Drugs, Poisons and Controlled Substances
Amendment Regulations 2012
S.R. No. 136/2012
TABLE OF PROVISIONS
Regulation
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
Page
Objective
Authorising provisions
Commencement
Principal Regulations
Definitions
Possession of Schedule 4 poisons, Schedule 8 poisons and
Schedule 9 poisons
Patient identity and therapeutic need to be determined—
nurse practitioners
Patient identity and therapeutic need to be determined—
authorised registered nurse
New regulation 9B inserted
9B
Patient identity and therapeutic need to be
determined—authorised registered midwife
Patient identity and therapeutic need to be determined for
drugs of dependence—pharmacists
Notification of fraudulent obtaining of drugs or poisons
Pharmacist administration, sale or supply authorised from
within Victoria
Disclosure of drug use within previous 8 weeks required
Persons authorised to write prescriptions
Style and required particulars for prescriptions
Emergency directions to pharmacists regarding supply
Containers of drugs to be labelled with certain details
Retention of original prescriptions or orders once supply
completed
General security requirement—Schedule 4 poisons
Storage of Schedule 8 and Schedule 9 poisons
Persons required to keep records
Details to be contained in records
Use of drugs and poisons restricted to person or animal for
whom they were supplied
Administration of drugs and poisons to be authorised
Administration of drugs and poisons by a nurse or midwife
Self-administration of drugs and poisons restricted
i
1
2
2
2
2
2
4
4
5
5
7
7
7
8
8
8
8
9
9
10
10
10
11
11
11
11
13
Regulation
Page
27
28
Exceptions
New regulation 58B inserted
58B
Therapeutic need to be determined—authorised
registered midwives
29
Therapeutic need to be determined—pharmacists
30
Requirements to supply
31
Lost or stolen poisons to be notified
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ENDNOTES
ii
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14
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15
15
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STATUTORY RULES 2012
S.R. No. 136/2012
Drugs, Poisons and Controlled Substances Act 1981
Drugs, Poisons and Controlled Substances
Amendment Regulations 2012
The Governor in Council makes the following Regulations:
Dated: 27 November 2012
Responsible Minister:
DAVID DAVIS
Minister for Health
MATTHEW McBEATH
Clerk 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
Regulation 47(3) describes circumstances in
which a nurse may administer a Schedule 4 poison.
For example, regulation 47(3)(b) allows a nurse to
administer a Schedule 4 poison on the written
instruction of a registered medical practitioner.".
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
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 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
Regulation 47(3) describes circumstances in
which a nurse may administer a Schedule 4 poison.
For example, regulation 47(3)(b) allows a nurse to
administer a Schedule 4 poison on the written
instruction of a registered medical practitioner.".
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—
(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 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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(2) In regulation 27(4) of the Principal Regulations,
after "nurse practitioner," insert "an authorised
registered midwife,".
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".
(4) In regulation 29(4)(b) of the Principal
Regulations, for "midwife" substitute
"registered midwife".
(5) In regulation 29(6)(b) of the Principal
Regulations, for "midwife" substitute
"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,".
(4) In regulation 34(4)(c) of the Principal
Regulations, for "midwife" substitute
"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".
(2) In regulation 35(6)(c) of the Principal
Regulations, for "midwife" substitute
"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".
(3) In regulation 47(2) 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".
(8) In regulation 47(3) of the Principal Regulations,
for "midwife" (wherever occurring) substitute
"registered midwife".
(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".
(13) In regulation 47(4) of the Principal Regulations,
after "nurse practitioner," insert "an authorised
registered midwife,".
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".
(3) In regulation 51(3)(a) of the Principal
Regulations, for "midwife" substitute
"registered midwife".
(4) In regulation 51(4)(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—
(a) that poison is for the midwifery
treatment of a person under his or her
care; and
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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,".
(2) In regulation 63(3) of the Principal Regulations,
after "nurse practitioner," 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
S.R. No. 136/2012
ENDNOTES
1
Reg. 4: S.R. No. 57/2006. Reprint No. 1 as at 16 June 2011. Reprinted to
S.R. No. 131/2010.
16