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Sample records for medical drug compliance

  1. [Insufficient medication compliance in Parkinson's disease].

    PubMed

    Aerts, Marjolein B; van der Eijk, Martijn; Kramers, Kees; Bloem, Bastiaan R

    2011-01-01

    Medication compliance is generally suboptimal, particularly in patients with complex polypharmacy. This generic treatment problem is described here for Parkinson's disease (PD). We would expect patients with PD to have good medication compliance, since missed doses immediately result in worsening of symptoms. However, recent research has revealed that PD patients demonstrate poor medication compliance. Poor medication compliance is particularly undesirable for patients with PD because regular intake of medication is required for optimal treatment effect. Possible ways of improving medication compliance are pharmacotherapeutic measures and behavioural interventions. Modern methods of communication (text message reminders) and 'smart' pill dispensers may be beneficial, but the advantages of such interventions have not yet been scientifically studied. PMID:21527053

  2. 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…

  3. Patient Compliance and Medication Perception.

    ERIC Educational Resources Information Center

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

    1986-01-01

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

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

    PubMed Central

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

    2015-01-01

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

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

    PubMed

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

    2015-07-01

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

  6. Improvement of medication compliance in uncontrolled hypertension.

    PubMed

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

    1976-06-12

    38 hypertensive Canadian steelworkers who were neither compliant with medications nor at goal diastolic blood-pressure six months after starting treatment were allocated either to a control group or to an experimental group who were taught how to measure their own blood-pressures, asked to chart their home blood-pressures and pill taking, and taught how to tailor pill taking to their daily habits and rituals; these men were also seen fortnightly by a highschool graduate with no formal health professional training who reinforced the experimental manoeuvres and rewarded improvements in compliance and blood-pressure. Six months later, average compliance had fallen by 1.5% in the control group but rose 21.3% in the experimental group. Blood-pressures fell in 17 of 20 experimental patients (to goal in 6) and in 10 of 18 control patients (to goal in 2). PMID:73694

  7. Enhancing medication compliance in coffee groups.

    PubMed

    Olarte, S W; Masnik, R

    1981-06-01

    In an adult outpatient department of a hospital serving a severely disadvantaged population, coffee groups have become an effective means of treating chronic, treatment-resistant patients and reinforcing their compliance with medication regimens. In dealing with the patients, many of whom have problems communicating needs and information, the therapists have developed such approaches as using concrete language, recognizing that many patients use medication transactions to reflect dissatisfaction with changes in group routine, anticipating common problems related to medication, and at times accepting patients' idiosyncratic chemotherapeutic preferences. Important elements of the coffee groups are the caring attitude of the co-therapists, a nonpressured atmosphere, and the presence of a familiar peer group. PMID:7262849

  8. 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

  9. Therapeutic drug monitoring of psychotropic medications

    PubMed Central

    Mitchell, Philip B

    2000-01-01

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

  10. 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...

  11. 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 ...

  12. 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. PMID:26454916

  13. Compliance with an oral asthma medication: a pilot study using an electronic monitoring device.

    PubMed

    Chung, K F; Naya, I

    2000-09-01

    Compliance with prescribed asthma medication is commonly estimated from tablet counts for oral medications and canister weights for inhaled medications. Recently, electronic medication monitoring devices, developed to evaluate numerical compliance as well as drug use patterns, were used to assess compliance with inhaled steroids and beta2-agonists. This was the first study to electronically assess compliance with an oral asthma medication. Fifty-seven asthmatic patients, stable on inhaled beta2-agonists only with a mean FEV1 of 77% predicted (+/- 13%, SD) began 12 weeks of treatment with zafirlukast 20 mg twice daily. The monitoring device, an electronic TrackCap, recorded the date and time on each occasion that patients removed and replaced their medication bottle caps. Patients were told that compliance would be assessed as part of the study, but patients were not told about the specifics of the TrackCap. Compliance was defined: 1. as the number of TrackCap events per number of prescribed tablets; and 2. as the difference between number of tablets dispensed and number returned per number prescribed. Adherence was defined as the number of days with two TrackCap events at least 8 h apart per the total number of days' dosing. Forty-seven patients completed the study with a median compliance of 89% (mean. 80%) and a median adherence of 71% (mean, 64%) as measured by TrackCap events. Compliance as estimated from return-tablet count was slightly higher (median, 92%). High rates of compliance were maintained throughout the trial. These results show that compliance with and adherence to a treatment of an oral, twice-daily, maintenance asthma medication, such as zafirlukast, is high. PMID:11001076

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

    PubMed

    Smith, Brenda D

    2003-01-01

    This study uses Cox regression to assess the relationships among parental drug use, drug treatment compliance, and reunification from substitute care. The study finds that drug treatment compliance is associated with faster reunification, even when accounting for ongoing drug use and three parenting measures. The findings are consistent with a conceptual framework suggesting that certain client actions, such as drug treatment compliance, may serve as markers that substantially affect client outcomes. PMID:12769395

  15. 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…

  16. 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

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

    ERIC Educational Resources Information Center

    Smith, Brenda D.

    2003-01-01

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

  18. 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

  19. 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. PMID:20217535

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

    PubMed

    Urquhart, J

    1999-03-01

    Variable compliance with prescribed drug regimens is a leading source of variability in drug response. Specifics differ by drug and disease. The role of variable compliance was clearly defined in 2 trials of lipid-lowering agents, cholestyramine and gemfibrozil, in which exceptionally careful measurements of compliance were made, which has not been done in later trials. Economic consequences of variable compliance are estimated by converting dose-dependent changes in absolute risk of incident coronary disease into the unicohort format, which designates how many patients must be treated to prevent, in a given time, a defined 'coronary event'. Two strong influences on the costs of treatment are: (i) the shape of the relation between drug intake and risk reduction; and (ii) the strength of the linkage between intake and prescription refills. The intake-effect relation for cholestyramine is linear, making compliance-neutral the cost to prevent 1 coronary event, provided that refills match intake. If refills exceed intake, treatment costs rise. The intake-effect relation for gemfibrozil is more typically nonlinear, so poorer compliers purchase and take the drug in amounts that have little benefit, increasing the cost to prevent 1 coronary event. If refills run at a higher rate than intake, costs increase still further. A key question for future study is: do policies that encourage timely refills increase compliance enough to offset their potential to waste money in the purchasing of an untaken drug? PMID:10537430

  1. 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

  2. Drug related admissions to medical wards

    PubMed Central

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

    1992-01-01

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

  3. 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

  4. 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.  PMID:22211347

  5. [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

  6. [Effect of a vascular event on drug regimen compliance in patients with coronary atherosclerosis].

    PubMed

    Bunova, S S; Usacheva, E V; Ivanov, A Yu

    2015-01-01

    In order to assess the effect of a vascular event on adherence to treatment we examined a total of 68 patients presenting with coronary atherosclerosis. The patients' age varied from 31 to 84 years (mean 57.1±8.7). There were 55 (81.1%) men and 13 (18.9%) women. Drug regimen compliance was evaluated by means of the Morisky-Green Medication Adherence Questionnaire before and after the vascular event. Of the 68 examined patients, 15 (22.1%) had not taken any therapeutic agents before the vascular event occurred, despite existing arterial hypertension. Drug regimen compliance prior to the vascular event was low in 82.4% of cases. The number of patients with coronary atherosclerosis and low compliance to treatment before the vascular event decreased significantly thereafter (p=0.0012). After the vascular event, the number of patients adhering to the doctor's recommendations on medicamentous therapy increases considerably. At the same time, a sufficiently great number of patients [about 30% of patients after endured myocardial infarction (MI) and 18% after transcutaneous coronary intervention (TCI)] still remain in the category of those "having low drug regimen compliance" and, accordingly, have high risk for the development of recurrent vascular events. Endured TCI increases patient compliance more significantly than MI, which requires additional study of a psychological component of the given fact. PMID:26035560

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

    PubMed Central

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

    2016-01-01

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

  8. 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…

  9. Medication compliance aids: a qualitative study of users' views

    PubMed Central

    Lecouturier, Jan; Cunningham, Bill; Campbell, David; Copeland, Richard

    2011-01-01

    Background Despite the rapid rise in the use of multicompartmental compliance aids (MCAs), little is known about the role they play in self-management of medication. Aim To explore the perceived benefits of MCAs for people using them to manage their own or a relative's medication. Design of study Qualitative study using in-depth interviews. Setting West Northumberland. Method Recruitment was via posters and leaflets in general practices and community pharmacies. In-depth interviews were conducted using a topic guide. Results Nineteen people were interviewed. Three overarching themes emerged in relation to medicine taking: disruption, organisation, and adherence, which impacted on control. The medication regime had caused disruption to their lives and this had led to the purchase of an MCA. The MCA enabled them to organise their medication, which they believed had improved the efficiency of medicine taking and saved time. Although the MCA did not prompt them to take their medication, they could see whether they had actually taken it or not, which alleviated their anxiety. To meet their individual needs and lifestyles, some had developed broader systems of medication management, incorporating the MCA. For a small cost – the initial outlay for the MCA and time spent loading it – they gained control over the management of their medication and their condition. Conclusion This group found the use of an MCA to be beneficial, but advice and support regarding how best to manage their medication and on the most appropriate design to suit their needs would be helpful. PMID:21276336

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

    PubMed

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

    2016-02-01

    Several practice guidelines were published by French regulatory agencies between 2006 and 2009 to improve psychotropic drug use in older patients. The objectives of the study were to assess compliance with these guidelines in older patients hospitalized in psychiatric units and to identify characteristics associated with compliance. A cross-sectional study was conducted in 117 patients aged 65 years and older hospitalized in two psychiatric departments of a public hospital, at three dates randomly chosen between January and May 2014. Medical and sociodemographic characteristics were collected from electronic medical records. In all, 8% of psychotropic prescriptions were compliant with guidelines. A total of 98% of antidepressant prescriptions complied with guidelines for product selection (no tricyclics) and 72% for initial dosage (half of that recommended for younger adults). Regarding benzodiazepines, short half-life drugs were chosen in 73% of treatments, low maintenance dosage was found in 64% of treatments, and a discontinuous administration rhythm was noted in 33% of treatments. Regarding antipsychotics, initial dosage was a quarter of the allowed initial dosage for younger adults in 39% of prescriptions and metabolic blood testing was performed in 17% of prescriptions. Neurological and cognitive tolerance was monitored in 41% and 61% of prescriptions, respectively. Few clinical factors were found to be associated with compliance or noncompliance with guidelines in older psychiatric inpatients. Practice guidelines on psychotropic drug prescription were partially respected in older inpatients. Practitioners should take into account the risks associated with non-recommended patterns of psychotropic drug use in this vulnerable population. PMID:26555674

  11. The relationships among medicine symptom distress, self-efficacy, patient-provider relationship, and medication compliance in patients with epilepsy.

    PubMed

    Chen, Hsiu-Fang; Tsai, Yun-Fang; Lin, Yea-Pyng; Shih, Mo-Song; Chen, Jui-Chen

    2010-09-01

    The purpose of this study was to investigate the relationships among medicine symptom distress, self-efficacy, patient-provider relationship, and medication compliance in patients with epilepsy. Patients with epilepsy (n=357) were recruited using convenience sampling from three medical centers in northern Taiwan. Results showed significant differences in relationships between medication compliance and the following factors: gender, employment status, comorbid chronic diseases, self-driving, daily drug dosing frequency, seizure after a missed dose, and self-efficacy. Logistic regression analysis indicated that comorbid chronic disease, self-driving, seizure after a missed dose, and self-efficacy were significantly associated with medication compliance. These data suggest that health care providers of patients with epilepsy pay more attention to treatment of comorbid chronic diseases, the safety issues of self-driving, seizures occurring after missed doses, and awareness of self-efficacy. PMID:20719572

  12. 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…

  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. Medication adherence to oral anticancer drugs: systematic review.

