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interactions with other medicines
or foods) or advise consumers
on the safe and correct use of the
medicine, in order to optimise
health outcomes. These should
be attached to the immediate
container of the dispensed
medicine wherever possible.
Take on an empty stomach
at least half an hour before
food or two hours after food.
• 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. Pharmacists
should use their professional
judgement in deciding where to
place these instructions.
Do not crush or chew
CALs that are incorporated into
pharmacy dispensing software act as
a prompt or reminder for pharmacists
during the dispensing process. While
this information is sourced from the
APF, pharmacists have a professional
responsibility to ensure that all CALs
are used in a manner consistent
with current CAL recommendations.
Pharmacists should consult the current
edition of the APF to confirm that CALs
in dispensing software are correct and
Are you using currently
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.3
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
A significant number of changes
have been made to the CAL
recommendations since APF21
was published. 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 on page 16 of
APF22. 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 recent changes
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
Consult your doctor or pharmacist
before taking other medicines for
pain or in ammation.
• a change of title for label 19, which is
now referred to as label 19a.
Contains PA RACETA MOL.
Consult your doctor or pharmacist before
taking other paracetamol products.
• 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.
Avoid excessive skin exposure
to sunlight and sunlamps while
being treated with this medicine.
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 please email: email@example.com .
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 1 (SUSMP 1). Poisons Standard 2010 [online] 2010.
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.
Guidelines for producing readable text [revised Apr 2010]. Vision
Australia [online] 2010. At: www.visionaustralia.org.au/info.
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