Patient information leaflet (PIL) of the month

PILs (Patient Information Leaflets) are improving in quality as a result of new legal obligations on manufacturers to test the documents on potential patients. Testing makes sure that the presentation of the information enables patients to find and understand key messages for safe use of the medicine within the PIL and thereby enable them to use the medicine safely and effectively. To promote this new initiative and share best practice, we are publishing a series of examples below to illustrate improvements and to aid learning.  All leaflets associated with this scheme are published with the agreement of the marketing authorisation holder responsible for the medicine to which they relate.

The leaflets in this scheme have been supported by a user test carried out in compliance with article 59(3) of Council Directive 2001/83/EC. However, quality of the information can be assessed in other ways. The Commission on Human Medicines Expert Advisory Group on Patient Information has developed a quality scoring system to help identify by means of a numerical score good quality patient information. Leaflet included in this initiative have scored significantly higher in the new layout and design than previously. Marketing authorisation holders may find it helpful to use this scoring system to help develop better quality patient information leaflets:

› Quality criteria for patient information leaflets (18Kb)

A selection of patient information leaflets demonstrating best practice:

Date issued	Product
31 October 2008	Sertraline (4207Kb)
31 October 2008	Molipaxin (3212Kb)
31 October 2008	Amisulpride (97Kb)
17 October 2008	Telfast (71Kb)
10 September 2008	Livial (1916Kb)
5 August 2008	Saw Palmetto Capsules (635Kb)
2 July 2008	AmBisone (69Kb)
6 June 2008	Aldactone (1037Kb)
9 May 2008	Epipen (290Kb)
18 April 2008	Vicks Sinex Soother Nasal Spray (111Kb)
20 February 2008	Nicorette Microtab (1180Kb)
29 November 2007	Lamisil (454Kb)
19 March 2008	Hedrin (511Kb)
8 October 2007	Crestor (1649Kb)
8 November 2007	Creon 10000 Capsules (68Kb)
27 April 2007	Calpol Sugar Free Infants Suspension (144Kb)
8 October 2007	Andropatch 2.5 mg 24 hours Transdermal Patch (139Kb)

Enquiries should be directed to patient.information@mhra.gsi.gov.uk