Drugs, Poisons and Controlled Substances Amendment Regulations 2009

i Drugs, Poisons and Controlled Substances Amendment Regulations 2009 S.R. No. 16/2009 TABLE OF PROVISIONS Regulation Page 1 Objective 1 2 Authorising provision 1 3 Commencement 1 4 Principal Regulations 2 5 Definitions 2 6 Regulations 18 to 22 substituted and new regulations 22A and 22B inserted 2 18 Form of notification of a drug-dependent person 2 19 Form of application for Schedule 9 permit or Schedule 8 permit 2 20 Form of Schedule 9 permit and Schedule 8 permit 3 21 Permit required in particular circumstances for supply of methadone 3 22 Permit required in particular circumstances for supply of amphetamine, dexamphetamine, methylamphetamine and methylphenidate 4 22A Applications for permits under regulations 21 or 22 5 22B Secretary may issue a Schedule 8 permit 5 7 Storage of Schedule 8 or Schedule 9 poisons 6 8 Forms DP1, DP2 and DP3 substituted and new Form DP2A 6 Form DP1—Notification of Drug-Dependent Person 6 Form DP2—Treatment with Schedule 9 Poisons by a Registered Medical Practitioner 8 Form DP2A—Treatment with Schedule 8 Poisons by a Registered Medical Practitioner or a Nurse Practitioner 10 Form DP3—Schedule 8 Permit/Schedule 9 Permit 12 9 Statute law revision 13 ═══════════════ ENDNOTES 14 -- 1 of 15 -- 1 STATUTORY RULES 2009 S.R. No. 16/2009 Drugs, Poisons and Controlled Substances Act 1981 Drugs, Poisons and Controlled Substances Amendment Regulations 2009 The Governor in Council makes the following Regulations: Dated: 24 February 2009 Responsible Minister: DANIEL ANDREWS Minister for Health RYAN HEATH Clerk of the Executive Council 1 Objective The objective of these Regulations is to amend the Drugs, Poisons and Controlled Substances Regulations 2006 as a consequence of the enactment of Part 3 of the Drugs, Poisons and Controlled Substances Amendment Act 2008 dealing with Schedule 8 poisons and Schedule 9 poisons, and make other minor amendments. 2 Authorising provision These Regulations are made under section 132 of the Drugs, Poisons and Controlled Substances Act 1981. 3 Commencement (1) These Regulations, except regulations 6, 7 and 8, come into operation on the day on which these Regulations are made. -- 2 of 15 -- S.R. No. 16/2009 Drugs, Poisons and Controlled Substances Amendment Regulations 2009 2 (2) Regulations 6, 7 and 8 come into operation on 1 March 2009. 4 Principal Regulations In these Regulations, the Drugs, Poisons and Controlled Substances Regulations 2006 1 are called the Principal Regulations. 5 Definitions In regulation 4 of the Principal Regulations insert the following definition— "thalidomide means— (a) thalidomide for human use; or (b) a substance listed as a thalidomide-like substance in Part 2 of Chapter 1 of the Poisons Code;". 6 Regulations 18 to 22 substituted and new regulations 22A and 22B inserted For regulations 18 to 22 of the Principal Regulations substitute— "18 Form of notification of a drug-dependent person For the purposes of section 33(5) of the Act, the prescribed form is the form of DP1 in Schedule 2. 19 Form of application for Schedule 9 permit or Schedule 8 permit (1) For the purposes of section 33A(2) of the Act, the prescribed form of application for a Schedule 9 permit is the form of DP2 in Schedule 2. (2) For the purposes of sections 34(4) of the Act, the prescribed form of application for a Schedule 8 permit is the form of DP2A in Schedule 2. r. 4 -- 3 of 15 -- S.R. No. 16/2009 Drugs, Poisons and Controlled Substances Amendment Regulations 2009 3 20 Form of Schedule 9 permit and Schedule 8 permit (1) For the purposes of section 33B(2) of the Act, the prescribed form of a Schedule 9 permit is the form of DP3 in Schedule 2. (2) For the purposes of section 34A(2) of the Act, the prescribed form of a Schedule 8 permit is the form of DP3 in Schedule 2. 21 Permit required in particular circumstances for supply of methadone (1) For the purposes of preventing the improper use of methadone, a registered medical practitioner or nurse practitioner must not administer, supply or prescribe methadone in circumstances where the registered medical practitioner or nurse practitioner is not required to hold a Schedule 8 permit unless he or she— (a) has a permit from the Secretary authorising that registered medical practitioner or nurse practitioner to administer, supply or prescribe methadone; or (b) is authorised by section 34D, 34E or 34F of the Act to administer, supply or prescribe methadone. Penalty: 100 penalty units. (2) Despite subregulation (1), a registered medical practitioner or nurse practitioner is not required to have a permit under this regulation if— (a) he or she is treating a patient at an oncology clinic or a pain clinic at a hospital; or r. 6 -- 4 of 15 -- S.R. No. 16/2009 Drugs, Poisons and Controlled Substances Amendment Regulations 2009 4 (b) he or she is treating a patient who is under the care of a palliative care service. 