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Patient Safety Commissioner

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.

Summary written by this site.

Published 31 March 2025 4 recommendations Government response Partial response, 2 May 2025

The government response status is recorded by this site.

Recommendations 4

Recommendation 1

Response: Accepted

Addressed to MHRA

Recommendation (the Commissioner's words)
The MHRA needs to review – working alongside patients – whether their current guidance and regulations for the licencing and packaging of medicines goes as far as is possible to enable their safe use by those with sensory impairment.

Recommendation 2

Response: Accepted

Addressed to ABPI, MHRA, DHSC

Recommendation (the Commissioner's words)
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.

Recommendation 3

Response: Pending

Addressed to NHS England

Recommendation (the Commissioner's words)
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.

Recommendation 4

Response: Pending

Addressed to DHSC, NHS England

Recommendation (the Commissioner's words)
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 required, especially for people with visual impairment.