Evaluation of patient comprehension and quality of consumer medicine information
Main Article Content
Keywords
Consumer Health Information, Assessment, Patient Safety
Abstract
Background: Consumer medicine information (CMI) is voluntarily produced by pharmaceutical manufacturers in Thailand, but quality assessment of Thai- CMI is not routinely performed. Objective: This study aimed to evaluate the content and design quality of CMI available in Thailand and assess patient understanding of the medicine information provided. Methods: A cross-sectional study that consisted of two phases. Phase 1 was expert assessment of CMI using 15-item content checklists. Phase 2 was patient assessment of CMI by user-testing and the Consumer Information Rating Form. Participants (n=130) were outpatients aged 18 years or older with an educational level of less than grade 12. Self-administered questionnaires were distributed to patients at two university-affiliated hospitals in Thailand. Results: A total of 60 CMI produced by 13 Thai pharmaceutical manufacturers were included in the study. Most of the CMI contained essential information about the medicines, but lacked information about serious adverse effects, maximum dose, warnings, and use in specific patient groups. Of 13 CMI selected for user-testing, none met the passing criteria with only 40.8% – 70.0% of answers found in the correct position and answered correctly. The mean values of patients’ rating the CMI were between 2.5 (SD=0.8) and 3.7 (SD=0.5) for utility on a 4-point scale, and 2.3 (SD=0.7) to 4.0 (SD=0.8) for comprehensibility and 2.0 (SD=1.2) to 4.9 (SD=0.3) for design quality on a 5-point scale. Eight CMI were rated as poor (less than 3.0) for font size. Conclusion: More safety information about medications should be included in Thai CMI and the design quality must be improved. CMI needs to be evaluated before distribution to consumers.
References
2. Shrank WH, Avorn J. Educating patients about their medications: the potential and limitations of written drug information.Health Aff (Millwood). 2007;26(3):731-740. https://doi.org/10.1377/hlthaff. 26. 3.731
3. Pires C, Vigário M, Cavaco A. Readability of medicinal package leaflets: a systematic review. Rev Saude Publica. 2015;49:4.https://doi.org/10.1590/s0034-8910.2015049005559
4. Steering Committee for the Collaborative. Development of a Long-Range Action Plan for the Provision of Useful Prescription Medicine Information. 1996. Available: http://www.keystone.org/ spp/documents/ FinalActionplan.pdf. Accessed 8 September 2021.
5. European Commission. Guideline on the Readability of the Labelling and Package Leaflet of Medicinal Products for Human Use. 2009. Available: https://ec.europa.eu/health/sites/ /files/files/eudralex/ vol-2/c/2009_01_12_readability_ guideline_final_en.pdf. Accessed 8 September 2021.
6. Sustersic M, Gauchet A, Foote A, et al. How best to use and evaluate patient information leaflets given during a consultation:a systematic review of literature reviews. Heal Expect. 2017;20(4):531-542. https://doi.org/10.1111/hex.12487
7. Tong V, Raynor DK, Aslani P. Design and comprehensibility of over-the-counter product labels and leaflets: a narrative review.Int J Clin Pharm. 2014;36(5):865-872. https://doi.org/10.1007/s11096-014-9975-0
8. Jay E, Aslani P, Raynor D. User testing of consumer medicine information in Australia. Health Educ J. 2011;70(4):420-427.https://doi.org/10.1177%2F0017896910376131
9. Medicine Act B.E. 2510. (1967). Available: http://web.krisd ika.go.th/data/law/law2/ %C204/%C204-20-9999-updat e.pdf.Accessed 6 July 2021.
10. Raynor DK. User testing in developing patient medication information in Europe. Res Social Adm Pharm. 2013;9(5):640-645.https://doi.org/10.1016/j.sapharm.2013.02.007
11. Division of Innovative Health Products and Services, Food and Drug Administration (2020). Thai database of patient information leaflets. Available: https://www.fda.moph.go.th/sites/ oss/SitePages/.aspx. Accessed 6 July 2021.
12. Medicines and Healthcare Products Regulatory Agency. Best Practice Guidance on Patient Information Best Practice Guidance on Patient. 2012. Available: https://www.gov.uk/ government/ uploads/system/uploads/attachment_data/file/328405/Best_practice_guidance_on_patient_information_leaflets.pdf. Accessed 6 July 2021.
