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Adverse effects: means of increasing reporting

Effective local initiatives have been set up in several French regions to improve the gathering of reports of adverse effects.

Adverse drug reactions have an impact on patients' quality of life, multiply or prolong hospital stays, and increase mortality. And yet, in France in particular, they are largely under-reported by healthcare professionals.

In 2011, several initiatives seeking to improve the reporting of  adverse effects were carried out and presented by the regional pharmacovigilance centres at the 32nd French pharmacovigilance conference.

The Brest, Rennes and Caen regional pharmacovigilance centres independently conducted studies based on the operational data from hospitals. They compared these with the adverse effects that had been reported to them by healthcare professionals, or with  data from the French pharmacovigilance database. In each case, studying the hospital data provided additional information on adverse effects, going beyond the reports received by  pharmacovigilance centres.

In July 2010 the Toulouse regional pharmacovigilance centre set up a system to allow online reporting of  adverse effects by healthcare professionals. Compared with the cases reported in the traditional manner, the effects reported were of similar seriousness, but the type of adverse effects, the drugs implicated and the type of  healthcare professionals reporting them were different. This method was used in particular by healthcare professionals in private practice. Online reporting makes it easier to gather data and to involve other healthcare professionals, and this initiative ought to be extended to the rest of France.

In the wake of the disaster caused in France by the weight-loss drug Mediator°, it is high time to expand these successful initiatives and to develop an active pharmacovigilance system.

©Prescrire 1 May 2012

"Towards better reporting of adverse drug reactions" Prescrire Int 2012; 21 (126): 128-129. (Pdf, subscribers only).
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