Abstract
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.
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References
Blom AT, Rens JA. Information about over-the-counter medication: the role of the pharmacy. Patient Educ Couns. 1989;14(3):181–9.
Newby DA, Hill SR, Barker BJ, Drew AK, Henry DA. Drug information for consumers: should it be disease or medication specific? Results of a community survey. Aust New Zeal J Publ Health. 2001;25(6):564–70.
Simoens S, Lobeau M, Verbeke K, van Aerschot A. Patient experiences of over-the-counter medicine purchases in Flemish community pharmacies. Pharm World Sci. 2009;31(4):450–7.
Gray NJ, Cantrill JA, Noyce PR. ‘Health repertories’: an understanding of lay management of minor ailments. Patient Educ Couns. 2002;47(3):237–44.
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.
Birchley N, Conroy S. Parental management of over-the-counter medicines. Paediatr Nurs. 2002;14(9):24–8.
Nabors LA, Lehmkuhl HD, Parkins IS, Drury AM. Reading about over-the-counter medications. Issues Compr Pediatr Nurs. 2004;27(4):297–305.
Over-the-counter human drugs; Labeling requirements; Final Rule (1999 Mar 17).
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.
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.
Holt GA, Hollon JD, Hughes SE, Coyle R. OTC labels: can consumers read and understand them? Am Pharm. 1990;NS30(11):51–4.
Auta A, Shalkur D, Dayom D, Banwat S. Readability of over-the-counter medicine information leaflets in Nigeria. IJPFR. 2011;1(2):61–7.
Bradley B, Singleton M, Li Wan Po A. Readability of patient information leaflets on over-the-counter (OTC) medicines. J Clin Pharm Ther. 1994;19(1):7–15.
El-Ibiary SY, Youmans SL. Health literacy and contraception: a readability evaluation of contraceptive instructions for condoms, spermicides and emergency contraception in the USA. Eur J Contracept Reprod Health Care. 2007;12(1):58–62.
Stevens AB, McDaniel KS, Glover ED, Wallace LS. Are instructions for over-the-counter nicotine replacement therapy products readable? Am J Health Behav. 2007;31(Suppl 1):S79–84.
Sansgiry SS, Cady PS, Patil S. Readability of over-the-counter medication labels. J Am Pharm Assoc. 1997;NS37(5):522–8.
Sansgiry SS, Shringarpure G. Manufacturers’ compliance with the US Food and Drug Administration’s over-the-counter human drugs: labeling requirements. Packag Technol Sci. 2003;16(3):91–8.
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.
Brass EP, Vassil T, Replogle A, Hwang P, Rusche S, Shiffman S, et al. Can consumers self-select for appropriate use of an over-the-counter statin? The self evaluation of lovastatin to enhance cholesterol treatment study. Am J Cardiol. 2008;101(10):1448–55.
Catlin JR, Pechmann C, Brass EP. The influence of need for cognition and principal display panel factors on over-the-counter Drug Facts label comprehension. Health Commun. 2012;27(3):264–72.
Ciociola AA, Sirgo MA, Pappa KA, McGuire JA, Fung K. A study of the nonprescription drug consumer’s understanding of the ranitidine product label and actual product usage patterns in the treatment of episodic heartburn. Am J Ther. 2001;8(6):387–98.
Lokker N, Sanders L, Perrin EM, Kumar D, Finkle J, Franco V, et al. Parental misinterpretations of over-the-counter pediatric cough and cold medication labels. Pediatrics. 2009;123(6):1464–71.
Patel VL, Branch T, Arocha JF. Errors in interpreting quantities as procedures: the case of pharmaceutical labels. Int J Med Inform. 2002;65(3):193–211.
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.
Raymond EG, Dalebout SM, Camp SI. Comprehension of a prototype over-the-counter label for an emergency contraceptive pill product. Obstet Gynecol. 2002;100(2):342–9.
Raymond EG, L’Engle KL, Tolley EE, Ricciotti N, Arnold MV, Park S. Comprehension of a prototype emergency contraception package label by female adolescents. Contraception. 2009;79(3):199–205.
Rogers D, Shulman A, Sless D, Beach R. Designing better medicine labels: report to PHARM. Australia: Communication Research Institute of Australia; 1995 69 p.
Simon H, Weinkle D. Over-the-counter medications: do parents give what they intend to give? Arch Pediatr Adolesc Med. 1997;151(7):654–6.
