The AMSP-project: Pharmacovigilance in psychiatry - Presentation, challenges and results

Abstract

For the introduction of novel drugs on the market, a limited number of patients have participated in clinical studies about their efficacy, safety and tolerance. However, many adverse effects and their impact are only revealed after the drug has been described in real life conditions, in comorbid and comedicated patients, in off-label situations or in populations not studied previously. Isolated severe adverse reactions have to be announced spontaneously by the physician to the authorities, but pharmacovigilance projects have the advantage of a more systematic approach. More than 25-years-ago, the Arzneimittelsicherheit in der Psychiatry (AMSP) project on pharmacovigilance in psychiatry was introduced in Germany, and then in Switzerland and in Austria. In 55 psychiatric hospitals, severe adverse effects of psychotropic drugs are continuously assessed; twice in a year, drug prescriptions are recorded [1]. This project has a high educational value in the clinical institutions, and it allows creating an important data base with material for investigations in several fields: Interactions between psychotropic and other drugs and clinical risks, age effect on drug safety, case studies on very rare adverse effects, pharmacoepidemiology on drug prescription habits in different institutions. More than 180 papers related to pharmacovigilance were published reporting original data, and many of them were reviews, articles for continuing education purposes and case reports (2005–2014).

Pharmacovigilance projects such as the AMSP project help to increase the knowledge about clinical properties of drugs and to improve their use in clinical practice [2,3].

Disclosure of interest

Pierre Baumann (mailto:[email protected][email protected]) was or still is a member of national advisory boards of Lundbeck, BMS, Takeda, Janssen, Pfizer. He gets honoraries for teaching activities (co-sponsored continuous education seminars) from most pharmaceutical companies who sell psychotropic drugs in Switzerland. Earlier, most companies sponsored research projects. There is no financial or any other conflict in relationship with this presentation/abstract.