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.

Applying for Chief Health Officer Approval

Prescribers must have approval from the Chief Health Officer (CHO) 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.

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. Please contact the HPS on 02 5124 9208 or pss@act.gov.au if you wish to start using the HealthLink portal.

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).

Opioid Maintenance Treatment

Only endorsed prescribers may commence a patient on opioid maintenance treatment or prescribe for more than 5 stable patients at the same time.

Non-endorsed prescribers can only prescribe methadone, buprenorphine or buprenorphine/naloxone for up to 5 drug dependent patients.

Category 3 of the ACT Controlled Medicines Prescribing Standards states conditions and criteria for prescribing methadone, buprenorphine or buprenorphine/naloxone under an approval. You are also required to prescribe these drugs in line with the National Guidelines for Medication Assisted Treatment of Opioid Dependence. Prescribers should also endeavour to comply with the Opioid Maintenance Treatment in the ACT: Local Policies and Procedures wherever possible.

If you would like to become an endorsed prescriber to treat drug dependency in the ACT, you are required to undertake ACT Health training. These requirements are outlined in the Medicines, Poisons and Therapeutic Goods (Guidelines for treatment of opioid dependency) Approval. Please submit an Application for Endorsement to Treat Drug Dependency to us.

Pharmacies

Community pharmacies in the ACT must be licensed to dispense methadone, buprenorphine or buprenorphine/naloxone for treatment of drug dependency. Pharmacists can apply to HPS to obtain an Opioid Dependency Treatment Centre Licence. You can apply for this by submitting an Application for Opioid Dependency Treatment Centre Licence (Pharmacist).

You must also dispense methadone, buprenorphine or buprenorphine/naloxone in line with the National Guidelines for Medication Assisted Treatment of Opioid Dependence. You should also comply with the Opioid Maintenance Treatment in the ACT: Local Policies and Procedures wherever possible.

All pharmacists dispensing treatment must successfully complete training for the safe administration and dispensing of opioid maintenance treatment. These requirements are outlined in the Medicines, Poisons and Therapeutic Goods (Guidelines for treatment of opioid dependency) Approval.

You can access local contacts and program related information from the Alcohol and Drug Services webpage.

Medicines, Poisons and Therapeutic Goods (MPTG) Regulation

Definition of Drug Dependent Person

*The MPTG Regulation defines a drug dependent person, in relation to a controlled medicine as being a person with a condition:

(a) who, as a result of the administration of the medicine or substance, demonstrates, in relation to the person’s use of the medicine or substance—

(i) impaired control; or

(ii) drug-seeking behaviour that suggests impaired control; and

(b) who, as a result of the cessation of the administration of the medicine or substance, is likely to experience symptoms of mental or physical distress or disorder.

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 CHO on complex clinical matters involving the prescribing and supply of medicines in the ACT. Specifically, the MAC provides advice to the CHO 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 CHO 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 CHO as described by the following table. 

Considered Matter

MAC Recommendation to CHO

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 CHO decision about a controlled medicine approval.

Either:

  1. Confirm a previous CHO decision; or
  2. Revoke a previous CHO decision and recommend a substitute decision.

Applications for review of a CHO decision to refuse an endorsement to treat drug-dependency.

Either:

  1. Confirm a previous CHO decision; or
  2. Revoke a previous CHO decision and approve the application as recommended by the MAC.

Guidelines for the CHO 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 Rashmi Sharma

Chair

General Practice

DI2017-23 - until 8 March 2020

Dr Antonio Di Dio

Member

General Practice

DI2017-23 - until 8 March 2020

Dr Peter Norrie

Member

Psychiatry

NI2017-111 – until 8 March 2020

Ms Amanda Galbraith

Member

Pharmacy

Dl2018-26 – until 21 February 2021

Dr Romil Jain

Member

Pain Medicine and
Intensive Care Medicines

 
 

Member

Consumer Representation

 

Dr Marianne Bookallil

Member

General Practice and
Public Health Medicine

NI2017-112 – until 8 March 2020

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: 29 Mar 2019