The BBC recently picked up on a study from The Academy of Medical Sciences this month, running with the headline: "Medicine information leaflets 'too scary', say experts."

The report's recommendations echo the recent report for the European Commission on the "shortcomings" of patient information leaflets (PILs) – of which I was a joint author – produced by the Universities of Utrecht and Leeds. However, 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 – in the words of the Academy – “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 call 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 some of the Academy’s 12 recommendations are easier said than done.

Confusion over statin statements

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 five years, one of them will be prevented from having a heart attack or stroke."

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.

The Academy quotes a study estimating "2,000 excess cardiovascular disease events over the next 10 years" due to questions raised about the risk-benefit balance of statins. But if some patients make 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.

Could NMS be the answer?

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. The authors suggest that the new medicine service, available from pharmacies in England, might be an appropriate place for discussing such uncertainty.

As the report points out, the PIL may be the only piece of information about their medicines that patients receive, and so it could be argued that pharmacy staff should use the PIL to help them when talking to patients about their medicines – taking it out of the box, pointing out the key points in the leaflet, and focussing on those most relevant to the particular patient.

In this way, the patient may see more value in the PIL, and it [also] helps the pharmacist to include all the key points and tailor their discussion to the individual patient.

Theo Raynor is professor of pharmacy practice at the University of Leeds, and a member of the Royal Pharmaceutical Society’s expert advisory panel on pharmaceutical science