Abstrakt: |
Prescription-event monitoring (PEM) is a term applied to a method of post-marketing surveillance using prospective observational cohort studies of selected individual drugs. The article describes how the method has been developed in New Zealand as the main tool of the Intensive Medicines Monitoring Programme (IMMP). The basic methodology of the IMMP is that of long-term prospective observational cohort studies on selected new drugs, aiming for cohorts of around 10,000 patients. At times PEM is used only in certain regions and the programme then relies on intensified spontaneous reporting for the other regions. |