PubMed · 10584596
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L Love, M P Couig. 1999. The MedWatch Program.. https://pubmed.ncbi.nlm.nih.gov/10584596/
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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.
The medical literature is full of associations between drugs and adverse events which have not been proven by epidemiological studies, such as the 30-year-old discussion on levodopa use and the development of melanoma. The organisation of drug safety (pharmacovigilance) by marketing authorisation holders and regulatory authorities relies heavily on voluntary reporting schemes, despite the fact that such schemes suffer from substantial underreporting. Nevertheless, even though marketing authorisation holders are legally responsible for the product, regulatory authorities scarcely oblige them to perform hypothesis-testing epidemiological studies. In view of the importance of drug safety for healthcare and the need for checks and balances, pharmacovigilance should be coordinated by an organisation which is independent from the pharmaceutical industry and regulatory authorities, such as the Dutch Healthcare Inspectorate.
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