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Are patient information leaflets in top gear? Jeremy Clarkson doesn’t think so

Jeremy Clarkson (Rex/Geoffrey Swain)

Jeremy Clarkson has raised issues about patient information leaflets that pharmacists can learn from

Jeremy Clarkson has taken a pop at patient information leaflets in The Sun. He has a point and pharmacists must not be complacent about their usefulness, writes Theo Raynor

In his column in The Sun newspaper towards the end of last year, Jeremy Clarkson wrote a piece headed “Warned off pill popping”, which made apparently sarcastic remarks about the patient information leaflet his mother had been given with dexamethasone. The language used in the piece, such as describing the leaflet as “hysterical”, could lead to this being regarded as a cheap shot, but if his view reflects even partially what some members of the public think, we need to make sure there are no lessons we can learn.

Context

First we need to clarify the context, in that the mandated patient information leaflet which manufacturers have to write and supply inside every medicine pack are, on the whole, much improved. Since 2009, all UK leaflets have had to go through user-testing, where performance-based testing assesses how well lay people can find and understand key points of information.

This has led many pharmaceutical companies to take the leaflets much more seriously, and some of the improved leaflets can be seen on the Medicines and Healthcare products Regulatory Agency website under “PIL of the month”. Such leaflets have come a long way from the old days, when nearly all were poor — and the EU legislation requiring user-testing means that we are well ahead of our colleagues in the US and Australia.1

Clarkson starts by pointing out that the leaflet says that the medicine (dexamethasone) should not be taken by people who are allergic to dexamethasone; his response is an expletive. However, patients know many medicines by their brand name (and some are in combination products), so the patient may not know that it contained the said dexamethasone. If the patient did not know, the headline “Patient dies from drug allergy mix-up” might appear.

Clarkson then goes on to recite part of the long list of possible side effects from dexamethasone, implicitly saying that there are too many listed. But these side effects are all possible, and research shows that patients do not want a partial list. If we did not list all of them, the likely headline would be “Drug side effects hidden from patients”.

In practice these side effects, since the advent of user-testing, are no longer listed in an undifferentiated paragraph, but as a bulleted list, which patients find much easier to use. And many of those effects he lists are actually written in patient-friendly terms, such as “being unable to sleep” (“insomnia” would have been the word used in the old days) and “runny nose” (rather than “rhinitis”).

Finally, he notes a “final warning” that “sudden withdrawal can cause a severe loss in blood pressure, it may kill you”, which appears to be his interpretation, rather than the actual wording. Nevertheless, information about the need to decrease the dose gradually over time, rather than sudden withdrawal, is important information for the patient. Otherwise the headline “Patient stops medicine and dies” might result.

So, I have suggested that, if the information Clarkson complains about were not in the leaflet, alternative headlines about serious medicines misadventure might be the outcome. However, some current patient leaflets, despite being tested, remain less than optimal, possibly because user-testing is sometimes regarded as an end in itself, rather than being integrated with expertise in information writing and design.

Testing only identifies where the problems are; it does not resolve them. User-testing should always be regarded as an iterative and formative process: testing, improving, then testing again. Other necessary improvements have been identified by the MHRA, including a greater focus on good design, and a better balance of benefit and harm information.2

Double whammy

If some patients or carers do have impressions similar to Clarkson, then we have to address them — and that “we” means primarily pharmacists. Every time a patient gets a new medicine, the pharmacist should go through the leaflet with them, pointing out the important points and correcting any misunderstandings such as those which Clarkson appears to have had.

Pharmacists using the patient leaflet as an aide-memoire when talking to patients about their medicine is a double whammy: it provides a structure for such a consultation, providing prompts for the key points to cover, and it shows the patient that the information leaflet is important and relevant to them. Of course this presupposes that pharmacists are routinely talking to patients when they collect their prescriptions.3

Finally, it is good to note that further improvements to patient leaflets should arise from a research study commissioned at European level, looking at the “shortcomings” of current patient leaflets and ways to improve them.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2014.11133872

Readers' comments (1)


  • JC likes to be contentious for the sake of it but what is a surprise is that he has actually read a PIL.  I have no idea what percentage of leaflets are read but I am pretty sure that it is very small and probably occurs only when the consumer has a problem or query.  Much of the information that JC ridicules is of course in the PIL to negate liability for the manufacturer.  I would compare this to the pages of safety information in car manuals that you have to wade through before finding out how to start it.  Most of us put the key in the ignition and switch on without reference to the manual, probably for the same reasons that few people read the PILs provided.


    So good article Theo but until such time as we can change attitudes to such manuals, PILs and instruction leaflets most of them are probably a waste of paper.  Of course better counselling by the pharmacist at point of dispensing will help.


    David Green

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