There are strict legal requirements around the prescription of drugs of addiction or controlled drugs, known as Schedule 8 (S8) medicines.
Inappropriate S8 prescribing may result in criminal prosecution, financial penalties, the loss of a doctor’s authority to prescribe S8 drugs or disciplinary action.
The legislative requirements vary in each state and territory. Importantly, the legislative requirements for prescribing S8 drugs vary depending on the person’s dependence:
- For drug dependent persons, S8 medications (and in some states and territories some benzodiazepines) cannot be prescribed without a permit or an appropriate approval from the relevant state or territory health department’s pharmaceutical services unit (PSU), via an authority/permit/ approval, to patients who are known or suspected to be drug dependent. 22
- For non-drug-dependent persons, S8 medications cannot be prescribed for a period greater than 2 months without an appropriate approval in some states or territories. 22
Before prescribing an S8 drug, GPs must take all reasonable steps to ensure a therapeutic need exists.
In 2020 changes were made to the approved indications of immediate and modified release opioids as part of opioid reforms by the Therapeutic Goods Administration (TGA) to help address opioid misuse and abuse.
Immediate release products should only be used for the management of severe acute pain, where patients must be unresponsive or intolerant, or have achieved inadequate relief of their acute pain to maximum tolerated doses on non-opioid treatments.
Immediate release opioids play an important role in the short-term management of severe acute pain, although many forms of acute pain subside in 24-72 hours, and it is important that the opioid course is not continued when the pain is no longer severe. Provision of smaller quantities without repeats reduces the quantity of unused opioid medicine available for diversion or inappropriate use at a later stage.
Modified-release products should only be used for the management of severe pain where:
- other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain; and
- the pain is opioid-responsive and the patient requires daily, continuous, long-term treatment.
Modified-release opioids are not indicated to treat chronic non-cancer pain (other than in exceptional circumstances), or to be used for ‘as-needed’ (PRN) pain relief. In addition, hydromorphone and fentanyl modified release products should not be used in opioid naïve patients. The new indications can be found on the TGA web page.
The TGA has deliberately not defined ‘exceptional circumstances’ as it is acknowledged there may be a range of potential situations where they might apply to an individual patient, subject to the clinical judgment of the prescriber. However, the overall outcome of the indication change is to narrow the circumstances in which opioids are prescribed for chronic non-cancer pain and for prescribers to rule out other potential treatment modalities before determining ‘exceptional circumstances’ apply.
Once a therapeutic need is established, GPs are required to comply with state- or territory-specific health legislation (refer to Appendix C.1) and the fact sheets listed below and, where necessary, obtain an authority/permit from the relevant PSU. These authorities are distinct from, and in addition to, any authority under the PBS for scripts.23
Patients who require long-term treatment of chronic pain with opioids may access larger pack sizes and repeat prescriptions in line with Pharmaceutical Benefits Scheme (PBS) restrictions.
Pharmaceutical Benefits Scheme (PBS) and Repatriation Pharmaceutical Benefits Scheme (RPBS) requirements:
The PBS requires that if opioid use exceeds or is expected to exceed 12 months, patients’ pain management and continuing opioid treatment must be reviewed by another medical practitioner.
For palliative care patients the secondary review can be by a palliative care nurse practitioner. Further, the requirements for the annual secondary reviews have been removed for palliative care patients whose clinical condition is such that a secondary review is rendered not possible.
Under the PBS or RPBS the maximum quantity for chronic pain is generally for one month’s treatment (through telephone / electronic authority) or up to 3 months treatment (electronic / written authority)
Opioid medications under this guidance include:
When a PBS or RPBS authority application is for an S8 medicine (other than dexamphetamine sulphate or methylphenidate), the following guidelines apply:24
- the maximum quantity is generally for 1 month’s supply (eg 1 week’s therapy with three repeats)
- where supply for a longer period is warranted, quantities are usually for up to 3 months’ therapy
- telephone approvals are limited to 1 month’s supply.
Prescribers need to state the interval of repeat where repeats are called for and ensure state or territory health authorities are notified about ongoing treatment. Review by a second doctor is required for PBS prescription of an opioid beyond 12 months.24
Inappropriate S8 prescribing may result in criminal prosecution, financial penalties, the loss of a doctor’s authority to prescribe S8 drugs or disciplinary action.22
Refer to the appropriate state and territory legislation and contacts at Appendix C.2.
There are useful fact sheets available at: