;   Medical Translation Insight: Requirements for readability testing of PILs - ForeignExchange Translations

Requirements for readability testing of PILsSince 2005, marketing authorization holders of medicines are required to have the patient information leaflets (PILs) for their products readability tested.

European Directive 2004/27/EC [PDF link] defines it as follows:

The package leaflet shall reflect the results of consultations with target patient groups to ensure that it is legible, clear and easy to use' (art. 59-3)
The results of assessments carried out in cooperation with target patient groups shall also be provided to the competent authorities (art. 61-1)
But as is of the case with many Directives, there is no absolutely clear information on how readability tests should be performed.

The regulatory authorities want to ensure that PILs were tested in a professional manner and that patients would be able to find the requested information, understand it and act appropriately. Most providers of readability test services use the method that is described in the revised (2009) EC Readability Guideline:
At least 90% of test participants should be able to find the requested information, and of those again, 90% should understand the information.
But as the European Directive uses terms such as "readable", "clear", and "understandable", it is still not totally clear how readable a leaflet has to be.

One of the experts on this topic is Simon Andriesen of MediLingua. His presentation Readability Testing for Patient Information in Europe sheds light on many of the difficult, hands-on issues faced by practitioners:
  • Where and how to recruit "average persons"
  • Formulating testing questions
  • Test score differences between men and women, old and young, education levels
  • Using readability testing for other types of documents

If you are at all connected with QRDs, pharmaceutical labeling, or, usability testing, be sure to listen in!

ForeignExchange Translations provides specialized medical translations for electronic as well as paper-based regulatory submissions. Contact us to find out more.


  1. Waqas Sial said...
    Since last 5 years we have been reading patient information leaflets addressing directly to patients, but as far as my region is concerned (Middle East, Africa and Asia) I do not find any guidelines on these.
    In my opinion this leaflet should cover at least all the information directly related to the drug indication, usability, precautions, contraindications, interactions, storage and disposal. (this is normally seen in these leaflets).

    We also see such leaflets for Oncology products directly addressing patients but in such leaflets "information for medical professionals" is also given separately.

    [Via LinkedIn]
    Marion Frank said...
    There is a Guidance available from EMA how to do this and today there are a number of agencies already out there specialized on preparing and performing readability testing.

    In 2005 I was involved in a testing for a new prescription brand and at those times none of these agencies were yet around. We started the testing early and worked together with a market research agency. It took us two rounds until the PI leaflet was easy enough to understand.
    What we learned later on then was that it is critical to find a consistent and understandable wording for the side effects. This is important throughout a company but also across products including products from other companies. therefore I assume today there must be a guidance out there for consistent wording.

    [Via LinkedIn]

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