Project description:Nonsteroidal anti-inflammatory drugs (NSAIDs) are one of the most common medications reported in pregnancy. NSAIDs directly impact prostaglandin pathways and have been proposed as potential risk factors for spontaneous abortions (SABs, gestation <20 weeks). SAB risk and drug response across several medications differ by race; therefore, we evaluated whether associations between NSAIDs and SAB risk differ by race.Women were enrolled in the Right from the Start (2004-2010) prospective cohort. Data regarding over-the-counter NSAIDs up to the sixth week of pregnancy were obtained from interviews. Race was self-reported. Cox proportional hazards regression models were used to estimate the association between NSAID exposure and SAB, adjusted for confounders.Among 2493 pregnancies, 12% were African American and 88% were Caucasian. NSAID exposure was reported by 40% (n = 124) of African Americans and 43% (n = 945) of Caucasians. Race-stratified analyses showed protection from SAB among African Americans (adjusted hazard ratio [aHR], 0.84; 95% confidence interval [CI], 0.73-0.96) but no effect in Caucasians (aHR, 1.01; 95% CI 0.88-1.16).Our findings suggest that risk for SAB due to over-the-counter NSAIDs in early pregnancy is modified by race. Further investigation of dose, timing in gestation, and indication may help to further reconcile the relationship between race, NSAIDs, and SAB.
Project description:BACKGROUND:In Japan, non-pharmacists who are accredited as registered salespersons can sell over-the-counter (OTC) drugs, and they play a very important role in supporting proper OTC drug use by consumers. The purpose of this study was to evaluate information provided to and information collected from consumers, and cooperation with pharmacists during OTC drug sales by registered salespersons, and to clarify their related concerns and behaviors. METHODS:A cross-sectional questionnaire-based survey of 385 registered salespersons working at 56 drugstores throughout Japan was conducted. Based on the questionnaire survey, the frequency of information provision/collection in various categories was determined for the registered salespersons. The relation between concerns of registered salespersons relating to OTC drug sales and the frequency of information provision/collection was examined. The frequency of consultation of registered salespersons with a pharmacist was calculated for registered salespersons with/without in-store pharmacists. The χ-square test or Fisher's exact test was performed to assess the significance of differences. RESULTS:Two hundred and seven registered salespersons (53.7%) responded completely. A greater number of OTC drug purchasers per day was associated with a greater frequency of information provision about "side effects" and information collection about "favorite items" (alcohol, tobacco, health foods, etc.) (p < 0.05). One hundred and thirty-nine (67.2%) participants had concerns about "interactions between OTC drugs and prescription drugs", and these concerns were related to the frequency of information provision/collection (p < 0.05). Regarding the frequency of consultation with a pharmacist, 35 of 46 participants (76.1%) working with pharmacists answered "always" or "usually", whereas only 19 of 161 participants (11.8%) working without full-time pharmacists answered "always" or "usually". More than half of the registered salespersons thought that cooperation with a pharmacist was necessary when they were "asked about concomitant use with prescription drugs" or "told that side effects happened." CONCLUSIONS:The results of this study show that experienced registered salespersons selling OTC drugs are more likely to collect information from consumers and to provide information to consumers. It appears to be important for registered salespersons to cooperate with pharmacists in order to provide and collect appropriate information about concomitant medications.
Project description:Several over-the-counter (OTC) drugs are known to be misused. Among them are opioids such as codeine, dihydrocodeine, and loperamide. This work elucidates their pharmacology, interactions, safety profiles, and how pharmacology is being manipulated to misuse these common medications, with the aim to expand on the subject outlined by the authors focusing on abuse prevention and prevalence rates. The reviewed literature was identified in several online databases through searches conducted with phrases created by combining the international non-proprietary names of the drugs with terms related to drug misuse. The results show that OTC opioids are misused as an alternative for illicit narcotics, or prescription-only opioids. The potency of codeine and loperamide is strongly dependent on the individual enzymatic activity of CYP2D6 and CYP3A4, as well as P-glycoprotein function. Codeine can also be utilized as a substrate for clandestine syntheses of more potent drugs of abuse, namely desomorphine ("Krokodil"), and morphine. The dangerous methods used to prepare these substances can result in poisoning from toxic chemicals and impurities originating from the synthesis procedure. OTC opioids are generally safe when consumed in accordance with medical guidelines. However, the intake of supratherapeutic amounts of these substances may reveal surprising traits of common medications.
