User testing of drug's instruction

In accordance with Decision N88 of the Council of the Eurasian Economic Commission of November 3, 2016, the requirement for the mandatory provision of an insert leaflet for the user was added to the instructions for medical use (IMP) of prescription medicines, as well as user testing of the package insert to confirm its compliance with all the requirements of the regulator.

Why is the user testing of the package leaflet important?

The information contained in the package insert should be easy to find, understandable and legible, and presented in a clear and concise manner. The organization of the presented data is also important to ensure ease of use and understanding of complex information. The simple design package insert helps as many patients as possible find and use the information they need to use the drug in the safest and most effective way.

In order to determine the compliance of the package leaflet with the requirements of the regulator, user testing is carried out, as a result of which at least 90% of test participants must find the information requested from them, and 90% of them must understand this information.

For conducting user testing, ResearchView developed a specialized methodology that fully complies with the requirements of the regulator. Since 2018 to date, ResearchView has regularly conducted this kind of custom testing of drug leaflets in various therapeutic areas: infectious diseases, rheumatology, women's health and many others.

What tasks does user testing solve?

The tests carried out showed how the package leaflets work in practice, allowed to identify obstacles that reduce the ability of people to understand and use the information presented, and also identified problem areas that require additional attention. In particular, the influence of the design of the section headings, the font size of the text, the logic of the arrangement of information in the sections, the complexity and length of the formulations on the success of the search and understanding of the necessary information was revealed.

What research methods are used?

Qualitative methods are used for testing, namely individual interviews. The recruited respondents have to meet the main criteria of the target audience of the study drug and be able to adequately test the text of the instruction.

ResearchView is happy to share its experience in user testing with pharmaceutical companies. In the shortest possible time and according to the approved methodology, our agency conducts drug testing and provides full reporting with the conclusion of the established form, in accordance with the requirements of the Ministry of Health of the Russian Federation.

In our agency, you can order user testing of the package leaflet, leaving your details in the feedback form or by calling us on the contact phone number. Our research will allow you to get the necessary conclusion for submitting the dossier and registering the drug in the Ministry of Health of the Russian Federation.