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Drugs, Poisons and Controlled Substances (Health
Professions Amendment) Regulations 2007
S.R. No. 63/2007
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
Page
Objective
Authorising provisions
Commencement
Principal Regulations
Definitions
Possession of Schedule 4 poisons, Schedule 8 poisons and
Schedule 9 poisons
Approval of Schedule 4 poisons and Schedule 8 poisons
6
Approval of Schedule 4 poisons and Schedule 8
poisons
Therapeutic need to be determined—authorised podiatrists
11A
Therapeutic need to be determined—authorised
podiatrists
Notification of fraudulent obtaining of drugs or poisons
Pharmacist administration, sale or supply authorised from
within Victoria
Pharmacist administration, sale or supply authorised from
outside Victoria
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
General security requirement—Schedule 4 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
Self administration of drugs and poisons restricted
Exceptions
Prescribed poisons for categories of nurse practitioner
i
1
1
1
1
2
3
5
5
5
5
6
6
6
6
7
7
7
8
8
8
9
9
9
10
10
11
Regulation
Page
25
New Regulations 60A and 60B inserted
60A
Therapeutic need to be determined—authorised
optometrists
60B
Therapeutic need to be determined—authorised
podiatrists
26
Therapeutic need to be determined—pharmacists
27
Requirements to supply
28
Lost or stolen poisons to be notified
29
Schedule 3 revoked
═══════════════
ENDNOTES
ii
11
11
12
12
12
12
12
13
STATUTORY RULES 2007
S.R. No. 63/2007
Drugs, Poisons and Controlled Substances Act 1981
Drugs, Poisons and Controlled Substances (Health
Professions Amendment) Regulations 2007
The Governor in Council makes the following Regulations:
Dated: 26 June 2007
Responsible Minister:
BRONWYN PIKE
Minister for Health
RUTH LEACH
Clerk of the Executive Council
1 Objective
The objective of these Regulations is to amend the
Drugs, Poisons and Controlled Substances
Regulations 2006 consequential on the Health
Professions Registration Act 2005.
2 Authorising provisions
These Regulations are made under sections 129,
131, 132 and 132B of the Drugs, Poisons and
Controlled Substances Act 1981.
3 Commencement
These Regulations come into operation on 1 July
2007.
4 Principal Regulations
In these Regulations, the Drugs, Poisons and
Controlled Substances Regulations 20061 are
called the Principal Regulations.
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Drugs, Poisons and Controlled Substances (Health Professions Amendment)
Regulations 2007
r. 5
S.R. No. 63/2007
5 Definitions
(1) In regulation 4 of the Principal Regulations—
(a) in the definition of authorised optometrist,
for "section 11 of the Optometrists
Registration Act 1996" substitute
"section 23 of the Health Professions
Registration Act 2005";
(b) in the definition of nurse—
(i) in paragraph (a), for "of nurses
established under the Nurses Act 1993"
substitute "kept by the Nurses Board
of Victoria under section 30 of the
Health Professions Registration Act
2005";
(ii) in paragraph (b), for "8C" substitute
"22";
(c) in the definition of pharmacy, for
"Pharmacy Practice Act 2004" substitute
"Health Professions Registration Act
2005";
(d) in the definition of pharmacy business, for
"Pharmacy Practice Act 2004" substitute
"Health Professions Registration Act
2005";
(e) in the definition of pharmacy department,
for "Pharmacy Practice Act 2004"
substitute "Health Professions
Registration Act 2005";
(f) the definition of podiatrist is revoked;
2
Drugs, Poisons and Controlled Substances (Health Professions Amendment)
Regulations 2007
S.R. No. 63/2007
(g) for the definition of registered dental
auxiliary substitute—
"registered dental hygienist means a person
who is registered in the division of
dental hygienists of the register kept by
the Dental Practice Board of Victoria
under section 30 of the Health
Professions Registration Act 2005;
registered dental therapist means a person
who is registered in the division of
dental therapists of the register kept by
the Dental Practice Board of Victoria
under section 30 of the Health
Professions Registration Act 2005;".
