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Requiring documentation of opioid tolerance with every TIRF prescription for outpatient use.
Requiring inpatient pharmacies to develop policies and procedures to verify opioid tolerance in inpatients who require TIRF medicines while hospitalized.
Educating prescribers, pharmacists and patients that the safe use of TIRF medicines requires patients to be opioid-tolerant throughout treatment.
Mitigate the risk of accidental exposure by educating prescribers, pharmacists and patients about proper storage and disposal of TIRF medicines.
Monitor for accidental exposure, misuse, abuse, addiction, and overdose by enrolling all patients who receive a TIRF medicine for outpatient use into a registry and using surveillance systems and other data sources.
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.
Successfully complete the Prescriber Knowledge Assessment
and submit it to the REMS program.
| Prescriber Knowledge Assessment |
Enroll in the REMS by completing the Prescriber Enrollment
Form and submitting it to the REMS program.
| Prescriber Enrollment Form |
Before treatment initiation
Assess the patient for risk factors of opioid addiction, abuse,
and misuse.
Counsel the patient on the safe use of TIRF medicines using
the Medication Guide for the prescribed TIRF medicine and
the Patient Counseling Guide. Provide a copy of the materials
to the patient.
| Patient Counseling Guide |
Assess the patient’s opioid tolerance. Document and submit
to the REMS program using the Patient Enrollment Form.
| Patient Enrollment Form |
Enroll the patient by completing and submitting the
Patient Enrollment Form to the REMS program.
| Patient Enrollment Form |
During treatment, before each
prescription
Assess the patient’s health status for opioid tolerance,
appropriateness of dose, misuse, abuse, addiction, and
overdose. Document and submit to the REMS program using
the Patient Status and Opioid Tolerance Form.
| Patient Status and Opioid Tolerance Form |
During treatment, every 2 years
Counsel the patient on the safe use of TIRF medicines using
the Medication Guide for the prescribed TIRF medicine and
the Patient Counseling Guide. Provide a copy of the materials
to the patient.
| Patient Counseling Guide |
Re-enroll the patient in the REMS by completing the
Patient Enrollment Form and submitting it to the REMS
program.
| Patient Enrollment Form |
Before treatment re-initiation,
lapse in treatment of 6 months or
longer
Counsel the patient on the safe use of TIRF medicines using
the Medication Guide for the prescribed TIRF medicine and
the Patient Counseling Guide. Provide a copy of the materials
to the patient.
| Patient Counseling Guide |
To maintain certification to
prescribe, every 2 years
Review the Prescribing Information for the TIRF medicines.
Counsel the patient using the Medication Guide for any new
TIRF medicine not previously prescribed. Provide a copy to
the patient.
Report serious adverse events of accidental exposure,
misuse, abuse, addiction, and overdose to the REMS program
using the Adverse Events of Special Interest Reporting Form.
| Adverse Events of Special Interest Reporting Form |
Report treatment discontinuations to the REMS Program using
the Patient Discontinuation Form.
| Patient Discontinuation Form |
Patients who are prescribed TIRF medicines for outpatient use:
Before treatment initiation
Receive counseling from the prescriber on the safe use of TIRF
medicines using the Medication Guide and the
Patient Counseling Guide.
| Patient Counseling Guide |
Enroll in the REMS program by completing the
Patient Enrollment Form with the prescriber. Enrollment
information will be provided to the REMS program.
| Patient Enrollment Form |
Before treatment re-initiation,
lapse in treatment of 6 months or
longer
Receive counseling from the prescriber on the safe use of TIRF
medicines using the Medication Guide and the
Patient Counseling Guide.
| Patient Counseling Guide |
During treatment, every 2 years
Receive counseling from the prescriber on the safe use of TIRF
medicines using the Medication Guide and the
Patient Counseling Guide.
| Patient Counseling Guide |
Re-enroll in the REMS program by completing the
Patient Enrollment Form with the prescriber. Enrollment
information will be provided to the REMS program.
| Patient Enrollment Form |
At all times
Adhere to safe use conditions: taking around-the-clock opioid
pain medicine when using TIRF medicines, not sharing TIRF
medicines, properly storing and disposing your TIRF
medicines.
Inform the prescriber if your TIRF medicine does not relieve
your pain. Do not change your dose or take a TIRF medicine
more often than your prescriber directed.
