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August 2008

Labelling Recommendations

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Parenteral Medicines, Fluids and Lines:
Parenteral Medicines, Fluids and Lines: Labelling Recommendations Copyright NSW Therapeutic Advisory Group Inc. 2008 | A

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Parenteral Medicines, Fluids and Lines: Labelling Recommendations

Incorporating recommendations for labelling of injectable medicines and fluids; tubing (administration sets and catheters); infusion devices (infusion pumps and syringe drivers), invasive monitoring lines and entry portals.

Contents
Summary ________________________________________________________________ 2 1. Introduction ___________________________________________________________ 3 2. Scope _________________________________________________________________ 5 3. Principles ______________________________________________________________ 7 4. Labelling recommendations_____________________________________________ 11 Glossary of terms ________________________________________________________ 16 References ______________________________________________________________ 18 Appendix 1: Colour coding according to target tissue _________________________ 19 Appendix 2: Acknowledgements ___________________________________________ 20 Duality of interest________________________________________________________ 20

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Safer Medicines Group NSW Therapeutic Advisory Group (NSW TAG)

Parenteral Medicines, Fluids and Lines: Labelling Recommendations Copyright NSW Therapeutic Advisory Group Inc. 2008

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Summary

Labelling of injectable medicines and fluids, and the devices used to deliver these, has been identified as a patient safety issue. The incidence of errors with injectable medicines is higher than with other forms of medication.1,2 Multiple manipulations required to prepare the drug combined with inadequate or absent labelling are major contributors to these errors. Specifically, labelling of infusions, syringes and monitoring lines has been identified as a potential source of error in the administration of injectable medicines and fluids. Recommendations for labelling injectable medicines and fluids have been developed by a Working Group of NSW TAG Safer Medicines Group (Appendix 2) comprising clinicians, nurses and pharmacists with extensive clinical experience in this area. The recommendations aim to achieve quality use of medicines in the area of parenteral therapy and promote the safe administration of injectable medicines. As part of the development process, NSW TAG has conducted a literature review including a search of Embase (January 1996-2008, week 17) using the following MESH terms: (exp Injections or Medication errors). The recommendations were circulated to NSW TAG Safer Medicines Group, NSW TAG and NSW TAGNet members for review (Appendix 2). It is acknowledged that adoption of the recommendations would represent a major practice change in Australian public hospitals. Hence, NSW TAG strongly advise the recommendations undergo national field based testing with involvement of key clinical groups, such as nurses, pharmacists, anaesthetists and intensive care specialists, accompanied by appropriate educational material and subsequent audit.

A review of the first 4,000 incidents reported in the Australian Incident Monitoring Study (AIMS), identified 1199 incidents involving drugs, 5% of which, identified a 'drug label problem', as a contributory factor.3 The most common cause of death (n=4) was due to the sequelae of intrathecal administration of a local anaesthetic.3 In a another review of 896 reports from the AIMS database, just over 50% of incidents were due to syringe and drug preparation errors, including 187 due to selection of the wrong ampoule or drug labelling errors.4

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Infusions Syringes

In November 2007, the Institute for Safe Medication Practices (ISMP) in the United States reported several factors that can increase risk to patients requiring injectable medicines,5 highlighting the risk from unlabelled syringes. From a survey conducted in over 1000 nurses, by the American Nurses Association, 68% of nurses indicated more consistent syringe labelling would reduce medication errors.6

These figures highlight the risks associated with the administration of injectable medicines and fluids and the need for clarification of labelling procedures to minimise these risks.

Labelling of drug infusions, particularly for patients transferred from operating rooms has been identified as a problem. An audit of 18 consecutive cardiothoracic patients transferred from an operating room to an Intensive Care Unit in a Melbourne teaching hospital, identified 53 infusions in situ, none of which were labelled correctly.7

In general, labelling of syringes loaded with medication is problematic. Clinicians often perceive that syringes do not require labelling as they are usually drawn up with an expectation of immediate (i.e. bolus) administration. In a recent Australian case a baby died at 4 days from injuries sustained at birth which involved two unlabelled syringes drawn up in preparation for delivery.8 The coroner clearly indicated that the preparation of these drugs before being required 'fell far short of best practice and represented a causal link to the babys demise'. In addition, an unpublished survey undertaken by NSW TAG Safer Medicines Group, which reviewed labelling practices in 33 wards and departments of four NSW public teaching hospitals, identified that approximately 40% of syringes for bolus use were not labelled in three of the four hospitals surveyed.9 The same survey also identified labelling inconsistencies within and between hospitals. Labelling issues included poor awareness of processes and/or multiple approval processes for initial approval and subsequent version control for ordering and design of labels. Labelling of syringes is a worldwide problem. A multi-centre, prospective audit of six hospital wards in Germany, the United Kingdom and France found that for 40% of German and 20% of UK drugs drawn up in syringes, the label was absent or incomplete and the dose not administered immediately (i.e. within 10 minutes of preparation).2 Both the Joint Commissions 2008 Patient Safety Goals (Hospital)10 and the UK National Patient Safety Agencys Patient Safety Alert Number 20 (Promoting safer use of injectable medicines) stipulate that all syringes containing medications must be labelled.11 The potential for a mix-up to occur is greater when two syringe-loaded medicines are prepared at the same time and it is recommended that only one medicine is prepared and administered for the one patient at the one time.12

