Drug Safety in Psychiatry (AMSP)

Aims of the program

The AMSP-Project (Arzneimittelsicherheit in der Psychiatrie) is a prospective multicenter program for continuous assessment of severe adverse drug reactions (ADR) of marketed psychotropic drugs in psychiatric inpatients under the naturalistic conditions of routine clinical treatment. It corresponds to a dynamic cohort study, in which the cohort - the patient population of the participating clinics - is changing over time. Currently 60 hospitals in Germany, Switzerland and Austria are participating in the AMSP project, monitoring about 30,000 inpatients per year. Severe ADRs are detected by active and regular screening of all participating wards by local drug monitors. They are documented and analysed in a standardised manner in order to permit data collection and retrieval for more in depth analyses. Causality assessments include time correlations, alternative causes, underlying diseases, spontaneous events and knowledge about the same type of ADR. Each severe ADR case, as well as the association between the ADR and pharmacological treatment, is discussed during pharmacovigilance conferences, held several times per year.

To estimate the incidence of all assessed ADRs, all prescriptions of the wards are assessed on two references per year.

This database has existed since 1993, and several studies have been undertaken using pharmacoepidemiological tools to assess cause and effect.

Besides being an efficient pharmacovigilance instrument, the AMSP-Project has turned out to be a valuable quality assurance instrument in as much as it seems to increase the awareness of participating physicians and other health providers of drug safety issues.

Scientific collaborations

Approximately 60 psychiatric clinics from Germany, Austria and Switzerland are currently participating in the AMSP project; the Department of Psychiatry and Psychotherapy at the University of Göttingen is acting as the center of the " Northern Regional Group". The project is in close cooperation with national ("Bundesinstitut für Arzneimittel und Medizinprodukte", BfArM; "Arzneimittelkommissionen der deutschen Ärzteschaft" (AkdÄ)) and international (Austria, Switzerland) governmental institutions and is a member of the "European Network of Centres for Pharmacoepidemiology and Pharmacovigilance" ECsPP under the direction of the "European Medicines Agency" EMA.