Dissemination of additional risk minimisation measures for patients and healthcare professionals in EU/EEA countries

Duration: Mar 2025 - Aug 2026

Background

Risk Minimisation Measures (RMM) have been introduced to prevent or reduce the occurrence of adverse reaction from exposure to a medicinal product, or, in case an adverse reaction occurs, to reduce its negative impact. These additional tools are imposed in case routine RMM are insufficient to control risks (Hapani 2022) and have to be put into place. This project described focuses on additional Risk Minimasation Measurs (aRMM) tools and their implementation.

Doel 

The overall objective is to gain in-depth understanding of the current practice of dissemination of aRMM materials for patients and HCPs in clinical practice, including the challenges encountered by stakeholders involved in the dissemination process and their preferences for aRMM tools and how they want to receive them. A secondary objective is to provide recommendations to regulators for regulatory decision-making on aRMM based on patients’ and HCPs’ preferences and needs.

Project design

The study will include the following steps:

1. desk research
2. online interviews with marketing authorization holders (MAH)
3. a focus group with representatives of national competent authorities,
4. online surveys and focus groups among healthcare professionals (HCPs), patient organisations and patients
5. a webinar with representatives from all EU/EEA member states to discuss the results of the study.

For steps 1 to 4 six countries with different healthcare systems will be included: the Netherlands, Finland, Italy, Hungary, Romania and Lithuania.

Result

The results of the project will help inform regulatory decision-making on the selection of aRMM (aRMM) tools and on evaluating their overall effectiveness. The study will be performed by a multidisciplinary team of researchers with extensive experience in international health services research and the methods conducted within the study.