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4th November 2014

The Secretary

Communications and Secretariat

Therapeutic Goods Administration

PO Box 100

WODEN ACT 2606

Re: Consultation: Medicine labelling

The NSW Therapeutic Advisory Group (NSW TAG) is an independent not-for-profit association that

promotes the Quality Use of Medicines (QUM) within and across the continuum of acute care. Our

members are clinical pharmacologists, pharmacists, and other clinicians from each of the Drug and

Therapeutics Committees (DTCs) in NSW public hospitals and Local Health Districts. Our goal is to

promote QUM by sharing unbiased, evidence based information about drug therapy. Our objectives

are to investigate and evaluate new initiatives in therapeutics, to support Drug and Therapeutics

Committees and to promote rational, high quality, safe prescription, dispensing and administration

of medicines in public hospitals and the wider community.

NSW TAG recommends that changes to the labelling standards proposed in Therapeutic Goods

Order No. 79 (TGO 79) should be mandatory and that this should replace TGO 69; that is, that

Option 3 of the Regulation Impact Statement is supported. NSW TAG recommends that TGO 79 be

implemented according to the proposed Option 3A which allows for a two-year transition period;

that is, as promptly as possible.

In addition and as included in the consultation provided to the proposed labelling changes in 2012,

NSW TAG strongly supports the formation of a Labelling and Packaging Advisory Committee. Many

of the safety issues that are associated with confusion of the consumer are in the proprietary names

of the medicines, which have not been vetted by end-users (health care professionals and

consumers). Much of the feedback NSW TAG has provided below could have been avoided if such a

committee had prior access to the specific medicine submissions proposals outlined.

NSW TAG has comments and suggestions for alternative options, as invited. These are outlined

below for the two of the three documents available for review (the Guidelines for labelling of

medicines, and the Therapeutic Good Order 79). In particular, NSWTAG highlights two major issues

of labelling and packaging that are recurring concerns for our members and also hospitals across

Australia. These are the labelling and packaging of neuromuscular blocking agents and also of

Schedule 8 liquids. Recommendations for these are included in Guideline number 8, Medicines with

specific ingredients, in the table below.

It should be noted that ‘Purchasing [pharmaceutical products] for Safety’ is gaining momentum and

is likely to play an increasing part of the purchasing strategies of health care facilities. Hence

pharmaceutical companies that adopt such an approach are likely to retain or improve their market

share.

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Contact details:

Dr Sasha Bennett Executive Officer NSW Therapeutic Advisory Group (NSW TAG) PO Box 766, Darlinghurst, NSW, Australia 2010 Email: nswtag@stvincents.com.au Telephone: 02 8382 2852 Website: www.nswtag.org.au

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CONSULTATION: GUIDELINES FOR THE LABELLING OF MEDICINES

Guideline number

NSW TAG comment NSW TAG recommendation

2.1 General requirements

NSW TAG supports the general requirements, in particular the minimum font size using Arial for comparison.

The document however is confusing in the use of the “name” of medicine and “name of active ingredients” as the use of these is not consistent throughout.

That the “name of medicine” be defined at the outset as the registered product and that this terminology is used consistently throughout the document. (Further examples are to follow, see 3.1, 3.2, 3.4 below.)

2.2.1 Information on the main label

As per 9(2) of TGO79, the quantity of medicine should not appear on the same line as the name of the medicine.

This information be included here as well for clarity, or a hyperlink provided.

The requirement for what constitutes a “cohesive unit” is not obvious.

The use of the word “quantity” which relates to both the active ingredient and pack size is confusing.

That a different terminology is employed when referring to the packaged contents; for instance, “amount” or “pack size” to refer to for instance, the number of tablets or the volume.

An example of the recommended layout of the label be provided to explain the terminologies used and requirements.

