Making sense of medicine information leaflets

Date: Aug-05-2013You may take patient information leaflets for granted, yet behind these innocuous little slips of paper tucked into the drug packaging lies a murky sea of controversy and uncertainty.

There is a delicious irony in the European Commission (EC) becoming the guardian of comprehensible labeling across the continent. This, after all, was the organization that produced such masterpieces as the following:

"A compulsory [product] labeling system shall be introduced and shall be obligatory in all member states from 1 January 2000 onwards. However, this compulsory system shall not exclude the possibility for a member state to decide to apply the system merely on an optional basis [in respect of the product] sold in that same member state."

Confused? You should be. And that is before you have been subjected to paragraph 7(a) of the EC Public Services Contracts Regulations (1993), a great slab of legalese so unintelligible that Dickens or Kafka would have hesitated to parody it. The first part of this paragraph reads:

"The contracting authority shall calculate the amount referred to in paragraph (6) above either: (a) by taking the aggregate of the value of the consideration given by the contracting authority under public services contracts which have similar characteristics and which were for the provision of services of the type to be provided under the contract, during its last financial year ending before, or during the period of 12 months ending immediately before, the relevant time and by adjusting that amount to take account of any expected changes in the quantity and cost of the services in the period of 12 months commencing with the relevant time, or..."

Well, let us not stick around for (b), because it is even less readable.

Puzzling pronouncement

Yet here was that selfsame EC pronouncing - in Article 59 of the European Directive 2001/83/EC (as amended by Directive 2004/27/EC) - 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."

Bravo! A model of brevity and clarity... until one tests the words for actual meaning.

Legible? To whom? Native speakers in the language? Those with average eyesight (whatever that might be)? Those of what age and degree of education? Does "clear" mean clarity in typography, in layout, or in meaning? What about "easy to use?" Does that mean easy to take out of the pack, unfold and read?

As for "reflecting the results of consultations with target patient groups," the scope for individual interpretation is even greater.

For example, does each product have just one target patient group and, if not, which group should be consulted? What constitutes a representative group anyway? Perhaps most mysterious of all, in what way should the results of that consultation be "reflected?"

A new patient leaflet industry is born

Ensuing articles of the EC directive attempted to hammer out some of these ambiguities but the end result was a widely shared degree of puzzlement across the pharmaceutical industry on what companies should actually do to comply with these new regulations.

Can you trust your patient information leaflet?

The EU eventually realised it had created a "clarity gap" of its own and attempted to close it in 2009 with the release of "Guideline on the readability of the labeling and package leaflet of medicinal products for human use."

We now learned, for example, that "legible" meant:

Using a font that was at least 8-point in size
Having no long sentences or complicated paragraphs
Ensuring vague terms such as "very common" are spelled out as meaning more than one patient in ten.

However, by then a small industry had begun to form of companies offering services in designing and testing patient information leaflets, as well as translating them for subsidiary markets.

Leading players include DiaPharm from Germany, CambReg, GRS and Spectrum in the UK and the Prague-based ELC Group. Some of these companies were specialists in technical writing that extended into pharmaceutical language and translation and some have moved in the opposite direction.

Typical of the latter group is MediLingua, a Dutch-based specialist in medical translation that has recently begun to offer patient information leaflet "readibillity testing." The company's managing director, Simon Andriesen, has produced a study of the readability regulations and differing responses. He agrees that "legible, clear and easy to use" leaves much to individual interpretation.

"How readability tests have to be performed and what requirements there are for a leaflet to pass the test were left undefined, however. On the basis of the various sources, providers of readability test services have extracted their own test method, with most of these based on 'an example of a method for testing the readability of the leaflet' that was published by the EC. However, there does not seem to be a consensus on the test criteria to be used."

Conflicting criteria on best practice for leaflets

At first glance, it would seem that the "gold standard" for test results is the "90% of 90%" criterion, proposed by the Australian authors David Sless and Rob
Wiseman in their landmark 1997 study, "Writing about medicines for people."

Many testing agencies profess to work to this standard, which also seemed to be embraced by the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) in "Always read the leaflet," the 2005 report of its working group on patient information.

Thus when talking about a model test method based on two rounds of questioning, the MHRA defines "success criteria" as:

"A satisfactory test outcome for the method outlined above 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."

This gives a theoretical assurance rate of 81%. However, the context here is important. The UK pharmaceutical regulator is saying only that this a possible method of testing patient literature - not the only method that will be accepted.

90% of what?

The EU's readability guideline uses similar language in a similar context, but then goes on to muddy the waters even further by adding:

"That means to have 16 out of 20 participants able to find the information and answer each question correctly and act appropriately. However, it need not be the same 16 participants in each case. The success criteria will need to be achieved with each question. Results cannot be aggregated."

MediLingua's Simon Andriesen points out there are several non-sequiturs here, the most important being that 16 out of 20 actually translates to 80%. In effect, he says this means that leaflets with final test scores as low as 70% could be approved after only two rounds of questioning, whereas strict observance of the 90% level would require a third round of testing.

Furthermore, it means the most important part of readability, the actual understanding of the language used, is not being tested to a 90% criterion.

Simon Andriesen observes:

"National authorities, such as the British MHRA and the Dutch CBG-MEB, treat the criteria flexibly.

In case of low scores, they would expect to see revisions in the leaflet and a better score during the next round.

They seem to be more interested in general improvements and an overall learning curve than in the absolute scores."

Nor is this all. The directive and guideline require readability testing to be done in only one language (at a typical cost of €7,000-10,000 a test). From here on, it is assumed, readability will be assured by flawless translation. This makes large assumptions about the assured fluency, technical understanding and rigor of translators.

So, how many medicine consumers in all those different languages actually can read and understand that little leaflet in the packet? The clear answer is that we really do not know.

Written by: Nick Valentine

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