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Single shared REMS for TIRF products receives FDA approval

July 05, 2017

prescribing and dispensing TIRF medicines only to appropriate patients, including use only in opioid-tolerant patientspreventing inappropriate conversion between fentanyl productspreventing accidental exposure to children and others for whom TIRF medicines were not prescribededucating prescribers, pharmacists, and patients on the potential for misuse, abuse, addiction, and overdose.

Several TIRF products already have an individual REMS in place. Prescribers and pharmacies already enrolled in an individual REMS program for at least one TIRF medicine will automatically be transitioned to the shared TIRF REMS Access program.

Health care professionals who prescribe TIRF medicines that will only be used in an inpatient setting (hospitals, hospices, or long-term care facilities) will not be required to enroll in the TIRF REMS Access program. Similarly, patients who receive TIRF medicines in an inpatient setting are not required to enroll in the program. Long term care and hospice patients who obtain their medications from outpatient pharmacies must still be enrolled.

SOURCE U.S. Food and Drug Administration