Unregulated usage of labour-inducing medication in a region of Pakistan with poor drug regulatory control: characteristics and risk patterns.

Science.gov (United States)

Shah, Safieh; Van den Bergh, Rafael; Prinsloo, Jeanne Rene; Rehman, Gulalai; Bibi, Amna; Shaeen, Neelam; Auat, Rosa; Daudi, Sabina Mutindi; Njenga, Joyce Wanjiru; Khilji, Tahir Bashir-Ud-Din; Maïkéré, Jacob; De Plecker, Eva; Caluwaerts, Séverine; Zachariah, Rony; Van Overloop, Catherine

2016-03-01

In developing countries such as Pakistan, poor training of mid-level cadres of health providers, combined with unregulated availability of labour-inducing medication can carry considerable risk for mother and child during labour. Here, we describe the exposure to labour-inducing medication and its possible risks in a vulnerable population in a conflict-affected region of Pakistan. A retrospective cohort study using programme data, compared the outcomes of obstetric risk groups of women treated with unregulated oxytocin, with those of women with regulated treatment. Of the 6379 women included in the study, 607 (9.5%) received labour-inducing medication prior to reaching the hospital; of these, 528 (87.0%) received unregulated medication. Out of 528 labour-inducing medication administrators, 197 (37.3%) traditional birth attendants (also known as dai) and 157 (29.7%) lady health workers provided unregulated treatment most frequently. Women given unregulated medication who were diagnosed with obstructed/prolonged labour were at risk for uterine rupture (RR 4.1, 95% CI: 1.7-9.9) and severe birth asphyxia (RR 3.9, 95% CI: 2.5-6.1), and those with antepartum haemorrhage were at risk for stillbirth (RR 1.8, 95% CI: 1.0-3.1). In a conflict-affected region of Pakistan, exposure to unregulated treatment with labour-inducing medication is common, and carries great risk for mother and child. Tighter regulatory control of labour-inducing drugs is needed, and enhanced training of the mid-level cadres of healthcare workers is required. © The Author 2015. Published by Oxford University Press on behalf of Royal Society of Tropical Medicine and Hygiene.

Drug-induced liver injury associated with HIV medications.

Science.gov (United States)

Jain, Mamta K

2007-08-01

Antiretroviral therapy (ART) for HIV infection frequently has been associated with elevated liver enzyme levels. Determining the cause of elevated liver enzyme levels in patients who have HIV is difficult because ART usually consists of three different drugs, patients may be taking additional hepatotoxic medications and patients who have HIV often suffer from other liver diseases. Several agents, however, are recognized as having noteworthy and specific patterns of toxicity. This article reviews the different HIV drug classes, incidence of elevated liver enzyme values by class and by individual drug, risk factors, specific toxicities, and possible mechanisms of injury.

Risk for borderline ovarian tumours after exposure to fertility drugs

DEFF Research Database (Denmark)

Bjørnholt, Sarah Marie; Kjaer, Susanne Krüger; Nielsen, Thor Schütt Svane

2015-01-01

numbers. To obtain information on use of fertility drugs, hospital files and medical records of infertility-associated visits to all Danish fertility clinics were collected and supplemented with information from the Danish IVF register. We used case-cohort techniques to calculate rate ratios (RRs......STUDY QUESTION: Do fertility drugs increase the risk for borderline ovarian tumours, overall and according to histological subtype? SUMMARY ANSWER: The use of any fertility drug did not increase the overall risk for borderline ovarian tumours, but an increased risk for serous borderline ovarian...... tumours was observed after the use of progesterone. WHAT IS KNOWN ALREADY: Many epidemiological studies have addressed the connection between fertility drugs use and risk for ovarian cancer; most have found no strong association. Fewer studies have assessed the association between use of fertility drugs...

Perception of the risk of adverse reactions to analgesics: differences between medical students and residents

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Sandra Castillo-Guzman

2016-07-01

Full Text Available Background. Medications are not exempt from adverse drug reactions (ADR and how the physician perceives the risk of prescription drugs could influence their availability to report ADR and their prescription behavior. Methods. We assess the perception of risk and the perception of ADR associated with COX2-Inbitors, paracetamol, NSAIDs, and morphine in medical students and residents of northeast of Mexico. Results. The analgesic with the highest risk perception in both group of students was morphine, while the drug with the least risk perceived was paracetamol. Addiction and gastrointestinal bleeding were the ADR with the highest score for morphine and NSAIDs respectively. Discussion. Our findings show that medical students give higher risk scores than residents toward risk due to analgesics. Continuing training and informing physicians about ADRs is necessary since the lack of training is known to induce inadequate use of drugs.

Medication knowledge, certainty, and risk of errors in health care: a cross-sectional study

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Johansson Inger

2011-07-01

Full Text Available Abstract Background Medication errors are often involved in reported adverse events. Drug therapy, prescribed by physicians, is mostly carried out by nurses, who are expected to master all aspects of medication. Research has revealed the need for improved knowledge in drug dose calculation, and medication knowledge as a whole is poorly investigated. The purpose of this survey was to study registered nurses' medication knowledge, certainty and estimated risk of errors, and to explore factors associated with good results. Methods Nurses from hospitals and primary health care establishments were invited to carry out a multiple-choice test in pharmacology, drug management and drug dose calculations (score range 0-14. Self-estimated certainty in each answer was recorded, graded from 0 = very uncertain to 3 = very certain. Background characteristics and sense of coping were recorded. Risk of error was estimated by combining knowledge and certainty scores. The results are presented as mean (±SD. Results Two-hundred and three registered nurses participated (including 16 males, aged 42.0 (9.3 years with a working experience of 12.4 (9.2 years. Knowledge scores in pharmacology, drug management and drug dose calculations were 10.3 (1.6, 7.5 (1.6, and 11.2 (2.0, respectively, and certainty scores were 1.8 (0.4, 1.9 (0.5, and 2.0 (0.6, respectively. Fifteen percent of the total answers showed a high risk of error, with 25% in drug management. Independent factors associated with high medication knowledge were working in hospitals (p Conclusions Medication knowledge was found to be unsatisfactory among practicing nurses, with a significant risk for medication errors. The study revealed a need to improve the nurses' basic knowledge, especially when referring to drug management.

Relationship of Prescribed Drugs with the Risk of Fall in Inpatients.

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Kozono, Aki; Isami, Keisuke; Shiota, Kimiko; Tsumagari, Kyouichi; Nagano, Masahisa; Inoue, Daisuke; Adachi, Rui; Hiraki, Yoichi; Nakagawa, Yoshihiro; Kamimura, Hidetoshi; Yamamichi, Ken

2016-01-01

Falls are common in elderly patients and are often serious. Several drugs have been associated with an increased risk of fall. Older adults often take multiple drugs for chronic diseases, and thus may be at increased risk from drugs associated with fall. We investigated the association between drug use and falling in hospitalized older people, with the goal of identifying medications that may increase the risk of a fall. A retrospective case control study was performed at the National Hospital Organization Kumamoto Saishunso Hospital in Japan. Medications taken by patients who fell (n=57) were compared with those taken by patients who did not fall (n=63). The median age (interquartile range; IQR) of the fall and non-fall groups were 75.0 (67.0-83.0) and 80.0 (70.3-84.5) years, respectively. The characteristics of the two groups were similar, with no significant differences in age, sex, or body weight. The probability of falling increased when the patients used zolpidem [odds ratio (OR)=2.47; 95%CI: 1.09-5.63; pfall due to sleepiness, and blood pressure control may be important to prevent orthostatic high blood pressure. In the treatment of elderly people, medical staff should try to choose drugs that prevent fall or are not associated with falling.

Type, number or both? A population-based matched case-control study on the risk of fall injuries among older people and number of medications beyond fall-inducing drugs.

Directory of Open Access Journals (Sweden)

Lucie Laflamme

Full Text Available Drug use is a modifiable risk factor for fall-related injuries in older people. Whereas the injurious effect of polypharmacy is established, that of low numbers of medications has not been fully ascertained. Neither do we know whether it is the number per se or the type of medications that actually matters. We assessed this question for fall injuries leading to hospitalization.National register-based, population-based, matched case-control study.Community dwellers aged 65+ years living in Sweden between March 2006 and December 2009.Cases (n = 64,399 were identified in the national inpatient register and four controls per case were randomly matched by gender, date of birth and residential area. The association between number of prescribed medications, assessed through linkage with the Swedish prescribed drug register, and the risk of injurious falls was estimated with odds ratios with 95% confidence intervals using conditional logistic regression, adjusted for demographic and health status.The number of medications was associated with an increased risk of fall injury in a dose-response fashion, even after adjustment for marital status, comorbidity and number of fall-risk-inducing drugs (FRIDs. Using ten or more medications was associated with an almost two-fold higher risk (adjusted OR: 1.76, 95% CI: 1.66 to 1.88. When stratified by use (or not of at least one FRID, the association weakened slightly among both non-users (adjusted OR: 1.50, 95% CI: 1.34 to 1.67 and users (adjusted OR: 1.67, 95% CI: 1.58 to 1.77.In older people, not only large but also small numbers of medications may affect the risk for them to sustain injurious falls. Although the mechanisms lying behind this are complex, the finding challenges the prevention strategies targeting either specific types of medications (FRIDs or high numbers of them.

Type, number or both? A population-based matched case-control study on the risk of fall injuries among older people and number of medications beyond fall-inducing drugs.

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Laflamme, Lucie; Monárrez-Espino, Joel; Johnell, Kristina; Elling, Berty; Möller, Jette

2015-01-01

Drug use is a modifiable risk factor for fall-related injuries in older people. Whereas the injurious effect of polypharmacy is established, that of low numbers of medications has not been fully ascertained. Neither do we know whether it is the number per se or the type of medications that actually matters. We assessed this question for fall injuries leading to hospitalization. National register-based, population-based, matched case-control study. Community dwellers aged 65+ years living in Sweden between March 2006 and December 2009. Cases (n = 64,399) were identified in the national inpatient register and four controls per case were randomly matched by gender, date of birth and residential area. The association between number of prescribed medications, assessed through linkage with the Swedish prescribed drug register, and the risk of injurious falls was estimated with odds ratios with 95% confidence intervals using conditional logistic regression, adjusted for demographic and health status. The number of medications was associated with an increased risk of fall injury in a dose-response fashion, even after adjustment for marital status, comorbidity and number of fall-risk-inducing drugs (FRIDs). Using ten or more medications was associated with an almost two-fold higher risk (adjusted OR: 1.76, 95% CI: 1.66 to 1.88). When stratified by use (or not) of at least one FRID, the association weakened slightly among both non-users (adjusted OR: 1.50, 95% CI: 1.34 to 1.67) and users (adjusted OR: 1.67, 95% CI: 1.58 to 1.77). In older people, not only large but also small numbers of medications may affect the risk for them to sustain injurious falls. Although the mechanisms lying behind this are complex, the finding challenges the prevention strategies targeting either specific types of medications (FRIDs) or high numbers of them.

Anesthetic drugs in status epilepticus: Risk or rescue?

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Marsch, Stephan; Fuhr, Peter; Kaplan, Peter W.; Rüegg, Stephan

2014-01-01

Objective: To evaluate the risks of continuously administered IV anesthetic drugs (IVADs) on the outcome of adult patients with status epilepticus (SE). Methods: All intensive care unit patients with SE from 2005 to 2011 at a tertiary academic medical care center were included. Relative risks were calculated for the primary outcome measures of seizure control, Glasgow Outcome Scale score at discharge, and death. Poisson regression models were used to control for possible confounders and to assess effect modification. Results: Of 171 patients, 37% were treated with IVADs. Mortality was 18%. Patients with anesthetic drugs had more infections during SE (43% vs 11%; p < 0.0001) and a 2.9-fold relative risk for death (2.88; 95% confidence interval 1.45–5.73), independent of possible confounders (i.e., duration and severity of SE, nonanesthetic third-line antiepileptic drugs, and critical medical conditions) and without significant effect modification by different grades of SE severity and etiologies. As IVADs were used after first- and second-line drugs failed, there was a correlation between treatment-refractory SE and the use of IVADs, leading to insignificant results regarding the risk of IVADs and outcome after additional adjustment for refractory SE. Conclusion: Our findings heighten awareness regarding adverse effects of IVADs. Randomized controlled trials are needed to further clarify the association of IVADs with outcome in patients with SE. Classification of evidence: This study provides Class III evidence that patients with SE receiving IVADs have a higher proportion of infection and an increased risk of death as compared to patients not receiving IVADs. PMID:24319039

Self-reported medical, medication and laboratory error in eight countries: risk factors for chronically ill adults.

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Scobie, Andrea

2011-04-01

To identify risk factors associated with self-reported medical, medication and laboratory error in eight countries. The Commonwealth Fund's 2008 International Health Policy Survey of chronically ill patients in eight countries. None. A multi-country telephone survey was conducted between 3 March and 30 May 2008 with patients in Australia, Canada, France, Germany, the Netherlands, New Zealand, the UK and the USA who self-reported being chronically ill. A bivariate analysis was performed to determine significant explanatory variables of medical, medication and laboratory error (P error: age 65 and under, education level of some college or less, presence of two or more chronic conditions, high prescription drug use (four+ drugs), four or more doctors seen within 2 years, a care coordination problem, poor doctor-patient communication and use of an emergency department. Risk factors with the greatest ability to predict experiencing an error encompassed issues with coordination of care and provider knowledge of a patient's medical history. The identification of these risk factors could help policymakers and organizations to proactively reduce the likelihood of error through greater examination of system- and organization-level practices.

Potentially inappropriate medication: Association between the use of antidepressant drugs and the subsequent risk for dementia.

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Heser, Kathrin; Luck, Tobias; Röhr, Susanne; Wiese, Birgitt; Kaduszkiewicz, Hanna; Oey, Anke; Bickel, Horst; Mösch, Edelgard; Weyerer, Siegfried; Werle, Jochen; Brettschneider, Christian; König, Hans-Helmut; Fuchs, Angela; Pentzek, Michael; van den Bussche, Hendrik; Scherer, Martin; Maier, Wolfgang; Riedel-Heller, Steffi G; Wagner, Michael

2018-01-15

Potentially inappropriate medication (PIM) is associated with an increased risk for detrimental health outcomes in elderly patients. Some antidepressant drugs are considered as PIM, but previous research on the association between antidepressants and subsequent dementia has been inconclusive. Therefore, we investigated whether the intake of antidepressants, particularly of those considered as PIM according to the Priscus list, would predict incident dementia. We used data of a prospective cohort study of non-demented primary care patients (n = 3239, mean age = 79.62) to compute Cox proportional hazards models. The risk for subsequent dementia was estimated over eight follow-ups up to 12 years depending on antidepressant intake and covariates. The intake of antidepressants was associated with an increased risk for subsequent dementia (HR = 1.53, 95% CI: 1.16-2.02, p = .003; age-, sex-, education-adjusted). PIM antidepressants (HR = 1.49, 95% CI: 1.06-2.10, p = .021), but not other antidepressants (HR = 1.04, 95% CI: 0.66-1.66, p = .863), were associated with an increased risk for subsequent dementia (in age-, sex-, education-, and depressive symptoms adjusted models). Significant associations disappeared after global cognition at baseline was controlled for. Methodological limitations such as selection biases and self-reported drug assessments might have influenced the results. Only antidepressants considered as PIM were associated with an increased subsequent dementia risk. Anticholinergic effects might explain this relationship. The association disappeared after the statistical control for global cognition at baseline. Nonetheless, physicians should avoid the prescription of PIM antidepressants in elderly patients whenever possible. Copyright © 2017 Elsevier B.V. All rights reserved.

Risk evaluation and mitigation strategies for drugs with abuse liability: public interest, special interest, conflicts of interest, and the industry perspective.

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Wright, Curtis; Schnoll, Sidney; Bernstein, David

2008-10-01

Risk evaluation and mitigation strategies (REMS) formerly known as Risk Minimization Action Plans (RiskMAPs) are a regulatory technique for dealing with anticipated risks of new medications and are especially important for new drugs with abuse potential. This paper describes the origin and history of risk-management plans for drugs that might be abused, the proper use of these plans in minimizing the risk to the public, and the special difficulties inherent in managing risks for drugs with abuse potential. Drugs with abuse liability are distinctive since the risks inherent in manufacture and distribution include not only risks to patients prescribed the medications, but also risks to the general public including subgroups in the population not intended to get the drug and who receive no medical benefit from the medication. The crafting of risk-management plans intended to protect nonpatient populations is unique for these products. The content, extent, and level of intensity of these plans affect areas of medical ethics, civil liability, and criminal prosecution. The need for risk-management plans for drugs with abuse liability can potentially act as a deterrent to investment and is a factor in decisions concerning the development of new medications for the treatments of pain, ADHD, anxiety disorders, and addictions. This paper provides a framework for moving the process of REMS development forward and criteria for evaluating the probity and adequacy of such programs.

Non-medical use of psychoactive prescription drugs is associated with fatal poisoning.

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Haukka, Jari; Kriikku, Pirkko; Mariottini, Claudia; Partonen, Timo; Ojanperä, Ilkka

2018-03-01

The aims of this study were to estimate the prevalence and predictors of non-medical substance use, and to assess the association between non-medical substance use and fatal poisoning or history of drug abuse in Finland. Retrospective cohort study of all medico-legally investigated death cases in Finland. The postmortem toxicology database was linked together with the register on reimbursed prescription medicines. All postmortem cases between 2011 and 2013 positive for one or more of the following drugs: oxycodone, fentanyl, tramadol, clonazepam, gabapentin, pregabalin, tizanidine, olanzapine, quetiapine, risperidone, alprazolam, zolpidem, mirtazapine and bupropion, n = 2974. Non-medical use of substance was the outcome variable. Predictors were the following: gender, residence at the time of death, place of death, blood alcohol concentration, age, drug abuse, number of prescriptions of any psychoactive drugs in last year and proportion of prescriptions issued by psychiatrist in last year. In 50.4% of the studied cases, at least one drug was detected without a prescription. Clonazepam, alprazolam and tramadol were the most prevalent non-medical findings in these cases (6.6, 6.1 and 5.6%, respectively). The risk of non-medical use of prescription drugs was especially high in cases with history of drug abuse (88.5%) and in fatal poisonings (71.0%). The proportion of non-medical use of the studied substances varied between 5.9% [95% confidence interval (CI) = 3.1-10.1%)] for risperidone and 55.7% for fentanyl (95% CI = 44.1-66.9%). Valid prescription for one or more of any psychoactive drug was associated with lower odds for non-medical use of the studied substances. Additionally, the higher the proportion of psychoactive drugs prescribed by a psychiatrist, the lower the probability of non-medical use. Non-prescribed psychoactive drugs are found commonly at postmortem in drug poisoning deaths in Finland, with history of drug abuse being a major contributing

Potential drug-drug interactions on in-patient medication ...

African Journals Online (AJOL)

Potential drug-drug interactions on in-patient medication prescriptions at Mbarara Regional Referral Hospital (MRRH) in western Uganda: prevalence, clinical importance and associated factors. SJ Lubinga, E Uwiduhaye ...

Drug-Gene Interactions of Antihypertensive Medications and Risk of Incident Cardiovascular Disease: A Pharmacogenomics Study from the CHARGE Consortium.

Directory of Open Access Journals (Sweden)

Joshua C Bis

Full Text Available Hypertension is a major risk factor for a spectrum of cardiovascular diseases (CVD, including myocardial infarction, sudden death, and stroke. In the US, over 65 million people have high blood pressure and a large proportion of these individuals are prescribed antihypertensive medications. Although large long-term clinical trials conducted in the last several decades have identified a number of effective antihypertensive treatments that reduce the risk of future clinical complications, responses to therapy and protection from cardiovascular events vary among individuals.Using a genome-wide association study among 21,267 participants with pharmaceutically treated hypertension, we explored the hypothesis that genetic variants might influence or modify the effectiveness of common antihypertensive therapies on the risk of major cardiovascular outcomes. The classes of drug treatments included angiotensin-converting enzyme inhibitors, beta-blockers, calcium channel blockers, and diuretics. In the setting of the Cohorts for Heart and Aging Research in Genomic Epidemiology (CHARGE consortium, each study performed array-based genome-wide genotyping, imputed to HapMap Phase II reference panels, and used additive genetic models in proportional hazards or logistic regression models to evaluate drug-gene interactions for each of four therapeutic drug classes. We used meta-analysis to combine study-specific interaction estimates for approximately 2 million single nucleotide polymorphisms (SNPs in a discovery analysis among 15,375 European Ancestry participants (3,527 CVD cases with targeted follow-up in a case-only study of 1,751 European Ancestry GenHAT participants as well as among 4,141 African-Americans (1,267 CVD cases.Although drug-SNP interactions were biologically plausible, exposures and outcomes were well measured, and power was sufficient to detect modest interactions, we did not identify any statistically significant interactions from the four

Maternal drug use: evaluation of risks to breast-fed infants.

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Kirksey, A; Groziak, S M

1984-01-01

This paper, based on a review of the literature, evaluates the risks to infants of maternal drug use during lactation. The potential harm of a particular drug to the breastfed infant is related both to the complex mechanism of milk synthesis and secretion and the mode of passage of the drug from plasma into milk. The 1st part of the paper discusses mammary cell and milk synthesis, milk secretion and composition, the mode of passage of drugs into milk, and factors influencing drug concentrations in milk. Drug concentrations in milk are dependent on 6 major factors: drug dosage, proportion bound in plasma, molecular weight, lipid solubility, degree of ionization, and pH difference between plasma and milk. Drugs that are weak acids are ionized to a greater extent and are more protein-bound than weak alkaline drugs. The 2nd part of the paper evaluates the risks to breastfed infants of selected pharmacons. Some categories of drugs that contain pharmacons that should be limited or avoided by nursing mothers are alkylating agents, analgesics and anti-inflammatory agents, anticoagulants, anticonvulsants, anti-infective agents, central nervous system stimulants, hormones, laxatives, minerals, provitamins, psychotherapeutic agents, thyroid affecting agents, and vitamins. The following precautions are suggested to minimize the risks of potentially harmful pharmacons: 1) all unnecessary medications should be avoided by nrusing mothers; 2) if medication is necessary during lactation, drug dosage should be controlled and the infant should be monitored for adverse symptoms; 3) drugs should be administered shortly after breastfeeding and the interval prolonged before the next feeding; and 4) if the infant must be fed soon after a potentially harmful drug has been taken by the mother, bottle feeding is recommended.

Non-medical use of prescription drugs in a national sample of college women.

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

2011-07-01

Non-medical use of prescription drugs (NMUPD) is one of the fastest growing forms of illicit drug use, with research indicating that college students represent a particularly high risk population. The current study examined demographic characteristics, health/mental health, substance misuse, and rape experiences as potential risk correlates of NMUPD among a national sample of college women (N=2000). Interviews were conducted via telephone using Computer-Assisted Telephone Interviewing technology. NMUPD was assessed by asking if, participants had used a prescription drug non-medically in the past year. NMUPD was endorsed by 7.8% of the sample (n=155). Although incapacitated and drug-alcohol facilitated rape were associated with NMUPD in the initial model, the final multivariable model showed that only lifetime major depression and other forms of substance use/abuse were significantly uniquely associated with an increased likelihood of NMUPD. Implications for primary and secondary prevention and subsequent research are addressed. Published by Elsevier Ltd.

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

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Ahmed A. Al-Sayed

2014-01-01

Full Text Available 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.

Risk perception of medicinal marijuana in medical students from northeast Mexico

OpenAIRE

Castillo-Guzman Sandra; Palacios-Ríos Dionicio; Nava-Obregon Teresa A; Arredondo-Mendoza Julio C; Alcalá-Alvarado Olga V; Alonso-Bracho Sofía A; Becerril-Gaitan Daniela A; González-Santiago Omar

2017-01-01

This article discribe by the first time the risk perception of medicinal marijuana in medical students. The evaluation was done with a scale of 10 cm, similar to other studies that analyze risk perception to prescription drugs.

Antenatal drug consumption: the burden of self-medication in a developing world setting.

Science.gov (United States)

Adanikin, Abiodun Idowu; Awoleke, Jacob Olumuyiwa

2017-07-01

This institutional-based cross-sectional study examines the burden of self-medication during pregnancy in a middle-income country setting and the impact on fetal wellbeing. Using a blend of open-ended and indication-oriented questionnaires, 346 pregnant women at term were interviewed about their pregnancy complaints and drug intake. Inferential statistical data analysis was employed with level of significance (α) set at 0.05. Excluding routine supplements and vaccinations, 251 (72.5%) women used medicines, of whom 79 (31.5%) had self-medicated. Consuming drugs without prescription was associated with increased US Food & Drug Administration (FDA) risk category (χ 2  = 8.375; P = 0.015). There is therefore a need to scale up efforts towards educating women about the dangers of self-medication, while also introducing effective restrictive policies on over-the-counter drug sales.

Automation of a high risk medication regime algorithm in a home health care population.

Science.gov (United States)

Olson, Catherine H; Dierich, Mary; Westra, Bonnie L

2014-10-01

Create an automated algorithm for predicting elderly patients' medication-related risks for readmission and validate it by comparing results with a manual analysis of the same patient population. Outcome and Assessment Information Set (OASIS) and medication data were reused from a previous, manual study of 911 patients from 15 Medicare-certified home health care agencies. The medication data was converted into standardized drug codes using APIs managed by the National Library of Medicine (NLM), and then integrated in an automated algorithm that calculates patients' high risk medication regime scores (HRMRs). A comparison of the results between algorithm and manual process was conducted to determine how frequently the HRMR scores were derived which are predictive of readmission. HRMR scores are composed of polypharmacy (number of drugs), Potentially Inappropriate Medications (PIM) (drugs risky to the elderly), and Medication Regimen Complexity Index (MRCI) (complex dose forms, instructions or administration). The algorithm produced polypharmacy, PIM, and MRCI scores that matched with 99%, 87% and 99% of the scores, respectively, from the manual analysis. Imperfect match rates resulted from discrepancies in how drugs were classified and coded by the manual analysis vs. the automated algorithm. HRMR rules lack clarity, resulting in clinical judgments for manual coding that were difficult to replicate in the automated analysis. The high comparison rates for the three measures suggest that an automated clinical tool could use patients' medication records to predict their risks of avoidable readmissions. Copyright © 2014 Elsevier Inc. All rights reserved.

The Relationship of Social Problem-Solving Skills and Dysfunctional Attitudes with Risk of Drug Abuse among Dormitory Students at Isfahan University of Medical Sciences.

Science.gov (United States)

Nasrazadani, Ehteram; Maghsoudi, Jahangir; Mahrabi, Tayebeh

2017-01-01

Dormitory students encounter multiple social factors which cause pressure, such as new social relationships, fear of the future, and separation from family, which could cause serious problems such as tendency toward drug abuse. This research was conducted with the goal to determine social problem-solving skills, dysfunctional attitudes, and risk of drug abuse among dormitory students of Isfahan University of Medical Sciences, Iran. This was a descriptive-analytical, correlational, and cross-sectional research. The research sample consisted of 211 students living in dormitories. The participants were selected using randomized quota sampling method. The data collection tools included the Social Problem-Solving Inventory (SPSI), Dysfunctional Attitude Scale (DAS), and Identifying People at Risk of Addiction Questionnaire. The results indicated an inverse relationship between social problem-solving skills and risk of drug abuse ( P = 0.0002), a direct relationship between dysfunctional attitude and risk of drug abuse ( P = 0.030), and an inverse relationship between social problem-solving skills and dysfunctional attitude among students ( P = 0.0004). Social problem-solving skills have a correlation with dysfunctional attitudes. As a result, teaching these skills and the way to create efficient attitudes should be considered in dormitory students.

Drugs associated with teratogenic mechanisms. Part II : a literature review of the evidence on human risks

NARCIS (Netherlands)

van Gelder, Marleen M. H. J.; de Jong-van den Berg, Lolkje T. W.; Roeleveld, Nel

What is the current state of knowledge on the human risks of drugs suspected to be associated with teratogenic mechanisms? Evidence for the presence or absence of human risks of birth defects is scarce or non-existent for the majority of drugs associated with teratogenic mechanisms. Medical drugs

Fall-Risk-Increasing Drugs: A Systematic Review and Meta-analysis: III. Others.

Science.gov (United States)

Seppala, Lotta J; van de Glind, Esther M M; Daams, Joost G; Ploegmakers, Kimberley J; de Vries, Max; Wermelink, Anne M A T; van der Velde, Nathalie

2018-04-01

The use of psychotropic medication and cardiovascular medication has been associated with an increased risk of falling. However, other frequently prescribed medication classes are still under debate as potential risk factors for falls in the older population. The aim of this systematic review and meta-analysis is to evaluate the associations between fall risk and nonpsychotropic and noncardiovascular medications. A systematic review and meta-analysis. A search was conducted in Medline, PsycINFO, and Embase. Key search concepts were "falls," "aged," "medication," and "causality." Studies were included that investigated nonpsychotropic and noncardiovascular medications as risk factors for falls in participants ≥60 years or participants with a mean age ≥70 years. A meta-analysis was performed using the generic inverse variance method, pooling unadjusted and adjusted odds ratio (OR) estimates separately. In a qualitative synthesis, 281 studies were included. The results of meta-analysis using adjusted data were as follows (a pooled OR [95% confidence interval]): analgesics, 1.42 (0.91-2.23); nonsteroidal anti-inflammatory drugs (NSAIDs), 1.09 (0.96-1.23); opioids, 1.60 (1.35-1.91); anti-Parkinson drugs, 1.54 (0.99-2.39); antiepileptics, 1.55 (1.25-1.92); and polypharmacy, 1.75 (1.27-2.41). Most of the meta-analyses resulted in substantial heterogeneity that did not disappear after stratification for population and setting in most cases. In a descriptive synthesis, consistent associations with falls were observed for long-term proton pump inhibitor use and opioid initiation. Laxatives showed inconsistent associations with falls (7/20 studies showing a positive association). Opioid and antiepileptic use and polypharmacy were significantly associated with increased risk of falling in the meta-analyses. Long-term use of proton pump inhibitors and opioid initiation might increase the fall risk. Future research is necessary because the causal role of some medication

Impact of Risk-Benefit Perception and Trust on Medical Technology Acceptance in Relation to Drug and Device Lag: A Tripartite Cross-Sectional Survey.

Science.gov (United States)

Todaka, Koji; Kishimoto, Junji; Ikeda, Masayuki; Ikeda, Koji; Yamamoto, Haruko

2017-01-01

New drug and medical device introduction in Japan usually lags behind that in the West. Many reports indicate that in Japan, the associated risks are considered greater than the benefits recognized in other countries. This study aimed to compare the relationship between risk-benefit perception and acceptance of medical technologies in 3 leading markets. A tripartite cross-sectional survey of the general public was used. In total, 3345 adults in the United Kingdom, the United States, and Japan participated, and sexes and age groups were equally represented. Questions about the perception of risk, benefit, and acceptance of medical and other scientific technologies, and trust of medical product providers or regulatory authorities were included. Five-step Likert coding for risk/benefit/acceptance of 4 medical items (x-rays, antibiotics, vaccines, and cardiac pacemakers) and 6 general items (such as automobiles and airplanes) were collected. Relationships between benefit perception and acceptance were linear for 4 medical technologies. The relationship had a similar slope but was shifted downward in Japan compared with the UK and US ( P medical technologies, benefits of medical technologies, trust in doctors, and trust in the Department of Health. The UK and US attributes were clustered with positive responses such as "useful," "acceptable," and "trustworthy," whereas Japan was clustered with intermediate to negative responses such as "neither" and "untrustworthy." Acceptance of medical technologies was low in Japan because of significant differences in trust for doctors and authorities compared with that in the UK and US. This is a possible basis for delays of 24 to 60 months for medical product approval in Japan.

Drug packaging in 2014: authorities should direct more efforts towards medication safety.

Science.gov (United States)

2015-05-01

In 2014, Prescrire examined the packaging quality of about 250 drugs. A few advances stand out, mainly involving recent drugs, but on the whole, the situation is worrisome in terms of medication safety. Although pharmaceutical companies and drug regulatory agencies seem to be taking more account of the risk of accidental poisoning in children, the level of protection remains low overall in the absence of stringent measures on the part of the authorities. New drugs too often have poor-quality or even dangerous packaging at the time of their market introduction. And the packaging quality of older drugs is disturbing. Pharmaceutical companies no longer invest in the packaging of these products, and agencies often fail to take advantage of the opportunities provided by their reassessment to improve the situation. The inappropriate labelling of certain injectable drugs remains a source of medication errors, sometimes resulting in very serious consequences. In 2014, signs of progress in the packaging of several drugs show that its role in medication safety is better appreciated. But the persistence of dangers in the pharmaceuticals market, created by "unfinished", overly complex or poor-quality packaging, raises the question of the responsibility of pharmaceutical companies and agencies for past and present accidents.

Mining FDA drug labels for medical conditions.

Science.gov (United States)

Li, Qi; Deleger, Louise; Lingren, Todd; Zhai, Haijun; Kaiser, Megan; Stoutenborough, Laura; Jegga, Anil G; Cohen, Kevin Bretonnel; Solti, Imre

2013-04-24

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. 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. 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. 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.

Exploring the relationship between fall risk-increasing drugs and fall-related fractures.

Science.gov (United States)

De Winter, Sabrina; Vanwynsberghe, Sarah; Foulon, Veerle; Dejaeger, Eddy; Flamaing, Johan; Sermon, An; Van der Linden, Lorenz; Spriet, Isabel

2016-04-01

Hospital admissions due to fall-related fractures are a major problem in the aging population. Several risk factors have been identified, including drug use. Most studies often retrieved prescription-only drugs from national databases. These are associated with some limitations as they do not always reliably reproduce the complete patient's active drug list. To evaluate the association between the number of FRIDs intake identified by a standardised medication reconciliation process and a fall-related fracture leading to a hospital admission in older adults. The first cohort has been recruited from one traumatology ward of a tertiary teaching hospital in Belgium and the second cohort has been recruited from 11 community pharmacies in Belgium. A prospective study with two individually matched cohorts was performed. Adult patients (≥75 years) admitted with an injury due to a fall were included in the first cohort (faller group). The second cohort consisted of patients who did not suffer from a fall within the last 6 months (non-faller group). Matching was performed for age, gender, place of residence and use of a walking aid. In both groups, clinical pharmacists and undergraduate pharmacy students obtained the medication history, using a standardised approach. A list of drugs considered to increase the risk of falling was created. It included cardiovascular drugs and drugs acting on the nervous system. A linear mixed model was used to compare the number of fall risk-increasing drugs between fallers and non-fallers. The number of fall risk-increasing drugs in a faller versus a non-faller group. Sixty-one patients were matched with 121 non-fallers. Patients received on average 3.1 ± 2.1 and 3.2 ± 1.8 fall risk-increasing drugs in the faller and in the non-faller group, respectively. The mean number of fall risk-increasing drugs was comparable in both groups (p = 0.844), even after adjusting for alcohol consumption, fear of falling, vision and foot problems (p = 0

Risk of fracture and pneumonia from acid suppressive drugs.

Science.gov (United States)

Eom, Chun-Sick; Lee, Sang-Soo

2011-09-26

A recently published systematic review and meta-analysis, incorporating all relevant studies on the association of acid suppressive medications and pneumonia identified up to August 2009, revealed that for every 200 patients, treated with acid suppressive medication, one will develop pneumonia. They showed the overall risk of pneumonia was higher among people using proton pump inhibitors (PPIs) [adjusted odds ratio (OR) = 1.27, 95% CI: 1.11-1.46, I(2) = 90.5%] and Histamine-2 receptor antagonists (H2RAs) (adjusted OR = 1.22, 95% CI: 1.09-1.36, I(2) = 0.0%). In the randomized controlled trials, use of H2RAs was associated with an elevated risk of hospital-acquired pneumonia (relative risk 1.22, 95% CI: 1.01-1.48, I(2) = 30.6%). Another meta-analysis of 11 studies published between 1997 and 2011 found that PPIs, which reduce stomach acid production, were associated with increased risk of fracture. The pooled OR for fracture was 1.29 (95% CI: 1.18-1.41) with use of PPIs and 1.10 (95% CI: 0.99-1.23) with use of H2RAs, when compared with non-use of the respective medications. Long-term use of PPIs increased the risk of any fracture (adjusted OR = 1.30, 95% CI: 1.15-1.48) and of hip fracture risk (adjusted OR = 1.34, 95% CI: 1.09-1.66), whereas long-term H2RA use was not significantly associated with fracture risk. Clinicians should carefully consider when deciding to prescribe acid-suppressive drugs, especially for patients who are already at risk for pneumonia and fracture. Since it is unnecessary to achieve an achlorhydric state in order to resolve symptoms, we recommend using the only minimum effective dose of drug required to achieve the desired therapeutic goals.

RIGHT MEDICATION RELATED TO DRUG CENTRALIZED IN RSUD SIDOARJO

Directory of Open Access Journals (Sweden)

Aprilia Aprilia

2017-02-01

Full Text Available Introduction. Centralized drug is a management of the entire drug which is entirely done by nurses to administration to patients. Right medication is the process of right drug administration which is done by nurses based on 6 rights of medication, and wary of side effects. The purpose of this study was to analyze the corelation between centralized drug, team leadership, and nurse`s knowledge with right medication among nurses. Methods.The design of the study was descriptive corelational with cross-sectional approach. The population was inpatient nurses in RSUD Sidoarjo. Total sample was 114 respondents was selected by purposive sampling. The independent variables in this study: centralized drug, team leadership, and nurse`s knowledge. The dependent variable was right medication. Data were collected by using questionnares for independent variables and dependent variable. Data were analyzed by using Binary Logistic Regression with degree of significance α>0,05. Results. Binary Logistic Regression test showed non significance level between centralized drug with right medication (P=0.501, team leadership with right medication (P=0.874, and nurses`s knowledge with right medication (P=0.243. Discussion. This study concluded centralized drug, team leadership, and nurse`s knowledge were good. But, there are nurses that have negative value at right medication, however right medication in RSUD Sidoarjo has majority positive value. Keywords: centralized drug, right medication

The risks of risk aversion in drug regulation.

Science.gov (United States)

Eichler, Hans-Georg; Bloechl-Daum, Brigitte; Brasseur, Daniel; Breckenridge, Alasdair; Leufkens, Hubert; Raine, June; Salmonson, Tomas; Schneider, Christian K; Rasi, Guido

2013-12-01

Drugs are approved by regulatory agencies on the basis of their assessment of whether the available evidence indicates that the benefits of the drug outweigh its risks. In recent years, regulatory agencies have been criticized both for being overly tolerant of risks or being excessively risk-averse, which reflects the challenge in determining an appropriate balance between benefit and risk with the limited data that is typically available before drug approval. The negative consequences of regulatory tolerance in allowing drugs onto the market that turn out to be unsafe are obvious, but the potential for adverse effects on public health owing to the absence of new drugs because of regulatory risk-aversion is less apparent. Here, we discuss the consequences of regulatory risk-aversion for public health and suggest what might be done to best align acceptance of risk and uncertainty by regulators with the interests of public health.

Medical Readings on Drug Abuse.

Science.gov (United States)

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…

Risks versus benefits of medication use during pregnancy : What do women perceive?

NARCIS (Netherlands)

Mulder, Bianca; Bijlsma, Maarten J; Schuiling-Veninga, Catharina Cm; Morssink, Leonard P; van Puijenbroek, Eugene; Aarnoudse, Jan G; Hak, Eelko; de Vries, Tjalling W

2018-01-01

Background: Understanding perception of risks and benefits is essential for informed patient choices regarding medical care. The primary aim of this study was to evaluate the perception of risks and benefits of 9 drug classes during pregnancy and associations with women's characteristics. Methods:

[Food-drug interactions: an underestimated risk].

Science.gov (United States)

Sönnichsen, A C; Donner-Banzhoff, N; Baum, E

2005-11-03

With only few exceptions, administration of medicaments should, in principle, be independent of food intake (at least half an hour before or two hours after eating). This ensures uniform and assessable bioavailability. However, it also entails the risk that the patient is more likely to forget to take medication postponed to 2 hours after a meal, than when it is directly coupled to a meal. Certain foodstuffs or food constituents, such as, for example, grapefruit, Seville orange juice, red wine, alcoholic drinks in general, or large quantities of caffeine and garlic should be avoided during drug treatment. In addition, specific interactions with certain drugs must also be taken into account (e.g. MAO inhibitors and tyramine, curamine and vitamin K).

Can medical students calculate drug doses? | Harries | Southern ...

African Journals Online (AJOL)

... with calculations when the drug concentration was expressed either as a ratio or a percentage. Conclusion: Our findings support calls for the standardised labelling of drugs in solution and for dosage calculation training in the medical curriculum. Keywords: drug dosage calculations, clinical competence, medication errors

[Consumption of medications, alcohol and smoking in pregnancy and assessment of teratogenic risks].

Science.gov (United States)

Rocha, Rebeca Silveira; Bezerra, Samara Cavalcante; Lima, José Welington de Oliveira; Costa, Fabrício da Silva

2013-06-01

Medications, alcohol and smoking can cause fetal damage. A cross-sectional study was conducted with 326 mothers of the Fortaleza General Hospital to evaluate the use of drugs, alcohol and smoking during pregnancy and its relation to teratogenic potential in different population characteristics, between 2006 and 2007. Postpartum women who had their babies in the research site were included and those whose babies were not admitted as hospital inpatients were excluded. Chi-square tests and t-tests were used in the analysis, with a p value drugs/ pregnancy) and self-medication occurred in 11.3% of the cases. Single women took more drugs with high teratogenic potential (p=0.037). 11 cases of fetal malformation were observed, five of them were exposed to high teratogenic risks. Smoking occurred in 11.3% and alcohol use in 16%. Being single was found to be a risk factor for exposure to high teratogenic potential. Quality of prenatal care and other sociodemographic variables weren't related to exposure to teratogenic risks.

Safety risks with investigational drugs: Pharmacy practices and perceptions in the veterans affairs health system.

Science.gov (United States)

Cruz, Jennifer L; Brown, Jamie N

2015-06-01

Rigorous practices for safe dispensing of investigational drugs are not standardized. This investigation sought to identify error-prevention processes utilized in the provision of investigational drug services (IDS) and to characterize pharmacists' perceptions about safety risks posed by investigational drugs. An electronic questionnaire was distributed to an audience of IDS pharmacists within the Veteran Affairs Health System. Multiple facets were examined including demographics, perceptions of medication safety, and standard processes used to support investigational drug protocols. Twenty-one respondents (32.8% response rate) from the Northeast, Midwest, South, West, and Non-contiguous United States participated. The mean number of pharmacist full-time equivalents (FTEs) dedicated to the IDS was 0.77 per site with 0.2 technician FTEs. The mean number of active protocols was 22. Seventeen respondents (81%) indicated some level of concern for safety risks. Concerns related to the packaging of medications were expressed, most notably lack of product differentiation, expiration dating, barcodes, and choice of font size or color. Regarding medication safety practices, the majority of sites had specific procedures in place for storing and securing drug supply, temperature monitoring, and prescription labeling. Repackaging bulk items and proactive error-identification strategies were less common. Sixty-seven percent of respondents reported that an independent double check was not routinely performed. Medication safety concerns exist among pharmacists in an investigational drug service; however, a variety of measures have been employed to improve medication safety practices. Best practices for the safe dispensing of investigational medications should be developed in order to standardize these error-prevention strategies.

Drug shortages: Implications for medical toxicology.

