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October 2, 2002

Rates of Spontaneous Reporting of Adverse Drug Reactions in France

Author Affiliations

Stephen J.LurieMD, PhD, Senior EditorIndividualAuthor

JAMA. 2002;288(13):1588. doi:10.1001/jama.288.13.1585

To the Editor: Spontaneous reporting remains the most used and efficient method of identifying new adverse drug reactions (ADRs) in the postmarketing phase.1 We assessed the magnitude of underreporting for serious ADRs in France by using data from 3 field pharmacoepidemiological studies.

The 3 studies we selected for analysis2-4 were published in peer-reviewed journals, conducted in France in 1997 through 1998, and based on a representative sample of the source population. Each study was intended to estimate the number of hospitalizations caused by drugs. Therefore, estimating the magnitude of underreporting was possible by comparing the reported ADRs to the number of cases spontaneously reported to the French pharmacovigilance system during the same period and within the same territory.