Sless D, Tyers A. Medicine labelling for consumers. Australia: Communication Research Institute of Australia.
Wilke T, Müller S, Neumann K, Loder T. Does package design matter for patients? The association between package design and patients’ drug knowledge. Pharm Med. 2011;25(5):307–17.
Wogalter MS, Vigilante WJ Jr. Effects of label format on knowledge acquisition and perceived readability by younger and older adults. Ergonomics. 2003;46(4):327–44.
Fuchs J, Hippius M. Inappropriate dosage instructions in package inserts. Patient Educ Couns. 2007;67(1–2):157–68.
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.
Friedman CP, Romeo D, Hinton SS. Healthcare decisions and product labeling: results of a consumer comprehension study of prototype labeling for proposed over-the-counter cholestyramine. Am J Med. 1997;102(2A):50–6.
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.
Hellier E, Tucker M, Kenny N, Rowntree A, Edworthy J. Merits of using color and shape differentiation to improve the speed and accuracy of drug strength identification on over-the-counter medicines by laypeople. J Patient Saf. 2010;6(3):158–64.
Mendat CC, Watson AM, Mayhorn CB, Wogalter MS. Age differences in search time for two over-the-counter (OTC) drug label formats. Proc Hum Fact Ergon Soc Annu Meet. 2005;49(2):200–3.
Murty S, Sansgiry SS. Consumer comprehension of OTC medication labels and the scope for improvement in font size. J Pharm Technol. 2007;23(4):207–13.
Sansgiry SS, Cady PS. The effect of label content and placement on consumers’ understanding of OTC product label information. J Pharm Mark Manag. 1995;9(3):55–68.
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.
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.
Watanabe RK, Gilbreath K, Sakamoto CC. The ability of the geriatric population to read labels on over-the-counter medication containers. J Am Optom Assoc. 1994;65(1):32–7.
Wogalter MS, Magurno AB, Scott KL, Dietrich DA. Facilitating information acquisition for over-the-counter drugs using supplemental labels. Proc Hum Fact Ergon Soc Annu Meet. 1996;40(14):732–6.
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.
Dickinson D, Raynor DK, Duman M. Patient information leaflets for medicines: using consumer testing to determine the most effective design. Patient Educ Couns. 2001;43(2):147–59.
Sless D, Shrensky R. Writing about medicines for people: usability guidelines for consumer medicine information. 3rd ed. North Sydney: Australian Self Medication Industry; 2006.
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.
Luk A, Aslani P. Tools used to evaluate written medicine and health information: document and user perspectives. Health Educ Behav. 2011;38(4):389–403.
Hoar N, Hoar ME. Readability formulas: are they enough? Contemp Pharm Pract. 1981;4(3):145–9.
Holt G, Dorcheus L, Hall E, Beck D, Ellis E, Hough J. Patient interpretation of label instructions. Am Pharm. 1992;NS32(3):58–62.
Wolf MS, Davis TC, Shrank W, Rapp DN, Bass PF, Connor UM, et al. To err is human: patient misinterpretations of prescription drug label instructions. Patient Educ Couns. 2007;67(3):293–300.
Davis TC, Federman AD, Bass PF, Jackson RH, Middlebrooks M, Parker RM, et al. Improving patient understanding of prescription drug label instructions. J Gen Intern Med. 2009;24(1):57–62.
Davis TC, Wolf MS, Bass PF 3rd, Thompson JA, Tilson HH, Neuberger M, et al. Literacy and misunderstanding prescription drug labels. Ann Intern Med. 2006;145(12):887–94.
Bailey SC, Pandit AU, Yin S, Federman A, Davis TC, Parker RM, et al. Predictors of misunderstanding pediatric liquid medication instructions. Fam Med. 2009;41(10):715–21.
Jay E, Aslani P, Raynor D. User testing of consumer medicine information in Australia. Health Educ J. 2011;70(4):420–7.
Communication Research Institute of Australia. Labelling code of practice: designing usable non-prescription medicine labels for consumers. Canberra: Communication Research Press; 2004. p. 19.
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.
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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.
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Tong, V., Raynor, D.K. & Aslani, P. Design and comprehensibility of over-the-counter product labels and leaflets: a narrative review. Int J Clin Pharm 36, 865–872 (2014). https://doi.org/10.1007/s11096-014-9975-0
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DOI: https://doi.org/10.1007/s11096-014-9975-0