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

  • Global Perspectives: Original Research
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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.

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Authors and Affiliations

  1. Pharmacy and Bank Building (A15), The University of Sydney, Sydney, New South Wales, 2006, Australia

    Vivien Tong BPharm(Hons), GradCertPharmPrac, Kim K. Hamrosi BPharm(Hons), PhD & Parisa Aslani BPharm(Hons), MSc, PhD, G Cert Ed Stud (Higher Ed)

  2. School of Healthcare, University of Leeds, Leeds, UK

    David K. Raynor BPharm, PhD

  3. School of Pharmacy, The University of Nottingham, Nottingham, UK

    Basoori Acharya MPharm & Nisha Panchal MPharm

Authors
  1. Vivien Tong BPharm(Hons), GradCertPharmPrac
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  2. David K. Raynor BPharm, PhD
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  3. Kim K. Hamrosi BPharm(Hons), PhD
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  4. Basoori Acharya MPharm
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  5. Nisha Panchal MPharm
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  6. Parisa Aslani BPharm(Hons), MSc, PhD, G Cert Ed Stud (Higher Ed)
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Corresponding author

Correspondence to Vivien Tong BPharm(Hons), GradCertPharmPrac.

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Tong, V., Raynor, D.K., Hamrosi, K.K. et al. Consumer Opinions on Existing and Proposed Australian Over-the-Counter Medicine Labeling Strategies in Comparison With the Standardized US Drug Facts Label. Ther Innov Regul Sci 50, 427–435 (2016). https://doi.org/10.1177/2168479016628301

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