Receive counseling from the prescriber on the safe use of each
new TIRF medicine you are prescribed.
Inform the prescriber of serious adverse events of accidental
exposure, abuse, misuse, addiction, and overdose.
Pharmacies that dispense TIRF medicines for outpatient use 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 review the
Pharmacy Education.
| Pharmacy Education |
Have the authorized representative successfully complete the
Pharmacy Knowledge Assessment and submit it to the REMS
program.
| Pharmacy Knowledge Assessment |
Establish processes and procedures to assess the patient’s
medication use for a change in opioid tolerance.
Have the authorized representative enroll in the REMS Program
by completing and submitting the Outpatient Pharmacy
Enrollment Form.
| Outpatient Pharmacy Enrollment Form |
Train all relevant staff involved in dispensing of TIRF medicines
on the risks associated with TIRF medicines and the
requirements of the REMS program using the
Pharmacy Education.
| Pharmacy Education |
Before dispensing
Provide the patient with the product-specific Medication Guide.
Assess the patient’s medication use for a change in opioid
tolerant status. Document and submit the results to the REMS
Program.
Obtain authorization to dispense each prescription by
contacting the REMS program to verify that the prescriber and
the patient are enrolled, and the patient is opioid tolerant.
To maintain certification to
dispense
Have any new authorized representative enroll in the REMS
Program by reviewing the Pharmacy Education, successfully
completing the Pharmacy Knowledge Assessment and the
Outpatient Pharmacy Enrollment Form and submitting both to
the REMS Program.
| Outpatient Pharmacy Enrollment Form |
| Pharmacy Education |
| Pharmacy Knowledge Assessment |
At all times
Not distribute, transfer, loan, or sell TIRF medicines.
Maintain records of staff training.
Comply with audits carried out by the manufacturers or a third
party acting on behalf of the manufacturers to ensure that all
processes and procedures are in place and are being followed.
Report serious adverse events of accidental exposure, misuse,
abuse, addiction, and overdose to the REMS program using the
Adverse Events of Special Interest Reporting Form.
| Adverse Events of Special Interest Reporting Form |
Pharmacies that dispense TIRF medicines for inpatient use 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 review the
Pharmacy Education.
| Pharmacy Education |
Have the authorized representative successfully complete the
Pharmacy Knowledge Assessment and submit it to the REMS
program.
| Pharmacy Knowledge Assessment |
Have the authorized representative enroll in the REMS program
by completing the Inpatient Pharmacy Enrollment Form and
submitting it to the REMS program.
| Inpatient Pharmacy Enrollment Form |
Train all relevant staff involved in dispensing of TIRF medicines
on the risks associated with TIRF medicines and the requirements of the REMS program using the
Pharmacy Education.
| Pharmacy Education |
Establish processes and procedures to verify that the patient is
opioid tolerant.
Before dispensing
Verify the patient is opioid tolerant through the processes and
procedures established as a requirement of the REMS program.
To maintain certification to
dispense
Have any new authorized representative enroll in the REMS
Program by reviewing Pharmacy Education, successfully
completing the Pharmacy Knowledge Assessment and the
Inpatient Pharmacy Enrollment Form and submitting both to
the REMS Program.
| Inpatient Pharmacy Enrollment Form |
| Pharmacy Education |
| Pharmacy Knowledge Assessment |
At all times
Not distribute, transfer, loan, or sell TIRF medicines.
Maintain records of staff training.
Comply with audits carried out by the manufacturers or a third
party acting on behalf of the manufacturers to ensure that all
processes and procedures are in place and are being followed.
Not dispense TIRF medicines for outpatient use.
Wholesalers-Distributors that distribute TIRF medicines must:
To be able to distribute
Establish processes and procedures to ensure that the drug is
distributed only to certified pharmacies.
Train all relevant staff involved in distributing TIRF medicines
on the procedures and the REMS program requirements.
At all times
Distribute only to certified pharmacies.
Maintain records of shipments to certified pharmacies.
Comply with audits carried out by TIRF Applicants or a third
party acting on behalf of the TIRF Applicants 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 Transmucosal Immediate-Release Fentanyl (TIRF) Products REMS, see the DailyMed link on the Products tab.
