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
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Buvidal
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Sublocade
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Sponsor
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Camerus
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Indivior
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PBS approved
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Yes- S100
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Yes- S100
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Products
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Weekly injections
8mg, 16mg, 24mg, 32mg
Monthly injections
64mg, 96mg, 128mg
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Monthly injections
300mg loading for 2 months
100mg monthly maintenance
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Induction
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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.
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Stabilisation on sublingual buprenorphine products for at least 7 days.
Commence with 300mg injection monthly for 2 months, then 100mg monthly
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Withdrawal management
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8mg injection
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Sublingual products
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Dosing flexibility
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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
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Monthly injections can be given up to a week either side of the scheduled due date
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Storage
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Room temperature, usual controlled medicines safe
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Refrigerated secure storage, can be at room temperature for up to 28 days prior to administration
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