Medicines safety information from regulators in clinical practice guidelines: a mixed-method case study

Abstract Objectives The role of Danish clinical practice guidelines in making the health care sector aware of and act in accordance with medicines safety information from regulators, has not been extensively studied. The objectives of this study were 1) to describe the extent to which information from additional risk minimization measures is included in Danish clinical practice guidelines and 2) to explore guideline developers’ attitudes towards including additional risk minimization measures in Danish clinical practice guidelines. Methods The study focused on five therapeutic areas and combined quantitative document analyses of 91 Danish clinical practice guidelines and qualitative semi-structured interviews with 14 key informants expected to have knowledge about the guideline development in Denmark. Key findings The average inclusion rate of clinical actions from additional risk minimization measures in Danish clinical practice guideline is low (3.5%), and guideline developers have a low willingness to include information originating from additional risk minimization measures in the guidelines. Guideline developers typically claim to have sufficient access to new risk information on medicinal products via other sources, especially direct and targeted messages. Conclusions The findings confirm previous studies highlighting the paramount role of direct and targeted messages as opposed to guidelines when disseminating medicinal risk information to clinicians. The findings provide a new in-depth understanding of attitudes towards various types of medicinal risk information in clinical practice and guidelines and give rise to future studies assessing clinicians’ access to, awareness of, compliance with, and unmet needs regarding any medicinal risk information.