Opioid Maintenance Treatment

 

Prescribers

In the ACT, prescribers are required to obtain a Chief Health Officer approval prior to prescribing opioid maintenance treatment (OMT) to a drug dependent patient.

Endorsed prescribers

Prescribers seeking Chief Health Officer approval to initiate OMT, or prescribe OMT for greater than 5 patients, are required by ACT Health to obtain an endorsement to treat drug dependency. 

Endorsement requires the completion of a designated course and practical component, as outlined in the Medicines, Poisons and Therapeutic Goods (Guidelines for treatment of opioid dependency) Approval Medicines, Poisons and Therapeutic Goods (Guidelines for treatment of opioid dependency) Approval 2018.  For information on course availability, please contact Canberra Health Services  Alcohol and Drug Services.

Should you wish to become an endorsed prescriber, please complete the application form and submit to ACT Health.  Application forms can be found here.

Non-endorsed prescribers

Non-endorsed prescribers are able to obtain Chief Health Officer approval to prescribe maintenance therapy for up to 5 drug dependent patients already established on methadone, buprenorphine or buprenorphine/naloxone.

Chief Health Officer approval types and conditions

Category 3 Chief Health Officer approvals may be issued to authorise the prescribing of OMT in most circumstances. Category 3 approvals are subdivided into two sub-categories depending on treatment type as follows:

  • Category 3A: liquid methadone
  • Category 3B: sublingual buprenorphine, buprenorphine/naloxone or depot buprenorphine

An Approval by Drug may also be issued to authorise the prescribing of treatment that does not meet the criteria for a Category 3 approval.

Chapter 3 of the ACT Controlled Medicines Prescribing Standards (the Standards) states the conditions and criteria for prescribing methadone, buprenorphine or buprenorphine/naloxone under an approval.  Prescribers issued with a Category 3 approval are required to prescribe these medicines 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.

To apply for a Chief Health Officer approval to prescribe OMT, please refer to the “Applying for Chief Health Officer Approval” section of the website found here.

Pharmacists

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 2018.

For information on course availability, please contact Canberra Health Services Alcohol and Drug Services.

Depot Buprenorphine

From June 2019, depot formulations of buprenorphine, Buvidal® and Sublocade®, have been registered for use in Australia for the treatment of opioid dependence and are now available to all prescribers. From 2 April 2021, the Standards have been updated to enable the prescribing of depot buprenorphine under a Category 3B approval.  The updated Standards can be found here.

As depot buprenorphine formulations are associated with additional risks compared to oral or sublingual forms of OMT, additional conditions have been placed on Chief Health Officer approvals for the prescribing of depot products under a Category 3B approval, relating to the supply and administration, as outlined in the Standards.

To ensure patient safety, the following conditions have been added to the Standards and now apply to prescribing depot buprenorphine under a Category 3B approval:

  • breakthrough sublingual doses of buprenorphine are not authorised under a category 3B approval.  Any supplemental dosing of sublingual buprenorphine will require a separate Chief Health Officer application for Approval by Drug;
  • the patient is NOT to be given the depot buprenorphine prescription by the prescriber;
  • if the product is supplied from a pharmacy, the prescriber must arrange collection of the product from the pharmacy to ensure the patient is not in possession of the product prior to administration;
  • the prescriber must have undertaken depot buprenorphine training; and
  • the prescriber must ensure the person administering the depot buprenorphine has undertaken training in the administration of the product.

Prescribers may opt to obtain and store depot buprenorphine products at the medical practice for administration directly to patients.

Prescribers at practices that choose to keep depot buprenorphine products are required to ensure appropriate storage, noting schedule 8 (controlled) medicines storage and possible cold storage requirements, in accordance with sections 515 and 532 of the ACT Medicines, Poisons and Therapeutic Goods Regulation, 2008.

Pharmacists must ensure:

  • a patient is never directly dispensed, or in possession of, any depot buprenorphine product;
  • a delivery/collection system is established between the pharmacy and medical practice, if required.

Unlike daily dose methadone or buprenorphine, depot preparations should never be supplied directly to a patient or their carer as there is a risk of diversion and death if administered intravenously.

Buprenorphine depot product comparisons

 

Buvidal

Sublocade

Sponsor

Camerus

Indivior

PBS approved

Yes- S100

Yes- S100

Products

Weekly injections

8mg, 16mg, 24mg, 32mg

Monthly injections

64mg, 96mg, 128mg

Monthly injections

300mg loading for 2 months

100mg monthly maintenance

Induction

Stabilisation on sublingual buprenorphine products for at least 7 days.

Start with weekly injections before moving to monthly if preferred and appropriate. Dosage depends on previous levels of opioid use.

Stabilisation on sublingual buprenorphine products for at least 7 days.

 

Commence with 300mg injection monthly for 2 months, then 100mg monthly

Withdrawal management

8mg injection

Sublingual products

Dosing flexibility

Weekly injections can be given up to 2 days either side of the scheduled due date

Monthly injections can be given up to a week either side of the scheduled due date

Monthly injections can be given up to a week either side of the scheduled due date

Storage

Room temperature, usual controlled medicines safe

Refrigerated secure storage, can be at room temperature for up to 28 days prior to administration

COVID-19 contingency arrangements

Information on contingency arrangements for OMT during COVID-19 isolation or quarantine can be found here.

Definition of Drug Dependent Person

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

  1. 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-
    1. impaired control; or
    2. drug-seeking behaviour that suggests impaired control; and
  2. 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.
Page last updated on: 12 May 2021