Guidance

Compliance with Regulation 259 of the Human Medicines Regulations (2012) - provision of Patient Information Leaflets in formats appropriate for blind and partially sighted patients

Updated 22 December 2023

Marketing Authorisation Holders (MAHs) must ensure that the Patient Information Leaflet (PIL) is made available on request in formats suitable for blind and partially sighted patients. Alternative formats may include Braille, large print, audio tape or CD-rom. To help with this and to enable patients to easily access the information in a format to suit their needs, the PIL should include details on how to access this information.

Additional guidance concerning graphical images in PILs

We have recently been in discussion with RNIB (Royal National Institute of Blind People) about difficulties currently being experienced by MAHs when converting some documents to accessible formats for blind and partially sighted patients which contain pictograms or other graphic elements. To help patients with sight loss, it is recommended that information illustrated through graphics in PILs is also described in the text. The following guidance will help those writing the leaflet information to determine what to include and how.

• Establish what information the image is showing and ensure that this information is included in the text. The images are usually instructional and generally demonstrate how to do something, hold something, clean or open something. The text has to reflect what the image is showing.
• If orientation for usage is critical to successful use of the medicine, this must be specifically described in the description. Avoid statements such as “hold upright as shown” without expanding on what is actually being shown. For example if an image shows how to hold an inhaler; state how it is being held “Hold the inhaler as shown in figure one, with thumb on the rounded base and middle finger on the flat top of the canister”.
• Describe any features of medicines which will feel distinctive to enable someone to orientate the medicine correctly by touch, for example words such as wide, narrow, rounded, flat.
• Establish which details are important; for example if packaging has an indicator – avoid saying “open via indicator as shown” – describe where this indicator is on the packaging.
• Ensure that where instructions are presented step by step with an image for each point, that the text reflects its accompanying image. Avoid writing text which implies that the image shows something which is not described.
• The text does not need to reflect what the image looks like, so for example, it is not necessary to describe that it is a black and white picture. It is the information in the image that is significant.
• Images which show a ‘before and after’ or photographs or showing a condition will also need to be described if important; for example, “the photograph shows a foot with a rash covering the entire big toe.”
• The appearance of conditions should be described as well as illustrated, together with an instruction for people to seek professional advice.

Applicants may find that changes are required to PILs which include images to ensure that the information is accessible when converted to an alternative format.

Such changes should be made to the PIL in the usual manner by application to the Patient Information Quality Unit.

Further information

Further advice can be obtained from RNIB.

Product Information Quality Unit (PIQU): [email protected]