Fentanyl (Onsolis) has received FDA approval for the management of breakthrough pain in cancer patients age 18 and older who already use opioid pain medication daily and who need and are able to safely use high doses of an additional opioid medicine.
Because fentanyl is subject to misuse, the drug was approved with a “Risk Evaluation and Mitigation Strategy” (REMS), which is a required plan for managing risks associated with a drug or biological product. As part of the plan, fentanyl will be available only through a restricted distribution plan called the FOCUS (Full Ongoing Commitment to User Safety) program. Only those prescribers, patients, and pharmacies registered with the program will be able to prescribe, dispense, and receive fentanyl.
Training and educational materials will also be provided for prescribers and pharmacy personnel, and a counseling call will be placed to patients prior to dispensing to ensure that they have been adequately educated about the appropriate use of the drug.
The approval also included use of a boxed warning stating that the medication should not be used for the management of migraines, dental pain, or postoperative pain or by patients who use opioids intermittently, or on an as-needed basis. The language also warns that the drug should be kept out of the reach of children and should not be substituted for other fentanyl products.