Opioid maintenance treatment
Prescribers need Chief Health Officer (CHO) approval to prescribe opioid maintenance treatment (OMT) to a drug-dependent patient.
Prescribers
Endorsed prescribers
Prescribers seeking approval to prescribe opioid maintenance treatment for more than 5 patients need endorsement to treat drug dependency.
Endorsement is obtained by completing a training course as outlined in the Guidelines for Treatment of Opioid Dependency, prior to applying.
For information on course availability, contact Canberra Health Services Alcohol and Drug Services on (02) 5124 9977.
After completing all training requirements, you can apply online to become an endorsed prescriber.
Non-endorsed prescribers
Non-endorsed prescribers can obtain 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
In most circumstances, approval to subscribe Opioid Maintenance Treatment falls under Chapter 3 of the Controlled Medicines Prescribing Standards.
There are 2 sub-categories depending on treatment type:
- Category 3A: liquid methadone
Category 3B: sublingual buprenorphine, buprenorphine/naloxone or depot buprenorphine
Approval by drug may also be issued if criteria for a Category 3 approval is not met.
Prescribers with approvals should note that:
- criteria for prescribing methadone, buprenorphine or buprenorphine/naloxone under an approval can be found in the ACT Controlled Medicines Prescribing Standards.
- Category 3 approvals must be prescribed in line with the National Guidelines for Medication Assisted Treatment of Opioid Dependence
- you should comply where possible with the Opioid Maintenance Treatment in the ACT: Local Policies and Procedures.
How to apply for approvals
You can apply for approval using the following options:
- Canberra Script online application
- electronic SmartForm via the HealthLink portal if your practice uses Best Practice Premier, Genie Solution, or Medical Director software
- fax a completed Application for Approval to Prescribe Controlled Medicines Form directly to Pharmaceutical Services on (02) 5124 9309.
Pharmacists
Community pharmacies must be licensed to dispense methadone, buprenorphine or buprenorphine/naloxone for treatment of drug dependency. You can apply for a free Opioid Dependency Treatment Centre Licence.
You must:
- dispense methadone, buprenorphine or buprenorphine/naloxone in line with the National Guidelines for Medication Assisted Treatment of Opioid Dependence
- comply with the Opioid Maintenance Treatment in the ACT: Local Policies and Procedures wherever possible.
- complete training for the safe administration and dispensing of opioid maintenance treatment. These requirements are outlined in the Guidelines for Treatment of Opioid Dependence.
For information on course availability, contact Canberra Health Services Alcohol and Drug Services on (02) 5124 9977.
Dispensing depot buprenorphine
Pharmacists must ensure that a patient or their carer is never directly given any depot buprenorphine product. There are risks of misuse or death if administered intravenously.
A delivery or collection system must be established between the pharmacy and medical practice for depot buprenorphine.
Prescriber information for depot buprenorphine
Depot formulations of buprenorphine, Buvidal ® and Sublocade ®, are available for the treatment of opioid dependence.
Depot buprenorphine formulations are associated with additional risks compared to oral or sublingual forms of opioid maintenance treatment.
This means there are now additional conditions on Chief Health Officer (CHO) approvals for prescribing depot products under a Category 3B:
- breakthrough sublingual doses of buprenorphine are not authorised under a category 3B approval
- any supplemental dosing of sublingual buprenorphine will require a separate CHO application for approval by drug
- You must not give a prescription for depot buprenorphine to the patient
- if the product is supplied by a pharmacy, you must arrange collection to ensure the patient is not in possession of the product before administration
- you must have completed depot buprenorphine training.
- you must ensure the person administering the depot buprenorphine has undertaken appropriate training
- you may opt to source and store depot buprenorphine products at your practice for administration directly to patients.
Prescribers at practices that keep depot buprenorphine products must ensure appropriate storage, in accordance with sections 515 and 532 of the ACT Medicines, Poisons and Therapeutic Goods Regulation, 2008.
Buprenorphine depot product comparisons
| Buvidal | Sublocade | |
|---|---|---|
| Sponsor | Camerus Pty Ltd | Indivior Pty Ltd |
| PBS–approved | Yes | Yes |
| Products | Buvidal Monthly 64 mg/0.18 mL buprenorphine Buvidal Monthly 96 mg/0.27 mL buprenorphine Buvidal Monthly 128 mg/0.36 mL buprenorphine Buvidal Monthly 160 mg/0.45 mL buprenorphine | Sublocade 100 mg/0.5 mL buprenorphine Sublocade 300 mg/1.5 mL buprenorphine |
| Induction | Stabilisation on sublingual buprenorphine products for at least 7 days | |
| Start with weekly injections (8mg to 32mg) before moving to monthly (64mg to 160mg) if preferred and appropriate. Dosage depends on previous levels of opioid use. | 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 | Store below 25°, controlled medicines safe. | Refrigerated secure storage, can be at room temperature for up to 28 days prior to administration. |
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 who:
- has demonstrated, in relation to the person’s use of the medicine impaired control; or drug-seeking behaviour that suggests impaired control
- on ceasing the medicine, is likely to experience symptoms of mental or physical distress or disorder.