    PubMed

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

    2016-04-01

    Many studies have demonstrated that non-adherence to oral anticancer drugs (OACDs) has challenged treatment efficacy. Otherwise, few validated tools exist to measure patients' adherence to medication regimen in clinical practice. To synthesize previous studies on adherence by cancer patients taking OACDs, especially in targeted therapy, a systematic search of several electronic databases was conducted. We analyzed existing scales' contents for various cancer patients and outcomes of studies assessing adherence. However, a well-validated scale designed particularly for OACD adherence is still lacking. Most adherence scales used in the studies reviewed contain items focused on measuring patients' medication-taking behavior more than their barriers to medication compliance and beliefs. However, non-adherence to OACDs is a complex phenomenon, and drug-taking barriers and patient beliefs significantly affect patients' non-adherence. To understand the key drivers and predisposing factors for non-adherence, we need to develop a well-validated, multidimensional scale. PMID:26935964

  15. 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 ...

  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 Compliance and the Aged: An Educational Challenge.

    ERIC Educational Resources Information Center

    Skolnick, Bruce D.; And Others

    1984-01-01

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

  18. 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 ...

  19. Medical innovation, unmet medical needs, and the drug pipeline.

    PubMed

    Mather, Charles M

    2006-01-01

    This paper outlines and illustrates the working of a theoretical approach from the social sciences for analyzing medical innovation, unmet medical need, and the drug pipeline. Using the social history of three drugs made from recombinant DNA (insulin, human growth hormone, and tissue-plasminogen activator) the paper shows how drugs can be both technically and organizationally efficient while the needs they satisfy can be created or identified. The paper posits that drugs that require more organizational efficiency tend to satisfy identified, rather then created needs. Key words: Recombinant DNA, technical efficiency, organizational efficiency, anthropology. PMID:16493177

  20. 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.…

  1. 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…

  2. 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

  3. 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

    ... (42 U.S.C. 1320a-7i). This new section requires the submission of certain drug sample information to... 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...

  4. 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

  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. Medication errors during hospital drug rounds.

    PubMed Central

    Ridge, K W; Jenkins, D B; Noyce, P R; Barber, N D

    1995-01-01

    Objective--To determine the nature and rate of drug administration errors in one National Health Service hospital. Design--Covert observational survey be tween January and April 1993 of drug rounds with intervention to stop drug administration errors reaching the patient. Setting--Two medical, two surgical, and two medicine for the elderly wards in a former district general hospital, now a NHS trust hospital. Subjects--37 Nurses performing routine single nurse drug rounds. Main measures--Drug administration errors recorded by trained observers. Results--Seventy four drug rounds were observed in which 115 errors occurred during 3312 drug administrations. The overall error rate was 3.5% (95% confidence interval 2.9% to 4.1%). Errors owing to omissions, because the drug had not been supplied or located or the prescription had not been seen, accounted for most (68%, 78) of the errors. Wrong doses accounted for 15% (17) errors, four of which were greater than the prescribed dose. The dose was given within two hours of the time indicated by the prescriber in 98.2% of cases. Conclusion--The observed rate of drug administration errors is too high. It might be reduced by a multidisciplinary review of practices in prescribing, supply, and administration of drugs. PMID:10156392

  7. 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

  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. 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

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

    PubMed

    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. 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

    ... reportable food that is the subject of a summary posting and that are part of a chain of establishments with... 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...

  12. 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…

  13. 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

  14. 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...

  15. 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...

  16. 71 FR 34249 - Prescription Drug Marketing Act Pedigree Requirements; Effective Date and Compliance Policy Guide...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2006-06-14

    ...), 1988N-0258 (Formerly 88N- 0258), 2006D-0226] Prescription Drug Marketing Act Pedigree Requirements... provisions of the final regulation published in the Federal Register of ] December 3, 1999 (64 FR 67720). The... of a new compliance policy guide (CPG) 160.900 entitled ``Prescription Drug Marketing Act...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-25

    ... HUMAN SERVICES Food and Drug Administration Food and Drug Administration Clinical Trial Requirements... 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,...

  18. Effectiveness of a motivational interviewing intervention on medication compliance.

    PubMed

    Minkin, Alison; Snider-Meyer, Jill; Olson, Debra; Gresser, Susan; Smith, Heather; Kier, Frederick J

    2014-09-01

    This study investigated the effectiveness of training geriatric home-based primary care (HBPC) nursing staff in motivational interviewing (MI) techniques, with the goal of increasing patient medication adherence. Nursing staff received 4 hours of training in MI techniques from a licensed psychologist. Results indicated that the MI training increased medication adherence in the HBPC veteran sample by a small, but statistically significant, margin both 1 month and 6 months after the intervention. Although the effect size may be considered small, the clinical and cost ramifications of even a small gain in adherence are extremely important for the patient, clinician, and the medical facility. MI techniques may provide a cost-effective and impactful means of enhancing patient adherence to medications. PMID:25171241

  19. 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…

  20. 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…

  1. 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

  2. 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.…

  3. 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. PMID:25750169

  4. 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

  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. Physician and patient perceptions of cultural competency and medical compliance.

    PubMed

    Ohana, S; Mash, R

    2015-12-01

    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. Echo New Studio 2007; 91:18-28) might reduce this phenomenon. Structured questionnaires were distributed to 90 physicians working in outpatient clinics in a central hospital in Israel, and to 417 of their patients. Each physician had four to six sampled patients.The findings showed a significant negative correlation (r = -0.50, P < 0.05) between the physicians' perception of their cultural competence and the patients' perception of physician competence. The more patients perceive the physician as culturally competent, the more they comply with their medical recommendations. In addition, the findings show that ethnicity significantly affects patients' perception of the cultural competence of physicians, and their satisfaction with the medical care they receive. PMID:26590243

  7. [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. PMID:22921169

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-09

    ... 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...

  9. 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…

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

    PubMed

    Takacs, Barnabas; Hanak, David

    2008-01-01

    We have developed a prototype home robot to improve drug compliance. The robot is a small mobile device, capable of autonomous behaviour, as well as remotely controlled operation via a wireless datalink. The robot is capable of face detection and also has a display screen to provide facial feedback to help motivate patients and thus increase their level of compliance. An RFID reader can identify tags attached to different objects, such as bottles, for fluid intake monitoring. A tablet dispenser allows drug compliance monitoring. Despite some limitations, experience with the prototype suggests that simple and low-cost robots may soon become feasible for care of people living alone or in isolation. PMID:18852325

  11. 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

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

    PubMed

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

    1975-05-31

    230 Canadian steelworkers with hypertension took part in a randomised trial to see if compliance with antihypertensive drug regimens could be improved. For care and follow-up these men were randomly allocated to see either their own family doctors outside working-hours or industrial physicians during work shifts; the same men were randomly allocated to receive or not receive an educational programme aimed at instructing them about hypertension and its treatment. Surprisingly, the convenience of follow-up at work had no effect upon these men's compliance with antihypertensive drug regimens. Similarly, although men receiving health education learned a lot about hypertension, they were not more likely to take their medicine. PMID:48832

  13. A simple scheme to improve compliance in patients taking tuberculosis medication.

    PubMed

    Hill, J P; Ramachandran, G

    1992-10-01

    Compliance with prescribed treatment remains a major problem in the control of tuberculosis worldwide. We describe a simple method of improving patient compliance with hospital-based treatment. Eighty-two patients paid a deposit at the start of their treatment which entitled them to cheaper drugs and was refundable on completion of the prescribed course. Sixty-two per cent of patients completed the course compared with 23% of retrospective controls. A direct relationship was found between the amount of deposit paid and the rate of completion. Reasons why poor patients (who paid a lower deposit) may default are discussed, as are the merits of short-course drug regimens. It is recommended that similar schemes be assessed elsewhere. PMID:1440883

  14. Pill burden does not influence compliance with oral medication in recipients of renal transplant

    PubMed Central

    Adhikari, Uma Rani; Taraphder, Abhijit; Hazra, Avijit; Das, Tapas

    2016-01-01

    Objectives: Insights about the predictors of noncompliance are key to develop compliance enhancing strategy in a given therapeutic situation. Renal transplantation is a critical surgical procedure that imposes a large medication burden on patients. There is a suspicion that the large pill burden may lead to noncompliance. Our objective was to ascertain the influence of pill burden on medication compliance in renal transplant patients in the Indian sociocultural context. Methods: A longitudinal observational study was conducted in two Tertiary Care Hospitals in Kolkata running renal transplant program – one each from the government and private sectors. Totally 120 literate adult transplant recipients were recruited through purposive sampling and followed up at 3 months intervals for 1 year. Data were collected through interview and review of prescriptions and medical records. Results: Data of 110 subjects were analyzed. The pill burden was high – ranging from 10-21 (median 14) at first visit shortly after discharge to 7–22 (median 11) at last visit at 12 months in the government sector; corresponding figures in the private sector were 14–32 (median 21) and 10–28 (median 17). Pill burden increased with age. Only 60.91% of the patients were fully compliant until 1 year after transplantation. The rate of immunosuppressant noncompliance was 27.78% in government sector and 25.00% in private sector. There was no significant association between median pill burden and medication compliance. Satisfaction with caregiver support was associated with better immunosuppressant compliance. Conclusions: Noncompliance in renal transplant recipients is likely to be multifactorial. Contrary to popular belief, pill burden was not a major determinant of noncompliant behavior. PMID:26997717

  15. 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

  16. Mass drug administration for lymphatic filariasis elimination in a coastal state of India: a study on barriers to coverage and compliance

    PubMed Central

    2014-01-01

    Background Lymphatic filariasis is targeted for elimination in India through mass drug administration (MDA) with diethylcarbamazine (DEC) combined with albendazole (ABZ). For the strategy to be effective, >65% of those living in endemic areas must be covered by and compliant to MDA. Post the MDA 2011 campaign in the endemic district of Odisha, we conducted a survey to assess: (i) the filariasis knowledge in the community, (ii) the coverage and compliance of MDA from the community perspective, and (iii) factors affecting compliance, as well as the operational issues involved in carrying out MDA activities from the drug distributor’s perspective. Methods A sample of 691 participants – both male and female, aged two years or above – were selected through multistage stratified sampling and interviewed using a semi-structured questionnaire. Additionally, drug distributors and the medical officers in charge of the MDA were also interviewed to understand some of the operational issues encountered during MDA. Results Ninety-nine percent of the study participants received DEC and ABZ tablets during MDA, of which only just above a quarter actually consumed the drugs. The cause of non-compliance was mostly due to fear of side effects, lack of awareness of the benefits of MDA, and non-attendance of health staff in the villages. Lack of adequate training of drug distributors and poor health communication activities before the MDA campaign commenced and the absence of follow-up by health workers following MDA were a few of the operational difficulties encountered during the MDA campaign. Conclusion Currently MDA is restricted to the distribution of drugs only and the key issues of implementation in compliance, health education, managing side effects, and logistics are not given enough attention. It is therefore essential to address the issues linked to low compliance to make the program more efficient and achieve the goal of filariasis elimination. PMID:25237478

  17. 77 FR 52741 - Compliance Policy Guide Sec. 420.300 Changes in Compendial Specifications and New Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-30

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

  18. Associations between Difficulty Paying Medical Bills and Forgone Medical and Prescription Drug Care.

    PubMed

    Baughman, Kristin R; Burke, Ryan C; Hewit, Michael S; Sudano, Joseph J; Meeker, James; Hull, Sharon K

    2015-10-01

    Problems paying medical bills have been reported to be associated with increased stress, bankruptcy, and forgone medical care. Using the Behavioral Model for Vulnerable Populations developed by Gelberg et al as a framework, as well as data from the 2010 Ohio Family Health Survey, this study examined the relationships between difficulty paying medical bills and forgone medical and prescription drug care. Logistic regression was used to examine associations between difficulty paying medical bills and predisposing, enabling, need (health status), and health behaviors (forgoing medical care). Difficulty paying medical bills increased the effect of lack of health insurance in predicting forgone medical care and had a conditional effect on the association between education and forgone prescription drug care. Those who had less than a bachelor's degree were more likely to forgo prescription drug care than those with a bachelor's degree, but only if they had difficulty paying medical bills. Difficulty paying medical bills also accounted for the relationships between several population characteristics (eg, age, income, home ownership, health status) in predicting forgone medical and prescription drug care. Policies to cap out-of-pocket medical expenses may mitigate health disparities by addressing the impact of difficulty paying medical bills on forgone care. PMID:25856468

