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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. 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

  16. 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…

  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. 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

  3. 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

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

    ERIC Educational Resources Information Center

    Isaac, Lisa M.; And Others

    1993-01-01

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

  16. 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 ...

  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. 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.)

  8. 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

  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. 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,...

  17. 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...

  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. 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

  4. Medication monitoring and drug testing ethics project.

    PubMed

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

    2015-01-01

    In 2012, Duke University initiated a research project, funded by an unrestricted research grant from Millennium Laboratories, a drug testing company. The project focused on assessing the frequency and nature of questionable, unethical, and illegal business practices in the clinical drug testing industry and assessing the potential for establishing a business code of ethics. Laboratory leaders, clinicians, industry attorneys, ethicists, and consultants participated in the survey, were interviewed, and attended two face-to-face meetings to discuss a way forward. The study demonstrated broad acknowledgment of variations in the legal and regulatory environment, resulting in inconsistent enforcement of industry practices. Study participants expressed agreement that overtly illegal practices sometimes exist, particularly when laboratory representatives and clinicians discuss reimbursement, extent of testing, and potential business incentives with medical practitioners. Most respondents reported directly observing probable violations involving marketing materials, contracts, or, in the case of some individuals, directly soliciting people with offers of clinical supplies and other "freebies." While many study respondents were skeptical that voluntary standards alone would eliminate questionable business practices, most viewed ethics codes and credentialing as an important first step that could potentially mitigate uneven enforcement, while improving quality of care and facilitating preferred payment options for credentialed parties. Many were willing to participate in future discussions and industry-wide initiatives to improve the environment. PMID:25750169

  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. 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

  13. 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

  14. 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

  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. 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

  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. 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

  1. 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

  2. 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

  3. 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...

  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. 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

  6. Patterns of prescription medication diversion among drug dealers

    PubMed Central

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

    2012-01-01

    This research examined the following questions: (1) how do drug dealers acquire their inventories of prescription medications? and (2) which types of prescription medications do dealers most commonly sell? Data are drawn from a National Institute on Drug Abuse-funded research study that examined prescription drug diversion and abuse in South Florida. In-depth semi-structured interviews (n = 50) were conducted with an ethnically diverse sample of prescription drug dealers from a variety of milieus to assess patterns of diversion. Audiotapes of the interviews were transcribed, coded, and thematically analysed using the NVivo 8 software program. Dealers relied on a wide array of diversion methods including visiting multiple pain clinics, working with pharmacy employees to steal medications from pharmacies, and purchasing medications from indigent patients. The type of medication most commonly sold by dealers was prescription opioid analgesics, and to a lesser extent benzodiazepines such as alprazolam. These findings inform public health policy makers, criminal justice officials, the pharmaceutical industry and government regulatory agencies in their efforts to reduce the availability of diverted prescription drugs in the illicit market. Specifically, these data support the need for statewide prescription drug monitoring programs and increased training for healthcare workers who have access to controlled medications. PMID:22665955

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

    PubMed Central

    Mortari, Luigina

    2014-01-01

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

  8. 19 CFR 147.23 - Compliance with Plant Quarantine Act and Federal Food, Drug, and Cosmetic Act.

    Code of Federal Regulations, 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...

  9. 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…

  10. 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

  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. 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

  1. 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

  2. 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

  3. 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

  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. 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.

  18. 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

  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. 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

  8. 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

  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. 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

  18. 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

  19. 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

  20. [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

  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. 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...

  15. 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,…

  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. 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) ...

  5. 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...

  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. 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

  4. 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)

  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. 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...

  7. 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...

  8. 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...

  9. 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...

  10. 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...

  11. 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...

  12. 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...

  13. 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...

  14. 49 CFR 242.115 - Substance abuse disorders and alcohol drug rules compliance.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

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

  15. 49 CFR 242.115 - Substance abuse disorders and alcohol drug rules compliance.

    Code of Federal Regulations, 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...

  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. 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

  1. 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

  2. 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

  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. 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

  15. 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

  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. 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...

  7. 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

  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. 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.

  11. 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

  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. 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

  14. 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

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-17

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

  3. 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...

  4. 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...

  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 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

  9. [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

  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

  11. Results of barbiturate antiepileptic drug discontinuation on antipsychotic medication dose in individuals with intellectual disability.

    PubMed

    Hanzel, T E; Bauernfeind, J D; Kalachnik, J E; Harder, S R

    2000-04-01

    Five individuals with intellectual disability prescribed both a barbiturate antiepileptic drug (AED) and an antipsychotic medication were identified in a public residential facility. It was hypothesized that antipsychotic medication was prescribed at doses higher than necessary as a result of inadvertent barbiturate AED behavioural side-effects thought to be part of the underlying psychiatric or behavioural condition. To test this hypothesis, barbiturate AEDs were gradually reduced, and replaced with either carbamazepine or valproic acid, and antipsychotic medication was gradually reduced as well. Challenging behaviours, such as physical aggression, self-injurious behaviour and property destruction, were measured with a frequency count or partial interval recording, and retrospectively analysed for time periods of approximately 60 days before phenobarbital reduction, after phenobarbital discontinuation and after the lowest antipsychotic medication dose. Challenging behaviour collectively decreased by 81.5% after barbiturate discontinuation, mean antipsychotic medication dose significantly decreased from 146 mg day(-1) (SD = 98) to 106 mg day(-1) (SD = 88) chlorpromazine equivalence, and antipsychotic medication was discontinued in the cases of two individuals. Compared to the prebarbiturate AED reduction period, challenging behaviour collectively decreased by 96.3% after the lowest antipsychotic medication dose, which confirmed that reduced antipsychotic medication was not achieved at the expense of behaviour deterioration. The data supported the hypothesis that discontinuation of barbiturate AEDs results in decreased challenging behaviour and less antipsychotic medication. PMID:10898379

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

    PubMed Central

    2012-01-01

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

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

    PubMed Central

    Ross, W. Donald

    1963-01-01

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

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

    PubMed Central

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

    2014-01-01

    Compliance with mass drug administration (MDA) can be affected by rumors and mistrust about the drug. Communication campaigns are an effective way to influence attitudes and health behaviors in diverse public health contexts, but there is very little documentation about experiences using health communications in schistosomiasis control programs. A qualitative study was conducted with community health workers (CHWs) as informants to explore the effect of a health communication campaign on their experiences during subsequent praziquantel MDA for schistosomiasis. Discussions were audio-recorded, transcribed verbatim, translated into English where applicable, and analyzed thematically using ATLAS.ti software. According to the CHWs, exposure to mass media messages improved awareness of the MDA, which in turn, led to better treatment compliance. Our findings suggest that communication campaigns influence health behaviors and create awareness of schistosomiasis control interventions, which may ultimately improve praziquantel MDA. PMID:25246690

  15. Comparing compliance patterns between randomized treatments.

    PubMed

    Vrijens, B; Goetghebeur, E

    1997-06-01

    When two equally efficacious drugs enter the market, the one with the better compliance is likely to be more widely used. Special management of the delivery may produce increased compliance. In this paper we analyze a trial of a single drug dosing prescription with patients randomized to either daily self monitoring of the outcome (blood pressure) or not. The study used Medication Event Monitoring Systems (MEMS) to record each exact time and date when a patient opened the pill container. No established method is available for comparing these high-dimensional compliance patterns between groups. This paper investigates several summary measures that highlight different dimensions of the pattern and the drug context in which they may be meaningful. Further, we examine conditional and marginal models that enable comparisons of the full pattern of daily dosing indicators for subjects between the groups. We found no simple difference in average compliance levels, but we found an interesting interaction between treatment and time: similar compliance existed initially among patients in both randomized groups, with a stronger decline over time for patients who did not monitor their blood pressure. We discuss how a balance between simplicity of interpretation and efficiency of data use may be sought in this case. PMID:9204220

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

    PubMed Central

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

    2011-01-01

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

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

    ERIC Educational Resources Information Center

    Pokorny, Alex; And Others

    1978-01-01

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

  18. Medications for alcohol, illicit drug, and tobacco dependence. An update of research findings.

    PubMed

    Litten, R Z; Allen, J P

    1999-03-01

    Physiologic, behavioral, and social factors contribute to dependence on alcohol, nicotine, and other drugs. During the past decade substantial research has focused on identification/development of medications to assist in reducing urge to use these substances. This article describes these agents and reviews recent research findings on them. PMID:10023607

  19. 42 CFR 423.153 - Drug utilization management, quality assurance, and medication therapy management programs (MTMPs).

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 42 Public Health 3 2013-10-01 2013-10-01 false Drug utilization management, quality assurance, and medication therapy management programs (MTMPs). 423.153 Section 423.153 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICARE PROGRAM (CONTINUED) VOLUNTARY MEDICARE PRESCRIPTION...

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

    PubMed

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

    2016-02-01

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

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

    PubMed Central

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

    2015-01-01

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

  2. Literature Based Drug Interaction Prediction with Clinical Assessment Using Electronic Medical Records: Novel Myopathy Associated Drug Interactions

    PubMed Central

    Subhadarshini, Abhinita; Karnik, Shreyas D.; Li, Xiaochun; Hall, Stephen D.; Jin, Yan; Callaghan, J. Thomas; Overhage, Marcus J.; Flockhart, David A.; Strother, R. Matthew; Quinney, Sara K.; Li, Lang

    2012-01-01

    Drug-drug interactions (DDIs) are a common cause of adverse drug events. In this paper, we combined a literature discovery approach with analysis of a large electronic medical record database method to predict and evaluate novel DDIs. We predicted an initial set of 13197 potential DDIs based on substrates and inhibitors of cytochrome P450 (CYP) metabolism enzymes identified from published in vitro pharmacology experiments. Using a clinical repository of over 800,000 patients, we narrowed this theoretical set of DDIs to 3670 drug pairs actually taken by patients. Finally, we sought to identify novel combinations that synergistically increased the risk of myopathy. Five pairs were identified with their p-values less than 1E-06: loratadine and simvastatin (relative risk or RR = 1.69); loratadine and alprazolam (RR = 1.86); loratadine and duloxetine (RR = 1.94); loratadine and ropinirole (RR = 3.21); and promethazine and tegaserod (RR = 3.00). When taken together, each drug pair showed a significantly increased risk of myopathy when compared to the expected additive myopathy risk from taking either of the drugs alone. Based on additional literature data on in vitro drug metabolism and inhibition potency, loratadine and simvastatin and tegaserod and promethazine were predicted to have a strong DDI through the CYP3A4 and CYP2D6 enzymes, respectively. This new translational biomedical informatics approach supports not only detection of new clinically significant DDI signals, but also evaluation of their potential molecular mechanisms. PMID:22912565

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

    PubMed

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

    2016-04-01

    Telemedicine-based medication management improves hypertension control, but has been evaluated primarily in patients with low antihypertensive drug counts. Its impact on patients taking three or more antihypertensive agents is not well-established. To address this evidence gap, the authors conducted an exploratory analysis of an 18-month, 591-patient trial of telemedicine-based hypertension medication management. Using general linear models, the effect of medication management on blood pressure for patients taking two or fewer antihypertensive agents at study baseline vs those taking three or more was compared. While patients taking two or fewer antihypertensive agents had a significant reduction in systolic blood pressure with medication management, those taking three or more had no such response. The between-subgroup effect difference was statistically significant at 6 months (-6.4 mm Hg [95% confidence interval, -12.2 to -0.6]) and near significant at 18 months (-6.0 mm Hg [95% confidence interval, -12.2 to 0.2]). These findings suggest that baseline antihypertensive drug count may impact how patients respond to hypertension medication management and emphasize the need to study management strategies specifically in patients taking three or more antihypertensive medications. PMID:26370918

  4. Perceptions of Pakistani medical students about drugs and alcohol: a questionnaire-based survey

    PubMed Central

    Shafiq, Majid; Shah, Zaman; Saleem, Ayesha; Siddiqi, Maham T; Shaikh, Kashif S; Salahuddin, Farah F; Siwani, Rizwan; Naqvi, Haider

    2006-01-01

    Background Drug abuse is hazardous and known to be prevalent among young adults, warranting efforts to increase awareness about harmful effects and to change attitudes. This study was conducted to assess the perceptions of a group of medical students from Pakistan, a predominantly Muslim country, regarding four drugs namely heroin, charas, benzodiazepines and alcohol. Results In total, 174 self-reported questionnaires were received (87% response rate). The most commonly cited reasons for why some students take these drugs were peer pressure (96%), academic stress (90%) and curiosity (88%). The most commonly cited justifiable reason was to go to sleep (34%). According to 77%, living in the college male hostel predisposed one to using these drugs. Sixty percent of students said that the drugs did not improve exam performance, while 54% said they alleviated stress. Seventy-eight percent said they did not intend to ever take drugs in the future. Females and day-scholars were more willing to discourage a friend who took drugs. Morality (78%), religion (76%) and harmful effects of drugs (57%) were the most common deterrents against drug intake. Five suggestions to decrease drug abuse included better counseling facilities (78%) and more recreational facilities (60%). Conclusion Efforts need to be made to increase student awareness regarding effects and side effects of drugs. Our findings suggest that educating students about the adverse effects as well as the moral and religious implications of drug abuse is more likely to have a positive impact than increased policing. Proper student-counseling facilities and healthier avenues for recreation are also required. PMID:17064420

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

    PubMed

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

    2016-07-01

    Nearly all HIV PIs and the integrase inhibitor elvitegravir require a pharmacokinetic enhancer in order to achieve therapeutic plasma concentrations at the desired dose and frequency. Whereas ritonavir has been the only available pharmacokinetic enhancer for more than a decade, cobicistat has recently emerged as an alternative boosting agent. Cobicistat and ritonavir are equally strong inhibitors of cytochrome P450 (CYP) 3A4 and consequently were shown to be equivalent pharmacokinetic enhancers for elvitegravir and for the PIs atazanavir and darunavir. Since cobicistat is a more selective CYP inhibitor than ritonavir and is devoid of enzyme-inducing properties, differences are expected in their interaction profiles with some co-medications. Drugs whose exposure might be altered by ritonavir but unaltered by cobicistat are drugs primarily metabolized by CYP1A2, CYP2B6, CYP2C8, CYP2C9 and CYP2C19 or drugs undergoing mainly glucuronidation. Thus, co-medications should be systematically reviewed when switching the pharmacokinetic enhancer to anticipate potential dosage adjustments. PMID:26945713

  6. 77 FR 70166 - Provisions of the Food and Drug Administration Safety and Innovation Act Related to Medical Gases...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-23

    ...The Food and Drug Administration (FDA) is establishing a public docket for information pertaining to FDA's implementation of the provisions of the Food and Drug Administration Safety and Innovation Act (FDASIA) related to medical gases. This action is intended to ensure that information submitted to FDA on the implementation of the medical gas provisions of FDASIA is available to all......

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

    PubMed Central

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

    2016-01-01

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

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

    PubMed Central

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

    2014-01-01

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

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

    PubMed

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

    2014-01-01

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

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

    PubMed

    Brooks, Eleanor; Geyer, Robert

    2016-04-01

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

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

    PubMed Central

    Ihezue, U. H.

    1988-01-01

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

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

    PubMed

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

    2016-02-01

    In a society highly focused on physical appearance, people are increasingly using the so-called performance and image-enhancing drugs (PIEDs) or life-style drugs as an easy way to control weight. Preliminary data from online sources (e.g. websites, drug forums, e-newsletters) suggest an increased use of cannabis amongst the general population as a PIED due to its putative weight-loss properties. The use of cannabis and/or cannabis-related products to lose weight may represent a new substance-use trend that should be carefully monitored and adequately investigated, especially in light of the well-known adverse psychiatric and somatic effects of cannabis, its possible interaction with other medications/drugs and the unknown and potentially dangerous composition of synthetic cannabimimetics preparations. PMID:26456495

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

    PubMed

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

    1999-10-28

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

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

    PubMed

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

    2010-01-01

    Practicing physicians have limited time for consulting medical knowledge and records. We have previously shown that using icons instead of text to present drug monographs may allow contraindications and adverse effects to be identified more rapidly and more accurately. These findings were based on the use of an iconic language designed for drug knowledge, providing icons for many medical concepts, including diseases, antecedents, drug classes and tests. In this paper, we describe a new project aimed at extending this iconic language, and exploring the possible applications of these icons in medicine. Based on evaluators' comments, focus groups of physicians and opinions of academic, industrial and associative partners, we propose iconic applications related to patient records, for example summarizing patient conditions, searching for specific clinical documents and helping to code structured data. Other applications involve the presentation of clinical practice guidelines and improving the interface of medical search engines. These new applications could use the same iconic language that was designed for drug knowledge, with a few additional items that respect the logic of the language. PMID:20841669

  15. Increased Use Of Prescription Drugs Reduces Medical Costs In Medicaid Populations.

    PubMed

    Roebuck, M Christopher; Dougherty, J Samantha; Kaestner, Robert; Miller, Laura M

    2015-09-01

    We used data on more than 1.5 million Medicaid enrollees to examine the impact of changes in prescription drug use on medical costs. For three distinct groups of enrollees, we estimated the effects of aggregate prescription drug use-and, more specifically, the use of medications to treat eight chronic noncommunicable diseases-on total nondrug, inpatient, outpatient, and other Medicaid spending. We found that a 1 percent increase in overall prescription drug use was associated with decreases in total nondrug Medicaid costs by 0.108 percent for blind or disabled adults, 0.167 percent for other adults, and 0.041 percent for children. Reductions in combined inpatient and outpatient spending from increased drug utilization in Medicaid were similar to an estimate for Medicare by the Congressional Budget Office. Moving forward, policy makers evaluating proposed changes that alter medication use among the nearly seventy million Medicaid recipients should consider the net effects on program spending to ensure that scarce federal and state health care dollars are allocated efficiently. PMID:26355062

  16. Computerized Detection of Adverse Drug Reactions in the Medical Intensive Care Unit

    PubMed Central

    Kane-Gill, Sandra L.; Visweswaran, Shyam; Saul, Melissa I.; Wong, An-Kwok Ian; Penrod, Louis E.; Handler, Steven M.

