Drugs, Poisons and Controlled Substances Amendment Regulations 2010
i
Drugs, Poisons and Controlled Substances
Amendment Regulations 2010
S.R. No. 131/2010
TABLE OF PROVISIONS
Regulation Page
1 Objective 1
2 Authorising provisions 1
3 Principal Regulations 2
4 Definitions 2
5 New definitions inserted 4
6 Possession of Schedule 4 poisons, Schedule 8 poisons and
Schedule 9 poisons 5
7 New regulation 9A inserted 6
9A Patient identity and therapeutic need to be determined—
authorised registered nurse 6
8 Notification of fraudulent obtaining of drugs or poisons 6
9 Pharmacist administration, sale or supply authorised from
outside Victoria 7
10 Disclosure of drug use within previous 8 weeks required 7
11 Style and required particulars for prescriptions 7
12 Containers of drugs to be labelled with certain details 7
13 General security requirement—Schedule 4 poisons 8
14 Storage of Schedule 8 and Schedule 9 poisons 8
15 Persons required to keep records 8
16 Details to be contained in records 8
17 Use of drugs and poisons restricted to person or animal for
whom they were supplied 8
18 Administration of drugs and poisons by a nurse 8
19 Exceptions 9
20 Requirement for warrants 10
21 Warrant number to be included in any prescription 10
22 New regulation 58A inserted 10
58A Therapeutic need to be determined—authorised
registered nurses 10
23 Requirements to supply 11
24 Forms DP1 and DP2A amended 11
25 Statute law revision 11
═══════════════
ENDNOTES 12
-- 1 of 13 --
1
STATUTORY RULES 2010
S.R. No. 131/2010
Drugs, Poisons and Controlled Substances Act 1981
Drugs, Poisons and Controlled Substances
Amendment Regulations 2010
The Governor in Council makes the following Regulations:
Dated: 26 October 2010
Responsible Minister:
DANIEL ANDREWS
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) as a consequence of the enactment of the
Health Practitioner Regulation National
Law (Victoria) Act 2009, which implements
the Health Practitioner Regulation National
Law as a law in Victoria; and
(b) 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.
-- 2 of 13 --
S.R. No. 131/2010
Drugs, Poisons and Controlled Substances Amendment Regulations 2010
2
3 Principal Regulations
In these Regulations, the Drugs, Poisons and
Controlled Substances Regulations 2006 1 are
called the Principal Regulations.
4 Definitions
In regulation 4 of the Principal Regulations—
(a) for the definition of authorised optometrist
substitute—
"authorised optometrist means a registered
optometrist whose registration is
endorsed under section 94 of the Health
Practitioner Regulation National Law;";
(b) for the definition of authorised podiatrist
substitute—
"authorised podiatrist means a registered
podiatrist whose registration is
endorsed under section 94 of the Health
Practitioner Regulation National Law;";
(c) for the definition of nurse substitute—
"nurse means—
(a) a registered nurse;
(b) an enrolled nurse other than an
enrolled nurse who has a notation
on his or her registration
indicating that he or she is not
qualified to administer
medication;";
(d) for the definition of pharmacy substitute—
"pharmacy has the same meaning as it has in
the Pharmacy Regulation Act 2010;";
r. 3
-- 3 of 13 --
S.R. No. 131/2010
Drugs, Poisons and Controlled Substances Amendment Regulations 2010
3
(e) for the definition of pharmacy business
substitute—
"pharmacy business has the same meaning
as it has in the Pharmacy Regulation
Act 2010;";
(f) for the definition of pharmacy department
substitute—
"pharmacy department has the same
meaning as it has in the Pharmacy
Regulation Act 2010;";
(g) for the definition of registered dental
hygienist substitute—
"registered dental hygienist means a person
registered under the Health Practitioner
Regulation National Law—
(a) to practise in the dental profession
as a dental hygienist (other than as
a student); and
(b) in the dental hygienists division of
the Register of Dental
Practitioners.";
(h) for the definition of registered dental
therapist substitute—
"registered dental therapist means a person
registered under the Health Practitioner
Regulation National Law—
(a) to practise in the dental profession
as a dental therapist (other than as
a student); and
(b) in the dental therapists division of
the Register of Dental
Practitioners;".
r. 4
-- 4 of 13 --
S.R. No. 131/2010
Drugs, Poisons and Controlled Substances Amendment Regulations 2010
4
5 New definitions inserted
In regulation 4 of the Principal Regulations, insert
the following definitions—
"authorised registered nurse means a registered
nurse (Division 1) whose registration is
endorsed under section 94 of the Health
Practitioner Regulation National Law;
enrolled nurse means a person registered under
the Health Practitioner Regulation National
Law—
(a) to practise in the nursing and midwifery
profession as a nurse (other than as a
student); and
(b) in the enrolled nurses division of the
Register of Nurses;
midwife means a person registered under the
Health Practitioner Regulation National
Law—
(a) to practise in the nursing and midwifery
profession as a midwife (other than as a
nurse or student); and
(b) in the Register of Midwives kept for
that profession;
registered oral health therapist means a person
registered under the Health Practitioner
Regulation National Law—
(a) to practice in the dental profession as
an oral health therapist (other than as a
student); and
(b) in the oral health therapists division of
the Register of Dental Practitioners;".
