title: Power and weakness of spontaneous reporting: a probabilistic approach.
abstract: It has been clearly demonstrated that spontaneous reporting remains one of the best ways for picking up new adverse drug reactions (ADRs) once a drug is on the market. The probability of revealing a new ADR by spontaneous reporting was studied as a function of reporting rate, strength of drug-event association (relative risk), background incidence of the event and number of patients treated. The model included determination of (i) the probability of reporting at least one drug-event association case and (ii) the overall probability of concluding that the drug-event association is not coincidental. Both probabilities were generally low. The results suggest that the identification of a new risk by spontaneous reporting implies a strong association between the drug treatment and the occurrence of the event.
authors.affiliation: I.N.S.E.R.M. U.169, Villejuif, France.
authors.forename: P
authors.initials: P
authors.lastname: Tubert
authors.forename: B
authors.initials: B
authors.lastname: Bégaud
authors.forename: J C
authors.initials: JC
authors.lastname: Péré
authors.forename: F
authors.initials: F
authors.lastname: Haramburu
authors.forename: J
authors.initials: J
authors.lastname: Lellouch
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems; D016903:Drug Monitoring / Q000379:methods*; D004812:Epidemiologic Methods; D006801:Humans; D016012:Poisson Distribution; D012306:Risk