Parenteral and Monitoring lines

Patient safety issues have been raised concerning labelling of invasive parenteral and monitoring lines.13 An Institute of Safe Medication Practices (ISMP) newsletter highlighted several fatal incidents associated with tubing misconnections.14 One recommendation arising out of these incidents is the appropriate labelling of intravenous lines. In the previously referred to, unpublished NSW TAG survey, labelling of invasive monitoring lines was variable in the four survey hospitals (18 to 57%).9

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1. Introduction

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Two Australian Standards exist for labelling:

User-applied identification labels for use on fluid bags, syringes and drug administration lines (AS 4940:2002) and Amendment 1 (2003).15 This Standard sets out requirements for labels to be attached by users to fluid bags, syringes, their administration lines, and adjacent to the injection ports of administration lines and to designate the target tissue being treated. This Standard only covers colour, pattern and adhesive qualities of the label and some dimensions. There is no Australian Standard for label content, other than drug name on syringe labels (see point below). User-applied labels for use on syringes containing drugs used during anaesthesia (AS/NZS 4375:1996).16 This Standard sets out requirements for labels attached by the user to drug-filled syringes to identify contents just before use during anaesthesia in operating rooms. These labels are colour coded and generally document the drug name only. There is no Australian Standard for strength, volume, concentration, route, or time and date drawn up.

These NSW TAG Safer Medicines Group recommendations have been developed to compliment these two existing Standards and address patient safety issues associated with labelling of injectable medicines and fluids; tubing; infusion devices and invasive monitoring lines. The recommendations aim to assist health care professionals to identify the correct medicine and/or fluid at all times (source), the status of that injectable medicine or fluid, the means by which the injectable medicine or fluid is introduced to the patient (conduit) and the patient administration portal (Figure 1). Rigorous application of these recommendations will assist in reducing medication errors and improve safe drug use with regard to injectable medicines and fluids.

Figure 1: Parenteral Products and Lines

SOURCE
CoNTAINeRS Fluid bags Bottles Syringes Burettes +/ SUbSTANCeS Therapeutic substances e.g. medicines Fluids Nutrition i.e. parenteral

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PATIENT

CONDUIT

TUbING IV giving sets Epidural lines Pressure transducer lines (arterial lines) Pulmonary arterial lines

+/ DevICeS Burette Pump/syringe driver

ENTRY PORTAL

PATIeNT ADMINISTRATIoN PoRTALS Refer Table 1

Parenteral Medicines, Fluids and Lines: Labelling Recommendations Copyright NSW Therapeutic Advisory Group Inc. 2008

The purpose of these recommendations is to enhance patient safety by clear labelling of injectable medicines and fluids at all points: source, conduit and entry portal.

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These recommendations identify:

2.1 NSW TAG Safer Medicines Group recommendations apply to labelling of:

Injectable medicines and fluids, including dialysis fluids > Conduits (tubing and devices) for the administration of injectable medicines and fluids > Patient administration portals (cannulae) through which injectable medicines and fluids are administered to patients (Table 1) Invasive monitoring lines where they may also be used to deliver injectable medicines > and fluids See Figure 1: Parenteral products and lines These recommendations apply to all clinical areas of Australian hospitals including: 'Hospital in the Home', where injectable medicines and fluids are administered; procedure rooms (e.g. endoscopy rooms) and the perioperative environment. Exceptions to these recommendations are listed in 2.2 below.

2.2 NSW TAG Safer Medicines Group recommendations Do NoT apply where a relevant Australian Standard already exists
The Australian/New Zealand Standard: User-applied labels for use on syringes containing drugs used during anaesthesia (AS/NZS 4375:1996) 16 should be implemented for the labelling of injectable medicines drawn up in SyRINGES and used within OPERATING ROOMS. However, note: a. Standard (AS/NZS 4375:1996) 16 applies only to medicines drawn up in syringes and does not apply to medicines or fluids administered via bags/bottles. For labelling of medicines or fluids administered via bags/bottles refer to these NSW TAG Safer Medicines Group recommendations Standard (AS/NZS 4375:1996) 16 applies only during anaesthesia and therefore, in the operating room. For labelling of medicines and fluids in areas of the perioperative environment outside the operating room refer to these NSW TAG Safer Medicines Group recommendations (see 3.6) The principles within these NSW TAG Safer Medicines Group recommendations should be considered when applying Standard (AS/NZS 4375:1996) 16

b.

c.

