Figuring out those medicine information leaflets

How many of us actually read those little pieces of paper that accompany prescribed or over-the-counter medicine that people take every day. We rely on the fact that because the medication has been prescribed by a medical practitioner or pharmacist it should be safe and appropriate for a specific diagnosis.

By being curious and taking the trouble to read the enclosed information leaflets in medicine packaging, more information can be gleaned about the efficacy of a medicine and its possible side effects. Although most of the printed matter can be understood, there is usually other information written in medical terms about which only a medical professional is familiar. This can cause uncertainty and confusion in the interpretation of the positive and negative performance of the medication.

The European Commission has become the custodian of comprehensive labelling across the continent. In Article 59 of the European Directive – 2001/83/EC (amended by Directive 2004/27/EC) – they declared that from November 2005: “The package leaflet shall reflect the results of consultations with target patient groups to ensure that it is legible, clear and easy to use”. The individual interpretation of this statement can vary with regard to the words ‘legible’, ‘clear’ and ‘easy to use’. Does ‘legible’ refer to the mother tongue of the reader or those with normal vision, does ‘clarity’ mean a good print layout and does ‘easy to use’ apply to the easy removal and unfolding of the leaflet from the packaging in order for it to be read. What does “reflect the results of consultations with target patient groups” imply? Is each product specific to a single target patient group and if not, which group should be consulted. Also, of what does a representative group comprise?

An effort to solve these ambiguities in subsequent articles of the EC directive only seemed to cause more confusion across the pharmaceutical sector, as to how   companies should act in order to abide by these new regulations. In 2009 the EU tried to clarify the situation further, by issuing “Guideline on the readability of the labelling and package leaflet of medicinal products for human use”. This revealed that the meaning of ‘legible’ was – “Using a font that was at least 8-point in size, constructing no long sentences or complicated paragraphs and making sure that terms such as ‘very common’ are explained as meaning more than one patient in ten”. By this time however, a small band of companies had begun to offer facilities for designing and testing patient information leaflets, including the translation of them for other markets. Those who have become involved include leading companies such as DiaPharm of Germany, CambReg, GRS and Spectrum in the UK and the ELC Group based in Prague. A few of these companies were specialists in technical writing that stretched into pharmaceutical jargon and translation. Recently, a Dutch-based expert in medical translation, MediLingua, has initiated testing for the readability of patient information leaflets.

The way in which these tests are carried out and the criteria needed for a leaflet to pass the test, has however not been ascertained. There are conflicting standards as to what is the best method for leaflets, but it appears that the ‘90% of 90%’ benchmark suggested by Australian authors, David Sless and Rob Wiseman in their 1997 study, “Writing about medicines for people”, is the best guideline for test results. Numerous testing agencies admit to adhering to this principle. The Medicines and Healthcare Products Regulatory Agency (MHRA) of the UK also seems to have included these standards in the 2005 report of its working group on patient information – “Always read the leaflet”. Therefore, when it comes to discussing an ideal method of testing based on two stages of questioning, the MHRA interprets successful criteria as – “A satisfactory test outcome for the method outlined is when 90% of literate adults are able to find the information requested within the leaflet, of whom 90% can show that they understand it”. Theoretically, this delivers an assurance rate of 81%. The pharmaceutical regulator of the UK says that this method of testing patient information is perhaps attainable, but is not the only one that will be agreed to.

This brings into question how many multi-language medicine users can actually read and comprehend what is printed on the paper insert that partners their medication. The actual answer to that one is a mystery at present.

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Richard Maxwell

3rd September

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