectious Waste Incinerators § 60.56c Compliance and performance testing....

  11. 40 CFR 60.39e - Compliance times.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

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

  12. 40 CFR 60.39e - Compliance times.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

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

  13. 40 CFR 60.39e - Compliance times.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 6 2010-07-01 2010-07-01 false Compliance times. 60.39e Section 60.39e... PERFORMANCE FOR NEW STATIONARY SOURCES Emission Guidelines and Compliance Times for Hospital/Medical/Infectious Waste Incinerators § 60.39e Compliance times. (a) Each State in which a designated facility...

  14. [Improve the accessibility of essential drugs for the populations of one medical region in Burkina Faso].

    PubMed

    Ridde, Valéry; Nitièma, Abdoulaye P; Dadjoari, Moussa

    2005-01-01

    Despite the formulation of the Bamako initiative in 1992 in Burkina Faso, not until 2001 and the launching of a project by a nongovernmental organization was the policy really implemented in a region of the country. One of the goals of this policy is to improve access to health care by using generic essential drugs. The objective of this article is to summarize the results of the evaluation of the project's ability to improve the population's access to drugs. The project lasted three years (2001-2003) and the interventions took place in 41 basic health centres of three districts. According to WHO, improving access to drugs requires consideration of four essential factors: rational use, affordable prices, financial viability, and effectiveness of the distribution. The average number of drugs prescribed per prescription sheet (n = 1061) was 2.4; 93% of the drugs were prescribed by their generic name (international non-proprietary names); 44% of infant diarrheas were treated with oral rehydration salt. National drug prices were respected but not the directives aiming at exempting from payment or subsidizing certain population sub-groups (children, indigents). The average annual cash flow of the basic health centres was 1.2 million F CFA and it increased by 854% compared to the beginning of the project. The cost-recovery scheme for administrative expenses was 106%. The average annual availability of the 10 essential drugs was 89%. Utilization rates increased (0.13 in 1999 to 0.21 in 2003) but not significantly differently than in other basic health centres of the area not supported by the project (p = 0.084). The project succeeded in improving access to these drugs for the overall population but not for the worst-off. The drugs are now geographically available for all and financially accessible for those who can afford to pay. The intervention strategy supported the sustainability of the project's activities but much remains to be done to provide the poorest with

  15. Drug release behavior of electrospun twisted yarns as implantable medical devices.

    PubMed

    Maleki, H; Gharehaghaji, A A; Toliyat, T; Dijkstra, P J

    2016-01-01

    In this study, twisted drug-loaded poly(L-lactide) (PLLA) and hybrid poly(L-lactide)/poly(vinyl alcohol) (PLLA/PVA) yarns were produced using an electrospinning technique based on two oppositely charged nozzles. Cefazolin, an antibiotic drug was incorporated in the yarn fibers by addition to the PLLA electrospinning solution. Morphological studies showed that independent of the twist rate, uniform and smooth fibers were formed. The diameter of the electrospun fibers in the yarns decreased at higher twist rates but produced yarns with larger diameters. At increasing twist rates the crystallinity of the fibers in the yarns increased. In the presence of cefazolin the fiber diameter, yarn diameter and crystallinity were always lower than in the non-drug loaded yarns. In addition the yarn mechanical properties revealed a slightly lower strength, modulus and elongation at break upon drug loading. The effect of the twist rate on the cefazolin in vitro release behavior from both PLLA and hybrid yarns revealed similar profiles for both types of drug-loaded yarns. However, the total amount of drug released from the hybrid PLLA/PVA yarns was significantly higher. The release kinetics over a period of 30 d were fitted to different mathematical models. Cefazolin release from electrospun PLLA yarns was governed by a diffusion mechanism and could best be fitted by Peppas and Higuchi models. The models that were found best to describe the drug release mechanism from the hybrid PLLA/PVA yarns were a first-order model and the Higuchi model. PMID:27634914

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

    PubMed Central

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

    2014-01-01

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

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

    PubMed Central

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

    2016-01-01

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

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

    PubMed Central

    2013-01-01

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

  19. Drug Formulation Advances in Extended-Release Medications for Pain Control.

    PubMed

    Jones, Mark R; Carney, Martin J; Kaye, Rachel J; Prabhakar, Amit; Kaye, Alan D

    2016-06-01

    Prescription opioid abusers frequently tamper with opioid tablets in order to either accelerate the delivery of the euphoria-inducing agent or to alter the route of delivery, such that it may be delivered intranasally or intravenously. As one strategy to combat the opioid epidemic in the USA, drug manufacturers have begun to explore formulations which resist such tampering by abusers. Techniques to prevent tampering consist of physical barriers to crushing, chewing, and drug extraction, or aversive or antagonistic agents, incorporated within the formulation itself. Recent years have seen the development of numerous extended-release opioid agents, which are described in this review. This article provides a comprehensive summary of the pharmacology, benefits, risks, and processes behind the development of currently available extended-release opioid drugs, as well as a glimpse into promising future formulations. PMID:27084375

  20. Role of scanning electron microscopy in identifying drugs used in medical practice.

    PubMed

    Fazil Marickar, Y M; Sylaja, N; Koshy, Peter

    2009-10-01

    Several plant preparations are administered for treatment of stone disease without scientific basis. This paper presents the results of in vitro and animal experimental studies using scanning electron microscopy (SEM) in the identification of the therapeutic properties of trial drugs in medicine. In the first set of the study, urinary crystals namely calcium oxalate monohydrate and calcium oxalate dehydrate were grown in six sets of Hane's tubes in silica gel medium. Trial drugs namely scoparia dulcis Lynn, musa sapiens and dolicos biflorus were incorporated in the gel medium to identify the dopant effect of the trial drugs on the size and extent of crystal column growth. The changes in morphology of crystals were studied using SEM. In the second set, six male Wistar rats each were calculogenised by administering sodium oxalate and ethylene glycol and diabetised using streptozotocin. The SEM changes of calculogenisation were studied. The rats were administered trial drugs before calculogenisation or after. The kidneys of the rats studied under the scanning electron microscope showed changes in tissue morphology and crystal deposition produced by calculogenisation and alterations produced by addition of trial drugs. The trial drugs produced changes in the pattern of crystal growth and in the crystal morphology of both calcium oxalate monohydrate and calcium oxalate dihydrate grown in vitro. Elemental distribution analysis showed that the crystal purity was not altered by the trial drugs. Scoparia dulcis Lynn was found to be the most effective anticalculogenic agent. Musa sapiens and dolicos biflorus were found to have no significant effect in inhibiting crystal growth. The kidneys of rats on calculogenisation showed different grades of crystals in the glomerulus and interstitial tissues, extrusion of the crystals into the tubular lumen, collodisation and tissue inflammatory cell infiltration. Scoparia dulcis Lynn exhibited maximum protector effect against the

  1. 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

    ... Staff; Medical Devices; Neurological and Physical Medicine Device Guidance Document; Reopening of... for the notice that appeared in the Federal Register of April 5, 2010 (75 FR 17143). In the notice, FDA requested comments on draft guidance documents for 11 neurological and physical medicine...

  2. 78 FR 21612 - Medical Device Classification Product Codes; Guidance for Industry and Food and Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-11

    ... structure and organization. These 16 Panels have largely been the driving force for CDRH's internal organizational structure as well. These Panels were established with the 1976 Medical Device Amendments, and... unclassified devices and devices not yet classified. In the Federal Register of January 3, 2012 (77 FR...

  3. 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

    ... Staff; Medical Devices; Neurological and Physical Medicine Device Guidance Document; Reopening of... July 28, 2010 (75 FR 44267). The document reopened the comment period for a notice of availability of draft guidance documents for 11 neurological and physical medicine devices. The document was...

  4. Adolescent Attitudes toward Psychiatric Medication: The Utility of the Drug Attitude Inventory

    ERIC Educational Resources Information Center

    Townsend, Lisa; Floersch, Jerry; Findling, Robert L.

    2009-01-01

    Background: Despite the effectiveness of psychotropic treatment for alleviating symptoms of psychiatric disorders, youth adherence to psychotropic medication regimens is low. Adolescent adherence rates range from 10-80% (Swanson, 2003; Cromer & Tarnowski, 1989; Lloyd et al., 1998; Brown, Borden, and Clingerman, 1985; Sleator, 1985) depending on…

  5. 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

    ... establishment of a docket to receive suggestions, recommendations, and comments for topics from interested... development and implementation within CDER and consistent, predictable communication of medical policy.... Experts from within CDER and other FDA offices provide expertise as needed for specific policy...

  6. Estimation of Drug Effectiveness by Modeling Three Time-dependent Covariates: An Application to Data on Cardioprotective Medications in the Chronic Dialysis Population.

    PubMed

    Phadnis, Milind A; Shireman, Theresa I; Wetmore, James B; Rigler, Sally K; Zhou, Xinhua; Spertus, John A; Ellerbeck, Edward F; Mahnken, Jonathan D

    2014-01-01

    In a population of chronic dialysis patients with an extensive burden of cardiovascular disease, estimation of the effectiveness of cardioprotective medication in literature is based on calculation of a hazard ratio comparing hazard of mortality for two groups (with or without drug exposure) measured at a single point in time or through the cumulative metric of proportion of days covered (PDC) on medication. Though both approaches can be modeled in a time-dependent manner using a Cox regression model, we propose a more complete time-dependent metric for evaluating cardioprotective medication efficacy. We consider that drug effectiveness is potentially the result of interactions between three time-dependent covariate measures, current drug usage status (ON versus OFF), proportion of cumulative exposure to drug at a given point in time, and the patient's switching behavior between taking and not taking the medication. We show that modeling of all three of these time-dependent measures illustrates more clearly how varying patterns of drug exposure affect drug effectiveness, which could remain obscured when modeled by the more standard single time-dependent covariate approaches. We propose that understanding the nature and directionality of these interactions will help the biopharmaceutical industry in better estimating drug efficacy. PMID:25343005

  7. Drugs.

    ERIC Educational Resources Information Center

    Hurst, Hunter, Ed.; And Others

    1984-01-01

    This document contains the third volume of "Today's Delinquent," an annual publication of the National Center for Juvenile Justice. This volume deals with the issue of drugs and includes articles by leading authorities in delinquency and substance abuse who share their views on causes and cures for the drug problem among youth in this country.…

  8. Socio-Psychological Correlates of Non-Medical Use of Drugs Among University Students.

    ERIC Educational Resources Information Center

    Mehra, N.

