Permit and notification requirements 2015.1
This document has been prepared by Drugs and Poisons Regulation (DPR) to assist medical practitioners to understand permit and notification requirements associated with the prescribing of amphetamines and methylphenidate in Victoria. For simplicity of reading, this document does not refer to all legislative requirements; merely those that are relevant to treatment with the noted drugs. Documents dealing with other key legislative requirements may be found on the DPR website (at www.health.vic.gov.au/dpcs/reqhealth). For full details, reference should be made to the Drugs Poisons and Controlled Substances Act 1981 and Drugs Poisons and Controlled Substances Regulations 2006 (at www.legislation.vic.gov.au).
Paediatricians and psychiatrists
Most medical practitioners must obtain a permit before prescribing amphetamine, dexamphetamine, lisdexamfetamine, methylamphetamine or methylphenidate. However, in recognition of their specialist expertise and the greater likelihood that paediatricians and psychiatrists will wish to initiate treatment for ADHD (without first obtaining a permit) and to continue treating the patient (without the administrative burden associated with renewing or amending permits), there are exceptions to permit requirements that do not apply to other medical practitioners.
To determine whether a permit is required, paediatricians and psychiatrists should address the following four questions in the noted sequence.
1. Is the patient a drug-dependent person?
· If you have reason to believe a patient is a drug-dependent person, you must obtain a Schedule 8 treatment permit before prescribing any of the noted drugs.
2. Are you initiating treatment of a patient diagnosed with attention deficit hyperactivity disorder?
· A permit is not required to initiate treatment with the noted drugs but a permit must be obtained (or a notification submitted by submitting the permit application form with section 3 completed) if the prescribed quantity of medication represents treatment for a continuous period greater than 8 weeks.
· Note: A single prescription with repeats might represent treatment for a period greater than 8 weeks.
3. Do you intend to prescribe dexamphetamine, lisdexamfetamine or methylphenidate for a patient (less than 18 years of age) for childhood ADHD for a period greater than 8 weeks?
· A permit is not required - provided DPR is notified of the proposed treatment by submitting the permit application form with section 3 completed.
4. Do you intend to prescribe any of the noted drugs for a patient (18 years or older) for ADHD for a period greater than 8 weeks?
· A permit must be obtained before the period of treatment of an adult exceeds 8 weeks.
· Note: Permits are unlikely to be issued in relation to amphetamine or methylamphetamine because these drugs are not registered for use in Australia.
· Note: In the case of an inherited patient, an application for a permit or notification form must be submitted immediately if there is reason to believe that the intended prescribing will contribute to a patient being treated for a continuous period greater than 8 weeks (including any preceding period of treatment by any prescriber/s).
Private prescriptions
PBS authority prescriptions for Schedule 8 poisons merely indicate that Medicare Australia will subsidise the cost of the medicine; medical practitioners must still obtain a Schedule 8 permit where required under Victorian legislation.
Other medical practitioners (not paediatricians and psychiatrists)
Medical practitioners who are not paediatricians or psychiatrists should note that prescribing amphetamine, dexamphetamine, lisdexamfetamine, methylamphetamine or methylphenidate without first obtaining a permit – any quantity / even on one occasion – is an offence unless a specific exception applies.
General exceptions – prisons, residential aged care services, hospital inpatients
In circumstances where patients are confined and not personally managing their medications, the risk of concurrent prescribing is significantly reduced. Accordingly, a permit is not required to prescribe Schedule 8 poisons for prisoners being treated in a prison, residents being treated in a residential aged care service and patients receiving inpatient treatment in a hospital (not including day procedure centres).
Exception for multi-practitioner clinics
In recognition of the fact that more than one medical practitioner at a clinic might be involved in the management of some patients, each practitioner is not required to obtain a permit provided a valid permit is held by one practitioner at the clinic and the prescribing is consistent with and does not exceed the permit limits or conditions.
Note: To ensure compliance it is recommended that details of permits, including maximum dosage plus expiry or cancellation dates, are prominently displayed within patient records.
More information for general practitioners
The DPR website (www.health.vic.gov.au/dpcs/reqhealth) contains the following documents, which provide further clarification of permit requirements for general practitioners.
· “Schedule 8 treatment permits” (including general and specific exceptions)
· “General practitioner checklist: Schedule 8 treatment permits”
Permit applications by general practitioners
Attention Deficit Hyperactivity Disorder
The department policy is that specialist involvement is necessary for the diagnosis and ongoing management of all ADHD patients.
· General practitioners will generally only be issued with permits to prescribe dexamphetamine, lisdexamfetamine or methylphenidate where there is evidence of a specialist diagnosis and that a specialist review has taken place within a specified period.
· Permits are unlikely to be issued in relation to amphetamine or methylamphetamine because these drugs are not registered for use in Australia.
Narcolepsy
The department policy is that an initial diagnosis of narcolepsy must involve a respiratory physician or a specialist in sleep disorders.
· A general practitioner will generally not be issued with a permit unless the application indicates that the physician or specialist has been consulted and endorses the treatment.
· The department considers that, once narcolepsy has been diagnosed, ongoing treatment by a general practitioner is generally appropriate without further reference to the physician or specialist, provided other risks to patient safety are not evident.
· Permits are unlikely to be issued in relation to amphetamine or methylamphetamine because these drugs are not registered for use in Australia.
Permit application forms
Permit application forms and notification forms may be submitted online or downloaded from the DPR website (at www.health.vic.gov.au/dpcs/reqhealth)
For further information
Department of Health & Human Services (DHHS)Drugs and Poisons Regulation
GPO Box 4057
Melbourne 3001
Tel: 1300 364 545
Fax: 1300 360 830
Email:
Web: www.health.vic.gov.au/dpcs
To receive this publication in an accessible format contact Drugs and Poisons Regulation on 1300 364 545. Authorised and published by the Victorian Government, 1 Treasury Place, Melbourne.
July 2015
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