2.2.1 Information on the main label

Ensuring that the active ingredients and how much of each active ingredient is present and identifiable is supported; however NSW TAG would support stronger guidelines or mandate. The premise of the labelling review is to enhance the safety and understanding of medicine labelling for consumers.

Consumers should be immediately able to recognise what is the registered (brand) name and what are the active ingredients of a product. Furthermore the active ingredients and quantity of active ingredient should be presented on every label in a consistent manner so these can be readily identified. One way to do this would be to always have the active ingredients enclosed in a frame or border.

When there are two or more active ingredients, a consistent approach to the order in which these appear on the label would be beneficial.

When a competitor follows an innovator in the manufacture of a compound medicine, that the listed order of the ingredients follows the innovator labelling.

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Guideline number

NSW TAG comment NSW TAG recommendation

2.2.3 Information on a label

NSW TAG support all of these excellent recommendations, with the exception of:

Ingredients included in Schedule 1 be permitted to be included only in package insert for prescription-only medicines

Required warning statements, such as use in pregnancy, are required only for Schedule 4 (S4) and Schedule (8) medicines.

That the requirements for listing of Schedule 1 ingredients and all mandated warnings be placed on all labels regardless of their scheduling.

This requirement would add an additional safeguard and provide prompts for the pharmacist dispensing as well as for the consumer who may not read the package insert.

Additionally, NSW TAG strongly recommends that place or country of manufacture be included on the label.

3. The name of the medicine

3.1 How the name is displayed

NSW TAG supports the recommendation for use of similar size and fonts, however these could be strengthened for clarity. No maximum font size is included for the registered name of the medicine.

That the recommendations be requirements and included in TGO79. If colours are used to differentiate strengths or products within the same range from the manufacturer, that these colours are reflected in the actual colours of the capsule or tablet, as applicable. That there be consideration given to restricting the size of the font of the name of the registered medicine.

The last paragraph (commencing “When a registered medicine contains two or three active ingredients”) and dot points refer to the names of the active ingredients.

These requirements should be moved to the section below (3.2 Name of active ingredients) as that is where they are applicable.

For the recommendation to use different colours for different components of the medicine name, it is unclear whether this refers only to strengths of ingredients contained therein, or additional enhancements to the name, such as “PLUS” or “XR” or “FORTE”. When such a distinction is used, consumers do not always recognise the extra wording as indeed included in the name of the medicine.

Although colour may be used for differentiation of strengths, it should be recommended against in the name of a medicine where it could be interpreted as not being integral to the name.

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Guideline number

NSW TAG comment NSW TAG recommendation

3.3 Use of capital letters

Permitting capital letters and unrestricted font size of the name of the medicine detracts from the ease of identification of the name of the active ingredients by the consumer. This is potentially problematic when there has been a switch of brand and does not allow for ease of identification of the active ingredients by the consumer.

Rather than include in the guideline that capitals do not need to be used, include as a requirement that the name of the medicine be in sentence case only.

3.4 Font size of names

This point relates to the names of the active ingredients. Rename this section “Font size of names of active ingredients.

3.4.2 Names on small and very small containers

There is a minimum font size stipulated for the name of the medicine (6 point Arial) with all other information permitted as 4 point Arial. This is quite small and does not allow for easy reading of a technical name by the consumer.

The names of the active ingredients require equal attention as the name of the medicine; that is, at least 6 point Arial.

The permission to include only the name of the medicine and not the active ingredient on very small containers within a primary pack is potentially problematic once the outer packaging is discarded.

NSW TAG does not support this permission and recommend that the names of all active ingredients appear on the label and if necessary, that the label size and/or packaging be increased to accommodate these.

4 How to quantify active ingredients

Labels are to provide consistent strength information for all medicines containing the same active ingredient.

NSW TAG strongly supports this requirement.

4.1 Salts, hydrates and solvates

There is an allowance for exclusion of the salt from the name of there is only one salt registered in Australia. It is unclear from this the requirements once a second medicine is registered and whether the requirement be applied retrospectively.