Science.gov (United States)

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

2015-07-01

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

Lipid-lowering medication and risk of cancer

DEFF Research Database (Denmark)

Olsen, Jørgen H.; Johansen, Christoffer; Sørensen, Henrik Toft

1999-01-01

of up to 4 years, 41 cancers were observed among users of lipid-lowering drugs, with 42.9 expected, to yield an age- and sex-standardized incidence ratio of 1.0 (95% confidence interval, 0.7–1.3). Although limited by small numbers and short follow-up period, examination by site of cancer and type......Low or declining levels of serum cholesterol have been associated with increased mortality from cancer. We conducted a population-based cohort study of 1882 patients from one Danish county who received lipid-lowering drugs between January 1, 1991 and December 31, 1994. During the follow-up period...... of drug provided no evidence of an association. Further research is needed, however, with longer follow-up to assess more fully any potential cancer risk with these medications....

Non-medical use of prescription drugs among illicit drug users: A case study on an online drug forum.

Science.gov (United States)

Rönkä, Sanna; Katainen, Anu

2017-01-01

The non-medical use of prescription drugs is a growing phenomenon associated with increasing health-related harms. However, little is known about the drivers of this process among illicit drug users. Our aim is to show how the qualities of pharmaceutical drugs, pharmaceutical related knowledge, online communities sharing this knowledge and medical professionals mediate and transform the consumption behaviour related to pharmaceutical drugs. The data consist of discussion threads from an online drug use forum. Using actor network theory (ANT), we analysed translations that mediate the online user community's relationship with pharmaceutical drugs. Differences in experienced drug effects are explained both as a process of 'learning' and as differences in brain chemistry at the receptor level. Both science- and experience-based information are shared on best practices to optimise use, avoid adverse health effects and maximise the experience of intoxication. The expanded context of doctors' practices places stress on the medical framework for drug use. Our analysis shows how the non-medical use of psychoactive pharmaceuticals relates to joint, medicalised ideas of bodies as sites of medical experimentation, as well as to the collective process of constructing 'pharmaceutical competences' in user networks. Understandings of intoxication have increasingly been permeated with the pharmacological and scientific logic of knowledge. The forum works as a platform for harm reduction inspired exchange of knowledge. However, the user community's knowledge sharing practices can generate a shared perception of a sufficient or even superior drug use experience and knowledge. This may lead to overdoses and other risky behaviour, and thereby contribute to increased harms related to non-medical use of prescription drugs. Copyright © 2016 Elsevier B.V. All rights reserved.

Risk attitudes and personality traits predict perceptions of benefits and risks for medicinal products: a field study of European medical assessors.

Science.gov (United States)

Beyer, Andrea R; Fasolo, Barbara; de Graeff, P A; Hillege, H L

2015-01-01

Risk attitudes and personality traits are known predictors of decision making among laypersons, but very little is known of their influence among experts participating in organizational decision making. Seventy-five European medical assessors were assessed in a field study using the Domain Specific Risk Taking scale and the Big Five Inventory scale. Assessors rated the risks and benefits for a mock "clinical dossier" specific to their area of expertise, and ordinal regression models were used to assess the odds of risk attitude or personality traits in predicting either the benefit or the risk ratings. An increase in the "conscientiousness" score predicted an increase in the perception of the drug's benefit, and male assessors gave higher scores for the drug's benefit ratings than did female assessors. Extraverted assessors saw fewer risks, and assessors with a perceived neutral-averse or averse risk profile saw greater risks. Medical assessors perceive the benefits and risks of medicines via a complex interplay of the medical situation, their personality traits and even their gender. Further research in this area is needed to determine how these potential biases are managed within the regulatory setting. Copyright © 2015 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

Prevalence of drug-related problems in self-medication in Danish community pharmacies

Directory of Open Access Journals (Sweden)

Bente Frøkjær

2012-01-01

Full Text Available Background: Drug-related problems are known to be a major problem associated with pharmacotherapy. A broad range of studies, mainly in the area of prescription-only medicines, supports this fact. Only a few studies have evaluated drug-related problems with over-the-counter medicine and the role of community pharmacies in this. Purpose: To quantify drug-related problems in self-medication (use of over-the-counter medicine identified by community pharmacies in Denmark and to document the interventions by pharmacy staff in relation to the identified drug-related problems. Method: A descriptive study mapping drug-related problems in self-medication registered at the counter at a selected number of Danish community pharmacies. Results: Data for 3,868 consecutive customers with requests for over-the-counter (OTC medicines were registered at 39 community pharmacies. The pharmacies registered a total number of 4,324 OTC medicines requests, illustrating that a customer requested 1.1 OTC medicines on average. Drug-related problems (DRPs were identified for 813 customers, equivalent to DRPs for 21.0 % of all customers, presenting symptoms or requesting OTC medicines, and for 20 % of all over-the-counter medicines requests. 1,239 DRPs were registered, corresponding to an average of 1.5 DRPs per customer requesting OTC medicines. Community pharmacies estimated that they solved or partly solved 76.2 % of the detected DRPs; 73 % were solved without involving a general practitioner. Conclusions: DRPs were identified for 21.0 % of the pharmacy customers presenting a symptom or asking for an OTC medicine. The community pharmacy counselled the customers with DRPs more thoroughly than other customers by giving 2.4 pieces of professional advice, compared to an average of 2.1 to customers in general. It is not possible to determine the magnitude of the safety risk involved. Based on the most frequent categories of DRPs, there were risks of insufficient effect

Prevalence of drug-related problems in self-medication in Danish community pharmacies

Directory of Open Access Journals (Sweden)

Charlotte Rossing

2012-01-01

Full Text Available Background: Drug-related problems are known to be a major problem associated with pharmacotherapy. A broad range of studies, mainly in the area of prescription-only medicines, supports this fact. Only a few studies have evaluated drug-related problems with over-the-counter medicine and the role of community pharmacies in this.Purpose: To quantify drug-related problems in self-medication (use of over-the-counter medicine identified by community pharmacies in Denmark and to document the interventions by pharmacy staff in relation to the identified drug-related problems.Method: A descriptive study mapping drug-related problems in self-medication registered at the counter at a selected number of Danish community pharmacies.Results: Data for 3,868 consecutive customers with requests for over-the-counter (OTC medicines were registered at 39 community pharmacies. The pharmacies registered a total number of 4,324 OTC medicines requests, illustrating that a customer requested 1.1 OTC medicines on average. Drug-related problems (DRPs were identified for 813 customers, equivalent to DRPs for 21.0 % of all customers, presenting symptoms or requesting OTC medicines, and for 20 % of all over-the-counter medicines requests. 1,239 DRPs were registered, corresponding to an average of 1.5 DRPs per customer requesting OTC medicines.Community pharmacies estimated that they solved or partly solved 76.2 % of the detected DRPs; 73 % were solved without involving a general practitioner.Conclusions: DRPs were identified for 21.0 % of the pharmacy customers presenting a symptom or asking for an OTC medicine. The community pharmacy counselled the customers with DRPs more thoroughly than other customers by giving 2.4 pieces of professional advice, compared to an average of 2.1 to customers in general. It is not possible to determine the magnitude of the safety risk involved. Based on the most frequent categories of DRPs, there were risks of insufficient effect, unintended

Assessing suicidal risk with antiepileptic drugs

Directory of Open Access Journals (Sweden)

Marco Mula

2010-09-01

Full Text Available Marco Mula2, Gail S Bell1, Josemir W Sander1,31Department of Clinical and Experimental Epilepsy, UCL Institute of Neurology, and National Hospital for Neurology and Neurosurgery, UCL Hospitals NHS Foundation Trust, London, United Kingdom; 2Department of Clinical and Experimental Medicine, Division of Neurology, Amedeo Avogadro University, University Hospital Maggiore della Carità, Novara, Italy; 3SEIN – Epilepsy Institute in the Netherlands Foundation, Heemstede, The NetherlandsAbstract: Recently, the US Food and Drug Administration issued an alert about an increased risk for suicidality during treatment with antiepileptic drugs (AEDs for different indications, including epilepsy. We discuss the issue of suicide in epilepsy with special attention to AEDs and the assessment of suicide in people with epilepsy. It has been suggested that early medical treatment with AEDs might potentially reduce suicide risk of people with epilepsy, but it is of great importance that the choice of drug is tailored to the mental state of the patient. The issue of suicidality in epilepsy is likely to represent an example of how the underdiagnosis of psychiatric symptoms, the lack of input from professionals (eg, psychologists, social workers, and psychiatrists, and the delay in an optimized AED therapy may worsen the prognosis of the condition with the occurrence of severe complications such as suicide.Keywords: epilepsy, suicide, adverse effect, depression

Reducing risk for illicit drug use and prescription drug misuse: High school gay-straight alliances and lesbian, gay, bisexual, and transgender youth.

Science.gov (United States)

Heck, Nicholas C; Livingston, Nicholas A; Flentje, Annesa; Oost, Kathryn; Stewart, Brandon T; Cochran, Bryan N

2014-04-01

Previous research suggests that lesbian, gay, bisexual, and transgender (LGBT) youth are at elevated risk for using illicit drugs and misusing prescription drugs relative to heterosexual youth. Previous research also indicates that LGBT youth who attend high schools with a gay-straight alliance (GSA) report having fewer alcohol problems and lower levels of cigarette smoking. The present study investigates whether the absence of a GSA is associated with risk for illicit drug use and prescription drug misuse in a sample of 475 LGBT high school students (M age=16.79) who completed an online survey. After controlling for demographic variables and risk factors associated with illicit drug use, the results of 12 logistic regression analyses revealed that LGBT youth attending a high school without a GSA evidenced increased risk for using cocaine (adjusted odds ratio [adjOR]=3.11; 95% confidence interval [95% CI]=1.23-7.86), hallucinogens (adjOR=2.59; 95% CI=1.18-5.70), and marijuana (adjOR=2.22; 95% CI=1.37-3.59) relative to peers attending a high school with a GSA. Youth without a GSA also evidenced increased risk for the misuse of ADHD medication (adjOR=2.00; 95% CI=1.02-3.92) and prescription pain medication (adjOR=2.00; 95% CI=1.10-3.65). These findings extend the research base related to GSAs and further demonstrate the importance of providing LGBT youth with opportunities for socialization and support within the school setting. Important limitations of the present study are reviewed. Copyright © 2014 Elsevier Ltd. All rights reserved.

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

Science.gov (United States)

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

2015-12-01

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

Number of medications and adverse drug events by unintentional poisoning among older adults in consideration of inappropriate drug use : A Swedish population-based matched case-control study

NARCIS (Netherlands)

Rausch, Christian; Laflamme, L.; Bultmann, U.; Moller, J.

Purpose This national, population-based study aims to determine the association between the number of prescribed medications and adverse drug events (ADE) by unintentional poisoning and examine this risk when known indicators of inappropriate drug use (IDU) are accounted for. Methods We employed a

Drug-related problems identified in medication reviews by Australian pharmacists

DEFF Research Database (Denmark)

Stafford, Andrew C; Tenni, Peter C; Peterson, Gregory M

2009-01-01

OBJECTIVE: In Australia, accredited pharmacists perform medication reviews for patients to identify and resolve drug-related problems. We analysed the drug-related problems identified in reviews for both home-dwelling and residential care-facility patients. The objective of this study was to exam......OBJECTIVE: In Australia, accredited pharmacists perform medication reviews for patients to identify and resolve drug-related problems. We analysed the drug-related problems identified in reviews for both home-dwelling and residential care-facility patients. The objective of this study....... These reviews had been self-selected by pharmacists and submitted as part of the reaccreditation process to the primary body responsible for accrediting Australian pharmacists to perform medication reviews. The drug-related problems identified in each review were classified by type and drugs involved. MAIN...... OUTCOME MEASURE: The number and nature of drug-related problems identified in pharmacist-conducted medication reviews. RESULTS: There were 1,038 drug-related problems identified in 234 medication reviews (mean 4.6 (+/-2.2) problems per review). The number of problems was higher (4.9 +/- 2.0 vs. 3.9 +/- 2...

Medication use and associated risk of falling in a geriatric outpatient population.

Science.gov (United States)

Freeland, Kathryn N; Thompson, Amy N; Zhao, Yumin; Leal, Julie E; Mauldin, Patrick D; Moran, William P

2012-09-01

Studies have shown that approximately one third of community-dwelling people aged 65 years and older will experience a fall each year. Many studies indicate that use of multiple medications may put patients at an increased risk of falling, but few studies have been conducted to correlate the number of medications with the risk of falls. To determine the medications most frequently used in patients aged 65 years or older who have experienced a fall within the past year, with particular attention to type or number of medications most commonly associated with multiple falls or a fall with injury. We conducted a chart review in an outpatient internal medicine clinic over a 13-month period. A total of 118 patients 65 years of age or older who were taking 4 or more medications and had experienced at least 1 fall in the previous 12 months were included. Data relating to sex, age, race, diagnoses, medications, and number and type of falls were obtained during the chart review. The primary end point of the study was number and type of medications most commonly used in patients experiencing a fall. A total of 116 patients were examined for trends in fall risk. A logistic regression model and receiver operating characteristic curve demonstrated significant fall risk with the addition of medications, with patients experiencing a 14% increase in fall risk with the addition of each medication beyond a 4-medication regimen (OR 1.14; 95% CI 1.02 to 1.27; p = 0.027). The addition of medications is associated with a significant increase in risk of falls in elderly patients, regardless of drug class. Further studies are needed to assess the possible increased risk of falls with increasing number of medications.

Medication use and kidney cancer risk: A population-based study.

Science.gov (United States)

Nayan, Madhur; Juurlink, David N; Austin, Peter C; Macdonald, Erin M; Finelli, Antonio; Kulkarni, Girish S; Hamilton, Robert J

2017-09-01

Exposure to commonly prescribed medications may be associated with cancer risk. However, there is limited data in kidney cancer. Furthermore, methods of classifying cumulative medication exposure in previous studies may be prone to bias. We conducted a population-based case-control study of 10,377 incident kidney cancer cases aged ≥66 years matched with 35,939 controls on age, sex, history of hypertension, comorbidity score, and geographic location. Cumulative exposure to commonly prescribed medications hypothesised to modulate cancer risk was obtained using prescription claims data. We modelled exposure in four different fashions: (1) as continuous exposures using (a) fractional polynomials (which allow for a non-linear relationship between an exposure and outcome) or (b) assuming linear relationships; and 2) as dichotomous exposures denoting (a) ≥3 years versus kidney cancer. The directions of association were relatively consistent across analyses; however, the magnitudes were sensitive to the method of analysis. When utilising fractional polynomials, increasing cumulative exposure to acetylsalicylic acid, selective serotonin reuptake inhibitors, and proton-pump inhibitors was associated with significantly reduced risk of kidney cancer, while increasing exposure to antihypertensive drugs was associated with significantly increased risk. Our study provides impetus to further explore the effect of commonly prescribed medications on carcinogenesis to identify modifiable pharmacological interventions to reduce the risk of kidney cancer. Copyright © 2017 Elsevier Ltd. All rights reserved.

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

Science.gov (United States)

2013-02-25

...] Joint Meeting of the Medical Imaging Drugs Advisory Committee and the Oncologic Drugs Advisory Committee... be open to the public. Name of Committees: Medical Imaging Drugs Advisory Committee and the Oncologic... Special Medical Programs. [FR Doc. 2013-04141 Filed 2-22-13; 8:45 am] BILLING CODE 4160-01-P ...

Type, Number or Both? A Population-Based Matched Case-Control Study on the Risk of Fall Injuries among Older People and Number of Medications beyond Fall-Inducing Drugs

OpenAIRE

Laflamme, Lucie; Mon?rrez-Espino, Joel; Johnell, Kristina; Elling, Berty; M?ller, Jette

2015-01-01

Objectives Drug use is a modifiable risk factor for fall-related injuries in older people. Whereas the injurious effect of polypharmacy is established, that of low numbers of medications has not been fully ascertained. Neither do we know whether it is the number per se or the type of medications that actually matters. We assessed this question for fall injuries leading to hospitalization. Design National register-based, population-based, matched case-control study. Setting Community dwellers ...

The Association between Non-Medical Prescription Drug Use and Suicidal Behavior among United States Adolescents

Directory of Open Access Journals (Sweden)

Amanda L. Divin

2014-11-01

Full Text Available Adolescence represents a vulnerable time for the development of both drug use/abuse and mental illness. Although previous research has substantiated a relationship between drug use and suicidal behavior, little research has examined this relationship with non-medical prescription drug use. Given the growing prevalence of non-medical prescription drug use (NMPDU among adolescents, this study explored the association between NMPDU and suicidal behavior. Nationally representative data were derived from 16, 410 adolescents who completed the 2009 National Youth Risk Behavior Survey. Approximately 19.8% of participants reported lifetime NMPDU. NMPDU was associated with significantly increased odds of suicidal behavior (P < 0.01, with seriously considering attempting suicide and making a plan about attempting suicide representing the strongest correlates for males and females. Results suggest the importance of 1 continued reinforcement of drug education programs in high school begun at earlier ages and 2 mental health care and screenings among adolescents.

Risk of drug interaction: combination of antidepressants and other drugs

Directory of Open Access Journals (Sweden)

Miyasaka Lincoln Sakiara

2003-01-01

Full Text Available OBJECTIVE: To assess the frequency of combination of antidepressants with other drugs and risk of drug interactions in the setting public hospital units in Brazil. METHODS: Prescriptions of all patients admitted to a public hospital from November 1996 to February 1997 were surveyed from the hospital's data processing center in São Paulo, Brazil. A manual search of case notes of all patients admitted to the psychiatric unit from January 1993 to December 1995 and all patients registered in the affective disorders outpatient clinic in December 1996 was carried out. Patients taking any antidepressant were identified and concomitant use of drugs was checked. By means of a software program (Micromedex® drug interactions were identified. RESULTS: Out of 6,844 patients admitted to the hospital, 63 (0.9% used antidepressants and 16 (25.3% were at risk of drug interaction. Out of 311 patients in the psychiatric unit, 63 (20.2% used antidepressants and 13 of them (20.6% were at risk. Out of 87 patients in the affective disorders outpatient clinic, 43 (49.4% took antidepressants and 7 (16.2% were at risk. In general, the use of antidepressants was recorded in 169 patients and 36 (21.3% were at risk of drug interactions. Twenty different forms of combinations at risk of drug interactions were identified: four were classified as mild, 15 moderate and one severe interaction. CONCLUSION: In the hospital general units the number of drug interactions per patient was higher than in the psychiatric unit; and prescription for depression was lower than expected.

Medical and nonmedical users of prescription drugs among college students.

Science.gov (United States)

Rozenbroek, Katelyn; Rothstein, William G

2011-01-01

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

Polypharmacy and the risk of drug-drug interactions among Danish elderly

DEFF Research Database (Denmark)

Rosholm, J U; Bjerrum, L; Hallas, J

1998-01-01

OBJECTIVE: To analyze the use of all subsidized prescription drugs with special attention to the elderly (> or = 70 years of age), including their use of drug combination generally accepted as carrying a risk of severe interactions. DESIGN: Descriptive prevalence study. SETTING: Odense...... accepted as carrying a risk of severe interactions. RESULTS: Among persons less than 70 years, 67.9% used none, 16.5% used one drug and 15.6% used two or more prescription drugs. The corresponding prevalences for the elderly were 35.7%, 15.9% and 48.4%. The 26,337 elderly patients with at least two drugs...... used 21,293 different combinations. Of the elderly patients who had purchased > or = two drugs, 4.4% had combinations of drugs carrying a risk of severe interactions. CONCLUSIONS: Most elderly use drugs and usually several drugs concomitantly. The elderly form a heterogeneous group of drug users. Drug...

Medication Desensitization: Characterization of Outcomes and Risk Factors for Reactions.

Science.gov (United States)

Murray, Taryn S; Rice, Todd W; Wheeler, Arthur P; Phillips, Elizabeth J; Dworski, Ryszard T; Stollings, Joanna L

2016-03-01

Although its mechanisms are poorly understood, desensitization has been used to induce a temporary state of immune unresponsiveness in patients who have IgE-, non-IgE-, or pharmacologically mediated reactions when a drug has no alternatives. The purpose of this study was to characterize the outcomes and identify risk factors for reactions during drug desensitization. A retrospective review of electronic medical records of adult patients undergoing drug desensitization from January 1, 2011, to December 31, 2013, was conducted in 2 intensive care units at a tertiary medical center. We used multivariate analysis to determine if specified risk factors were associated with reacting during the desensitization. Reactions were classified according to the pretest probability prior to desensitization, and then, reactions during desensitization were classified based on the occurrence of cutaneous reactions as follows: successful with no reaction, mild reaction, moderate reaction, or failed. Failure could result from any systemic allergic or cutaneous reaction resulting in procedure termination. The desensitizations were also assessed to determine if the patient required de-escalation secondary to a reaction. A total of 88 desensitizations were performed in 69 patients. Desensitization was completed with no cutaneous reaction in 85% of patients. No baseline characteristic, medication class (P = 0.46), or indication for desensitization (P = 0.59) was associated with having a reaction. Reported histories of urticaria (P desensitization. However, neither history of urticaria nor labored breathing was independently associated with having a reaction in multivariate analysis (OR = 0.979, 95% CI = 0.325-2.952, P = 0.970, and OR = 1.626, 95% CI = 0.536-4.931, P = 0.739, respectively). Drug desensitization is safe for patients who have no alternative for therapy. Reported allergy histories of urticaria and labored breathing are both associated with having a reaction during the

Evaluation of the Risk of Drug Addiction with the Help of Fuzzy Sets

Directory of Open Access Journals (Sweden)

L. Rakesh

2010-01-01

Full Text Available The primary focus of this paper is to present a general view of the current applications of fuzzy logic in medical analogy of consumption of drugs. The paper also deals with the origin, structure and composition of fuzzy sets. We particularly review the medical literature using fuzzy logic. Fuzzy set theory can be considered as a suitable formalism to deal with the imprecision intrinsic to many real world problems. Fuzzy set theory provides an appropriate framework for the representation of vague medical concepts and imprecise modes of reasoning. We present two concrete illustrations to investigate the impact of the risk related to drug addictions, like smoking and alcohol drinking and thereby highlighting the social problem related to health.

Fertility drugs and the risk of breast and gynecologic cancers.

Science.gov (United States)

Brinton, Louise A; Sahasrabuddhe, Vikrant V; Scoccia, Bert

2012-04-01

The evaluation of cancer risk among patients treated for infertility is complex, given the need to consider indications for use, treatment details, and the effects of other factors (including parity status) that independently affect cancer risk. Many studies have had methodologic limitations. Recent studies that have overcome some of these limitations have not confirmed a link between drug use and invasive ovarian cancers, although there is still a lingering question as to whether borderline tumors might be increased. It is unclear whether this merely reflects increased surveillance. Investigations regarding breast cancer risk have produced inconsistent results. In contrast, an increasing number of studies suggest that fertility drugs may have a special predisposition for the development of uterine cancers, of interest given that these tumors are recognized as particularly hormonally responsive. Additional studies are needed to clarify the effects on cancer risk of fertility drugs, especially those used in conjunction with in vitro fertilization. Because many women who have received such treatments are still relatively young, further monitoring should be pursued in large well-designed studies that enable assessment of effects within a variety of subgroups defined by both patient and disease characteristics. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

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

Science.gov (United States)

2010-04-09

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0142] 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...

[Targeted pharmacist-led medication order review in hospital: Assessment of a selection method for drug prescriptions].

Science.gov (United States)

Jarre, C; Bouchet, J; Hellot-Guersing, M; Leromain, A-S; Derharoutunian, C; Gadot, A; Roubille, R

2017-11-01

The aim of this study was to assess a selection method for drug prescriptions developed at the hospital level that allows to target pharmacist-led medication order review for at-risk patients and drugs. A one-month study has been conducted on all targeted medication orders in 19 care units. Selection criteria have been identified: biological criteria, alert medications and drug interactions. Pharmacists' interventions proposed during medication order review were listed and the possible links to the selection criteria were determined. A total of 1612 prescriptions were analysed and 236 pharmacists' interventions were performed (14.6 interventions per 100 prescriptions). Physicians' acceptance rate was 60.6%. The percentage of pharmacists' interventions linked to the selection criteria was 35.6%. The relevance of the biological criteria was identified, particularly the one identifying patients with creatinine clearance below 30ml/min. Six alert medications were also relevant selection criteria: dabigatran, morphine, gentamicin, methotrexate, potassium chloride and trimethoprim sulfamethoxazole. Drug interactions criteria was irrelevant. This study allowed a first assessment of the selection criteria used. A largest study seems necessary to continue the analysis of this selection method for prescriptions, especially the assessment of the alert medications list, in order to refine the prescriptions targeting. Copyright © 2017 Académie Nationale de Pharmacie. Published by Elsevier Masson SAS. All rights reserved.

Antiprogestin drugs: ethical, legal and medical issues.

Science.gov (United States)

Cook, R J; Grimes, D A

1992-01-01

RU 486 allows women the choice of a medical rather than a surgical abortion, and, for most women, the choice is one of procedure, not of whether to have an abortion. Issues surrounding RU 486 were explored in an American Society of Law and Medicine conference in December 1991 entitled "Antiprogestin Drugs: Ethical, Legal and Medical Issues." An introduction to 14 conference papers provides an overview of the proceedings. Baulieu, the father of RU 486, described updated developments in its use and the medically supervised method of abortion. Bygdeman and Swahn presented their work in Sweden on combining RU 486 with a prostaglandin to make abortion more effective. They suggested that the drug may be an attractive postovulation contraceptive. Greenslad et al. discussed service delivery aspects of the use of RU 486. Holt considered the implications of use of the drug in low-resource settings. A survey of obstetricians and gynecologists, presented by Heilig, indicates that 22% more physicians would perform a medical abortion. Patient perspectives were addressed by David, who stated that measuring acceptability of an abortion technique is difficult; women have historically used whatever method is available. A collaborative research project in India and Cuba on why women chose certain methods was reported by Winikoff et al. (90% of women would choose medical abortion if faced with the choice again). Berer analyzed French data on women's perspectives on medical vs. surgical abortion. The question of adolescent use of the drug was considered by Senderowitz, who lamented the lack of data on the subject and described what is known about adolescent pregnancy. Macklin proposed a framework for ethical analysis and used facts to address ethical questions. Weinstein provided another ethical framework, to analyze whether pharmacists have a right to refuse to provide abortifacient drugs. Buc approached the subject from a legal point of view and concluded that, whereas legal problems

Non-steroidal anti-inflammatory drug prescriptions in hospital inpatients: are we assessing the risks?

LENUS (Irish Health Repository)

Kitchen, J

2012-02-01

AIM: To determine non-steroidal anti-inflammatory drug (NSAID) prescribing practices in a tertiary referral hospital. METHODS: A single time-point audit of drug kardexes and clinical notes of n = 388 patients on 2 July 2008 was carried out assessing demographics, gastrointestinal and coronary heart disease risk factors, renal function and co-prescribed medications. RESULTS: Fifty-seven of 388 (14.7%) hospital patients were on NSAIDs. Forty-nine were prescribed NSAID after admission. Nineteen (32.2%) were on regular NSAID (11\\/19 on PPI) and 38 patients were on PRN NSAID (12\\/38 on PPI). Seventeen of 49 patients were on other medications associated with gastrointestinal bleeding (10\\/17 were on PPI). Nineteen patients (33.3%) were >60 years. Eight patients had three or four risk factors for gastrointestinal bleeding; six were on PPI. Thirteen patients had two risks; 7 were on PPI. Six of 19 patients with one risk factor were on PPI. 40.3% had stage 2\\/3 chronic kidney disease. 35.1% had ischaemic heart disease. CONCLUSIONS: NSAIDs and PPIs are often prescribed inappropriately.

Registries Help Moms Measure Medication Risks

Science.gov (United States)

... in the case of the North American Antiepileptic Drug Pregnancy Registry, which studies the effects of drugs for ... is taking. For example, the North American Antiepileptic Drug Pregnancy Registry website lists more than 30 medications being ...

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

Science.gov (United States)

2013-01-04

...] Medical Imaging Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS... and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Medical Imaging Drugs Advisory Committee. General Function of the Committee: To provide advice and recommendations...

Increased Risk for ESBL-Producing Bacteria from Co-administration of Loperamide and Antimicrobial Drugs for Travelers' Diarrhea.

Science.gov (United States)

Kantele, Anu; Mero, Sointu; Kirveskari, Juha; Lääveri, Tinja

2016-01-01

Antimicrobial drug treatment of travelers' diarrhea is known to increase the risk for colonization with extended-spectrum β-lactamase-producing Enterobacteriaceae. Among 288 travelers with travelers' diarrhea, the colonization rate without medications was 21%. For treatment with loperamide only, the rate was 20%; with antimicrobial drugs alone, 40%; and with loperamide and antimicrobial drugs, 71%.

Leaving the Hospital Against Medical Advice Among People Who Use Illicit Drugs: A Systematic Review

Science.gov (United States)

Ti, Lianlian

2015-01-01

Background. Leaving the hospital against medical advice is an increasing problem in acute care settings and is associated with an array of negative health consequences that may lead to readmission for a worsened health outcome or mortality. Leaving the hospital against medical advice is particularly common among people who use illicit drugs (PWUD) and has been linked to a number of complex issues; however, few studies have focused specifically on this population beyond identifying them as being at an increased risk of leaving the hospital prematurely. Furthermore, programs and interventions for reducing the rate of leaving the hospital against medical advice among PWUD in acute care settings have not been well studied. Objectives. We systematically assessed the literature examining hospital discharge against medical advice from acute care among this population and identified potential methods to minimize the occurrence of this phenomenon. Search methods. We searched 5 electronic databases (from database inception to August 2014) and article reference lists for articles investigating hospital discharge from acute care against medical advice among PWUD. Search terms consistent across databases included “patient discharge,” “hospital discharge,” “against medical advice,” “drug user,” “substance-related disorders,” and “intravenous substance abuse.” Selection criteria. Studies were eligible for inclusion if they were published in a peer-reviewed journal as an original research article in English. We excluded gray literature, case reports, case series, reviews, and editorials. We retained original studies that reported illicit drug use as a predictor of leaving the hospital against medical advice and studies of discharge against medical advice that included PWUD as a population of interest, and we assessed significance through appropriate statistical tests. We excluded studies that reported patients leaving the hospital against medical advice

Association of medication errors with drug classifications, clinical units, and consequence of errors: Are they related?

Science.gov (United States)

Muroi, Maki; Shen, Jay J; Angosta, Alona

2017-02-01

Registered nurses (RNs) play an important role in safe medication administration and patient safety. This study examined a total of 1276 medication error (ME) incident reports made by RNs in hospital inpatient settings in the southwestern region of the United States. The most common drug class associated with MEs was cardiovascular drugs (24.7%). Among this class, anticoagulants had the most errors (11.3%). The antimicrobials was the second most common drug class associated with errors (19.1%) and vancomycin was the most common antimicrobial that caused errors in this category (6.1%). MEs occurred more frequently in the medical-surgical and intensive care units than any other hospital units. Ten percent of MEs reached the patients with harm and 11% reached the patients with increased monitoring. Understanding the contributing factors related to MEs, addressing and eliminating risk of errors across hospital units, and providing education and resources for nurses may help reduce MEs. Copyright © 2016 Elsevier Inc. All rights reserved.

A survey of attitudes, practices, and knowledge regarding drug-drug interactions among medical residents in Iran

NARCIS (Netherlands)

Nabovati, Ehsan; Vakili-Arki, Hasan; Taherzadeh, Zhila; Saberi, Mohammad Reza; Abu-Hanna, Ameen; Eslami, Saeid

2017-01-01

Background When prescribing medications, physicians should recognize clinically relevant potential drug-drug interactions (DDIs). To improve medication safety, it is important to understand prescribers' knowledge and opinions pertaining to DDIs. Objective To determine the current DDI information

Common adverse drug reactions with psychiatric medications and ...

African Journals Online (AJOL)

Common adverse drug reactions with psychiatric medications and an approach to their management: Adverse drug reactions are as important in psychiatric practice as they are in any other branch of medicine.

Illicit drug use is increasing among non-medical users of prescription drugs-Results from population-based surveys 2002-2014.

Science.gov (United States)

Karjalainen, Karoliina; Lintonen, Tomi; Hakkarainen, Pekka

2017-09-01

Non-medical use of prescription drugs (NMUPD) is known to be associated with illicit drug use, but less is known about how illicit drug use has changed in NMUPD. We examined (1) the changes in illicit drug use among Finnish non-medical users of prescription drugs during the 2000s and (2) whether the trends of illicit drug use differ by non-medical use of prescription drugs in the general population. Data were derived from population-based (aged 15-69) Drug Surveys conducted in Finland in 2002, 2006, 2010 and 2014. The response rates varied between 63% and 48%. NMUPD during the last year was measured (n=252). Past-year illicit drug use among non-medical users of prescription drugs and the reference population not reporting NMUPD (n=10,967) was compared. Logistic regression was used to estimate the p-values for trends. Illicit drug use has increased notably among Finnish non-medical users of prescription drugs (from 21% to 70%, p for trendillicit drug use also increased statistically significantly, but much more moderately (from 2.5% to 5.4%). The difference between the trends was confirmed by an interaction test (p=0.022). NMUPD seems to be increasingly merging with illicit drug use. This indicates an increasing prevalence of polydrug use among non-medical users of prescription drugs, which may bring about more severe harms and worse health outcomes for users and more challenges in regard to treatment. Copyright © 2017 Elsevier B.V. All rights reserved.

Self-medication with antimicrobial drugs in Europe

NARCIS (Netherlands)

Grigoryan, L; Haaijer-Ruskamp, FM; Burgerhof, JGM; Mechtler, R; Deschepper, R; Tambic-Andrasevic, A; Andrajati, R; Monnet, DL; Cunney, R; Di Matteo, A; Edelstein, H; Valinteliene, R; Alkerwi, A; Scicluna, EA; Grzesiowski, P; Bara, AC; Tesar, T; Cizman, M; Campos, J; Lundborg, CS; Birkin, J

We surveyed the populations of 19 European countries to compare the prevalence of antimicrobial drug self-medication in the previous 12 months and intended self-medication and storage and to identify the associated demographic characteristics. By using a multistage sampling design, 1,000-3,000

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

Science.gov (United States)

2011-07-29

.... FDA-2010-N-0002] Advisory Committee; Medical Imaging Drugs Advisory Committee; Re- Establishment... (FDA) is announcing the re- establishment of the Medical Imaging Drugs Advisory Committee in FDA's Center for Drug Evaluation and Research. This rule amends the current language for the Medical Imaging...

Occupational Exposure to Antineoplastic Drugs: Identification of Job Categories Potentially Exposed throughout the Hospital Medication System

Directory of Open Access Journals (Sweden)

Chun-Yip Hon

2011-09-01

Conclusion: We found drug contamination on select surfaces at every stage of the medication system, which indicates the existence of an exposure potential throughout the facility. Our results suggest that a broader range of workers are potentially exposed than has been previously examined. These results will allow us to develop a more inclusive exposure assessment encompassing all healthcare workers that are at risk throughout the hospital medication system.

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

Directory of Open Access Journals (Sweden)

Jaykaran Charan

2011-01-01

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

Drug interaction databases in medical literature

DEFF Research Database (Denmark)

Kongsholm, Gertrud Gansmo; Nielsen, Anna Katrine Toft; Damkier, Per

2015-01-01

PURPOSE: It is well documented that drug-drug interaction databases (DIDs) differ substantially with respect to classification of drug-drug interactions (DDIs). The aim of this study was to study online available transparency of ownership, funding, information, classifications, staff training...... available transparency of ownership, funding, information, classifications, staff training, and underlying documentation varies substantially among various DIDs. Open access DIDs had a statistically lower score on parameters assessed....... and the three most commonly used subscription DIDs in the medical literature. The following parameters were assessed for each of the databases: Ownership, classification of interactions, primary information sources, and staff qualification. We compared the overall proportion of yes/no answers from open access...

Analysis of clinical drug-drug interaction data to predict uncharacterized interaction magnitudes between antiretroviral drugs and co-medications.

Science.gov (United States)

Stader, Felix; Kinvig, Hannah; Battegay, Manuel; Khoo, Saye; Owen, Andrew; Siccardi, Marco; Marzolini, Catia

2018-04-23

Despite their high potential for drug-drug-interactions (DDI), clinical DDI studies of antiretroviral drugs (ARVs) are often lacking, because the full range of potential interactions cannot feasibly or pragmatically be studied, with some high-risk DDI studies also ethically difficult to undertake. Thus, a robust method to screen and to predict the likelihood of DDIs is required.We developed a method to predict DDIs based on two parameters: the degree of metabolism by specific enzymes such as CYP3A and the strength of an inhibitor or inducer. These parameters were derived from existing studies utilizing paradigm substrates, inducers and inhibitors of CYP3A, to assess the predictive performance of this method by verifying predicted magnitudes of changes in drug exposure against clinical DDI studies involving ARVs.The derived parameters were consistent with the FDA classification of sensitive CYP3A substrates and the strength of CYP3A inhibitors and inducers. Characterized DDI magnitudes (n = 68) between ARVs and co-medications were successfully quantified meaning 53%, 85% and 98% of the predictions were within 1.25-fold (0.80 - 1.25), 1.5-fold (0.66 - 1.48) and 2-fold (0.66 - 1.94) of the observed clinical data. In addition, the method identifies CYP3A substrates likely to be highly or conversely minimally impacted by CYP3A inhibitors or inducers, thus categorizing the magnitude of DDIs.The developed effective and robust method has the potential to support a more rational identification of dose adjustment to overcome DDIs being particularly relevant in a HIV-setting giving the treatments complexity, high DDI risk and limited guidance on the management of DDIs. Copyright © 2018 American Society for Microbiology.

Risk perception of prescription drugs: results of a survey among experts in the European regulatory network.

Science.gov (United States)

Beyer, Andrea R; Fasolo, Barbara; Phillips, Lawrence D; de Graeff, Pieter A; Hillege, Hans L

2013-05-01

Experts are perceived to be veridical and to focus only on objective data when evaluating risk. Only a few research studies have attempted to characterize the subjectivity in risk evaluation among experts. The hypothesis of this study is that expert evaluation of a pharmaceutical drug can be partly explained by dimensions that describe the drug and by individual characteristics. Seventy-five medical assessors in 9 EU countries evaluated a list of 28 pharmaceutical drugs using 4 scales: risk, benefit, seriousness of harm, and patients' knowledge of the risk. They were also given a mock "clinical dossier" and asked to rate it on 8 dimensions: risk, benefit, worry, magnitude of the exposure, scientific knowledge of the risk, familiarity of the risk, ethical concerns, and risk acceptability. Female assessors perceived significantly higher benefits than men for a large number of the 28 drugs. Principal component analysis of the ratings for the clinical dossiers revealed 2 underlying components: seriousness of harm and scientific evidence. A regression model predicting the risk perception of the drug showed that the variables seriousness of harm (benefit, worry, magnitude of exposure, ethical concerns, and risk acceptability), years of regulatory experience, gender, and type of drug explained 54% of the variability among assessors. Assessors' view of the risks associated with pharmaceutical drugs is influenced by worry for patient safety, magnitude of patient exposure, and ethical concerns. These dimensions may influence their perceptions of benefit and risk acceptability. Senior assessors are more risk averse than junior assessors, and female assessors seem to be sensitive to the promise of benefit from medicines and consequently may be less risk averse than male assessors.

Information and communication on risks related to medications and proper use of medications for healthcare professionals and the general public: precautionary principle, risk management, communication during and in the absence of crisis situations.

Science.gov (United States)

Molimard, Mathieu; Bernaud, Corine; Lechat, Philippe; Bejan-Angoulvant, Theodora; Benattia, Cherif; Benkritly, Amel; Braunstein, David; Cabut, Sandrine; David, Nadine; Fourrier-Réglat, Annie; Gallet, Benoit; Gersberg, Marta; Goni, Sylvia; Jolliet, Pascale; Lamarque-Garnier, Véronique; Le Jeunne, Claire; Leurs, Irina; Liard, François; Malbezin, Muriel; Micallef, Joelle; Nguon, Marina

2014-01-01

Recent drug crises have highlighted the complexity, benefits and risks of medication communication. The difficulty of this communication is due to the diversity of the sources of information and the target audience, the credibility of spokespersons, the difficulty to communicate on scientific uncertainties and the precautionary principle, which is influenced by variable perceptions and tolerances of the risk. Globally, there is a lack of training in risk management with a tendency of modern society to refuse even the slightest risk. Communication on medications is subject to regulatory or legal requirements, often uses tools and messages that are not adapted to the target audience and is often based on a poor knowledge of communication techniques. In order to improve this situation, the available information must be coordinated by reinforcing the unique medication information website and by coordinating communication between authorities by means of a single spokesperson. A particular effort must be made in the field of training in the proper use and risk of medications for both the general population and patients but also for healthcare professionals, by setting up a unified academic on-line teaching platform for continuing medical education on medications and their proper use. © 2014 Société Française de Pharmacologie et de Thérapeutique.

Consumption of medicines in high-risk pregnancy: evaluation of determinants related to the use of prescription drugs and self-medication

OpenAIRE

Araújo, Danielle Dayse; Leal, Marineide Marinho; Santos, Eliane Jucielly Vasconcelos; Leal, Leila Bastos

2013-01-01

The use of drugs during pregnancy still represents a challenge for medicine, since the majority of drugs cross the placental barrier with a potential to cause several congenital problems to the fetus, and most of them have not been clinically tested in pregnant patients. At the same time, the medicalization phenomenon, self-medication, and lack of patient information about the misuse of medicines are additional problems. Thus, the aim of this study was to evaluate the pattern of medicine cons...

Drug allergy passport and other documentation for patients with drug hypersensitivity

DEFF Research Database (Denmark)

Brockow, Knut; Aberer, Werner; Atanaskovic-Markovic, M

2016-01-01

The strongest and best-documented risk factor for drug hypersensitivity (DH) is the history of a previous reaction. Accidental exposures to drugs may lead to severe or even fatal reactions in sensitized patients. Preventable prescription errors are common. They are often due to inadequate medical...... history or poor risk assessment of recurrence of drug reaction. Proper documentation is essential information for the doctor to make sound therapeutic decision. The European Network on Drug Allergy and Drug Allergy Interest Group of the European Academy of Allergy and Clinical Immunology have formed...... a task force and developed a drug allergy passport as well as general guidelines of drug allergy documentation. A drug allergy passport, a drug allergy alert card, a certificate, and a discharge letter after medical evaluation are adequate means to document DH in a patient. They are to be handed...

Risk evaluation mitigation strategies: the evolution of risk management policy.

Science.gov (United States)

Hollingsworth, Kristen; Toscani, Michael

2013-04-01

The United States Food and Drug Administration (FDA) has the primary regulatory responsibility to ensure that medications are safe and effective both prior to drug approval and while the medication is being actively marketed by manufacturers. The responsibility for safe medications prior to marketing was signed into law in 1938 under the Federal Food, Drug, and Cosmetic Act; however, a significant risk management evolution has taken place since 1938. Additional federal rules, entitled the Food and Drug Administration Amendments Act, were established in 2007 and extended the government's oversight through the addition of a Risk Evaluation and Mitigation Strategy (REMS) for certain drugs. REMS is a mandated strategy to manage a known or potentially serious risk associated with a medication or biological product. Reasons for this extension of oversight were driven primarily by the FDA's movement to ensure that patients and providers are better informed of drug therapies and their specific benefits and risks prior to initiation. This article provides an historical perspective of the evolution of medication risk management policy and includes a review of REMS programs, an assessment of the positive and negative aspects of REMS, and provides suggestions for planning and measuring outcomes. In particular, this publication presents an overview of the evolution of the REMS program and its implications.

