Unit Drug Safety

The Drug Safety Unit conducts research in the area of prescription drugs and vaccines and their associated risks after approval. Clinical studies prior to the market release of new drugs often do not detect certain risks because they test for a relatively short period of time on a limited patient collective, e.g. mostly excluding children, pregnant women or elderly people. However, rare drug risks can often only be detected in long-term trials with large, heterogeneous populations which include these special patient groups as well as patients with previous and accompanying ailments or co-medications. The identification of drug risks after market approval can lead to warnings, limitations on indications or even a withdrawal from the market.

The Drug Safety Unit covers a wide spectrum of research questions from the area of drug and vaccine safety. This includes different indications as well as different groups of people (e.g. children or elderly people). The researched medications and vaccines range from newly released products (e.g. as part of post-authorisation safety studies or risk management plans required by regulatory authorities) to already established products whose risk profile has mostly not been examined yet. In order to examine specific questions of pharmacoepidemiology on a larger data scale, BIPS cooperates with various European partners in research projects which are funded by the 7th framework programme of the European Union.

During the last decade, research using secondary data resources has become an integral part of pharmacoepidemiology. Pharmacoepidemiological research databases allow the identification of rare risks and rare exposures over long periods of time, thus sustainably enlarging the basis for drug safety research. Since secondary data are not collected for research purposes, their quality and suitability for the respective research questions need to be checked. Therefore the validation of the pharmacoepidemiological research database established at BIPS is another focus of the Drug Safety Unit. This validation includes the verification of the representativeness of the database, the reproduction of correlations and external validation.

The establishment and further development of different pharmacoepidemiological methods is another research focus of the unit. Particularly methods for handling confounders in database studies are tested and developed further in close cooperation with the unit Statistical Methods in Pharmacoepidemiology.