Skip to main content
Log in

Comparative User Testing of Australian and UK Over-the-Counter Labels and Leaflets for Diclofenac

  • Global Perspectives: Original Research
  • Published:
Therapeutic Innovation & Regulatory Science Aims and scope Submit manuscript

Abstract

Background

Limited research has evaluated the consumer usability of written information available with similar over-the-counter (OTC) products in different countries. This study evaluated the usability of labels and leaflets for Australian and UK OTC diclofenac products and explored consumer perspectives on their design, content, usability, and potential improvements.

Methods

Australian and UK OTC diclofenac products were selected for user testing. Demographically matched groups of Australian and UK consumers were recruited to user test each label and leaflet set to determine whether 9 salient clinical messages could be found and understood. Consumer perspectives on the tested label and leaflet were explored using semi-structured interviews as part of user testing.

Results

Forty consumers user tested the Voltaren Rapid 25 (Australia) and Voltarol Pain-eze Extra Strength 25-mg tablets (UK) information (10 participants per brand per country). Dosage, maximum daily dose, and contraindications information was found and understood by most (≥9/10 per group), except the Voltaren dosage which was misunderstood by 4/20. However, 12/20 could not locate the maximum duration of continuous use in the Voltaren leaflet. Participants had difficulty determining that another nonsteroidal anti-inflammatory drug could not be used with diclofenac (7/20 and 9/20 understood this in the Voltaren and Voltarol groups, respectively). Suggested label and leaflet improvements included increased font size, bolding/highlighting, and color.

Conclusion

When evaluated in both countries, not all key clinical information was effectively communicated by information accompanying Australian and UK diclofenac products. Improvements in how information is communicated are needed.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Similar content being viewed by others

References

  1. Medicines and Healthcare products Regulatory Agency. Medicines: reclassify your product. https://www.gov.uk/guidance/medicines-reclassify-your-product. Published December 18, 2014. Accessed May 6, 2016.

  2. Australian Government Department of Health Therapeutic Goods Administration. Poisons Standard July 2016: Schedule 1—Standard for the Uniform Scheduling of Medicines and Poisons No. 13, Australia. https://www.legislation.gov.au/Details/F2016L01071. Accessed September 24, 2016.

  3. Bolaños H. Responsible self-medication in Latin America. Drug Inf J. 2005;39:99–107.

    Article  Google Scholar 

  4. European Commission. Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use. Brussels: European Commission; 2001.

    Google Scholar 

  5. Australian Government Department of Health Therapeutic Goods Administration. Therapeutic Goods Order No. 69—General requirements for labels for medicines. https://www.legislation.gov.au/Details/F2014C00926. Accessed September 24, 2016.

  6. New South Wales Government. Poisons and Therapeutic Goods Regulation 2008. http://www.legislation.nsw.gov.au/inforce/a24253a9-82f5-4c65-957d-096fb162a62d/2008-392.pdf. Accessed September 24, 2016.

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

    Article  Google Scholar 

  8. Tong V, Raynor DK, Aslani P. Design and comprehensibility of over-the-counter product labels and leaflets: a narrative review. Int J Clin Pharm. 2014;36:865–872.

    Article  Google Scholar 

  9. Raynor DK, Knapp P, Silcock J, Parkinson B, Feeney K. “User-testing” as a method for testing the fitness-for-purpose of written medicine information. Patient Educ Couns. 2011;83:404–410.

    Article  Google Scholar 

  10. Raynor DK. User testing in developing patient medication information in Europe. Res Soc Adm Pharm. 2013;9:640–645.

    Article  CAS  Google Scholar 

  11. Sless D, Shrensky R. Writing About Medicines for People: Usability Guidelines for Consumer Medicine Information. 3rd ed. Sydney, NSW: Australian Self-Medication Industry; 2006.

    Google Scholar 

  12. 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. Accessed September 24, 2016.

    Google Scholar 

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

    Google Scholar 

  14. Medicines and Healthcare products Regulatory Agency. Best practice guidance on the labelling and packaging of medicines. https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/474366/Best_practice_guidance_labelling_and_packaging_of_medicines.pdf. Accessed September 24, 2016.

  15. Jay E, Aslani P, Raynor DK. User testing of consumer medicine information in Australia. Health Educ J. 2011;70:420–427.

    Article  Google Scholar 

  16. Medicines and Healthcare products Regulatory Agency. Oral diclofenac presentations with legal status ‘P’—reclassified to POM. https://www.gov.uk/drug-device-alerts/drug-alert-oral-diclofenac-presentations-with-legal-status-p-reclassified-to-pom. Published January 14, 2015. Accessed September 24, 2016.

  17. Australian Government Department of Health Therapeutic Goods Administration. Safety review of diclofenac version 2.1, October 2014. ACT: Therapeutic Goods Administration. https://www.tga.gov.au/sites/default/files/medicines-review-safety-diclofenac.pdf. Accessed September 24, 2016.

  18. Luk A, Tasker N, Raynor DKT, Aslani P. Written medicine information from English-speaking countries—how does it compare? Ann Pharmacother. 2010;44:285–294.

    Article  Google Scholar 

  19. Raynor DK, Svarstad B, Knapp P, et al. Consumer medication information in the United States, Europe, and Australia: a comparative evaluation. J Am Pharm Assoc (2003). 2007;47:717–724.