This requires clarification.

Providing one example of exemption of labelling requirements appears short-sighted as it is unclear where future medicines which are combination of salts will fit in to this requirement.

A requirement that is generic to all salt formulations to avoid ambiguity is preferred over the targeting of one formulation.

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Guideline number

NSW TAG comment NSW TAG recommendation

4.3 Metric units Permission given to use the abbreviations for microgram such as ‘mcg’ and ‘µ’ is contrary to all safe medicine practices as emphasised internationally [1] and in Australia [2], due to the risk of misinterpretation of these as ‘mg’.

NSW TAG strongly recommends against permitting the use of these symbols.

4.8 Sodium and potassium in oral medicines

The requirement to include sodium and potassium content of medicines is strongly supported. However, clarification is required:

Is this requirement for all medicines without exclusions, or permitted to be included only in the product insert for S4 and S8 medicines (as is outlined in 8(1)j of the proposed TGO79)?

As the daily dose of some medicines which are high in sodium and potassium can vary, the requirement should take into consideration all medicines that are high in sodium and potassium and have the potential to exceed the limits that have been determined.

All medicines containing sodium and potassium, if, when taken in the possible dosage range, could exceed the determined daily amount (of 1mmol of potassium and 120mg sodium) should have their sodium and potassium content included on the label AND the package insert.

Whatever the requirement is, it should be easily interpreted by a patient needing to make a selection decision.

See comments on Schedule 1, TGO79 in the table following for further comment requiring clarification (ie cannot have a sodium restriction that applies to both daily dose and individual dose).

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Guideline number

NSW TAG comment NSW TAG recommendation

5. Use of colour

Use of colour to distinguish the strength of the tablet in the labelling and /or packaging and also the actual tablets does not always align. For instance, a consumer may identify their strength of medicine by the colour of the box which can be interpreted as the colour of the tablet.

If there is a range of strengths available in a product range and colour differentiation is used to distinguish the strengths, then there is consistency in the colours used in the packaging and that of the actual tablet or capsule.

5.2 Colour coding

The concern expressed over the use of colour coding on “anaesthetics” on labels approved by the TGA is contrary to that adopted by the FDA and that considered by users as one strategy to avoid the adverse events associated with the inadvertent administration of neuromuscular-locking agents (NMBAs), most recently resulting in the death of children when used to mistakenly reconstitute vaccines [3].

The FDA has in place recommendations that all manufacturers provide labelling and packaging of NMBAs with features shown to be an effective strategy in reducing incidents related to NMBAs [4].

Canada has also adopted these as safe practice [5], the success of which have recently been reviewed and manufacturers commended for their compliance with the labelling recommendations [6].

Reports of inadvertent administration of NMBAs are noted frequently in the voluntary incident reports from Victorian healthcare networks, NSW Health Incident Information Management Systems and to the TGA and anecdotally. In NSW, NMBA incidents involving death lead to the NSW Coroner recommending release of the ‘NMBA – Minimising Risk Alert’ in November 2011 [7].

Other high-risk medicines are subject to individual controls of packaging and labelling (vincristine, potassium and methotrexate) which have has been in response to administration-related mix-ups, so precedence exists.

That distinctive packaging and labelling be a requirement for NMBAs. This is discussed in detail below (see Section 8, below)

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Guideline number

NSW TAG comment NSW TAG recommendation

5.1 Colour differentiation

The recommendation that colour be used to differentiate medicines, strengths and highlight important warnings is supported, as is the recommendation that a generic medicine must follow the same colour differentiation as the innovator.

Consideration could be given to including this in the TGO79 so that it becomes a requirement and not only a recommendation.

As above, that if colour is used for differentiation between strengths then the colour be consistent across the tablet, labelling and packaging.

