Established Schedule 8 treatment permit requirements
The purpose of issuing Schedule 8 permits is to prevent unsanctioned concurrent prescribing ('prescription shopping') of Schedule 8 medicines to individual patients and to minimise the risk of addiction to these substances.
There are four basic circumstances when a medical practitioner must obtain or apply for a permit from the department.
- Prescribing for a drug-dependent person – A medical practitioner must obtain a permit before treating a drug-dependent person with any Schedule 8 medicine. Permits to prescribe methadone or buprenorphine (Subutex® or Suboxone®) as opioid replacement therapy (ORT) to treat opioid dependence also fall into this category.
- Prescribing a special Schedule 8 medicine – In most circumstances, a medical practitioner must obtain a permit before prescribing methadone (Physeptone®), nabiximols (Sativex®), amphetamine, dexamphetamine, lisdexamfetamine (Vyvanse®), methylamphetamine or methylphenidate (Ritalin®, Concerta®).
- Prescribing treatment for a period greater than 8 weeks – A medical practitioner does not need a permit to initiate treatment of a person (who is not drug-dependent) with any other Schedule 8 medicine, but must obtain a permit to prescribe treatment for a continuous period greater than 8 weeks. Note: the 8-week period relates to the duration of prescribed treatment and not the dates of consultations.
- Prescribing for transient and/or occasional patients – A medical practitioner who prescribes a Schedule 8 medicine (other than where a permit must be obtained before prescribing) must immediately apply for a permit if there is reason to believe that their prescription will contribute to a patient being treated for a continuous period greater than 8 weeks (including any preceding period of treatment by any prescriber). To avoid delaying treatment for a patient with a genuine therapeutic need, a medical practitioner is authorised to continue treating the patient until the outcome of their permit application has been determined, but they must submit a permit application immediately – even if there is no intention to prescribe again.
Because more than one medical practitioner at a clinic might be involved in managing some patients, each practitioner is not required to obtain a permit, provided a current permit is held by one practitioner at the clinic and the cumulative prescribing is consistent with and does not exceed any limits and conditions on the permit (see below). Details of permits, including maximum dosage plus expiry or cancellation dates, should be prominently displayed within patient records.
Permits may be amended, suspended or revoked by the Secretary at any time if a notification of drug dependency or aberrant drug-related behaviour has been reported to the department. For example, permits issued may be amended to specify an expiry date and include the advice that a review by a specialist will be necessary to affirm ongoing treatment is appropriate for the management of the patient’s condition by the expiration of the permit.
Specialist advice should be sought for patients requiring opioid doses exceeding oral morphine 100 mg daily, oxycodone 60 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 behaviour. Many permits include advice or conditions that relate to this recommendation.
Pharmaceutical Benefits Scheme (PBS) authority prescriptions for Schedule 8 medicines merely indicate that Medicare Australia will subsidise the cost of the medication; medical practitioners must still obtain a Schedule 8 permit if required under Victorian legislation.
Meaning of ‘continuous period greater than 8 weeks’
The legislation refers to treatment for a ‘continuous period greater than 8 weeks’ in relation to various permit requirements and exceptions but the term does not relate to the dates of consultations or prescriptions; it relates to the quantity of the drug that is prescribed or supplied. For example:
- A prescription for 100 tablets with directions of ‘one tablet twice daily’ corresponds to 50 days’ treatment (i.e. less than 8 weeks) whereas the same prescription with repeats authorised would correspond to providing treatment for a continuous period greater than 8 weeks.
- Additionally, a practitioner who is not initiating treatment but considers it necessary to treat a patient with a Schedule 8 poison must also take account of the preceding period of administration, supply or prescription of a Schedule 8 poison (authorised by any other prescriber/s) where there is reason to believe that there has been previous prescribing.
Exceptions to permit requirements
General exceptions – (prisons, residential aged care services, hospital inpatients)
In circumstances where a person is confined and not personally managing their medicines, the risk of concurrent prescribing is significantly reduced. Accordingly, a permit is not required to prescribe Schedule 8 medicines for:
- prisoners being treated in a prison or police gaol
- patients receiving inpatient treatment in a hospital
- patients receiving treatment in a hospital emergency department or a day procedure centre
- Note: Each of the above exceptions includes a period not exceeding 7 days following the release or discharge of the person from the corresponding establishments.
