Current Pharmaceutical Biotechnology
The aim of this study was to analyze the number of Adverse Drug Reactions published as case reports (PubMed indexed journals) from January 2018 to June 2019, and observe if they are translated in regulatory frameworks like Vigibase, and package inserts.
Abstract
DOI: 10.2174/1574886316666210609115148 Abstract: Introduction: An adverse drug reaction case report refers to a scientific publication that is written by a health care professional who suspects a casual relationship between a drug and an adverse drug reaction (ADR). ADR case reports help to identify potential risks associated with the use of drug. Most of the case reports do not mention about reporting the ADR to regulatory authorities. With this objective, the aim of this study was to analyze the number of Adverse Drug Reactions (ADR) published as case reports (PubMed indexed journals) from January 2018 to June 2019, and observe if they are translated in regulatory frameworks like Vigibase, and package inserts.