Readability testing: user testing of the package leaflet

Article 59(3) of Directive 2001/83/EC requires the package leaflet to reflect the results of consultations with target patient groups to ensure that it is legible, clear and easy to use, and Article 61(1) requires the results of those assessments to be submitted with the application. The Commission's guideline on the readability of the labelling and package leaflet of medicinal products for human use, revised in January 2009, describes the accepted method. The common approach is a diagnostic user test: a structured interview in which participants from the target population are asked to find specified items of information in the leaflet and to show that they understand them. The guideline's benchmark is that 90% of participants can find each item and that 90% of those can act on it correctly, tested in two rounds of ten participants with the leaflet improved between rounds, although other methods that meet the same aim are acceptable.

A full test is expected for a new leaflet, for example at first authorisation or when the leaflet is restructured. Where a leaflet is close to one that has already been tested, the applicant can submit a bridging report that explains why the earlier test covers the new text, which is the usual route for generics, line extensions and later variations. Some authorities also accept a focus test for small changes. The report describes the participants, the questions, the results of each round and the changes made, and the authority reviews it as part of the assessment of the product information.

What goes wrong: tests are run on an English draft and the national leaflets are never checked; the test uses a leaflet that is later rewritten on the QRD template, so the tested text is not the approved text; bridging arguments stretch too far, for instance from a tablet leaflet to an injection; participants are recruited from staff rather than patients; and the key safety messages that the authority expects to be tested, such as what to do after a missed dose, are not among the questions. In mutual recognition and decentralised procedures a concerned member state may ask for the test report or a bridging justification late in the procedure, so it has to be ready before Day 0.