Approved Risk Evaluation and Mitigation Strategies (REMS)

REMS@FDA

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Probuphine (buprenorphine hydrochloride)
NDA #204442
REMS last update: 11/01/2018



What is the purpose of the REMS?

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:

  1. 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
  2. Ensuring pharmacies are certified and only provide Probuphine to healthcare settings in which a certified prescriber is practicing
  3. Informing patients about the risks of complications of migration, protrusion, expulsion and nerve damage associated with insertion and removal, as well as the risk 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.

View application holder(s) REMS Website See Disclaimer page regarding links to external sites

Health Care Providers who prescribe Probuphine must

To become certified to prescribe
  • Review the drug’s Prescribing Information.
  • Take the Live Training: Lecture and Practicum.
  • Successfully complet 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 intiation
  • 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 with 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 using the Insertion/Removal Log or another method/system (e.g., electronic health record). Provider’s practice.

Health Care 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 Probuphine REMS program.
  • Review the drug’s Prescribing Information, including the Instructions for Use.
  • Take the Live Training: Lecture and Practicum.
  • Successfullly coplete the Knowledge Assessment and submit it to the REMS Program.
  • Successfully complete the Criteria for Procedural Competency.
  • Enroll in the REMS by completing the appropriate enrollment form: Healthcare Provider Who Performs Probuphine Surgical Procedures Enrollment Form or the Healthcare Provider Dual Enrollment Form and submitting it to the REMS Program.
Before 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 helath record0 to document the date, serial number, number o f iplants inserted, name of healthecare provider performing the procedure, and anatomical location of each implant for each patient.
During treatment
  • Assess the patinet's need for removal of Probuphine.
Before removal
  • Have the appropriate equipment to perform inseetions 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 o f iplants inserted, name of healthecare 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 form.
At all times
  • Insert and remove Probuphine only in helathcare 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 healthecare 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., elcectronic health record).
  • Comply with audits carried out by Titan Pharmaceuticals , Inc. or a third party acting on behalf of Titan 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 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 Patients Guide.
Before insertion
  • Receive counseling from the healthcare provider who inserts Probuphine of 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 helathcare 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 process and oversee implementation and compliance with the REMS Program on behalf of the pharmacy.
  • 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 dipense
  • 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 Titan Pharmaceuticals, Inc.
  • Comply with audits carried out by Titan Pharmaceuticals, Inc. or a third

Wholesalers 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 and procedures to verify that prescribers and pharmacies are certified
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 Titan Pharmaceuticals, Inc.
  • Comply with audits carried out by Titan Pharmaceuticals, Inc. or a third party acting on behalf of Titan 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.

Material Name Material Name Link
Criteria for Procedural Competency (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Probuphine_2018_11_01_Criteria for_Procedural_Competency.pdf
Healthcare Provider Dual Enrollment Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Probuphine_2018_11_01_Healthcare_Provider_Dual_Enrollment_Form.pdf
Healthcare Provider Who Performs Surgical Procedures Enrollment Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Probuphine_2018_11_01_Healthcare_Provider_Who_Perform_Surgical_Procedures_Enrollment_Form.pdf
Healthcare Provider Who Performs Surgical Procedures Recertification Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Probuphine_2018_11_01_Healthcare_Provider_Who_Performs_Surgical_Procedures_Recertification_Form.pdf
Insertion/Removal Log (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Probuphine_2018_11_01_InsertionRemoval_Log.pdf
Knowledge Assessment (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Probuphine_2018_11_01_Knowledge_Assessment.pdf
Pharmacy Enrollment Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Probuphine_2018_11_01_Pharmacy_Enrollment_Form.pdf
Prescriber Enrollment Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Probuphine_2018_11_01_Prescriber_Enrollment_Form.pdf
Procedure Record for Recertification (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Probuphine_2018_11_01_Procedure_Record_for_Recertification.pdf
REMS Document (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Probuphine_2018_11_01_REMS_Document.pdf
REMS Full (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Probuphine_2018_11_01_REMS_Full.pdf
REMS Website Screenshots (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Probuphine_2018_11_01_REMS_Webiste_Screenshots.pdf
Sllides for Live Training Lecture and Practicum (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Probuphine_2018_11_01_Slides_for_Live_Trainng_Lecture_and_Practicum.pdf
Surgical Procedures Recertificaation Video (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Probuphine_2018_11_01_Surgical_Procedures_Recertification_Video.pdf
What You Need to Know About Probuphine: A Patients Guide (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Probuphine_2018_11_01_What_You_Need_to_Know_About_Probuphine_A_Patients_Guide.pdf

What updates have been made to the REMS?

Date Summary of change
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.

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