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2. Scope

what should be labelled what should be included on the label the location of the label

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However, note:
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Labelling of injectable medicines and fluids prepared by hospital pharmacy departments within Australia should comply with the National Coordinating Committee on Therapeutic Goods (NCCTG) 'Standard for the Preparation of Pharmaceuticals in Australian Hospital Pharmacy Departments' 17 and the range of practice guidelines developed by the Society of Hospital Pharmacists of Australia.18 Pharmacy staff must be aware of these recommendations and their application to the labelling of pharmaceutical products at the point of patient care Where the labelling of injectable medicines sourced from an external compounding centre or manufacturer (e.g. cytotoxic preparations), does not provide all the details as recommended in this document, additional labelling by the hospital pharmacy may be required

2.3 Non-injectable solutions drawn up in syringes:

While these recommendations apply to injectable medicines and fluids, some of the principles in these recommendations apply to the labelling of non-injectable medicines drawn up in syringes to be administered via non-injectable routes such as inhalation, oral, nasogastric or gastrostomy. Wherever these routes are used the syringes must also be clearly labelled with 'For Inhalation Only', 'For Oral Use Only', 'For Nasogastric Use Only', etc.

Syringes specifically designed for administration of medicines orally or via a nasogastric or gastrostomy tube should only be used for the purpose for which they are designed. To protect the patient these syringes are NOT compatible with parenteral entry portals.19

3.1 one central body should be responsible for governance of processes related specifically to labels within each hospital or Area Health Service (AHS)

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These processes include: the decision to introduce new labels; label design; range of preprinted labels; version control; inventory control and procurement. The central governance body may be for example, the Drug and Therapeutics Committee (DTC) or Patient Safety Committee. Where the governance body is not the DTC, then the DTC should also be consulted for final approval.

3.2 To facilitate these recommendations, there should be timely access to:

Patient identification stickers in drug preparation areas or close to patients beds A range of pre-printed labels. Such labels should be approved by the local governance body overseeing labels (refer item 3.1) and stocked in all clinical areas

3.3 The colour and size of the label should comply with Appendix 1 of Australian Standard AS 4940:2002 User-applied identification labels for use on fluid bags, syringes and drug administration lines and Amendment 1 (2003)15
Where use of such labels is impractical, specific procedures for use of alternative label formats must be approved by the local governance body.

3.4 Syringes:
Hospitals and AHS are encouraged to purchase pre-loaded syringe presentations wherever such a product is available on the Australian market, or from a licensed manufacturer, where the product has been assessed as suitable by the DTC. Wherever possible, standard strengths of these products should be purchased All injectable medicines drawn up in syringes in clinical areas should be labelled IMMEDIATELy after preparation by the person drawing up the drug or solution. This includes those intended for bolus use, even if only one injectable medication is to be administered The manufacturers labelling and the calibrations on the syringe scale must remain visible after the label has been applied Each injectable medicine drawn up in a syringe should be prepared, labelled and administered as a single operation by a single person for immediate use If multiple syringes are required, they should be prepared, labelled and administered sequentially as independent operations. The preparation of two syringe-loaded medicines requires labelling of BOTH Unlabelled syringes must not be left unattended or in the presence of other unlabelled medication Any unlabelled syringe containing a solution should be immediately discarded Where injectable medicines are drawn up in a syringe for use in emergency situations (e.g. during resuscitation), careful consideration should be given to procedures to ensure that these principles are followed The ONLy exception to these labelling requirements is where the preparation and the bolus administration of a SINGLE medicine is one uninterrupted process, the unlabelled syringe DOES NOT leave the hands of the person who prepared it and that same person administers the medicine IMMEDIATELy

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3. Principles

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3.5 Pre-mixed intravenous fluids:

These recommendations should be cross referenced to other policies on the use of pre-mixed intravenous injections, e.g. pre-mixed intravenous potassium chloride, heparin, magnesium, amino acids.

3.6 Perioperative environments:

Labelling of medicines drawn up in syringes in the operating room should comply with AS/NZ4375:1996 16 In general, medicines drawn up in syringes within the operating room should remain there. Exceptions could be made, e.g. when an anaesthetist may prepare a medication in a syringe for Patient Controlled Analgesia (PCA) infusion at the end of a procedure which remains attached when the patient is transferred to the post- anaesthetic recovery unit Injectable medicines and IV fluids commenced in the operating room which remain in place when patients are transferred to post anaesthetic recovery unit should be labelled according to recommendations outlined in this document Injectable medicines administered within the post anaesthetic recovery unit should be drawn up in recovery and labelled according to these recommendations Labelling of tubing, infusion devices and invasive monitoring lines in all areas of the perioperative environment should comply with these recommendations

3.7 other sterile fields (i.e. aseptic conditions):

Where sterile labels are available, labelling should fit best practice as described in these recommendations In the absence of sterile labels, local policy may be developed to clearly differentiate injectable medicines prepared under sterile conditions

3.8 These recommendations do not replace or obviate the need for other clearly defined quality and safety processes relating to the administration of injectable medicines and fluids
The following processes adapted from NHS National Patient Safety Agency (NPSA) Alert Number 20 (28 March 2007), 'Promoting safer use of injectable medicines' 6 should be considered: Undertaking risk assessments of injectable medicines procedures and products in all clinical areas to identify high risks, and develop an action plan to minimise them Keeping up-to-date protocols and procedures for prescribing, preparing and administering injectable medicines and fluids, including checking processes Training of all staff involved in prescribing, administering and monitoring of injectable medicines and fluids, including training of those staff that are supervising and checking these processes Assuring timely access to up-to-date technical information on injectable medicines by health care professionals Implementing a 'purchasing for safety' policy to promote procurement of injectable medicines with inherent safety features including 'safe' labelling as outlined in these recommendations Undertaking audits of all practices associated with injectable medicines. For example an audit of relevant items of the Medication Safety Self Assessment for Australian Hospitals. This may be accessed via http://mssa.cec.health.nsw.gov.au/MSSA_introduction.html

