Consultation submission: nsw therapeutic advisory group inc.

ANZTPA
Therapeutic Goods administration
PO Box 100
WODEN ACT 2606
Email: [email protected]

Re: Description of a possible joint regulatory scheme for therapeutic products under
ANZTPA

The NSW Therapeutic Advisory Group 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 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 and
hence the relevance of our position in putting forward this submission.
NSW TAG welcomes the opportunity to review and comment on the description of a possible
joint regulatory scheme for therapeutic products under ANZTPA. We support the general
approach as outlined and support the concept of harmonisation between Australia and New
Zealand with regard to medicines and associated regulations and policies. In particular we
support the aim of ANZTPA to align with ‘international best practice’ and ‘harmonise
requirements with overseas regulators of equivalent standard.’ We provide a few comments
regarding this ‘conversation starter’ description of the scheme and would be happy to provide
further input as the scheme develops, particularly around scheduling, advertising and consumer
information.
1. NSW TAG suggests that the definition for medicines may require expansion to ensure that loopholes such as may occur now (eg supplementary dietary products), cannot occur. In line with the Australian Pharmaceutical Advisory Council’s definition, if a product is aimed at producing a pharmacological effect to prevent, diagnose, cure, control or alleviate a disease or enhance physical or mental well-being, it should be deemed a medicine. It is also unclear what the approach to medicines in animals is under the proposed scheme. 2. We wish to emphasis the recommendations made in our submission to the 2012 Labelling and Packaging Consultation being conducted by the TGA and believe the ANZTPA Standards should take these recommendations into consideration, such as labelling with the active ingredient and its strength as the most prominent text on labelling and packaging. Failure to comply with ANZTPA Labelling and Packaging Standards should result in Revocation of approval after notice of proposal to revoke. We also wish to highlight recent instances encountered by our members with regard to the labelling of investigational products and ensure that ANZTPA develops Standards with regard to these products to optimise patient safety. We would be happy to provide further information about what we believe should be mandatory requirements. 3. Our members also believe Standards for medicines storage should be included in the ANZTPA and that this information should align with Australian conditions. Currently information about storage including during transport is lacking for many products. Information to deal with temperature excursions should be a mandatory component of information that must be provided to the regulators prior to approval and then able to be accessed by health care providers such as pharmacists. Currently a huge amount of money and effort is required when hospital refrigerators malfunction. Moreover storage conditions in Australian patient’s homes, community pharmacies (especially overnight), or during transport are unlikely to meet the storage conditions as recommended in the product specifications. 4. Current consumer health literacy should be an important consideration in the development of the Standards given the fundamental principle of ANZTPA to reduce risk to Australian and New Zealand consumers. Given that medicines manufacturers often produce other information or resources that accompany product launches and marketing, we believe this should be a part of ANZTPA’s remit. 5. NSW TAG believes there is a need for paediatric regulatory reform in Australia and see the ANZTPA scheme as an ideal opportunity to align with international regulatory best practice regarding this vulnerable population. We draw your attention to recent articles in the British Journal of Clinical Pharmacology 2012; 68:1-10 by Hoppu K et al titled ‘The status of paediatric medicines initiatives around the world- what has happened and what has not?’ and JAMA 2012; 307:1914-5 by Sachs AN et al ‘Pediatric Information in Drug Product Labelling’. 6. NSW TAG recommends that advertising for any off-label use of an approved medicine should not be allowed and that this should encompass information on funded websites, testimonials or support literature with failure to comply to result in revocation of approval. 7. With regard to Post Marketing Monitoring and Compliance, NSW TAG recommends that public notification acknowledges current levels of health literacy and numeracy and matches information accordingly, while working with others to improve consumer health literacy and numeracy regarding potential medicine benefits and harms. 8. Our members report great frustration with product recalls and the processes to alert them. We look forward to further discussions to improve this recall system.
Your consideration of the above points is appreciated.
Date: 21st February 2013
Contact details:
Dr Sasha Bennett
Executive Officer
NSW Therapeutic Advisory Group (NSW TAG)
PO Box 766, Darlinghurst, NSW, Australia 2010
Email: [email protected]
Telephone: 02 8382 2852
Website: www.nswtag.org.au
Attached: NSW TAG Submission to TGA Packaging and Labelling Review 2012

TGA Medicine Labelling and Packaging Review
23rd August 2012
Contact for further information:
Dr Sasha Bennett
Executive Officer
NSW Therapeutic Advisory Group
Email: [email protected]

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 in NSW public hospital and Local Health Districts.
