drugs, poisons and controlled substances …file/12-136sr.docx · web viewdavid davis minister for...

Drugs, Poisons and Controlled Substances Amendment Regulations 2012

S.R. No. 136/2012

TABLE OF PROVISIONS

Regulation Page

1 Objective 12 Authorising provisions 23 Commencement 24 Principal Regulations 25 Definitions 26 Possession of Schedule 4 poisons, Schedule 8 poisons and

Schedule 9 poisons 27 Patient identity and therapeutic need to be determined—

nurse practitioners 48 Patient identity and therapeutic need to be determined—

authorised registered nurse 49 New regulation 9B inserted 5

9B Patient identity and therapeutic need to be determined—authorised registered midwife 5

10 Patient identity and therapeutic need to be determined for drugs of dependence—pharmacists 7

11 Notification of fraudulent obtaining of drugs or poisons 712 Pharmacist administration, sale or supply authorised from

within Victoria 713 Disclosure of drug use within previous 8 weeks required 814 Persons authorised to write prescriptions 815 Style and required particulars for prescriptions 816 Emergency directions to pharmacists regarding supply 817 Containers of drugs to be labelled with certain details 918 Retention of original prescriptions or orders once supply

completed 919 General security requirement—Schedule 4 poisons 1020 Storage of Schedule 8 and Schedule 9 poisons 1021 Persons required to keep records 1022 Details to be contained in records 1123 Use of drugs and poisons restricted to person or animal for

whom they were supplied 1124 Administration of drugs and poisons to be authorised 1125 Administration of drugs and poisons by a nurse or midwife 1126 Self-administration of drugs and poisons restricted 13

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27 Exceptions 1428 New regulation 58B inserted 14

58B Therapeutic need to be determined—authorised registered midwives 14

29 Therapeutic need to be determined—pharmacists 1530 Requirements to supply 1531 Lost or stolen poisons to be notified 15

═══════════════ENDNOTES 16

STATUTORY RULES 2012

S.R. No. 136/2012

Drugs, Poisons and Controlled Substances Act 1981


The Governor in Council makes the following Regulations:

Dated: 27 November 2012

Responsible Minister:

DAVID DAVISMinister for Health

MATTHEW McBEATHClerk of the Executive Council

1 Objective

The objective of these Regulations is to amend the Drugs, Poisons and Controlled Substances Regulations 2006—

(a) to provide for the following matters as a consequence of the enactment of the Drugs, Poisons and Controlled Substances Amendment (Supply by Midwives) Act 2012—

(i) the authorisation of registered midwives to possess, use, sell or supply certain drugs required for midwifery practice; and

(ii) changes in the terminology used to refer to midwives; and

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(b) to clarify the relationship between certain offences; and

(c) to make other miscellaneous amendments.

2 Authorising provisions

These Regulations are made under sections 129, 131, 132, 132A and 132B of the Drugs, Poisons and Controlled Substances Act 1981.

3 Commencement

These Regulations come into operation on 30 November 2012.

4 Principal Regulations

In these Regulations, the Drugs, Poisons and Controlled Substances Regulations 20061 are called the Principal Regulations.

5 Definitions

(1) In regulation 4 of the Principal Regulations insert the following definition—

"authorised registered midwife means a registered midwife whose registration is endorsed under section 94 of the Health Practitioner Regulation National Law;".

(2) In regulation 4 of the Principal Regulations the definition of midwife is revoked.

(3) In regulation 4 of the Principal Regulations, in the definition of registered dental hygienist, in paragraph (b), for "Practitioners." substitute "Practitioners;".

6 Possession of Schedule 4 poisons, Schedule 8 poisons and Schedule 9 poisons

(1) In the Table in regulation 5(1) of the Principal Regulations, in item 2, Column 2, paragraph (c), for "or nurse practitioner" substitute ", nurse practitioner or authorised registered midwife".

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(2) In the Table in regulation 5(1) of the Principal Regulations, in item 2, Column 2, paragraph (d), for "or nurse practitioner" substitute ", nurse practitioner or authorised registered midwife".

(3) In the Table in regulation 5(1) of the Principal Regulations, in item 4, Column 1, for "or authorised registered nurse" substitute ", authorised registered nurse or authorised registered midwife".

