post-marketing surveillance (PMS)

syn. drug monitoring, pharmacoepidemiology involves the collection of clinical data on marketed medicines, primarily on drug safety (incidence of esp. rare side effects, new hazards, specific risk factors, risk/benefit analysis) but also on unexpected benefits, and their scientific evaluation or cost/benefit aspects, and to evaluate if drugs are prescribed as directed; often the approach is retrospective which might then cause severe bias; surveillance can be “pasive”, i.e. spontaneous reporting of ADRs to National Authority, Event Monitoring, ICSR, or “active/”solicited”“, i.e. as studies by industry or academic institutions (safety follow-up, ph IV, observational st., “sentinel” sites, prescription-event monitoring, …); true PMS technique should tap the results of field use of a medicine without disturbing prescribing decision or patient selection; for marketing, PMS provides therefore information on the performance of the drug in general use, often on the base of automated record linkage rather than in data sheet use, and may be an alternative to megatrials or long-term follow-up; in some EC member states, e.g. Austria, Belgium, France, Germany, Ireland, PMS studies may be a condition of marketing approval (restricted marketing authorisation) and required by health authorities (post-approval research)