(2) In regulation 4 of the Principal Regulations, insert
the following definition—
"authorised podiatrist means a registered
podiatrist whose registration is endorsed
under section 24 of the Health Professions
Registration Act 2005;".
6 Possession of Schedule 4 poisons, Schedule 8 poisons
and Schedule 9 poisons
(1) In paragraph (e) in item 2 in Column 2 of the
Table in regulation 5(1) of the Principal
Regulations, for "optometrist." substitute
"optometrist; or".
(2) After paragraph (e) in item 2 in Column 2 of the
Table in regulation 5(1) of the Principal
Regulations insert—
"(f) in the case of a Schedule 4 poison specified
in his or her endorsement of registration, an
authorised podiatrist.".
3
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Regulations 2007
r. 6
S.R. No. 63/2007
(3) After item 6 in the Table in regulation 5(1) of the
Principal Regulations insert—
"6A
A person for whom a
Schedule 4 poison has been
supplied in accordance with the
Act and these Regulations by an
authorised podiatrist whose
endorsement of registration
specifies that Schedule 4 poison.
That Schedule 4
poison to the
extent and for
the purpose for
which it is
supplied.".
(4) In item 15 in Column 1 of the Table in
regulation 5(1) of the Principal Regulations, after
"A" insert "registered".
(5) For item 20 in the Table in regulation 5(1) of the
Principal Regulations substitute—
"20
A registered dental
hygienist or
registered dental
therapist.
Those Schedule 4 poisons
approved by the Secretary
that are required for the
provision of dental care by
the registered dental
hygienist or registered
dental therapist.".
(6) In regulation 5 of the Principal Regulations—
(a) in subregulation (2)(a)(iii), after "authorised
optometrist" insert "or an authorised
podiatrist";
(b) in subregulation (3)(c), after "authorised
optometrist" insert "or an authorised
podiatrist";
(c) in subregulation (4)(b), for "or authorised
optometrist" substitute ", an authorised
optometrist or an authorised podiatrist".
4
Drugs, Poisons and Controlled Substances (Health Professions Amendment)
Regulations 2007
S.R. No. 63/2007
7 Approval of Schedule 4 poisons and Schedule 8
poisons
For regulation 6 of the Principal Regulations
substitute—
"6 Approval of Schedule 4 poisons and
Schedule 8 poisons
The Secretary may approve Schedule 4
poisons or Schedule 8 poisons or classes of
Schedule 4 poisons or Schedule 8 poisons
for possession and use by a person or class of
persons specified in an item in Column 1 of
Part 2 of the table in regulation 5 to the
extent specified in column 2 of the item
applicable to that person or class of person.".
8 Therapeutic need to be determined—authorised
podiatrists
After regulation 11 of the Principal Regulations
insert—
"11A Therapeutic need to be determined—
authorised podiatrists
An authorised podiatrist must not administer,
prescribe, sell or supply a Schedule 4 poison
unless—
(a) that poison is for the podiatric treatment
of a person under his or her care; and
(b) the podiatrist has taken all reasonable
steps to ensure a therapeutic need exists
for that poison.
Penalty: 100 penalty units.".
5
r. 7
Drugs, Poisons and Controlled Substances (Health Professions Amendment)
Regulations 2007
r. 9
S.R. No. 63/2007
9 Notification of fraudulent obtaining of drugs or
poisons
After regulation 14(3) of the Principal Regulations
insert—
"(4) An authorised podiatrist who suspects or has
reason to believe that a person has obtained
from him or her by means of a false
pretence, a Schedule 4 poison or an order or
prescription for a Schedule 4 poison, must
immediately inform the Secretary and a
member of the Victoria Police of that
suspicion or belief.
Penalty: 50 penalty units.".
10 Pharmacist administration, sale or supply
authorised from within Victoria
(1) In regulation 15(1)(b)(iii) of the Principal
Regulations, after "authorised optometrist" insert
"or an authorised podiatrist".
(2) In regulation 15(1)(e)(ii) of the Principal
Regulations, after "authorised optometrist" insert
"or an authorised podiatrist".