Handling chemotherapy drugs-Do medical gloves really protect?

Science.gov (United States)

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. © 2014 UICC.

Drug Holidays From ADHD Medication: International Experience Over the Past Four Decades.

Science.gov (United States)

Ibrahim, Kinda; Donyai, Parastou

2015-07-01

ADHD is managed by stimulants that are effective but can cause growth retardation. Prescribers should ideally monitor children and trial a "drug holiday" to enable catch-up growth. Our aim was to map the experience of drug holidays from ADHD medication in children and adolescents. A comprehensive search of the literature identified 22 studies published during the period 1972 to 2013. Drug holidays are prevalent in 25% to 70% of families and are more likely to be exercised during school holidays. They test whether medication is still needed and are also considered for managing medication side effects and drug tolerance. The impact of drug holidays was reported in terms of side effects and ADHD symptoms. There was evidence of a positive impact on child growth with longer breaks from medication, and shorter breaks could reduce insomnia and improve appetite. Drug holidays from ADHD medication could be a useful tool with multiple purposes: assessment, management, prevention, and negotiation. © 2014 SAGE Publications.

Personality, lifestyles, alcohol and drug consumption in a sample of British medical students.

Science.gov (United States)

Ashton, C H; Kamali, F

1995-05-01

Personality characteristics and lifestyle variables were assessed in two cohorts of second-year medical students at the University of Newcastle upon Tyne, UK as part of a psychopharmacology 'teach-in' in 1993 and 1994. The pooled sample included 186 students: 77 men, 109 women, mean age 20.4 +/- 1.8 years. Measures included the Eysenck Personality Questionnaire, the Hospital Anxiety Depression Scale, and a questionnaire concerning consumption of alcohol, tobacco, cannabis and other illicit drugs, and physical exercise. The results were compared, where possible, with a similar survey in Newcastle upon Tyne medical students in 1983 and 1984. Personality variables, prevalence of cigarette smoking, levels of caffeine consumption and participation in sports had not changed significantly over the decade. There appeared to be a modest overall increase in alcohol consumption and in the 1993 and 1994 cohorts of students, 25.5% of those who drank alcohol exceeded recommended low risk levels (comparable data not available for 1983 and 1984). Reported use of cannabis and other illicit drugs had more than doubled, and in the present survey 49.2% of students recorded using cannabis and 22% had tried other illicit drugs. Corresponding figures for 1983 and 1984 were 20.9% for cannabis and 3.3% for other illicit drugs. Anxiety levels were not measured in 1983 and 1984 but in the present survey 39.3% of the students had anxiety ratings within the clinically significant range. The high levels of alcohol consumption and illicit drug use, and the high anxiety ratings, in this sample of medical students are a cause for concern.(ABSTRACT TRUNCATED AT 250 WORDS)

Better adherence to antithyroid drug is associated with decreased risk of stroke in hyperthyroidism patients.

Science.gov (United States)

Tsai, M-S; Chuang, P-Y; Huang, C-H; Shih, S-R; Chang, W-T; Chen, N-C; Yu, P-H; Cheng, H-J; Tang, C-H; Chen, W-J

2015-12-01

An increased risk for ischaemic stroke has been reported in young hyperthyroidism patients independent of atrial fibrillation (AF). However, whether the use of antithyroid drugs in hyperthyroidism patients can reduce the occurrence of ischaemic stroke remains unclear. A total of 36,510 newly diagnosed hyperthyroidism patients during 2003-2006 were identified from the Taiwan National Health Insurance Research database. Each patient was individually tracked for 5 years from their index date (beginning the antithyroid drugs) to identify those who suffered from new episode of ischaemic stroke. Medication possession ratio (MPR) was used to represent the antithyroid drug compliance. The association between the MPR and the risk of stroke was examined. The stroke incidence rates for hyperthyroidism patients with age hyperthyroidism patients without AF, good antithyroid drugs compliance also reduced the incidence of stroke significantly (adjusted HR, range: 1.52-1.61; p = 0.02); but not in hyperthyroidism with AF. Hyperthyroidism patients with good antithyroid drug compliance had a lower risk of ischaemic stroke than patients with poor compliance. © 2015 John Wiley & Sons Ltd.

Pill-poppers and dopers: a comparison of non-medical prescription drug use and illicit/street drug use among college students.

Science.gov (United States)

Ford, Jason A; Arrastia, Meagan C

2008-07-01

Data from the 2001 College Alcohol Study, a national sample of U.S. college students, were used to conduct multinomial logistic regression analysis examining correlates of substance use. Students were divided into three groups based on their lifetime substance use: non-users, non-medical prescription drug use only, and illicit/street drug use only. The purpose of this analytic strategy was to examine the similarities/differences in the correlates of non-medical prescription drug use and illicit/street drug use. Findings indicate that race, age, G.P.A., sexual activity, health, binge drinking, marijuana use, social bonding and social learning measures are correlates of non-medical prescription drug use. Correlates of illicit/street drug use include gender, Hispanic ethnicity, sexual activity, binge drinking, marijuana use, social bonding and social learning measures. Finally, the focus of the paper is a comparison of students who report only non-medical prescription drug use to students who report only illicit/street drug use. Findings indicate that gender, race, marital status, sexual activity, marijuana use, and social bonding measures significantly distinguish illicit/street drug use from non-medical prescription drug use. Important implications, limitations, and future research needs were discussed.

[The Pharmaceuticals and Medical Devices Agency's Approach to Facilitate Risk Communication and Its Challenges].

Science.gov (United States)

Kondo, Emiko; Torii, Mayumi; Oba, Izumi; Okamoto, Mai

2018-01-01

　The issue of drug lag in Japan has been rapidly reduced in recent years, and newly approved drugs now become available on Japanese and international markets at the same time. In this context, the risk management plan (RMP) system was introduced in 2012. RMPs describe important safety concerns recognized by Japan's Pharmaceuticals and Medical Devices Agency (PMDA) and marketing authorization holders (MAHs), as well as safety measures that MAHs request healthcare professionals (HCPs) to follow. The publication of RMPs is expected to support the sharing of drug risk management among HCPs during the postmarketing phase. In addition, to encourage risk communication between HCPs and patients, the PMDA website provides drug guides for patients and other information to promote proper understanding of drugs by patients and their families and enable them to identify serious adverse drug reactions at an early stage. However, the results of surveys conducted by the PMDA in FY2014 and FY2015 revealed low levels of awareness of RMPs and drug guides for patients in hospitals and other healthcare institutions. The surveys also showed that information regarding the proper use of drugs from MAHs and the PMDA was not incorporated into practice at healthcare institutions, resulting in the repeated release of identical safety alerts. To facilitate the increased utilization of risk communication tools, the PMDA has been providing and disseminating these tools through its website. This study addresses those efforts and the associated challenges.

[Risk reduction and drug use in detention: study about the detainees of Liancourt Penitentiary].

Science.gov (United States)

Sannier, Olivier; Verfaillie, Florent; Lavielle, Dorothée

2012-07-01

The prison population is drug users. Recent debates around the provision of devices to reduce the risks associated with drug use (syringe exchange programs and snort kit) lead us to question local practices of the prison population. An anonymous questionnaire was offered to the prison population of the Liancourt penitentiary. The questions addressed the use of drugs before and during incarceration, knowledge of HIV and B and C hepatitis status, taking an opiate substitution treatment and advice on the implementation of syringe exchange programs and snort kit. A percentage of 54.4 of the prisoners responded to the questionnaire. An amount of 60.1 % of respondents consumed at least one drug before incarceration and 43.6 % of respondents consumed at least one drug during their incarceration. Cannabis was the most consumed drug before and during incarceration. Barely half of respondents reported knowing their HIV and hepatitis B and C status. Over 10 % of respondents said they were interesting in establishing needle exchange programs or snort kit. The prison concentrate drug users and is not a repressive tool of efficient risk reduction. The strategies implemented by the medical unit of Liancourt prison require adaptations that warrant development of health resources. Then, only new tools to reduce risks associated with drug use can be established. Copyright © 2012 Elsevier Masson SAS. All rights reserved.

Risk of interactions between complementary and alternative medicine and medication for comorbidities in patients with melanoma.

Science.gov (United States)

Loquai, Carmen; Dechent, Dagmar; Garzarolli, Marlene; Kaatz, Martin; Kaehler, Katharina C; Kurschat, Peter; Meiss, Frank; Stein, Annette; Nashan, Dorothee; Micke, Oliver; Muecke, Ralph; Muenstedt, Karsten; Stoll, Christoph; Schmidtmann, Irene; Huebner, Jutta

2016-05-01

Complementary and alternative medicine (CAM) is used widely among cancer patients. Beside the risk of interaction with cancer therapies, interactions with treatment for comorbidities are an underestimated problem. The aim of this study was to assess prevalence of interactions between CAM and drugs for comorbidities from a large CAM usage survey on melanoma patients and to classify herb-drug interactions with regard to their potential to harm. Consecutive melanoma outpatients of seven skin cancer centers were asked to complete a standardized CAM questionnaire including questions to their CAM use and their taken medication for comorbidities and cancer. Each combination of conventional drugs and complementary substances was evaluated for their potential of interaction. 1089 questionnaires were eligible for evaluation. From these, 61.6% of patients reported taking drugs regularly from which 34.4% used biological-based CAM methods. Risk evaluation for interaction was possible for 180 CAM users who listed the names or substances they took for comorbidities. From those patients, we found 37.2% at risk of interaction of their co-consumption of conventional and complementary drugs. Almost all patients using Chinese herbs were at risk (88.6%). With a high rate of CAM usage at risk of interactions between CAM drugs and drugs taken for comorbidities, implementation of a regular assessment of CAM usage and drugs for comorbidities is mandatory in cancer care.

Adverse effects and Drug Interactions Associated with Inhaled Recreational and Medical Marijuana

Directory of Open Access Journals (Sweden)

Maisha Kelly Freeman

2016-06-01

Full Text Available Objectives: To provide an overview of the addiction potential; adverse effects (e.g., cardiovascular, immune dysfunction, respiratory system, mental health disorders; drug interactions; effects of accidental exposure; crime statistics; and pharmacist’s considerations for the use of inhaled medical marijuana. Methods: A PubMed search was conducted from 1966 to March 2016 to identify articles in which the safety of inhaled medical marijuana was assessed. Key MeSH search terms included medical marijuana with a subheading for adverse effect. Only articles in adult patients were considered. In addition, medical marijuana or cannabis plus one of the following search terms were searched: drug interactions, herb-drug interactions, drug-related side effects and adverse drug reactions, substance-related disorders, addiction, and abuse. A free-text search was also conducted to identify articles not included in the MeSH term search. A bibliographic search was also conducted. Articles were included if they addressed adverse effects of medical marijuana for the treatment of a condition. Meta-analyses, randomized controlled clinical trials, and case reports were included in the review if the primary focus of the article related to the adverse effect profile of inhaled medical marijuana. Medical marijuana efficacy studies were not assessed. In the absence of this information, case reports or reports of inhaled recreational marijuana use was used. Studies were excluded if published in languages other than English. In addition, studies highlighting mechanisms of action, studies of pharmacodynamics or pharmacokinetic effects were excluded, unless these effects were due to drug-drug interactions. Prescription products containing marijuana or derivatives were excluded from evaluation. An Internet search was conducted to locate the most up-to-date information on the laws concerning medical marijuana. Key findings: A PubMed search revealed 58 articles and 28 of

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

Science.gov (United States)

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

2015-01-01

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

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

Directory of Open Access Journals (Sweden)

Seemüller Florian

2012-02-01

Full Text Available Abstract 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.

Drug use prevalence among students of universities of medical sciences in Tehran

Directory of Open Access Journals (Sweden)

Farhad Taremian

2014-02-01

Full Text Available Objective: This study was aimed to determine the prevalence of drug use among students of universities of Medical Sciences in Tehran. Method: Four thousands of medical students (both sexes in academic year 1388-89 in different level of education, B.A., M.Sc. and Ph.D. were selected by random stratified sampling method. These students were selected from Iran, Tehran and Shahid Beheshti Universities of Medical Sciences considering their sex and level of education. We used drug use prevalence questionnaire. Findings: The most prevalent drug of abuse in life time period was qalyan (classical pipe, followed by cigarette, and alcohol. The least frequent drug of abuse was Shisheh, followed by heroine krack. As we expected, drugs morphine, ritalin and tramadol were placed in forth, fifth and sixth of prevalent drugs. Use of different substances was significantly more prevalent in male students. Conclusion: Using soft drugs (qalyan, cigarette and alcohol was more prevalent than hard drugs (hashish, taryak, heroine kerack among Universities Medical Sciences of Tehran. Similar to drug use pattern in society, use of all of drugs were more prevalent in male students. We should pay special attention to use of drugs such as tramadol, ritalin, petedin and morphine.

Estimation of risks from medical irradiation

International Nuclear Information System (INIS)

Persson, B.R.R.

1983-01-01

This paper discuss various concepts of quantifying risks from medical irradiation. The expected individual risk from specific medical examination can be derived by estimation the dose-equivalent in different organs and tissues and apply the risk factors recommended for these tissues. A more practical way is to estimate or measure the energy imparted which has been found to correlate quite well with the total risk derived by summing up the risks for the involved tissues. The effective dose-equivalent concept can be used to derive the collective effective dose-equivalent in a population in order to compare the contribution from medical exposure with the contribution from other sources of irradiation in the society. In many countries it is thus shown that medical exposures gives the largest man-made contribution to the population dose

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

Science.gov (United States)

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

2005-04-01

Collaboration between the medical school at Leicester and a local pharmaceutical company, AstraZeneca, led to the design and implementation of an optional third year special science skills module teaching medical students about drug discovery and development. The module includes didactic teaching about the complexities of the drug discovery process leading to development of candidate drugs for clinical investigation as well as practical experience of the processes involved in drug evaluation preclinically and clinically. It highlights the major ethical and regulatory issues concerned with the production and testing of novel therapies in industry and the NHS. In addition it helps to reinforce other areas of the medical school curriculum, particularly the understanding of clinical study design and critical appraisal. The module is assessed on the basis of a written dissertation and the critical appraisal of a drug advertisement. This paper describes the objectives of the module and its content. In addition we outline the results of an initial student evaluation of the module and an assessment of its impact on student knowledge and the opinion of the pharmaceutical industry partner. This module has proven to be popular with medical students, who acquire a greater understanding of the work required for drug development and therefore reflect more favourably on the role of pharmaceutical companies in the UK.

OBJECTIVE AND SUBJECTIVE FACTORS OF MEDICAL DRUG CHOICE

Directory of Open Access Journals (Sweden)

E. B. Babanskaya

2017-01-01

Full Text Available Aim. To analyze the factors of medical choice in the prescription of medicinal drug (MD for the treatment of cardiovascular diseases. Material and methods. A questionnaire survey of 212 doctors (138 physicians and 42 general practitioners was performed in Irkutsk region and Republic of Buryatia. Questions were related to the physicians’ choice of the original or generic MD and the factors that influence this choice. Results. The majority of respondents prefer the foreign MD, while they prescribed both original and generic drugs (60.4%. The determining factor in the prescription of MD is its efficacy (91.5-95.3%. The main source of information of MD for physicians is the medical literature (78.3%. Only 23.6% of doctors choose the MD based on the results of clinical trials and information about it in specialized medical literature. A half of the respondents believe that their knowledge of cardiovascular MD is insufficient. Doctors need and are interested in information on the pharmacokinetics and pharmacodynamics of MD, side effects, drug interactions and results of clinical studies. Conclusion. It is necessary to focus on the clinical pharmacology of cardiovascular MD during the training of doctors in specialized courses of continuous medical education.

Adverse Drug Events and Medication Errors in African Hospitals: A Systematic Review.

Science.gov (United States)

Mekonnen, Alemayehu B; Alhawassi, Tariq M; McLachlan, Andrew J; Brien, Jo-Anne E

2018-03-01

Medication errors and adverse drug events are universal problems contributing to patient harm but the magnitude of these problems in Africa remains unclear. The objective of this study was to systematically investigate the literature on the extent of medication errors and adverse drug events, and the factors contributing to medication errors in African hospitals. We searched PubMed, MEDLINE, EMBASE, Web of Science and Global Health databases from inception to 31 August, 2017 and hand searched the reference lists of included studies. Original research studies of any design published in English that investigated adverse drug events and/or medication errors in any patient population in the hospital setting in Africa were included. Descriptive statistics including median and interquartile range were presented. Fifty-one studies were included; of these, 33 focused on medication errors, 15 on adverse drug events, and three studies focused on medication errors and adverse drug events. These studies were conducted in nine (of the 54) African countries. In any patient population, the median (interquartile range) percentage of patients reported to have experienced any suspected adverse drug event at hospital admission was 8.4% (4.5-20.1%), while adverse drug events causing admission were reported in 2.8% (0.7-6.4%) of patients but it was reported that a median of 43.5% (20.0-47.0%) of the adverse drug events were deemed preventable. Similarly, the median mortality rate attributed to adverse drug events was reported to be 0.1% (interquartile range 0.0-0.3%). The most commonly reported types of medication errors were prescribing errors, occurring in a median of 57.4% (interquartile range 22.8-72.8%) of all prescriptions and a median of 15.5% (interquartile range 7.5-50.6%) of the prescriptions evaluated had dosing problems. Major contributing factors for medication errors reported in these studies were individual practitioner factors (e.g. fatigue and inadequate knowledge

Use of FMEA analysis to reduce risk of errors in prescribing and administering drugs in paediatric wards: a quality improvement report.

Science.gov (United States)

Lago, Paola; Bizzarri, Giancarlo; Scalzotto, Francesca; Parpaiola, Antonella; Amigoni, Angela; Putoto, Giovanni; Perilongo, Giorgio

2012-01-01

Administering medication to hospitalised infants and children is a complex process at high risk of error. Failure mode and effect analysis (FMEA) is a proactive tool used to analyse risks, identify failures before they happen and prioritise remedial measures. To examine the hazards associated with the process of drug delivery to children, we performed a proactive risk-assessment analysis. Five multidisciplinary teams, representing different divisions of the paediatric department at Padua University Hospital, were trained to analyse the drug-delivery process, to identify possible causes of failures and their potential effects, to calculate a risk priority number (RPN) for each failure and plan changes in practices. To identify higher-priority potential failure modes as defined by RPNs and planning changes in clinical practice to reduce the risk of patients harm and improve safety in the process of medication use in children. In all, 37 higher-priority potential failure modes and 71 associated causes and effects were identified. The highest RPNs related (>48) mainly to errors in calculating drug doses and concentrations. Many of these failure modes were found in all the five units, suggesting the presence of common targets for improvement, particularly in enhancing the safety of prescription and preparation of endovenous drugs. The introductions of new activities in the revised process of administering drugs allowed reducing the high-risk failure modes of 60%. FMEA is an effective proactive risk-assessment tool useful to aid multidisciplinary groups in understanding a process care and identifying errors that may occur, prioritising remedial interventions and possibly enhancing the safety of drug delivery in children.

Risk of hospitalization associated with anticholinergic medication for patients with dementia.

Science.gov (United States)

Watanabe, Shuichi; Fukatsu, Takahide; Kanemoto, Kosuke

2018-01-01

With the ageing of the general population, demand has grown for measures to prevent hospitalization for dementia, which can exacerbate problems associated with activities of daily living in elderly individuals. Anticholinergic medication has been shown to cause falls, delirium, and cognitive impairment in aged patients. However, the risk of hospitalization associated with the administration of anticholinergics is unclear. We analyzed the records of 61 outpatients (26 men, 35 women; mean age: 78 ± 7 years; mean follow-up period: 420 days) diagnosed with dementia (Alzheimer's disease: n = 45; dementia with Lewy bodies: n = 3; undifferentiated n = 13) and prescribed anti-dementia drugs between May 2013 and December 2014. Medication history was noted, and the patients were divided into two groups according to the Anticholinergic Risk Scale: with risk (n = 13) and without risk (n = 48). Outcome was judged based on an end-point of hospitalization or death. Kaplan-Meier survival and Cox proportional hazard analyses were performed. Eight patients with anticholinergic risk and 12 without anticholinergic risk reached the end-point (P dementia. The Anticholinergic Risk Scale findings were shown to be a strong predictor of hospitalization for patients with dementia. We should evaluate the anticholinergic burden before initiating anti-dementia therapy. © 2018 Japanese Psychogeriatric Society.

Gut microbiota in toxicological risk assessment of drugs and chemicals: The need of hour.

Science.gov (United States)

Velmurugan, Ganesan

2018-03-06

The advent of industrial revolution caused a large inflow of synthetic chemicals for medical, agricultural, industrial and other purposes in the world. In general, these chemicals were subjected to toxicological risk assessment for human health and ecology before release for public use. But today we are witnessing a negative impact of some of these chemicals on human health and environment indicating an underestimation of toxic effects by current risk assessment protocol. Recent studies established gut microbiota as one of the key player in intercession of toxicity of drugs and synthetic chemicals. Hence, the need of the hour is to include the assessment for microbiota specifically gut microbiota in human toxicological risk assessment protocol. Herewith we are proposing a framework for assessment of gut microbiota upon exposure to drugs or chemicals.

Beyond post-marketing research and MedWatch: Long-term studies of drug risks.

Science.gov (United States)

Resnik, David B

2007-10-01

Critics of the drug safety system have discussed many different potential reforms, ranging from mandatory registration of clinical trials to increasing the power of regulatory agencies, but few have discussed one of the most important ways of enhancing safety: increasing the number of long-term studies of medications. Long-term studies of the risks and benefits of drugs can provide useful information for regulators, healthcare professionals, and patients. Government funding agencies should lead the effort to conduct long-term studies of drugs, but private companies should also be required to lend financial support. Because cost-effectiveness is likely to be an important consideration in conducting this research, funding agencies should focus, at first, on drugs that are used to treat common, chronic conditions.

Adherence to drug treatment in association with how the patient perceives care and information on drugs.

Science.gov (United States)

Ulfvarson, Johanna; Bardage, Carola; Wredling, Regina A-M; von Bahr, Christer; Adami, Johanna

2007-01-01

This study was to explore concordance with drugs prescribed and the patient's self-reported drug consumption, in relation to the older patient's perceived care and information given. Lack of adherence to prescriptions may lead to therapeutic failure with risks for relapse, unnecessary suffering and increased costs. A cross-sectional study with structured interviews of 200 patients who had recently been treated in a medical ward. Patients' medical records were studied to obtain information on their current use of drugs. The data were analyzed by logistic regression, adherence being the dependent response variable. The mean age of the study group was 79 years. The number of drugs reported in the medical chart ranged from one to 17 with a mean of 6.9. The patients reported a drug consumption ranging from 0 to 24 with a mean of 7.3. When comparing the interview results with the information in the medical charts, 30% of the patients showed adherence. An association was found between adherence and self-reported health status. Patients in the non-adherent group reported a higher consumption of drugs. Patients felt that the opportunity to ask questions of either the responsible physicians or of the nurses was influential in decreasing risk. In this study, the patient's total drug consumption was considered. The study showed a large discrepancy between the drugs stated in the medical chart and patient's self-reported drug consumption. The study failed to show that perceived information or educational level had an impact on the results but implicate that the quality of information influences adherence. It is of importance to recognize patients at risk for non-adherence. Decreased health status and many drugs are the main risk factors for patients being non-adherent, and should be recognized as such.

[Medical students and drug marketing].

Science.gov (United States)

Calderón Larrañaga, Sara; Rabanaque Hernández, María José

2014-03-01

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

Risk factors for the development of pneumonia in acute psychotropic drugs poisoning

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Vučinić Slavica

2005-01-01

following parameters: sex (p < 0.05, chronic alcohol intake (p < 0.05, underlying diseases (p < 0.01, central venous catheter (p < 0.05 vasopressors (p < 0.05, coma (p < 0.001, H2 blockers (p < 0.001 and corticosteroids (p < 0.001. The multivariate analysis retained endotracheal intubation and antidepressant drug poisoning as an independent risk factor for pneumonia. Conclusion. Using univariate and multivariate analysis, risk factors for developing pneumonia were disclosed. Some of these factors may be modified by simple medical procedures, thus the incidence and mortality rate of pneumonia in drug poisoning might be substantially reduced.

Risk assessment principle for engineered nanotechnology in food and drug.

Science.gov (United States)

Hwang, Myungsil; Lee, Eun Ji; Kweon, Se Young; Park, Mi Sun; Jeong, Ji Yoon; Um, Jun Ho; Kim, Sun Ah; Han, Bum Suk; Lee, Kwang Ho; Yoon, Hae Jung

2012-06-01

While the ability to develop nanomaterials and incorporate them into products is advancing rapidly worldwide, understanding of the potential health safety effects of nanomaterials has proceeded at a much slower pace. Since 2008, Korea Food and Drug Administration (KFDA) started an investigation to prepare "Strategic Action Plan" to evaluate safety and nano risk management associated with foods, drugs, medical devices and cosmetics using nano-scale materials. Although there are some studies related to potential risk of nanomaterials, physical-chemical characterization of nanomaterials is not clear yet and these do not offer enough information due to their limitations. Their uncertainties make it impossible to determine whether nanomaterials are actually hazardous to human. According to the above mention, we have some problems to conduct the human exposure risk assessment currently. On the other hand, uncertainty about safety may lead to polarized public debate and to businesses unwillingness for further nanotechnology investigation. Therefore, the criteria and methods to assess possible adverse effects of nanomaterials have been vigorously taken into consideration by many international organizations: the World Health Organization, the Organization for Economic and Commercial Development and the European Commission. The object of this study was to develop risk assessment principles for safety management of future nanoproducts and also to identify areas of research to strengthen risk assessment for nanomaterials. The research roadmaps which were proposed in this study will be helpful to fill up the current gaps in knowledge relevant nano risk assessment.

Hepatotoxicity with antituberculosis drugs: the risk factors

International Nuclear Information System (INIS)

Mahmood, K.; Samo, A.H.; Jairamani, K.L.; Talib, A.

2007-01-01

To assess the severity and frequency of hepatotoxicity caused by different antituberculosis (ATT) drugs and to evaluate whether concurrence of risk factors influence the antituberculosis drug induced hepatotoxicity. This prospective cohort study was conducted in Medical Unit-V and OPD department of Civil Hospital Karachi from July 2004 to July 2005. A total of 339 patients diagnosed of active tuberculosis infection with normal pretreatment liver function were monitored clinically as well as biochemically. Their data were collected on proforma and patients were treated with Isoniazid, Rifampicin and Pyrazinamide. Duration after which derangement in function, if any, occurred and time taken for normalization was noted. Treatment was altered as needed, with exclusion of culprit drug. Finally data was analyzed by SPSS version 10.0. ATT induced hepatotoxicity was seen in 67 (19.76%) out of 339 patients. Females were more affected as compared to males (26.3% vs. 19.7%). BMI (kg/m2) of 91% of diseased group were less than 18.5 (p<0.01) most of them were anemic having low albumin level suggestive of lean body mass. Hepatotoxicity was more severe in AFB smear positive patients. Concomitant use of alcohol, paracetamol and low serum cholesterol were proved as predisposing factors. Isoniazid (37 patients (55.21%), p<0.01) was the main culprit followed by Rifampicin (23 patients, 34.21%) and Pyrazinamide (7 patients, 10.5%). Most of the patients (61%) developed the hepatotoxicity within two weeks of starting antituberculosis therapy with mild to moderate alteration in ALT and AST. ATT-induced hepatitis is significantly more frequent and more severe in patients with hepatotoxicity risk factors. (author)

Characteristics of medication errors with parenteral cytotoxic drugs

OpenAIRE

Fyhr, A; Akselsson, R

2012-01-01

Errors involving cytotoxic drugs have the potential of being fatal and should therefore be prevented. The objective of this article is to identify the characteristics of medication errors involving parenteral cytotoxic drugs in Sweden. A total of 60 cases reported to the national error reporting systems from 1996 to 2008 were reviewed. Classification was made to identify cytotoxic drugs involved, type of error, where the error occurred, error detection mechanism, and consequences for the pati...

Drug use, travel and HIV risk.

Science.gov (United States)

Lee, D; Bell, D C; Hinojosa, M

2002-08-01

A study was conducted to examine the travel experiences of a community sample of 160 drug users and 44 non-users recruited as part of a study of HIV risk. Of the sample, 47% (96/204) reported intercity travel in the previous ten years. Results showed that men were more likely to travel than women, Anglos more than minorities, and young persons more than old. When travellers testing HIV-seropositive (n = 13) were compared with seronegative travellers, HIV-positive travellers reported more sex while travelling than HIV-negative persons, but virtually all of the difference reported involved sex with condoms. There were no significant differences in sex risk behaviours while travelling between drug users and non-drug users, or in sex risk behaviors between drug injectors and non-injectors. Travellers had fewer injection partners while travelling than they had while at home. There was also a significant difference in number of sex partners with whom a condom was not used, with fewer sex partners while travelling.

Medication-related risks of CT-procedures in neonates and young infants

International Nuclear Information System (INIS)

Abel, M.

1985-01-01

In very young pediatric patients CT-investigations require sedative-hypnotic drug treatment to ensure complete immobilisation during scanning. The case report of a neonate with respiratory arrest after a repeated CT-premedication underlines the high risk of these procedures, especially in patients with central nervous system disorders. We compared organisational requirements, risks and complication rates of 146 oral and intramuscular promazine medications for CT-scanning of the head in 146 infants and neonates (93,8% adequate sedation response) to those of reported alternative methods. Oral promazine proved to be a very effective and safe medication (average dosage in 57 patients without complications: 5,2 mg/kg body weight/90 minutes before CT-scanning; 96% successful sedation procedures) in comparison to 89 patients with i.m. promazine (average dosage: 2,3 mg/kg body weight/45 min before CT with 92% adequate sedations but a complication rate of 7,9%). For neuropediatric examinations of outpatients fast recovery and EEG-compatibility are further important advantages of oral promazine CT-medication. (orig.) [de

Motivators and barriers of tamoxifen use as risk-reducing medication amongst women at increased breast cancer risk: a systematic literature review.

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Meiser, B; Wong, W K T; Peate, M; Julian-Reynier, C; Kirk, J; Mitchell, G

2017-01-01

Selective estrogen receptor modulators, such as tamoxifen, reduce breast cancer risk by up to 50% in women at increased risk for breast cancer. Despite tamoxifen's well-established efficacy, many studies show that most women are not taking up tamoxifen. This systematic literature review aimed to identify the motivators and barriers to tamoxifen use 's amongst high-risk women. Using MEDLINE, PsycINFO, and Embase plus reviewing reference lists of relevant articles published between 1995 and 2016, 31 studies (published in 35 articles) were identified, which addressed high-risk women's decisions about risk-reducing medication to prevent breast cancer and were peer-reviewed primary clinical studies. A range of factors were identified as motivators of, and barriers to, tamoxifen uptake including: perceived risk, breast-cancer-related anxiety, health professional recommendation, perceived drug effectiveness, concerns about side-effects, knowledge and access to information about side-effects, beliefs about the role of risk-reducing medication, provision of a biomarker, preference for other forms of breast cancer risk reduction, previous treatment experience, concerns about randomization in clinical trial protocols and finally altruism. Results indicate that the decision for high-risk women regarding tamoxifen use or non-use as a risk-reducing medication is not straightforward. Support of women making this decision is essential and needs to encompass the full range of factors, both informational and psychological.

Drug choice in medical practice : rationales, routines and remedies

NARCIS (Netherlands)

Denig, Petra

1994-01-01

The aim of the studies presented in this dissertation is to describe and analyse drug choice in medical practice, and provide a better understanding of the possible shortcomings and the role of biomedical knowledge in the drug choice process.

Medical databases in studies of drug teratogenicity: methodological issues

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Vera Ehrenstein

2010-03-01

Full Text Available Vera Ehrenstein1, Henrik T Sørensen1, Leiv S Bakketeig1,2, Lars Pedersen11Department of Clinical Epidemiology, Aarhus University Hospital, Aarhus, Denmark; 2Norwegian Institute of Public Health, Oslo, NorwayAbstract: More than half of all pregnant women take prescription medications, raising concerns about fetal safety. Medical databases routinely collecting data from large populations are potentially valuable resources for cohort studies addressing teratogenicity of drugs. These include electronic medical records, administrative databases, population health registries, and teratogenicity information services. Medical databases allow estimation of prevalences of birth defects with enhanced precision, but systematic error remains a potentially serious problem. In this review, we first provide a brief description of types of North American and European medical databases suitable for studying teratogenicity of drugs and then discuss manifestation of systematic errors in teratogenicity studies based on such databases. Selection bias stems primarily from the inability to ascertain all reproductive outcomes. Information bias (misclassification may be caused by paucity of recorded clinical details or incomplete documentation of medication use. Confounding, particularly confounding by indication, can rarely be ruled out. Bias that either masks teratogenicity or creates false appearance thereof, may have adverse consequences for the health of the child and the mother. Biases should be quantified and their potential impact on the study results should be assessed. Both theory and software are available for such estimation. Provided that methodological problems are understood and effectively handled, computerized medical databases are a valuable source of data for studies of teratogenicity of drugs.Keywords: databases, birth defects, epidemiologic methods, pharmacoepidemiology

The consumption of two or more fall risk-increasing drugs rather than polypharmacy is associated with falls.

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Zia, Anam; Kamaruzzaman, Shahrul B; Tan, Maw P

2017-03-01

The presemt study aimed to determine the association between the risk of recurrent and injurious falls with polypharmacy, fall risk-increasing drugs (FRID) and FRID count among community-dwelling older adults. Participants (n = 202) were aged ≥65 years with two or more falls or one injurious fall in the past year, whereas controls (n = 156) included volunteers aged ≥65 years with no falls in the past year. A detailed medication history was obtained alongside demographic data. Polypharmacy was defined as "regular use of five or more prescription drugs." FRID were identified as cardiovascular agents, central nervous system drugs, analgesics and endocrine drugs; multiple FRID were defined as two or more FRID. Multiple logistic regression analyses were used to adjust for confounders. The use of non-steroidal anti-inflammatory drugs was independently associated with an increased risk of falls. Univariate analyses showed both polypharmacy (OR 2.23, 95% CI 1.39-3.56; P = 0.001) and the use of two or more FRID (OR 2.9, 95% CI 1.9-4.5; P = 0.0001) were significantly more likely amongst fallers. After adjustment for age, sex and comorbidities, blood pressure, and physical performance scores, polypharmacy was no longer associated with falls (OR 1.6, 95% CI 0.9-2.9; P = 0.102), whereas the consumption of two or more FRID remained a significant predictor for falls (OR 2.8, 95% CI 1.4-5.3; P = 0.001). Among high risk fallers, the use of two or more FRID was an independent risk factor for falls instead of polypharmacy. Our findings will inform clinical practice in terms of medication reviews among older adults at higher risk of falls. Future intervention studies will seek to confirm whether avoidance or withdrawal of multiple FRID reduces the risk of future falls. Geriatr Gerontol Int 2017; 17: 463-470. © 2016 Japan Geriatrics Society.

Epidemiology and risk factors for drug allergy.

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Thong, Bernard Y-H; Tan, Teck-Choon

2011-05-01

The aim of this review was to describe the current evidence-based knowledge of the epidemiology, prevalence, incidence, risk factors and genetic associations of drug allergy. Articles published between 1966 and 2010 were identified in MEDLINE using the key words adult, adverse drug reaction reporting systems, age factors, anaphylactoid, anaphylaxis, anaesthetics, antibiotics, child, drug allergy, drug eruptions, ethnic groups, hypersensitivity, neuromuscular depolarizing agents, neuromuscular nondepolarizing agents, sex factors, Stevens Johnson syndrome and toxic epidermal necrolysis. Additional studies were identified from article reference lists. Relevant, peer-reviewed original research articles, case series and reviews were considered for review. Current epidemiological studies on adverse drug reactions (ADRs) have used different definitions for ADR-related terminology, often do not differentiate immunologically and non-immunologically mediated drug hypersensitivity, study different study populations (different ethnicities, inpatients or outpatients, adults or children), utilize different methodologies (spontaneous vs. non-spontaneous reporting, cohort vs. case-control studies), different methods of assessing drug imputability and different methods of data analyses. Potentially life-threatening severe cutaneous adverse reactions (SCAR) are associated with a high risk of morbidity and mortality. HLA associations for SCAR associated with allopurinol, carbamazepine and abacavir have been reported with the potential for clinical use in screening prior to prescription. Identification of risk factors for drug allergy and appropriate genetic screening of at-risk ethnic groups may improve the outcomes of drug-specific SCAR. Research and collaboration are necessary for the generation of clinically-relevant, translational pharmacoepidemiological and pharmacogenomic knowledge, and success of health outcomes research and policies on drug allergies. © 2011 The Authors

[Targeting high-risk drugs to optimize clinical pharmacists' intervention].

Science.gov (United States)

Mouterde, Anne-Laure; Bourdelin, Magali; Maison, Ophélie; Coursier, Sandra; Bontemps, Hervé

2016-12-01

By the Order of 6 April 2011, the pharmacist must validate all the prescriptions containing "high-risk drugs" or those of "patients at risk". To optimize this clinical pharmacy activity, we identified high-risk drugs. A list of high-risk drugs has been established using literature, pharmacists' interventions (PI) performed in our hospital and a survey sent to hospital pharmacists. In a prospective study (analysis of 100 prescriptions for each high-risk drug selected), we have identified the most relevant to target. We obtained a statistically significant PI rate (P<0.05) for digoxin, oral anticoagulants direct, oral methotrexate and colchicine. This method of targeted pharmaceutical validation based on high-risk drugs is relevant to detect patients with high risk of medicine-related illness. Copyright © 2016 Société française de pharmacologie et de thérapeutique. Published by Elsevier Masson SAS. All rights reserved.

Hypnotic Medications and Suicide: Risk, Mechanisms, Mitigation, and the FDA.

Science.gov (United States)

McCall, W Vaughn; Benca, Ruth M; Rosenquist, Peter B; Riley, Mary Anne; McCloud, Laryssa; Newman, Jill C; Case, Doug; Rumble, Meredith; Krystal, Andrew D

2017-01-01

Insomnia is associated with increased risk for suicide. The Food and Drug Administration (FDA) has mandated that warnings regarding suicide be included in the prescribing information for hypnotic medications. The authors conducted a review of the evidence for and against the claim that hypnotics increase the risk of suicide. This review focused on modern, FDA-approved hypnotics, beginning with the introduction of benzodiazepines, limiting its findings to adults. PubMed and Web of Science were searched, crossing the terms "suicide" and "suicidal" with each of the modern FDA-approved hypnotics. The FDA web site was searched for postmarketing safety reviews, and the FDA was contacted with requests to provide detailed case reports for hypnotic-related suicide deaths reported through its Adverse Event Reporting System. Epidemiological studies show that hypnotics are associated with an increased risk for suicide. However, none of these studies adequately controlled for depression or other psychiatric disorders that may be linked with insomnia. Suicide deaths have been reported from single-agent hypnotic overdoses. A separate concern is that benzodiazepine receptor agonist hypnotics can cause parasomnias, which in rare cases may lead to suicidal ideation or suicidal behavior in persons who were not known to be suicidal. On the other hand, ongoing research is testing whether treatment of insomnia may reduce suicidality in adults with depression. The review findings indicate that hypnotic medications are associated with suicidal ideation. Future studies should be designed to assess whether increases in suicidality result from CNS impairments from a given hypnotic medication or whether such medication decreases suicidality because of improvements in insomnia.

Comparisons of Food and Drug Administration and European Medicines Agency risk management implementation for recent pharmaceutical approvals: report of the International Society for Pharmacoeconomics and outcomes research risk benefit management working group.

Science.gov (United States)

Lis, Yvonne; Roberts, Melissa H; Kamble, Shital; J Guo, Jeff; Raisch, Dennis W

2012-12-01

1) To compare the Food and Drug Administration's (FDA's) Risk Evaluation and Mitigation Strategies (REMS) and European Medicines Agency's (EMA's) Risk Management Plan (RMP) guidances and 2) to compare REMS and RMPs for specific chemical entities and biological products. FDA, EMA, and pharmaceutical company Web sites were consulted for details pertaining to REMS and RMPs. REMS requirements include medication guides, communication plans, elements to ensure safe use, implementation systems, and specified assessment intervals. RMP requirements are increased pharmacovigilance and risk minimization activities. We compared these requirements for drugs requiring both REMS and RMPs. We identified 95 drugs on FDA's REMS list as of March 2010. Of these, there were 29 drugs (11 biologics and 18 new chemical entities) with EMA RMPs. REMS and RMPs are similar in objectives, with comparable toolkits. Both allow flexibility in product-specific actions, recognizing adverse effects of potential concern. Of the 29 drugs reviewed, REMS requirements not included in RMPs were patient medication guides (100% of the drugs), provider communication plans (38%), and routine monitoring of REMS (66%). RMP requirements not included in REMS were specific adverse event reporting (45% of the drugs), prospective registry studies (34%), prospective epidemiology studies (24%), additional trial data (28%), and Summary of Product Characteristics contraindications (76%). Both REMS and RMPs provide positive guidance for identification, monitoring, and minimization of risk to patient safety. Currently, neither agency provides specific guidance on how risk should be related to benefit either qualitatively or quantitatively. Copyright © 2012 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

Elderly users of fall-risk-increasing drug perceptions of fall risk and the relation to their drug use - a qualitative study.

Science.gov (United States)

Bell, Hege Therese; Steinsbekk, Aslak; Granas, Anne Gerd

2017-09-01

The aim of the study was to explore how home-dwelling elderly who use fall-risk-increasing drugs (FRIDs) perceive their fall risk and how they relate this to their drug use. A qualitative study with 14 home-dwelling elderly FRID users between 65 and 97 years in Central Norway participating in semi-structured individual interviews. The data were analyzed thematically by using systematic text condensation. The main finding was that the informants did not necessarily perceive the use of FRIDs to be a prominent risk factor for falls. Some informants said they did not reflect upon drug use whatsoever and said they fully trusted their physician's choices. When either experiencing dizziness, fall episodes or by reading the patient information leaflet the informants said to either adjust their drug use or to contact their physician. Some felt rejected due to not getting their point across or their wish to alter the drug was not granted by the physician. Elderly FRID users did not necessarily relate their drug use to fall risk or struggled to present their perceived drug-related problems. Physicians need to regularly inform, monitor and assess the drug treatment when treating elderly with FRIDs.

[Drug advertising to the general public: conceptual parameters of a risk producer practice].

Science.gov (United States)

Nascimento, Alvaro César

2010-11-01

This article analyzes some concepts relating to marketing, advertising, medications, regulation and manipulation. It discusses ethical and health surveillance parameters of drugs advertising for the general public. The focus of this work is the analysis of contradictions from a conceptual point of view between the practice of pharmaceutical advertising as a tool for the increase of sales and the conquest of markets versus the policy of rational use of medicines. Academic studies and monitoring of drugs advertising conducted by the National Health Surveillance Agency show that the contents of the advertising pieces oriented towards the general public overestimate the - sometimes dubious - qualities of their medication, focusing almost exclusively on the benefits and put them in a central position in the therapeutic process. They also fail to mention the risks inherent in their use. Rather than focusing on regulatory proposals aimed at creating constraints to this practice, this article discusses the impossibility, considering the interests of public health, of the coexistence of marketing with the policies for the correct, rational and safe use of drugs.

