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. 1 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 r. 6 Drugs, Poisons and Controlled Substances (Health Professions Amendment) 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". 6 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 r. 13 Drugs, Poisons and Controlled Substances (Health Professions Amendment) 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 r. 19 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