Consumer Opinions on Existing and Proposed Australian Over-the-Counter Medicine Labeling Strategies in Comparison With the Standardized US Drug Facts Label. (July 2016)

• Record Type: Journal Article
• Authors: Tong, Vivien; Raynor, David K.; Hamrosi, Kim K.; Acharya, Basoori; Panchal, Nisha; Aslani, Parisa
• Is Part Of: Therapeutic innovation & regulatory science. Volume 50:Number 4(2016:Jul.)
• Page Start: 427
• Page End: 435
• Publication Date: 2016-07
• Subjects: drug labeling -- consumers -- nonprescription medicines -- focus groups -- consumer perspectives; Drugs -- Periodicals; Pharmacology -- Periodicals; Drugs -- Research -- Periodicals; Drugs -- Testing -- Periodicals; 615.1
• DOI: 10.1177/2168479016628301
• Languages: English
• ISSNs: 2168-4790

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.