Readability testing of patient information leaflets (PIL)
We are still looking for volunteers to participate to this tests. An online registration form can be found here (Dutch version).
This page recapitulates all the necessary information a pharmaceutical company needs to organise and evaluate PIL readability testing. aMACE will keep on informing you about all the latest updates of regulatory reports and requirements. aMACE can help with the concrete planning and elaboration of all your national or European readability tests.
For more concrete information or a quotation (without engagement), don’t hesitate to contact us (info@amace.eu).
aMACE’s PIL readability test phases
Main test requirements
Language requirements
The PIL readability test can be undertaken in one of the European Economic Area languages.
For European procedures, reporting of the results has to be in English.
For national procedures, the report should be made or in English or in one of the national languages. If the report is made in English, at least the front page and the conclusions should be translated in one of the official national languages.
Test objectives
The PIL readability test focuses on readability (ease to read a text) as well as legibility (typeface and layout).
The readability test must optimize the ease to find and understand all the key information of the patient information leaflet, in order to pursue an appropriate use of the drug:
- intake of the right dose at the right moment
- refer to the physician when necessar
- avoid interactions with other drugs and food
Test methodology
The PIL readability test should be designed in such a way that it can demonstrate traceability (the ease to find the relevant information) and comprehensibility (the ease to understand and interpret the information) of the patient information leaflet.
At least 20 people should be tested in at least 2 testing rounds (10 + 10).
The PIL should be corrected after the first round, according to the test results (readability and legibility!). If the results are not satisfactory after the second round, one test round (or more) should be included.
Before starting the testing round it is preferable to test the clarity of the questionnaire in a pilot phase with 3-5 consumers.
The PIL will be judged as ‘readable’ if 90% of the consumers can find the information and 90% of them also understand the information (90% /90% rule).
The PIL testing should be done according to the Australian method (e.g. using face to face interviews). Scientifically qualified co-workers of aMACE conduct these interviews with people recruited out of a well-determined pool of consumers/patients.
aMACE has a lot of expertise in developing reliable questionnaires to identify if the key messages are well found and understood:
- What is the product used for?
- What is the correct dosage and frequency of administration?
- Are there any undesirable effects?
- How to react to warnings and safety information?
- Is the use during pregnancy and lactation safe?
- Are there particular contraindications or interactions?
Bridging
Bridging should apply to leaflets that are sufficiently similar in content, writing style and layout (e.g. use of pictograms, fonts, colours and paper size and weight) for medication with the same active ingredient or, in some cases, within the same therapeutic class.
PILs of combination products can be bridged with the PILs of the separate ingredients in case the indication and the safety profile does not differ from the individual components.
A successful user test on one PIL (parent PIL) can be used to support a justification for not testing other similar leaflets (daughter PIL). In some cases, a daughter PIL can rely on more than one parent PIL readability test.
Communication experts in our aMACE team will help you to judge the feasibility for bridging and the development of motivational reports.
Specific Belgian requirements
- All safety issues must be addressed
- User testing is very important for OTC-drugs and is required for every Rx to OTC-switch.
- User testing is required in case of the registration of a new drug (new active substance) and acceptance of line extension.
- User testing is also needed when particular critical safety issues are added to the PIL.
For those who want to read more…
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