31170 Parenteral Labelling Recommendations

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AParenteral Medicines, Fluids and Lines: Labelling RecommendationsCopyright – NSW Therapeutic Advisory Group Inc. 2008

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Parenteral Medicines,Fluids and Lines:

Lalling Rcmmndatins

August 2008





1Parenteral Medicines, Fluids and Lines: Labelling RecommendationsCopyright – NSW Therapeutic Advisory Group Inc. 2008

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Sar Mdicins GrupNSW Thraputic Adisry Grup NSW TAG

Parenteral Medicines, Fluids and Lines: Labelling RecommendationsIncorporating recommendations or labelling o injectable medicines and uids; tubing(administration sets and catheters); inusion devices (inusion pumps and sringe drivers),invasive monitoring lines and entr portals.

ContentsSummary ________________________________________________________________ 2

1. Intrductin ___________________________________________________________ 32. Scp _________________________________________________________________ 5

3. Principls ______________________________________________________________ 7

4. Lalling rcmmndatins _____________________________________________ 11

Glssary trms ________________________________________________________ 16

Rrncs ______________________________________________________________ 18

Appndix 1: Clur cding accrding t targt tissu _________________________ 19

Appndix 2: Acknwldgmnts ___________________________________________ 20

Duality intrst________________________________________________________ 20



2 Parenteral Medicines, Fluids and Lines: Labelling RecommendationsCopyright – NSW Therapeutic Advisory Group Inc. 2008

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SummaryLabelling o injectable medicines and uids, and the devices used to deliver these, has beenidentied as a patient saet issue.

The incidence o errors with injectable medicines is higher than with other orms o medication.1,2 Multiple manipulations required to prepare the drug combined with inadequateor absent labelling are major contributors to these errors. Specicall, labelling o inusions,sringes and monitoring lines has been identied as a potential source o error in theadministration o injectable medicines and uids.

Recommendations or labelling injectable medicines and uids have been developed b aWorking Group o NSW TAG Saer Medicines Group (Appendix 2) comprising clinicians, nursesand pharmacists with extensive clinical experience in this area. The recommendations aimto achieve qualit use o medicines in the area o parenteral therap and promote the saeadministration o injectable medicines.

As part o the development process, NSW TAG has conducted a literature review includinga search o Embase (Januar 1996-2008, week 17) using the ollowing MESH terms: (“expInjections” or “Medication errors”). The recommendations were circulated to NSW TAG SaerMedicines Group, NSW TAG and NSW TAGNet members or review (Appendix 2).

It is acknowledged that adoption o the recommendations would represent a major practicechange in Australian public hospitals. Hence, NSW TAG strongl advise the recommendationsundergo national eld based testing with involvement o ke clinical groups, such as nurses,pharmacists, anaesthetists and intensive care specialists, accompanied b appropriateeducational material and subsequent audit.




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1. IntroductionA review o the rst 4,000 incidents reported in the Australian Incident Monitoring Stud(AIMS), identied 1199 incidents involving drugs, 5% o which, identied a 'drug label problem',as a contributor actor.3 The most common cause o death (n=4) was due to the sequelae o intrathecal administration o a local anaesthetic.3 In a another review o 896 reports rom theAIMS database, just over 50% o incidents were due to sringe and drug preparation errors,including 187 due to selection o the wrong ampoule or drug labelling errors.4

In November 2007, the Institute or Sae Medication Practices (ISMP) in the United Statesreported several actors that can increase risk to patients requiring injectable medicines,5 highlighting the risk rom unlabelled sringes. From a surve conducted in over 1000 nurses,b the American Nurses Association, 68% o nurses indicated more consistent sringe labellingwould reduce medication errors.6

These gures highlight the risks associated with the administration o injectable medicines anduids and the need or clarication o labelling procedures to minimise these risks.

Inusins

Labelling o drug inusions, particularl or patients transerred rom operating rooms has beenidentied as a problem. An audit o 18 consecutive cardiothoracic patients transerred roman operating room to an Intensive Care Unit in a Melbourne teaching hospital, identied 53inusions in situ, none o which were labelled correctl.7

Syrings

In general, labelling o sringes loaded with medication is problematic. Clinicians otenperceive that sringes do not require labelling as the are usuall drawn up with anexpectation o immediate (i.e. bolus) administration. In a recent Australian case a bab diedat 4 das rom injuries sustained at birth which involved two unlabelled sringes drawn upin preparation or deliver.8 The coroner clearl indicated that the preparation o these drugsbeore being required 'ell ar short o best practice and represented a causal link to thebab’s demise'. In addition, an unpublished surve undertaken b NSW TAG Saer MedicinesGroup, which reviewed labelling practices in 33 wards and departments o our NSW publicteaching hospitals, identied that approximatel 40% o sringes or bolus use were notlabelled in three o the our hospitals surveed.9 The same surve also identied labellinginconsistencies within and between hospitals. Labelling issues included poor awareness o processes and/or multiple approval processes or initial approval and subsequent versioncontrol or ordering and design o labels.