Our goal is to promote QUM by sharing unbiased, evidence based information about drug
therapy and its use. Our objectives include supporting Drug and Therapeutics Committees to
achieve safe, rational, high quality, cost-effective use of medicines in public hospitals and the
wider community and hence the relevance of our position in putting forward this submission.
The objective of the TGA review of the requirements for medicines labels and packaging is to
develop appropriate regulatory solutions that effectively address consumer safety risks. NSW
TAG would like to emphasise that these consumer risks may be both direct and indirect.
Changes to the regulation of medicines labels and packaging must consider the risks to
consumers that may occur through medication handling by health care professionals in settings
such as hospitals and extended care facilities, as well as those that may be encountered by
consumers living in the community. Hospital settings represent quite different risks relative to
the consumer’s home use of medicines because of the vast range of medicines, the nature of
those medicines, the numerous health care professionals handling medicines and the various
complex hospital areas where medicines are handled.
NSW TAG acknowledges the difficulties that may be faced in reaching consensus opinion on
the labelling and packaging of medicines, given the conflicting interests of the numerous
stakeholders. We recommend that the best interests of the consumer be considered first and
foremost in consideration of responses to the consultation, as this review provides a rare
opportunity to significantly improve the safe and quality use of medicines for all Australians.
Prominence of active ingredients on medicine labels (1.1 – 1.5)
NSW TAG supports the concept of increasing the prominence and standardising the location of
the active ingredient(s) on the medicine label. However, to achieve the goal of improving
consumer knowledge of the active ingredient and also to reduce errors associated with product
selection by health care professionals, NSW TAG strongly believes that the active ingredient
name and its strength must be the most prominent feature on the medicine label. It is strongly
recommended that the active ingredient(s) must be listed immediately below “Keep Out of
Reach of Children” and above the brand name. This will ensure that consumers and health
care professionals can readily locate the active ingredient name and strength.
Requirements of different letter spacing, font colour and style as proposed, will enable manufacturer’s to make the brand name more prominent. The proposed regulatory changes would also allow manufacturer’s to use upper case lettering, different colour backgrounds, bolding and/or italics to make the brand name appear more prominent than the active ingredient name. It is therefore recommended that greater specification is given to the attributes (and location) of the active ingredient and brand name. NSW TAG understands that differentiation between the brand name and active ingredient name is important and we therefore propose the following: the active ingredient name should be appear in a consistent format so as to be instantly recognizable. We suggest that the active ingredient name(s) should be white emboldened lettering on a black background. The brand name may use a different font colour to achieve prominence and differentiation but must be on white/off-white background. the font size of the active ingredient name(s) must be greater than that of the the active ingredient name(s) must be the largest font size of any writing on the the brand name must be directly under the active ingredient name.
It may be also prudent to specify minimum (and maximum) heights of lettering in millimetres
rather than font size only.
Difficulties arise when there are more than three active ingredients in a product. The current
recommendations suggest that the most abundant active ingredients should be listed (not
including cough and cold products). However, abundance does not always reflect potency or
predilection to adverse reactions. Further consideration is required regarding the description of
active ingredients where there are more than three active ingredients in the product. Strategies
may be identified from international regulators.
We also believe that the drug strength should have equal prominence to the active ingredient
name, should appear directly next to the active ingredient name in the same font so that the
exact product can be read and identified in one step. This will assist consumers to identify the
strength they are taking and minimize selection of the wrong strength by health care
professionals.
Bearing in mind that products are usually stored in pharmacy and clinical areas with the ends of
the box displayed, to avoid product selection errors we believe that the active ingredient name
and strength should appear on all faces of the box with greater prominence than the brand
name
Standardising expression of product strength (concentration)
For all liquid medicines, including oral liquids and injections, a standard expression of strength
(concentration) should be recommended. We suggest that the strength should be stated as
quantity per mL. At present manufacturers can state the strength of the liquid in any way,
resulting in significant variation (e.g. per mL, per 5mL, per 10mL, as a percentage or as a ratio).
Misreading or misinterpretation of the strength leads to miscalculation of the volume required to
administer a dose and serious adverse outcomes, often in high risk populations such as
children.
