User testing of patient information leaflets

From 1 July 2005 new legal provisions exist in the UK for patient information particularly in relation to involving patients in ensuring that the information provided is legible, clear and easy to use. We have issued guidance and a question and answer document:

› Always Read the Leaflet: Getting the best information with every medicine - July 2005 (602Kb)
› Guidance on the user testing of patient information leaflets (33Kb)
› Questions and answers to support the MHRA guidance on user testing of patient information leaflets - June 2005 (37Kb)
› Additional questions and answers on user testing of patient information leaflets - June 2006 (21Kb)

Additional guidance on compliance with article 59(3) of Council Directive 2001/83/EC - User Testing of Patient Information Leaflets is now available.  The guidance has been produced as a result of a recent survey of those companies who undertake such work on behalf of marketing authorisation holders.   The survey results are also available from the website (28Kb).

› Further guidance on designing patient information leaflets and how to achieve success in user testing - March 2007 (38Kb)

Assessment of user tested patient information: Information for applicants
The Patient Information Quality Unit is currently receiving a very high volume of applications for assessment of user tested patient information and this has resulted in some delay in processing applications.

We are working to reduce backlogs and minimise delays by employing additional staff and streamlining assessment processes. To help us provide the best possible service and reduce backlogs as quickly as possible, please do not contact us directly or via the patient information mailbox to check the progress of your application unless it is more than 90 days since receiving notification of a start date for the procedure. If you have not received an acknowledgment of your submission or a procedure start date, please follow the advice provided in the FAQs.

Marketing authorisations which have been the subject of an approvable application (see Dear MAH letter of 2 April) or a notification that the product will not be marketed, will be considered compliant with the requirement for user tested patient information.

Changes to the assessment process in the Patient Information Quality Unit - April 2008
In the light of the large volume of applications currently in the system and the timeframe for compliance of all marketing authorisations, changes to the assessment procedure for patient information leaflets accompanied by data demonstrating compliance with article 59(3) of Council Directive 2001/83/EC [user testing] have been put in place. These are set out below:

• Assessment is focussed on key areas of the leaflet to ensure that key messages for safe use in line with current clinical practice are included and displayed prominently.
• Assessors are working in therapeutic areas to make best use of assessor experience.
• Compliance with the summary of product characteristics (SPC) is no longer part of the assessment process.
• The time to assessment will be prioritised according to known variables (particular test houses, companies or products).

We have taken a risk-based approach to these changes. Focussing assessment on key safety issues ensures that the most important elements of safe use are prioritised. We have analysed the value of the SPC compliance check and determined that few checks result in compliance issues and those that do, do not impact on safety or raise public health issues (this is, in any case, the responsibility of the marketing authorisation holder rather than the MHRA).

Where key information is not included in the proposed patient information leaflet because it does not appear in the summary of product characteristics, applicants should consider what variation applications should be made subsequently in order to ensure the SPC reflects current clinical knowledge.

Compliance with legal requirements on consultation with target patient groups: 30 June 2008 deadline for applications
A reminder was sent to all marketing authorisation holders to submit applications to update marketing authorisations (MAs) with an approved patient information leaflet to comply with the new legal requirements in articles 59(1) [information to be shown] and 59(3) [consultation with target patient groups] of Council Directive 2001/83/EC. It is a legal requirement that all products have an updated MA by 1 July 2008.
› Letter to marketing authorisation holders - Patient Information Leaflets: compliance with legal requirements on consultation with target patient groups: 30 June 2008 deadline for applications (31Kb)

Glossary of lay terms for patient information
Patients and carers are often unfamiliar with terms used in patient information leaflets to describe unwanted effects of a medicine. In order to promote consistency and aid production of clear and understandable leaflet, the MHRA and CSM Working Group in Patient Information developed a short glossary of medical terms with suggested wording suitable for lay readers to describe the possible adverse effects of a medicine. The original glossary of 56 terms is included as Annex 8 in the publication:

›  “Always Read The Leaflet – getting the best information with every medicine (ARTL)” (602Kb)
The glossary has now been updated to include an additional 26 terms.

› Always Read The Leaflet - consolidated glossary of terms (24Kb)
This document is not comprehensive and further terms will be added in the future. Suggestions for additions to the glossary should be sent to patient.information@mhra.gsi.gov.uk .  The glossary will be reviewed and new terms added on a six monthly basis.

Bridging studies
We have issued the following document which provides information on user testing and the circumstances when "bridging studies" will be accepted by assessors in the MHRA including guidance on the way in which these studies should be carried out:
› Guidance for the Pharmaceutical Industry on the use of bridging studies to demonstrate compliance with article 59(3) of Council Directive 2001/83/EC [Consultation with Target Patient Groups] (35Kb)

Remember, when you change the order of the information in a patient information leaflet to comply with the new requirements as set out in article 59(1) of Council Directive 2001/83/EC the UK law also requires you to submit data demonstrating compliance with article 59(3) at the same time.  One way of achieving this is to submit a bridging study. Also all medicines on the UK market are required to comply with these new requirements by 1 July 2008 and you must submit your applications and the supporting data in relation to article 59(3) in good time before this date.

Report of the findings of the survey of user test houses undertaken on behalf of the Commission on Human Medicines Expert Advisory Group on Patient Information (CHMEAGPI)
Eighteen months on from the introduction of a new legal requirement in the UK for all patient information leaflets to be subject to some form of patient testing MHRA undertook a survey on behalf of the CHMEAGPI.   We invited those involved in the user testing of patient information to share their learning from this activity and help to promote best practice. The survey was undertaken between 20 December 2006 and 11 January 2007 and the report of the findings is available below.
› Report of the findings of the survey of user test houses undertaken on behalf of the Commission on Human Medicines Expert Advisory Group on Patient Information (CHMEAGPI) (28Kb)

Contact for further information
The Unit responds to and investigates enquiries and complaints regarding patient information reported by members of the public and the pharmaceutical industry. Enquiries and complaints should be made in writing and sent to: The Patient Information Quality Unit, MHRA, 14-1, Market Towers, 1 Nine Elms Lane, Vauxhall, London SW8 5NQ or e-mail patient.information@mhra.gsi.gov.uk.