Medizinische Hochschule Hannover : AMSP_Research Group Drug Safety in Psychiatry

Drug Safety in Psychiatry (AMSP)

Research group leaders: Prof. Dr. Stefan Bleich, PD Dr. med. Sermin Toto

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

Research project 1

Psychopharmacotherapy during the COVID-19 pandemic

The current severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic has affected nearly all aspects of medical care and daily living. This also applies to psychopharmacotherapy. In a recent publication in a German journal for neurology and psychiatry (“Der Nervenarzt”), we presented multiple aspects of psychopharmacotherapy, which are especially important to bear in mind due to the higher risk of infection. Among other aspects, we have made recommendations for the treatment initiation of clozapine. Further, we discussed potential interactions such as an increased risk for thromboembolic events, changes in drug metabolism via the cytochrome P450 system, and respiratory depression.

Resulting publication:

Seifert J, Heck J, Eckermann G, Singer M, Bleich S, Grohmann R, Toto S. Psychopharmakotherapie in Zeiten der COVID-19-Pandemie [Psychopharmacotherapy during the COVID-19 pandemic]. Nervenarzt. 2020 Jul;91(7):604-610. PMID: 32488413; PMCID: PMC7265158. DOI

Research project 2

Antipsychotic drug-induced liver injury

Drug-induced liver injury (DILI) can result in severe consequences for patients. Understanding which drugs carry an increased risk for causing DILI is of pivotal importance because psychiatric patients often display other risk factors for liver injury (i.e. substance misuse/abuse, unhealthy lifestyle). A paper analyzing individual antipsychotic drugs attempts to better assess the risk of DILI in psychopharmacotherapy.

Resulting publication:

Druschky K, Toto S, Bleich S, Baumgärtner J, Engel RR, Grohmann R, Maier HB, Neyazi A, Rudolph YJ, Rüther E, Schwörer H, Seifert J, Stübner S, Degner D. Severe drug-induced liver injury in patients under treatment with antipsychotic drugs: data from the AMSP study. World J Biol Psychiatry. 2020 Sep 7:1-29. PMID: 32892689. DOI

Research project 3

Psychopharmacotherapy of depression. Trends by time, gender, and symptom severity

Major depressive disorder (MDD) is one of the most common psychiatric conditions. Psychopharmacotherapy, comprising not only antidepressant drugs, represents one commonly applied treatment strategy. Researchers from MHH are currently analyzing psychotropic drug treatment of patients with MDD and hereby taking multiple aspects into consideration, for example genders differences and time trends over a 17-year period in psychotropic drug treatment of psychiatric inpatients with MDD.

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)