Use of symbols and abbreviations on packaging
The Australian Commission on Safety and Quality in Health Care’s Recommendations for
Terminology, Abbreviations and Symbols used in the Prescribing and Administration of
Medicines
(http://www.safetyandquality.gov.au/wp-content/uploads/2012/01/32060v2.pdf) should be taken into consideration in the labelling pharmaceutical products. Whilst this
document is primarily intended for use by healthcare professionals when prescribing and
administering medicines, compliance with its use would be supported if pharmaceutical
companies also adhered to its recommendations. For example, the use of “u” for units has been
the cause of many medication errors, mainly because it can be misread as a zero resulting in a
10 times overdose. The use of “iu” for international units has resulted in the i being read as a 1
(e.g. 14 iu read as 141 u). These abbreviations are discouraged from use in prescribing,
however are frequently seen on product packaging which acts to support their use.
Anti-inflammatory warning (1.7)
In relation to the warning regarding the use of ibuprofen: a similar warning should be on all
over-the-counter non-steroidal anti-inflammatory medications such as diclofenac and naproxen.
Look-alike and sound-alike (LASA) medicine brand names and look-alike (LA) packaging
and branding (3.1 - 3.3)
NSW TAG supports the process of risk assessment of LA packaging prior to the release of the
product on the Australian market. NSW TAG is alerted to at least one incident involving LA
packaging on a monthly basis. NSW TAG strongly supports ‘purchasing for safety’ initiatives of
procuring organisations.
We support electronic screening of proposed new brand names against existing brand names
to identify potential LASA names. However, this proposal should be extended to include
screening of all new generic drug names, which are frequently confused with each other (e.g.
amlodipine/amitriptyline; glipizide/gliclazide/glibenclamide; fluoxetine/fluvoxamine). Confusion
between
duloxetine/Doloxene). We also suggest that a more rigorous method of assessing the likelihood of drug selection errors should be considered when assessing new drug names for safety. International literature should be reviewed to identify and evaluate mechanisms currently in place for assessing potential new drug/brand names. One example that NSW TAG is aware of is the ERRS model, developed by the Institute for Safe Medication Practice (ISMP) in the USA, which uses a rigorous testing process to evaluate the potential for LASA errors with new drug names. The ERRS evaluation process involves testing the interpretation of the name when written in different handwritings and when spoken with different voices/accents. More information is available at http://www.med-errs.com/Contents/ErrsModel.aspx NSW TAG does not believe the proposed threshold of two letters is sufficient to reduce LA names and packaging. This is exemplified by the ‘Coversyl” and “Coumadin” controversy that occurred in 2010. This LASA issue would not be averted under the proposed changes. Other factors such as place in the alphabet, indication and visual shape or length of the name and strength(s) of the product must also be considered in the risk assessment of potential LASA names and LA packaging. Examples of other products that vary by more than three letters and are frequently confused by both patients and healthcare professionals include: Diamicron/Diaformin/Diabex; Avandia/Avapro/Avandamet; Topamax/Tofranil; Nexium/Lexapro. We could list many others.
Computerised techniques may assist with identification of potential LASA names and LA
packaging. Any new screening technique should be employed to identify potential issues with
both existing and new products. Currently organisations are reactive to incidents that occur due
to LASA medicines which results in significant cost to the manufacturer in changing its
packaging and a period of time when a known risk still exists due to the time involved in
rectifying it. A screening system would enable us to be proactive in preventing errors. For
products identified as being at risk for confusion, NSW TAG supports the proposal to use
contrasting colours and designs to differentiate the two products. Particular attention should be
given to injectable drug products, which are frequently packaged in plain boxes (due to them
not being marketed to consumers) and are the subject of many product selection errors in the
acute care setting. Examples, including images, were provided to the TGA in a recent letter
(dated 2nd May 2012) highlighting these issues (attached). In addition, major concern is
currently being expressed in the hospital sector with regard to look-alike Pfizer polyamps.
Medicine Branding (3.4 - 3.6)
We strongly suggest that consideration be given as to whether generic brands of existing
prescription medicines should be allowed to be given new brand names. This practice adds to
the ever-increasing pool of product names and increases the risk of LASA errors. Healthcare
practitioners cannot be expected to be aware of all brand names for every medicine, and as
such the potential for medication errors is increased. Consideration should be given to the UK
model for naming of generic medicines.
Use of the same prefix for multiple products, for example, APO, Sandoz, Hexal etc., should be
discouraged. It is not uncommon in hospitals for a patient to report they take “Sandoz” thinking
it is their medicine’s name. This practice also increases product selection errors and
encourages unclear prescribing. These prefixes have also been involved in generic versus
brand name confusion, for example APO brand of morphine has been interpreted as
apomorphine.
