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• Additional instructions (labels
A–N) provide information about
the appropriate use or storage of
the medicine. They can either be
attached to the primary medicine
container or incorporated into the
main dispensing label. One exception
is CAL D, which is not produced as a
‘stand-alone’ label and is designed to be
incorporated into the main dispensing
label. Pharmacists should use their
professional judgement in deciding the
most appropriate way to display the
Pharmacists have a professional
responsibility to use approved CALs
in a manner consistent with the CAL
recommendations published in the
current edition of APF. Pharmacy
dispensing software prompts can be a
helpful reminder of the appropriate CALs
to use for particular medicines at the
point of dispensing. When responding
to dispensing software prompts,
pharmacists need to be satisfied that
the recommendations included in
the prompts are consistent with the
recommendations published in APF22 in
both wording and application.
Are you using currently approved
CALs are reviewed and updated with
each new edition of the APF. Decisions
are based on current evidence from
published literature, including approved
product information and consumer
medicine information; current clinical
best-practice; and statutory requirements
in Appendix K of the SUSMP.2
The CALs review process is carried out
by a CAL Working Group comprising
pharmacists from all areas of practice,
with feedback and recommendations
from other external stakeholders.
The design and specifications of the
labels (including suitable colours,
contrast, type size, typefaces, type styles
and spacing) are based on advice and
information from Vision Australia, to
address the needs of consumers with
vision impairment. The recommendations
of the CAL Working Group are considered
and approved by the APF Editorial Board.
While there may be other supplementary
labels available, these are not approved
by the APF Editorial Board. Approved CALs
should be used wherever possible, as
they have undergone rigorous review and
development, and are best suited to meet
the needs of consumers. This also reduces
the risk of incorrect label use, ensures
compliance with legislative requirements
in the SUSMP, and promotes consistent
use of CALs across Australian pharmacies.
A number of changes are made to the
CAL recommendations with each new
edition of the APF. These changes may
represent a therapeutic protocol change
or a clarification recommended by the
CAL Working Group to assist consumers.
Pharmacists are advised to review these
changes by referring to the ‘Medicines
requiring cautionary advisory labels’
table in APF22 and updates available
on the PSA website. To avoid confusion
and promote optimal safety and health
outcomes for consumers, previous
versions of CALs should not be used. All
pharmacies should ensure that they are
using the currently approved CALs.
Are you aware of changes to CALs?
Changes to CALs in APF22 include:
• The creation of a new label (19b)
for use on all oral and rectal
formulations containing non-steroidal
anti-inflammatories (NSAIDs). This new
label has been introduced to highlight
to consumers products that contain
NSAIDs. There have been concerns
that consumers may inadvertently
self-administer multiple NSAIDs
(e.g. by combining prescription and
over-the-counter NSAID products,
or taking multiple NSAIDs prescribed
for different indications).
• A change of title for label 19, which is
now referred to as label 19a.
Do not crush or chew
contains pA rAceTA mol.
consult your doctor or pharmacist before
taking other paracetamol products.
consult your doctor or pharmacist
before taking other medicines for
pain or inflammation.
• A change of colour for label 18.
The colour has been modified due to
feedback that it too closely resembled
the colour of label 8.
The explanatory text for the application
and correct use of each CAL has also
been expanded. This is to ensure that
adequate information and guidance are
provided about what types of medicines
each label should be used on, why its
use is recommended, and how it is to be
applied in practice.
If you have any questions specifically
regarding the use of CALs in your practice
email to APF@psa.org.au.
Legibility guidelines. Vision Australia [online].
2013. At: www.visionaustralia.org.au.
1. Sansom L, ed. Australian Pharmaceutical Formulary and
Handbook. 22nd edn. Canberra: Pharmaceutical Society of
2. Standard for the Uniform Scheduling of Medicines and Poisons
No 3 (SUSMP 3). Poisons Standard 2012. [online] 2012. At:
3. Guidelines for dispensing of medicines. Pharmacy Board of
Australia [online]. 2010. At: www.pharmacyboard.gov.au/
4. Professional Practice Standards, Version 4. Canberra:
Pharmaceutical Society of Australia Ltd.; 2010.
the History of
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