6.1.2 Machine readable code and space for dispensing label

The requirement for a machine-readable code on the labels of S4 and S8 medicines is welcome. Dispensing and administration mistakes however still occur with non-prescription drugs with similar names and with potential for adverse outcomes in unintended patient populations. Some examples include, for instance, Panadol Extra™ (instead of Panadol™ or Panadol Osteo™) and Nurofen Plus™ (instead of Nurofen™)

That machine readable codes be included on all medicines.

The standard size of label used in Australia is 80 x 40 mm (current advice as per TGA) and the size of the designated space for a label of 70 x 30 mm.

The allocated dispensing label area should be the same size or slightly larger than the standard dispensing label size.

6.1.3 Declaring substances in Schedule 1 of TGO 79

The declaration of potential allergens and other ingredients on the label of medicines is strongly supported, however restricting this to only non-prescription items is questioned. Consumers will still require this information; they may discard the package insert and additionally, inclusion of this information on the label can also serve as a prompt for the dispensing pharmacist when providing advice and precautions about the medicine.

All medicines, scheduled and unscheduled, be labelled with Schedule 1 ingredients, as per 8(1)j of the proposed TGO79.

6.2 Registered

non-prescription medicines – Medicine Information panel

The requirement for a Medicine Information Panel is supported. However there are some modifications which NSW TAG would support (see following)

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Guideline number

NSW TAG comment NSW TAG recommendation

6.2.3 Only include required information

This is supported by NSW TAG.

Further information, or a hyperlink, should be provided as to what is NOT permitted other than direct-to-consumer advertising. For instance, claims such as “easy to swallow” or “direct-acting” should not be permitted in the section on the label allowing for other information.

Note: This also refers to Section 10 (2) (b) iii which is a typo as this section is concerning injections intended for energy…should read 10 (20) (b) iii

Only evidence-based information or extended safety or storage information should be permitted in this section of the Medicine Information Panel.

6.2.7 Ingredients ‘Only those excipients specified in TGO 79 are required to be declared in the Ingredients section of the panel’

Note: there presently two points numbered 6.2.7

Insert a hyperlink to relevant section of guidelines; that is, 8.1.1

6.2.8 Uses The examples have both headings: USES and WHAT THIS MEDICINE IS USED FOR.

NSW TAG recommends that only one of these be offered as a heading. The preference would be for ‘What this medicine is used for’

The guidelines here state that ‘We recommend.…’ but then ‘they must not include promotional or marketing statements’. There is no requirement included in TGO79.

NSW TAG strongly urges that this recommendation be included as a requirement in TGO79.

6.2.9.1 Use in pregnancy warning

This is strongly supported. Consideration should be given to applying this to all medicines, both prescription and non-prescription whenever it is required.

6.2.10.2 Specifying age groups

Currently there is variation in the way a number of products, particularly non-prescription item present dose tables. This may lead to confusion using different products either at different times or for different children.

That age-related dose information is consistent across non-prescription paediatric products and that the dose is provided in both mg and mL units

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Guideline number

NSW TAG comment NSW TAG recommendation

6.2.10.5 Dosing for liquid, solid or semi-solid products

The requirement that the dose be expressed in metric units is supported, as is the note NOT to express in terms of culinary spoonsful. Consistency regarding dosing information across products should be strengthened.

Avoiding wording of dosing in culinary terms should also be included in the TGO79. Instructions should be provided about how the product should be dosed. Mandatory inclusion of an ACCURATE dose administration device (for instance, an oral syringe) within the packaging is strongly recommended for oral liquids, particularly non-prescription products and that the dosing information refers to this device.

6.2.13 Examples of Medicine Information panels

Providing illustrative samples within the guidelines is supported, however the examples used should be improved and highlight potential concerns that could arise and lead to misinterpretations that threaten safety. For instance: in the example of the continuation of a Medicine Information panel

(clotrimazole 1% w/w, hydrocortisone 1% w/w), as there is not a definite border or divider between the warnings, the message could be interpreted potentially as

Do not use for more than 7 days for children under 2 years old Do not use in the eyes for acne

for the example of clear directions for use, the warning could be interpreted as

Do not use in children under 6 years of age for more than 3 days (Note also: there appears to be a typo as “children” is repeated.)

