Consumer medication information: legislative gap and challenges of practice
Main Article Content
Keywords
Consumer medication, Package leaflet, Consumer information, Over-the-counter drugs, Patient education, Drug regulatory legislation
Abstract
Objectives: To assess and evaluate OTC package inserts in terms of availability of key medical information and patient understanding of such information, as well as package insert user satisfaction and perceptions. Methods: This study used two quantitative methods: Evaluation of the Over-the-Counter Package Inserts and assessing package inserts user’s satisfaction and perspectives using a cross-sectional survey. Descriptive analysis was used to calculate the response proportion of each group of respondents. Results: A total of 60 package inserts of Over-the-Counter drugs were evaluated. Less than onethird (30%) of the medication under investigation was found to have information about the unit of measurement of the active ingredient. Less than half (44.5%) of respondents reported they usually use the package inserts for information about their medication, and 42.2% rarely use or read package inserts. Difficulty reading or finding information in the package inserts was reported by 37.3 % of respondents. Conclusion: This research identified several factors associated with the proper use of package inserts among the general population in the United Arab Emirates and potential opportunities. Also, due to the lack of binding legislative texts, consumers are dissatisfied with the packaging inserts regarding their appearance and content. A mandatory guideline should be enacted by the competent authorities to ensure the comprehensiveness and readability of pharmacological information.
References
2. Al Aqeel S, Abanmy N, Aldayel A, et al. Readability of written medicine information materials in Arabic language: Expert and consumer evaluation. BMC Health Serv Res. 2018;18(1):1-7. https://doi.org/10.1186/s12913-018-2944-x
3. Alaqeel S, Al Obaidi N. Patient Evaluation of Medication Package Leaflets in Al Kharj City, Saudi Arabia. Ther Innov Regul Sci. 2017;51(1):45-50. https://doi.org/10.1177/2168479016659320
4. Bekker CL, Mohsenian Naghani S, Natsch S, et al. Information needs and patient perceptions of the quality of medication information available in hospitals: a mixed method study. Int J Clin Pharm. 2020;42(6):1396. https://doi.org/10.1007/s11096-
020-01125-x
5. Theo Raynor DK, Svarstad B, Knapp P, et al. Consumer medication information in the United States, Europe, and Australia: A comparative evaluation. J Am Pharm Assoc. 2007;47(6):717-724. https://doi.org/10.1331/japha.2007.06141
6. Adepu R, Swamy MK. Development and Evaluation of Patient Information Leaflets (PIL) Usefulness. Indian J Pharm Sci. 2012;74(2):174-178. https://doi.org/10.4103/0250-474x.103857
7. 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. Health Expect. 2017;20(4):531-542. https://doi.org/10.1111/hex.12487
8. Brazilian Health Regulatory Agency. The Brazilian Health Regulatory Agency issued Medication Labeling Guide and Medication Labeling Guide. 2017. Available from: https://www.gov.br/anvisa/pt-br
9. Lee CH, Chang FC, Hsu S Der, et al. Inappropriate self-medication among adolescents and its association with lower medication literacy and substance use. PLoS One. 2017;12(12):e0189199. https://doi.org/10.1371/journal.pone.0189199
10. Fayyad M. A glance at unfair terms in consumer transactions in Arab legal systems and Islamic law: What Arab lawyers can learn from the European experience? Int J Priv Law. 2012;5(2):200-227. https://doi.org/10.1504/ijpl.2012.046061
11. Baker, Tom, Silver C. How Liability Insurers Protect Patients and Improve Safety. DePaul Law Rev. 2019;86(2):209.
12. Fayyad M. Measures of the Principle of Good Faith in European Consumer Protection and Islamic Law, a Comparative Analysis. Arab Law Q. 2014;28(3):205-230. https://doi.org/10.1163/15730255-12341283
13. Al Aqeel S, Abanmy N, Aldayel A, et al. Readability of written medicine information materials in Arabic language: Expert and consumer evaluation. BMC Health Serv Res. 2018;18(1). https://doi.org/10.1186/s12913-018-2944-x
14. Fayyad M. Misleading advertising practices in consumer transactions: Can arab lawmakers gain an advantage from European insight? Arab Law Q. 2012;26(3):287-311. https://doi.org/10.1163/15730255-12341234
15. Gustafsson J, Kälvemark S, Nilsson G, et al. Patient information leaflets--patients’ comprehension of information about interactions and contraindications. Pharm World Sci. 2005;27(1):35-40. https://doi.org/10.1007/s11096-005-1413-x
16. Storck J-P. Le défaut d’un médicament. Recl Dalloz. 2019;61.
17. Koch VG. Crisis Standards of Care and State Liability Shields. San Diego Law Rev. 2020;57(4):973.
18. Da T, Dal S, Garcia C, et al. Medicine package inserts from the users’ perspective: are they read and understood? Rev Bras Epidemiol. 2019;22. https://doi.org/10.1590/1980-549720190009
19. Alsubaei W. Errors in a drug leaflet for “oncology” threaten health complications. Emirates Today. 2020.
20. Alburikan KA, AbuAlreesh A, Alenazi M, et al. Patients’ understanding of prescription drug label instructions in developing nations: The case of Saudi Arabia. Res Soc Adm Pharm. 2018;14(5):413-417. https://doi.org/10.1016/j.sapharm.2017.05.004
21. Fuchs J. The Way Forward in Package Insert User Tests from a CRO’s Perspective. 2010;44(2):119-129. http://dx.doi.
org/101177/009286151004400203
22. Al-Aqeel SA. Evaluation of medication package inserts in Saudi Arabia. Drug Healthc Patient Saf. 2012;4(1):33-38. https://doi.org/10.2147/dhps.s29402
23. Lee CH, Chang FC, Hsu S Der, et al. Inappropriate self-medication among adolescents and its association with lower medication literacy and substance use. PLoS One. 2017;12(12):1-14. https://doi.org/10.1371/journal.pone.0189199
24. Fayyad MI, Hayajneh AM. Reconsidering the Special Rules of Mitigation of Damages for Breach of Contract for the Sale of Goods in UAE Law. Arab Law Q. 2022;1(aop):1-30. https://doi.org/10.1163/15730255-bja10101
25. Gorny A. L’obligation d’information sur les effets indésirables des médicaments. Recl Dallo z. 2005;1012.
Article Sidebar
Article Details
This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.