Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Risk minimisation measures in the pharmaceutical industry – a review of the handling of Direct Healthcare Professional Communication (DHPC) and Educational Material (EM) in Germany, Austria and Switzerland ***

Katharina Dupont (Abschlußjahr: 2024)

Summary
Language: English
Additional risk minimisation measures have the aim to reduce the potential risk for the patients during the use of the medicinal product. EMA provides basic guidelines for the creation and dissemination of direct healthcare professional information (DHPC) and educational material (EM), however the implementation of additional risk minimisation measures respectively the risk communication via DHPCs take place at a national level. Germany, Austria and Switzerland follow the EMA principles of the creation of DHPCs, however the final dissemination to the healthcare professionals shows some differences at national level. All three countries publish the DHPCs on the respective website of the responsible competent authority, although the dissemination in Austria and Switzerland is mainly still done in paper form. Only Germany has at current timepoint made a further step to a faster and more efficient distribution of DHPCs and EM. Software providers offer solutions to make DHPCs and EM electronically available for healthcare professionals. This is a necessary step for increased transparency and faster distribution to the respective recipients. Moreover, there is a close collaboration between associations and the respective MAHs in Germany for the creation and dissemination of (joint) DHPCs/(joint) EM. In Austria and Switzerland, educational material is not made publicly available on the authority website, however the MAH has the possibility to publish the educational material on its company website. Currently, no guidance for the creation and dissemination of EM is being provided by the Swiss competent authority. This is a challenging situation especially for pharmaceutical companies, as they have no guidance on the creation of EM and no review process and approval is currently in place with the Swiss competent authority. Problematic is that information provided via EM and DHPCs does often not reach the patients as the materials are not clearly labeled with a blue or respectively red hand logo as in Germany and Austria. Measures in Switzerland are being proposed to enhance the handling of DHPC and EM. Focus is made on an improved creation and dissemination process of educational material for generic medicinal products in Switzerland. The proposed measures might give more clarity and structure that lead finally to more transparency for patients and healthcare professionals in Switzerland.
Pages: 64
Annexes: 2, Pages: 5