    2011-01-01

    Objective Clinical event monitors are a type of active medication monitoring system that can use signals to alert clinicians to possible adverse drug reactions. The primary goal was to evaluate the positive predictive values of select signals used to automate the detection of ADRs in the medical intensive care unit. Method This is a prospective, case series of adult patients in the medical intensive care unit during a six-week period who had one of five signals presents: an elevated blood urea nitrogen, vancomycin, or quinidine concentration, or a low sodium or glucose concentration. Alerts were assessed using 3 objective published adverse drug reaction determination instruments. An event was considered an adverse drug reaction when 2 out of 3 instruments had agreement of possible, probable or definite. Positive predictive values were calculated as the proportion of alerts that occurred, divided by the number of times that alerts occurred and adverse drug reactions were confirmed. Results 145 patients were eligible for evaluation. For the 48 patients (50% male) having an alert, the mean ± SD age was 62 ± 19 years. A total of 253 alerts were generated. Positive predictive values were 1.0, 0.55, 0.38 and 0.33 for vancomycin, glucose, sodium, and blood urea nitrogen, respectively. A quinidine alert was not generated during the evaluation. Conclusions Computerized clinical event monitoring systems should be considered when developing methods to detect adverse drug reactions as part of intensive care unit patient safety surveillance systems, since they can automate the detection of these events using signals that have good performance characteristics by processing commonly available laboratory and medication information. PMID:21621453

  17. Drug allergies

    MedlinePlus

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

  18. Early Human Screening of Medications to Treat Drug Addiction: Novel Paradigms and the Relevance of Pharmacogenetics

    PubMed Central

    Perkins, KA; Lerman, C

    2011-01-01

    Initial screening of medications for efficacy in treating drug dependence may be accomplished more efficiently by using novel approaches that combine the practical advantages of within-subject laboratory studies with the clinical validity provided by clinical trials. A priori selection of functional gene variants associated with the pharmacokinetic or pharmacodynamic effects of a medication may aid this effort by controlling for individual variability as to clinical response or adverse effects; however, there are limitations to this approach, and these should be carefully considered. PMID:21270792

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

    PubMed

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

    2008-01-01

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

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

    PubMed

    Kishimoto, Keiko; Fukushima, Noriko

    2011-01-01

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

  1. Pulmonary drug delivery. Part I: Physiological factors affecting therapeutic effectiveness of aerosolized medications

    PubMed Central

    Labiris, N R; Dolovich, M B

    2003-01-01

    As the end organ for the treatment of local diseases or as the route of administration for systemic therapies, the lung is a very attractive target for drug delivery. It provides direct access to disease in the treatment of respiratory diseases, while providing an enormous surface area and a relatively low enzymatic, controlled environment for systemic absorption of medications. As a major port of entry, the lung has evolved to prevent the invasion of unwanted airborne particles from entering into the body. Airway geometry, humidity, mucociliary clearance and alveolar macrophages play a vital role in maintaining the sterility of the lung and consequently are barriers to the therapeutic effectiveness of inhaled medications. In addition, a drug's efficacy may be affected by where in the respiratory tract it is deposited, its delivered dose and the disease it may be trying to treat. PMID:14616418

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

    PubMed

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

    2014-07-01

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

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

    PubMed Central

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

    2015-01-01

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

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

    PubMed Central

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

    2014-01-01

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

  5. Do drug advertisements in Russian medical journals provide essential information for safe prescribing?

    PubMed Central

    Vlassov, Vasiliy; Mansfield, Peter; Lexchin, Joel; Vlassova, Anna

    2001-01-01

    Objective To examine pharmaceutical advertisements in medical journals for their adequacy of information. Methods We selected a convenience sample of 5 major Russian medical journals covering different fields of medicine and different types of publications. We evaluated all the ads in all the issues of the selected journals published during 1998. We counted the number of appearances of trade, chemical, and generic names; indication and contraindication; pharmacologic group; safety warnings; and references. Counts in all categories were aggregated for each advertiser. Results There were 397 placements of 207 distinct advertisements. Only 154 placements (40%) mentioned the generic name, 177 (45%) mentioned any indication, 42 (11%) mentioned safety warnings and contraindications, 21 (5%) warned about drug interactions, and 8 (2%) provided references. The 6 companies responsible for the most ads on average provided less information than the other companies. Conclusions Almost none of the drug ads published in Russian medical journals provide the basic information required for appropriate prescribing. This is despite the fact that in Russia, ads that omit essential information and that could lead consumers to misunderstandings about an advertised product are illegal. The arrival of drug advertising in Russia has brought little information and has been potentially damaging. PMID:11381003

  6. Drug interactions associated with methadone, buprenorphine, cocaine, and HIV medications: implications for pregnant women

    PubMed Central

    McCance-Katz, Elinore F.

    2010-01-01

    Pregnancy in substance-abusing women with HIV/AIDS presents a complex clinical challenge. Opioid-dependent women need treatment with opioid therapy during pregnancy to protect the health of mother and developing fetus. However, opioid therapies, methadone and buprenorphine, may have drug interactions with some HIV medications that can have adverse effects leading to suboptimal clinical outcomes. Further, many opioid-dependent individuals have problems with other forms of substance abuse, for example, cocaine abuse, that could also contribute to poor clinical outcomes in a pregnant woman. Physiological changes, including increased plasma volume and increased hepatic and renal blood flow, occur in the pregnant woman as the pregnancy progresses and may alter medication needs with the potential to exacerbate drug interactions, although there is sparse literature on this issue. Knowledge of possible drug interactions between opioids, other abused substances such as cocaine, HIV therapeutics, and other frequently required medications such as antibiotics and anticonvulsants is important to assuring the best possible outcomes in the pregnant woman with opioid dependence and HIV/AIDS. PMID:20965297

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

    PubMed

    Shimazawa, Rumiko; Ikeda, Masayuki

    2015-01-01

    To develop approval regulations for drugs against chemical, biological, radiological, or nuclear (CBRN) agents in Japan, and to help inform arguments about the development of anti-CBRN agents, we analyzed documentation describing approval processes and data for drugs against CBRN agents. Sixteen countermeasure products against 10 CBRN agents have been approved in Japan. Approval schemes were grouped into 3 categories: application for off-label uses, expedited review for antiterrorism measures, and expedited review. Ten drug applications were designated "priority reviews," and the median review time was 4.4 months. No application relied exclusively on clinical trials to expose patients to CBRN threats. Clinical experience with drugs in victims of unexpected exposure was not necessarily important for approval. The United States is the most advanced country in terms of developing medical countermeasure products against CBRN agents. Japan has similarities with the US in approved products and application packages, but there were 3 unapproved products or indications that were approved under the Animal Rule in the US. The Animal Rule might encourage development of a novel product by providing efficacy evaluation in animal studies. The US also has regulations that do not exist in Japan that authorize administration of an investigational drug outside a clinical trial for patients. Introduction of the Animal Rule and expanded access of investigational drugs could contribute to development and approvals of novel countermeasure products and improve an emergency response in a crisis in Japan. PMID:25813978

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

    PubMed

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

    2013-08-01

    Studies have shown more erectile dysfunction (ED) in men living with HIV (MLHIV), relative to age matched HIV-negative men. Erection enhancing medication (EEM) is more frequently used by HIV-positive men than in the general male population. Increased sexually transmitted infection has been described in HIV-positive men with ED using EEM. This study investigated the use of EEM and party drugs (methyleendioxymethamfetamine (XTC), gammahydroxybutyrate (GHB) "fluid XTC" and alkyl nitrites "poppers") among MLHIV. Self-administered questionnaires were distributed consecutively to all patients attending 17 European HIV treatment centers. The sample included 1118 HIV-positive men, among whom 74.5% men having sex with men (MSM). The use of EEM was more frequent in MSM than in heterosexual men (odds ratio (OR) 3.33, p<0.001) and was associated with increased sexual risk behavior (OR 3.27, p<0.001). Nonmedically indicated use of EEM was linked to increased use of party drugs (OR 2.30, p=0.01). Physicians taking care of MLHIV need to be aware of the high prevalence of (nonmedical) use of EEM and party drugs. Medical provision of EEM should be combined with a discussion on safer sex behavior and the risk related to concomitant use of party drugs and illegal EEM. PMID:23244618

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

    PubMed

    Massó, Paloma

    2015-09-01

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

  10. PEROXISOME PROLIFERATOR-ACTIVATED RECEPTOR (PPAR) AGONISTS AS PROMISING NEW MEDICATIONS FOR DRUG ADDICTION: PRECLINICAL EVIDENCE

    PubMed Central

    Foll, Bernard Le; Ciano, Patricia Di; Panlilio, Leigh V.; Goldberg, Steven R.; Ciccocioppo, Roberto

    2013-01-01

    This review examines the growing literature on the role of peroxisome proliferator-activated receptors (PPARs) in addiction. There are two subtypes of PPAR receptors that have been studied in addiction: PPAR-α and PPAR-γ. The role of each PPAR subtype in common models of addictive behavior, mainly pre-clinical models, is summarized. In particular, studies are reviewed that investigated the effects of PPAR-α agonists on relapse, sensitization, conditioned place preference, withdrawal and drug intake, and effects of PPAR-γ agonists on relapse, withdrawal and drug intake. Finally, studies that investigated the effects of PPAR agonists on neural pathways of addiction are reviewed. Taken together this preclinical data indicates that PPAR agonists are promising new medications for drug addiction treatment. PMID:23614675

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

    PubMed Central

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

    2012-01-01

    Drug treatment courts are an increasingly important tool in reducing the census of those incarcerated for non-violent drug offenses; medication assisted treatment (MAT) is proven to be an effective treatment for opioid addiction. However, little is known about the availability of and barriers to MAT provision for opioid-addicted people under drug court jurisdiction. Using an online survey, we assessed availability, barriers, and need for MAT (especially agonist medication) for opioid addiction in drug courts. Ninety-eight percent reported opioid-addicted participants, 47% offered agonist medication (56% for all MAT including naltrexone). Barriers included cost and court policy. Responses revealed significant uncertainty, especially among non-MAT providing courts. Political, judicial and administrative opposition appear to affect MAT’s inconsistent use and availability in drug court settings. These data suggest that a substantial, targeted educational initiative is needed to increase awareness of the treatment and criminal justice benefits of MAT in the drug courts. PMID:23217610

  12. Medication assisted treatment in US drug courts: results from a nationwide survey of availability, barriers and attitudes.

    PubMed

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

    2013-01-01

    Drug treatment courts are an increasingly important tool in reducing the census of those incarcerated for non-violent drug offenses; medication assisted treatment (MAT) is proven to be an effective treatment for opioid addiction. However, little is known about the availability of and barriers to MAT provision for opioid-addicted people under drug court jurisdiction. Using an online survey, we assessed availability, barriers, and need for MAT (especially agonist medication) for opioid addiction in drug courts. Ninety-eight percent reported opioid-addicted participants, and 47% offered agonist medication (56% for all MAT including naltrexone). Barriers included cost and court policy. Responses revealed significant uncertainty, especially among non-MAT providing courts. Political, judicial and administrative opposition appear to affect MAT's inconsistent use and availability in drug court settings. These data suggest that a substantial, targeted educational initiative is needed to increase awareness of the treatment and criminal justice benefits of MAT in the drug courts. PMID:23217610

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

    PubMed Central

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

    2014-01-01

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

  14. Medicare and Private Insurance Variations in New Medical Technology: The Case of Drug Eluting Stents

    PubMed Central

    Bayindir, Esra Eren; Mandic, Pinar Karaca

    2016-01-01

    Importance Little is known about the geographic and hospital variations of the new medical technologies in Medicare. Even less is known about these variations for the privately insured. Objective To examine geographic and hospital variations in the diffusion of drug eluting stents, comparing Medicare and privately insured populations. Design Retrospective analyses of discharges from the State Inpatient Databases for 11 states (2004–2005) supplemented with data on hospital characteristics from the American Hospital Association Annual Survey. Setting/participants Study sample included discharges with percutaneous coronary intervention (PCI) procedures that involved a cardiac stent. Exposure Insurance type: Medicare versus private insurance. Main outcome Use of a drug eluting stent during the PCI was our outcome variable. We estimated linear probability models at the discharge level that related our outcome variable to patient and hospital characteristics separately for Medicare and private insurance. To examine variations across hospital referral regions (HRRs) and across hospitals, our models included HRR and hospital indicators respectively. Results Our analysis included 390,649 records (237,991 Medicare, 152,658 private insurance). We found large HRR variations in the use of drug eluting stents in 2004 for both payer types, the year after drug eluting stents were approved (adjusted CoV: 0.35 (Medicare); 0.24 (Private Insurance)). We also found large hospital variations in 2004 (adjusted CoV: 0.32 (Medicare); 0.29 (Private Insurance)). Between 2004 and 2005, adjusted HRR and hospital variations decreased across both payer types, suggesting that practice styles converged as the drug eluting stents diffused and became more common. Finally, adjusted drug eluting stent rates were highly correlated both at the HRR and hospital level across payer types. Conclusion Our findings are consistent with the hypothesis that private insurance closely follows the lead of

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

    ERIC Educational Resources Information Center

    US Department of Education, 2010

    2010-01-01

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

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

    PubMed Central

    Clark, H W

    1990-01-01

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

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

    PubMed Central

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

    2015-01-01

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

  18. Residual activity of anticoccidial drugs in chickens after withdrawal of medicated feeds.

    PubMed

    McDougald, L R; Seibert, B P

    1998-01-31

    Seven anticoccidial drugs commonly used in poultry (diclazuri), monensin, salinomycin, halofuginone, nicarbazin, robenidine, amprolium, and lasalocid) were tested for residual activity after withdrawal. In each test, the products were given at the recommended level to cages of 10 broiler chickens. Oral inoculation with coccidia was given after withdrawal of medication. Birds pretreated with 1 ppm of diclazuril and inoculated with Eimeria tenella after drug withdrawal had normal weight gain and very low lesion scores. Residual activity depleted gradually over several days, as shown by higher lesion scores when medication was withdrawn for up to 3 days before inoculation. Similar results were observed when young birds were inoculated with a mixture of E. tenella, E. maxima and E. acervulina, and also when birds were given diclazuril to market weight (6 weeks of age) and inoculated with a mixture of six species of Eiméria (The above species plus E. brunetti, E. mitis, and E. necatrix) after withdrawal of medication for 2 days. In contrast, there was no evidence of residual anticoccidial activity with nicarbazin, halofuginone, lasalocid, amprolium, salinomycin or monensin. Overall, the residual activity was unique to diclazuril. PMID:9561697

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

    PubMed

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

    2016-01-01

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

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

    PubMed Central

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

    2015-01-01

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

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

    NASA Astrophysics Data System (ADS)

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

    2013-05-01

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

  2. Novel composite fiber structures to provide drug/protein delivery for medical implants and tissue regeneration.

    PubMed

    Zilberman, Meital

    2007-01-01

    A novel class of bioresorbable composite (core/shell) fiber structures loaded with bioactive agents was developed and studied. These unique polymeric structures are designed to combine good mechanical properties with a desired controlled release profile, in order to serve as scaffolds for tissue regeneration applications and as basic elements of medical implants. These core/shell fiber structures were formed by "coating" core polymer fibers with drug/protein-containing poly(dl-lactic-co-glycolic acid) porous structures. The shell preparation ("coating") was performed by the freeze-drying of water-in-oil emulsions. Both water soluble and water insoluble agents can be incorporated in these structures and their activity is preserved, since the fiber fabrication requires neither high temperatures nor harsh solvents in the vicinity of the bioactive agents. Examples for release profiles of protein (horseradish peroxidase) and drug (paclitaxel) are presented. We have demonstrated that appropriate selection of the emulsion's parameters can yield a variety of new core/shell fiber structures with desirable drug/protein release behavior. This will lead to the engineering of new implants and scaffolds, and will advance the field of tissue regeneration and medical implants. PMID:16956799

  3. Electrochemical etching of micro-pores in medical grade cobalt-chromium alloy as reservoirs for drug eluting stents.

    PubMed

    Fuchsberger, Kai; Binder, Karoline; Burkhardt, Claus; Freudigmann, Christian; Herrmann, Markus; Stelzle, Martin

    2016-03-01

    Drug eluting stents (DES) have shown efficacy in reducing restenosis after angioplasty followed by application of a coronary stent. However, polymer matrices typically used for immobilizing drugs on the stent surface may cause irritation and have limited drug loading capacity. In contrast, drug loading into micro- or nanopores created within the stent material could avoid these problems. We present a technology based on electrochemically induced pitting corrosion to form pores in medical grade steel, followed by loading with rapamycin. This process is applied to pore formation and drug loading in coronary stents consisting of L605 medical steel. Sustained release of the drug over 28 days at rates comparable to established DES was demonstrated. This technology is capable of creating pores with well-defined pore size and filling of these pores by a drug employing a crystallization process thus completely avoiding polymer matrices to immobilize drugs. Electrochemically induced pitting corrosion provides a generic means to introduce micro-pores suitable as drug reservoirs into medical grade steel without the need for any further matrix material. Further research will expand these findings to other materials and types of implants that could benefit from the additional function of drug release and/or improved implant/tissue integration. PMID:26758894

  4. Patient use and compliance with medical advice delivered by a web-based triage system in primary care.

    PubMed

    Nijland, Nicol; Cranen, Karlijn; Boer, Henk; van Gemert-Pijnen, Julia E W C; Seydel, Erwin R

    2010-01-01

    We studied a web-based triage system which was accessible to the general public in the Netherlands. In a retrospective analysis we investigated the type of complaints that were submitted and the kind of advice provided. Over a period of 15 months, 13,133 different people began using the web-based triage system and 3812 patients went right through the triage process to the end. The most frequent complaints were common cold symptoms, such as cough and a sore throat (22%), itch problems (13%), urinary complaints (12%), diarrhoea (10%), headache (8%) and lower back pain (8%). Most commonly, the system generated the advice to contact a doctor (85%) and in 15% of the cases the system provided fully automated, problem-tailored, self-care advice. A total of 192 patients participated in a prospective study and completed an online survey immediately after the delivery of advice. A follow-up questionnaire on actual compliance was completed by 35 patients. Among these, 20 (57%) had actually complied with the advice provided by the system. A regression analysis revealed that intention to comply was strongly related to actual compliance. In turn, intention to comply was strongly related to attitude towards the advice (P < 0.001). Web-based triage can contribute to a more efficient primary care system, because it facilitates the gatekeeper function. PMID:20086260

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

    PubMed Central

    Babalola, EO; Akinhanmi, A; Ogunwale, A

    2014-01-01

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

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

    PubMed

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

    2015-04-01

    The Maltese Medicines Authority was tasked with developing a reporting form that captures high-quality case information on adverse drug reactions (ADRs) and medication errors in order to fulfil its public-health obligations set by the European Union (EU) legislation on pharmacovigilance. This paper describes the process of introducing the first combined ADR/medication error reporting form in the EU for health-care professionals, the analysis of reports generated by it and the promotion of the system. A review of existing ADR forms was carried out and recommendations from the European Medicines Agency and World Health Organization audits integrated. A new, combined ADR/medication error reporting form was developed and pilot tested based on case studies. The Authority's quality system (ISO 9001 certified) was redesigned and a promotion strategy was deployed. The process used in Malta can be useful for countries that need to develop systems relative to ADR/medication error reporting and to improve the quality of data capture within their systems. PMID:26077519

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

    PubMed

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

    2015-06-01

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

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

    PubMed

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

    2012-02-01

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

  9. 77 FR 22328 - Guidance for Industry on the Judicious Use of Medically Important Antimicrobial Drugs in Food...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-13

    ... Register of June 29, 2010 (75 FR 37450), FDA published the notice of availability for a draft guidance... thinking on the use of medically important antimicrobial drugs in animal agriculture. DATES: Submit either... announcing: (1) The availability of a draft guidance entitled ``New Animal Drugs and New Animal...

