Dextropropoxyphene update
September 23, 2013
The TGA has provided updated
information about the regulatory
status of pain killers containing
dextropropoxyphene.
The move follows the recent
Administrative Appeals Tribunal
decision (PD 16 Sep) which allowed
Di-Gesic and Doloxene to continue
to be available subject to a number
of conditions.
Prescribers of the medications
must sign a form confirming
several items including that they
have warned the patient about
appropriate use, have explained
the contraindications and that the
doctor or dentist is aware that the
medicine is only approved for use
in patients unable to be treated
with other mild analgesics..
The signed form must be
presented to the pharmacist prior
to supply, and pharmacies will be
audited to ensure the forms are
being collected as required.
The AAT decision takes effect
on 10 Oct 2013, 28 days after the
ruling was handed down.
However if either the TGA or
the sponsors lodge an appeal the
decision becomes effective after
any appeal is finally determined.
After that the sponsor has 14
days to lodge an application
with the TGA to vary the Product
Information for Di-Gesic and
Doloxene, and following the TGA’s
decision on that application the
other conditions nominated in the
AAT decision must be implemented,
including within 30 days sending
letters to doctors, dentists and
pharmacists explaining the new
arrangements.
The above article was sent to subscribers in Pharmacy Daily's issue from 23 Sep 13To see the full newsletter, see the embedded issue below or CLICK HERE to download Pharmacy Daily from 23 Sep 13
