AMSP Methods and Results on Severe ADR due to Antipsychotics

The AMSP (Arzneimittelsicherheit in der Psychiatry) study is a drug safety program that ensures the continuous assessment of severe adverse drug reactions (ADR) in psychiatric inpatients under the natural conditions of routine clinical treatment. Currently 45 hospitals participate in the study. The methods of the AMSP are described, including detailed definitions of ADRs assessed to be „severe“, and the implications of these definitions and the methodological approach for evaluating the AMSP data are discussed.

Until the end of 2000, 86,439 patients treated with at least one neuroleptic agent were monitored. In 1.1% of the patients severe ADR occurred. In contrast to the results from controlled trials, ‘atypical’ neuroleptics caused more severe ADR than ‘typical’ neuroleptics. This result was mainly caused by the high amount of severe ADR in patients treated with clozapine. ‘Atypical’ neuroleptics were found to be superior in EPS and urological ADR. Excluding the data on clozapine, we found ‘typical’ and ‘atypical’ neuroleptics to be similar in the occurrence of severe ADR, although the profiles differ between these two groups as well as between the single substances.

In addition, recent data on neuroleptics acquired in the AMSP program from 2001–2003 are analysed.

The AMSP data provide valuable information on type and frequency of ADR in psychiatric practice thus enabling differential indication of neuroleptics not only based on the efficacy and tolerability data of controlled trials but also on their differential ADR profile occurring in the ‘real life’ setting of routine clinical treatment.