Drugs, Poisons and Controlled Substances Amendment Regulations 2012

Authorised by the Chief Parliamentary Counsel Authorised Version i Drugs, Poisons and Controlled Substances Amendment Regulations 2012 S.R. No. 136/2012 TABLE OF PROVISIONS Regulation Page 1 Objective 1 2 Authorising provisions 2 3 Commencement 2 4 Principal Regulations 2 5 Definitions 2 6 Possession of Schedule 4 poisons, Schedule 8 poisons and Schedule 9 poisons 2 7 Patient identity and therapeutic need to be determined— nurse practitioners 4 8 Patient identity and therapeutic need to be determined— authorised registered nurse 4 9 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 7 12 Pharmacist administration, sale or supply authorised from within Victoria 7 13 Disclosure of drug use within previous 8 weeks required 8 14 Persons authorised to write prescriptions 8 15 Style and required particulars for prescriptions 8 16 Emergency directions to pharmacists regarding supply 8 17 Containers of drugs to be labelled with certain details 9 18 Retention of original prescriptions or orders once supply completed 9 19 General security requirement—Schedule 4 poisons 10 20 Storage of Schedule 8 and Schedule 9 poisons 10 21 Persons required to keep records 10 22 Details to be contained in records 11 23 Use of drugs and poisons restricted to person or animal for whom they were supplied 11 24 Administration of drugs and poisons to be authorised 11 25 Administration of drugs and poisons by a nurse or midwife 11 26 Self-administration of drugs and poisons restricted 13 -- 1 of 18 -- Regulation Page ii Authorised by the Chief Parliamentary Counsel 27 Exceptions 14 28 New regulation 58B inserted 14 58B Therapeutic need to be determined—authorised registered midwives 14 29 Therapeutic need to be determined—pharmacists 15 30 Requirements to supply 15 31 Lost or stolen poisons to be notified 15 ═══════════════ ENDNOTES 16 -- 2 of 18 -- Authorised by the Chief Parliamentary Counsel Authorised Version 1 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 -- 3 of 18 -- S.R. No. 136/2012 Drugs, Poisons and Controlled Substances Amendment Regulations 2012 2 Authorised by the Chief Parliamentary Counsel (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". r. 2 -- 4 of 18 -- S.R. No. 136/2012 Drugs, Poisons and Controlled Substances Amendment Regulations 2012 3 Authorised by the Chief Parliamentary Counsel (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,". r. 6 -- 5 of 18 -- S.R. No. 136/2012 Drugs, Poisons and Controlled Substances Amendment Regulations 2012 4 Authorised by the Chief Parliamentary Counsel 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). r. 7 -- 6 of 18 -- S.R. No. 136/2012 Drugs, Poisons and Controlled Substances Amendment Regulations 2012 5 Authorised by the Chief Parliamentary Counsel 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 r. 9 -- 7 of 18 -- S.R. No. 136/2012 Drugs, Poisons and Controlled Substances Amendment Regulations 2012 6 Authorised by the Chief Parliamentary Counsel (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.". r. 9 -- 8 of 18 -- S.R. No. 136/2012 Drugs, Poisons and Controlled Substances Amendment Regulations 2012 7 Authorised by the Chief Parliamentary Counsel 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". r. 10 -- 9 of 18 -- S.R. No. 136/2012 Drugs, Poisons and Controlled Substances Amendment Regulations 2012 8 Authorised by the Chief Parliamentary Counsel (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". r. 13 -- 10 of 18 -- S.R. No. 136/2012 Drugs, Poisons and Controlled Substances Amendment Regulations 2012 9 Authorised by the Chief Parliamentary Counsel (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". r. 17 -- 11 of 18 -- S.R. No. 136/2012 Drugs, Poisons and Controlled Substances Amendment Regulations 2012 10 Authorised by the Chief Parliamentary Counsel 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". r. 19 -- 12 of 18 -- S.R. No. 136/2012 Drugs, Poisons and Controlled Substances Amendment Regulations 2012 11 Authorised by the Chief Parliamentary Counsel 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". r. 22 -- 13 of 18 -- S.R. No. 136/2012 Drugs, Poisons and Controlled Substances Amendment Regulations 2012 12 Authorised by the Chief Parliamentary Counsel (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,". r. 25 -- 14 of 18 -- S.R. No. 136/2012 Drugs, Poisons and Controlled Substances Amendment Regulations 2012 13 Authorised by the Chief Parliamentary Counsel (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". r. 26 -- 15 of 18 -- S.R. No. 136/2012 Drugs, Poisons and Controlled Substances Amendment Regulations 2012 14 Authorised by the Chief Parliamentary Counsel (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 r. 27 -- 16 of 18 -- S.R. No. 136/2012 Drugs, Poisons and Controlled Substances Amendment Regulations 2012 15 Authorised by the Chief Parliamentary Counsel (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,". ═══════════════ r. 29 -- 17 of 18 -- S.R. No. 136/2012 Drugs, Poisons and Controlled Substances Amendment Regulations 2012 16 Authorised by the Chief Parliamentary Counsel ENDNOTES 1 Reg. 4: S.R. No. 57/2006. Reprint No. 1 as at 16 June 2011. Reprinted to S.R. No. 131/2010. Endnotes -- 18 of 18 --