TRIM 49566
National Recommendations for User-applied Labelling of
Injectable Medicines, Fluids and Lines
Issues Register
© Commonwealth of Australia 2012
This work is copyright. It may be reproduced in whole or in part for study or training purposes
subject to the inclusion of an acknowledgement of the source. Requests and inquiries concerning
reproduction and rights for purposes other than those indicated above requires the written
permission of the Australian Commission on Safety and Quality in Health Care, GPO Box 5480
Sydney NSW 2001 or mail@safetyandquality.gov.au
Suggested citation
Australian Commission on Safety and Quality in Health Care 2012, National Recommendations for
User-applied Labelling of Injectable Medicines, Fluids and Lines: Issues Register, ACSQHC,
Sydney.
Acknowledgment
Many individuals and organisations have freely given their time and expertise to support the
development of this document. In particular, ACSQHC wishes to acknowledge State and Territory
contacts that have coordinated implementation, and health services which have fed back
implementation experiences and which have been the basis of this document. The involvement
and willingness of all concerned to share their experience and expertise is greatly appreciated.
This paper is available on the ACSQHC web site at www.safetyandquality.gov.au
Labelling Recommendations: Issues Register
2
National Recommendations for User-applied Labelling of Injectable Medicines, Fluids and Lines:
Issues Register
Table of contents
Section
Page
1
Introduction
3
2.
Issues considered by HSMEAG
4
3.
Details of registered issues
6
IR 1, IR 2
7
IR 3, IR4
8
IR 5, IR 6
9
IR 7, IR 8
10
IR 9, IR10
11
IR11
12
IR 12, IR13
13
IR14, IR15, IR16, IR17
14
1. Introduction
The Australian Commission on Safety and Quality in Health Care (ACSQHC) is responsible for
maintaining the National Recommendations for User-applied Labelling of Medicines, Fluids and
Lines (the Labelling Recommendations) and for identifying and reducing national barriers to
implementation.
The Labelling Recommendations Issues Register reports issues that:
1. Cannot be resolved by recourse to Labelling Recommendations, related implementation
resources and outcomes from the piloting process which developed the Labelling
Recommendations; and
2. Have been referred to ACSQHC’s advisory groups for consideration.
Labelling Recommendations issues referred to ACSQHC’s advisory groups are recorded in the
Labelling Recommendations Issues Register on the ACSQHC web site at
http://www.safetyandquality.gov.au/internet/safety/publishing.nsf/Content/PriorityProgram06_UaLIMFL
Frequently asked questions (FAQs) are issues which have been raised often during
implementation of the Labelling Recommendations and which were answered with reference to the
Labelling Recommendations and the accompanying explanatory notes, implementation guide or
with outcomes from the Labelling Recommendations pilot. These are collated in the Labelling
Recommendations Frequently Asked Questions which is available on the ACSQHC web site at
http://www.safetyandquality.gov.au/internet/safety/publishing.nsf/Content/PriorityProgram06_UaLIMFL
Implementation of the Labelling Recommendations is an evolving process. ACSQHC invites
facilities encountering implementation issues which cannot be answered by the Labelling
Recommendations and implementation resources (including the FAQs and Labelling
Recommendations Issues Register) to contact their jurisdictional contact in the first instance and,
for health services with no jurisdictional representative, ACSQHC at mail@safetyandquality.gov.au.
Labelling Recommendations: Issues Register
3
2. Issues summary
Issue
Suggested change
Proponent
Date
Response
Reasoning/Action
IR 1
Should pre-populated
medicine line labels follow
AS/NZS 4375 colour coding?
Medicine line labels to follow
colour coding of AS/NZS
4375
All
05/2011
Yes
There is no established standard for
colour coding medicine labels outside
of those described in AS/NZS 4375
and ISO 26825.
IR 2
Do the Labelling
Recommendations extend to
all health services?
Broaden direct
communication of Labelling
Recommendations
All
05/2011
Yes
Yes, any situation where injectable
medicines and fluids require
identification.
IR 3
Do the Labelling
Recommendations apply to
ambulance services?
No change
01/2011
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. See Labelling
Recommendations page 5, Point 2.
IR 4
Do labels provided by
suppliers of custom packs
need to comply with the
Labelling Recommendations?
No change
ACSQHC
04/ 2011
Yes
Labels are currently provided in
custom surgical procedure packs.
Suppliers must ensure these now
comply with the Labelling
Recommendations. Suppliers have
been contacted directly by ACSQHC.
IR 5
Is use of ‘units’ on container
labels ambiguous?
Remove ‘units’ from container
labels
Tas
05/2011
No
Units are included to prompt the user
to complete this as part of the dose.
Education will support the intention of
this prompt.
IR 6
Should container labels be
developed for specific IV
routes?
Introduce a central venous
container label.
NSW
03/2011
No
The differentiation of central and
peripheral delivery is confirmed via
the line label.
IR 7
Should the Labelling
Recommendations include an
intra-arterial container label?
Include an intra-arterial
container label
SA
09/2011
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).
Labelling Recommendations: Issues Register
4
IR 8
Can the labels be removed
from stainless steel
containers?
Specifications of removable
labels are established.
All
Various
Yes