  19. Improving venous thromboembolism risk assessment compliance using the electronic tool in admitted medical patients.

    PubMed

    Taha, Haytham; Raji, Salama J; Ellahham, Samer; Bashir, Nihal; Al Hanaee, Manar; Boharoon, Hessa; AlFalahi, May

    2015-01-01

    Sheikh Khalifa Medical City (SKMC) in Abu Dhabi is the main tertiary care referral hospital in the United Arab Emirates (UAE) with 560 bed capacity that is fully occupied most of the time. SKMC senior management has made a commitment to make quality and patient safety a top priority. Venous thromboembolism (VTE) risk assessment has been identified as a critical patient safety measure and key performance indicator. The electronic VTE risk assessment form a computerized decision support tool was introduced to improve adherence with deep venous thrombosis (DVT) prophylaxis recommendations. A multidisciplinary task force team was formed and led this quality improvement project. The purpose of this publication is to indicate the quality improvement interventions implemented to enhance compliance with VTE risk assessment and the outcomes of those interventions. We chose to conduct the pilot study in General Medicine as it is the busiest department in the hospital. The study period was from April 2014 till August 2015.The lessons learned were disseminated throughout the hospital. Our aim was to improve VTE risk assessment compliance by using the electronic form in order to ensure patient safety and reduce preventable harm. VTE risk assessment compliance improved in general medicine from 4% to 98%, and overall SKMC compliance from 21% to above 90%. PMID:26734399

  20. Improving venous thromboembolism risk assessment compliance using the electronic tool in admitted medical patients

    PubMed Central

    Taha, Haytham; Raji, Salama J.; Ellahham, Samer; Bashir, Nihal; Al hanaee, Manar; Boharoon, Hessa; AlFalahi, May

    2015-01-01

    Sheikh Khalifa Medical City (SKMC) in Abu Dhabi is the main tertiary care referral hospital in the United Arab Emirates (UAE) with 560 bed capacity that is fully occupied most of the time. SKMC senior management has made a commitment to make quality and patient safety a top priority. Venous thromboembolism (VTE) risk assessment has been identified as a critical patient safety measure and key performance indicator. The electronic VTE risk assessment form a computerized decision support tool was introduced to improve adherence with deep venous thrombosis (DVT) prophylaxis recommendations. A multidisciplinary task force team was formed and led this quality improvement project. The purpose of this publication is to indicate the quality improvement interventions implemented to enhance compliance with VTE risk assessment and the outcomes of those interventions. We chose to conduct the pilot study in General Medicine as it is the busiest department in the hospital. The study period was from April 2014 till August 2015.The lessons learned were disseminated throughout the hospital. Our aim was to improve VTE risk assessment compliance by using the electronic form in order to ensure patient safety and reduce preventable harm. VTE risk assessment compliance improved in general medicine from 4% to 98%, and overall SKMC compliance from 21% to above 90%. PMID:26734399

  1. Self-medication with mood changing drugs.

    PubMed Central

    Grahame-Smith, D G

    1975-01-01

    The aim of this article is to examine some of the consequences of the recent advances in neurobiology in terms of the ability of drugs to manipulate the mind. Most laymen are totally ignorant of the general mechanism underlying the brain-mind relationship and therefore of the action of mind-altering drugs. Professor Grahame-Smith considers that one of the intrinsic evils of man's neurobiological make up is that a prime motive of the brain seems to be to bring comfort, security and pleasure for itself. Therefore it is not surprising that drugs - notably the barbiturates and more recently the benzodiazepines (tranquilizers) - have been prescribed to give to the brain that peace of mind that it seeks. However, it can be argued that such drugs cannot replace anxiety with peace of mind or unhappiness or depression with happiness. The action of such drugs upon the molecules of the brain is negative - a placebo effect. PMID:1214268

  2. 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...

  3. Compliance with adjuvant capecitabine in patients with stage II and III colon cancer: comparison of administrative versus medical record data.

    PubMed

    Amlani, Adam; Kumar, Aalok; Ruan, Jenny Y; Cheung, Winson Y

    2016-08-01

    We aimed to examine the frequency of treatment delays as well as the reasons and appropriateness of such delays in early stage colon cancer patients receiving adjuvant capecitabine by comparing data from pharmacy dispensing versus medical records. Patients diagnosed with stage II or III colon cancer from 2008 to 2012 and who received at least two cycle of adjuvant capecitabine were reviewed for treatment delays. Data from pharmacy dispensing and patient medical records were compared. Multivariate regression models were constructed to identify predictors of treatment delays. A total of 697 patients were analyzed: median age was 70 years (IQR 30-89), 394 (57%) were men, 598 (86%) reported Eastern Cooperative Oncology Group 0/1, and 191 (27%) had stage II disease. In this study cohort, 396 (57%) patients experienced at least 1 treatment delay during their adjuvant treatment. Upon medical record review, half of treatment delays identified using pharmacy administrative data were actually attributable to side effects, of which over 90% were considered clinically appropriate for patients to withhold rather than to continue the drug. The most prevalent side effects were hand-foot syndrome and diarrhea which occurred in 176 (44%) and 67 (17%) patients, respectively. Multivariate analysis revealed a statistically significant association between stage and inappropriate treatment delays whereby patients with stage II disease were more likely to experience drug noncompliance (OR 1.79, 95% CI: 1.27-2.53, P < 0.001) than those with stage III disease. Compliance with adjuvant capecitabine was reasonable. Adherence ascertained from pharmacy administrative data differs significantly from that obtained from medical records. PMID:27228415

  4. Drug-drug interactions with the use of psychotropic medications. Interview by Diane M. Sloan.

    PubMed

    Ereshefsky, Larry

    2009-08-01

    Drug interactions with psychotropics can result in poor tolerability or reduced efficacy, or both, which can negatively impact patient outcomes. Most drug interactions with psychotropics are pharmacokinetic and involve the CYP family of enzymes. Clinicians can improve outcomes for patients by considering the potential for DDIs when selecting a specific psychotropic, and when evaluating patient progress, compliance, and the incidence of AEs throughout the course of treatment. Resources for clinicians include internet databases, software programs, package inserts, and consultation with pharmacists. PMID:20085108

  5. 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

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

    PubMed

    Morgan, Melissa; Montagne, Michael

    2011-01-01

    Antidepressant medications have been the fastest growing category of use of pharmaceutical products over the past decade. Selected Internet web sites providing information on antidepressant medications were identified and assessed using code of conduct criteria for posting health information on the Internet as developed by the Health on the Internet Foundation. Thirteen representative web sites were evaluated. Degree of compliance with each of the eight criterion varied by site, though all 13 sites met the criterion for legality of content and conduct on their web site. WebMD and FamilyDoctor.org met most of the criteria, while pharmaceutical company sites tended to meet the fewest criteria. PMID:21895517

  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. MEDIC: An Approach to Student Responsibility in Drug Usage

    ERIC Educational Resources Information Center

    Coppoc, Gordon L.; Stuckey, William J.

    1977-01-01

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

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

    PubMed

    Roebuck, M Christopher

    2014-10-01

    This brief commentary extends earlier work on the value of adherence to derive medical cost offset estimates from prescription drug utilization. Among seniors with chronic vascular disease, 1% increases in condition-specific medication use were associated with significant (P  less than  0.001) reductions in gross nonpharmacy medical costs in the amounts of 0.63% for dyslipidemia, 0.77% for congestive heart failure, 0.83% for diabetes, and 1.17% for hypertension. PMID:25278321

  10. 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

    ... 19 Customs Duties 2 2011-04-01 2011-04-01 false Compliance with Plant Quarantine Act and Federal Food, Drug, and Cosmetic Act. 147.23 Section 147.23 Customs Duties U.S. CUSTOMS AND BORDER PROTECTION, DEPARTMENT OF HOMELAND SECURITY; DEPARTMENT OF THE TREASURY (CONTINUED) TRADE FAIRS Requirements of Other Laws § 147.23 Compliance with...

  11. Extraction of potential adverse drug events from medical case reports

    PubMed Central

    2012-01-01

    The sheer amount of information about potential adverse drug events published in medical case reports pose major challenges for drug safety experts to perform timely monitoring. Efficient strategies for identification and extraction of information about potential adverse drug events from free‐text resources are needed to support pharmacovigilance research and pharmaceutical decision making. Therefore, this work focusses on the adaptation of a machine learning‐based system for the identification and extraction of potential adverse drug event relations from MEDLINE case reports. It relies on a high quality corpus that was manually annotated using an ontology‐driven methodology. Qualitative evaluation of the system showed robust results. An experiment with large scale relation extraction from MEDLINE delivered under‐identified potential adverse drug events not reported in drug monographs. Overall, this approach provides a scalable auto‐assistance platform for drug safety professionals to automatically collect potential adverse drug events communicated as free‐text data. PMID:23256479

  12. 75 FR 53973 - Guidance for Industry; Small Entities Compliance Guide-Designation of New Animal Drugs for Minor...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-02

    ... requirements of the final rule published in the Federal Register of July 26, 2007 (72 FR 41010). FDA has...-- Designation of New Animal Drugs for Minor Uses or Minor Species; Availability AGENCY: Food and Drug... Animal Drugs for Minor Uses or Minor Species.'' This small entities compliance guide (SECG) aids...

  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. PMID:25807604

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

    PubMed

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

    2004-01-01

    In seeking approval from the US Food and Drug Administration (FDA) for clinical trial evaluation of an experimental medical device, a sponsor is required to submit experimental findings and support documentation to demonstrate device safety and efficacy that are in compliance with Good Laboratory Practices (GLP). The objective of this project was to develop an integrated data acquisition (DAQ) system and documentation strategy for monitoring and recording physiological data when testing medical devices in accordance with GLP guidelines mandated by the FDA. Data aquisition systems were developed as stand-alone instrumentation racks containing transducer amplifiers and signal processors, analog-to-digital converters for data storage, visual display and graphical user-interfaces, power conditioners, and test measurement devices. Engineering standard operating procedures (SOP) were developed to provide a written step-by-step process for calibrating, validating, and certifying each individual instrumentation unit and the integrated DAQ system. Engineering staff received GLP and SOP training and then completed the calibration, validation, and certification process for the individual instrumentation components and integrated DAQ system. Eight integrated DAQ systems have been successfully developed that were inspected by regulatory affairs consultants and determined to meet GLP guidelines. Two of these DAQ systems were used to support 40 of the pre-clinical animal studies evaluating the AbiCor artificial heart (ABIOMED, Danvers, MA). Based in part on these pre-clinical animal data, the AbioCor clinical trials began in July 2001. The process of developing integrated DAQ systems, SOP, and the validation and certification methods used to ensure GLP compliance are presented in this article. PMID:15174367

  15. Controversies in Glaucoma: Current Medical Treatment and Drug Development.

    PubMed

    Bucolo, Claudio; Platania, Chiara Bianca Maria; Reibaldi, Michele; Bonfiglio, Vincenza; Longo, Antonio; Salomone, Salvatore; Drago, Filippo

    2015-01-01

    Elevated eye pressure is the main risk factor for glaucoma; intraocular pressure rises when the ratio between aqueous humor formation (inflow) and its outflow is unbalanced. Currently, the main goal of medical treatment is the reduction of intraocular pressure. Five main classes of topical drugs are available; they include betablockers, carbonic anhydrase inhibitors, prostaglandin derivatives, sympathomimetics and miotics. Beta-blockers and carbonic anhydrase inhibitors slow the formation of aqueous humor and may be considered as "inflow" drugs; the other three classes reduce the resistance to the drainage of aqueous humor and may be considered as "outflow" drugs. Despite the variety of drugs accessible in the market, there is a real need for ophthalmologists to have more potent medications for this disease. This review focuses on medical treatment of glaucoma with particular attention to novel molecules in pre-clinical or clinical development. PMID:26350532