    This study was designed to collect and analyze study reactions on a broad range of social, cultural and educational issues including the nonmedical use of drugs. Two questionnaires and a personality inventory were used in the collection of data that was obtained from a stratified random sample of 282 students of the University of Alberta. An…

  9. Trends in medical student use of tobacco, alcohol and drugs in an Irish university, 1973-2002.

    PubMed

    Boland, M; Fitzpatrick, P; Scallan, E; Daly, L; Herity, B; Horgan, J; Bourke, G

    2006-11-01

    Questionnaire surveys of medical students in an Irish university were carried out in 1973 (n=765), 1990 (n=522) and 2002 (n=537), with differentiation of western students (e.g., from the Republic of Ireland, the UK, or Australia) and non-western students (e.g., Malaysia). We report on changes in tobacco smoking, drinking and drug-taking over three decades, and we note that, among western students, estimated prevalence of being a current smoker has declined overall from 28.8% in 1973 to 15.3% in 1990 to 9.2% in 2002 (p<0.001), falling in both males (p<0.001) and females (p<0.01). Ex-smokers rose from 5.9% to 15.1% between 1990 and 2002, corresponding with the decline in current smokers. The prevalence of current drinkers has risen over the period, to 82.5% among western students in 2002 (p<0.05); female drinking has increased steadily since 1973 (p<0.001), and the overall proportion of CAGE-positive drinkers has risen since 1990 (p<0.001). The mean weekly alcohol consumption has risen in both sexes since 1990 (males 14.3 units to 19.4, p<0.01; females 6.0 to 9.5, p<0.001). There was an increase in the proportion of students ever offered drugs between 1973 and 2002 (p<0.001). Although smoking rates have fallen, our findings show a marked increase in alcohol and drug consumption between 1973 and 2002. Personal misuse of addictive substances by doctors may mean that doctors will fail to take misuse by patients seriously. A need for preventative and ameliorative action during the medical school years is clear. PMID:16735098

  10. Psychological and Drug Abuse Symptoms Associated with Non-medical Use of Opioid Analgesics among Adolescents

    PubMed Central

    Boyd, Carol J; Young, Amy; McCabe, Sean E

    2014-01-01

    Background This exploratory study examined the psychological and substance abuse symptoms and motivations associated with adolescents’ medical and nonmedical use of opioid analgesics. We compared three groups of adolescents: 1) those who never used an opioid analgesic; 2) those who used a prescribed opioid analgesic (medical users); and 3) those who used someone else’s opioid analgesics (nonmedical users). Nonmedical use was defined as using someone else’s opioid analgesic medication. Comparisons among the groups were made on psychological and substance abuse symptoms as well as motivations to engage in nonmedical use. Methods A web-based survey, the Secondary Student Life Survey (SSLS) was administered to a sample of students who attended one of five secondary schools in southeastern Michigan. The sample included 2,627 respondents and was evenly distributed by sex and grade. Sixty-five percent (65.0%) were White/Caucasian and 29.5% African-American. The average age was 14.8 years (SD=1.9). Results Seventy percent (70.4%, n=1850) reported never using opioid analgesics in their lifetimes. Of the remaining 24.5% (n=644) of opioid analgesic users, most were medical users. However, 3.5% (n=92) were classified as nonmedical users who used someone else’s medication for pain relief only, and 1.6% (n=41) were classified as nonmedical users for reasons other than for pain relief (e.g. to get high). In contrast to never users, both medical users and nonmedical users reported more substance abuse symptoms and symptoms associated with pain. Further, those nonmedical users who used opioids to sensation seek had greater odds of having psychological symptoms. Conclusions These data: 1) provide additional support for the existence of distinct subgroups of adolescent opioid analgesic users; 2) provide evidence of psychological symptoms associated with nonmedical use; and 3) highlight the psychological differences among nonmedical users who self-treat for pain versus

  11. Health Services Utilization and Payments in Patients With Cancer Pain: A Comparison of Intrathecal Drug Delivery vs. Conventional Medical Management

    PubMed Central

    Stearns, Lisa J.; Hammond, Krisstin; Berryman, Eric; Janjan, Nora A.

    2016-01-01

    Introduction To compare health services utilization and payments for cancer patients who received an implantable intrathecal drug delivery (IDD) system, consisting of a pump and catheter, vs. conventional medical management (CMM) for the treatment of cancer‐related pain. Methods This retrospective claims‐data analysis compared health services utilization and payments in a population of patients receiving either IDD or CMM for treatment of cancer pain. Patients were propensity score‐matched 1:1 based on characteristics including, but not limited to, age, gender, cancer type, comorbid conditions, and health care utilization and payments. Results From a sample of 142 IDD patients and 3188 CMM patients who met all inclusion/exclusion criteria, 73 matched pairs were obtained. In the year following implant, IDD patients had a consistent trend of lower medical utilization, and total payments that were $3195 lower compared to CMM. Conclusions Despite the high initial cost of IDD, this analysis suggests that patients with IDD incur lower medical utilization and payments over the first year post‐implant. Further analysis comprised of a larger, longitudinal sample would contribute to health economics and outcomes research, and assist with future practice guideline development. PMID:26816205

  12. Integration of pharmacogenetics and pharmacogenomics in drug development: implications for regulatory and medical decision making in pediatric diseases.

    PubMed

    Piana, Chiara; Surh, Linda; Furst-Recktenwald, Sabine; Iolascon, Achille; Jacqz-Aigrain, Evelyne M; Jonker, Ineke; Russo, Roberta; van Schaik, Ron H N; Wessels, Judith; Della Pasqua, Oscar E

    2012-05-01

    This article aims to provide an overview of the current situation regarding pharmacogenetic and pharmacogenomic (PG) studies in pediatrics, with a special focus on the role of PG data in the regulatory decision-making process. Despite the gap in pharmacogenetic research due to the lack of translational studies in adults and children, several technologies exist in drug development and biomarkers validation, which could supply valuable information concerning labeling and dosing recommendations. If performed under strict good clinical practice quality criteria, such findings could be included in the submission package of new chemical entities and used as additional information for prescribers, supporting further evaluation and understanding of the efficacy and safety profile of new medicines. Even though regulatory authorities may be aware of the potential role of PG in medical practice and guidances are available about the integration of PG in drug development, most data obtained from PG studies are not used by prescribers. The challenge is to better understand whether PG markers can be used to assess potential differences in drug response during the clinical program, so PG data can be integrated into the regulatory decision-making process, enabling the introduction of labeling information that promotes optimal dosing in the pediatric population. PMID:21566202

  13. Probable Drug-Related Meningioma Detected During the Course of Medication Review Services.

    PubMed

    Alderman, Christopher P

    2016-09-01

    There is evidence to support a link between treatment with high-dose cyproterone acetate and the development of meningioma. This report describes a case where an elderly man with intellectual disability who was treated with cyproterone for problematic sexual behavior developed a meningioma. The case was the subject of a residential medication management review provided under the auspices of a program funded by the Commonwealth Government of Australia. A discussion of clinical and ethical implications of the case is provided. PMID:27636874

  14. Assessing the comparative effectiveness of newly marketed medications: methodological challenges and implications for drug development.

    PubMed

    Schneeweiss, S; Gagne, J J; Glynn, R J; Ruhl, M; Rassen, J A

    2011-12-01

    Comparative-effectiveness research (CER) aims to produce actionable evidence regarding the effectiveness and safety of medical products and interventions as they are used outside of controlled research settings. Although CER evidence regarding medications is particularly needed shortly after market approval, key methodological challenges include (i) potential bias due to channeling of patients to the newly marketed medication because of various patient-, physician-, and system-related factors; (ii) rapid changes in the characteristics of the user population during the early phase of marketing; and (iii) lack of timely data and the often small number of users in the first few months of marketing. We propose a mix of approaches to generate comparative-effectiveness data in the early marketing period, including sequential cohort monitoring with secondary health-care data and propensity score (PS) balancing, as well as extended follow-up of phase III and phase IV trials, indirect comparisons of placebo-controlled trials, and modeling and simulation of virtual trials. PMID:22048230

  15. Medication and participation: A qualitative study of patient experiences with antipsychotic drugs.

    PubMed

    Lorem, Geir F; Frafjord, Jartrud S; Steffensen, Marie; Wang, Catharina E A

    2014-05-01

    Patient autonomy is recognised within mental healthcare, although the capacity to participate in one's own treatment planning is often reduced during a psychotic crisis. The patient may not be sufficiently competent to give consent or express preferences at the time treatment decisions are made. Nine participants were interviewed shortly after a crisis. We discussed participation in the treatment planning and recovery process with particular emphasis on interactions with professionals and understanding treatment. The participants recognised the need for drugs and mental healthcare but emphasised the need for better cooperation and communication. To facilitate the development of patient autonomy, we recommend an increased emphasis on providing information and participating in a dialogue about drug treatment options. This could counteract many of the negative experiences reported. The use of debriefing during hospitalisation and following coercion can be a practical tool for clarifying patient preferences and mutual understanding.

