The .gov means it's official. Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
The site is secure. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.
The goal of the Probuphine REMS is to mitigate the risk of complications of migration, protrusion, expulsion and nerve damage associated with the insertion and removal of Probuphine and the risks of accidental overdose, misuse and abuse by:
Ensuring that healthcare providers are educated on the following:
proper insertion and removal of Probuphine
risk of complications of migration, protrusion, expulsion and nerve damage associated with the insertion and removal of Probuphine
risks of accidental overdose, misuse and abuse if an implant comes out or protrudes from the skin
Ensuring pharmacies are certified and only provide Probuphine to healthcare settings in which a
certified prescriber is practicing
Informing patients about the risks of complications of migration, protrusion, expulsion and nerve damage associated with insertion and removal, as well as the risks of accidental overdose, misuse and abuse if an implant comes out or protrudes from the skin.
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 providers who prescribe Probuphine must:
To become certified to
prescribe
Review the Prescribing Information including the Instructions for Use.
Take the Live Training: Lecture and Practicum provided by the REMS
Program.
Successfully complete the Knowledge Assessment and submit it to the
REMS Program.
Enroll in the REMS by completing the Prescriber Enrollment Form and
submitting it to the REMS Program.
Before treatment
initiation
Counsel the patient on the risks of insertion and removal, accidental
overdose, misuse and abuse and the importance of appropriate wound
care using the What You Need to Know about Probuphine: A Patient’s
Guide.
Provide the patient the What You Need to Know about Probuphine: A
Patient’s Guide.
At all times
Not loan or sell Probuphine.
Not transfer Probuphine, except to certified inserters.
Maintain records of insertion and removal of Probuphine, including the
date, serial number, number of implants inserted, name of healthcare
provider performing the procedure, and anatomical location of each
implant in each patient’s medical record by using the Insertion/Removal
Log or by using another method/system (e.g., electronic health record).
Healthcare providers who insert and remove Probuphine must:
To become certified to
insert
Have performed a surgical procedure in the three months immediately
preceding enrollment in the REMS.
Review the Prescribing Information including the Instructions for Use.
Take the Live Training: Lecture and Practicum provided by the REMS
Program.
Successfully complete the Knowledge Assessment and submit it to the
REMS Program.
Successfully complete the Criteria for Procedural Competency.
Enroll in the REMS by completing the Healthcare Provider Who Performs
Probuphine Surgical Procedures Enrollment Form or Healthcare Provider
Dual Enrollment Form and submitting it to the REMS Program.
insertion
Have the appropriate equipment to perform insertions and removals of
Probuphine on-site.
Counsel the patient on the risks of insertion and removal; accidental
overdose, misuse, and abuse; and the importance of appropriate wound
care using the Medication Guide. Provide a copy to the patient.
After insertion
Complete the Insertion/Removal Log or use another method/system
(e.g., electronic health record) to document the date, serial number,
number of implants inserted, name of healthcare provider performing the
procedure, and anatomical location of each implant for each patient.
During treatment
Assess the patient’s need for removal of Probuphine.
Before removal
Have the appropriate equipment to perform insertions and removals of
Probuphine on site.
After removal
Complete the Insertion/Removal Log or use another method system
(e.g., electronic health record) to document the date, serial number,
number of implants removed, name of healthcare provider performing
the procedure, and anatomical location of each implant for each patient.
To maintain certification
to insert; every year
Complete the Healthcare Provider Who Performs Probuphine Surgical
Procedures Recertification Form and the recertification training
requirements as described in the Healthcare Provider Who Performs
Probuphine Surgical Procedures Recertification Form.
At all times
Insert and remove Probuphine only in healthcare settings in which a
certified prescriber is practicing.
Maintain records of the insertion and removal of Probuphine, including
the date, serial number, number of implants inserted, name of
healthcare provider performing the procedure, and anatomical location of
each implant for each patient by using the Insertion/Removal Log or by
using another method/system (e.g., electronic health record).
Comply with audits carried out by ReacX Pharmaceuticals, Inc. or a third
party acting on behalf of ReacX Pharmaceuticals, Inc. to ensure that all
processes and procedures are in place and are being followed.
Patients who are prescribed Probuphine:
Before treatment
initiation
Receive counseling from the prescriber on the risks of Probuphine
insertion and removal, accidental overdose, misuse and abuse and the
importance of appropriate wound care using the What You Need to Know
about Probuphine: A Patient’s Guide.
Before insertion
Receive counseling from the healthcare provider who inserts Probuphine
on the risks of Probuphine insertion and removal, accidental overdose,
misuse and abuse and the importance of appropriate wound care using
the Medication Guide.
During treatment
Be monitored for the need to remove Probuphine.
At all times
Get Probuphine removed by a healthcare provider who is certified to
insert Probuphine.
Pharmacies that dispense Probuphine must:
To become certified to
dispense
Designate an authorized representative to carry out the certification
Have the authorized representative enroll in the REMS Program by
completing the Pharmacy Enrollment Form and submitting it to the REMS
Program.
Train all relevant staff involved in dispensing that Probuphine is
dispensed only to healthcare settings in which a certified prescriber is
practicing and that the drug is not dispensed directly to the patient.
Establish processes and procedures to verify that Probuphine is provided
to a healthcare setting in which a certified prescriber is practicing and
the drug is not dispensed directly to the patient.
Before dispensing
Verify that the prescriber who will receive the drug is certified to
prescribe Probuphine.
To maintain certification
to dispense
Have a new authorized representative enroll in the REMS Program by
completing the Pharmacy Enrollment Form if the authorized
representative changes.
At all times
Not distribute, transfer, or sell Probuphine, except to healthcare settings
in which a certified prescriber is practicing.
Maintain records of staff training and of all processes and procedures
including compliance with those processes and procedures.
Maintain and submit records of all shipments of Probuphine to ReacX
Pharmaceuticals, Inc.
Comply with audits carried out by ReacX Pharmaceuticals, Inc. or a third
party acting on behalf of ReacX Pharmaceuticals, Inc. to ensure that all
processes and procedures are in place and are being followed.
Wholesalers-Distributors that distribute Probuphine must:
To be able to distribute
Establish processes and procedures to ensure that the drug is distributed
only to certified pharmacies and to healthcare settings in which a certified
prescriber is practicing.
Train all relevant staff involved in distributing Probuphine on the process
At all times
Distribute only to certified pharmacies and to healthcare settings in
which a certified prescriber is practicing.
Maintain records of all processes and procedures including compliance
with those processes and procedures.
Maintain and submit records of all shipments of Probuphine to ReacX
Comply with audits carried out by ReacX Pharmaceuticals, Inc. or a third
party acting on behalf of ReacX Pharmaceuticals, 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.
This webpage provides REMS assessment plan measures, metrics, and indicators for drug and biological products with a REMS. The REMS assessment plan measures, metrics, and indicators are part of the overall REMS assessment plan used by FDA to evaluate the performance of a REMS and are included in FDA approval letters. The current REMS assessment plan measures, metrics, and indicators are extracted from regulatory letters that contain REMS information, including FDA approval letters,
and posted here as they become available.
What updates have been made to the REMS?
Date
Summary of change
12/11/2024
Updated to include applicants name and contact information on REMS website and REMS materials.
11/01/2018
Modified to make changes to the REMS document and materials to include pharmacy certification requirements.
04/19/2017
Modified to make modifications to the Probuphine REMS Program Surgical Procedures Recertification Transcript.
06/14/2016
Revised to correct a typographical error(s).
05/26/2016
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.
