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Drugs, Poisons and Controlled Substances Amendment (Administration of Schedule 3 and 4 Poisons by Pharmacists) Regulations 2016

S.R. No. 20/2016

TABLE OF PROVISIONS

Regulation  Page

1Objective

2Authorising provisions

3Commencement

4Pharmacist administration, sale or supply authorised from within Victoria

5New regulations 49A and 49B inserted

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Endnotes

STATUTORY RULES 2016

S.R. No. 20/2016

Drugs, Poisons and Controlled Substances Act 1981

Drugs, Poisons and Controlled Substances Amendment (Administration of Schedule 3 and 4 Poisons by Pharmacists) Regulations 2016

The Governor in Council makes the following Regulations:

Dated: 12 April 2016

Responsible Minister:

JILL HENNESSY
Minister for Health

ANDREW ROBINSON

Clerk of the Executive Council

1Objective

The objective of these Regulations is to amend the Drugs, Poisons and Controlled Substances Regulations 2006 in relation to the administration of Schedule 3 poisons and Schedule 4 poisons by pharmacists.

2Authorising provisions

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

3Commencement

These Regulations come into operation on 13 April 2016.

4Pharmacist administration, sale or supply authorised from within Victoria

After regulation 15(1)(c) of the Drugs, Poisons and Controlled Substances Regulations 2006[1] insert—

"(ca)in accordance with regulation 49A(1); or".

5New regulations 49A and 49B inserted

After regulation 49 of the Drugs, Poisons and Controlled Substances Regulations 2006 insert—

"49A   Administration of Schedule 4 poison by a pharmacist without instruction

(1)A pharmacist may administer a Schedule 4 poison without an instruction from a registered medical practitioner, dentist, nurse practitioner or an authorised registered 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 49B; and

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

(2)A pharmacist may administer a Schedule 3 poison without an instruction from a registered medical practitioner, dentist, nurse practitioner or an authorised registered midwife if—

(a)as a consequence of the administration of a Schedule 4 poison, a therapeutic need exists for the Schedule 3 poison; and

(b)the pharmacist has taken all reasonable steps to ensure that therapeutic need exists.

(3)Nothing in subregulation (2) limits any other authorisation of a pharmacist to administer a Schedule 3 poison.

49BSecretary may approve Schedule 4 poison for administration by pharmacist without instruction

(1)For the purposes of regulation 49A(1), the Secretary may, by notice published in the Government Gazette, approve a Schedule 4 poison as suitable for administration as described in that regulation.

(2)An approval notice under subregulation (1) takes effect—

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

(b)on a later date specified in the notice.

(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.

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

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

(b)a condition that a pharmacist may administer the Schedule 4 poison specified in the approval only if the pharmacist has completed specified training or qualifications; or

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

(d)any other condition the Secretary considers is necessary for the proper administration of the Schedule 4 poison.".

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Endnotes

[1] Reg. 4: S.R. No. 57/2006. Reprint No. 1 as at 16 June 2011. Reprinted to S.R. No. 131/2010 and subsequently amended by S.R. Nos 136/2012, 50/2013, 107/2013, 108/2013, 194/2014, 14/2015 and 110/2015.