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MEDICINES, POISONS AND THERAPEUTIC GOODS AMENDMENT REGULATION 2010 (NO 3) (NO 16 OF 2010)
THE LEGISLATIVE ASSEMBLY FOR
THE
AUSTRALIAN CAPITAL
TERRITORY
MEDICINES, POISONS AND
THERAPEUTIC GOODS AMENDMENT
REGULATION 2010 (NO 3)
SL2010-16
EXPLANATORY
STATEMENT
Minister for Health
Medicines, Poisons and Therapeutic Goods Amendment
Regulation 2010 (No 3)
The Medicines, Poisons and Therapeutic Goods Act 2008 (the
Act) consolidated four Acts and their regulations regarding ACT law on
medicines, poisons and prohibited substances; by repealing and replacing the
Poisons and Drugs Act 1978, the Poisons Act 1933, the
Public Health (Prohibited Drugs) Act 1957, and significantly
amending the Drugs of Dependence Act 1989.
The Act gave
effect to reforms required by the National Competition Policy Review of Drugs,
Poisons and Controlled Substances Legislation (Galbally Review), and served to
provide a more unified and workable scheme. In doing so, the Act adopts the
Standard for the Uniform Scheduling of Drugs and Poisons (the SUSDP), developed
by the National Drugs and Poisons Schedule Committee established under the
Therapeutic Goods Act 1989 (Cwlth).
The objective of the Act,
as recommended by the Galbally Review, is to promote and protect public health
and safety by minimising medicinal misadventure with and diversion of regulated
substances, accidental or deliberate poisonings and the manufacture of regulated
substances that are subject to abuse. The Act also has the purpose of ensuring
that consumers of prescription and non-prescription medicines have adequate
information to allow them to use medicines safely and effectively.
The
Act establishes an authorisation and licensing framework for medicines and
poisons, as well as grounds and powers for disciplinary action to be taken
against authorised and licensed persons. The Act also controls the way in which
medicines and poisons are dealt with through a range of offences, imposing a
range of potential penalties, including the imposition of terms of imprisonment
where appropriate. Enforcement of the offences is achieved through a
comprehensive range of inspection and seizure powers, including the capacity to
take and analyse samples.
The Medicines, Poisons and Therapeutic Goods Regulation
The
Medicines, Poisons and Therapeutic Goods Regulation (the MPTG Regulation)
provides the detail for the regulatory framework established by the Act. The
MPTG Regulation contains the more substantive detail, specific requirements, or
conditions for a range of activities and obligations contained within the Act.
Some provisions of the MPTG Regulation prescribe additional information required
for licences or authorisations, whereas other provisions impose statutory
licence conditions. There are also provisions of the MPTG Regulation specifying
requirements for activities such as labelling or packaging.
This Regulation
The Act and the MPTG Regulation were developed to
maintain, as much as possible, the status quo for health professionals in the
ACT in the performance of their duties. On that basis, what a health
professional, including nurse practitioners, could and could not do prior to the
commencement of the Act was intended to be the same following the commencement
of the Act.
Nurse practitioners in the ACT are prohibited from
prescribing Schedule 8 medicines, generally referred to as Controlled
Medicines. Nurse practitioners across the border in New South Wales, however,
are able to prescribe Schedule 8 medicines. So too are nurse practitioners
in Victoria, Tasmania and Queensland.
The inability of ACT nurse
practitioners to prescribe controlled medicines is a significant restriction,
and one which is particularly disadvantageous to nurse practitioners providing
end-of-life care and treatment for acute pain management. Establishing the role
of nurse practitioners is part of the ACT Government commitment to building a
strong, sustainable nursing workforce in the Territory. Aligning the powers and
functions of nurse practitioners in the Territory will enhance the use of these
health professionals in the ACT. Accordingly, this Regulation amends the MPTG
Regulation
Clauses
Clause 1 – Name of regulation
This section sets out the
name of the Regulation as the Medicines, Poisons and Therapeutic Goods
Amendment Regulation 2010 (No 3).
Clause 2 – Commencement
Pursuant to this provision, all
of the Regulation, with the exception of Schedule 1, is to commence on the
day after notification.
The commencement of Schedule 1 is linked
to that of section 3 in the Health Practitioner Regulation National
Law (ACT) Act 2010.
