Search

Background Self-medication is a worldwide phenomenon of using medications without medical supervision. It is even more prevalent in low-income countries, where individuals seek community pharmacies because of accessibility and affordability. Although self-medication is associated with an increased risk of medication errors, few studies have been conducted to examine the quality of community pharmacy management towards self-medicating individuals of at-risk populations such as pregnant women. Objective We sought to investigate the quality of community pharmacies management of self-medication requests of tetracyclines for pregnant women. Setting The study was conducted in community pharmacies in Minya, Egypt. Methods A random sample of 150 community pharmacies was chosen from the urban areas of five districts of Minya, Egypt. To evaluate the actual practice, a simulated client was trained to visit pharmacies and purchase doxycycline for a pregnant woman. In a random subset of the sampled pharmacies (n = 100), interviews were conducted to evaluate pharmacy staff knowledge and attitudes regarding information gathering and dispensing practice. Main outcome measure Dispensing rate of doxycycline for pregnant women. Results From simulated client visits, almost all pharmacy staff (99.1%) dispensed doxycycline without requesting a prescription or collecting any information. About 25% of staff members did not abstain from dispensing even after knowing about pregnancy. On the other hand, most interviewed pharmacy staff (91.5%) reported that they ask about pregnancy before dispensing. Conclusion Our findings show that the current community pharmacy practice puts pregnant women at high risk of experiencing harmful self-medication outcomes. Therefore, strict legislative measures and pharmacy education programs should be considered in Egypt to lessen inappropriate dispensing rates in community pharmacies.

Repeat administration of tetanus toxoid-containing vaccines has rarely been associated with Arthus phenomenon, an immune-complex reaction. In the US, since 2013, tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccines (Tdap) have been recommended for administration during each pregnancy. Separately, in 2019, one Tdap was approved for repeat administration in adults in the US. We aimed to describe trends in spontaneously reported Arthus reactions following Tdap in the US and to assess the risk of this phenomenon in persons receiving Tdap repeatedly. We reviewed Arthus reports in the Vaccine Adverse Events Reporting System (VAERS), 1990–2018. Reporting rates were estimated using Tdap doses distributed data. A systematic literature review was conducted in MEDLINE for any Arthus cases reported in Tdap clinical trials and observational studies published between 2000 and 2019. We found 192 Arthus reports in VAERS after any vaccine, of which 36 occurred after Tdap and none were reported during pregnancy. The Arthus reporting rate was estimated at 0.1 per million doses distributed. We identified eight published studies of Tdap administration within five years after a previous dose of tetanus toxoid-containing vaccine; no Arthus cases were reported. We conclude that Arthus reaction following Tdap is extremely rare. Increasing frequency of repeat Tdap administration in adults in the US did not result in a detectable increase in reporting rates of this phenomenon, confirming the favorable safety profile of Tdap.

Introduction P2Y12 inhibitors show different bleeding-related safety profiles in premarketing trials. However, little is known about their potential safety from spontaneous reporting systems and postmarketing data. Objective To describe and evaluate the bleeding-related adverse events associated with use of P2Y12 inhibitors utilizing data from the FDA Adverse Event Reporting System (FAERS) database. Materials and methods We identified adverse events reports listing clopidogrel, prasugrel, or ticagrelor as the primary suspected agent in the FAERS database from the 1st quarter of 2014 to the 4th quarter of 2016. Using MedDRA version 20.0, we identified search terms for bleeding-related adverse events, within which we filtered for gastrointestinal bleeding and intracranial bleeding. Results We identified 2,252, 2,450, and 549 adverse event reports attributed to clopidogrel, ticagrelor, and prasugrel use, respectively. Prasugrel had the highest proportional reporting ratio (PRR) (4.63; 95% confidence intervals (CI): 4.21 - 5.10) and reporting odds ratio (ROR) (7.46, 95% CI: 6.30 - 8.83) for bleeding followed by clopidogrel (PRR: 4.56; 95% CI: 4.34 - 4.78; ROR: 7.21; 95% CI: 6.63 - 7.84) and ticagrelor (PRR: 2.79; 95%CI: 2.61 - 2.98; ROR: 3.42; 95% CI: 3.12 - 3.74). Within intracranial bleeding events, both ticagrelor and prasugrel had a similarly higher incidence of fatal events than clopidogrel. Meanwhile, the incidence of gastrointestinal bleeding events leading to hospitalization was highest with clopidogrel. Conclusion Reports on bleeding differed among P2Y12 inhibitors with respect to type and outcome. Although FAERS is subject to significant limitations, our results show that the safety profiles of P2Y12 inhibitors in the spontaneous reporting system did not differ from the results of premarketing studies. .