Labelling o sringes is a worldwide problem. A multi-centre, prospective audit o six hospitalwards in German, the United Kingdom and France ound that or 40% o German and 20%o UK drugs drawn up in sringes, the label was absent or incomplete and the dose notadministered immediatel (i.e. within 10 minutes o preparation).2 Both the Joint Commission’s2008 Patient Saet Goals (Hospital)10 and the UK National Patient Saet Agenc’s PatientSaet Alert Number 20 (Promoting saer use o injectable medicines) stipulate that all sringescontaining medications must be labelled.11 The potential or a mix-up to occur is greater whentwo sringe-loaded medicines are prepared at the same time and it is recommended that onlone medicine is prepared and administered or the one patient at the one time. 12

Parntral and Mnitring lins

Patient saet issues have been raised concerning labelling o invasive parenteral andmonitoring lines.13 An Institute o Sae Medication Practices (ISMP) newsletter highlightedseveral atal incidents associated with tubing misconnections.14 One recommendation arisingout o these incidents is the appropriate labelling o intravenous lines. In the previousl reerred

to, unpublished NSW TAG surve, labelling o invasive monitoring lines was variable in the oursurve hospitals (18 to 57%).9




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Tw Australian Standards xist r lalling:

Usr-applid idnticatin lals r us n fuid ags, syrings and drug>

administratin lins AS 4940:2002 and Amndmnt 1 2003.15 This Standard sets outrequirements or labels to be attached b users to uid bags, sringes, their administrationlines, and adjacent to the injection ports o administration lines and to designate thetarget tissue being treated.

This Standard onl covers colour, pattern and adhesive qualities o the label and somedimensions. There is no Australian Standard or label content, other than drug name onsringe labels (see point below).

Usr-applid lals r us n syrings cntaining drugs usd during anasthsia>

AS/NZS 4375:1996.16 This Standard sets out requirements or labels attached b the userto drug-lled sringes to identi contents just beore use during anaesthesia in operatingrooms. These labels are colour coded and generall document the drug name onl.

There is no Australian Standard or strength, volume, concentration, route, or time anddate drawn up.

These NSW TAG Saer Medicines Group recommendations have been developed tocompliment these two existing Standards and address patient saet issues associated withlabelling o injectable medicines and uids; tubing; inusion devices and invasive monitoringlines. The recommendations aim to assist health care proessionals to identi the correctmedicine and/or uid at all times (source), the status o that injectable medicine or uid, themeans b which the injectable medicine or uid is introduced to the patient (conduit) andthe patient administration portal (Figure 1). Rigorous application o these recommendationswill assist in reducing medication errors and improve sae drug use with regard to injectablemedicines and uids.

Figur 1: Parntral Prducts and Lins

CoNTAINeRS +/– SUbSTANCeS

Fluid bags

Bottles

Sringes

Burettes

Therapeutic substances e.g.medicines

Fluids

Nutrition i.e. parenteral

PATIeNT ADMINISTRATIoN PoRTALS

Reer Table 1

TUbING +/– DevICeS

IV giving sets Burette

Epidural linesPump/sringedriver

Pressure transducer lines(arterial lines)

Pulmonar arterial lines




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2. Scope

The purpose o these recommendations is to enhance patient saety by

clear labelling o injectable medicines and uids at all points: source,

conduit and entry portal.

These recommendations identiy:

> what should be labelled

what should be included on the label>

the location o the label>

2.1 NSW TAG Sar Mdicins Grup rcmmndatins apply tlalling :

Injectable medicines and uids, including dialsis uids>

Conduits (tubing and devices) or the administration o injectable medicines and uids>

Patient administration portals (cannulae) through which injectable medicines and uids>

are administered to patients (Table 1)

Invasive monitoring lines where the ma also be used to deliver injectable medicines>

and uids

See Figure 1: Parenteral products and lines

These recommendations appl to all clinical areas o Australian hospitals including:

'Hospital in the Home', where injectable medicines and uids are administered; procedurerooms (e.g. endoscop rooms) and the perioperative environment. Exceptions to theserecommendations are listed in 2.2 below.

2.2 NSW TAG Sar Mdicins Grup rcmmndatins Do NoTapply whr a rlant Australian Standard alrady xists

The Australian/New Zealand Standard®: User-applied labels or use on sringes containingdrugs used during anaesthesia (AS/NZS 4375:1996) 16 should be implemented or the labellingo injectable medicines drawn up in SyRINGES and used within OPERATING ROOMS.