    Article  Google Scholar 

  20. Pires CM, Cavaco AM. Exploring the perspectives of potential consumers and healthcare professionals on the readability of a package insert: a case study of an over-the-counter medicine. Eur J Clin Pharmacol. 2014;70:583–588.

    Article  Google Scholar 

  21. Voltaren® Rapid 25 [package insert]. Mulgrave, VIC: Novartis Consumer Health Australasia Pty Ltd; 2008.

  22. Voltarol® Pain-eze Extra Strength 25 mg tablets [package insert]. Horsham, UK: Novartis Consumer Health; 2011.

  23. Voltaren® Rapid 25 (10 tablets). Novartis Consumer Health Australasia Pty Ltd; n.d.

  24. Voltarol® Pain-eze Extra Strength 25 mg tablets (10 tablets). Novartis Consumer Health; n.d.

  25. Sansom LN, ed. Australian Pharmaceutical Formulary and Handbook: The Everyday Guide to Pharmacy Practice. 22nd ed. Canberra, ACT: Pharmaceutical Society of Australia; 2012.

    Google Scholar 

  26. Australian Medicines Handbook. Adelaide, SA: Australian Medicines Handbook Pty Ltd; 2012.

  27. Tong V, Raynor DK, Aslani P. ‘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. Health Expect. 2016;19:948–961.

    Article  Google Scholar 

  28. Aslani P, Hamrosi K, Feletto E, et al. Investigating Consumer Medicine Information (I-CMI) Project. Sydney, NSW: The Pharmacy Guild of Australia, Australian Government Department of Health and Ageing; 2010.

    Google Scholar 

  29. Chew LD, Griffin JM, Partin MR, et al. Validation of screening questions for limited health literacy in a large VA outpatient population. J Gen Intern Med. 2008;23:561–566.

    Article  Google Scholar 

  30. Green J, Thorogood N. Qualitative Methods for Health Research. 3rd ed. London, UK: Sage Publications; 2014.

    Google Scholar 

  31. Miles MB, Huberman AM. Qualitative Data Analysis: An Expanded Sourcebook. 2nd ed. Thousand Oaks, CA: Sage Publications; 1994.

    Google Scholar 

  32. Tong V, Raynor DK, Aslani P. User testing as a method for identifying how consumers say they would act on information related to over-the-counter medicines. Res Soc Adm Pharm. 2017;13:476–484.

    Article  Google Scholar 

  33. Wolf MS, Davis TC, Shrank W, et al. To err is human: patient misinterpretations of prescription drug label instructions. Patient Educ Couns. 2007;67:293–300.

    Article  Google Scholar 

  34. Nabors LA, Lehmkuhl HD, Parkins IS, Drury AM. Reading about over-the-counter medications. Issues Compr Pediatr Nurs. 2004;27:297–305.

    Article  Google Scholar 

  35. Blom ATG, Rens JAL. Information about over-the-counter medication: the role of the pharmacy. Patient Educ Couns. 1989;14:181–189.

    Article  CAS  Google Scholar 

  36. Hamrosi KK, Aslani P, Raynor DK. Beyond needs and expectations: identifying the barriers and facilitators to written medicine information provision and use in Australia. Health Expect. 2014;17:220–231.

    Article  Google Scholar 

  37. Fuchs J, Hippius M. Inappropriate dosage instructions in package inserts. Patient Educ Couns. 2007;67:157–168.

    Article  Google Scholar 

  38. Dickinson D, Raynor DK, Duman M. Patient information leaflets for medicines: using consumer testing to determine the most effective design. Patient Educ Couns. 2001;43:147–159.

    Article  CAS  Google Scholar 

  39. King JP, Davis TC, Bailey SC, et al. Developing consumer-centered, nonprescription drug labeling: a study in acetaminophen. Am J Prev Med. 2011;40:593–598.

    Article  Google Scholar 

  40. Sleath B, Rubin RH, Campbell W, Gwyther L, Clark T. Physician-patient communication about over-the-counter medications. Soc Sci Med. 2001;53:357–369.

    Article  CAS  Google Scholar 

  41. Australian Government Department of Health Therapeutic Goods Administration. Consultation: non-steroidal anti-inflammatory drugs (diclofenac, flurbiprofen, ibuprofen, ketoprofen, mefenamic acid and naproxen) for oral use: proposed additional advisory statements for medicines. https://www.tga.gov.au/consultation/consultation-non-steroidal-anti-inflammatory-drugs-diclofenac-flurbiprofen-ibuprofen-ketoprofen-mefenamic-acid-and-naproxen-oral-use-proposed-additional-advisory-statements-medicines. Published February 4, 2015. Accessed May 28, 2016.

  42. Raynor DK, Dickinson D. Key principles to guide development of consumer medicine information—content analysis of information design texts. Ann Pharmacother. 2009;43:700–706.

    Article  Google Scholar 

Download references

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Vivien Tong BPharm (Hons), Grad Cert Pharm Prac, PhD.

Electronic supplementary material

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Tong, V., Raynor, D.K. & Aslani, P. Comparative User Testing of Australian and UK Over-the-Counter Labels and Leaflets for Diclofenac. Ther Innov Regul Sci 52, 38–48 (2018). https://doi.org/10.1177/2168479017711730

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1177/2168479017711730

Keywords

Navigation