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.
Both reports calling for a leaflet with a better balance between benefit and harm information. However, as the Commission report notes, there is no consensus on how best to present such balanced information – so the Academy’s recommendation is easier said than done. A study from the University of Leeds looked at providing numerical information about the benefits of statins in a PIL – one of the debates said to have triggered the report. We found that people greatly over-estimated the possible benefits of statins – and were surprised if this statement was included in their statin PIL: ‘If 17 people like you take this medicine over the next 5 years, one of them will be prevented from having a heart attack or stroke’. (2) The recent debate on statins has focussed on the perceived over-estimation of the possible harms of statins – if we do give more information about the possible benefits – which we should – then this might equally make people think twice about taking a statin.
The Academy report notes that ultimately, the decision to use a medicine lies with the patient – the obvious consequence of that is that we should accept informed decisions not to take a medicine. This means that if the perceived low level of possible benefit from a medicine leads a patient not to take a medicine, that is a good outcome. They quote a study estimating 2,000 ‘excess’ cardiovascular events over the next 10 years due to questions raised about the risk-benefit balance of statins – but if some patients make an informed decisions, the term ‘excess’ is not appropriate – we cannot and should not make people take preventative medicines. An informed patient is not necessarily an obedient patient. (3)
The Academy’s report notes the uncertainty about whether a particular drug might benefit a specific patient – which might suggest that the PIL is not the place for such information – and they note that the New Medicines Service available from pharmacies in England might be an appropriate place for discussing such uncertainty. However, as the report points out, the PIL may be the only piece of information about their medicines that patients receive, as so it could be argued that pharmacy staff should use the PIL to help them when talking to patients about their medicines – take it out of the box, point out the key points in the leaflet – focussing on those most relevant to the particular patient. In this way the patient may see more value in the PIL – and it helps the pharmacist to include all the key points and tailor their discussion to the individual patient.
1. Raynor DK, van Dijk L, Monteiro SP, Vervloet M, de Bie J. Study on the package leaflets and summaries of product characteristics of medicinal products for human use. European Commission 2015 http://ec.europa.eu/health/files/committee/75meeting/pil_s.pdf
2. Rebecca Dickinson, David K Raynor, Peter Knapp, Jan MacDonald. Providing additional information about the benefits of statins in a leaflet for patients with coronary heart disease: a qualitative study of the impact on attitudes and beliefs. BMJ Open 2016 December 2, 6 (12): e012000
3. Raynor DK. Health literacy – time to move the focus from patient to provider? BMJ 2012; 344: 7