Sublocade Policy-Procedure

              SUBLOCADE® (buprenorphine extended-release)

 

Ø  SUBLOCADE is intended for abdominal subcutaneous injection only by a healthcare provider.

Ø   SUBLOCADE is available only through SUBLOCADE REMS Program because of the risk of serious harm or death that could result from intravenous self-administration.

Ø  All healthcare settings and pharmacies that dispense SUBLOCADE must be certified in the SUBLOCADE REMS program.

Ø  Healthcare providers, healthcare settings, and pharmacies must obtain SUBLOCADE through a restricted distribution program.

Ø  SUBLOCADE must never be dispensed directly to a patient and is only administered by a healthcare provider

Ø  Healthcare prescribers who are DATA 2000-waivered can obtain SUBLOCADE in 2 ways:

o   Through a contracted and REMS-certified Pharmacy for a specific named patient .

o   By ordering directly through a contracted Wholesaler/ Distributor to store a supply of SUBLOCADE. Must be REMS certified.

Ø  When prescribing SUBLOCADE for a specific named patient, the DATA-2000 waivered prescriber must indicate if the REMS-certified pharmacy should dispense to the prescriber’s DEA registered location or to the DEA registered location of the alternate HCP who will act as the administering practitioner.

Ø  SUBLOCADE delivery should be coordinated with the patient’s administration appointment.

Ø  An administering practitioner must be a DEA-registrant following all local, state and federal regulations.

Ø  To dispense to an administering practitioner, the REMS-certified pharmacy contract must include the required dispensing data and the pharmacy must have the capability to submit data for required compliance checks.

Ø  Indivior must monitor healthcare settings, pharmacies, and wholesaler/distributors on an ongoing basis to ensure the requirements of the REMS are being met. Take corrective action if non-compliance is identified, up to and including de-certification.

*Sublocade is a CIII, so it requires a PDMP check to be completed prior to filling first fill for patient or change in dose, or change in provider.

*Sublocade has a hard copy note on the drug profile associated with all dispenses that states this medication can NEVER be provided directly to the patient, it can only be delivered to the provider office for administration.

*Sublocade has a hard coded sig that states the medication can NOT be given the patient directly

*Each patient prescribed Sublocade will never be given to a patient directly, it will be delivered or shipped to Provider on the script address.  This address for the provider must match the address in RX30 that matches the active address that is linked to that provider per their DEA license.

*Store refrigerated. Once outside the refrigerator, this product may be stored in its original packaging at room temperature for up to seven (7) days prior to administration. Discard SUBLOCADE if left at room temperature for longer than seven (7) days.

*All Sublocade prescriptions must be delivered or shipped in validated cooler following the pack out for the season (outside temperature).  These pack out visuals are posted at shipping/delivery station.

 *Asti's is required to submit weekly reporting to the manufacturer for REMS requirements, at this time we will only be ordering manually to validate weekly dispenses.

*Samantha Pitzarella serves as the REMS coordinator for this program, any questions/concerns should be directed to her attention.

*I certify my understanding of all of the above information regarding Sublocade and Asti's South Hills Pharmacy policy/procedure to dispense the medication.

Policy Update: 6/22/2023 @4:51pm Version 1.2
-Must document verfication of DEA registered address as a hard copy note on prescriptionrecord_PMS (pharmacy management system) will timestamp data
DEA verfication is completed by following steps on this webpage:

https://apps.deadiversion.usdoj.gov/webforms2/spring/validationLogin?execution=e1s1

-DEA address of provider must match the delivery address of the medication
Patient delivery address must be manually changed to reflect the DEA verified address of the
provider for delivery. The address is double checked prior to dispatch for delivery or shipment
services. 
-All prescriptions pharmacy label for Sublocade has mandatory sig to include: "Sublocade must never be dispensed directly to a patient and only to Healthcare Provider Office".
-All Sublocade prescription receipts/manifests will have Address of Delivery equal to DEA
-Validated address of Provider office. Home address of the patient will be removed from receipt
with Auxillary sticker *see photo*

Policy Update 4/23/25 V1.3:

-Pharmacists may now administer Sublocade at Asti's Pharmacy.  All pharmacists that have received hands-on or virtual training may perform administration.  This will be appointment based upon a filled prescription order from a provider.  This medication may be filled at Asti's or may be shipped to Asti's for administration from another pharmacy per patients insurance restrictions.  

-This medication is NEVER to be handed to a patient for self administration and can only be shipped/delivered to provider office directly from pharmacy or administred by trained Pharmacist at Asti's

-All staff must sign off on this updated policy change to reflect understanding of the REMS program and updates to the on-site administration changes.

Administration information can be found:
https://www.sublocadehcp.com/pdfs/sublocade-dosing-administration-guide.pdf