Vigilance (Pharmacovigilance)
What the exam tests
The exam tests whether you can take a report from a patient to a validated case, decide expectedness and seriousness, and know which clock starts. It also tests the signal-to-label cycle.
Elements of a report
A valid individual case safety report needs four elements: an identifiable patient, an identifiable reporter, a suspect product and an adverse event. Missing any one makes it invalid and it must be followed up. Standard fields: demographics, suspect and concomitant drugs with dose and dates, reaction with onset and outcome, causality, and seriousness criteria (death, life-threatening, hospitalisation, disability, congenital anomaly, medically important).
Clocks and documents
Companies must operate a pharmacovigilance system with a named responsible person and a pharmacovigilance system master file. Serious unexpected suspected adverse reactions go to the authority within 7 days (fatal or life-threatening) or 15 days (other serious); periodic safety update reports follow defined intervals. The national pharmacovigilance centre collects reports from health professionals and consumers and contributes to the WHO global database.
From signal to action
Disproportionate reporting → signal evaluation (case series, literature, class effects) → risk management plan → label update, restriction or withdrawal.
Worked example
Three reports of severe cutaneous reactions with a newly registered antiepileptic arrive in one quarter. Each case is serious and unexpected, all three go to the authority within 15 days, the company opens a signal, and the warnings section of the label is updated by variation.
Traps
Judging expectedness against clinical experience instead of the reference safety information; late reporting because the case seemed 'not serious in my view'; assuming a consumer report is invalid; forgetting that lack of efficacy and abuse are reportable; treating the PSUR as a marketing document.