Portal de investigação
Challenges in the Implementation of EU Risk Minimisation Measures for Medicinal Products in Clinical Practice Guidelines: Mixed Methods Multi-Case Study
Data de publicação:
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Autores da FMUP
Participantes de fora da FMUP
- Mollebaek, M
- Gardarsdottir, H
- Bikou, AG
- Kodric, A
- Silva, AM
- Andersen, A
- Kontogiorgis, C
- Poplavska, E
- Ahmadizar, F
- Dermiki-Gkana, F
- Rutkovska, I
- Kos, M
- Barao, P
- Grupstra, R
- Alves, TL
- Almarsdóttir, AB
Unidades de investigação
Abstract
IntroductionRisk 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.ObjectivesTo determine the extent to which RMMs are included in the relevant CPGs and to describe factors that determine RMM inclusion.MethodsA 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.ResultsIn 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.ConclusionsThe 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.
Dados da publicação
- ISSN/ISSNe:
- 1179-1942, 1179-1942
- Tipo:
- Article
- Páginas:
- 161-177
Drug Safety Adis International Ltd
Citações Recebidas na Web of Science: 1
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Financiamento
Proyectos asociados
Impact of EU label changes and regulatory communication on SARS-CoV-2 adenovirus vector vaccines in context of thrombosis with thrombocytopenia syndrome (TTS): risk awareness and adherence.
Investigador Principal: Fernanda Inês de Carvalho Pereira Ribeiro
Estudo Observacional Académco (RiskAwareTTS) . 2022
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Mollebaek M,Gardarsdottir H,Bikou AG,Kodric A,Silva AM,Andersen A,Kontogiorgis C,Poplavska E,Ahmadizar F,Dermiki F,Rutkovska I,Vaz IR,Kos M,Barao P,Grupstra R,Alves TL,Almarsdóttir AB. Challenges in the Implementation of EU Risk Minimisation Measures for Medicinal Products in Clinical Practice Guidelines: Mixed Methods Multi-Case Study. Drug Saf. 2025. 48. (2):p. 161-177. IF:4,200. (1).
