Editorial

The issue of drug safety has become increasingly important over the last years, especially for determining the innovative potential of new drugs, their actual usefulness in clinical practice, and the relationship between their costs and benefits. While a differentiated risk-benefit evaluation is now considered relevant for any drug treatment, only a few scientific institutions have initiated systematic studies to assess adverse drug reactions.

In clinical psychopharmacology, however, research on the subject of drug safety has a long-standing tradition. The advent of antidepressants and neuroleptics in the 1950 s was soon accompanied by the description of both their adverse and positive effects in psychiatric therapy. In Germany two drug surveillance programs, first the AMÜP (Arzneimittelüberwachung in der Psychiatrie) and later the AMSP (Arzneimittelsicherheit in der Psychiatry), have assumed the task of assessing the adverse reactions to psychotropic drugs in a systematic way since 1979. Relevant findings were made available to the public in a considerable number of publications, workshops, and symposia.

This supplement issue of ”Pharmacopsychiatry” presents the comprehensive data compiled by these two programs. A description of their development and methodological procedures in comparison to other methods of assessment of adverse drug reactions is followed by an overview of the data from the first period covering 1979 to 1989 as well as the more recent period from 1993 to 2000.

The introduction of new classes of antidepressants and neuroleptics in clinical practice over these past decades has considerably changed treatment strategies. Data from drug surveillance programs over such extended periods of time are particularly useful for observing changes in prescription patterns and establishing the profiles of adverse reactions to newer and older antidepressants and neuroleptics. The data presented in this supplement describe these changes along with their advantages and shortcomings in several articles.

Certain data in this supplement were first presented at a symposium on the occasion of the foundation of the Institute for Drug Safety in Psychiatry (”Institut für Arzneimittelsicherheit in der Psychiatrie, AMSP e. V.”; www.amsp.de) in 2001. The goal of this institute is to establish a solid basis and a network for scientific psychopharmacological research on the subject of drug safety in psychiatry.

The editors wish to express their thanks to all colleagues from the participating hospitals in Germany, Austria and Switzerland, the Drug Commission of the German Medical Association, and the national agency (BfArM) for their long-standing contributions to AMSP and to the preparation of this supplement. We also thank the pharmaceutical companies that have supported the work of AMSP with funds and expertise.

To successfully continue this ambitious project unequalled by any other specialized drug surveillance program in Europe, we will require the continuing effort of all participants and additional financial support of institutions within the national public health system in connection with their quality assurance policies as required by law.

Supplement editors:
Renate Grohmann (Munich)
Bruno Müller-Oerlinghausen (Berlin/Cologne)
Eckart Rüther (Goettingen)