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
Sex-related differences may affect both the use and tolerability of psychotropic medications. A better understanding of these differences is important for individualized pharmacological treatment. Using AMSP data, we investigate sex-specific differences in severe adverse drug reactions (ADRs) associated with antidepressants and antipsychotics, as well as differences in the pharmacological treatment of patients with schizophrenia.
Published article:
Seifert et al. (2026). A 24-year pharmacovigilance study on sex differences in adverse drug reactions to antidepressant drugs. Naunyn-Schmiedeberg's Archives of Pharmacology, 399, 7597–7613.
The pharmacological treatment of people with intellectual disabilities poses particular clinical challenges. Establishing treatment indications and assessing efficacy and tolerability can be especially difficult. Using AMSP cross-sectional drug utilization data, we investigate which psychotropic medications are used in people with intellectual disabilities and examine different treatment strategies, particularly monotherapy and combination treatment.
Quetiapine is one of the commonly used antipsychotics and has gained increasing importance in psychiatric care over recent decades. Using AMSP data, we investigate how quetiapine use in routine clinical practice has changed over time. Our focus is on the frequency of use, prescribed dosages, and primary psychiatric diagnoses of patients receiving quetiapine.
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
PD Dr. med. Sermin Toto
Managing Senior Physician, Specialist in Psychiatry and Psychotherapy
Phone: +49 511 532 2403
PD Dr. med. Johanna Seifert
Senior Physician, Specialist in Psychiatry and Psychotherapy
Seifert.Johanna@mh-hannover.de
Secretariat
Marzena Schaefer
Phone: +49 511 532 5565
Fax: +49 511 532 18573