Halo and spillover effect illustrations for selected beneficial medical devices and drugs

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Brent D. Kerger

2016-09-01

Full Text Available Abstract Background Negative news media reports regarding potential health hazards of implanted medical devices and pharmaceuticals can lead to a ‘negative halo effect,’ a phenomenon whereby judgments about a product or product type can be unconsciously altered even though the scientific support is tenuous. To determine how a ‘negative halo effect’ may impact the rates of use and/or explantation of medical products, we analyzed the occurrence of such an effect on three implanted medical devices and one drug: 1 intrauterine contraceptive devices (IUDs; 2 silicone gel-filled breast implants (SGBI; 3 metal-on-metal hip implants (MoM; and 4 the drug Tysabri. Methods Data on IUD use from 1965 to 2008 were gathered from the Department of Health and Human Services Vital and Health Statistics and peer-reviewed publications. Data regarding SGBI implant and explantation rates from 1989 to 2012 were obtained from the Institute of Medicine and the American Society of Plastic Surgeons. MoM implant and explantation data were extracted from the England and Wales National Joint Registry and peer-reviewed publications. Tysabri patient data were reported by Elan Corporation or Biogen Idec Inc. Data trends for all products were compared with historical recall or withdrawal events and discussed in the context of public perceptions following such events. Results We found that common factors altered public risk perceptions and patterns of continued use. First, a negative halo effect may be driven by continuing patient anxiety despite positive clinical outcomes. Second, negative reports about one product can spill over to affect the use of dissimilar products in the same category. Third, a negative halo effect on an entire category of medical devices can be sustained regardless of the scientific findings pertaining to safety. Fourth, recovery of a product’s safety reputation and prevalent use may take decades in the U.S., even while these products may

Turkish Final Year Medical Students' Exposure to and Attitudes Concerning Drug Company Interactions: A Perspective from a Minimally Regulated Environment for Medical Students.

Science.gov (United States)

Beyhun, Nazim Ercument; Kolayli, Cevriye Ceyda; Can, Gamze; Topbas, Murat

2016-01-01

Interactions between drug companies and medical students may affect evidence-based medical practice and patient safety. The aim of this study was to assess drug company-medical student interactions in a medical faculty where limited specific national or institutional regulations apply between drug companies and medical students. The objectives of the study were to determine the exposure and attitudes of final year medical students in terms of drug company-medical student and physician interactions, to identify factors affecting those attitudes and to provide data for policymakers working on the regulation of interactions between drug companies and medical students. This anonymous questionnaire-based study of 154 medical final year medical students at the Karadeniz Technical University Medical Faculty, Trabzon, Turkey, in April and May 2015 attracted a response rate of 92.2% (n/N, 154/164). Exposure to interaction with a pharmaceutical representative was reported by 90.3% (139/154) of students, and 68.8% (106/154) reported experiencing such interaction alongside a resident. In addition, 83.7% (128/153) of students reported an interaction during internship. Furthermore, 69.9% (107/153) of students agreed that interactions influence physicians' prescription preferences, while 33.1% (51/154) thought that a medical student should never accept a gift from a drug company and 24.7% (38/154) agreed with the proposition that "drug companies should not hold activities in medical faculties". Students with rational prescription training expressed greater agreement with the statement "I am skeptical concerning the information provided by drug companies during interactions" than those who had not received such training, and this finding was supported by logistic regression [O.R.(C.I), p -3.7(1.2-11.5), p = 0.022]. Acceptance of advertisement brochures was found to significantly reduce the level of agreement with the proposition that "A physician should not accept any gift from a

Turkish Final Year Medical Students' Exposure to and Attitudes Concerning Drug Company Interactions: A Perspective from a Minimally Regulated Environment for Medical Students.

Directory of Open Access Journals (Sweden)

Nazim Ercument Beyhun

Full Text Available Interactions between drug companies and medical students may affect evidence-based medical practice and patient safety. The aim of this study was to assess drug company-medical student interactions in a medical faculty where limited specific national or institutional regulations apply between drug companies and medical students. The objectives of the study were to determine the exposure and attitudes of final year medical students in terms of drug company-medical student and physician interactions, to identify factors affecting those attitudes and to provide data for policymakers working on the regulation of interactions between drug companies and medical students. This anonymous questionnaire-based study of 154 medical final year medical students at the Karadeniz Technical University Medical Faculty, Trabzon, Turkey, in April and May 2015 attracted a response rate of 92.2% (n/N, 154/164. Exposure to interaction with a pharmaceutical representative was reported by 90.3% (139/154 of students, and 68.8% (106/154 reported experiencing such interaction alongside a resident. In addition, 83.7% (128/153 of students reported an interaction during internship. Furthermore, 69.9% (107/153 of students agreed that interactions influence physicians' prescription preferences, while 33.1% (51/154 thought that a medical student should never accept a gift from a drug company and 24.7% (38/154 agreed with the proposition that "drug companies should not hold activities in medical faculties". Students with rational prescription training expressed greater agreement with the statement "I am skeptical concerning the information provided by drug companies during interactions" than those who had not received such training, and this finding was supported by logistic regression [O.R.(C.I, p -3.7(1.2-11.5, p = 0.022]. Acceptance of advertisement brochures was found to significantly reduce the level of agreement with the proposition that "A physician should not accept any

Turkish Final Year Medical Students’ Exposure to and Attitudes Concerning Drug Company Interactions: A Perspective from a Minimally Regulated Environment for Medical Students

Science.gov (United States)

Beyhun, Nazim Ercument; Kolayli, Cevriye Ceyda; Can, Gamze; Topbas, Murat

2016-01-01

Interactions between drug companies and medical students may affect evidence-based medical practice and patient safety. The aim of this study was to assess drug company–medical student interactions in a medical faculty where limited specific national or institutional regulations apply between drug companies and medical students. The objectives of the study were to determine the exposure and attitudes of final year medical students in terms of drug company–medical student and physician interactions, to identify factors affecting those attitudes and to provide data for policymakers working on the regulation of interactions between drug companies and medical students. This anonymous questionnaire-based study of 154 medical final year medical students at the Karadeniz Technical University Medical Faculty, Trabzon, Turkey, in April and May 2015 attracted a response rate of 92.2% (n/N, 154/164). Exposure to interaction with a pharmaceutical representative was reported by 90.3% (139/154) of students, and 68.8% (106/154) reported experiencing such interaction alongside a resident. In addition, 83.7% (128/153) of students reported an interaction during internship. Furthermore, 69.9% (107/153) of students agreed that interactions influence physicians’ prescription preferences, while 33.1% (51/154) thought that a medical student should never accept a gift from a drug company and 24.7% (38/154) agreed with the proposition that “drug companies should not hold activities in medical faculties”. Students with rational prescription training expressed greater agreement with the statement “I am skeptical concerning the information provided by drug companies during interactions” than those who had not received such training, and this finding was supported by logistic regression [O.R.(C.I), p -3.7(1.2–11.5), p = 0.022]. Acceptance of advertisement brochures was found to significantly reduce the level of agreement with the proposition that “A physician should not

Characteristics of Clinical Studies Used for US Food and Drug Administration Approval of High-Risk Medical Device Supplements.

Science.gov (United States)

Zheng, Sarah Y; Dhruva, Sanket S; Redberg, Rita F

2017-08-15

High-risk medical devices often undergo modifications, which are approved by the US Food and Drug Administration (FDA) through various kinds of premarket approval (PMA) supplements. There have been multiple high-profile recalls of devices approved as PMA supplements. To characterize the quality of the clinical studies and data (strength of evidence) used to support FDA approval of panel-track supplements (a type of PMA supplement pathway that is used for significant changes in a device or indication for use and always requires clinical data). Descriptive study of clinical studies supporting panel-track supplements approved by the FDA between April 19, 2006, and October 9, 2015. Panel-track supplement approval. Methodological quality of studies including randomization, blinding, type of controls, clinical vs surrogate primary end points, use of post hoc analyses, and reporting of age and sex. Eighty-three clinical studies supported the approval of 78 panel-track supplements, with 71 panel-track supplements (91%) supported by a single study. Of the 83 studies, 37 (45%) were randomized clinical trials and 25 (30%) were blinded. The median number of patients per study was 185 (interquartile range, 75-305), and the median follow-up duration was 180 days (interquartile range, 84-270 days). There were a total of 150 primary end points (mean [SD], 1.8 [1.2] per study), and 57 primary end points (38%) were compared with controls. Of primary end points with controls, 6 (11%) were retrospective controls and 51 (89%) were active controls. One hundred twenty-one primary end points (81%) were surrogate end points. Thirty-three studies (40%) did not report age and 25 (30%) did not report sex for all enrolled patients. The FDA required postapproval studies for 29 of 78 (37%) panel-track supplements. Among clinical studies used to support FDA approval of high-risk medical device modifications, fewer than half were randomized, blinded, or controlled, and most primary outcomes were

Denial of pain medication by health care providers predicts in-hospital illicit drug use among individuals who use illicit drugs.

Science.gov (United States)

Ti, Lianping; Voon, Pauline; Dobrer, Sabina; Montaner, Julio; Wood, Evan; Kerr, Thomas

2015-01-01

Undertreated pain is common among people who use illicit drugs (PWUD), and can often reflect the reluctance of health care providers to provide pain medication to individuals with substance use disorders. To investigate the relationship between having ever been denied pain medication by a health care provider and having ever reported using illicit drugs in hospital. Data were derived from participants enrolled in two Canadian prospective cohort studies between December 2012 and May 2013. Using bivariable and multivariable logistic regression analyses, the relationship between having ever been denied pain medication by a health care provider and having ever reported using illicit drugs in hospital was examined. Among 1053 PWUD who had experienced ≥ 1 hospitalization, 452 (44%) reported having ever used illicit drugs while in hospital and 491(48%) reported having ever been denied pain medication. In a multivariable model adjusted for confounders, having been denied pain medication was positively associated with having used illicit drugs in hospital (adjusted OR 1.46 [95% CI 1.14 to 1.88]). The results of the present study suggest that the denial of pain medication is associated with the use of illicit drugs while hospitalized. These findings raise questions about how to appropriately manage addiction and pain among PWUD and indicate the potential role that harm reduction programs may play in hospital settings.

Personnel Risks in Ensuring Safety of Medical Activity

Directory of Open Access Journals (Sweden)

O. L. Zadvornaya

2017-01-01

Full Text Available Purpose: modern strategies of management of the organization require the formation of special management approaches based on the analysis of the mechanisms and processes of the organization of medical activities related to possible risks in activity of medical personnel. Based on international experience and own research the authors have identified features of a system of management of personnel risk in medical activities, examined approaches showing the sequence and contents of the main practical activities of the formation, maintenance and development of the system of management of personnel risks. Emphasized is the need for further research and implementation of the system of management of personnel risk in health care organizations. Study and assessment of personnel risks affecting the security of medical activities aimed at the development of the system of personnel risk management, development of a system of identification and monitoring of HR risk indicators with a purpose to improve institutional management and increase efficiency of activity of medical organizations. Methods: in the present study, the following methods were used: systemic approach, content analysis, methods of social diagnosis (questionnaires, interviews, comparative analysis, method of expert evaluations, method of statistical processing of information. Results: approaches to predict the occurrence and development of personnel risks have been reviewed and proposed. Conclusions and Relevance: patient safety is a global issue affecting countries at all levels of development. Each year, the WHO identifies a number of systemic and technical aspects and trends in the field of patient safety related to actions of medical workers. Existing imbalances in the staffing of the health system of the Russian Federation increase the probability of potential risks in medical practice. The personnel policy of healthcare of the Russian Federation requires further improvement and

Prenatal drug exposure and teratological risk: one-year experience of an Italian Teratology Information Service.

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De Santis, Marco; Cesari, Elena; Ligato, Maria Serena; Nobili, Elena; Straface, Gianluca; Cavaliere, Annafranca; Caruso, Alessandro

2008-02-01

Concern about exposure to drugs, radiation, or infection during pregnancy occur often because pregnancy is not always planned. A teratology information service offers rapid scientific counseling to all those worried about prenatal exposure. The aim of this study is to present data on the most common pharmaceutical products responsible for teratogenic risk in the one-year experience of a teratology information service in Italy. The survey was conducted among 8664 callers who contacted our Teratology Information Service in Rome between January and December 2006. Data on maternal age, gravidity, parity, maternal health status, and details of exposure (dose and timing) were collected and stored in a specific data base. Scientific counseling on prenatal exposure was given to the caller by a specialized service operator, specifying the type of risk and suggesting appropriate tests for prenatal diagnosis. Most of the people called regarding drug exposure; increased risk was present in only 5% of the pregnant women calling during pregnancy. Selective serotonin reuptake inhibitors (SSRIs) are the first category that are actually considered of increased risk to the fetus. The second category is represented by antiepileptic drugs. This experience confirms previous data that there is a high teratological risk perception among both women and physicians. The drugs estimated to present increased risk are medications used for chronic neurological diseases, mainly mood disorders and epilepsy. Preconceptional counseling for these women could be an effective strategy to prevent such exposure and to improve maternal and fetal outcome.

Adverse Drug Events caused by Serious Medication Administration Errors

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Sawarkar, Abhivyakti; Keohane, Carol A.; Maviglia, Saverio; Gandhi, Tejal K; Poon, Eric G

2013-01-01

OBJECTIVE To determine how often serious or life-threatening medication administration errors with the potential to cause patient harm (or potential adverse drug events) result in actual patient harm (or adverse drug events (ADEs)) in the hospital setting. DESIGN Retrospective chart review of clinical events that transpired following observed medication administration errors. BACKGROUND Medication errors are common at the medication administration stage for hospitalized patients. While many of these errors are considered capable of causing patient harm, it is not clear how often patients are actually harmed by these errors. METHODS In a previous study where 14,041 medication administrations in an acute-care hospital were directly observed, investigators discovered 1271 medication administration errors, of which 133 had the potential to cause serious or life-threatening harm to patients and were considered serious or life-threatening potential ADEs. In the current study, clinical reviewers conducted detailed chart reviews of cases where a serious or life-threatening potential ADE occurred to determine if an actual ADE developed following the potential ADE. Reviewers further assessed the severity of the ADE and attribution to the administration error. RESULTS Ten (7.5% [95% C.I. 6.98, 8.01]) actual adverse drug events or ADEs resulted from the 133 serious and life-threatening potential ADEs, of which 6 resulted in significant, three in serious, and one life threatening injury. Therefore 4 (3% [95% C.I. 2.12, 3.6]) serious and life threatening potential ADEs led to serious or life threatening ADEs. Half of the ten actual ADEs were caused by dosage or monitoring errors for anti-hypertensives. The life threatening ADE was caused by an error that was both a transcription and a timing error. CONCLUSION Potential ADEs at the medication administration stage can cause serious patient harm. Given previous estimates of serious or life-threatening potential ADE of 1.33 per 100

Medical Emergencies Related to Ethanol and Illicit Drugs at an Annual, Nocturnal, Indoor, Electronic Dance Music Event.

Science.gov (United States)

Calle, Paul; Sundahl, Nora; Maudens, Kristof; Wille, Sarah Mr; Van Sassenbroeck, Diederik; De Graeve, Koen; Gogaert, Stefan; De Paepe, Peter; Devriese, Dieter; Arno, Geert; Blanckaert, Peter

2018-02-01

Introduction Medical problems are frequently encountered during electronic dance music (EDM) events. Problem There are uncertainties about the frequencies and severity of intoxications with different types of recreational drugs: ethanol, "classical" illicit party drugs, and new psychoactive substances (NPS). Statistical data on the medical problems encountered during two editions of an indoor electronic dance event with around 30,000 attendants were retrieved from the Belgian Red Cross (Mechelen, Belgium) database. Data on drug use were prospectively collected from the patient (or a bystander), the clinical presentation, and/or toxicological screening. In the on-site medical station, 487 patients were treated (265 in 2013 and 222 in 2014). The most frequent reasons were trauma (n=171), headache (n=36), gastro-intestinal problems (n=44), and intoxication (n=160). Sixty-nine patients were transferred to a hospital, including 53 with severe drug-related symptoms. Analysis of blood samples from 106 intoxicated patients detected ethanol in 91.5%, 3,4-methylenedioxymethamphetamine (MDMA) in 34.0%, cannabis in 30.2%, cocaine in 7.5%, amphetamine in 2.8%, and gamma-hydroxybutyric acid (GHB) in 0.9% of patients (alone or in combination). In only six of the MDMA-positive cases, MDMA was the sole substance found. In 2014, the neuroleptic drug clozapine was found in three cases and ketamine in one. Additional analyses for NPS were performed in 20 cases. Only in one agitated patient, the psychedelic phenethylamines 25B-NBOMe and 25C-NBOMe were found. At this particular event, recreational drug abuse necessitated on-site medical treatment in one out of 350 attendants and a hospital transfer in one out of 1,000. Ethanol remains the most frequently abused (legal) drug, yet classical illicit recreational drugs are also frequently (co-) ingested. The most worrying observation was high-risk poly-drug use, especially among MDMA users. Regarding NPS, the number of cases was low and the

Risk perception about medication sharing among patients: a focus group qualitative study on borrowing and lending of prescription analgesics

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Markotic F

2017-02-01

Full Text Available Filipa Markotic,1 Davorka Vrdoljak,2 Marijana Puljiz,3 Livia Puljak,4 1Centre for Clinical Pharmacology, University Clinical Hospital Mostar, Mostar, Bosnia and Herzegovina; 2Department of Family Medicine, University of Split School of Medicine, Split, 3Family Medicine Clinic, Health Centre Imotski, Kamenmost, 4Laboratory for Pain Research, University of Split School of Medicine, Split, Croatia Background: One form of self-medication is sharing of medications, defined as borrowing or lending medications in situations where the receiver of these drugs is not the individual to whom the medications were allocated. Objective: To explore experiences and opinions of patients about sharing prescription analgesics, reasons for sharing prescription analgesics, the way in which patients choose to share those medications, their awareness of risk regarding sharing prescription analgesics, and how they estimated the potential risk.Methods: This qualitative study was conducted by focus group discussions with 40 participants led by a moderator trained in focus group methodology using a semi-structured moderator guide. Adults aged ≥18 years who had received a prescription for an analgesic at least once in a lifetime were included. Six separate focus groups were conducted to discuss participants’ perception of risks associated with sharing of prescription analgesics among patients. Additionally, participants filled out two questionnaires on demographic data, their own behavior regarding sharing analgesics, and their attitudes about risks associated with sharing prescription analgesics.Results: In a questionnaire, 55% of the participants indicated that they personally shared prescription analgesics, while subsequently in the focus group discussions, 76% confessed to such behavior. Participants recognized certain risks related to sharing of prescription analgesics, mentioned a number of reasons for engaging in such behavior, and indicated certain positive

Checklist Usage as a Guidance on Read-Back Reducing the Potential Risk of Medication Error

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Ida Bagus N. Maharjana

2014-06-01

Full Text Available Hospital as a last line of health services shall provide quality service and oriented on patient safety, one responsibility in preventing medication errors. Effective collaboration and communication between the profession needed to achieve patient safety. Read-back is one way of doing effective communication. Before-after study with PDCA TQM approach. The samples were on the medication chart patient medical rd rd records in the 3 week of May (before and the 3 week in July (after 2013. Treatment using the check list, asked for time 2 minutes to read-back by the doctors and nurses after the visit together. Obtained 57 samples (before and 64 samples (after. Before charging 45.54% incomplete medication chart on patient medical records that have the potential risk of medication error to 10.17% after treatment with a read back check list for 10 weeks, with 77.78% based on the achievement of the PDCA TQM approach. Checklist usage as a guidance on Read-back as an effective communication can reduce charging incompleteness drug records on medical records that have the potential risk of medication errors, 45.54% to 10.17%.

Risk of violence in drug rehabilitation centers: perceptions of people who inject drugs in Tijuana, Mexico.

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Harvey-Vera, Alicia Yolanda; González-Zúñiga, Patricia; Vargas-Ojeda, Adriana Carolina; Medina-Mora, Maria Elena; Magis-Rodríguez, Carlos Leonardo; Wagner, Karla; Strathdee, Steffanie Anne; Werb, Daniel

2016-01-26

In 2009, Mexico reformed its health law to partially decriminalize drug possession considered for personal use and to increase mandatory referrals to certified drug rehabilitation centers in lieu of incarceration. Concurrently, news media reported violent attacks perpetrated by drug cartels against Mexican drug rehabilitation centers and instances of human rights violations by staff against people who inject drugs (PWID) in treatment. In many cases, these violent situations took place at "Peer Support" (Ayuda Mutua) drug rehabilitation centers that house a large number of drug-dependent PWID. In an effort to understand barriers to treatment uptake, we examined prevalence and correlates of perceived risk of violence at drug rehabilitation centers among PWID in Tijuana, Mexico. Secondary analysis of baseline data collected between March 2011 and May 2013 of PWID recruited into a prospective cohort study in Tijuana. Interviewer-administered surveys measured perceived risk of violence at drug rehabilitation centers by asking participants to indicate their level of agreement with the statement "going to rehabilitation puts me at risk of violence". Logistic regression was used to examine factors associated with perceived risk of violence. Of 733 PWID, 34.5 % perceived risk of violence at drug rehabilitation centers. In multivariate analysis, reporting ever having used crystal methamphetamine and cocaine (separately), having a great or urgent need to get help for drug use, and ever receiving professional help for drug/alcohol use were negatively associated with perceived risk of violence at drug rehabilitation centers, while having been told by law enforcement that drug rehabilitation attendance is mandatory was positively associated with perceived risk of violence. All associations were significant at a 0.05 alpha level. The perception of violence at drug rehabilitation centers among PWID does not represent the lived experience of those PWID who attended

Increased Risk of Drug-Induced Hyponatremia during High Temperatures

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Anna K Jönsson

2017-07-01

Full Text Available Purpose: To investigate the relationship between outdoor temperature in Sweden and the reporting of drug-induced hyponatremia to the Medical Products Agency (MPA. Methods: All individual adverse drug reactions (ADR reported to MPA from 1 January 2010 to 31 October 2013 of suspected drug-induced hyponatremia and random controls were identified. Reports where the ADR had been assessed as having at least a possible relation to the suspected drug were included. Information on administered drugs, onset date, causality assessment, sodium levels, and the geographical origin of the reports was extracted. A case-crossover design was used to ascertain the association between heat exposure and drug-induced hyponatremia at the individual level, while linear regression was used to study its relationship to sodium concentration in blood. Temperature exposure data were obtained from the nearest observation station to the reported cases. Results: During the study period, 280 reports of hyponatremia were identified. More cases of drug-induced hyponatremia were reported in the warmer season, with a peak in June, while other ADRs showed an opposite annual pattern. The distributed lag non-linear model indicated an increasing odds ratio (OR with increasing temperature in the warm season with a highest odds ratio, with delays of 1–5 days after heat exposure. A cumulative OR for a lag time of 1 to 3 days was estimated at 2.21 at an average daily temperature of 20 °C. The change in sodium per 1 °C increase in temperature was estimated to be −0.37 mmol/L (95% CI: −0.02, −0.72. Conclusions: Warm weather appears to increase the risk of drug-induced hyponatremia

Herb-drug interactions. Interactions between saw palmetto and prescription medications.

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Bressler, Rubin

2005-11-01

Patients over age 50 typically present with one chronic disease per decade. Each chronic disease typically requires long-term drug therapy, meaning most older patients require several drugs to maintain health. Simultaneously, use of complementary and alternative medicine (CAM) has increased in the United States in the last 20 years, reaching 36% in 2002; herbal medicine use accounts for approximately 22% of all CAM use. Older adults often add herbal medicines to prescription medications, yet do not always inform their physicians. The drug metabolizing enzyme systems process all compounds foreign to the body, including prescription and herbal medications. Therefore use of both medicinals simultaneously has a potential for adverse interactions. This review, which discusses saw palmetto, is the last in a series covering the documented interactions among the top 5 efficacious herbal medicines and prescription drugs.

Psychotropic drugs and the risk of fractures in old age: a prospective population-based study.

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Nurminen, Janne; Puustinen, Juha; Piirtola, Maarit; Vahlberg, Tero; Kivelä, Sirkka-Liisa

2010-07-06

There is evidence that the use of any psychotropic and the concomitant use of two or more benzodiazepines are related to an increased risk of fractures in old age. However, also controversial results exist. The aim was to describe associations between the use of a psychotropic drug, or the concomitant use of two or more of these drugs and the risk of fractures in a population aged 65 years or over. This study was a part of a prospective longitudinal population-based study carried out in the municipality of Lieto, South-Western Finland. The objective was to describe gender-specific associations between the use of one psychotropic drug [benzodiazepine (BZD), antipsychotic (AP) or antidepressant (AD)] or the concomitant use of two or more psychotropic drugs and the risk of fractures in a population 65 years or over. Subjects were participants in the first wave of the Lieto study in 1990-1991, and they were followed up until the end of 1996. Information about fractures confirmed with radiology reports in 1,177 subjects (482 men and 695 women) during the follow-up was collected from medical records. Two follow-up periods (three and six years) were used, and previously found risk factors of fractures were adjusted as confounding factors separately for men and women. The Poisson regression model was used in the analyses. The concomitant use of two or more BZDs and the concomitant use of two or more APs were related to an increased risk of fractures during both follow-up periods after adjusting for confounding factors in men. No similar associations were found in women. The concomitant use of several BZDs and that of several APs are associated with an increase in the risk of fractures in older men. Our findings show only risk relations. We cannot draw the conclusion that these drug combinations are causes of fractures.

Drug dosing in chronic kidney disease.

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Gabardi, Steven; Abramson, Stuart

2005-05-01

Patients with chronic kidney disease (CKD) are at high risk for adverse drug reactions and drug-drug interactions. Drug dosing in these patients often proves to be a difficult task. Renal dysfunction-induced changes in human pathophysiology regularly results may alter medication pharmacodynamics and handling. Several pharmacokinetic parameters are adversely affected by CKD, secondary to a reduced oral absorption and glomerular filtration; altered tubular secretion; and reabsorption and changes in intestinal, hepatic, and renal metabolism. In general, drug dosing can be accomplished by multiple methods; however, the most common recommendations are often to reduce the dose or expand the dosing interval, or use both methods simultaneously. Some medications need to be avoided all together in CKD either because of lack of efficacy or increased risk of toxicity. Nevertheless, specific recommendations are available for dosing of certain medications and are an important resource, because most are based on clinical or pharmacokinetic trials.

Does Medical Cannabis Use Increase or Decrease the Use of Opioid Analgesics and Other Prescription Drugs?

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Bachhuber, Marcus A; Arnsten, Julia H; Cunningham, Chinazo O; Sohler, Nancy

2018-04-17

: In observational and retrospective studies, people who use cannabis are more likely than people who do not use cannabis to also use other drugs. People who take medical cannabis are also more likely to report medical and non-medical use of opioid analgesics, stimulants, and tranquilizers. Given that people who take medical cannabis and those who do not are likely to have different underlying morbidity, it is possible that medical cannabis use reduces prescription drug use yet prescription drug use remains relatively high. Studies comparing people who take medical cannabis with people who do not take it cannot draw conclusions about the effect of medical cannabis on drug use. To fully understand the effect of medical cannabis on the use of other drugs, prospective longitudinal studies randomizing individuals to cannabis versus other treatments are urgently needed.

Matching Judicial Supervision to Clients’ Risk Status in Drug Court

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Marlowe, Douglas B.; Festinger, David S.; Lee, Patricia A.; Dugosh, Karen L.; Benasutti, Kathleen M.

2007-01-01

This article reports outcomes from a program of experimental research evaluating the risk principle in drug courts. Prior studies revealed that participants who were high risk and had (a) antisocial personality disorder or (b) a prior history of drug abuse treatment performed better in drug court when scheduled to attend biweekly judicial status hearings in court. In contrast, participants who were low risk performed equivalently regardless of the court hearings schedule. This study prospectively matches drug court clients to the optimal schedule of court hearings based on an assessment of their risk status and compares outcomes to clients randomly assigned to the standard hearings schedule. Results confirmed that participants who were high risk and matched to biweekly hearings had better during-treatment outcomes than participants assigned to status hearings as usual. These findings provide confirmation of the risk principle in drug courts and yield practical information for enhancing the efficacy and cost-efficiency of drug courts. PMID:18174915

Temperament and character modify risk of drug addiction and influence choice of drugs.

Science.gov (United States)

Milivojevic, Dragan; Milovanovic, Srdjan D; Jovanovic, Minja; Svrakic, Dragan M; Svrakic, Nenad M; Svrakic, Slobodan M; Cloninger, C Robert

2012-01-01

Drug addiction and alcoholism involve a complex etiopathogenesis with a variable degree of risk contributions from the host (person), environment, and addictive substances. In this work, temperament and character features of individuals addicted to opiates or alcohol are compared with normal controls to study personality factors in the overall risk for drug addiction. The study was done in a permissive environment, with easy access to alcohol and heroin, which facilitated analyses of personality factors in drug choice. Participants included 412 consecutive patients (312 opiate addicts, 100 alcohol addicts) treated at the Specialized Hospital for Chemical Dependency in Belgrade, Serbia, and a community sample of 346 controls. Opiate addicts manifested antisocial temperament configuration (high Novelty Seeking, low Reward Dependence) coupled with high Self-transcendence (ie, susceptibility to fantasy and imagination). Alcohol addicts manifested sensitive temperament configuration (high Novelty Seeking coexisting with high Harm Avoidance). Immature personality was observed far more frequently in opiate addicts than in alcoholics or normals. Novelty Seeking appears to be a general risk factor for drug addiction. High Harm Avoidance appears to channel individuals with high Novelty Seeking towards alcoholism. Immature character traits and probable Personality Disorder increase the risk of illegal drugs. Based on equivalent research in nonpermissive environments, at least a portion of our opiate addicts could have developed alcoholism instead in environments with more limited access to opiates. Personality factors provide useful guidelines for preventive work with young individuals with personality risk factors for drug addiction. Copyright © American Academy of Addiction Psychiatry.

HOW ADVERSE DRUG-REACTIONS CAN PLAY A ROLE IN INNOVATIVE DRUG RESEARCH - SIMILARITIES IN ADVERSE DRUG REACTION PROFILES OF CAPTOPRIL AND PENICILLAMINE

NARCIS (Netherlands)

RIKKEN, F; VOS, R

1995-01-01

We describe how adverse drug reactions (ADRs) can play an important role in pharmaceutical research and drug development. Not only do ADRs represent the risks and drawbacks associated with drugs but they can also be related to other knowledge available in pharmaceutical and medical research. We

Perceptions of personal health risks by medical and non-medical workers in a university medical center: a survey study

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Nap Raoul E

2010-11-01

Full Text Available Abstract Background Health care workers (HCWs are faced with many work-related choices which may depend on how they perceive risk, such as whether or not to comply with safety regulations. Little research has investigated risk perception in medical workers in comparison with non-medical workers and the extent to which risk perception differs in these groups. The current study thus investigates risk perception of medical and non-medical workers to inform and complement future research on safety compliance. The study has implications for the design of intervention programmes to increase the level of compliance of HCWs. Methods A survey study was conducted in which questionnaires were distributed to 6380 HCWs. The questionnaire asked for ratings of risk perception for cold, annual influenza, pandemic influenza, cancer, heart attack and food poisoning. Of 2495 returned questionnaires (response rate: 39%, 61.40% were from medical workers (24.1% of these were from physicians, 39.7% from nurses and 36.2% from paramedics and 38.60% were from non-medical workers. Results Medical workers gave lower risk perception ratings than did non-medical workers for cancer, but not for other health risks. Within the medical workers, physicians rated the risk of getting a cold as higher, but of having a heart attack as lower than did nurses and paramedics; physicians also rated their risk of getting cancer as lower than did nurses. Perceived risk was higher as a function of age for pandemic influenza, cancer and heart attack, but lower for cold and annual influenza. HCWs who lived with a partner and children rated the risk of getting a cold or annual influenza higher than those who lived alone or with a partner only. Full-time HCWs gave lower ratings for annual influenza than did part-time HCWs. Conclusions Different base levels of risk perception between medical and non-medical workers need to be taken into account for successful implementation of safety regulations

Risk of cataract among medical staff in neurosurgical department occupationally exposed to radiation

International Nuclear Information System (INIS)

Stankova-Mileva, I.; Vassileva, J.; Djounova, J.

2012-01-01

In this study we present the risk of cataract among medical staff in neurosurgical department occupationally exposed to radiation compared to those of non-radiation workers. Cataract is the most common degenerative opacity of the crystalline lens developing with aging. Other risk factors for cataract are: infrared and ultraviolet radiation, systemic diseases (diabetes, hypertonic disease), eye diseases (glaucoma, high myopia), drugs (steroids), etc. High risk of developing cataract we find among staff occupationally exposed to radiation during operations - interventional cardiologists and neurosurgeons. This study includes 30 people between 33 and 60 years of age working in neurosurgical department and control group (the same amount and age of people not exposed to radiation in their work). After visual acuity measurement, the lens was examined by retroillumination method (red reflex) and using a bio microscope. The patients were asked for presence of ocular and systemic diseases, eye trauma, drug, alcohol and tobacco abuse and for how many years they work in this department. There was one case with cataract among neurosurgeons. The doctor doesn't have eye or systemic diseases, doesn't take any drugs and is not alcohol or tobacco abuser. In the control group there were two persons with subcapsular cataract but they have diabetes. Radiation is one of the risk factors for cataract. Continuing of this epidemiological survey will provide further knowledge on the potential risk of occupational radiation-induced cataract among neurosurgical staff and will contribute for optimization of radiation protection. (authors)

Clinical risk management in Dutch community pharmacies: the case of drug-drug interactions.

NARCIS (Netherlands)

Buurma, H.; Smet, P.A.G.M. de; Egberts, A.C.G.

2006-01-01

BACKGROUND: The prevention of drug-drug interactions requires a systematic approach for which the concept of clinical risk management can be used. The objective of our study was to measure the frequency, nature and management of drug-drug interaction alerts as these occur in daily practice of Dutch

Drug-related problems and changes in drug utilization after medication reviews in nursing homes in Oslo, Norway.

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Fog, Amura Francesca; Kvalvaag, Gunnar; Engedal, Knut; Straand, Jørund

2017-12-01

We describe the drug-related problems (DRPs) identified during medication reviews (MRs) and the changes in drug utilization after MRs at nursing homes in Oslo, Norway. We explored predictors for the observed changes. Observational before-after study. Forty-one nursing homes. MRs performed by multidisciplinary teams during November 2011 to February 2014. In all, 2465 long-term care patients. DRPs identified by explicit criteria (STOPP/START and NORGEP) and drug-drug interaction database; interventions to resolve DRPs; drug use changes after MR. A total of 6158 DRPs were identified, an average of 2.6 DRPs/patient, 2.0 for regular and 0.6 for pro re nata (prn) drugs. Of these patients, 17.3% had no DRPs. The remaining 82.7% of the patients had on average 3.0 DRPs/patient. Use of unnecessary drugs (43.5%), excess dosing (12.5%) and lack of monitoring of the drug use (11%) were the most frequent DRPs. Opioids and psychotropic drugs were involved in 34.4% of all DRPs. The mean number of drugs decreased after the MR from 6.8 to 6.3 for regular drugs and from 3.0 to 2.6 for prn drugs. Patients with DRPs experienced a decrease of 1.1 drugs after MR (0.5 for regular and 0.6 for prn drugs). The reduction was most pronounced for the regular use of antipsychotics, antidepressants, hypnotics/sedatives, diuretics, antithrombotic agents, antacid drugs; and for prn use of anxiolytics, opioids, hypnotics/sedatives, metoclopramide and NSAIDs. The medication review resulted in less drug use, especially opioids and psychotropic drugs.

The Impact of Disease and Drugs on Hip Fracture Risk.

Science.gov (United States)

Leavy, Breiffni; Michaëlsson, Karl; Åberg, Anna Cristina; Melhus, Håkan; Byberg, Liisa

2017-01-01

We report the risks of a comprehensive range of disease and drug categories on hip fracture occurrence using a strict population-based cohort design. Participants included the source population of a Swedish county, aged ≥50 years (n = 117,494) including all incident hip fractures during 1 year (n = 477). The outcome was hospitalization for hip fracture (ICD-10 codes S72.0-S72.2) during 1 year (2009-2010). Exposures included: prevalence of (1) inpatient diseases [International Classification of Diseases (ICD) codes A00-T98 in the National Patient Register 1987-2010] and (2) prescribed drugs dispensed in 2010 or the year prior to fracture. We present age- and sex-standardized risk ratios (RRs), risk differences (RDs) and population attributable risks (PARs) of disease and drug categories in relation to hip fracture risk. All disease categories were associated with increased risk of hip fracture. Largest risk ratios and differences were for mental and behavioral disorders, diseases of the blood and previous fracture (RRs between 2.44 and 3.00; RDs (per 1000 person-years) between 5.0 and 6.9). For specific drugs, strongest associations were seen for antiparkinson (RR 2.32 [95 % CI 1.48-1.65]; RD 5.2 [1.1-9.4]) and antidepressive drugs (RR 1.90 [1.55-2.32]; RD 3.1 [2.0-4.3]). Being prescribed ≥10 drugs during 1 year incurred an increased risk of hip fracture, whereas prescription of cardiovascular drugs or ≤5 drugs did not appear to increase risk. Diseases inferring the greatest PARs included: cardiovascular diseases PAR 22 % (95 % CI 14-29) and previous injuries (PAR 21 % [95 % CI 16-25]; for specific drugs, antidepressants posed the greatest risk (PAR 16 % [95 % CI 12.0-19.3]).

Risk management and post-marketing surveillance of CNS drugs.

Science.gov (United States)

Henningfield, Jack E; Schuster, Charles R

2009-12-01

Drugs affecting the central nervous system span a broad range of chemical entities, dosage forms, indications, and risks. Unintended consequences include potential abuse and overdose in non-patient drug abusers, deliberate tampering of drug dosage forms, and criminal behavior associated with diversion. Regulators must consider diverse factors to find the appropriate conditions of approval to minimize unintended consequences while enabling a level of access desired by health care providers and patients. This commentary appears as part of a special issue of Drug and Alcohol Dependence that focuses on risk management and post-marketing surveillance and addresses key issues that pose real-world challenges to pharmaceutical sponsors and regulators in particular. For example, in the U.S., Controlled Substances Act drug scheduling can be considered a risk management strategy but its legal authorities and administrative processes are independent from those of risk management (including Risk Evaluation and Mitigation Strategies or REMS); better harmonization of these approaches is vital from drug development and regulatory perspectives. Risk management would ideally be implemented on a strong science foundation demonstrating that the tools employed to mitigate risks and ensure safe use are effective. In reality, research and evaluation of tools in this area is in its infancy and will necessarily be an evolutionary process; furthermore, there is little precedent for linking interventions and program evolution to unintended consequences such as regional outbreaks of abuse and diversion. How such issues are resolved has the potential to stimulate or stifle innovations in drug development and advance or imperil health care.

[Neonatal risks of drugs exposure at the end of pregnancy].

Science.gov (United States)

Autret-Leca, Elisabeth; Cissoko, Hawaré; Jonville-Béra, Annie Pierre

2011-01-01

Foetal drugs exposure consequences depend according to the drug involved and to the length of the exposure which in the sum of length of treatment and of drug elimination (5 half life). Decisions are based upon risk evaluation and are a compromise between a risk banalisation and an excess of carefully. We described risks management for drugs used for a disease due to the pregnancy (glucocorticoïdes, antibiotics) then for drugs used for a chronic disease often preceding the pregnancy (non steroidal anti-inflammatory, serotonin recapture inhibitors, benzodiazepines, antiepileptics, conversion enzyme inhibitors/renine angiotensine antagonists, betabloquants). We also present the elements to take in account for the best drug choice at the end of pregnancy and/or for an adapted advice if the drug has been already taken: the drug itself (pharmacological effects, kinetics in neonate, toxicity marker, risk detection tool), drug amount possibly received by the neonate and literature data about neonatal manifestations due to the drug. © 2011 Société Française de Pharmacologie et de Thérapeutique.

Counterfeit drugs and medical devices in developing countries

Directory of Open Access Journals (Sweden)

Glass BD

2014-03-01

Full Text Available Beverley D GlassSchool of Pharmacy and Molecular Sciences, James Cook University, Townsville, QLD, AustraliaAbstract: The World Health Organization has reported that counterfeit medicines potentially make up more than 50% of the global drug market, with a significant proportion of these fake products being encountered in developing countries. This occurrence is attributed to a lack of effective regulation and a weak enforcement capacity existing in these countries, with an increase in this trade resulting from the growing size and sophistication of drug counterfeiters. In addition, due to both cost and lack of availability of medicines, consumers in developing countries are more likely to seek out these inexpensive options. The World Health Organization is mindful of the impact of counterfeit drugs on consumer confidence in health care systems, health professionals, the supply chain, and genuine suppliers of medicines and medical devices. Antibiotics, antituberculosis drugs, and antimalarial and antiretroviral drugs are frequently targeted, with reports of 60% of the anti-infective drugs in Asia and Africa containing active pharmaceutical ingredients outside their pharmacopoeial limits. This has obvious public health implications of increasing drug resistance and negating all the efforts that have already gone into the provision of medicines to treat these life threatening conditions in the developing world. This review, while focusing on counterfeit medicines and medical devices in developing countries, will present information on their impact and how these issues can be addressed by regulation and control of the supply chain using technology appropriate to the developing world. The complexity of the problem will also be highlighted in terms of the definition of counterfeit and substandard medicines, including gray pharmaceuticals. Although this issue presents as a global public health problem, outcomes in developing countries where counterfeit

Photosensitizing medication use and risk of skin cancer

DEFF Research Database (Denmark)

Kaae, Jeanette; Boyd, Heather A; Hansen, Anne

2010-01-01

Many commonly used medications, including both medications for long-term (daily) use and short-term use (treatment courses of finite duration), have photosensitizing properties. Whether use of these medications affects skin cancer risk, however, is unclear.......Many commonly used medications, including both medications for long-term (daily) use and short-term use (treatment courses of finite duration), have photosensitizing properties. Whether use of these medications affects skin cancer risk, however, is unclear....

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

Directory of Open Access Journals (Sweden)

Oshikoya KA

2009-06-01

Full Text Available 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

Risk behaviours of illicit drug users while travelling

Directory of Open Access Journals (Sweden)

Tatja Kostnapfel Rihtar

2013-07-01

Full Text Available Introduction: Despite various formal limitations, an increasing number of opioid users, especially those stabilised in substitution therapy, travel abroad, away from their permanent residence to neighbouring and remote countries on other continents. Drug users are particularly at risk to get infected with hepatitis A, B, C and HIV during travelling.The main objectives of the study were to identify and determine the frequency of potential travel-related risk behaviour, such as illicit drug use, sharing of injecting equipment, unprotected sex, involvement in criminal activities and the extent of risk in illicit drug users, included in the programmes of the Centers for Prevention and Treatment of Drug Addiction in Slovenia.Methods: The study was carried out in two phases. The first phase included semi-structured interviews conducted in a group of drug users willing to participate in the study. Based on the analysis of transcripts and additional data, the original questionnaire Risky behaviour of illicit drug users during travels was developed and filled in anonymously and on a voluntary basis at the network of Centres for Prevention and Treatment of Drug Addiction. Univariate analysis between independent and dependent factors was conducted based on chi-square test and t-test for independent factors. Multivariate analysis of the impact of independent factors on the dependent factor was conducted based on binary logistic regression.Results: The questionnaire was filled out anonymously and voluntarily by 776 individuals in 14 Slovene centres for prevention and treatment of drug addiction. The results confirmed the first hypothesis that drug users travelling away from their permanent residence are more likely to share their injecting equipment, and engage in unprotected sex and in drug-related crime, and the second hypothesis stating that illegal drug users included in the substitution treatment programmes, who regularly use drugs at home, more often

Medication Errors: New EU Good Practice Guide on Risk Minimisation and Error Prevention.