  16. Increasing Compliance with Medical Examination Requests Directed to Children with Autism: Effects of a High-Probability Request Procedure

    ERIC Educational Resources Information Center

    Riviere, Vinca; Becquet, Melissa; Peltret, Emilie; Facon, Bruno; Darcheville, Jean-Claude

    2011-01-01

    The purpose of this study was to evaluate the effectiveness of a high-probability (high-"p") request sequence as a means of increasing compliance with medical examination tasks. Participants were children who had been diagnosed with autism and who exhibited noncompliance during general medical examinations. The inclusion of the high-"p" request…

  17. Medical complications of new antipsychotic drugs.

    PubMed

    Umbricht, D; Kane, J M

    1996-01-01

    Although antipsychotic drugs have a high therapeutic index (ratio of clinical benefit to adverse effects), they are associated with a range of adverse effects in most patients. The majority of these side effects are tolerable, readily managed, and not life threatening. The most troublesome side effects are neurological. Two new antipsychotics (clozapine and risperidone) have recently been introduced and are the first of a new generation of compounds that may further improve the therapeutic index of routine antipsychotic drug administration. Clozapine clearly has a reduced risk of drug-induced parkinsonism, akathisia, and tardive dyskinesia, while producing an increased risk of agranulocytosis, seizures, and weight gain. Risperidone at low doses produces relatively few parkinsonian side effects, but it can cause tardive dyskinesia (though relative risk remains to be established). Risperidone has not been associated with blood dyscrasias or increased risk of seizures, but weight gain can be a problem for some patients. Neuroleptic malignant syndrome has been reported with both drugs, but relative risk has not been established. PMID:8873298

  18. 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…

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

    PubMed Central

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

    2014-01-01

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

  20. Medical aspects of drug use in the gym.

    PubMed

    2004-01-01

    Use of performance-enhancing drugs by athletes and bodybuilders appears to be common in the UK. Although there are no comprehensive national figures, there is evidence that such drugs are also widely used in sections of the general and gym-using populations, in the expectation of physical and cosmetic benefits. Use of performance-enhancing drugs often takes place with little knowledge or acceptance of potential harmful effects, and clinicians in many settings may see patients who are experiencing problems related to such (usually covert) use. Here we consider medical aspects of performance-enhancing drugs. PMID:14768297

  1. Role of self-esteem and autonomy in determining medication compliance among adolescents with juvenile rheumatoid arthritis.

    PubMed

    Litt, I F; Cuskey, W R; Rosenberg, A

    1982-01-01

    This study was designed to improve understanding of adolescents' compliance with medical regimens. Compliance with salicylate therapy among adolescents with juvenile rheumatoid arthritis was examined in relationship to two of the most important issues of adolescent psychosocial development--self-image and autonomy. Standardized instruments that assessed these variables were administered to 38 adolescents with juvenile rheumatoid arthritis during the year in which compliance was determined, utilizing serum salicylate measurements. Patients and disease-related characteristics were also recorded, and interactions with personality variables were examined. The data show that adolescents with juvenile rheumatoid arthritis who comply with their medical regimen are those who have high self-esteem and are allowed more autonomy than the noncompliers. The longer the duration of the illness and the more symptoms present at onset, the poorer was self-concept, and hence compliance, at adolescence. PMID:7054755

  2. Polypharmacy, Drug-Drug Interactions, and Potentially Inappropriate Medications in Older HIV-Infected Adults

    PubMed Central

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

    2014-01-01

    Objectives To describe the frequency of medication-related problems in older HIV-infected adults Design Retrospective chart review Setting And Participants Community dwelling HIV-infected adults age 60 and older and age and sex-matched HIV-uninfected adults Measurements Total number of medications, potentially inappropriate medications as defined by the modified Beers criteria, anticholinergic drug burden as defined by the Anticholinergic Risk Scale, and drug-drug interactions using Lexi-Interact online drug interactions database. Results Of 89 HIV-infected participants, most were Caucasian (91%) and male (94%) with a median age of 64 (range 60-82). Common comorbidities included hyperlipidemia, hypertension, and depression. Participants were taking a median of 13 medications (range 2-38), of which only a median of 4 were antiretrovirals. At least one potentially inappropriate medication was prescribed in 46 participants (52%). Sixty-two (70%) participants had at least one Category D (consider therapy modification) drug-drug interaction and 10 (11%) had a Category X (avoid combination) interaction. One-third of these interactions were between two non-antiretroviral medications. We identified 15 participants (17%) with an anticholinergic risk scale score ≥3. In contrast, HIV-uninfected participants were taking a median of 6 medications, 29% had at least one potentially inappropriate medication, and 4% had an anticholinergic risk scale score ≥ 3 (p-value <0.05 for each comparison except p=0.07 for anticholinergic burden). Conclusion HIV-infected older adults have a high frequency of medication-related problems, of which a large portion is due to medications used to treat comorbid diseases. These medication issues were substantially higher than HIV-uninfected participants. Attention to the principles of geriatric prescribing is needed as this population ages in order to minimize complications from multiple medication use. PMID:24576251

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

    PubMed Central

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

    2016-01-01

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

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

    PubMed

    Child, Holly; McIntyre, Dara

    2015-01-01

    Although the evidence is accumulating to substantiate the successes of Family Drug Courts (FDC), there is little research on the relationship between parent compliance and successful reunification of children with their parent(s). This study looked at data from 206 families participating in a FDC in Sacramento County, California. Four compliance measures were examined individually and collectively, after controlling for participant characteristics, using logistic regression models to determine how FDC participation benchmarks impact child reunification. This study found the best predictors of reunification was participation in support group meetings and negative tests for substance use. These findings indicate that initiatives designed to address the needs of families affected by child maltreatment and substance use should take into account and support engagement in informal, community-based activities as well as formal, clinically focused interventions. PMID:26827465

  5. 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

    ...The Food and Drug Administration (FDA) is announcing the availability of a revised guidance entitled ``Marketed Unapproved Drugs--Compliance Policy Guide Sec. 440.100, Marketed New Drugs Without Approved NDAs or ANDAs'' (CPG 440.100). CPG 440.100 describes how FDA intends to exercise its enforcement discretion with regard to drug products marketed in the United States that do not have required......

  6. 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

  7. 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

  8. 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

  9. 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, DEPARTMENT OF HOMELAND SECURITY; DEPARTMENT OF THE TREASURY (CONTINUED) TRADE FAIRS Requirements of Other Laws § 147.23 Compliance with Plant Quarantine Act and Federal Food, Drug, and Cosmetic Act. (a)...

  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, DEPARTMENT OF HOMELAND SECURITY; DEPARTMENT OF THE TREASURY (CONTINUED) TRADE FAIRS Requirements of Other Laws § 147.23 Compliance with Plant Quarantine Act and Federal Food, Drug, and Cosmetic Act. (a)...

  11. 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, DEPARTMENT OF HOMELAND SECURITY; DEPARTMENT OF THE TREASURY (CONTINUED) TRADE FAIRS Requirements of Other Laws § 147.23 Compliance with Plant Quarantine Act and Federal Food, Drug, and Cosmetic Act. (a)...

  12. 19 CFR 147.23 - Compliance with Plant Quarantine Act and Federal Food, Drug, and Cosmetic Act.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... Food, Drug, and Cosmetic Act. 147.23 Section 147.23 Customs Duties U.S. CUSTOMS AND BORDER PROTECTION, DEPARTMENT OF HOMELAND SECURITY; DEPARTMENT OF THE TREASURY (CONTINUED) TRADE FAIRS Requirements of Other Laws § 147.23 Compliance with Plant Quarantine Act and Federal Food, Drug, and Cosmetic Act. (a)...

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

    PubMed Central

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

    2015-01-01

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

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

    PubMed

    Rawson, Nigel S B

    2016-01-01

    In a research article published in BMC Medicine, Onakpoya and colleagues provide a historical review of withdrawals of medications for safety reasons. However, withdrawn medications are only one part of the picture about how regulatory agencies manage drug risks. Moreover, medications introduced before the increased pre-marketing regulations and post-marketing monitoring systems instituted after the thalidomide tragedy have little relevance when considering the present drug safety picture because the circumstances under which they were introduced were completely different. To more fully understand drug safety management and regulatory agency actions, withdrawals should be evaluated within the setting and timeframe in which the medications are approved, which requires information about approvals and safety warnings. Studies are needed that provide a more comprehensive current picture of the identification and evaluation of drug safety risks as well as how regulatory agencies deal with them. Please see related research article: http://bmcmedicine.biomedcentral.com/articles/10.1186/s12916-016-0553-2. PMID:26873482

  15. [Commitment of drug abusers in Israel: medical or social responsibility?].

    PubMed

    Sigal, M; Gelkopf, M; Ben-Or, H M

    1991-01-01

    In 1977 a new paragraph was added to Israel's penal law allowing rehabilitation of convicted drug abusers by compulsory psychiatric treatment. The commitment was implemented on the basis of a court order. Notwithstanding the doubts of psychiatrists the law permitted the commitment of a significant number of drug abusers to psychiatric wards. The rehabilitation treatment through commitment and some of its negative consequences are described in a study that covers 10 years of activity at the Pardessia Menta Health Center. We present 3 typical profiles of drug abusers who were treated in our center as specified by the law. None needed medical help in physical withdrawal from the drug. All took advantage of the opportunity to spend part of their incarceration time in the hospital instead of in jail. The law was amended in July 1989 and since February 1990 treatment is conducted under the supervision of probation officers and not in a medical institution. The amended law reflects the approach to drug abuse as a social not psychopathological problem, so that social agencies and no medical instances are in charge. PMID:2010135

  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. PMID:25575555

  17. 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

  18. Preliminary studies on the use of modulation sensing for noninvasive monitoring of drug compliance

    NASA Astrophysics Data System (ADS)

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

    1999-05-01

    Presently two methods in concert, a marker method and an electronic monitoring method, have been emphasized for an objective monitoring of drug compliance in ambulatory care. While the marker method proves dose ingestion, the electronic monitoring method provides continuous record of timing of presumptive drug doses. The marker method is however time intensive with associated safety problems, and the electronic monitoring method is easily defeated. We here present preliminary results on modulation sensing, a new method that could be used to non-invasively monitor patient compliance. Measurement is based on observing the amplitude modulation of the emission from both a short lifetime marker fluorophore of interest and a long lifetime reference fluorophore contained in the monitoring device. At some intermediate frequencies, the observed modulation of the combined emission is nearly equivalent to the fractional intensity of the marker fluorophore. This method precludes problems associated with measuring fluorescence intensities in highly scattering media. Using this method we measured the presence of rhodamine 800 (Rh800) in intralipid suspensions and chicken tissue. Rh800 is excited at long wavelengths not absorbed by tissues. Micromolar concentrations of this dye were detected in intralipid and chicken muscle covered with a layer of chicken skin.

