spacer
home > pmps > spring 2007 > readability testing – a bitter ‘pil’ to swallow?
PUBLICATIONS
Pharmaceutical Manufacturing and Packing Sourcer

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.


Read full article from PDF >>

Rate this article You must be a member of the site to make a vote.  
Average rating:
0
     

There are no comments in regards to this article.

 You must be a member of the site to make a comment.
spacer
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.
spacer
Sophie Hobson
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

Northway Biotechpharma and Hansa Biopharma initiate a new Contract Development and Manufacturing project in immunological diseases

Vilnius, Lithuania, and Lund, Sweden - December 20th, 2019 – Northway Biotechpharma, a leading biopharmaceutical Contract Development and Manufacturing Organization (CDMO), and Hansa Biopharma, the leader in immunomodulatory enzyme technology for rare IgG-mediated diseases, today announced a new service agreement to develop the next generation of IgG cleaving enzymes.
More info >>

White Papers

Crossing the Blood Brain Barrier (BBB): Which Route to Take?

Aptar Pharma

Aptar Pharma recently hosted an expert panel/roundtable on the various approaches to treating central nervous system (CNS) diseases. This international scientific forum was held in Paris, France on December 5th, 2014. The roundtable was organized to explore and exchange views on the challenges, approaches and opportunities that exist with regard to effectively crossing the blood brain barrier (BBB) and successfully treating a host of CNS diseases.
More info >>

 
Industry Events

SMi Presents the 4th Annual: Highly Potent Active Pharmaceutical Ingredients (HPAPI)

11-13 May 2020, Copthorne Tara Hotel, London, UK

SMi is delighted to announce its 4th Annual Highly Potent Active Pharmaceutical Ingredients conference coming to London on the 11th – 12th May 2020. HPAPI 2020 conference focuses on the growing landscape driven by the demand for highly potent drugs in oncology, diabetes and autoimmune disease treatment. This event will address the biggest challenges the industry is facing with regards to determining toxicology limits, assessing hazards, implementing risk procures, translating risk assessment into facility engineering, preventing and dealing with cross-contamination and adhering to GMP regulatory guidelines.
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement