Power and weakness of spontaneous reporting: a probabilistic approach.
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.
Tubert
P
P
I.N.S.E.R.M. U.169, Villejuif, France.
Bégaud
B
B
Péré
J C
JC
Haramburu
F
F
Lellouch
J
J
D016907:Adverse Drug Reaction Reporting Systems; D016903:Drug Monitoring / Q000379:methods*; D004812:Epidemiologic Methods; D006801:Humans; D016012:Poisson Distribution; D012306:Risk