(4) In the Table in regulation 5(1) of the Principal Regulations, in item 5, Column 1, for "or authorised registered nurse" substitute ", authorised registered nurse or authorised registered midwife".

(5) In regulation 5(2) of the Principal Regulations, for "midwife" (where twice occurring) substitute "registered midwife".

(6) In regulation 5(2)(a)(ii) of the Principal Regulations, after "nurse practitioner" insert "or an authorised registered midwife".

(7) In regulation 5(3) of the Principal Regulations, for "midwife or class of midwife" substitute "registered midwife or class of registered midwife".

(8) In regulation 5(3)(b) of the Principal Regulations, after "nurse practitioner" insert "or an authorised registered midwife".

(9) In regulation 5(4)(b) of the Principal Regulations, for "midwife" substitute "registered midwife".

(10) In regulation 5(4)(b) of the Principal Regulations, after "nurse practitioner," insert "an authorised registered midwife,".

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7 Patient identity and therapeutic need to be determined—nurse practitioners

(1) After regulation 9(1) of the Principal Regulations insert—

"(1A) Nothing in subregulation (1) prohibits a nurse practitioner from administering a Schedule 8 poison in accordance with regulation 47(2).Note

Regulation 47(2) describes circumstances in which a nurse may administer a Schedule 8 poison. For example, regulation 47(2)(b) allows a nurse to administer a Schedule 8 poison on the written instruction of a registered medical practitioner.".

(2) After regulation 9(2) of the Principal Regulations insert—

"(3) Nothing in subregulation (2) prohibits a nurse practitioner from administering a Schedule 4 poison in accordance with regulation 47(3).Note


8 Patient identity and therapeutic need to be determined—authorised registered nurse

(1) After regulation 9A(1) of the Principal Regulations insert—

"(1A) Nothing in subregulation (1) prohibits an authorised registered nurse from administering a Schedule 8 poison in accordance with regulation 47(2).

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Note


(2) After regulation 9A(2) of the Principal Regulations insert—

"(3) Nothing in subregulation (2) prohibits an authorised registered nurse from administering a Schedule 4 poison in accordance with regulation 47(3).Note


9 New regulation 9B inserted

After regulation 9A of the Principal Regulations insert—

"9B Patient identity and therapeutic need to be determined—authorised registered midwife

(1) An authorised registered midwife must not administer, prescribe, sell or supply a Schedule 8 poison unless—

(a) that poison is for the midwifery treatment of a person under his or her care; and

(b) he or she has taken all reasonable steps to ascertain the identity of that person; and

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(c) he or she has taken all reasonable steps to ensure a therapeutic need exists for that poison.

Penalty: 100 penalty units.

(2) Nothing in subregulation (1) prohibits an authorised registered midwife from administering a Schedule 8 poison in accordance with regulation 47(2).Note

Regulation 47(2) describes circumstances in which a registered midwife may administer a Schedule 8 poison. For example, regulation 47(2)(b) allows a registered midwife to administer a Schedule 8 poison on the written instruction of a registered medical practitioner.

(3) An authorised registered midwife must not administer, prescribe, sell or supply a Schedule 4 poison unless—


(b) he or she has taken all reasonable steps to ensure a therapeutic need exists for that poison.

Penalty: 100 penalty units.

(4) Nothing in subregulation (3) prohibits an authorised registered midwife from administering a Schedule 4 poison in accordance with regulation 47(3).Note

Regulation 47(3) describes circumstances in which a registered midwife may administer a Schedule 4 poison. For example, regulation 47(3)(b) allows a registered midwife to administer a Schedule 4 poison on the written instruction of a registered medical practitioner.".

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10 Patient identity and therapeutic need to be determined for drugs of dependence—pharmacists

In regulation 12(1) of the Principal Regulations, for "or nurse practitioner" substitute ", nurse practitioner or an authorised registered midwife".

11 Notification of fraudulent obtaining of drugs or poisons

In regulation 14(2) of the Principal Regulations, after "nurse practitioner" insert "or an authorised registered midwife".

12 Pharmacist administration, sale or supply authorised from within Victoria

(1) In regulation 15(1)(b)(i) of the Principal Regulations, for "or nurse practitioner;" substitute ", nurse practitioner or an authorised registered midwife;".

