LOS ANGELES COUNTY
DEPARTMENT OF MENTAL HEALTH
  Policy 351.03 Buprenorphine Extended-Release (SUBLOCADE) Injection (306.33)
 
Policy Category:  Clinical
Distribution Level:  Directly Operated
Responsible Party:  Pharmacy and Therapeutics
 
Approved by Curley L. Bonds II, MD, Chief Medical Officer, on Feb 02, 2023
 
I.  PURPOSE
 
This policy establishes the use of buprenorphine extended-release (SUBLOCADE) injection as a treatment for moderate to severe opioid use disorder in clients who have initiated treatment with a transmucosal buprenorphine-containing product, followed by dose adjustment for a minimum of 7 days, in Los Angeles County Department of Mental Health (DMH/Department) directly operated programs.
 
II.  DEFINITIONS
 
Authorized Personnel: Registered nurses, licensed vocational nurses, psychiatric technicians, psychiatrists, nurse practitioners, and clinical pharmacists.

Clinic: Any DMH directly operated program.
 
III.  POLICY
 
SUBLOCADE shall only be obtained through a restricted distribution program called SUBLOCADE Risk Evaluation and Mitigation Strategy (REMS) as required by the United States Food and Drug Administration (FDA).

SUBLOCADE prescription shall only be sent to a REMS-certified community, retail, or specialty pharmacy.

Only authorized personnel who have received training shall administer SUBLOCADE.

SUBLOCADE shall not be dispensed directly to clients.

SUBLOCADE shall not be distributed, transferred, loaned, or sold.

Authorized staff shall read SUBLOCADE product labeling which has notification regarding not to dispense SUBLOCADE directly to clients.

Authorized staff shall follow documentation requirements detailed in the attached procedure for SUBLOCADE administration.

Authorized staff shall administer SUBLOCADE by abdominal subcutaneous injection only.

A permanent record for training shall be kept, maintained, and be readily accessible.

A record of all shipments of SUBLOCADE received and dispensed shall be kept for a minimum of 3 years and be readily accessible. The record shall also include client name, dose, and date administered.

Once SUBLOCADE is delivered to the clinic, it shall be:
  • Storage of SUBLOCADE shall be in accordance with Policy 306.18.
  • Kept in a secure place per state and federal regulations.
  • 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.
 
IV.  PROCEDURES
 
Procedures - Buprenorphine Extended-Release (SUBLOCADE) Injection
 
V.  AUTHORITY
 
VI.  ATTACHMENT