13. Koo MM, Krass I, Aslani P. Evaluation of written medicine information: validation of the consumer information rating form. AnnPharmacother. 2007;41(6):951-956. http://dx.doi.org/10.1345/aph.1K083
14. Hill J, Bird H. The development and evaluation of a drug information leaflet for patients with rheumatoid arthritis. Rheumatology (Oxford). 2003;42(1):66-70. https://doi.org/10.1093/rheumatology/keg032
15. Morris. Effects of written drug information on patient’s knowledge and compliance: a literature review. Am J Public Health. 1979;69(1):47-52. https://doi.org/10.2105/ajph.69.1.47
16. Davis TC, Wolf MS, Bass PF, et al. Literacy and misunderstanding prescription drug labels. Ann Intern Med. 2006;145(12):887-894. https://doi.org/10.7326/0003-4819-145-12-200612190-00144
17. Wolf MS, Davis TC, Osborn CY, et al. Literacy, self-efficacy, and HIV medication adherence. Patient Educ Couns. 2007;65(2):253-260. https://doi.org/10.1016/j.pec.2006.08.006
18. Phueanpinit P, Pongwecharak J, Krska J, et al. Medicine information leaflets for non-steroidal anti-inflammatory drugs in Thailand. Int J Clin Pharm. 2016;38(1):25-29. https://doi.org/10.1007/s11096-015-0220-2
19. Rolfes L, van Hunsel F, Taxis K, et al. The impact of experiencing adverse drug reactions on the patient’s quality of life: a retrospective cross-sectional study in the Netherlands. Drug Saf. 2016;39(8):769-776. https://doi.org/10.1007/s40264-016-0422-0
20. Schmitz J, Kamping S, Wiegratz J, et al. Impact of patient information leaflets on pain medication intake behavior: a pilot study. Pain Rep. 2017;2(6):e620. https://doi.org/10.1097/pr9.0000000000000620
21. Berry DC, Raynor DK, Knapp P. Communicating risk of medication side effects: an empirical evaluation of EU recommended terminology. Psychol Heal Med. 2003;8(3):251-263. https://doi.org/10.1080/1354850031000135704
22. Young SD, Oppenheimer DM. Different methods of presenting risk information and their influence on medication compliance intentions: results of three studies. Clin Ther. 2006;28(1):129-139. https://doi.org/10.1016/j.clinthera.2006.01.013
23. Büchter RB, Fechtelpeter D, Knelangen M, et al. Words or numbers? Communicating risk of adverse effects in written consumer health information: a systematic review and meta-analysis. BMC Med Inform Decis Mak. 2014;14:76. https://doi.org/10.1186/1472-6947-14-76
24. Knapp P, Gardner PH, Carrigan N, et al. Perceived risk of medicine side effects in users of a patient information website: a studyof the use of verbal descriptors, percentages and natural frequencies. Br J Health Psychol. 2009;14(Pt 3):579-594. https://doi.org/10.1348/135910708x375344
25. Al-Aqeel SA. Evaluation of medication package inserts in Saudi Arabia. Drug Healthc Patient Saf. 2012;4:33-38. https://doi.org/10.2147/dhps.s29402
26. Shivkar YM. Clinical information in drug package inserts in India. J Postgrad Med. 2009;55(2):104-107. https://doi.org/10.4103/0022-3859.52840
27. Liu F, Abdul-Hussain S, Mahboob S, et al. How useful are medication patient information leaflets to older adults? A content,
readability and layout analysis. Int J Clin Pharm. 2014;36(4):827-834. https://doi.org/10.1007/s11096-014-9973-2
28. Steinmetz KL, Coley KC, Pollock BG. Assessment of geriatric information on the drug label for commonly prescribed drugs inolder people. J Am Geriatr Soc. 2005;53(5):891-894. https://doi.org/10.1111/j.1532-5415.2005.53273.x
29. 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):404-410. https://doi.org/10.1016/j.pec.2011.03.016
30. Maat HM, Lentz L. Improving the usability of patient information leaflets. Patient Educ Couns. 2010;80(1):113-119. https://doi.org/10.1016/j.pec.2009.09.030
31. Desplenter F, Laekeman G, Demyttenaere K, et al. Medication information for Flemish inpatients with major depression:
evaluation and construct validity of the consumer information rating form. J Clin Pharm Ther. 2009;34(6):645-655. https://doi.
org/10.1111/j.1365-2710.2009.01039.x
Article Sidebar
Article Details
This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.