[Surveillance and assessment of undesirable effects in drug treatment: pilot project]

Since 1986 the Institute for Health Systems Research Kiel has been constructing a system of intensive post marketing surveillance of new drugs by general practitioners. The purpose of the project is to develop a methodology for documenting the applications of new drugs and recording adverse drug reactions (ADR). The primary goal is to quantify adverse drug reactions and to discover previously unknown ADR. Participating physicians record their treatment of the patient and atypical events, which are then analysed for suspected ADR. This paper describes the documentation and evaluation methods and the current stage of research. The validity of the data collected on suspected ADR is evaluated by comparing the results obtained to those of other post marketing studies.