Our members believe that suffixes used in product names should be standardised. For
example, the consistency in naming and labelling of controlled release products needs to be
improved. There are numerous different terms which may or may not imply that the product is
controlled release. Controlled release preparations may use suffixes such as XL, XR, ER, CR,
and CD amongst others. There can also be confusion in the meaning of these suffixes. For
example, CD may stand for “controlled delivery” or “chewable/dispersible”; ED may mean
“extended delivery” or “every day”. Some controlled release products do not use a suffix (e.g.
Imdur (isosorbide mononitrate SR) and Kapanol (morphine sulfate SR)) and often the release
characteristics of these products are only printed in small writing on the packaging. There can
be variation between the terminology used for identical products from different manufacturers
(e.g. controlled release nifedipine: Adefin XL, Adalat Oros, Addos XR; controlled release
venlafaxine: Efexor XR, Elaxine SR, Altven). Consistent terminology would assist health
professionals and patients to easily recognise and identify controlled release formulations and
prevent the wrong product being dispensed or administered. Another consequence of the
confusion is that medicines may be crushed or chewed inappropriately, which may result in
adverse effects.
Furthermore suffixes such as ‘HCT’ and “Plus” to indicate an add-on drug to another medication
are not acceptable. In our experience this is confusing to patients (for example, misinterpreted
as being the “stronger” version of the drug) and is often missed in medication history taking. It
also often results in the wrong preparation being dispensed or administered to the patient. It is
unclear whether Point 3.6 applies to this practice, and perhaps this point should be expanded
for clarity.
With regard to point 3.5, NSW TAG recommends that products cannot be marketed as “BRAND
headache” etc., if they include the same active ingredients no matter what the quantity.
Standardised Information Format: the Medicine Information Box (4.1 – 4.6)
NSW TAG supports the consistent placement and presentation of key medicines information so
that consumers are assisted in making informed choices and using medicines safely. These
boxes represent an added safeguard for medicine use but are not a substitute for patient
counselling or provision of CMIs. The way in which information is currently presented in Figures
6, 7 and 8 is hard to read and contains inconsistent content and headings. Rules regarding how
information is presented including the language used and the layout are required.
It is paramount that these boxes contain evidence-based information and acknowledge that not
all patients may derive benefit from a medicine. This is exemplified in Figure 6 where the
information under “Uses of Chondroiton” is not evidence-based and suggests certainty of
action. This figure also gives details of sodium content per daily dose rather than per tablet,
which could cause confusion to consumers. The medicines information box should state facts
only and should not feature any marketing messages, such as the use of “easy to swallow”
tablet in Figure 6.
The messages in the “When using this medicine” panel require greater prominence and
emboldening of “If pregnant or breastfeeding” and “Keep out of reach of children”. We suggest
this section be entitled “Precautions”. The latter precaution applies to every medicine and
should be given greater prominence at the top of the panel. For all oral liquids the packaging
should feature a reminder to replace the child resistant cap after each dose. Incidents have
occurred where a bung is inserted into the bottle and the cap not replaced and children have
then been able to consume the medicine.
It is also noted that in Figure 6 there is information under “Storage Information” that is not
storage information. If information about the product appearance is deemed a requirement in
the Medicines Information Box, this may need its own section. Furthermore regarding potential
side effects contained in the “Warnings and Allergy Information” section, it is unclear what
threshold for listing of side effects will be used for inclusion in the panel. In Figure 7 the
“Warnings and Allergy Information” contains ‘floating’ information regarding preservative
content (as required by point 4.5 of the recommendations). This information should have a
standardised placement in the Medicine Information Box and have an emboldened heading
such as “Potential allergen: contains X% YYYYYY as a preservative”.
An alternative suggestion could be to include this information in a section titled “Other
ingredients”. It would also be useful for consumers to be able to quickly and easily identify
ingredients they may wish/need to avoid, such as gelatin, colours, flavours, sucrose, lactose
etc. Some E-numbers may be of animal or vegetable origin and there are many who want to
know the origin of a substance (bovine, porcine etc.) "Emulsifying agent" is not sufficiently
informative. Equally if a product has been made adopting a religious practice e.g. halal gelatin,
this should be made clear on the labelling.
As the Medicines Information Box has been modeled on the FDA’s Drug Facts Box, we suggest
it may be useful to seek feedback from FDA regarding perceptions of the Drug Facts box and
any proposed changes to their version. Moreover it is unclear whether the Medicines
Information Box applies to prescription products as well as OTC products. If used for
prescription products, confusion may be raised with the Indication listings when medicines are
used ‘off-label’.