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
08/28/2024
Modified to add a Website Pop-Up Message to the TIRF REMS to inform healthcare providers of the discontinuation of TIRF products and the removal of some REMS website functionalites (i.e., online REMS
enrollment/certification, website account creation) to support the discontinuation of TIRF
products.
12/08/2022
Modified to change the timetable for submission of assessments in the REMS Document.
11/22/2022
Modified to revise the Actiq and Fentora Medication guides and to include a medication guide URL in order to be able to produce the medication guide electronically.
08/17/2022
Modified to make changes to the Pharmacy Education and Prescriber Education.
03/07/2022
Revised to reflect editorial changes.
12/03/2021
Modified to make changes in order to narrow the number of annual outpatient pharmacy audits required, not to exceed 400 pharmacies.
The REMS Document was updated to reflect that TIRF application holders must annually audit all certified outpatient pharmacies, or a maximum of 400, that have
received at least one shipment of a TIRF medicine in the past 12 months.
12/23/2020
Modified to reflect the following changes to the REMS Program:
Require that prescribers document a patient’s opioid tolerance with each prescription of a TIRF medicine for outpatient use;
Require outpatient pharmacies dispensing TIRF medicines to document and verify a patient’s opioid tolerance before dispensing;
Require inpatient pharmacies to develop internal policies and procedures to verify opioid tolerance in patients who require TIRF medicines while hospitalized; and
Require a new patient registry for use, along with other data sources, to monitor for accidental exposure, misuse, abuse, addiction, and overdose.
09/07/2017
Modified to make changes to the REMS document, and appended materials consistent with the safety label changes approved on December 16, 2016, as well as additional minor modifications.
04/11/2017
Modified to add the authorized generic and a Medication Guide that is identical to that of the branded product, except that only the authorized generic (fentanyl buccal tablets) is listed as the product name.
12/21/2015
Modified to include the new strength of 300mcg per spray in the Medication Guide.
12/24/2014
Modified to:
Remove NDC Numbers from the Independent Outpatient Pharmacy Enrollment Form, Chain Outpatient Pharmacy Enrollment Form, and TIRF REMS Website.
Remove reference to generic equivalents of specific products and replacement with a footnote in the Education Program for Prescribers and Pharmacists and TIRF REMS Website.
Remove “Attachment 1: List of TIRF Medicines Available Only through the TIRF REMS Access Program,” and replacement with a hyperlink to the new TIRF REMS Webpage in the TIRF REMS Document, Overview for Prescribers, Prescriber Enrollment Form, Overview for Patients and Caregivers, Independent Outpatient Pharmacy Overview, Chain Outpatient Pharmacy Overview, Closed System Outpatient Pharmacy Overview, Independent Outpatient Pharmacy Enrollment Form, Chain Outpatient Pharmacy Enrollment Form, Closed System Outpatient Enrollment Form, Inpatient Pharmacy Enrollment Form, Distributor Enrollment Form, and TIRF REMS Website and Website Landing Page.
Revise criteria for inactivation of Patient-Prescriber Agreement Form (PPAF) in the TIRF REMS Document.
Revise to enhance knowledge about conversion of TIRF Medicines in the Education Program for Prescribers and Pharmacists and TIRF REMS Website.
Add information clarifying the process to electronically transmit TIRF REMS Cash Claims in the TIRF REMS Document, TIRF REMS Access Program Frequently Asked Questions (FAQ), Independent Outpatient Pharmacy Overview, Chain Outpatient Pharmacy Overview, Closed System Outpatient Pharmacy Overview.
11/04/2014
Modified to add the Abstral product to the shared system REMS.
11/07/2013
Modified to:
Revise terminology, processes, and definitions for outpatient pharmacies.
Revise attestations for physicians and patients to address concerns regarding patient access.
Revise Program Overview and Frequently Asked Questions to improve clarity and content.
Reflect the completion of the transition phase for the TIRF REMS Access Program in the REMS materials.
06/05/2012
Modified to:
Edit the Patient-Prescriber Agreement Form, add the Closed System Pharmacy Enrollment Form, add the newly approved TIRF product, Subsys (fentanyl sublingual spray), make minor editorial changes.
Update the TIRF REMS Access Program “go-live” placeholder date to the actual "go-live" date of March 12, 2012.
12/28/2011
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.