Science.gov (United States)

Goedecke, Thomas; Ord, Kathryn; Newbould, Victoria; Brosch, Sabine; Arlett, Peter

2016-06-01

A medication error is an unintended failure in the drug treatment process that leads to, or has the potential to lead to, harm to the patient. Reducing the risk of medication errors is a shared responsibility between patients, healthcare professionals, regulators and the pharmaceutical industry at all levels of healthcare delivery. In 2015, the EU regulatory network released a two-part good practice guide on medication errors to support both the pharmaceutical industry and regulators in the implementation of the changes introduced with the EU pharmacovigilance legislation. These changes included a modification of the 'adverse reaction' definition to include events associated with medication errors, and the requirement for national competent authorities responsible for pharmacovigilance in EU Member States to collaborate and exchange information on medication errors resulting in harm with national patient safety organisations. To facilitate reporting and learning from medication errors, a clear distinction has been made in the guidance between medication errors resulting in adverse reactions, medication errors without harm, intercepted medication errors and potential errors. This distinction is supported by an enhanced MedDRA(®) terminology that allows for coding all stages of the medication use process where the error occurred in addition to any clinical consequences. To better understand the causes and contributing factors, individual case safety reports involving an error should be followed-up with the primary reporter to gather information relevant for the conduct of root cause analysis where this may be appropriate. Such reports should also be summarised in periodic safety update reports and addressed in risk management plans. Any risk minimisation and prevention strategy for medication errors should consider all stages of a medicinal product's life-cycle, particularly the main sources and types of medication errors during product development. This article

Drug utilization research and risk management

NARCIS (Netherlands)

Mazzaglia, Giampiero; Mol, Peter G. M.; Elseviers, Monique; Wettermark, Björn; Almarsdóttir, Anna Birna; Andersen, Morten; Benko, Ria; Bennie, Marion; Eriksson, Irene; Godman, Brian; Krska, Janet; Poluzzi, Elisabetta; Taxis, Katja; Vlahovic-Palcevski, Vera; Stichele, Robert Vander

2016-01-01

Good risk management requires continuous evaluation and improvement of planned activities. The evaluation impact of risk management activities requires robust study designs and carefully selected outcome measures. Key learnings and caveats from drug utilization research should be applied to the

Fertility drugs, reproductive strategies and ovarian cancer risk.

Science.gov (United States)

Tomao, Federica; Lo Russo, Giuseppe; Spinelli, Gian Paolo; Stati, Valeria; Prete, Alessandra Anna; Prinzi, Natalie; Sinjari, Marsela; Vici, Patrizia; Papa, Anselmo; Chiotti, Maria Stefania; Benedetti Panici, Pierluigi; Tomao, Silverio

2014-01-01

Several adverse effects have been related to infertility treatments, such as cancer development. In particular, the relationship between infertility, reproductive strategies, and risk of gynecological cancers has aroused much interest in recent years. The evaluation of cancer risk among women treated for infertility is very complex, mainly because of many factors that can contribute to occurrence of cancer in these patients (including parity status). This article addresses the possible association between the use of fertility treatments and the risk of ovarian cancer, through a scrupulous search of the literature published thus far in this field. Our principal objective was to give more conclusive answers on the question whether the use of fertility drug significantly increases ovarian cancer risk. Our analysis focused on the different types of drugs and different treatment schedules used. This study provides additional insights regarding the long-term relationships between fertility drugs and risk of ovarian cancer.

Impact of regulatory guidances and drug regulation on risk minimization interventions in drug safety: a systematic review.

Science.gov (United States)

Nkeng, Lenhangmbong; Cloutier, Anne-Marie; Craig, Camille; Lelorier, Jacques; Moride, Yola

2012-07-01

Therapeutic risk management has received growing interest in recent years, particularly since the publication of regulatory guidances in 2005 and 2006, paralleled with a change in drug regulation. The characteristics of risk minimization interventions (RMIs) that have been implemented or approved remain inadequately explored. The aim of this study was to review RMIs published in the literature or posted on regulatory agency websites over the past 10 years, and to assess whether publication of regulatory guidances on risk management is associated with changes in the number and types of interventions. Sources were searched for RMIs published/posted between 1 January 2000 and 31 December 2009. For the literature search, MEDLINE and EMBASE databases were used using key words related to drug safety (i.e. 'drug toxicity') and the individual RMI names. The website review involved searches of major regulatory authority websites such as the European Medicines Agency, US FDA, Health Canada, the UK's Medicines and Healthcare products Regulatory Agency, Japan's Pharmaceutical and Medical Devices Agency and Australia's Therapeutic Goods Administration. The following eligibility criteria were applied for inclusion in the review: published/posted between the years 2000 and 2009, inclusive; involving drug products; use in humans; and involving RMIs, or tools used to increase the reporting of adverse events (AEs). Natural healthcare products, devices, diagnostic chemicals, pregnancy registries without follow-up, medication errors and products not used as therapy for illness were not retained. For each source, the following characteristics were extracted: nature of the intervention, target population, therapeutic area, AE(s) of special interest, country/regulatory agency and year of publication. A total of 119 unique interventions were identified in the literature (54 published in 2000-4 and 65 published in 2005-9). Interventions included educational material (n = 37; 31%), black

Drug allergy passport and other documentation for patients with drug hypersensitivity - An ENDA/EAACI Drug Allergy Interest Group Position Paper

NARCIS (Netherlands)

Brockow, K.; Aberer, W.; Atanaskovic-Markovic, M.; Bavbek, S.; Bircher, A.; Bilo, B.; Blanca, M.; Bonadonna, P.; Burbach, G.; Calogiuri, G.; Caruso, C.; Celik, G.; Cernadas, J.; Chiriac, A.; Demoly, P.; Oude Elberink, J. N. G.; Fernandez, J.; Gomes, E.; Garvey, L. H.; Gooi, J.; Gotua, M.; Grosber, M.; Kauppi, P.; Kvedariene, V.; Laguna, J. J.; Makowska, J. S.; Mosbech, H.; Nakonechna, A.; Papadopolous, N. G.; Ring, J.; Romano, A.; Rockmann, H.; Sargur, R.; Sedlackova, L.; Sigurdardottir, S.; Schnyder, B.; Storaas, T.; Torres, M.; Zidarn, M.; Terreehorst, I.

2016-01-01

The strongest and best-documented risk factor for drug hypersensitivity (DH) is the history of a previous reaction. Accidental exposures to drugs may lead to severe or even fatal reactions in sensitized patients. Preventable prescription errors are common. They are often due to inadequate medical

Swedish high-school pupils’ attitudes towards drugs in relation to drug usage, impulsiveness and other risk factors

Directory of Open Access Journals (Sweden)

Fariba Mousavi

2014-06-01

Full Text Available Background. Illicit drug use influences people’s lives and elicits unwanted behaviour. Current research shows that there is an increase in young people’s drug use in Sweden. The aim was to investigate Swedish high-school pupils’ attitudes, impulsiveness and gender differences linked to drug use. Risk and protective factors relative to drug use were also a focus of interest.Method. High school pupils (n = 146 aged 17–21 years, responded to the Adolescent Health and Development Inventory, Barratt Impulsiveness Scale and Knowledge, and the Attitudes and Beliefs. Direct logistic, multiple regression analyses, and Multivariate Analysis of Variance were used to analyze the data.Results. Positive Attitudes towards drugs were predicted by risk factors (odds ratio = 37.31 and gender (odds ratio = .32. Risk factors (odds ratio = 46.89, positive attitudes towards drugs (odds ratio = 4.63, and impulsiveness (odds ratio = 1.11 predicted drug usage. Risk factors dimensions Family, Friends and Individual Characteristic were positively related to impulsiveness among drug users. Moreover, although boys reported using drugs to a greater extent, girls expressed more positive attitude towards drugs and even reported more impulsiveness than boys.Conclusion. This study reinforces the notion that research ought to focus on gender differences relative to pro-drug attitudes along with testing for differences in the predictors of girls’ and boys’ delinquency and impulsiveness. Positive attitudes towards drugs among adolescents seem to be part of a vicious circle including risk factors, such as friendly drug environments (e.g., friends who use drugs and unsupportive family environments, individual characteristics, and impulsiveness.

Interest in use of mHealth technology in HIV prevention and associated factors among high-risk drug users enrolled in methadone maintenance program.

Science.gov (United States)

Shrestha, Roman; Karki, Pramila; Copenhaver, Michael

2017-09-01

The adoption of mobile technologies for health (mHealth) in healthcare has grown considerably in recent years, but systematic assessment of interest in the use of mHealth in HIV prevention efforts among people who use drugs (PWUD) is lacking. We therefore examined interest in use of mHealth technology in HIV prevention and associated individual-level factors among high-risk PWUD enrolled in methadone maintenance program. A total of 400 HIV-negative PWUD, who reported drug- and/or sex-related risk behaviors completed a standardized assessment using audio computer assisted self-interview (ACASI). Results revealed significant interest in using mHealth-based approaches for specific purposes, including: to receive medication reminders (72.3%), to receive information about HIV risk reduction (65.8%), and to assess HIV risk behaviors (76.5%). Multivariate analysis showed that interest in receiving medication reminders was associated with currently taking medication and being neurocognitively impaired, whereas interest in receiving HIV-risk reduction information was associated with being non-white, married, and perceiving the person was at high-risk for contracting HIV. Similarly, participants' interested in using mHealth for HIV risk behavior assessment was associated with having recently visited a healthcare provider and exhibiting depressive symptoms. Overall, this study demonstrated that high-risk PWUD are interested in using mHealth-based tools as a key part of an HIV prevention approach within a common type of drug treatment settings. Thus, formative research on preferences for design and functionality of mHealth-based HIV prevention tools are now needed, followed by practical development, implementation, and evaluation of these new intervention strategies.

Radiation as a microbiological contamination control of drugs, cosmetics and medical devices

International Nuclear Information System (INIS)

Ishizeki, Chuichi

1985-01-01

This paper deals with current status of radiation sterilization or disinfection of drugs, cosmetics, their materials, and medical devices, and with quality control as a tool for securing microbiological safety, especially current status of sterilization tests. Ointment containing tetracyclin, steroid hormones, gelatin, and enzymes are presented as drug samples to be irradiated, and explanations for radiation sterilization of these drugs are provided. An outline of the application of radiation in cosmetics and medical devices is given. Issues are also provided from the viewpoint of safey and effectiveness of radiation sterilization. (Namekawa, K.)

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

Science.gov (United States)

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

2016-04-01

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. 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. General practice in The Netherlands. 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. Agreement on information on medication use and drug-related problems collected with the questionnaire and interview was calculated. 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. 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.

Illicit drug use and HIV risk in the Dominican Republic: tourism areas create drug use opportunities.

Science.gov (United States)

Guilamo-Ramos, Vincent; Lee, Jane J; Ruiz, Yumary; Hagan, Holly; Delva, Marlyn; Quiñones, Zahira; Kamler, Alexandra; Robles, Gabriel

2015-01-01

While the Caribbean has the second highest global human immunodeficiency virus (HIV) prevalence, insufficient attention has been paid to contributing factors of the region's elevated risk. Largely neglected is the potential role of drugs in shaping the Caribbean HIV/acquired immune deficiency syndrome epidemic. Caribbean studies have almost exclusively focused on drug transportation and seldom acknowledged local user economies and drug-related health and social welfare consequences. While tourism is consistently implicated within the Caribbean HIV epidemic, less is known about the intersection of drugs and tourism. Tourism areas represent distinct ecologies of risk often characterised by sex work, alcohol consumption and population mixing between lower and higher risk groups. Limited understanding of availability and usage of drugs in countries such as the Dominican Republic (DR), the Caribbean country with the greatest tourist rates, presents barriers to HIV prevention. This study addresses this gap by conducting in-depth interviews with 30 drug users in Sosúa, a major sex tourism destination of the DR. A two-step qualitative data analysis process was utilised and interview transcripts were systematically coded using a well-defined thematic codebook. Results suggest three themes: (1) local demand shifts drug routes to tourism areas, (2) drugs shape local economies and (3) drug use facilitates HIV risk behaviours in tourism areas.

Risk-taking related to drug use: an application of the shift-to-risk design.

Science.gov (United States)

Deren, S; Des Jarlais, D C

1977-01-01

The utility of the shift-to-risk design for studying the influence of peer groups on drug taking was investigated. Two studies using this design with drug content were conducted, varying the level of information provided about a drug. Subjects were from two college classes consisting of 26 and 28 students. Results indicated that the specification of possible harmful drug effects which are somewhat minimal lead to a significantly greater willingness to recommend trying the drug. In addition, a tendency for a shift-to-caution was found. It was concluded that the shift-to-risk designwas useful for studying decision-making regarding drug use, and that both users and nonusers of drugs should be included in future research.

[Post-marketing drug safety-risk management plan(RMP)].

Science.gov (United States)

Ezaki, Asami; Hori, Akiko

2013-03-01

The Guidance for Risk Management Plan(RMP)was released by the Ministry of Health, Labour and Welfare in April 2012. The RMP consists of safety specifications, pharmacovigilance plans and risk minimization action plans. In this paper, we outline post-marketing drug safety operations in PMDA and the RMP, with examples of some anticancer drugs.

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

Science.gov (United States)

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

2015-05-01

A novel recommendation-based drug repositioning strategy is presented to simultaneously determine novel drug indications and side effects in one integrated framework. This strategy provides a complementary method to medical genetics-based drug repositioning, which reduces the occurrence of false positives in medical genetics-based drug repositioning, resulting in a ranked list of new candidate indications and/or side effects with different confidence levels. Several new drug indications and side effects are reported with high prediction confidences. © 2015 American Society for Clinical Pharmacology and Therapeutics.

[Cost] effectiveness of withdrawal of fall-risk increasing drugs versus conservative treatment in older fallers: design of a multicenter randomized controlled trial (IMPROveFALL-study).

Science.gov (United States)

Hartholt, Klaas A; Boyé, Nicole D A; Van der Velde, Nathalie; Van Lieshout, Esther M M; Polinder, Suzanne; De Vries, Oscar J; Kerver, Albert J H; Ziere, Gijsbertus; Bruijninckx, Milko M M; De Vries, Mark R; Mattace-Raso, Francesco U S; Uitterlinden, André G; Van Beeck, Ed F; Lips, Paul; Patka, Peter; Van der Cammen, Tischa J M

2011-08-21

Fall incidents represent an increasing public health problem in aging societies worldwide. A major risk factor for falls is the use of fall-risk increasing drugs. The primary aim of the study is to compare the effect of a structured medication assessment including the withdrawal of fall-risk increasing drugs on the number of new falls versus 'care as usual' in older adults presenting at the Emergency Department after a fall. A prospective, multi-center, randomized controlled trial will be conducted in hospitals in the Netherlands. Persons aged ≥65 years who visit the Emergency Department due to a fall are invited to participate in this trial. All patients receive a full geriatric assessment at the research outpatient clinic. Patients are randomized between a structured medication assessment including withdrawal of fall-risk increasing drugs and 'care as usual'. A 3-monthly falls calendar is used for assessing the number of falls, fallers and associated injuries over a one-year follow-up period. Measurements will be at three, six, nine, and twelve months and include functional outcome, healthcare consumption, socio-demographic characteristics, and clinical information. After twelve months a second visit to the research outpatient clinic will be performed, and adherence to the new medication regimen in the intervention group will be measured. The primary outcome will be the incidence of new falls. Secondary outcome measurements are possible health effects of medication withdrawal, health-related quality of life (Short Form-12 and EuroQol-5D), costs, and cost-effectiveness of the intervention. Data will be analyzed using an intention-to-treat analysis. The successful completion of this trial will provide evidence on the effectiveness of withdrawal of fall-risk increasing drugs in older patients as a method for falls reduction. The trial is registered in the Netherlands Trial Register (NTR1593).

[Cost]effectiveness of withdrawal of fall-risk increasing drugs versus conservative treatment in older fallers: design of a multicenter randomized controlled trial (IMPROveFALL-study

Directory of Open Access Journals (Sweden)

Mattace-Raso Francesco US

2011-08-01

Full Text Available Background Fall incidents represent an increasing public health problem in aging societies worldwide. A major risk factor for falls is the use of fall-risk increasing drugs. The primary aim of the study is to compare the effect of a structured medication assessment including the withdrawal of fall-risk increasing drugs on the number of new falls versus 'care as usual' in older adults presenting at the Emergency Department after a fall. Methods/Design A prospective, multi-center, randomized controlled trial will be conducted in hospitals in the Netherlands. Persons aged ≥65 years who visit the Emergency Department due to a fall are invited to participate in this trial. All patients receive a full geriatric assessment at the research outpatient clinic. Patients are randomized between a structured medication assessment including withdrawal of fall-risk increasing drugs and 'care as usual'. A 3-monthly falls calendar is used for assessing the number of falls, fallers and associated injuries over a one-year follow-up period. Measurements will be at three, six, nine, and twelve months and include functional outcome, healthcare consumption, socio-demographic characteristics, and clinical information. After twelve months a second visit to the research outpatient clinic will be performed, and adherence to the new medication regimen in the intervention group will be measured. The primary outcome will be the incidence of new falls. Secondary outcome measurements are possible health effects of medication withdrawal, health-related quality of life (Short Form-12 and EuroQol-5D, costs, and cost-effectiveness of the intervention. Data will be analyzed using an intention-to-treat analysis. Discussion The successful completion of this trial will provide evidence on the effectiveness of withdrawal of fall-risk increasing drugs in older patients as a method for falls reduction. Trial Registration The trial is registered in the Netherlands Trial Register (NTR1593

Maternal medical risks during pregnancy and childhood externalizing behavior.

Science.gov (United States)

Jackson, Dylan B; Vaughn, Michael G

2018-04-25

Research has indicated that maternal health during the prenatal period and at delivery carries far reaching significance for the development of offspring. Even so, the role of the accumulation of maternal medical risks during pregnancy in the development of externalizing behavior during childhood has generally been overlooked. The present study investigates whether the accumulation of maternal medical risks during the prenatal period is positively associated with childhood externalizing behavior, and whether this association is stronger among male offspring. We examined a large, nationally representative sample of children who participated in the Early Childhood Longitudinal Study, Birth Cohort (ECLS-B). Information concerning maternal medical history, including the presence of a number of medical risks during pregnancy, was obtained through hospital records. A subsample of children with both parent and teacher reports of externalizing behavior during kindergarten was employed in the present study. A greater number of maternal medical risks during pregnancy increased the odds of childhood externalizing behavior across settings, but only among male offspring. The predicted probability of persistent externalizing behavior among males increased from .084 in the absence of maternal medical risks during pregnancy to .241 in the presence of three or more maternal medical risks during pregnancy. Our findings suggest that maternal medical risks during the prenatal period can have far-reaching consequences for the behavioral development of male offspring. Treatment of medical risks among expectant mothers may have the added benefit of reducing the likelihood of childhood externalizing behavior among male progeny. Copyright © 2018 Elsevier Ltd. All rights reserved.

Encouraging the Disuse of Illicit Drugs Among At-Risk Youth.

Science.gov (United States)

Cheung, Chau-kiu; Ngai, Steven Sek-yum

2016-05-01

Youth at risk of illicit drug abuse and other delinquent acts are the target of social work services. Preventing or discouraging the use of illicit drugs among at-risk youth is a long-standing practical and research concern. For this reason, the preventive function of courage is a research gap the present study seeks to fill. The study collected data from 169 at-risk youths and their social workers with two-wave panel surveys. Results show that courage in Wave 1 presented a strong negative effect on illicit drug use in Wave 2 in the youth, controlling for illicit drug use in Wave 1 and background characteristics. Moreover, the negative effect was stronger when Wave 1 drug use was more likely. These results imply the helpfulness of encouraging at-risk youth to gather courage to resist the temptation to use illicit drugs. © The Author(s) 2014.

Risk of Herpes Zoster and Disseminated Varicella Zoster in Patients Taking Immunosuppressant Drugs at the Time of Zoster Vaccination.

Science.gov (United States)

Cheetham, T Craig; Marcy, S Michael; Tseng, Hung-Fu; Sy, Lina S; Liu, In-Lu Amy; Bixler, Felicia; Baxter, Roger; Donahue, James G; Naleway, Allison L; Jacobsen, Steven J

2015-07-01

To determine the risks associated with zoster vaccine when administered to patients taking immunosuppressant medications. Patients enrolled in 1 of 7 managed care organizations affiliated with the Vaccine Safety Datalink between January 1, 2006, and December 31, 2009, were eligible. The exposure of interest was zoster vaccination in patients with current or remote immunosuppressant drug use. The primary outcomes were disseminated varicella zoster virus (VZV) and herpes zoster in the 42 days after vaccination. Automated data were collected on immunosuppressant drugs and baseline medical conditions. A logistic regression model using inverse probability treatment weights was used to estimate the odds of developing VZV or herpes zoster. A total of 14,554 individuals had an immunosuppressant medication dispensed around the time of vaccination, including 4826 with current use and 9728 with remote use. Most patients were taking low-dose corticosteroids. No cases of disseminated VZV were found in the current or remote users. The risk of herpes zoster was elevated in the 42 days after vaccination in current vs remote users (adjusted odds ratio, 2.99; 95% CI, 1.58-5.70). We found that patients taking immunosuppressant medications at the time of vaccination had a modest increased risk of herpes zoster in the 42 days after vaccination. The development of herpes zoster within 42 days after vaccination suggests that this is more likely due to reactivation of latent zoster virus than dissemination of the vaccine-derived varicella virus. These findings support the current zoster vaccination guidelines. Copyright © 2015 Mayo Foundation for Medical Education and Research. All rights reserved.

Drug Use Pattern Among Medical Students in a Nigerian University

African Journals Online (AJOL)

Item 21 - 31 ... Studies have reported that for medical students to cope with ... might be on the rise and may be related to the level of stress among them. ... management strategies in their curriculum. ... studies in Nigeria had evaluated the relationship between drug ..... teachers' knowledge and views about drug abuse in Ogun.

Is the clinical relevance of drug-food and drug-herb interactions limited to grapefruit juice and Saint-John's Wort?

Science.gov (United States)

Mouly, Stéphane; Lloret-Linares, Célia; Sellier, Pierre-Olivier; Sene, Damien; Bergmann, J-F

2017-04-01

An interaction of drug with food, herbs, and dietary supplements is usually the consequence of a physical, chemical or physiologic relationship between a drug and a product consumed as food, nutritional supplement or over-the-counter medicinal plant. The current educational review aims at reminding to the prescribing physicians that the most clinically relevant drug-food interactions may not be strictly limited to those with grapefruit juice and with the Saint John's Wort herbal extract and may be responsible for changes in drug plasma concentrations, which in turn decrease efficacy or led to sometimes life-threatening toxicity. Common situations handled in clinical practice such as aging, concomitant medications, transplant recipients, patients with cancer, malnutrition, HIV infection and those receiving enteral or parenteral feeding may be at increased risk of drug-food or drug-herb interactions. Medications with narrow therapeutic index or potential life-threatening toxicity, e.g., the non-steroidal anti-inflammatory drugs, opioid analgesics, cardiovascular medications, warfarin, anticancer drugs and immunosuppressants may be at risk of significant drug-food interactions to occur. Despite the fact that considerable effort has been achieved to increase patient' and doctor's information and ability to anticipate their occurrence and consequences in clinical practice, a thorough and detailed health history and dietary recall are essential for identifying potential problems in order to optimize patient prescriptions and drug dosing on an individual basis as well as to increase the treatment risk/benefit ratio. Copyright © 2016 Elsevier Ltd. All rights reserved.

Cardiovascular Risk Factors among First Year Medical Students

Directory of Open Access Journals (Sweden)

Raj Krishna Dangol

2017-12-01

Full Text Available Introduction: Detection of cardiovascular risk in young age is important to motivate them to modify life styles and seek health care early to lower the chances of acquiring cardiovascular disease in later age. This study was done to assess cardiovascular risk factors among first year medical students. Methods: A cross-sectional study was conducted throughout September and October 2017 in which all first year medical students from a medical college were assessed for the presence of cardiovascular risk factors. Participants’ demography, family history of illness, anthropometric measurements, and blood reports of lipid profile and fasting glucose were acquired. Data were analyzed with Statistical Package for Social Sciences (SPSS-21. Result: There were 99 participants; 55 males and 44 females. One or more risk factors were present in 87 (87.9% participants. Moreover, 67.7% (n = 67 participants had more than one risk factors. Low HDL-cholesterol was the most common (n = 55, 55.6% risk factor followed by elevated triacylglycerol (n = 47, 47.5% and family history of hypertension (n = 45, 45.5%. There was no significant difference in presence of various risk factors between genders. Conclusion: There was higher prevalence of cardiovascular risk factors among first year medical students. Majority of them had more than one risk factors. Low HDL-cholesterol was the most common risk factor. The risk factors were comparable in males and females.

Urine drug screening in the medical setting.

Science.gov (United States)

Hammett-Stabler, Catherine A; Pesce, Amadeo J; Cannon, Donald J

2002-01-01

The term drug screen is a misnomer since it implies screening for all drugs, which is not possible. Current practice is to limit the testing to the examination of serum for several drugs such as ethanol, acetaminophen, salicylate, and of urine for several specific drugs or classes of drugs. In the emergency setting the screen should be performed in less than one hour. Controversies continue to exist regarding the value of urine drug testing in the medical setting. The reasons for these include the drugs involved, the sample, the methods utilized to perform the tests, and the level of understanding of the physician using the data, all of which are closely related to the other. Current automated methods provide rapid results demanded in emergency situations, but are often designed for, or adapted from, workplace testing and are not necessarily optimized for clinical applications. Furthermore, the use of these methods without consideration of the frequency in which the drugs are found in a given area is not cost-effective. The laboratory must understand the limitations of the assays used and provide this information to the physician. Additionally, the laboratory and the physicians using the data must cooperate to determine which drugs are appropriate and necessary to measure for their institution and clinical setting. In doing so it should be remembered that for many drugs, the sample, urine, contains the end product(s) of drug metabolism, not the parent drug. Furthermore, it is necessary to understand the pharmacokinetic parameters of the drug of interest when interpreting data. Finally, while testing for some drugs may not appear cost-effective, the prevention or reduction of morbidity and mortality may offset any laboratory costs. While the literature is replete with studies concerning new methods and a few regarding physician understanding, there are none that we could find that thoroughly, objectively, and fully addressed the issues of utility and cost-effectiveness.

75 FR 10490 - Joint Meeting of the Arthritis Drugs Advisory Committee and the Drug Safety and Risk Management...

Science.gov (United States)

2010-03-08

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Joint Meeting of the Arthritis Drugs Advisory Committee and the Drug Safety and Risk Management Advisory... Drug Safety and Risk Management Advisory Committee. General Function of the Committees: To provide...

Deeply discounted medications: Implications of generic prescription drug wars.

Science.gov (United States)

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

2010-01-01

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

A prospective three-step intervention study to prevent medication errors in drug handling in paediatric care.

Science.gov (United States)

Niemann, Dorothee; Bertsche, Astrid; Meyrath, David; Koepf, Ellen D; Traiser, Carolin; Seebald, Katja; Schmitt, Claus P; Hoffmann, Georg F; Haefeli, Walter E; Bertsche, Thilo

2015-01-01

To prevent medication errors in drug handling in a paediatric ward. One in five preventable adverse drug events in hospitalised children is caused by medication errors. Errors in drug prescription have been studied frequently, but data regarding drug handling, including drug preparation and administration, are scarce. A three-step intervention study including monitoring procedure was used to detect and prevent medication errors in drug handling. After approval by the ethics committee, pharmacists monitored drug handling by nurses on an 18-bed paediatric ward in a university hospital prior to and following each intervention step. They also conducted a questionnaire survey aimed at identifying knowledge deficits. Each intervention step targeted different causes of errors. The handout mainly addressed knowledge deficits, the training course addressed errors caused by rule violations and slips, and the reference book addressed knowledge-, memory- and rule-based errors. The number of patients who were subjected to at least one medication error in drug handling decreased from 38/43 (88%) to 25/51 (49%) following the third intervention, and the overall frequency of errors decreased from 527 errors in 581 processes (91%) to 116/441 (26%). The issue of the handout reduced medication errors caused by knowledge deficits regarding, for instance, the correct 'volume of solvent for IV drugs' from 49-25%. Paediatric drug handling is prone to errors. A three-step intervention effectively decreased the high frequency of medication errors by addressing the diversity of their causes. Worldwide, nurses are in charge of drug handling, which constitutes an error-prone but often-neglected step in drug therapy. Detection and prevention of errors in daily routine is necessary for a safe and effective drug therapy. Our three-step intervention reduced errors and is suitable to be tested in other wards and settings. © 2014 John Wiley & Sons Ltd.

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

Science.gov (United States)

2010-03-29

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Food and Drug Administration/Xavier University Global Medical Device Conference AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public conference. SUMMARY: The Food and Drug Administration (FDA...

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

Science.gov (United States)

2013-03-13

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Food and Drug Administration/Xavier University Global Medical Device Conference AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public conference. SUMMARY: The Food and Drug Administration (FDA...

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

Science.gov (United States)

2012-02-22

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Food and Drug Administration/Xavier University Global Medical Device Conference AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public conference. SUMMARY: The Food and Drug Administration (FDA...

High-risk sexual behavior among drug-using men.

Science.gov (United States)

Seidman, S N; Sterk-Elifson, C; Aral, S O

1994-01-01

Drug-using men are at high risk for acquisition and transmission of STD, presumably due to the risky behaviors practiced in environments of drug use. To study behaviors associated with STD transmission among drug-using men. Drug outreach workers distributed vouchers to self-identified drug-using men in urban Atlanta. Vouchers could be redeemed for cash at a storefront clinic where subjects provided urine for a urethritis screening test (leukocyte esterase test) and a drug screen, and were interviewed. Of 382 voucher recipients, 252 (66%) came to the clinic. Subjects were predominantly black (92%), homeless (70%), and aged 20 to 40 (88%). All used illicit drugs; none were currently receiving drug abuse treatment. Urine drug screen confirmed recent cocaine use in 63%, and recent opiate use in 4%. Three-fourths reported a history of STD, mostly gonorrhea. In the preceding 3 months, 14% had not had sex, 80% had sex exclusively with women, 4% had sex with both men and women, and 2% had sex exclusively with men. Of the heterosexually active men, 29% had 5 or more recent partners. Compared to other heterosexually active men, these men were more likely to always use alcohol or crack before having sex (prevalence ratio [PR] = 2.0, 95% CI = 1.3-2.5) and to drink alcohol every day (PR = 2.0, 95% CI = 1.2-3.3). Daily crack use was associated with choosing partners at elevated STD risk; daily alcohol use with having more partners. Positive drug screen for cocaine was associated with self-reported crack use. Urethritis, detected in 16%, was not correlated with behavior. A substantial number of drug-using men practice high-risk sexual behavior and should be targeted for intervention. Monetary and other incentives should be considered for recruitment. Further study is needed to clarify the relationship between sexual behavior, cocaine use, and STD.

Risk Management Post-Marketing Surveillance for the Abuse of Medications Acting on the Central Nervous System: Expert Panel Report

Science.gov (United States)

Johanson, Chris-Ellyn; Balster, Robert L.; Henningfield, Jack E.; Schuster, Charles R.; Anthony, James C.; Barthwell, Andrea G.; Coleman, John J.; Dart, Richard C.; Gorodetzky, Charles W.; O’Keeffe, Charles; Sellers, Edward M.; Vocci, Frank; Walsh, Sharon L.

2010-01-01

The abuse and diversion of medications is a significant public health problem. This paper is part of a supplemental issue of Drug and Alcohol Dependence focused on the development of risk management plans and post-marketing surveillance related to minimizing this problem. The issue is based on a conference that was held in October, 2008. An Expert Panel was formed to provide a summary of the conclusions and recommendations that emerged from the meeting involving drug abuse experts, regulators and other government agencies, pharmaceutical companies and professional and other non-governmental organizations. This paper provides a written report of this Expert Panel. Eleven conclusions and eleven recommendations emerged concerning the state of the art of this field of research, the regulatory and public health implications and recommendations for future directions. It is concluded that special surveillance tools are needed to detect the emergence of medication abuse in a timely manner and that risk management tools can be implemented to increase the benefit to risk ratio. The scientific basis for both the surveillance and risk management tools is in its infancy, yet progress needs to be made. It is also important that the unintended consequences of increased regulation and the imposition of risk management plans be minimized. PMID:19783383

Accuracy and completeness of drug information in Wikipedia medication monographs.

Science.gov (United States)

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

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

Analysis of drug abuse data reported by medical institutions in Taiwan from 2002 to 2011

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Jui Hsu

2014-06-01

Full Text Available Drug abuse has become a global issue of concern. It affects not only individual users, but also their families and communities. Data were retrieved from the database of the Taiwan Surveillance System of Drug Abuse and Addiction Treatment (SSDAAT from 2002 to 2011, and 147,660 cases reported by medical institutions in Taiwan were reviewed. This study showed that the top five reported abused drugs by medical institutions during the last decade were heroin, methamphetamine, benzodiazepines, ketamine, and zolpidem. Heroin and methamphetamine continued to be the first two abused drugs reported by medical institutions. Heroin abuse was significant, but has shown a downward trend. However, emerging abused drugs, such as ketamine and zolpidem, presented upward trends. 3,4-Methylenedioxy-N-methylamphetamine (MDMA abuse seems to have re-emerged and has increased gradually since 2010. Injection without needle sharing has become the most common route of administration of abused drugs since 2002. The majority of causes for these reported drug abuses were drug dependence, followed by peer influence and stress relief. Hepatitis C was the most commonly reported infectious disease, followed by hepatitis B and AIDS in the drug abusers reported by medical institutions. It should be noted that access to drugs via the Internet increased year by year, and this is clearly an area needing constant monitoring.

Risk of falls after withdrawal of fall-risk-increasing drugs: a prospective cohort study

NARCIS (Netherlands)

van der Velde, Nathalie; Stricker, Bruno H. Ch; Pols, Huib A. P.; van der Cammen, Tischa J. M.

2007-01-01

AIMS: Falling in older persons is a frequent and serious clinical problem. Several drugs have been associated with increased fall risk. The objective of this study was to identify differences in the incidence of falls after withdrawal (discontinuation or dose reduction) of fall-risk-increasing drugs

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

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Sebastian eSattler

2016-01-01

Full Text Available 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= 6,454, 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 (reuse 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 (reuse 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

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

Science.gov (United States)

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

The Integrated Medical Model: A Risk Assessment and Decision Support Tool for Space Flight Medical Systems

Science.gov (United States)

Kerstman, Eric; Minard, Charles; Saile, Lynn; deCarvalho, Mary Freire; Myers, Jerry; Walton, Marlei; Butler, Douglas; Iyengar, Sriram; Johnson-Throop, Kathy; Baumann, David

2009-01-01

The Integrated Medical Model (IMM) is a decision support tool that is useful to mission planners and medical system designers in assessing risks and designing medical systems for space flight missions. The IMM provides an evidence based approach for optimizing medical resources and minimizing risks within space flight operational constraints. The mathematical relationships among mission and crew profiles, medical condition incidence data, in-flight medical resources, potential crew functional impairments, and clinical end-states are established to determine probable mission outcomes. Stochastic computational methods are used to forecast probability distributions of crew health and medical resource utilization, as well as estimates of medical evacuation and loss of crew life. The IMM has been used in support of the International Space Station (ISS) medical kit redesign, the medical component of the ISS Probabilistic Risk Assessment, and the development of the Constellation Medical Conditions List. The IMM also will be used to refine medical requirements for the Constellation program. The IMM outputs for ISS and Constellation design reference missions will be presented to demonstrate the potential of the IMM in assessing risks, planning missions, and designing medical systems. The implementation of the IMM verification and validation plan will be reviewed. Additional planned capabilities of the IMM, including optimization techniques and the inclusion of a mission timeline, will be discussed. Given the space flight constraints of mass, volume, and crew medical training, the IMM is a valuable risk assessment and decision support tool for medical system design and mission planning.

Matching Judicial Supervision to Clients' Risk Status in Drug Court

Science.gov (United States)

Marlowe, Douglas B.; Festinger, David S.; Lee, Patricia A.; Dugosh, Karen L.; Benasutti, Kathleen M.

2006-01-01

This article reports outcomes from a program of experimental research evaluating the risk principle in drug courts. Prior studies revealed that participants who were high risk and had (a) antisocial personality disorder or (b) a prior history of drug abuse treatment performed better in drug court when scheduled to attend biweekly judicial status…

Use of fall risk increasing drugs in residents of retirement villages: a pilot study of long term care and retirement home residents in Ontario, Canada.

Science.gov (United States)

Rojas-Fernandez, Carlos; Dadfar, Farzan; Wong, Andrea; Brown, Susan G

2015-10-14

Falls continue to be a problem for older people in long-term care (LTC) and retirement home (RH) settings and are associated with significant morbidity and health care use. Fall-risk increasing drugs (FRIDs) are known to increase fall risk and represent modifiable risk factors. There are limited data regarding the use of FRIDs in contemporary LTC and RH settings, and it has not been well documented to what extent medication regimens are reviewed and modified for those who have sustained falls. The objective of this study is to characterize medication related fall risk factors in LTC and RH residents and on-going use of medications known to increase fall risk. Retrospective chart review of residents aged >65 who sustained one or more falls living in LTC or RH settings. 105 residents who fell one or more times during 2009-2010 were identified with a mean age of 89 years, a mean of nine scheduled medications and seven diagnoses, and 83% were women. Residents in LTC were ostensibly at higher risk for falls relative to those in RH settings as suggested by higher proportion of residents with multiple falls, multiple comorbidities, comorbidities that increase fall risk and visual impairment. Post fall injuries were sustained by 42% of residents, and residents in RH sustained more injuries relative to LTC residents (47 vs 34%). Use of FRIDs such as benzodiazepines, antipsychotic, antidepressant and various antihypertensive drugs was common in the present sample. No medication regimen changes were noted in the 6-month post fall period. The present study documented common use FRIDs by LTC and RH residents with multiple falls. These potentially modifiable falls risk factors are not being adequately addressed in contemporary practice, demonstrating that there is much room for improvement with regards to the safe and appropriate use of medications in LTC and RH residents.

Medical emergencies facing general practitioners: Drugs for the doctor's bag

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Janković Slobodan

2014-01-01

Full Text Available General practitioners are frequently facing medical emergencies. In order to react properly and administer therapy on time, a general practitioner needs to prepare and keep with himself the appropriate set of drugs which could be effectively used for treatment of the emergencies. The following drugs should find their place in the doctor's bag: acetaminophen (for mild and moderate pain, and for fever, morphine (for severe pain, naloxone (for heroin poisoning, ceftriaxone (for meningococcal meningitis, albuterol (for bronchial asthma attack, hydrocortisone (for bronchial asthma attack, glucagon (for severe hypoglycemia, dextrose (for mild to moderate hypoglycemia, diazepam (for febrile convulsions or epileptic status, epinephrine (for anaphylaxis and cardiac arrest, atropine (for symptomatic bradicardia, chloropyramine (for acute allergy, aspirin (for acute myocardial infarction, nitroglycerine (for acute coronary syndrome, metoclopramide (for nausea and vomiting, haloperidol (for delirium, methylergometrine (for control of bleeding after delivery or abortion, furosemide (for acute pulmonary edema and flumazenil (for benzodiazepine poisoning. For each of the listed drugs a physician should well know the recommended doses, indications, contraindications and warnings. All of the listed drugs are either registered in Serbia or available through special import, so general practitioners may fill their bags with all necessary drugs and effectively and safely treat medical emergencies.

Medical Advice from Lawyers: A Content Analysis of Advertising for Drug Injury Lawsuits.

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Tippett, Elizabeth

2015-01-01

This study examined the medical information contained in a sample of television ads soliciting consumers for lawsuits against drug and medical device manufactures. Almost all such ads involved drugs or devices that have not been recalled and remain on the market. These ads raise important public health questions because they may influence the prospective medical decisions of viewers. The ads contained extensive descriptions of serious adverse events associated with the drugs or devices but almost uniformly failed to disclose information relating to the likelihood of such events. They also failed to effectively advise viewers to consult a doctor. Results also identified a subset of ads that mimicked public service announcements, claiming to be. a "medical alert" "consumer alert" or "FDA warning" at the start of the ad. Most such ads did not disclose the attorney source of the advertising until the final few seconds.

Use of Preclinical Drug vs. Food Choice Procedures to Evaluate Candidate Medications for Cocaine Addiction.

Science.gov (United States)

Banks, Matthew L; Hutsell, Blake A; Schwienteck, Kathryn L; Negus, S Stevens

2015-06-01

Drug addiction is a disease that manifests as an inappropriate allocation of behavior towards the procurement and use of the abused substance and away from other behaviors that produce more adaptive reinforcers (e.g. exercise, work, family and social relationships). The goal of treating drug addiction is not only to decrease drug-maintained behaviors, but also to promote a reallocation of behavior towards alternative, nondrug reinforcers. Experimental procedures that offer concurrent access to both a drug reinforcer and an alternative, nondrug reinforcer provide a research tool for assessment of medication effects on drug choice and behavioral allocation. Choice procedures are currently the standard in human laboratory research on medications development. Preclinical choice procedures have been utilized in biomedical research since the early 1940's, and during the last 10-15 years, their use for evaluation of medications to treat drug addiction has increased. We propose here that parallel use of choice procedures in preclinical and clinical studies will facilitate translational research on development of medications to treat cocaine addiction. In support of this proposition, a review of the literature suggests strong concordance between preclinical effectiveness of candidate medications to modify cocaine choice in nonhuman primates and rodents and clinical effectiveness of these medications to modify either cocaine choice in human laboratory studies or metrics of cocaine abuse in patients with cocaine use disorder. The strongest evidence for medication effectiveness in preclinical choice studies has been obtained with maintenance on the monoamine releaser d -amphetamine, a candidate agonist medication for cocaine use analogous to use of methadone to treat heroin abuse or nicotine formulations to treat tobacco dependence.

Physicians' Perception of Teratogenic Risk and Confidence in Prescribing Drugs in Pregnancy-Influence of Norwegian Drug Information Centers.

Science.gov (United States)

Bakkebø, Tina; Widnes, Sofia Frost; Aamlid, Synnøve Stubmo; Schjøtt, Jan

2016-05-01

Clinical decision support provided by drug information centers is an intervention that can ensure rational drug therapy for pregnant women. We have examined whether physicians' teratogenic risk perceptions and confidence in prescribing drugs to pregnant women is altered after advice from the Norwegian drug information centers, Regional Medicines and Pharmacovigilance Centres i Norway (RELIS). Physicians who consulted RELIS for advice on patient-specific drug use in pregnancy from November 2013 to April 2014 completed questionnaires before and after receiving the advice. A scale from 1 to 7 was used to rate confidence in prescribing and perception of teratogenic risk. The lower part of the scale represented a low perception of teratogenic risk and a high confidence in prescribing a drug in pregnancy. The data were analyzed using a mixed linear model. A total of 45 physicians participated in the study and they assessed 64 drugs or categories of drugs. Advice from RELIS increased confidence in prescribing, with a statistically significant mean change on the scale from 4.1 to 2.9. The assessment of teratogenic risk was reduced after advice from RELIS, with a mean change from 3.2 to 2.5, though this was not significant. A subgroup of 26 physicians completed questionnaires both before and after advice from RELIS and assessed a total of 32 drugs or categories of drugs. In 94% of these assessments, advice from RELIS altered the physician's confidence in prescribing. Perception of teratogenic risk was altered in 78% of the assessments. Our results show that physicians' perception of teratogenic risk and confidence in prescribing drugs to pregnant women is influenced by advice from Norwegian drug information centers. Copyright © 2016 Elsevier HS Journals, Inc. All rights reserved.