The font size for the Medicine Information Box may be too small, and the cramped spacing (in
order for it to fit on the package) may make it too hard for people with visual impairment to read.
A potential solution is to make a printout of the Medicine Information Box with the text in large
font and wrap this around the actual medication blister strips or bottles inside the packaging
then hold it together with a small removable seal containing the words “Warning: Please read
the following information carefully prior to using this medication.”
The use of scannable QR codes on packaging has also been suggested by our members.
These would link the consumer to full product information and may avoid consumers accessing
less reputable information about their medicines on the internet.

Dispensing label space (5.1 – 5.3)
NSW TAG supports a designated space for the dispensing label on prescription medicines.
This will ensure important consumer information is not covered by a label. However there
appears to be an inconsistency between the information provided: “The standard size of label
used in Australia is 80 x 40 mm” (page 30) and the size of the designated space for a label of
70 x 30 mm (page 31). The allocated dispensing label area should be the same size or slightly
larger than the standard dispensing label size.

Consideration should also be given to the findings from the 3D Labels Project, which can be
accessed via
http://beta.guild.org.au/uploadedfiles/Research_and_Development_Grants_Program/Projects/2
003-010_fr.pdf
We suggest that the recommendations are more prescriptive on exactly where the dispensing
label space should be (i.e. internal or external packaging). The external box is often thrown
away, so we would advise that dispensing label space be included on the direct medicine
container wherever possible, for example with topical preparations, inhalers, oral liquids and
tablets/capsules that come in a bottle within an external box.
Blister strip labelling (6.1 – 6.5)
NSW TAG does not believe the proposed changes for blister strip labelling are sufficient. As
mentioned above, it should be borne in mind that in hospitals blister strips are often removed
from the external packaging for supply to patients (in plain labelled boxes) or to clinical areas
for administration to patients. The information on the blister strip is therefore relied upon for
clear and accurate product identification. It is common practice to cut or divide blister strips to
avoid wastage, so information needs to remain intact if this occurs.
With the current recommendations, vital information about the product may be obscured or lost
if the blister strip is cut or divided. In addition we feel that the labelling may become obscured
once the contents are removed from blisters. We recommend that active ingredient, strength,
brand name, expiry date and batch number plus a bar code must be on every unit of the blister
pack. It may sometimes be difficult to fit all information on one side of the blister unit and in
these cases expiry dates and batch numbers could be placed on the other side of the
packaging for each unit. Labelling of the individual dosage units would ensure that the product
remains identifiable down to the last dose being removed from the blister, and if the blister were
cut or split. It should also be noted that in the example shown in Figure 10, if the perforation
down the middle of the blister pack is used, the information about the medicine would become
inadequate on each half of the blister. Hence, it should be considered that any perforation that
can be used to separate units must ensure each unit contains the recommended information
when the units are separated.
Barcoding of unit doses
Barcoding at the point of care is a simple but effective way of significantly reducing medication
administration errors in hospitals and care facilities. It works with electronic medication records,
an area into which Australia is rapidly advancing at the current time. The professional
administering the medication scans the patient’s wristband which brings up the patient’s
medication chart. The professional then selects and scans the drug product and the system will
alert the user if the wrong product has been selected. This system is in widespread use in the
USA and has been shown to dramatically reduce administration errors (ref: ASHP Statement on
Bar-Code-Enabled Medication Administration Technology, available at
http://www.ashp.org/DocLibrary/BestPractices/AutoITStBCMA.aspx). The ASHP document
states that each unit dose package should be labelled with both human-readable medication
identification information and a machine-readable code that includes the medication’s unique
identifier and, when feasible, its lot number and expiration date. Reportedly, the driver behind
implementation in the USA was a mandate from the FDA that all drug products must be
barcoded at unit dose level. Australia needs to consider barcoding at the point of care
alongside the implementation of electronic medication records. Pharmaceutical companies
should be encouraged by the TGA to prepare for the implementation of barcoding systems. A
mandate from the TGA to insist that medications are barcoded at the unit-dose level would
mean that Australia would be ready to advance this important medication safety initiative. The
TGA labelling and packaging review provides an excellent opportunity to explore this further
with key stakeholders.
Small containers (7.1 – 7.3)
NSW TAG agrees with the recommendation that the label on the internal container for small
containers should contain details in a letter height no less than 1.5mm. The active ingredient(s)
and strength should be given prominence, as for external packaging. Unusual abbreviations
and terminology, such as guttae, otic etc., should be avoided as per the ACSQHC
recommendations, because these are not universally understood and can lead to errors.
