Quality-Monitoring of Psychotropic Drug Therapy in Post-Marketing Surveillance

Abstract

I Thanks to their non-intervening nature, post-marketing drug utilization observation (DUO) studies reflect both the properties of the substance under investigation and doctors' treatment decisions, thus - in contrast with clinical trials - allowing the interactions of these two factors to be investigated. A DUO study involving the administration of moclobemide to 9419 patients investigated the prescribing behavior of about two-thirds of all general practitioners and internists in Germany prescribing moclobemide during the study period. The results obtained suggest that, on the whole, moclobemide is being prescribed knowledgeably and correctly for the treatment of the full spectrum of depressive disorders. The management of these patients tended to adhere strictly to existing treatment recommendations while at the same time revealing a certain degree of latitude for treatment optimization. This applies particularly to the utilization of the recommended dosage range, especially in severely depressed states, and the consistent, syndrome-based combination treatment with hypnotics/sedatives or neuroleptics in the respective patient groups indicated. Potential interactions - though comparatively few are known for moclobemide - were taken into account in most cases. The safety profile closely matches the experience gained from clinical trials. Despite the large sample size involved there was no evidence of any hitherto unknown serious events.

The experience gained during this survey suggests that the DUO study is a suitable instrument for monitoring the use of an anti-depressant in the early post-registration period, enabling action to be taken at an early stage to correct any systematic deviations from the conditions of registration.