Decision of the Council of the Eurasian Economic Commission No. 88 dated November 3, 2016 approved the requirements for the instructions for the medical use of medicinal products and general characteristics of medicinal products for medical use (Summary of Product Characteristics - SmPC), as well as the requirements for providing the results of user testing of the leaflet.
Leaflet user testing:
- Ensures that the patient's opinion about the content, design and layout is taken into account;
- Ensures that the majority of users of a medicinal product can make safe and correct decisions about its use.
Statandocs has developed a unique methodology that allows user testing of the medicinal product leaflet in various therapeutic areas within a short period of time.
The Statandocs methodology includes:
- Analysis for compliance of the leaflet with the requirements of the Decision of the Council of the Eurasian Economic Commission No. 88 dated 03.11.2016;
- Testing of the leaflet in 2 stages. Conducting pilot and main rounds of testing in accordance with the requirements of the EAEU;
- Participation of respondents only from a population representative of a particular medicinal product;
- Development of questionnaires that allow assessing the ability of patients (consumers) to find and understand important information about the medicinal product contained in the leaflet, and based on this information to make safe and correct decisions about its use;
- Development of a protocol for each medicinal product;
- Conducting individual interviews by experienced interviewers. As part of the interview, not only the registration of answers to questions takes place, but also how each participant handles the leaflet and searches for information is monitored;
- Preparation of a test report;
- Conducting testing within a a short period of time and in accordance with applicable regulatory requirements.
The results of the user tests carried out on the leaflets have been successfully accepted by the regulatory authorities.