Challenges in the Implementation of EU Risk Minimisation Measures for Medicinal Products in Clinical Practice Guidelines: Mixed Methods Multi-Case Study
The inclusion of RMM information in relevant CPGs is remarkably limited. It may be explained by characteristics of CPGs and of RMMs as well as lack of connection between national regulators and organisations and authors developing CPGs. More collaboration between stakeholders, national regulators and the EMA may advance implementation.
Authors
- Ana Marta Silva (ORCID: https://orcid.org/0000-0003-2355-2310)
- Elita Poplavska (ORCID: https://orcid.org/0000-0002-9649-2120)
- Mathias Møllebæk (ORCID: https://orcid.org/0000-0001-9960-9024)
- Inês Ribeiro‐Vaz (ORCID: https://orcid.org/0000-0002-3442-8158)
- Teresa Leonardo Alves (ORCID: https://orcid.org/0000-0003-4967-1916)
- Fariba Ahmadizar (ORCID: https://orcid.org/0000-0002-6261-9445)
- Ieva Rutkovska (ORCID: https://orcid.org/0000-0003-4522-1803)
- Alexia Bikou (ORCID: https://orcid.org/0000-0003-1211-9124)
- Christos Kontogiorgis (ORCID: https://orcid.org/0000-0001-7835-8246)
- Ana Kodrič (ORCID: https://orcid.org/0000-0003-4033-3451)
- Mitja Kos (ORCID: https://orcid.org/0000-0002-6801-6450)
- Renske J. Grupstra (ORCID: https://orcid.org/0009-0004-8598-6936)
- Helga Gardarsdóttir (ORCID: https://orcid.org/0000-0001-5623-9684)
- Anna Birna Almarsdóttir (ORCID: https://orcid.org/0000-0002-5354-2976)
- Foteini Dermiki‐Gkana
- Armin Andersen (ORCID: https://orcid.org/0009-0004-9713-4407)
- Paula Barão
Institutions
- University of Copenhagen (DK)
- University of Lisbon (PT)
- Democritus University of Thrace (GR)
- University of Ljubljana (SI)
- University of Iceland (IS)
- Universidade do Porto (PT)
- Utrecht University (NL)
- University Medical Center Utrecht (NL)
- National Institute for Public Health and the Environment (NL)
- Riga Stradiņš University (LV)
Publication Details
- Journal
- Drug Safety
- Published
- 2024-11-21
- DOI
- https://doi.org/10.1007/s40264-024-01487-5
- Citations
- 4
- Primary Topic
- Health Systems, Economic Evaluations, Quality of Life
- Type
- article
- Field-Weighted Citation Impact
- 4.52
Funders
- Københavns Universitet
- European Medicines Agency