The main limitation of adverse drug reactions (ADRs) reporting, particularly by general practitioners (GP), to the regional pharmacovigilance centers is under-reporting. The Midi-Pyrénées Regional Pharmacovigilance Center (South western, France) sets up regular visits by a clinical research assistant (CRA) to GP in order to increase the number of ADR reports. The aim of this pilot study was to assess the effect of regular visits of a CRA in GPs offices on the rate of ADR reporting.
View Article and Find Full Text PDFIntroduction: Spontaneous reporting of adverse drug reactions (ADRs) remains the cornerstone of postmarketing drug safety surveillance (pharmacovigilance); however, one of its main limitations is incomplete data, thus limiting conclusions about causality assessment.
Objective: The primary aim of this study was to assess the completeness of ADR reports sent by general practitioners (GPs) to regional pharmacovigilance centres and the secondary objective was to identify factors associated with complete ADR reports.
Methods: All ADR reports sent by GPs to the Midi-Pyrénées Regional Pharmacovigilance Center (Toulouse, France) from 1 January 2010 to 31 December 2013 were reviewed.