Schedule 8 permits and notifications

Evolution of the permit system

The permit system was introduced towards the middle of the 20^th century in an attempt to limit a person’s ability to obtain Schedule 8 poisons from multiple prescribers. Since then, more health practitioners have been authorised to prescribe Schedule 8 poisons and the extent of prescribing (and of prescription-shopping) has significantly and progressively increased.

Numerous variations and exceptions to the original permit system, over many decades, made the permit system much more complex whereas problems associated with prescription-shopping and excessive prescribing of Schedule 8 poisons and many Schedule 4 poisons continued to increase.

To address the primary reason for having a permit system, Victoria introduced a monitored poisons database (SafeScript) that enables medical practitioners, nurse practitioners and pharmacists to review recent dispensing records for individual patients in order to make a better informed decision, about whether it is safe to prescribe one or more Schedule 8 poisons and/or monitored Schedule 4 poisons before doing so.

PBS authorities or private (non-PBS) prescriptions

Authority prescriptions, approved under the Pharmaceutical Benefits Scheme, merely indicate that Medicare Australia will subsidise the cost of the medicine; medical practitioners must still comply with the requirements for a Schedule 8 treatment permit under Victorian legislation.

Similarly, in the case of a ‘private’ (non-PBS) prescription, medical practitioners must still obtain a Schedule 8 permit where required under Victorian legislation.

How to determine whether a permit is required

When considering prescribing a Schedule 8 poison, please follow the following instructions, in order:

• Determine whether any general or specific exceptions to permit requirements are applicable.
• If not, proceed to the series of FIVE questions, shown below in the section, ‘Permit requirements for most practitioners’
  • Ask the questions in the sequence shown until you can answer ‘yes’ to a question.
  • When you can answer ‘yes’ to a question, you need not consider the subsequent questions because you will have your answer.

General exceptions (prisons, gaols, residential aged care services, inpatients)

In circumstances where patients are confined or not personally managing their medicines, the risk of concurrent prescribing and prescription-shopping is significantly reduced. Accordingly, a permit is not required to prescribe Schedule 8 poisons 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 preceding 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)

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.

None of the following exceptions is applicable to permit requirements that relate to prescribing a Schedule 8 poison for a drug-dependent person.

Other exceptions (for patients who are not drug-dependent persons)

Gazettal notice that outlines these exceptions

Now that it is mandatory for a medical practitioner or nurse practitioner to check a patient’s SafeScript profile, on each occasion, before prescribing a Schedule 8 poison for that patient, additional exceptions apply to certain specified circumstances and/or specified specialist practitioners.

Palliative care

A practitioner is not required to obtain a Schedule 8 treatment permit 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 required to prescribe an opioid analgesic to treat pain caused by cancer or complications arising from cancer.

Opioid analgesics (when the total daily dosage does not exceed 100mg MED)

A practitioner is not required to obtain a Schedule 8 permit to prescribe one (or more) of the following opioid analgesic formulations provided the combined daily dose of opioids listed below does not exceed 100 milligrams in morphine equivalence.

• Oxycodone oral or suppository
• Morphine oral
• Hydromorphone oral
• Tapentadol oral
• Buprenorphine patch
• Fentanyl patch

Note:

• Checking a patient’s profile on SafeScript should be considered an essential step to determine the full extent of a patient’s use of opioid analgesics.

Medicinal Cannabis

A practitioner is not required to obtain a permit to prescribe Schedule 8 cannabis or Schedule 8 tetrahydrocannabinol for human therapeutic use if the following circumstances apply:

the practitioner has obtained Commonwealth approval through the Special Access Scheme or Authorised prescriber scheme to administer, supply or prescribe Schedule 8 cannabis or Schedule 8 tetrahydrocannabinol for human therapeutic use for the patient; or

the practitioner is administering, supplying or prescribing Schedule 8 cannabis or Schedule 8 tetrahydrocannabinol for human therapeutic use that is included in the Australian Register of Therapeutic Goods.

Methadone

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

Paediatricians and psychiatrists (only)

Most medical practitioners must obtain a permit before prescribing special Schedule 8 poisons. However, in recognition of their specialist expertise and the greater likelihood that paediatricians and psychiatrists will diagnose and initiate treatment for patients for ADHD, the Secretary (of the Department of Health) has specified that medical condition and related circumstances under which a Schedule 8 poison may be prescribed, administered or supplied without first obtaining a permit.

Attention deficit hyperactivity disorder (patient is less than 18 years old)

A paediatrician or a psychiatrist is not required to obtain a special 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.

Attention deficit hyperactivity disorder (patient is 18 years or more)

A psychiatrist is not required to obtain a special 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;

Permit requirements for most practitioners

If none of the preceding exceptions is applicable, consider the following five questions:

• When you can answer ‘yes’ to a question, you need not consider the subsequent questions because you will have your answer.

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.

Inherited, transient and occasional patients

A practitioner who is not initiating treatment but considers it necessary to treat a patient with a Schedule 8 poison (other than where a permit must be obtained before prescribing) must immediately apply for a permit if there is reason to believe that issuing a prescription will contribute to a patient being treated for a continuous period greater than 8 weeks - including the preceding period of treatment (by any and all other prescriber/s).

• The mandatory requirement to check SafeScript is an essential step to enable a practitioner to fully assess the extent of previous prescribing and/or to determine whether the exception relating to opioid analgesics, in relation to a total daily dosage of less than 100mg MED), might apply.
  • The National Prescribing Service recommends that daily doses should not exceed 100mg in morphine equivalence (approximately 60 mg of oxycodone) without specialist advice.

To avoid delaying treatment for a genuine patient, a practitioner is authorised to treat the patient until the outcome of the permit application has been determined provided a permit application is submitted immediately – even if there is no intention to treat or prescribe for the patient on subsequent occasions.

This provision is intended to prevent drug-seeking patients (with or without genuine documentation) from obtaining multiple prescriptions from a clinic on the pretext that their regular treating practitioner is interstate, overseas or otherwise unavailable.

Applying for a permit

Prescribers may apply for a permit directly in SafeScript.

For help with applying for a permit in SafeScript, please visit the SafeScript Help Topics webpage.

Opioid-replacement therapy (ORT)

Most medical practitioners wishing to prescribe methadone, buprenorphine (Subutex^®) or buprenorphine in combination with naloxone (Suboxone^®) to treat opioid-dependent patients, are required to undertake relevant training and assessment to gain approval from the department as ORT prescribers.

However, in recognition of the greater safety associated with the use of Suboxone^® film, any medical practitioner may prescribe Suboxone^® for up to 5 patients without undergoing the training or assessment to become an approved ORT prescriber.

• Note: The requirement to obtain a permit before prescribing a Schedule 8 poison for a drug-dependent person is still applicable.

Medical practitioners who are not approved ORT prescribers are advised to seek advice from an approved prescriber (preferably in the same practice or through the Drug and Alcohol Clinical Advisory Service (DACAS) before prescribing to a patient. Brief guides, in document and video format, are available on the MPR website in the section relating to ‘Pharmacotherapy’.

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.

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