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MEDICINES, POISONS AND THERAPEUTIC GOODS (PRESCRIBING AUTHORISATION OPTOMETRISTS) AMENDMENT REGULATION 2012 (NO 1) (NO 34 OF 2012)
THE LEGISLATIVE ASSEMBLY FOR
THE
AUSTRALIAN CAPITAL
TERRITORY
MEDICINES, POISONS AND
THERAPEUTIC GOODS (PRESCRIBING AUTHORISATION – OPTOMETRISTS) AMENDMENT
REGULATION 2012 (No 1)
SL2012-34
EXPLANATORY
STATEMENT
Minister for Health
Medicines, Poisons and Therapeutic Goods (Prescribing
Authorisation – Optometrists) Amendment
Regulation 2012 (No 1)
The National Registration and Accreditation Scheme (NRAS) to centralise registration and regulation of ten major health professions – including optometry – commenced in July 2010. Since then, all States and Territories except the ACT have amended their regulatory frameworks to allow endorsed optometrists to prescribe, or supply for topical use, the Schedule 4 poisons listed in the Optometry Board of Australia (OBA) Endorsement for scheduled medicines registration standard (the national list).
At present, the ACT Medicines, Poisons and Therapeutic Goods Regulation 2008 (the MPTG Regulation) lists the medicines that endorsed optometrists may prescribe in the ACT. The list of medicines in the MPTG Regulation is not consistent with the national list, which has resulted in a lack of consistency in optometry practice between the ACT and other States and Territories, most notably between the ACT and NSW.
This Regulation seeks to achieve consistency in this area by amending the
Medicines, Poisons and Therapeutic Goods Regulation (the MPTG Regulation) to
apply the national list.
Background information
The
Medicines, Poisons and Therapeutic Goods Act 2008 (the MPTG Act)
adopted the Standard for the Uniform Scheduling of Drugs and Poisons developed
by the National Drugs and Poisons Schedule Committee established under the
Therapeutic Goods Act 1989 (Cwlth). The Standard for the
Uniform Scheduling of Drugs and Poisons was later renamed the Standard for the
Uniform Scheduling of Medicines and Poisons (the SUSMP).
The objective of
the MPTG Act 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 MPTG 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 MPTG 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 licences persons. The MPTG 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 MPTG Regulation provides the detail for the
regulatory framework established by the MPTG Act. The MPTG Regulation contains
the more substantive detail, specific requirements and 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.
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). The objective of the
Agreement was to fully implement a national scheme of registration and
accreditation for health professions (the NRAS) in Australia by
1 July 2010. In the ACT the NRAS was achieved through the Health
Practitioner Regulation National Law (ACT) Act 2010.
The consequential amendment section of the Health Practitioner
Regulation National Law (ACT) Act 2010 contained amendments
to other existing ACT legislation affected by the reforms; such as the Health
Act 1993 and Health Professionals Regulation 2004. Prior to the
NRAS local boards for a range of health professionals, including optometrists,
were established through Schedules in the Health Professionals
Regulation 2004. To give effect to the NRAS, and thereby the shift to
National boards, relevant Schedules in the Health Professionals
Regulation 2004 were removed by the Health Practitioner Regulation
National Law (ACT) Act 2010.
The first clause of the Regulation declares that the name of the Regulation
to be the Medicines, Poisons and Therapeutic Goods (Prescribing
Authorisation – Optometrists)
Amendment Regulation 2012 (No 1).
Pursuant to this provision, the Regulation is to commence on the day after
notification.
Due to the operation of section 75(1) of the
Legislation Act 2001 (the Legislation Act) the naming and
commencement provisions of this Regulation, clauses 1 and 2, commence
automatically on the day the Regulation is notified. A note to that effect is
included in the provision.
This provision alerts the reader that this Regulation amends the Medicines,
Poisons and Therapeutic Goods Regulation 2008.
Upon commencement
this Regulation will alter the Medicines, Poisons and Therapeutic Goods
Regulation 2008 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
Medicines, Poisons and Therapeutic Goods Regulation 2008 will be available.
That new republication will feature the alterations made by this
Regulation.
Section 12 of the MPTG Regulation essentially reiterates that
section 44 of the MPTG Act requires a person authorised to deal with a
medicine to comply with conditions to which the authorisation is subject.
