labelling recommendations frequently asked questions
TRANSCRIPT
TRIM 44130
National Recommendations for User-applied Labelling of Injectable Medicines, Fluids and Lines:
Frequently Asked Questions
7 August 2013
© Commonwealth of Australia 2013 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 [email protected] Suggested citation Australian Commission on Safety and Quality in Health Care 2013, National Recommendations for User-applied Labelling of Injectable Medicines, Fluids and Lines: Frequently Asked Questions, ACSQHC, Sydney. Acknowledgment Many individuals and organisations have freely given their time and expertise to support the development of this document. In particular, the Commission 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 Commission web site at www.safetyandquality.gov.au
Labelling Recommendations: Frequently Asked Questions 7 August 2013 2
National Recommendations for User-applied Labelling of Injectable Medicines, Fluids and Lines: Frequently Asked Questions
Table of contents
Section Page
Introduction 3
Frequently asked questions
1. Implementation 4
2. Clinical application: General 5
3. Clinical application: Containers 9
4. Clinical application: Lines 12
5. Perioperative area 14
6. Special situations 19
7. Label procurement 22
8. Labels from external sources 23
Introduction The Australian Commission on Safety and Quality in Health Care (the Commission) is responsible for maintaining the National Recommendations for User-applied Labelling of Injectable Medicines, Fluids and Lines (the Labelling Recommendations) and for identifying and reducing national barriers to implementation.
These 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. Questions are grouped and each is provided with an answer. FAQs are updated regularly on the Commission web site at www.safetyandquality.gov.au/our-work/medication-safety/user-applied-labelling/labelling-recommendations-frequently-asked-questions/
Some issues raised during implementation cannot be answered by referring to the source documents, or the pilot, and must be referred to the Commission’s advisory groups. These issues, and the responses to them, are recorded in the Labelling Recommendations Issues Register on the Commission web site at www.safetyandquality.gov.au/our-work/medication-safety/user-applied-labelling/issues-register/
Implementation of the Labelling Recommendations is an evolving process. The Commission 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 Labelling Recommendations jursidictional contact in the first instance, and for health facilities with no jurisdictional contact, the Commission at [email protected]
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1. Implementation Q1.1: Why are the Labelling Recommendations important? A: Incomplete or inaccurate labelling of injectable medicines and fluids is a recognised risk in the safe administration of medicines. The Labelling Recommendations assist the user to identify medicines which can no longer be identified by their original packaging to promote safer use of medicines through standardisation and best practice.
Q1.2: Is there a timeline for introducing the Labelling Recommendations? The Labelling Recommendations were endorsed by Australian Health Ministers in 2010. Health services seeking accreditation to the National Safety and Quality Health Standards are required to implement the Labelling Recommendations as outlined in the source documents.
Q1.3: How should the implementation of the Labelling Recommendations be audited? Current incident management systems record incidents on a case by case basis and can reveal if errors in labelling were involved regardless of whether the incident led to harm, did not lead to harm or were detected prior to administration. Statistical rate analysis is not possible without recording the denominator (total number of drug administrations). However, it is possible to audit uptake and compliance with the Labelling Recommendations through the audit tools provided on the Commission web site at www.safetyandquality.gov.au/our-work/medication-safety/user-applied-labelling/support-materials/
Q1.4: Will additional resources be made available to support implementation? No additional funding will be available for implementation. The cost of providing labels and storage must be taken from existing ward allocations. Existing QUM and best practice groups will meet the cost of education. The Commission will support these groups through the Labelling Recommendations Reference Group (LRRG).
Q1.5: My hospital is producing a poster for each ward to assist with education. Do I need to acknowledge copyright? A: Yes, the materials are free to use. However a statement acknowledging copyright in the National Recommendations for User-applied Labelling of Injectable Medicines, Fluids and Lines to the Australian Commission on Safety and Quality in Health Care is required.
Q1.6: How do I cite the Labelling Recommendations? A: Suggested citation: Australian Commission on Safety and Quality in Health Care (2013) National Recommendations for User-applied Labelling of Injectable Medicines, Fluids and Lines, ACSQHC, Sydney.
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2. Clinical application: General
Q2.1: Is it possible to make changes to the labels? A: In theory, it is possible provided the minimum requirements of the Labelling Recommendations are met.
However, when introducing new information consider:
• whether information can be recorded elsewhere
• increasing information content may reduce the clarity of minimum requirements
• pilot testing did not identify any necessary additional information
The use of non-standard labels has the following implications:
• They risk demonstrated safety benefits by not reflecting outcomes and feedback from national piloting.
• Additional label production costs through compromised economies of scale as label manufacturers incur additional set up and print costs.
• Implementation and education resources provided and maintained by the Commission would no longer be applicable.