  10. Psychosocial stress, demoralization and the consumption of tobacco, alcohol and medical drugs by veterinarians

    PubMed Central

    Harling, Melanie; Strehmel, Petra; Schablon, Anja; Nienhaus, Albert

    2009-01-01

    Background In this cross-sectional study the association between psychosocial stress, demoralization and the consumption of psychotropic substances in veterinarians was examined using data from a sample of 1,060 subjects (52.7% response). Methods Multiple logistic regression models were used to determine risk factors for psychosocial stress, demoralization, tobacco consumption (≹ 10 items/day), high-risk alcohol consumption (men > 20 g pure alcohol/day, women > 10 g pure alcohol/day), binge drinking, problem drinking according to CAGE and regular medical drug intake (at least weekly). Results Intense psychosocial stress is a risk factor for binge drinking and for regular drug use. High demoralization values are associated with tobacco consumption, problem drinking and regular drug intake. The probability of a high demoralization value increased with intense psychosocial stress. Practicing veterinarians are more frequently affected by psychosocial stress and have a greater risk of alcohol or drug consumption than veterinarians working in a non-clinical area of work (e.g. Department of Veterinary Services, Industry). Conclusion The findings support the hypothesis of complex interrelationships between psychosocial stress, demoralization and the consumption of psychotropic substances in the veterinary profession and underscore the need of further research. PMID:19243579

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

    PubMed Central

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

    2015-01-01

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

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

    PubMed

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

    2016-01-01

    Naloxone administration is an important component of resuscitation attempts by emergency medical services (EMS) for opioid drug overdoses. However, EMS providers must first recognize the possibility of opioid overdose in clinical encounters. As part of a public health response to an outbreak of opioid overdoses in Rhode Island, we examined missed opportunities for naloxone administration and factors potentially influencing EMS providers' decision to administer naloxone. We reviewed medical examiner files on all individuals who died of an opioid-related drug overdose in Rhode Island from January 1, 2012 through March 31, 2014, underwent attempted resuscitation by EMS providers, and had records available to assess for naloxone administration. We evaluated whether these individuals received naloxone as part of their resuscitation efforts and compared patient and scene characteristics of those who received naloxone to those who did not receive naloxone via chi-square, t-test, and logistic regression analyses. One hundred and twenty-four individuals who underwent attempted EMS resuscitation died due to opioid overdose. Naloxone was administered during EMS resuscitation attempts in 82 (66.1%) of cases. Females were nearly three-fold as likely not to receive naloxone as males (OR 2.9; 95% CI 1.2-7.0; p-value 0.02). Additionally, patients without signs of potential drug abuse also had a greater than three-fold odds of not receiving naloxone (OR 3.3; 95% CI 1.2-9.2; p-value 0.02). Older individuals, particularly those over age 50, were more likely not to receive naloxone than victims younger than age 30 (OR 4.8; 95% CI 1.3-17.4; p-value 0.02). Women, older individuals, and those patients without clear signs of illicit drug abuse, were less likely to receive naloxone in EMS resuscitation attempts. Heightened clinical suspicion for opioid overdose is important given the recent increase in overdoses among patients due to prescription opioids. PMID:26383533

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

    PubMed

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

    2000-05-01

    Medication compliance is one of the foremost problems affecting neuroleptic efficacy in psychiatric patients. To date, compliancy has most commonly been assessed with the Drug Attitude Inventory (DAI) developed by Hogan et al. (Hogan, T.P., Awad, A.G., Eastwood, R., 1983. A self-report scale predictive of drug compliance in schizophrenics: reliability and discriminative validity. Psychol. Med. 13, 177-183). The present study identified several deficiencies in the DAI. Using the partial credit version of the Item Response Theory measurement model, the DAI was refined with the aim of greater validity and clinical utility. The new inventory was administered to 66 patients, the majority of whom were diagnosed with schizophrenia. When available, lithium levels and carer ratings of compliance were also recorded and used to verify compliancy. The new inventory appears to be a valid and reliable measure of compliancy for psychoactive medications. PMID:10785582

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

    PubMed

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

    2009-01-01

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

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

    PubMed

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

    2016-01-01

    The main objective of this study was to assess the practice at retail pharmacies in Pakistan and to compare the same in rural and urban areas. The maintenance of pharmacy and drug inspectors' visit was also assessed. This cross sectional study was conducted in Abbottabad, Pakistan during October-November, 2012. A sample of 215 drug sellers or drug stores was selected by employing convenient sampling method. With a response rate of 91.6%, 197 drug sellers participated in this study. All the drug sellers were male. Overall, 35% (n = 197) of the drug sellers did not have any professional qualification. A majority of the drug sellers were involved in various malpractices like selling of medicines without prescription (80.7%), prescribing practice (60.9%), prescription intervention (62.4%) and selling of controlled substances (66%) without a license for selling it. These malpractices were significantly higher in rural area than that in urban area. PMID:27476300

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

    PubMed

    van der Hoogte, Arjo Roersch; Pieters, Toine

    2010-01-01

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

  17. Medical devices; gastroenterology-urology devices; nonimplanted, peripheral electrical continence device. Food and Drug Administration, HHS. Final rule.

    PubMed

    2000-04-01

    The Food and Drug Administration (FDA) is classifying the nonimplanted, peripheral electrical continence 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 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:11010624

  18. Effect of automated drug distribution systems on medication error rates in a short-stay geriatric unit

    PubMed Central

    Cousein, Etienne; Mareville, Julie; Lerooy, Alexandre; Caillau, Antoine; Labreuche, Julien; Dambre, Delphine; Odou, Pascal; Bonte, Jean-Paul; Puisieux, François; Decaudin, Bertrand; Coupé, Patrick

    2014-01-01

    Rationale, aims and objectives To assess the impact of an automated drug distribution system on medication errors (MEs). Methods Before-after observational study in a 40-bed short stay geriatric unit within a 1800 bed general hospital in Valenciennes, France. Researchers attended nurse medication administration rounds and compared administered to prescribed drugs, before and after the drug distribution system changed from a ward stock system (WSS) to a unit dose dispensing system (UDDS), integrating a unit dose dispensing robot and automated medication dispensing cabinet (AMDC). Results A total of 615 opportunities of errors (OEs) were observed among 148 patients treated during the WSS period, and 783 OEs were observed among 166 patients treated during the UDDS period. ME [medication administration error (MAE)] rates were calculated and compared between the two periods. Secondary measures included type of errors, seriousness of errors and risk reduction for the patients. The implementation of an automated drug dispensing system resulted in a 53% reduction in MAEs. All error types were reduced in the UDDS period compared with the WSS period (P < 0.001). Wrong dose and wrong drug errors were reduced by 79.1% (2.4% versus 0.5%, P = 0.005) and 93.7% (1.9% versus 0.01%, P = 0.009), respectively. Conclusion An automated UDDS combining a unit dose dispensing robot and AMDCs could reduce discrepancies between ordered and administered drugs, thus improving medication safety among the elderly. PMID:24917185

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

    PubMed

    Schut, J

    1975-06-01

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

  20. Medication reviews in primary care in Sweden: importance of clinical pharmacists' recommendations on drug-related problems.

    PubMed

    Modig, Sara; Holmdahl, Lydia; Bondesson, Åsa

    2016-02-01

    Background One way of preventing and solving drug-related problems in frail elderly is to perform team-based medication reviews. Objective To evaluate the quality of the clinical pharmacy service to primary care using structured medication reviews, focusing on the clinical significance of the recommendations made by clinical pharmacists. Setting A random sample of 150 patients (out of 1541) who received structured team based medication reviews. The patients lived at a geriatric nursing home or were ≥65 years and lived in ordinary housing with medication-related community help. Method Based on information on symptoms, kidney function, blood pressure, diagnoses and the medication list, a pharmacist identified possible drug-related problems and supplied recommendations for the general practitioner to act on. Two independent physicians retrospectively ranked the clinical significance of the recommendations according to Hatoum, with rankings ranging between 1 (adverse significance) and 6 (extremely significant). Main outcome measure The clinical significance of the recommendations. Results In total 349 drug-related problems were identified, leading to recommendations. The vast majority of the recommendations (96 %) were judged to have significance 3 or higher and more than the half were judged to have significance 4 or higher. Conclusion The high proportion of clinically significant recommendations provided by pharmacists when performing team-based medication reviews suggest that these clinical pharmacy services have potential to increase prescribing quality. As such, the medication reviews have the potential for contributing to a better and safer drug therapy for elderly patients. PMID:26582483

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

    PubMed

    Simpson, F O

    1990-10-01

    Antihypertensive drugs have been of major benefit to people with moderate or severe hypertension and have contributed enormously to fundamental physiological knowledge. Antihypertensive therapy in milder hypertension reduces the incidence of stroke by 40% or more, may reduce myocardial infarction and prevents progression to more severe hypertension or heart failure but is being criticised as not cost-effective. Much of this criticism is based on deductions from inappropriate data. Nevertheless, it is likely that money is in some cases being wasted on the treatment of people who were not truly hypertensive in the first place. It is also likely that drug dosage is often unnecessarily high. Clearly it is vital that treatment is delivered as economically as possible. A reduction in the prevalence of hypertension would be the best way to reduce costs. Obesity and a high alcohol intake are associated with a higher blood pressure at any age. A high salt intake throughout life appears to be associated with a rise in blood pressure in the second half of life and may well be the main factor in hypertension. A radical rethinking of the method of pricing of medical care should be considered, so as to provide incentives to people to adopt life-style measures that lead to avoidance of hypertension (and other cardiovascular risk factors) or, in established hypertension, to a reduction in the need for medication. PMID:2126730

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

    PubMed Central

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

    2015-01-01

    The use of nonprescription medicines (NPDs) for children illnesses without a doctor's suggestion can lead to unnecessary medication use and is not free of risks. The aim of our study was to examine attitudes and practice of parents towards NPDs use for their children. We also investigated the conditions that may predict NPDs use. A cross-sectional survey was conducted on parents of children attending Community Based Pediatrician (CBP) consultation and data were collected through structured interviews. Positive attitude on NPDs use was reported by 71.4% of parents, and 61.5% of them had administered NPDs in the previous 6 months. Antipyretic drugs were the most frequently used medication class without the supervision of the CBP. A positive attitude towards NPDs was significantly more frequent in parents who did not use the CBP as the sole source of information about drugs. The study demonstrated a widespread use of NPDs in children in our context, supported by a substantial positive attitude towards their safety. However, considering potential harms related to some NPDs and the finding that most parents rely on CBP advice, role of CBP on appropriate use of NPDs by parents should be emphasized. PMID:26106606

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

    PubMed

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

    2013-04-01

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

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

    PubMed

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

    2015-01-01

    The use of nonprescription medicines (NPDs) for children illnesses without a doctor's suggestion can lead to unnecessary medication use and is not free of risks. The aim of our study was to examine attitudes and practice of parents towards NPDs use for their children. We also investigated the conditions that may predict NPDs use. A cross-sectional survey was conducted on parents of children attending Community Based Pediatrician (CBP) consultation and data were collected through structured interviews. Positive attitude on NPDs use was reported by 71.4% of parents, and 61.5% of them had administered NPDs in the previous 6 months. Antipyretic drugs were the most frequently used medication class without the supervision of the CBP. A positive attitude towards NPDs was significantly more frequent in parents who did not use the CBP as the sole source of information about drugs. The study demonstrated a widespread use of NPDs in children in our context, supported by a substantial positive attitude towards their safety. However, considering potential harms related to some NPDs and the finding that most parents rely on CBP advice, role of CBP on appropriate use of NPDs by parents should be emphasized. PMID:26106606

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

    PubMed

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

    2015-09-01

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

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

    PubMed Central

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

    2014-01-01

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

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

    PubMed

    Xu, Shuai; Kesselheim, Aaron S

    2014-01-01

    Effective medical innovation is a common goal of policymakers, physicians, researchers, and patients both in the private and public sectors. With the recent slowdown in approval of new transformative prescription drugs, many have looked back to the "golden years" of the 1980s and 1990s when numerous breakthrough products emerged. We conducted a qualitative study of innovators (n=127) directly involved in creation of groundbreaking drugs during that era to determine what made their work successful and how the process of conducting medical innovation has changed over the past 3 decades. Transcripts were analyzed using standard coding techniques and the constant comparative method of qualitative data analysis to identify the positive features of and challenges posed by the past and present therapeutic innovation environments (70 of the 127 interviewees explicitly addressed these issues). Interviewees emphasized the continued central role played by individuals and the institutions they were a part of in driving innovation. In addition, respondents discussed the importance of collaboration between individuals and institutions to share resources and expertise. Strong underlying basic science was also cited to be a major contributing factor to the success of an innovation. The climate for modern-day medical innovation involves a greater emphasis on patenting in academia, difficulty negotiating the technology transfer process, and funding constraints. Regulatory demands or reimbursement concerns were not commonly cited as factors that influenced transformative innovation. This study suggests that generating future transformative innovation will require a simplification of the current technology transfer process, continued commitment to basic science research, and policy changes that promote meaningful collaboration between individuals from disparate institutions. PMID:25565621

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

    PubMed Central

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

    2016-01-01

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

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

    PubMed Central

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

    2010-01-01

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

  10. Drug allergies

    MedlinePlus

    Allergic reaction - drug (medication); Drug hypersensitivity; Medication hypersensitivity ... Adverse reactions to drugs are common. (adverse means unwanted or unexpected.) Almost any drug can cause an adverse reaction. Reactions range from irritating ...

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

    PubMed

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

    2015-06-01

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

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

    PubMed Central

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

    2015-01-01

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

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

    PubMed Central

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

    2014-01-01

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

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

    PubMed

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

    2006-07-01

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

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

    PubMed

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

    2011-10-01

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

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

    PubMed

    1999-11-24

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

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

    PubMed Central

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

    2015-01-01

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

  18. Physician drug dispensing.

    PubMed

    Lober, C W; Behlmer, S D; Penneys, N S; Shupack, J L; Thiers, B H

    1988-11-01

    We have reviewed the issue of physician drug dispensing by focusing upon quality of care, economic considerations, drug availability, patient compliance, safety, and increased governmental regulation. From a quality of care perspective, the increased use of pharmacist assistants, the tendency toward generic and therapeutic drug substitution, and the less specialized clinical education of pharmacists all pose hazards rather than safety checks upon physician prescribing. There is no evidence that pharmacists charge less than physicians. If they did, there would be no need to protect their incomes legislatively by restricting physician dispensing. Economic motivation per se is less important to a physician than providing a true convenience for his patients and thus encouraging a closer doctor-patient relationship. Physician dispensing adds to the availability of medication and may minimize the number of patients shuttling between pharmacies to obtain complex multi-ingredient preparations. Compliance is enhanced as availability increases. Prepackaged pharmaceuticals prepared under the auspices of pharmacists and dispensed by physicians are at least as safe as those prepared by the ungloved hands of a pharmacist hidden behind store counters. Thus, restricting the physician's right to dispense can negatively affect the quality of medical care, the cost of medications, safety, the availability of pharmaceuticals, and patient compliance. Such limitation is certainly not in the best interest of our patients. PMID:3056999

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

    PubMed Central

    Sattler, Sebastian; Schunck, Reinhard

    2016-01-01

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

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

    PubMed

    Sattler, Sebastian; Schunck, Reinhard

    2015-01-01

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

  1. Automatically Recognizing Medication and Adverse Event Information From Food and Drug Administration’s Adverse Event Reporting System Narratives

    PubMed Central

    Polepalli Ramesh, Balaji; Belknap, Steven M; Li, Zuofeng; Frid, Nadya; West, Dennis P

    2014-01-01

    Background The Food and Drug Administration’s (FDA) Adverse Event Reporting System (FAERS) is a repository of spontaneously-reported adverse drug events (ADEs) for FDA-approved prescription drugs. FAERS reports include both structured reports and unstructured narratives. The narratives often include essential information for evaluation of the severity, causality, and description of ADEs that are not present in the structured data. The timely identification of unknown toxicities of prescription drugs is an important, unsolved problem. Objective The objective of this study was to develop an annotated corpus of FAERS narratives and biomedical named entity tagger to automatically identify ADE related information in the FAERS narratives. Methods We developed an annotation guideline and annotate medication information and adverse event related entities on 122 FAERS narratives comprising approximately 23,000 word tokens. A named entity tagger using supervised machine learning approaches was built for detecting medication information and adverse event entities using various categories of features. Results The annotated corpus had an agreement of over .9 Cohen’s kappa for medication and adverse event entities. The best performing tagger achieves an overall performance of 0.73 F1 score for detection of medication, adverse event and other named entities. Conclusions In this study, we developed an annotated corpus of FAERS narratives and machine learning based models for automatically extracting medication and adverse event information from the FAERS narratives. Our study is an important step towards enriching the FAERS data for postmarketing pharmacovigilance. PMID:25600332

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

    PubMed Central

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

    2016-01-01

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

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

    PubMed

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

    2010-01-01

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

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

    PubMed

    2008-01-01

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

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

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... that meets the Medicare DMEPOS Supplier Quality and Accreditation Standards at 42 CFR 424.57. ... provided pharmacist services must include evaluation of a patient's response to medication therapy...) An employee who has completed a State-approved training program in medication administration;...

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

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... that meets the Medicare DMEPOS Supplier Quality and Accreditation Standards at 42 CFR 424.57. ... provided pharmacist services must include evaluation of a patient's response to medication therapy...) An employee who has completed a State-approved training program in medication administration;...

  7. 42 CFR 418.106 - Condition of participation: Drugs and biologicals, medical supplies, and durable medical equipment.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... that meets the Medicare DMEPOS Supplier Quality and Accreditation Standards at 42 CFR 424.57. ... provided pharmacist services must include evaluation of a patient's response to medication therapy...) An employee who has completed a State-approved training program in medication administration;...

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

    PubMed Central

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

    2016-01-01

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

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

    PubMed Central

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

    2015-01-01

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

  10. Tolerability and patient compliance.

    PubMed

    Roose, S P

    1999-01-01

    Currently available antidepressants interact with several types of receptors, which may explain both wanted and unwanted effects of these drugs. These effects are different and distinctive, and knowledge about them may help clinicians understand differences between compounds in terms of their tolerability profiles. Given roughly comparable efficacy, tolerability profile is the critical determinant in selecting an antidepressant medication for a particular patient. In addition, tolerability is inseparably linked to patient compliance, both in acute and long-term treatment, and ultimately to overall success of treatment. Refinement in pharmacologic profiles of all newly introduced antidepressants resulted in overall advantages in tolerability in comparison with older tricyclic compounds. However, differences in receptor interactions between antidepressants are directly reflected in tolerability (adverse event) profiles. Among new antidepressants, mirtazapine and the selective serotonin reuptake inhibitors share favorable overall tolerability and safety, especially with respect to low premature termination rates because of adverse events, cardiac safety, and safety in overdose. However, the different pharmacologic profile of mirtazapine is reflected in its different tolerability profile. Because of interactions with the histamine (H1) receptor, mirtazapine may be related to transient initial somnolence and weight gain in some patients. Its serotonin-2 (5-HT2)-blocking properties may account for lack of sexual dysfunction, insomnia, nervousness, and agitation. Mirtazapine's 5-HT3-blocking properties are unique among all currently available antidepressants and may account for lack of gastrointestinal adverse events. PMID:10446736

  11. Drug utilisation and off-label use of medications in anaesthesia in surgical wards of a teaching hospital

    PubMed Central

    Patil, Amol E; Shetty, Yashashri C; Gajbhiye, Snehalata V; Salgaonkar, Sweta V

    2015-01-01

    Background and Aims: When a drug is used in a way that is different from that described in regulatory body approved drug label, it is said to be ‘off label use’. Perioperative phase is sensitive from the point of view of patient safety and off-label drug use in this setup can prove to be hazardous to patient. Hence, it was planned to assess the pattern of drug utilisation and off-label use of perioperative medication during anaesthesia. Methods: Preoperatively, demographic details and adverse events check list were filled from a total of 400 patients from general surgery, paediatric surgery and orthopaedics departments scheduled to undergo surgery. The perioperative assessment form was assessed to record all prescriptions followed by refilling of adverse events checklist in case record form. World Health Organization (WHO) prescribing indicators were used for analysis of drug utilisation data. National Formulary of India 2011 was used as reference material to decide off-label drug use in majority instances along with package insert. Results: A total of 3705 drugs were prescribed to the 400 participants and average number of drugs per patient was 9.26 ± 3.33. Prescriptions by generic name were 68.07% whereas 85.3% drugs were prescribed from hospital schedule. Off-label drugs overall formed 20.19% of the drugs prescribed. At least one off-label drug was prescribed to 82.5% of patients. Inappropriate dose was the most common form of off-label use. There was 1.6 times greater risk of occurrence of adverse events associated with the use of off-label drugs. Conclusion: Prescription indicators were WHO compliant. Off-label drug use was practiced in anaesthesia department with questionable clinical justification in some instances. PMID:26755837

