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POISONS AND DRUGS AMENDMENT REGULATION 2006 (NO 1) (NO 40 OF 2006)
Australian Capital Territory
Poisons and Drugs Amendment Regulation 2006 (No 1)
made under the
Clozapine is an anti-psychotic medication. It is a prescription only
medicine, and is also listed in Appendix D of the Standard for the Uniform
Scheduling of Drugs and Poisons (the Standard). This means that the national
standard for regulating prescription of this medicine is that it may only be
prescribed by someone who has received an authorisation to do so. This reflects
the need to ensure that doctors prescribing clozapine are properly qualified and
aware of the monitoring that must be done in order to minimise the risk of an
adverse incident for patients who are taking this medication.
This part of the Standard has been implemented under the Poisons and Drugs
Act 1933 (the Act) and the Poisons and Drug Regulation 1993 (the
Regulation). The Appendix D medicines, including clozapine, are listed in as
“restricted substances” in the Regulation. This means that only
specialists may prescribe it, and then only after seeking written permission
from the Chief Health Officer (the CHO). At the time this was done, it was
considered prudent to restrict the right to prescribe this (and other Appendix D
medicines) to specialists, even though the Standard does not require this for
all Appendix D medicines, and in particular does not require it for clozapine.
Other Australian jurisdictions allow clozapine to be prescribed by GPs who have
the relevant approval (a requirement which more closely reflects the
Standard).
The removal of clozapine from the list of “restricted
substances” in the Poisons and Drug Regulation 1993 will enable
clozapine to be regulated by other means. As this amendment is made, a
declaration will be made under the Public Health Act 1997 to make the
prescribing of clozapine a licensable public health risk activity. The net
result of this is that individual doctors who want to prescribe clozapine will
need to apply under the Public Health Act 1997 for approval to do so
rather than the Poisons and Drugs Act 1933. However, such applications
will not be restricted to specialists, and, importantly, such approvals will be
able to be granted to the doctors on staff at Mental Health who are
appropriately qualified to prescribe and handle the drug properly even though
they are not specialists as defined in the
Poisons and Drugs Act
1933.
No regulatory impact statement has been prepared
for this amendment. The instrument being made under the Public Health Act
1997 maintains a level of regulatory control over prescribing of clozapine
very similar to that imposed by the Poisons and Drugs Regulation 1993,
and in fact relaxes the restrictions to allow more doctors to be given
permission to prescribe clozapine.