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Letters | October 2, 2002

Rates of Spontaneous Reporting of Adverse Drug Reactions in France

Bernard Bégaud, MD, PhD; Karin Martin, PharmD, MPH; Françoise Haramburu, MD, MPH; Nicholas Moore, MD, PhD

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

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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.

Rossi ACKnapp DEAnello C et al. Discovery of adverse drug reactions: a comparison of selected phase IV studies with spontaneous reporting methods. JAMA. 1983;249:2226-2228.

Lacoste-Roussillon CPouyanne PHaramburu FMiremont GBégaud B Incidence of adverse drug reactions in general practice: a prospective study. Clin Pharmacol Ther. 2001;69:458-462.

Imbs JPouyanne PHaramburu F et al. Adverse drug reactions: prevalence in French public hospitals. Therapie. 1999;52:21-27.

Pouyanne PHaramburu FImbs JLBégaud B Admissions to hospital caused by adverse drug reactions: a cross-sectional incidence study: French pharmacovigilance centres. BMJ. 2000;320:1036.

Eland IABelton KJVan Grootheest ACMeiners APRawlins MDStricker BH Attitudinal survey of voluntary reporting of adverse drug reactions. Br J Clin Pharmacol. 1999;48:623-627.

National Pharmacovigilance Systems, Country Profiles and Overview. 2nd ed. Uppsala, Sweden: Uppsala Monitoring Centre; 1999.

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Bégaud B, Martin K, Haramburu F, Moore N. Rates of Spontaneous Reporting of Adverse Drug Reactions in France. JAMA. 2002;288(13):1588. doi:10.1001/jama.288.13.1585.

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