  16. Should performance-enhancing drugs in sport be legalized under medical supervision?

    PubMed

    Wiesing, Urban

    2011-02-01

    This review examines the question of whether performance-enhancing drugs should be permitted in sport under the control of physicians, and evaluates the expected outcomes of such a scenario. Such a change in regulation would need to be tightly controlled because of the risks involved. The results of legalizing performance-enhancing drugs in competitive sport would be either unhelpful or negative, and the unwanted aspects of doping control would not disappear. Athletes, including children and adolescents who wanted to pursue competitive sports, would be forced to take additional, avoidable health risks. The 'natural lottery' of athletic talents would be compensated for only partially by use of performance-enhancing agents. It would also be complemented by another 'natural lottery' of variable responses to doping measures, combined with the inventiveness of doping doctors. There would be no gain in 'justice' (i.e. fairer results that reflected efforts made) for athletes as a result of legalizing doping. Legalization would not reduce restrictions on athletes' freedom; the control effort would remain the same, if not increased. Extremely complicated international regulations would have to be adopted. The game of the 'tortoise and the hare' between doping athletes and inspectors would remain because prohibited but not identifiable practices could still provide additional benefits from use of permissible drugs. Audience mistrust, particularly toward athletes who achieved outstanding feats, would remain because it would still be possible that these athletes were reliant on illegal doping practices. Doping entails exposing the athletes to avoidable risks that do not need to be taken to increase the appeal of a sport. Most importantly, the function of sport as a role model would definitely be damaged. It is not necessary to clarify the question of what constitutes the 'spirit of sport' and whether this may be changed. From a practical point of view, a legalization of

  17. Should performance-enhancing drugs in sport be legalized under medical supervision?

    PubMed

    Wiesing, Urban

    2011-02-01

    This review examines the question of whether performance-enhancing drugs should be permitted in sport under the control of physicians, and evaluates the expected outcomes of such a scenario. Such a change in regulation would need to be tightly controlled because of the risks involved. The results of legalizing performance-enhancing drugs in competitive sport would be either unhelpful or negative, and the unwanted aspects of doping control would not disappear. Athletes, including children and adolescents who wanted to pursue competitive sports, would be forced to take additional, avoidable health risks. The 'natural lottery' of athletic talents would be compensated for only partially by use of performance-enhancing agents. It would also be complemented by another 'natural lottery' of variable responses to doping measures, combined with the inventiveness of doping doctors. There would be no gain in 'justice' (i.e. fairer results that reflected efforts made) for athletes as a result of legalizing doping. Legalization would not reduce restrictions on athletes' freedom; the control effort would remain the same, if not increased. Extremely complicated international regulations would have to be adopted. The game of the 'tortoise and the hare' between doping athletes and inspectors would remain because prohibited but not identifiable practices could still provide additional benefits from use of permissible drugs. Audience mistrust, particularly toward athletes who achieved outstanding feats, would remain because it would still be possible that these athletes were reliant on illegal doping practices. Doping entails exposing the athletes to avoidable risks that do not need to be taken to increase the appeal of a sport. Most importantly, the function of sport as a role model would definitely be damaged. It is not necessary to clarify the question of what constitutes the 'spirit of sport' and whether this may be changed. From a practical point of view, a legalization of

  18. Personalized prescribing: a new medical model for clinical implementation of psychotropic drugs

    PubMed Central

    Eap, Chin B.

    2016-01-01

    The use of pharmacogenetic tests was already being proposed in psychiatry in the early 2000s because genetic factors were known to influence drug pharmacokinetics and pharmacodynamics. However, sufficient levels of evidence to justify routine use have been achieved for only a few tests (eg, major histocompatibility complex, class I, B, allele 1502 [HLA-B*1502] for carbamazepine in epilepsy and bipolar disorders); many findings are too preliminary or, when replicated, of low clinical relevance because of a small effect size. Although drug selection and dose adaptation according to cytochrome P450 genotypes are sound, a large number of patients need to be genotyped in order to prevent one case of severe side effect and/or nonresponse. The decrease in cost for genetic analysis shifts the cost: benefit ratio toward increasing use of pharmacogenetic tests. However, they have to be combined with careful clinical evaluations and other tools (eg, therapeutic drug monitoring and phenotyping) to contribute to the general aim of providing the best care for psychiatric patients. PMID:27757065

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

    PubMed

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

    2013-04-01

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

  20. [Twenty-year History and Future Challenges in Transparency Enhancement of Review Process for Approval: Focus on Public Release of Review Reports regarding New Drugs and Medical Devices].

    PubMed

    Morimoto, Kazushige; Kawasaki, Satoko; Yoshida, Yasunori

    2015-01-01

    For 20 years, the Ministry of Health, Labour and Welfare (MHLW, formerly Ministry of Health and Welfare (MHW)) has been trying to increase transparency of the review process for approving reports in order to promote the rational use of newly approved drugs and medical devices. The first Summary Basis of Approval (SBA) was published by MHW in 1994. In 1999, evaluation reports were prepared by MHW and the Pharmaceuticals and Medical Devices Evaluation Center to make them available to the public. In 2005, a notice from the Chief Executive of the Pharmaceuticals and Medical Devices Agency (PMDA) made procedures for public release of information on reviewing applications for new drugs. In 2006, 90 review reports of newly approved drugs and eight medical devices were revealed on PMDA websites. The dissemination of information by the United States Food and Drug Administration (FDA) and that of the European Medicines Agency (EMA) were studied and compared with that of the MHLW and PMDA. While common technical documents (CTD) for new drugs and summary technical documents (STED) for new medical devices have been released by PMDA, such documents are not released by the FDA and EMA. The European Public Assessment Report (EAPR) summary for the public is an interesting questionnaire approach that uses the "What," "How" and "Why" format. Finally, future proposals for the next decade are also outlined. PMID:26427100

  1. Compensating for literature annotation bias when predicting novel drug-disease relationships through Medical Subject Heading Over-representation Profile (MeSHOP) similarity

    PubMed Central

    2013-01-01

    Background Using annotations to the articles in MEDLINE®/PubMed®, over six thousand chemical compounds with pharmacological actions have been tracked since 1996. Medical Subject Heading Over-representation Profiles (MeSHOPs) quantitatively leverage the literature associated with biological entities such as diseases or drugs, providing the opportunity to reposition known compounds towards novel disease applications. Methods A MeSHOP is constructed by counting the number of times each medical subject term is assigned to an entity-related research publication in the MEDLINE database and calculating the significance of the count by comparing against the count of the term in a background set of publications. Based on the expectation that drugs suitable for treatment of a disease (or disease symptom) will have similar annotation properties to the disease, we successfully predict drug-disease associations by comparing MeSHOPs of diseases and drugs. Results The MeSHOP comparison approach delivers an 11% improvement over bibliometric baselines. However, novel drug-disease associations are observed to be biased towards drugs and diseases with more publications. To account for the annotation biases, a correction procedure is introduced and evaluated. Conclusions By explicitly accounting for the annotation bias, unexpectedly similar drug-disease pairs are highlighted as candidates for drug repositioning research. MeSHOPs are shown to provide a literature-supported perspective for discovery of new links between drugs and diseases based on pre-existing knowledge. PMID:23819887

  2. Medical care and drug-related problems: Do doctors and pharmacists speak the same language?

    PubMed

    Foppe van Mil, J W; Westerlund, Tommy; Brown, Lawrence; Chen, Timothy F; Henman, Martin; Hersberger, Kurt; McElnay, James; Schulz, Martin

    2016-04-01

    Optimal communication between physicians and pharmacists is important for patient care. However, pharmacists and doctors do not always seem to understand each other. They have been professionalized differently, and do not always speak the same language. Especially in the areas of prescribing, medication review, and medicine use, there can be differences in views. This contribution clarifies some essential concepts that doctors and pharmacists use. Thus we hope that our commentary contributes to a better understanding of each other's role and the importance of interprofessional cooperation for the benefit of the patient.

  3. Blood Donors on Medication - an Approach to Minimize Drug Burden for Recipients of Blood Products and to Limit Deferral of Donors.

    PubMed

    Becker, Christian D K; Stichtenoth, Dirk O; Wichmann, Michael G; Schaefer, Christof; Szinicz, Ladislaus

    2009-01-01

    BACKGROUND: Blood products derived from donors on medication can contain drugs which might pose a risk for the recipients or influence the quality of the product itself. MATERIAL AND METHODS: To judge the eligibility of blood donors on medication, 4 drug classes have been formed with respect to their pharmacological properties, and blood products have been divided in accordance with their single-donor plasma contents. RESULTS: For drugs with dose-dependent pharmacodynamics, no deferral periods are necessary for donation of blood products containing less than 50 ml single-donor plasma for application to adults. Waiting periods of t(max) + 5 t(1/2) were calculated for the other blood products. Teratogenic drugs do not require special considerations (exception: retinoids, thalidomide and lenalidomide, dutasteride or finasteride with waiting periods for all blood products). A deferral period of t(max) + 24 t(1/2) is proposed for every blood product from blood donors on genotoxic drugs. Drugs without systemic effects can be neglected. Irreversible inhibitors of platelet function cause a 10-day waiting period if production of platelet concentrates is intended. CONCLUSION: Donors on medication are allowed to donate blood for blood products containing less than 50 ml plasma of a single donor, like red blood cell concentrates, for the use in adults without deferral periods, except those taking retinoids, thalidomide, lenalidomide, dutasteride, finasteride, or genotoxic drugs. PMID:20823991

  4. Investigating clandestine drug laboratories: adverse medical effects in law enforcement personnel.

    PubMed

    Burgess, J L; Barnhart, S; Checkoway, H

    1996-10-01

    A retrospective cohort study was conducted among an international group of 46 law enforcement chemists and 13 Washington State clandestine drug laboratory investigation team members with more than 2,800 combined investigations. Each participant completed a questionnaire concerning previous drug laboratory investigations and adverse health effects during response activities. Methamphetamine laboratories accounted for 81-97% of all responses. Total illness incident rates varied between 0.75-3.4% of responses. Most exposures were through inhalation, and many occurred in the years prior to use of personal protective equipment. Symptoms were primarily those of headache and respiratory, mucous membrane, and skin irritation. Most illness episodes occurred during the processing phase of laboratory responses, and none occurred during the entry phase. A majority of illness episodes occurred in laboratories with leak/spills, fire/explosion, or uncontrolled reactions. Responding to an active laboratory was associated with a 7 to 15-fold risk of becoming ill as compared with setup, in-transit, or former (equipment removed) laboratory responses. No other laboratories characteristics were consistently associated with a significantly elevated relative risk of adverse health effects. PMID:8892555

  5. Colleague interactions and new drug prescribing behavior: the case of the initial prescription of antidepressants in Taiwanese medical centers.

