The contribution of direct patient reported ADRs to drug safety signals in the Netherlands from 2010 to 2015

Pharmacoepidemiology and Drug Safety
Florence van HunselLinda Härmark

Abstract

The purpose of this study was to investigate the contribution of patient reports to signals sent by the Netherlands Pharmacovigilance Centre Lareb to the Dutch Medicines Evaluation Board and to determine if there are certain types of signals where patient report add a distinct contribution. All signals from 2010 until 2015 were included. First, we investigated how many patient reports were present in the signals and the characteristics of these reports compared to the health care professional and marketing authorization holders' reports. In addition to source, the analysis included ATC code of the drug, MedDRA® system organ class and preferred term for the adverse drug reaction (ADR), seriousness of the ADR, and 7 other factors like reports on over-the-counter medication, and how often an ADR listed in the important medical event terms list was present. Secondly, we determined the proportion of reports submitted by the individual groups to signals, in a cross-sectional manner. A total of 150 signals were included, including 1691 ADR reports. Our results show that 26.3% of all ADR reports in Dutch drug safety signals were reported by patients, and 30.5% of the patient reports in the signals contained one or more terms listed as ...Continue Reading

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Sep 2, 2016·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Cristiano MatosFlorence van Hunsel
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Citations

Oct 26, 2018·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Cristiano MatosFlorence van Hunsel
Apr 30, 2019·Expert Opinion on Drug Safety·Florence van HunselLeàn Rolfes
Aug 6, 2019·Frontiers in Medicine·Carla TorreAna Paula Martins
Sep 22, 2017·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Sarah WatsonFlorence van Hunsel
May 30, 2019·International Journal of Clinical Pharmacy·Rasaq AdisaTitilayo Oyelola Fakeye
Jul 15, 2018·International Journal of Clinical Pharmacy·Pedro InácioMarja Airaksinen
Dec 23, 2017·Pharmacoepidemiology and Drug Safety·Joep H G SchollEugène P van Puijenbroek
Nov 11, 2020·European Journal of Clinical Pharmacology·J Riera-ArnauG Cereza García
Apr 12, 2021·Pharmacoepidemiology and Drug Safety·Florence van HunselJarno Hoekman

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