22 Permit required in particular circumstances for supply of amphetamine, dexamphetamine, methylamphetamine and methylphenidate (1) For the purposes of preventing the improper use of amphetamine, dexamphetamine, methylamphetamine or methylphenidate, a registered medical practitioner or nurse practitioner must not administer, supply or prescribe any one or more of those substances in circumstances where the registered medical practitioner or nurse practitioner is not required to hold a Schedule 8 permit unless he or she— (a) has a permit from the Secretary authorising that registered medical practitioner or nurse practitioner to administer, supply or prescribe one or more of those substances; or (b) is authorised by section 34D, 34E or 34F of the Act to administer, supply or prescribe any one or more of those substances. Penalty: 100 penalty units. (2) Despite subregulation (1), a registered medical practitioner is not required to have a permit under this regulation if he or she is— (a) a paediatrician who is treating a person for attention deficit disorder; or (b) a psychiatrist who is treating a person for attention deficit disorder. r. 6 -- 5 of 15 -- S.R. No. 16/2009 Drugs, Poisons and Controlled Substances Amendment Regulations 2009 5 22A Applications for permits under regulations 21 or 22 (1) The prescribed form of an application for a permit required under regulation 21 authorising the administration, supply or prescription of methadone is the form of DP2A in Schedule 2. (2) The prescribed form of an application for a permit required under regulation 22 authorising the administration, supply or prescription of amphetamine, dexamphetamine, methylamphetamine or methylphenidate is the form of DP2A in Schedule 2. 22B Secretary may issue a Schedule 8 permit (1) On receiving an application for a permit under regulation 21, the Secretary may issue a Schedule 8 permit to a registered medical practitioner or a nurse practitioner authorising the practitioner to administer, supply or prescribe methadone to or for a person who is not a drug-dependent person. (2) On receiving an application for a permit under regulation 22, the Secretary may issue a Schedule 8 permit to a registered medical practitioner or a nurse practitioner authorising the practitioner to administer, supply or prescribe amphetamine, dexamphetamine, methylamphetamine or methylphenidate to or for a person who is not a drug-dependent person. (3) A Schedule 8 permit issued under subregulation (1) or (2) must be in the form of DP3 in Schedule 2. r. 6 -- 6 of 15 -- S.R. No. 16/2009 Drugs, Poisons and Controlled Substances Amendment Regulations 2009 6 (4) The Secretary may at any time amend, suspend or revoke a Schedule 8 permit issued under subregulation (1) or (2) and any permit which is suspended or revoked ceases to have effect". 7 Storage of Schedule 8 or Schedule 9 poisons For regulation 35(5) of the Principal Regulations substitute— "(5) Despite subregulations (1) and (3), a person to whom this regulation applies may keep up to 6 divided doses of a Schedule 8 poison in a lockable storage facility for use in an emergency.". 8 Forms DP1, DP2 and DP3 substituted and new Form DP2A (1) For Forms DP1 and DP2 in Schedule 2 to the Principal Regulations substitute— "FORM DP1 Regulation 18 Drugs, Poisons and Controlled Substances Regulations 2006 NOTIFICATION OF DRUG-DEPENDENT PERSON I, [full name of registered medical practitioner/nurse practitioner] of [address, telephone and fax numbers of registered medical practitioner/nurse practitioner] have reason to believe that [full name of patient] of [address of patient] is dependent on [name of drug(s)] and my belief is based on the following grounds: PATIENT DETAILS Aliases (if any) Height Occupation Sex Date of birth r. 7 -- 7 of 15 -- S.R. No. 16/2009 Drugs, Poisons and Controlled Substances Amendment Regulations 2009 7 Approximate period of drug dependency Other drugs used by patient DPU number (if known) Source of drugs Was a Schedule 8 poison or Schedule 9 poison or a Schedule 4 poison that is a drug of dependence requested? If so, which Schedule poison(s) Is it your intention to prescribe a Schedule 8 poison or Schedule 9 poison or a Schedule 4 poison that is a drug of dependence? If so, which Schedule poison(s) Signature of registered medical practitioner/nurse practitioner Date __________________ r. 8 -- 8 of 15 -- S.R. No. 16/2009 Drugs, Poisons and Controlled Substances Amendment Regulations 2009 8 FORM DP2 Regulations 19(1) Drugs, Poisons and Controlled Substances Regulations 2006 TREATMENT WITH SCHEDULE 9 POISONS BY A REGISTERED MEDICAL PRACTITIONER (Application for permit to administer, prescribe or supply) FOR TREATMENT WITH SCHEDULE 9 POISONS Section 1: (To be