(2) In regulation 15(1)(b)(ii) of the Principal Regulations, for "or nurse practitioner;" substitute ", nurse practitioner or an authorised registered midwife;".

(3) In regulation 15(1)(d) of the Principal Regulations, for "or nurse practitioner;" substitute ", nurse practitioner or an authorised registered midwife;".

(4) In regulation 15(1)(e)(i) of the Principal Regulations, for "or nurse practitioner;" substitute ", nurse practitioner or an authorised registered midwife;".

(5) In regulation 15(2) of the Principal Regulations, for "or nurse practitioner if" substitute ", nurse practitioner or an authorised registered midwife if".

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(6) In regulation 15(2)(a)(ii) of the Principal Regulations, for "or nurse practitioner;" substitute ", nurse practitioner or an authorised registered midwife;".

13 Disclosure of drug use within previous 8 weeks required

In regulation 24(1) of the Principal Regulations, for "or authorised registered nurse" substitute ", an authorised registered nurse or an authorised registered midwife".

14 Persons authorised to write prescriptions

(1) In regulation 25(2) of the Principal Regulations, for "or nurse practitioner" substitute ", nurse practitioner or an authorised registered midwife".

(2) In regulation 25(3) of the Principal Regulations, after "nurse practitioner," insert "an authorised registered midwife,".

(3) In regulation 25(5) of the Principal Regulations, after "nurse practitioner" insert "or an authorised registered midwife".

15 Style and required particulars for prescriptions

In regulation 26(3)(g)(ii) of the Principal Regulations, for "midwife" substitute "registered midwife".

16 Emergency directions to pharmacists regarding supply

(1) In regulation 27(2) of the Principal Regulations—

(a) after "nurse practitioner" (where first occurring) insert "or an authorised registered midwife";

(b) after "nurse practitioner" (where secondly occurring) insert "or authorised registered midwife".

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17 Containers of drugs to be labelled with certain details

(1) In regulation 29(2)(c) of the Principal Regulations, for "midwife" substitute "registered midwife".

(2) In regulation 29(3) of the Principal Regulations, for "or authorised registered nurse" substitute ", an authorised registered nurse or authorised registered midwife".

(3) In regulation 29(4) of the Principal Regulations—

(a) for "or authorised registered nurse" (where first occurring) substitute ", an authorised registered nurse or an authorised registered midwife";

(b) for "or authorised registered nurse" (where secondly occurring) substitute ", authorised registered nurse or authorised registered midwife".



18 Retention of original prescriptions or orders once supply completed

In regulation 33(1) of the Principal Regulations, after "of a nurse practitioner" insert "or an authorised registered midwife".

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19 General security requirement—Schedule 4 poisons

(1) In regulation 34(2)(b) of the Principal Regulations—

(a) after "nurse practitioner," insert "an authorised registered midwife,";

(b) for "or midwife" substitute "or registered midwife".

(2) In regulation 34(3) of the Principal Regulations, after "nurse practitioner," (where twice occurring) insert "an authorised registered midwife,".

(3) In regulation 34(4)(a) of the Principal Regulations, after "nurse practitioner," insert "an authorised registered midwife,".


20 Storage of Schedule 8 and Schedule 9 poisons

(1) In regulation 35(6)(a) of the Principal Regulations, for "and nurse practitioner" substitute ", nurse practitioner and an authorised registered midwife".


21 Persons required to keep records

(1) In regulation 39(a) of the Principal Regulations, after "nurse practitioner," insert "an authorised registered midwife,".

(2) In regulation 39(c) of the Principal Regulations, for "midwife" substitute "registered midwife".

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22 Details to be contained in records

(1) In regulation 40(1)(g) of the Principal Regulations, after "nurse practitioner" insert "or an authorised registered midwife".

(2) In regulation 40(1)(h) of the Principal Regulations, for "midwife" substitute "registered midwife".

(3) In regulation 40(2) of the Principal Regulations after "nurse practitioner," insert "an authorised registered midwife,".

23 Use of drugs and poisons restricted to person or animal for whom they were supplied

In regulation 45(2) of the Principal Regulations, after "nurse practitioner" insert ", an authorised registered midwife".

24 Administration of drugs and poisons to be authorised

(1) In regulation 46(2) of the Principal Regulations, after "A nurse practitioner" insert "or an authorised registered midwife".

