When medicine labelling is more complex than it appears

Clinical
By
Sharon Ambalal MPS
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Mum and Dad are at work. Nan squints at a tiny, folded label on Amoxil Paediatric. Little Ella is clingy. How much was I supposed to give? She wonders. ‘This label is tiny!’

Who’s your audience?

Labels must comply with relevant national, state and territory requirements.,1,2 They must be in English, accurate, unambiguous, legible and durable, and include mandatory information.2,3 Increasingly, there is consensus for patient-centred labels, recognising that communication and health literacy barriers can make labels difficult to interpret.4,5 People with hearing, vision, intellectual or cognitive disability may require supporting information, such as images or large print.4

Keep labels concise and free from jargon.1–3 Be mindful that ‘straightforward’ instructions can be misinterpreted.6 In one study, ‘take two tablets by mouth twice daily’ was correctly interpreted by only 71% of consumers with adequate literacy skills and 33% of consumers with lower literacy.7 Explicit directions, such as ‘take two tablets in the morning and take two tablets in the evening’ improve comprehension.6

Write ranges in words (e.g. 1 to 2, not 1–2), spell out fractions (e.g. half, quarter) and consider tables for complicated dosing (e.g. prednisolone). Include discard instructions for medicines with shortened expiry.

Does placement matter?

Yes. Firmly and neatly attach labels to the primary container (the packaging in direct contact with the medicine), provided this does not impede medicine use; otherwise label outer packaging – informing the patient if seals must be broken.2,3,8 For some medicines, such as inhalers, opening foil pouches to apply labels may shorten the in-use expiry period.9 Discuss anticipated use with the patient before opening the pouch. Label each primary container when supplying multiple packs, specifying ‘pack 1, pack 2’ etc (e.g. creams), or label each component pack in pre-packaged multipacks (e.g. Nexium HP7).2,10

Avoid folding labels over corners and edges, which can reduce readability.1 Some manufacturers provide designated label spaces that may be too small. Place the label elsewhere on the packaging where it is fully visible without obscuring important information like batch number and expiry.2 For small containers (e.g. eye drops), a standard sized dispensing label can be adhered to a transparent flag label affixed to the primary container – keeping information visible.1,2

Beyond the label

Effective medicine labelling avoids unintended misuse and supports better health outcomes for consumers, like little Ella.2 Look beyond the label and consider the person, like Nan, who must interpret and safely act on label information. 

References

  1. Australian Commission on Safety and Quality in Health Care. National standard for labelling dispensed medicines. Sydney NSW: Australian Commission on Safety and Quality in Health Care; 2021.
  2. Sansom LN, ed. Australian pharmaceutical formulary and handbook: dispensing and labelling 2026. At: https://apf.psa.org.au/dispensing-and-labelling/good-dispensing-practice/dispensing.
  3. Pharmacy Board of Australia. Guidelines for dispensing of medicines. 2015. At: www.pharmacyboard.gov.au/News/2015-10-02-revised-guidelines.aspx
  4. Pharmaceutical Society of Australia. Medicine safety: disability care. 2022.
  5. La Caze A. Safer dispensing labels for prescription medicines. Aust Prescr 2018;41:46–9.
  6. Lalor D. Medicines labelling. Aust Prescr. 2011;34:39–42.
  7. Davis TC, Federman AD, Bass PF, 3rd, et al. Improving patient understanding of prescription drug label instructions. J Gen Intern Med 2009;24(1):57–62.
  8. Australian Government Department of Health, Disability and Ageing. Therapeutic goods administration: understanding packaging definitions for medicines. 2024. At: www.tga.gov.au/resources/guidance/understanding-packaging-definitions-medicines
  9. National Asthma Council Australia. In-use shelf life of inhalers. 2026. At: www.nationalasthma.org.au/living-with-asthma/resources/health-professionals/information-paper/in-use-shelf-life-of-inhalers
  10. The Pharmacy Guild of Australia. Position statement: packaging and labelling of medicines 2024. At: www.guild.org.au/about-us/policies-position-statements