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

    PubMed

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

    1996-12-01

    A study was carried out in a group of opiate addicts who reported to various centers in Nagpur city, India, to know the sequential pattern of nonmedical drug use in the drug career of opiate dependents in Nagpur. The mean age of the study group was 28.2 years, the majority were males, educated up to 10th standard, employed in various occupations like petty business, vehicle driving, etc, with an average monthly income of Rs. 316. The average number of drugs ever used per person was 3.7 +/- 1.2, those recently used was 2.6 +/- 0.9 and currently used was 2.2 +/- 0.6. The study group experienced 13 drug types in their addict careers. Beedi¿cigarette was the first drug abused by the majority. Drug careers starting with beedi¿cigarette, progressing to alcohol and then to canabis and finally to heroin were observed in a majority of subjects. There appeared to be a shift from multidrug use to the singular combination of heroin and beedi¿cigarette currently. Use of all other drugs declined in favor of heroin as the career progressed. The study indicates that preventive programs should be directed at reducing the use of initial drugs like beedi¿cigarette and alcohol and also reducing the social acceptability of these drugs as measure for preventing progression to hard drugs like heroin. PMID:9253883

  13. Oral anticancer agent medication adherence by outpatients.

    PubMed

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

    2014-11-01

    In the present study, medication adherence and factors affecting adherence were examined in patients taking oral anticancer agents. In June 2013, 172 outpatients who had been prescribed oral anticancer agents by Ogaki Municipal Hospital (Ogaki, Gifu, Japan) completed a questionnaire survey, with answers rated on a five-point Likert scale. The factors that affect medication adherence were evaluated using a customer satisfaction (CS) analysis. For patients with good and insufficient adherence to medication, the median ages were 66 years (range, 21-85 years) and 73 years (range, 30-90 years), respectively (P=0.0004), while the median dosing time was 131 days (range, 3-3,585 days) and 219 days (24-3,465 days), respectively (P=0.0447). In 36.0% (62 out of 172) of the cases, there was insufficient medication adherence; 64.5% of those cases (40 out of 62) showed good medication compliance (4-5 point rating score). However, these patients did not fully understand the effects or side-effects of the drugs, giving a score of three points or less. The percentage of patients with good medication compliance was 87.2% (150 out of 172). Through the CS analysis, three items, the interest in the drug, the desire to consult about the drug and the condition of the patient, were extracted as items for improvement. Overall, the medication compliance of the patients taking the oral anticancer agents was good, but the medication adherence was insufficient. To improve medication adherence, a better understanding of the effectiveness and necessity of drugs and their side-effects is required. In addition, the interest of patients in their medication should be encouraged and intervention should be tailored to the condition of the patient. These steps should lead to improved medication adherence. PMID:25295117

  14. Oral anticancer agent medication adherence by outpatients

    PubMed Central

    KIMURA, MICHIO; USAMI, EISEKI; IWAI, MINA; NAKAO, TOSHIYA; YOSHIMURA, TOMOAKI; MORI, HIROMI; SUGIYAMA, TADASHI; TERAMACHI, HITOMI

    2014-01-01

    In the present study, medication adherence and factors affecting adherence were examined in patients taking oral anticancer agents. In June 2013, 172 outpatients who had been prescribed oral anticancer agents by Ogaki Municipal Hospital (Ogaki, Gifu, Japan) completed a questionnaire survey, with answers rated on a five-point Likert scale. The factors that affect medication adherence were evaluated using a customer satisfaction (CS) analysis. For patients with good and insufficient adherence to medication, the median ages were 66 years (range, 21–85 years) and 73 years (range, 30–90 years), respectively (P=0.0004), while the median dosing time was 131 days (range, 3–3,585 days) and 219 days (24–3,465 days), respectively (P=0.0447). In 36.0% (62 out of 172) of the cases, there was insufficient medication adherence; 64.5% of those cases (40 out of 62) showed good medication compliance (4–5 point rating score). However, these patients did not fully understand the effects or side-effects of the drugs, giving a score of three points or less. The percentage of patients with good medication compliance was 87.2% (150 out of 172). Through the CS analysis, three items, the interest in the drug, the desire to consult about the drug and the condition of the patient, were extracted as items for improvement. Overall, the medication compliance of the patients taking the oral anticancer agents was good, but the medication adherence was insufficient. To improve medication adherence, a better understanding of the effectiveness and necessity of drugs and their side-effects is required. In addition, the interest of patients in their medication should be encouraged and intervention should be tailored to the condition of the patient. These steps should lead to improved medication adherence. PMID:25295117

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

    Code of Federal Regulations, 2013 CFR

    2013-10-01

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

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

    Code of Federal Regulations, 2010 CFR

    2010-10-01

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

  17. 49 CFR 240.119 - Criteria for consideration of data on substance abuse disorders and alcohol/drug rules compliance.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

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

  18. 49 CFR 240.119 - Criteria for consideration of data on substance abuse disorders and alcohol/drug rules compliance.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

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

  19. 49 CFR 240.119 - Criteria for consideration of data on substance abuse disorders and alcohol/drug rules compliance.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

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

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

    PubMed Central

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

    2014-01-01

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

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

    PubMed

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

    2010-08-01

    The success of many medical treatments is built on compliance. Electronic monitoring is the most accurate tool to quantify compliance by measuring adherence. In order to assess the efficiency of a recently introduced miniature monitoring device for eye drop application, we evaluated adherence in ophthalmic patients undergoing post-operative short-term topical treatment. This pilot study enrolled 30 outpatients (mean age 61.8 +/- 18.5 years) after cataract (n = 24) and glaucoma filtration surgery (n = 6) applying fixed-combination eye drops containing prednisolone and gentamicin five times daily for 2 weeks. Patients received eye drops in conventional bottles each equipped with a miniature monitoring device recording events of application. Two patients failed to bring back the monitoring device; therefore data collected from only 28 patients could be examined. Data showed highly variable results with a mean dose compliance of 50.2%. Dose compliance was below 25% in approximately one out of five patients. Four cataract patients, but no glaucoma patient, discontinued therapy prematurely. The observed mean dosage interval was calculated for each patient and ranged 4.6-19.7 h. Thirty percent of analysed dosage intervals exceeded 12.0 h. Different patterns of compliance behaviour-like early non-persistence, drug holiday and low treatment frequency could be identified and illustrated using electronic data. Age or gender did not significantly influence compliance rates. Our pilot study demonstrates successful electronic compliance monitoring using a technology capable of continuous data recording over weeks of treatment. The low compliance rate for a relevant part of the patients demonstrates the necessity to study and improve compliance in ophthalmology. In future, new application methods and electronic application devices may improve treatment response in eye care. PMID:20373127

  2. Assessing Student Pharmacists’ Ability to Identify Drug-Related Problems in Patients Within a Patient-Centered Medical Home

    PubMed Central

    Bulkley, Christina F.; Truong, Teresa; Carter, Sandra M.

    2014-01-01

    Objective. To quantify, describe, and categorize patient drug-related problems (DRPs) and recommendations identified by fourth-year (P4) student pharmacists during a live medication reconciliation activity within a patient-centered medical home (PCMH). Methods. Fourth-year student pharmacists conducted chart reviews, identified and documented DRPs, obtained live medication histories, and immediately provided findings and recommendations to the attending physicians. Documentation of DRPs and recommendations were analyzed retrospectively. Results. Thirty-eight students completed 99 medication reconciliation sessions from June 2011 to October 2012 during their advanced pharmacy practice experience (APPE). The students obtained 676 patient medication histories and identified or intervened on 1308 DRPs. The most common DRPs reported were incomplete medication list and diagnostic/laboratory testing needed. Physicians accepted 1,018 (approximately 78%) recommendations. Conclusion. Student pharmacists successfully identified and reduced DRPs through a live medication reconciliation process within an academic-based PCMH model. Their medication history-taking skills improved and medication use was optimized. PMID:24558274

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

    MedlinePlus

    ... possibility whenever a new medication is prescribed. For questions regarding medications, contact ... “Medications and Myasthenia Gravis (A Reference for Health Care Professionals.” www.myasthenia. ...

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

    ERIC Educational Resources Information Center

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

    2011-01-01

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

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

    PubMed

    Amano, Hiroshi

    2002-01-01

    Doctors were very nervous about the movements of pharmacists toward achievement of the separation of drug dispensaries in the medical practices and drug dispensation in 1914 and 1915. They specifically blamed one person, Professor Tokichiro Niwa of Tokyo Imperial University who strongly advocated the separation of dispensaries in the medical practices. Furthermore, they were also very anxious that the Japan Pharmacists Association had supported legislators who had stood by the separation of dispensaries from medical practice at the twelfth general election held on March 25, 1915. They were concerned that the domain of doctors' activities would be narrowed by such a separation. Professor Kunika Katayama of the Tokyo Imperial University School of Medicine published a thesis at his own cost advocating a modification of the doctor's law to prohibit the separation of dispensaries be legislation and insisting that the right prescribe a drug to a patient must remain with the doctor. Moreover, Professor Mitsue Ichimura of Kyoto Imperial University also insisted that a doctor has the right to give drugs to patients, and that as a jurist he disagreed with the separation of dispensaries from medical practice. PMID:12412598

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

    PubMed

    Marks, Zach

    2014-01-01

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

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

    SciTech Connect

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

    2012-04-01

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

  8. Methodology for the analysis and representation of the medical information about drugs in the Summary of Product Characteristics (SPC).

    PubMed Central

    Venot, A.; Duclos, C.

    1999-01-01

    We present a methodology for the representation of the medical knowledge in the drug SPCs. It includes four steps, the two first of which are automated. All instances of a particular SPC text are gathered into a single file. Lexical analysis of the content of this file is performed and a lexicon with the occurrence of words and groups of words is built. Semantic analysis is carried out considering the concepts underlying each word of the lexicon and the most important concepts are kept. This semantic analysis results in a list of attributes which are then included in an object-oriented model. We have used this method to structure drug indications. This application clearly illustrates the advantages of this method over purely manual analysis. This method could be generalized for all categories of medical information about drugs. PMID:10566342

  9. Discrepancies Between Self-Report and Objective Measures for Stimulant Drug Use in HIV: Cognitive, Medication Adherence and Psychological Correlates

    PubMed Central

    Reinhard, M. J.; Hinkin, C. H.; Barclay, T. R.; Levine, A. J.; Marion, S.; Castellon, S. A.; Longshore, D.; Newton, T.; Durvasula, R. S.; Lam, M. N.; Myers, H.

    2009-01-01

    While it has long been recognized that self-reported drug use may be at variance with objectively obtained evidence such as urine toxicology assays, few studies have explored the behavioral correlates of such discrepancies. Here we compared self-reported and objective measures of stimulant drug use for 162 HIV infected individuals and identified a sub-group with discrepancies between data obtained via the two methods. Results showed poorer neurocognitive performance (attention, learning/memory) and lower medication adherence rates for the discrepant group as compared to those who either acknowledged their drug use or accurately denied recent stimulant use. Using the Millon Clinical Multiaxial Inventory –III, it was also found that those in the discrepant group were more hesitant to reveal psychopathology. Comparisons of self-reported and objectively measured medication adherence data are also discussed. PMID:17499443

  10. Medical Appointments

    MedlinePlus

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

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

    PubMed

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

    2007-03-22

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

  12. Drugs and other product choices.

    PubMed

    Hyman, Paul M; Carvajal, Ricardo

    2009-01-01

    Dermatologists have at their disposal a wide range of products to recommend or prescribe to their patients, all of which are regulated in some way by the Food and Drug Administration (FDA). However, the degree to which FDA has confirmed the safety and efficacy of a dermatological product can vary widely. Most prescription and some over-the-counter drugs and medical devices are approved by the FDA based on scientific data. Most over-the-counter drugs are marketed in compliance with FDA regulations based on expert medical review. The FDA clears most medical devices based on their substantial equivalence to other legally marketed devices. Cosmetics, medical foods, and dietary supplements are subject only to general postmarket prohibitions against adulterated and misbranded products, although the FDA may review ingredient safety and specific claims for dietary supplements. Some product information is available on FDA's Web site, but the prudent physician should supplement that information by reviewing available scientific literature. PMID:19453345

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

    PubMed

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

    2013-01-01

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

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

    PubMed Central

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

    2014-01-01

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

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

    PubMed

    Stockigt, Jim R

    2007-01-15

    Product information (PI) for thyroid-related medications endorsed by the Therapeutic Goods Administration, as reproduced in the commonly used compilation publications June 2006 MIMS (Monthly index of medical specialties) annual, MIMS Online and the Australian prescription products guide 2006, was evaluated to see whether it reflects contemporary therapeutic practice. Compared with current medical literature, these PI-based sources provide inadequate, inaccurate or outdated therapeutic directives. Examples include: Incorrect advice that thyroxine therapy should always begin at very low dosage. Failure to recommend increased thyroxine dosage early in pregnancy (thus placing the offspring of women being treated for hypothyroidism at risk of impaired fetal brain development). Incorrect and potentially unsafe advice to treat thyrotoxicosis with stable iodide in late pregnancy. Failure to advise serial adjustment of antithyroid drug dosage until after a patient becomes euthyroid (this can result in iatrogenic thyroid dysfunction). Outdated advice that antithyroid drugs are not compatible with breastfeeding. Recent initiatives to upgrade consumer medicine information (CMI) appear to accept PI-based sources as a reliable benchmark for CMI. That inference is not warranted for thyroid-related medications. Accountability for the updating of clinical information in PI needs to be defined, and the process for updating PI may need to be modified. Quality drug information, both PI and CMI, depends on fluent, evidence-based collaboration between suppliers, regulators, prescribers, specialist clinicians and consumers. PMID:17223768

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

    PubMed

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

    2014-12-01

    Medical devices are of great importance for the prevention, diagnosis and treatment of many diseases. With their broad range and interdisciplinarity, they represent both a very dynamic field of innovation and a significant sector of the economy. The European and thus the German Medical Devices Act aim in this context to make new medical devices for patients and users rapidly available while ensuring safety and performance at the same time. The main responsibility for this lies with the manufacturer. In addition, others are involved in a complex collaboration in the conformity assessment and also later in the marketing phase for the early identification, assessment and minimization of potential risks. This paper presents the legal framework for medical devices and the related roles and responsibilities of various stakeholders, especially the two federal agencies the German Federal Institute for Drugs and Medical Devices (BfArM) and the Paul Ehrlich Institute (PEI). From the perspective of the BfArM the procedure and criteria for risk assessment of incident reports are explained and the experiences and wishes from regulatory practice are described. The active engagement of the BfArM to contribute knowledge from the incident report assessment within the relevant standards organisations and the medical profession is described using examples of medical devices from the field of out-of-hospital ventilation. The paper concludes with a look at future challenges, e.g. in combination products, IT networks and automatization, as well as on current developments to improve risk identification and assessment in a European context. PMID:25370170

  17. Compliance status

    SciTech Connect

    Black, D.G.

    1995-06-01

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

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

    NASA Astrophysics Data System (ADS)

    Serbezov, Valery; Sotirov, Sotir; Serbezov, Svetlin

    2013-03-01

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

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

    PubMed

    Sharma, Vikas; Chamroonswasdi, Kanittha; Srisorrachatr, Suwat

    2016-03-01

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

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

    PubMed

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

    2016-08-01

    Male-to-female transgender women (TGW) experience high rates of substance use and HIV. A recent substance use trend is the use of prescription medication without a doctor's consent. No research to date has examined the associations between this non-medical use of prescription drugs and HIV risk behaviour in TGW. In the present study, TGW recruited from community venues (N = 104) in the Mid-Atlantic region of the United States completed surveys assessing demographic information, non-medical use of prescription drugs, other substance use, injection practices and sexual risk behaviour. Twenty-four per cent of the sample reported lifetime non-medical use of prescription drugs across the following categories: analgesics (21.2%), anxiolytics (14.4%), stimulants (12.5%) and sedatives (8.7%). Participants reporting non-medical use of prescription drugs were more likely to report other substance use, needle use to inject drugs, injecting silicone and sharing needles. In multivariable analyses, non-medical use of prescription drugs was associated with unprotected sex, sex after engaging in substance use, and commercial sex work, after controlling for demographic factors. Self-esteem and social support from family served as protective factors for non-medical use of prescription drugs. HIV-prevention programmes focused on TGW in the United States may wish to expand their assessment of substance use to include the use of prescription medications without a physician's consent. PMID:26185044

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

    PubMed Central

    Brannigan, Vincent

    1986-01-01

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

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

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... consider the medical history of the employee or applicant, as well as any other relevant biomedical... accordance with the criteria provided in the Medical Review Officer Manual issued by the Department of...

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

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... consider the medical history of the employee or applicant, as well as any other relevant biomedical... accordance with the criteria provided in the Medical Review Officer Manual issued by the Department of...

  4. Attitudes of Students Living in Dormitories of Zahedan University of Medical Sciences Towards the Causes of Drug Addiction

    PubMed Central

    Mir Lotfi, Parvizreza; Javadimehr, Mani; Adrome, Mahdiye

    2015-01-01

    Background: Health-threatening behavior is one of the most challenges of social and mental health, that most countries are involved somehow in it, and as a result widespread and severe problems are imposed on communities. Objectives: The aim of this study was to assess the attitudes of students living in dormitories of Zahedan University of Medical Sciences towards causes of drug addiction. Patients and Methods: In this study, 100 students (60 boys and 40 girls) living in dormitories (Kooser and Misagi) of Zahedan University of Medical Sciences were selected using the simple random sampling method. Data were collected by oral interview and participants were asked demographic, geographic and economic oral questions about their attitude towards causes of drug addiction. The interview was conducted by psychology experts and respondents’ answers were recorded on tape recorder and then transcribed on papers, and finally the data were analyzed by SPSS (15). Results: Different percentages of participants expressed different views about the causes of drug addiction. Results showed that 75%, 65%, 55.5% 90%, 40% and 85%, of participants believed being away from their parents, curiosity, unconsidered friendships, smoking, using drug at home, and easy accessibility were as major contributing factors involved in drug addiction, respectively, and the same factors underlie the student's involvement in addiction. Conclusions: Many contributing factors of drug abuse obtained in this study can influence on tendency towards drug use for new students. It is evident that the period of residency in dormitories is one of the most critical periods in students' life. Thus, the concerned authorities take necessary measures to overcome the students’ mental and social problems. PMID:26405683

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

    PubMed

    2000-01-14

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

  6. Compliance measurements.

    NASA Technical Reports Server (NTRS)

    Bubsey, R. T.; Fisher, D. M.; Jones, M. H.; Srawley, J. E.

    1973-01-01

    The uses of compliance measurements in linear fracture mechanics are discussed as a technique for determining the crack-extension force vs load, specimen dimensions, and elastic constants. Some practical examples of application are given, including specimen and transducer descriptions, experimental procedure, instrumentation, calculations, measurement precautions, friction effects, and data reduction. The limitations and advantages of compliance measurements are discussed. It is pointed out that good results can be obtained by the compliance method when its measurement precision is not lower than that required for Young's modulus.

  7. Prevalence of drug-drug interactions upon addition of simeprevir- or sofosbuvir-containing treatment to medication profiles of patients with HIV and hepatitis C coinfection.

