Prescription–Event Monitoring (PEM): The Evolution to the New Modified PEM and its Support of Risk Management

In New Zealand (NZ), prescription–event monitoring (PEM) is used by the Intensive Medicines Monitoring Programme (IMMP) to proactively study selected medicines in postmarketing use. Prospective observational cohort studies are performed, in which nationwide patient cohorts are established from prescription dispensing data and adverse events are solicited from prescribers, primarily by follow-up questionnaires. Additional follow-up methods, including linkage to national datasets, enable identification of adverse events from other sources during this intensive monitoring in NZ. This chapter provides a detailed overview of PEM methods applied by the IMMP, with examples of studies performed since its inception in 1977. The IMMP primarily conducts safety studies to establish rates of adverse events and investigate safety issues, but also conducts drug utilization studies, studies in special populations (pregnant women, children, women using intrauterine devices) and pharmacogenetic studies. Studies are published as research papers and are actively communicated to health professionals in NZ and worldwide. The valuable datasets provide much potential for future development.