30 September 2016

National standard for user-applied labelling of injectable medicines, fluids and lines

Labelling of injectable medicines and fluids, and the devices used to deliver them, has been identified as a patient safety issue.

In response, to this patient issue, the Australian Commission on Safety and Quality in Health Care developed the National Standard for user-applied labelling of injectable medicines, fluids and lines (external site). This initiative was created to improve safety in this important practice area.

The National Standard for user-applied labelling of injectable medicines, fluids and lines (the labelling standards) are designed to assist health care professionals identify the correct:

  • medicines and/or fluid at all times (container)
  • route of administration of the injectable medicines (conduit).

They also describe requirements for label inclusions and label placement.

The labelling standard aims to:

  • promote safer use of injectable medicines
  • standardise user-applied labelling of injectable medicines
  • provide minimum requirements for user-applied labelling of injectable medicines.

The Labelling Standard (OD 0647/16) includes:

  • Labelling of containers in perioperative settings (including cardiac catheter and interventional radiology units)
  • Colour-coded pre-printed medicine labels for use on dedicated continuous infusion lines
  • Liquid medicines for oral, enteral and inhalational use
  • Labelling of non-injectable medicines and fluids prepared in the same area as injectable medicines.

Hospitals are required to comply with the Labelling Standard (including the WA modification identified in Operational Directive 0647/16) by March 2016.

Scope of the Labelling Standard

The labelling standard applies to all clinical areas in Australia where injectable medicines and fluids are administered.

While the labelling standard will be applicable in most hospital clinical areas, application goes beyond hospitals to primary care.

This includes any situation involving administration of injectable medicines, such as:

  • GP super clinics
  • Hospital in the Home
  • flying doctor services.

Pilot testing did not include a community setting but there were no indications to suggest extension to the community is inappropriate.

Western Australian modification to the Labelling Standard

WA implementation of the labelling standard, including modifications to the recommendations, is outlined in OD 0647/16 National Standard for user-applied labelling of Injectable Medicines, Fluids and Lines.

Stippling change to beige, blue and red labels

The national labelling standard specifies a 70 per cent stipple (70 per cent shade of the label’s primary colour) to the background of container, conduit and line labels.

Following feedback on the legibility of written information on certain coloured labels – specifically beige (subcutaneous), red (intra-arterial) and blue (intravenous) – container, conduit and line labels used in WA will employ a stipple of 50 per cent to the background area (the area inside the border) of the label.

Border colours must not be altered from those specified in the national labelling recommendations.

Purchase of labels

A mandatory whole of health contract, HSS100116, commenced 1st December 2016.

All are available in iProcurement using the health catalogue numbers referenced on the contract.

  • Contract HSS100116 User Applied Labels for WAHCU-WoH: contact HSS if supply information is requiredt

Support material

Label examples

Safety risk register

The issues register reports issues not directly addressed by the standard, the support materials and the development process.

Please email safetyandquality@health.wa.gov.au with issues associated with the national labelling standard.

These items will be referred to the Health Services Medication Expert Advisory Group for appropriate action or advice.

Please refer to the FAQ section on the Australian Commission on Safety and Quality in Health Care (external site) website for issues addressed with reference to the labelling standard, explanatory notes, implementation guide or the pilot test experience.

Neuraxial Connectors and ISO 80369-6:2016

Administration of medicines or substances by the wrong route, including intrathecal and epidural, comprise a small but serious proportion of the problem of injection errors in medicines administration.

The International Standard ISO 80369-6:2016 Small bore connectors for liquids and gases in healthcare applications – Part 6: Connectors for neuraxial applications (external site) was introduced with the aim of reducing the injection of erroneous substances via intrathecal, epidural and other neural routes. ISO 80369-6:2016 specifies the design and dimensions of small-bore connectors intended for all neural applications, including neuraxial, peripheral and regional applications.

In a joint statement (external site), The Australian and New Zealand College of Anaesthetists (ANZCA) and the Commission recommend that ISO 80369-6:2016 be adopted in Australia as part of a global initiative to improve patient safety.

More information

Medicines and Technology Unit
Address: 3 Forrest Place, Perth
Email: DoH.MedicinesandTechnologyUnit@health.wa.gov.au 

Last reviewed: 30-09-2016
Produced by

Patient Safety and Clinical Quality