• The labels in Word format posters for customisation by individual wards will no longer be valid.
• Health professionals working across a number of hospitals will experience varied “national” labelling requirements.
Q2.2: Can the pink ‘miscellaneous’ label be used for any route if labels are out of stock? A: No. A generic pink label headed ‘ROUTE’ in large bold type with a space adjacent for completion of route is included to enable safe labelling of all routes not specifically covered by the Labelling Recommendations. These miscellaneous pink labels are NOT to be used for routes with a dedicated label. Maintenance of adequate stock levels is critical to safe labelling.
Q2.3: During the implementation phase, what do I do if a patient is transferred into my clinical unit without the new labelling? A: Leave current labelling in-situ for the remainder of the infusion. Do not transcribe onto a ‘new’ label. Use the labels directed by the Labelling Recommendations for the next infusion. Communicate the issue to the referring area or ward.
Q2.4: How should extemporaneously prepared items for individual patient administration be labelled? These often come with lines attached so should these also be labelled? A: No additional labelling is necessary for a medicine remaining in its original container. Items prepared for individual patients will already identify the patient identity and user and checked by signature prompts are usually included. Refer to page 6 of the Labelling Recommendations. Lines attached to these original containers must comply with the Labelling Recommendations when the user makes a decision on the route of administration and will require a line label to identify route.
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Q2.5: How should cytotoxics be labelled? A: The Labelling Recommendations apply to any medicine, including cytotoxics. In practice, these are likely to remain in their original container prepared for individual patient use (see Q2.4). A purple ‘cytotoxic’ label may be used to highlight presence of a cytotoxic in addition to the minimum requirements of the Labelling Recommendations. (See Clinical Oncological Society of Australia (COSA): Guidelines for the Safe Prescribing, Supply and Administration of Cancer Chemotherapy, November 2008) at www.cosa.org.au/media/1093/cosa_guidelines_safeprescribingchemo2008.pdf
Q2.6: Do enteral medicines and fluids require labelling? A: Enteral medicines and fluids are outside the scope of the Labelling Recommendations. However, the principles of the Labelling Recommendations apply to medicines and fluids given via the enteral route. See Labelling Recommendations, page 13; Labelling non-injectable solutions.
• Non-injectable solutions must NEVER be given via the parenteral route • Some of the principles in the Labelling Recommendations apply to the labelling
of non-injectable medicines drawn up in syringes to be administered via non-injectable routes such as inhalation, oral and other enteral routes.
• ONLY syringes specifically designed for administration of medicines orally or via other enteral routes (e.g. nasogastric) should be used for these purposes. They should be clearly labelled ‘For Oral Use Only’, ‘For Enteral Use Only’, etc.
• Syringes used for non-injectable solutions, including oral and enteral syringes, must NOT be compatible with parenteral entry portals.
Green (PMS 361) labels are suggested for identifying medicines and fluids for enteral use (see figures 1 and 2 below). This issue is held in the Labelling Recommendations Issues Register (Issues Register 23).
Figure 1: Example container label for medicines delivered via the enteral route
Figure 2: Example line label for medicines delivered via the enteral route
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Q2.7: Should nebuliser solution drawn up in a syringe be labelled? A: Medicines for inhalation are outside the scope of the Labelling Recommendations. However, the same principles apply and medicines and fluids given via inhalation, including nebuliser solutions, must be identified at all times (see Q2.6 and Labelling Recommendations, page 13; Labelling non-injectable solutions). Ideally, single use nebules avoid measurement in a syringe and potential for wrong route administration. If the nebuliser solution is measured in a syringe, the syringe must be clearly identified. A white label with wording ‘For Inhalation Only’ is suggested to identify medicines and fluids removed from their original container for inhalation (see Figure 3 below).
Figure 3: Example container label for medicines delivered via inhalation
Q2.8: What is the difference between an epidural and regional block? And how should the Labelling Recommendations be applied? A: A regional anaesthetic block provides local anaesthesia to a discrete area of the body for the management of pain. Common regional anaesthetic blocks include extrapleural or para-vertebral blocks, intrapleural blocks, femoral nerve block, a catheter placed directly into the wound and an epidural block.
For an epidural regional block, the local anaesthetic is delivered directly into the epidural space via the thoracic, lumbar or caudal area.
The Labelling Recommendations provide a specific label for identification of containers and lines delivering an epidural block. For all other regional blocks, use the ‘For Regional Use Only’ container label and write the route of the anaesthetic block in the first line of the label prompted by the word ‘Type’ (see Figure 4 below).
Figure 4: Epidural and Regional container labels
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Q2.9: Do pre-filled syringes require labelling? A: Pre-filled syringes fall outside the scope of the Labelling Recommendations. Manufacturers of pre-filled syringes are governed by Therapeutic Goods Administration (TGA) guidelines for identification of these products.