Medication-Related Fall Incidents in an Older, Ambulant Population: The B-PROOF Study

NARCIS (Netherlands)

Ham, Annelies C.; Swart, Karin M. A.; Enneman, Anke W.; van Dijk, Suzanne C.; Oliai Araghi, Sadaf; van Wijngaarden, Janneke P.; van der Zwaluw, Nikita L.; Brouwer-Brolsma, Elske M.; Dhonukshe-Rutten, Rosalie A. M.; van Schoor, Natasja M.; van der Cammen, Tischa J. M.; Lips, Paul; de Groot, Lisette C. P. G. M.; Uitterlinden, André G.; Witkamp, Renger F.; Stricker, Bruno H.; van der Velde, Nathalie

2014-01-01

Background Medication use is a potentially modifiable risk factor for falling; psychotropic and cardiovascular drugs have been indicated as main drug groups that increase fall risk. However, evidence is mainly based on studies that recorded falls retrospectively and/or did not determine medication

A review of drug-drug interactions in older HIV-infected patients.

Science.gov (United States)

Chary, Aarthi; Nguyen, Nancy N; Maiton, Kimberly; Holodniy, Mark

2017-12-01

The number of older HIV-infected people is growing due to increasing life expectancies resulting from the use of antiretroviral therapy (ART). Both HIV and aging increase the risk of other comorbidities, such as cardiovascular disease, osteoporosis, and some malignancies, leading to greater challenges in managing HIV with other conditions. This results in complex medication regimens with the potential for significant drug-drug interactions and increased morbidity and mortality. Area covered: We review the metabolic pathways of ART and other medications used to treat medical co-morbidities, highlight potential areas of concern for drug-drug interactions, and where feasible, suggest alternative approaches for treating these conditions as suggested from national guidelines or articles published in the English language. Expert commentary: There is limited evidence-based data on ART drug interactions, pharmacokinetics and pharmacodynamics in the older HIV-infected population. Choosing and maintaining effective ART regimens for older adults requires consideration of side effect profile, individual comorbidities, interactions with concurrent prescriptions and non-prescription medications and supplements, dietary patterns with respect to dosing, pill burden and ease of dosing, cost and affordability, patient preferences, social situation, and ART resistance history. Practitioners must remain vigilant for potential drug interactions and intervene when there is a potential for harm.

Editorial : Clinical drug interactions | Kokwaro | East African Medical ...

African Journals Online (AJOL)

Journal Home > Vol 78, No 10 (2001) >. Log in or Register to get access to full text downloads. Username, Password, Remember me, or Register. Editorial: Clinical drug interactions. G. O. Kokwaro. Abstract. (East African Medical Journal 2001 78 (10): 505-506). Full Text: EMAIL FREE FULL TEXT EMAIL FREE FULL TEXT

Television advertisement format and the provision of risk information about prescription drug products.

Science.gov (United States)

Glinert, Lewis H; Schommer, Jon C

2005-06-01

Considerable attention has been afforded to analyzing the content of and assessing consumers' reaction to print direct-to-consumer drug ads, but not so for televised ads. To determine whether advertisements with different risk severity and risk presentation would significantly affect viewers' (1) recall of information contained in the advertisement, (2) evaluation of the advertisement, and (3) perceptions of the advertised product's risks. Data were collected from a sample of 135 first-year pharmacy students at a Midwestern college of pharmacy. After viewing 1 of the 6 advertisements designed for this study, participants were asked to complete a self-administered survey. Chi-square and analysis of variance were used to analyze the data. A 2x3 between subjects design was used to test the effects of 2 levels of risk severity (high- vs low-risk severity) and 3 levels of risk presentation (original ad containing integrated risk message, deintegrated risk message/dual modality using male voice-over, deintegrated risk message/dual modality using female voice-over). Results of analysis of variance procedures revealed that deintegrating risk information by placing it at the end of the advertisement and the use of captions in addition to oral messages (dual modality) (1) improved the recall of general and specific side effect information, (2) led to a perception that the advertisement had greater informational content, (3) resulted in lower Advertisement Distraction, and (4) lessened cognitive and affective aspects of information overload for the advertisement containing the high-risk severity medication. However, this pattern of findings was not found for the low-risk severity medication. Alternative methods for presenting risk information in direct-to-consumer ads affected some aspects of information recall and advertisement evaluation, but were not shown to affect risk perceptions regarding the advertised products.

Trust and risk: a model for medical education.

Science.gov (United States)

Damodaran, Arvin; Shulruf, Boaz; Jones, Philip

2017-09-01

Health care delivery, and therefore medical education, is an inherently risky business. Although control mechanisms, such as external audit and accreditation, are designed to manage risk in clinical settings, another approach is 'trust'. The use of entrustable professional activities (EPAs) represents a deliberate way in which this is operationalised as a workplace-based assessment. Once engaged with the concept, clinical teachers and medical educators may have further questions about trust. This narrative overview of the trust literature explores how risk, trust and control intersect with current thinking in medical education, and makes suggestions for potential directions of enquiry. Beyond EPAs, the importance of trust in health care and medical education is reviewed, followed by a brief history of trust research in the wider literature. Interpersonal and organisational levels of trust and a model of trust from the management literature are used to provide the framework with which to decipher trust decisions in health care and medical education, in which risk and vulnerability are inherent. In workplace learning and assessment, the language of 'trust' may offer a more authentic and practical vocabulary than that of 'competency' because clinical and professional risks are explicitly considered. There are many other trust relationships in health care and medical education. At the most basic level, it is helpful to clearly delineate who is the trustor, the trustee, and for what task. Each relationship has interpersonal and organisational elements. Understanding and considered utilisation of trust and control mechanisms in health care and medical education may lead to systems that maturely manage risk while actively encouraging trust and empowerment. © 2017 John Wiley & Sons Ltd and The Association for the Study of Medical Education.

Predicting transporter-mediated drug interactions: Commentary on: "Pharmacokinetic evaluation of a drug transporter cocktail consisting of digoxin, furosemide, metformin and rosuvastatin" and "Validation of a microdose probe drug cocktail for clinical drug interaction assessments for drug transporters and CYP3A".

Science.gov (United States)

Zhang, L; Sparreboom, A

2017-04-01

Transporters, expressed in various tissues, govern the absorption, distribution, metabolism, and excretion of drugs, and consequently their inherent safety and efficacy profiles. Drugs may interact with a transporter as a substrate and/or an inhibitor. Understanding transporter-mediated drug-drug interactions (DDIs), in addition to enzyme-mediated DDIs, is an integral part of risk assessment in drug development and regulatory review because the concomitant use of more than one medication in patients is common. © 2016 ASCPT.

Drug choice, spatial distribution, HIV risk, and HIV prevalence among injection drug users in St. Petersburg, Russia

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Shaboltas Alla V

2009-07-01

Full Text Available Abstract Background The HIV epidemic in Russia has been driven by the unsafe injection of drugs, predominantly heroin and the ephedrine derived psychostimulants. Understanding differences in HIV risk behaviors among injectors associated with different substances has important implications for prevention programs. Methods We examined behaviors associated with HIV risk among 900 IDUs who inject heroin, psychostimulants, or multiple substances in 2002. Study participants completed screening questionnaires that provided data on sociodemographics, drug use, place of residence and injection- and sex-related HIV risk behaviors. HIV testing was performed and prevalence was modeled using general estimating equation (GEE analysis. Individuals were clustered by neighborhood and disaggregated into three drug use categories: Heroin Only Users, Stimulant Only Users, and Mixed Drug Users. Results Among Heroin Only Users, younger age, front/backloading of syringes, sharing cotton and cookers were all significant predictors of HIV infection. In contrast, sharing needles and rinse water were significant among the Stimulant Only Users. The Mixed Drug Use group was similar to the Heroin Only Users with age, front/back loading, and sharing cotton significantly associated with HIV infection. These differences became apparent only when neighborhood of residence was included in models run using GEE. Conclusion The type of drug injected was associated with distinct behavioral risks. Risks specific to Stimulant Only Users appeared related to direct syringe sharing. The risks specific to the other two groups are common to the process of sharing drugs in preparation to injecting. Across the board, IDUs could profit from prevention education that emphasizes both access to clean syringes and preparing and apportioning drug with these clean syringes. However, attention to neighborhood differences might improve the intervention impact for injectors who favor different drugs.

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

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Ronald E. See

2011-06-01

Full Text Available 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.

How many people in Canada use prescription opioids non-medically in general and street drug using populations?

Science.gov (United States)

Popova, Svetlana; Patra, Jayadeep; Mohapatra, Satya; Fischer, Benedikt; Rehm, Jürgen

2009-01-01

Medical prescriptions for opioids as well as their non-medical use have increased in Canada in recent years. This study aimed to estimate the number of non-medical prescription opioid (PO) users in the general and street drug using populations in Canada. The number of non-medical PO users among the general population and the number of non-medical PO users, heroin users, or both among the street drug using population was estimated for Canada and for the most populous Canadian provinces. Different estimation methods were used: 1) the number of non-medical PO users in the Canadian general population was estimated based on Canadian availability data, and the ratio of US availability to non-medical PO use from US survey data; 2) numbers within the street drug using population were indirectly estimated based on overdose death data, and a key informants survey. Distribution and trends by usage of opioids were determined by using the multi-site Canadian OPICAN cohort data. Between 321,000 to 914,000 non-medical PO users were estimated to exist among the general population in Canada in 2003. The estimated number of non-medical PO users, heroin users, or both among the street drug using population was about 72,000, with more individuals using nonmedical PO than heroin in 2003. Based on data from the OPICAN survey, in 2005 the majority of the street drug using population in main Canadian cities was non-medical PO users, with the exception of Vancouver and Montreal. A relative increase of 24% was observed from 2002 to 2005 in the proportion of the street drug using population who used non-medical POs only. There is an urgent need to further assess the extent and patterns of non-medical prescription opioid use, related problems and drug distribution channels in Canada.

Pharmacokinetic drug-drug interaction and their implication in clinical management

OpenAIRE

Palleria, Caterina; DI PAOLO, Antonello; Giofrè, Chiara; Caglioti, Chiara; Leuzzi, Giacomo; Siniscalchi, Antonio; De Sarro, Giovambattista; Gallelli, Luca

2013-01-01

Drug-drug interactions (DDIs) are one of the commonest causes of medication error in developed countries, particularly in the elderly due to poly-therapy, with a prevalence of 20-40%. In particular, poly-therapy increases the complexity of therapeutic management and thereby the risk of clinically important DDIs, which can both induce the development of adverse drug reactions or reduce the clinical efficacy. DDIs can be classify into two main groups: pharmacokinetic and pharmacodynamic. In thi...

Sharing of Needles and Syringes among Men Who Inject Drugs: HIV Risk in Northwest Bangladesh.

Directory of Open Access Journals (Sweden)

M Kamal Pasa

-syringe sharing. Utilization and impact of risk reduction programmes might be improved with expanded clean needle/syringe distribution at times and venues convenient for PWID, better trained and non-judgmental staff, and medical assistance for health problems, including drug withdrawal symptoms.

Examining the Acceptability of mHealth Technology in HIV Prevention Among High-Risk Drug Users in Treatment.

Science.gov (United States)

Shrestha, Roman; Huedo-Medina, Tania B; Altice, Frederick L; Krishnan, Archana; Copenhaver, Michael

2017-11-01

Despite promising trends of the efficacy of mobile health (mHealth) based strategies to a broad range of health conditions, very few if any studies have been done in terms of the examining the use of mHealth in HIV prevention efforts among people who use drugs in treatment. Thus, the goal of this study was to gain insight into the real-world acceptance of mHealth approaches among high-risk people who use drugs in treatment. A convenience sample of 400 HIV-negative drug users, who reported drug- and/or sex-related risk behaviors, were recruited from a methadone clinic in New Haven, Connecticut. Participants completed standardized assessments of drug- and sex-related risk behaviors, neurocognitive impairment (NCI), and measures of communication technology access and utilization, and mHealth acceptance. We found a high prevalence of current ownership and use of mobile technologies, such as cell phone (91.5%) including smartphone (63.5%). Participants used mobile technologies to communicate mostly through phone calls (M = 4.25, SD = 1.24), followed by text messages (M = 4.21, SD = 1.29). Participants expressed interest in using mHealth for medication reminders (72.3%), receive information about HIV (65.8%), and to assess drug-related (72.3%) and sex-related behaviors (64.8%). Furthermore, participants who were neurocognitively impaired were more likely to use cell phone without internet and show considerable interest in using mHealth as compared to those without NCI. The findings from this study provide empirical evidence that mHealth-based programs, specifically cell phone text messaging-based health programs, may be acceptable to this high-risk population.

Financial risk relationships and adoption of management strategies in physician groups for self-administered injectable drugs.

Science.gov (United States)

Agnew, Jonathan D; Stebbins, Marilyn R; Hickman, David E; Lipton, Helene Levins

2003-01-01

To consider the extent, nature, and range of risk arrangements between physician groups and health maintenance organizations (HMOs) for self-administered injectable (SAI) drugs; to examine types and frequencies of SAI drug-use management strategies adopted by physician groups; and to explore the relationship between locus and level of financial risk for SAIs and physician group strategy adoption. We used a multiple case-study design to select physician groups and their health maintenance organization (HMO) contractual partners in 4 markets in the United States (Northwest, Northeast, Midwest, Southwest). Physician groups in these markets were chosen based on size (e50 physicians) and experience with drug risk (e1 year). Physician groups were asked to identify their 3 major HMO contractual partners in each market. Telephone interviews were conducted from January 2000 to June 2001, with the resulting purposive sample of 37 individuals representing 20 physician groups. We found that the level and locus of SAI financial risk were related to the adoption of management strategies. Physician groups with higher financial risk for SAIs adopted more strategies than lower-risk groups. Groups with SAI financial risk in the medical services capitation (MSC) adopted 9.2 strategies per group. In contrast, groups with SAI financial risk in the pharmacy-risk budget (PRB) averaged 1.5 strategies per group. Groups with SAI financial risk in both the MSC and PRB fell in-between, averaging 4.5 strategies per group. The most frequently adopted strategy was designing evidenced-based therapeutic guidelines, i.e., protocols based on evidence from the peer-reviewed literature used to guide physicians in the treatment of typically chronic conditions (9 groups, 45% of sample). The second most common strategy involved adapting the existing utilization management system to process SAIs (7 groups, 35%) and the establishment of office procedures for internal authorization (5 groups, 25%). The

Hospitalization Risk and Potentially Inappropriate Medications among Medicare Home Health Nursing Patients.

Science.gov (United States)

Lohman, Matthew C; Cotton, Brandi P; Zagaria, Alexandra B; Bao, Yuhua; Greenberg, Rebecca L; Fortuna, Karen L; Bruce, Martha L

2017-12-01

Hospitalizations and potentially inappropriate medication (PIM) use are significant and costly issues among older home health patients, yet little is known about the prevalence of PIM use in home health or the relationship between PIM use and hospitalization risk in this population. To describe the prevalence of PIM use and association with hospitalization among Medicare home health patients. Cross-sectional analysis using data from 132 home health agencies in the US. Medicare beneficiaries starting home health nursing services between 2013 and 2014 (n = 87,780). Prevalence of individual and aggregate PIM use at start of care, measured using the 2012 Beers criteria. Relative risk (RR) of 30-day hospitalization or re-hospitalization associated with individual and aggregate PIM use, compared to no PIM use. In total, 30,168 (34.4%) patients were using at least one PIM, with 5969 (6.8%) taking at least two PIMs according to the Beers list. The most common types of PIMs were those affecting the brain or spinal cord, analgesics, and medications with anticholinergic properties. With the exception of nonsteroidal anti-inflammatory drugs (NSAIDs), PIM use across all classes was associated with elevated risk (10-33%) of hospitalization compared to non-use. Adjusting for demographic and clinical characteristics, patients using at least one PIM (excluding NSAIDs) had a 13% greater risk (RR = 1.13, 95% CI: 1.09, 1.17) of being hospitalized than patients using no PIMs, while patients using at least two PIMs had 21% greater risk (RR = 1.21, 95% CI: 1.12, 1.30). Similar associations were found between PIMs and re-hospitalization risk among patients referred to home health from a hospital. Given the high prevalence of PIM use and the association between PIMs and hospitalization risk, home health episodes represent opportunities to substantially reduce PIM use among older adults and prevent adverse outcomes. Efforts to address medication use during home health episodes

HIV/STI Risk Behavior of Drug Court Participants

Science.gov (United States)

Robertson, Angela A.; St. Lawrence, Janet S.; McCluskey, D. Lee

2012-01-01

Drug abusing offenders have high rates of HIV and other sexually transmitted infections (STI). To date, the HIV/STI prevention needs of offenders in drug court programs have been ignored. This multi-method study employed interviews to assess drug court professionals' perceptions of the need for an HIV risk reduction intervention to be integrated…

The prescription talk – an approach to teach patient-physician conversation about drug prescription to medical students

Directory of Open Access Journals (Sweden)

Hauser, Katarina

2017-05-01

Full Text Available Background: Medication communication from physicians to patients often is poor, by this among others enhancing the risk of non-adherence. In this context, a neglect regarding the prescription talk has been complained.Aim of the project: In a newly developed elective medical students work on physician-patient conversations dealing with drug prescription. Essential aspects related to an effective and safe drug treatment are combined with steps of shared decision-making. Together with a tutor, students develop a (model conversation guide that might be tailored according to individual needs and views.Description/Methods: In a one-week course 3rd-5th year medical students treat a paper case according to problem-based learning. This is accompanied by a one-hour lecture and literature provided on an online learning platform (ILIAS. During a workshop, aspects of drug treatment and patient participation are integrated into a guide for a prescription talk. At the end of the week the students are invited to apply the (if need be individualized guide in a simulated physician-patient communication with an actor. The conversation is evaluated using a checklist based upon the (model conversation guide.Results: Informal and formalized feedback indicate high acceptance and satisfaction of participants with this elective. The checklist turned out to be of acceptable to good reliability with mostly selective items. Portfolio entries and written evaluation suggest that participants’ positions and attitudes are influenced.

Risk management and post-marketing surveillance for the abuse of medications acting on the central nervous system: expert panel report.

Science.gov (United States)

Johanson, Chris-Ellyn; Balster, Robert L; Henningfield, Jack E; Schuster, Charles R; Anthony, James C; Barthwell, Andrea G; Coleman, John J; Dart, Richard C; Gorodetzky, Charles W; O'Keeffe, Charles; Sellers, Edward M; Vocci, Frank; Walsh, Sharon L

2009-12-01

The abuse and diversion of medications is a significant public health problem. This paper is part of a supplemental issue of Drug and Alcohol Dependence focused on the development of risk management plans and post-marketing surveillance related to minimizing this problem. The issue is based on a conference that was held in October 2008. An Expert Panel was formed to provide a summary of the conclusions and recommendations that emerged from the meeting involving drug abuse experts, regulators and other government agencies, pharmaceutical companies and professional and other non-governmental organizations. This paper provides a written report of this Expert Panel. Eleven conclusions and 11 recommendations emerged concerning the state of the art of this field of research, the regulatory and public health implications and recommendations for future directions. It is concluded that special surveillance tools are needed to detect the emergence of medication abuse in a timely manner and that risk management tools can be implemented to increase the benefit to risk ratio. The scientific basis for both the surveillance and risk management tools is in its infancy, yet progress needs to be made. It is also important that the unintended consequences of increased regulation and the imposition of risk management plans be minimized.

Use of fertility drugs and risk of ovarian cancer.

Science.gov (United States)

Diergaarde, Brenda; Kurta, Michelle L

2014-06-01

The purpose of this review is to highlight recent research and insights into the relationship between fertility drug use and ovarian cancer risk. Results from two large case-control studies provided further evidence that fertility drug use does not significantly contribute to risk of ovarian cancer among the majority of women when adjusting for known confounding factors. However, questions regarding the effect on certain subgroups, including long-term fertility drug users, women who remain nulligravid after fertility treatment, women with BRCA1 or BRCA2 mutations and borderline ovarian tumours, still remain. In addition, it may currently just be too early to determine whether there is an association between fertility drug use and ovarian cancer risk given that many of the exposed women are only now beginning to reach the ovarian cancer age range. Whether use of fertility drugs increases the risk of ovarian cancer is an important question that requires further investigation, in particular given the large number of women utilizing fertility treatments. Fortunately, results from recent studies have been mainly reassuring. Large well designed studies with sufficient follow-up time are needed to further evaluate the effects of fertility treatments within subgroups defined by patient and tumour characteristics.

77 FR 65000 - Drug Safety and Risk Management Advisory Committee; Notice of Meeting

Science.gov (United States)

2012-10-24

...] Drug Safety and Risk Management Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Drug Safety and Risk Management Advisory Committee. General Function of the Committee: To provide... Use (ETASU) before CDER's Drug Safety and Risk Management Advisory Committee (DSaRM). The Agency plans...

78 FR 30929 - Drug Safety and Risk Management Advisory Committee; Notice of Meeting

Science.gov (United States)

2013-05-23

...] Drug Safety and Risk Management Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Drug Safety and Risk Management Advisory Committee. General Function of the Committee: To provide... (REMS) with elements to assure safe use (ETASU) before its Drug Safety and Risk Management Advisory...

Fake and Counterfeit Drug: A review

African Journals Online (AJOL)

intent to deceptively represent its origin authenticity or effectiveness. A counterfeit drug ... version of medication. The business of fake drugs is a lucrative crime that is .... management of target or most vulnerable groups of patients with high risk ...

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

Science.gov (United States)

2010-01-01

... another test, performed by the gas chromatography/mass spectrometry method (GC/MS). This procedure is... 10 Energy 4 2010-01-01 2010-01-01 false Medical review of results of tests for illegal drug use... Procedures § 707.13 Medical review of results of tests for illegal drug use. (a) All test results shall be...

Risk evaluation of medical and industrial radiation devices

International Nuclear Information System (INIS)

Jones, E.D.; Cunningham, R.E.; Rathbun, P.A.

1994-03-01

In 1991, the NRC, Division of Industrial and Medical Nuclear Safety, began a program to evaluate the use of probabilistic risk assessment (PRA) in regulating medical devices. This program represents an initial step in an overall plant to evaluate the use of PRA in regulating the use of nuclear by-product materials. The NRC envisioned that the use of risk analysis techniques could assist staff in ensuring that the regulatory approach was standardized, understandable, and effective. Traditional methods of assessing risk in nuclear power plants may be inappropriate to use in assessing the use of by-product devices. The approaches used in assessing nuclear reactor risks are equipment-oriented. Secondary attention is paid to the human component, for the most part after critical system failure events have been identified. This paper describes the risk methodology developed by Lawrence Livermore National Laboratory (LLNL), initially intended to assess risks associated with the use of the Gamma Knife, a gamma stereotactic radiosurgical device. For relatively new medical devices such as the Gamma Knife, the challenge is to perform a risk analysis with very little quantitative data but with an important human factor component. The method described below provides a basic approach for identifying the most likely risk contributors and evaluating their relative importance. The risk analysis approach developed for the Gamma Knife and described in this paper should be applicable to a broader class of devices in which the human interaction with the device is a prominent factor. In this sense, the method could be a prototypical model of nuclear medical or industrial device risk analysis

Youth Drug Offenders: An Examination of Criminogenic Risk and Juvenile Recidivism

OpenAIRE

Papp, Jordan; Campbell, Christina; Onifade, Eyitayo; Anderson, Valerie; Davidson, William; Foster, Dawn

2016-01-01

Understanding the criminogenic risk factors and treatment needs of juvenile drug offenders is important because of the myriad negative outcomes that befall juveniles that are involved in drugs. A widely used juvenile risk assessment tool, the Youth Level of Service/Case Management Inventory (YLS/CMI) was utilized to explore criminogenic risk factors and treatment needs to predict recidivism. Demographic differences between drug and nondrug offenders were also examined. Results ...

77 FR 75176 - Drug Safety and Risk Management Advisory Committee; Notice of Meeting

Science.gov (United States)

2012-12-19

...] Drug Safety and Risk Management Advisory Committee; Notice of Meeting AGENCY: Food and Drug... being rescheduled due to the postponement of the October 29-30, 2012, Drug Safety and Risk Management... Committee: Drug Safety and Risk Management Advisory Committee. General Function of the Committee: To provide...

Automated drug dispensing system reduces medication errors in an intensive care setting.

Science.gov (United States)

Chapuis, Claire; Roustit, Matthieu; Bal, Gaëlle; Schwebel, Carole; Pansu, Pascal; David-Tchouda, Sandra; Foroni, Luc; Calop, Jean; Timsit, Jean-François; Allenet, Benoît; Bosson, Jean-Luc; Bedouch, Pierrick

2010-12-01

We aimed to assess the impact of an automated dispensing system on the incidence of medication errors related to picking, preparation, and administration of drugs in a medical intensive care unit. We also evaluated the clinical significance of such errors and user satisfaction. Preintervention and postintervention study involving a control and an intervention medical intensive care unit. Two medical intensive care units in the same department of a 2,000-bed university hospital. Adult medical intensive care patients. After a 2-month observation period, we implemented an automated dispensing system in one of the units (study unit) chosen randomly, with the other unit being the control. The overall error rate was expressed as a percentage of total opportunities for error. The severity of errors was classified according to National Coordinating Council for Medication Error Reporting and Prevention categories by an expert committee. User satisfaction was assessed through self-administered questionnaires completed by nurses. A total of 1,476 medications for 115 patients were observed. After automated dispensing system implementation, we observed a reduced percentage of total opportunities for error in the study compared to the control unit (13.5% and 18.6%, respectively; perror (20.4% and 13.5%; perror showed a significant impact of the automated dispensing system in reducing preparation errors (perrors caused no harm (National Coordinating Council for Medication Error Reporting and Prevention category C). The automated dispensing system did not reduce errors causing harm. Finally, the mean for working conditions improved from 1.0±0.8 to 2.5±0.8 on the four-point Likert scale. The implementation of an automated dispensing system reduced overall medication errors related to picking, preparation, and administration of drugs in the intensive care unit. Furthermore, most nurses favored the new drug dispensation organization.

[Cost]effectiveness of withdrawal of fall-risk increasing drugs versus conservative treatment in older fallers: design of a multicenter randomized controlled trial (IMPROveFALL-study)

NARCIS (Netherlands)

Hartholt, K.A.; van der Velde, N.; van Lieshout, E.M.M.; Polinder, S.; de Vries, O.J.; Boyé, N.D.A.; Kerver, A.J.H.; Ziere, G.; Bruijninckx, M.M.M.; de Vries, M.R.; Mattace-Raso, F.U.S.; Uitterlinden, A.G.; van Beeck, E.F.; Lips, P.T.A.M.; Patka, P.; van der Cammen, T.J.

2011-01-01

Background: Fall incidents represent an increasing public health problem in aging societies worldwide. A major risk factor for falls is the use of fall-risk increasing drugs. The primary aim of the study is to compare the effect of a structured medication assessment including the withdrawal of

Global patient safety and antiretroviral drug-drug interactions in the resource-limited setting.

Science.gov (United States)

Seden, Kay; Khoo, Saye H; Back, David; Byakika-Kibwika, Pauline; Lamorde, Mohammed; Ryan, Mairin; Merry, Concepta

2013-01-01

Scale-up of HIV treatment services may have contributed to an increase in functional health facilities available in resource-limited settings and an increase in patient use of facilities and retention in care. As more patients are reached with medicines, monitoring patient safety is increasingly important. Limited data from resource-limited settings suggest that medication error and antiretroviral drug-drug interactions may pose a significant risk to patient safety. Commonly cited causes of medication error in the developed world include the speed and complexity of the medication use cycle combined with inadequate systems and processes. In resource-limited settings, specific factors may contribute, such as inadequate human resources and high disease burden. Management of drug-drug interactions may be complicated by limited access to alternative medicines or laboratory monitoring. Improving patient safety by addressing the issue of antiretroviral drug-drug interactions has the potential not just to improve healthcare for individuals, but also to strengthen health systems and improve vital communication among healthcare providers and with regulatory agencies.

[Prescribed and dispensed in the third trimester of pregnancy drugs: What practices and risks?].

Science.gov (United States)

Parent, G; Mottet, N; Mairot, P; Baudier, F; Carel, D; Goguey, M; Riethmuller, D; Limat, S

2016-09-01

The aim of the study was to describe the prescribing of drugs to pregnant women during the third trimester of pregnancy. The retrospective analysis is interested by pregnant women from August 2009 to April 2011, living in Franche-Comté. The used data are recorded in the database of the French Health Insurance Service. Drugs prescribing were analyzed and classified according to three categories: drugs that are contraindicated, not recommended drugs and drugs that are used. This classification is based on two databases: the Summaries of Product Characteristics of Vidal 2010 and data from the National Security Agency of Medicines. The potential exposure of patients was pointed out. On 15,027 patients, 80% had a prescription. Six percent of prescriptions containing drugs not recommended and 1% drugs that contraindicated. Therapeutic classes identified are analgesics, anti-infective drugs and medicines supplementing with vitamins and minerals. Contraindicated drugs (10%) are NSAIDs, rubella vaccine, cyclins and ACE inhibitors and ARBs. Approximately 2.7% of women were potentially exposed to these drugs. Despite the recommendations of the ANSM, some drugs that are contraindicated are prescribed for pregnant women in their third trimester of pregnancy. In the absence of studies, the decision must be made on a case by case basis by assessing the risk-benefit ratio. Particular care is to bring about the drugs taken in self-medication. Information and advice are key steps to avoid incidents. Copyright © 2015 Elsevier Masson SAS. All rights reserved.

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

Science.gov (United States)

Meier, Brian P; Lappas, Courtney M

2016-11-01

Research indicates that there is a preference for natural v. synthetic products, but the influence of this preference on drug choice in the medical domain is largely unknown. We present 5 studies in which participants were asked to consider a hypothetical situation in which they had a medical issue requiring pharmacological therapy. Participants ( N = 1223) were asked to select a natural, plant-derived, or synthetic drug. In studies 1a and 1b, approximately 79% of participants selected the natural v. synthetic drug, even though the safety and efficacy of the drugs were identical. Furthermore, participants rated the natural drug as safer than the synthetic drug, and as that difference increased, the odds of choosing the natural over synthetic drug increased. In studies 2 and 3, approximately 20% of participants selected the natural drug even when they were informed that it was less safe (study 2) or less effective (study 3) than the synthetic drug. Finally, in study 4, approximately 65% of participants chose a natural over synthetic drug regardless of the severity of a specific medical condition (mild v. severe hypertension), and this choice was predicted by perceived safety and efficacy differences. Overall, these data indicate that there is a bias for natural over synthetic drugs. This bias could have implications for drug choice and usage. © The Author(s) 2015.

Federalizing Medical Campaigns against Alcoholism and Drug Abuse

Science.gov (United States)

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

Federalizing medical campaigns against alcoholism and drug abuse.

Science.gov (United States)

Metlay, Grischa

2013-03-01

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. Drawing on a variety of primary, secondary, and archival sources, this article describes the creation and early years of these agencies. 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. 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. © 2013 Milbank Memorial Fund.

Student Drug Use, Risk-Taking and Alienation.

Science.gov (United States)

Rouse, Beatrice A.; Ewing, John A.

This study seeks: (1) to detect whether an increase in drug use occurred in the two years since a previous similar study; (2) to determine the kinds and levels of risk which the students associated with the nonprescription use of various drugs; and (3) to examine the extent to which the marihuana groups showed alienation. The study drew a…

Stimulant ADHD medication and risk for substance abuse.

Science.gov (United States)

Chang, Zheng; Lichtenstein, Paul; Halldner, Linda; D'Onofrio, Brian; Serlachius, Eva; Fazel, Seena; Långström, Niklas; Larsson, Henrik

2014-08-01

There are persistent concerns of long-term effects of stimulant ADHD medication on the development of substance abuse. Using Swedish national registers, we studied all individuals born between 1960 and 1998 and diagnosed with ADHD (26,249 men and 12,504 women). We investigated the association between stimulant ADHD medication in 2006 and substance abuse during 2009. Substance abuse was indexed by substance-related death, crime, or hospital visits. ADHD medication was not associated with increased rate of substance abuse. Actually, the rate during 2009 was 31% lower among those prescribed ADHD medication in 2006, even after controlling for medication in 2009 and other covariates (hazard ratio: 0.69; 95% confidence interval: 0.57-0.84). Also, the longer the duration of medication, the lower the rate of substance abuse. Similar risk reductions were suggested among children and when investigating the association between stimulant ADHD medication and concomitant short-term abuse. We found no indication of increased risks of substance abuse among individuals prescribed stimulant ADHD medication; if anything, the data suggested a long-term protective effect on substance abuse. Although stimulant ADHD medication does not seem to increase the risk for substance abuse, clinicians should remain alert to the potential problem of stimulant misuse and diversion in ADHD patients. © 2013 The Authors. Journal of Child Psychology and Psychiatry © 2013 Association for Child and Adolescent Mental Health.

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

Science.gov (United States)

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. Published 2015. This article is a U.S. Government work and is in the public domain in the USA.

The Prevalence of HIV Risk Behaviors among Felony Drug Court Participants.

Science.gov (United States)

Festinger, David S; Dugosh, Karen L; Metzger, David S; Marlowe, Douglas B

2012-01-01

A small percentage of participants in a large metropolitan felony Drug Court engaged in high-risk injection drug use, but a large percentage engaged in high-risk sexual behaviors. HIV risk behaviors were associated with being male, African-American, and younger. A large proportion of Drug Court participants resided in areas of the city with a high prevalence of persons living with HIV/AIDS, thus heightening the probability of exposure to the virus.

Risk factors associated with injection initiation among drug users in Northern Thailand

Directory of Open Access Journals (Sweden)

Suriyanon Vinai

2006-03-01

Full Text Available Abstract Background Circumstances surrounding injection initiation have not been well addressed in many developing country contexts. This study aimed to identify demographic factors, sexual behaviors and drug use characteristics related to injection initiation among drug users in northern Thailand. Methods A cross-sectional survey was conducted among 2,231 drug users admitted to the Northern Drug Treatment Center in Mae Rim, Chiang Mai, Thailand, between February 1, 1999 and December 31, 2000. A multiple logistic regression was employed to identify the independent effects from potential risk factors of transition into injection. Results After controlling for other covariates, being 20 years of age or older, single, ever receiving education, urban residence, and having a history of smoking or incarceration were significantly associated with higher likelihood of injection initiation. Multiple sex partners and an experience of sex abuse were associated with an increased risk of injection initiation. Comparing to those whose first drug was opium, individuals using heroin as their initiation drug had greater risk of injection initiation; conversely, those taking amphetamine as their first drug had less risk of injection initiation. Age of drug initiation was negatively associated with the risk of injection initiation: the older the age of drug initiation, the less the risk of injection initiation. Conclusion Injection initiation was related to several demographic factors, sexual behaviors and drug use characteristics. Understanding these factors will benefit the design of approaches to successfully prevent or delay transition into injection.

Risk factors in prevention of drug dependences

NARCIS (Netherlands)

Orosova, Ol'ga; Gajdosova, Beata; Madarasova-Geckova, Andrea; Van Dijk, Jitse P.

2007-01-01

The study presents the state-of-art of knowledge of risk factors of drug use as a form of risk behaviour in adolescents in individual, interpersonal, and environmental domain (family, school, society). The attention is paid to general deviation syndrome and to the construct of general tendency to

Efficient discovery of risk patterns in medical data.

Science.gov (United States)

Li, Jiuyong; Fu, Ada Wai-chee; Fahey, Paul

2009-01-01

This paper studies a problem of efficiently discovering risk patterns in medical data. Risk patterns are defined by a statistical metric, relative risk, which has been widely used in epidemiological research. To avoid fruitless search in the complete exploration of risk patterns, we define optimal risk pattern set to exclude superfluous patterns, i.e. complicated patterns with lower relative risk than their corresponding simpler form patterns. We prove that mining optimal risk pattern sets conforms an anti-monotone property that supports an efficient mining algorithm. We propose an efficient algorithm for mining optimal risk pattern sets based on this property. We also propose a hierarchical structure to present discovered patterns for the easy perusal by domain experts. The proposed approach is compared with two well-known rule discovery methods, decision tree and association rule mining approaches on benchmark data sets and applied to a real world application. The proposed method discovers more and better quality risk patterns than a decision tree approach. The decision tree method is not designed for such applications and is inadequate for pattern exploring. The proposed method does not discover a large number of uninteresting superfluous patterns as an association mining approach does. The proposed method is more efficient than an association rule mining method. A real world case study shows that the method reveals some interesting risk patterns to medical practitioners. The proposed method is an efficient approach to explore risk patterns. It quickly identifies cohorts of patients that are vulnerable to a risk outcome from a large data set. The proposed method is useful for exploratory study on large medical data to generate and refine hypotheses. The method is also useful for designing medical surveillance systems.

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

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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.

Drug and alcohol crash risk : traffic safety facts : research note.

Science.gov (United States)

2015-02-01

While the extent of use of alcohol by drivers and the risks posed by alcohol use have been well known for many decades, relatively little has been known about the use of other drugs by drivers and the associated risks. However, drug-impaired driving ...

EXPLORING THE PATTERN OF POLYPHARMACY AND PROPORTION OF DRUG TO DRUG INTERACTIONS AND ADVERSE DRUG REACTIONS IN THE ELDERLY

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Vijayashree Thyagaraj

2017-07-01

Full Text Available BACKGROUND The geriatric population is increasing as a result of advanced medical facilities. This population also faces a number of medical health challenges. They tend to receive multiple medications often leading to Drug-Drug Interactions (DDIs Adverse Drug Reactions (ADRs and other clinical consequences, which compromises their quality of life if not endangering it as well. There are few Indian studies focusing on this problem. Hence, this study was undertaken with the aim to assess the polypharmacy pattern, proportion of DDIs and adverse drug reactions in the geriatric population in a tertiary care hospital. MATERIALS AND METHODS This was a cross-sectional study wherein data from 201 geriatric inpatient’s prescriptions were collected. The prescriptions were assessed for demographic details such as age, gender, comorbidities and drugs prescribed. All prescriptions were evaluated for polypharmacy, DDIs and ADRs. DDIs were assessed using Micromedex software. Patients were stratified into groups and DDIs were compared between the groups, gender and also with number of drugs used. RESULTS There were 201 patients with a mean age of approximately 70 years. Polypharmacy occurred in 73.63% of them with mean number of drugs being 6.23. The number of drugs used increased significantly with age (p=0.0001. Hypertension was the most common comorbidity. Polypharmacy was strongly associated with hypertension and dyslipidaemia. A total of 129 (64.17% patients accounted for 425 potential DDIs. The most common drug involved in DDIs was aspirin. A subset analysis of ADRs showed an occurrence of 50.68% with 10.81% being definitely avoidable. CONCLUSION Elderly individuals are at increased risk of being on polypharmacy. This comes with the risk of several potential DDIs, which in turn may lead to adverse drug reactions, which results in morbidity. Doctors involved in the care of the elderly should be aware of these facts and exercise caution while adding any

Children who face development risks due to maternal addiction during pregnancy require extra medical and psychosocial resources.

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Rangmar, Jenny; Lilja, Maria; Köhler, Marie; Reuter, Antonia

2018-05-21

This study examined medical and psychosocial risk factors in children born to women with addiction problems during pregnancy and the children's needs for extra medical and psychosocial resources. Swedish midwives routinely screen pregnant women for drugs and alcohol and refer women with addictions to the Maternity and Child Healthcare Resource Team. We investigated the medical records of 127 children (51% girls) whose mothers were referred to the Resource Team from 2009-2015. Additional data were obtained from local child healthcare services (CHS), which provide routine paediatric care. More than three-quarters (76%) of the children had prenatal exposure to alcohol and drugs and 17% were born with withdrawal symptoms. The mothers had a high rate of psychiatric diagnoses (38%) and were more likely to smoke after delivery and less likely to breastfeed than the general population. However, adherence to the CHS programme was generally high. Additional visits to the nurse, referrals to specialists, collaboration meetings and reports of concerns to social services decreased when the children began attending ordinary CHS centres. Children born to women with addictions during pregnancy faced a high risk of developmental problems and should be offered additional CHS resources to minimise negative long-term consequences. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

Patterns and predictors of self-medication in northern Uganda.

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Moses Ocan

Full Text Available Self-medication with antimicrobial agents is a common form of self-care among patients globally with the prevalence and nature differing from country to country. Here we assessed the prevalence and predictors of antimicrobial self-medication in post-conflict northern Uganda. A cross-sectional study was carried out using structured interviews on 892 adult (≥18 years participants. Information on drug name, prescriber, source, cost, quantity of drug obtained, and drug use was collected. Households were randomly selected using multistage cluster sampling method. One respondent who reported having an illness within three months in each household was recruited. In each household, information was obtained from only one adult individual. Data was analyzed using STATA at 95% level of significance. The study found that a high proportion (75.7% of the respondents practiced antimicrobial self-medication. Fever, headache, lack of appetite and body weakness were the disease symptoms most treated through self-medication (30.3%. The commonly self-medicated antimicrobials were coartem (27.3%, amoxicillin (21.7%, metronidazole (12.3%, and cotrimoxazole (11.6%. Drug use among respondents was mainly initiated by self-prescription (46.5% and drug shop attendants (57.6%. On average, participants obtained 13.9±8.8 (95%CI: 12.6-13.8 tablets/capsules of antimicrobial drugs from drug shops and drugs were used for an average of 3.7±2.8 days (95%CI: 3.3-3.5. Over half (68.2% of the respondents would recommend self-medication to another sick person. A high proportion (76% of respondents reported that antimicrobial self-medication had associated risks such as wastage of money (42.1%, drug resistance (33.2%, and masking symptoms of underlying disease (15.5%. Predictors of self-medication with antimicrobial agents included gender, drug knowledge, drug leaflets, advice from friends, previous experience, long waiting time, and distance to the health facility. Despite

Drug consumption among medical students in São Paulo, Brazil: influences of gender and academic year.

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Oliveira, Lucio Garcia de; Barroso, Lucia Pereira; Wagner, Gabriela Arantes; Ponce, Julio de Carvalho; Malbergier, André; Stempliuk, Vladimir de Andrade; Andrade, Arthur Guerra de

2009-09-01

To analyze alcohol, tobacco and other drug use among medical students. Over a five-year period (1996-2001), we evaluated 457 students at the Universidade de São Paulo School of Medicine, located in São Paulo, Brazil. The students participated by filling out an anonymous questionnaire on drug use (lifetime, previous 12 months and previous 30 days). The influence that gender and academic year have on drug use was also analyzed. During the study period, there was an increase in the use of illicit drugs, especially inhalants and amphetamines, among the medical students evaluated. Drug use (except that of marijuana and inhalants) was comparable between the genders, and academic year was an important influencing factor. Increased inhalant use was observed among the medical students, especially among males and students in the early undergraduate years. This is suggestive of a specific behavioral pattern among medical students. Our findings corroborate those of previous studies. Inhalant use is on the rise among medical students at the Universidade de São Paulo School of Medicine. Because of the negative health effects of illicit drug use, further studies are needed in order to deepen the understanding of this phenomenon and to facilitate the development of preventive measures.