However, note:

Standard (AS/NZS 4375:1996)a. 16 applies onl to medicines drawn up in sringes and doesnot appl to medicines or uids administered via bags/bottles. For labelling o medicines

or uids administered via bags/bottles reer to these NSW TAG Saer Medicines Grouprecommendations

Standard (AS/NZS 4375:1996)b. 16 applies onl during anaesthesia and thereore, in theoperating room. For labelling o medicines and uids in areas o the perioperativeenvironment outside the operating room reer to these NSW TAG Saer Medicines Grouprecommendations (see 3.6)

The principles within these NSW TAG Saer Medicines Group recommendations should bec.considered when appling Standard (AS/NZS 4375:1996) 16




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Labelling o injectable medicines and uids prepared b hospital pharmac departments withinAustralia should compl with the National Coordinating Committee on Therapeutic Goods(NCCTG) 'Standard or the Preparation o Pharmaceuticals in Australian Hospital Pharmac

Departments' 17 and the range o practice guidelines developed b the Societ o HospitalPharmacists o Australia.18

However, note:

Pharmac sta must be aware o these recommendations and their application to the>

labelling o pharmaceutical products at the point o patient care

Where the labelling o injectable medicines sourced rom an external compounding>

centre or manuacturer (e.g. ctotoxic preparations), does not provide all the details asrecommended in this document, additional labelling b the hospital pharmac mabe required

2.3 Nn-inctal slutins drawn up in syrings:

While these recommendations appl to injectable medicines and uids, some o the principles

in these recommendations appl to the labelling o non-injectable medicines drawn up insringes to be administered via non-injectable routes such as inhalation, oral, nasogastric orgastrostom. Wherever these routes are used the sringes must also be clearl labelled with 'ForInhalation Onl', 'For Oral Use Onl', 'For Nasogastric Use Onl', etc.

Syringes specifcally designed or administration o medicines orally or

via a nasogastric or gastrostomy tube should only be used or the purpose

or which they are designed. To protect the patient these syringes are NOT

compatible with parenteral entry portals.19




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3. Principles3.1 on cntral dy shuld rspnsil r grnanc

prcsss rlatd spcically t lals within ach hspital rAra Halth Sric AHS

These processes include: the decision to introduce new labels; label design; range o pre-printed labels; version control; inventor control and procurement. The central governancebod ma be or example, the Drug and Therapeutics Committee (DTC) or Patient SaetCommittee. Where the governance bod is not the DTC, then the DTC should also be consultedor nal approval.

3.2 T acilitat ths rcmmndatins, thr shuld timly

accss t:Patient identication stickers in drug preparation areas or close to patients’ beds>

A range o pre-printed labels. Such labels should be approved b the local governance>

bod overseeing labels (reer item 3.1) and stocked in all clinical areas

3.3 Th clur and siz th lal shuld cmply with Appndix 1 Australian Standard AS 4940:2002 Usr-applid idnticatinlals r us n fuid ags, syrings and drug administratinlins and Amndmnt 1 200315

Where use o such labels is impractical, specic procedures or use o alternative label ormatsmust be approved b the local governance bod.

3.4 Syrings:

Hospitals and AHS are encouraged to purchase pre-loaded sringe presentations>

wherever such a product is available on the Australian market, or rom a licensedmanuacturer, where the product has been assessed as suitable b the DTC. Whereverpossible, standard strengths o these products should be purchased

All injectable medicines drawn up in sringes in clinical areas should be labelled>

IMMEDIATELy ater preparation b the person drawing up the drug or solution. Thisincludes those intended or bolus use, even i onl one injectable medication is to beadministered

The manuacturer’s labelling and the calibrations on the sringe scale must remain visible>

ater the label has been applied

Each injectable medicine drawn up in a sringe should be prepared, labelled and>

administered as a single operation b a single person or immediate use

I multiple sringes are required, the should be prepared, labelled and administered>

sequentiall as independent operations. The preparation o two sringe-loaded medicinesrequires labelling o BOTH

Unlabelled sringes must not be let unattended or in the presence o other unlabelled>

medication

An unlabelled sringe containing a solution should be immediatel discarded>

Where injectable medicines are drawn up in a sringe or use in emergenc situations (e.g.>

during resuscitation), careul consideration should be given to procedures to ensure thatthese principles are ollowed

The ONLy exception to these labelling requirements is where the preparation and the>

bolus administration o a SINGLE medicine is one uninterrupted process, the unlabelled

sringe DOES NOT leave the hands o the person who prepared it and that same personadministers the medicine IMMEDIATELy




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3.5 Pr-mixd intranus fuids:

These recommendations should be cross reerenced to other policies on the use o pre-mixed

intravenous injections, e.g. pre-mixed intravenous potassium chloride, heparin, magnesium,amino acids.

3.6 Priprati nirnmnts:

Labelling o medicines drawn up in sringes in the operating room should compl with>

AS/NZ4375:1996 16

In general, medicines drawn up in sringes within the operating room should remain>

there. Exceptions could be made, e.g. when an anaesthetist ma prepare a medication ina sringe or Patient Controlled Analgesia (PCA) inusion at the end o a procedure whichremains attached when the patient is transerred to the post- anaesthetic recover unit

Injectable medicines and IV uids commenced in the operating room which remain in>

place when patients are transerred to post anaesthetic recover unit should be labelled

according to recommendations outlined in this documentInjectable medicines administered within the post anaesthetic recover unit should be>

drawn up in recover and labelled according to these recommendations

Labelling o tubing, inusion devices and invasive monitoring lines in all areas o the>

perioperative environment should compl with these recommendations

3.7 othr stril lds i.. asptic cnditins:

Where sterile labels are available, labelling should t best practice as described in these>

recommendations

In the absence o sterile labels, local polic ma be developed to clearl dierentiate>

injectable medicines prepared under sterile conditions

3.8 Ths rcmmndatins d nt rplac r iat th nd rthr clarly dnd quality and saty prcsss rlating t thadministratin inctal mdicins and fuids