Q2.10: What are AS/NZS4375:1996 and ISO 26825:2008 and are they the same? A: AS/NZS4375:1996 is an Australian and New Zealand standard for user-applied labels used on syringes containing drugs used during anaesthesia.
ISO 26825:2008 is an international standard for user-applied labels for syringes containing drugs used during anaesthesia. ISO 26825:2008 supersedes AS/NZ4375:1996. They are not the same. However ISO 26825:2008 draws heavily on AS/NZ 4375:1996 with additional information regarding label quality and the differentiation of heparin and protamine from other medicines in the miscellaneous category labelled with black text on a white background.
ISO26825:2008 is available from www.iso.org/iso/iso_catalogue/catalogue_tc/catalogue_detail.htm?csnumber=43811
In this document, ISO26825:2008 will be referred to as the anaesthetic labelling standard.
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3. Clinical application: Containers Q3.1 How many patient identifiers are required? The National Safety and Quality Health Service Standards (Standard 5: Patient Identification and Procedure Matching) states ‘At least three approved patient identifiers are used when providing care, therapy or services’ (see www.safetyandquality.gov.au/our-work/accreditation/ ). To comply with the standards, the container labels in the Labelling Recommendations were revised in November 2011 to include a third patient identifier, date of birth, described as DOB (see Figure 5 below). The revised container labels are available in print-ready format at www.safetyandquality.gov.au/our-work/medication-safety/user-applied-labelling/labels/
Figure 5: Container label for medicines delivered via the intravenous route
The revision applies to both sizes of container labels for all routes, intravenous, intrathecal, epidural, regional, subcutaneous, miscellaneous and the burette label.
The revision was valid from November 2011.
Q3.2: Our hospital labels contain "Drug & Quantity Added". Why do we need to include the calculation of concentration? A: The Labelling Recommendations require the total amount of active ingredient/s, the total amount of fluid and the concentration to be identified and written as a calculation. The amount of medicine not expressed as a concentration has been recognised as a source of medicine administration error. Feedback from pilot sites, and from incident data, indicate that strength should be expressed as Amount (units), Volume (mL), and Concentration (units/mL) with the calculation recorded on the label to eliminate ambiguity.
Q3.3: What does “Units” mean? A: The dose, volume and resulting concentration in units/ml is completed on the label. Units refers to the unit of measure e.g. microgram, milligram, gram, nanogram, micromole, or international unit.
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Q3.4: The intra-arterial line is only used for monitoring, why is a container label provided? A: It is essential to identify the intra-arterial line with the route line label regardless of the purpose of the line (see Figure 6 below). In the majority of cases the line will be used for monitoring and it is important no drugs are introduced into the line.
Figure 6: Intra-arterial line label
In the rare event a drug is required to be administered via the intra-arterial route, e.g. heparinised saline, the drug is added to a container (syringe or bag) which is then labelled. The container label to identify a container holding a medicine for delivery via the intra- arterial route is red (PMS 1787), includes the wording 'For Intra-ARTERIAL Use Only' and has the same prompts as other container labels (see Figure 7 below).
Figure 7: Intra-arterial container label
During development of the Labelling Recommendations there was no perceived demand for the container label and concern that a container label may cause confusion over the purpose of the line. However, it has been recognised that occasionally it is necessary to administer via the intra-arterial route and it is important to identify the container. Intra-arterial container labels in EPS and PDF format are now available at www.safetyandquality.gov.au/our-work/medication-safety/user-applied-labelling/labels/
Q3.5: How do the Labelling Recommendations apply with the Vialmate device? A: When the additive from the Vialmate is introduced to the base fluid/diluent, the contents of the bag are no longer as described on the original container and must be identified. Immediately apply a bag label with details of patient, medicine, date and time and user ID.
One of the most important messages from the pilot testing was to highlight the presence of an additive in bags by using fully coloured labels. The application of the completed bag label to the Vialmate will:
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• indicate presence of an additive
• identify the medicine added via the Vialmate
• record bag contents should Vialmate detach from the base fluid bag.
Q3.6: Can the volume of fluid be monitored when bag labels are applied to infusion bags? A: Yes. To identify an additive in an infusion, place the label on the front of the bag to cover all information except the name of the base fluid, the batch number and expiry. Also, place the label slightly to the left or right to ensure the graduations on at least one side of the bag are visible to monitor fluid delivery.
Q3.7 Do syringes in syringe drivers and pumps require labelling? A: Yes. A container label with full details must be completed and applied directly onto the syringe containing the medicine or fluid. Errors have been associated with labelling the driver or pump and leaving the syringe (primary container) unidentified.
