Patients with vision or hearing impairments face safety risks when taking medicines and using medical devices, the Patient Safety Commissioner for England has warned.
A report commissioned by Dr Henrietta Hughes identified “serious gaps and deficiencies” in how people with sensory impairments can access the information needed to use these products safely.
The report drew on evidence collected between September and December 2024. Sources included focus groups, responses to an electronic survey, and Yellow Card reports submitted to the Medicines and Healthcare products Regulatory Agency (MHRA).
Common issues included inaccessible packaging, unreadable patient information, poor communication about medication changes, and a lack of suitable reporting mechanisms.
Millions of Errors Linked to Medication
The report, The Safety Gap: Safety and Accessibility of Medicines and Medical Devices for people with sensory impairment, estimated that 237 million medication errors occur in England each year, despite safety campaign efforts.
People with sensory impairment — including sight loss, deafness, hearing loss, or tinnitus — face “greater barriers to access the knowledge and information about medicines and medical devices needed to stay safe,” it highlighted.
More than two million people in the UK live with visual impairment, including those with diabetes. Over 18 million adults experience hearing loss.
Accessible Information Is Key to Patient Safety
The report’s author, Margaret Watson, professor of health services research and pharmacy practice at the University of Strathclyde, Glasgow, said better access is vital. “For any patient to use a medicine as it is intended, they must first of all have sufficient and accessible information to make an informed choice regarding whether to use it, and the anticipated benefits and risks of using it.”
The report recommended a series of actions to improve safety for patients with sensory impairments. These included:
- The MHRA should review whether current licensing and packaging guidelines support safe use for patients with sensory loss.
- The MHRA, Department of Health and Social Care, and Association of the British Pharmaceutical Industry (ABPI) should promote digital patient information for accessible use.
- NHS England’s diabetes programme team should establish a reference group focused on medical devices and education for patients with sensory loss.
- The NHS app should be evaluated for accessibility, particularly for visually impaired users.
Industry and Regulator Responses
Dr Amit Aggarwal, medical director at the ABPI, explained that the industry is working on a “digital first” future for patient information. However, he acknowledged that non-digital formats must remain available for those who need them.
“We and other industry associations are currently working with both the medicines regulator and the Department of Health on this and will continue the drive towards piloting and then hopefully implementing electronic patient information leaflets,” he told Medscape News UK.
Printed leaflets remain a legal requirement in the UK. However, other countries — including the European Union, Australia, South Africa, Japan, and Singapore — offer a more flexible approach. This includes offering digital-first medicines information while ensuring that printed leaflets remain available upon request.
Julian Beach, interim executive director for healthcare quality and access at the MHRA, welcomed publication of the commissioner’s report. He noted that the regulator had provided feedback ahead of publication.
“We are committed to ensuring people of all abilities, including those with sensory impairment, have access to safe, effective, and high quality medicines and medical devices that they are able to use without issue,” Beach told Medscape News UK.
He added that the regulator had set requirements, underpinned by legislation, to ensure manufacturers provide further accessible formats of product information for patients where required.
Current legislation mandates that licensed medicines include the product name in braille on the carton, and information available in large print, braille, or in audio format on request.
Beach said the MHRA supports ongoing efforts, including by patient groups, to improve access.
“We recognise there are opportunities to improve medicines information based upon user research, including this latest report, to ensure the needs of this patient group are met, and we are committed to that work,” he said.
Impact on Health Outcomes
The Royal National Institute of Blind People (RNIB) said that it regularly hears from blind and partially sighted patients who struggle with medicine labelling, as well as having to repeatedly register their communication needs with health services.
Anna Tylor, chair of trustees for the RNIB, who is severely sight impaired, said, “If you receive appointment information in a format you can’t read or are given medications with instructions in a tiny font, how can you manage your condition effectively?”
Tylor welcomed the report’s findings. “The principles set out in the report are long overdue and are about putting patients at the heart of everything, so that people are treated equitably, and feel safer,” she told Medscape News UK.
Dr Sheena Meredith is an established medical writer, editor, and consultant in healthcare communications, with extensive experience writing for medical professionals and the general public. She is qualified in medicine and in law and medical ethics.