Prescription Event Monitoring (PEM) is an active pharmacovigilance method that tracks safety outcomes associated with prescribed medicines in real-world use.
PEM typically captures adverse events and clinical outcomes after product exposure, often using healthcare records or structured follow-up, to detect safety signals not observed in pre-approval trials. It is especially valuable for identifying rare, delayed, or population-specific risks after broader use. PEM findings can influence labeling updates, risk management strategies, and additional safety studies. Robust PEM supports public health protection and strengthens lifecycle safety oversight.