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Coughs colds and
With the winter months now upon us I thought it timely to revisit the decision
made last year by the Therapeutic Goods Administration following its
comprehensive review of the use of cough and cold medicines in children.
As a result of this review, a number of
changes have been made to the way such
medicines can be sold.
These changes include stating that a
number of cough and cold medicines
are not recommended for children
under six years of age. In addition, the
recommendations state that cough and
cold medicines should only be given to
children aged 6--11 years of age on the
advice of a doctor, pharmacist or nurse
practitioner. Another change is that from
September last year new stocks of cough
and cold medicines must include warnings
and instructions reflecting these changes
and will be in child-resistant packaging.
It was interesting that TGA, perhaps
foreseeing some confusion about these
changes, was at pains to point out that its
decisions were taken in the interests of
Nevertheless, the decisions have caused
some anger and confusion among
pharmacists, and the difficulty now is how
to manage that young age group with
cough and cold systems.
I am not going to try to debate the merits
of the different views on this decision.
The reality is that we have a new set of
procedures under which to operate and
PSA, in conjunction with the Pharmacy
Guild and PDL, has been active in educating
its members about the new requirements
and helping to address any confusion
experienced by members.
Basically the changes are that the TGA has
advised that under the new requirements:
• No changes have been made to the
scheduling of over-the-counter cough
and cold medicines and a prescription
is not required.
• Recommendation for treatment with
a cough and cold medicine in a child
aged less than six years constitutes
off-label use and should not be made
without serious consideration of the
risks and benefits. Your professional
judgment would then need to be used
in individual cases.
• The TGA maintains there is no robust
evidence of efficacy for these medicines
in children and there are a number of
• While the safety concerns are lower in
children aged 6--11 years of age than
in children aged less than six years
of age, the TGA advises such safety
considerations should be taken into
account when advising parents on the
management of coughs and colds.
• The new labels will provide no dosing
information for children aged less than
six years of age and, in some cases, for
children aged less than 12 years of age.
• The use of the individual medicines for
indications other than cough and cold
(for example for pain or allergies) is not
affected by the new system.
Although comprehensive, the changes
have caused some confusion in a number
of areas, not least of which is when a patient
presents a doctor's prescription or note for
an OTC cough and cold medicine for a child
aged less than six years of age. The new
requirements are that in such situations,
there is great scope for pharmacists to be
confused and the first thing that needs
to be done is to ascertain if the doctor is
aware of the new TGA recommendations.
This will help determine the pharmacist's
course of action.
For the pharmacist, options in a situation
such as this include asking the customer
what the doctor has told them about
the medication as it may well have been
prescribed for an allergy or inflammatory
condition rather than cough and cold.
One view comes from PDL which
advises that based on this knowledge,
if a pharmacist does not believe it is
appropriate to dispense a prescribed
medicine, they should decline the request
and discuss the matter with the prescriber.
Any claim against a pharmacist arising
from dispensing such a medicine could be
reviewed by a health complaints panel and/
or the Pharmacy Board of Australia.
To further help pharmacists deal with the
changes, PSA has developed a range of
resources, (at: www.psa.org.au) including
a fact sheet which looks at six possible
scenarios where a pharmacist may face a
In the PSA fact sheet, one scenario
examines a case where a customer enters
the pharmacy and appears to be in a hurry
and says to the staff: 'Could I please have
a bottle of Phenergan (promethazine) or
Polaramine (dexchlorpheniramine) for
my four-year-old? We are going overseas
tomorrow and I've used it with my other
children when we have travelled on
The scenario examines whether this should
be treated the same as the cold and flu
scenarios and can the pharmacist make the
decision on whether this is appropriate.
Another scenario looks at a situation where
a customer presents to the pharmacy with
her three-year-old daughter who has a
cold. She self-selects some liquid cold and
flu medicine and brings it to the counter to
pay where the pharmacist determines that
the medicine is for the child and that she
has used it before. However, the customer is
informed that it is no longer recommended
for children under six years of age.
The scenarios examines issues such as the
age of the child, the dosing instructions
still being on the product label, the fact the
customer has used it before with no adverse
effects and also how does the pharmacist
refuse the sale without losing the customer.
All the scenarios offer advice and solutions
for what may be difficult situations.
The resources are available from the PSA
website at: www.psa.prg.au.
THE NATIONAL PRESIDENT SAYS
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