On 26 March 2008 the
Council of Australian Governments (COAG) signed the 2008 Intergovernmental
Agreement for a National Registration and Accreditation Scheme for Health
Professions. The agreement establishes a national scheme of registration
and accreditation for health professions in Australia (the National Scheme) by
1 July 2010. The Health Practitioner Regulation National
Law (ACT) Act 2010 represents the ACT’s involvement in the third
and final stage of the implementation process of the National Scheme.
The National Scheme’s proposed implementation date is
1 July 2010. Until that time, current State and Territory based
regulation will continue to apply to registered health practitioners.
Clause 3 - Legislation amended
This section expressly states
that the legislation amended is the Medicines, Poisons and Therapeutic Goods
Regulation 2008.
Clause 4 – Section 510 (a), except
note
Doctors, dentists, optometrists, podiatrists and veterinary surgeons
are prescribed persons for Chapter 11 of the MPTG Regulation by
virtue of section 510(a). This amendment adds nurse practitioners to
section 510(a), and in doing adds nurse practitioners to the list of
prescribed persons for Chapter 11.
Clause 5 – Section 510 (a), new note 2
This
provision inserts a new note, note 2, which will follow section 510(a).
The note explains that a nurse practitioner does not include a person
who is conditionally registered as a nurse practitioner. The reader is also
directed to the dictionary. Clause 13 of this Regulation amends the
dictionary to insert a definition of nurse practitioner that will apply for
chapters 11 and 12 only.
Clause 6 – Section 532 (1), definition of
designated person, paragraph (a)
Section 532 of the MPTG
Regulation imposes obligations on designated persons in regard to the
storage of controlled medicines.
A designated person includes,
in section 532(1)(a), a dentist, doctor, or veterinary surgeon, other than
such a health professional at an institution. Again, a reference to a dentist,
doctor or veterinary surgeon does not include trainees or interns.
This
provision adds nurse practitioners to section 532(1)(a) to the health
professionals already included in that paragraph.
Dentists, doctors,
nurse practitioners and veterinary surgeons at an institution are not a
designated person because in those circumstances the person in charge of
the ward at the institution is responsible for recording and storage of
controlled medicines.
Clause 7 – Section 532 (1), definition of
designated person, note 2
This provision inserts a new note 2
after section 532(1). The existing note 2 becomes note 3, by
virtue of this provision.
The note explains that a nurse practitioner
does not include a person who is conditionally registered as a nurse
practitioner. The reader is also directed to the dictionary. Clause 13 of
this Regulation amends the dictionary to insert a definition of nurse
practitioner that will apply for chapters 11 and 12 only.
Clause 8 - Section 533 (1), definition of excluded
person, paragraph (a)
Persons to which section 533 of the
MPTG Regulation applies must ensure that controlled medicines are stored in a
storage receptacle, which includes medicine cabinets, safes, strong rooms and
vaults.
Unless excluded, section 533 of the MPTG Regulation
applies to persons listed in section 510 as prescribed persons. If
they work at an institution, section 533(1) excludes a dentist, doctor,
veterinary surgeon and, by virtue of this amendment, a nurse practitioner.
Dentists, doctors, nurse practitioners and veterinary surgeons at an
institution are excluded because in those circumstances the person in charge of
the ward at the institution is responsible for recording and storage of
controlled medicines.
Clause 9 – Table 540, new item 14
Within
section 540 of the MPTG Regulation is Table 540. Table 540 lists 13
items, each of which is a profession or category of person deemed to be
prescribed persons who must keep a controlled medicines register for all
controlled medicines in their possession. Column 3 of the same table
specifies where the register is to be kept.
A fourteenth item is added
to Table 540 by this provision. Column 2 of the new item serves to
make nurse practitioners a prescribed person for the purposes of
section 540 of the MPTG Regulation. This means that any nurse practitioner
in possession of a controlled medicine will need to keep a controlled medicines
register. Column 3 of the new item instructs that the controlled medicine
is to be kept at the nurse practitioner’s place of practice.
Clause 10 - Section 541 (1), definition of designated
person, paragraph (a)
The MPTG Regulation establishes a bag or
container of medicines and other medical supplies kept by a person for the
purposes of health care or emergency treatment is a first-aid kit.