Stainless steel and other reusable
containers are used in a high
proportion of health care facilities.
Labels from 3 manufacturers have
been tested on reusable hollowware
used in the perioperative area. Labels
from 2 manufacturers exposed to 3
frequently encountered fluids were
removed with alcohol wipes and/or
eucalyptus oil in most cases.
IR 9
Are three patient identifiers
required on container labels?
Add third patient identifier
ACSQHC
09/2011
Yes
To comply with National Safety and
Quality Health Service Standards,
June 2011
IR 10
Should AS/NZS4375 be
applied to identify medicines
in containers in open practice
areas?
Use labels with medicine and
concentration only
(AS/NZS4375) in open
practice areas such as
emergency department and
post anaesthetic recovery
(PACU).
All
09/2011
No
In open practice areas identify
medicines in containers with full
labelling according to the Labelling
Recommendations.
In closed practice areas, identify
medicines in containers with full
labelling according to the Labelling
Recommendations OR with medicine
name and concentration only
according to AS/NZS4375.
IR 11
What specifications apply to
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
07/2011
Under
evaluation
Pre-printed labels to identify
medicines in containers on the sterile
field are being evaluated for size,
content and colour in a perioperative
area.
Colour coding on trial pre-printed
labels follows AS/NZS 4375 and
results will be available mid 2012.
IR 12
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
10/2011
No
Full inclusions are required on the
primary container. Attached lines and
devices may not be relabelled at
syringe change.
IR 13
Does the application of a
To be advised
Vic
05/2011
No
CME response.
Labelling Recommendations: Issues Register
5
syringe label affect the
operation of a Niki T34
syringe driver?
IR14
Can pre-printed container
labels be used in cardiac
catheter laboratories?
In the closed practice
environment of the cardiac
catheter laboratory, labels
can be pre-printed with
medicine and concentration
only. Colour coding to be
applied according to
AS/NZS4375.
All
IR15
Line labels to identify the
neural route are all coloured
yellow with different borders.
Do the labels require further
differentiation?
There is further differentiation
of epidural, intrathecal and
regional routes with use of
different colours.
IR16
Can the medicine name be
pre-printed on the same line
route label?
IR17
Do all lines require route
identification when multiple
lines are cited?
Yes
The cardiac catheter laboratory is a
closed practice area where the
identity of the patient and patient care
team are beyond doubt and recorded.
Medicines in containers may be
identified with medicine name and
concentration according to
AS/NZS4375.
Various
No
The differentiation of the intraneural
routes in the Labelling
Recommendations is appropriate.
Intraneural route identification will be
monitored.
Create a line label with
medicine name and route of
administration.
Manufacturer
No
No rationale for combination.
Label each line for route and
medicine when several
dedicated continuous
infusions are running.
LRRG
No
Replication of route identification may
detract from medicine identification.
Labelling Recommendations: Issues Register
Various
03/2012
6
3. Details of registered issues
IR 1: 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. Pre-printed labels to identify the active
ingredient are acceptable and may be more convenient in high-use areas.
Line medicine labels can be printed ‘black on white’. However, facilities may prefer to use
colour to support the written information 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: 1996 User-applied labels on
syringes containing drugs used during anaesthesia. In the absence of an established
standard for colour coding medicine line labels, where it is standard practice to apply colour,
any colour should comply with AS/NZS 4375.
Labels for medicines in the miscellaneous category of AS/NZS 4375 (such as heparin, insulin
and 0.9% sodium chloride) are should be printed black on white.
The international Standard ISO 26825:2008
http://www.iso.org/iso/iso_catalogue/catalogue_tc/catalogue_detail.htm?csnumber=43811
draws heavily on Australian and New Zealand Standard ASNZ 4375:1996. ISO 26825:2008
specifies differentiation of heparin and protamine with a solid black border for heparin and a
black and white hatched border for protamine.
In pilot testing, AS/NZS 4375 labels manufactured for use in anaesthesia were found to be
too small and adhered poorly to lines. Ideally, use medicine labels produced specifically for
the purpose of line identification. However, if the smaller anaesthetic labels are used, ensure
any labels that detach are replaced immediately.
The font used on the medicine line labels may use Tall Man lettering.
The extension of standard AS/NZS4375:1996 to labelling dedicated continuous infusion lines
is an interim position. ACSQHC will continue to work with users and the Labelling
Recommendations Reference Group to establish the validity of the extension, including
testing of the extension in intensive care units.
IR 2: 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;
•
Australian College of Critical Care Nurses;
•
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
Labelling Recommendations: Issues Register
7
IR 3: 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 indicate that identification of medicines and safe
administration is important in the emergency situation. 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; and