Applying the container label directly to the syringe may require the label to be folded back on itself and applied as a ‘flag’. It is important to ensure the medicine name and other details are identifiable without removal from the syringe driver.
One practical solution would be to use clear overlay flag labels to attach full container labels to small syringes and syringes in syringe drivers. Clear overlay flag labels were originally designed to label small items such as eye drops in the pharmacy. A clear flag label applied over a container label and attached to a syringe may allow for reading the container label whilst ensuring the graduations on the syringe remain visible and the syringe driver remains operational. The ophthalmic pharmacy label is readily available; alternatively a clear flag may be customised to fit the syringe label.
Note: The clear overlay flag may not be physically suitable for all syringe driver/pump arrangements.
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4. Clinical application: Lines Q4.1: Can pre-populated medicine line labels be used to identify medicine content in a dedicated continuous infusion line? A: All dedicated continuous infusion lines must be labelled to identify route and with a separate label to identify medicine. Pre-printed and coloured labels should be used for identifying medicines commonly used in continuous infusions. Colour should comply with the anaesthetic labelling standard ISO 26825:2008 (Anaesthetic and respiratory equipment- User-applied labels for syringes containing drugs used during anaesthesia – colours design and performance). Examples of pre-printed medicine line labels are provided in the guide www.safetyandquality.gov.au/wp-content/uploads/2012/02/Line-label-guide-A4-PRESS.pdf. See also FAQ2.10 and the Labelling Recommendations Issues Register (Issues Register 1 and 21) www.safetyandquality.gov.au/our-work/medication-safety/user-applied-labelling/issues-register/
Q4.2: Where is line label placed when a multi-way port is in use? A: Label the route of administration e.g. IV, after the port. Label the medicine prior to the multi-way tap if possible. Label each lumen if access to this site is unavailable.
Q4.3: Where are line labels placed on lines for paediatric patients? A: Label the line near the container for patients who may tamper with the line label, including paediatric patients, (page 9, Labelling Recommendations).
Q4.4: Can the maintenance (intermittent) drug administration line be labelled for medicine content? A: For dedicated continuous infusions, a medicine label is completed and attached to the line to identify the active ingredient (see page 9, Labelling Recommendations). Infusion lines accommodating intermittent drug administration are often used for different active ingredients. Although these lines may be labelled to identify the active ingredient, medicine labels must be removed when the infusion is completed.
Q4.5: Are line labels washable? A: Line labels tested during pilot testing withstood reasonable handling but were not water resistant. Any damaged labels will need to be replaced to ensure the line may be identified at all times.
Q4.6: Do pulmonary artery (PA) catheters require labelling? A: Labelling the PA catheter is not necessary. It is important to differentiate between the central venous catheter and the pulmonary artery and a label is provided for the central venous catheter. It is generally well accepted that PA catheters are coloured yellow and overuse of an additional label is not expected to improve patient safety.
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Q4.7: Do intracranial pressure monitoring lines require labelling? A: Labelling of the intracranial pressure monitoring line is not necessary. The ICP line is used for monitoring purposes and not for administration. It is generally well accepted that the ICP monitoring line is coloured green and overuse of an additional label is not expected to improve patient safety.
Q4.8 Do Intra-arterial lines used for monitoring require labelling? A: Yes, intra-arterial monitoring lines which may be used occasionally to administer medicines and include an administration port must be identified with a red label ‘For Intra-arterial Use Only’.
Q4.9 Do bladder irrigation lines require labelling? A: Yes, if there is any possibility the bladder irrigation line could be confused with any other line. Use the pink ‘miscellaneous’ line label for this purpose and populate the ‘Route’ prompt with the wording ‘Bladder irrigation’.
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5. Perioperative area Q5.1: Anaesthetists in our hospital would like to continue using colour-coded medicine labels. Is this practice consistent with the Labelling Recommendations? A: The anaesthetic labelling standard, ISO 26825:2008 (Anaesthetic and respiratory equipment- User-applied labels for syringes containing drugs used during anaesthesia – colours design and performance) applies to pre-printed labels for medicines in syringes used during anaesthesia.
Use the anaesthetic labelling standard to identify drugs in syringes used for the purposes of anaesthesia. This is consistent with the Australian and New Zealand College of Anaesthetists Guidelines for the safe administration of injectable drugs in anaesthesia www.anzca.edu.au/resources/professional-documents/documents/professional-standards/professional-standards-51.html
Use the Labelling Recommendations for all other medicine containers and lines in the perioperative environment.
The Commission and the Australian and New Zealand College of Anaesthetists (ANZCA) issued a joint statement supporting user-applied labelling standardisation of injectable medicines. In addition, the Commission, ANZCA and the Australian College of Operating Room Nurses (ACORN) endorsed a poster demonstrating user-applied labelling of medicines and fluids in open and closed practice perioperative environments.
