Background: Risk minimisation (RM) is critical to patient safety often requiring additional measures to improve safe use, understanding and adherence. Paper-based materials often pose challenges, including logistical difficulties in distribution, and limited end-user accessibility. More user-friendly, engaging formats are needed to enhance the effectiveness of RM strategies.
Objectives: We explored the potential of transitioning from paper-based to ‘digital-first’ aRMMs to enhance usability and engagement for HCPs and patients, focusing on making risk communication more user-centred. We chose a biosimilar indicated for the treatment of rheumatoid arthritis (RA) with approved printed educational materials as a test case to evaluate patient and HCP preferences.
Methods: A digital aRMM tool was designed based on the originator product’s aRMM materials, structured to meet digital standards while delivering concise educational content on drug administration and side effects. User testing aimed to obtain feedback on the site structure, content presentation, and overall usability. An unmoderated interview approach was employed using an interactive prototype of the proposed site. Ten patients diagnosed with RA for five years or more were recruited, consisting of five male and five female participants aged 22 to 47. Each patient was tasked with completing ten questions, focusing on their current behaviours resulting from their understanding of the risks associated with the drugs, and their feedback on the site design and perceived usability. Collected data were analysed thematically, with particular attention to recurring feedback on usability, aesthetics and device preferences, offering actionable insights into user engagement.
Results: Participants strongly preferred to access the RM tool on mobile devices, particularly smartphones, emphasising the need for responsive design optimised for smaller screens. While tablets and laptops were considered viable alternatives, smartphones were overwhelmingly preferred. Patients suggested including specific tools for personalised engagement, such as digital diaries for symptom tracking and forums for sharing treatment experiences
Conclusions: The transition from paper-based to digital RM materials for the biosimilar product demonstrated several advantages in accessibility, engagement, and user satisfaction for HCPs and patients. User feedback guided key improvements, such as a more inviting visual design, mobile optimisation, and patient-focused educational content, particularly around biosimilars. These enhancements helped create a tool that better meets user needs while building confidence in the medicine’s safety and efficacy.
