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Michael Reumerman, J Tichelaar, B Piersma, M C Richir, M A van Agtmael
OBJECTIVES: Pharmacovigilance education is essential since adverse drug reactions (ADRs) are a serious health problem and contribute to unnecessary patient burden and hospital admissions. Healthcare professionals have little awareness of pharmacovigilance and ADR reporting, and only few educational interventions had durable effects on this awareness. Our future healthcare providers should therefore acquire an adequate set of pharmacovigilance competencies to rationally prescribe, distribute, and monitor drugs...
June 20, 2018: European Journal of Clinical Pharmacology
Damien Driot, Lucile Figuet, Jordan Birebent, Sandra Coste, Geneviève Durrieu, Julien Jacquot, Michel Bismuth
OBJECTIVE: General practitioners (GPs) report little adverse drug reactions (ADR), although it is mandatory in France. The objective was to evaluate the satisfaction of the GPs who participated to a pharmacovigilance ADR declaration support network via a clinical research assistant (CRA) moving to their GP office in the French South-West region of Midi-Pyrénées. STUDY DESIGN: A satisfaction questionnaire was sent to the 59 active GPs of this network in November 2016...
April 28, 2018: Thérapie
Andrea D Pratico, Laura Longo, Silvana Mansueto, Lucia Gozzo, Ignazio Barberi, Venera Tiralongo, Vincenzo Salvo, Raffaele Falsaperla, Giovanna Vitaliti, Mario La Rosa, Antonio Rotondo, Nicoletta Avola, Debora Sgarlata, Annalisa Damiano, Massimo Tirantello, Gaspare Anzelmo, Domenico Cipolla, Angelo Rizzo, Antonio Russo, Martino Ruggieri, Salvatore Salomone, Filippo Drago
BACKGROUND: Given the growing use of off-label in pediatric practice, there is a growing interest on pharmacovigilance programs monitoring the occurrence of adverse drug reactions related to off-label drug prescription in childhood. PATIENTS AND METHODS: The results of a one-year program of pharmacovigilance issued in the Sicilian Region, Italy, are herein presented. The study involved 6 pediatric and neonatal centres and prospectively reviewed the prescriptions of 5,060 patients, who were stratified for age (newborn, infant, children, adolescents)...
June 19, 2018: Current Drug Safety
S Hamaui Cuadrado, M Guinart Vidal
The Drug Information Association (DIA) Europe held its annual meeting from April 17-19, 2018, in Basel, Switzerland. The key topics discussed in the 3-day meeting were related to pharmacovigilance, clinical development, patient engagement, data and data standards, preclinical development and early-phase clinical research, regulatory science, translational medicine and science, and value and access. The program was principally focused on the current opportunities and future landscape of the healthcare system as a result of the increasingly innovative technologies and effective utilization of big data...
May 2018: Drugs of Today
Anna Laven, Katharina Schmitz, Wilhelm-Hubertus Franzen
Background The detection, assessment and prevention of adverse drug reactions along the product's life cycle is known as pharmacovigilance. German pharmacists are obliged by law to conduct pharmacovigilance measures, a specific training is not required. Objectives To assess the knowledge, contribution and perception of German pharmacy professionals regarding pharmacovigilance activities, in order to identify their needs to report better on the issue. Setting A semi-quantitative survey among German pharmacy professionals was conducted in November 2017...
June 16, 2018: International Journal of Clinical Pharmacy
Amneh Al-Husseini, Mayyada Wazaify, Marie Claire Van Hout
Pregabalin is currently approved for the treatment of epilepsy, generalized anxiety disorder, neuropathic pain, and fibromyalgia. A qualitative study was undertaken in Jordan, where concerns have been raised about its unprescribed availability in community pharmacies and thereby its abuse. Semi-structured interviews were conducted with all patients with a history of pregabalin use in two Jordanian addiction treatment centers. All were male patients aged 21-30 years ( n  = 11). The majority was poly-drug abusers and had a previous history of substance abuse (tramadol, Captagon, synthetic cannabinoids, and marijuana) ...
