Home' Australian Pharmacist : Australian Pharmacist June 2013 Contents 74 Australian Pharmacist June 2013 I ©Pharmaceutical Society of Australia Ltd.
BUSINESS AND INDUSTRY NEWS
report shows that the number of new PBS
medicines listed last year was the lowest
in 20 years,' Dr Shaw said.
He said: 'That's very alarming because
it means many patients who need new
treatments aren't getting access to them.
Consumers expect better than that.
Australia should be a country that can
afford new medicines for patients.
'This decline is not due to any fall in
the number of new therapies being
proposed by companies. It has been due
to things like higher rejection rates at
the Pharmaceutical Benefits Advisory
Committee and delays in the listing
process for new medicines.
'The real challenge now is to ensure these
multi-billion dollar savings are used to get
new therapies to patients. The rationale
behind PBS reforms with successive
governments was to drive savings in the
off-patent market, and use those savings
to list new medicines. Those savings have
been delivered; the issue now is ensuring
new medicines can be listed.
'This report and the Government's own
Budget both confirm that PBS reforms
implemented over the last decade
are driving substantial savings for
government and consumers,' he said."
The report was also welcomed by the
Pharmacy Guild. The Guild's Executive
Director David Quilty said the report
provided a further demonstration that
price disclosure is achieving its desired
objective of ensuring that the PBS is
sustainable and provides value-for-money
for taxpayers and consumers.
'However, it is important that the very
large savings from price disclosure do
not undermine the viability of industry
participants, including community
pharmacy,' Mr Quilty said.
The report was commissioned by
Medicines Australia and is available at:
ASMI backs pholcodine
The Australian Self Medication Industry
(ASMI) has sought to reassure consumers
that cough medicines and lozenges
containing pholcodine can continue to
be used, as directed, for the treatment of
non-productive (dry) cough.
The advice was released in response to
media coverage in which the Australian
and New Zealand Anaesthetic Allergy
Group called for restrictions on the
availability of pholcodine-containing
According to ASMI these calls were made
on the basis that there is a rare chance
that a small group of patients may be at
increased risk of anaphylaxis when using
neuromuscular blocking agents for some
types of surgeries.1
While ASMI supports any future studies
reviews investigating the possibility of
an association between pholcodine and
analphylatic reactions to neuromuscular
blocking agents, there is a concern that
statements from the group may cause
undue alarm and confusion among
consumers and healthcare professionals.
Steve Scarff, ASMI's Scientific and
Regulatory Affairs Director said:
'Consumers and healthcare professionals
are reminded that the benefits of
pholcodine continue to outweigh its
risks for the treatment of non-productive
cough, and that no new risks have been
identified with cough medicines and
lozenges containing pholcodine.'
He said that any calls to restrict
the availability of these medicinal
substances should be based on firm
evidence rather than associations with
'Pholcodine has been used as a cough
suppressant since the 1950s. It has an
established safety profile and remains
an efficacious pharmacy-only cough
'The issue that the group has raised
concerns the rare potential of pholcodine
to trigger increased sensitivity to
neuromuscular blocking agents in a
small number of people. The precise
mechanism of action has not been
established. This issue is around immune
sensitivity to unrelated chemicals and
does not relate to a drug interaction'.
The European Medicines Agency
reviewed the available evidence and
concluded that the benefits of pholcodine
in the treatment of dry cough outweigh
the risks, and that the benefit-risk profile
of pholcodine-containing products in the
treatment of dry cough is positive under
1. Medew J. Cough syrup link to toxic shock during surgery. The
Age, 4 May 2013.
2. European Medicines Agency. Assessment report for
Pholcodine containing medicinal products. 2012.
EMEA/H/A-31/1292. At: www.ema.europa.eu/docs/en_GB/
WC500124716.pdf [last accessed 6 May 2013]
3. Annex II. Scientific conclusions and ground for the
mountainous of the marketing authorisations presented by
the EMA. At: www.ema.europa.eu/docs/en_GB/document_
pdf [last accessed 6 May 2013]
4. European Medicines Agency. Questions and answers on
the review of the marketing authorisations for medicines
containing pholcodine: Outcome of a procedure under
Article 31 of Directive 2001/83/EC as amended. 2012.
EMA/890819/2011 rev.1. EMEA/H/A-31/1292
Paediatric medicines dosing
Australian health professionals will have
access to a new national paediatric
medicines dosing resource this month
with the release of the AMH Children's
Dosing Companion, a subscription-only
online guide to prescribing and
administering medicines for young
people in Australia.
It provides detailed dosing information
for individual drugs, with dosages
arranged by indications and/or age
groupings from infants to 18 years, as well
as other specific information relating to
each drug's paediatric use. All content is
evidence-based and peer-reviewed.
According to an AMH spokesperson,
the AMH Children's Dosing Companion
will provide an essential reference with
specific Australian information and will be
a primary resource for treating children in
local community and acute care settings.
'It fulfils a need that has long been
identified by local paediatricians,
general practitioners, pharmacists and
'There is a paucity of reliable information
available about paediatric medicines
usage, and local practitioners have had
to rely on overseas resources or access to
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