  19. 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

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

    PubMed

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

    2015-10-15

    Due to their potential mutagenic, carcinogenic and teratogenic effects occupational exposure to chemotherapy drugs should be kept to a minimum. Utilization of personnel protective devices, especially the use of protective medical gloves, is a mainstay to avoid skin contact. The choice of appropriate gloves is of outstanding importance. For optimal protection in the oncology setting it is essential to establish general guidelines evaluating appropriate materials and defining quality standards. Establishing these guidelines can facilitate better handling and avoid potential hazards and late sequelae. In Europe there are no specific requirements or test methodologies for medical gloves used in the oncology environment. The implementation of uniform standards for gloves used while handling chemotherapy drugs would be desirable. In contrast, in the US medical gloves used to handle chemotherapy drugs have to fulfill requirements according to the ASTM International (American Society of Testing and Materials) standard D 6978-05. Nitrile or natural rubber latex is a preferred basic glove material, while vinyl is considered inappropriate because of its generally increased permeability. For extended exposure to chemotherapy drugs, double gloving, the use of thicker gloves and the frequent change of gloves increases their protective power. PMID:24978061

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

    PubMed

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

    2010-01-01

    The limitation of medical intern and resident work hours, known as the Bell 405 regulations, was initiated in New York State in 1989 with a modification to the state hospital code. The Bell 405 regulations were strengthened in 2000, and facilities would now be fined for noncompliance. Monitoring systems in place at that time were insufficient to provide an adequate level of review for the New York City Health and Hospitals Corporation (HHC) with more than 7,000 medical residents whose training is based at or who rotate through these public hospitals. A "simple to use," yet comprehensive, method of monitoring compliance needed to be developed to ensure that residents and interns complied with laws regulating working hours. The subsequent development of national accreditation standards increased the stakes for reliable scrutiny. HHC developed and implemented a Web-based Structured Query Language (SQL) application that facilitated easy access to work hour surveys captured through electronic time sheets. The time sheet data automatically entered a database that provided instant analysis of conformance to state law. The development of an electronic on-line application accessible from anywhere allowed HHC to efficiently identify nonconformance and pinpoint corrective action. Since the inception of the application and its expansion allowing access through the intranet, 26,000 individual time sheets have been submitted for evaluation. With the national movement regulating work hours, other hospitals still at the pencil and manual computation stage would greatly benefit by developing a similar application. PMID:20150790

  2. Safe Medical Devices Act: management guidance for hospital compliance with the new FDA requirements.

    PubMed

    Alder, H C

    1993-10-01

    The Safe Medical Devices Act of 1990 (Public Law 101-629) was signed by President George Bush almost three years ago on November 28, 1990. The law expanded the Food and Drug Administration's (FDA) authority to regulate medical devices and grew out of congressional concerns about the FDA's ability to quickly learn when a medical device caused an adverse patient event, and to ensure that hazardous devices are removed from hospitals and other health care facilities in a timely manner. The Safe Medical Devices Act is an extension of the Medical Device Amendments of 1976, which imposed production, distribution, and sales rules on medical device manufacturers. It gives the FDA the legal authority to directly regulate the use of medical devices in health care facilities. Among the Safe Medical Devices Act's provisions are specific requirements for hospitals, health professionals, and other users of medical devices to report patient incidents involving medical devices to the manufacturer and to the FDA if a device caused or contributed to a serious injury, death, or other "adverse experience." Adverse experiences are defined by the FDA to include concussions, fractures, burns, temporary paralysis, and temporary loss of sight, hearing, or smell. Hospitals have been required to comply with this provision of the law, called user reporting, since 1991. Hospitals are also required to participate in tracking certain medical devices whose failure could result in a serious adverse health outcome. The law requires distributors and manufacturers of specific devices to adopt a method for device tracking. Hospitals are required to cooperate with and provide device manufacturers with information about patients with permanently implantable devices and life-sustaining and life-supporting devices used outside device user facilities. The law also gives the FDA the authority to designate other devices subject to tracking if the agency determines such tracking is warranted to preserve the

  3. 75 FR 35439 - Medical Diagnostic Equipment Accessibility Standards

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-22

    ... TRANSPORTATION BARRIERS COMPLIANCE BOARD Medical Diagnostic Equipment Accessibility Standards AGENCY... consultation with the Food and Drug Administration, to issue accessibility standards for medical diagnostic... accessibility needs of individuals with disabilities with respect to medical diagnostic equipment and...

  4. Persistence and compliance with newly initiated antihypertensive drug treatment in patients with chronic kidney disease

    PubMed Central

    Truong, Viet Thanh; Moisan, Jocelyne; Kröger, Edeltraut; Langlois, Serge; Grégoire, Jean-Pierre

    2016-01-01

    Background Patients with chronic kidney disease initiating an antihypertensive drug (AH) treatment must persist and comply with it to slow disease progression and benefit from the reduction of cardiovascular morbidity and mortality. Objectives This study evaluates the persistence and compliance with AH treatment and identifies the associated factors among chronic kidney disease patients who initiated AH treatment. Methods A population-based cohort study using Quebec administrative data was conducted. Patients who still take any AH 1 year after initiation were considered persistent. Of these patients, those who had ≥80% of days covered with an AH in the year after initiation were considered compliant. Factors associated with persistence and compliance were identified using a modified Poisson regression. Results Of the 7,119 eligible patients, 78.8% were persistent, 87.7% of whom were compliant with their AH treatment. Compared with patients on diuretic monotherapy, those who initially used angiotensin-converting enzyme inhibitor monotherapy, angiotensin II receptor blocker monotherapy, calcium channel blocker monotherapy, β-blocker monotherapy, or multidrug therapy were more likely to be persistent. In contrast, individuals who visited their physicians ≥17 times were less likely to be persistent than those who visited between 0 and 8 times. The patients who were more likely to be compliant had initially used an angiotensin-converting enzyme inhibitor, β-blocker, calcium channel blocker, or multitherapy as opposed to a diuretic. Conclusion A year after initiating AH treatment, nearly a third of chronic kidney disease patients were either not taking an AH or had not been compliant. Factors associated with persistence and compliance could help identify patients who need help in managing their AH treatment. PMID:27382260

  5. 78 FR 12762 - Joint Meeting of the Medical Imaging Drugs Advisory Committee and the Oncologic Drugs Advisory...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-25

    ... HUMAN SERVICES Food and Drug Administration Joint Meeting of the Medical Imaging Drugs Advisory Committee and the Oncologic Drugs Advisory Committee; Notice of Meeting. AGENCY: Food and Drug... of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of...

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

    PubMed

    2008-05-01

    The Editorial Board of the Journal of Endodontics has developed a literature-based study guide of topical areas related to endodontics. This study guide is intended to give the reader a focused review of the essential endodontic literature and does not cite all possible articles related to each topic. Although citing all articles would be comprehensive, it would defeat the idea of a study guide. This section will cover medical emergencies and drugs. PMID:18457703

  7. Anti-relapse medications: Preclinical models for drug addiction treatment

    PubMed Central

    Yahyavi-Firouz-Abadi, Noushin; See, Ronald E.

    2009-01-01

    Addiction is a chronic relapsing brain disease and treatment of relapse to drug-seeking is considered the most challenging part of treating addictive disorders. Relapse can be modeled in laboratory animals using reinstatement paradigms, whereby behavioral responding for a drug is extinguished and then reinstated by different trigger factors, such as environmental cues or stress. In this review, we first describe currently used animal models of relapse, different relapse triggering factors, and the validity of this model to assess relapse in humans. We further summarize the growing body of pharmacological interventions that have shown some promise in treating relapse to psychostimulant addiction. Moreover, we present an overview on the drugs tested in cocaine or methamphetamine addicts and examine the overlap of existing preclinical and clinical data. Finally, based on recent advances in our understanding of the neurobiology of relapse and published preclinical data, we highlight the most promising areas for future anti-relapse medication development. PMID:19683019

  8. 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

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

    PubMed Central

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

    2006-01-01

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

  10. 78 FR 16679 - Center for Drug Evaluation and Research Medical Policy Council; Request for Comments

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-18

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

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

    PubMed Central

    2013-01-01

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

  12. Antihypertensive medication compliance in African-American stroke patients: behavioral epidemiology and interventions.

    PubMed

    Friday, G H

    1999-01-01

    Hypertension is a major cause of stroke in the African-American community, and lack of control of hypertension appears to be common. Improving compliance to antihypertensive therapy in African-American stroke patients could have a significant impact on recurrent stroke rates. Little is known about factors affecting compliance in this community and which interventions would be effective in improving compliance. Health behavior models which assess the patient's perception of stroke and hypertension, barriers to the desired behavior, perception of ability to perform the behavior, perception of others' acceptance of the behavior and the patient's behavioral stage could be used to tailor interventions to improve compliance. A plan to improve compliance should take into account the target population's baseline rates of compliance, perception of need for intervention and risk factors for noncompliance. PMID:10461046

  13. Federalizing Medical Campaigns against Alcoholism and Drug Abuse

    PubMed Central

    Metlay, Grischa

    2013-01-01

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

  14. 42 CFR 423.153 - Drug utilization management, quality assurance, and medication therapy management programs (MTMPs).

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... medication therapy management programs (MTMPs). 423.153 Section 423.153 Public Health CENTERS FOR MEDICARE... Drug utilization management, quality assurance, and medication therapy management programs (MTMPs). (a... to reduce medication errors and adverse drug interactions and improve medication use that include...

  15. 42 CFR 423.153 - Drug utilization management, quality assurance, and medication therapy management programs (MTMPs).

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... medication therapy management programs (MTMPs). 423.153 Section 423.153 Public Health CENTERS FOR MEDICARE... Drug utilization management, quality assurance, and medication therapy management programs (MTMPs). (a... to reduce medication errors and adverse drug interactions and improve medication use that include...

  16. Medication dyes as a source of drug allergy.

    PubMed

    Swerlick, Robert A; Campbell, Caren F

    2013-01-01

    Excipients are defined as inert substances added to a drug or food to confer a suitable consistency, appearance, or form. They may be added for bulk, to change dissolution or the kinetics of absorption, to improve stability, to influence palatability, or to create a distinctive appearance. The last function may depend heavily on the use of coloring agents, especially when there are multiple dosages (such as with warfarin), and dose confusion may result in profound complications. While described as inert, excipients have been associated with triggering immunological reactions, although this is almost never considered in common practice when patients have reactions to medications, even when they appear to react to many different and distinct drugs. We have found a cohort of 11 patients with chronic, unexplained pruritic skin disorders that have responded to medication changes centered around avoidance of coloring agents, particularly FD&C Blue No. 1 (bright blue) and Blue No. 2 (indigo carmine). We believe that reactions to agents that color medications and foods may be more common than previously appreciated and that recognition of this phenomenon may provide therapeutic alternatives to patients with intractable pruritic disorders. PMID:23377335

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

    PubMed Central

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

    2016-01-01

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

  18. [Rapid Delivery of Pharmaceutical Drugs in Home Medical Care].

    PubMed

    Kawamata, Michiko; Hirohara, Masayoshi; Kushida, Kazuki

    2015-12-01

    The population of individuals over age 65 has grown in recent years, leading to a revision of the way medical care is provided, including an increased use of home care services, for example. Medicines are delivered to home care patients in accordance with a specific schedule and based on prescriptions written by home care doctors. Although this system functions perfectly well when the patient's condition is stable, a rapidly worsening condition may lead to changes or additions to the list of prescriptions. Moreover, in addition to specialized check-ups by home care doctors, patients may also visit ophthalmologists, orthopedic specialists, or dermatologists on an outpatient basis. In such cases, the provision of drugs often does not follow a regular schedule and may require special delivery to the patients' homes. These types of alterations to medications often happen suddenly and may require drug delivery outside the pharmacies' normal hours of operation, thus imposing a great burden on them. This report aims to describe the realities faced by pharmacies as they attempt to accommodate these sudden demands for drug delivery. PMID:26809401

  19. Differential pharmacology of drugs used for intravenous pre-medication.

    PubMed

    Dionne, R A

    1984-06-01

    The differential effects of drugs used for intravenous pre-medication are reviewed using the results of controlled clinical trials in dental outpatients. The evaluation of clinical success requires experimental control of factors which can confound both the therapeutic and evaluation processes. The evaluation of drugs which are given primarily to alleviate anxiety requires that this effect be assessed by the patient's self-report rather than by the clinician's estimate of drug effect based on external manifestations. The results of the studies reviewed suggest that intravenous diazepam accomplishes the therapeutic objectives of anxiety relief, decreased pain perception, and amnesia. The addition of a narcotic, while reducing the diazepam dose, does not result in any greater effect, but does improve patient cooperation. It is concluded that diazepam, administered to clinical end-point, accomplishes most of the goals of intravenous pre-medication with minimal potential for adverse effects. The use of additional agents may improve patient cooperation, but this possible advantage must be weighed against the potential for increased systemic effects. PMID:6145734

  20. 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

  1. 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. PMID:24728444

  2. 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

  3. 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

  4. 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

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

    PubMed Central

    2011-01-01

    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 duplication or

  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. Approaches to Increasing Ethical Compliance in China with Drug Trial Standards of Practice.