Under section 541 of the MPTG Regulation, if a first-aid kit
includes a controlled medicine the designated person who possesses that
first-aid kit must also keep a controlled medicines register with the first-aid
kit. A designated person for the purposes of section 541 includes a
first-aid kit licence-holder, and ambulance officers employed by the
Commonwealth, or by a State or Territory. Section 541(1)(a) also includes
dentists, doctors and veterinary surgeons as prescribed persons, although
interns and trainees are excluded.
This provision adds nurse
practitioners to section 541(1)(a) to the health professionals already
included in that paragraph.
Clause 11 - Section 541 (1), definition of designated
person, note 2
This provision inserts a new note 2 after
section 541(1). The existing note 2 becomes, by virtue of this
provision note 3.
The note explains that a nurse practitioner does
not include a person who is conditionally registered as a nurse practitioner.
The reader is also directed to the dictionary. Clause 13 of this
Regulation amends the dictionary to insert a definition of nurse practitioner
that will apply for chapters 11 and 12 only.
Clause 12 - Schedule 1, part 1.6, item 5,
column 3, paragraph (d)
Schedule 1 of the MPTG Regulation
sets out the authorisations for medicines held by each type of health-related
occupation. This includes nurses, who are listed in Part 1.6 of the
Schedule.
Part 1.6 consists of a table with three columns; item, person
authorised, and authorisation. There are a total of five items.
Prior
to this amendment item 5 of Part 1.6 authorised a nurse practitioner
to prescribe medicines, other than controlled medicines. The authorisation was,
and will continue to be, subject to two key restrictions. The first is that the
authorisation is to the extent necessary to practise nursing and within the
scope of employment. The other is that the authorised prescription is in
accordance with their approved scope of practice as set out in section 11
of the Health Regulation 2004.
The effect of this amendment is
simply to remove the words “(other than controlled medicines)”
thereby now enabling nurse practitioners to prescribe controlled medicines in
the same way, and subject to the same rules and restrictions, as other
prescribers (such as doctors).
Clause 13 – Dictionary, new definition of nurse
practitioner
The dictionary in ACT Legislation Act 2001
explains that a nurse practitioner is a person registered as a nurse in the
specialist area of nurse practitioner, and refers the reader to the Health
Professionals legislation.
This provision inserts into the dictionary of
the MPTG Regulation a definition of nurse practitioner that will apply for
chapters 11 and 12. The definition to be inserted states that a nurse
practitioner does not include a person who is conditionally registered as a
nurse practitioner.
The effect of the definition is to narrow that in
the ACT Legislation Act 2001, as it would otherwise apply to
Chapters 11 and 12 of the MPTG Regulation, so that the provisions in those
chapters only apply to unconditionally registered nurse practitioners.
Schedule 1 – Amendments consequential on Health Practitioner
Regulation National Law (ACT) Act 2010
This Regulation has amended
or inserted a number of notes in the MPTG Regulation, as well as inserted a
definition of nurse practitioner into the dictionary of the MPTG Regulation.
Once the Health Practitioner Regulation National Law (ACT) Act 2010
commences, however, some definitions will become obsolete.
This
Schedule has been included in this Regulation because it is recognised that
changes to the MPTG Regulation are imminent due to the expected commencement in
2010 of the Health Practitioner Regulation National Law (ACT)
Act 2010. Schedule 1 of this Regulation contains amendments that
are consequential on the Health Practitioner Regulation National Law (ACT)
Act 2010.
Provision 1.1 of this Schedule makes further
amendments to the MPTG Regulation on commencement of the Health Practitioner
Regulation National Law (ACT) Act 2010. Those amendments are to places
in the MPTG Regulation that make mention of conditionally registered nurse
practitioners, terminology that will be abandoned once the Health
Practitioner Regulation National Law (ACT) Act 2010 is in
operation.
Accordingly, provision 1.1 of this Schedule will replace
references to “a person who is conditionally registered as a nurse
practitioner” with “a person holding limited or provisional
registration to practise as a nurse practitioner”. Despite the change in
terminology, the effect is the same; only nurse practitioners with full
registration will be covered by Chapters 11 and 12 of the MPTG
Regulation.
The changes made by provision 1.1 of this Schedule will apply
to note 2 in sections 510(a), 532(1) and 541(1), as well as to the
definition of nurse practitioner in the dictionary.