Adverse drug reactions

Abstract

A drug monitoring system was established at psychiatric university hospitals in Berlin, Goettingen and Munich [West Germany] since 1979 in order to investigate adverse reactions to psychotropic drugs. This report describes the system and presents results obtained over 3 yr. Randomly selected patients (504) were observed by intensive drug monitoring; 75% of them had an adverse drug reaction (ADR) during hospitalization that was assessed as possible, probable or definite including all grades (I-III) of severity. Other patients (5096) were monitored by organized spontaneous reporting during treatment with psychotropic drugs; ADR were responsible for drug withdrawal (severity grade III) in .apprx. 10% of them. Parkinsonism, psychomotor disturbance, akathisia, delirium, oversedation and increased transaminases were the most frequent ADR of this kind. The relative frequency of ADR was calculated, and ADR-profiles established for drugs most frequently withdrawn. The impact of ADR on ongoing therapy of patients was assessed. Reliable data obtained by drug monitoring systems can be expected to aid in therapeutic decisions in patients with special risks of side effects to psychotropic drugs.