| Patient Information Leaflets (PIL) Testing | | Print | |
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Readability and usefulness tests will be soon compulsory for the patient information leaflet. A part of the registration dossier for a new pharmaceutical product had been put aside by almost all regulations : the patient information leaflet (PIL). This is changing now ! Day after day, at the mercy of new national, European and worldwide directives and guidelines (in the context of the International Conference on Harmonization between Japan, USA and Europe [ICH]), building a registration dossier for a new pharmaceutical product as well as for a generic compound has become one of the most complex and uphill task. There is however a part of the dossier which was been put aside by almost all regulations, the patient information leaflet (PIL). The Directive 2004/27/EC intends to correct this situation. It is indeed crucial to ensure a good readability and usefulness of the PIL for the final user, i.e. the patient. If the treatment has to be administered by doctors themselves (vaccine, intravenous injection, …), they will be considered as final users and they will have to correctly and fully understand the PIL. This Directive was to come into operation from the end of 2005, but as usual, EU member states, among which Belgium, have delayed the integration of new texts into their own legislation. It should however not be long and it is therefore strongly recommended to pharmaceutical companies to anticipate this new regulation. The European Commission has published guidelines in August 2005 (still a draft). This text explains how to test PILs in target patient groups and how to report the testing results and the impact it had on the PIL to regulatory authorities in the CTD (Common Technical Document) format. It is however very theoretical and does not define the methodology to follow. A limited action freedom is thus left to pharmaceutical companies. Squarepoint-Pointcarré , a CRO dedicated to biostatistics, medical writing and regulatory affairs, and ResearchLink , a Site Management Organization (SMO) with a large network of general practitioners, are happy to announce that they will provide a new service to the pharmaceutical industry to help regulatory departments to fulfil these new European guidelines. The new service provided to pharmaceutical companies will consist of a 6-step package : 1. Analysis of the current leaflet and preparation of evaluation questionnaires (standard to all leaflets and specific to the concerned drug) 2. Planning of the testing methodology a. Target populations b. Number of patients c. Availability of patients 3. Instructions to general practitioners 4. Collection of data 5. Statistical analysis of collected data 6. Report for the regulatory bodies (according to the recommendations of the Directive 2004/27/EC) a. Product description b. Test or consultation details c. Questionnaire i. Method ii. Choice of population iii. Language tested d. Original and revised package leaflets e. Summary and discussion of results f. Conclusion Our ServicesSome useful links : Directive 2004/27/EC The European Commission guidelines Guidance on the user testing of patient Information Leaflets |