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Challenges in the Implementation of EU Risk Minimisation Measures for Medicinal Products in Clinical Practice

Mathias Møllebæk1, Helga Gardarsdottir2,3, Alexia-Georgia Bikou4

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Risk minimisation measures (RMMs) are rarely included in clinical practice guidelines (CPGs). This limited inclusion stems from low clinician awareness, perceived lack of utility, and poor collaboration between regulators and guideline developers.

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Area of Science:

  • Pharmacovigilance and Drug Safety
  • Clinical Practice Guideline Development
  • Healthcare Policy and Regulation

Background:

  • Risk Minimisation Measures (RMMs) are crucial for safe medicine use but face implementation challenges due to diverse stakeholder involvement.
  • Clinical Practice Guidelines (CPGs) are key decision-making tools in clinical practice.

Purpose of the Study:

  • To assess the extent of RMM inclusion in relevant CPGs.
  • To identify factors influencing the inclusion of RMMs in CPGs.

Main Methods:

  • A multi-case study combining quantitative document analysis of CPGs with qualitative interviews.
  • Analysis of 136 CPGs across five therapeutic areas in six EU member states.
  • Inductive analysis of 71 interviews with CPG development stakeholders.

Main Results:

  • Only 25% of analyzed CPGs included RMM information.
  • Key barriers include low clinician awareness of RMMs, low perceived clinical utility, and unfamiliarity with supporting data.
  • Perceived incompatibility between CPG scope and RMM information also hinders inclusion.

Conclusions:

  • RMM information inclusion in CPGs is significantly limited.
  • Explanations involve CPG and RMM characteristics, and a disconnect between regulators and guideline authors.
  • Enhanced collaboration among stakeholders, national regulators, and the EMA is recommended to improve implementation.