[The legally required guidelines for reporting risks or side-effects caused by blood components].

Abstract

Objective: To prevent dangers to health resulting from the application of drugs, the legislator requires the central registration and evaluation of all drug risks, especially of side effects and reciprocal effects. Since 1988 pharmaceutical enterprises have had to denominate a qualified person ('Stufenplanbeauftragter') who is responsible for the fulfilment of obligatory reporting. In case of complaints or side effects he has to take suitable measures according to a special plan ('Stufenplan').

Data sources: The basis of this survey are the legal requirements for drugs ('Arzneimittelgesetz') and supplementary regulations which define the duties of the 'Stufenplanbeauftragter'.

Results: Blood components are subject to the legal requirements ('Arzneimittelgesetz') without reservations. Therefore the corresponding regulations have to be applied without modification in institutes for transfusion medicine. In this article the tasks of the 'Stufenplanbeauftragter' are summarized and practical experience of a university institute for transfusion medicine is presented.

Conclusions: In connection with the transmission of viral infectious diseases it became evident that the 'Stufenplanbeauftragter' is very important for the initiation of effective measures in case of serious side effects. The security of blood components could be improved by the realization of the corresponding legal requirements in the institutes for transfusion medicine.