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3.9 other considerations:

The details on the manufacturers product label should not be obscured. Manufacturers are guided by 'Best practice guideline on prescription medicine labelling' prepared by the Drug Safety Evaluation Branch of the Therapeutic Goods Administration (TGA) for all licensed medicines.20 This guideline combined with the mandatory Labelling Order 21 ensures product labels 'enhance the ability of health care professionals and consumers to select the correct medicine, use it safely and therefore, aid in reducing medication errors' Any labels in addition to the manufacturers product label must be hospital approved. Additional labels provided by manufacturers should not be used unless approved by the governance committee responsible for labels and the DTC (Refer 3.1) Infection control surveillance and medication stability must be considered in labelling. Time, date prepared and expiry date should be included on labels for injectable medicines added to fluids. Scheduled 'change' dates and times should comply with local policies (including tubing change expiry dates and times) Abbreviations used on labels should comply with NSW TAG Safer Medicines Group 'Recommendations for Terminology, Abbreviations and Symbols used in Prescribing and Administration of Medicines' 22

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Note: This list includes examples to assist in the interpretation of these recommendations and is not intended to be exhaustive PATIeNT ADMINISTRATIoN PoRTALS CoveReD bY THeSe ReCoMMeNDATIoNS Subcutaneous Intramuscular Neural

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Vascular access Intra-cavity Bone Enteral Intra-cavity Intra-vesicular Cutaneous (i.e. via skin) Inhalation 10 |

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Table 1: Patient Administration Portals (Cannulae)

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Epidural Intrathecal Intraventricular Intra-arterial Intravenous Intraperitoneal Intraosseous Nasogastric Orogastric Jejunostomy Pleural tubes Rectal Intra-articular Umbilical

Peripheral nerve/plexus Peripheral arterial Pulmonary arterial Intra-aortic Midline catheters Central venous catheter (CVC) Peripherally inserted central venous catheter (PICC) Peripheral intravenous cannula (PIV) Central venous implanted ports (e.g. portacaths)

PATIeNT ADMINISTRATIoN PoRTALS NoT CoveReD bY THeSe ReCoMMeNDATIoNS

Percutaneous enteral gastrostomy (PEG)

Indwelling catheters Supra pubic catheter (SPC) Bladder catheter

Parenteral Medicines, Fluids and Lines: Labelling Recommendations Copyright NSW Therapeutic Advisory Group Inc. 2008

These recommendations represent the MINIMUM requirement for labelling

SoURCe (INjeCTAbLe MeDICINeS AND FLUIDS, INCLUDING CoNTAINeR) LAbeLLING ReCoMMeNDATIoNS RATIoNALe/ADDITIoNAL CoNSIDeRATIoNS
> Identification labels are

Fluid bags and bottles for infusion where no additional injectable medicines are added to the bag or bottle in any clinical area This includes: > Intravenous fluids > Pre-mixed solutions e.g. lignocaine, potassium, heparin infusions > Intravenous admixtures prepared in the pharmacy > Peritoneal dialysis fluids > Blood products such as normal immunoglobulin and albumin

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4. Labelling recommendations (Refer Figure 1)

In addition to manufacturers/pharmacy label > Patient name and Medical Record Number (MRN) > Date and time administration commenced necessary: (a) For infection control purposes, e.g. to facilitate timely bag changes (b) When fluids are detached, e.g. for patient showering (c) For infusion rate monitoring
> Labels must remain clear

and legible, even when pressure bags are used

Fluid bags, bottles, burettes and syringes for infusion where injectable medicines are added to the bag or bottle in all clinical areas.

1. General Labelling > Patient name and MRN > Generic drug name of additive > Base fluid name (where not evident) > Amount of drug added e.g. milligrams, units > Amount of drug contained per total volume e.g. 100 mg/100mL > Route of administration > Infusion rate (if non variable) > Date and time prepared > Date and time administration commenced > Date and time to be discarded > Prepared by > Checked by

> Explore flag labels for use

with syringes and other small containers > Labels must remain clear and legible, even when pressure bags are used

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SoURCe (INjeCTAbLe MeDICINeS AND FLUIDS, INCLUDING CoNTAINeR)