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/NZ 4375, may be suitable for
the ambulance service. However, these are not suitable if the patient identity needs to be
recorded.
IR 4: 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 ACSQHC:
•
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
If you represent a supplier of custom packs not listed above, and require further information
on the Labelling Recommendations, please contact mail@safetyandquality.gov.au
In all clinical areas, medicines taken from their original container must be identified in the new
container (syringe, bag etc.) with the following information:
Labelling Recommendations: Issues Register
8

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); and

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).
IR 5: 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. Health services
are advised to monitor the situation through incident management system audit during
implementation.
IR 6: 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; and

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 through 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.
Labelling Recommendations: Issues Register
9
IR 7: 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 IntraARTERIAL Use Only’.
At all times it is essential to label the intra-arterial line to identify the route of the line.
IR 8: Use of disposable vs. stainless steel containers on the sterile field
Labels may be difficult to remove from stainless steel and other reusable hollow ware used in
operating rooms. This would render containers unsuitable for reuse.
Jurisdictions advise ACSQHC that stainless steel and other reusable containers are used in
preference to disposable containers in a high proportion of health facilities in Australia. Thus,
it is a requirement that labels may be removed entirely after use.
The Labelling Recommendations specify ‘peel off’ labels are used for container labels on the
perioperative sterile field.
ACSQHC engaged a health facility to evaluate sterile labels and adherence to reusable
containers used in the perioperative area to establish the viability of container reissue.
ACSQHC acknowledge the valuable contribution made by those involved at St Vincent’s
Hospital, Sydney.
The evaluation looked specifically at the performance of labels from 3 suppliers to establish
the potential for these labels to be removed from reusable plastic or stainless steel containers
after exposure to 3 fluids frequently used in the perioperative sterile field.
Whilst the ease of removal of labels was the key focus, the adherence of the label for periods
intended to reflect practice, was also established. Results indicate that labels from 2 of the
three manufacturers could be removed either with or without application of alcohol wipes
and/or eucalyptus oil. The following limitations are noted:
a) only 3 fluids were tested and labels appeared to perform differently with exposure to
different fluids
b) fluids were tested by adding a 'wipe' of fluid not by making the label very wet or
immersing the label for any time.
Identification of medicines in containers on the sterile field is mandatory. Therefore, the ability
to remove ‘peel off’ labels from reusable containers used on the perioperative sterile field
supports the continued use of reusable containers. Further details of the evaluation are
available on request from mail@safetyandquality.gov.au
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.
Labelling Recommendations: Issues Register
10
IR 9: Are three 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 (see Figure 1 below).
Figure 1: Revised container label with patient date of birth. The intravenous route
container label is example shown
The revision is valid immediately, but may take effect as existing label stocks are exhausted.
The revised container labels are available in print ready form on the ACSQHC web site at
http://www.safetyandquality.gov.au/internet/safety/publishing.nsf/Content/PriorityProgram06_UaLIMFL
IR 10: Should AS/NZS 4375 or the Labelling Recommendations be applied to identify
medicines in containers in open practice areas?
Containers (bags and syringes) holding medicines removed from their original containers
must be identified with full label inclusions, as per the container label in the Labelling
Recommendations, in all open practice environments. The following elements are the
minimum requirement:

