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Patient-initiated postmarketing surveillance: a validation study
S Fisher1, S G Bryant, B L Solovitz
1Department of Psychiatry, University of Texas Medical Branch, Galveston 77550.
Journal of Clinical Pharmacology
|November 1, 1987
Summary
A new pharmacy system prompts patients to report drug side effects. This patient-initiated adverse drug reaction (ADR) monitoring complements existing physician-based surveillance, showing promising results.
Area of Science:
- Pharmacovigilance
- Drug Safety
- Public Health
Background:
- Postmarketing surveillance is crucial for monitoring drug safety after market release.
- Existing systems primarily rely on healthcare professionals, potentially missing patient-reported events.
Purpose of the Study:
- To describe and validate a novel patient-initiated, pharmacy-based postmarketing surveillance system.
- To assess the effectiveness of patient self-reporting of adverse drug reactions (ADRs).
Main Methods:
- A prospective study involving 2705 outpatients receiving targeted medications (oral antibiotics, tricyclic antidepressants) who were prompted to report symptoms.
- A control group of 1109 patients was interviewed 2 weeks later without prior prompting.
- Standardized adverse drug reaction interviews were conducted via telephone.
Main Results:
- Patient-initiated reports in the experimental group closely matched those from the control group across both drug classes.
- Both groups reported expected frequencies of common adverse drug reactions.
- The system successfully identified known side effect profiles for oral antibiotics and tricyclic antidepressants.
Conclusions:
- A patient-initiated, pharmacy-based surveillance system is a viable method for detecting adverse drug reactions.
- This system shows potential as a valuable supplement to traditional physician-based pharmacovigilance.
- Empowering patients to report symptoms enhances comprehensive drug safety monitoring.