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LAbeLLING ReCoMMeNDATIoNS RATIoNALe/ADDITIoNAL CoNSIDeRATIoNS 2. Additional labelling > epidural therapy: All fluid bags, bottles and syringes intended for epidural therapy (either purchased commercially, manufactured by the hospital pharmacy or prepared in clinical areas) must be labelled 'For Epidural Use Only' 23 > Intrathecal therapy: All fluid bags, bottles and syringes intended for intrathecal therapy (either purchased commercially, manufactured by the hospital pharmacy or prepared in clinical areas) must be labelled 'For Intrathecal Use Only'. This includes labelling the outer wrapper where applicable > Peripheral and central intravenous therapy: Where peripheral and central lines are BOTH present label all fluid bags, bottles and syringes 'Peripheral intravenous route' or 'Central intravenous route' as appropriate > Chemotherapy: Each container must be labelled with a cytotoxic warning label in accordance with local health and safety requirements 24 epidural therapy and intrathecal therapy: Amendment 1 (2003) of Australian Standard: Userapplied identification labels for use on fluid bags, syringes and drug administration lines (AS 4940:2002),15 specifies that labels for administration via a neural route, including epidural and intrathecal therapy, must be coloured YeLLoW

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Syringes for bolus administration 1. Pre-labelled syringes This includes pre-loaded syringes provided by manufacturers and those prepared by hospital pharmacy

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1.(a) Pre-labelled syringes No additional label required However, consider labelling high risk medicines, e.g. cytotoxic agents, with the patients name 1.(b) Pre-labelled syringes for incremental use > Date and time of administration of first increment

Refer to principle 3.4 > It is imperative to express the ToTAL amount of drug contained in the syringe (e.g. 10 mg/10 mL) rather than the concentration (e.g. 1 mg/mL in 10 mL). The latter has been associated with errors 1

Parenteral Medicines, Fluids and Lines: Labelling Recommendations Copyright NSW Therapeutic Advisory Group Inc. 2008

SoURCe (INjeCTAbLe MeDICINeS AND FLUIDS, INCLUDING CoNTAINeR)

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LAbeLLING ReCoMMeNDATIoNS RATIoNALe/ADDITIoNAL CoNSIDeRATIoNS
> Do not obscure the syringe

2. Non-pre-labelled syringes This includes injectable medicines drawn up in a syringe in any clinical area

2.(a) Non pre-labelled syringes > Generic drug name > Amount of drug contained in the syringe per total volume e.g. 10 mg/10mL > Patient name and MRN > Route of administration 2.(b) Non-pre-labelled syringes for incremental use > Generic drug name > Amount of drug contained in the syringe per total volume e.g. 10 mg/10mLs > Patient name and MRN > Route of administration > Date and time of administration of first increment

calibrations with the label

> A duplicate label should be

applied to any over wrapper (i.e. outer wrapper) which is opaque or does not allow direct label to be read > For syringes prepared in a sterile field (e.g. for administration via a Hickmans catheter), use purchased sterile labels, sterilise labels or disinfect surface of label > Consider pre-printed labels for commonly used preparations administered via bolus route (e.g. normal saline flushes). These pre-printed labels could also include space for the patients name > Consider bar-coding preprinted labels

3. Additional labelling for pre-labelled and non-pre-labelled syringes > epidural Therapy: All syringes intended for epidural therapy (either purchased commercially, manufactured by the hospital pharmacy or prepared in clinical areas) must be labelled 'For Epidural Use Only' 23 > Intrathecal Therapy: All syringes intended for intrathecal therapy (either purchased commercially, manufactured by the hospital pharmacy or prepared in clinical areas) must be labelled with 'For Intrathecal Use Only'. This includes labelling the outer wrapper where applicable > Peripheral and central intravenous therapy: Where peripheral and central lines are BOTH present, label all syringes 'Peripheral intravenous route' or 'Central intravenous route' as appropriate > Chemotherapy: Each container must be labelled with a cytotoxic warning label in accordance with local health and safety requirements 24

epidural therapy and intrathecal therapy: Amendment 1 (2003) of Australian Standard: Userapplied identification labels for use on fluid bags, syringes and drug administration lines (AS 4940:2002),15 specifies that labels for administration via a neural route, including epidural and intrathecal therapy, must be coloured YeLLoW

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CoNDUIT (TUbING, INFUSIoN DevICeS AND INvASIve MoNIToRING LINeS)

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LAbeLLING ReCoMMeNDATIoNS

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RATIoNALe/ADDITIoNAL CoNSIDeRATIoNS

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1. Tubing This includes extension tubing and giving sets used to deliver fluids and/or medication into a patient by any parenteral route

1. Label Label all tubing as per following example label

> To prevent the inadvertent

Intravenous Route

Date tubing attached: .................................

Above design of label should be pre-printed for the different routes, i.e. intravenous route, intra-arterial route, epidural route and intrathecal route Where peripheral and central lines are BOTH present, identify 'Peripheral intravenous route' or 'Central intravenous route' as appropriate Label to be colour coded as per Australian Standard: User-applied identification labels for use on fluid bags, syringes and drug administration lines (AS 4940:2002) and Amendment 1 (2003) 15 (Refer Appendix 1) 2. Location of label Label close to the fluid and/or injectable medicine source AND close to the patient entry portal (See Illustration 1)

administration of a drug or fluid via an incorrect route > For infection control purposes, e.g. to facilitate timely tubing changes > If pre-printed labels for different routes are not available then the following generic label is suggested:

Route: .................................................. Date tubing attached: ............................................