Patient name (first 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 (complete for syringes);

Date and time prepared;

Prepared by (signature);

Checked by (signature); and

Route of administration (where not specified by wording and colour).
The exception to this rule is the closed practice environment where the following applies

The identity of the patient is beyond doubt

The identities of the patient care team are recorded

The medicine is administered completely within the closed practice environment.
Labelling Recommendations: Issues Register
11
Examples of closed practice environments include the operating room, endoscopy, cardiac
catheter lab, radiology suites.
AS/NZS 4375:1996 standard describes labels colour coded according to drug class preprinted with medicine name and a prompt for concentration and applies to syringes containing
drugs used during anaesthesia. AS/NZS 4375:1996 labels, used for the purpose for which
they are designed, identify medicines drawn up and administered by the same practitioner. It
is appropriate to extend compliance with AS/NZS4375:1996 to identify medicine name and
concentration to closed practice environments beyond anaesthesia.
At the end of a procedure in a closed practice environment all medicines prepared for use in
the closed practice environment, including partially used or unused medicines, are to be
discarded promptly.
Medicines prepared in the closed practice environment which will move with the patient to an
open area must comply with the Labelling Recommendations. Examples include continued
delivery of additives in fluid bags on patient transfer from the operating room to post
anaesthetic recovery unit (PACU) or syringes prepared to accompany the patient on transfer
to the intensive care unit (ICU).
Closed practice environments include, but are not limited to, the endoscopy room, cardiac
catheter laboratories, radiology and the operating room.
The emergency department (ED) is an open practice environment and labelling must comply
with the Labelling Recommendations and which states

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.
IR 11: Are there specifications for pre-printed labels on the sterile field in the
perioperative area?
The operating room of the perioperative area is a closed practice environment. The Labelling
Recommendations provide an abbreviated container label as a generic label to identify all
medicines and fluids on the sterile field in the perioperative area. Patient and user
identifications are omitted as these details are recorded elsewhere.
Pilot testing acknowledged pre-printed labels for use by scrub nurses and surgeons in the
perioperative sterile field have advantages and are a suitable alternative to the abbreviated
container label for routine operations where the same medicines are used frequently.
Most operating rooms will be able to identify a short list of medicines used regularly and preprint labels with the following advantages:

No need for sterile marker

Readily available

Less time to select and apply
Preprinted sterile container 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 AS/NZS 4375: 1996 User-applied labels on syringes containing drugs used during
anaesthesia. In the absence of an established standard for colour coding labels for the
perioperative sterile field, ACSQHC suggest colour should comply with AS/NZS 4375:1996.
Labels for medicines in the miscellaneous category of AS/NZS 4375 (such as heparin, insulin
and 0.9% sodium chloride) are should be printed black on white. The international Standard
ISO 26825:2008
http://www.iso.org/iso/iso_catalogue/catalogue_tc/catalogue_detail.htm?csnumber=43811
Labelling Recommendations: Issues Register
12
draws heavily on Australian and New Zealand Standard ASNZ 4375:1996. ISO 26825:2008
specifies differentiation of heparin and protamine with a solid black border for heparin and a
black and white hatched border for protamine.
Label quality must be such that labels are fit for purpose, progress through sterilisation intact
and retain integrity throughout the procedure.
ACSQHC have engaged Calvary Wakefield Hospital, South Australia to test sets of sterile
perioperative labels, to prepare a label sheet including medicines most frequently used in
routine procedures, to procure individually packaged sterile sheets and to evaluate their use
in terms of identification and label quality. The trial of procured labels is expected to undergo
evaluation in June 2012. The evaluation will assist other facilities across health services to
implement the Labelling Recommendations to safely identify medicines on the sterile field in
the perioperative area.
IR 12: Should syringes in syringe drivers and pumps carry abbreviated labelling?
Containers (syringes) in syringe drivers and pumps should be identified with full label
inclusions

