약국 외에서 판매되는 안전상비의약품 설명서의 난이도 평가

Readability of the Product Labelling Information of Over-The-Counter Pharmaceuticals in Convenience Store

  • 투고 : 2015.01.13
  • 심사 : 2015.03.06
  • 발행 : 2015.03.31

초록

Background: Since November 2012, some of over-the-counter (OTC) medications have been sold in convenience store without pharmacist' s supervision. We purposed to examine if the product labels of OTCs provide sufficient information that is appropriate for consumers who may have low health literacy. Methods: We compared the difficulty of words that are utilized in pharmaceutical product labels of interest (intervention) with those in the $6^{th}$ grade textbook (control). Pharmaceutical products of interest were comprised of 13 OTCs which have been sold currently in convenience stores. We grouped words into the 4 levels of difficulty based on the Korean Vocabulary Classification for Education, and statistically tested words frequency in each level between OTCs and control. Results: The 13 OTC labels included lay language (easier or equal to language used in primary school) about 10% less; professional language about 10% more (p < 0.001 in all). Labels for analgesics had the longest and most difficult information, followed by common cold preparations, muscle pain relievers as plaster or cataplasma and digestives. Conclusion: The 13 OTC labels might fail to provide appropriate information for safety use by consumers in terms of the difficulty level of words. The improvement of labels of OTC medications and consumer education strategies are called for safety use of OTC medications sold in convenience stores.

키워드

참고문헌

  1. Kim CW, Suh H, Yoon JC, et al. National literacy survey. Seoul: The National Institute of The Korean Language, 2008.
  2. Lee I-H, Lee HW, Je NK, et al. Assessment of readability and appropriate usability based on the product labelling of over-the-counter drugs in Korea. Yakhak Hoeji 2012;56(5):333-45.
  3. Song Y-J, Yoo H-J. Exploring the standard and contents of drug labelling among Korea, China and Japan. Korean J Risk Manage 2010;6(2):139-62.
  4. Kim EH, Bang JS. Changes in perception of consumers for non-prescription drug policy since sales begins at the outside of pharmacy. Korean J Clin Pharm 2014;24(3):183-92.
  5. Ko SJ. 2.7-fold increase in side effects of acetaminophen during the recent 3 years. Doctor's news. 2014 October 10 2014. Available from: http://www.doctorsnews.co.kr/news/articlePrint.html?idxno=99278 [accessed December 23, 2014]
  6. Gunn VL, Taha SH, Liebelt EL, et al. Toxicity of over-the-counter cough and cold medications. Pediatrics 2001;108(3):E52. https://doi.org/10.1542/peds.108.3.e52
  7. Sheen CL, Dillon JF, Bateman DN, et al. Paracetamol toxicity: epidemiology, prevention and costs to the health-care system. QJM 2002;95(9):609-19. https://doi.org/10.1093/qjmed/95.9.609
  8. Zarcadoolas C, Pleasant AF, Greer DS. Defining health literacy. Advancing health literacy: A framework for understanding and action. San Francisco, CA: Whiley, 2006;45-67.
  9. U.S. Department of Health and Human Services OoDPaHP. National action plan to improve health literacy. Washington, DC: Author, 2010;
  10. Safeer RS, Keenan J. Health literacy: the gap between physicians and patients. Am Fam Physician 2005;72(3):463-8.
  11. Bazaldua OV, Kripalani S. Health literacy and medication use. In: DiPiro JT, Talbert RL, Yee GC, et al., eds. Pharmacotherapy: A pathophysiologic approach. 8th ed. Columbus, OH: McGraw-Hill Education, LLC., 2011;5-6.
  12. Lee SY, Yoon KJ, Lee JA. Changes in utilization and perception of OTC medications before and after convenience stores selling. Seoul: Korea Institute for Health and Social Affairs, 2013.
  13. Sohn S, Kwon K. Health right and labelling system of drugs for convenience store. Crisis and Emergency Management: Theory and Praxis 2014;10(8):99-117.
  14. Health Literacy Innovations. National survey of Medicaid guidelines for heatlh literacy. Health Literacy Innovations, 2007.
  15. Kim K. Korean vocabulary for education. Seoul: Pagijong press, 2003.
  16. Natmal. Institute of Korean Vocabulary Classification. 2008. Available from: http://www.natmal.com/ [accessed February 27, 2015].
  17. Kwon KH. Pharmaceutical products: Consumer information must be provided in accord with the purposes of product. 2012. Available from: http://www.kfda.go.kr/webzine/201201/12jan/kfda/ibook43.html [accessed January 5, 2015].
  18. Nam SJ, Yoo HJ. Information on medication and consumer competency. Consumption Culture Study 2010;13(1):21-37.
  19. Krypel LL. Constructing a self-care curriculum. Am J Pharm Educ 2006;70(6):140. https://doi.org/10.5688/aj7006140
  20. Park S, Park EJ, Chae SM. Comparative analysis of drug labeling. Health-welfare Policy Forum 2010;160:40-55.
  21. Raynor DK, Knapp P, Silcock J, et al. "User-testing" as a method for testing the fitness-for-purpose of written medicine information. Patient Educ Couns 2011;83(3):404-10. https://doi.org/10.1016/j.pec.2011.03.016
  22. Brooke RE, Herbert NC, Isherwood S, et al. Balance appointment information leaflets: employing performance-based user-testing to improve understanding. Int J Audiol 2013;52 (3):162-8. https://doi.org/10.3109/14992027.2012.745200
  23. Knapp P, Raynor DK, Silcock J, et al. Can user testing of a clinical trial patient information sheet make it fit-for-purpose?--a randomized controlled trial. BMC Med 2011;9:89. https://doi.org/10.1186/1741-7015-9-89
  24. Haynes RB, Ackloo E, Sahota N, et al. Interventions for enhancing medication adherence. Cochrane Database of Syst Rev 2008;2: CD000011.
  25. Lee IH, Kye S, Lee S. Consumer perspectives and utilization of drug information in Korea. Korean J Clin Pharm 2013;23(4):334-43.