Clear guides to the requirements are necessary to avoid potential misinterpretations, especially when there is more than one warning.

7.3 For injection

As specific instructions are to be included on the label, it is possible that this could extend to safety precautions as well. For instance, by inclusion of additional warning statements: “For intravenous use only”

“For sub-cutaneous use only”

“Must be diluted before injection”

“Must be injected undiluted” The safety instructions should be framed positively to avoid misinterpretations.

That additional safety advice on the method of injection be provided where such precautions exist in product information.

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Guideline number

NSW TAG comment NSW TAG recommendation

7.3 For injection (continued)

Advice provided on the expression of the quantity of active ingredient of the injectable product is strongly supported and the guideline and TGO could be enhanced by providing examples.

Examples be provided in the guideline and TGO for this requirement.

Expressing concentration as proportions, or parts per thousand, for example, is problematic and not easily interpreted. Other examples are

1:100 (one in one hundred)

1:1,000,000 (one in one million).

Include explicit prohibition of expressions as a proportion within the section on requirements for preferred expression of concentrations in the TGO79

8 Medicines with specific ingredients

This section includes detailed guidance as to the labelling of potassium, vincristine and methotrexate as these have all been the medicines involved in significant and repeated incidents where safety has been compromised.

These medicines belong to group of high risk medicines identified by the mnemonic APINCH (Anti-infectives, Potassium and other electrolytes, Insulin and other hypoglycaemics, Narcotics and other sedatives, Cytotoxic therapy, Heparin and other antithromboiics). Extra packaging and labelling precautions should be made for any drug coming onto the market that falls under the umbrella of this mnemonic to ensure risk of harm is mitigated.

A similar recommendation is also made for other drugs (such as neuromuscular blocking agents) that are not captured by this mnemonic but where similar safety issues have been identified. A proactive approach should be taken to identify these medicines. (For example review of the FDA labelling requirements, Institute of Safe Medication Practices, coroner’s reports and TGA adverse drug reporting as they relate to packaging and labelling issues.) Medicines captured in the APINCH guide, as well as the NMBAs are included as “high-alert” medicines internationally [8] and deserve proactive consideration of their labelling and packaging to minimise the risk of adverse events.

A Labelling and Packaging Advisory Committee should be convened by the TGA with relevant stakeholders (including frontline clinicians) to identify when such drugs may be marketed and the specific strategies that should be instituted to minimise risk of harm.

It is strongly recommended that the guidance is reflected in the TGO79 as required labelling and that the medicines that this section is applicable to are expanded as outlined.

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Guideline number

NSW TAG comment NSW TAG recommendation

8 Medicines with specific ingredients (Continued)

As per recommendations previously made in response to Victorian incidents with NMBAs [9], all NMBAs are to be packaged and labelled in a manner that uniquely identifies them. That is, that they:

are packaged in standardised vials rather than ampoules to differentiate them from other agents used in similar settings and to allow sufficient space for warning labels to be included on the vial cap, ferrule and label;

have a red vial cap and red ferrule or patient-safety cap, with white lettering: “Warning: paralysing agent” or Paralysing agent”;

include a peel-off label for user syringe application, for identification after withdrawal from the vial;

give prominence of the NMBA generic name on the label with the strength expressed over the total volume of the ampoule.;

Include TALL-man lettering for generic names of the NMBAs; and

Include a bar code (or space for application).

It is strongly recommended that the neuromuscular blocking agents be included as medicines of similar concern, and with the labelling requirements, as recommended.

Hospitals throughout Australia have reported difficulties with the current packaging and labelling of S8 liquid preparations and the workarounds required to fulfil legislative requirements when these are supplied to the ward areas.

