Prescription Event Monitoring (PEM) is a non-interventional cohort technique used to study the safety of new drugs in real-world use. It involves collecting data on all clinical events reported after a patient is prescribed a new drug. PEM was first used in the UK and New Zealand to detect adverse drug reactions that were not found in spontaneous reporting. PEM establishes the number of reports of an event as the numerator and the number of exposed patients as the denominator to calculate incidence densities of events during drug treatment. PEM provides estimates of event incidence over a defined follow up period but is limited by non-response rates and potential for confounding factors.
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