Victorian Consolidated Regulations Victorian Consolidated RegulationsSch. 2 Form 1 revoked by S.R. No. 72/2018 reg. 10.
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Sch. 2 Form 2 substituted by S.R. No. 96/2022 reg. 18.
FORM 2
Drugs, Poisons and Controlled Substances Regulations 2017
APPLICATION FOR PERMIT TO ADMINISTER, SUPPLY OR PRESCRIBE SCHEDULE 9 POISONS BY A REGISTERED MEDICAL PRACTITIONER FOR A CLINICAL TRIAL
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Full name of patient participating in trial |
Date of birth |
Sex |
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Private address of patient |
Postcode | |
Full name and qualifications of applying registered medical practitioner
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Address of applying registered medical practitioner |
Postcode | |
Telephone and fax no. of applying registered medical practitioner
Name and address of site where patient is participating in the clinical trial
Schedule 9 poison(s) for which permit is requested:
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POISON NAME |
PROPRIETARY NAME (if available) |
DOSE FORM |
DOSE PER UNIT |
EXPECTED MAXIMUM DAILY DOSE |
| | | | | |
| | | | | |
Name and address of supplier
Is this product registered for therapeutic use? If Yes, in which countries?
Details of other treatment (if applicable)
Section 3: Details of clinical trial and human research ethics committee
Name and registration number of the clinical trial
Purpose of the clinical trial
Name of principal investigators of the clinical trial
Registry that the clinical trial is registered on
Date that clinical trial was registered on the registry
Sites for which the clinical trial approval has been granted in Victoria
Has the clinical trial received approval from a human research ethics committee?
Ethics approval number
Date ethics approval was granted
Date ethics approval expires
Name and registration number of the human research ethics committee that granted the ethics approval
Institution responsible for the human research ethics committee, if applicable
Signature of applying registered medical practitioner
Date
FORM 3
Drugs, Poisons and Controlled Substances Regulations 2017
TREATMENT WITH SCHEDULE 8 POISONS BY A REGISTERED MEDICAL PRACTITIONER OR A NURSE PRACTITIONER
(Application for permit to administer, prescribe or supply)
This is an application for a permit under [ regulation 11(1) of the Drugs, Poisons and Controlled Substances Regulations 2017/section 34A of the Drugs, Poisons and Controlled Substances Act 1981 ].
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
Schedule 8 poison(s) for which permit is requested:
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NAME OF POISON(S) |
EXPECTED MAXIMUM DAILY DOSE |
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| | |
| | |
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
Aboriginal or Torres Strait Islander origin
Yes, Aboriginal
Yes, Torres Strait Islander
Yes, Aboriginal and Torres Strait Islander
No
Not stated
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
FORM 4
Regulations 12(2), 130 and 131
Drugs, Poisons and Controlled Substances Regulations 2017