    PubMed

    Lin, Shu-Jou; Jan, Kuan-An; Kao, Jen-Tse

    2011-10-01

    This research explores the social factors influencing hospital physicians' initial adoption of duloxetine hydrochloride, with a focus on colleague interactions. The study analyzes archival data compiled by the National Health Insurance Research Database of Taiwan to examine how the prescribing decisions made by psychiatrists' colleagues influence the likelihood of the psychiatrists' initial prescription. The results show that the adoption ratio of a physician's colleagues in a medical center is positively associated with the likelihood of a physician's adoption of the new drug. Specifically, colleague groups with similar and longer tenure as well as similar and older age have significantly positive effects. Colleague groups with the same and different gender also have positive effects. In summary, tenure and age, rather than gender, are vital sources of heterogeneous colleague interactions.

  6. Geographical expansion and the reconfiguration of medical authority: Garcia de Orta's Colloquies on the simples and drugs of India (1563).

    PubMed

    da Costa, Palmira Fontes

    2012-03-01

    The Colloquies on the simples and drugs of India (1563) were conceived and published at a sensitive moment, both in terms of the history of print culture and of European geographical expansion. They represented the culmination of a life-time project for their author Garcia de Orta who had lived for almost thirty years in Portuguese Goa. Although the importance of the work in sixteenth-century natural history and medicine has been generally acknowledged in Portuguese and international historiography, there are very few recent, detailed studies of the book informed by new approaches. This paper presents an integrated analysis of Orta's Colloquies as a literary, medical and cultural text. It aims to reveal not only the rich and subtle dynamics of the work but also to contribute to a better understanding of Orta's legitimation strategies as an author in a sixteenth-century world reconfigured by the new opportunities of the printing press, geographical expansion and increased material and cultural mobility.

  7. Impact of weight-loss medications on the cardiovascular system: focus on current and future anti-obesity drugs.

    PubMed

    Drolet, Benoit; Simard, Chantale; Poirier, Paul

    2007-01-01

    Overweight and obesity have been rising dramatically worldwide and are associated with numerous co-morbidities such as cardiovascular disease (CVD), type 2 diabetes mellitus, hypertension, certain cancers, and sleep apnea. In fact, obesity is an independent risk factor for CVD and CVD risks have also been documented in obese children. The majority of overweight and obese patients who achieve a significant short-term weight loss do not maintain their lower bodyweight in the long term. This may be due to a lack of intensive counseling and support from a facilitating environment including dedicated healthcare professionals such as nutritionists, kinesiologists, and behavior specialists. As a result, there has been a considerable focus on the role of adjunctive therapy such as pharmacotherapy for long-term weight loss and weight maintenance. Beyond an unfavorable risk factor profile, overweight and obesity also impact upon heart structure and function. Since the beginning, the quest for weight loss drugs has encountered warnings from regulatory agencies and the withdrawal from the market of efficient but unsafe medications. Fenfluramine was withdrawn from the market because of unacceptable pulmonary and cardiac adverse effects. Nevertheless, there is extensive research directed at the development of new anti-obesity compounds. The effect of these molecules on CVD risk factors has been studied and reported but information regarding their impact on the cardiovascular system is sparse. Thus, instead of looking at the benefit of weight loss on metabolism and risk factor management, this article discusses the impact of weight loss medications on the cardiovascular system. The potential interaction of available and potential new weight loss drugs with heart function and structure is reviewed. PMID:17696568

  8. The male heart and the female mind: a study in the gendering of antidepressants and cardiovascular drugs in advertisements in Irish medical publication.

    PubMed

    Curry, Phillip; O'Brien, Marita

    2006-04-01

    Stereotypes which suggest that cardiovascular disease and depression are related to gender can have consequences for the mental and physical health outcomes of both men and women. This study examines how these stereotypes may be reinforced by medical publications advertising for cardiovascular and antidepressant medication. A random sample of 61 (with no repeats) advertisements which appeared in Irish medical publications between July 2001 and December 2002 were analysed using both content and semiotic analysis. Results indicate that the meanings created by advertisers for cardiovascular drugs and antidepressants did in fact gender these products. Women were depicted as the predominant users of antidepressants and men as the main users of cardiovascular drugs. The images used identified two stereotyped patients: the 'male' heart patient and the depressed 'female' patient. Furthermore, the imagery and language used to promote the two categories of medication tended to strengthen gendered associations. PMID:16214280

  9. Assessment of rational use of drugs and self-medication in Turkey: A pilot study from Elazıg and its suburbs.

    PubMed

    Nayir, Tufan; Okyay, Ramazan Azim; Yesilyurt, Hakki; Akbaba, Muhsin; Nazlıcan, Ersin; Acık, Yasemin; Akkus, Halil Ibrahim

    2016-07-01

    The concepts of "essential drugs" and "national drug policy" described by the World Health Assembly in 1975 were the first steps taken towards the rational use of drugs (RUD). According to WHO, more than half of all medicines worldwide are prescribed, dispensed or sold inappropriately and half of the patients fail to take them appropriately. The aim of this study has been to evaluate the habits of patients related to RUD with a specific aim to investigate the factors associated with self-medication. This descriptive survey study was carried out in Elazıg, located at the Southeastern region of Turkey. A Rational Usage of Drug Questionnaire", querying the socio-demographic characteristics, health status, knowledge and manners of people with respect to rational drug use and insensible consumption of over the counter (OTC) drugs was applied to a total of 3521 patients during 19.09.2014 to 26.09.2014.The number of females and males were almost equal and the majority were in the range of 25-45 years of age. It was found that 58.9% of patients were practising some form of self-medication, 29.4% of the patients were reported using antibiotics without prescriptionand55.5% of them discontinued antibiotherapy. Self-medication was found to be more common among males, more educated patients and less frequent among patients under 18 years and over 65 years of age and patients with a chronic disease. Patient awareness about RUD is inadequate in Turkey as in many countries. Considering the high rates of haphazard use of drugs, drug usage without prescription, i.e. OTC drugs, should be discouraged. It is possible to take significant steps towards increasing awareness in terms of RUD with the cooperation of physicians, health organizations, educational institutions, non-governmental organizations and media. Might then be possible to achieve the expected benefits of the drugs. PMID:27592477

  10. Medical management of refractory epilepsy--practical treatment with novel antiepileptic drugs.

    PubMed

    Ben-Menachem, Elinor

    2014-01-01

    The ultimate treatment goal in epilepsy therapy is always freedom from seizures with as few treatment adverse effects as possible. If seizures persist with the first monotherapy, alternative monotherapy with another antiepileptic drug (AED) should be considered. Continuing seizures should lead to a reevaluation of differential diagnosis and adherence. Epilepsy surgery as an alternative therapy may be suitable in selected cases. If the diagnosis of epilepsy is established and epilepsy surgery is not appropriate, AED treatment should be optimized. Evidence for how to proceed is lacking. Concepts such as rational polytherapy have been advocated but remain speculative concerning better efficacy based on the use of AEDs with differing modes of action. A variety of new AEDs including rufinamide, lacosamide, vigabatrin, perampanel, and retigabine have been recently introduced in the United States. They are briefly characterized in this update review. PMID:24400690

  11. Orphan drug development and the impact on non-medical support groups.

    PubMed

    Manuel, Jeremy; Collin-Histed, Tanya

    2013-11-01

    The Orphan Drug legislation in the United States and later in the EU has had a significant impact on patients worldwide who suffer from an orphan condition. Apart from providing statutory encouragement and incentives to pharmaceutical companies to develop therapeutic products it has resulted in the encouragement of patients to come together to form patient bodies to advocate on behalf of patients. Starting in a modest way patient groups have gained experience in working with clinicians and scientists and representing their members to companies and to healthcare providers in national European and global environments. This article describes the history and evolution of the patient body and the coming together of national patient groups through umbrella organisations which have proven to be a powerful advocate for pan European and global collaboration and humanitarian aid. It also will review of some unintended consequences of the legislation.

