Home' Australian Pharmacist : Australian Pharmacist March 2015 Contents Australian Pharmacist March 2015 I ©Pharmaceutical Society of Australia Ltd. 13
the APF Editorial Board about CALs
and the assignations of CALs to new
and existing medicines. In making CAL
recommendations, the CAL Working
Group considers current evidence
from published literature, approved
product information, consumer
medicine information, current clinical
best-practice, statutory requirements in
the Poisons Standard2 and feedback from
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.
Other supplementary labels that are
not approved by the APF Editorial
Board may be available. Approved CALs
have undergone rigorous review and
development to ensure they 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 Poisons
Standard, and promotes consistent use
of CALs in Australian pharmacies.
The CALs and CAL recommendations
approved by the APF Editorial Board may
not be reproduced without obtaining
explicit permission from PSA. Requests
for permission to reproduce CAL content
and a full set of CAL specifications can be
directed to PSA on 02 6283 4777.
Changes to CALs
The new edition of APF contains a
number of significant changes to the CAL
recommendations. These changes may
represent a therapeutic protocol change
or a clarification recommended by the
CAL Working Group to assist consumers.
Pharmacists can review these changes
by referring to the 'Recommended
cautionary advisory labels for medicines'
table in APF23 and updates available
on the PSA website. Pharmacists should
ensure they are using the currently
approved CALs, to avoid confusion and
promote optimal safety and health
outcomes for consumers.
Summary of new labels
Ask your doctor or pharmacist before
taking medicines for heartburn, re ux
Label 4b is for use on medicines that are
susceptible to reduced absorption when
gastric pH is raised (e.g. itraconazole).
This product has been
compounded by the pharmacist.
Label 23 is for use on medicines that
have been extemporaneously prepared.
FOR 3 DAYS USE ONLY
can cause addiction
Label 24 is for use on non-prescription
analgesic medicines containing codeine
or non-prescription dihydrocodeine
Summary of revised labels
Do not take dairy products, antacids or
mineral supplements within two hours
of each dose of this medicine.
Label 4 has been revised to reflect the two
different mechanisms that are involved
in interactions between medicines and
metallic ions, such as calcium (chelation
and raised pH). Label 4a is used for
medicines that form chelates in the
gastrointestinal tract (e.g. doxycycline).
DO NOT TA KE ASPIRIN OR
ANTI-INFLAMMAT ORY MEDICINES
while being treated with this medicine unless
advised by your doctor.
Label 10b has been revised to include
anti-inflammatories. Label 10b is for use
on oral anticoagulants, which should not
be taken with aspirin or non-steroidal
CERTAIN FOODS AND JUICES
SHOULD BE AVOIDED
Label I has been revised to account for
emerging evidence that juices other than
grapefruit juice can interact with some
medicines. It is still relevant for use on
monoamine oxidase inhibitors, but can
now also be used on medicines that have
been shown to interact with juices other
than grapefruit juice (e.g. atenolol).
Special handling and
disposal required ---
ask your pharmacist.
A significant change in APF23 relates
to the expansion of the use of label 21.
APF23 contains a list of hazardous
medicines that are considered to
pose a health and safety risk to
people handling the medicine (e.g.
carers, family members, healthcare
professionals) as a result of unintended
exposure. Medicines included in this
list meet one or more of the following
• designated as pregnancy category
• reported to pose a risk to patients
or carers through inappropriate
It is recommended that medicines
included in this list are labelled with
label 21 and label A (oral products).
Explanatory notes for label 21 in APF23
provide further details about the
special handling requirements for these
APF23 contains further information
about the application and correct use of
each CAL. Questions regarding the use
of CALs in your practice can be sent to:
Legibility guidelines. Vision Australia
[online]. 2013. At: www.visionaustralia.
1. Sansom L, ed. Australian Pharmaceutical Formulary and
Handbook. 23rd edn. Canberra: Pharmaceutical Society of
2. Therapeutic Goods Administration. Poisons Standard
2014. At: www.comlaw.gov.au/Details/F2014L01343
3. Pharmacy Board of Australia. Guidelines for dispensing of
medicines. Melbourne: Pharmacy Board of Australia; 2010.
4. Pharmaceutical Society of Australia. Professional practice
standards. Version 4. Canberra: PSA; 2010.
5. Therapeutic Goods Administration. Prescribing medicines
in pregnancy database. 2014. At: www.tga.gov.au/
6. Connor TH, MacKenzie BA, DeBord DG, et al. National
Institute for Occupational Safety and Health List of
antineoplastic and other hazardous drugs in healthcare
settings. Cincinnati, OH: US Department of Health
and Human Services, Centers for Disease Control and
Prevention, NIOSH; 2014.
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