The section also draws the reader’s attention to the fact that
conditions on authorisations are additional to other restrictions that may be
placed upon a person’s authorisation under the MPTG legislation. To aid
understanding of the provision an example is included in the section.
The
example previously provided in section 12 related to optometrists, but is
no longer accurate or relevant due to the amendments made by this Regulation.
Accordingly, a new example is to be inserted into section 12.
The
new example relates to limitations imposed on prescribing rights of eligible
midwives. Part 1.5 of Schedule 1 of the MPTG Regulation sets out the
authorisations applying to midwives, and item 2 of the part specifically
pertains to ‘eligible midwives’. Specifically, prescribing of items
on the Pharmaceutical Benefits Scheme is authorised by an ‘eligible
midwife’ if they are also an ‘authorised midwife’ for the
purposes of the National Health Act 1953 (Cwlth).
Section 47 of the Legislation Act notes that in some circumstances it is
simpler to adopt someone else’s law or instrument rather than remake it.
One reason to adopt a law or instrument is to achieve a uniform national
approach to dealing with a common problem. The Health Practitioner
Regulation National Law (ACT) Act 2010 is such an example.
For technical areas it is also often easier to adopt a law or instrument
prepared outside of the ACT than it would be to reproduce the detail of the
requirements directly in a law or instrument. This is especially so if the
technical documentation, instrument or law is particularly voluminous, or if
national consistency is particularly critical. The adoption of the SUSMP by the
MPTG Act is an example of a technical and voluminous document for which
consistent adoption Australia wide was highly important.
Although there
may be good practical reasons to adopt a law or instrument, there are also a
number of policy issues relevant to the adoption of laws and instruments from
another source. If the law or instrument is adopted on the basis that future
changes will automatically apply, this means that the entity who makes the
changes becomes a ‘lawmaker’ not only where the law or instrument
originally applied but also where it has been adopted. To this extent the
Legislative Assembly is by-passed.
As such, section 47 (3) of
the Legislation Act provides establishes that the normal rule is that a law or
instrument prepared outside of the ACT is applied as in force at a particular
time. Subsection (4) however, provides that this normal rule can be
displaced. In this Regulation that has been done through the definition of
Optometry Endorsement Scheduled Medicines Registration Standard to be
inserted by clause 9.
When a law or instrument is applied as in
force from time to time, section 47 (6) sets a number of requirements
designed to ensure that the requirements for accessibility are satisfied. These
include that the adopted law or instrument is taken to be a notifiable
instrument. Furthermore, if the law or instrument applies as in force from time
to time, each amendment of the law or instrument is also to be a notifiable
instrument.
Through this provision, the normal operation of
section 47(6) of the Legislation Act is displaced in regard to the
Optometry Endorsement Scheduled Medicines Registration Standard.
Accordingly, the Optometry Endorsement Scheduled Medicines Registration
Standard does not need to be placed on the ACT Legislation Register as a
notifiable instrument. Links to the Optometry Endorsement Scheduled
Medicines Registration Standard on the website of the Optometry Board of
Australia are included to ensure accessibility.
The effect of the previous clause is to displace the operation of
section 47(6) of the Legislation Act in regard to the Optometry
Endorsement Scheduled Medicines Registration Standard.
This
provision inserts a new note into section 863. The new note, note 3,
alerts the reader to the web address at which the Optometry Endorsement
Scheduled Medicines Registration Standard can be accessed. That address is
http://www.optometryboard.gov.au
, which is the website for the Optometry Board of Australia.
The table currently in Part 1.8 of Schedule 1 of the MPTG
Regulation is replaced by virtue of this clause.
It is through
Schedule 1 of the MPTG Regulation that the various health related
occupations are assigned authorisation to deal with medicines. There are 13
Parts to Schedule 1, each containing a table dealing with a different
health related occupation. Part 1.8 pertains to optometrists. The person
authorised in the table is listed in column 2, and what that person is
authorised to do is specified in column 3. Currently in Part 1.8 the
person authorised is an optometrist.
The replacement table inserted by
this provision will contain two items as it will now set out authorisations for
optometrists generally, as well as authorisations for an optometrist whose
registration has been endorsed by the Optometry Board of Australia.
The
new table alters the authorisations applying to optometrists generally. To the
extent necessary to practice optometry, and confined to the scope of their
employment, all optometrists will now be able to obtain, possess and administer
medicines set out in Schedules 2, 3 and 4 of the SUSMP. They
will also be able to issue purchase orders or requisitions for these
medicines.