Some of the specific concerns expressed to NSW TAG include:

the volume of the Dilaudid™ (473mL) is too large considering the size of the usual starting dose of 1 to2 ml;

the risk of cumulative deficit by the time the bottle is finished, given the large pack volumes and small doses. This necessitates generating an

NSW TAG strongly recommends the introduction of requirements to the packaging and labelling of S8 liquid preparations.

Specifically, these would be:

to make available alternative pack sizes, particularly when the usual dose of the S8 liquid (as per approved Product Information) is a small volume;

introduction of a standardised overage;

to include the actual volume of the contained liquid in

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incident report according to NSW Pharmaceutical Services policy directive, as diversion issues are a concern;

the prepacking of numerous sized bottles from the 473mL Dilaudid™ bottle for use of hydromorphone on the wards, a practice discouraged by legislative bodies and the manufacturer, requiring significant pharmacist time and additional resources. In one hospital, 200mL of Dilaudid™ is being supplied in individually calibrated bottles for stock which is very time-consuming;

the pre-packing into smaller volume sizes (10mL, 20mL, 50mL and 100mL) of other S8 liquids, with similar issues to above;

inaccurate gradations on the side of the Ordine™ bottles as these are dependent upon label placement;

the lack of gradations in-situ on the Dilaudid™ preparation; and

inconsistencies in the overage supplied, with up to 9% extra volume in the Ordine™ and little or none in OxyNorm™ and Dilaudid™. This leads to additional potential discrepancies.

the labelling;

a recommendation for utilising bottles with external gradations etched into the bottle;

in the absence of 4 (above), a requirement included for the consistent placement of a label pre-printed with gradations to allow for a visual assessment of the remaining volume in the bottle; and

a requirement that all bottles are securely labelled with a tamper-proof seal .

8.1.1 Substances that must be declared

Schedule 1 substances such as preservatives be included in labelling for injection as well; for instance, dexamethasone injection

8.2 Potassium for injection or infusion

The points contained in the guideline are all supported. NSW TAG strongly recommends that these be requirements for labelling and included in the TGO79 as mandatory.

8.4 Methotrexate

The proposed warning is welcome (‘Check dose and frequency - methotrexate is usually taken once a week’).

That this warning be boxed or highlighted. That this be included in the TGO79 as a requirement.

9.3 Intermediate packaging

Expiry date and prefix to be included. It is noted that some injections have a different expiry date from that of the original, unopened product (for instance, tobramycin).

The details of shortened expiry be included in the labelling of the opened product. A space be included to fill in the date of opening.

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Guideline number

NSW TAG comment NSW TAG recommendation

9.8 Individually wrapped medicines

The requirement for labelling to include relevant details on the individually wrapped primary containers is strongly supported.

The transdermal patch recommendations are supported.

Note: there is a typo here, it should read 10 (16) d

In addition, it is recommended that an additional space be included on the individual transdermal patches for the date of application, with a prompt, for instance;

“Date patch applied ../../..”

9.9 Transdermal patches, intrauterine or implanted drug delivery systems

The requirement that labelling include total quantity contained as well as release quantity per specific time period is supported.

Different manufacturers of the same active ingredient can choose to express these in different ways. It is recommended for consistency, that it is stipulated HOW these are expressed; for instance…

Contains….mg of …. Releases……mg per ….hour.

9.10.1 Requirements for blister, strip and dial packs

Note: a typo….

the expiry prefix and expiry number (should be date).

The requirement that more information is to be available for blister packages is supported, but could be strengthened. Given that they are dosage units, the recommendation should apply to the unit not two units.

That the requirements as stipulated in section 10(17)(c) of TGO79 be applied for every dosage unit of a blister pack and not across every two. The information is printed in ink and not embossed.

10 Optional information

That a hyperlink to the specific s be provided for what is allowable as “other information”. That stronger guidance be given as to what is not permitted.

