TRIM 49566
National Recommendations for User-applied Labelling of Injectable Medicines, Fluids and Lines
Issues Register - November 2011
The issues register reports issues not directly addressed by the National Recommendations for User-applied Labelling of Medicines, Fluids and Lines (the Labelling Recommendations), the Labelling Recommendations support materials and the development process. These items have been referred to the Health Services Medication Expert Advisory Group and reflect the decisions of that group with suggested actions as appropriate.
Please refer to the FAQ section on the Australian Commission on Safety and Quality in Health Care (the Commission) website at
http://www.safetyandquality.gov.au/internet/safety/publishing.nsf/Content/PriorityProgram-06_UaLIMFL for issues addressed with reference to the Labelling Recommendations, explanatory notes, implementation guide or the pilot test experience,
The implementation of the Labelling Recommendations is an evolving process and the Commission invite facilities to request support by contacting for issues not covered by the Issues Register and FAQs.
Changes proposed and considered by the Health Services Medication Expert Advisory Group (HSMEAG)
Issue / Suggested change / Proponent / Date / Response / Reasoning/ActionIR1 Should pre-populated medicine labels follow AS/NZS4375 colour coding? / Medicine line labels of varied colours continue to circulate / All / May 2011 / Yes / There is no established standard for colour coding medicine labels outside of those described in AS/NZS 4375.
IR2 Do the Labelling Recommendations extend to all health services? / Broaden direct communication of Labelling Recommendations / All / May 2011 / Yes / Yes, any situation where injectable medicines and fluids require identification.
IR3 Do LR apply to ambulance services? / No change / Jan 2011 / Yes. / Any situation requiring identification of medicines and fluids (removed from original container) and lines connected to the patient whether or not these are intended for administration. LR page 5, no.2.
IR4 Do labels provided by suppliers of custom packs need to comply with LR / No change / ACSQHC / April 2011 / Yes / Labels are currently provided in custom surgical procedure packs. Suppliers must ensure these now comply with LR. Suppliers have been contacted directly by ACSQHC.
IR5 Is use of ‘units’ on container labels ambiguous? / Remove ‘units’ from container labels / Tasmania / May 2011 / No / Units are included to prompt the user to complete this as part of the dose. Education will support the intention of this prompt.
IR6 Should container labels be developed for specific IV routes? / Introduce a central venous container label. / NSW / March 2011 / No / The differentiation of central and peripheral delivery is confirmed via the line label.
IR7 Should the LR include an intra-arterial container label? / Include an intra-arterial container label / SA / September 2011 / No / Individual facilities may produce an intra-arterial container label using the template for other container labels and incorporating the wording ‘For Intra-arterial Use Only’ and PMS 1787 (Red).
IR8 Can the labels be removed from stainless steel containers? / Specifications of removable labels are known / All / Various / Unknown / Establish extent of stainless steel container use before investigating practicality of container reuse post-labelling.
IR9 Are 3 patient identifiers required on container labels? / Add third patient identifier / ACSQHC / September 2011 / Yes / To comply with National Safety and Quality Health Service (NSQHS) Standards, June 2011.
IR10 Should AS/NZS4375 or the Labelling Recommendations be applied to identify medicines in containers in areas beyond the perioperative area? / Use labels with medicine and concentration only outside perioperative area. / All / September 2011 / No / Identification of containers in open areas requires patient and user ID
IR11 Are there specifications for pre-printed labels on the sterile field in the perioperative area? / Provide size and content and colour for pre-printed labels in perioperative area / All / July 2011 / No / Use generic abbreviated container label as guide. There is no established standard for colour coding medicine labels outside of those described in AS/NZS 4375.
IR12 Should syringes in syringe drivers and pumps carry abbreviated labelling? / Label lines attached to syringes in pumps and drivers with full details and include only medicine name on syringe. / SA / October 2011 / No / Full inclusions are required on the primary container as attached lines and devices may not be relabelled at syringe change.
IR13 Does the application of a syringe label effect the operation of a Niki T34 syringe driver? / To be advised / Vic / May 2011 / No / CME (REM Systems to advise)
IR1: Can medicine line labels be pre-printed? If so, can these labels be coloured?