The ollowing processes adapted rom NHS National Patient Saet Agenc (NPSA) AlertNumber 20 (28 March 2007), 'Promoting saer use o injectable medicines' 6 should beconsidered:

Undertaking risk assessments o injectable medicines procedures and products in all>

clinical areas to identi high risks, and develop an action plan to minimise them

Keeping up-to-date protocols and procedures or prescribing, preparing and>

administering injectable medicines and uids, including checking processes

Training o all sta involved in prescribing, administering and monitoring o injectable>

medicines and uids, including training o those sta that are supervising and checking

these processesAssuring timel access to up-to-date technical inormation on injectable medicines b>

health care proessionals

Implementing a 'purchasing or saet' polic to promote procurement o injectable>

medicines with inherent saet eatures including 'sae' labelling as outlined in theserecommendations

Undertaking audits o all practices associated with injectable medicines. For example an>

audit o relevant items o the Medication Saet Sel Assessment or Australian Hospitals. This ma be accessed via http://mssa.cc.halth.nsw.g.au/MSSA_intrductin.html




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3.9 othr cnsidratins:

The details on the manuacturer’s product label should not be obscured. Manuacturers>

are guided b 'Best practice guideline on prescription medicine labelling' prepared bthe Drug Saet Evaluation Branch o the Therapeutic Goods Administration (TGA) orall licensed medicines.20 This guideline combined with the mandator Labelling Order 21 ensures product labels 'enhance the abilit o health care proessionals and consumers toselect the correct medicine, use it sael and thereore, aid in reducing medication errors'

An labels in addition to the manuacturer’s product label must be hospital approved.>

Additional labels provided b manuacturers should not be used unless approved b thegovernance committee responsible or labels and the DTC (Reer 3.1)

Inection control surveillance and medication stabilit must be considered in labelling.>

Time, date prepared and expir date should be included on labels or injectable medicinesadded to uids. Scheduled 'change' dates and times should compl with local policies(including tubing change expir dates and times)

Abbreviations used on labels should compl with NSW TAG Saer Medicines Group>

'Recommendations or Terminolog, Abbreviations and Smbols used in Prescribing andAdministration o Medicines' 22




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Tal 1: Patint Administratin Prtals Cannula

Note: This list includes examples to assist in the interpretation o these recommendations and is not intended to be exhaustive

PATIeNT ADMINISTRATIoN PoRTALS CoveReD bY THeSe ReCoMMeNDATIoNS

Subcutaneous

Intramuscular

Neural Epidural

Intrathecal

Intraventricular

Peripheral nerve/plexus

Vascular access Intra-arterial Peripheral arterialPulmonar arterial

Intra-aortic

Midline catheters

Intravenous Central venous catheter (CVC)

Peripherall inserted central venous catheter(PICC)

Peripheral intravenous cannula (PIV)

Central venous implanted ports (e.g.

portacaths)

Intra-cavit Intraperitoneal

PATIeNT ADMINISTRATIoN PoRTALS NoT CoveReD bY THeSe ReCoMMeNDATIoNS

Bone Intraosseous

Enteral Percutaneous enteral gastrostom (PEG)

Nasogastric

Orogastric

Jejunostom

Intra-cavit Pleural tubes

Rectal

Intra-articular

Intra-vesicular Indwelling catheters

Supra pubic catheter (SPC)

Bladder catheter

Umbilical

Cutaneous (i.e. via skin)

Inhalation




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4. Labelling recommendations (Refer Figure 1)

Ths rcmmndatins rprsnt th MINIMUM rquirmnt r lalling

SoURCe (INjeCTAbLeMeDICINeS AND FLUIDS,INCLUDING CoNTAINeR)

LAbeLLING ReCoMMeNDATIoNS RATIoNALe/ADDITIoNALCoNSIDeRATIoNS

Fluid bags and bottles or inusionwhr n additinal inctalmdicins ar addd to the bagor bottle in an clinical area

This includes:

Intravenous uids>

Pre-mixed solutions e.g.>

lignocaine, potassium, heparininusions

Intravenous admixtures>

prepared in the pharmac

Peritoneal dialsis uids>

Blood products such as normal>

immunoglobulin and albumin

In addition to manuacturer’s/pharmac label

Patient name and Medical Record Number>

(MRN)

Date and time administration commenced>

Identication labels are>

necessar:

(a) For inection controlpurposes, e.g. to acilitatetimel bag changes

(b) When uids are detached,

e.g. or patient showering(c) For inusion rate monitoring

Labels must remain clear>

and legible, even whenpressure bags are used

Fluid bags, bottles, burettes andsringes r inusin whrinctal mdicins ar addd to the bag or bottle in all clinical

areas.