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

    PubMed

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

    2016-01-01

    Recalls of non-prescription drugs can contribute to preventing harm to human health, however, they also interrupt the supply of medicines to the market. The aim of the present study was to investigate the trends in non-prescription drug recalls in Japan. Class I, II, and III recalls reported from April 2009 to March 2014 were obtained from the websites of the Ministry of Health, Labour and Welfare and the Pharmaceuticals and Medical Devices Agency. Each drug recall was classified according to year, dosage form, therapeutic category, and reasons for the recall. The trends over the 5 year period were assessed for each class. A total of 220 recalls were reported in the 5-year study period. The numbers of drug recalls were 21, 16, 80, 58, and 45 in 2009, 2010, 2011, 2012, and 2013, respectively. The drugs recalled consisted of 177 internal medications, 35 topical agents, and 8 others. Drug recalls were observed in 12 therapeutic categories of drug effects. The largest number of recalls was for Chinese herbal medicines and crude drugs. Of all the drug recalls in 2011, Chinese herbal medicines and crude drugs produced by one manufacturer accounted for 84%. Slightly more than half (54%) of drug recalls were due to a violation of the regulations. One manufacturer recalled many drugs because of non-compliance with the standard regulations for manufacturing drugs after 2011. In conclusion, non-prescription drug recalls can occur for any drug regardless of the dosage form and therapeutic category. PMID:27592833

  13. Adverse Drug Reactions Causing Admission to Medical Wards: A Cross-Sectional Survey at 4 Hospitals in South Africa.

    PubMed

    Mouton, Johannes P; Njuguna, Christine; Kramer, Nicole; Stewart, Annemie; Mehta, Ushma; Blockman, Marc; Fortuin-De Smidt, Melony; De Waal, Reneé; Parrish, Andy G; Wilson, Douglas P K; Igumbor, Ehimario U; Aynalem, Getahun; Dheda, Mukesh; Maartens, Gary; Cohen, Karen

    2016-05-01

    Limited data exist on the burden of serious adverse drug reactions (ADRs) in sub-Saharan Africa, which has high HIV and tuberculosis prevalence. We determined the proportion of adult admissions attributable to ADRs at 4 hospitals in South Africa. We characterized drugs implicated in, risk factors for, and the preventability of ADR-related admissions.We prospectively followed patients admitted to 4 hospitals' medical wards over sequential 30-day periods in 2013 and identified suspected ADRs with the aid of a trigger tool. A multidisciplinary team performed causality, preventability, and severity assessment using published criteria. We categorized an admission as ADR-related if the ADR was the primary reason for admission.There were 1951 admissions involving 1904 patients: median age was 50 years (interquartile range 34-65), 1057 of 1904 (56%) were female, 559 of 1904 (29%) were HIV-infected, and 183 of 1904 (10%) were on antituberculosis therapy (ATT). There were 164 of 1951 (8.4%) ADR-related admissions. After adjustment for age and ATT, ADR-related admission was independently associated (P ≤ 0.02) with female sex (adjusted odds ratio [aOR] 1.51, 95% confidence interval [95% CI] 1.06-2.14), increasing drug count (aOR 1.14 per additional drug, 95% CI 1.09-1.20), increasing comorbidity score (aOR 1.23 per additional point, 95% CI 1.07-1.41), and use of antiretroviral therapy (ART) if HIV-infected (aOR 1.92 compared with HIV-negative/unknown, 95% CI 1.17-3.14). The most common ADRs were renal impairment, hypoglycemia, liver injury, and hemorrhage. Tenofovir disoproxil fumarate, insulin, rifampicin, and warfarin were most commonly implicated, respectively, in these 4 ADRs. ART, ATT, and/or co-trimoxazole were implicated in 56 of 164 (34%) ADR-related admissions. Seventy-three of 164 (45%) ADRs were assessed as preventable.In our survey, approximately 1 in 12 admissions was because of an ADR. The range of ADRs and implicated drugs reflect South Africa's high HIV

  14. Drug and herb induced liver injury: Council for International Organizations of Medical Sciences scale for causality assessment.

    PubMed

    Teschke, Rolf; Wolff, Albrecht; Frenzel, Christian; Schwarzenboeck, Alexander; Schulze, Johannes; Eickhoff, Axel

    2014-01-27

    Causality assessment of suspected drug induced liver injury (DILI) and herb induced liver injury (HILI) is hampered by the lack of a standardized approach to be used by attending physicians and at various subsequent evaluating levels. The aim of this review was to analyze the suitability of the liver specific Council for International Organizations of Medical Sciences (CIOMS) scale as a standard tool for causality assessment in DILI and HILI cases. PubMed database was searched for the following terms: drug induced liver injury; herb induced liver injury; DILI causality assessment; and HILI causality assessment. The strength of the CIOMS lies in its potential as a standardized scale for DILI and HILI causality assessment. Other advantages include its liver specificity and its validation for hepatotoxicity with excellent sensitivity, specificity and predictive validity, based on cases with a positive reexposure test. This scale allows prospective collection of all relevant data required for a valid causality assessment. It does not require expert knowledge in hepatotoxicity and its results may subsequently be refined. Weaknesses of the CIOMS scale include the limited exclusion of alternative causes and qualitatively graded risk factors. In conclusion, CIOMS appears to be suitable as a standard scale for attending physicians, regulatory agencies, expert panels and other scientists to provide a standardized, reproducible causality assessment in suspected DILI and HILI cases, applicable primarily at all assessing levels involved.

  15. Medical eligibility, comprehension of the consent process, and retention of injection drug users recruited for an HIV vaccine trial.

    PubMed

    Harrison, K; Vlahov, D; Jones, K; Charron, K; Clements, M L

    1995-11-01

    Injection drug users (IDUs) at high risk for human immunodeficiency virus (HIV) infection are being identified as a population for HIV vaccine trials. We studied willingness of drug users to enroll and their comprehension of consent procedures in the context of a Phase II trial at one site. Of 175 people screened for enrollment and whose data sets were complete, 119 (68%) were IDUs. Of the 71 who were eligible, 39 (55%) were IDUs. Exclusion of IDUs was usually for medical reasons. Using a 17-item true/false test, comprehension of the informed consent procedure was high (median score, 16 of 17 for IDUs and non-IDUs); only three subjects (all of whom were IDUs) were excluded from enrollment due to lack of comprehension. Follow-up rates were similar for IDUs and non-IDUs. These data suggest that recruitment of IDUs into HIV vaccine trials is feasible, that IDUs can comprehend and complete the informed consent procedures, and that they return for follow-up visits.

  16. Medical marijuana patient counseling points for health care professionals based on trends in the medical uses, efficacy, and adverse effects of cannabis-based pharmaceutical drugs.

    PubMed

    Parmar, Jayesh R; Forrest, Benjamin D; Freeman, Robert A

    2016-01-01

    The purpose of this report is to present a review of the medical uses, efficacy, and adverse effects of the three approved cannabis-based medications and ingested marijuana. A literature review was conducted utilizing key search terms: dronabinol, nabilone, nabiximols, cannabis, marijuana, smoke, efficacy, toxicity, cancer, multiple sclerosis, nausea, vomiting, appetite, pain, glaucoma, and side effects. Abstracts of the included literature were reviewed, analyzed, and organized to identify the strength of evidence in medical use, efficacy, and adverse effects of the approved cannabis-based medications and medical marijuana. A total of 68 abstracts were included for review. Dronabinol's (Marinol) most common medical uses include weight gain, chemotherapy-induced nausea and vomiting (CINV), and neuropathic pain. Nabiximol's (Sativex) most common medical uses include spasticity in multiple sclerosis (MS) and neuropathic pain. Nabilone's (Cesamet) most common medical uses include CINV and neuropathic pain. Smoked marijuana's most common medical uses include neuropathic pain and glaucoma. Orally ingested marijuana's most common medical uses include improving sleep, reducing neuropathic pain, and seizure control in MS. In general, all of these agents share similar medical uses. The reported adverse effects of the three cannabis-based medications and marijuana show a major trend in central nervous system (CNS)-related adverse effects along with cardiovascular and respiratory related adverse effects. Marijuana shares similar medical uses with the approved cannabis-based medications dronabinol (Marinol), nabiximols (Sativex), and nabilone (Cesamet), but the efficacy of marijuana for these medical uses has not been fully determined due to limited and conflicting literature. Medical marijuana also has similar adverse effects as the FDA-approved cannabis-based medications mainly consisting of CNS related adverse effects but also including cardiovascular and respiratory

  17. Medical marijuana patient counseling points for health care professionals based on trends in the medical uses, efficacy, and adverse effects of cannabis-based pharmaceutical drugs.

    PubMed

    Parmar, Jayesh R; Forrest, Benjamin D; Freeman, Robert A

    2016-01-01

    The purpose of this report is to present a review of the medical uses, efficacy, and adverse effects of the three approved cannabis-based medications and ingested marijuana. A literature review was conducted utilizing key search terms: dronabinol, nabilone, nabiximols, cannabis, marijuana, smoke, efficacy, toxicity, cancer, multiple sclerosis, nausea, vomiting, appetite, pain, glaucoma, and side effects. Abstracts of the included literature were reviewed, analyzed, and organized to identify the strength of evidence in medical use, efficacy, and adverse effects of the approved cannabis-based medications and medical marijuana. A total of 68 abstracts were included for review. Dronabinol's (Marinol) most common medical uses include weight gain, chemotherapy-induced nausea and vomiting (CINV), and neuropathic pain. Nabiximol's (Sativex) most common medical uses include spasticity in multiple sclerosis (MS) and neuropathic pain. Nabilone's (Cesamet) most common medical uses include CINV and neuropathic pain. Smoked marijuana's most common medical uses include neuropathic pain and glaucoma. Orally ingested marijuana's most common medical uses include improving sleep, reducing neuropathic pain, and seizure control in MS. In general, all of these agents share similar medical uses. The reported adverse effects of the three cannabis-based medications and marijuana show a major trend in central nervous system (CNS)-related adverse effects along with cardiovascular and respiratory related adverse effects. Marijuana shares similar medical uses with the approved cannabis-based medications dronabinol (Marinol), nabiximols (Sativex), and nabilone (Cesamet), but the efficacy of marijuana for these medical uses has not been fully determined due to limited and conflicting literature. Medical marijuana also has similar adverse effects as the FDA-approved cannabis-based medications mainly consisting of CNS related adverse effects but also including cardiovascular and respiratory

  18. Quality beyond compliance.

    PubMed

    Centanni, N; Monroe, M; White, L; Larson, R

    1999-01-01

    The service sector within the biopharmaceutical industry has experienced phenomenal growth over the past decade. In the highly regulated Good Laboratory Practices environment, the need for timely, high-quality service, accurate results, and on-time deliverables becomes paramount for the success and profitability of biopharmaceutical companies. The quality assurance process is a vital component of this drug product-development cycle and ensures compliance to the highest domestic and international regulatory standards. Quality-assurance professionals historically have held the role of independent auditors of the processes, who certify that results meet current standards of practice. Covance, a contract research organization that includes Good Laboratory Practices laboratories, reorganized and expanded the functional responsibilities of its quality assurance team in 1997. Auditors and quality assurance professionals have assumed roles beyond traditional compliance auditing and are forging new leadership and mentoring roles as process-improvement specialists. The results have been tangible, measurable benefits for clients and the Covance organization. This article provides an overview of this cultural change and the processes put in place to improve efficiency, productivity, and customer and employee satisfaction.