    PubMed

    Rosenberg, Jacob

    2016-03-29

    Zeng et al.'s Ethics Review highlights some of the challenges associated with clinical research in China. They found that only a minority of published clinical trials of anti-dementia drugs reported that they fulfilled the basic ethical principles as outlined in the Declaration of Helsinki. With recent reports of scientific misconduct from China, there is an urgent need to find approaches to compel researchers to adhere to ethical research practices. This problem does not call for a simple solution, but if forces are joined with governmental regulations, education in ethics issues for medical researchers, and strong reinforcement by Chinese journal editors not to publish studies with these flaws, then research ethics and publication standards will probably improve. Other solutions to foster ethical practice of drug trials are discussed including Chinese initiatives directed at managing conflict of interest from the pharmaceutical industry and educating clinical researchers. PMID:27031489

  8. [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

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

    PubMed

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

    2015-04-01

    The American College of Clinical Pharmacy (ACCP) previously published position statements on collaborative drug therapy management (CDTM) in 1997 and 2003. Since 2003, significant federal and state legislation addressing CDTM has evolved and expanded throughout the United States. CDTM is well suited to facilitate the delivery of comprehensive medication management (CMM) by clinical pharmacists. CMM, defined by ACCP as a core component of the standards of practice for clinical pharmacists, is designed to optimize medication-related outcomes in collaborative practice environments. New models of care delivery emphasize patient-centered, team-based care and increasingly link payment to the achievement of positive economic, clinical, and humanistic outcomes. Hence clinical pharmacists practicing under CDTM agreements or through other privileging processes are well positioned to provide CMM. The economic value of clinical pharmacists in team-based settings is well documented. However, patient access to CMM remains limited due to lack of payer recognition of the value of clinical pharmacists in collaborative care settings and current health care payment policy. Therefore, the clinical pharmacy discipline must continue to establish and expand its use of CDTM agreements and other collaborative privileging mechanisms to provide CMM. Continued growth in the provision of CMM by appropriately qualified clinical pharmacists in collaborative practice settings will enhance recognition of their positive impact on medication-related outcomes. PMID:25884536

  10. Medication Adherence and the Use of Generic Drug Therapies

    PubMed Central

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

    2010-01-01

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

  11. 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

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

    PubMed

    Yang, Hu; Leffler, Christopher T

    2013-03-01

    Glaucoma therapy typically begins with topical medications, of which there are 4 major classes in common use in the United States: beta-adrenergic antagonists, alpha-agonists, carbonic anhydrase inhibitors, and prostaglandin analogs. Unfortunately, all 4 classes require at least daily dosing, and 3 of the 4 classes are approved to be administered 2 or 3 times daily. This need for frequent dosing with multiple medications makes compliance difficult. Longer-acting formulations and combinations that require less frequent administration might improve compliance and therefore medication effectiveness. Recently, we developed an ocular drug delivery system, a hybrid dendrimer hydrogel/poly(lactic-co-glycolic acid) nanoparticle platform for delivering glaucoma therapeutics topically. This platform is designed to deliver glaucoma drugs to the eye efficiently and release the drug in a slow fashion. Furthermore, this delivery platform is designed to be compatible with many of the glaucoma drugs that are currently approved for use. In this article, we review this new delivery system with in-depth discussion of its structural features, properties, and preclinical application in glaucoma treatment. In addition, future directions and translational efforts for marketing this technology are elaborated. PMID:23249385

  13. Medical devices; refurbishers, rebuilders, reconditioners, servicers, and "as is" remarketers of medical devices; review and revision of compliance policy guides and regulatory requirements; request for comments and information--FDA. Advance notice of proposed rulemaking.

    PubMed

    1997-12-23

    The Food and Drug Administration (FDA) is announcing its intention to review and, as necessary, to revise or to amend its compliance policy guides and regulatory requirements relating to the remarketing of used medical devices and the persons who refurbish, recondition, rebuild, service, or remarket such devices. The agency is considering these actions because it believes evolving industry practices warrant reevaluation of current policy and the application of certain regulatory requirements in order to ensure that particular remarketed devices meet suitable performance requirements for their intended uses, and are as safe as the originally marketed finished device. FDA is soliciting comments, proposals for alternative regulatory approaches, and information on these issues. In a future issue of the Federal Register, FDA will announce an open meeting of the Good Manufacturing Practices (GMP) Advisory Committee concerning these matters. PMID:10179309

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-08

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

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

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... medication therapy management programs (MTMPs). 423.153 Section 423.153 Public Health CENTERS FOR MEDICARE... management, quality assurance, and medication therapy management programs (MTMPs). (a) General rule. Each... and systems to reduce medication errors and adverse drug interactions and improve medication use...

  18. 75 FR 51825 - Quality and Compliance in Merging and Emerging Cultures; Public Conference

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-23

    ...The Food and Drug Administration (FDA) is announcing a public conference entitled ``The New Paradigm: Quality and Compliance in Merging and Emerging Cultures.'' The conference, cosponsored with the Parenteral Drug Association (PDA), will focus on challenges facing the medical products industry in navigating regulatory compliance, achieving worldwide quality improvement, and enhancing quality......

  19. 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…

  20. 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... Medical Policy, Food and Drug Administration, 10903 New Hampshire Ave, Bldg. 51, rm. 6360, Silver...

  1. 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…

  2. Adverse drug reactions caused by drug-drug interactions reported to Croatian Agency for Medicinal Products and Medical Devices: a retrospective observational study

    PubMed Central

    Mirošević Skvrce, Nikica; Macolić Šarinić, Viola; Mucalo, Iva; Krnić, Darko; Božina, Nada; Tomić, Siniša

    2011-01-01

    Aim To analyze potential and actual drug-drug interactions reported to the Spontaneous Reporting Database of the Croatian Agency for Medicinal Products and Medical Devices (HALMED) and determine their incidence. Methods In this retrospective observational study performed from March 2005 to December 2008, we detected potential and actual drug-drug interactions using interaction programs and analyzed them. Results HALMED received 1209 reports involving at least two drugs. There were 468 (38.7%) reports on potential drug-drug interactions, 94 of which (7.8% of total reports) were actual drug-drug interactions. Among actual drug-drug interaction reports, the proportion of serious adverse drug reactions (53 out of 94) and the number of drugs (n = 4) was significantly higher (P < 0.001) than among the remaining reports (580 out of 1982; n = 2, respectively). Actual drug-drug interactions most frequently involved nervous system agents (34.0%), and interactions caused by antiplatelet, anticoagulant, and non-steroidal anti-inflammatory drugs were in most cases serious. In only 12 out of 94 reports, actual drug-drug interactions were recognized by the reporter. Conclusion The study confirmed that the Spontaneous Reporting Database was a valuable resource for detecting actual drug-drug interactions. Also, it identified drugs leading to serious adverse drug reactions and deaths, thus indicating the areas which should be in the focus of health care education. PMID:21990078

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

    PubMed Central

    Krasowski, Matthew D.

    2010-01-01

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

  4. 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

    ... 42 Public Health 3 2013-10-01 2013-10-01 false Condition of participation: Drugs and biologicals, medical supplies, and durable medical equipment. 418.106 Section 418.106 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICARE PROGRAM (CONTINUED) HOSPICE CARE Conditions of...

  5. 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) ...

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

    PubMed Central

    Brown, Marty Skemp; Maurer, Martha A

    2014-01-01

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

  7. 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…

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

    PubMed

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

    2015-04-01

    Medications indicated for helminthes and other parasitic infections are frequently being used in mass populations in endemic areas. Currently, there is a lack of guidance for clinicians on how to appropriately manage drug interactions when faced with patients requiring short-term anthelmintic therapy with albendazole or mebendazole while concurrently taking other agents. The objective of this review was to systematically summarize and evaluate published literature on the pharmacokinetics of albendazole or mebendazole when taken with other interacting medications. A search of MEDLINE (1946 to October 2014), EMBASE (1974 to October 2014), International Pharmaceutical Abstracts (1970 to October 2014), Google, and Google Scholar was conducted for articles describing the pharmacokinetics of albendazole or mebendazole when given with other medications (and supplemented by a bibliographic review of all relevant articles). Altogether, 17 articles were included in the review. Studies reported data on pharmacokinetic parameters for albendazole or mebendazole when taken with cimetidine, dexamethasone, ritonavir, phenytoin, carbamazepine, phenobarbital, ivermectin, praziquantel, diethylcarbamazine, azithromycin, and levamisole. Cimetidine increased the elimination half-life of albendazole and maximum concentration (Cmax) of mebendazole; dexamethasone increased the area under the plasma concentration-time curve (AUC) of albendazole; levamisole decreased the Cmax of albendazole; anticonvulsants (phenytoin, phenobarbital, carbamazepine) decreased the AUC of albendazole; praziquantel increased the AUC of albendazole; and ritonavir decreased the AUC of both albendazole and mebendazole. No major interactions were found with ivermectin, azithromycin, or diethylcarbamazine. Future research is required to clarify the clinical relevance of the interactions observed. PMID:25691367

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

    PubMed

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

    2015-07-25

    Medicated shellac nanofibers providing colon-specific sustained release were fabricated using coaxial electrospinning. A solution of 7.5 g shellac and 1.5 g of ferulic acid (FA) in 10 mL ethanol was used as the core fluid, and a mixture of ethanol and N,N-dimethylformamide (8/10 v/v) as the shell. The presence of the shell fluid was required to prevent frequent clogging of the spinneret. The diameters of the fibers (D) can be manipulated by varying the ratio of shell to core flow rates (F), according to the equation D=0.52 F(-0.19). Scanning electron microscopy images revealed that fibers prepared with F values of 0.1 and 0.25 had linear morphologies with smooth surfaces, but when the shell fluid flow rate was increased to 0.5 the fiber integrity was compromised. FA was found to be amorphously distributed in the fibers on the basis of X-ray diffraction and differential scanning calorimetry results. This can be attributed to good compatibility between the drug and carrier: IR spectra indicated the presence of hydrogen bonds between the two. In vitro dissolution tests demonstrated that there was minimal FA release at pH 2.0, and sustained release in a neutral dissolution medium. The latter occurred through an erosion mechanism. During the dissolution processes, the shellac fibers were gradually converted into nanoparticles as the FA was freed into solution, and ultimately completely dissolved. PMID:26043827

  10. 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

  11. 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

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-25

    ... 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.... In the Federal Register of July 21, 2011 (76 FR 43689), FDA announced the availability of the...

  13. 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

    ...The Food and Drug Administration (FDA) is requesting nominations for 12 members to serve on the Medical Imaging Drugs Advisory Committee in the Center for Drug Evaluation and Research. FDA has a special interest in ensuring that women, minority groups, and individuals with physical disabilities are adequately represented on advisory committees and, therefore, extends particular encouragement......

  14. Modeling drug exposure data in electronic medical records: an application to warfarin.

    PubMed

    Liu, Mei; Jiang, Min; Kawai, Vivian K; Stein, Charles M; Roden, Dan M; Denny, Joshua C; Xu, Hua

    2011-01-01

    Identification of patients' drug exposure information is critical to drug-related research that is based on electronic medical records (EMRs). Drug information is often embedded in clinical narratives and drug regimens change frequently because of various reasons like intolerance or insurance issues, making accurate modeling challenging. Here, we developed an informatics framework to determine patient drug exposure histories from EMRs by combining natural language processing (NLP) and machine learning (ML) technologies. Our framework consists of three phases: 1) drug entity recognition - identifying drug mentions; 2) drug event detection - labeling drug mentions with a status (e.g., "on" or "stop"); and 3) drug exposure modeling - predicting if a patient is taking a drug at a given time using the status and temporal information associated with the mentions. We applied the framework to determine patient warfarin exposure at hospital admissions and achieved 87% precision, 79% recall, and an area under the receiver-operator characteristic curve of 0.93. PMID:22195139

  15. [Drug safeguards to ensure the ambulatory medication safety of elderly people].