Q5.2 Can the Labelling Recommendations abbreviated container label be used in the preparation and recovery areas of the perioperative suite? A: No. The abbreviated container labels (Figure 9, page 16) are only for use on the perioperative sterile field. This is a closed practice environment and patient and user identification is recorded elsewhere. In the open practice environment outside of the operating room, including preparation and recovery areas, full identification provided by the Labelling Recommendations container labels apply. Refer to the Labelling Recommendations Issues Register (Issues Register 10) www.safetyandquality.gov.au/our-work/medication-safety/user-applied-labelling/issues-register/
Q5.3: Do contrast media require labelling? A: Yes. Contrast media are injectable fluids and should be identified if removed from their original packaging and placed in containers, including syringes. The minimum requirements of the Labelling Recommendations apply to contrast media. Use of the generic term ‘contrast’ in the closed practice environment of the operating room is appropriate; specifying the contrast material by brand or generic name(s) is unlikely to confer a benefit and may be misleading.
Labelling is not required where contrast is decanted directly into a high speed pump reserved solely for the purpose of contrast injection.
This issue is held and monitored in the Labelling Recommendations Issues Register (Issues Register 20) www.safetyandquality.gov.au/our-work/medication-safety/user-applied-labelling/issues-register/
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Q5.4: Where can hospitals obtain sterilised labels consistent with the Labelling Recommendations for use on the sterile field? A: Several label manufacturers supply labels described in the Labelling Recommendations. A proportion of these are able to supply labels packaged and sterilised for use on the perioperative sterile field. The provision of sterile packaged printed labels requires additional facilities. Please contact individual suppliers for more information. See also Q7.2, Q7.3.
Q5.5: What method of sterilisation is preferred for paper labels? Labels for pilot testing were printed, packaged and sterilised in three separate processes. This was chiefly due to the small quantities required. A single process of printing, packaging and sterilisation may be commercially viable for larger label quantities.
Steam sterilisation within local hospital facilities may be appropriate but there are several issues with the process:
• Print dye may ‘gas’ during heat treatment.
• Print dye may also be affected by steam.
• Adherent properties of glue may be lost.
Ethylene oxide (EO) has the following advantages:
• EO is highly unlikely to effect the condition of the labels.
• Header bags will not become brittle and will remain sealed and peelable to open after sterilisation.
Gamma irradiation is an ideal method of sterilisation for paper products. For the small-scale pilot test operation this method was not viable for the following reasons:
• Packaging: Certain plastics will become brittle through gamma irradiation. Knowledge of the tolerance and acceptability of plastic packaging components following gamma irradiation is required.
• Radiation levels: The correct amount of gamma irradiation to achieve a sterile product requires calculation
• Testing: A test sterilisation of sample labels and packaging is necessary before proceeding with a full-scale operation.
Q5.6: A pre-printed labels set was evaluated at Calvary Wakefield Hospital. Is each health facility required to use this set? A: No. The set was devised specifically for the perioperative health services at Calvary Wakefield Hospital. A single set of labels was established to cover all operations undertaken at the facility. Each operating theatre was issued with individually packaged sets of labels and a single set of labels was used for each procedure.
Health services may choose to produce label sets for perioperative areas in the same way. Alternatively, labels may be pre-printed and sterile packed individually or provided in labels sets to cover a particular procedure.
Q5.7 Can the Labelling Recommendations abbreviated container label be used instead of pre-printing any labels for the perioperative sterile field? Yes. However, the Calvary Wakefield Hospital evaluation demonstrated a preference for pre-printed labels which were easy to handle and select, reduced preparation time
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compared with populating an abbreviated label and negated the use of sterile marker pens.
The abbreviated container label provides a suitable alternative for medicine and fluid identification when no pre-printed alternative is available. A poster describing requirements and providing examples for the abbreviated container label is on the Commission website www.safetyandquality.gov.au/wp-content/uploads/2012/02/Labelling-recommendations-A4-Word-poster-CONTAINER-Word2003.pdf
Q5.8 Do the pre-printed and abbreviated container labels for the sterile perioperative area need to be removable? Yes, for health services using reusable hollowware containers on the perioperative sterile field. For these containers to be cleaned and resterilised, the label is required to be removed in its entirety without leaving a residue. Evaluations of label adhesion to reusable hollowware containers have been conducted.with results and outcomes reported at www.safetyandquality.gov.au/our-work/medication-safety/user-applied-labelling/support-materials/ in Report 1(PDF 318 KB) and Report 2 (PDF 410 KB).
Health facilities that use disposable containers may use, but do not require, ‘peel off’ labels.