The Labelling Recommendations include a generic 'medicine' label to identify the active ingredient in a dedicated continuous infusion line. The use of pre-printed labels to identify the active ingredient is acceptable. Indeed, high-use areas may find pre-populated labels more convenient.
Line medicine labels can be printed ‘black on white’. However, facilities may prefer to use colour to support the written word in assisting recognition of medicines and fluids. There is no specific standard for this purpose. Colour coding according to drug class is adopted by Australian/New Zealand Standard (AS/NZS) 4375: User-applied labels on syringes containing drugs used during anaesthesia. In the absence of an established standard for colour coding medicine line labels, the Commission suggest colour should comply with AS/NZS4375. Using this principle, labels for medicines in the miscellaneous category of AS/NZS4375 (such as heparin, insulin and 0.9%sodium chloride) will be printed black on white.
In pilot testing, AS/NZS 4375 ‘anaesthetic labels’ were found to be too small with poor adherence to lines. Hence, their suitability for use on lines is not established and medicine labels (either generic black on white or pre-populated with medicine name) specifically produced for the purpose are more suitable.
IR2: Do the Labelling Recommendations extend to all health services?
Yes, any situation where injectable medicines and fluids require identification.
The following organisations received detailed information on the Labelling Recommendations.
• Australian Dental Association;
• The Royal Australian and New Zealand College of Radiologists;
• Australian College of Operating Room Nurses (ACORN);
• Australian College of Critical Care Nurses (ACCCN);
• The Aged Care Standards & Accreditation Agency Ltd.;
• Cardiac Electrophysiology Institute of Australasia
• Cardiac Society of Australia and New Zealand
• Paramedics Australasia
• Australian Institute of Radiography
IR3: Do emergency situations referred to in the Labelling Recommendations (page 8) apply to ambulance services and do these services need to implement the Labelling Recommendations?
Results from the pilot test in the emergency department and other clinical areas likely to perform emergency resuscitation procedures in hospital indicate:
· Identification of medicines and safe administration is important in the emergency situation and principles from the Labelling Recommendations should be followed if staff are available in sufficient numbers to label syringes without compromising speed of drug delivery in an emergency.
This is reflected in the Labelling Recommendations as follows:
· Label medicines in an emergency. See pages 8 and 9: “Where injectable medicines are drawn up in a syringe for immediate emergency use (e.g. during resuscitation), standard operating procedures in emergency care should ensure that the principles in the Labelling Recommendations are followed to the extent possible. Pre-printed active ingredient (generic medicine) labels from AS/NZS 4375 should be considered.”
Note exemptions to labelling:
· When a single person draws up and immediately administers a medicine without the syringe leaving the hand.
· Fluid bags for infusion where NO additional injectable medicines are added prior to administration e.g. IV fluids (e.g. 0.9% Sodium Chloride, 5% glucose), pre-mixed solutions (e.g. potassium, heparin infusion bags).
Use of pre-printed active ingredient labels, consistent with AS/NZ4375, may be suitable for the ambulance service. However, these are not suitable if the patient identity needs to be recorded.
IR4: Do suppliers of custom procedure packs need to supply medicine labels compliant with the Labelling Recommendations in these packs?
Yes, suppliers of custom procedure packs should ensure labels included in the packs to identify route of administration and medicines used on the sterile field, e.g. operating rooms and catheter labs, comply with the Labelling Recommendations.
The following suppliers have received correspondence relating to the Labelling Recommendations from the Commission:
Medline
B. Braun Australia Pty Ltd
ICU Medical Australia Pty Ltd
Proact Medical Systems
REM System Pty Ltd
Mayo Healthcare Pty Ltd
Bard Australia Pty Ltd
Covidien Pty Ltd
Kimberley-Clark Health Care
Medical Specialties Australia
Please contact if you represent a supplier of custom packs not listed above and require further information on the Labelling Recommendations.