    PubMed

    Yeh, Min-Li

    2013-04-01

    Medication safety is a primary patient safety goal. Medication safety addresses a comprehensive process that includes prescription issuance, medication dispensing, administration, and patient consumption. The application of mobile communication technology to healthcare products and to the extension of medication safety beyond the hospital into daily life are important trends. The elderly are a high risk group for adverse drug events due to age and higher incidences of chronic disease, multiple medication use, and improper medication behavior. Drug safeguards delivered through mobile services can enhance the medication safety of elders. Such services provide an education, care giving, and response link among institutions, homes, and the community, making it easier to integrate medication safety technology into daily life. PMID:23588691

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

    PubMed

    Fincham, Jack E

    2007-01-01

    These "Next Dose" spoons were marketed until the 1960s in the United States. Unfortunately, the further paths crossed by Messieurs Morgan and Bushey cannot be further elucidated. Nor can further information be identified for the eventual marketer of the "Next Dose" spoon. What we can surmise is that the use of specialized devices to administer and remind patients about dosing is not new. There is scant mention of compliance in the literature too years ago, but pharmacies and patients no doubt found these devices to be useful. For the pharmacist, advertising on the spoon provided a reminder of their services, and for the patient, a reminder was present on the body of the spoon to remind them of the next dosing time. Most medications during this time were in liquid form, and a device to help accurately measure liquid, elixir, tonic, suspensions was a highly sought-after item welcomed by patients and/or caregivers. PMID:19069217

  17. 71 FR 66448 - Prescription Drug Marketing Act Pedigree Requirements under 21 CFR Part 203 Compliance Policy...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2006-11-15

    ... 92N-0297), 1988N-0258 (Formerly 88N- 0258), 2006D-0226] Prescription Drug Marketing Act Pedigree... Marketing Act Pedigree Requirements Questions and Answers; Notice of Availability AGENCY: Food and Drug... ``Prescription Drug Marketing Act--Pedigree Requirements under 21 CFR Part 203'' (PDMA CPG). This CPG...

  18. 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

  19. 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

  20. [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

  1. Electronic medication ordering with integrated drug database and clinical decision support system.

    PubMed

    Cufar, Andreja; Droljc, Anže; Orel, Andrej

    2012-01-01

    Medication errors have been identified as one of the most important causes of adverse drug events. Computerized physician order-entry (CPOE) systems, coupled with decision support (Medication allergy checking, drug interactions, and dose calculations), are considered to be appropriate solutions for reducing medication errors and standardizing care. It is quite useful if clinical information system (CIS) supports order sets, which help with standardizing care, preventing omission errors, and expediting the ordering process. Order sets are predefined groups of orders pertinent to one or more specific clinical conditions or diagnoses. The article describes how a clinical information system can be used to support medication process (prescribing, ordering, dispensing, administration and monitoring) and offer participating medical teams real time warnings and key information regarding medications and patient status, thus reducing medication errors. Integrated electronic prescribing support system benefits for total parenteral nutrition (TPN) are discussed at the end. PMID:22874280

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

    PubMed

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

    2016-04-01

    Background Information on medication use and drug-related problems is important in the preparation of clinical medication reviews. Critical information can only be provided by patients themselves, but interviewing patients is time-consuming. Alternatively, patient information could be obtained with a questionnaire. Objective In this study the agreement between patient information on medication use and drug-related problems in older patients obtained with a questionnaire was compared with information obtained during an interview. Setting General practice in The Netherlands. Method A questionnaire was developed to obtain information on actual medication use and drug-related problems. Two patient groups ≥65 years were selected based on general practitioner electronic medical records in nine practices; I. polypharmacy and II. ≥1 predefined general geriatric problems. Eligible patients were asked to complete the questionnaire and were interviewed afterwards. Main outcome measure Agreement on information on medication use and drug-related problems collected with the questionnaire and interview was calculated. Results Ninety-seven patients participated. Of all medications used, 87.6 % (95 % CI 84.7-90.5) was reported identically in the questionnaire and interview. Agreement for the complete medication list was found for 45.4 % (95 % CI 35.8-55.3) of the patients. On drug-related problem level, agreement between questionnaire and interview was 75 %. Agreement tended to be lower in vulnerable patients characterized by ≥4 chronic diseases, ≥10 medications used and low health literacy. Conclusion Information from a questionnaire showed reasonable agreement compared with interviewing. The patients reported more medications and drug-related problems in the interview than the questionnaire. Taking the limitations into account, a questionnaire seems a suitable tool for medication reviews that may replace an interview for most patients. PMID:26830412

  3. 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)

  4. Medical innovation prize fund: new idea in drug development.

    PubMed

    James, John S

    2005-05-27

    This proposal, now introduced in Congress as HR 417, would replace current drug marketing with system better designed to reward effective innovation. All drugs would be treated as generics immediately when approved by the FDA, and patent holders would be rewarded from a $60 billion a year award fund for innovations that actually led to better health. PMID:16047411

  5. 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

  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. 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...

  8. 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...

  9. 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...

  10. 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...

  11. 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...

  12. 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...

  13. 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...

  14. 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...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-15

    ... 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...

  16. 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…

  17. Drug dependence, a chronic medical illness: implications for treatment, insurance, and outcomes evaluation.

    PubMed

    McLellan, A T; Lewis, D C; O'Brien, C P; Kleber, H D

    2000-10-01

    The effects of drug dependence on social systems has helped shape the generally held view that drug dependence is primarily a social problem, not a health problem. In turn, medical approaches to prevention and treatment are lacking. We examined evidence that drug (including alcohol) dependence is a chronic medical illness. A literature review compared the diagnoses, heritability, etiology (genetic and environmental factors), pathophysiology, and response to treatments (adherence and relapse) of drug dependence vs type 2 diabetes mellitus, hypertension, and asthma. Genetic heritability, personal choice, and environmental factors are comparably involved in the etiology and course of all of these disorders. Drug dependence produces significant and lasting changes in brain chemistry and function. Effective medications are available for treating nicotine, alcohol, and opiate dependence but not stimulant or marijuana dependence. Medication adherence and relapse rates are similar across these illnesses. Drug dependence generally has been treated as if it were an acute illness. Review results suggest that long-term care strategies of medication management and continued monitoring produce lasting benefits. Drug dependence should be insured, treated, and evaluated like other chronic illnesses. JAMA. 2000;284:1689-1695. PMID:11015800

  18. 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

  19. Drug Utilization Study in Medical Emergency Unit of a Tertiary Care Hospital in North India

    PubMed Central

    Kaur, Sharonjeet; Rajagopalan, Sujit; 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

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

    PubMed Central

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

    2015-01-01

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

  1. 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

  2. New medications for drug addiction hiding in glutamatergic neuroplasticity

    PubMed Central

    Kalivas, PW; Volkow, ND

    2011-01-01

    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

  3. 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

    ...The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Medical Device Classification Product Codes.'' This document describes how device product codes are used in a variety of FDA program areas to regulate and track medical devices regulated by the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research......

  4. 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

    ...The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Medical Device Reporting for Manufacturers.'' This draft guidance describes and explains the current FDA regulation that addresses reporting and recordkeeping requirements applicable to manufacturers of medical devices for certain device-related adverse events. This draft guidance is intended......

  5. 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... opportunity to report to the MRO the use of any prescription or over-the-counter medication. If the...

  6. 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... opportunity to report to the MRO the use of any prescription or over-the-counter medication. If the...

  7. 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... opportunity to report to the MRO the use of any prescription or over-the-counter medication. If the...

  8. 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.…

  9. 77 FR 10537 - Food and Drug Administration/Xavier University Global Medical Device Conference

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-22

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

  10. 75 FR 15439 - Food and Drug Administration/Xavier University Global Medical Device Conference

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-29

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

  11. 76 FR 15986 - Food and Drug Administration/Xavier University Global Medical Device Conference

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-22

    ... conference will be held on the campus of Xavier University, 3800 Victory Pkwy., ] Cincinnati, OH 45207, 513... HUMAN SERVICES Food and Drug Administration Food and Drug Administration/Xavier University Global... University, is announcing a public conference entitled ``FDA/Xavier University Global Medical...

  12. 78 FR 15957 - Food and Drug Administration/Xavier University Global Medical Device Conference

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-13

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

  13. 78 FR 734 - Medical Imaging Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-04

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

  14. Medical devices; laser fluorescence caries detection device. Food and Drug Administration, HHS. Final rule.

    PubMed

    2000-04-01

    The Food and Drug Administration (FDA) is classifying the laser fluorescence caries detection device into class II (special controls). The special controls that will apply to this device are set forth below. The agency is taking this action in response to a petition submitted under the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Medical Device Amendments of 1976 (the amendments), the Safe Medical Devices Act of 1990, and the Food and Drug Administration Modernization Act of 1997. The agency is classifying this device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. PMID:11010622

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

    PubMed

    Zafar, Atif

    2007-01-01

    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. PMID:18694263

  16. 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

  17. 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. PMID:25988826

  18. 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. PMID:26545484

  19. Non-medical use of prescription drugs and sexual risk behavior in young adults.

    PubMed

    Benotsch, Eric G; Koester, Stephen; Luckman, Diana; Martin, Aaron M; Cejka, Anna

    2011-01-01

    In recent years, the non-medical use of prescription drugs (without a doctor's prescription) has increased dramatically, particularly in young adults. Previous work has noted associations between the non-medical use of prescription drugs and the use of illicit drugs, and associations between the use of illicit drugs and sexual risk behavior. Investigations examining associations between the non-medical use of prescription drugs (NMUPD) and sexual risk behavior are sparse. In the present study, undergraduate students (n=435) ages 18-25 completed an instrument assessing these behaviors. Overall, 35.6% of participants reported NMUPD. Individuals who reported NMUPD were more likely to also report the use of alcohol, marijuana, ecstasy, cocaine, methamphetamine, and poppers. Participants who indicated they had used prescription medications without a doctor's consent had significantly higher rates of sexual risk behavior, including more sexual partners and more instances of unprotected sex in the previous 3 months. Results suggest that a significant minority of young adults are using prescription medication recreationally and are risking negative consequences, including the potential for addiction, dangerous interactions between prescription and recreational drugs, and greater risk for contracting sexually transmitted infections. PMID:20863626

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

    PubMed Central

    Mitchell, M. Faith

    1983-01-01

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

  1. Drug-related problems (DRPs) identified from geriatric medication safety review clinics.

    PubMed

    Chan, Ding-Cheng; Chen, Jen-Hau; Kuo, Hsu-Ko; We, Chiung-Jung; Lu, I-Shu; Chiu, Lee-Shu; Wu, Shwu-Chong

    2012-01-01

    Drug-related problems (DRPs) were identified from baseline data of 193 Medication Safety Review Clinic (MSRC) patients. MSRCs enroll older adults (≥ 65 years) with either (1) prescriptions of ≥ 8 chronic medications (drugs prescribed for ≥ 28 days) or (2) a visit to ≥ 3 different physicians at the two participating hospitals in Taipei, Taiwan from August to October 2007. The Pharmaceutical Care Network Europe (PCNE) Classification Version 5.01 was used to report DRPs. Mean age was 76.2 ± 6.2 years and 53% of participants were male. Participants had, on average, 9.0 ± 2.6 chronic conditions and took 8.9 ± 3.1 chronic medications and 1.7 ± 1.8 dietary supplements. Eighty-seven percent had at least one DRP. Being older, having orthostatic hypotension and taking more chronic medications were associated with higher likelihood of having at least one DRP. For the 1713 medications and 331 diet supplements reviewed, 427 DRPs were found, 490 causes (1.1 ± 0.4 per problem) identified and 1067 interventions proposed (2.5 ± 0.6 per problem). The most common DRP category was "drug not taken/administered" (35%), and the most common offending drug category was cardiovascular agents (33%). Prevalence of DRPs was high among geriatric outpatients prescribed multiple medications. Careful medication review is needed in routine clinical practice to improve prescription quality. PMID:21353318

  2. 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…

  3. 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

  4. 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

  5. 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

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

    PubMed Central

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

    2011-01-01

    Drug addiction is a chronic illness characterized by high rates of relapse. Relapse to drug use can be triggered by re-exposure to drug-associated cues, stressful events, or the drug itself after a period of abstinence. Pharmacological intervention to reduce the impact of relapse-instigating factors offers a promising target for addiction treatment. Growing evidence has implicated an important role of the orexin/hypocretin system in drug reward and drug-seeking, including animal models of relapse. Here, we review the evidence for the role of orexins in modulating reward and drug-seeking in animal models of addiction and the potential for orexin receptors as specific targets for anti-relapse medication approaches. PMID:23997653

  7. 27 CFR 17.136 - Compliance with Food and Drug Administration requirements.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 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 a product in accordance with its formula would violate the ban or restriction, then the manufacturer...

