Further development, optimization and application of an algorithm for the detection of severe adverse drug reactions on the basis of claims data


Severe adverse drug events/reactions (ADEs/ADRs) pose a serious problem for the patients concerned and for the healthcare system. According to a cohort study from Germany conducted about 20 years ago, about 9.4 out of 10,000 hospital admissions were due to ADRs. The proportion in the group of over 70-year-olds was 20 out of 10,000. However, despite the relevance of this topic, it is currently not possible to monitor the occurrence of severe ADRs nationwide in Germany.
The aim of this project is to evaluate the potential of health insurance claims data to identify and characterize ADR-related hospital admissions. To achieve this goal, an existing algorithm for the identification of ADE/ADR-related hospital admissions will be optimized and further developed.
Two large databases will be used in this project: the German Pharmacoepidemiological Research Database GePaRD (health insurance claims data of approx. 25 million persons) and the ADR database at the Federal Institute for Drugs and Medical Devices (approximately 170,000 ADR-related hospital admissions). In addition to comparative analyses between the databases, the project includes a feasibility study on the linkage of ADR reports from the databases. The project is funded for three years with a total of approx. 347,000 Euros.
If the project is successful, there will be an optimized algorithm for the detection of severe adverse drug reactions based on health insurance claims data by the end of the project. The algorithm will be prepared and documented in such a way that it may also be used as an analytical tool by other users, such as health insurance providers. In this way, the occurrence of severe adverse drug reactions could be monitored continuously and comprehensively in the future. In addition, it will be possible to identify potential starting points to avoid ADR-related hospital admissions, thus increasing patient safety and reducing ADR-related costs.

Funding period

Begin:   April 2020
End:   October 2023


  • The Federal Joint Committee (G-BA)


 Nikolaj Rischke