    PubMed

    Patel, Nimish; Nasiri, Mona; Koroglu, Arden; Amin, Ronish; McGuey, Liam; McNutt, Louise-Anne; Roman, Martha; Miller, Christopher

    2015-02-01

    The objectives were to (1) compare the frequency of contraindicated drug-drug interactions (XDDI) when simeprevir (SIM)- and sofosbuvir (SOF)-containing regimens are theoretically added to a patient's medication profile; (2) identify which hepatitis C (HCV) regimen is associated with the lowest frequency of XDDIs within different types of antiretroviral treatment (ART) regimens; and (3) determine the risk factors for XDDIs with each regimen. A cross-sectional study was performed among adult HIV/HCV-coinfected patients. Demographics, comorbidities, and medication lists were collected from medical records. Medication lists were entered into Lexi-Interact drug interaction software and XDDI before/after the addition of SIM- and SOF-containing therapy was documented. Classification and regression tree (CART) analyses identified breakpoints in continuous variables. Before the addition of any HCV therapy, XDDIs were present in 20% of the 335 included patients. After the addition of SIM-containing therapy, the frequency of XDDIs significantly increased to 88.4% (p<0.001). After adding SOF-containing therapy, the prevalence of XDDIs increased to 24.5% (p<0.001). The prevalence of XDDIs was significantly lower for SOF-containing HCV therapy within various types of ART regimens. Use of ≥7 non-HIV medications (CART breakpoint) was the only variable to predict XDDIs before the addition of any HCV therapy. Similarly, this was the only variable to predict XDDIs after the addition of SOF-containing therapy (PR: 4.80; 95% CI: 2.57-8.96, p<0.001). Variables independently associated with XDDIs after the addition of SIM-containing therapy were NNRTI regimen (prevalence ratio, PR: 1.62; 95% confidence interval, CI: 1.38-1.91, p<0.001), PI regimen (PR: 1.64; 95% CI: 1.40-1.93, p<0.001), and ≥7 non-HIV medications (PR: 1.06; 95% CI: 1.00-1.14, p=0.09). The addition of SOF-containing therapy was associated with a lower prevalence of XDDI than SIM-containing therapy. PMID:25432275

  8. Automated discovery of drug treatment patterns for endocrine therapy of breast cancer within an electronic medical record

    PubMed Central

    Olson, Janet E; Murphy, Sean P; Cafourek, Victoria L; Couch, Fergus J; Goetz, Matthew P; Ingle, James N; Suman, Vera J; Chute, Christopher G; Weinshilboum, Richard M

    2011-01-01

    Objective To develop an algorithm for the discovery of drug treatment patterns for endocrine breast cancer therapy within an electronic medical record and to test the hypothesis that information extracted using it is comparable to the information found by traditional methods. Materials The electronic medical charts of 1507 patients diagnosed with histologically confirmed primary invasive breast cancer. Methods The automatic drug treatment classification tool consisted of components for: (1) extraction of drug treatment-relevant information from clinical narratives using natural language processing (clinical Text Analysis and Knowledge Extraction System); (2) extraction of drug treatment data from an electronic prescribing system; (3) merging information to create a patient treatment timeline; and (4) final classification logic. Results Agreement between results from the algorithm and from a nurse abstractor is measured for categories: (0) no tamoxifen or aromatase inhibitor (AI) treatment; (1) tamoxifen only; (2) AI only; (3) tamoxifen before AI; (4) AI before tamoxifen; (5) multiple AIs and tamoxifen cycles in no specific order; and (6) no specific treatment dates. Specificity (all categories): 96.14%–100%; sensitivity (categories (0)–(4)): 90.27%–99.83%; sensitivity (categories (5)–(6)): 0–23.53%; positive predictive values: 80%–97.38%; negative predictive values: 96.91%–99.93%. Discussion Our approach illustrates a secondary use of the electronic medical record. The main challenge is event temporality. Conclusion We present an algorithm for automated treatment classification within an electronic medical record to combine information extracted through natural language processing with that extracted from structured databases. The algorithm has high specificity for all categories, high sensitivity for five categories, and low sensitivity for two categories. PMID:22140207

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

    PubMed

    Babaley, M

    2006-12-01

    One of the main objectives of pharmaceutical policies in developing countries is to ensure accessibility and affordability of good quality medicines for the population. The Essential Medicines and Generic Drugs Purchasing Central (French acronym, CAMEG-Togo) is a not-for-profit association established in 1998 to ensure procurement for public and not-for-profit private public health facilities within the framework of recovery of costs. Although attention has been focused mainly on medicines, medical devices account for a growing part of the pharmaceutical products purchased by central stores, hospitals and health programs. Recognizing this need in 2002, CAMEG-Togo in collaboration with the French cooperation agency decided to upgrade its competency in evaluating the quality of medical devices. For that purpose the information sheet used to preselect suppliers for international tenders and the technical specifications sheet for medical devices was revised and pharmacists responsible for processing these files were given specific training. European directive N 93/42/CEE of 14 June 1993 is currently used by CAMEG-Togo as the regulatory basis for preselection of medical device suppliers. Referencing based on American regulatory requirements is now under way to widen the scope of suppliers eligible for preselection. The purpose of this article is first to describe the main guidelines of the European directive used by medical device manufacturers to obtain EC certification and second to present the procedures used by the CAMEG-Togo to preselect medical device suppliers, with special focus on the technical specifications sheet. PMID:17286037

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

    PubMed

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

    2014-01-01

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

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

    PubMed Central

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

    2008-01-01

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

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

    PubMed Central

    Labiris, N R; Dolovich, M B

    2003-01-01

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

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

    PubMed Central

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

    2014-01-01

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

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

    PubMed Central

    Ihezue, U. H.

    1988-01-01

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

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

    NASA Astrophysics Data System (ADS)

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

    2016-07-01

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

  16. [Adverse or toxic effects of drugs in medical practice: a one-year follow-up].

    PubMed

    Grange, J C

    1990-01-01

    In order to analyse the response of pharmaceutical companies to adverse drug reaction reports, 37 suspected side effects were sent by mail to the 30 companies concerned. The time period involved was 1 year and corresponded to a total of 3341 consultations in general practice. Companies answered in 29 cases (78.3%), sent 21 reply forms and returned 3 evaluations of adverse drugs reactions to the reporting doctor. The high percentage of adverse drug reactions (1.07 per one hundred consultations), the doctor's work-load and poor feed-back lead one to reflect on the usefulness of systematic adverse drug reaction reporting by general practitioners. PMID:2399517

  17. Confidentiality laws and secrecy in medical research: improving public access to data on drug safety.

    PubMed

    Kesselheim, Aaron S; Mello, Michelle M

    2007-01-01

    Pharmaceutical manufacturers have long considered results collected from drugs' clinical trials to be confidential information or trade secrets, even after submission to the Food and Drug Administration (FDA). We describe FDA policies regarding disclosure of clinical trial data and evaluate how courts have interpreted the Freedom of Information Act in cases seeking access to unreleased information. Recent examples of approved drugs later found to have dangerous side effects show the importance of complete dissemination of safety information. We suggest regulatory and legislative policy changes regarding how the FDA handles confidential information that can improve understanding of the risks of prescription drugs. PMID:17339677

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

    PubMed

    Nakata, M; Tang, W

    2008-10-01

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

  19. [Progression of drug delivery system for glaucoma].

    PubMed

    Xu, Yan; Lyu, Liu

    2014-12-01

    Reduction of intraocular pressure (IOP) by drugs is a major treatment for glaucoma. Clinically, diverse antiglaucoma drugs take effect to decrease the IOP through different mechanisms.However, due to limitations of traditional form of eye drops, the bioavailability of the drug and the patient compliance is lowered, the clinical efficacy is not good and also some toxic and side-effects come out.Otherwise, traditional medication is not suitable for neuroprotective drugs to work on both retina and optic nerve. Drug delivery system has the potential to improve the bioavailability of the drug, prolong the time of drug action, decrease the dosage and frequency of drugs, reduce the side-effects, and improve the patient compliance and efficacy.It is one of the most important studies in glaucoma medication development because it is valuable for patients' neuroprotection.Nowadays, several novel delivery systems have been designed. This review will focus on the progressions of some of the sustained-release antiglaucoma eye drops, polymeric gels, colloidal systems, membrane-controlled drug delivery system, ocular implants, and transscleral drug delivery systems. PMID:25619186

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

    ERIC Educational Resources Information Center

    Dezelsky, Thomas L.; And Others

    1981-01-01

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

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

    PubMed

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

    2012-01-01

    Currently, there is a need to reduce the occupational exposure of health care workers to anticancer drugs. Environmental contamination by anticancer drugs and subsequent exposure of health care workers are associated with vaporization of anticancer drugs. Furthermore, carcinomatous unpleasant odor is an additional problem to vaporized anticancer drugs in the field of clinical cancer therapy. We attempted to degrade vaporized anticancer drug and unpleasant odor using a photocatalyst. Cyclophosphamide or unpleasant odors (ammonia, formaldehyde, isovaleric acid, and butyric acid) were vaporized by heating in a closed chamber. Plates of photocatalyst coated with titanium dioxide were placed into the chamber and irradiated by light source. Vaporized cyclophosphamide in the chamber was recovered by bubbling the internal air through acetone and derivatized by trifluoroacetic anhydride for analysis by gas chromatographic-mass spectrometric assay. Vaporized odors were determined using a gas-detector tube, which changed color depending on the concentration. Following activation of the photocatalyst by a light source, the residual amounts of anticancer drug and unpleasant odor components were significantly decreased compared with when the photocatalyst was not activated without a light source. These results indicate that the photocatalysts can accelerate the degradation of vaporized anticancer drugs and odor components. Air-cleaning equipment using a photocatalyst is expected to be useful in improving the QOL of cancer patients experiencing carcinomatous unpleasant odor, and in reducing occupational exposure of health care workers to anticancer drugs. PMID:23037705

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

    PubMed Central

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

    2015-01-01

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

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

    PubMed Central

    Daroudi, Rajabali; Mirzania, Mehrzad; Zendehdel, Kazem

    2016-01-01

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

  4. Medication Reconciliation Improvement Through the Use of Video.

    PubMed

    Dewan, Maya; Kraus, Blair; Davis, Daniela; McCloskey, John

    2015-01-01

    Accurate medication reconciliation at the time of hospital admission is vital to preventing adverse drug events. Compliance with medication reconciliation in our pediatric intensive care unit was low initially with overall medication reconciliation at 70%. Due to the high front line provider turnover in our unit, we focused on technological reminders for completion and used unique and innovative ways to motivate our supervising staff. Our goal was to reach >95% completion within 24 hours for medication reconciliation for all patients admitted to the pediatric intensive care unit. Pre-pilot discussions focused on examples of errors of medication reconciliation within our own institution resulting in patient harm via traditional power point presentation. The initial pilot phase instituted a job aid on how to add the medication reconciliation completion reminder column. Email updates on completion status began one week after initiation. During the implementation and spread phase, fun interactive videos were used to acknowledge roll out to the full unit. Compliance was monitored and humorous biweekly video updates emphasizing accountability were introduced. In the sustain phase, monthly video updates served as education and a reminder for provider staff. The use of a medication reconciliation completion column and reminder emails resulted in goal completion (>95%) by three weeks post intervention for the pilot unit. Overall medication reconciliation completion also reached goal of >95% completion within the entire unit after three weeks of implementation and spread. Compliance fell below goal so video updates were modified utilizing humor and emphasizing accountability. This resulted in sustained compliance now more than forty weeks post implementation. Unit compliance currently remains >95% completion within 24 hours now more than forty weeks post intervention. The use of the medication reconciliation reminder column resulted in improvement in compliance; however

  5. Fomepizole (orphan medical).

    PubMed

    Hantson, P

    2001-06-01

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

  6. A Prospective Examination of the Association of Stimulant Medication History and Drug Use Outcomes among Community Samples of ADHD Youths

    PubMed Central

    WINTERS, KEN C.; LEE, SUSANNE; BOTZET, ANDRIA; FAHNHORST, TAMARA; REALMUTO, GEORGE M.; AUGUST, GERALD J.

    2012-01-01

    A continuing debate in the child psychopathology literature is the extent to which pharmacotherapy for children with attention-deficit/hyperactivity disorder (ADHD), in particular stimulant treatment, confers a risk of subsequent drug abuse. If stimulant treatment for ADHD contributes to drug abuse, then the risk versus therapeutic benefits of such treatment is greatly affected. We have prospectively followed an ADHD sample (N = 149; 81% males) for approximately 15 years, beginning at childhood (ages 8 to 10 years) and continuing until the sample has reached young adulthood (ages 22 to 24 years). The sample was originally recruited via an epidemiologically derived community procedure, and all youths were diagnosed with ADHD during childhood. We report on the association of childhood psychostimulant medication and subsequent substance use disorders and tobacco use. The substance use outcomes were based on data collected at three time points when the sample was in late adolescence and young adulthood (age range approximately 18 to 22 years old). We did not find evidence to support that childhood treatment with stimulant medication, including the course of stimulant medication, was associated with any change in risk for adolescent or young adulthood substance use disorders and tobacco use. These results from a community-based sample extend the growing body of literature based on clinically derived samples indicating that stimulant treatment does not create a significant risk for subsequent substance use disorders. PMID:22582022

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

    NASA Astrophysics Data System (ADS)

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

    2004-06-01

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

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

    PubMed

    Peck, J A

    2016-01-01

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

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-21

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

  10. 76 FR 45402 - Advisory Committee; Medical Imaging Drugs Advisory Committee; Re-Establishment

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-29

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

  11. Cable compliance

    NASA Technical Reports Server (NTRS)

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

    1992-01-01

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

  12. Cable compliance

    NASA Astrophysics Data System (ADS)

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

    1992-06-01

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

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

    PubMed Central

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

    2016-01-01

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

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

    PubMed Central

    Kumbar, Shivaprasad Kalakappa

    2015-01-01

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

  15. The non-medical use of prescription psychotropic drugs by school boys in greater Cairo.

    PubMed

    Soueif, M I; Darweesh, Z A; Taha, H S

    1985-05-01

    Data, previously collected in the context of a large-scale study of the extent of substance use among male Egyptian secondary and technical school students, were broken down along a parameter of use/non-use of prescription psychoactive drugs. Users were compared with non-users on five clusters of queries included in a standardized questionnaire, relating to: family ties, participation in peers' activities, exposure to drug-related stimuli, boldness and health problems. Users were found to report weak family ties, persistent participation in peers' activities and consistent exposure to drug-related stimuli. They were daring in relating to the drug universe and were less healthy (physically and psychologically) than non-users. These findings are discussed in the light of relevant previously reported results of epidemiological studies. PMID:4017875

  16. Development of a nanoporous and multilayer drug-delivery platform for medical implants

    PubMed Central

    Karagkiozaki, Varvara; Vavoulidis, Eleftherios; Karagiannidis, Panagiotis G; Gioti, Maria; Fatouros, Dimitrios G; Vizirianakis, Ioannis S; Logothetidis, Stergios

    2012-01-01

    Biodegradable polymers can be applied to a variety of implants for controlled and local drug delivery. The aim of this study is to develop a biodegradable and nanoporous polymeric platform for a wide spectrum of drug-eluting implants with special focus on stent-coating applications. It was synthesized by poly(DL-lactide-co-glycolide) (PLGA 65:35, PLGA 75:25) and polycaprolactone (PCL) in a multilayer configuration by means of a spin-coating technique. The antiplatelet drug dipyridamole was loaded into the surface nanopores of the platform. Surface characterization was made by atomic force microscopy (AFM) and spectroscopic ellipsometry (SE). Platelet adhesion and drug-release kinetic studies were then carried out. The study revealed that the multilayer films are highly nanoporous, whereas the single layers of PLGA are atomically smooth and spherulites are formed in PCL. Their nanoporosity (pore diameter, depth, density, surface roughness) can be tailored by tuning the growth parameters (eg, spinning speed, polymer concentration), essential for drug-delivery performance. The origin of pore formation may be attributed to the phase separation of polymer blends via the spinodal decomposition mechanism. SE studies revealed the structural characteristics, film thickness, and optical properties even of the single layers in the triple-layer construct, providing substantial information for drug loading and complement AFM findings. Platelet adhesion studies showed that the dipyridamole-loaded coatings inhibit platelet aggregation that is a prerequisite for clotting. Finally, the films exhibited sustained release profiles of dipyridamole over 70 days. These results indicate that the current multilayer phase therapeutic approach constitutes an effective drug-delivery platform for drug-eluting implants and especially for cardiovascular stent applications. PMID:23071394

  17. Availability of drugs and medical supplies for emergency obstetric care: experience of health facility managers in a rural District of Tanzania

    PubMed Central

    2014-01-01

    Background Provision of quality emergency obstetric care relies upon the presence of skilled health attendants working in an environment where drugs and medical supplies are available when needed and in adequate quantity and of assured quality. This study aimed to describe the experience of rural health facility managers in ensuring the timely availability of drugs and medical supplies for emergency obstetric care (EmOC). Methods In-depth interviews were conducted with a total of 17 health facility managers: 14 from dispensaries and three from health centers. Two members of the Council Health Management Team and one member of the Council Health Service Board were also interviewed. A survey of health facilities was conducted to supplement the data. All the materials were analysed using a qualitative thematic analysis approach. Results Participants reported on the unreliability of obtaining drugs and medical supplies for EmOC; this was supported by the absence of essential items observed during the facility survey. The unreliability of obtaining drugs and medical supplies was reported to result in the provision of untimely and suboptimal EmOC services. An insufficient budget for drugs from central government, lack of accountability within the supply system and a bureaucratic process of accessing the locally mobilized drug fund were reported to contribute to the current situation. Conclusion The unreliability of obtaining drugs and medical supplies compromises the timely provision of quality EmOC. Multiple approaches should be used to address challenges within the health system that prevent access to essential drugs and supplies for maternal health. There should be a special focus on improving the governance of the drug delivery system so that it promotes the accountability of key players, transparency in the handling of information and drug funds, and the participation of key stakeholders in decision making over the allocation of locally collected drug funds. PMID

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

    PubMed

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

    2015-07-01

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

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

    SciTech Connect

    Kasinathan, R.; Kanchan, A.

    1995-12-31

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

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

    PubMed Central

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

    2014-01-01

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

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

    PubMed

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

    2016-01-01

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

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

    PubMed Central

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

    2016-01-01

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

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

    PubMed

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

    2016-06-01

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

  4. Shape-switching microrobots for medical applications: the influence of shape in drug delivery and locomotion.

    PubMed

    Fusco, Stefano; Huang, Hen-Wei; Peyer, Kathrin E; Peters, Christian; Häberli, Moritz; Ulbers, André; Spyrogianni, Anastasia; Pellicer, Eva; Sort, Jordi; Pratsinis, Sotiris E; Nelson, Bradley J; Sakar, Mahmut Selman; Pané, Salvador

    2015-04-01

    The effect of dynamic shape switching of hydrogel bilayers on the performance of self-folding microrobots is investigated for navigation in body orifices and drug release on demand. Tubular microrobots are fabricated by coupling a thermoresponsive hydrogel nanocomposite with a poly(ethylene glycol)diacrylate (PEGDA) layer, to achieve spontaneous and reversible folding from a planar rectangular structure. Graphene oxide (GO) or silica-coated superparamagnetic iron oxide nanoparticles are dispersed in the thermoresponsive hydrogel matrix to provide near-infrared (NIR) light sensitivity or magnetic actuation, respectively. The NIR light-responsive microstructures are fabricated for triggered drug delivery while magnetic nanocomposite-based microrobots are used to analyze the role of shape in locomotion. Experimental analysis and computational simulations of tubular structures show that drug release and motility can be optimized through controlled shape change. These concepts are finally applied to helical microrobots to show a possible way to achieve autonomous behavior. PMID:25751020

  5. Injection drug use, unsafe medical injections, and HIV in Africa: a systematic review

    PubMed Central

    Reid, Savanna R

    2009-01-01

    The reuse of injecting equipment in clinical settings is well documented in Africa and appears to play a substantial role in generalized HIV epidemics. The U.S. and the WHO have begun to support large scale injection safety interventions, increased professional education and training programs, and the development and wider dissemination of infection control guidelines. Several African governments have also taken steps to control injecting equipment, including banning syringes that can be reused. However injection drug use (IDU), of heroin and stimulants, is a growing risk factor for acquiring HIV in the region. IDU is increasingly common among young adults in sub-Saharan Africa and is associated with high risk sex, thus linking IDU to the already well established and concentrated generalized HIV epidemics in the region. Demand reduction programs based on effective substance use education and drug treatment services are very limited, and imprisonment is more common than access to drug treatment services. Drug policies are still very punitive and there is widespread misunderstanding of and hostility to harm reduction programs e.g. needle exchange programs are almost non-existent in the region. Among injection drug users and among drug treatment patients in Africa, knowledge that needle sharing and syringe reuse transmit HIV is still very limited, in contrast with the more successfully instilled knowledge that HIV is transmitted sexually. These new injection risks will take on increased epidemiological significance over the coming decade and will require much more attention by African nations to the range of effective harm reduction tools now available in Europe, Asia, and North America. PMID:19715601

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

    PubMed

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

    2009-10-01

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

  7. TRICARE; off-label uses of devices; partial list of examples of unproven drugs, devices, medical treatments or procedures. Final rule.