1. Gnral Lalling

Patient name and MRN>

Generic drug name o additive>

Base uid name (where not evident)>

Amount o drug added e.g. milligrams, units>

Amount o drug contained per total volume>

e.g. 100 mg/100mL

Route o administration>

Inusion rate (i non variable)>

Date and time prepared>

Date and time administration commenced>

Date and time to be discarded>

Prepared b>

Checked b>

Explore ag labels or use>

with sringes and othersmall containers

Labels must remain clear>

and legible, even whenpressure bags are used




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SoURCe (INjeCTAbLeMeDICINeS AND FLUIDS,

INCLUDING CoNTAINeR)


2. Additinal lalling

epidural thrapy> : All uid bags, bottles andsringes intended or epidural therap (eitherpurchased commerciall, manuactured b thehospital pharmac or prepared in clinical areas)must be labelled 'For Epidural Use Onl' 23

Intrathcal thrapy> : All uid bags, bottlesand sringes intended or intrathecal therap(either purchased commerciall, manuacturedb the hospital pharmac or prepared in clinicalareas) must be labelled 'For Intrathecal Use Onl'. This includes labelling the outer wrapper whereapplicable

Priphral and cntral intranus thrapy> :Where peripheral and central lines are BOTHpresent label all uid bags, bottles and sringes'Peripheral intravenous route' or 'Centralintravenous route' as appropriate

Chmthrapy> : Each container mustbe labelled with a ctotoxic warning labelin accordance with local health and saetrequirements 24

epidural thrapy andintrathcal thrapy:Amendment 1 (2003) o Australian Standard: User-applied identication labelsor use on uid bags, sringesand drug administration lines(AS 4940:2002),15 species thatlabels or administration via aneural route, including epiduraland intrathecal therap, must

be coloured YeLLoW

Syrings r lusadministratin

1. Pr-lalld syrings

This includes pre-loaded sringesprovided b manuacturersand those prepared b hospitalpharmac

1.a Pr-lalld syrings

No additional label required

However, consider labelling high risk medicines, e.g.cytotoxic agents, with the patient’s name

1. Pr-lalld syrings r incrmntal us

Date and time o administration o rst>

increment

Rr t principl 3.4

It is imprati t xprss>

th ToTAL amunt drugcntaind in th syring.g. 10 mg/10 mL rathrthan th cncntratin.g. 1 mg/mL in 10 mL.Th lattr has nassciatd with rrrs 1




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SoURCe (INjeCTAbLeMeDICINeS AND FLUIDS,

INCLUDING CoNTAINeR)


2. Nn-pr-lalld syrings

This includes injectable medicinesdrawn up in a sringe in anclinical area

2.a Nn pr-lalld syrings

Generic drug name>

Amount o drug contained in the sringe per>

total volume e.g. 10 mg/10mL

Patient name and MRN>


2. Nn-pr-lalld syrings rincrmntal us

Generic drug name>

Amount o drug contained in the sringe per>

total volume e.g. 10 mg/10mLsPatient name and MRN>


Date and time o administration o rst>

increment

Do not obscure the sringe>

calibrations with the label

A duplicate label should be>

applied to an over wrapper(i.e. outer wrapper) which isopaque or does not allowdirect label to be read

For sringes prepared>

in a sterile eld (e.g. oradministration via aHickman’s catheter), usepurchased sterile labels,sterilise labels or disinectsurace o label

Consider pre-printed>

labels or commonl usedpreparations administeredvia bolus route (e.g. normalsaline ushes). Thesepre-printed labels couldalso include space or thepatients’ name

Consider bar-coding pre->

printed labels

3. Additinal lalling r pr-lalld andnn-pr-lalld syrings

epidural Thrapy> : All sringes intended orepidural therap (either purchased commerciall,manuactured b the hospital pharmac orprepared in clinical areas) must be labelled 'ForEpidural Use Onl' 23

Intrathcal Thrapy> : All sringes intendedor intrathecal therap (either purchasedcommerciall, manuactured b the hospitalpharmac or prepared in clinical areas) mustbe labelled with 'For Intrathecal Use Onl'. Thisincludes labelling the outer wrapper whereapplicable

Priphral and cntral intranus>

thrapy: Where peripheral and central linesare BOTH present, label all sringes 'Peripheralintravenous route' or 'Central intravenous route'as appropriate

Chmthrapy> : Each container mustbe labelled with a ctotoxic warning labelin accordance with local health and saetrequirements 24

epidural thrapy andintrathcal thrapy:Amendment 1 (2003) o Australian Standard: User-applied identication labelsor use on uid bags, sringesand drug administration lines(AS 4940:2002),15 species thatlabels or administration via aneural route, including epiduraland intrathecal therap, must

be coloured YeLLoW




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CoNDUITTUbING, INFUSIoN

DevICeS AND INvASIveMoNIToRING LINeS


1. Tuing

This includes extensiontubing and giving sets usedto deliver uids and/ormedication into a patient ban parenteral route

1. Lal

Label all tubing as per ollowing xampl label

Intranus Rut

Dat tuing attachd: .................................

