Operational Considerations
- May only be ordered and dispensed by a REMS-certified pharmacy.
- Organizations medical, legal and internal/external pharmacy teams can be helpful with establishing protocols and workflows for ordering, storing, dispensing, and documenting use of Sublocade.
- Establish naloxone monitoring and restocking protocols and agreements with community partners.
- Licensing: Organizations must comply with their on-site DEA license requirements.
- Ordering: Establish process and procedure to verify that long-acting injectable buprenorphine is provided directly to healthcare provider for administration by a healthcare provider.
- Long-acting injectable buprenorphine is available in two ways:
- Buy and Bill Method: buy the medication in bulk billing to insurance following administration.
- Order through specialty pharmacy: bill through patient’s insurance and have it delivered to the site.
- Long-acting injectable buprenorphine cannot be…
- dispensed to or handled by the patient.
- distributed, transferred, or sold by the healthcare provider.
- Storage and Handling:
- Medication must be double locked (for example, stored in a locked unit in a locked medication room).
- Per DEA regulations, a log must be kept in the locked medication room which documents: medication inventory, medication receipt, administrating, and wasting/reverse distribution.
Available Training and Technical Assistance (TTA)
Evaluation Metrics1
- Percentage of individuals with an OUD diagnosis who were administered long-acting injectable buprenorphine
- Percentage of individuals who were administered long-acting injectable buprenorphine for at least 6 months
- Number of units dispensed from REMS-certified pharmacy
Acknowledgements
We wish to express our thanks to all community partners who have implemented these programs during the HEALing Communities Study. Key insights from these partners were crucial in the development of these resources that will be important tools for programs looking to build on the successes of these strategies to reduce fatal overdoses.
Endnote
1Mar, Tami, et al., “State Measures for Improving Opioid Use Disorders Treatment Implementation Toolkit” (2022), https://www.pewtrusts.org/-/media/assets/2022/11/14798_pew_metrics_toolkit_111722.pdf .