  19. Quality beyond compliance.

    PubMed

    Centanni, N; Monroe, M; White, L; Larson, R

    1999-01-01

    The service sector within the biopharmaceutical industry has experienced phenomenal growth over the past decade. In the highly regulated Good Laboratory Practices environment, the need for timely, high-quality service, accurate results, and on-time deliverables becomes paramount for the success and profitability of biopharmaceutical companies. The quality assurance process is a vital component of this drug product-development cycle and ensures compliance to the highest domestic and international regulatory standards. Quality-assurance professionals historically have held the role of independent auditors of the processes, who certify that results meet current standards of practice. Covance, a contract research organization that includes Good Laboratory Practices laboratories, reorganized and expanded the functional responsibilities of its quality assurance team in 1997. Auditors and quality assurance professionals have assumed roles beyond traditional compliance auditing and are forging new leadership and mentoring roles as process-improvement specialists. The results have been tangible, measurable benefits for clients and the Covance organization. This article provides an overview of this cultural change and the processes put in place to improve efficiency, productivity, and customer and employee satisfaction. PMID:10707374

  20. Compliance with nedocromil sodium and a nedocromil sodium/salbutamol combination. Compliance Working Group.

    PubMed

    Braunstein, G L; Trinquet, G; Harper, A E

    1996-05-01

    Nonadherence to prescribed preventive medication is common in asthma. We wanted to assess whether the combination of a beta 2-bronchodilator with an anti-inflammatory treatment in the same metered-dose inhaler (MDI) with a regular dosing schedule might improve compliance. A double-blind study was used to compare use (two actuations four times daily for 12 weeks) of 2 mg nedocromil sodium (n = 101) with a combination of 2 mg nedocromil sodium and 100 micrograms salbutamol (n = 100) in mild-to-moderate asthma patients (mean age 42 +/- 14 yrs; 98 males and 103 females). Compliance was measured using the electronic Nebulizer Chronolog (NC) device, change in MDI canister weight, patient questionnaire and physician assessment. The mean +/- SD number of actuations per day for nedocromil sodium and the combination during the primary period of assessment (Weeks 11-12) was 4.2 +/- 2.6 and 4.6 +/- 2.5 (NC), 5.3 +/- 2.1 and 5.3 +/- 2.0 (canister weight), and 7.5 +/- 1.3 and 7.4 +/- 1.3 (questionnaire), respectively. Physician assessment rated compliance as "good" to "excellent". The first and final days of the period were not used in the NC analysis to exclude part-days of treatment and drug-dumping (repeated actuations without inhalation), and may account for the difference between NC and canister weight results. The mean number of two-actuation doses per day determined from the NC was 2.1 +/- 1.3 for nedocromil sodium and 2.4 +/- 2.1 for the combination. Thirty five percent (nedocromil sodium) and 34% (combination) of the patients were compliant (6-10 actuations per day for > or = 60% of the days). We conclude that compliance is poor in asthma, electronic recording revealed the dumping phenomenon and, in this study, the combination of an inhaled beta 2-bronchodilator with a preventive treatment did not improve compliance over a three month period in patients with mild-to-moderate asthma.

  1. Measuring Adherence to Medication in Schizophrenia: The Relationship between Attitudes toward Drug Therapy and Plasma Levels of New-Generation Antipsychotics

    PubMed Central

    Yalcin-Siedentopf, Nursen; Wartelsteiner, Fabienne; Kaufmann, Alexandra; Biedermann, Falko; Edlinger, Monika; Kemmler, Georg; Rettenbacher, Maria A.; Widschwendter, Christian G.; Zernig, Gerald; Fleischhacker, W. Wolfgang

    2015-01-01

    Background: Nonadherence to medication is still a major problem in the treatment of schizophrenia. The current longitudinal study investigated whether the patients’ attitudes toward treatment correlated with the ratio of observed vs expected plasma levels of antipsychotic drugs as an objective measurement of adherence. Methods: Data of patients starting monotherapy with a new-generation antipsychotic were collected 2, 4, and 12 weeks after the initiation of treatment. Next to the assessment of patients’ attitudes toward medication by means of the Drug Attitude Inventory, the ratio of the observed vs expected plasma level was calculated. Antipsychotic-induced side effects were evaluated by means of the Udvalg for Kliniske Undersogelser Side Effect Rating Scale. Results: A total of 93 patients were eligible for statistical analysis. About one-half of the ratios of observed vs expected plasma levels ranged from 0.5 to 2 and were considered normal, whereas the other ratios were considered either too low (<0.5) or too high (>2). No consistent correlation between patients’ attitude toward drug therapy and the individual ratios of observed vs expected plasma levels of medication was detected. This finding was not affected by side effects. Conclusions: Our results highlight the importance of recognizing the complex nature of adherence to medication in schizophrenia patients. Importantly, we found no consistent correlation between subjective and objective measures of medication adherence. Therefore, monitoring adherence to medication remains a challenge in clinical practice. PMID:25522423

  2. Reducing the risk of medication errors in women.

    PubMed

    Grissinger, Matthew C; Kelly, Kate

    2005-01-01

    We outline some of the causes of medication errors involving women and recommend ways that healthcare practitioners can prevent some of these errors. Patient safety has become a major concern since the November 1999 release of the Institute of Medicine (IOM) report, "To Err Is Human." Errors involving prescription medications are responsible for up to 7000 American deaths per year, and the financial costs of drug-related morbidity and mortality may be nearly $77 billion a year. The Institute for Safe Medication Practices (ISMP) collects and analyzes voluntary confidential medication error reports and makes recommendations on the prevention of such errors. This paper uses the expertise of ISMP in medication error prevention to make recommendations to prevent medication errors involving women. Healthcare practitioners should focus on areas of the medication use process that would have the greatest impact, including obtaining complete patient information, accurately communicating drug information, and properly educating patients. Although medication errors are not more common in women, there are some unique concerns with medications used for treating women. In addition, sharing of information about medication use and compliance with medication regimens have been identified as concerns. Through the sharing of information and improving the patient education process, healthcare practitioners should play a more active role in medication error reduction activities by working together toward the goal of improving medication safety and encouraging women to become active in their own care.

  3. Medical treatment of breast cancer bone metastasis: from bisphosphonates to targeted drugs.

    PubMed

    Erdogan, Bulent; Cicin, Irfan

    2014-01-01

    Breast cancer bone metastasis causing severe morbidity is commonly encountered in daily clinical practice. It causes pain, pathologic fractures, spinal cord and other nerve compression syndromes and life threatening hypercalcemia. Breast cancer metastasizes to bone through complicated steps in which numerous molecules play roles. Metastatic cells disrupt normal bone turnover and create a vicious cycle to which treatment efforts should be directed. Bisphosphonates have been used safely for more than two decades. As a group they delay time to first skeletal related event and reduce pain, but do not prevent development of bone metastasis in patients with no bone metastasis, and also do not prolong survival. The receptor activator for nuclear factor κB ligand inhibitor denosumab delays time to first skeletal related event and reduces the skeletal morbidity rate. Radionuclides are another treatment option for bone pain. New targeted therapies and radionuclides are still under investigation. In this review we will focus on mechanisms of bone metastasis and its medical treatment in breast cancer patients.

  4. Advancing regulatory science to bring novel medical devices for use in emergency care to market: the role of the Food and Drug Administration.

    PubMed

    Scully, Christopher G; Forrest, Shawn; Galeotti, Loriano; Schwartz, Suzanne B; Strauss, David G

    2015-04-01

    The Food and Drug Administration (FDA) performs regulatory science to provide science-based medical product regulatory decisions. This article describes the types of scientific research the FDA's Center for Devices and Radiological Health performs and highlights specific projects related to medical devices for emergency medicine. In addition, this article discusses how results from regulatory science are used by the FDA to support the regulatory process as well as how the results are communicated to the public. Regulatory science supports the FDA's mission to assure safe, effective, and high-quality medical products are available to patients.

  5. Advancing regulatory science to bring novel medical devices for use in emergency care to market: the role of the Food and Drug Administration.

