The systematic monitoring of authorized drugs (pharmacovigilance) for the occurrence of adverse drug reactions is crucial to detect and minimize risks for patients.

Currently, in Germany pharmacovigilance is exclusively based on a “spontaneous reporting system” organized by the "Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)“ and is subject to a number of limitations. For example, there is the risk of non- or over-reporting of adverse drug reactions.

Therefore, our goal is to establish a pharmacovigilance system that is based on the systematic analysis of routine health insurance data and can be used in addition to the spontaneous reported data. In particular, the focus is on the avoidance of false-positive signals for drug risks, the identification of rare risks and the determination of risk profiles.

We are closely cooperating with the „Leibniz-Institut für Präventionsforschung und Epidemiologie (BIPS)“ in Bremen and the „Wissenschaftliches Institut der Techniker Krankenkasse für Nutzen und Effizienz im Gesundheitswesen (WINEG)“ in Hamburg.

In cooperation with the Department of Pharmacy, the Clinic of Plastic Surgery, Department of Infectious Diseases and Microbiology, Department of Cardiology, Angiology and Intensive Care Medicine we monitor the plasma concentrations of piperacillin during standard piperacillin/tazobactam treatment of burn patients and internal medicine ICU patients, to perform dose optimization by in-silico analyses and to finally prove whether predicted target effects after dose adjustment can be revealed in patients.