Q5.9: What are the practical considerations for labels used on the sterile field? A: The lessons learned from pilot testing in the perioperative area and from the Calvary Wakefield trial of label sets inform implementation of the Labelling Recommendations on the perioperative sterile field. These evaluations found that:
• Route can change during a procedure. Therefore, route is purposely omitted from the abbreviated container label.
• Medicine name and concentration prompts are required. An abbreviated container label is available (see Figure 9 below).
Figure 9: Abbreviated container label for user-applied medicine identification in the closed practice environment e.g. the perioperative sterile field
• Prompts for ‘Amount’ and ‘Volume’ are not required. The abbreviated container label (see Figure 9 above) is available at www.safetyandquality.gov.au/our-work/medication-safety/user-applied-labelling/labels/
• Containers may be handled many times during a procedure. Label integrity must be retained even with repeated exposure to fluids. Individual manufacturers should be contacted for further information on the suitability of their products for use in the perioperative area.
• Labels must adhere to the container for the duration of the procedure. The compatibility of sterile field labels with commonly used medicines may need to be tested. For example, in the pilot test, papaverine released the test label from the container.
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• After the procedure, ensure labels can be removed entirely from any equipment which will be cleaned and sterilised for reuse. Any residue on a stainless steel container will render it unfit for sterilisation.
• Do not pre-print disposable containers with a medicine name. The use of pre-printed containers has been associated with medication errors. There is a possibility that the receptacle will be selected for another medicine if it is the only container available.
• Keep label packaging small to minimise waste and facilitate handling.
• Ensure sterile pens are fit for purpose. Writing must remain clearly legible. Some surgical markers have a tendency to run.
Q5.10: The Labelling Recommendations state ‘All labelled containers on the sterile field must be discarded after the procedure (page 9, 4a). If we use containers that are intended for re-use after cleaning, do these have to be discarded completely? A: The intention of the statement is to ensure all medicines removed from their original container and placed into a container and then labelled are discarded at the end of the procedure, regardless whether they were used or not. All single use syringes and disposable containers will be discarded completely.
Any other labelled containers, which are potentially reusable, will be removed from the sterile field. They should be handled and reissued according to local policy.
Ensure labels are removed entirely from any equipment to be cleaned and sterilised for reuse. Any residue on a stainless steel container will render it unfit for sterilisation. Q5.11: Should containers on the sterile field be labelled even if they do not contain injectable medicines? A: Yes. All containers containing medicines or fluids should be labelled in the sterile field. See Labelling Recommendations, page 2 Minimum Requirements:
1. All medicines and fluids removed from the manufacturer's or hospital pharmacy's original packaging must be identifiable. Also refer to page 9, 4a): Labelling on the sterile field: all medicine containers, including jugs, basins and syringes, should be labelled according to the Labelling Recommendations; and page 13 ‘The Labelling Recommendations could be extended to include all solutions, chemicals and reagents used in perioperative units’.
Q5.12: What solvents may be used to remove adhesive residue from reusable hollowware containers? A: The removal of residue is undertaken in the sterilising services unit or department. A number of solvents may be used to remove residue from reusable hollowware including alcohol swabs/solutions and eucalyptus oil. All these products are flammable and are required to be used sparingly with care. They are used in the cleaning area away from the patients in the perioperative area.
Eucalyptus is oil-based and requires the appropriate temperature and detergent for removal of solvent residue.
Q5.13: Will the removal of pre-printed and generic abbreviated container labels from reusable hollowware be impractically labour intensive?
A: The time taken to remove adhesive residue is comparable to the time taken to remove blood products and preparation solutions such as povidone-iodine. Adhesive
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residue removal is an integral part of the cleaning process and should not disproportionately affect time and cost.
Q5.14: Is the sterile field confined to the operating room? A: No. The sterile field is any specified area considered free from microorganisms and includes an area immediately around a patient that has been prepared for a surgical procedure.
A sterile field may be established in areas other than the operating room. This sterile field will still most probably involve only one patient in a closed practice environment where pre-printed labels for medicine and route without patient identifiers are acceptable.
Sterile container (e.g. syringe) labels should be used to identify drugs withdrawn from their original containers on a sterile field in an open practice environment. The appropriate container labels will need to be packaged and sterilised for the purpose.
Q5.15: Are there any examples of labels used on the operating room sterile field? Implementation support materials contain posters for ward/clinical area use. The poster for the perioperative sterile field has examples of the generic and pre-printed abbreviated container labels.
www.safetyandquality.gov.au/wp-content/uploads/2012/02/Labelling-recommendations-A4-Word-poster-CONTAINER-Word2003.pdf
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6. Special situations Q6.1: Ambulatory patients: Do lines remaining ‘in situ’ on hospital discharge and in use by lay carers require labelling? A: All medicine containers and lines should be identified for medicine (active ingredient) and route of administration. It is important these are identifiable by all health professionals responsible for patient care and labelling should be applied. Where the patient identity is beyond doubt and the person administering the medicine is known, the abbreviated container label is provided as an alternative to the full bag/syringe labels.