The Guidelines for use of scheduled medicines as
approved by the Optometry Board of Australia, which is available at http://www.optometryboard.gov.au
, may be used to determine the Schedule 2, 3 and 4
medicines that would be considered necessary to practice optometry, or within
the scope of an optometrist’s employment.
Medicines in
Schedule 2 of the SUSMP are pharmacy only medicines. Medicines in
Schedule 3 of the SUSMP are pharmacist only medicines, and prescription
only medicines are set out in Schedule 4 of the SUSMP. The terms
requisition and purchase order are defined in the Dictionary of
the MPTG Act.
The Optometry Endorsement Scheduled Medicines
Registration Standard contains a list of scheduled medicines endorsed by the
Optometry Board of Australia for optometry use. This list is referred to as the
national list. Clause 9 of this Regulation inserts into the dictionary of
the MPTG Regulation definitions for ‘Optometry Endorsement Scheduled
Medicines Standard’ and ‘national list’.
Medicines
that are included on the national list can be prescribed by an optometrist whose
registration has been endorsed by the Optometry Board of Australia. Endorsed
optometrists will also be able to supply medicines that are included on the list
during consultations, provided that the medicines are labelled as required by
section 161 of the MPTG Regulation. Section 161 details the
information that must be included on a label for medicines supplied during a
consultation. Standard information that is to appear includes the name of the
person that supplied the medicines, the date of supply, the form, strength and
quantity of the medicine, and directions about the use of the medicine.
Optometrists will also need to satisfy paragraph (k) of the section by
including the words “for optometry use only” on the
label.
Like optometrists generally, endorsed optometrists will also be
able to obtain, possess and administer medicines set out in
Schedules 2, 3 and 4 of the SUSMP. This authorisation is again
limited to the extent necessary to practice optometry, and confined to the scope
of their employment.
A note is also included below the table to be
inserted, which refers the reader to the Dictionary of the MPTG Regulation for
the meaning of national list. Clause 9 of this Regulation will
insert into the dictionary that definition.
Clause 8 removes from the MPTG Regulation Schedule 2.
Schedule 2 currently contains two tables; Table 2.1 and
Table 2.2. Table 2.1 identifies general optometry medicines and the
prescribed purposes for which those medicines could be used. Table 2.2 sets
out restricted optometry medicines and the conditions to which the medicines can
be used. At present, dealing with a restricted optometry medicines in
Table 2.2 is restricted to optometrists that hold a restricted medicines
authority. When the MPTG Regulation was first created the restricted medicines
authority was issued by the ACT Optometrists Board. When the Health
Practitioner Regulation National Law (ACT) Act 2010 commenced
the reference to the ACT Optometrists Board in the MPTG Regulation was simply
replaced with a reference to the Optometrist Board of Australia.
As this
Regulation is adopting and applying the national list of medicines endorsed by
the Optometry Board of Australia, Schedule 2 of the MPTG Regulation is no
longer required and is to be deleted.
Clause 9 inserts two new definitions into the Dictionary in the MPTG
Regulation.
The first new definition to be added to the Dictionary of
the MPTG Regulation is Optometry Endorsement Scheduled Medicines
Standard. Pursuant to this definition, the term ‘Optometry
Endorsement Scheduled Medicines Registration Standard’ means the
Optometry Endorsement Scheduled Medicines Registration Standard that was
approved by the Ministerial Council under section 12 of the Health
Practitioner Regulation National Law (ACT) Act 2010, as in
force from time to time.
The inclusion of the words ‘from
time to time’ expressly displaces the operation of section 47(3) of
the Legislation Act. Accordingly, any new versions of the Optometry
Endorsement Scheduled Medicines Registration Standard’ will
automatically have application to the MPTG Regulation.
The second
new definition to be added is national list. Applying this
definition, a reference in the MPTG Regulation to national list is to be read as
the Optometry Endorsement Scheduled Medicines Registration Standard,
table 1. Essentially, this is a list of medicines endorsed by the
Optometry Board of Australia that have been endorsed for optometry usage.
A note to the definition alerts the reader to the web address at which
the Optometry Endorsement Scheduled Medicines Registration Standard can
be accessed. That address is http://www.optometryboard.gov.au
, which is the website for the Optometry Board of Australia.