Evaluation of summary of product characteristics and patient information leaflet of the best-selling drugs in Turkey in terms of readability

Abstract

Background and Aims: Readability can be defined as the easiness or difficulty of texts to be understood by readers. In our study, it was aimed to evaluate the patient information leaflet and the summary of product characteristics in terms of readability in Turkish. Methods: Our study is a cross-sectional study. For our study, the best-selling drugs included in the "Turkish Pharmaceutical Market Monitoring Report-8, 2020 Market Status in Terms of Sales Volume and Value" prepared by the Turkish Medicines and Medical Devices Agency in 2021, were evaluated by using Turkish readability formulas (Ateşman and Bezirci-Yılmaz). Results: 138 patient information leaflet and summary of product characteristics of a total of 69 products were evaluated. It has been determined that an average of at least undergraduate education is required for the readability of the texts. The patient information leaflets are significantly shorter than the summary of product characteristics (p=0.000). However, in terms of readability, it was easier in Ateşman calculation and more difficult in Bezirci-Yılmaz calculation (p=0.007 and p=0.000, respectively). Conclusion: It has been seen that patient information leaflets are not easy to read texts prepared for patients. While preparing the texts to be read by the patients, the texts should be easily understandable and should be read and understood by people of all education levels.