Vigilance (Pharmacovigilance)
What this domain tests
Vigilance tests detection, reporting, assessment and prevention of adverse effects after medicines reach patients.
Core rules and concepts
- Health professionals report suspected adverse drug reactions (ADRs) and adverse events following immunisation (AEFIs) to PPB using the approved reporting system.
- Reports should include patient details, medicine, dose, timing, reaction, outcome and reporter information; completeness improves assessment.
- Causality assessment considers temporality, biological plausibility, dechallenge/rechallenge and alternative causes.
- Signals are reviewed and may lead to label changes, risk-minimisation measures or suspension.
- MA holders have additional duties: periodic safety reports, literature review and risk-management planning.
Worked example
A patient develops angioedema after starting an ACE inhibitor. Reasoning: report the suspected ADR even though the reaction is labelled; the report contributes to frequency and population data. Record timing, dose, outcome and concomitant medicines. Do not wait for proof of causality. The prescriber should be advised to stop the medicine and manage the reaction.
Traps that cost marks
Reporting only unexpected reactions. Waiting for certainty before reporting. Omitting the medicine batch or dates. Failing to follow up an incomplete report. Confusing an ADR with a medication error, although both may need reporting.