영국의 약물 유해사례 감시체계

Drug Adverse Event Monitoring Systems in UK

The thalidomide disaster during the early 1960s produced more than 10,000 deformed babies in the countries in which the drug was widely used. Recently phenyl propoanolamine induced hemorrhagic cerebrovascular disease and rofecoxib induced cardiovascular events were reported. At the time when a new drug is marketed the clinical safety database is very limited and comprises a rather small number of patients. So pharmacologically effective drugs are not entirely without hazard and not all hazards can be known before a drug is marketed. Thus, post-marketing surveillance (PMS) of drugs is imperative to quantify common adverse drug reactions (ADRs) and to identify rare adverse reactions. In the UK there are two unique drug adverse reaction monitoring systems, the Medicine Monitoring Service (MEMO) and Prescription-Event Monitoring (PEM). The MEMO is a university based organization that was set up to carry out studies to detect and quantify serious drug toxicity in the Tayside region of Scotland, using record linkage techniques. The PEM is the form of PMS which prompts all doctors using new drugs intended for widespread use in primary care to report the events which follow their use. It is of importance that the MEMO and PEM data represent the real world use of the newly marketed medicines in the age and sex distribution and with the concurrent medication that typifies everyday practical clinical use of the drug. They generate signals which, through pharmacoepidemiology, can be investigated in order to determine relevant concerns over drug safety. We reviewed MEMO and PEM to inquire into efficient PMS in general population.