Adverse Drug Reactions, Pharmacovigilance, and Patient Safety
What the exam tests
This domain tests recognition and reporting of adverse drug reactions (ADRs), vaccine events, medication errors, and product quality defects. You should know what to report, how to assess seriousness, and how to document without blaming the patient.
Core rules
- An ADR is a harmful, unintended response to a medicine at normal doses. A medication error is a preventable failure in the treatment process; both can coexist.
- Report suspected serious, unexpected, new, or life-threatening reactions, including those to vaccines and traditional products. Do not wait for certainty of causation.
- Seriousness usually includes death, hospitalisation or prolongation, disability, congenital anomaly, or a life-threatening event. “Severe” symptoms are not automatically “serious” in the regulatory sense.
- Use the national ADR reporting form or system. Record patient details, medicine, dose, batch, timing, reaction, outcome, and reporter contact. Keep confidentiality.
- Causality tools such as WHO-UMC categories help structure assessment, but reporting does not require a proven causal link.
Worked example
A patient develops a widespread rash and facial swelling two days after starting a new antibiotic. This is potentially serious and unexpected. Stop further doses, refer for urgent medical care, and report the suspected ADR with the drug name, batch if available, onset, and outcome. Do not decide that “antibiotics often cause rash” and skip reporting.
Traps that cost marks
Reporting only when causation is certain; confusing severity with seriousness; omitting the batch number or timing; failing to report traditional or vaccine products; and discussing the case outside the reporting system.