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MEDICINES, POISONS AND THERAPEUTIC GOODS AMENDMENT REGULATION 2017 (NO 1) (NO 27 OF 2017)
Medicines, Poisons and Therapeutic Goods Amendment Regulation 2017 (No 1)
Subordinate law SL2017–27
made under the
Medicines, Poisons and Therapeutic Goods Act 2008, Section 184 (Regulation-making power)
EXPLANATORY STATEMENT
The objective of the Medicines, Poisons and Therapeutic Goods
Act 2008 (MPTG Act) is to promote and protect public health and safety
by minimising medicinal misadventure with, and diversion of, regulated
substances, and the manufacture of regulated substances that are subject to
abuse.
The Medicines, Poisons and Therapeutic Goods Regulation 2008 (MPTG
Regulation) provides the detail for the regulatory framework established by the
MPTG Act. The MPTG Regulation sets out which health professionals are able to
prescribe, administer and dispense a medicine, and conditions relating to such
dealings. Some provisions of the MPTG Regulation also prescribe additional
information required for licences or authorisations.
Section 560 of the
MPTG Regulation establishes that any designated prescriber may apply to the
Chief Health Officer (CHO) for approval to prescribe a controlled medicine.
However, in the context of seeking approval to prescribe a controlled medicine
to treat drug-dependency the applicant must first hold an endorsement under
section 582 of the MPTG Regulation.
This Regulation makes minor
technical changes to the MPTG Regulation to enable a designated prescriber to
become authorised to prescribe controlled medicines (methadone and
buprenorphine) to treat drug-dependency. This authorisation is subject to
approval and endorsement by the CHO. For example, a nurse practitioner will,
within their scope of practice, be able to prescribe controlled medicines to
treat drug-dependency subject to approval to prescribe a controlled medicine and
endorsement to treat drug-dependency by the CHO.
This change aims to
better align the ACT with other jurisdictions and improve timely access to
alcohol and other drug services for people with substance misuse disorders.
Details
A detailed explanation of each clause of the
Regulation follows.
Clauses
Clause 1 Name of regulation
The first clause of the
Regulation declares the name of the Regulation to be the Medicines, Poisons
and Therapeutic Goods Amendment Regulation 2017 (No 1).
Clause 2 Commencement
Pursuant to this provision, the
Regulation is to commence on the day after its notification day.
Clause 3 Legislation amended
This provision alerts the reader that this Regulation amends the MPTG
Regulation.
Upon commencement this Regulation will alter the MPTG
Regulation in accordance with the provisions that this Regulation contains.
This Regulation will then be immediately repealed.
Consequentially, from
the date that this Regulation commences a new republication of the MPTG
Regulation will be available. That new republication will feature the
alterations made by this Regulation.
Clause 4 Section 557 (1)
Schedule 1, part 1.3 item 2 (d) of the MPTG Regulation allows for an intern
doctor to prescribe medicines (including controlled medicines) in restricted
circumstances.
This provision amends section 557 (1) to provide that an
intern doctor can only prescribe controlled medicines (methadone and
buprenorphine) to treat drug-dependency when acting under the direct supervision
of a doctor.
Clause 5 Section 557 (2) and (3)
Clause 7 Section 563 (b) (i)
Clause 9 Section 563 (b) (iii) to (v)
Clause 12 Section 581
Clause 14 Section 581 (2)
Clause 16 Section 582
Clause 17 Section 582 (5)
Clause 18 Section 583 (a)
Clause 19 Section 584
These provisions amend relevant sections of the MPTG Regulation to replace
select references to a ‘doctor’ with references to a
‘designated prescriber’. This is a necessary alteration to enable
broadening, beyond just doctors, of the range of health practitioners authorised
to prescribe controlled medicines to treat drug-dependency. Under this change
health professionals with the requisite authorisations (as set out in Schedule 1
of the MPTG Regulation) will, after obtaining approval and endorsement by the
CHO, be able to prescribe controlled medicines to treat drug-dependency.
This
change aims to better align the ACT with other jurisdictions and improve the
access needs of people with substance misuse disorders.
Clause 6 New Section 563 (1)
Clause 15 New Section 581 (4)
These provisions insert a subsection
into the above named sections of the MPTG Regulation which establish that the
meaning of a ‘designated prescriber’ in these sections does not
capture an intern doctor.
Clause 8 Section 563 (b) (ii), new note
This provision inserts
a note into section 563 (b) (ii) relating to a ‘doctor’ as it is the
only place in this section where the term is mentioned.
Clause 10 Section 563 (b) (v), note
Clause 13 Section 581 (1), note
These provisions omit a note
currently within sections 563 and 581 of the MPTG Regulation. The retention of
the notes is made unnecessary by other amendments made by this
Regulation.
Clause 11 Section 580, note
This provision substitutes the first mention of ‘doctor’ in the note with ‘designated prescriber’. As with other similar substitutions made by this Regulation this change is necessary so that designated prescribers, subject to approval to prescribe a controlled medicine and endorsement to treat drug-dependency by the CHO, be able to prescribe controlled medicines to treat drug-dependency.