The preservative content should be listed for injections, not just eye drops as currently
proposed.
Patients with visual impairment often struggle to read the information on small packages.
Health care professionals may select the wrong product from the shelf due to the product
identification being too small. We would suggest that small containers have normal size
packaging that complies with all of the TGA new recommendations. A cardboard insert or
sleeve can be placed inside the packaging to hold the medication.
Labelling of Internal Packaging Other than Blister Strips and Small Containers
As stated previously, it is commonplace in hospitals for products to be removed from their
external packaging (box) and the external packaging discarded. Indeed many patients do this in
their homes. Although the recommendations consider the labelling of blister strips and small
containers, we feel the recommendations are unclear on the labelling of other internal packaging. We believe that all internal packaging, whether or not this forms a part of the delivery system, should be subject to the same standards for labelling of drug name, brand name and strength, batch number and expiry date as the external packaging (including layout of information and allocation of dispensing label space). This includes the packaging for injectable solutions, inhalers, patches, nebuliser solutions, sprays, oral liquids etc.
A recent example highlights the heightened risk to consumers that inadequate internal
packaging and labelling represents in the hospital setting. Clexane® (enoxaparin) syringe
packaging was recently changed because of consumer complaints about syringe access. The
paper backing, which was previously labelled with the proprietary name and strength of the
product, was changed to a clear backing with no description of the product. The syringe is too
small for adequate labelling containing the description of the product. Whilst the changes may
have helped the consumer access a one-strength syringe in their home, the change represents
major risks to hospital handling of Clexane® where multiple strengths are stocked. It is unclear
whether the proposed packaging and labelling changes had been evaluated by hospital
practitioners prior to introduction. The company informed NSW TAG that the TGA had accepted
the packaging and labelling changes. Information from the company suggests that re-labelling
of the packaging is unlikely to occur in the future as the changes have been made globally. It
should also be noted that rectification would add expense to the current packaging. In response
to our and others’ concerns, Sanofi Aventis produced posters for use in hospitals to advertise
the change but this is unlikely to adequately address the increased risk to consumers and
health care practitioners that this packaging and labelling change represents. This incident
further highlighted another issue regarding packaging and labelling: that companies were likely
to be more responsive to our concerns when actual harm had occurred as opposed to
preventing harm.

Package Inserts (8.1 - 8.2)
It would be an extremely valuable addition to include a removable sticker stating the active
ingredient(s), brand name and strength inside the package for patients to remove and keep in
their medication record. This will facilitate the transfer of this important information to all
healthcare providers.
Labelling and Packaging of Schedule 8 and Schedule 4D Medicines
Pharmacist members have indicated that it would be useful if liquid Schedule 8 medicines were
printed with accurate volume markings on the bottle, to enable the pharmacist to accurately
record the remaining volume in the bottle to meet legislative requirements.
Schedule 8 and Schedule 4D medications should be sealed with a tamper evident seal
(including liquid formulations).
Labelling of Batch number and Expiry Date
NSW TAG suggests that batch number and expiry date should be printed on the packaging, not
embossed. Embossed details can be very difficult to read for both health care professionals and
consumers.
Evaluation of changes
NSW TAG is unable to comment on the value of the recommendations to reduce the potential
for harm as they currently stand, as no evidence has been presented that any of the
interventions have an impact in practice. As such NSW TAG recommends evaluation of changes to the labelling and packaging of medicines. Labels and packaging advisory committee
As outlined at the beginning of this submission, medication management in hospitals and
similar settings can be hazardous to consumers given the vast range of medicines, the nature
of these medicines and the numerous and diverse range of health care professionals that
handle medicines. In particular, look alike and sound alike (LASA) medicines pose increased
risks to consumers in hospitals. There have been numerous incidents and near-misses due to
LASA medicines in recent months in NSW hospitals.
NSW TAG strongly supports the formation of a TGA labels and packaging advisory
committee that includes independent multidisciplinary health care practitioners working
in a variety of health care settings as well as consumers and regulators i) to screen any
proposed changes to packaging and labelling of ALL medicines and ii) to assess
labelling and packaging of ALL new medicines prior to their registration in Australia.


In summary, NSW TAG recommends that the TGA takes a strong and leading position on labelling and packaging of medicines that incorporates evidence where available, to ensure medicines are used with optimum safety by both consumers and health care professionals in all

Source: http://www.anztpa.org/pdf/submissions/consult-anztpa-scheme-130108-submission-nswtag.pdf