The Safety Gap Report
Report commissioned from Professor Margaret Watson examining safety gaps in medicines and medical devices for people with sensory impairment. Found serious gaps and deficiencies in how people with visual and/or hearing impairment access and use medicines and medical devices safely. Makes 4 recommendations to MHRA, ABPI, DHSC, and NHS England. MHRA responded on 2 May 2025: Recommendation 1 included in their Agency Business Plan; Recommendation 2 included in their 2025-2026 Business Plan. Recommendations 3 and 4 awaiting response.
Recommendations
The MHRA needs to review – working alongside patients – whether their current guidance and regulations for the licensing and packaging of medicines goes as far as is possible to enable their safe use by those with sensory impairment.
The ABPI, MHRA and DHSC should work together to restart work – alongside published milestones – to digitise paper-based patient information leaflets via the existing UK Electronic Patient Information Task Force (ePIL). As part of this restart, ePIL – working with patients – should examine how to maximise the benefits of this work for patients with sensory impairment.
NHS England's Diabetes Programme Team should launch a patient reference group to assess, understand and mitigate the barriers and enablers to the safe and effective roll-out of medical devices and other education programmes for the management of diabetes (such as DAFNE) for those with sensory impairments.
DHSC and NHS England need to ensure the work announced to improve and expand the NHS App in 'Reforming elective care for patients' includes an assessment – conducted with the input of patients – to determine whether further accessibility improvements are needed.