Above design o label should be pre-printedor the dierent routes, i.e. intravenousroute, intra-arterial route, epidural route andintrathecal route

Where peripheral and central lines are BOTHpresent, identi 'Peripheral intravenous route' or'Central intravenous route' as appropriate

Label to be colour coded as per AustralianStandard: User-applied identication labelsor use on uid bags, sringes and drugadministration lines (AS 4940:2002) andAmendment 1 (2003) 15 (Reer Appendix 1)

2. Lcatin lal

Label close to the uid and/or injectablemedicine source AND close to the patient entrportal (See Illustration 1)

To prevent the inadvertent>

administration o a drug or uidvia an incorrect route

For inection control purposes,>

e.g. to acilitate timel tubingchanges

I pre-printed labels or dierent>

routes are not available thenthe ollowing generic label issuggested:

Rut: ..................................................

Dat tuing

attachd: ............................................

2. Inusin dics andurtts

1. Syring pumps:No labelling required

2. burtts with inctal mdicins addddirctly int th urtt:

Label burette as per non pre-labelled sringes

Do not obscure the burette>

calibrations with the label

3. Inasi mnitring lins Label monitoring lines as per ollowing xampl label

Intranus Rut

Dat tuing attachd: .................................

Above design o label to be pre-printed or thedierent routes, i.e. intravenous route, intra-arterial route and pulmonar arterial route

Label to be colour coded as per AustralianStandard: User-applied identication labelsor use on uid bags, sringes and drugadministration lines (AS 4940:2002) andAmendment 1 (2003) 15 (Reer Appendix 1)

To prevent the inadvertent>

administration o a drug or uidvia an incorrect route

I pre-printed labels or dierent>

routes are not available thensuggest the ollowing genericlabel:

Rut: ..................................................

Dat tuing

attachd: ............................................

PATIeNT ADMINISTRATIoNPoRTALS

LAbeLLING ReCoMMeNDATIoNSRATIoNALe/ADDITIoNALCoNSIDeRATIoNS

Patient administration portals Additional labelling to state: Tpe o patient administration portal>

Date o insertion>

As per local polic




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Illustratin 1: Typical intranus inusin with an inusin dic

(For use in conjunction with 4. Labelling recommendations, page 11)

Label close to IV uid *

* Label close to patient

LABEL SOURCES A, B AND C

A = Bag/Bottle infusion uid

B = Syringe

C = Burette (if present)

A

B

BC

Label tubing at points marked *




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Glossary of termsboLUS (PUSH) Administration rom a sringe o a small volume o a single dose o a sterile solution directl into

a tissue, organ or vein, over a short period, usuall, between 30 seconds and 10 minutes (NPSAdenition)

CATHeTeR Including:

Angiographic catheter

Arterial catheter

Butter cannula

Cardiac catheter

Central venous catheter

Epidural catheter

Implantable port e.g. Port-a-Cath ®

Intraperitoneal catheter or port

Intrathecal catheter or port

Midline catheter

Peripheral intravenous catheter (PIV)

Peripherall inserted central venous catheter (PICC)

Subcutaneous catheter

Tenckho catheter

Tunnelled catheter e.g. Hickmans ®, Broviac ®

CLINICAL AReA An area in the hospital where injectable medicines and uids are administered including:

Wards

Outpatient areas

'Hospital in the Home'

Procedure rooms (e.g. endoscop rooms)

Perioperative environments

eMeRGeNCY USe Administration o drugs in an emergenc,i.e. where an unpredicted situation involvingthe patient arises, e.g. during resuscitation

"Immdiat emrgncy Us" – the drug isdrawn up into a sringe and administeredwithin seconds. Usuall the person drawing up

the sringe is the same person who administersit and the sringe does not leave that person’shand until ater it has been administered

"Nt Immdiat emrgncy Us" – the drug isdrawn up and not administered within seconds

FLUSH To purge access devices (e.g. cannulae) beore and/or ater injection o a medicine or betweeninjections o dierent medicines (NPSA denition), e.g. with a sterile solution o diluent, such assodium chloride 0.9%

INCReMeNTAL USe The administration o a drug within a single sringe or other deliver device in staggered doses. This ma appl to emergenc situations (e.g. during resuscitation) or to administration in theoperating room




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INFUSIoN Administration (rom a sringe, or other rigid or collapsible container e.g. plastic bag) o avolume o sterile solution containing an injectable medicine directl into a tissue, organ veinor arter, at a constant rate, under gravit or b means o an electronic or mechanical pumpor b other means o rate control, over a dened period o at least 10 minutes (based on NPSAdenition)

INjeCTAbLeMeDICINe

Sterile medicine intended or administration b bolus injection, perusion or inusion b ano the ollowing routes: Intravenous, intramuscular, intrathecal, intra-arterial, subcutaneous,intradermal, intraventricular, epidural, intravescicular, intravitreal, intrapleural and intraocular(NPSA/2007/20)

oPeRATING RooM The room in which a surgical procedure is undertaken, with or without the administration o ananaesthetic (Australian College o Operating Room Nurses [ACORN] 2006 Standards 25)

PATIeNTADMINISTRATIoNPoRTAL

The point o entr to the bod. Also, the most proximal entr to the catheter or device whichenters the patient’s bod. This ma be an injection port or bung on a catheter or entr site o ahuber needle or implantable ports

PeRIoPeRATIve The period beore, during and ater an anaesthetic, surgical or other procedure (ACORN 2006Standards 25)

