Pharmacovigilance

Clinical description

• Pharmacovigilance: detect, assess, understand and prevention of adverse effects or any other

drug related problems.

• Adverse drug reactions (ADRs) can be detected by either a patient, guardian or health worker.
• Report all suspected ADRs (minor or serious) to the National Pharmacovigilance Centre within

48 hours using standardized reporting tools: Fill the ADR Reporting Form (Version 1.1) and submit details via the Medsafe-360 USSD platform.

• Serious ADRs (e.g., death) must be reported within 24 hours.

o Death; life-threatening; disability; hospitalization/prolonged hospitalization;

congenital anomaly; or any other important medical event.

• The Pharmacovigilance Centre is based at the Pharmacy and Medicines Regulatory Authority

(PMRA). PMRA is in charge of collecting, follow-up and aggregation of ADR reports.