r. 5
-- 5 of 13 --
S.R. No. 131/2010
Drugs, Poisons and Controlled Substances Amendment Regulations 2010
5
6 Possession of Schedule 4 poisons, Schedule 8 poisons
and Schedule 9 poisons
(1) In item 4 in Column 1 of the Table in
regulation 5(1) of the Principal Regulations, for
"or nurse practitioner" substitute ", nurse
practitioner or authorised registered nurse".
(2) In item 5 in Column 1 of the Table in
regulation 5(1) of the Principal Regulations, for
"or nurse practitioner" substitute ", nurse
practitioner or authorised registered nurse".
(3) In item 19 in Column 1 of the Table in
regulation 5(1) of the Principal Regulations, after
"nurse" insert "or midwife".
(4) In item 20 in Column 1 of the Table in
regulation 5(1) of the Principal Regulations, for
"or registered dental therapist" substitute
", registered dental therapist or registered oral
health therapist".
(5) In item 20 in Column 2 of the Table in
regulation 5(1) of the Principal Regulations, for
"or registered dental therapist" substitute
", registered dental therapist or registered oral
health therapist".
(6) In regulation 5(2) of the Principal Regulations,
after "nurse" (where first and secondly occurring)
insert "or midwife".
(7) In regulation 5(3) of the Principal Regulations, for
"nurse or class of nurses" substitute "nurse, class
of nurses, midwife or class of midwife".
(8) In regulation 5(4)(b) of the Principal Regulations,
after "nurse" (where first occurring) insert "or
midwife".
r. 6
-- 6 of 13 --
S.R. No. 131/2010
Drugs, Poisons and Controlled Substances Amendment Regulations 2010
6
7 New regulation 9A inserted
After regulation 9 of the Principal Regulations
insert—
"9A Patient identity and therapeutic need to be
determined—authorised registered nurse
(1) An authorised registered nurse must not
administer or supply a Schedule 8 poison
unless—
(a) that poison is for the 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
(c) he or she has taken all reasonable steps
to ensure a therapeutic need exists for
that poison.
Penalty: 100 penalty units.
(2) An authorised registered nurse must not
administer or supply a Schedule 4 poison
unless—
(a) that poison is for the 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.".
8 Notification of fraudulent obtaining of drugs or
poisons
After regulation 14(4) of the Principal Regulations
insert—
"(5) An authorised registered nurse who suspects
or has reason to believe that a person has
obtained from him or her by means of a false
r. 7
-- 7 of 13 --
S.R. No. 131/2010
Drugs, Poisons and Controlled Substances Amendment Regulations 2010
7
pretence a Schedule 8 poison or Schedule 4
poison must immediately inform the
Secretary and a member of the Victoria
Police of that suspicion or belief.
Penalty: 50 penalty units.".
9 Pharmacist administration, sale or supply
authorised from outside Victoria
In regulation 17(a) of the Principal Regulations—
(a) omit "medicine, nursing,";
(b) omit ", dentistry, optometry or podiatry".
10 Disclosure of drug use within previous 8 weeks
required
In regulation 24(1) of the Principal Regulations,
for "dentist or nurse practitioner" substitute
"dentist, nurse practitioner or authorised registered
nurse".
11 Style and required particulars for prescriptions
In regulation 26(3)(g)(ii) of the Principal
Regulations, for "podiatrist or nurse" substitute
"podiatrist, nurse or midwife".
12 Containers of drugs to be labelled with certain
details
(1) In regulation 29(2)(c) of the Principal
Regulations, for "podiatrist or nurse" substitute
"podiatrist, nurse or midwife".
(2) In regulation 29(3) of the Principal Regulations,
after "nurse practitioner" insert "or authorised
registered nurse".
(3) In regulation 29(4) of the Principal Regulations,
after "nurse practitioner" (wherever occurring)
insert "or authorised registered nurse".
r. 9
-- 8 of 13 --
S.R. No. 131/2010
Drugs, Poisons and Controlled Substances Amendment Regulations 2010
8
(4) In regulation 29(4)(b) of the Principal
Regulations, for "podiatrist or nurse" substitute
"podiatrist, nurse or midwife".
(5) In regulation 29(6)(b) of the Principal
Regulations, for "podiatrist or nurse" substitute
"podiatrist, nurse or midwife".
13 General security requirement—Schedule 4 poisons
(1) In regulation 34(2)(b) of the Principal
Regulations, for "podiatrist or nurse" substitute
"podiatrist, nurse or midwife".