Improving measurement of injection drug risk behavior using item response theory.

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Janulis, Patrick

2014-03-01

Recent research highlights the multiple steps to preparing and injecting drugs and the resultant viral threats faced by drug users. This research suggests that more sensitive measurement of injection drug HIV risk behavior is required. In addition, growing evidence suggests there are gender differences in injection risk behavior. However, the potential for differential item functioning between genders has not been explored. To explore item response theory as an improved measurement modeling technique that provides empirically justified scaling of injection risk behavior and to examine for potential gender-based differential item functioning. Data is used from three studies in the National Institute on Drug Abuse's Criminal Justice Drug Abuse Treatment Studies. A two-parameter item response theory model was used to scale injection risk behavior and logistic regression was used to examine for differential item functioning. Item fit statistics suggest that item response theory can be used to scale injection risk behavior and these models can provide more sensitive estimates of risk behavior. Additionally, gender-based differential item functioning is present in the current data. Improved measurement of injection risk behavior using item response theory should be encouraged as these models provide increased congruence between construct measurement and the complexity of injection-related HIV risk. Suggestions are made to further improve injection risk behavior measurement. Furthermore, results suggest direct comparisons of composite scores between males and females may be misleading and future work should account for differential item functioning before comparing levels of injection risk behavior.

Assessment of Medical Risks and Optimization of their Management using Integrated Medical Model

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Fitts, Mary A.; Madurai, Siram; Butler, Doug; Kerstman, Eric; Risin, Diana

2008-01-01

The Integrated Medical Model (IMM) Project is a software-based technique that will identify and quantify the medical needs and health risks of exploration crew members during space flight and evaluate the effectiveness of potential mitigation strategies. The IMM Project employs an evidence-based approach that will quantify probability and consequences of defined in-flight medical risks, mitigation strategies, and tactics to optimize crew member health. Using stochastic techniques, the IMM will ultimately inform decision makers at both programmatic and institutional levels and will enable objective assessment of crew health and optimization of mission success using data from relevant cohort populations and from the astronaut population. The objectives of the project include: 1) identification and documentation of conditions that may occur during exploration missions (Baseline Medical Conditions List [BMCL), 2) assessment of the likelihood of conditions in the BMCL occurring during exploration missions (incidence rate), 3) determination of the risk associated with these conditions and quantify in terms of end states (Loss of Crew, Loss of Mission, Evacuation), 4) optimization of in-flight hardware mass, volume, power, bandwidth and cost for a given level of risk or uncertainty, and .. validation of the methodologies used.

Use of Fall-Risk Inducing Drugs in Patients Using Anti-Parkinson Drugs (APD: A Swedish Register-Based Study.

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Ylva Haasum

Full Text Available Many drugs increase the risk of falls in old age. Although persons with Parkinson's disease (PD are at increased risk of experiencing falls and fractures, the use of fall-risk inducing drugs (FRIDs in this population has not previously been investigated. The objective of this study was to investigate the burden of use of FRIDs in older persons treated with anti-Parkinson drugs (APD; used as a proxy for PD, compared to persons without APD.We analyzed individual data on age, sex, type of housing and drug use in 1 346 709 persons aged ≥ 65 years in the Swedish Prescribed Drug Register on the date of 30 September 2008. Main outcome measure was the use of FRIDs.FRIDs were used by 79% of persons with APD and 75% of persons without APD. Persons with APD were more likely to use ≥ 1 FRIDs compared to persons without APD (adjusted OR: 1.09; 95% CI: 1.06-1-12. The association was stronger for concomitant use of ≥ 5 FRIDS (adjusted OR: 1.49; 95% CI: 1.44-1.55.The high use of FRIDs among persons with APD indicates that these patients may be at increased risk of drug-induced falls. Further studies are needed to investigate how these drugs affect the risk of falling in persons with PD.

Coprescribing proton-pump inhibitors with nonsteroidal anti-inflammatory drugs: risks versus benefits

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Gwee KA

2018-02-01

Full Text Available Kok Ann Gwee,1 Vernadine Goh,2 Graca Lima,3 Sajita Setia4 1Stomach, Liver, and Bowel Centre, Gleneagles Hospital, 2Department of Pharmacy, National University of Singapore, Singapore; 3Global Medical Affairs, Asia-Pacific Region, Pfizer, Hong Kong; 4Medical Affairs, Pfizer, Singapore Abstract: Nonsteroidal anti-inflammatory drugs (NSAIDs are often coadministered with proton-pump inhibitors (PPIs to reduce NSAID-induced gastrointestinal (GI adverse events. This coadministration is generally regarded as safe, and is included in many of the guidelines on NSAID prescription. However, recent evidence indicates that the GI risks associated with NSAIDs can be potentiated when they are combined with PPIs. This review discusses the GI effects and complications of NSAIDs and how PPIs may potentiate these effects, options for prevention of GI side effects, and appropriate use of PPIs in combination with NSAIDs. Keywords: PPIs, COX2 inhibitors, NSAIDs, enteropathy, gastrointestinal

Are patients reliable when self-reporting medication use? Validation of structured drug interviews and home visits by drug analysis and prescription data in acutely hospitalized patients

DEFF Research Database (Denmark)

Glintborg, Bente; Hillestrøm, Peter René; Olsen, Lenette Holm

2007-01-01

inspected, and patients were interviewed about their drug use. Additional blood samples were drawn for drug analysis. The median age of included patients was 72 years, and 298 patients (60%) were women. Patients reported use of 3 (median) prescription-only medications (range, 0-14) during the structured...... interview. The congruence between self-report and drug analysis was high for all 5 drugs measured (all kappa >0.8). However, 9 patients (2%) reported use of drugs that were not detected in their blood samples. In 29 patients (6%), the blood samples contained drugs not reported during the structured...... to an acute medical department at a Danish university hospital were interviewed on the day of admission about their recent medication use. Blood samples drawn immediately after admission were screened for contents of 5 drugs (digoxin, bendroflumethiazide, amlodipine, simvastatin, glimepiride), and the results...

Medical emergencies facing general practitioners: Drugs for the doctor's bag

OpenAIRE

Janković Slobodan

2014-01-01

General practitioners are frequently facing medical emergencies. In order to react properly and administer therapy on time, a general practitioner needs to prepare and keep with himself the appropriate set of drugs which could be effectively used for treatment of the emergencies. The following drugs should find their place in the doctor's bag: acetaminophen (for mild and moderate pain, and for fever), morphine (for severe pain), naloxone (for heroin poisoning), ceftriaxone (for meningococcal ...

[Guidance of FDA risk evaluation and mitigation strategy and enlightenment to drug risk management of post-marketing Chinese medicine].

Science.gov (United States)

Li, Yuanyuan; Xie, Yanming

2011-10-01

The FDA risk evaluation and mitigation strategy (REMS) aims to drugs or biological products known or potential serious risk management. Analysis with the example of the content of the Onsolis REMS named FOCOS. Our country can be reference for the analysis of relevant experience and establish a scientific evaluation mechanism, strengthen the drug risk consciousness, promote the rational drug use, organic combined with the before-marketing and post-marketing evaluation of traditional Chinese medicine, and promote the evaluation of risk management of the drug development and improvement.

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

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Riva, Silvia; Monti, Marco; Antonietti, Alessandro

2011-01-01

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

Inappropriate medication use and risk of falls – A prospective study in a large community-dwelling elderly cohort

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Fourrier Annie

2009-07-01

Full Text Available Abstract Background Explicit criteria for determining potentially inappropriate medication consumption in elderly were elaborated by Beers et al. These lists have been used worldwide to evaluate medical prescriptions but there is little epidemiologic evidence demonstrating negative consequences of inappropriate medication use. It has been reported that some drugs could increase the risk of falls, which are a frequent and serious problem in elderly population. We aimed to evaluate the association between the use of potentially inappropriate medications and the risk of falls. Methods The 3C Study is a multicentre prospective cohort study conducted in France with 4 years of follow-up. Non-institutionalized men and women aged 65 years or over (N = 6343 were randomly selected from electoral rolls. Data on socio-demographic, medical characteristics and medication use (based on self-reports and data from the national healthcare insurance were collected. Use of inappropriate medication for elderly was defined from established criteria. Data about falls were collected at the two follow-up examinations (2 years and 4 years after baseline. The association between the exposure to inappropriate medications and the risk of falls was evaluated using multivariate models (Cox model and logistic regression. Results 32% of subjects reported inappropriate medication use at baseline and 29% at least two of the three examinations; 22% had fallen 2 times or more during follow-up. Overall, inappropriate medication users had an increased risk of falling. This increase was mainly due to the use of long-acting benzodiazepines (adjusted odds ratio (OR = 1.4, 95% confidence interval: [1.1–1.8], in both occasional and regular users, other inappropriate psychotropics (adjusted OR = 1.7 [1.7–2.7] in regular users, or medication with anticholinergic properties (adjusted OR = 1.6 [1.2–2.1] in regular users. Neither occasional, nor regular use of short- or intermediate

Perceptions of personal health risks by medical and non-medical workers in a university medical center : a survey study

NARCIS (Netherlands)

Listyowardojo, Tita Alissa; Nap, Raoul E.; Johnson, Addie

2010-01-01

Background: Health care workers (HCWs) are faced with many work-related choices which may depend on how they perceive risk, such as whether or not to comply with safety regulations. Little research has investigated risk perception in medical workers in comparison with non-medical workers and the

Effect of medication burden on persistent use of lipid-lowering drugs among patients with hypertension.

Science.gov (United States)

Robertson, Teisha A; Cooke, Catherine E; Wang, Jingshu; Shaya, Fadia T; Lee, Helen Y

2008-11-01

To determine the effect of medication burden on persistent use of newly added lipid-lowering (LL) drugs among patients with hypertension. This retrospective database study used medical and pharmacy claims from a mid-Atlantic managed care organization. The cohort was obtained from continuous member enrollment in pharmacy and medical benefits from January 1, 2003, to December 31, 2005. Prescription claims were obtained for 18 months following the date of the first filled LL prescription (ie, index date). Patients were stratified into patients who changed LL drug or strength (group 1) and patients who did not change LL drug or strength (group 2). The primary outcome measure was persistence to newly added LL therapy. Persistence was defined by the length of time a member remained on therapy following the index date. The secondary outcome measure was the medication possession ratio (MPR). The MPR was calculated as the ratio of the sum of the days' supply of prescription filled divided by the number of days filled, plus the days' supply for the final prescription fill. Associations between the daily medication burden, defined as the number of unique drug products, and the outcome measures were analyzed. In the cohort of 3058 patients, the mean medication burden was 2.9 medications. Medication burden was positively associated with persistence and MPR through 18 months. Patients who had greater medication burden had longer persistence (P 80%) (P attention should focus on patients who have changes to their LL regimen compared with patients who continue on the same LL prescription.

Potentially inappropriate prescribing and the risk of adverse drug reactions in critically ill older adults

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Galli TB

2016-12-01

Full Text Available Background: Potentially inappropriate medication (PIM use in the elderly is associated with increased risk of adverse drug reactions (ADRs, but there is limited information regarding PIM use in the intensive care unit (ICU setting. Objective: The aim of the study is to describe the prevalence and factors associated with the use of PIM and the occurrence of PIM-related adverse reactions in the critically ill elderly. Methods: This study enrolled all critically ill older adults (60 years or more admitted to medical or cardiovascular ICUs between January and December 2013, in a large tertiary teaching hospital. For all patients, clinical pharmacists listed the medications given during the ICU stay and data on drugs were analyzed using 2012 Beers Criteria, to identify the prevalence of PIM. For each identified PIM the medical records were analyzed to evaluate factors associated with its use. The frequency of ADRs and, the causal relationship between PIM and the ADRs identified were also evaluated through review of medical records. Results: According to 2012 Beers Criteria, 98.2% of elderly patients used at least one PIM (n=599, of which 24.8% were newly started in the ICUs. In 29.6% of PIMs, there was a clinical circumstance that justified their prescription. The number of PIMs was associated with ICU length of stay and total number of medications. There was at least one ADR identified in 17.8% of patients; more than 40% were attributed to PIM, but there was no statistical association. Conclusions: There is a high prevalence of PIM used in acutely ill older people, but they do not seem to be the major cause of adverse drug reactions in this population. Although many PIMs had a clinical circumstance that led to their prescription during the course of ICU hospitalization, many were still present upon hospital discharge. Therefore, prescription of PIMs should be minimized to improve the safety of elderly patients.

Aspirin, nonaspirin nonsteroidal anti-inflammatory drug, and acetaminophen use and risk of invasive epithelial ovarian cancer

DEFF Research Database (Denmark)

Trabert, Britton; Ness, Roberta B; Lo-Ciganic, Wei-Hsuan

2014-01-01

BACKGROUND: Regular aspirin use is associated with reduced risk of several malignancies. Epidemiologic studies analyzing aspirin, nonaspirin nonsteroidal anti-inflammatory drug (NSAID), and acetaminophen use and ovarian cancer risk have been inconclusive. METHODS: We analyzed pooled data from 12...... population-based case-control studies of ovarian cancer, including 7776 case patients and 11843 control subjects accrued between 1992 and 2007. Odds ratios (ORs) for associations of medication use with invasive epithelial ovarian cancer were estimated in individual studies using logistic regression...... and combined using random effects meta-analysis. Associations between frequency, dose, and duration of analgesic use and risk of ovarian cancer were also assessed. All statistical tests were two-sided. RESULTS: Aspirin use was associated with a reduced risk of ovarian cancer (OR = 0.91; 95% confidence interval...

Incidence of cutaneous adverse drug reactions among medical inpatients of Sultanah Aminah Hospital Johor Bahru.

Science.gov (United States)

Latha, S; Choon, S E

2017-06-01

Cutaneous adverse drug reactions (cADRs) are common. There are only few studies on the incidence of cADRs in Malaysia. To determine the incidence, clinical features and risk factors of cADRs among hospitalized patients. A prospective study was conducted among medical inpatients from July to December 2014. A total of 43 cADRs were seen among 11 017 inpatients, yielding an incidence rate of 0.4%. cADR accounted for hospitalization in 26 patients. Previous history of cADR was present in 14 patients, with 50% exposed to the same drug taken previously. Potentially lifethreatening severe cutaneous adverse reactions (SCAR), namely drug reaction with eosinophilia and systemic symptoms (DRESS: 14 cases) and Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis (SJS/TEN: 6 cases) comprise almost 50% of cADRs. The commonest culprit drug group was antibiotics (37.2%), followed by anticonvulsants (18.6%). Cotrimoxazole, phenytoin and rifampicin were the main causative drugs for DRESS. Anticonvulsants were most frequently implicated in SJS/TEN (66.7%). Most cases had "probable" causality relationship with suspected drug (69.8%). The majority of cases were of moderate severity (65.1%), while 18.6% had severe reaction with 1 death recorded. Most cases were not preventable (76.7%). Older age (> 60 years) and mucosal involvement were significantly associated with a more severe reaction. The incidence of cADRs was 0.4%, with most cases classified as moderate severity and not preventable. The commonest reaction pattern was DRESS, while the main culprit drug group was antibiotics. Older age and mucosal membrane involvement predicts a severe drug reaction.

Impact of cardiovascular risk factors on medical expenditure: evidence from epidemiological studies analysing data on health checkups and medical insurance.

Science.gov (United States)

Nakamura, Koshi

2014-01-01

Concerns have increasingly been raised about the medical economic burden in Japan, of which approximately 20% is attributable to cardiovascular disease, including coronary heart disease and stroke. Because the management of risk factors is essential for the prevention of cardiovascular disease, it is important to understand the relationship between cardiovascular risk factors and medical expenditure in the Japanese population. However, only a few Japanese epidemiological studies analysing data on health checkups and medical insurance have provided evidence on this topic. Patients with cardiovascular risk factors, including obesity, hypertension, and diabetes, may incur medical expenditures through treatment of the risk factors themselves and through procedures for associated diseases that usually require hospitalization and sometimes result in death. Untreated risk factors may cause medical expenditure surges, mainly due to long-term hospitalization, more often than risk factors preventively treated by medication. On an individual patient level, medical expenditures increase with the number of concomitant cardiovascular risk factors. For single risk factors, personal medical expenditure may increase with the severity of that factor. However, on a population level, the medical economic burden attributable to cardiovascular risk factors results largely from a single, particularly prevalent risk factor, especially from mildly-to-moderately abnormal levels of the factor. Therefore, cardiovascular risk factors require management on the basis of both a cost-effective strategy of treating high-risk patients and a population strategy for reducing both the ill health and medical economic burdens that result from cardiovascular disease.

Prognosis of medical and economic efficiency of a patient-oriented program implementation aimed at formation of adherenceto drug therapy among rural population

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E A Kitaeva

2018-02-01

Full Text Available Aim. Development and implementation of novel organizational management technologies of medical care aimed at formation of adherence to drug therapy in patients from rural areas and calculation of medical and economic efficiency of implementation of this project. Methods. The study subject was the population of Rybnaya Sloboda district of the Republic of Tatarstan. Patient recruitment into the groups was conducted in the polyclinic of Rybnaya Sloboda central regional hospital. The duration of the study was 6 months for each of two groups with further follow-up and evaluation of adherence to therapy for 2 months. Results. Annually stroke affects 5.6 to 6.6 million of people around the world, 35% of whom die in the acute period. Recently, serious rejuvenation of cardiovascular disorders has been observed. The main reason for such trend is low patients’ compliance to drug therapy. And patients’ compliance itself allows significantly decreasing the risk of cardiovascular complications. The article discussed the issues of low compliance to drug therapy, presents the methods of its formation in patients from rural area. The examples of foreign and Russian experience of increasing patients’ compliance to drug therapy are described and the key intervention points for patients are determined. On the basis of conducted analysis, implementation was developed and suggested for patient-oriented program aimed at formation of adherence to drug therapy of rural population. Also, the authors performed evaluation of medical and economic efficiency of implementation of a patient-oriented program aimed at formation of adherence to drug therapy of rural population (assessment of expenditures for medications, hospital stay, incapacity related to the main disease; evaluation of expenditures for prevention of complications and disability. Conclusion. Effective organization of prophylactic activity is of great importance for prevention of cardiovascular disease

Risk mitigation for children exposed to drugs during gestation: A critical role for animal preclinical behavioral testing.

Science.gov (United States)

Zucker, Irving

2017-06-01

Many drugs with unknown safety profiles are administered to pregnant women, placing their offspring at risk. I assessed whether behavioral outcomes for children exposed during gestation to antidepressants, anxiolytics, anti-seizure, analgesic, anti-nausea and sedative medications can be predicted by more extensive animal studies than are part of the FDA approval process. Human plus rodent data were available for only 8 of 33 CNS-active drugs examined. Similar behavioral and cognitive deficits, including autism and ADHD emerged in human offspring and in animal models of these disorders after exposure to fluoxetine, valproic acid, carbamazepine, phenytoin, phenobarbital and acetaminophen. Rodent data helpful in identifying and predicting adverse effects of prenatal drug exposure in children were first generated many years after drugs were FDA-approved and administered to pregnant women. I recommend that enhanced behavioral testing of rodent offspring exposed to drugs prenatally should begin during preclinical drug evaluation and continue during Phase I clinical trials, with findings communicated to physicians and patients in drug labels. Copyright © 2017 Elsevier Ltd. All rights reserved.

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

Science.gov (United States)

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

2015-01-01

Internationally, there is a remarkable achievement in the areas of drug discovery, drug design, and clinical trials. New and efficient drug formulation techniques are widely available which have led to success in treatment of several diseases. Despite these achievements, large number of patients continue to experience adverse drug reactions (ADRs), and majority of them are yet to be on record. The purpose of this survey is to compare knowledge, attitude, and practice with respect to ADRs and pharmacovigilance (PV) between medical students of Malaysia and Nigeria and to determine if there is a relationship between their knowledge and practice. A cross-sectional, questionnaire-based survey involving year IV and year V medical students of the Department of Medicine, Universiti Sultan Zainal Abidin and Bayero University Kano was carried out. The questionnaire which comprised 25 questions on knowledge, attitude, and practice was adopted, modified, validated, and administered to them. The response was analyzed using SPSS version 20. The response rate from each country was 74%. There was a statistically significant difference in mean knowledge and practice score on ADRs and PV between medical students of Malaysia and Nigeria, both at PMalaysia, although they need improvement. Imparting knowledge of ADRs and PV among medical students will upgrade their practice and enhance health care delivery services in the future.

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

Science.gov (United States)

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.

The Protective Effect of Pregnancy on Risk for Drug Abuse: A Population, Co-Relative, Co-Spouse, and Within-Individual Analysis.

Science.gov (United States)

Kendler, Kenneth S; Ohlsson, Henrik; Svikis, Dace S; Sundquist, Kristina; Sundquist, Jan

2017-10-01

The authors sought to determine whether pregnancy is an intrinsic motivator for cessation of drug abuse. The authors conducted prospective cohort, co-relative, co-spouse, and within-person analyses of registration for drug abuse during pregnancy among Swedish women born between 1980 and 1990 who gave birth between ages 20 and 35 (N=149,512). Drug abuse was assessed from medical, criminal, and pharmacy registries. In the population, rates of drug abuse were lower during pregnancy (unadjusted odds ratio=0.67, 95% CI=0.60, 0.74). Compared with population results, the negative association between pregnancy and drug abuse was moderately stronger in cousins (odds ratio=0.49, 95% CI=0.39, 0.62) and substantially stronger in siblings (odds ratio=0.35, 95% CI=0.24, 0.51) discordant for pregnancy. The estimated odds ratio for drug abuse in pregnancy-discordant monozygotic twins was even stronger, at 0.17 (95% CI=0.10, 0.31). Within individuals, the odds ratio for drug abuse while pregnant compared with an equivalent prepregnancy interval was similar to that seen in pregnancy-discordant monozygotic twins, at 0.22 (95% CI=0.19, 0.26). Compared with cohabiting fathers, mothers had a greater reduction in risk for drug abuse during pregnancy (odds ratio=0.40, 95% CI=0.34, 0.47). Pregnancy was more protective in women with low parental education and without a cohabiting, actively drug-abusing father. Compared with prepregnancy baseline, within-individual analyses indicate that risk for drug abuse is also substantially reduced in the postpartum period, for example, the odds ratio for postpartum days 0-242 was 0.13 (95% CI=0.11, 0.16). Risk for drug abuse in women is substantially reduced during pregnancy. Multiple analyses suggest that this association is largely causal, suggesting that pregnancy is indeed a strong intrinsic motivator for drug abuse cessation. Similar strong protective effects may be present in the immediate postpartum period. Our results have implications for our

Risk of amphetamine use disorder and mortality among incident users of prescribed stimulant medications in the Veterans Administration.

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Westover, Arthur N; Nakonezny, Paul A; Halm, Ethan A; Adinoff, Bryon

2018-05-01

Non-medical use of prescribed stimulant medications is a growing concern. This study's aims were to ascertain the demographics of stimulant medication users compared with non-users, examine temporal trends of stimulant medication use and estimate risk factors for development of amphetamine use disorder (AUD) and mortality among new users of stimulant medications. Cox proportional hazards regression in a retrospective cohort adjusted by baseline covariates. United States, national administrative database of the Veterans Affairs (VA) health-care system. Adult incident users of stimulant medications (n = 78 829) from fiscal years (FY) 2001 to 2012. Primary outcomes were time-to-event: (1) occurrence of AUD diagnosis and (2) death. Baseline covariates included demographic information, Food and Drug Administration (FDA)-approved indications for stimulant use, substance use disorders (SUD) and depression. Stimulant users compared with non-users were younger, more likely to be non-Hispanic white and female. Incident stimulant medication users increased threefold from FY2001-FY2012 and eightfold among adults aged 18-44 years. Nearly one in 10 incident users in FY2012 had a comorbid baseline SUD. Off-label use was common-nearly three of every five incident users in FY2012. Comorbid SUDs among incident stimulant medication users were risk factors for occurrence of AUD during follow-up, with adjusted hazard ratio (AHR) estimates ranging from 1.54 to 2.83 (Ps users in the Veterans Affairs health-care system, measured from fiscal years 2001 to 2012, comorbid substance use disorders were common and were risk factors for development of an amphetamine use disorder (AUD). Increased mortality risk among incident users of stimulant medications was observed among both those who developed an AUD later and those whose use was defined as off-label. © 2017 Society for the Study of Addiction.

Long-term effects of ovulation-stimulating drugs on cancer risk.

Science.gov (United States)

Brinton, Louise

2007-07-01

Although nulliparity has been extensively related to the risk of ovarian, breast and endometrial cancers, with many studies showing the relationship largely attributable to infertility, treatment effects on cancer risk are poorly understood. Two early studies raised substantial concern when ovulation-stimulating drugs were linked with large increases in ovarian cancer, supporting the notion of an important aetiological role of incessant ovulation. Subsequent studies have been mainly reassuring, although some have suggested possible risk increases among nulligravid women, those with extensive follow-up, and those developing borderline tumours. Results regarding effects of fertility drugs on breast cancer risk are conflicting, with some showing no associations and others demonstrating possible risk increases, although for varying subgroups. In contrast, endometrial cancer results are more consistent, with two recent studies showing increased risks related to clomiphene usage. This is of interest given that clomiphene is structurally similar to tamoxifen, a drug extensively linked with this cancer. Given the recent marketing of fertility drugs and the fact that exposed women are only beginning to reach the cancer age range, further follow-up is necessary. This will also be important to fully resolve effects of exposures such as gonadotrophins, used more recently in conjunction with IVF.

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

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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

This study used role-play demonstrations to train medical students to communicate drug therapy and evaluated the perceptions on this instructional approach. 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. 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). Role-play demonstrations were well accepted by medical students and led to the development of their competence in communicating drug therapy to patients.

A Mobile Device App to Reduce Time to Drug Delivery and Medication Errors During Simulated Pediatric Cardiopulmonary Resuscitation: A Randomized Controlled Trial.

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Siebert, Johan N; Ehrler, Frederic; Combescure, Christophe; Lacroix, Laurence; Haddad, Kevin; Sanchez, Oliver; Gervaix, Alain; Lovis, Christian; Manzano, Sergio

2017-02-01

During pediatric cardiopulmonary resuscitation (CPR), vasoactive drug preparation for continuous infusion is both complex and time-consuming, placing children at higher risk than adults for medication errors. Following an evidence-based ergonomic-driven approach, we developed a mobile device app called Pediatric Accurate Medication in Emergency Situations (PedAMINES), intended to guide caregivers step-by-step from preparation to delivery of drugs requiring continuous infusion. The aim of our study was to determine whether the use of PedAMINES reduces drug preparation time (TDP) and time to delivery (TDD; primary outcome), as well as medication errors (secondary outcomes) when compared with conventional preparation methods. The study was a randomized controlled crossover trial with 2 parallel groups comparing PedAMINES with a conventional and internationally used drugs infusion rate table in the preparation of continuous drug infusion. We used a simulation-based pediatric CPR cardiac arrest scenario with a high-fidelity manikin in the shock room of a tertiary care pediatric emergency department. After epinephrine-induced return of spontaneous circulation, pediatric emergency nurses were first asked to prepare a continuous infusion of dopamine, using either PedAMINES (intervention group) or the infusion table (control group), and second, a continuous infusion of norepinephrine by crossing the procedure. The primary outcome was the elapsed time in seconds, in each allocation group, from the oral prescription by the physician to TDD by the nurse. TDD included TDP. The secondary outcome was the medication dosage error rate during the sequence from drug preparation to drug injection. A total of 20 nurses were randomized into 2 groups. During the first study period, mean TDP while using PedAMINES and conventional preparation methods was 128.1 s (95% CI 102-154) and 308.1 s (95% CI 216-400), respectively (180 s reduction, P=.002). Mean TDD was 214 s (95% CI 171-256) and

Risk of high-grade cervical dysplasia and cervical cancer in women with systemic lupus erythematosus receiving immunosuppressive drugs.

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Feldman, C H; Liu, J; Feldman, S; Solomon, D H; Kim, S C

2017-06-01

Objective Prior studies suggest an increased risk of cervical cancer among women with systemic lupus erythematosus. However, the relationship with immunosuppressive drugs is not well studied in US nationwide cohorts. We compared the risk of high-grade cervical dysplasia and cervical cancer among women with systemic lupus erythematosus who started immunosuppressive drugs versus hydroxychloroquine. Methods We identified systemic lupus erythematosus patients initiating immunosuppressive drugs or hydroxychloroquine using claims data from two US commercial health plans and Medicaid (2000-2012). We used a validated claims-based algorithm to identify high-grade cervical dysplasia or cervical cancer. To account for potential confounders, including demographic factors, comorbidities, medication use, HPV vaccination status, and health care utilization, immunosuppressive drugs and hydroxychloroquine initiators were 1:1 matched on the propensity score. We used inverse variance-weighted, fixed effect models to pool hazard ratios from the propensity score-matched Medicaid and commercial cohorts. Results We included 2451 matched pairs of immunosuppressive drugs and hydroxychloroquine new users in the commercial cohort and 7690 matched pairs in Medicaid. In the commercial cohort, there were 14 cases of cervical dysplasia or cervical cancer among immunosuppressive drugs users and five cases among hydroxychloroquine users (hazard ratio 2.47, 95% CI 0.89-6.85, hydroxychloroquine = ref). In Medicaid, there were 46 cases among immunosuppressive drugs users and 29 cases in hydroxychloroquine users (hazard ratio 1.24, 95% CI 0.78-1.98, hydroxychloroquine = ref). The pooled hazard ratio of immunosuppressive drugs was 1.40 (95% CI 0.92-2.12). Conclusion Among women with systemic lupus erythematosus, immunosuppressive drugs may be associated with a greater, albeit not statistically significant, risk of high-grade cervical dysplasia and cervical cancer compared to patients receiving

Drug Use among Seniors on Public Drug Programs in Canada, 2012.

Science.gov (United States)

Proulx, Jeff; Hunt, Jordan

2015-01-01

Seniors take more drugs than younger Canadians because, on average, they have a higher number of chronic conditions. Although taking multiple medications may be necessary to manage these conditions, it is important to consider the benefits and risks of each medication and the therapeutic goals of the patient. This article provides an in-depth look at the number and types of drugs used by seniors using drug claims data from the CIHI's National Prescription Drug Utilization Information System Database, representing approximately 70% of seniors in Canada. In 2012, almost two-thirds (65.9%) of seniors on public drug programs had claims for five or more drug classes, while 27.2% had claims for 10 or more, and 8.6% had claims for 15 or more. The most commonly used drug class was statins, used by nearly half (46.6%) of seniors. Nearly two-thirds (60.9%) of seniors living in long-term care (LTC) facilities had claims for 10 or more drug classes. Proton pump inhibitors were the most commonly used drug class among seniors living in LTC facilities (used by 37.0% of seniors in LTC facilities), while statins ranked seventh (29.8%).

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

Science.gov (United States)

2010-06-29

... animals in order to help minimize antimicrobial resistance development. Based on a consideration of the...] Draft Guidance: The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals... Medically Important Antimicrobial Drugs in Food- Producing Animals.'' This draft guidance is intended to...

Risk management and regulations for lower limb medical exoskeletons: a review

Directory of Open Access Journals (Sweden)

He Y

2017-05-01

Full Text Available Yongtian He, David Eguren, Trieu Phat Luu, Jose L Contreras-Vidal Laboratory for Noninvasive Brain-Machine Interface Systems, Department of Electrical and Computer Engineering, University of Houston, Houston, TX, USA Abstract: Gait disability is a major health care problem worldwide. Powered exoskeletons have recently emerged as devices that can enable users with gait disabilities to ambulate in an upright posture, and potentially bring other clinical benefits. In 2014, the US Food and Drug Administration approved marketing of the ReWalk™ Personal Exoskeleton as a class II medical device with special controls. Since then, Indego™ and Ekso™ have also received regulatory approval. With similar trends worldwide, this industry is likely to grow rapidly. On the other hand, the regulatory science of powered exoskeletons is still developing. The type and extent of probable risks of these devices are yet to be understood, and industry standards are yet to be developed. To address this gap, Manufacturer and User Facility Device Experience, Clinicaltrials.gov, and PubMed databases were searched for reports of adverse events and inclusion and exclusion criteria involving the use of lower limb powered exoskeletons. Current inclusion and exclusion criteria, which can determine probable risks, were found to be diverse. Reported adverse events and identified risks of current devices are also wide-ranging. In light of these findings, current regulations, standards, and regulatory procedures for medical device applications in the USA, Europe, and Japan were also compared. There is a need to raise awareness of probable risks associated with the use of powered exoskeletons and to develop adequate countermeasures, standards, and regulations for these human–machine systems. With appropriate risk mitigation strategies, adequate standards, comprehensive reporting of adverse events, and regulatory oversight, powered exoskeletons may one day allow individuals

Drugged Driving: Increased Traffic Risks Involving Licit and Illicit Substances

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Pilkinton, Melinda W.; Robertson, Angela; McCluskey, D. Lee

2013-01-01

Driving under the influence of drugs poses risks for traffic safety. Most research attention has been focused on the most prevalent drugs of abuse, such as alcohol, illegal drugs, and prescription drugs with high abuse potential. The objectives of this study were to determine the types of drugs used by convicted DUI offenders on the day of their…

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

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

2013-12-01

It can be challenging to successfully monitor medication compliance in pain management. Clinicians and laboratorians need to collaborate to optimize patient care and maximize operational efficiency. The test menu, assay cutoffs, and testing algorithms utilized in the urine drug testing panels should be periodically reviewed and tailored to the patient population to effectively assess compliance and avoid unnecessary testing and cost to the patient. Pain management and pathology collaborated on an important quality improvement initiative to optimize urine drug testing for monitoring medication compliance in pain management. We retrospectively reviewed 18 months of data from our pain management center. We gathered data on test volumes, positivity rates, and the frequency of false positive results. We also reviewed the clinical utility of our testing algorithms, assay cutoffs, and adulterant panel. In addition, the cost of each component was calculated. The positivity rate for ethanol and 3,4-methylenedioxymethamphetamine were us to optimize our testing panel for monitoring medication compliance in pain management and reduce cost. Wiley Periodicals, Inc.

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

Science.gov (United States)

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

2010-10-01

Dose calculation errors can cause serious life-threatening clinical incidents. We designed eDrugCalc as an online self-assessment tool to develop and evaluate calculation skills among medical students. We undertook a prospective uncontrolled study involving 1727 medical students in years 1-5 at the University of Edinburgh. Students had continuous access to eDrugCalc and were encouraged to practise. Voluntary self-assessment was undertaken by answering the 20 questions on six occasions over 30 months. Questions remained fixed but numerical variables changed so each visit required a fresh calculation. Feedback was provided following each answer. Final-year students had a significantly higher mean score in test 6 compared with test 1 [16.6, 95% confidence interval (CI) 16.2, 17.0 vs. 12.6, 95% CI 11.9, 13.4; n= 173, P variable in all tests with 2.7% of final-year students scoring formative dose-calculation package and encouragement to develop their numeracy. Further research is required to establish whether eDrugCalc reduces calculation errors made in clinical practice. © 2010 The Authors. British Journal of Clinical Pharmacology © 2010 The British Pharmacological Society.

Evaluation of drug administration errors in a teaching hospital

Directory of Open Access Journals (Sweden)

Berdot Sarah

2012-03-01

Full Text Available Abstract Background Medication errors can occur at any of the three steps of the medication use process: prescribing, dispensing and administration. We aimed to determine the incidence, type and clinical importance of drug administration errors and to identify risk factors. Methods Prospective study based on disguised observation technique in four wards in a teaching hospital in Paris, France (800 beds. A pharmacist accompanied nurses and witnessed the preparation and administration of drugs to all patients during the three drug rounds on each of six days per ward. Main outcomes were number, type and clinical importance of errors and associated risk factors. Drug administration error rate was calculated with and without wrong time errors. Relationship between the occurrence of errors and potential risk factors were investigated using logistic regression models with random effects. Results Twenty-eight nurses caring for 108 patients were observed. Among 1501 opportunities for error, 415 administrations (430 errors with one or more errors were detected (27.6%. There were 312 wrong time errors, ten simultaneously with another type of error, resulting in an error rate without wrong time error of 7.5% (113/1501. The most frequently administered drugs were the cardiovascular drugs (425/1501, 28.3%. The highest risks of error in a drug administration were for dermatological drugs. No potentially life-threatening errors were witnessed and 6% of errors were classified as having a serious or significant impact on patients (mainly omission. In multivariate analysis, the occurrence of errors was associated with drug administration route, drug classification (ATC and the number of patient under the nurse's care. Conclusion Medication administration errors are frequent. The identification of its determinants helps to undertake designed interventions.

Screening for substance abuse risk in cancer patients using the Opioid Risk Tool and urine drug screen.

Science.gov (United States)

Barclay, Joshua S; Owens, Justine E; Blackhall, Leslie J

2014-07-01

The use of opioids for management of cancer-related pain has increased significantly and has been associated with a substantial rise in rates of substance abuse and diversion. There is a paucity of data not only on the prevalence of substance abuse in cancer patients, but also for issues of drug use and diversion in family caregivers. This study aimed to evaluate the frequency of risk factors for substance abuse and diversion, and abnormal urine drug screens in cancer patients receiving palliative care. A retrospective chart review was performed for patients with cancer who were seen in the University of Virginia Palliative Care Clinic during the month of September 2012. We evaluated Opioid Risk Tool variables and total scores, insurance status, and urine drug screen results. Of the 114 cancer patients seen in September 2012, the mean Opioid Risk Tool score was 3.79, with 43% of patients defined as medium to high risk. Age (16-45 years old, 23%) and a personal history of alcohol (23%) or illicit drugs (21%) were the most common risk factors identified. We obtained a urine drug screen on 40% of patients, noting abnormal findings in 45.65%. Opioids are an effective treatment for cancer-related pain, yet substantial risk for substance abuse exits in the cancer population. Screening tools, such as the Opioid Risk Tool, should be used as part of a complete patient assessment to balance risk with appropriate relief of suffering.

Seroepidemiology and risk factors of Hepatitis B and C virus infections among drug users in Jakarta, Indonesia

Directory of Open Access Journals (Sweden)

Rino A. Gani

2002-03-01

Full Text Available The number of drug users is markedly increased in recent times. Data were collected consecutively in Cipto Mangunkusumo Hospital and Mitra Menteng Abadi Hospital in Jakarta. HBsAg were examined using reverse passive hemaglutination assay (RPHA and anti-HCV with dipstick method; both were from the laboratoium Hepatika, Mataram, Indonesia. In a 5 month period (March - August 1999 there were 203 cases of drug users. Most of them were male ( 185 cases or 91.1% with a mean age of 21.2 ± 4.3 years. Mean age in starting to use the drug was 18.8 ± 4.0 years. The prevalence of anti-HCV and HBsAg positivity were 74.9% (151 cases and 9.9% (19 cases, respectively. The prevalence of double infection was 7.4% (15 cases. Injection drug users (IDU were 168 cases (84%. Extramarital sex was done by 62 cases (30.5%, but only 16 cases (8% with more than one partner. Tattoo was found in 32 cases ( 15.8%. Multivariate analysis revealed that lDU and tattoo were the risk factors for anti-HCV positivity, with the OR of 9.15 (95% CI 3.28-5.53 and 13.24 (96% CI 1.6 - 109.55, respectively. No significant medical risk factor could be identified for HBsAg positivity. Double infection of HBV and HCV was found in 15 cases (7.4%. We concluded that the prevalence of HBV, HCV infection and double infection of HBV - HCV in drug users were high, with tattoo and injection drug usage as risk factors for hepatitis C virus infection. (Med J Indones 2002; 11: 48-55Keywords: HBsAg, Anti-HCV, tattoo, injection drug users

Competing risk bias was common in Kaplan-Meier risk estimates published in prominent medical journals.

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van Walraven, Carl; McAlister, Finlay A

2016-01-01

Risk estimates from Kaplan-Meier curves are well known to medical researchers, reviewers, and editors. In this study, we determined the proportion of Kaplan-Meier analyses published in prominent medical journals that are potentially biased because of competing events ("competing risk bias"). We randomly selected 100 studies that had at least one Kaplan-Meier analysis and were recently published in prominent medical journals. Susceptibility to competing risk bias was determined by examining the outcome and potential competing events. In susceptible studies, bias was quantified using a previously validated prediction model when the number of outcomes and competing events were given. Forty-six studies (46%) contained Kaplan-Meier analyses susceptible to competing risk bias. Sixteen studies (34.8%) susceptible to competing risk cited the number of outcomes and competing events; in six of these studies (6/16, 37.5%), the outcome risk from the Kaplan-Meier estimate (relative to the true risk) was biased upward by 10% or more. Almost half of Kaplan-Meier analyses published in medical journals are susceptible to competing risk bias and may overestimate event risk. This bias was found to be quantitatively important in a third of such studies. Copyright © 2016 Elsevier Inc. All rights reserved.

Medication as a risk factor for falls in older women in Brazil

Directory of Open Access Journals (Sweden)

Rozenfeld Suely

2003-01-01

preceding year, after adjusting for cardiovascular disease. Recurrent falls were reported 2.0 times as often among beta-blocker users as among nonusers, after adjusting for cardiovascular disease. The risk of recurrent falls among users of anxiolytics/sedatives who had postural hypotension was 4.9 times as high as among nonusers. CONCLUSIONS: Our data indicate an association between single falls and recurrent falls and several groups of medications. Some falls could be avoided through the more rational use of drugs, and measures should be developed and implemented to encourage this.

Epilepsy, anti-epileptic medication use and risk of cancer

DEFF Research Database (Denmark)

Kaae, Jeanette; Carstensen, Lisbeth; Wohlfahrt, Jan

2014-01-01

Whether the powerful medications used to treat epilepsy increase the risk of cancer has been debated for decades, but until now no study could disentangle the contributions of anti-epileptic medications and epilepsy itself to cancer risk. Using a cohort comprising all Danish residents ≥ 16 years ...

[Prevalence and determinants of medication during pregnancy by risk class among mothers of liveborn infants].

Science.gov (United States)

Geib, Lorena Teresinha Consalter; Vargas Filho, Edson Fauth; Geib, Débora; Mesquita, Débora Iasmin; Nunes, Magda Lahorgue

2007-10-01

In order to identify the maternal determinants of the consumption of medication during pregnancy according to risk class, we conducted a population cohort baseline cross-sectional study with 2,262 mothers of liveborn infants in Passo Fundo, Rio Grande do Sul, Brazil. Data were collected from the Information System on Live Births and through home interviews (an instrument adapted from the Maternity Advice Survey). The drugs were classified according to criteria. We conducted bivariate analyses and logistic regression according to the hierarchical model of determination. 80% of the mothers consumed at least one medicine during the pregnancy, distributed in risk classes as follows: A (53.4%), B (18.1%), C (24.46%), D (1.47%), X (0.06%), and V (various) (2.1%). Incomplete prenatal care and maternal age consumption of medication in class A and pregnancy complications in classes B, C, and D. In class C, cesarean section and previous abortion also determined consumption, which in class V was independent of the variables analyzed. Maternal factors, especially health complications, determine the consumption of medicines during pregnancy, suggesting that the prescribing physician should orient the safe and proper use of such medication.

