gms | German Medical Science

30. Jahrestagung der Gesellschaft für Arzneimittelanwendungsforschung und Arzneimittelepidemiologie (GAA)

Gesellschaft für Arzneimittelanwendungsforschung und Arzneimittelepidemiologie

09.11. - 10.11.2023, Köln

Medical drug expertise assessments in the Quality Assurance in the Medical Advisory Service Institutions in Germany

Qualitätssicherung für die Arzneimittelgutachten in den regionalen Medizinischen Diensten in Deutschland

Meeting Abstract

Gesellschaft für Arzneimittelanwendungsforschung und Arzneimittelepidemiologie e.V. (GAA). 30. Jahrestagung der Gesellschaft für Arzneimittelanwendungsforschung und Arzneimittelepidemiologie. Köln, 09.-10.11.2023. Düsseldorf: German Medical Science GMS Publishing House; 2023. Doc23gaa20

doi: 10.3205/23gaa20, urn:nbn:de:0183-23gaa204

Published: November 7, 2023

© 2023 Ries et al.
This is an Open Access article distributed under the terms of the Creative Commons Attribution 4.0 License. See license information at



Background: Medical expertise assessments for German in- and out-patient care performed by the Regional Medical Advisory Service Institutions have to accomplish a nationwide quality assurance plan, since public quality reporting became mandatory by national law in 2024. To err is human and occurs among medical experts, as well. Our aim is to establish a continuous mutual learning situation within a benchmark framework for a nationwide quality assurance plan covering all medical expertise assessments performed by the Medical Service Institution. This year, drug treatment reports were included as a new module in the nationwide quality assurance plan.

Materials and methods: In the German Health Care system, medical health care expertise is provided by the 15 Regional Medical Advisory Service Institutions (MD) established by the social code (SGB, Sozialgesetzbuch). All workflows are completely digitalized using mathematical IT-based procedures for randomized sampling and for an equal distribution of the medical expertise assessments to be reviewed. Our technical framework for peer review distribution, data collection and final result analysis includes a completely IT-based workflow not only masking the origin of the medical expertise assessments discussed, but routing the peer review processes in a way that independent and impartial review sheets are produced by peers that were previously not yet involved in the reviewing process. By January 2023, the rollout of the new quality assurance plan was accomplished by including new and unconventional diagnostic and therapeutic methods or medical devices, drug prescription and drug treatment. Using 19 quality criteria, the experts decide which output type in the range ‘correct’, ‘improvement potential’ and ‘incorrect’ is given.

Results: By the end of September 2024, 660 Medical expertise assessments by the Regional Medical Advisory Service Institutions and 280 external cross-over assessments performed by one of the other 14 Medical Advisory Service Institutions were available. The largest proportion of assessments concerned the off-label use of drugs, followed by new and unconventional diagnostic and therapeutic methods or medical devices and then by reviews of medical cannabinoids. A topic point of view is the comparison of the internal and the external evaluation of the expertise assessments of an MD, whereby the different quality of the expertise assessments is mainly considered. The external review is a representative mix of all other MDs over a sufficiently long period of time so that a moderate severity of the assessment is applied. There were only 2.7% extreme differences between the ‘correct’ and the ‘incorrect’ rating results.

Conclusion: The results of quality assurance will be published in great detail in accordance with the recently adopted statistics guideline. We present a valuable tool creating maximum transparency of the quality assurance outcomes and at the same time founded on positive criticism without blaming individual Institutions or individual medical experts participating. We hope that this powerful tool will ease the improvement processes. This is achieved by an insightful self-assessment and benchmarking fostering a mindful dialogue within the 15 Medical Advisory Institutions involved. Consensus-conferences are meant to be a very satisfactory and efficient quality assurance tool to ascertain high quality in the peer review process.


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