Medication-labelling-standards

The Australian Commission on Safety and Quality in Health Care (the Commission) has published a new National Standard for Labelling Dispensed Medicines. This document is intended for all health professionals who dispense medicines, including pharmacists, pharmacy technicians, nurse practitioners, general practitioners, optometrists and dentists.

The purpose of the standard is to guide medicine labelling so that the messages conveyed are clear and consistent. Labelling issues have been reported to contribute to a large number of errors. One study suggests that around 46% of patients misunderstand one or more dosage instructions, with this figure rising to 62.7% in patients with low literacy levels. Variability in labelling and terminology use can contribute to this issue.

This new standard supports the quality use of medicines by optimising the delivery of important information via the medicine label. Points considered in the standard include what information is included on the label, the placement of information within the label, and how it should be formatted to improve consumer understanding.

The twelve standards are shown in Table 1.

Table 1. Summary of the twelve standards

Standard Details
1 Prominently display the information that consumers need to take their medicine safely and effectively

  • The font should be as large as possible to maximise legibility
2 Use a standardised format and order so that each element appears in the same place every time
3 Signpost and display the active ingredient name first, followed by the brand name

  • Consistent with the legislation for active ingredient prescribing
  • The brand name only can be used for medicines with four or more active ingredients. However, consumers should still be aware of the importance of knowing which active ingredients are included in the formulation.
  • Medicines listed by brand only that have an increased risk of harm should identify the active ingredient either individually or by class, e.g. ‘contains paracetamol.’
4 Include strength, as a quantity of active ingredient(s) with the relevant unit(s) of measure, after each active ingredient name. Use a clear statement of strength for liquid medicines
5 Include the formulation in full
6 Use numerals (digits) for dosage quantities, except for fractions

  • Consumer testing for the National Guidelines for On-Screen Display of Medicines Information indicate that numerals are easier to understand than written words when interpreting doses.
  • However, user testing for the labelling standard found no difference in the ability of consumers to understand numbers compared to words.
  • Fractions should be written in words to prevent confusion. E.g. write ‘HALF’ instead of ‘½’ as this could be interpreted as one or two.
7 Use explicit and clear dosing instructions

  • For medicines taken multiple times a day, repeating the dose for each dosing time provides clarity. E.g. ‘Take 1 tablet in the morning and 1 tablet in the evening’ may be clearer than ‘Take 1 tablet in the morning and evening’.
  • For medicines that are taken on an ‘as needed’ basis, the maximum dose should be clearly stated.
8 Include the indication for use of the medicine, whenever possible, and consider consumer confidentiality

  • Inclusion of the indication on the dispensing label may help clarify when ‘as needed’ medicines should be taken.
  • Indications should be expressed in simple language, avoiding medical terms that may not be easily understood.
  • Consider patient confidentiality
9 Include the maximum dose, if relevant
10 Express the pack size or quantity with units and place in a separate location from the strength
11 Express discard-by information with a date, if possible

  • The discard-by information will match the manufacturer’s expiry date in most cases. However, for some medicines (e.g. eye drops and reconstituted medicines), the discard-by date will be different. This information should be clearly stated on the label.

E.g. ‘Discard on 1 August 2021’ or ‘Discard 4 weeks after opening’
12 Include a machine-readable verification code on the dispensed label to allow verification of the medicine during the dispensing process

  • The code on the dispensed label can be cross-checked with the code on the manufacturer’s packaging to prevent selection errors.

The standard does not specifically address:

  • Dose forms other than oral solid and liquid dose forms as these were not user tested. However, the general principles of the standard are relevant across all dose forms;
  • Additional warning and advisory labels
    • Mandatory warning labels are listed in the Standard for the Uniform Scheduling of Medicines and Poisons (e.g. medicines listed in Appendix K require a sedation warning)
    • The wording and presentation of other cautionary and advisory labels are guided by the recommendations of the Australian Pharmaceutical Formulary and Handbook
  • Medicine-related information in electronic devices and displays; or
  • Visual aids and other types of labelling.

Safe medicine use is dependent upon clear and unambiguous labelling. Ensuring that patients understand how and when to take their medicines can improve medication adherence and health outcomes. The recommendations contained within the new standard should be applied in conjunction with relevant state or territory legislative requirements.

References:

  1. Australian Commission on Safety and Quality in Health Care. National standard for labelling dispensed medicines. Sydney: ACSQHC; 2021.
  2. Davis TC, Wolf S, Bass PF, Thompson JA, Tilson HH, Neuberger M, et al. Literacy and misunderstanding prescription drug labels. Ann Intern Med. 2006; 145(12): 887-94.

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