Challenges in the Implementation of EU Risk Minimisation Measures for Medicinal Products in Clinical Practice Guidelines: Mixed Methods Multi-Case Study

Mathias Møllebæk (), Helga Gardarsdottir, Alexia-Georgia Bikou, Ana Kodrič, Ana Marta Silva, Armin Andersen, Christos Kontogiorgis, Elita Poplavska, Fariba Ahmadizar, Foteini Dermiki-Gkana, Ieva Rutkovska, Inês Ribeiro Vaz, Mitja Kos, Paula Barão, Renske Grupstra, Teresa Leonardo Alves and Anna Birna Almarsdóttir
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Mathias Møllebæk: Copenhagen Centre for Regulatory Science, University of Copenhagen
Helga Gardarsdottir: University Medical Center, Utrecht University
Alexia-Georgia Bikou: Democritus University of Thrace
Ana Kodrič: University of Ljubljana
Ana Marta Silva: University of Porto
Armin Andersen: University of Copenhagen
Christos Kontogiorgis: Democritus University of Thrace
Elita Poplavska: Riga Stradins University
Fariba Ahmadizar: UMC Utrecht
Foteini Dermiki-Gkana: Democritus University of Thrace
Ieva Rutkovska: Riga Stradins University
Inês Ribeiro Vaz: University of Porto
Mitja Kos: University of Ljubljana
Paula Barão: University of Lisbon
Renske Grupstra: University Medical Center, Utrecht University
Teresa Leonardo Alves: National Institute for Public Health and the Environment, Centre for Health Protection Medicines Department
Anna Birna Almarsdóttir: Copenhagen Centre for Regulatory Science, University of Copenhagen

Drug Safety, 2025, vol. 48, issue 2, No 6, 177 pages

Abstract: Abstract Introduction Risk minimisation measures (RMMs) aim to ensure safe use of medicines, but their implementation in clinical practice is complicated by the diversity of stakeholders whose clinical decision making they seek to inform. Clinical practice guidelines (CPGs) are considered integral in clinical decision making. Objectives To determine the extent to which RMMs are included in the relevant CPGs and to describe factors that determine RMM inclusion. Methods A multi-case study design using quantitative document analysis of CPGs combined with qualitative interviews with informants from organisations that issue CPGs. Cases from five therapeutic areas (TAs) with a regulatory requirement for further RMMs were studied individually in six EU member states (Denmark, Greece, Latvia, Netherlands, Portugal and Slovenia). Clinical practice guidelines were analysed using pre-defined coding frameworks. Interviewees were sampled purposively for experience and knowledge about CPG development and RMM inclusion. Verbatim interview transcripts were analysed inductively. Results In total, 136 CPGs were analysed, and RMM information about TAs was included in 25% of CPGs. Based on 71 interviews we found that factors that determine RMM inclusion in CPGs include clinicians’ low awareness of RMMs despite awareness of RMMs’ safety concern, low expectation of RMMs’ clinical utility, and unfamiliarity with pharmacovigilance data supporting RMMs and perceived incompatibility of CPGs’ scope and purpose and RMM information. Conclusions 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.

Date: 2025
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DOI: 10.1007/s40264-024-01487-5

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