Design and comprehensibility of over-the-counter product labels and leaflets: a narrative review
- 843 Downloads
Background Over-the-counter medicines must be supplied with appropriate, user-friendly medicine information to satisfactorily support consumer self-management and safe use. Product labels and written medicine information leaflets are highly accessible over-the-counter medicine information sources for consumers. Factors such as comprehensibility and design underpin the usefulness of over-the-counter labels and leaflets and should be further examined to better inform future optimisation strategies. Aim of the review To undertake an in-depth exploration of studies that have evaluated design and/or comprehensibility of over-the-counter labels and written medicine information leaflets Methods Database searches were performed using Medline, Embase, International Pharmaceutical Abstracts and PubMed. Studies exploring over-the-counter medicine label and/or leaflet comprehensibility and/or design were identified. Additional author and reference list searches were performed to identify studies which met the inclusion criteria and key terms. Results A total of 35 studies were included in the review, which explored OTC medicine information design and/or comprehensibility via researcher evaluation alone (n = 8) or with consumers (n = 27). Researcher-determined over-the-counter written medicine information leaflet readability (n = 4) has highlighted suboptimal readability, with few studies evaluating over-the-counter leaflet performance using the gold standard method of ‘user testing’ with consumers (n = 2). Variable over-the-counter label comprehensibility was identified in consumer studies, ranging from satisfactory understanding to considerable misunderstanding. The review findings indicate that consumer outcomes were influenced by information design, where implementation of good design principles generally improved over-the-counter label and leaflet performance. Significant diversity existed in study design aspects such as sampling frames, sample sizes and tools used to evaluate over-the-counter medicine information, which hindered the ability to adequately compare various study aspects and findings. Conclusion A wide spectrum of consumer understanding of over-the-counter medicine labels is evident in the literature, with limited studies examining over-the-counter written medicine information leaflet comprehensibility with consumers. The application of good information design principles in over-the-counter labels and leaflets contribute to improved performance. Well-designed consumer studies are needed to ascertain and optimise over-the-counter label and leaflet performance.
KeywordsComprehension Consumers Drug labeling Non-prescription drugs Review Usability
Conflicts of interest
David K. Raynor is the co-founder and academic advisor for Luto Research Ltd., a company that provides performance-based user testing services for health information.
- 5.Harris interactive for NCPIE (National Council on Patient Information and Education). Attitudes and beliefs about the use of over-the-counter medicines: a dose of reality; a national survey of consumers and health professionals; 2002.Google Scholar
- 8.Over-the-counter human drugs; Labeling requirements; Final Rule (1999 Mar 17).Google Scholar
- 9.Medicines and healthcare products regulatory agency committee on safety of medicines. Always read the leaflet: getting the best information with every medicine—report of the Committee on Safety of Medicines Working Group on Patient Information. London: The Stationery Office; 2005.Google Scholar
- 10.Australian Government Department of Health and Ageing Therapeutic Goods Administration. TGA medicine labelling and packaging review: Consultation Paper Version 1.0 May 2012. Australian Capital Territory: Commonwealth of Australia, 2012. Report number.:R12/759506.Google Scholar
- 12.Auta A, Shalkur D, Dayom D, Banwat S. Readability of over-the-counter medicine information leaflets in Nigeria. IJPFR. 2011;1(2):61–7.Google Scholar
- 16.Sansgiry SS, Cady PS, Patil S. Readability of over-the-counter medication labels. J Am Pharm Assoc. 1997;NS37(5):522–8.Google Scholar
- 18.Twomey C. An analysis of patient information leaflets supplied with medicines sold by pharmacists in the United Kingdom. Library and Information Research News. 2001;25(80):3–12.Google Scholar
- 24.Proprietary Medicines Association of Australia. Making medicine labels work: the impact of changing the design and content of labels. North Sydney: Proprietary Medicines Association of Australia; 1992. p. 12.Google Scholar
- 27.Rogers D, Shulman A, Sless D, Beach R. Designing better medicine labels: report to PHARM. Australia: Communication Research Institute of Australia; 1995 69 p.Google Scholar
- 29.Sless D, Tyers A. Medicine labelling for consumers. Australia: Communication Research Institute of Australia.Google Scholar
- 33.Lee I, Lee HW, Je NK, Lee S. Examining the readability of two package inserts for self-medication in South Korea. Pharmacoepidem Dr S. 2012;21(Suppl 3):214.Google Scholar
- 35.Drug labelling study A main questionnaire pink [document on the Internet]. U.S Food and Drug Administration; 1997 [cited 2013 Mar 06]. http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/DevelopmentResources/Over-the-CounterOTCDrugs/ucm105977.pdf.
- 40.Sansgiry SS, Cady PS, Sansgiry S. Effect of package design on evaluation of OTC medication information. J Soc Adm Pharm. 2001;18(1):24–34.Google Scholar
- 41.Shaver EF, Wogalter MS. A comparison of older vs. newer over-the-counter (OTC) nonprescription drug labels on search time accuracy. Proc Hum Fact Ergon Soc. Annu Meet. 2003;47(5):826–30.Google Scholar
- 44.Aslani P, Hamrosi K, Feletto E, Raynor DK, Knapp P, Parkinson B et al. Investigating Consumer Medicine Information (I-CMI) project. Sydney: The Pharmacy Guild of Australia, Australian Government Department of Health and Ageing; 2010.Google Scholar
- 46.Sless D, Shrensky R. Writing about medicines for people: usability guidelines for consumer medicine information. 3rd ed. North Sydney: Australian Self Medication Industry; 2006.Google Scholar
- 47.U.S Department of Health and Human Services- Food and Drug Administration, Centre for Drug Evaluation and Research, Centre for Biologics Evaluation and Research. Guidance: Useful Written Consumer Medical Information (CMI) [internet]. 2006 Jul [cited 2013 Dec 02]. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm080602.pdf.
- 50.Holt G, Dorcheus L, Hall E, Beck D, Ellis E, Hough J. Patient interpretation of label instructions. Am Pharm. 1992;NS32(3):58–62.Google Scholar
- 56.Communication Research Institute of Australia. Labelling code of practice: designing usable non-prescription medicine labels for consumers. Canberra: Communication Research Press; 2004. p. 19.Google Scholar
- 57.Division of Nonprescription Clinical Evaluation and the Office of Biostatistics, Center for Drug Evaluation and Research. Guidance for industry: label comprehension studies for nonprescription drug products. U.S.: U.S Department of Health and Human Services Food and Drug Administration; 2010 July.Google Scholar