    PubMed

    2012-06-27

    The Department of Defense is publishing this final rule to revise the definition of ``unlabeled or off-label drug'' to ``off-label use of a drug or device.'' This provision codifies the coverage of those medically necessary indications for which there are demonstrations from medical literature, national organizations, or technology assessment bodies that the off-label use is safe and effective and in accordance with nationally accepted standards of practice in the medical community. Additionally, this rule removes the partial list of examples of unproven drugs, devices, and medical treatments or procedures proscribed in TRICARE regulations. We are removing the partial list from the regulation but will maintain the partial list in the TRICARE Policy Manual at www.tricare.mil. PMID:22737762

  8. 75 FR 44267 - Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices; Neurological...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-28

    ... April 5, 2010 (75 FR 17093), FDA published a notice announcing the availability of draft special... for the notice that appeared in the Federal Register of April 5, 2010 (75 FR 17143). In the notice... Staff; Medical Devices; Neurological and Physical Medicine Device Guidance Document; Reopening...

  9. 75 FR 47604 - Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices; Neurological...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-06

    ... July 28, 2010 (75 FR 44267). The document reopened the comment period for a notice of availability of..., Silver Spring, MD 20993, 301-796-9148. SUPPLEMENTARY INFORMATION: In FR Doc. 2010-18406, appearing on... Staff; Medical Devices; Neurological and Physical Medicine Device Guidance Document; Reopening...

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

    ERIC Educational Resources Information Center

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

    2009-01-01

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

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

    PubMed Central

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

    2014-01-01

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

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

    PubMed

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

    2014-01-01

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

  13. 47 CFR 18.212 - Compliance information.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

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

  14. 47 CFR 18.212 - Compliance information.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

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

  15. 47 CFR 18.212 - Compliance information.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

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

  16. 47 CFR 18.212 - Compliance information.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

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

  17. 47 CFR 18.212 - Compliance information.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

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

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

    ERIC Educational Resources Information Center

    Mehra, N.

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

  19. Adherence to medication and drug monitoring in apparent treatment-resistant hypertension.

    PubMed

    Eskås, Per Anders; Heimark, Sondre; Eek Mariampillai, Julian; Larstorp, Anne Cecilie K; Fadl Elmula, Fadl Elmula M; Høieggen, Aud

    2016-08-01

    Poor drug adherence is one of the main reasons for the failure to achieve treatment targets in hypertensive patients. In patients who receive pharmacological treatment, assessment of drug adherence is of the utmost importance. The aim of this review is to present an update of the methods available to reveal and monitor non-adherence in patients with apparent treatment-resistant hypertension. Methods for monitoring adherence are divided into indirect and direct methods. The indirect methods are mainly based on self-reported adherence and can easily be manipulated by the patient. Directly observed therapy and therapeutic drug monitoring are examples of direct methods. There are limitations and advantages to all of the methods, and because of the patient's ability to manipulate the outcome of indirect methods, direct methods should be preferred. Therapeutic drug monitoring and directly observed therapy with subsequent ambulatory blood pressure measurement are considered to be reliable methods and should be used more in the routine assessment of patients with apparent treatment-resistant hypertension. PMID:26729283

  20. Drug abuse first aid

    MedlinePlus

    Drug abuse is the misuse or overuse of any medication or drug, including alcohol. This article discusses first ... use of these drugs is a form of drug abuse. Legitimate medications can be abused by people who ...

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

    PubMed

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

    2006-11-01

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

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

    PubMed

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

    2011-12-01

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

  3. Prescribing patterns and the use of therapeutic drug monitoring of psychotropic medication in a psychiatric high-security unit.

    PubMed

    Castberg, Ingrid; Spigset, Olav

    2008-10-01

    The aim of this study was to investigate the use of psychotropic medication and therapeutic drug monitoring in a high-security psychiatric unit and to compare the doses and serum concentrations both with the recommended intervals and with the doses and serum concentrations in a control group. One hundred thirty-two patients were admitted in the period from January 2000 to December 2005. All available samples were used when comparing serum concentrations and doses with the recommended ranges. For the comparison of doses and serum concentration-to-dose (C:D) ratios with the control group only 1 sample from each patient was used. A total of 459 analyses of 27 different drugs in samples from 8 women and 73 men were included. The median number of therapeutic drug monitoring analyses per patient was 4 (range 1-29). Thirty-seven of the 81 patients (46%) used 2 or more antipsychotics at the same time. Clozapine, lamotrigine, olanzapine, quetiapine, ziprasidone, and zuclopenthixol were often given in doses above the recommended. The serum levels were frequently above those recommended for clozapine, olanzapine, quetiapine, risperidone, ziprasidone, and zuclopenthixol. The serum levels were significantly higher in the study group than in the control group for clozapine, lamotrigine, quetiapine, and zuclopenthixol. The given dose was significantly higher in the study group than in the control group for clozapine, lamotrigine and zuclopenthixol. The C:D ratio was significantly lower in the study group than in the control group for olanzapine but higher for quetiapine. The non-evidence based practice of high-dose polypharmacy with several antipsychotics is widely used in this unit. The use of higher doses in the study group than in the control group was not due to differences in metabolism or adherence to treatment between the 2 groups. The frequent use of therapeutic drug monitoring did not seem to have a great impact on the prescribed doses. PMID:18708990

  4. 40 CFR 60.39e - Compliance times.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 40 Protection of Environment 7 2014-07-01 2014-07-01 false Compliance times. 60.39e Section 60.39e... PERFORMANCE FOR NEW STATIONARY SOURCES Emission Guidelines and Compliance Times for Hospital/Medical/Infectious Waste Incinerators § 60.39e Compliance times. (a) Each State in which a designated facility...

  5. 40 CFR 60.39e - Compliance times.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

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

  6. 40 CFR 60.39e - Compliance times.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

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

  7. 40 CFR 60.39e - Compliance times.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

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

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

    PubMed

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

    2016-04-01

    Optimal communication between physicians and pharmacists is important for patient care. However, pharmacists and doctors do not always seem to understand each other. They have been professionalized differently, and do not always speak the same language. Especially in the areas of prescribing, medication review, and medicine use, there can be differences in views. This contribution clarifies some essential concepts that doctors and pharmacists use. Thus we hope that our commentary contributes to a better understanding of each other's role and the importance of interprofessional cooperation for the benefit of the patient. PMID:26797769

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

    PubMed Central

    2013-01-01

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

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

    PubMed

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

    2009-01-01

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

  11. US Food and Drug Administration Regulation of Medical Devices and Radiation Oncology: Can Reform Improve Safety?

    PubMed Central

    Hattangadi, Jona A.; O'Reilly, James T.; Recht, Abram

    2012-01-01

    Although radiation therapy is highly safe and effective in treating cancer, recent reports of dangerous radiation-related errors have focused a national spotlight on the field of radiation oncology and, more specifically, on the rapidly evolving and complex nature of radiation devices and how they are regulated. The purpose of this review is to explore the issues involved in medical device regulation in radiation oncology. We start with a general review of federal medical device regulation, including explanations of the legal and regulatory framework, and then discuss issues specific to radiation oncology with real-world examples. We also provide our thoughts on potential solutions and reforms to the current system, including better reporting of radiation-related errors in a centralized database, well-defined criteria for establishing substantial equivalence of a new device, and standard postmarket surveillance of radiation devices. Modern radiation therapy is a powerful tool that can help cure many patients' cancers and alleviate others' suffering with limited adverse effects. We must ensure that this promise is never compromised by avoidable mistakes. PMID:22548012

  12. Critical gaps in the world's largest electronic medical record: Ad Hoc nursing narratives and invisible adverse drug events.

    PubMed

    Hurdle, John F; Weir, Charlene R; Roth, Beverly; Hoffman, Jennifer; Nebeker, Jonathan R

    2003-01-01

    The Veterans Health Administration (VHA), of the U.S. Department of Veteran Affairs, operates one of the largest healthcare networks in the world. Its electronic medical record (EMR) is fully integrated into clinical practice, having evolved over several decades of design, testing, trial, and error. It is unarguably the world's largest EMR, and as such it makes an important case study for a host of timely informatics issues. The VHA consistently has been at the vanguard of patient safety, especially in its provider-oriented EMR. We describe here a study of a large set of adverse drug events (ADEs) that eluded a rigorous ADE survey based on prospective EMR chart review. These numerous ADEs were undetected (and hence invisible) in the EMR, missed by an otherwise sophisticated ADE detection scheme. We speculate how these invisible nursing ADE narratives persist and what they portend for safety re-engineering. PMID:14728184

  13. Dosage strength is associated with medication persistence with Ginkgo biloba drug products: a cohort study of ambulatory drug claims data in Germany

    PubMed Central

    2013-01-01

    Background Ginkgo biloba drugs (Gb) are reimbursed within the German statutory health insurance (SHI) scheme for treatment of dementia. In 2008, a novel Gb product containing 240 mg Ginkgo extract EGb761® per tablet was introduced aiming to facilitate medication use by incorporating the recommended daily dose in one single tablet. The aim of this study was to evaluate the relationship between dosage strength and persistence in a representative population of patients treated with Gb. Methods Retrospective cohort study in ambulatory drug claims database within the German SHI system. Persistence was defined as continuous treatment with an allowable gap of 20% between refills. Multivariate regression models were conducted to identify variables associated with persistence. Results Among 13,810 patients initiating treatment with Gb in 2008, 430 (3.1%) received a dosage strength of 240 mg, 7,070 (51.2%) a dosage strength of 120 mg and 6,310 (45.7%) dosage strengths containing less than 120 mg Gb per tablet. After 6 months, persistence was highest for patients treated with the 240 mg dosage form (22.8% of patients), although persistence was low in general (5.7% and 0% of patients treated with 120 mg and less than 120 mg, respectively). Risk for non-persistence was reduced in patients receiving 240 mg products compared to 120 mg (HR = 0.63; 95%CI 0.57 – 0.70). Conclusions Patients initially treated with Gb 240 mg were more persistent compared to those receiving lower dosage strengths. Nevertheless, persistence with Gb therapy is generally low and should be improved in order to better realize therapeutic effects. PMID:24156348

  14. Associations among Pain, Non-Medical Prescription Opioid Use, and Drug Overdose History

    PubMed Central

    Bonar, Erin E.; Ilgen, Mark A.; Walton, Maureen; Bohnert, Amy S.B.

    2014-01-01

    Background and Objective Recently, use of prescription opioids (POs) has increased; non-medical PO (NMPO) use is linked to overdose. NMPO use is common among individuals prescribed opioids for pain, and those in Substance Use Disorder (SUD) treatment with pain could be at increased risk for unintentional overdose due to NMPO use. We examined associations between pain, NMPO use, and overdose among SUD treatment patients. Methods Among 342 patients at a residential SUD treatment center, logistic regression examined the association of overdose with pain, adjusting for substance use, suicide attempts, and demographics. Results Pain was positively related to NMPO use. Heroin use, suicide attempts, pain, and NMPO use were positively associated with overdose; but NMPO use attenuated the pain-overdose relationship. Conclusions The relationship between pain and overdose among substance users may be, in part, explained by the association between pain and heavy NMPO use. PMID:24313240

  15. Adverse Drug Effects and Preoperative Medication Factors Related to Perioperative Low-Dose Ketamine Infusions.

    PubMed

    Schwenk, Eric S; Goldberg, Stephen F; Patel, Ronak D; Zhou, Jon; Adams, Douglas R; Baratta, Jaime L; Viscusi, Eugene R; Epstein, Richard H

    2016-01-01

    High-dose opioid administration is associated with significant adverse events. Evidence suggests that low-dose ketamine infusions improve perioperative analgesia over conventional opioid management, but usage is highly variable. Ketamine's adverse drug effects (ADEs) are well known, but their prevalence during low-dose infusions in a clinical setting and how often they lead to infusion discontinuation are unknown. The purposes of this study were 3-fold: (1) to identify patient factors associated with initiation of ketamine infusions during spine surgery, (2) to identify specific spine procedures in which ketamine has been used most frequently, and (3) to identify ADEs associated with postoperative ketamine infusions and which ADEs most frequently led to discontinuation. Spine surgery was chosen because of its association with moderate to severe pain and a relatively high use of ketamine infusions in this population at our hospital. PMID:27281730

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

    PubMed

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

    2016-05-01

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

  17. Raman and SERS microspectroscopy on living cells: a promising tool toward cellular drug response and medical diagnosis

    NASA Astrophysics Data System (ADS)

    Beljebbar, Abdelilah; Sockalingum, Ganesh D.; Morjani, Hamid; Manfait, Michel

    1999-04-01

    Raman spectroscopy has been sued to differentiate between sensitive and MDR-resistant cells using Raman spectral imaging with a 632.8 nm excitation wavelength. The comparison between two spectral images allowed to quantify the differences between sensitive and resistant cell lines in term of proteins, lipids when MDR phenotype is expressed. SER spectroscopy has become a powerful and non-invasive probe for investigating the molecular and cellular interaction of drugs with their targets. The comparison between these models allow to elucidate the biological effect of the drugs. The development of new types of SERS- active substrates has extended the applicability of this technique to medical diagnosis. Two kinds of SERS active substrates, characterized as 'bio-compatible' systems, can be used for investigation on single living cells: colloid suspensions and microelectrodes and island films. This methodology is used for the study of cell membrane components in interaction with the SERS substrates with the aim to understand the resistance mechanism. The constitution of a data bank will allow the follow-up of cancer and future monitoring of therapeutic intervention.

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

    PubMed

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

    2016-01-01

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

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

    PubMed Central

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

    2015-01-01

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

  20. Drug use evaluation of cefepime in the first affiliated hospital of Bengbu medical college: a retrospective and prospective analysis

    PubMed Central

    2013-01-01

    Background Cefepime is a fourth generation cephalosporin antimicrobial. Its extended antimicrobial activity and infrequent tendency to engender resistance make it popular for the treatment of infections. However, proper use of cefepime has not been studied adequately. In this study, we used a retrospective cohort and a prospective cohort to evaluate the usage pattern, adverse effects and cost-effectiveness of cefepime by conducting a drug use evaluation (DUE) program in the First Affiliated Hospital of Bengbu Medical College, Anhui, China. Methods The DUE criteria for cefepime were established by applying literature review and expert consultation, an effective method to promote interventions that will improve patient outcomes and the cost-effectiveness of drug therapy. According to the criteria, we performed a cross-sectional retrospective (cycle A) study on 96 hospitalized patients who received cefepime treatment and a prospective (cycle B) study on 111 hospitalized patients with cefepime treatment intervention. After identifying problems with usage and completing a cefepime use evaluation for cycle A, 2 months of educational intervention among professionals were given and a more effective and rational system of cefepime use was set up. During the 2 months, the lectures were arranged and attendance of prescribers was required. Results The data from cycle A showed that the biggest problem was irrational prescription of cefepime; bacterial culture and drug sensitivity tests for cefepime were also not carried out. Following 2 months of educational intervention among professionals, the results for cycle B showed that the correct indication rate was 94.59%, compared with 84.38% in cycle A. Use of bacterial culture and sensitivity tests also improved, by 88.29% in cycle B compared with 65.22% in cycle A. Compared with cycle A, the significantly improved items (P < 0.05) in cycle B were blood examination, liver function monitoring, renal function monitoring, dose and

  1. The accuracy of self-reported drug ingestion histories in emergency department patients.

    PubMed

    Monte, Andrew A; Heard, Kennon J; Hoppe, Jason A; Vasiliou, Vasilis; Gonzalez, Frank J

    2015-01-01

    Inaccuracies in self-reports may lead to duplication of therapy, failure to appreciate non-compliance leading to exacerbation of chronic medical conditions, or inaccurate research conclusions. Our objective is to determine the accuracy of self-reported drug ingestion histories in patients presenting to an urban academic emergency department (ED). We conducted a prospective cohort study in ED patients presenting for pain or nausea. We obtained a structured drug ingestion history including all prescription drugs, over-the-counter medication (OTC) drugs, and illicit drugs for the 48 hours prior to ED presentation. We obtained urine comprehensive drug screens (CDS) and determined self-report/CDS concordance. Fifty-five patients were enrolled. Self-reported drug ingestion histories were poor in these patients; only 17 (30.9%) of histories were concordant with the CDS. For the individual drug classes, prescription drug-CDS was concordant in 32 (58.2%), OTC-CDS was concordant in 33 (60%), and illicit drug-CDS was concordant in 45 (81.8%) of subjects. No demographic factors predicted an accurate self-reported drug history. Sixteen patients had drugs detected by CDS that were unreported by history. Nine of these 16 included an unreported opioid. In conclusion, self-reported drug ingestion histories are often inaccurate and resources are needed to confirm compliance and ensure unreported drugs are not overlooked. PMID:25052325

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

    PubMed

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

    2015-04-01

    The Food and Drug Administration (FDA) performs regulatory science to provide science-based medical product regulatory decisions. This article describes the types of scientific research the FDA's Center for Devices and Radiological Health performs and highlights specific projects related to medical devices for emergency medicine. In addition, this article discusses how results from regulatory science are used by the FDA to support the regulatory process as well as how the results are communicated to the public. Regulatory science supports the FDA's mission to assure safe, effective, and high-quality medical products are available to patients. PMID:25128009

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

    PubMed

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

    2016-01-01

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

  4. Antiretroviral Drug Diversion Links Social Vulnerability to Poor Medication Adherence in Substance Abusing Populations

    PubMed Central

    Tsuyuki, Kiyomi; Surratt, Hilary L.

    2015-01-01

    Antiretroviral (ARV) medication diversion to the illicit market has been documented in South Florida, and linked to sub-optimal adherence in people living with HIV. ARV diversion reflects an unmet need for care in vulnerable populations that have difficulty engaging in consistent HIV care due to competing needs and co-morbidities. This study applies the Gelberg-Andersen Behavioral Model of Health Care Utilization for Vulnerable Populations to understand how social vulnerability is linked to ARV diversion and adherence. Cross-sectional data were collected from a targeted sample of vulnerable people living with HIV in South Florida between 2010 and 2012 (n=503). Structured interviews collected quantitative data on ARV diversion, access and utilization of care, and ARV adherence. Logistic regression was used to estimate the goodness-of-fit of additive models that test domain fit. Linear regression was used to estimate the effects of social vulnerability and ARV diversion on ARV adherence. The best fitting model to predict ARV diversion identifies having a low monthly income and unstable HIV care as salient enabling factors that promote ARV diversion. Importantly, health care need factors did not protect against ARV diversion, evidence that immediate competing needs are prioritized even in the face of poor health for this sample. We also find that ARV diversion provides a link between social vulnerability and sub-optimal ARV adherence, with ARV diversion and domains from the Behavioral Model explaining 25% of the variation in ARV adherence. Our analyses reveal great need to improve engagement in HIV care for vulnerable populations by strengthening enabling factors (e.g. patient-provider relationship) to improve retention in HIV care and ARV adherence for vulnerable populations. PMID:25893656

  5. Antiretroviral drug diversion links social vulnerability to poor medication adherence in substance abusing populations.