11 Pharmacist administration, sale or supply
authorised from outside Victoria
In regulation 17(a) of the Principal Regulations,
for "dentistry or optometry" substitute "dentistry,
optometry or podiatry".
12 Persons authorised to write prescriptions
(1) In regulation 25(3) of the Principal Regulations,
for "or authorised optometrist" substitute ", an
authorised optometrist or an authorised
podiatrist".
(2) In regulation 25(6) of the Principal Regulations,
after "authorised optometrist" insert "or an
authorised podiatrist".
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Drugs, Poisons and Controlled Substances (Health Professions Amendment)
Regulations 2007
S.R. No. 63/2007
13 Style and required particulars for prescriptions
In regulation 26(3)(g)(ii) of the Principal
Regulations, after "authorised optometrist" insert
", authorised podiatrist".
14 Emergency directions to pharmacists regarding
supply
(1) In regulation 27(3) of the Principal Regulations—
(a) after "an authorised optometrist" insert "or
an authorised podiatrist";
(b) after "the authorised optometrist" insert "or
the authorised podiatrist".
(2) In regulation 27(4) of the Principal Regulations,
for "or authorised optometrist" substitute ", an
authorised optometrist or an authorised
podiatrist".
15 Containers of drugs to be labelled with certain
details
(1) In regulation 29(2)(c) of the Principal
Regulations, after "authorised optometrist" insert
", authorised podiatrist".
(2) In regulation 29(4)(b) of the Principal
Regulations, after "authorised optometrist" insert
", authorised podiatrist".
(3) In regulation 29(5) of the Principal Regulations,
after "An authorised optometrist" insert "or an
authorised podiatrist".
(4) In regulation 29(6) of the Principal Regulations—
(a) after "An authorised optometrist" insert "or
an authorised podiatrist";
(b) in paragraph (a), after "authorised
optometrist" insert "or authorised
podiatrist";
7
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Regulations 2007
r. 16
S.R. No. 63/2007
(c) in paragraph (b), for "authorised optometrist"
substitute "an authorised optometrist, an
authorised podiatrist".
16 General security requirement—Schedule 4 poisons
(1) In regulation 34(2)(b) of the Principal
Regulations, for "authorised optometrist or"
substitute "an authorised optometrist, an
authorised podiatrist or".
(2) In regulation 34(3) of the Principal Regulations,
for "or authorised optometrist" (wherever
occurring) substitute ", an authorised optometrist
or an authorised podiatrist".
(3) In regulation 34(4)(a) of the Principal
Regulations, for "and authorised optometrist"
substitute ", an authorised optometrist and an
authorised podiatrist".
17 Persons required to keep records
In regulation 39(a) of the Principal Regulations,
for "and authorised optometrist" substitute ", an
authorised optometrist and an authorised
podiatrist".
18 Details to be contained in records
(1) After regulation 40(1)(g) of the Principal
Regulations insert—
"(ga) in the case of a Schedule 8 poison listed in
the health services permit held by an
ambulance service within the meaning of the
Ambulance Services Act 1986 which has
been destroyed by an operational staff
member within the meaning of that Act in
accordance with regulation 51(4A)(a), the
matters set out in regulation 51(4A)(b); and".
8
Drugs, Poisons and Controlled Substances (Health Professions Amendment)
Regulations 2007
S.R. No. 63/2007
(2) In regulation 40(2) of the Principal Regulations,
for "or authorised optometrist" substitute ", an
authorised optometrist or an authorised
podiatrist".
19 Use of drugs and poisons restricted to person or
animal for whom they were supplied
In regulation 45(3) of the Principal Regulations,
after "authorised optometrist" insert "or an
authorised podiatrist".
20 Administration of drugs and poisons to be
authorised
(1) In regulation 46(3) of the Principal Regulations,
after "authorised optometrist" insert "or an
authorised podiatrist".
(2) In regulation 46(6) of the Principal Regulations,
after "authorised optometrist" insert "or an
authorised podiatrist".
21 Administration of drugs and poisons by a nurse
(1) In regulation 47(3)(a) and (b) of the Principal
Regulations, for "or authorised optometrist"
(wherever occurring) substitute ", an authorised
optometrist or an authorised podiatrist".