    PubMed

    Scully, Christopher G; Forrest, Shawn; Galeotti, Loriano; Schwartz, Suzanne B; Strauss, David G

    2015-04-01

    The Food and Drug Administration (FDA) performs regulatory science to provide science-based medical product regulatory decisions. This article describes the types of scientific research the FDA's Center for Devices and Radiological Health performs and highlights specific projects related to medical devices for emergency medicine. In addition, this article discusses how results from regulatory science are used by the FDA to support the regulatory process as well as how the results are communicated to the public. Regulatory science supports the FDA's mission to assure safe, effective, and high-quality medical products are available to patients. PMID:25128009

  6. Kickbacks, courtesies or cost-effectiveness?: Application of the Medicare antikickback Law to the marketing and promotional practices of drug and medical device manufacturers.

    PubMed

    Bulleit, T N; Krause, J H

    1999-01-01

    This article summarizes the purposes and history of the antikickback law and describes its evolution into a potent weapon against the corruption of medical decision making in the procurement of prescription drugs and medical devices. The article also details a variety of strategies for reducing risks under the law in several key areas of importance to manufacturers. While the purposes of the law are laudable, its current broad interpretation may impede not only corruption, but also benign forms of customer relations and innovative approaches to cost-effective medical care.

  7. Antiretroviral Drug Diversion Links Social Vulnerability to Poor Medication Adherence in Substance Abusing Populations

    PubMed Central

    Tsuyuki, Kiyomi; Surratt, Hilary L.

    2015-01-01

    Antiretroviral (ARV) medication diversion to the illicit market has been documented in South Florida, and linked to sub-optimal adherence in people living with HIV. ARV diversion reflects an unmet need for care in vulnerable populations that have difficulty engaging in consistent HIV care due to competing needs and co-morbidities. This study applies the Gelberg-Andersen Behavioral Model of Health Care Utilization for Vulnerable Populations to understand how social vulnerability is linked to ARV diversion and adherence. Cross-sectional data were collected from a targeted sample of vulnerable people living with HIV in South Florida between 2010 and 2012 (n=503). Structured interviews collected quantitative data on ARV diversion, access and utilization of care, and ARV adherence. Logistic regression was used to estimate the goodness-of-fit of additive models that test domain fit. Linear regression was used to estimate the effects of social vulnerability and ARV diversion on ARV adherence. The best fitting model to predict ARV diversion identifies having a low monthly income and unstable HIV care as salient enabling factors that promote ARV diversion. Importantly, health care need factors did not protect against ARV diversion, evidence that immediate competing needs are prioritized even in the face of poor health for this sample. We also find that ARV diversion provides a link between social vulnerability and sub-optimal ARV adherence, with ARV diversion and domains from the Behavioral Model explaining 25% of the variation in ARV adherence. Our analyses reveal great need to improve engagement in HIV care for vulnerable populations by strengthening enabling factors (e.g. patient-provider relationship) to improve retention in HIV care and ARV adherence for vulnerable populations. PMID:25893656

  8. Antiretroviral drug diversion links social vulnerability to poor medication adherence in substance abusing populations.

    PubMed

    Tsuyuki, Kiyomi; Surratt, Hilary L

    2015-05-01

    Antiretroviral (ARV) medication diversion to the illicit market has been documented in South Florida, and linked to sub-optimal adherence in people living with HIV. ARV diversion reflects an unmet need for care in vulnerable populations that have difficulty engaging in consistent HIV care due to competing needs and co-morbidities. This study applies the Gelberg-Andersen behavioral model of health care utilization for vulnerable populations to understand how social vulnerability is linked to ARV diversion and adherence. Cross-sectional data were collected from a targeted sample of vulnerable people living with HIV in South Florida between 2010 and 2012 (n = 503). Structured interviews collected quantitative data on ARV diversion, access and utilization of care, and ARV adherence. Logistic regression was used to estimate the goodness-of-fit of additive models that test domain fit. Linear regression was used to estimate the effects of social vulnerability and ARV diversion on ARV adherence. The best fitting model to predict ARV diversion identifies having a low monthly income and unstable HIV care as salient enabling factors that promote ARV diversion. Importantly, health care need factors did not protect against ARV diversion, evidence that immediate competing needs are prioritized even in the face of poor health for this sample. We also find that ARV diversion provides a link between social vulnerability and sub-optimal ARV adherence, with ARV diversion and domains from the Behavioral Model explaining 25 % of the variation in ARV adherence. Our analyses reveal great need to improve engagement in HIV care for vulnerable populations by strengthening enabling factors (e.g. patient-provider relationship) to improve retention in HIV care and ARV adherence for vulnerable populations.

  9. Theory of effective drug release from medical implants based on the Higuchi model and physico-chemical hydrodynamics.

    PubMed

    Dukhin, Stanislav S; Labib, Mohamed E

    2012-09-01

    Combining the approach of colloid transport with the generalized Higuchi theory of drug release and with the concept of minimum inhibitory concentration (MIC) known in microbiology, the theory of effective drug release from implants has been developed. Effective release of an antibiotic at a concentration above MIC is a necessary condition to achieve protection against infection from implants such as central catheters. The Higuchi theory in its present form is not predictive of the therapeutic effect from medical implants. The theory of effective release presented in this paper specifies two release modes, namely: one with therapeutic usefulness (effective release) and another without therapeutic effect. Therapeutic usefulness may be achieved when the antibiotic concentration, Cti , on the implant surface kills the organisms of interest and prevents the formation and propagation of biofilm when Cti exceeds the corresponding MIC of the released antibiotic compound. Currently, neither the Higuchi theory nor any other theory can provide such prediction. The present approach requires quantification of the antibiotic transport from the drug-polymer blend implant surface into the tissue and accounts for its coupling with drug diffusion inside the blend, a task that has not been developed in existing theories. Our solution to this task resulted in the derivation of an equation for the time of duration of effective release, Te , which depends on MIC, the Higuchi invariant and the characteristics of convective diffusion within the tissue. The latter characteristics include: diffusivity Dti and diffusion layer thickness δ which is controlled by the velocity of the interstitial fluid in tissue. A smaller Dti is favorable because transport from the catheter surface is weaker, while a thinner diffusion layer is harmful because this transport is stronger. The influence of the tangential component of interstitial velocity in the tissue is especially harmful because the diffusion

  10. Review of the 2015 Drug Supply Chain Security Act.

    PubMed

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

    2016-06-01

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

  11. The Role of Traumatic Event History in Non-Medical Use of Prescription Drugs among a Nationally Representative Sample of US Adolescents

    ERIC Educational Resources Information Center

    McCauley, Jenna L.; Danielson, Carla Kmett; Amstadter, Ananda B.; Ruggiero, Kenneth J.; Resnick, Heidi S.; Hanson, Rochelle F.; Smith, Daniel W.; Saunders, Benjamin E.; Kilpatrick, Dean G.

    2010-01-01

    Background: Building on previous research with adolescents that examined demographic variables and other forms of substance abuse in relation to non-medical use of prescription drugs (NMUPD), the current study examined potentially traumatic events, depression, posttraumatic stress disorder (PTSD), other substance use, and delinquent behavior as…

  12. “Is This a Drug?” Answers From Medical Students in a Tertiary Care Teaching Hospital in Eastern India

    PubMed Central

    Kundu, Tania Sur; Sengupta, Parama; Ghosh, Arijit; Das, Nina

    2016-01-01

    Introduction World Health Organization (WHO) defines what is drug and what is not. Second year MBBS students learn the principles of Pharmacology that they use in their later clinical practice life. The aim of the survey was to determine how medical students classify a range of preparations they might encounter in their professional lives and whether a brand name or a commercial preparation of a drug would influence their decision in the categorization of the preparation as a ‘drug’ or ‘not a drug’. Aim To assess the knowledge of medical students, if a substance or product is a drug. Materials and Methods We surveyed 2 concurrent years of medical students to classify 60 candidate medicinal preparations into “drug” and “not-drug” from a validated questionnaire. The candidate preparations were named either in generic or in their commercially available forms and they were all essential drugs as per WHO definition. Results The two groups of students, A and B, included 192 and 215 students respectively. Demographically there was little difference in the two groups. Agents like Aspirin, Paracetamol, Amphetamine, Salbutamol, Atropine, Dextromethorphan, Codeine, Diazepam, Ciprofloxacin ear drops, Levonorgestrol, Neosporin eye ointment, Furosemide, Metronidazole, Penicillin, Sorbitrate, Lignocaine, Methotrexate, Penicillin, Zolpidem and Thalidomide received almost unanimous votes as drugs. Arsenic trioxide, Fentanyl and petroleum jelly were considered to be “non-drugs” by most participants. The two groups did not differ significantly in their responses. Conclusion Some major lacunae were noted in the knowledge of the participating students despite book teaching on the definition of a drug. Drugs used for prophylaxis and those used in physiological conditions or topically, were often missed. These gaps need to be filled by more emphasis on definition of a drug and its clinical applicability based on example and case based studies. PMID:27656461

  13. Medication adherence in patients with diabetes mellitus: does physician drug dispensing enhance quality of care? Evidence from a large health claims database in Switzerland

    PubMed Central

    Huber, Carola A; Reich, Oliver

    2016-01-01

    Background The drug-dispensing channel is a scarcely explored determinant of medication adherence, which is considered as a key indicator for the quality of care among patients with diabetes mellitus. In this study, we investigated the difference in adherence between diabetes patients who obtained their medication directly from a prescribing physician (physician dispensing [PD]) or via a pharmacy. Methods A retrospective cohort study was conducted using a large health care claims database from 2011 to 2014. Patients with diabetes of all ages and receiving at least one oral antidiabetic drug (OAD) prescription were included. We calculated patients’ individual adherence to OADs defined as the proportion of days covered (PDC), which was measured over 1 year after patient identification. Good adherence was defined as PDC ≥80%. Multivariate logistic regression analysis was performed to assess the relationship between the PDC and the dispensing channel (PD, pharmacy). Results We identified a total of 10,430 patients prescribed drugs by a dispensing physician and 16,292 patients receiving drugs from a pharmacy. Medication adherence was poor in both patient groups: ~40% of the study population attained good adherence to OADs. We found no significant impact of PD on the adherence level in diabetes patients. Covariates associated significantly with good adherence were older age groups, male sex, occurrence of comorbidity and combined diabetes drug therapy. Conclusion In conclusion, adherence to antihyperglycemic medication is suboptimal among patients with diabetes. The results of this study provide evidence that the dispensing channel does not have an impact on adherence in Switzerland. Certainly, medication adherence needs to be improved in both supply settings. Physicians as well as pharmacists are encouraged to develop and implement useful tools to increase patients’ adherence behavior. PMID:27695299

