Deutsche Version

Background

The number of patients investigated in clinical trials prior to the marketing approval of a drug is limited and may not sufficiently reflect everyday clinical practice due to the artificial setting of such trials. The post-marketing surveillance of a drug is therefore of particular importance.

According to the definition of the World Health Organization (WHO), pharmacovigilance comprises the analysis and prevention of drug risks and the development of activities that serve to discover, evaluate, understand, and prevent adverse drug reactions (ADRs). The detection and analysis of serious ADRs and their prevention are therefore also part of „culture of error" in hospitals.

Aims of the research group

The primary aim of the AMSP-Project (Arzneimittelsicherheit in der Psychiatrie) is the continuous improvement of drug safety within psychopharmacology. Currently more than 50 hospitals in Germany, Switzerland and Austria are participating in the AMSP project and collect severe adverse drug reactions (ADR) occurring under treatment with psychotropic drugs (non-interventional).

After their detection, ADRs are further analyzed and causality is established.  Incidence rates of ADRs and specific risk-benefit assessment for subclasses of psychotropic drugs as well as individual drugs are determined and compared with one another.

Main focus points are the relevance of drug-drug-interactions, at-risk drug combinations, polypharmacy, relevant patient-related variables (age, gender), and pharmacogenetics (polymorphisms) within psychopharmacological treatment.

Further, the AMSP project is designed to inform about clinically relevant and/or new ADRs. Surveillance of drug therapy in psychiatry is an integral part of quality assurance in the treatment of patients but also as part of clinical risk management. Drug safety should be considered a cornerstone of extensive patient safety.

Current projects

Scientific collaboration

The AMSP project currently involves > 50 psychiatric clinics from Germany, Austria and Switzerland. The Department of Psychiatry, Social Psychiatry and Psychotherapy of MHH is headquarters of the AMSP in intensive cooperation with Ludwig Maximilian University of Munich and part of AMSP’s  "Regional Group North". The project is in close cooperation with state institutions at national and international levels (e.g. with the Federal Institute for Medicinal Products and Medical Devices, BfArM; the Medicines Commission of the German Medical Association (AkdÄ)) and is a member of the "European Network of Centres for Pharmacoepidemiology and Pharmacovigilance" ECsPP under the direction of the "European Medicines Agency" EMA.

 

Special cooperation partners

  • Department of Psychiatry and Psychotherapy, LMU Munich (Dr. R. Grohmann, Prof. E. Rüther,)
  • Department of Psychiatry and Psychotherapy, UMG Göttingen (Prof. D. Degner)
  • Institute for Clinical Pharmacology, MHH Hannover (Prof. D. O. Stichtenoth, Dr. J. Heck)

AMSP Homepage

For more information about AMSP eV., see here.

Research group members

Research group leader

Prof. Dr. med. Stefan Bleich

Director of the Department of Psychiatry, Social Psychiatry and Psychotherapy

First chairman of AMSP

Phone: +49 511 532 6748

bleich.stefan@mh-hannover.de

 

Dr. med. Sermin Toto

Managing Senior Physician, Specialist in Psychiatry and Psychotherapy

Phone: +49 511 532 2403

toto.sermin@mh-hannover.de

 

Sekretariat

Marzena Schaefer

Phone: +49 511 532 5565

Fax: +49 511 532 18573

schaefer.marzena@mh-hannover.de