As mentioned in our last article, within the framework of bringing the dossier into compliance with the requirements of the EAEU, it may be necessary to provide the patient leaflet (PL) and the results of readability test (more on this: https://beawire.com/ru/2020/09/21/procedure-for-bringing-the-registration-dossier-in-line-with-the-requirements-of-the-eaeu/). In this article we will try to elaborate on the readability test and the necessary format of its provision.
Readability test is analytical methods aimed at studying readability, comprehensiveness and ease of perception of PL by target groups of patients. The purpose of incorporating readability test as a supplement to the PL is to improve the PL developed and submitted in the registration file and, as a result, to create a PL that allows most users of the drug make safe and correct decisions about its use.
According to the requirements of Decision No. 78, when presenting the results of readability test, it is necessary to summarize how the testing was performed and how to the final revision of the PL was obtained. A summary should be provided in section 3.3. of Module 1 (1.3.3.), in the following form:
- brief description of the medicine;
- a brief description of the test or study of individual elements of the PL (used method, explanations of criteria for selecting participants for testing, language of testing);
- used questionnaires (questionnaires, including instructions for completing them and monitoring forms);
- original and revised version of the PL;
- brief description and discussion of test results (responses of subjects, identified problems and changes made to the relevant sections of the PL);
It should be noted that regulatory authorities give an example of readability test in Appendix 17 to Decision No. 78, but also accept other methods. Ultimately, experts assess data showing that people who will use PL are able to find the necessary information and take advantage of it properly.
It is also important to say that decision No. 78 contains the form of the Preliminary Summary Report on Critical Assessment of PL, which specifies the criteria for evaluating the results of the testing (Document quality verification sheet to review the results of readability testing). This list contains several basic verification blocks:
- Product information (name of the medicine; name and address of the applicant; name of the company that conducted readability testing; etc.)
- Technical assessment (Questionnaire; Temporary aspects, etc.)
- Assessment of patient responses (Evaluation system; rating system of questions)
- Data Processing
- Quality Aspects (Assessment of diagnostic issues; Evaluation of layout and design)
- Quality of diagnostics (assessment) (Whether weaknesses of PL are eliminated)
- Conclusion (Whether expert opinions are true; whether tasks are solved)
More information about readability testing can be obtained by contacting us: firstname.lastname@example.org
- THE EURASIAN ECONOMIC COMMISSION SOLUTION N 78 ON THE RULES FOR REGISTRATION AND EXAMINATION OF MEDICINES FOR MEDICAL USE;
- Materials of the Scientific and Practical Conference “Expertise and registration of medicines in the EAEU” ReGLEK — EAEU 2020