(2) In regulation 46(5) of the Principal Regulations, after "a nurse practitioner" insert "or an authorised registered midwife".

25 Administration of drugs and poisons by a nurse or midwife

(1) In the heading to regulation 47 of the Principal Regulations, after "or" insert "registered".

(2) In regulation 47(1) of the Principal Regulations, for "midwife" (wherever occurring) substitute "registered midwife".


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(4) In regulation 47(2)(a) of the Principal Regulations, for "or nurse practitioner" substitute ", nurse practitioner or an authorised registered midwife".

(5) In regulation 47(2)(b) of the Principal Regulations, for "or nurse practitioner" substitute ", nurse practitioner or an authorised registered midwife".

(6) In regulation 47(2)(c) of the Principal Regulations—

(a) for "or nurse practitioner" (where first occurring) substitute ", nurse practitioner or an authorised registered midwife";

(b) for "or nurse practitioner" (where secondly occurring) substitute ", nurse practitioner or authorised registered midwife".

(7) After regulation 47(2)(d) of the Principal Regulations insert—

"(da) in the case of a nurse who is a nurse practitioner, in accordance with regulation 9(1); or

(db) in the case of a nurse who is an authorised registered nurse, in accordance with regulation 9A(1); or

(dc) in the case of a registered midwife who is an authorised registered midwife, in accordance with regulation 9B(1); or".


(9) In regulation 47(3)(a) of the Principal Regulations, after "nurse practitioner," insert "an authorised registered midwife,".

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(10) In regulation 47(3)(b) of the Principal Regulations, after "nurse practitioner," insert "an authorised registered midwife,".

(11) In regulation 47(3)(c) of the Principal Regulations—

(a) after "nurse practitioner," (where first occurring) insert "an authorised registered midwife,";

(b) after "nurse practitioner," (where secondly occurring) insert "authorised registered midwife,".

(12) After regulation 47(3)(d) of the Principal Regulations insert—

"(da) in the case of a nurse who is a nurse practitioner, in accordance with regulation 9(2); or

(db) in the case of a nurse who is an authorised registered nurse, in accordance with regulation 9A(2); or

(dc) in the case of a registered midwife who is an authorised registered midwife, in accordance with regulation 9B(3); or".


26 Self-administration of drugs and poisons restricted

(1) In regulation 48(b)(i) of the Principal Regulations, for "or nurse practitioner" substitute ", nurse practitioner or an authorised registered midwife".

(2) In regulation 48(b)(ii) of the Principal Regulations, for "or nurse practitioner" substitute ", nurse practitioner or authorised registered midwife".

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(3) In regulation 48(c)(i)(A) of the Principal Regulations, for "or nurse practitioner" substitute ", nurse practitioner or an authorised registered midwife".

(4) In regulation 48(c)(ii) of the Principal Regulations, after "nurse practitioner," insert "authorised registered midwife,".

27 Exceptions

(1) In regulation 51(2)(a) of the Principal Regulations, after "nurse practitioner" insert "or an authorised registered midwife".

(2) In regulation 51(2)(a) of the Principal Regulations, for "midwife" substitute "registered midwife".



28 New regulation 58B inserted

After regulation 58A of the Principal Regulations insert—

"58B Therapeutic need to be determined—authorised registered midwives

An authorised registered midwife must not administer, prescribe, sell or supply a Schedule 3 poison unless—


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(b) he or she has taken all reasonable steps to ensure a therapeutic need exists for that poison.

Penalty: 50 penalty units.".

29 Therapeutic need to be determined—pharmacists

In regulation 61(b) of the Principal Regulations, after "dentist," insert "an authorised registered midwife,".

30 Requirements to supply

(1) In regulation 63(1) of the Principal Regulations, after "an authorised registered nurse," insert "an authorised registered midwife,".


31 Lost or stolen poisons to be notified

In regulation 70(2)(a) of the Principal Regulations, after "nurse practitioner," insert "an authorised registered midwife,".

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ENDNOTES

Endnotes S.R. No. 136/2012


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1 Reg. 4: S.R. No. 57/2006. Reprint No. 1 as at 16 June 2011. Reprinted to S.R. No. 131/2010.

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