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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.â©.
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Sistemas de Notificação de Reações Adversas a Medicamentos , Clopidogrel/efeitos adversos , Hemorragia/induzido quimicamente , Cloridrato de Prasugrel/efeitos adversos , Antagonistas do Receptor Purinérgico P2Y/efeitos adversos , Ticlopidina/efeitos adversos , Humanos , Estados Unidos , United States Food and Drug AdministrationRESUMO
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. Ltd.
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Pesquisa Biomédica/normas , Catarata/diagnóstico , Bases de Dados Factuais/normas , Medicina Geral/normas , Glaucoma/diagnóstico , Classificação Internacional de Doenças/normas , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Pesquisa Biomédica/estatística & dados numéricos , Catarata/epidemiologia , Bases de Dados Factuais/estatística & dados numéricos , Feminino , Medicina Geral/estatística & dados numéricos , Glaucoma/epidemiologia , Humanos , Masculino , Pessoa de Meia-Idade , Reprodutibilidade dos Testes , Reino Unido/epidemiologia , Adulto JovemRESUMO
Background: COVID-19 is associated with significant morbidity and mortality. This study aimed to explore the early predictors of intensive care unit (ICU) admission among patients with COVID-19. Methods: This was a case-control study of adult patients with confirmed COVID-19. Cases were defined as patients admitted to ICU during the period February 29-May 29, 2020. For each case enrolled, one control was matched by age and gender. Results: A total of 1,560 patients with confirmed COVID-19 were included. Each group included 780 patients with a predominant male gender (89.7%) and a median age of 49 years (interquartile range = 18). Predictors independently associated with ICU admission were cardiovascular disease (adjusted odds ratio (aOR) = 1.64, 95% confidence interval (CI): 1.16-2.32, p = 0.005), diabetes (aOR = 1.52, 95% CI: 1.08-2.13, p = 0.016), obesity (aOR = 1.46, 95% CI: 1.03-2.08, p = 0.034), lymphopenia (aOR = 2.69, 95% CI: 1.80-4.02, p < 0.001), high AST (aOR = 2.59, 95% CI: 1.53-4.36, p < 0.001), high ferritin (aOR = 1.96, 95% CI: 1.40-2.74, p < 0.001), high CRP (aOR = 4.09, 95% CI: 2.81-5.96, p < 0.001), and dyspnea (aOR = 2.50, 95% CI: 1.77-3.54, p < 0.001). Conclusion: Having cardiovascular disease, diabetes, obesity, lymphopenia, dyspnea, and increased AST, ferritin, and CRP were independent predictors for ICU admission in patients with COVID-19.
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COVID-19 , Doenças Cardiovasculares , Diabetes Mellitus , Linfopenia , Adulto , Humanos , Masculino , Pessoa de Meia-Idade , COVID-19/epidemiologia , Estudos de Casos e Controles , Catar/epidemiologia , Fatores de Risco , Unidades de Terapia Intensiva , Obesidade , Dispneia , FerritinasRESUMO
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 149 464 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.
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Uso de Medicamentos/estatística & dados numéricos , Cardiopatias Congênitas/epidemiologia , Efeitos Tardios da Exposição Pré-Natal/epidemiologia , Inibidores Seletivos de Recaptação de Serotonina/efeitos adversos , Adolescente , Adulto , Criança , Pré-Escolar , Estudos de Coortes , Bases de Dados Factuais , Feminino , Cardiopatias Congênitas/induzido quimicamente , Humanos , Lactente , Pessoa de Meia-Idade , Gravidez , Efeitos Tardios da Exposição Pré-Natal/induzido quimicamente , Pontuação de Propensão , Inibidores Seletivos de Recaptação de Serotonina/administração & dosagem , Inibidores Seletivos de Recaptação de Serotonina/uso terapêutico , Inquéritos e Questionários , Reino Unido/epidemiologia , Adulto JovemRESUMO
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.
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Serviços Comunitários de Farmácia , Farmácias , Egito , Feminino , Humanos , Gravidez , Gestantes , TetraciclinasRESUMO
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.
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Antibiotic misuse, either by patients or healthcare professionals, is one of the major contributing factors to antimicrobial resistance. In many Middle Eastern countries including Egypt, there are no strict regulations regarding antibiotic dispensing by community pharmacies. In this study, we examined antibiotic dispensing patterns in Egyptian community pharmacies. About 150 community pharmacies were randomly chosen using convenience sampling from the five most populous urban districts of Minia Governorate in Egypt. Two simulated patient (SP) scenarios of viral respiratory tract infection requiring no antibiotic treatment were used to assess the actual antibiotics dispensing practice of. Face-to-face interviews were then conducted to assess the intended dispensing practice. Descriptive statistics were calculated to report the main study outcomes. In 238 visits of both scenarios, 98.3% of service providers dispensed amoxicillin. Although stated otherwise in interviews, most pharmacy providers (63%) dispensed amoxicillin without collecting relevant information from presenting SPs. Findings showed high rates of antibiotic misuse in community pharmacies. Discrepancies between interviews and patient simulation results also suggest a practiceâknowledge gap. Corrective actions, whether legislation, enforcement, education, or awareness campaigns about antibiotic misuse, are urgently needed to improve antibiotic dispensing practices in Egyptian community pharmacies.