(2) In regulation 34(4)(c) of the Principal
Regulations, after "nurse" insert "or midwife".
14 Storage of Schedule 8 and Schedule 9 poisons
In regulation 35(6)(c) of the Principal
Regulations, after "nurse" insert "or midwife".
15 Persons required to keep records
In regulation 39(c) of the Principal Regulations,
after "nurse" insert "or midwife".
16 Details to be contained in records
In regulation 40(1)(h) of the Principal
Regulations, for "or nurse" substitute ", nurse or
midwife".
17 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 "or authorised
registered nurse".
18 Administration of drugs and poisons by a nurse
(1) In the heading to regulation 47 of the Principal
Regulations, after "nurse" insert "or midwife".
r. 13
-- 9 of 13 --
S.R. No. 131/2010
Drugs, Poisons and Controlled Substances Amendment Regulations 2010
9
(2) In regulation 47(1) of the Principal Regulations,
after "nurse" (wherever occurring) insert "or
midwife".
(3) In regulation 47(2) of the Principal Regulations,
after "nurse" (where first occurring) insert "or
midwife".
(4) In regulation 47(2)(c) of the Principal
Regulations, after "to the nurse" insert "or
midwife".
(5) In regulation 47(2)(d) of the Principal
Regulations, after "nurse" insert "or midwife".
(6) In regulation 47(3) of the Principal Regulations,
after "nurse" (where first occurring) insert "or
midwife".
(7) In regulation 47(3)(c) of the Principal
Regulations, after "to the nurse" insert "or
midwife".
(8) In regulation 47(3)(d) of the Principal
Regulations, after "nurse" insert "or midwife".
19 Exceptions
(1) In regulation 51(2)(a) of the Principal
Regulations, for "dentist or nurse" substitute
"dentist, nurse or midwife".
(2) In regulation 51(3)(a) of the Principal
Regulations, for "dentist or nurse" substitute
"dentist, nurse or midwife".
(3) In regulation 51(4)(a) of the Principal
Regulations, for "dentist or nurse" substitute
"dentist, nurse or midwife".
r. 19
-- 10 of 13 --
S.R. No. 131/2010
Drugs, Poisons and Controlled Substances Amendment Regulations 2010
10
20 Requirement for warrants
After regulation 53(2) of the Principal Regulations
insert—
"(3) A nurse practitioner acting in accordance
with the instruction of a registered medical
practitioner who holds a warrant may use,
supply or prescribe an ovulatory stimulant, a
prostaglandin, a retinoid or thalidomide with
respect to a specific patient in accordance
with the authorisation given by the warrant.".
21 Warrant number to be included in any prescription
For regulation 54(2) of the Principal Regulations
substitute—
"(2) A registered medical practitioner or nurse
practitioner who prescribes an ovulatory
stimulant, a prostaglandin, a retinoid or
thalidomide on the direction of the warrant
holder must include on the prescription—
(a) the name of the registered medical
practitioner who holds the warrant; and
(b) the warrant number.
Penalty: 10 penalty units.".
22 New regulation 58A inserted
After regulation 58 of the Principal Regulations
insert—
"58A Therapeutic need to be determined—
authorised registered nurses
An authorised registered nurse must not
administer or supply a Schedule 3 poison
unless—
(a) that poison is for the treatment of a
person under his or her care; and
r. 20
-- 11 of 13 --
S.R. No. 131/2010
Drugs, Poisons and Controlled Substances Amendment Regulations 2010
11
(b) he or she has taken all reasonable steps
to ensure a therapeutic need exists for
that poison.
Penalty: 50 penalty units.".
23 Requirements to supply
In regulation 63(1) of the Principal Regulations,
after "nurse practitioner," insert "an authorised
registered nurse,".
24 Forms DP1 and DP2A amended
(1) In Form DP1 in Schedule 2 to the Principal
Regulations omit—
(a) "Occupation"; and
(b) "Height".
(2) In Form DP2A in Schedule 2 to the Principal
Regulations omit—
(a) "Name and address of hospital where patient
is undergoing treatment (if applicable)"; and
(b) "Height".
25 Statute law revision
(1) In regulation 22B(4) of the Principal Regulations,
for "effect" substitute "effect.".
(2) In Form DP2 in Schedule 2 to the Principal
Regulations, for "Regulations 19(1)" substitute
"Regulation 19(1)".
(3) In Form DP3 in Schedule 2 to the Principal
Regulations, for "Regulation 20" substitute
"Regulations 20".
═══════════════
r. 23
-- 12 of 13 --
S.R. No. 131/2010
Drugs, Poisons and Controlled Substances Amendment Regulations 2010
12
ENDNOTES
1 Reg. 3: S.R. No. 57/2006 as amended by S.R. Nos 63/2007 and 16/2009.
Endnotes
-- 13 of 13 --