Di-Gesic to stay on ARTG
September 16, 2013
THE Administrative Appeals
Tribunal of Australia (AAT) has
ruled that medications containing
dextropropoxypene, including
Di-Gesic and Doloxene, should
remain on the Australian Register
of Therapeutic Goods.
The move is the latest twist in the
long-running saga which has seen
the TGA repeatedly issue warnings
of the potential safety risks of the
products (PD 15 Apr).
An appeal by Aspen
Pharmaceuticals has been upheld
by the AAT but several conditions
have been applied, after the
company was unable to reach
agreement with the TGA.
Under these conditions, doctors
must provide a ‘Prescriber
Confirmation Form’ which indicates
that they are aware that the
products are only approved for
patients who are not able to be
adequately treated with other mild
analgesics, and have warned the
patient about the appropriate use
of the product.
The PSA will produce guidelines
for dispensing of the products,
and the Guild will also help to
promulgate the recommendations
which will aim to promote
compliance with the requirement
not to dispense the goods (on
a first dispensing) unless the
pharmacists have obtained the
Prescriber Confirmation From.
The AAT has also ordered
regular monitoring of a sample of
pharmacists and wholesalers to
ensure they are complying with the
requirements.
CLICK HERE to see full details of
the judgement.
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