Laws and regulations

There are strict legal requirements around the prescription of drugs of addiction or controlled drugs, known as Schedule 8 (S8) medicines.

 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:

• Tramadol
• Tapentadol
• Codeine
• Buprenorphine
• Hydromorphone
• Morphine
• Oxycodone
• Fentanyl
• Methadone

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.

Additional information

There are useful fact sheets available at:

• New South Wales – Summary of Controls on the Prescribing and Handling of Drugs of Dependence
• Northern Territory – Remote Health Atlas; Restricted S4 Medicines
• Queensland – Regulatory requirements and resources
• South Australia - Drugs of dependence
• Victoria – Things medical practitioners need to know – key prescribing requirements
• Western Australia – Requirements for the prescribing of S4 and S8 Medicines in Western Australia

Pharmaceutical Benefits Scheme

Recent changes to PBS listings for opioid medicines for the treatment of pain came into effect on 1 June 2020. A summary of these changes including new indications and pack sizes can be found at Summary of PBS opioid listings.

Therapeutic Goods Administration

All products for therapeutic use are controlled by the Therapeutic Goods Administration (TGA), which is a division of the Federal Department of Health. The TGA controls regulated (or scheduled) medicines and listed medicines, which are unscheduled.

Scheduled medicines are included in the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP or Poisons Standard). The Poisons Standard is maintained by the TGA, but is implemented as state-level legislation.

To view the Poisons Standard, visit the Federal register of legislatation website. 

Drugs of dependence units (state and territory based)

State and territory departments and government-funded drugs of dependence units provide information for medical practitioners in each state and territory.

Refer to Appendix C for details.

Australian Health Practitioner Regulation Agency

The Australian Health Practitioner Regulation Agency (AHPRA) and the associated state or territory medical boards have the power to take disciplinary action, including immediate suspension of a doctor’s registration or impose conditions, in the case of inappropriate S8 prescribing.²²

For further information, vist the AHPRA website.

The RACGP

The RACGP’s Standards, are standards developed by the profession for the profession. The Standards are designed as a template for safe, high-quality care in the increasingly complex environment of Australian general practice.

Accreditation by an independent body against the Standards demonstrates that a practice is serious about providing high-quality, safe and effective care to standards of excellence determined by the general practice profession.

Accreditation is an important component of the regulatory framework for quality and safety in health.

The Standards requires practices to comply with jurisdictional requirements on Schedule 4 (S4, prescription only) and S8 medicines.²⁰

The Standards is available on the RACGP website.

Australian Medical Association

The Australian Medical Association (AMA) provides resources to help prescribers navigate laws and regulations.

For more information, visit the AMA website. 

Medicare

Medicare Australia regularly reviews PBS prescribing data, looking for inappropriate prescribing by doctors.²⁵