Consumer Opinions on Existing and Proposed Australian Over-the-Counter Medicine Labeling Strategies in Comparison With the Standardized US Drug Facts Label

Abstract

Background:

With common over-the-counter (OTC) medication use, OTC labels as medicine information sources must be of high quality and usability. Standardized OTC labeling has been proposed in Australia using the Medicine Information Box (MIB), modeled on the US Drug Facts label. However, limited research has explored consumer opinions on existing nonstandardized Australian OTC, US Drug Facts, and proposed MIB labels. Therefore, this study aimed to explore consumer opinions on all 3 groups of OTC labels.

Methods:

Three focus groups (N = 21 participants) were conducted in Sydney, Australia. Participants were shown existing Australian OTC labels, US Drug Facts labels, and mock MIB formats based on the Australian Therapeutic Goods Administration proposal. Discussions were audio recorded, transcribed verbatim, and thematically analyzed.

Results:

Participants expressed varying opinions regarding existing nonstandardized Australian OTC labels’ content and design, from acknowledgment of positive aspects (clear headings, relevant content) to decreased perceived readability (suboptimal color use, font size) and content discrepancies. Participants identified key Drug Facts and MIB label characteristics that contributed to perceived usability and format clarity (good headings, black-and-white format). Many preferred the Drug Facts label because of its greater perceived clarity and usability. Missing content (inactive ingredients, further contact details) were identified and consequently became opportunities for MIB improvement.

Conclusions:

Most participants seemed to prefer the US Drug Facts label, partly because of its perceived completeness. These findings suggest further improvements for the proposed MIB as a step toward Australian OTC label standardization.

Keywords

drug labeling consumers nonprescription medicines focus groups consumer perspectives

Get full access to this article

View all access options for this article.

References

Harris Interactive Inc. Attitudes and beliefs about the use of over-the-counter medicines: a dose of reality; a national survey of consumers and health professionals. http://www.bemedwise.org/survey/final_survey.pdf. Published 2002. Accessed December 7, 2015.

Blom

Rens

. Information about over-the-counter medication: the role of the pharmacy. Patient Educ Couns. 1989;14:181–189.

Nabors

Lehmkuhl

Parkins

Drury

. Reading about over-the-counter medications. Issues Compr Pediatr Nurs. 2004;27:297–305.

Evans

John

Bloor

Luscombe

. Use of non-prescription advice offered to the public by community pharmacists. Int J Pharm Pract. 1997;5:16–25.

Tong

Raynor

Aslani

. Design and comprehensibility of over-the-counter product labels and leaflets: a narrative review. Int J Clin Pharm. 2014;36:865–872.

Over-the-counter human drugs; labeling requirements. Federal Register. 1999;64:13254–13303. http://www.gpo.gov/fdsys/pkg/FR-1999-03-17/pdf/99-6296.pdf. Accessed December 7, 2015.

Aikin

KJ.

Consumer comprehension and preference for variations in the proposed over-the-counter drug labeling format: final report. Bethesda, MD: Center for Drug Evaluation and Research, US Food and Drug Administration; 1998.

Mendat

Watson

Mayhorn

Wogalter

. Age differences in search time for two over-the-counter (OTC) drug label formats. Proc Hum Fact Ergon Soc Annu Meet. 2005;49:200–203.

Shaver

Wogalter

. 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;47:826–830.

10.

Lalor

. Medicines labelling. Aust Prescr. 2011;34:136–138.

11.

Aslani

. Consumer medicine information conundrums. Aust Prescr. 2007;30:122–124.

12.

Australian Government Department of Health and Ageing Therapeutic Goods Administration. Australian regulatory guideline for over-the-counter medicines. Appendix 3: Guidelines on presentation aspects of OTC applications Version 1.0, October 2012. Australian Capital Territory: Therapeutic Goods Administration, 2012.

13.

Therapeutic Goods Order No. 69: General requirements for labels for medicines, Australia. http://www.comlaw.gov.au/Details/F2014C00926. Published July 14, 2014. Accessed December 7, 2015.