75 FR 23782 - Drug Safety and Risk Management Advisory Committee; Notice of Meeting

Science.gov (United States)

2010-05-04

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Drug Safety and Risk Management Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Drug Safety and Risk Management Advisory Committee. General Function of the Committee: To provide...

Factors influencing alcohol and illicit drug use amongst first year medical students

NARCIS (Netherlands)

Popescu, Codruta Alina; Bob, Mihai Horatiu; Junjan, Veronica; Armean, Sebastian Mihai; Buzoianu, Anca Dana

2014-01-01

The aims of this study were a) to investigate patterns of alcohol, smoking and illicit drug use and b) evaluate the relationship between substance abuse and personality factors in a cohort of 267 first year medical students. 12.3 % (men) and 11.8% (female) medical students reported to be drinking

Food-drug interactions in older people

NARCIS (Netherlands)

Witkamp, R.F.

2008-01-01

As a general rule, the use of medication increases considerably with advancing years. In many cases, the elderly are using drugs for chronic and degenerative disease for longer periods of time. Polypharmacy, the combined use of several drugs, is generally regarded as a high risk, especially in a

Substituting cannabis for prescription drugs, alcohol and other substances among medical cannabis patients: The impact of contextual factors.

Science.gov (United States)

Lucas, Philippe; Walsh, Zach; Crosby, Kim; Callaway, Robert; Belle-Isle, Lynne; Kay, Robert; Capler, Rielle; Holtzman, Susan

2016-05-01

Recent years have witnessed increased attention to how cannabis use impacts the use of other psychoactive substances. The present study examines the use of cannabis as a substitute for alcohol, illicit substances and prescription drugs among 473 adults who use cannabis for therapeutic purposes. The Cannabis Access for Medical Purposes Survey is a 414-question cross-sectional survey that was available to Canadian medical cannabis patients online and by hard copy in 2011 and 2012 to gather information on patient demographics, medical conditions and symptoms, patterns of medical cannabis use, cannabis substitution and barriers to access to medical cannabis. Substituting cannabis for one or more of alcohol, illicit drugs or prescription drugs was reported by 87% (n = 410) of respondents, with 80.3% reporting substitution for prescription drugs, 51.7% for alcohol, and 32.6% for illicit substances. Respondents who reported substituting cannabis for prescription drugs were more likely to report difficulty affording sufficient quantities of cannabis, and patients under 40 years of age were more likely to substitute cannabis for all three classes of substance than older patients. The finding that cannabis was substituted for all three classes of substances suggests that the medical use of cannabis may play a harm reduction role in the context of use of these substances, and may have implications for abstinence-based substance use treatment approaches. Further research should seek to differentiate between biomedical substitution for prescription pharmaceuticals and psychoactive drug substitution, and to elucidate the mechanisms behind both. [Lucas P, Walsh Z, Crosby K, Callaway R, Belle-Isle L, Kay B, Capler R, Holtzman S. Substituting cannabis for prescription drugs, alcohol, and other substances among medical cannabis patients: The impact of contextual factors. Drug Alcohol Rev 2016;35:326-333]. © 2015 Australasian Professional Society on Alcohol and other Drugs.

CNS metabolism in high-risk drug abuse, German version. Insights gained from "1H- and "3"1P MRS and PET

International Nuclear Information System (INIS)

Bodea, S.V.

2017-01-01

High-risk drug consumption is a considerable problem for public health actors in industrialised countries. The latest trends show a market tendency towards diversification and increasing demand for high-purity synthetic drugs. Whilst most consumers seek medical help after cannabis use, it is high-risk drugs like cocaine, heroin and amphetamines that account for most of the 1000 drug-related deaths that occur in Germany every year. This article presents the most prominent in vivo cerebral metabolic information in cocaine, heroin and methamphetamine users provided by MRI spectroscopy and PET imaging. We reviewed the literature reporting neuroimaging studies of in vivo metabolic data for methamphetamine, cocaine and heroin consumption published up to March 2017. The search was conducted using PubMed with the following key words: methamphetamine, cocaine, heroin, MR spectroscopy, PET. MRI and PET are indispensable tools in gauging brain metabolic response to illegal drug abuse. Future breakthroughs in this field will most likely come from the investigation of novel neurotransmitter systems in PET and imaging phosphorus and carbon metabolites in MRI. (orig.) [de

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

Science.gov (United States)

Riva, Silvia; Monti, Marco; Antonietti, Alessandro

2011-01-01

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

Ketamine - A Multifaceted Drug.

Science.gov (United States)

Meng, Lingzhong; Li, Jian; Lu, Yi; Sun, Dajin; Tao, Yuan-Xiang; Liu, Renyu; Luo, Jin Jun

There is a petition for tight control of ketamine from the Chinese government to classify ketamine as a Schedule I drug, which is defined as a drug with no currently accepted medical use but a high potential for abuse. However, ketamine has unique properties that can benefit different patient populations. Scholars from the Translational Perioperative and Pain Medicine and the International Chinese Academy of Anesthesiology WeChat groups had an interactive discussion on ketamine, including its current medical applications, future research priorities, and benefits versus risks. The discussion is summarized in this manuscript with some minor edits.

Potential Risks of Ecological Momentary Assessment Among Persons Who Inject Drugs.

Science.gov (United States)

Roth, Alexis M; Rossi, John; Goldshear, Jesse L; Truong, Quan; Armenta, Richard F; Lankenau, Stephen E; Garfein, Richard S; Simmons, Janie

2017-06-07

Ecological momentary assessment (EMA)-which often involves brief surveys delivered via mobile technology-has transformed our understanding of the individual and contextual micro-processes associated with legal and illicit drug use. However, little empirical research has focused on participant's perspective on the probability and magnitude of potential risks in EMA studies. To garner participant perspectives on potential risks common to EMA studies of illicit drug use. We interviewed 38 persons who inject drugs living in San Diego (CA) and Philadelphia (PA), United States. They completed simulations of an EMA tool and then underwent a semi-structured interview that systematically explored domains of risk considered within the proposed revisions to the Federal Policy for the Protection of Human Subjects or the "Common Rule." Interviews were transcribed verbatim and coded systematically to explore psychological, physical, social, legal, and informational risks from participation. Participants perceived most risks to be minimal. Some indicated that repetitive questioning about mood or drug use could cause psychological (i.e., anxiety) or behavioral risks (i.e., drug use relapse). Ironically, the questions that were viewed as risky were considered motivational to engage in healthy behaviors. The most cited risks were legal and social risks stemming from participant concerns about data collection and security. Improving our understanding of these issues is an essential first step to protect human participants in future EMA research. We provide a brief set of recommendations that can aid in the design and ethics review of the future EMA protocol with substance using populations.

Are patients reliable when self-reporting medication use? Validation of structured drug interviews and home visits by drug analysis and prescription data in acutely hospitalized patients

DEFF Research Database (Denmark)

Glintborg, Bente; Hillestrøm, Peter René; Olsen, Lenette Holm

2007-01-01

were compared to the patients' self-reported medication history. Information on prescribed drugs dispensed from any Danish pharmacy was collected from nationwide real-time pharmacy records. The authors performed home visits in a subgroup of 115 patients 4 weeks after their discharge. Stored drugs were......The medication history among hospitalized patients often relies on patients' self-reports due to insufficient communication between health care professionals. The aim of the present study was to estimate the reliability of patients' self-reported medication use. Five hundred patients admitted...... to an acute medical department at a Danish university hospital were interviewed on the day of admission about their recent medication use. Blood samples drawn immediately after admission were screened for contents of 5 drugs (digoxin, bendroflumethiazide, amlodipine, simvastatin, glimepiride), and the results...

Antiepileptic drugs and risk of suicide: a nationwide study

DEFF Research Database (Denmark)

Olesen, J.B.; Hansen, Peter Riis; Erdal, Jesper

2010-01-01

Purpose Patients with epilepsy or psychiatric diseases have increased risk of suicide, but whether the risk is influenced by antiepileptic drug (AED) treatment is unclear. Studies have suggested that AEDs in general increase the risk of suicidal behaviour shortly after initiation. This study inve...

Medication abortion: Potential for improved patient access through pharmacies.

Science.gov (United States)

Raifman, Sarah; Orlando, Megan; Rafie, Sally; Grossman, Daniel

2018-05-08

To discuss the potential for improving access to early abortion care through pharmacies in the United States. Despite the growing use of medications to induce termination of early pregnancy, pharmacist involvement in abortion care is currently limited. The Food and Drug Administration's Risk Evaluation and Mitigation Strategy (REMS) for Mifeprex® (mifepristone 200 mg), the principal drug used in early medication abortion, prohibits the dispensing of the drug by prescription at pharmacies. This commentary reviews the pharmacology of medication abortion with the use of mifepristone and misoprostol, as well as aspects of service delivery and data on safety, efficacy, and acceptability. Given its safety record, mifepristone no longer fits the profile of a drug that requires an REMS. The recent implementation of pharmacy dispensing of mifepristone in community pharmacies in Australia and some provinces of Canada has improved access to medication abortion by increasing the number of medication abortion providers, particularly in rural areas. Provision of mifepristone in pharmacies, which involves dispensing and patient counseling, would likely improve access to early abortion in the United States without increasing risks to women. Copyright © 2018 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.

Medication use and risk of falls among nursing home residents: a retrospective cohort study.

Science.gov (United States)

Bor, Andrea; Matuz, Mária; Csatordai, Márta; Szalai, Gábor; Bálint, András; Benkő, Ria; Soós, Gyöngyvér; Doró, Péter

2017-04-01

Background Geriatric falls are leading causes of hospital trauma admissions and injury-related deaths. Medication use is a crucial element among extrinsic risk factors for falls. To reduce fall risk and the prevalence of adverse drug reactions, potentially inappropriate medication (PIM) lists are widely used. Objective Our aim was to investigate the possible predictors of geriatric falls annualized over a 5-year-long period, as well as to evaluate the medication use of nursing home residents. Setting Nursing home residents were recruited from the same institution between 2010 and 2015 in Szeged, Hungary. Method A retrospective epidemiological study was performed. Patient data were analysed for the first 12 months of residency. Chi-squared test and Fisher's-test were applied to compare the categorical variables, Student's t test to compare the continuous variables between groups. Binary logistic regression analysis was carried out to determine the association of falls with other variables found significant in univariate analysis. Microsoft Excel, IBM SPSS Statistics (version 23) and R (3.2.2) programs were used for data analysis. Main outcome measure Falls affected by age, gender, number of chronic medications, polypharmacy, PIM meds. Results A total of 197 nursing home residents were included, 150 (76.2%) women and 47 (23.8%) men, 55 fallers (annual fall prevalence rate was 27.9%) and 142 non-fallers. Gender was not a predisposing factor for falls (prevalence in males: 23.4 vs 29.3% in females, p > 0.05). Fallers were older (mean years ± SD; 84.0 ± 7.0) than non-fallers (80.1 ± 9.3, p factor for falls (p factor of falls (p fall risk were taken by 70.9% of fallers and 75.3% of non-fallers (p > 0.05). Taking pantoprazole, vinpocetine or trimetazidine was a significant risk factor for falls. Conclusion Older age, polypharmacy and the independent use of pantoprazole, vinpocetine, and trimetazidine were found to be major risk factors for falls. Further

Living with risk. The British Medical Association guide

Energy Technology Data Exchange (ETDEWEB)

1987-01-01

Personal risk estimation is discussed under the following headings: history and background of risk study, the nature and measurement of risk, the main causes of death, major risk factors (smoking, alcohol and other drugs, diet), occupational risks, transport, risks in the home, recreational risks, medicine and surgery, natural disasters, chemical risks, the perception, acceptability and management of risk, and risks and energy production. The latter chapter includes consideration of comparative risks in electricity generation. The extraction of fuel for, construction and operation of nuclear power stations is discussed, including references to Sellafield, leukemia clustering, and the Three Mile Island and Chernobyl disasters.

The effectiveness of risk management program on pediatric nurses' medication error.

Science.gov (United States)

Dehghan-Nayeri, Nahid; Bayat, Fariba; Salehi, Tahmineh; Faghihzadeh, Soghrat

2013-09-01

Medication therapy is one of the most complex and high-risk clinical processes that nurses deal with. Medication error is the most common type of error that brings about damage and death to patients, especially pediatric ones. However, these errors are preventable. Identifying and preventing undesirable events leading to medication errors are the main risk management activities. The aim of this study was to investigate the effectiveness of a risk management program on the pediatric nurses' medication error rate. This study is a quasi-experimental one with a comparison group. In this study, 200 nurses were recruited from two main pediatric hospitals in Tehran. In the experimental hospital, we applied the risk management program for a period of 6 months. Nurses of the control hospital did the hospital routine schedule. A pre- and post-test was performed to measure the frequency of the medication error events. SPSS software, t-test, and regression analysis were used for data analysis. After the intervention, the medication error rate of nurses at the experimental hospital was significantly lower (P error-reporting rate was higher (P medical environment, applying the quality-control programs such as risk management can effectively prevent the occurrence of the hospital undesirable events. Nursing mangers can reduce the medication error rate by applying risk management programs. However, this program cannot succeed without nurses' cooperation.

Evaluation of the ASCO Value Framework for Anticancer Drugs at an Academic Medical Center.

Science.gov (United States)

Wilson, Leslie; Lin, Tracy; Wang, Ling; Patel, Tanuja; Tran, Denise; Kim, Sarah; Dacey, Katie; Yuen, Courtney; Kroon, Lisa; Brodowy, Bret; Rodondi, Kevin

2017-02-01

Anticancer drug prices have increased by an average of 12% each year from 1996 to 2014. A major concern is that the increasing cost and responsibility of evaluating treatment options are being shifted to patients. This research compared 2 value-based pricing models that were being considered for use at the University of California, San Francisco (UCSF) Medical Center to address the growing burden of high-cost cancer drugs while improving patient-centered care. The Medication Outcomes Center (MOC) in the Department of Clinical Pharmacy, University of California, San Francisco (UCSF), School of Pharmacy focuses on assessing the value of medication-related health care interventions and disseminating findings to the UCSF Medical Center. The High Cost Oncology Drug Initiative at the MOC aims to assess and adopt tools for the critical assessment and amelioration of high-cost cancer drugs. The American Society of Clinical Oncology (ASCO) Value Framework (2016 update) and a cost-effectiveness analysis (CEA) framework were identified as potential tools for adoption. To assess 1 prominent value framework, the study investigators (a) asked 8 clinicians to complete the ASCO Value Framework for 11 anticancer medications selected by the MOC; (b) reviewed CEAs assessing the drugs; (c) generated descriptive statistics; and (d) analyzed inter-rater reliability, convergence validity, and ranking consistency. On the scale of -20 to 180, the mean ASCO net health benefit (NHB) total score across 11 drugs ranged from 7.6 (SD = 7.8) to 53 (SD = 9.8). The Kappa coefficient (κ) for NHB scores across raters was 0.11, which is categorized as "slightly reliable." The combined κ score was 0.22, which is interpreted as low to fair inter-rater reliability. Convergent validity indicates that the correlation between NHB scores and CEA-based incremental cost-effectiveness ratios (ICERs) was low (-0.215). Ranking of ICERs, ASCO scores, and wholesale acquisition costs indicated different results

Medical device risk management and its economic impact

Directory of Open Access Journals (Sweden)

Katerina Krsteva Jakimovska

2013-10-01

Full Text Available The importance of medical devices in everyday users/patients lives is imensse. This is the reason why emphasis must be put on safety during their use. Satisfactory safety level can be achived by implementation of quality and risk management standards. Medical device manufacturers must learn to deal with the potential risks by using theoretical and practical examples and measures in order to protect their users/patients and themselves from suffering huge losses arising from adverse events or recall of their products. The best moment for implementation of risk management methods and analysis begins from the device design and development through manufacturing, sales and distribution. These way medical device manufacturers will succseed in protecting their users/patients from serious adverse events and at the same time protect their brand and society status, while minimizing economic losses.

The risk of alcohol and drug dependence among healthcare workers as a result of excessive stress.

OpenAIRE

Chudá, Romana

2012-01-01

Charles University in Prague First Faculty of Medicine Department of Psychiatry, Center for Addictology School Year: 2007/2010 Abstract of the bachelor work Name: Romana Chudá Specialization: Adiktologie Matriculation year: 2007 Supervisor: MUDr. Petr Popov Opponent: MUDr. Dušan Randák Pages: 61 The title of the bachelor work: The risk of alcohol and drug dependence aminy healthcare workers as a result of excessive stress Abstract: The author has several times seen medical staff, who had been...

Biological risks of medical irradiations: Medical physics monograph 5

International Nuclear Information System (INIS)

Fullerton, G.D.; Kopp, D.T.; Waggener, R.G.; Webster, E.W.

1980-01-01

This book is the fifth in a series of monographs by the American Association of Physicists in Medicine (AAPM) and is a compendium of papers presented at an AAPM regional symposium conducted in San Antonio in July 1980. The book is divided into three sections: (1) biological fundamentals of ionizing radiation, (2) risk evaluation and reduction in three principle radiologic subspecialties (diagnostic radiology, nuclear medicine and radiation therapy), and (3) medical-legal implications. The first section includes a historical review of radiation biology, including a discussion of somatic and genetic effects and statistical approaches to risk estimates. The section on risk evaluation and reduction includes a good review of the units of exposure and activity including the international (SI) system employing the gray, becquerel, and seivert that respectively replace the rad, Curie, and rem. The unavoidable problem of legal responsibility and liability is the subject of the third, and last, section of the monograph. A chapter summarizing the legal history of medical irradiation also includes a glossary of pertinent legal terms. Recent court decisions that impact upon the clinical use of radiation are presented and discussed as well as proposed changes in federal guidelines that could have a large impact on the practice of medicine in general and radiology in particular

A case-control study estimating accident risk for alcohol, medicines and illegal drugs.

Directory of Open Access Journals (Sweden)

Kim Paula Colette Kuypers

Full Text Available The aim of the present study was to assess the risk of having a traffic accident after using alcohol, single drugs, or a combination, and to determine the concentrations at which this risk is significantly increased.A population-based case-control study was carried out, collecting whole blood samples of both cases and controls, in which a number of drugs were detected. The risk of having an accident when under the influence of drugs was estimated using logistic regression adjusting for gender, age and time period of accident (cases/sampling (controls. The main outcome measures were odds ratio (OR for accident risk associated with single and multiple drug use. In total, 337 cases (negative: 176; positive: 161 and 2726 controls (negative: 2425; positive: 301 were included in the study.Main findings were that 1 alcohol in general (all the concentrations together caused an elevated crash risk; 2 cannabis in general also caused an increase in accident risk; at a cut-off of 2 ng/mL THC the risk of having an accident was four times the risk associated with the lowest THC concentrations; 3 when ranking the adjusted OR from lowest to highest risk, alcohol alone or in combination with other drugs was related to a very elevated crash risk, with the highest risk for stimulants combined with sedatives.The study demonstrated a concentration-dependent crash risk for THC positive drivers. Alcohol and alcohol-drug combinations are by far the most prevalent substances in drivers and subsequently pose the largest risk in traffic, both in terms of risk and scope.

Marijuana: modern medical chimaera.

Science.gov (United States)

Lamarine, Roland J

2012-01-01

Marijuana has been used medically since antiquity. In recent years there has been a resurgence of interest in medical applications of various cannabis preparations. These drugs have been cited in the medical literature as potential secondary treatment agents for severe pain, muscle spasticity, anorexia, nausea, sleep disturbances, and numerous other uses. This article reviews the research literature related to medical applications of various forms of cannabis. Benefits related to medical use of cannabinoids are examined and a number of potential risks associated with cannabis use, both medical and recreational, are considered. There is a clearly identified need for further research to isolate significant benefits from the medical application of cannabinoids and to establish dosage levels, appropriate delivery mechanisms and formulations, and to determine what role, if any, cannabinoids might play in legitimate medical applications. It is also imperative to determine if reported dangers pose a significant health risks to users.

Understanding kidney transplant patients' treatment choices: The interaction of emotion with medical and social influences on risk preferences.

Science.gov (United States)

Harrington, Jean; Morgan, Myfanwy

2016-04-01

Following renal transplantation patients experience on-going immunosuppressant medication to reduce the risk of graft rejection. Over the long term the side effects of immunosuppressive drugs may affect graft survival and significantly increase risks of cancers, stroke and cardiovascular disease. To reduce these risks research is underway to develop a biomarker test to identify those patients who are likely to be 'tolerant' to their graft and therefore able to reduce immunosuppression. Biomarker tests may however incorrectly identify some patients as tolerant, thus jeopardising their graft. Following a quantitative assessment of risk preferences we undertook a qualitative study to investigate the range of influences that shaped the substantial variations found in the level of risk transplant recipients were hypothetically willing to take. In-depth interviews were carried out in the United Kingdom between May 2013 and July 2014 with 24 transplant recipients all of whom had stable kidney graft function. These interviews identified a range of factors that patients take into account when making risk assessments, including familial views, trust and the ritual of 'gift exchange' that permeates the social space of kidney transplantation. Our data support the notion that emotion is not part of a linear process, preceding and separate to reason, but is intertwined with personal understanding and perception of risk and involves a complex interplay between different influences on decision-making. Our data also support Lupton's view that risk judgements are shared and collective rather than located within the individual and suggests that patient choice rather than involving a purely rational weighing of medical benefit is often based on influences that may not accord with the framework nor intention of medical professionals and medical research. Copyright © 2016 Elsevier Ltd. All rights reserved.

A practical approach to risk-benefit estimation in pediatric drug research.

Science.gov (United States)

Koren, Gideon

2015-02-01

One of the most difficult challenges in pediatric drug research is in exposing children to risk, often without a balanced chance of benefits. While the concept of risk is similar in adult research, the adult patient can decide for himself/herself on an acceptable level of risk, whereas children have to accept the decisions of their guardians. This paper attempts to put the complexities of estimating risk in pediatric drug research into their practical perspective, and to familiarize the reader with the way such processes are conducted in different parts of the world. Although there are regional differences, all authorities typically quantify risks of pediatric research in general, and drug research in particular, in three levels: those experienced in day-to-day life; risks slightly above this 'baseline' risk; and risks substantially above 'baseline risk'. Proportionally, the diligence of the ethics process depends on these levels, as well as on the potential benefits (or lack of) to the child involved in the research. Importantly, risk is context dependent, and a particular intervention may be effective or safe in one setting but not in another, based on local experience, staffing levels, and similar variabilities.

Self-Medication: potential risks and hazards among pregnant ...

African Journals Online (AJOL)

Self-Medication: potential risks and hazards among pregnant women in Uyo, ... Reasons for using these substances range from protection from witches and ... shows that self-medication is common among pregnant women in our environment.

[Regional analysis of drug treatment prevalence and medication of diabetes mellitus in Germany].

Science.gov (United States)

Willert, T; Walker, J; Schramm, W

2012-11-01

Diabetes mellitus is a widespread chronic disease. Diabetes prevalence was already analyzed in multiple complex studies. The goal of this analysis was the determination of the regional drug treatment prevalence and medication of diabetes mellitus in Germany. Simultaneously, we examined and validated the applicability of prescription data of the German statutory health insurance (SHI) as the basis for reliable and comparable prevalence estimations. For the analysis, we used anonymized data from a prescription database as well as the member statistics of the German federal Ministry of Health. By using defined prescription profiles with anti-diabetic medication, we determined the diabetic patients and treatment schemes per Association of SHI Physicians. Subsequently, we calculated and described the drug treatment prevalence and medication. A differentiation between type 1 and type 2 diabetes was not possible. The total prevalence of drug-treated patients in Germany was 7.77%. The regional values ranged from 6.40% in Schleswig-Holstein until 11.37% in Saxony-Anhalt. The highest numbers of drug treatment prevalence were found in the East of Germany. Insulin treatment was frequent in Hamburg, but rare in Bavaria. Insulin combined with oral anti-diabetic medication was mainly dispensed in Saxony-Anhalt and Brandenburg, least in Hamburg. A treatment with one or more oral anti-diabetics was most common in Bavaria and Bremen, lowest in Rhineland-Palatinate and Mecklenburg-West Pomerania. We developed an easy to use evaluation algorithm for prescription data to estimate the drug treatment prevalence of a chronic disease. The estimated prevalence confirms the increasing trend reported from other studies and appears to be plausible in comparison. More research is required to validate and enhance the method. © Georg Thieme Verlag KG Stuttgart · New York.

Drug interactions with phenprocoumon and the risk of serious haemorrhage: a nested case-control study in a large population-based German database.

Science.gov (United States)

Jobski, Kathrin; Behr, Sigrid; Garbe, Edeltraut

2011-09-01

Phenprocoumon is the most frequently used vitamin K antagonist in Germany. The aim of this study was to estimate the risk of serious bleeding as a result of the use of drugs with potential interaction with phenprocoumon. We conducted a nested case-control study in a cohort of 246,220 phenprocoumon users in the German Pharmacoepidemiological Research Database. Cases were patients hospitalised for haemorrhage of different kinds. Ten controls were matched to each case by health insurance, birth year and sex using incidence density sampling. Odds ratios (OR) with 95% confidence intervals (CI) of the risk of serious bleeding associated with combined use of phenprocoumon and potentially interacting drugs versus phenprocoumon alone were estimated using conditional logistic regression analysis. Our analyses considered multiple risk factors, such as bleeding history, other comorbidities or co-medication. Our study included 2,553 cases and 25,348 matched controls. An increased risk of bleeding was observed for the combined use of phenprocoumon and clopidogrel vs phenprocoumon use alone (OR: 1.83, 95% CI: 1.41-2.36). Antibiotic drugs associated with an increased risk of haemorrhage in the population of phenprocoumon users included the group of quinolones with ORs ranging from 2.74 (95% CI: 1.80-4.18) for ciprofloxacin to 4.40 (95% CI: 2.45-7.89) for levofloxacin, amoxicillin plus clavulanic acid (OR: 2.99, 95% CI: 1.39-6.42) and cotrimoxazole (OR 3.57, 95% CI: 2.36-5.40). Among non-steroidal anti-inflammatory drugs (NSAIDs), ketoprofen and naproxen were associated with the highest risks. Significantly elevated risks of major bleeding were mainly observed for drugs with known pharmacodynamic interaction with phenprocoumon, and less for drugs with possible pharmacokinetic interaction.

Framing medical tourism: an examination of appeal, risk, convalescence, accreditation, and interactivity in medical tourism web sites.

Science.gov (United States)

Mason, Alicia; Wright, Kevin B

2011-02-01

This exploratory study analyzed the content of medical tourism Web sites in an attempt to examine how they convey information about benefits and risks of medical procedures, how they frame credibility, and the degree to which these Web sites include interactive features for consumers. Drawing upon framing theory, the researchers content analyzed a sample of 66 medical tourism Web sites throughout the world. The results indicated that medical tourism Web sites largely promote the benefits of medical procedures while downplaying the risks, and relatively little information regarding the credibility of these services appears. In addition, the presentation of benefits/risks, credibility, and Web site interactivity were found to differ by region and type of facility. The authors discuss the implications of these findings concerning the framing of medical tourism Web site content, future directions for research, and limitations.

Nuclear risk: information of medical practitioners in Isere Department. Impact of the booklet: 'doctors and nuclear risk'

International Nuclear Information System (INIS)

Jonquet, M.E.

1990-02-01

In this thesis, the author first presents 'Isere, pilot department' operation, then the importance of nuclear risks in Isere, considers the role and place of medical practitioners in the management of this risk and in information request of medical personnel. The author also presents the booklet 'Doctors and nuclear risk' and analyzes the results of study on its impact close to medical population. 9 tabs., 25 figs

Analysis of the drug formulary and the purchasing process at a Moroccan university medical center.

Science.gov (United States)

Lachhab, Z; Serragui, S; Hassar, M; Cherrah, Y; Errougani, A; Ahid, S

2018-05-31

To give an overview of the pharmaceutical policy in the largest medical center in Morocco, a developing country in socio-economic transition. This is an analytical descriptive study of the drug formulary and the purchasing process carried out at the Ibn Sina University Medical Center. Our formulary included 830 drugs belonging to 14 classes according to the Anatomical, Therapeutic and Chemical (ATC) Classification System. There was a respective predominance of class N (21.8%), class B (13.5%), and class J (12.6%). Injectable route was dominant (46%). Drugs had a significant actual benefit in 70% (according to the French Data), reimbursable in 42.8%, essential in 29.2% according to World Health Organization (WHO) list, and in 36.9% according to the Moroccan list. The calls for tenders included 542 drugs representing 65% of the formulary, and the attribution rate was 71%. The main reason for non-attribution was the lack of offers. Generics accounted for 45% by volume and 26.5% by value. With this first study, we were able to identify key indicators on drugs used in the largest medical center in Morocco. The current challenge is to introduce pharmacoeconomics in decision making concerning the updates of the drug formulary.

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

Science.gov (United States)

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. Copyright © 2013 Elsevier Inc. All rights reserved.

Drug injecting and HIV risk among injecting drug users in Hai Phong, Vietnam: a qualitative analysis.

Science.gov (United States)

Ahmed, Tanvir; Long, Thanh Nguyen; Huong, Phan Thi; Stewart, Donald Edwin

2015-01-29

Hai Phong, located in northern Vietnam, has become a high HIV prevalence province among Injecting Drug Users (IDUs) since the infection shifted from the southern to the northern region of the country. Previous research indicates high levels of drug and sex related risk behaviour especially among younger IDUs. Our recent qualitative research provides a deeper understanding of HIV risk behaviour and highlights views and experiences of IDUs relating to drug injecting and sharing practices. Fifteen IDUs participated in semi-structured interviews conducted in September-October, 2012. Eligible participants were selected from those recruited in a larger scale behavioural research project and identified through screening questions. Interviews were conducted by two local interviewers in Vietnamese and were audiotaped. Ethical procedures, including informed consent and participants' understanding of their right to skip and withdraw, were applied. Transcripts were translated and double checked. The data were categorised and coded according to themes. Thematic analysis was conducted and a qualitative data analysis thematic framework was used. Qualitative analysis highlighted situational circumstances associated with HIV risks among IDUs in Hai Phong and revealed three primary themes: (i) places for injecting, (ii) injecting drugs in small groups, and (iii) sharing practices. Our results showed that shared use of jointly purchased drugs and group injecting were widespread among IDUs without adequate recognition of these as HIV risk behaviours. Frequent police raids generated a constant fear of arrest. As a consequence, the majority preferred either rail lines or isolated public places for injection, while some injected in their own or a friend's home. Price, a heroin crisis, and strong group norms encouraged collective preparation and group injecting. Risk practices were enhanced by a number of factors: the difficulty in getting new syringes, quick withdrawal management

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

Science.gov (United States)

2011-07-21

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0530] Draft Guidance for Industry and Food and Drug Administration Staff; Mobile Medical Applications; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug...

Riscos de problemas relacionados com medicamentos em pacientes de uma instituição geriátrica Drug-related problems risks in patients of a geriatric institution

Directory of Open Access Journals (Sweden)

Cassyano Januário Correr

2007-03-01

Full Text Available Em pacientes geriátricos, o uso de medicamentos leva com freqüência ao surgimento de Problemas Relacionados com Medicamentos (PRM e exige estrat��gias de prevenção da morbi-mortalidade relacionada a esses produtos. Este estudo observacional teve por objetivo avaliar prescrições e a presença de riscos de PRM em uma instituição geriátrica. Dois farmacêuticos avaliaram esquemas farmacoterapêuticos de 76 pacientes com relação a duplicidades terapêuticas, desvios de dose, medicações inadequadas e interações medicamentosas potenciais. Os pacientes utilizavam em média 3 medicamentos, principalmente do aparelho cardiovascular (36,4% e sistema nervoso central (47,8%. 13,5% dos medicamentos utilizados (n=230 foram considerados inadequados com riscos de PRM ligados principalmente à segurança da terapia. Foram identificadas 69 interações medicamentosas em 38 pacientes (51,3%, com manifestações ligadas principalmente à efetividade da terapêutica. Os resultados reforçam a importância da avaliação do processo de uso de medicamentos. Os dados apontam, ainda, a necessidade de aprofundamento de estudos de avaliação de riscos de PRM nessa população.In geriatric patients, the use of medication frequently leads to the development of drug-related problems (DRP and demands prevention strategies about morbidity and mortality related to medication. This observational study aims to evaluate the medical prescriptions and the presence of DRP risks in a geriatric institution. Two clinical pharmacists had evaluated medication regimen of 76 internal patients observing therapeutical duplicities, dose-related problems, inadequate medication and potential drug interactions. To the patients, were administrated in average 3 medications, mainly to cardiovascular system (36.4% and central nervous system (47.8%. 13.5% of the used drugs (n=230 were considered inadequate with risks of DRP, mainly related to therapy safety. 69 drug interactions

Suicide risk among Thai illicit drug users with and without mental/alcohol use disorders

Science.gov (United States)

Kittirattanapaiboon, Phunnapa; Suttajit, Sirijit; Junsirimongkol, Boonsiri; Likhitsathian, Surinporn; Srisurapanont, Manit

2014-01-01

Background It is not yet known if the increased risk of suicide in substance abusers is caused by the causal and/or coexisting relationship between substance use and psychiatric disorders. This study was designed to estimate the suicide risk among individuals with illicit drug use alone, illicit drug users with mental disorders, and illicit drug users with alcohol use disorders. Methods Subjects were participants of the 2008 Thai National Mental Health Survey. They were asked for their illicit drug use in the past year. The Mini International Neuropsychiatric Interview (MINI), current suicidality (1 month prior to assessment), mood episodes, anxiety disorders, psychotic disorders, and alcohol use disorders were used for assessing mental/alcohol use disorders. A score of 1 or more for the MINI–Suicidality module was defined as the presence of suicide risk. Results Of the total 17,140 respondents, 537 currently used illicit drugs, while 1,194 respondents had a suicide risk. Common illicit drugs were kratom (59%) and (meth)amphetamine (24%). Compared with 16,603 Thais without illicit drug use, the illicit drug users with or without mental/alcohol use disorders (n=537) had an increased risk of suicide (adjusted odds ratio [OR], 95% confidence interval [CI] =2.09, 1.55–2.81). While those who used illicit drugs alone (no mental/alcohol use disorder) (n=348) had no increased risk of suicide (adjusted OR, 95% CI =1.04, 0.66–1.65), the illicit drug users with mental or alcohol use disorders (n=27 and n=162, respectively) had significantly increased risk of suicide (adjusted ORs, 95% CIs =14.06, 6.50–30.3 and 3.14, 1.98–4.99, respectively). Conclusion A key limitation of this study was the combined suicidal behaviors as a suicidality risk. Mental or alcohol use disorders found in this population actually increased the suicide risk. These findings support the coexisting relationship that mental and alcohol use disorders play a vital role in increasing the suicide

Psychotropic Drug Use among College Students: Patterns of Use, Misuse, and Medical Monitoring

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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.…

Adverse drug reactions and drug–drug interactions with over-the-counter NSAIDs

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Moore N

2015-07-01

Full Text Available Nicholas Moore,1 Charles Pollack,2 Paul Butkerait2 1Department of Pharmacology, Université de Bordeaux, Bordeaux, France; 2Pfizer Consumer Healthcare, Madison, NJ, USA Abstract: Nonsteroidal anti-inflammatory drugs (NSAIDs such as ibuprofen have a long history of safe and effective use as both prescription and over-the-counter (OTC analgesics/antipyretics. The mechanism of action of all NSAIDs is through reversible inhibition of cyclooxygenase enzymes. Adverse drug reactions (ADRs including gastrointestinal bleeding as well as cardiovascular and renal effects have been reported with NSAID use. In many cases, ADRs may occur because of drug–drug interactions (DDIs between the NSAID and a concomitant medication. For example, DDIs have been reported when NSAIDs are coadministered with aspirin, alcohol, some antihypertensives, antidepressants, and other commonly used medications. Because of the pharmacologic nature of these interactions, there is a continuum of risk in that the potential for an ADR is dependent on total drug exposure. Therefore, consideration of dose and duration of NSAID use, as well as the type or class of comedication administered, is important when assessing potential risk for ADRs. Safety findings from clinical studies evaluating prescription-strength NSAIDs may not be directly applicable to OTC dosing. Health care providers can be instrumental in educating patients that using OTC NSAIDs at the lowest effective dose for the shortest required duration is vital to balancing efficacy and safety. This review discusses some of the most clinically relevant DDIs reported with NSAIDs based on major sites of ADRs and classes of medication, with a focus on OTC ibuprofen, for which the most data are available. Keywords: adverse effects, nonsteroidal anti-inflammatory drugs, gastrointestinal, cardiovascular, renal

Assessment of cardiovascular risk of new drugs for the treatment of diabetes mellitus: risk assessment vs. risk aversion.

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Zannad, Faiez; Stough, Wendy Gattis; Lipicky, Raymond J; Tamargo, Juan; Bakris, George L; Borer, Jeffrey S; Alonso García, Maria de Los Angeles; Hadjadj, Samy; Koenig, Wolfgang; Kupfer, Stuart; McCullough, Peter A; Mosenzon, Ofri; Pocock, Stuart; Scheen, André J; Sourij, Harald; Van der Schueren, Bart; Stahre, Christina; White, William B; Calvo, Gonzalo

2016-07-01

The Food and Drug Administration issued guidance for evaluating the cardiovascular risk of new diabetes mellitus drugs in 2008. Accumulating evidence from several completed trials conducted within this framework raises questions as to whether requiring safety outcome studies for all new diabetes mellitus therapies remains justified. Given the burden of cardiovascular disease in patients with diabetes, the focus should shift towards cardiovascular outcome studies designed to evaluate efficacy (i.e. to determine the efficacy of a drug over placebo or standard care) rather than demonstrating that risk is not increased by a pre-specified safety margin. All stakeholders are responsible for ensuring that new drug approvals occur under conditions of appropriate safety and effectiveness. It is also a shared responsibility to avoid unnecessary hurdles that may compromise access to useful drugs and threaten the sustainability of health systems. It is critical to renew this debate so that stakeholders can collectively determine the optimal approach for developing new drugs to treat type 2 diabetes mellitus. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2016. For permissions please email: journals.permissions@oup.com.

Risk behaviours and healthcare needs of homeless drug users in Saint Lucia and Trinidad.

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Day, Marcus; Devieux, Jessy G; Reid, Sandra D; Jones, Dionne J; Meharris, Joseph; Malow, Robert M

2004-01-01

In the Caribbean AIDS has become the leading cause of death among those aged 15-45. The homeless are at high risk due to the nexus of mobility, psychiatric disorders and substance use, particularly crack. Seventy-four homeless, out-of-treatment drug users were recruited in Saint Lucia and Trinidad to assess risk behaviour and healthcare needs. Information was collected in several domains: medical, mental health, substance use, sexual risk, and barriers to care. Ninety-five percent of the sample reported crack cocaine use within the previous 30 days. Approximately 35% of the sample had ever been diagnosed with a sexually transmitted disease and 25% of the sample reported being HIV+. Approximately 40% had a history of trading sex for crack or money. Due to the range of needs in this population, interventions should be multimodal. A focus on the individual, community, and structural levels is warranted to improve chances of program effectiveness.

Polypharmacy or medication washout: an old tool revisited

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Hoffman DA

2011-10-01

Full Text Available Daniel A Hoffman1, Mark Schiller2, James M Greenblatt3, Dan V Iosifescu41Neuro-Therapy Clinic Inc, Denver, CO; 2Mind Therapy Clinic, 2299 Post Street, Suite 104A, San Francisco, CA; 3Comprehensive Psychiatric Resources, Waltham, MA; 4Mood and Anxiety Disorders Program, Mount Sinai School of Medicine, New York, NY, USAAbstract: There has been a rapid increase in the use of polypharmacy in psychiatry possibly due to the introduction of newer drugs, greater availability of these newer drugs, excessive confidence in clinical trial results, widespread prescribing of psychotropic medications by primary care, and pressure to augment with additional medications for unresolved side effects or greater efficacy. Even the new generation of medications may not hold significant advantages over older drugs. In fact, there may be additional safety risks with polypharmacy being so widespread. Washout, as a clinical tool, is rarely done in medication management today. Studies have shown that augmenting therapy with additional medications resulted in 9.1%–34.1% dropouts due to intolerance of the augmentation, whereas studies of medication washout demonstrated only 5.9%–7.8% intolerance to the washout procedure. These perils justify reconsideration of medication washout before deciding on augmentation. There are unwarranted fears and resistance in the medical community toward medication washout, especially at the moment a physician is trying to decide whether to washout or add more medications to the treatment regimen. However, medication washout provides unique benefits to the physician: it establishes a new baseline of the disorder, helps identify medication efficacy from their adverse effects, and provides clarity of diagnosis and potential reduction of drug treatments, drug interactions, and costs. It may also reduce overall adverse events, not to mention a potential to reduce liability. After washout, physicians may be able to select the appropriate

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

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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.

Inappropriate self-medication among adolescents and its association with lower medication literacy and substance use.

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Chun-Hsien Lee

Full Text Available While self-medication is common, inappropriate self-medication has potential risks. This study assesses inappropriate self-medication among adolescents and examines the relationships among medication literacy, substance use, and inappropriate self-medication.In 2016, a national representative sample of 6,226 students from 99 primary, middle, and high schools completed an online self-administered questionnaire. Multiple logistic regression analysis was used to examine factors related to inappropriate self-medication.The prevalence of self-medication in the past year among the adolescents surveyed was 45.8%, and the most frequently reported drugs for self-medication included nonsteroidal anti-inflammatory drugs or pain relievers (prevalence = 31.1%, cold or cough medicines (prevalence = 21.6%, analgesics (prevalence = 19.3%, and antacids (prevalence = 17.3%. Of the participants who practiced self-medication, the prevalence of inappropriate self-medication behaviors included not reading drug labels or instructions (10.1%, using excessive dosages (21.6%, and using prescription and nonprescription medicine simultaneously without advice from a health provider (polypharmacy (30.3%. The results of multiple logistic regression analysis showed that after controlling for school level, gender, and chronic diseases, the participants with lower medication knowledge, lower self-efficacy, lower medication literacy, and who consumed tobacco or alcohol were more likely to engage in inappropriate self-medication.Lower medication literacy and substance use were associated with inappropriate self-medication among adolescents.

Provider-caregiver-child discussions about risks associated with asthma control medications: content and prevalence.

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Gillette, Chris; Blalock, Susan J; Rao, Jaya K; Williams, Dennis; Loughlin, Ceila E; Sleath, Betsy

2014-08-01

The objectives of this study were to: (1) describe the extent to which general pediatric providers discuss risks associated with asthma control medications with families, and (2) examine factors that are associated with risk discussions. This study was a cross-sectional secondary analysis of audio taped medical visits involving 35 pediatric providers and 248 children with asthma with their caregivers. Transcripts of the visits were coded for discussions about asthma medication risks. Generalized estimating equations were used to analyze the data. Providers discussed asthma control medication risks during 23% of visits. Risks were more likely to be discussed when the visit was longer and when the provider prescribed a new asthma control medication. When providers discussed asthma control medication risks, they were most likely to ask the family general questions and make general statements. Across all of the visits, caregivers asked a total of 16 questions and made a total of 20 statements about risks associated with asthma medications; children asked a total of 3 questions and made two statements about risks associated with asthma control medications. Providers discussed risks associated with asthma control medications in less than one-quarter of medical visits. Providers should involve families in discussions about risks associated with medications during every visit to assess potential barriers to medication adherence. © 2013 Wiley Periodicals, Inc.