Q6.2: Labelling for safety in renal dialysis The dialysis catheter is used for haemodialysis and may require administration of fluid and medicines via this route.
Q6.2.1: Should the dialysis catheter be identified to define route and content?
Yes. Dialysis catheters should be labelled for route and used exclusively for dialysis (with exception in an emergency).
Yes, dialysis catheters should be labelled to identify the medicine in the catheter. The dialysis catheter is generally ‘heparin locked’ to maintain patency. Any medicine in the dialysis catheter ‘lock’ must be removed prior to use. There is potential risk of infusion of heparin in large doses resulting in over anticoagulation if heparin is not removed from the ‘lock’ prior to dialysis. Alteplase may be used as an alternative to heparin to maintain patency. Other medicines may be introduced into the dialysis catheter, including antibiotics and urokinase.
Currently the practice is to label with a blue central venous line label to identify route and another label to identify medicine. However, a label has been developed specifically for the dialysis catheter (Figure 10). It is coloured blue (PMS 2985) as the line is a central venous line. (See the Labelling Recommendations Issues Register, Issues Register 22) www.safetyandquality.gov.au/our-work/medication-safety/user-applied-labelling/issues-register/
Figure 10: Line label for medicine delivered via the dialysis catheter
The ‘dialysis catheter label’ is yet to be evaluated. Feedback on the use of this label will be reflected in the Labelling Recommendations Issues Register.
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Examples Example 1: Heparin is used to prevent catheters from thrombosing. Common accepted practice is to ‘lock’ the medication within the lumens of the catheter at a dose of either 1000units/ml or 5000units/ml.
Example 2: Urokinase may be used to break up a clot in a thrombosed catheter. It is instilled in the catheter and allowed to dwell for a period of time before removal. During this process the catheter appropriate medication label should be used on the catheter to indicate the drug.
Q6.2.2: Should syringes containing medicines for cannulation be labelled? Commonly, sodium chloride and lignocaine are used during the cannulation procedure. This procedure follows the principles of aseptic non-touch technique.
Syringe labelling will not be required if each drug is drawn up and administered one at a time without leaving the hand. That is, draw up and administer lignocaine, then draw up and administer sodium chloride 0.9% to flush.
Syringes should be prepared and labelled sequentially if cannulation does not occur immediately and more than one drug is required. Sterile labels are required for the purpose of labelling central line catheters on the aseptic field.
Pre-filled saline syringes and lignocaine syringes are beneficial in this environment.
Sterile labels are not required for any other haemodialysis related process.
6.2.3: How is dialysate labelled when additives are introduced? Dialysate (i.e. a combination of electrolytes, bicarbonate and water) is manufactured by the haemodialysis machine and could be termed ‘intravenous’ (as it crosses by diffusion from patient’s blood to dialyser and visa versa). The container of the dialysate is appropriately labelled for content by the manufacturer (TGA approved). Complete and apply the blue container label marked ‘For IntraVENOUS Use Only’ when additives are introduced to the concentrate.
6.2.4: How should we label medicines given via the extracorporeal route in patients undergoing haemodialysis? Other medicines such as intravenous heparin, iron, antibiotics are sometimes given via the extracorporeal circuit as an infusion and have the same minimum labelling requirements as every other clinical setting.
Q6.3: Are blood products included in Labelling Recommendations? A: Blood components are not specifically referenced in the Labelling Recommendations. However, blood products are injectable fluids and should be identified if removed from their original container for patient administration. The minimum requirements of the Labelling Recommendations apply equally to blood products and the Commission will work with the Australian and New Zealand Society of Blood Transfusion and other relevant authorities to ensure identification for safe delivery.
For further information on administration of blood products, please refer to the Australian and New Zealand Society of Blood Transfusion Guidelines for the Administration of Blood Products (December 2011) which is available at www.anzsbt.org.au/publications/#societyg
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Q6.4: Do the Labelling Recommendations extend to dental health and radiology? A: Yes. Any situation in which injectable medicines and fluids are used requires identification.
In addition to the peak professional bodies involved in the national consultation as described in the Labelling Recommendations (page 24), the Commission contacted the following organisations with details of the Labelling Recommendations:
• Australian Dental Association Inc.
• The Royal Australian and New Zealand College of Radiologists
• Australian College of Operating Room Nurses (ACORN)
• Australian College of Critical Care Nurses Ltd. (ACCCN)
• Australian Nursing and Midwifery Council
• Royal Australian College of General Practitioners (RACGP)
• Cardiac Electrophysiology Institute of Australasia (CEPIA)
• Cardiac Society of Australia and New Zealand
• The Aged Care Standards & Accreditation Agency Ltd.
