GUIDELINES REQUIRED BY LAW FOR THE MANAGE MENT OF COMPLAINTS OF SIDE-EFFECTS OF BLOOD COMPONENTS

Objective: To prevent dangers to health resulting from the application of drugs, the legislator requires the central registration and evalua tion of all drug risks, especially of side effects and reciprocal effe cts. Since 1988 pharmaceutical enterprises have had to denominate a qu alified person ('Stufenplanbeauftragter') who is responsible for the f ulfilment of obligatory reporting. In case of complaints or side effec ts he has to take suitable measures according to a special plan ('Stuf enplan'). Data Sources: The basis of this survey are the legal require ments for drugs ('Arzneimittelgesetz') and supplementary regulations w hich define the duties of the 'Stufenplanbeauftragter' Results: Blood components are subject to the legal requirements ('Arzneimittelgesetz' ) without reservations. Therefore the corresponding regulations have t o be applied without modification in institutes for transfusion medici ne. In this article the tasks of the 'Stufenplanbeauftragter' are summ arized and practical experience of a university institute for transfus ion medicine is presented. Conclusions: In connection with the transmi ssion of viral infectious diseases it became evident that the 'Stufenp lanbeauftragter' is very important for the initiation of effective mea sures in case of serious side effects. The security of blood component s could be improved by the realization of the corresponding legal requ irements in the institutes for transfusion medicine.