Purpose The aim of this study is to determine (i) the positive predictive value (PPV) of an algorithm using clinical codes to identify incident glaucoma and cataract events in the Clinical Practice Research Datalink (CPRD) and (ii) the ability to capture the correct timing of these clinical events. Methods A total of 21 339 and 5349 potential cataract and glaucoma cases, respectively, were identified in CPRD between 1 January 1990 and 31 December 2010. Questionnaires were sent to the general practitioners (GP) of 1169 (5.5%) cataract and 1163 (21.7%) glaucoma cases for validation. GPs were asked to verify the diagnosis and the timing of the diagnosis and to provide other supporting information. Results A total of 986 (84.3%) valid cataract questionnaires and 863 (74.2%) glaucoma questionnaires were completed. 92.1% and 92.4% of these used information beyond EMR to verify the diagnosis. Cataract and glaucoma diagnoses were confirmed in the large majority of the cases. The PPV (95% CI) of the cataract and glaucoma Read code algorithm were 92.0% (90.3–93.7%) and 84.1% (81.7–86.6%), respectively. However, timing of diagnosis was incorrect for a substantial proportion of the cases (20.3% and 32.8% of the cataract and glaucoma cases, respectively) among whom 30.4% and 49.2% had discrepancies in diagnosis timing greater than 1 year. Conclusions High PPV suggests that the algorithms based on the clinical Read codes are sufficient to identify the cataract and glaucoma cases in CPRD. However, these codes alone may not be able to accurately identify the timing of the diagnosis of these eye disorders. Copyright © 2014 John Wiley & Sons, Ltd.

Purpose Research on the association of maternal selective serotonin reuptake inhibitor (SSRI) use and cardiac malformations in the offspring has yielded conflicting findings. We therefore sought to further investigate the association using data from a large population-based cohort in the UK. Methods The study population consisted of 149464 pregnancies ending in a live birth between January/1996 and November/2010 from the Clinical Practice Research Datalink’s Mother Baby Link. We created propensity-score matched cohorts of first-trimester SSRI users who did not use other antidepressants in the same gestational period (‘SSRI users’, n=3046) and non-antidepressant users (no use from the 3 months before pregnancy through the second trimester of pregnancy, ‘non-users’; n=8991). Weighted logistic regression was used to estimate the odds ratio (OR) and 95% confidence interval (CI) of cardiac malformations overall and septal defects diagnosed in the first year of life, or in the first 6 years of life. Results Sixteen infants with cardiac malformations were identified among SSRI users; 10 of them were septal defects. Among non-users, there were 48 infants with cardiac malformations, 26 of whom had septal defects. The OR (95% CI) for cardiac malformations was 1.00 (0.50; 2.00), and for septal defects was 1.15 (0.46; 2.87). Results were similar for cardiac malformations diagnosed in the first 6 years of life, and in several sensitivity analyses that were also implemented. Conclusions The results of this study are most compatible with no association between maternal use of SSRIs in early pregnancy and cardiac malformations or septal defects in the offspring. Published 2013. This article is a U.S. Government work and is in the public domain in the USA. key words—congenital abnormalities; heart defects; propensity score; SSRIS; weighted logistic regression; mother–baby link; pharmacoepidemiology