2. Infusion devices and burettes

1. Syringe pumps: No labelling required 2. burettes with injectable medicines added directly into the burette: Label burette as per non pre-labelled syringes

> Do not obscure the burette

calibrations with the label

3. Invasive monitoring lines

Label monitoring lines as per following example label

> To prevent the inadvertent

Intravenous Route Date tubing attached: .................................

Above design of label to be pre-printed for the different routes, i.e. intravenous route, intraarterial route and pulmonary arterial route Label to be colour coded as per Australian Standard: User-applied identification labels for use on fluid bags, syringes and drug administration lines (AS 4940:2002) and Amendment 1 (2003) 15 (Refer Appendix 1)

administration of a drug or fluid via an incorrect route > If pre-printed labels for different routes are not available then suggest the following generic label:

Route: .................................................. Date tubing attached: ............................................

PATIeNT ADMINISTRATIoN PoRTALS Patient administration portals

LAbeLLING ReCoMMeNDATIoNS Additional labelling to state:

> Type of patient administration portal > Date of insertion

RATIoNALe/ADDITIoNAL CoNSIDeRATIoNS As per local policy

Parenteral Medicines, Fluids and Lines: Labelling Recommendations Copyright NSW Therapeutic Advisory Group Inc. 2008

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Illustration 1: Typical intravenous infusion with an infusion device (For use in conjunction with 4. Labelling recommendations, page 11)

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B

Label close to IV uid *

B C

LABEL SOURCES A, B AND C A = Bag/Bottle infusion uid B = Syringe C = Burette (if present) Label tubing at points marked * * Label close to patient

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boLUS (PUSH)

CATHeTeR

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CLINICAL AReA eMeRGeNCY USe FLUSH INCReMeNTAL USe 16 |

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Including: Angiographic catheter Arterial catheter Butterfly cannula Cardiac catheter Central venous catheter Epidural catheter Midline catheter Subcutaneous catheter Tenckhoff catheter Wards Outpatient areas 'Hospital in the Home'

Glossary of terms

Administration from a syringe of a small volume of a single dose of a sterile solution directly into a tissue, organ or vein, over a short period, usually, between 30 seconds and 10 minutes (NPSA definition)

Implantable port e.g. Port-a-Cath Intraperitoneal catheter or port Intrathecal catheter or port Peripheral intravenous catheter (PIV) Peripherally inserted central venous catheter (PICC)

Tunnelled catheter e.g. Hickmans , Broviac Any area in the hospital where injectable medicines and fluids are administered including:

Procedure rooms (e.g. endoscopy rooms) Perioperative environments Administration of drugs in an emergency, i.e. where an unpredicted situation involving the patient arises, e.g. during resuscitation "Immediate emergency Use" the drug is drawn up into a syringe and administered within seconds. Usually the person drawing up the syringe is the same person who administers it and the syringe does not leave that persons hand until after it has been administered "Not Immediate emergency Use" the drug is drawn up and not administered within seconds To purge access devices (e.g. cannulae) before and/or after injection of a medicine or between injections of different medicines (NPSA definition), e.g. with a sterile solution of diluent, such as sodium chloride 0.9% The administration of a drug within a single syringe or other delivery device in staggered doses. This may apply to emergency situations (e.g. during resuscitation) or to administration in the operating room

Parenteral Medicines, Fluids and Lines: Labelling Recommendations Copyright NSW Therapeutic Advisory Group Inc. 2008

INFUSIoN

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INjeCTAbLe MeDICINe oPeRATING RooM PATIeNT ADMINISTRATIoN PoRTAL PeRIoPeRATIve PeRIoPeRATIve eNvIRoNMeNT PoST ANAeSTHeTIC ReCoveRY UNIT (PARU) TUbING

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Administration (from a syringe, or other rigid or collapsible container e.g. plastic bag) of a volume of sterile solution containing an injectable medicine directly into a tissue, organ vein or artery, at a constant rate, under gravity or by means of an electronic or mechanical pump or by other means of rate control, over a defined period of at least 10 minutes (based on NPSA definition) Sterile medicine intended for administration by bolus injection, perfusion or infusion by any of the following routes: Intravenous, intramuscular, intrathecal, intra-arterial, subcutaneous, intradermal, intraventricular, epidural, intravescicular, intravitreal, intrapleural and intraocular (NPSA/2007/20) The room in which a surgical procedure is undertaken, with or without the administration of an anaesthetic (Australian College of Operating Room Nurses [ACORN] 2006 Standards 25)

The point of entry to the body. Also, the most proximal entry to the catheter or device which enters the patients body. This may be an injection port or bung on a catheter or entry site of a huber needle for implantable ports The period before, during and after an anaesthetic, surgical or other procedure (ACORN 2006 Standards 25) The service area where the provision of an anaesthetic, surgical or other procedure may be undertaken (ACORN 2006 Standards 25) An area set aside within the perioperative environment that is well planned, well equipped, well staffed and well managed for the safe immediate management of patients who have recently undergone a surgical or other procedure irrespective of the type of anaesthesia or sedation (ACORN 2006 Standards 25). Also known as 'Recovery' This includes all intravenous giving sets/administration lines/catheters through which injectable medicines and fluids are administered

