Leaflet readability tests

Leaflet readability tests

Poster

Vasko Georgiev, Emil Hristov, Kalina Andreevska, Tzvetomir Delyiski
Faculty of Chemistry and Pharmacy, Sofia University "Saint Kliment Ohridski", Bulgaria

Aim of the study: To study the requirements and regulations for conducting the leaflet readability tests provided with each medicine. Materials and methods: A documentary analysis of the following regulatory documents has been carried out: Directive 2001/83, the Law on Medicinal Products in Human Medcine, Art. 26, Instructions on the page of the BDA. Results: The package leaflet should reflect the results of the consultation with the target patient groups to ensure that it is legible, clear and easy to use and that the results of the evaluations carried out in cooperation with the target patient group are made available to the competent authority. One of the methods for assessing the leaflet's level of readability is User testing. In bridging, the successful test of the intelligibility level of a leaflet [mother leaflet] can be used as a reason not to test other similar leaflets [daughter leaflets]. The results of the legibility tests shall be presented in the form of a summary which must be included in Module 1.3.4 of the application for authorization of the medicinal product concerned. Discussion: Leaflet readability tests provide information on the level of understanding of the medicinal product by patients and are part of the application for authorization of medicinal products.
Keywords: leaflet comprehension level, User testing, bridging