In all clinical areas, medicines taken from their original container must be identified in the new container (syringe, bag etc.) with the following information:
· Patient name (given name and family name)
· Patient identifier (ID), e.g. URN, MRN
· Active ingredient/s (medicine/s) added to the bag or syringe
· Amount of medicine/s added (including units)
· Volume of fluid (mL) - total in bag or syringe
· Concentration (units/mL)
· Diluent (for syringes)
· Date and time prepared
· Prepared by (signature)
· Checked by (signature)
· Route of administration (where not specified by wording and colour)
However, if the patient and user identifications are beyond doubt and recorded elsewhere they are not required on the label and the abbreviated container label from the Labelling Recommendations is an appropriate choice.
Any pre-populated labels based on the abbreviated container label should be coloured in compliance with AS/NZS 4375 (colour code according to drug class).
IR5: Use of the word 'units' on container labels.
Concerns have been raised that use of the word 'units’ for amount on container labels may be interpreted as ‘units as in insulin/ heparin' rather than the amount of medicine. The issue has not occurred in clinical practice.
Units are included to prompt the user to include units when writing the dose. Monitor the situation via incident management system audit during implementation.
IR6: Should container labels for specific intravenous routes be introduced, e.g. peripheral venous, central venous, PICC etc.?
Container labels for the IV route are to remain as per the Labelling Recommendations and not tailored for specific IV routes.
Results of the pilot testing informed the final recommendations and two overriding factors were reported:
· Keep the number of different type and size labels to a minimum to facilitate a clear selection process
· Bag labels with a predominantly white background and a small colour border, are not sufficiently visible to draw attention to the presence of an additive.
Therefore, a single, fully coloured container label for intravenous bags with additives and syringes is included in the Labelling Recommendations for containers of medicines for either peripheral or central intravenous administration.
The differentiation between the peripheral and central administration is confirmed via the line label and a separate line label for central venous use is available. It is acknowledged that clear differentiation between peripheral intravenous and central intravenous line labels with the same colour is required.
IR7: Is an Intra-arterial container label required for the Labelling Recommendations?
Container labels for the Intra-arterial route will not be drawn up and included in the Labelling Recommendations.
However, an intra-arterial container label for medicines administered via the intra-arterial route, e.g. heparin, may occasionally be required.
Administration of medicines through the intra-arterial line was considered during development of the Labelling Recommendations. In most instances the intra-arterial line will be used for monitoring purposes only. Indeed, during pilot testing the intra-arterial line was only used as a monitoring line and there was no demand for a container label. Moreover, if a container label was introduced there may be a false implication that medicines are intended for routine administration via the intra-arterial line.
Health services requiring an intra-arterial container label should develop this consistent with the Labelling Recommendation principles. To identify a container holding a medicine to be delivered via the intra- arterial route a red (PMS 1787) label with wording 'For Intra-ARTERIAL Use Only’.
At all times it is essential to label the intra-arterial line to identify the route of the line.
IR8: Use of disposable vs. stainless steel containers on the sterile field
Labels may be difficult to remove from stainless steel containers used in operating rooms. This would render containers unsuitable for reuse. Are there any other advantages of disposable containers to drive a switch away from stainless steel equipment?
The Commission seeks advice from jurisdictions on the level of use of stainless steel containers in operating procedures, and whether they are preferred over disposable containers.
The Commission will contact CSSD units to establish if bio-burden from peelable labels is retained on containers.
Depending on outcomes from the two issues raised above, the use of disposable containers in operating procedures may be advocated.
Note: Pre-labelling disposable containers with medicine name is a source of medication error and the user should apply appropriate labels at the time the container is filled.
IR 9: Are 3 patient identifiers required on container labels?
The National Safety and Quality Health Service (NSQHS) Standards, June 2011, (Standard 5: Patient Identification and Procedure Matching) state ‘At least three approved patient identifiers are used when providing care, therapy or services’. To comply with the standards, the container labels in the Labelling Recommendations will be changed to include a third patient identifier, date of birth to be described as DOB (Figure 1).
Figure 1: Revised container label. The intravenous route container label is example shown
The revision is valid immediately, but may take effect as existing label stocks are exhausted.
IR 10: Should AS/NZS4375 or the Labelling Recommendations be applied to identify medicines in containers in areas beyond the perioperative area?
Containers (bags and syringes) holding medicines removed from their original containers must be identified with full label inclusions, except in areas where patient and user identities are beyond doubt or recorded elsewhere, e.g. perioperative area.