Prescribing drugs of dependence in general practice, Part A

2. Laws and regulations
2.1 Legislative requirements
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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. Once a therapeutic need is established, GPs are required to comply with state- or territory-specific health legislation (refer to Appendix C.1 in the PDF version) 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

When a PBS or Repatriation Pharmaceutical Benefits Scheme (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 in the PDF version.

There are useful fact sheets available at:

  1. MDA National. Things to Think About Before You… Prescribe Schedule 8 Drugs [press release]. MDA National.
  2. Cran A. Misuse of opioid drugs. Defence Update: A quarterly publication for MDA National Members [Internet]. Sydney: MDA National; 2013.  [Accessed January 2014].
  3. Prescription Benefits Scheme. 2. Prescribing Medicines – Information for PBS Prescribers Canberra: Department of Health. [Accessed January 2014].