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
|1||Prominently display the information that consumers need to take their medicine safely and effectively
|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
|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
|7||Use explicit and clear dosing instructions
|8||Include the indication for use of the medicine, whenever possible, and consider consumer 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
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 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.
- Australian Commission on Safety and Quality in Health Care. National standard for labelling dispensed medicines. Sydney: ACSQHC; 2021.
- 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.