Background: Spontaneous reporting of adverse drug reactions remains the cornerstone of postmarketing drug safety surveillance (pharmacovigilance). However, the marked underreporting of adverse drug reactions constitutes a major limitation. The main objective of this study was to assess the use of this simplified reporting by general practitioners (GPs) in Western Normandy based on the number of ADRs reported and to assess its impact on the quality of these reports.
Method: Simplified online pharmacovigilance reporting was proposed in June 2015 by the Caen Normandie regional pharmacovigilance center (CRPV) in conjunction with the Normandy Union régionale des médecins libéraux (URML Normandie) for GPs. This new tool is based on items to be completed by the GP. They were selected by members of CRPV in an attempt to combine good quality reporting and maximum simplicity.
Results: Between June 2014 and June 2016, 220 reports were made by 67 GPs. One year after introduction of this new tool, the monthly number of reports was multiplied by 4.8 and the number of reporting GPs was multiplied by two. The quality of reporting remained unchanged over the same period (p = 0.1). Simplified reporting allowed a decreased number of inaccurate reports (33% versus 36%, p = 0.04).
Conclusion: Simplified online reporting is effective quantitatively (increased number of reports) but also qualitatively (quality unchanged). We must now try to develop this tool in other French regions and reassess it over time.