Power and weakness of spontaneous reporting: A probabilistic approach

• Published in: Journal of clinical epidemiology Vol. 45; no. 3; pp. 283 - 286
• Main Authors: Tubert, Pascale, Bégaud, Bernard, Péré, Jean-Charles, Haramburu, Françoise, Lellouch, Joseph
• Format: Journal Article
• Language: English
• Published: New York, NY Elsevier Inc 01.03.1992; Elsevier
• Subjects: Adverse Drug Reaction Reporting Systems; Biological and medical sciences; Detection Underreporting; Drug Monitoring - methods; Epidemiologic Methods; Health and social institutions; Humans; Medical sciences; Pharmaceutical industries; Pharmacoepidemiology; Pharmacovigilance; Poisson Distribution; Poisson model; Public health. Hygiene; Public health. Hygiene-occupational medicine; Risk; Spontaneous reporting; France; Europe; Pharmacoepidemiology; Detection Underreporting; Poisson model; Pharmacovigilance; Spontaneous reporting; Drug; Statistical analysis; Information communication; Report; Toxicity; Spontaneous; Probabilistic model; Drug monitoring; Poisson distribution; Public health
• ISSN: 0895-4356; 1878-5921
• DOI: 10.1016/0895-4356(92)90088-5

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.