Evaluation of Simplified Tool In Pharmacovigilance For General Practitioners: 5 Years of Insight

Agathe Trenque, Andry Rabiaza, Marion Sassier, Basile Chretien, Joachim Alexandre, Sophie Fedrizzi, Xavier Humbert

Keywords: pharmacovigilance ; adverse drug reaction ; general practice ; surveillance

Spontaneous reporting of adverse drug reactions (ADRs) remains the cornerstone of postmarketing drug safety surveillance (pharmacovigilance). However, ADRs are often underreported.

Research questions:
The main objective of this study was to assess the use of this simplified reporting by general practitioners (GPs) on the number of reports of ADRs and, secondarily, to determine its impact on the quality of these reports.

An online tool was proposed in June 2015 by the regional pharmacovigilance center of Caen (Normand, France), in conjunction with the regional union of private GPs. It was evaluated in terms of number of monthly reports and number of reporting GPs before and after its initiation. Quality of reports was also evaluated.

Between June 2010 and May 2020, 1,000 reports were given by 307 GPs. At five years, monthly number of reports was multiplied by 3.6 and number of reporting GPs increased of 42%. The quality of reporting remained unchanged over the same period (35.35% versus 34.35%, p = 0.71), as was also the case with the simplified pharmacovigilance tool (33.61% versus 35.59%, p = 0,51).

This tool showed its effectiveness in quantitative terms without loss of quality. It should now developed in professional software and be extended to other regions in France.

Points for discussion:
Best method to increase pharmacovigilance reporting ?

How to conserve this good result in the future ?