2018: International Journal of Mental Health and Addiction
Nazar AbdulLateef Jassim, Yasameen Abbas Humadi
PURPOSE OF REVIEW: Biosimilars are of growing importance worldwide, and many leading countries are introducing them in their health care systems and are using them in many fields of medicine owing to their low price tags in comparison with the brands and to their similarities in terms of function and side effects. So we cannot look past them and continue to rely on the innovator drugs since many had proven their efficacies in number of researches and Trials, not to mention the burden that many diseases pose on the budgets of the third world countries making using a lower priced alternatives a much appealing choice for the decision makers...
June 13, 2018: Current Rheumatology Reports
Andrea C Tricco, Wasifa Zarin, Erin Lillie, Serena Jeblee, Rachel Warren, Paul A Khan, Reid Robson, Ba' Pham, Graeme Hirst, Sharon E Straus
BACKGROUND: A scoping review to characterize the literature on the use of conversations in social media as a potential source of data for detecting adverse events (AEs) related to health products. METHODS: Our specific research questions were (1) What social media listening platforms exist to detect adverse events related to health products, and what are their capabilities and characteristics? (2) What is the validity and reliability of data from social media for detecting these adverse events? MEDLINE, EMBASE, Cochrane Library, and relevant websites were searched from inception to May 2016...
June 14, 2018: BMC Medical Informatics and Decision Making
Shashank Gupta, Sachin Pawar, Nitin Ramrakhiyani, Girish Keshav Palshikar, Vasudeva Varma
BACKGROUND: Social media is a useful platform to share health-related information due to its vast reach. This makes it a good candidate for public-health monitoring tasks, specifically for pharmacovigilance. We study the problem of extraction of Adverse-Drug-Reaction (ADR) mentions from social media, particularly from Twitter. Medical information extraction from social media is challenging, mainly due to short and highly informal nature of text, as compared to more technical and formal medical reports...
June 13, 2018: BMC Bioinformatics
Jing Huang, Jingcheng Du, Rui Duan, Xinyuan Zhang, Cui Tao, Yong Chen
Data from the Vaccine Adverse Event Reporting System (VAERS) contain spontaneously reported adverse events (AEs) from the public. It has been a major data source for detecting AEs and monitoring vaccine safety. As one major limitation of spontaneous surveillance systems, the VAERS reports by themselves sometimes do not provide enough information to answer certain research questions. For example, patient level demographics are very limited in VAERS due to the protection of patient privacy, such that investigation of differential AE rates across race/ethnicity groups cannot be conducted using VAERS data only...
2018: Frontiers in Pharmacology
C Lee Ventola
Adverse drug events (ADEs), including drug interactions, have a tremendous impact on patient health and generate substantial health care costs. A "big data" approach to pharmacovigilance involves the identification of drug-ADE associations by data mining various electronic sources, including: adverse event reports, the medical literature, electronic health records, and social media. This approach has been useful in assisting the Food and Drug Administration and other regulatory agencies in monitoring and decision-making regarding drug safety...
June 2018: P & T: a Peer-reviewed Journal for Formulary Management
Hanna K Welch, John A Kellum, Sandra L Kane-Gill
STUDY OBJECTIVE: Acute kidney injury (AKI) is a common condition associated with both short-term and long-term consequences including dialysis, chronic kidney disease, and mortality. Although the United States Food and Drug Administration Adverse Event Reporting System (FAERS) database is a powerful tool to examine drug-associated events, to our knowledge, no study has analyzed this database to identify the most common drugs reported with AKI. The objective of this study was to analyze AKI reports and associated medications in the FAERS database...
June 8, 2018: Pharmacotherapy
Xuemei Zhang, Rui Niu, Bianling Feng, Jiadong Guo, Ying Liu, Xinyu Liu
BACKGROUND: Although China's adverse drug reaction (ADR) reporting and monitoring has developed rapidly, many challenges remain. This study assessed ADR monitoring and reporting in China and identified monitoring problems. RESEARCH DESIGN AND METHODS: A cross-sectional survey was conducted of ADR reporting institutions in six Chinese provinces in April-December 2014. Questionnaires assessed ADR systems, basic resources, and pharmacovigilance activity. RESULTS: Of 720 questionnaires distributed, the response rate was 81...
