| For a year now, the regulatory affairs departments of pharma companies have faced a new burden: readability testing of patient information leaflets. Simon Andriesen at MediLingua reports on ‘best practices’ based on some eight months of testing
Since November 2005 (and in the UK since July 2005), manufacturers of medicinal products are legally required to have their patient information leaflets (PILs) readability-tested in order to get their products approved. European Directive 2001/83/EC, as amended by Directive 2004/27/EC, defines that these leaflets should be “legible, clear and easy to use”, and that the manufacturer has to deliver a readability test report (with a positive conclusion) to the authorities. Currently, this requirement is concerned with new or significantly revised products, but eventually, patient information leaflets for most existing products will have to be tested too. According to the (British) Medicines and Healthcare products Regulatory Agency (MHRA), the reason for testing is “to help produce a leaflet that most medicine users can use to take safe and accurate decisions about their medicines”.
So, the leaflet has to be legible, clear and easy to use. 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 (see Different Criteria), providers of readability test services have extracted their own test methods, 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.
TEST PREPARATION
Any readability test project begins with a preparation phase, during which the text of the leaflet is carefully edited and checked, spelling or grammatical errors are corrected and sentences are rephrased. This is an important step: approximately 70% of all changes in the leaflet are made during the preparation phase. It is important to make sure that the leaflet complies with the template published by the Quality Review of Documents (QRD) group of the European Medicines Agency (EMEA). This template is available in 25 European languages; the English version is annotated with instructions (for leaflet writers) about what information has to be placed under the various headings. The templates can be downloaded from the EMEA website (1). |
