[DIA Europe 2023] Enablers & Behaviour Adoption For Risk Minimisation

Safe use of medicines is a key objective of pharmacovigilance. However, risk minimisation measures (RMM) have shown to have some limitations in effectiveness. It is hence suggested to study and implement enablers for knowledge and behaviour adoption for risk minimisation in healthcare. Potential enablers may emerge from engagement of patients and healthcare professionals to inform tools and designs of RMM, or from digital health transformation. Regarding engagement, the Pharmacovigilance Risk Assessment Committee (PRAC) at EMA created in 2022 an innovative pilot forum for analysing options for additional RMM together with PRAC members representing patients and healthcare professionals, called the PRAC Risk Minimisation Stakeholder Alliance (PRISMA). This aims at adding knowledge on healthcare systems and processes, as well as informal input to PRAC for their decisions on additional RMM, with a specific focus on their implementability. Also, regarding potential digital support for RMM, EMA has established a multistakeholder drafting group for developing a reflection paper on opportunities and challenges. Likewise, pharmaceutical industry has worked together to provide an overview of the existing experience with digital tools including the perspective from a multi-source/off-patent environment, in order to describe a more effective communication of additional RMM and propose solutions that embrace the advantages of digital health transformation. The potential of above initiatives and the impact on RMM tool selection and design are discussed in this session with a wider multistakeholder audience.