- Residents being treated in a residential aged care service
Drug-dependent persons (no other exceptions)
None of the following exceptions is applicable to permit requirements that relate to prescribing a Schedule 8 poison for a drug-dependent person.
Other than where a general exception applies, a medical practitioner or nurse practitioner must obtain a permit before treating a drug-dependent person with a Schedule 8 poison.
SafeScript exceptions (for patients who are not drug-dependent persons)
From 1 October 2018, a medical practitioner or nurse practitioner who checks SafeScript in relation to a patient, on each occasion, before prescribing a Schedule 8 poison for that patient will not be subject to certain permit and notification requirements. Use of SafeScript will not become mandatory until April 2020 so the existing permit system will continue to operate.
Trying to simplify complex requirements
A checklist has been developed to assist practitioners to progress sequentially through the many exceptions and permit requirements. Note: In the ‘Checklist’, SafeScript exceptions will be shown in red text beneath the requirement that will apply to practitioners who do not check SafeScript.
Other exceptions (for patients who are not drug-dependent persons)
Gazettal notice that outlines these exceptions
A practitioner is not required to obtain a treatment permit to treat a patient when the patient is suffering an incurable, progressive, far-advanced disease or medical condition; and the prognosis is of limited life expectancy due to the disease or medical condition; and the administration, supply or prescribing of a Schedule 8 poison is intended to provide palliative treatment.
Pain caused by cancer or complications arising from cancer
Where the diagnosis is made by a registered medical practitioner; a treatment permit is not needed to prescribe an opioid analgesic - provided the prescriber has given written notice to the department by submitting a permit application form (after completing the relevant section of the form) to notify the department about that treatment.
Notwithstanding the exceptions referred to above, most practitioners are required to hold a Schedule 8 permit before prescribing, administering or supplying methadone for any person (even on one occasion) unless:
- the practitioner is treating the patient at an oncology clinic in a hospital where the patient is not an in-patient; or
- the practitioner is treating the patient at a pain clinic in a hospital at which the patient is not an in-patient; or
- the patient is under the care of a palliative care service
Where the period of treatment exceeds 8 weeks, the practitioner must:
- obtain a Schedule 8 treatment permit; or
- submit a permit application form (after completing the relevant section of the form) to notify the department about the treatment, unless
- the 'pain caused by cancer or complications arising from cancer' exception (shown above) is applicable
Paediatricians and psychiatrists (only)
Attention deficit hyperactivity disorder (where the patient is less than 18 years old):
A paediatrician or a psychiatrist is not required to obtain a Schedule 8 treatment permit to treat a patient with a psychostimulant drug (approved by the TGA for the treatment of attention deficit hyperactivity disorder), provided:
- the patient is not a drug-dependent person; and
- the patient has not reached 18 years of age; and
- the duration of treatment does not exceed a continuous period greater than 8 weeks; and
- the prescriber submits a permit application form (after completing the relevant section of the form) to notify the department about that treatment
- Note: A practitioner who checks a patient’s information on SafeScript, on each occasion before prescribing, is not required to give written notice to the department
Attention deficit hyperactivity disorder (where the patient is 18 years or more):
A psychiatrist is not required to obtain a Schedule 8 treatment permit to treat a patient with a psychostimulant drug (approved by the TGA for the treatment of attention deficit hyperactivity disorder), provided:
- the patient is not a drug-dependent person; and
- the duration of the period of treatment does not exceed 8 weeks
- Note: To prescribe for a period greater than 8 weeks, a psychiatrist must obtain a permit.
- Note: A psychiatrist who checks a patient’s information on SafeScript, on each occasion before prescribing the Schedule 8 poison, is not required to obtain a permit.
Prescribing and Dispensing Suboxone®
Suboxone is a sublingual film that contains the active ingredients buprenorphine and naloxone and is registered with the Therapeutic Goods Administration for use in Australia for the treatment of opioid dependence. Through the Section 100 Opiate Dependence Treatment Program established under the National Health Act 1953, Suboxone is fully subsidised by the Commonwealth government under the Pharmaceutical Benefits Scheme (PBS) for opioid replacement therapy.
There has been some confusion about the legality and practicalities of prescribing and dispensing Suboxone for purposes other than opioid replacement therapy (off-label use).
Further information can be found in the Suboxone® factsheet attached to this webpage.