Pharmacopsychiatry 2004; 37: 12-15
DOI: 10.1055/s-2004-815506
Original Paper
© Georg Thieme Verlag Stuttgart · New York

Research Methods in Drug Surveillance

R. R. Engel1 , R. Grohmann1 , E. Rüther2 , H. Hippius1
  • 1Department of Psychiatry, Ludwig-Maximilians University, Munich, Germany
  • 2Department of Psychiatry, Georg-August University of Goettingen, Germany
Further Information

Publication History

Publication Date:
30 March 2004 (online)

Adverse drug reactions must be monitored, beginning with the development of a new drug, and continuing throughout its complete life cycle. During these various stages, different methods are necessary. This paper describes the advantages and disadvantages of common methods of collecting data on adverse drug reactions after a drug has been approved. We then concentrate on two drug surveillance projects, the Prescription Event Monitoring (PEM) of the Drug Surveillance Research Unit and the AMSP Project (”Arzneimittelsicherheit in der Psychiatrie”, Drug Safety in Psychiatry). AMSP is compared to cohort studies and spontaneous reporting systems on the one hand, and the specialised PEM project, on the other. The possible influence of various sources of bias is critically analysed.

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Rolf R. Engel

Psychiatric Hospital

University of Munich

Nussbaumstr. 7

D-80336 Muenchen

Germany

Phone: +49.89.51605561

Fax: +49.89.51605562

Email: Rolf.Engel@med.uni-muenchen.de