PeRIoPeRATIveeNvIRoNMeNT

The service area where the provision o an anaesthetic, surgical or other procedure ma beundertaken (ACORN 2006 Standards 25)

PoST ANAeSTHeTICReCoveRY UNIT(PARU)

An area set aside within the perioperative environment that is well planned, well equipped, wellstaed and well managed or the sae immediate management o patients who have recentlundergone a surgical or other procedure irrespective o the tpe o anaesthesia or sedation

(ACORN 2006 Standards25

). Also known as 'Recover'TUbING This includes all intravenous giving sets/administration lines/catheters through which injectable

medicines and uids are administered




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References1 Taxis K, Barber N. Ethanographic stud o the incidence and severit o 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,German and France. Qual Sa Health Care 2005;14:190-195

3 Paix AD, Bullock M, Runciman WB, Williamson JA. Crisis management during anaesthesia: problems associated with drugadministration during anaesthsia. Qual Sa Health Care2005;14: e15

4 Abesekera A, Bergman IJ, Kluger, MT et al. Drug error in anaesthetic practice: a review o 896 reports rom the AustralianIncident Monitoring Stud database. Anaesthesia, 2005, 60: 220-227

5 Institute or Sae Medication Practices. Errors with Injectable Medications: Unlabeled sringes are surprisingl common!November 15, 2007. Available rom: www.ismp.rg/Nwslttrs/acutcar/articls/20071115.asp?ptr=y

6 American Nurses Association. Medication errors and sringe saet are top concerns or nurses according to new national

stud. Press release: June 18, 20077 Burdeu G, Craword R, van de Vreede M et al. Taking Aim at Inusion Conusion. J Nurs Care Qual 2006; 21:151-159

8 Medications: Double Checking at the Bedside? Coronial Communique. A combined Victorian State Coroner’s Ofce andVictorian Institute o Forensic Medicine publication. November 2006. Volume 4 Issue 4

9 Kell M, Chandler S, Montgomer J et al. How Sae is Labeling o Parenteral products and Invasive Parenteral Lines in NSWPublic Hospitals? Poster Presentation at 4th Australasian Conerence on Saet & Qualit in Health Care. 21-23 August 2006

10 The Joint Commission, 2008 National Patient Saet Goals, Hospital Program.www.intcmmissin.rg/PatintSaty/NatinalPatintSatyGals/ 08

11 NHS – National Patient Saet Agenc, Patient Saet Alert Number 20 (28 March 2007) – Promoting saer use o injectablemedicines. www.npsa.nhs.uk/patintsaty/alrts-and-dirctis/alrts/inctal-mdicins

12 Medication Handling in New South Wales Public Hospitals. NSW Health Department Polic Directive PD2007_077.

Available rom: www.halth.nsw.g.au/plicis/pd/2007/PD2007_077.html 13 Cohen MR. Medication Errors, 2nd Edition. American Societ o Health-Sstem Pharmacists 2007: pp 278-9

14 Problems Persist with Lie-threatening Tubing Misconnections. Institute or Sae Medication Practices (ISMP) MedicationSaet Alert June17, 2004

15 Australian Standard: User-applied identication labels or use on uid bags, sringes and drug administration lines(AS 4940:2002). Standards Australia International Ltd, Sdne and Amendment 1 (2003)

16 Australian Standard: User-applied labels or use on sringes containing drugs used during anaesthesia (AS/NZS4375:1996). Standards Australia International Ltd, Sdne

17 Standard or the Preparation o Pharmaceuticals in Australian Hospital Pharmac Departments: National CoordinatingCommittee on Therapeutic Goods (NCCTG) September 1993. Aus J Hosp Pharm 1994: 24(2); 182-8. Available rom:www.halth.nsw.g.au/rsurcs/pulichalth/pharmacutical/pd/NCCTG_Sp93.pd

18 www.shpa.rg.au/dcs/practicstandards.html

19 Cohen MR. Medication Errors, 2nd Edition. American Societ o Health-Sstem Pharmacists 2007: pp 220-1

20 Drug saet and Evaluation Branch; Therapeutic Goods Administration. Best Practice guideline on prescription medicinelabeling. 17 November 2005. Available rom: www.tga.g.au/pmds/pmstpractic.htm

21 Therapeutic Goods Order 69 General requirements or labels or medicines (TGO 69). Available rom:www.tga.g.au/dcs/html/tg/tg69.htm

22 Recommendations or Terminolog, Abbreviations and Smbols used in the Prescribing and Administration o Medicines.Saer Medicines Group: New South Wales Therapeutic Advisor Group Inc. October 2006www.ciap.halth.nsw.g.au/nswtag/pulicatins/guidlins/TeRMINoLoGY/1206.pd

23 NHS – National Patient Saet Agenc. Patient Saet Alert Number 21 (28 March 2007): Saer practice with epiduralinjections and inusions.www.npsa.nhs.uk/patintsaty/alrts-and-dirctis/alrts/pidural-inctins-and-inusins/

24 Guidelines or the Sae Prescribing, Suppl and Administration o Cancer Chemotherap: Drat document or review.Clinical Oncolological Societ o Australia. Jul 8th 2008