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1 Taxis K, Barber N. Ethanographic study of the incidence and severity of intravenous medicine errors. Br Med J 2003; 326:684-687 2 Cousins DH, Sabatier B, Begue D et al. Medication errors in intravenous drug administration: a multicentre audit in the UK, Germany and France. Qual Saf Health Care 2005;14:190-195

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3 Paix AD, Bullock M, Runciman WB, Williamson JA. Crisis management during anaesthesia: problems associated with drug administration during anaesthsia. Qual Saf Health Care2005;14: e15 4 Abeysekera A, Bergman IJ, Kluger, MT et al. Drug error in anaesthetic practice: a review of 896 reports from the Australian Incident Monitoring Study database. Anaesthesia, 2005, 60: 220-227 5 Institute for Safe Medication Practices. Errors with Injectable Medications: Unlabeled syringes are surprisingly common! November 15, 2007. Available from: www.ismp.org/Newsletters/acutecare/articles/20071115.asp?ptr=y 6 American Nurses Association. Medication errors and syringe safety are top concerns for nurses according to new national study. Press release: June 18, 2007 7 Burdeu G, Crawford R, van de Vreede M et al. Taking Aim at Infusion Confusion. J Nurs Care Qual 2006; 21:151-159 8 Medications: Double Checking at the Bedside? Coronial Communique. A combined Victorian State Coroners Office and Victorian Institute of Forensic Medicine publication. November 2006. Volume 4 Issue 4 9 Kelly M, Chandler S, Montgomery J et al. How Safe is Labeling of Parenteral products and Invasive Parenteral Lines in NSW Public Hospitals? Poster Presentation at 4th Australasian Conference on Safety & Quality in Health Care. 21-23 August 2006 10 The Joint Commission, 2008 National Patient Safety Goals, Hospital Program. www.jointcommission.org/PatientSafety/NationalPatientSafetyGoals/08 11 NHS National Patient Safety Agency, Patient Safety Alert Number 20 (28 March 2007) Promoting safer use of injectable medicines. www.npsa.nhs.uk/patientsafety/alerts-and-directives/alerts/injectable-medicines 12 Medication Handling in New South Wales Public Hospitals. NSW Health Department Policy Directive PD2007_077. Available from: www.health.nsw.gov.au/policies/pd/2007/PD2007_077.html 13 Cohen MR. Medication Errors, 2nd Edition. American Society of Health-System Pharmacists 2007: pp 278-9 14 Problems Persist with Life-threatening Tubing Misconnections. Institute for Safe Medication Practices (ISMP) Medication Safety Alert June17, 2004 15 Australian Standard: User-applied identification labels for use on fluid bags, syringes and drug administration lines (AS 4940:2002). Standards Australia International Ltd, Sydney and Amendment 1 (2003) 16 Australian Standard: User-applied labels for use on syringes containing drugs used during anaesthesia (AS/NZS 4375:1996). Standards Australia International Ltd, Sydney 17 Standard for the Preparation of Pharmaceuticals in Australian Hospital Pharmacy Departments: National Coordinating Committee on Therapeutic Goods (NCCTG) September 1993. Aus J Hosp Pharm 1994: 24(2); 182-8. Available from: www.health.nsw.gov.au/resources/publichealth/pharmaceutical/pdf/NCCTG_Sep93.pdf 18 www.shpa.org.au/docs/practicestandards.html 19 Cohen MR. Medication Errors, 2nd Edition. American Society of Health-System Pharmacists 2007: pp 220-1 20 Drug safety and Evaluation Branch; Therapeutic Goods Administration. Best Practice guideline on prescription medicine labeling. 17 November 2005. Available from: www.tga.gov.au/pmeds/pmbestpractice.htm 21 Therapeutic Goods Order 69 General requirements for labels for medicines (TGO 69). Available from: www.tga.gov.au/docs/html/tgo/tgo69.htm 22 Recommendations for Terminology, Abbreviations and Symbols used in the Prescribing and Administration of Medicines. Safer Medicines Group: New South Wales Therapeutic Advisory Group Inc. October 2006 www.ciap.health.nsw.gov.au/nswtag/publications/guidelines/TeRMINoLoGY/1206.pdf 23 NHS National Patient Safety Agency. Patient Safety Alert Number 21 (28 March 2007): Safer practice with epidural injections and infusions. www.npsa.nhs.uk/patientsafety/alerts-and-directives/alerts/epidural-injections-and-infusions/ 24 Guidelines for the Safe Prescribing, Supply and Administration of Cancer Chemotherapy: Draft document for review. Clinical Oncolological Society of Australia. July 8th 2008 25 Australian College of Operating Room Nurses. ACORN Standards for Perioperative Nursing: including nursing roles, guidelines, position statements, competency standards 2008/ Australian College of Operating Room Nurses. Adelaide, SA: The College, 2008 Parenteral Medicines, Fluids and Lines: Labelling Recommendations Copyright NSW Therapeutic Advisory Group Inc. 2008

