[Quality of event data in detection of unwanted drug side-effects in general practice of established physicians].

Since 1986, the Federal Health Office (BGA) has supported the model project "Monitoring Adverse Drug Reactions (ADRs) in the Surgeries of Office-Based Physicians". The project itself is being carried out by the Institute for Health Systems Research in Kiel. The aim of the project is to develop a method for the systematic monitoring of the risks involved with selected new drugs. This should also facilitate the determining of the incidence rate of ADRs as well as reveal as yet unknown ADRs. Several conclusions can be drawn when examining the quality of event data when monitoring ADRs through office-based physicians. The documentation quality of the transferred data fluctuates from surgery to surgery. In order to obtain valid outcomes, the data should be thoroughly examined and checked by consulting the participating surgery. When quantifying known events with a suspected ADR, the Sentinel approach leads to reliable results. When monitoring drug therapies through office-based physicians, risk situations can be monitored and assessed more easily under everyday conditions. When assessing the quality of event data with regard to disclosing hitherto unknown, potential ADRs, the character of the individual surgery is of utmost importance. The object of the research project is to examine cause-effect associations which have nothing whatsoever to do with the participating physicians themselves but which reflect interactions between drugs and patients.