completed in all cases) Full name of patient Date of birth Sex Private address of patient Postcode Full name and qualifications of registered medical practitioner Address of registered medical practitioner Postcode Telephone and fax no. of registered medical practitioner Name and address of hospital where patient is undergoing treatment (if applicable) Clinical diagnosis Attach research literature which supports the efficacy of the Schedule 9 poison for that clinical diagnosis Pharmaceutical product which contains the Schedule 9 poison Country in which the Schedule 9 poison is registered for therapeutic use Section 2: Schedule 9 poison(s) for which permit is requested: NAME OF POISON(S) EXPECTED MAXIMUM DAILY DOSE r. 8 -- 9 of 15 -- S.R. No. 16/2009 Drugs, Poisons and Controlled Substances Amendment Regulations 2009 9 Details of other treatment (if applicable) Signature of registered medical practitioner Date __________________ r. 8 -- 10 of 15 -- S.R. No. 16/2009 Drugs, Poisons and Controlled Substances Amendment Regulations 2009 10 FORM DP2A Regulations 19(2), 22A Drugs, Poisons and Controlled Substances Regulations 2006 TREATMENT WITH SCHEDULE 8 POISONS BY A REGISTERED MEDICAL PRACTITIONER OR A NURSE PRACTITIONER (Application for permit to administer, prescribe or supply) PART A: FOR TREATMENT WITH SCHEDULE 8 POISONS OTHER THAN TREATMENT OF AN OPIOID DEPENDENT PERSON WITH METHADONE OR BUPRENORPHINE Section 1: (To be completed in all cases) Full name of patient Date of birth Sex Private address of patient Postcode Full name and qualifications of registered medical practitioner/nurse practitioner Address of registered medical practitioner/nurse practitioner Postcode Telephone and fax no. of registered medical practitioner/nurse practitioner Name and address of hospital where patient is undergoing treatment (if applicable) Clinical diagnosis Section 2: Schedule 8 poison(s) for which permit is requested: NAME OF POISON(S) EXPECTED MAXIMUM DAILY DOSE Details of other treatment (if applicable) r. 8 -- 11 of 15 -- S.R. No. 16/2009 Drugs, Poisons and Controlled Substances Amendment Regulations 2009 11 Signature of registered medical practitioner/nurse practitioner Date PART B: FOR TREATMENT OF AN OPIOID DEPENDENT PERSON WITH METHADONE OR BUPRENORPHINE I, [full name of registered medical practitioner/nurse practitioner] of [address of registered medical practitioner/nurse practitioner, including postcode, phone and fax numbers] certify that this patient shows evidence of dependence on an opioid drug and that, in my opinion, methadone/buprenorphine is required in support of treatment. Personal Details: Full name of patient Address of patient Date of birth DPU client number (if known) Sex Aliases (if any) Mother's full maiden name Height Medical Details of Patient: Starting drug Starting methadone/buprenorphine dose Anticipated date of first dose Period for which permit sought (if short term) r. 8 -- 12 of 15 -- S.R. No. 16/2009 Drugs, Poisons and Controlled Substances Amendment Regulations 2009 12 Has the patient been treated previously with methadone or buprenorphine for opioid dependency? Yes/No Is the patient transferring from another prescriber? Yes/No If yes, what was the last drug prescribed? When was the last dose administered? Has the previous prescriber been advised of the transfer? Yes/No Name of previous prescriber Name, address and telephone number of person dispensing methadone/buprenorphine Signature of registered medical practitioner/nurse practitioner Date _______________". (2) For Form DP3 in Schedule 2 to the Principal Regulations substitute— "FORM DP3 Regulation 20, 22B(3) Drugs, Poisons and Controlled Substances Regulations 2006 SCHEDULE 8 PERMIT/SCHEDULE 9 PERMIT This permit is granted to [full name and address of registered medical practitioner/nurse practitioner] and authorises that registered medical practitioner/nurse practitioner to administer, prescribe or supply the following poison(s) in accordance with the following details and conditions. The poison(s) must not be administered, prescribed or supplied in excess of the quantities specified, or for a period greater than that specified in this permit. r. 8 -- 13 of 15 -- S.R. No. 16/2009 Drugs, Poisons and Controlled Substances Amendment Regulations 2009 13 Name of patient Address of patient NAME OF POISON MAXIMUM DOSE Special conditions: (if any) This permit is valid from [date] to [date (if applicable)] unless sooner revoked or suspended. Date Secretary _______________". 9 Statute law revision In regulation 46(6) of the Principal Regulations for "podiatristif" substitute "podiatrist if". ═══════════════ r. 9 -- 14 of 15 -- S.R. No. 16/2009 Drugs, Poisons and Controlled Substances Amendment Regulations 2009 14 ENDNOTES 1 Reg. 4: S.R. No. 57/2006 as amended by S.R. No. 63/2007. Endnotes -- 15 of 15 --