    PubMed

    Tsuyuki, Kiyomi; Surratt, Hilary L

    2015-05-01

    Antiretroviral (ARV) medication diversion to the illicit market has been documented in South Florida, and linked to sub-optimal adherence in people living with HIV. ARV diversion reflects an unmet need for care in vulnerable populations that have difficulty engaging in consistent HIV care due to competing needs and co-morbidities. This study applies the Gelberg-Andersen behavioral model of health care utilization for vulnerable populations to understand how social vulnerability is linked to ARV diversion and adherence. Cross-sectional data were collected from a targeted sample of vulnerable people living with HIV in South Florida between 2010 and 2012 (n = 503). Structured interviews collected quantitative data on ARV diversion, access and utilization of care, and ARV adherence. Logistic regression was used to estimate the goodness-of-fit of additive models that test domain fit. Linear regression was used to estimate the effects of social vulnerability and ARV diversion on ARV adherence. The best fitting model to predict ARV diversion identifies having a low monthly income and unstable HIV care as salient enabling factors that promote ARV diversion. Importantly, health care need factors did not protect against ARV diversion, evidence that immediate competing needs are prioritized even in the face of poor health for this sample. We also find that ARV diversion provides a link between social vulnerability and sub-optimal ARV adherence, with ARV diversion and domains from the Behavioral Model explaining 25 % of the variation in ARV adherence. Our analyses reveal great need to improve engagement in HIV care for vulnerable populations by strengthening enabling factors (e.g. patient-provider relationship) to improve retention in HIV care and ARV adherence for vulnerable populations. PMID:25893656

  6. The Role of Traumatic Event History in Non-Medical Use of Prescription Drugs among a Nationally Representative Sample of US Adolescents

    ERIC Educational Resources Information Center

    McCauley, Jenna L.; Danielson, Carla Kmett; Amstadter, Ananda B.; Ruggiero, Kenneth J.; Resnick, Heidi S.; Hanson, Rochelle F.; Smith, Daniel W.; Saunders, Benjamin E.; Kilpatrick, Dean G.

    2010-01-01

    Background: Building on previous research with adolescents that examined demographic variables and other forms of substance abuse in relation to non-medical use of prescription drugs (NMUPD), the current study examined potentially traumatic events, depression, posttraumatic stress disorder (PTSD), other substance use, and delinquent behavior as…

  7. Alcohol and Illegal Drug Use Behaviors and Prescription Opioids Use: How do Nonmedical and Medical Users Compare, and Does Motive to Use Really Matter?

    PubMed Central

    Ghandour, Lilian A.; El Sayed, Donna S.; Martins, Silvia S.

    2013-01-01

    Background/Aims The study compared illegal drug and alcohol use behaviors between medical and nonmedical users of prescription opioids (PO) and nonmedical users with distinct motives to use. Method An ethically-approved cross-sectional study (2010) was conducted on a representative sample of private university students (n=570), using a self-filled anonymous questionnaire. Results About 25% reported using PO only medically and 15% nonmedically. The prevalence of alcohol and illegal drug use was consistently higher among nonmedical than medical PO users. Adjusting for age and gender, lifetime medical users of PO were more likely to use marijuana only (OR=1.8, 95%CI= 1.1, 2.8), while nonmedical users were at higher odds of using marijuana, ecstasy, cocaine/crack, and alcohol problematically. Compared to non-users, students who took PO nonmedically for non-therapeutic reasons were more likely to use various illegal drugs, but nonmedical users who took PO to relieve pain/help in sleep were only more likely to use marijuana (OR=2.5, 95%CI=1.1, 5.4) and alcohol (e.g., alcohol abuse, OR=3.8, 95%CI= 1.4, 10.1). Conclusion Youth who use PO nonmedically to self-treat have a different alcohol and illegal drug-using profile than those who take it for non-therapeutic reasons. PMID:23391856

  8. Differential Predictors of Medication Adherence in HIV: Findings from a Sample of African American and Caucasian HIV-Positive Drug-Using Adults

    PubMed Central

    Moizel, Jennifer; Panos, Stella E.; Patel, Sapna M.; Byrd, Desiree A.; Myers, Hector F.; Wyatt, Gail E.; Hinkin, Charles H.

    2012-01-01

    Abstract Modest or even occasional nonadherence to combined antiretroviral therapy (cART) can result in adverse clinical outcomes. African Americans demonstrate lower rates of adherence than Caucasians or Latinos. Identifying factors that influence medication adherence among African Americans is a critical step toward reducing HIV/AIDS disease progression and mortality. In a sample of 181 African American (n=144) and Caucasian (n=37) HIV-positive drug-using individuals [age (M=42.31; SD=6.6) education (M=13.41; SD=2.1)], we examined the influence of baseline drug use, literacy, neurocognition, depression, treatment-specific social support, and patient satisfaction with health care provider on medication adherence averaged over the course of 6 months (study dates 2002–2006). Our findings suggest differential baseline predictors of medication adherence for African Americans and Caucasians, such that patient satisfaction with provider was the strongest predictor of follow-up medication adherence for African Americans whereas for Caucasians depressive symptoms and treatment-specific social support were predictive of medication adherence (after controlling for duration of drug use). PMID:22889235

  9. 78 FR 102 - Guidance for Industry and Food and Drug Administration Staff; eCopy Program for Medical Device...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-02

    ..., Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg... CONTACT: Samie Allen, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New... HUMAN SERVICES Food and Drug Administration Guidance for Industry and......

  10. Review of the 2015 Drug Supply Chain Security Act.

    PubMed

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

    2016-06-01

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

  11. [Efficiency of KAT-quick P.f. test (KAT medical, SAR) among the populations of drug-resistant parasites].

    PubMed

    Rabinovich, S A; Le, Dines Kong; Nguen, Van Ha; Morozov, E N; Toropov, D E; Kukina, I V; Maksakovskaia, E V; Iakovenko, M A; Chalyĭ, V F; Fandeev, V A; Pozdniakova, E A; Nikitiuk, Iu E; Sergiev, V P

    2006-01-01

    The KAT-Quick P.f. test (KAT Medical, South African Republic) is based on the detection of protein HPR II produced by trophozoites and young gametocytes of P. falciparum. This test was conducted by the authors in the distribution areas of P. falciparum strains differing in the spectrum of drug resistance. Five hundred and forty-nine blood samples from febrile patients in Vietnam (n=84), Sierra Leone (n=41), Nigeria (n=14), Tanzania (n=8), Kenya (n=5), and Tadjikistan (n=397) were tested. Microscopy served as a primary control. Detection of P. falciparum DNA, using polymerase chain reaction (PCR) with included primers (nested PCR) of the most sensitive modification of PCR was a final control. The efficiency of the KAT-Quick P.f. test was estimated as a ratio of the number of its positive results to those of PCR. It was equal to 98-95%. The KAT-Quick P.f. test revealed no false-positive case associated with the genome of the parasite. The specificity of the test was determined as a ratio of the number of its negative (no P. falciparum) results to those of PCR. The blood samples from patients with vivax malaria and from those with nonmalarial fever were investigated. There was no cross reaction of the KAT-Quick P.f. test system for P. falciparum with that for P. vivax. The KAT-Quick P.f. test yielded no positive reaction with the blood from patients with non-malarial fever. Drug resistance depending on the spectrum of specific drugs caused its emergence may be determined by one or several mechanisms that are ultimately determined by one, the key mechanism. Thus, the findings suggest that multidrug resistance of P. falciparum does not trigger the occurrence of changes in its surface antigen--HRPII that is responsible for the efficiency of the KAT-Quick P.f. test. These may be also extrapolated to other rapid tests patterned after the same principle. PMID:16813240

  12. [Patient non-compliance as a cause of treatment failure].

    PubMed

    Kardas, P

    2000-10-01

    Patient non-compliance is a phenomenon which physician meets in his every-day practice. It covers different aspects of patient behaviour, but the most important role plays non-compliance with medication. Medication non-compliance is common among patients, with no respect to kind of disease or its severity. The consequences of non-compliance are serious. The inefficacy of conducted treatment, patient health status deterioration, additional hospitalisations or even deaths are some of them. Another negative influence of patient non-compliance is the increase of health system expenses. Nevertheless, numerous physicians are not fully conscious of this problem and its consequences, although in many instances treatment failure is caused by lack of patient adherence to medication. Many useful methods of compliance improvement are attainable in every physician work. Their broader use may lead to better therapy effectiveness. PMID:11144070

  13. Controlled drugs.

    PubMed

    2016-05-18

    Essential facts Controlled drugs are defined and governed by the Misuse of Drugs Act 1971 and associated regulations. Examples of controlled drugs include morphine, pethidine and methadone. Since 2012, appropriately qualified nurses and midwives can prescribe controlled drugs for medical conditions within their competence. There are some exceptions when treating addiction. PMID:27191427

  14. Automated personnel-assets-consumables-drug tracking in ambulance services for more effective and efficient medical emergency interventions.

    PubMed

    Utku, Semih; Özcanhan, Mehmet Hilal; Unluturk, Mehmet Suleyman

    2016-04-01

    Patient delivery time is no longer considered as the only critical factor, in ambulatory services. Presently, five clinical performance indicators are used to decide patient satisfaction. Unfortunately, the emergency ambulance services in rapidly growing metropolitan areas do not meet current satisfaction expectations; because of human errors in the management of the objects onboard the ambulances. But, human involvement in the information management of emergency interventions can be reduced by electronic tracking of personnel, assets, consumables and drugs (PACD) carried in the ambulances. Electronic tracking needs the support of automation software, which should be integrated to the overall hospital information system. Our work presents a complete solution based on a centralized database supported by radio frequency identification (RFID) and bluetooth low energy (BLE) identification and tracking technologies. Each object in an ambulance is identified and tracked by the best suited technology. The automated identification and tracking reduces manual paper documentation and frees the personnel to better focus on medical activities. The presence and amounts of the PACD are automatically monitored, warning about their depletion, non-presence or maintenance dates. The computerized two way hospital-ambulance communication link provides information sharing and instantaneous feedback for better and faster diagnosis decisions. A fully implemented system is presented, with detailed hardware and software descriptions. The benefits and the clinical outcomes of the proposed system are discussed, which lead to improved personnel efficiency and more effective interventions. PMID:26777434

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

    PubMed

    da Costa, Palmira Fontes

    2012-03-01

    The Colloquies on the simples and drugs of India (1563) were conceived and published at a sensitive moment, both in terms of the history of print culture and of European geographical expansion. They represented the culmination of a life-time project for their author Garcia de Orta who had lived for almost thirty years in Portuguese Goa. Although the importance of the work in sixteenth-century natural history and medicine has been generally acknowledged in Portuguese and international historiography, there are very few recent, detailed studies of the book informed by new approaches. This paper presents an integrated analysis of Orta's Colloquies as a literary, medical and cultural text. It aims to reveal not only the rich and subtle dynamics of the work but also to contribute to a better understanding of Orta's legitimation strategies as an author in a sixteenth-century world reconfigured by the new opportunities of the printing press, geographical expansion and increased material and cultural mobility. PMID:22530483

  16. Drug Interactions

    PubMed Central

    Tong Logan, Angela; Silverman, Andrew

    2012-01-01

    One of the most clinically significant complications related to the use of pharmacotherapy is the potential for drug-drug or drug-disease interactions. The gastrointestinal system plays a large role in the pharmacokinetic profile of most medications, and many medications utilized in gastroenterology have clinically significant drug interactions. This review will discuss the impact of alterations of intestinal pH, interactions mediated by phase I hepatic metabolism enzymes and P-glycoprotein, the impact of liver disease on drug metabolism, and interactions seen with commonly utilized gastrointestinal medications. PMID:22933873

  17. Everyday drug diversions: A qualitative study of the illicit exchange and non-medical use of prescription stimulants on a university campus

    PubMed Central

    Vrecko, Scott

    2015-01-01

    This article investigates everyday experiences and practises that are associated with processes of pharmaceuticalization and with practices of ‘drug diversion’—that is, the illicit exchange and non-medical use of prescription drugs. It reports results from a qualitative study that was designed to examine the everyday dimensions of non-medical prescription stimulant use among students on an American university campus, which involved 38 semi-structured interviews with individuals who used prescription stimulants as a means of improving academic performance. While discussions of drug diversion are often framed in terms of broad, population-level patterns and demographic trends, the present analysis provides a complementary sociocultural perspective that is attuned to the local and everyday phenomena. Results are reported in relation to the acquisition of supplies of medications intended for nonmedical use. An analysis is provided which identifies four different sources of diverted medications (friends; family members; black-market vendors; deceived clinicians), and describes particular sets of understandings, practices and experiences that arise in relation to each different source. Findings suggest that at the level of everyday experience and practice, the phenomenon of prescription stimulant diversion is characterised by a significant degree of complexity and heterogeneity. PMID:25455480

  18. Everyday drug diversions: a qualitative study of the illicit exchange and non-medical use of prescription stimulants on a university campus.

    PubMed

    Vrecko, Scott

    2015-04-01

    This article investigates everyday experiences and practises that are associated with processes of pharmaceuticalization and with practices of 'drug diversion'--that is, the illicit exchange and non-medical use of prescription drugs. It reports results from a qualitative study that was designed to examine the everyday dimensions of non-medical prescription stimulant use among students on an American university campus, which involved 38 semi-structured interviews with individuals who used prescription stimulants as a means of improving academic performance. While discussions of drug diversion are often framed in terms of broad, population-level patterns and demographic trends, the present analysis provides a complementary sociocultural perspective that is attuned to the local and everyday phenomena. Results are reported in relation to the acquisition of supplies of medications intended for nonmedical use. An analysis is provided which identifies four different sources of diverted medications (friends; family members; black-market vendors; deceived clinicians), and describes particular sets of understandings, practices and experiences that arise in relation to each different source. Findings suggest that at the level of everyday experience and practice, the phenomenon of prescription stimulant diversion is characterised by a significant degree of complexity and heterogeneity. PMID:25455480

  19. Psychological distress, drug use, sexual risks and medication adherence among young HIV-positive Black men who have sex with men: exposure to community violence matters.

    PubMed

    Quinn, Katherine; Voisin, Dexter R; Bouris, Alida; Schneider, John

    2016-07-01

    In the USA, Black males are disproportionately affected by community violence and HIV. The aim of this study was to assess whether exposures to community violence are related to psychological distress, drug use, sexual risk behaviors, and medication adherence among a sample of HIV-positive young Black men who had sex with men (YBMSM). Data are from 98 YBMSM ages 18-29 years recruited from Chicago who completed measures on demographics, exposures to community violence, psychological distress, drug use, condomless anal intercourse, and medication adherence. Rates of exposure to community violence were high and youth reported victimization and witnessing numerous types of violence in their lifetime. In adjusted logistic regression analyses, models indicate that YBMSM reporting higher levels of exposure to community violence had significantly higher rates of condomless anal intercourse in the previous 6 months (AOR: 5.33, 95%CI: 1.38-20.55). Additionally, exposure to community violence was positively associated with psychological distress, hard drug use, and use of marijuana as a sex drug. Adherence to HIV antiretroviral medication was negatively associated with community violence (AOR: 0.36, 95%CI: 0.13-0.97). Rates of exposure to community violence are especially high in urban communities. Overall findings suggest that treatment, intervention, and programmatic approaches that include initiatives to address exposure to community violence might correlate with better health-related outcomes for HIV-positive YBMSM. PMID:26917328

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

    PubMed

    Sinaiko, Jeff

    2002-01-01

    Contrary to conventional wisdom, which holds that compliance is often a net negative to a practice's financial performance, the fact is that compliance, operations, and the financial performance of a medical practice can all be simultaneously improved. This article will illustrate that the basic drivers of effective compliance are often the same fundamental business principles that lead to outstanding operations and enhanced financial performance. The lesson for medical practice managers is that if you improve compliance, you should actually improve your bottom line, not harm it. PMID:12534261

  1. Narcotic antagonists in drug dependence: pilot study showing enhancement of compliance with SYN-10, amino-acid precursors and enkephalinase inhibition therapy.

    PubMed

    Chen, Thomas J H; Blum, Kenneth; Payte, James T; Schoolfield, John; Hopper, David; Stanford, Mathew; Braverman, Eric R

    2004-01-01

    We decided to test the hypothesis that possibly by combining a narcotic antagonist and amino-acid therapy consisting of an enkephalinase inhibitor (D-phenylalanine) and neurotransmitter precursors (L-amino- acids) to promote neuronal dopamine release might enhance compliance in methadone patients rapidly detoxified with the narcotic antagonist Trexan (Dupont, Delaware). In this regard, Thanos et al. [J. Neurochem. 78 (2001) 1094] and associates found increases in the dopamine D2 receptors (DRD2) via adenoviral vector delivery of the DRD2 gene into the nucleus accumbens, significantly reduced both ethanol preference (43%) and alcohol intake (64%) of ethanol preferring rats, which recovered as the DRD2, returned to baseline levels. This DRD2 overexpression similarly produced significant reductions in ethanol non-preferring rats, in both alcohol preference (16%) and alcohol intake (75%). This work further suggests that high levels of DRD2 may be protective against alcohol abuse [JAMA 263 (1990) 2055; Arch, Gen. Psychiatr. 48 (1991) 648]. The DRD2 A1 allele has also been shown to associate with heroin addicts in a number of studies. In addition, other dopaminergic receptor gene polymorphisms have also associated with opioid dependence. For example, Kotler et al. [Mol. Phychiatr. 3 (1997) 251] showed that the 7 repeat allele of the DRD4 receptor is significantly overpresented in the opioid-dependent cohort and confers a relative risk of 2.46. This has been confirmed by Li et al. [Mol. Psychiatry 2 (1997) 413] for both the 5 and 7 repeat alleles in Han Chinese case control sample of heroin addicts. Similarly Duaux et al. [Mol. Psychiatry 3 (1998) 333] in French Heroin addicts, found a significant association with homozygotes alleles of the DRD3-Bal 1. A study from NIAAA, provided evidence which strongly suggests that DRD2 is a susceptibility gene for substance abusers across multiple populations (2003). Moreover, there are a number of studies utilizing amino-acid and

  2. Mental health and rape history in relation to non-medical use of prescription drugs in a national sample of women.

    PubMed

    McCauley, Jenna L; Amstadter, Ananda B; Danielson, Carla Kmett; Ruggiero, Kenneth J; Kilpatrick, Dean G; Resnick, Heidi S

    2009-08-01

    The current study examined prevalence and correlates of non-medical use of prescription drugs (NMUPD), with particular emphasis on lifetime history of rape and PTSD as risk associates. Interviews conducted via telephone using Computer-Assisted Telephone Interviewing technology, resulting in a nationally representative sample of 3001 non-institutionalized, civilian, English or Spanish speaking women (aged 18-86 years) residing in households with a telephone. Demographic characteristics, rape history, general health/mental health, and substance abuse variables were assessed. NMUPD was assessed by asking if, in the past year, participants had misused a prescription drug. Multivariable logistic regressions were conducted for each theoretically derived predictor set. Significant predictors from each set then entered into final multivariable logistic regression to determine significant predictors of past-year NMUPD. NMUPD was endorsed by 5.5% of the sample (n=164). Final multivariable model showed that Lifetime Posttraumatic Stress Disorder, other forms of substance use/abuse, and a history of drug or alcohol facilitated rape were significantly associated with increased likelihood of NMUPD. Risk reduction efforts targeting non-medical prescription drug use among women who have experienced traumatic events and/or abuse substances are warranted. Trauma-focused interventions for drug or alcohol facilitated rape victims should include treatment or prevention modules that specifically address NMUPD. PMID:19375238

  3. Medication/Drug Allergy

    MedlinePlus

    ... Profile Patient Rating 4.8 out of 5 stars Make an Appointment Christine B. Cho, MD + × Christine ... Profile Patient Rating 4.9 out of 5 stars Make an Appointment Lindsay K. Finkas, MD + × Lindsay ...

