By Professor D.K Theo Raynor, Professor of Pharmacy Practice, University of Leeds
A new report published by the Academy of Medical Sciences says that medicine information leaflets are too scary with too much focus on the potential side-effects of medicines and not enough on their benefits. The report calls for them to be rewritten to give a more balanced view.
This is a comprehensive and thoughtful report looking at enhancing the use of scientific evidence to judge the potential benefits and harms of medicines. Of particular interests to those working in Pharmacy are the recommendations relating to patient information leaflets (PILs) – found in the pack of every medicine dispensed in the UK. The key recommendations relating to ‘Improving the content of PILs’ are:
• All parties to improve the comprehension and readability of patient information leaflets in line with the current legislation.
• This should ensure a balanced appraisal of the medicine’s potential benefits and risks is made accessible in these documents.
These recommendations echo the recent report for the European Commission on the ‘shortcomings’ of PILs produced by the Universities of Utrecht and Leeds.(1) Not mentioned in the Academy’s report is that for more than 10 years, manufacturers have had to ‘user test’ their PILs with lay people – so they are already ‘revised in consultation with patients and carers’. Despite this testing, further improvements are needed, with a more rigorous application of the user testing process, ensuring that it is iterative – with repeated testing and improvement until the required level of readability is reached. Read more Better information on patient information leaflets