June 8, 2018: Expert Opinion on Drug Safety
Judith C Maro, Michael D Nguyen, Inna Dashevsky, Meghan A Baker, Martin Kulldorff
Objective: To perform sample size calculations when using tree-based scan statistics in longitudinal observational databases. Methods: Tree-based scan statistics enable data mining on epidemiologic datasets where thousands of disease outcomes are organized into hierarchical tree structures with automatic adjustment for multiple testing. We show how to evaluate the statistical power of the unconditional and conditional Poisson versions. The null hypothesis is that there is no increase in the risk for any of the outcomes...
June 12, 2017: EGEMS
Olivier Gaudin, Vannina Seta, Marina Alexandre, Gérôme Bohelay, Françoise Aucouturier, Sabine Mignot-Grootenboer, Saskia Ingen-Housz-Oro, Céline Bernardeschi, Pierre Schneider, Benoît Mellottee, Frédéric Caux, Catherine Prost-Squarcioni
Mucous membrane pemphigoids (MMPs) and bullous pemphigoid (BP) are autoimmune bullous diseases that share physiopathological features: both can result from autoantibodies directed against BP180 or BP230 antigens. An association has been reported between BP and intake of gliptins, which are dipeptidyl peptidase-IV inhibitors used to treat type 2 diabetes mellitus. Clinical and immunological differences have been reported between gliptin-induced BPs and classical BPs: mucosal involvement, non-inflammatory lesions, and target BP180 epitopes other than the NC16A domain...
2018: Frontiers in Immunology
Xiaoyi Chen, Carole Faviez, Stéphane Schuck, Agnès Lillo-Le-Louët, Nathalie Texier, Badisse Dahamna, Charles Huot, Pierre Foulquié, Suzanne Pereira, Vincent Leroux, Pierre Karapetiantz, Armelle Guenegou-Arnoux, Sandrine Katsahian, Cédric Bousquet, Anita Burgun
Background: The Food and Drug Administration (FDA) in the United States and the European Medicines Agency (EMA) have recognized social media as a new data source to strengthen their activities regarding drug safety. Objective: Our objective in the ADR-PRISM project was to provide text mining and visualization tools to explore a corpus of posts extracted from social media. We evaluated this approach on a corpus of 21 million posts from five patient forums, and conducted a qualitative analysis of the data available on methylphenidate in this corpus...
2018: Frontiers in Pharmacology
Lynne M Mofenson
No abstract text is available yet for this article.
June 4, 2018: Lancet Global Health
Shaun Comfort, Darren Dorrell, Shawman Meireis, Jennifer Fine
INTRODUCTION: Within the field of Pharmacovigilance, the most common approaches for assessing causality between a report of a drug and a corresponding adverse event are clinical judgment, probabilistic methods and algorithms. Although multiple methods using these three approaches have been proposed, there is currently no universally accepted method for assessing drug-event causality in ICSRs and variability in drug-event causality assessments is well documented. OBJECTIVE: This study describes the development and validation of an Individual Case Safety Report (ICSR) Causality Decision Support Tool to assist Safety Professionals (SPs) performing causality assessments...
June 6, 2018: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
Thomas Ly, Carol Pamer, Oanh Dang, Sonja Brajovic, Shahrukh Haider, Taxiarchis Botsis, David Milward, Andrew Winter, Susan Lu, Robert Ball
INTRODUCTION: The FDA Adverse Event Reporting System (FAERS) is a primary data source for identifying unlabeled adverse events (AEs) in a drug or biologic drug product's postmarketing phase. Many AE reports must be reviewed by drug safety experts to identify unlabeled AEs, even if the reported AEs are previously identified, labeled AEs. Integrating the labeling status of drug product AEs into FAERS could increase report triage and review efficiency. Medical Dictionary for Regulatory Activities (MedDRA) is the standard for coding AE terms in FAERS cases...
May 31, 2018: Journal of Biomedical Informatics
Xiaolu Nie, Ying Zhang, Zehao Wu, Lulu Jia, Xiaoling Wang, Sinéad M Langan, Eric I Benchimol, Xiaoxia Peng
OBJECTIVES: To appraise the reporting quality of studies which concerned linezolid related thrombocytopenia referring to REporting of studies Conducted using Observational Routinely-collected health Data (RECORD) statement. METHODS: Medline, Embase, Cochrane library and were searched for observational studies concerning linezolid related thrombocytopenia using routinely collected health data from 2000 to 2017. Two reviewers screened potential eligible articles and extracted data independently...
June 1, 2018: Expert Opinion on Drug Safety
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