Use of routine data for pharmacovigilance in Germany: Method development and initial applications

Description

Adverse drug events are one of the most frequent causes of death. There are market withdrawals for pharmaceutical products from time to time, because severe side effects were not recognized before approval. The pharmacovigilance systematically monitors drug safety after approval to identify these risks. Physicians and patients report adverse drug events to a spontaneous reporting system. However, this data is only of limited use to identify potential safety risks. Furthermore, little is known about the current health of the patients concerned.

The main focus of the project is to develop innovative statistical methods for the identification of adverse drug events by exploiting analogies from statistical methods typically used in genetic epidemiology. The novel methods shall be applied to research questions in drug safety research to (1) avoid false-positive signals for drug risks, (2) identify rare drug risks, and (3) identify risk profiles of patients. The suitability of the newly developed methods will also be examined in a research study on new oral anticoagulants (NOAKs) in collaboration with the department Clinical Epidemiology. The German Pharmacoepidemiological Research Database (GePaRD), a long-term database that allows for the identification of rare risks of these substances in clinical practice, serves as data basis for these tasks. The project also aims to provide the developed tools in such a way that they can be easily adapted to other groups of drugs in the future.

The research project is led by BIPS in collaboration with Techniker Krankenkasse (TK) and IPT (Institute of Experimental and Clinical Pharmacology and Toxicology).