  14. Medication adherence in patients with diabetes mellitus: does physician drug dispensing enhance quality of care? Evidence from a large health claims database in Switzerland

    PubMed Central

    Huber, Carola A; Reich, Oliver

    2016-01-01

    Background The drug-dispensing channel is a scarcely explored determinant of medication adherence, which is considered as a key indicator for the quality of care among patients with diabetes mellitus. In this study, we investigated the difference in adherence between diabetes patients who obtained their medication directly from a prescribing physician (physician dispensing [PD]) or via a pharmacy. Methods A retrospective cohort study was conducted using a large health care claims database from 2011 to 2014. Patients with diabetes of all ages and receiving at least one oral antidiabetic drug (OAD) prescription were included. We calculated patients’ individual adherence to OADs defined as the proportion of days covered (PDC), which was measured over 1 year after patient identification. Good adherence was defined as PDC ≥80%. Multivariate logistic regression analysis was performed to assess the relationship between the PDC and the dispensing channel (PD, pharmacy). Results We identified a total of 10,430 patients prescribed drugs by a dispensing physician and 16,292 patients receiving drugs from a pharmacy. Medication adherence was poor in both patient groups: ~40% of the study population attained good adherence to OADs. We found no significant impact of PD on the adherence level in diabetes patients. Covariates associated significantly with good adherence were older age groups, male sex, occurrence of comorbidity and combined diabetes drug therapy. Conclusion In conclusion, adherence to antihyperglycemic medication is suboptimal among patients with diabetes. The results of this study provide evidence that the dispensing channel does not have an impact on adherence in Switzerland. Certainly, medication adherence needs to be improved in both supply settings. Physicians as well as pharmacists are encouraged to develop and implement useful tools to increase patients’ adherence behavior.

  15. Controlled drugs.

    PubMed

    2016-05-18

    Essential facts Controlled drugs are defined and governed by the Misuse of Drugs Act 1971 and associated regulations. Examples of controlled drugs include morphine, pethidine and methadone. Since 2012, appropriately qualified nurses and midwives can prescribe controlled drugs for medical conditions within their competence. There are some exceptions when treating addiction. PMID:27191427

  16. Potential drug-drug interactions in Alzheimer patients with behavioral symptoms.

    PubMed

    Pasqualetti, Giuseppe; Tognini, Sara; Calsolaro, Valeria; Polini, Antonio; Monzani, Fabio

    2015-01-01

    The use of multi drug regimens among the elderly population has increased tremendously over the last decade although the benefits of medications are always accompanied by potential harm, even when prescribed at recommended doses. The elderly populations are particularly at an increased risk of adverse drug reactions considering comorbidity, poly-therapy, physiological changes affecting the pharmacokinetics and pharmacodynamics of many drugs and, in some cases, poor compliance due to cognitive impairment and/or depression. In this setting, drug-drug interaction may represent a serious and even life-threatening clinical condition. Moreover, the inability to distinguish drug-induced symptoms from a definitive medical diagnosis often results in addition of yet another drug to treat the symptoms, which in turn increases drug-drug interactions. Cognitive enhancers, including acetylcholinesterase inhibitors and memantine, are the most widely prescribed agents for Alzheimer's disease (AD) patients. Behavioral and psychological symptoms of dementia, including psychotic symptoms and behavioral disorders, represent noncognitive disturbances frequently observed in AD patients. Antipsychotic drugs are at high risk of adverse events, even at modest doses, and may interfere with the progression of cognitive impairment and interact with several drugs including anti-arrhythmics and acetylcholinesterase inhibitors. Other medications often used in AD patients are represented by anxiolytic, like benzodiazepine, or antidepressant agents. These agents also might interfere with other concomitant drugs through both pharmacokinetic and pharmacodynamic mechanisms. In this review we focus on the most frequent drug-drug interactions, potentially harmful, in AD patients with behavioral symptoms considering both physiological and pathological changes in AD patients, and potential pharmacodynamic/pharmacokinetic drug interaction mechanisms.

  17. Potential drug-drug interactions in Alzheimer patients with behavioral symptoms.

    PubMed

    Pasqualetti, Giuseppe; Tognini, Sara; Calsolaro, Valeria; Polini, Antonio; Monzani, Fabio

    2015-01-01

    The use of multi drug regimens among the elderly population has increased tremendously over the last decade although the benefits of medications are always accompanied by potential harm, even when prescribed at recommended doses. The elderly populations are particularly at an increased risk of adverse drug reactions considering comorbidity, poly-therapy, physiological changes affecting the pharmacokinetics and pharmacodynamics of many drugs and, in some cases, poor compliance due to cognitive impairment and/or depression. In this setting, drug-drug interaction may represent a serious and even life-threatening clinical condition. Moreover, the inability to distinguish drug-induced symptoms from a definitive medical diagnosis often results in addition of yet another drug to treat the symptoms, which in turn increases drug-drug interactions. Cognitive enhancers, including acetylcholinesterase inhibitors and memantine, are the most widely prescribed agents for Alzheimer's disease (AD) patients. Behavioral and psychological symptoms of dementia, including psychotic symptoms and behavioral disorders, represent noncognitive disturbances frequently observed in AD patients. Antipsychotic drugs are at high risk of adverse events, even at modest doses, and may interfere with the progression of cognitive impairment and interact with several drugs including anti-arrhythmics and acetylcholinesterase inhibitors. Other medications often used in AD patients are represented by anxiolytic, like benzodiazepine, or antidepressant agents. These agents also might interfere with other concomitant drugs through both pharmacokinetic and pharmacodynamic mechanisms. In this review we focus on the most frequent drug-drug interactions, potentially harmful, in AD patients with behavioral symptoms considering both physiological and pathological changes in AD patients, and potential pharmacodynamic/pharmacokinetic drug interaction mechanisms. PMID:26392756

  18. Non-Compliance and Related Factors in Patients With Bipolar I Disorder: A Six Month Follow-Up Study

    PubMed Central

    Azadforouz, Sanaz; Shabani, Amir; Nohesara, Shabnam; Ahmadzad-Asl, Masoud

    2016-01-01

    Background Medication treatment compliance among bipolar patients is quite widespread. Objectives Treatment compliance depends on multiple factors. The aim of this study was to evaluate the predicting factors of noncompliance in patients with bipolar I disorder admitted to an Iranian hospital during a six-month follow up period. Materials and Methods This cross-sectional study included 47 bipolar I disorder subjects who were admitted to the Iran psychiatric hospital and that were chosen using a non-randomized convenient sampling model. The patients were assessed at baseline, and at two and six months after admission. For evaluating the patients, we used the medication possession ratio (MPR), the drug attitude inventory (DIA-10), the young mania rating scale (Y-MRS) and the scale for the assessment of positive symptoms (SAPS). The data were analyzed using a general linear model by SPSS 16 software. Results The repeated measures analysis revealed that medication compliance increased successively (P = 0.045), and age, gender and symptom severity did not alter the pattern. Conclusions There is an increasing pattern in treatment compliance in bipolar I disorder patients, regardless of the known predicting factors for nonadherence. PMID:27803718

  19. Drug Interactions

    PubMed Central

    Tong Logan, Angela; Silverman, Andrew

    2012-01-01

    One of the most clinically significant complications related to the use of pharmacotherapy is the potential for drug-drug or drug-disease interactions. The gastrointestinal system plays a large role in the pharmacokinetic profile of most medications, and many medications utilized in gastroenterology have clinically significant drug interactions. This review will discuss the impact of alterations of intestinal pH, interactions mediated by phase I hepatic metabolism enzymes and P-glycoprotein, the impact of liver disease on drug metabolism, and interactions seen with commonly utilized gastrointestinal medications. PMID:22933873

  20. Transnational industrial power, the medical profession and the regulatory state: adverse drug reactions and the crisis over the safety of Halcion in the Netherlands and the UK.

    PubMed

    Abraham, John

    2002-11-01

    Taking the controversy over the safety of the hypnotic, Halcion, in the Netherlands and the UK, as a case study, this article examines the problems for public health associated with responses to warnings about drug hazards by regulatory agencies, governmental expert advisers, the pharmaceutical industry and the medical profession. It is argued that regulators and the medical profession rely too heavily on manufacturers to investigate warnings from doctors' spontaneous reporting of adverse effects of drug products on the market. It is demonstrated that a pharmaceutical firm's commitment to search effectively for evidence against the safety of its own product in order to confirm doctors' warnings can have severe limitations. Deficiencies in the socio-institutional responses to post-market 'early warning systems' about drug hazards imply that the regulatory policies of 'early licensing' and minimal pre-market checks for new drugs are misconceived and threaten public health. To improve public protection from drug injury, the regulators should abandon their conviction that compelling evidence of drug hazards are required to confirm doctors' warning signals prior to regulatory intervention. Instead, they should adopt a policy of measured regulatory intervention as an immediate response to warning signals, while investigators, independent of the manufacturers, assess the significance of the signal.