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The AMSP-Project (Arzneimittelsicherheit in der Psychiatrie) is a prospective multicenter program for continuous assessment of ADRs of marketed psychotropic drugs in psychiatric inpatients under naturalistic conditions of routine clinical treatment. It corresponds to a dynamic cohort study meaning the cohort the patient population of the participating clinics is changing over time. Currently 60 hospitals in Germany, Switzerland, Austria, Belgium and Hungary 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, to allow easy 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, and the association between ADR and pharmacological treatment, is discussed during pharmacovigilance conferences, held several times per year.

AMSP (Arzneimittelsicherheit in der Psychiatrie) as a model for a pharmacovigilance system for psychiatric inpatient populations