Vigilance (Pharmacovigilance)
Vigilance tests the detection, reporting and follow-up of adverse drug reactions (ADRs) and other medicine-related safety problems after marketing.
PV duties and timelines
Healthcare professionals and marketing authorisation holders should report suspected ADRs, especially serious or unexpected reactions, to PPB through its reporting channels. Under PPB pharmacovigilance guidance, expedited reports are generally due within 7 calendar days for fatal or life-threatening reactions and 15 calendar days for other serious unexpected reactions; follow-up information is submitted when available. Reports should identify the patient (anonymised), medicine, batch, dose, dates, reaction, outcome, causality and concomitant medicines. Seriousness is not the same as severity: a non-severe reaction can still be serious if it causes hospitalisation or disability. Marketing authorisation holders also prepare periodic safety reports, risk management plans and signal assessments.
Worked example
A patient develops Stevens-Johnson syndrome after starting carbamazepine. The reaction is serious and potentially life-threatening. The clinician stops the suspected medicine, provides urgent care and reports to PPB within the expedited timeline, even though the reaction is already known. The reason is that reporting frequency, batch and population data can reveal a signal or a quality problem; waiting for certainty is unsafe.
Traps that cost marks
- Reporting only reactions to newly marketed medicines.
- Waiting for confirmed causality before reporting.
- Missing the 7-day or 15-day expedited timelines.
- Omitting batch number, dates or concomitant medicines.
- Failing to follow up or document the outcome.
- Not counselling patients about when to seek help.