- Pharmacovigilance monitors, detects, and prevents adverse drug effects to ensure safe and effective medicine use.
- Once a drug is on the market, it’s still under continuous surveillance through pharmacovigilance.
Definition of Pharmacovigilance:
- It is the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or other drug-related problems.
Key Activities:
- Collection of adverse drug reaction (ADR) reports.
- Signal detection: Identifying patterns or trends in reported ADRs.
- Risk assessment and risk minimization strategies.
- Updating drug labels and warnings.
- Issuing safety alerts and recalls if necessary.
Why It’s Important:
- Some side effects are too rare to be detected in trials.
- Long-term or population-specific effects (e.g., in pregnant women) may not be evident until wide use.
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