(2) For regulation 47(3)(c) of the Principal
Regulations substitute—
"(c) on the oral instruction of a registered medical
practitioner, dentist, nurse practitioner, an
authorised optometrist or an authorised
podiatrist to the nurse, if in the opinion of the
registered medical practitioner, dentist, nurse
practitioner, authorised optometrist or
authorised podiatrist, an emergency exists;
or".
9
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Drugs, Poisons and Controlled Substances (Health Professions Amendment)
Regulations 2007
r. 22
S.R. No. 63/2007
(3) In regulation 47(4) of the Principal Regulations,
for "or authorised optometrist" substitute ", an
authorised optometrist or an authorised
podiatrist".
22 Self administration of drugs and poisons restricted
For regulation 48(c) of the Principal Regulations,
substitute—
"(c) in the case of a Schedule 4 poison—
(i) is a patient for whom—
(A) a registered medical practitioner,
dentist or nurse practitioner; or
(B) an authorised optometrist or an
authorised podiatrist (in
accordance with the endorsement
of his or her registration)—
has prescribed that poison; and
(ii) is not the registered medical
practitioner, dentist, nurse practitioner,
authorised optometrist or authorised
podiatrist who prescribed that poison;
and".
23 Exceptions
(1) After regulation 51(4) of the Principal Regulations
insert—
"(4A) Subject to subregulation (5), regulation 50
does not apply to the unused contents of a
previously sterile container containing a
Schedule 8 poison listed in the health
services permit held by an ambulance service
within the meaning of the Ambulance
Services Act 1986 that are not required for
administration to a patient if—
10
Drugs, Poisons and Controlled Substances (Health Professions Amendment)
Regulations 2007
S.R. No. 63/2007
(a) those contents are destroyed by an
operational staff member (within the
meaning of that Act) of that ambulance
service; and
(b) the details of the destruction are
recorded in the records required to be
kept under regulation 40, including—
(i) the name, strength and quantity of
the poison or controlled
substances destroyed; and
(ii) the method and place of
destruction; and
(iii) the name of the person carrying
out the destruction.".
(2) In regulation 51(5) of the Principal Regulations,
for "(3) or (4)" substitute "(3), (4) or (4A)".
24 Prescribed poisons for categories of nurse
practitioner
Part 3 of the Principal Regulations is revoked.
25 New Regulations 60A and 60B inserted
After regulation 60 of the Principal Regulations
insert—
"60A Therapeutic need to be determined—
authorised optometrists
An authorised optometrist must not
administer, prescribe, sell or supply a
Schedule 3 poison unless—
(a) that poison is for the ocular 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: 50 penalty units.
11
r. 24
Drugs, Poisons and Controlled Substances (Health Professions Amendment)
Regulations 2007
r. 26
S.R. No. 63/2007
60B Therapeutic need to be determined—
authorised podiatrists
An authorised podiatrist must not administer,
prescribe, sell or supply a Schedule 3 poison
unless—
(a) that poison is for the podiatric 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: 50 penalty units.".
26 Therapeutic need to be determined—pharmacists
In regulation 61(b) of the Principal Regulations,
after "dentist" insert ", an authorised optometrist,
an authorised podiatrist".
27 Requirements to supply
(1) In regulation 63(1) of the Principal Regulations,
for "or nurse practitioner" substitute ", nurse
practitioner, an authorised optometrist or an
authorised podiatrist".
(2) In regulation 63(3) of the Principal Regulations,
for "or nurse practitioner" substitute ", nurse
practitioner, an authorised optometrist or an
authorised podiatrist".
28 Lost or stolen poisons to be notified
In regulation 70(2)(a) of the Principal
Regulations, for "and an authorised optometrist"
substitute ", an authorised optometrist and an
authorised podiatrist".
29 Schedule 3 revoked
Schedule 3 to the Principal Regulations is
revoked.
═══════════════
12
Drugs, Poisons and Controlled Substances (Health Professions Amendment)
Regulations 2007
S.R. No. 63/2007
ENDNOTES
1
Reg. 4: S.R. No. 57/2006.
13
Endnotes