The Safety Gap: Safety and accessibility of medicines and medical devices for people with sensory impairment (Patient Safety Commissioner, 31 March 2025)

Summary

Patients with vision or hearing loss frequently encounter difficulties accessing vital health information, medication instructions, and effectively using medical devices. This report for the Patient Safety Commissioner for England, commissioned from Professor Margaret Watson, highlights serious gaps and deficiencies in the way that people with visual and/or hearing impairment or loss (referred to as sensory impairment) are able to access and use medicines and medical devices safely.

Content

This report presents the results of a short-term study to explore the challenges experienced by patients with sensory impairment in relation to their safe and effective access to and use of medicines and medical devices. This study was conducted from September to December 2024. The primary data that were generated were derived from three sources:

•  Focus groups involving individuals with visual impairment or loss, including people with diabetes.
• Key Informant responses to an electronic survey.
• Medicines and Healthcare products Regulatory Agency (MHRA) Yellow Card reports.

Patients reported distressing experiences due to inaccessible packaging, unreadable patient information, inadequate communication about medication changes and a lack of suitable reporting mechanisms for issues.

The report makes the following recommendations:

• 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.
• The Association of the British Pharmaceutical Industry (ABPI), MHRA and Department of Health and Social Care (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 required, especially for people with visual impairment. 

In a number of other areas, the report states that the Patient Safety Commissioner wants to make observations to a number of bodies – highlighting the outcome without specifying the solutions, in keeping with the ethos of the recent Health Services Safety Investigations Body (HSSIB) report ‘Recommendations but no action: improving the effectiveness of quality and safety recommendations in healthcare.’

The report makes the following observations:

• A patient’s medical record needs to include a prominent flag of accessibility needs and detailed information about these needs to ensure that the healthcare professional can provide any required reasonable adjustments. All relevant healthcare professionals – including community pharmacists – must have sufficient access to these patient records and flags.
• Healthcare professionals, particularly community pharmacy personnel and others involved in the direct supply of medicines and medical devices, must have sufficient funding to support the additional time and resources required by to undertake assessments of patient needs and provide the required ‘reasonable adjustments’ for medicines and medical devices.
• With the anticipated increase in prevalence of sensory impairment amongst the general population, further guidance is required to promote evidence-based practice by health and social care professionals in terms of the medicine journey of people with sensory impairment. It is also crucial that there is provision of training to healthcare professionals (ideally within the undergraduate curricula) regarding the needs of people with sensory impairment.
• People with experience of sensory impairment should be included in the design of medical devices, as well as user information and instructions to accompany their supply and use. Manufacturers need to provide more resources to facilitate the demonstration of the effective use of medical devices, especially for people with visual impairment.