14.

NPS Medicinewise. Naming, packaging and labelling of medicines: briefing prepared for the Department of Health and Ageing; quantitative and qualitative evidence and anecdotal information on the problems associated with confusing naming, packaging and labelling in Australia, November 2010. 2010.

15.

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: Therapeutic Goods Administration, 2012. 55 p. Report No.: R12/759506.

16.

Tong

Raynor

Aslani

. ‘It’s all there in black and white’—or is it? Consumer perspectives on the proposed Australian Medicine Information Box over-the-counter label format [published online July 31, 2015]. Health Expect. doi: 10.1111/hex.12389.

17.

Krueger

Casey

. Focus Groups: A Practical Guide for Applied Research. Thousand Oaks, CA: Sage Publications; 2009.

18.

Green

Thorogood

. Qualitative Methods for Health Research. 3rd ed. London: Sage Publications; 2014.

19.

Miles

Huberman

. Qualitative Data Analysis: An Expanded Sourcebook. 2nd ed. Thousand Oaks, CA: Sage Publications; 1994.

20.

Australian Government Department of Health and Ageing Therapeutic Goods Administration. Guideline for the labelling of medicines: Draft—Version 1.0, August 2014. Australian Capital Territory: Therapeutic Goods Administration, 2014. 39 p. Report No.: R14/643926.

21.

Calamusa

Di Marzio

Cristofani

. Factors that influence Italian consumers’ understanding of over-the-counter medicines and risk perception. Patient Educ Couns. 2012;87:395–401.

22.

Smith

Newbould

. Perspectives of community groups on the reclassification of medicines from prescription to non-prescription. Int J Health Promot Educ. 2002;40:21–30.

23.

Kumar

Rawlings

Beaman

. The mystery ingredients: sweeteners, flavorings, dyes, and preservatives in analgesic/antipyretic, antihistamine/decongestant, cough and cold, antidiarrheal, and liquid theophylline preparations. Pediatrics. 1993;91:927–933.

24.

Hibbert

Bissell

Ward

. Consumerism and professional work in the community pharmacy. Sociology of Health & Illness. 2002;24:46–65.

25.

Department for Transport. Over-the-counter medicines and the potential for unwanted sleepiness (No. 24). http://webarchive.nationalarchives.gov.uk/20070206175455/http://www.dft.gov.uk/pdf/pgr/roadsafety/research/rsrr/theme3/overthecountermedicinesandth4772. Accessed December 7, 2015.

26.

Joshi

Vaidya

De Sousa

Mangaonkar

. Assessment of over-the-counter medicine labels in India for patient information. Pharma Times. 2012;44:20–21.

27.

European Commission. Guideline on the readability of the labelling and package leaflet of medicinal products for human use. Revision 1, 12 January 2009. Brussels: European Commission. http://ec.europa.eu/health/files/eudralex/vol-2/c/2009_01_12_readability_guideline_final_en.pdf. Published 2009. Accessed December 7, 2015.

28.

Wogalter

Vigilante

Jr . Effects of label format on knowledge acquisition and perceived readability by younger and older adults. Ergonomics. 2003;46:327–344.

29.

Communication Research Institute of Australia. Labelling Code of Practice: Designing Usable Non-prescription Medicine Labels for Consumers. Canberra: Communication Research Press; 2004.

30.

Trivedi

Hannan

. Readability and comprehensibility of over-the-counter medication labels. Ren Fail. 2014;36:473–477.

31.

Yin

Parker

Wolf

. Health literacy assessment of labeling of pediatric nonprescription medications: examination of characteristics that may impair parent understanding. Acad Pediatr. 2012;12:288–296.

32.

National Council on Patient Information and Education. Uses and attitudes about taking over-the-counter medicines: findings of a 2003 national opinion survey conducted for the National Council on Patient Information and Education: executive summary. http://bemedwise.org/survey/summary_survey_findings.pdf. Accessed December 7, 2015.