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Readability Testing – A Bitter ‘Pil’ to Swallow?

Sophie Hobson at TRAC Services examines the processes fundamental to adapting patient information leaflets (PIL) in time for the July 2008 deadline

With less than 14 months before all patient information leaflets (PIL) in the UK have to comply with mandatory readability requirements, as set out in Article 59(3) of Directive 2004/27/EC, the question of whether pharmaceutical manufacturers are on target to meet the deadline is one that is being asked more frequently.

For those pharmaceutical manufacturers that have yet to start the process or that are in the early stages of testing their patient information leaflets, the clock is ticking a lot faster than they may think. This feature looks at the processes that pharmaceutical companies need to be going through if they are to meet the July 1st, 2008 deadline. Surveys have revealed that people in the UK want more medicines information than they currently get (1), and that they value the PIL more highly than any source, other than doctors and pharmacists (2). But in the past, the vast majority of PILs, whilst factually correct, did not present the information in a way that the patient could easily understand. European Law currently states:

“The package leaflet shall reflect the results of the consultations with the target patient groups to ensure that it is legible, clear and easy to use (3). The results of assessments carried out in cooperation with target patient groups shall also be provided to the competent authority (4)”.

Whilst improving PILs is something we are all now committed to, actually achieving this goal (and the cost of doing so) is something that is falling at the feet of those involved in the manufacture and marketing of pharmaceutical products.


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After graduating from the University of London, Sophie Hobson earned a place on a graduate scheme working in a regulatory consultancy. Having joined TRAC Services, she developed her knowledge and experience to create a readability and user testing service for the company to provide to its clients. As a result of this work Sophie researched, designed and developed a testing programme which was launched earlier this year and which she now manages full time.
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