Drugs, Poisons and Controlled Substances Amendment (Authorising Pharmacists) Regulations 2023 (Vic)

Drugs, Poisons and Controlled Substances Amendment (Authorising Pharmacists) Regulations 2023

S.R. No. 105/2023

TABLE OF PROVISIONS

Regulation  Page

1Objective

2Authorising provisions

3Principal Regulations

4Sale or supply of Schedule 4 poison by pharmacist

5New regulation 57A inserted

6Administration of Schedule 4 poison by pharmacist

7New regulations 99A and 99B inserted

8Secretary may approve Schedule 4 poison that pharmacist may administer without instruction

9New regulation 163A inserted

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Endnotes

STATUTORY RULES 2023

S.R. No. 105/2023

Drugs, Poisons and Controlled Substances Act 1981

Drugs, Poisons and Controlled Substances Amendment (Authorising Pharmacists) Regulations 2023

The Governor in Council makes the following Regulations:

Dated: 3 October 2023

Responsible Minister:

MARY-ANNE THOMAS
Minister for Health

ANGELA SMITH

Clerk of the Executive Council

1Objective

The objective of these Regulations is to amend the Drugs, Poisons and Controlled Substances Regulations 2017—

(a)to authorise pharmacists to sell, supply or administer certain Schedule 4 poisons without a prescription or other instruction or authorisation in accordance with an approval by the Secretary; and

(b)to provide for the Secretary to approve the sale, supply or administration of certain Schedule 4 poisons by pharmacists without a prescription or other instruction or authorisation.

2Authorising provisions

These Regulations are made under sections 129 and 132B of the Drugs, Poisons and Controlled Substances Act 1981.

3Principal Regulations

In these Regulations, the Drugs, Poisons and Controlled Substances Regulations 2017[1] are called the Principal Regulations.

4Sale or supply of Schedule 4 poison by pharmacist

(1)In regulation 47(1)(i) of the Principal Regulations, for "Table." substitute "Table; or".

(2)After regulation 47(1)(i) of the Principal Regulations insert—

"(j)sale or supply in accordance with regulation 57A.".

5New regulation 57A inserted

After regulation 57 of the Principal Regulations insert—

57ASale or supply of Schedule 4 poison by pharmacist for treatment of a person under the pharmacist's care without prescription or other instruction or authorisation"

For the purposes of regulation 47(1)(j), a pharmacist may sell or supply a Schedule 4 poison without a prescription or other instruction or authorisation referred to in regulation 47(1)(a) to (i) if—

(a)that sale or supply is for treatment of a person—

(i)under the pharmacist's care; and

(ii)to whom the poison is sold or supplied; and

(b)the pharmacist has taken all reasonable steps to ensure a therapeutic need exists for the poison; and

(c)the Secretary has approved the poison under regulation 163A(1); and

(d)the sale or supply complies with the conditions specified in the approval (if any).".

6Administration of Schedule 4 poison by pharmacist

For regulation 99(c) of the Principal Regulations substitute—

"(c)except in accordance with regulation 99A; or

(ca)except in accordance with regulation 99B; or".

7New regulations 99A and 99B inserted

After regulation 99 of the Principal Regulations insert—

99ACircumstances in which pharmacist may administer Schedule 4 poison to a person without instruction"

For the purposes of regulation 99(c), a pharmacist may administer a Schedule 4 poison without an instruction from a registered medical practitioner, a dentist, a nurse practitioner or an authorised midwife if—

(a)the pharmacist has taken all reasonable steps to ensure a therapeutic need exists for the poison; and

(b)the Secretary has approved the poison under regulation 163(1); and

(c)the administration complies with the conditions specified in the approval (if any).

99BCircumstances in which pharmacist may administer Schedule 4 poison for treatment of a person under the pharmacist's care without prescription or other instruction or authorisation

For the purposes of regulation 99(ca), a pharmacist may administer a Schedule 4 poison without a prescription or other instruction or authorisation from a registered medical practitioner, dentist, nurse practitioner, authorised midwife, authorised optometrist or authorised podiatrist if—

(a)the poison is administered for the treatment of a person other than the pharmacist; and

(b)the poison is for the treatment of a person under the pharmacist's care; and

(c)the pharmacist has taken all reasonable steps to ensure a therapeutic need exists for the poison; and

(d)the Secretary has approved the poison under regulation 163A(1); and

(e)the administration complies with the conditions specified in the approval (if any).".

8Secretary may approve Schedule 4 poison that pharmacist may administer without instruction

(1)In the heading to regulation 163 of the Principal Regulations, after "administer" insert "to a person".

(2)For regulation 163(1) of the Principal Regulations substitute—

"(1)The Secretary, by notice published in the Government Gazette, may approve a Schedule 4 poison that a pharmacist is to be authorised to administer to a person without an instruction from a registered medical practitioner, a dentist, a nurse practitioner or an authorised midwife.".

9New regulation 163A inserted

After regulation 163 of the Principal Regulations insert—

"163A   Secretary may approve Schedule 4 poison that pharmacist may sell, supply or administer for treatment of a person under the pharmacist's care without prescription or other instruction or authorisation

(1)The Secretary, by notice published in the Government Gazette, may approve a Schedule 4 poison that a pharmacist is to be authorised to sell, supply or administer for treatment of a person under the pharmacist's care without a prescription or other instruction or authorisation.

(2)The Secretary must not approve a Schedule 4 poison under subregulation (1) if the Schedule 4 poison is also a drug of dependence.

(3)The Secretary must not approve a Schedule 4 poison under subregulation (1) unless the Secretary considers that the approval is necessary for the provision of health services and section 14A of the Act does not apply.

(4)The Secretary may specify in an approval under subregulation (1) that the approval is subject to—

(a)a condition that a pharmacist may sell, supply or administer the Schedule 4 poison specified in the approval only in premises that satisfy criteria specified in the approval; or

(b)a condition that a pharmacist may sell, supply or administer the Schedule 4 poison specified in the approval only if the pharmacist—

(i)has completed training specified in the approval; or

(ii)holds qualifications specified in the approval; or

(c)a condition that a pharmacist may sell, supply or administer the Schedule 4 poison specified in the approval only to persons belonging to a class specified in the approval; or

(d)any other condition the Secretary considers is necessary for the proper sale, supply or administration of the Schedule 4 poison.

(5)An approval under subregulation (1) may be made in respect of—

(a)a Schedule 4 poison or a class of Schedule 4 poison; and

(b)all pharmacists or a class of pharmacists.

(6)An approval under subregulation (1) takes effect—

(a)on the date of publication in the Government Gazette; or

(b)on a later date specified in the approval.".

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ENDNOTES

[1] Reg. 3: S.R. No. 29/2017 as amended by S.R. Nos 31/2018, 45/2018, 72/2018, 178/2018, 15/2020, 73/2020, 13/2021, 174/2021, 13/2022, 16/2022, 96/2022, 112/2022, 113/2022, 20/2023, 46/2023 and 61/2023.