Depot Buprenorphine is a new long acting formulation of an existing opioid pharmacotherapy, buprenorphine.
There are two depot buprenorphine products at this time: Buvidal® and Sublocade®
- Buvidal® is available on the Pharmaceutical Benefits Scheme (PBS) from 1 September 2019 under a s100 Opioid Dependence listing.
- Sublocade® is in the process of gaining PBS approvals with the Australian Government Therapeutic Goods Administration (TGA).
New interim guidelines for depot buprenorphine were developed to provide a framework for clinical decision making by clinicians and consumers in a range of service settings involved in the delivery of treatment with long acting depot buprenorphine products.
For additional advice on selected topics not included in the above guidelines, please see the Depot buprenorphine clinical guideline addenda
Restricted Access Period and Prescriber Eligibility Criteria
The TGA approved depot buprenorphine products with an initial restricted access period of a minimum of 6 months. The restriction is to ensure experienced OTP prescribers who work in well supported clinical contexts (hospitals and specialist rehabilitation settings) are delivering this treatment. From April 3 2020 this restriction will only apply to prescribing and administering Sublocade®.
Eligibility is limited in the first six months to accredited prescribers who meet both criteria 1. and 2. below:
- Specialised skills:
Providing services in appropriately supported settings – that is, public or private clinics with on-site dispensing that have sufficient clinical/ staffing resources to implement depot buprenorphine.
- Addiction Medicine specialists and Addiction Psychiatry specialists in any setting, or
- VMOs, CMOs, Nurse Practitioners and Registrars working in public OTP clinics, or
- Prescribers in private OTP clinics with at least five years continuous accreditation and at least 100 patients
During the restricted access period the TGA requires intending eligible prescribers to review the depot buprenorphine educational packages from the pharmaceutical companies. Please refer to the education package for Buvidall®. The Sublocade® education package will be available once the product listed on the PBS.
To register as a Depot Buprenorphine prescriber in the restricted access period please contact Pharmaceutical Regulatory Unit.
Post-restricted access for Buvidal®
Non-accredited prescribers are permitted to induct and manage up to twenty (20) opioid dependent patients on buprenorphine medicines. This existing restriction in the NSW Clinical Guidelines: Treatment of Opioid Dependence 2018 on patient numbers for non-accredited medical practitioners now include patients on depot buprenorphine.
Non-accredited prescribers are urged to seek clinical advice on prescribing and case management of patients on depot buprenorphine from addiction medicine or addiction psychiatry specialists, their local health district drug and alcohol service, or the Drug and Alcohol Specialist Advisory Service (DASAS).
- Medical practitioners using direct wholesaler delivery or pharmacy delivery should be aware of the S8 storage requirements.
- Pharmacies make arrangements for direct delivery to medical clinics and must never dispense depot buprenoprhine to a patient.
A consumer information sheet on depot buprenorphine including frequently asked questions is available at NSW Government's Alcohol and Other Drugs information website Your Room.
The NSW Users and AIDS Association (NUAA) has developed a Depot Buprenorphine Starters' Guide for consumers wanting more information on what to expect from treatment on depot buprenorphine.
Resources for clinicians
The Royal Australian College of General Practitioners (RACGP) has made available a free webinar: Introduction to Depot Buprenorphine in the Treatment of Opioid Dependent Patients. This webinar, presented by Professor Nick Lintzeris and Dr Hester Wilson, explains the clinical guidance, evidence base, pharmacology, and risks associated with depot buprenorphine, and how to implement it as an Opioid Agonist Treatment (OAT) for opioid dependency.
The NSW Drug and Alcohol Specialist Advisory Service (DASAS) is a free 24/7 service for health professionals to seek advice on clinical diagnosis and management of patients with alcohol and other drug use. DASAS clinicians will provide advice on clinical issues related to depot buprenorphine.
Phone DASAS on:
- Sydney metropolitan: (02) 9361 8006
- Regional and rural NSW: 1800 023 687 (this free call number is not free from mobile phones, except Telstra mobiles)