Untitled document

Drugs, Poisons and Controlled Substances Amendment Regulations 2009

S.R. No. 16/2009

TABLE OF PROVISIONS

Regulation  Page

1Objective

2Authorising provision

3Commencement

4Principal Regulations

5Definitions

6Regulations 18 to 22 substituted and new regulations 22A and 22B inserted

18Form of notification of a drug-dependent person

19Form of application for Schedule 9 permit or
Schedule 8 permit

20Form of Schedule 9 permit and Schedule 8 permit

21Permit required in particular circumstances for
supply of methadone

22Permit required in particular circumstances for
supply of amphetamine, dexamphetamine, methylamphetamine and methylphenidate

22AApplications for permits under regulations 21 or 22

22BSecretary may issue a Schedule 8 permit

7Storage of Schedule 8 or Schedule 9 poisons

8Forms DP1, DP2 and DP3 substituted and new Form DP2A

Form DP1—Notification of Drug-Dependent Person

Form DP2—Treatment with Schedule 9 Poisons by a
Registered Medical Practitioner

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

9Statute law revision

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ENDNOTES

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

1Objective

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 Act2008 dealing with Schedule 8 poisons and Schedule 9 poisons, and make other minor amendments.

2Authorising provision

These Regulations are made under section 132 of the Drugs, Poisons and Controlled Substances Act 1981.

3Commencement

(1)These Regulations, except regulations 6, 7 and 8, come into operation on the day on which these Regulations are made.

(2)Regulations 6, 7 and 8 come into operation on 1 March 2009.

4Principal Regulations

In these Regulations, the Drugs, Poisons and Controlled Substances Regulations 2006[1] are called the Principal Regulations.

5Definitions

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;".

6Regulations 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.

19Form 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.

20Form 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.

21Permit 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

(b)he or she is treating a patient who is under the care of a palliative care service.

22Permit 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.

22AApplications 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.

22BSecretary 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.

(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".

7Storage 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.".

8Forms 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

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

__________________

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
Details of other treatment (if applicable)

Signature of registered medical practitioner

Date

__________________

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)

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)

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.

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

_______________".

9Statute law revision

In regulation 46(6) of the Principal Regulations for "podiatristif" substitute "podiatrist if".

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ENDNOTES

[1] Reg. 4: S.R. No. 57/2006 as amended by S.R. No. 63/2007.