Project description:BACKGROUND:Adverse drug reaction (ADR) reporting practices by health care professionals remain poor. Over-the-counter (OTC) drugs are perceived as safe; however, they can also cause ADRs. The objective of this study was to analyze ADR reporting for OTC drugs in a 10-year period, in order to evaluate frequency of ADRs, population that ADRs most affect and reporters of ADRs of OTC drugs in Croatia. METHODS:Spontaneously reported ADRs of non-analgesic OTC drugs, collected from January 2008 to December 2017 were analyzed. Data was obtained from Agency for Medicinal Products and Medical Devices of Croatia (HALMED). RESULTS:There were 547 ADRs of OTC drugs reported in total and an increase in number of reports through the years was observed. Pharmacists reported 45.4% of all ADRs, and were most frequent reporters (p?<?0.001). In 2017 majority of reports, 62 (49.2%), were obtained from consumers. ADRs were most frequently observed in patients aged 70?years and older (15% of ADRs). Five percent of all reports were accidental exposures among children. CONCLUSIONS:Pharmacists most frequently reported ADRs of OTC drugs and consumers' awareness of ADR reporting has risen. Other health care professionals (e.g., nurses and dentists) must be offered proper education in order to improve reporting practice of ADRs. Health care professionals should address concerns about OTC drug safety in elderly and children.
Project description:IntroductionPatients with chronic kidney disease (CKD) depend on advice from healthcare professionals to avoid using unsuitable over-the-counter (OTC) drugs. Recently, qualified, registered nonpharmacist salespersons became licensed to sell OTC drugs in Japan. However, registered salespersons' knowledge and awareness of precautions regarding unsuitable OTC drugs for use in patients with CKD are unclear.ObjectivesThis study aimed to clarify the awareness, knowledge, and implementation of precautions by registered salespersons regarding OTC drugs used by patients with CKD. Additionally, we evaluated the change of registered salespersons' knowledge and awareness of this topic generated by a pharmacist intervention.MethodsA questionnaire survey and pharmacist intervention were applied to 175 registered salespersons. The intervention comprised a 50-minute lecture imparted by a pharmacist who was trained in nephrology. The knowledge, awareness, and implementation of precautions by participants with respect to nonsteroidal anti-inflammatory drugs (NSAIDs) and antacids were evaluated before and after the intervention.ResultsApproximately half of the registered salespersons reported previous experience with selling OTC drugs that were inappropriate for patients with CKD (NSAIDs, 48.0%; antacids, 39.7%). Few participants recognized the need to check renal function when selling those drugs to such patients (NSAIDs, 25.7%; antacids, 47.5%). The registered salespersons' awareness and knowledge were significantly higher after the intervention than before it.ConclusionThe results indicate that before the intervention, the registered salespersons had low levels of awareness and knowledge regarding OTC drug use in patients with CKD despite having prior experience selling unsuitable OTC drugs. However, the pharmacist intervention improved the registered salespersons' awareness and knowledge. The educational program for registered salespersons might be necessary to prevent inappropriate OTC drug use by patients with CKD.
Project description:BackgroundStatins are an important intervention for primary and secondary cardiovascular disease (CVD) prevention. We aimed to establish the variation in primary preventive treatment for CVD with statins in the English population.MethodsCross sectional analyses of 6155 English primary care practices with 40,017,963 patients in 2006/7. Linear regression was used to model prescribing rates of statins for primary CVD prevention as a function of IMD (index of multiple deprivation) quintile, proportion of population from an ethnic minority, and age over 65 years. Defined Daily Doses (DDD) were used to calculate the numbers of patients receiving a statin. Statin prescriptions were allocated to primary and secondary prevention based on the prevalence of CVD and stroke.ResultsWe estimated that 10.5% (s.d.3.7%) of the registered population were dispensed a statin for any indication and that 6.3% (s.d. 3.0%) received a statin for primary CVD prevention. The regression model explained 21.2% of the variation in estimates of prescribing for primary prevention. Practices with higher prevalence of hypertension (β co-efficient 0.299 p <0.001) and diabetes (β co-efficient 0.566 p < 0.001) prescribed more statins for primary prevention. Practices with higher levels of ethnicity (β co-efficient-0.026 p <0.001), greater deprivation (β co-efficient -0.152 p < 0.001) older patients (β co-efficient -0.032 p 0.002), larger lists (β co-efficient -0.085, p < 0.001) and were more rural (β co-efficient -0.121, p0.026) prescribed fewer statins. In a small proportion of practices (0.5%) estimated prescribing rates for statins were so low that insufficient prescriptions were issued to meet the predicted secondary prevention requirements of their registered population.ConclusionsAbsolute estimated prescribing rates for primary prevention of CVD were 6.3% of the population. There was evidence of social inequalities in statin prescribing for primary prevention. These findings support the recent introduction of a financial incentive for primary prevention of CVD in England.