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References

Colour coding according to target tissue

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TARGeT TISSUe

From Australian Standard: User-applied identification labels for use on fluid bags, syringes and drug administration lines (AS 4940:2002) and Amendment 1 (2003).15
CoLoUR PANToNe MATCHING SYSTeM (PMS) AS 2700 eQUIvALeNT

Intravenous Intra-arterial Neural tissue

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Blue Red yellow Beige White

Appendix 1:

T
PMS Process Blue U PMS 1787 U PMS Pantone yellow U PMS 723 U B34 R22 y23 y55
Parenteral Medicines, Fluids and Lines: Labelling Recommendations Copyright NSW Therapeutic Advisory Group Inc. 2008 | 19

Subcutaneous tissue Miscellaneous

Acknowledgements

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These recommendations have been prepared by a Working Group of NSW TAG Safer Medicines Group comprising:
Ms jill Arcus Principal Pharmaceutical Advisor, Hospitals, Pharmaceutical Services Branch, NSW Health Department Ms Sarah Chandler Senior Pharmacist, Prince of Wales Hospital, Sydney

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Appendix 2:

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Ms Kaye Rolls Clinical Nurse Consultant, Clinical Project Officer, Intensive Care Coordination & Monitoring Unit, Sydney West Area Health Service (SWAHS) Ms Meredith verge Education & Training Pharmacist, Royal North Shore Hospital, Sydney Ms Sally Wilson Clinical Nurse Consultant, Pain Management, Royal Hospital for Women, Sydney Ms Sandy burrow Anaesthetic & Recovery Unit, Nepean Public Hospital, Kingswood Mr Graham Hextell Project Officer, Perioperative Education Program for Enrolled Nurses (PEPEN), SESIAHS Ms Mary Hodgetts Patient Safety Manager, Clinical Improvement Unit Central Network, SESIAHS Ms Karen Kaye Executive Manager, QUM Programs, National Prescribing Service Ltd Dr bridin Murnion Staff Specialist, Drug Health Services, Director of Physician Training, Royal Prince Alfred Hospital, Sydney Mr Kingsley Ng Director of Pharmacy, Westmead Hospital, Sydney Ms Anne McDade Clinical Nurse Consultant Infusion Management/TPN, Concord Repatriation General Hospital, Sydney Ms Diana Shipp Project Officer, NSW TAG Ms Shelley Tranter Nephrology Nurse Consultant, SESIAHS Ms bronwyn Warne Nurse Manager, Community Chronic & Complex Care (Western Cluster), Primary Care & Community Health Network, Integrated Health Cluster, SWAHS

Ms Pauline Dobson Clinical Nurse Consultant HIV/AIDS, Immunology & Infectious Diseases Unit, John Hunter Hospital, New Lambton, NSW A/Prof Robyn Gallagher Associate Professor Chronic & Complex Care, Coordinator Masters Honours Programs, Faculty of Nursing, Midwifery & Health, University of Technology, Sydney Ms Maria Kelly Executive Officer, NSW TAG A/Prof Ross MacPherson Director, Peri-operative Clinic, Dept of Pain Management & Anaesthetics; Chair, Drug Committee Royal North Shore Hospital & Ryde Health Service, Sydney Dr Gary Nicholls Clinical Pharmacology Registrar, St Vincents Hospital, Sydney Ms Penny Thornton Director of Pharmacy, Westmead Childrens Hospital, Sydney

NSW TAG also acknowledges the contribution of expert groups including the following:
NSW TAG Safer Medicines Group NSW TAG & TAGNet members representing all Drug & Therapeutic Committees in NSW public hospitals

NSW TAG also acknowledges contribution from the following individuals:

Dr Michael bennett Prince of Wales & Sydney Childrens Hospitals Drug & Therapeutics Committee, South Eastern Sydney & Illawarara Area Health Service (SESIAHS) Dr Patrick bolton Chair, Prince of Wales Medication Safety Sub-Committee, Director of Clinical Services (Medicines), Northern Hospitals Network, SESIAHS

Duality of interest
Ms Pauline Dobson has received travel and accommodation expenses from Baxter Healthcare for attending a conference as an invited speaker. Ms Dobson has worked with Baxter Healthcare as a 'hospital in the home' conference organising committee member on two occasions, receiving a plate after the first conference. No other duality of interest declared. Parenteral Medicines, Fluids and Lines: Labelling Recommendations Copyright NSW Therapeutic Advisory Group Inc. 2008 Ms Penny Thornton has received the Naismith Management Grant from SHPA (2006), sponsored by Baxter Healthcare. Ms Thornton's husband is Mr Mel Davis, a consultant to Baxter Healthcare. Ms Thornton has also provided advice to REM systems, but receives no funding from them.

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Phone Fax Email web
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NSW Therapeutic Advisory Group

Level 5, 376 Victoria Street PO Box 766 Darlinghurst NSW 2010 +61 2 8382 2852 +61 2 8382 3529 nswtag@stvincents.com.au www.nswtag.org.au

Parenteral Medicines, Fluids and Lines: Labelling Recommendations Copyright NSW Therapeutic Advisory Group Inc. 2008

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