The rules apply to transmucosal immediate-release fentanyl, or TIRF, drugs. The drugs contain fentanyl, a powerful opioid, and are used to manage breakthrough pain in adults with cancer. To be prescribed a TIRF drug, patients have to be opioid tolerant.
The agency updated rules for TIRF drugs’ risk evaluation and mitigation strategies, including:
- Requiring prescribers to document patients’ opioid tolerance with each TIRF prescription
- Requiring outpatient pharmacies that dispense TIRF drugs to document and verify patients’ opioid tolerance before dispensing
- Requiring inpatient pharmacies to develop policies and procedures to verify opioid tolerance in patients who are prescribed TIRF drugs
- Requiring a new patient registry to monitor for accidental exposure, misuse, abuse and overdose
The FDA said the new rules, announced Dec. 23, are designed to address the persistence of concerning prescribing practices and to improve its ability to monitor for adverse events.
“We remain committed to using all facets of our regulatory authority to lessen the impact of opioid addiction, misuse, and abuse while also striking a careful balance between patient access and safety to ensure that patients suffering from significant pain have access to appropriate medication,” the agency said.
Read the full news release here.
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