Project description:Widespread availability of antibiotics without prescription potentially facilitates overuse and contributes to selection pressure for antimicrobial resistant bacteria. Prior to this study, anecdotal observations in Guatemala identified corner stores as primary antibiotic dispensaries, where people purchase antibiotics without prescriptions. We carried out a cross sectional study to document the number and types of antibiotics available in corner stores, in four study areas in Guatemala. A total of 443 corner stores were surveyed, of which 295 (67%) sold antibiotics. The most commonly available antibiotics were amoxicillin, found in 246/295 (83%) stores, and tetracycline, found in 195/295 (66%) stores. Over the counter sales result from laissez-faire enforcement of antibiotic dispensing regulations in Guatemala combined with patient demand. This study serves as a baseline to document changes in the availability of antibiotics in informal establishments in light of new pharmacy regulations for antibiotic dispensing, which were adopted after this study was completed.
Project description:BackgroundDonepezil, an acetylcholinesterase inhibitor used in the treatment of Alzheimer's disease, has been widely cited in media and bioethics literature on cognitive enhancement (CE) as having the potential to improve the cognitive ability of healthy individuals. In both literatures, this claim has been repeatedly supported by the results of a small study published by Yesavage et al. in 2002 on non-demented pilots (30-70 years old). The factors contributing to this specific interpretation of this study's results are unclear.MethodsWe examined print media and interdisciplinary bioethics coverage of this small study, aiming to provide insight into how evidence from research may be shaped within different discourses, potentially influencing important policy, ethics, and clinical decisions. Systematic qualitative content analysis was used to examine how this study was reported in 27 media and 22 bioethics articles. Articles were analyzed for content related to: (1) headlines and titles; (2) colloquialisms; and, (3) accuracy of reporting of the characteristics and results of the study.ResultsIn media and bioethics articles referencing this small study, strong claims were made about donepezil as a CE drug. The majority of headlines, titles, and colloquialisms used enhancement language and the majority of these suggest that donepezil could be used to enhance intellectual ability. Further, both literatures moved between reporting the results of the primary study and magnifying the perceived connection between these results and the CE debate that was alluded to in the primary study. Specific descriptions of the results overwhelmingly reported an improvement in performance on a flight simulator, while more general statements claimed donepezil enhanced cognitive performance. Further, a high level of reporting accuracy was found regarding study characteristics of the original study, but variable levels of accuracy surrounded the presentation of complex characteristics (i.e., methods) or contentious properties of the CE debate (i.e., initial health status of the study subjects).ConclusionsHyped claims of CE effects cannot be completely accounted for by sheer inaccuracy in reporting. A complex interaction between the primary and secondary literature, and expectations and social pressures related to CE appears to drive enthusiastic reports.
Project description:Drug resistance is a major problem in health care, undermining therapy outcomes and necessitating novel approaches to drug design. Extensive studies on resistance to viral protease inhibitors, particularly those of HIV-1 and hepatitis C virus (HCV) protease, revealed a plethora of information on the structural and molecular mechanisms underlying resistance. These insights led to several strategies to improve viral protease inhibitors to counter resistance, such as exploiting the essential biological function and leveraging evolutionary constraints. Incorporation of these strategies into structure-based drug design can minimize vulnerability to resistance, not only for viral proteases but for other quickly evolving drug targets as well, toward designing inhibitors one step ahead of evolution to counter resistance with more intelligent and rational design.
Project description:OBJECTIVE:To compare the effects of two sequential policy changes-the addition of a high-potency statin to the Department of Veterans Affairs (VA) formulary and the release of the American College of Cardiology/American Heart Association (ACC/AHA) cholesterol guidelines-on VA provider prescribing. DATA SOURCES/STUDY SETTING:Retrospective analysis of 1,100,682 VA patients, 2011-2016. STUDY DESIGN:Interrupted time-series analysis of changes in prescribing of moderate-to-high-intensity statins among high-risk patients and across high-risk subgroups. We also assessed changes in prescribing of atorvastatin and other statin drugs. We estimated marginal effects (ME) of formulary and guideline changes by comparing predicted and observed statin use. DATA COLLECTION/EXTRACTION METHODS:Data from VA Corporate Data Warehouse. PRINCIPAL FINDINGS:The use of moderate-to-high-intensity statins increased by 2 percentage points following the formulary change (ME, 2.4, 95% confidence interval [CI], 2.2 to 2.6) and less than 1 percentage point following the guideline change (ME, 0.8, 95% CI, 0.6 to 0.9). The formulary change led to approximately a 12 percentage-point increase in the use of moderate-to-high-intensity atorvastatin (ME, 11.5, 95% CI, 11.3 to 11.6). The relatively greater provider response to the formulary change occurred across all patient subgroups. CONCLUSIONS:Addition of a high-potency statin to formulary affected provider prescribing more than the ACC/AHA guidelines.