• Paramedics Australasia
• Australian Institute of Radiography
Q6.5: Can the burette label be used as a temporary syringe label? A: Yes, a burette label be written and applied to a syringe when a medicine is drawn up into a syringe intended for introduction to a burette. When the contents of the syringe are placed into the burette, the burette label should then be removed from the syringe and placed on the burette. It has been suggested that two labels would not make this process inherently safer. The syringe should not be labelled with a burette label in any other circumstance.
Q6.6: How are radiopharmaceuticals labelled? Q6.6.1: Can the label be applied to the lead casing holding the syringe containing a radiopharmaceutical? It is important to identify the primary container of an injectable medicine and there are reports of medication error associated with identification of a secondary device e.g. syringe driver or pump that remains incorrectly labelled when the primary container is changed.
In radiopharmaceuticals, the lead casing (secondary container) enclosing the syringe (primary container) holding the radiopharmaceutical is of paramount importance for operator safety. Labelling of the secondary container allows for identification of content without unnecessary exposure to the syringe held within the casing. There is a potential for a syringe to be removed from a labelled casing after manufacture and placed in a different casing when the final calculation of radioactivity is performed. Provided only one encased syringe is opened at any one time there is no opportunity for a syringe to be inadvertently placed in a different casing which could then be incorrectly labelled. Labelling the secondary container and only removing one syringe at one time will provide operator and patient safety.
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6.6.2: How are extemporaneously dispensed radiopharmaceuticals labelled? A strict protocol for extemporaneous dispensing is followed when preparing a radiopharmaceutical. The end product is for a specific patient according to a prescription and is covered by best practice guidelines for preparation of radiopharmaceuticals. Additional user-applied labelling (container label) is not required provided the product is not removed from the original container. In this case, the syringe enclosed in the lead casing constitutes the original container (see above). In a similar way, injectable medicines and fluids prepared by hospital pharmacy departments are beyond the scope of the Labelling Recommendations.
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7. Label procurement
Q7.1: Does label quality differ between suppliers? A: Label quality will depend on the paper stock used. The stock is not specified in the Labelling Recommendations but it is expected that labels will be printed on paper stock of sufficient quality to be durable and fit for purpose. In addition, the paper finish must be suitable to accept handwriting. Ensure the paper stock from an individual supplier is appropriate and obtain samples before placing an order.
For the perioperative sterile field, label stock may need to be synthetic to ensure the label is fit for purpose. Exposure to fluids requires the quality of the label stock used on the sterile field to be suitable. The following requirements must be met for the duration of the procedure:
• label remains intact
• label remains adhered to the container
• writing remains legible.
Check the paper quality and order samples before placing an order.
Q7.2: Does glue strength vary? A: Yes, glues come in different strengths. Essentially all labels with the exception of the burette and abbreviated container label for use on reusable containers must adhere and remain adhered to the container and line after application. There is no reason for these to be removed. Indeed, for containers they must remain in place for audit purposes.
The burette labels and abbreviated container labels for use on reusable containers need to be removed and should be ordered with glue designed for this purpose.
Q7.3: Can we continue to use container labels with patient name and ID but no prompt for date of birth (DOB)? A: The third patient identifier, date of birth (DOB), has been introduced in line with the National Safety and Quality Health Service Standards that require at least three approved patient identifiers when care, therapy or other services are provided. The Labelling Recommendations container labels were revised November 2011 to include patient name (to be completed with given name and family name), ID (patient identifier, e.g. MRN, URN) and DOB (date of birth). Existing container label stock may continue to be used. However, when existing stocks are exhausted, manufacturers should switch to container labels with three patient identifiers using the EPS and PDF files available on the Commission web site www.safetyandquality.gov.au/our-work/medication-safety/user-applied-labelling/labels/
Posters intended for customisation by facilities for education purposes have also been updated to reflect the third patient identifier www.safetyandquality.gov.au/our-work/medication-safety/user-applied-labelling/support-materials/
Remaining materials including the Labelling Recommendations, implementation guide, slide presentation and explanatory notes will be updated in due course.
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8. Labels from external sources
Q8.1: Pharmaceutical manufacturers occasionally provide labels with their products. Are manufacturers being asked to comply with the Labelling Recommendations? A: Yes, all label suppliers in Australia have been notified of the Labelling Recommendations. This includes manufacturers of labels supplied to pharmaceutical companies provided they source the labels in Australia.
Q8.2: Route identification labels are often included in sterile procedure packs. Do these need to comply with the Labelling Recommendations? A: Yes, all label suppliers in Australia have been notified of the Labelling Recommendations. This will include manufacturers of labels used supplied to providers of customised giving set packs when the labels are sourced in Australia.
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