Archive \ Volume.15 2024 Issue 1

Patient Information Leaflets: How Do Patients Comprehend and Understand Drug Information?

Aleksandar Rašković , Maja Steinbach , Snežana Mugoša , Jovan Baljak*✉ , Dušan Prodanović , Stanislav Sabo , Dragica Bukumirić , Boris Milijašević , Milica Paut Kusturica
  1. Department of Pharmacology, Toxicology and Clinical Pharmacology, Faculty of Medicine Novi Sad, University of Novi Sad, Novi Sad, Serbia.
  2. Agency for Medicines and Medical Devices of Montenegro, Podgorica, Montenegro.
  3. Department of pharmacotherapy, Faculty of Medicine, University of Montenegro, Podgorica, Montenegro.
  4. Faculty of Medicine Novi Sad, University of Novi Sad, Novi Sad, Serbia.

  5. Institute of Health Disciplines, St. Elizabeth University of Health and Social Work, Bratislava, Slovakia.

  6. Department of Planning, Analyzing and Statistics, Primary Healthcare Center, Pančevo, Serbia.


Abstract

Pharmaceutical manufacturers are obligated by national drug regulations to provide package information leaflets (PIL), which is a patient-friendly form of the Summary Product Characteristics (SmPC). The main objective of this study was to evaluate whether and how these patients in Montenegro read PILs and to get insight into patients' opinions regarding comprehension and usefulness of said leaflets. The survey was conducted on randomly recruited patients at a private pharmacy in Podgorica, Montenegro. The survey was conducted in September 2019 on randomly recruited patients (>18 years of age) at the private pharmacy in Podgorica. Number of patients who read PILs, way and frequency of reading PILs, patients' opinions on clearness and usefulness of PILs. Of the 200 patients asked to participate in this research, 126 (63% response rate) filled out the questionnaire. The majority of the respondents thought that it is important to read the patient information leaflet (76.2%) and most of them (75.4%) reported that they always read the leaflet. Less than half of those who read the PIL read it thoroughly (47.9%). Around half of patients reported that the terms and expressions in leaflets are partially understandable (53.7%). After reading the leaflet, around a third of the patients often feel confused (28.1%) or anxious (32.5%). To improve the quality of the information, PILs need to convey the potential risk information in a language that is less fear-provoking.


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Vancouver
Rašković A, Steinbach M, Mugoša S, Baljak J, Prodanović D, Sabo S, et al. Patient Information Leaflets: How Do Patients Comprehend and Understand Drug Information? Arch Pharm Pract. 2024;15(1):7-11. https://doi.org/10.51847/n2jlaSAlbK
APA
Rašković, A., Steinbach, M., Mugoša, S., Baljak, J., Prodanović, D., Sabo, S., Bukumirić, D., Milijašević, B., & Kusturica, M. P. (2024). Patient Information Leaflets: How Do Patients Comprehend and Understand Drug Information? Archives of Pharmacy Practice, 15(1), 7-11. https://doi.org/10.51847/n2jlaSAlbK

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References
  1. Nualdaisri P, Corlett SA, Krska J. Provision and need for medicine information in Asia and Africa: A scoping review of the literature. Drug Saf. 2021;44(4):421-37.
  2. Bolislis WR, Mortazavi C, Riccioni R, Schaeffer PE, Kühler TC. From print to screen: Regulatory considerations to adopting innovative approaches for patient information and safety. TIRS. 2020;54:831-8.
  3. Herber OR, Gies V, Schwappach D, Thürmann P, Wilm S. Patient information leaflets: Informing or frightening? A focus group study exploring patients' emotional reactions and subsequent behavior towards package leaflets of commonly prescribed medications in family practices. BMC Fam Pract. 2014;15(1):163.
  4. Medina-Córdoba M, Cadavid S, Pérez-Acosta AM, Amaya-Giraldo V. Factors that facilitate and hinder the comprehension of patient information leaflets (pils): A brief scoping review. Front Pharmacol. 2021;12:740334.
  5. Pongpunna S, Pratipanawatr T, Jarernsiripornkul N. Survey of outpatients’ use and needs of patient medicine information leaflets in Thailand. Int J Clin Pharm. 2019;41:141-50.
  6. Leemans L, Heylen N, Quanten A, Deferme S. Consumer study on the use of patient information leaflets. J Pharm Belg. 2011;4:109-16.
  7. Almanasef M. Patient information leaflet in the era of digitalisation: A cross-sectional study on patients’ attitudes and practices. Ir J Med Sci. 2023:1-6.
  8. Al-Shamaileh AW, Aljarajreh AM, Dahmash Ez, Dayyih Wa, Khaleel A. Patient-information-leaflets (PILs) awareness and knowledge investigation in Jordan. Int J Pharm Res. 2021;13(1).
  9. Young A, Tordoff J, Smith A. ‘What do patients want?’ Tailoring medicines information to meet patients' needs. Res Social Adm Pharm. 2017;13(6):1186-90.
  10. Mullen RJ, Duhig J, Russell A, Scarazzini L, Lievano F, Wolf MS. Best-practices for the design and development of prescription medication information: A systematic review. Patient Educ Con. 2018;101(8):1351-67.
  11. Dwyer CP, Joyce RA, Rogers F, Hynes SM. Comparing the effects of a patient-designed-and-informed participant information leaflet in comparison with a standard, researcher-designed information leaflet on recruitment, retention and understanding: A study-within-a-trial. Contemp Clin Trials Commun. 2022;28:100936.
  12. Hunt WT, Sofela J, Mohd Mustapa MF, British Association of Dermatologists’ Clinical Standards Unit, Levell NJ, McDonald B, et al. Readability assessment of the British association of dermatologists’ patient information leaflets. Clin Exp Dermatol. 2022;47(4):684-91.
  13. Al Jeraisy M, Alshammari H, Albassam M, Al Aamer K, Abolfotouh MA. Utility of patient information leaflet and perceived impact of its use on medication adherence. BMC Public Health. 2023;23(1):488.
  14. Mühlbauer V, Prinz R, Mühlhauser I, Wegwarth O. Alternative package leaflets improve people’s understanding of drug side effects—A randomized controlled exploratory survey. PLoS One. 2018;13(9):e0203800.
  15. Fayyad M, Hassanein M, Al-Hiari AI, Othman AM, Abduelkarem AR. Consumer medication information: Legislative gap and challenges of practice. Pharm Pract. 2023;21(3):1-9.

 


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