Transmucosal Immediate Release Fentanyl (TIRF)
Risk Evaluation and Mitigation Strategy

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About the TIRF REMS Access Program

The Transmucosal Immediate Release Fentanyl (TIRF) products are available only through a Food and Drug Administration (FDA) mandated Risk Evaluation and Mitigation Strategy (REMS) program called the Transmucosal Immediate Release Fentanyl (TIRF) program. The TIRF REMS Access program is designed to ensure informed risk-benefit decisions before initiating treatment, and while patients are on treatment, to ensure appropriate use of TIRF medicines. The purpose of the TIRF REMS Access program is to mitigate the risk of misuse, abuse, addiction, overdose and serious complications due to medication errors with the use of TIRF medicines.

The goals of the TIRF REMS Access program are to mitigate the risk of misuse, abuse, addiction, overdose and serious complications due to medication errors by:
1.   Prescribing and dispensing TIRF medicines only to appropriate patients, which includes use only in opioid-tolerant patients.
2.   Preventing inappropriate conversion between TIRF medicines.
3.   Preventing accidental exposure to children and others for whom it was not prescribed.
4.   Educating prescribers, pharmacists, and patients on the potential for misuse, abuse, addiction, and overdose of TIRF medicines.

Prescribers are not eligible to prescribe TIRF medicines for outpatient use unless they are enrolled in the TIRF REMS Access program after reviewing the prescriber educational materials, including the Full Prescribing Information and have successfully completed the Knowledge Assessment and enrollment form

Patients must complete a Patient-Prescriber Agreement Form before they can be prescribed a TIRF medicine (not required for inpatients).

Outpatient Pharmacies will not be eligible to purchase or dispense TIRF medicines unless an authorized pharmacist has reviewed the TIRF REMS Access Education Program and successfully completed the Knowledge Assessment and enrollment form. Enrolled pharmacies can only dispense prescriptions for TIRF medicines if the prescriber and pharmacy are enrolled and active and the patient has not been inactivated in the program.

Inpatient Pharmacies will not be eligible to purchase or dispense TIRF medicines unless an authorized pharmacist has reviewed the TIRF REMS Access Education Program and successfully completed the Knowledge Assessment and enrollment form. For inpatient use of Fentanyl, patient and prescriber enrollment in the TIRF REMS Access program is not required. Inpatient pharmacies may not dispense Fentanyl for outpatient use.

Distributors enrolled in the program must verify current enrollment of the pharmacy in the TIRF REMS Access program before shipping TIRF medicines.

For assistance, please call the TIRF REMS Access program at 1-866-822-1483.