Untitled document

Drugs, Poisons and Controlled Substances Amendment (Schedule 8 Permit) Regulations 2013

S.R. No. 108/2013

TABLE OF PROVISIONS

Regulation  Page

1Objective

2Authorising provisions

3Principal Regulations

4New Regulation 21A inserted

21APermit required in particular circumstances for supply
of nabiximols

5Permit required in particular circumstances for supply of amphetamine, dexamphetamine, methylamphetamine and methylphenidate

6Regulation 22A substituted

22AApplications for permits under regulations 21, 21A
or 22

7Regulation 22B substituted

22BSecretary may issue a Schedule 8 permit

8Schedule 2—Form DP2A substituted

Form DP2A—Treatment with Schedule 8 Poisons by a Registered Medical Practitioner or a Nurse Practitioner

9Schedule 2—Form DP3

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ENDNOTES

STATUTORY RULES 2013

S.R. No. 108/2013

Drugs, Poisons and Controlled Substances Act 1981

Drugs, Poisons and Controlled Substances Amendment (Schedule 8 Permit) Regulations 2013

The Governor in Council makes the following Regulations:

Dated: 27 August 2013

Responsible Minister:

DAVID DAVIS
Minister for Health

YVETTE CARISBROOKE

Clerk of the Executive Council

1Objective

The objective of these Regulations is to amend the Drugs, Poisons and Controlled Substances Regulations 2006 to provide for the inclusion of—

(a)nabiximols in a manner consistent with its entry in the Commonwealth Standard;

(b)lisdexamfetamine such that its control is consistent with other amphetamine-type stimulants;

(c)additional information on the prescribed application form for a permit to treat a patient with Schedule 8 poisons.

2Authorising provisions

These Regulations are made under sections 129, 132, 132A and 132B of the Drugs, Poisonsand Controlled Substances Act 1981.

3Principal Regulations

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

4New Regulation 21A inserted

After regulation 21 of the Principal Regulations insert—

"21A   Permit required in particular circumstances for supply of nabiximols

For the purposes of preventing the improper use of nabiximols, a registered medical practitioner or nurse practitioner must not administer, supply or prescribe nabiximols 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 nabiximols; or

(b)is authorised by section 34D, 34E or 34F of the Act to administer, supply or prescribe nabiximols.

Penalty:100 penalty units.".

5Permit required in particular circumstances for supply of amphetamine, dexamphetamine, methylamphetamine and methylphenidate

(1)For the heading to regulation 22 of the Principal Regulations substitute—

"Permit required in particular circumstances for supply of amphetamine, dexamphetamine, lisdexamfetamine, methylamphetamine and methylphenidate".

(2)In regulation 22(1) of the Principal Regulations, after "dexamphetamine," insert "lisdexamfetamine,".

6Regulation 22A substituted

For regulation 22A of the Principal Regulations substitute—

"22A   Applications for permits under regulations 21, 21A 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 21A authorising the administration, supply or prescription of nabiximols is the form of DP2A in Schedule 2.

(3)The prescribed form of an application for a permit required under regulation 22 authorising the administration, supply or prescription of amphetamine, dexamphetamine, lisdexamfetamine, methylamphetamine or methylphenidate is the form of DP2A in Schedule 2.".

7Regulation 22B substituted

For regulation 22B of the Principal Regulations substitute—

"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 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 21A, the Secretary may issue a Schedule 8 permit to a registered medical practitioner or nurse practitioner authorising the practitioner to administer, supply or prescribe nabiximols to or for a person who is not a drug-dependent person.

(3)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, lisdexamfetamine, methylamphetamine or methylphenidate to or for a person who is not a drug-dependent person.

(4)A Schedule 8 permit issued under subregulation (1), (2) or (3) must be in the form of DP3 in Schedule 2.

(5)The Secretary may at any time amend, suspend or revoke a Schedule 8 permit issued under subregulation (1), (2) or (3) and any permit which is suspended or revoked ceases to have effect.".

8Schedule 2—Form DP2A substituted

For Form DP2A in Schedule 2 to the Principal Regulations substitute—

"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)

I have/have not previously applied for a permit to administer, prescribe or supply a Schedule 8 poison to this patient.

Please note that evidence-based practice guidelines recommend that specialist advice should be sought for patients requiring opioid doses exceeding oral morphine [quantity] mg daily, oxycodone [quantity] mg daily or equivalent, for the treatment of chronic non-cancer pain, or when prescribing opioids to a patient with a history of drug dependency or aberrant drug-related behaviours. Opioids should only be prescribed as part of a comprehensive pain management plan. When applying for a permit to treat a patient with an opioid, applicants may be requested by the Secretary to provide the Secretary with evidence of a pain management plan or specialist review.

The morbidity and mortality risks associated with long term opioid therapy should be discussed with the patient; in particular the increased mortality risks correlated with the prolonged use of opioids at doses exceeding [quantity] mg daily in morphine equivalents.

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

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

__________________".

9Schedule 2—Form DP3

In Form DP3 in Schedule 2 to the Principal Regulations, for "Regulations 20, 22B(3)" substitute "Regulations 20(1), 20(2), 22B(4)".

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ENDNOTES

[1] Reg. 3: S.R. No. 57/2006.  Reprint No. 1 as at 16 June 2011.  Reprinted to S.R. No. 131/2010.  Subsequently amended by S.R. No. 136/2012 and S.R. No. 50/2013.