Biomaterial Database

False-positives in spontaneous reporting: should we worry about them? 1994

B Begaud, and Y Moride, and P Tubert-Bitter, and A Chaslerie, and F Haramburu

Département de Pharmacologie, Université de Bordeaux II, Hôpital Pellegrin, France.

Spontaneous reporting remains the most used and, undoubtedly, the most cost-effective approach for the identification of adverse drug reactions (ADRs). Most of the limitations of this method are well recognised but the possibility of receiving false-positive reports of coincidental drug-event associations has received little attention. In this paper we propose a method based on the Poisson distribution for computing the maximum number of reports of an ADR that could be expected to be reported coincidentally. Three parameters are required: (i) the background risk of the event in the reference population, (ii) the total number of patients treated with the drug considered and, (iii) the proportion of cases that have been reported to the pharmacovigilance system. For most empirical situations occurring in the post-marketing surveillance setting, the expected number remains low and only a maximum of one to three cases could be accepted as possibly coincidental. For rare adverse events such as agranulocytosis or toxic epidermal necrolysis, coincidental associations are so unlikely that a number of reports greater than three constitutes a strong warning and requires further investigation. These findings suggest that for rare events, reports of coincidental drug-event associations are too unlikely to be considered as an important limitation of spontaneous reporting.

UI	MeSH Term	Description	Entries
D008962	Models, Theoretical	Theoretical representations that simulate the behavior or activity of systems, processes, or phenomena. They include the use of mathematical equations, computers, and other electronic equipment.	Experimental Model,Experimental Models,Mathematical Model,Model, Experimental,Models (Theoretical),Models, Experimental,Models, Theoretic,Theoretical Study,Mathematical Models,Model (Theoretical),Model, Mathematical,Model, Theoretical,Models, Mathematical,Studies, Theoretical,Study, Theoretical,Theoretical Model,Theoretical Models,Theoretical Studies
D011336	Probability	The study of chance processes or the relative frequency characterizing a chance process.	Probabilities
D011358	Product Surveillance, Postmarketing	Surveillance of drugs, devices, appliances, etc., for efficacy or adverse effects, after they have been released for general sale.	Drug Surveillance, Postmarketing,Evaluation Studies, Postmarketing,Postmarketing Product Surveillance,Product Surveillance, Post-Marketing,Drug Surveillances, Postmarketing,Evaluation Study, Postmarketing,Post-Marketing Product Surveillance,Post-Marketing Product Surveillances,Postmarketing Drug Surveillance,Postmarketing Drug Surveillances,Postmarketing Evaluation Studies,Postmarketing Evaluation Study,Postmarketing Product Surveillances,Product Surveillance, Post Marketing,Product Surveillances, Post-Marketing,Product Surveillances, Postmarketing,Studies, Postmarketing Evaluation,Study, Postmarketing Evaluation,Surveillance, Post-Marketing Product,Surveillance, Postmarketing Drug,Surveillance, Postmarketing Product,Surveillances, Post-Marketing Product,Surveillances, Postmarketing Drug,Surveillances, Postmarketing Product
D005189	False Positive Reactions	Positive test results in subjects who do not possess the attribute for which the test is conducted. The labeling of healthy persons as diseased when screening in the detection of disease. (Last, A Dictionary of Epidemiology, 2d ed)	False Positive Reaction,Positive Reaction, False,Positive Reactions, False,Reaction, False Positive,Reactions, False Positive
D006801	Humans	Members of the species Homo sapiens.	Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D016012	Poisson Distribution	A distribution function used to describe the occurrence of rare events or to describe the sampling distribution of isolated counts in a continuum of time or space.	Distribution, Poisson
D064420	Drug-Related Side Effects and Adverse Reactions	Disorders that result from the intended use of PHARMACEUTICAL PREPARATIONS. Included in this heading are a broad variety of chemically-induced adverse conditions due to toxicity, DRUG INTERACTIONS, and metabolic effects of pharmaceuticals.	Drug-Related Side Effects and Adverse Reaction,Adverse Drug Event,Adverse Drug Reaction,Drug Side Effects,Drug Toxicity,Side Effects of Drugs,Toxicity, Drug,Adverse Drug Events,Adverse Drug Reactions,Drug Event, Adverse,Drug Events, Adverse,Drug Reaction, Adverse,Drug Reactions, Adverse,Drug Related Side Effects and Adverse Reaction,Drug Related Side Effects and Adverse Reactions,Drug Side Effect,Drug Toxicities,Effects, Drug Side,Reactions, Adverse Drug,Side Effect, Drug,Side Effects, Drug,Toxicities, Drug