  4. e-Monitoring of Asthma Therapy to Improve Compliance in children using a real-time medication monitoring system (RTMM): the e-MATIC study protocol

    PubMed Central

    2013-01-01

    Background Many children with asthma do not have sufficient asthma control, which leads to increased healthcare costs and productivity loss of parents. One of the causative factors are adherence problems. Effective interventions improving medication adherence may therefore improve asthma control and reduce costs. A promising solution is sending real time text-messages via the mobile phone network, when a medicine is about to be forgotten. As the effect of real time text-messages in children with asthma is unknown, the primary aim of this study is to determine the effect of a Real Time Medication Monitoring system (RTMM) with text-messages on adherence to inhaled corticosteroids (ICS). The secondary objective is to study the effects of RTMM on asthma control, quality of life and cost-effectiveness of treatment. Methods A multicenter, randomized controlled trial involving 220 children (4–11 years) using ICS for asthma. All children receive an RTMM-device for one year, which registers time and date of ICS doses. Children in the intervention group also receive tailored text-messages, sent only when a dose is at risk of omission. Primary outcome measure is the proportion of ICS dosages taken within the individually predefined time-interval. Secondary outcome measures include asthma control (monthly Asthma Control Tests), asthma exacerbations, healthcare use (collected from hospital records, patient reports and pharmacy record data), and disease-specific quality of life (PAQLQ questionnaire). Parental and children’s acceptance of RTMM is evaluated with online focus groups and patient questionnaires. An economic evaluation is performed adopting a societal perspective, including relevant healthcare costs and parental productivity loss. Furthermore, a decision-analytic model is developed in which different levels of adherence are associated with clinical and financial outcomes. Also, sensitivity analyses are carried out on different price levels for RTMM. Discussion

  5. Factors Associated with Leaving Hospital against Medical Advice among People Who Use Illicit Drugs in Vancouver, Canada

    PubMed Central

    Ti, Lianping; Milloy, M-J; Buxton, Jane; McNeil, Ryan; Dobrer, Sabina; Hayashi, Kanna; Wood, Evan; Kerr, Thomas

    2015-01-01

    Background Leaving hospital against medical advice (AMA) is common among people who use illicit drugs (PWUD) and is associated with severe health-related harms and costs. However, little is known about the prevalence of and factors associated with leaving AMA among PWUD. Methods Data were collected through two Canadian prospective cohort studies involving PWUD between September 2005 and July 2011 and linked to a hospital admission/discharge database. Bivariable and multivariable generalized estimating equations were used to examine factors associated with leaving hospital AMA among PWUD who were hospitalized. Results Among 488 participants who experienced at least one hospitalization, 212 (43.4%) left the hospital AMA at least once during the study period. In multivariable analyses, factors positively and significantly associated with leaving hospital AMA included: unstable employment (AOR = 1.92; 95% confidence interval [CI]: 1.22–3.03); recent incarceration (AOR = 1.63; 95%CI: 1.07–2.49); ≥ daily heroin injection (AOR = 1.49; 95%CI: 1.05–2.11); and younger age per year younger (adjusted odds ratio [AOR] = 1.04; 95%CI: 1.02–1.06). Conclusions We found a substantial proportion of PWUD in this setting left hospital AMA and that various markers of risk and vulnerability were associated with this phenomenon. Our findings highlight the need to address substance abuse issues early following hospital admission. These findings further suggest a need to develop novel interventions to minimize PWUD leaving hospital prematurely. PMID:26509447

  6. Enrollment and Monitoring of Women in Post-Approval Studies for Medical Devices Mandated by the Food and Drug Administration

    PubMed Central

    Herz, Naomi; Loyo-Berrios, Nilsa; Tarver, Michelle

    2014-01-01

    Abstract Background: Disease presentation, prevalence, and treatment effects vary by sex, thus it is important to ensure adequate participation of both sexes in medical device post-approval studies (PAS). Methods: The goals of this study were to determine the participation rate of women in PAS mandated by the Food and Drug Administration (FDA) and if participation varied by clinical area. The study also evaluated the frequency in which enrollment by sex is reported by applicant reports and FDA reviews, as well as the frequency in which final study reports analyze whether outcomes differ by sex. Results: Of 89 studies with enrollment completed, data on sex of participants were available in 93% of submitted reports, while data on enrollment by sex was evaluated and noted in 43% of FDA review memos. Study participation varied by clinical area, with female participation ranging from 32% in cardiovascular PAS to 90% in PAS for reconstructive devices. Of 53 completed studies, data on enrollment by sex was provided in 49 of the final reports. Of these 14% included a multivariate analysis that included sex as a covariate and 4% included a subgroup analysis for female participants. Conclusions: Data on sex was not routinely assessed in FDA reviews. Based on these findings, FDA implemented new procedures to ensure participation by sex is evaluated in PAS reviews. FDA will continue working with applicants to develop PAS that enroll and retain proportions of women consistent with the sex-specific prevalence for the disease or condition the device is used to treat. PMID:24405314

  7. Decreasing the load? Is a Multidisciplinary Multistep Medication Review in older people an effective intervention to reduce a patient's Drug Burden Index? Protocol of a randomised controlled trial

    PubMed Central

    van der Meer, Helene G; Wouters, Hans; van Hulten, Rolf; Pras, Niesko; Taxis, Katja

    2015-01-01

    Introduction Older people often use medications with anticholinergic or sedative side effects which increase the risk of falling and worsen cognitive impairment. The Drug Burden Index (DBI) is a measure of the burden of anticholinergic and sedative medications. Medication reviews are typically done by a pharmacist in collaboration with a general practitioner to optimise the medication use and reduce these adverse drug events. We will evaluate whether a Multidisciplinary Multistep Medication Review (3MR) is an effective intervention to reduce a patient's DBI. Methods A randomised controlled trial including 160 patients from 15 community pharmacies will be conducted. Per pharmacy, 1 pharmacist will perform a structured 3MR in close collaboration with the general practitioner, including the objective to reduce the DBI. Analysis Primary outcome—the difference in proportion of patients having a decrease in DBI≥0.5 in the intervention and control groups at follow-up. Secondary outcomes—anticholinergic and sedative side effects, falls, cognitive function, activities of daily living, quality of life, hospital admission, and mortality. Ethics and dissemination The burden of patients will be kept at a minimum. The 3MR can be considered as usual care by the pharmacist and general practitioner. Medical specialists will be consulted, if necessary. The intervention is specifically aimed at older community-dwelling patients in an attempt to optimise prescribing, in particular, to reduce medication with anticholinergic and sedative properties. Study results will be published in peer-reviewed journals and will be distributed through information channels targeting professionals. Trial registration number NCT02317666; Pre-results. PMID:26700279

  8. Drug Plan Coverage Rules

    MedlinePlus

    ... works with other insurance Find health & drug plans Drug plan coverage rules Note Call your Medicare drug ... shingles vaccine) when medically necessary to prevent illness. Drugs you get in hospital outpatient settings In most ...

  9. The Accuracy of Self-Reported Drug Ingestion Histories In Emergency Department Patients

    PubMed Central

    Monte, Andrew A.; Heard, Kennon J.; Hoppe, Jason A.; Vasiliou, Vasilis; Gonzalez, Frank J.

    2014-01-01

    Inaccuracies in self-reports may lead to duplication of therapy, failure to appreciate non-compliance leading to exacerbation of chronic medical conditions, or inaccurate research conclusions. Our objective is to determine the accuracy of self-reported drug ingestion histories in patients presenting to an urban academic emergency department (ED). We conducted a prospective cohort study in ED patients presenting for pain or nausea. We obtained a structured drug ingestion history including all prescription drugs, OTC drugs, and illicit drugs for the 48 hours prior to ED presentation. We obtained urine comprehensive drug screens (CDS) and determined self-report/CDS concordance. Fifty-five patients were enrolled. Self-reported drug ingestion histories were poor in these patients; only 17 (30.9%) of histories were concordant with the CDS. For the individual drug classes, prescription drug-CDS was concordant in 32 (58.2%), OTC-CDS was concordant in 33 (60%), and illicit drug-CDS was concordant in 45 (81.8%) of subjects. No demographic factors predicted an accurate self-reported drug history. Sixteen patients had drugs detected by CDS that were unreported by history. Nine of these 16 included an unreported opioid. In conclusion, self-reported drug ingestion histories are often inaccurate and resources are needed to confirm compliance and ensure unreported drugs are not overlooked. PMID:25052325

  10. How do terminally ill patients at home take their medication?

    PubMed

    Zeppetella, G

    1999-11-01

    Compliance with prescribed medication was assessed in 111 terminally ill patients referred to a community palliative care team using semistructured interviews and pill counting. One-hundred-and-six patients were prescribed a total of 597 drugs; of these patients, 64 (60%) were noncompliant. Thirty-five patients (33%) took less medication than prescribed, usually due to experiencing, or anxieties about, adverse events; the commonest drugs involved were analgesics. Seventeen patients (16%) took additional medication, usually purchased over the counter in response to inadequate symptom control or to adverse events from other drugs; the most common preparations were vitamins and analgesics. Twelve patients (11%) both took less medication than prescribed and also purchased medication over the counter. Most patients (90%) had two or more prescribers; patients who saw their general practitioners as their main prescriber were more likely to adhere to their prescribed medication. Patients who omitted and/or reduced their medication were more likely to see the hospital as their main prescriber. Drugs prescribed four times daily were most likely to be omitted and/or reduced. PMID:10715753

  11. Methods and pitfalls in searching drug safety databases utilising the Medical Dictionary for Regulatory Activities (MedDRA).

    PubMed

    Brown, Elliot G

    2003-01-01

    The Medical Dictionary for Regulatory Activities (MedDRA) is a unified standard terminology for recording and reporting adverse drug event data. Its introduction is widely seen as a significant improvement on the previous situation, where a multitude of terminologies of widely varying scope and quality were in use. However, there are some complexities that may cause difficulties, and these will form the focus for this paper. Two methods of searching MedDRA-coded databases are described: searching based on term selection from all of MedDRA and searching based on terms in the safety database. There are several potential traps for the unwary in safety searches. There may be multiple locations of relevant terms within a system organ class (SOC) and lack of recognition of appropriate group terms; the user may think that group terms are more inclusive than is the case. MedDRA may distribute terms relevant to one medical condition across several primary SOCs. If the database supports the MedDRA model, it is possible to perform multiaxial searching: while this may help find terms that might have been missed, it is still necessary to consider the entire contents of the SOCs to find all relevant terms and there are many instances of incomplete secondary linkages. It is important to adjust for multiaxiality if data are presented using primary and secondary locations. Other sources for errors in searching are non-intuitive placement and the selection of terms as preferred terms (PTs) that may not be widely recognised. Some MedDRA rules could also result in errors in data retrieval if the individual is unaware of these: in particular, the lack of multiaxial linkages for the Investigations SOC, Social circumstances SOC and Surgical and medical procedures SOC and the requirement that a PT may only be present under one High Level Term (HLT) and one High Level Group Term (HLGT) within any single SOC. Special Search Categories (collections of PTs assembled from various SOCs by

  12. A Self-microemulsifying Drug Delivery System (SMEDDS) for a Novel Medicative Compound Against Depression: a Preparation and Bioavailability Study in Rats.

    PubMed

    Wu, Lan; Qiao, Yanli; Wang, Lina; Guo, Jiahua; Wang, Guocheng; He, Wei; Yin, Lifang; Zhao, Jinhua

    2015-10-01

    AJS is the code name of an untitled novel medicative compound synthesized by the Tasly Holding Group Company (Tianjin, China) based on the structure of cinnamamide, which is one of the Biopharmaceutics Classification System (BCS) class II drugs. The drug has better antidepressant effect, achieved by acting on the 5-hydroxytryptamine receptor. However, the therapeutic effects of the drug are compromised due to its poor water solubility and lower bioavailability. Herein, a self-microemulsifying drug delivery system (SMEDDS) was developed to improve its solubility and oral bioavailability. AJS-SMEDDS formulation was optimized in terms of drug solubility in the excipients, droplet size, stability, and drug precipitation using a pseudo-ternary diagram. The pharmacokinetic study was performed in rats, and the drug concentration in plasma samples was assayed using the high-performance liquid chromatography-electrospray tandem mass spectrometry (HPLC-MS/MS) method. The optimized formulation for SMEDDS has a composition of castor oil 24.5%, Labrasol 28.6%, Cremphor EL 40.8%, and Transcutol HP 2.7% (co-surfactant). No drug precipitation or phase separation was observed from the optimized formulation after 3 months of storing at 25°C. The droplet size of microemulsion formed by the optimized formulation was 26.08 ± 1.68 nm, and the zeta potential was -2.76 mV. The oral bioavailability of AJS-SMEDDS was increased by 3.4- and 35.9-fold, respectively, compared with the solid dispersion and cyclodextrin inclusion; meanwhile, the C max of AJS-SMEDDS was about 2- and 40-fold as great as the two controls, respectively. In summary, the present SMEDDS enhanced oral bioavailability of AJS and was a promising strategy to orally deliver the drug. PMID:25652729

  13. A study on socio-medical variables of drug-dependent persons volunteering for treatment in Penang, Malaysia.

    PubMed

    Navaratnam, V; Spencer, C P

    1978-01-01

    There has been a rapid increase in the past five years in the numbers of hospitalized drug dependents. While the studied population was clearly unrepresentative of the country-wide drug using population, it illustrates how the problem is neither limited to one particular stratum of society, nor to the few "traditional" drugs. Indeed, an increasingly youthful group of individuals drawn from all backgrounds is not only becoming dependent upon opiates, but is also using a range of other drugs, all of which are available on the market at relatively low cost. The market prices of drugs have an effect on the pattern of drug use; and many individuals move directly from tobacco to heroin smoking. Drug abuse continues to be a considerable public and governmental concern, and enforcement and treatment programmes are rapidly expanding in attempts to resolve this problem. PMID:352461

  14. Medical leasing.

    PubMed

    Holden, Elizabeth A

    2012-01-01

    Leases for medical space can have far-reaching (and sometimes unintentional) consequences for the future of the practice and the costs of the business. In order to prevent hardship and expense down the line, it is especially important to review the lease to make sure that it reflects the practice's goals, needs, and structure. This article provides a number of provisions that are especially crucial to review and negotiate when leasing medical space, including use restrictions, assignment and subleasing clauses, build-out terms, and legal compliance requirements. PMID:22594070

  15. Medication-Assisted Treatment in Criminal Justice Agencies Affiliated with the Criminal Justice-Drug Abuse Treatment Studies (CJ-DATS): Availability, Barriers & Intentions

    PubMed Central

    Friedmann, Peter D.; Hoskinson, Randall; Gordon, Michael; Schwartz, Robert; Kinlock, Timothy; Knight, Kevin; Flynn, Patrick M.; Welsh, Wayne N.; Stein, Lynda A. R.; Sacks, Stanley; O’Connell, Daniel J.; Knudsen, Hannah K.; Shafer, Michael S.; Hall, Elizabeth; Frisman, Linda K.

    2012-01-01

    Medication-assisted treatment (MAT) is underutilized in the treatment of drug-dependent, criminal justice populations. This study surveyed criminal justice agencies affiliated with the Criminal Justice Drug Abuse Treatment Studies (CJ-DATS) to assess use of MAT and factors influencing use of MAT. A convenience sample (N=50) of criminal justice agency respondents (e.g., jails, prisons, parole/probation, and drug courts) completed a survey on MAT practices and attitudes. Pregnant women and individuals experiencing withdrawal were most likely to receive MAT for opiate dependence in jail or prison, while those re-entering the community from jail or prison were the least likely to receive MAT. Factors influencing use of MAT included criminal justice preferences for drug-free treatment, limited knowledge of the benefits of MAT, security concerns, regulations prohibiting use of MAT for certain agencies, and lack of qualified medical staff. Differences across agency type in the factors influencing use and perceptions of MAT were also examined. MAT use is largely limited to detoxification and maintenance of pregnant women in criminal justice settings. Use of MAT during the community reentry period is minimal. Addressing inadequate knowledge and negative attitudes about MAT may increase its adoption, but better linkages to community pharmacotherapy during the reentry period might overcome other issues, including security, liability, staffing and regulatory concerns. The CJ-DATS collaborative MAT implementation study to address inadequate knowledge, attitudes and linkage will be described. PMID:22263709

  16. Antidiabetic medications and polypharmacy.

    PubMed

    Peron, Emily P; Ogbonna, Kelechi C; Donohoe, Krista L

    2015-02-01

    Polypharmacy, or the use of multiple medications, is a serious concern for providers who care for older adults, as polypharmacy is associated with medication nonadherence, drug-drug interactions, drug-disease interactions, and adverse drug events. Multiple medications, high chronic disease burden, and age-related physiologic changes make management of older adults with diabetes increasingly difficult. Given high medication burden and potential for increased medication sensitivity in this patient population, it is prudent that providers are aware of potential risks and benefits of antidiabetic medications and implement shared decision-making practices to ensure appropriate care for older adults with diabetes. PMID:25453298

  17. PECTIN IN CONTROLLED DRUG DELIVERY

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Controlled drug delivery remains a research focus for public health to enhance patient compliance, drug efficiency and to reduce the side effects of drugs. Pectin, an edible plant polysaccharide, has shown potential for the construction of drug delivery systems for site-specific drug delivery. Sev...

  18. Partial compliance in schizophrenia and the impact on patient outcomes.

    PubMed

    Llorca, Pierre-Michel

    2008-11-30

    This review evaluates the impact of partial compliance on treatment outcomes in schizophrenia and discusses strategies that may be implemented to enhance compliance. As such, a search of English language articles evaluating compliance in schizophrenia was performed using Medline and EMBASE, with no time limits. Abstracts and posters presented at key psychiatry congresses were also reviewed. Results demonstrated that partial compliance with antipsychotic medication is a significant barrier to achieving optimal outcomes in schizophrenia. The problem increases with the duration of treatment, and is difficult to monitor. The impact of partial compliance is significant, leading to increases in psychotic symptoms, the risk of relapse and rehospitalization, and even suicide. Compliance is a complex phenomenon, influenced by aspects of the illness itself such as cognitive impairment and patients' health beliefs. The patient's environment and therapeutic alliance also influence medication compliance. Behavioural and pharmacological measures should be used together to improve compliance. While atypical antipsychotics have demonstrated improvements in psychotic symptoms, insight and cognition, these may not be enough to ensure compliance with oral daily medication. Long-acting risperidone may therefore bring together the benefits of the atypical antipsychotics with the long-acting injection delivery system required to build a platform for improved outcomes. PMID:18849080

  19. Physicians’ influence on breast cancer patient compliance

    PubMed Central

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

    2014-01-01

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

  20. Demonstrating environmental compliance

    SciTech Connect

    Pankratz, R.H.

    1995-12-31

    Almost every company, plant, or government entity wants to be in compliance with environmental statutes, regulations, and permit provisions. Today wanting is not enough. At the Pantex Plant, we have taken the approach, that unless we can demonstrate compliance, we are not necessarily in compliance. This paper is intended to illustrate how the Pantex Plant has designed its various programs to demonstrate compliance with environmental statutes, regulations, and permit provisions. A major emphasis is to have permit provisions that are objective and measurable so as to aid in demonstrating compliance. In conjunction with unambiguous permit provisions, appropriate management systems are required to provide the necessary records for this documentation.