25 Australian College o Operating Room Nurses. ACORN Standards or Perioperative Nursing: including nursing roles,guidelines, position statements, competenc standards 2008/ Australian College o Operating Room Nurses. Adelaide, SA: The College, 2008




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Appendix 1:

Colour coding accordingto target tissueFrm Australian Standard: Usr-applid idnticatin lals r us n fuid ags, syrings and

drug administratin lins AS 4940:2002 and Amndmnt 1 2003.15

TARGeT TISSUe CoLoUR PANToNe MATCHING SYSTeM PMS AS 2700 eQUIvALeNT

Intravenous Blue PMS Process Blue U B34

Intra-arterial Red PMS 1787 U R22

Neural tissue yellow PMS Pantone yellow U y23

Subcutaneous tissue Beige PMS 723 U y55

Miscellaneous White ––– –––




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Appendix 2:

Acknowledgements

Duality of interest

Ths rcmmndatinsha n prpard y aWrking Grup NSWTAG Sar Mdicins Grupcmprising:

Ms jill Arcus Principal Pharmaceutical Advisor,Hospitals, Pharmaceutical

Services Branch,NSW Health Department

Ms Sarah Chandlr Senior Pharmacist,Prince o Wales Hospital, Sdne

Ms Paulin DsnClinical Nurse Consultant HIV/AIDS,Immunolog & Inectious Diseases Unit,John Hunter Hospital,New Lambton, NSW

A/Pr Ryn GallaghrAssociate Proessor Chronic & Complex

Care, Coordinator Masters HonoursPrograms,Facult o Nursing, Midwier & Health,Universit o Technolog, Sdne

Ms Maria KllyExecutive Ofcer, NSW TAG

A/Pr Rss MacPhrsnDirector, Peri-operative Clinic, Depto Pain Management & Anaesthetics;Chair, Drug CommitteeRoal North Shore Hospital & RdeHealth Service, Sdne

Dr Gary NichllsClinical Pharmacolog Registrar,St Vincents Hospital, Sdne

Ms Pnny ThrntnDirector o Pharmac,Westmead Children’s Hospital, Sdne

Ms Paulin Dsn has received travel andaccommodation expenses rom Baxter Healthcare orattending a conerence as an invited speaker. Ms Dobsonhas worked with Baxter Healthcare as a 'hospital in the

home' conerence organising committee member on twooccasions, receiving a plate ater the rst conerence.

Ms Pnny Thrntn has received the NaismithManagement Grant rom SHPA (2006), sponsored bBaxter Healthcare. Ms Thornton's husband is Mr Mel Davis,a consultant to Baxter Healthcare. Ms Thornton has also

provided advice to REM sstems, but receives no undingrom them.

Ms Kay RllsClinical Nurse Consultant, ClinicalProject Ofcer,Intensive Care Coordination &Monitoring Unit,Sdne West Area Health Service(SWAHS)

Ms Mrdith vrgEducation & Training Pharmacist,

Roal North Shore Hospital, SdneMs Sally WilsnClinical Nurse Consultant, PainManagement,Roal Hospital or Women, Sdne

NSW TAG als acknwldgsth cntriutin xprtgrups including thllwing:

NSW TAG Saer Medicines Group

NSW TAG & TAGNet membersrepresenting all Drug & TherapeuticCommittees in NSW public hospitals

NSW TAG als acknwldgscntriutin rm thllwing indiiduals:

Dr Michal bnntt Prince o Wales & Sdne Children’sHospital’s Drug & TherapeuticsCommittee,South Eastern Sdne & Illawarara Area

Health Service (SESIAHS)Dr Patrick bltnChair, Prince o Wales MedicationSaet Sub-Committee, Director o Clinical Services (Medicines),Northern Hospitals Network, SESIAHS

Ms Sandy burrw Anaesthetic & Recover Unit,Nepean Public Hospital, Kingswood

Mr Graham Hxtll Project Ofcer,Perioperative Education Program orEnrolled Nurses (PEPEN), SESIAHS

Ms Mary Hdgtts

Patient Saet Manager,Clinical Improvement Unit – CentralNetwork, SESIAHS

Ms Karn Kay Executive Manager, QUM Programs,National Prescribing Service Ltd

Dr bridin Murnin Sta Specialist, Drug Health Services,Director o Phsician Training,Roal Prince Alred Hospital, Sdne

Mr Kingsly Ng Director o Pharmac,

Westmead Hospital, Sdne

Ms Ann McDad Clinical Nurse Consultant InusionManagement/TPN,Concord Repatriation GeneralHospital, Sdne

Ms Diana Shipp Project Ofcer, NSW TAG

Ms Shlly Trantr Nephrolog Nurse Consultant,SESIAHS

Ms brnwyn Warn Nurse Manager, Communit Chronic &Complex Care (Western Cluster),Primar Care & Communit HealthNetwork, Integrated Health Cluster,SWAHS

No other duality of interest declared.




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PO Box 766

Darlinghurst NSW 2010

Phone +61 2 8382 2852

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Email [email protected]

web www.nswtag.org.au

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31170 Parenteral Labelling Recommendations