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

Year 2022, Volume: 52 Issue: 3, 342 - 348, 30.12.2022

Ersan Gürsoy , Kenan Taştan , Mehmet Akif Nas , İdeal Beraa Yılmaz Kartal

https://doi.org/10.26650/IstanbulJPharm.2022.1123242

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 read- ability 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 read- ability, 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 prepar- ing 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.

Keywords

health literacy, comprehension, Pharmaceutical Preparations, Prospectus

Project Number

yoktur

References

• Ateşman, E. (1997). Türkçede okunabilirliğin ölçülmesi. Dil Dergisi, 58(71-74).
• Auwal, F. I., Tanimu, M., Samira, A.-A., & Hadiza, M. A. (2022). As- sessment of knowledge and attitude of undergraduate students’ of Ahmadu Bello University Zaria towards depression. İstanbul Journal of Pharmacy, 52(1), 96-100.
• Ay, İ. E., & Duranoğlu, Y. (2022). Göz damlası prospektüslerinin okunabilirlik düzeyinin değerlendirilmesi. Anatolian Clinic the Journal of Medical Sciences, 27(1), 55-59.
• Baker, D. W., Parker, R. M., Williams, M. V., & Clark, W. S. (1998). Health literacy and the risk of hospital admission. Journal of gen- eral internal medicine, 13(12), 791-798.
• Bezirci, B., & Yilmaz, A. E. (2010). Metinlerin okunabilirliğinin ölçülmesi üzerine bir yazilim kütüphanesi ve Türkçe için yeni bir okunabilirlik ölçütü. Dokuz Eylül Üniversitesi Mühendislik Fakültesi Fen ve Mühendislik Dergisi, 12(3), 49-62.
• Calkins, D. R., Davis, R. B., Reiley, P., Phillips, R. S., Pineo, K. L., Delbanco, T. L., & Iezzoni, L. I. (1997). Patient-physician communication at hos- pital discharge and patients’ understanding of the postdischarge treatment plan. Archives of Internal Medicine, 157(9), 1026-1030.
• Desideri, I., Francolini, G., Ciccone, L., Stocchi, G., Salvestrini, V., Aquilano, M., . . . Scotti, V. (2021). Impact of COVID-19 on patient– doctor interaction in a complex radiation therapy facility. Sup- portive Care in Cancer, 29(6), 2931-2937.
• Enlund, H., Vainio, K., Wallenius, S., & Poston, J. W. (1991). Adverse drug effects and the need for drug information. Medical care, 29(6), 558-564.
• Erdoğan, Ö. N., & Araman, A. O. (2017). Health beliefs and func- tional health literacy; Interaction with the pharmaceutical ser- vices. İstanbul Journal of Pharmacy, 47(2), 68-71.
• Ilbars, H., & Özkan, S. (2020). Understanding of Turkish pharma- cists health literacy knowledge, attitudes, and behavior. İstanbul Journal of Pharmacy, 50(1), 64-70.
• Kanj, M., & Mitic, W. (2009). Promoting health and development: closing the implementation gap. Paper presented at the Unpub- lished conference document, 7th global conference on health promotion. Nairobi, Kenya: October.
• Kitching, J. (1990). Patient information leaflets-the state of the art. Journal of the Royal Society of Medicine, 83(5), 298-300.
• Makaryus, A. N., & Friedman, E. A. (2005). Patients’ understanding of their treatment plans and diagnosis at discharge. Mayo clinic proceedings, 80(8), 991-994.
• Nielsen-Bohlman, L., Panzer, A. M., & Kindig, D. A. (2004). Health literacy: a prescription to end confusion. Washington, DC, USA: Na- tional Academies Press.
• Philipson, S. J., Doyle, M. A., Gabram, S., Nightingale, C., & Philip- son, E. H. (1995). Informed consent for research: a study to evalu- ate readability and processability to effect change. Journal of in- vestigative medicine 43(5), 459-467.
• Sağlık Bakanlığı. (2005). Beşeri Tıbbi Ürünler Ruhsatlandırma Yönetmeliği. Retrieved from https://www.resmigazete.gov.tr/es- kiler/2005/01/20050119-7.htm
• Sağlık Bakanlığı. (2021). Türkiye İlaç Pazarı Gözlem Raporu-8 Satış Hacmi ve Değeri Açısından 2020 Yılı Pazar Durumu. Ankara: Sağlık Bakanlığı Yayınları.
• Solak, E., & Bayar, A. (2015). Current challenges in English lan- guage learning in Turkish EFL context. Participatory Educational Research, 2(1), 106-115.
• Türkiye İlaç ve Tıbbi Cihaz Kurumu. (2007). Kısa Ürün Bilgisine ilişkin Kılavuz. Retrieved from https://www.titck.gov.tr/mev- zuat/2103
• Türkiye İlaç ve Tıbbi Cihaz Kurumu. (2008). Kullanma Talimatı Stan- dart Değerlendirme Prosedürü Retrieved from https://titck.gov. tr/storage/legislation/726b1e1355118.pdf
• Türkiye İstatistik Kurumu. (2020). Türkiye İstatistikleri. Retrieved from https://www.tuik.gov.tr/media/announcements/turkiye_ istatistikleri_2020.pdf
• Vishnevetsky, J., Walters, C. B., & Tan, K. S. (2018). Interrater reliabil- ity of the patient education materials assessment tool (PEMAT). Patient Education and Counseling, 101(3), 490-496.
• Williams, M. V., Baker, D. W., Parker, R. M., & Nurss, J. R. (1998). Re- lationship of functional health literacy to patients’ knowledge of their chronic disease: a study of patients with hypertension and diabetes. Archives of Internal Medicine, 158(2), 166-172.