Controlled Medicines

The Health Protection Service (HPS) has a critical role in promoting the safe and effective use of controlled medicines in the ACT.

What are Controlled Medicines?

Controlled medicines are listed under Schedule 8 of the Commonwealth Poisons Standard. Examples of these medicines include morphine, oxycodone, dexamfetamine and alprazolam. The ACT adopts the Poisons Standard under the Medicines, Poisons and Therapeutic Goods Act 2008.

The Medicines, Poisons and Therapeutic Goods Regulation 2008 (MPTG Regulation) establishes the regulatory framework for prescribing and supplying controlled medicines in the ACT.

This Framework gives the ACT a unique opportunity to be a leader in reducing harm associated with the abuse, misuse and diversion of these medicines.

What are Monitored Medicines?

Monitored medicines are all controlled medicines or a medicine declared by the Minister for Health to be a monitored medicine. On 30 August 2021, the Minister for Health declared the following medicines as monitored medicines under the Medicines, Poisons and Therapeutic Goods Act 2008:

  • codeine
  • tramadol
  • all benzodiazepines
  • quetiapine
  • zolpidem and zopiclone
  • gabapentin and pregabalin 

These medicines have been declared due to evidence of harms including deaths associated with their abuse and misuse in the Australian community. The declaration will come into effect on 1 October 2021.

This means that from this date, the ACT Health Directorate will collect information on prescriptions of these medicines through the National Data Exchange. Information is collected under chapter 6A of the Medicines, Poisons and Therapeutic Goods Act 2008

Applying for Chief Health Officer Approval

Prescribers must have approval from the Chief Health Officer to prescribe controlled medicine for a drug-dependent patient or for ongoing treatment of more than two months in the ACT.

Prescribers can now apply for approval to prescribe a controlled medicine electronically using a Smartform. This Smartform allows prescribers to apply to the HPS for a controlled medicine approval directly via their practice management software or online through the HealthLink portal.

Prescribers wishing to use the Smartform can access the form via their practice software if they use Best Practice Premier®, Genie Solutions® or Medical Director®.

For further information please refer to the Smartform Quick Start Guides for each of the following practice software systems:

Prescribers who do not use any of the above practice management systems are still able to apply online using the Smartform via a HealthLink portal. If you wish to start using the HealthLink Portal, please complete the following MyHealthLink Portal Application form.

For further information please refer to the Smartform HealthLink Portal Quick Start Guide.

For those prescribers who still wish to submit applications by fax, they can submit the Application for approval to prescribe a controlled medicine to HPS.

The HPS can process an application within one to two working days providing further information is not required in support of the application.

Prescribers should tick the URGENT box on the application if an urgent approval is required. The HPS can consider urgent applications within one working day.

Controlled Medicines Prescribing Standards

The ACT Controlled Medicines Prescribing Standards support a flexible approach to the prescription of controlled medicines.

The Standards allow you to seek approval to prescribe a therapeutic class of controlled medicine(s) for patients. You can do this through a category approval system (Category Approval) or you can seek approval to prescribe by drug, form and strength (Approval by Drug).

Medicines Advisory Committee

The Medicines Advisory Committee (MAC) is a statutory body established under the Medicines, Poisons and Therapeutic Goods Act 2008 to provide expert advice to the ACT Chief Health Officer on complex clinical matters involving the prescribing and supply of medicines in the ACT. Specifically, the MAC provides advice to the ACT Chief Health Officer on applications for approval to prescribe controlled medicines, and applications for endorsement to treat drug dependency. The MAC may also consider applications for review of an unfavorable ACT Chief Health Officer decision on controlled medicine issues.

Under Chapters 13 and 15 of the Medicines, Poisons and Therapeutic Goods Regulation 2008, the MAC is responsible for reviewing and providing recommendations to the ACT Chief Health Officer as described by the following table. 

Considered Matter

MAC Recommendation to ACT Chief Health Officer

Referred applications for Approval to Prescribe a Controlled Medicine.

Either:

  1. Approve the application in same terms applied for;
  2. Approve the application in terms different from those applied for; or
  3. Refuse the application.

Applications for review of an unfavourable ACT Chief Health Officer decision about a controlled medicine approval.

Either:

  1. Confirm a previous ACT Chief Health Officer decision; or
  2. Revoke a previous ACT Chief Health Officer decision and recommend a substitute decision.

Applications for review of a ACT Chief Health Officer decision to refuse an endorsement to treat drug-dependency.

Either:

  1. Confirm a previous ACT Chief Health Officer decision; or
  2. Revoke a previous ACT Chief Health Officer decision and approve the application as recommended by the MAC.

Guidelines for the ACT Chief Health Officer decisions on applications to prescribe a controlled medicine.

Either:

  1. Accept a MAC draft Guideline; or
  2. Modify a previous Guideline; or
  3. Revoke a previous Guideline.

Membership

In accordance with the MPTG Regulation, the MAC consists of seven members including: a psychiatrist, pharmacist, general practitioner, consumer representative, doctor with experience in pain or addiction medicine, and nominee of the ACT Branch of the Australian Medical Association (AMA). The current membership of the MAC is as follows:

Member

Role

Specialty

Term of Appointment

Dr Marianne Bookallil

Chair

General Practice and Public Health Medicine

DI2021-34 – 21 Feb 2021 until 20 Feb 2024

Dr Antonio Di Dio

Member

General Practice

DI2021-34 – 21 Feb 2021 until 20 Feb 2024

Dr Bree Wyeth

Member

Psychiatry

7 Aug until 21 Feb 2024

Mrs Elise Apolloni

Member

Pharmacy

DI2021-34 – 21 Feb 2021 until 20 Feb 2024

Dr Vishal Arya

Member

General Practice

DI2021-34 – 21 Feb 2021 until 20 Feb 2024
Mr Mat Franklin

Member

Consumer Representation

DI2021-35 – 3 May 2021 until 20 Feb 2024

Dr Anandhi Rangaswamy

Member

Pain Medicine

NI2021-89 – 21 Feb 2021 until 20 Feb 2024

Subject to agreement by the Minister for Health or Chief Health Officer, sub-committees of the MAC may be established to assist the Committee in their role in providing expert advice about controlled medicines public health impact of controlled medicines i.e. the Medicinal Cannabis Medical Advisory Panel and the Medicinal Cannabis Advisory Group.

The Health Protection Service provides all Secretariat services for the MAC and can be contacted on the details below. Prescribers wishing to apply to the MAC for a review of an unfavourable decision on a controlled medicines approval or endorsement to treat drug-dependency, or for any other matter, may do so by forwarding correspondence to the below address.

Medicines Advisory Committee
C/-Health Protection Service
Locked Bag 5005
WESTON CREEK ACT 2611

Ph: (02) 5124 9208

Email: hps@act.gov.au   

Page last updated on: 6 Oct 2023