  8. Three-Dimensional Printed PCL-Based Implantable Prototypes of Medical Devices for Controlled Drug Delivery.

    PubMed

    Holländer, Jenny; Genina, Natalja; Jukarainen, Harri; Khajeheian, Mohammad; Rosling, Ari; Mäkilä, Ermei; Sandler, Niklas

    2016-09-01

    The goal of the present study was to fabricate drug-containing T-shaped prototypes of intrauterine system (IUS) with the drug incorporated within the entire backbone of the medical device using 3-dimensional (3D) printing technique, based on fused deposition modeling (FDM™). Indomethacin was used as a model drug to prepare drug-loaded poly(ε-caprolactone)-based filaments with 3 different drug contents, namely 5%, 15%, and 30%, by hot-melt extrusion. The filaments were further used to 3D print IUS. The results showed that the morphology and drug solid-state properties of the filaments and 3D prototypes were dependent on the amount of drug loading. The drug release profiles from the printed devices were faster than from the corresponding filaments due to a lower degree of the drug crystallinity in IUS in addition to the differences in the external/internal structure and geometry between the products. Diffusion of the drug from the polymer was the predominant mechanism of drug release, whereas poly(ε-caprolactone) biodegradation had a minor effect. This study shows that 3D printing is an applicable method in the production of drug-containing IUS and can open new ways in the fabrication of controlled release implantable devices. PMID:26906174

  9. 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

  10. 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

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

    NASA Astrophysics Data System (ADS)

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

    1999-10-01

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

  12. 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

  13. Cardiovascular outcome trials for anti-diabetes medication: A holy grail of drug development?

    PubMed

    John, Mathew; Gopalakrishnan Unnikrishnan, Ambika; Kalra, Sanjay; Nair, Tiny

    2016-01-01

    Since the time questions arose on cardiovascular safety of Rosiglitazone, FDA has suggested guidelines on conduct of studies on anti-diabetic drugs so as to prove that the cardiovascular risk is acceptable. Based on the cardiovascular risks of pre-approval clinical trials, guidelines have been made to conduct cardiovascular safety outcome trials (CVSOTs) prior to the drug approval or after the drug has been approved. Unlike the trials comparing the efficacy of antidiabetic agents, the CVSOTs examine the cardiovascular safety of a drug in comparison to standard of care. These trials are expensive aspects of drug development and are associated with various technical and operational challenges. More cost effective models of assessing cardiovascular safety like use of biomarkers, electronic medical records, pragmatic and factorial designs can be adopted. This article critically looks at the antidiabetic drug approval from a cardiovascular perspective by asking a few questions and arriving at answers. PMID:27543483

  14. The medical merry-go-round: drugs for 1998 are new but not novel.

    PubMed

    Gilden, D

    Several new drugs are under development, and four are expected to reach the U.S. market during 1998. Some of the drugs are variations of existing drugs, such as Fortovase, a soft gel formulation of saquinavir. Several protease inhibitors and non-nucleoside reverse transcriptase inhibitors are also being developed and tested. Questions remain about how effectively the drugs work in combination with each other, which combinations are least likely to lead to resistance and HIV mutation, and which may have potentially serious side effects associated with their use. There is concern with some of these new drugs that resistance to earlier drugs may have a cumulative effect, lessening the effectiveness of the medications. PMID:11364984

  15. How effective are common medications: a perspective based on meta-analyses of major drugs.

    PubMed

    Leucht, Stefan; Helfer, Bartosz; Gartlehner, Gerald; Davis, John M

    2015-01-01

    The vastness of clinical data and the progressing specialization of medical knowledge may lead to misinterpretation of medication efficacy. To show a realistic perspective on drug efficacy we present meta-analyses on some of the most commonly used pharmacological interventions. For each pharmacological intervention we present statistical indexes (absolute risk or response difference, percentage response ratio, mean difference, standardized mean difference) that are often used to represent efficacy. We found that some of the medications have relatively low effect sizes with only 11 out of 17 of them showing a minimal clinically important difference. Efficacy was often established based on surrogate outcomes and not the more relevant patient-oriented outcomes. As the interpretation of the efficacy of medication is complex, more training for physicians might be needed to get a more realistic view of drug efficacy. That could help prevent harmful overtreatment and reinforce an evidence-based, but personalized medicine. PMID:26431961

  16. Prescription drug advertising: medical journal practices under different types of control.

    PubMed

    Najman, J M; Siskind, V; Bain, C

    1979-05-19

    Medication is one important aspect of health care delivery. The sources of information used to select appropriate medication include drug advertisements which appear in professional journals. There is a need to monitor the quality of these advertisements. The study reported in this paper includes a longitudinal (1961 to 1977) and cross-societal (Britain, United States and Australia) content analysis of drug advertisements. Such a comparison contributes to the debate concerning the type of regulation likely to be effective for this form of advertising. PMID:470667

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

    PubMed Central

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

    2008-01-01

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

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

    PubMed

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

    2013-01-01

    Nurses report a negative, stereotypical, and moralistic view of substance-abusing patients. Unaddressed bias may impede delivery of quality care. There is limited research of the needs specific to medical-surgical nursing staff interacting with substance-abusing patients. Nursing therapeutic commitment refers to the degree the nurse feels prepared with an adequate knowledge base, professional support, and personal ownership of a patient condition. Low therapeutic commitment correlates with job dissatisfaction. The Drug and Drug Problems Perceptions Questionnaire assesses healthcare provider attitude and therapeutic commitment to patients using or abusing medication or illicit substances. This therapeutic commitment survey serves as a staff needs assessment for a targeted educational innovation. The results show that the medical and surgical nursing staff has a constructive attitude and a moderately high degree of therapeutic commitment to the drug-abusing patient population, similar to more specialized multidisciplinary, mental healthcare workers. This study showed that medical-surgical nurses feel professionally responsible and clinically supported with patients with primary or comorbid drug abuse. Consistent with established results, focused and ongoing education on the risk factors, outcomes, and physical and psychological effects of illicit substances is necessary to improve therapeutic commitment to drug-dependent patients. PMID:24621546

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

    PubMed

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

    2014-01-01

    Introduction. Medical students experience significant psychological stress and are therefore at higher risk of using sedatives. There are currently no studies describing the prevalence of sedative drug use among medical students in Saudi Arabia. The aim of this study was to evaluate the prevalence and factors associated with sedative drug use among medical students in Saudi Arabia. Materials and Methods. A cross-sectional convenience sampling study gathered data by anonymous questionnaire from students enrolled at the King Saud University College of Medicine in 2011. The questionnaires collected data regarding social and demographic variables, sleep patterns, and the use of stimulant and sedative drugs since enrollment. Sedatives were defined as any pharmaceutical preparations that induce sleep. Results and Discussion. Of the 729 students who returned questionnaires, 17.0% reported sedative drug use at some time since enrollment. Higher academic year, lower grade point average, regular exercise, fewer hours of sleep per day, poorer quality of sleep, and the presence of sleeping disorders were found to be significantly associated with sedative drug use. Conclusions. Further study is required to increase our understanding of sedative drug use patterns in this relatively high-risk group, as such understanding will help in the development of early intervention programs. PMID:24551449

  2. 77 FR 7584 - Draft Guidance for Industry on Heparin for Drug and Medical Device Use; Monitoring Crude Heparin...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-13

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

  3. 78 FR 38058 - Guidance for Industry on Heparin for Drug and Medical Device Use: Monitoring Crude Heparin for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-25

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

  4. 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...

  5. Collection of medical drug information in pharmacies: Drug Event Monitoring (DEM) in Japan.

    PubMed

    Hayashi, Sei-ichiro; Nanaumi, Akira; Akiba, Yasuji; Komiyama, Takako; Takeuchi, Koichi

    2005-07-01

    To establish a system for collecting and reporting information from community pharmacists such as that on adverse effects, the Japan Pharmaceutical Association (JPA) conducts Drug Event Monitoring (DEM). In the fiscal year 2002, a survey was carried out to clarify the incidence of sleepiness due to antiallergic drugs. The investigated active ingredients were ebastine, fexofenadine hydrochloride, cetirizine hydrochloride, and loratadine. Community pharmacists asked the following question to patients who visited their pharmacies: "Have you ever become sleepy after taking this drug?" During a 4-week survey period, reports of 94256 cases were collected. To evaluate the incidence of sleepiness, we analyzed cases in which reports showed alleged absence of concomitant oral drugs, and drug use in conformity with the dose and method described in package inserts. The incidence of sleepiness was significantly different among the drugs (chi(2)-test, p<0.001). The observed incidences of sleepiness due to the drugs (8.8-20.5%) were higher than those described in each package insert (1.8-6.35%). This may be because an active question was used ("Have you ever become sleepy after taking this drug?"). Active intervention by pharmacists may be useful for collecting more information on improvement in the QOL of patients and safety. In addition, the pharmacists were asked to report events other than "sleepiness" in the free description column of the report. Some symptoms not described in the package inserts were reported, suggesting that DEM may lead to the discovery of new adverse effects. These results suggest that community pharmacists have a good opportunity to collect information in DEM, and safety information such as that on adverse effects can be obtained from pharmacies. PMID:15997212

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

    PubMed Central

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

    2015-01-01

    Objective Standard Medicare Part D prescription drug benefits include substantial and complex cost-sharing. Many beneficiaries also have functional limitations that could affect self-care capabilities, including managing medications, but also have varying levels of social support to help with these activities. We examined the associations between drug cost responses, functional limitations, and social support. Data Sources and Study Setting We conducted telephone interviews in a stratified random sample of community-dwelling Medicare Advantage beneficiaries (N = 1,201, response rate = 70.0%). Participants reported their functional status (i.e., difficulty with activities of daily living) and social support (i.e., receiving help with medications). Drug cost responses included cost-reducing behaviors, cost-related non-adherence, and financial stress. Study Design We used multivariate logistic regression to assess associations among functional status, help with medications, and drug cost responses, adjusting for patient characteristics. Principal Findings Respondents with multiple limitations who did not receive help with their medications were more likely to report cost-related non-adherence (OR = 3.2, 95% CI: 1.2–8.5) and financial stress (OR = 2.4, 95% CI: 1.3–4.5) compared to subjects with fewer limitations and no help; however, those with multiple limitations and with medication help had similar odds of unfavorable cost responses as those with fewer limitations. Conclusion The majority of beneficiaries with functional limitations did not receive help with medications. Support with medication management for beneficiaries who have functional limitations could improve adherence and outcomes. PMID:26642195

  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. PMID:1523604

  9. Evaluation of use of cellphones to aid compliance with drug therapy for HIV patients.

    PubMed

    Skinner, D; Donald, S; Rivette, U; Ulrike, R; Bloomberg, C; Charissa, B

    2007-05-01

    Key to the care of people living with HIV is effective data on use of ARVs, their responses to the medication and additional needs. An adaptation of cellphone technology by Cell-Life provides an easy-to-use data capturing devise for use by therapeutic counsellors (home based carers). Individual in-depth interviews were conducted with all the counsellors using the technology at two points in time, six months apart. The technology was found to be easy to use, especially for those who had previously used a cellphone. It eased data collection considerably and reduced fears around loosing notes. Improvements in technology between the two sets of interviews showed responsiveness from Cell-Life to the users of the technology. The patients also responded well to the technology, feeling that it improved their treatment. The major concern for home-based carers was the risk of crime due to having a cellphone, which led to the therapeutic counsellors eventually leaving the cellphones at home when visiting patients and entering the data at a later point. While the carers initially felt that the technology was an intrusion in their lives they later adapted to it. PMID:17505920

  10. 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