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Differences in perceived and presented adverse drug reactions in general practice
J P Ottervanger1, H A Valkenburg, D E Grobbee
1Netherlands Centre for Monitoring of Adverse Reaction to Drugs, Rijswijk.
Journal of Clinical Epidemiology
|September 10, 1998
Summary
Patients report more suspected adverse drug reactions than their general practitioners (GPs) register. Postmarketing surveillance studies relying solely on GP data may underestimate adverse reaction incidence. Direct patient reporting via questionnaires offers valuable insights.
Area of Science:
- Pharmacovigilance
- Clinical Research
- Drug Safety
Background:
- Postmarketing surveillance (PMS) often relies on general practitioner (GP) data.
- Patients may not report all suspected adverse drug reactions to their GPs.
Purpose of the Study:
- To compare adverse drug reaction reporting between GPs and patients for sumatriptan.
- To assess the utility of patient questionnaires in postmarketing surveillance.
Main Methods:
- A postmarketing cohort study involving drug-dispensing GPs and their sumatriptan patients in The Netherlands.
- Anonymous questionnaires were sent to both GPs and patients to report suspected adverse reactions without prompting specific events.
Main Results:
- High response rates from both GPs (86%) and patients (70%).
- Patients reported significantly higher frequencies of suspected adverse reactions (e.g., paresthesia, dizziness) compared to GPs.
- No serious adverse reactions were reported by either group.
Conclusions:
- Patient reporting significantly exceeds GP registration of adverse drug reactions.
- GP-based postmarketing surveillance may underestimate the true incidence of adverse drug reactions.
- Direct patient questionnaires are a valuable method for gathering additional pharmacovigilance data.