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CONSULTATION: THERAPEUTIC GOODS ORDER NO. 79 Standard for the labelling of medicines

Section number NSW TAG comment NSW TAG recommendation

Section Introduction

2 Details of the purpose of the label and what it must contain Reference to be made to information that the label must NOT contain

4 There are two (4) points in the Introduction, and no (5)

Section 8(k)(ii) B S4 and S8 medicines to be exempt from labelling that includes warnings for use in pregnancy

That S4 and S8 medicines NOT be exempt from this requirement.

Section 10 Qualifications and special requirements

The medicines with specific ingredients and the recommendations are outlined in detail in the Guidelines to the proposed TGO79

That these recommendations be requirements and therefore include in the TGO79. Additionally, that neuromuscular blocking agents and S4 and S8 liquids be included here as separate entities.

Section 10 (20) (a) (i)

S4 and S8 medicines are exempt from the requirement for a Medicine Information panel. The consumer would benefit from the information contained in the panel. An abridged version could be applicable, without the inclusion of usual doses, to avoid confusion.

All scheduled medicines be required to include a version of the Medicine Information panel.

Section 11 (2) Expression of quantity or proportion of active ingredients (f)

Details of the permitted expressions of the proportion of active ingredients in injections are welcomed. The inclusion of examples would help clarify these.

Include another point which specifically prohibits the use of proportions in the labelling, such as 1:1000; 1 in 100.

Section Schedule 1 Column 2

The requirements for labelling of the potassium and sodium contents are welcome. However the wording of the instructions for sodium are confusing as they refer to the daily dose as well as the sodium quantity per dose

That the wording be simplified so that consumers can calculate exactly what the intake of sodium and potassium will be at their prescribed/intended daily dose.

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References: 1. Institute for Safe Medication Practice. ISMP: List of Error-Prone Abbreviations, Symbols and Dose Designations. 2013 Accessed 24th October 2014;

Available from: www.ismp.org/tools/errorproneabbreviations.pdf. 2. Australian Commission on Safety and Quality in Health Care. Recommendations for Terminology, Abbreviations and Symbols used in the Prescribing

and Administration of Medicines. 2011 Accessed 1st November 2104; Available from: http://www.safetyandquality.gov.au/wp-content/uploads/2012/01/32060v2.pdf.

3. Pakenham-Walsh, N and Ana, J, Confusing packaging contributes to death of 15 children. The Lancet Global Health, 2014. 2(11): pp. e634. 4. FDA. Patient Safety News #54: USP Statement on Preventing Errors with Neuromuscular Blocking Agents. 2006 Accessed 2nd November 2014;

Available from: http://www.fda.gov/downloads/Safety/FDAPatientSafetyNews/UCM417834.pdf. 5. Institute for Safe Medication Practices. Neuromuscular Blocking Agent Labelling and Packaging initiative. ISMP Canada Safety Bulletin [Internet]. 2006

Accessed; Available from: http://www.ismp-canada.org/download/ISMPCSB2006-02PotassiumPhosphates.pdf. 6. Institute for Safe Medication Practice. ISMP Canada Safety Bulletin. Neuromuscular Blocking Agents: Sustaining Packaging Improvements over Time.

2014 Accessed 4th November 2014; Available from: http://www.ismp-canada.org/download/safetyBulletins/2014/ISMPCSB2014-7_NeuromuscularBlockingAgents.pdf.

7. NSW Health, Safety Information 002/11 Neuromuscular Blocking Agents-Minising Risk. 2011 8. institute for Safe Medication Practice. ISMP List of High-Alert Medications in Acute Care Settings. 2014 Accessed 4th November 2014; Available from:

http://www.ismp.org/tools/highalertmedications.pdf. 9. McRae, A. Time for change: Proposed safety improvements to the labelling and packaging of Neuromuscular Blocking Agents in Australia. 2014.

Western Hospital, Western Health