Consumer Adverse Drug Reactions (ADRs) Reporting in Malaysia: A Retrospective Analysis of Spontaneous Reports from the National Pharmacovigilance Database from 2008 to 2015

摘要

Many countries are incorporating direct patient reporting of adverse drug reactions (ADRs) into their pharmacovigilance systems as patients provide a different insight into drug safety compared to healthcare professionals. In Malaysia, consumer reporting of ADRs and issues with product qualitiesbegan in 2007. The aim of this study was to examine consumer reports in terms of ADR categoriesby System Organ Class (SOC), suspected products and the seriousness of the ADRs.