Title
On the assessment of adverse drug reactions from spontaneous reporting systems: The influence of under-reporting on odds ratios
Author
van der Heijden, P.G.M.
van Puijenbroek, E.P.
van Buuren, S.
van der Hofstede, J.W.
Publication year
2002
Abstract
A well-known problem in spontaneous reporting systems (SRSs) for adverse drug reactions (ADRs) is under-reporting, that is, the problem that not all occurrences of ADRs are reported to the SRS. We look at the question of how to draw statistical conclusions from analyses of SRS data using reporting odds ratios. We will show that certain under-reporting problems play no role in assessing ADRS from SRSs: the results from the analyses turn out to be biased by some specific under-reporting problems, but not by others. SRS data can be particularly useful for the assessment of drug-drug interactions. If the assumption holds that there is an under-reporting problem for a first drug, and an under-reporting problem for a second drug, but that these two under-reporting problems do not influence each other, then reporting odds ratios estimated from SRSs are useful for signalling drug-drug interactions in the ADR-experiencing population. Similar results hold for covariate-drug interactions. We illustrate our results using two examples. Copyright © 2002 John Wiley & Sons, Ltd.
Subject
Health
Pharmacovigilance
Spontaneous reporting system
Under-reporting
Antifungal agent
Antineoplastic agent
Diclofenac
Diuretic agent
Nonsteroid antiinflammatory agent
Terbinafine
Congestive heart failure
Controlled study
Covariance
Drug hypersensitivity
Drug potentiation
Drug surveillance program
Hair loss
Information processing
Risk assessment
Sex difference
Adverse Drug Reaction Reporting Systems
Anaphylaxis
Anti-Inflammatory Agents, Non-Steroidal
Diclofenac
Diuretics
Drug Interactions
Female
Heart Failure, Congestive
Humans
Male
Middle Aged
Odds Ratio
Product Surveillance, Postmarketing
Sex Factors
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http://resolver.tudelft.nl/uuid:b76dabb9-02dc-42d5-8ab5-ac49530956df
DOI
https://doi.org/10.1002/sim.1157
TNO identifier
236615
ISSN
0277-6715
Source
Statistics in Medicine, 21 (14), 2027-2044
Document type
article