FDA Adopts More Stringent REMS for Transmucosal Immediate-Release Fentanyl

The FDA has toughened its risk evaluation and mitigation and strategy (REMS) requirements for transmucosal immediate-release fentanyl (TIRF) products, seeking to reduce inappropriate prescribing of the powerful opioids. REMS are post-market programs that the agency requires as part of its approval of certain drugs to help ensure that the benefits outweigh its risks.

Under the modified REMS, healthcare professionals must document a patient’s opioid tolerance each time they issue a prescription for the powerful drugs, and pharmacies that dispense TIRF products will also have to verify a patient’s opioid tolerance before giving out the medications.

In addition, the revised REMS mandates the creation of a patient registry that will be used to monitor for accidental exposure, misuse, abuse, addiction and overdose of opioids.