Patient name (first 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 (complete for syringes);

Date and time prepared;

Prepared by (signature);

Checked by (signature); and

Route of administration (where not specified by wording and colour).
It is appreciated the small container label is often too large to allow syringe graduations to
remain visible when using a syringe driver or pump. Facilities may consider changes to label
placement provided the full, completed container label remains directly attached to the
primary container, i.e. syringe.
IR 13: Does the application of a syringe label effect the operation of a Niki T34 syringe
driver?
Experience suggests the application of labels to syringes in Niki T34 syringe drivers does not
interfere with the ability of the device to accurately assess syringe volume. Caesarea Medical
Electronics (CME) advise:
‘The pump identifies syringes by their diameter. Most labels if applied carefully do not make a
significant difference to the diameter and mostly the pump will still identify the syringe
correctly. If the label is not flat and smooth the pump may initially guess the wrong syringe. I.e.
it will see a larger diameter.
At all times the user must check that the correct syringe is displayed before activating the
pump. If the incorrect syringe is displayed initially the user must use the UP/DOWN button to
select the correct syringe and then they can proceed.’
Labelling Recommendations: Issues Register
13
IR 14: Can pre-printed container labels be used in cardiac catheter laboratories?
In the closed practice environment of the cardiac catheter laboratory, where the identity of the
patient and patient care team are beyond doubt and recorded, labels can be pre-printed with
medicine and concentration only.
In cardiac catheter laboratories, the same sets of medicines are used following set protocols
for the same procedures. This allows for predictable label sets to be produced, including
specification of the concentration. Fluids not for injection can be labelled with name only. For
example, concentration is not required for Betadine, chlorhexidine.
Where colour coding is applied as standard, pre-printed sterile container labels should follow
colour coding according to drug class as adopted by AS/NZS 4375: 1996 User-applied labels
on syringes containing drugs used during anaesthesia. In the absence of an established
standard for colour coding labels for the cardiac catheter sterile field, ACSQHC suggest
colour should comply with AS/NZS 4375:1996.
Labels for medicines in the miscellaneous category of AS/NZS 4375 (such as heparin, insulin
and 0.9% sodium chloride) are should be printed black on white. The international Standard
ISO 26825:2008
http://www.iso.org/iso/iso_catalogue/catalogue_tc/catalogue_detail.htm?csnumber=43811
draws heavily on Australian and New Zealand Standard ASNZ 4375:1996. ISO 26825:2008
specifies differentiation of heparin and protamine with a solid black border for heparin and a
black and white hatched border for protamine.
Label quality must be such that labels are fit for purpose, progress through sterilisation intact
and retain integrity throughout the procedure.
The extension of standard AS/NZS4375:1996 to labelling in cardiac catheter and angiography
suites is an interim position. ACSQHC will continue to work with users and the Labelling
Recommendations Reference Group to establish the validity of the extension, including
testing in this clinical area.
IR 15: Line labels to identify the neural route are all coloured yellow with different
borders. Do the labels require further differentiation?
Labelling lines to identify the route is a mandatory requirement of the Labelling
Recommendations and the current differentiation of the intraneural routes is appropriate.
Intraneural route identification will continue to be monitored.
IR 16: Can the medicine name be pre-printed on the same line route label?
Currently, there is no evidence to support identification of drug delivery via the neural route by
including the medicine on the route identification line label. The route identification label
remains separate to the medicine (active ingredient) line label.
Combination of the two labels is not endorsed.
IR 17: Do all lines require route identification when multiple lines are present?
When a number of lines are in situ in intensive care settings, it is critical to ensure the drug in
each line can be promptly identified. Equally the route is important, particularly with intrathecal
and intra-arterial routes. For intravenous infusion, where multiple central lines converge into a
common central line, the common line must be identified for route, but the individual lines do
not require separate route labels. The individual lines will each be identified for active
ingredient.
Last updated 10 April 2012
Labelling Recommendations: Issues Register
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