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The goal of the SUBLOCADE REMS is to mitigate the risk of serious harm or death that could result from intravenous self-administration by:
Ensuring healthcare settings and pharmacies are certified and only dispense SUBLOCADE directly to a healthcare provider for administration by a healthcare provider.
What do participants need to know?
Below is a general overview of the REMS for all REMS participants (e.g., patients, pharmacies, and healthcare providers). See the application holder(s) REMS Website or the approved REMS materials for more information.
Healthcare settings and pharmacies that dispense SUBLOCADE must:
To become certified to
dispense
Designate an authorized representative to carry out the certification process
and oversee implementation and compliance with the REMS on behalf of the
healthcare setting or pharmacy.
Have the authorized representative enroll in the REMS by completing the
Healthcare Setting and Pharmacy Enrollment Form and submitting it to the
REMS.
| Healthcare Setting and Pharmacy Enrollment Form |
Train all relevant staff involved in dispensing that the drug must be
dispensed directly to a healthcare provider for administration by a
healthcare provider, and the drug must not be dispensed to the patient.
Establish processes and procedures to verify SUBLOCADE is dispensed
directly to a healthcare provider and the drug is not dispensed to the
patient.
Establish processes and procedures to notify the healthcare provider not to
dispense the drug directly to patients.
Before dispensing
Verify that SUBLOCADE is dispensed directly to a healthcare provider and
the drug is not dispensed to the patient.
Notify the healthcare provider not to dispense the drug directly to patients.
To maintain
certification to
dispense
Have a new authorized representative enroll in the REMS by completing the
Healthcare Setting and Pharmacy Enrollment Form if the authorized
representative changes.
| Healthcare Setting and Pharmacy Enrollment Form |
At all times
Not distribute, transfer, loan or sell SUBLOCADE.
Maintain records of all processes and procedures including compliance with
those processes and procedures.
Comply with audits by Indivior Inc. or a third party acting on behalf of
Indivior Inc. to ensure that all processes and procedures are in place and
are being followed.
Wholesalers/Distributors that distribute SUBLOCADE must:
To be able to
distribute
Establish processes and procedures to ensure that the drug is distributed
only to certified healthcare settings and pharmacies.
Train all relevant staff involved in distributing SUBLOCADE on the process
and procedures to verify the healthcare settings and pharmacies are
certified.
At all times
Distribute only to certified healthcare settings and pharmacies.
Maintain and submit records of all shipments of SUBLOCADE to Indivior Inc.
Comply with audits carried out by Indivior Inc. or a third party acting on
behalf of Indivior Inc. to ensure that all processes and procedures are in
place and are being followed.
What materials are included in the REMS?
The REMS includes a REMS Document. In addition, the REMS includes the following materials intended for patients and healthcare providers. For a specific Medication Guide of a product in the Sublocade REMS, see the DailyMed link(s).
REMS assessment plan unavailable for posting at this time.
What updates have been made to the REMS?
Date
Summary of change
04/19/2024
Modified to update the product storage
conditions (from 7 days to 12 weeks) to align with currently approved labeling, affecting
the following materials: Healthcare Provider REMS Letter, Fact Sheet: How to Obtain
SUBLOCADE and REMS Website.
07/03/2023
Modified to align with the repeal of the Drug Addiction Treatment Act of 2000 (DATA-2000)
through the enactment of the Mainstreaming Addiction Treatment (MAT)
Act of 2021, thereby removing the DATA 2000 waiver requirement for qualifying
practitioners in order to dispense certain narcotic drugs used for treatment of opioid use
disorders.
01/27/2023
Revised to reflect editorial changes.
01/06/2023
Modified to change all of the REMS materials to clarify certification requirements, reorganize information for better understanding of the content, and change the healthcare setting audit requirement.
09/30/2021
Editorial change.
09/22/2021
Modified to make changes in response to recent updates with the Drug Enforcement Administration (DEA) interim final rule (IFR)
published on November 2, 2020, that amended regulations for consistency with the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for
Patients and Communities Act of 2018 (the SUPPORT Act). REMS materials were updated to clarify that the pharmacy can deliver SUBLOCADE to either the prescribing
practitioner or the practitioner administering the controlled substance, as applicable.Materials affected include the REMS Fact Sheet and the REMS Website.
12/02/2020
Revised to reflect editorial changes.
06/15/2020
Modified to change the REMS Document to update audit plans for healthcare settings and pharmacies.
01/28/2020
Revised to make an editorial change.
11/07/2019
Revised to make an editorial c hange.
03/08/2018
Editorial change.
02/09/2018
Revised to update mailing address.
11/30/2017
Approval of the REMS.
Disclaimer: This webpage provides general information about REMS programs
to various REMS participants (e.g., patients, pharmacies, and healthcare providers).
The summary information provided herein is not comprehensive and may not include
all of the information relevant to REMS participants. This webpage does not
constitute a replacement, modification, or revision of the approved REMS document,
including any appended REMS materials. Refer to the approved REMS document
for complete information on the REMS requirements for each approved application.
