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Prescribing controlled and monitored medicines

Prescribers must have approval from the Chief Health Officer to prescribe a controlled medicine when:

  • a person is drug-dependent
  • a person has been prescribed the same controlled medicine within the previous 2 months
  • the person is expected to require the prescribed controlled medicine for longer than 2 months.

Types of approval

You can seek approval by either:

  • Category Approval: Authorises the prescribing of a medicine or medicines within a therapeutic class up to a maximum dose to treat a certain condition. Prescribers can request a Category Approval where they meet eligibility criteria outlined in the Controlled Medicines Prescribing Standards.
  • Approval by Drug: Authorises the prescribing of a particular dose, form, strength and quantity of a medicine for a person’s medical condition. A prescriber can request an Approval by Drug if preferred, or when the treatment doesn't meet the requirements of a Category Approval, including when a person is drug-dependent.

How to apply for approval

Approval process

  • Applications are assessed in accordance with the Controlled Medicines Prescribing Standards.
  • A Chief Health Officer (CHO) reference number will be issued for each approval.
  • Applications submitted via Canberra Script are prioritised and can be processed in 1 to 2 business days if no further information is needed.
  • Urgent applications can be processed within one working day if no further information is needed.
  • Pharmacists are obligated to check an approval is in place before dispensing a methadone or buprenorphine prescription for the treatment of opioid dependency and may be required to confirm details with the prescriber before dispensing.

Definition of a drug dependent person

The Medicines, Poisons and Therapeutic Goods Regulation 2008 defines a drug-dependent person, in relation to a controlled medicine as a person with a condition who:

  • has demonstrated, in relation to the person’s use of the medicine impaired control; or drug-seeking behaviour that suggests impaired control; and
  • on ceasing the medicine, is likely to experience symptoms of mental or physical distress or disorder.

Medicines Advisory Committee

The Medicines Advisory Committee is a statutory body established under the Medicines, Poisons and Therapeutic Goods Act 2008 and:

  • provides expert advice to the ACT Chief Health Officer on complex clinical matters involving the prescribing and supply of medicines in the ACT
  • provides expert advice on applications for approval to prescribe controlled medicines, and applications for endorsement to treat drug dependency
  • can consider applications for review of an unfavourable ACT Chief Health Officer decision on controlled medicine issues.

To apply to the Medicines Advisory Committee for a review of an unfavourable decision on a controlled medicines approval or endorsement to treat drug dependency, contact Health Protection Service on (02) 5124 9208 or email hps@act.gov.au.

Medicines advisory committee membership

In accordance with the Medicines, Poisons and Therapeutic Goods Regulation 2008, the Medicines Advisory Committee consists of members from the following areas:

  • at least one member experienced in teaching or practice of psychiatry
  • at least one member experienced in teaching or practice of pain or addiction medicine
  • at least one member who is a general practitioner
  • at least one member who is a pharmacist
  • one member who represents consumers
  • at least one member nominated by the ACT Branch of the Australian Medical Association.