FDA Approves Class REMS for Immediate-Release Fentanyl

Susan Jeffrey

December 29, 2011

December 29, 2011 — The US Food and Drug Administration (FDA) has approved a single, shared system risk evaluation and mitigation strategy (REMS) for the whole class of transmucosal immediate-release fentanyl (TIRF) drugs.

The shared system strategy, called the TIRF REMS Access Program, will replace individual REMS for these agents, allowing prescribers and pharmacies to enroll into a single system with the aim of "easing the burden on the health care system," a statement from the FDA notes.

This is the first approved class REMS for any opioid drugs, the FDA notes. "This TIRF REMS will ensure safe use and access to these drugs for patients who need them," said Janet Woodcock, MD, director of the FDA's Center for Drug Evaluation and Research, in the FDA release. "We have worked with the sponsors of both the innovator and generic drugs to develop this single, shared system that will streamline the process and decrease the burden of the REMS on the health care system."

TIRF opioid agents include brand-name drugs Abstral ([fentanyl] sublingual tablet; ProStrakan), Actiq ([fentanyl citrate] oral transmucosal lozenge; Cephalon) and its generic equivalents, Fentora ([fentanyl citrate] buccal tablet; Cephalon), Lazanda ([fentanyl] nasal spray; Archimedes Pharma), and Onsolis ([fentanyl] buccal; Meda Pharmaceuticals), which are used to manage breakthrough pain in adults with cancer who routinely take other opioid pain medications around the clock.

Sharon Hertz, MD, deputy director of the Division of Anesthesia, Analgesia, and Rheumatology Products at FDA's Center for Drug Evaluation and Research, pointed out that the value of a shared system became apparent as more of these TIRF agents were being approved for breakthrough cancer pain.

"All of the products in this group have been approved either initially under a risk management plan or, more recently, subsequent to us gaining authority for REMS, under individual REMS," Dr. Hertz told Medscape Medical News. "There are 3 REMS programs out there right now, so the advantage is that a prescriber can enroll once for all of the products in the class, and have 1 Web site and 1 set of information, and everything will be consistent."

In addition, prescribers can make the decision of which product is best for their patient without having to be concerned about which program they had previously enrolled in, Dr. Hertz added.

The program will begin in March 2012. Until that time, prescribers, patients, and pharmacies should continue to enroll in the individual REMS programs, the FDA statement notes.

Specifically, the release states, the stated goals of the TIRF REMS Access Program are "to ensure patient access to important medications and mitigate the risk for misuse, abuse, addiction, overdose and serious complications due to medication errors by:

  • prescribing and dispensing TIRF medicines only to appropriate patients, including use only in opioid-tolerant patients

  • preventing inappropriate conversion between fentanyl products

  • preventing accidental exposure to children and others for whom TIRF medicines were not prescribed

  • educating prescribers, pharmacists, and patients on the potential for misuse, abuse, addiction, and overdose."

Prescribers and pharmacies already enrolled in an individual REMS program for at least 1 TIRF medication will automatically be transitioned to the shared TIRF REMS Access Program, the FDA notes.

Prescribers will have to reenroll in the program every 2 years either from the date of enrollment into the class REMS or from the date of enrollment into the individual REMS, whichever is earlier.

To enroll, prescribers will be required to review the education program, successfully complete the knowledge assessment, and complete an enrollment form, according to FDA materials. Additional information about the enrollment process will be available on the TIRF REMS Access Program Web site when the program launches in March 2012.

Healthcare professionals who prescribe TIRF medications that will only be used in an inpatient setting, including hospitals, hospices, or long-term care facilities, will not be required to enroll in the TIRF REMS Access Program, nor will patients who receive TIRF medications in an inpatient setting. However, long-term care and hospice patients who get their medications from outpatient pharmacies must still be enrolled.

In outpatient settings, all healthcare providers must complete and sign a TIRF REMS Access Patient-Prescriber Agreement Form with each new patient before writing the patient's first TIRF prescription. The new system also requires healthcare providers to give patients a copy of the Medication Guide during counseling about the proper use of the TIRF medication.

The FDA provides more detailed questions and answers on their Web site.

The REMS currently applies only to these TIRF opioids, not other types of opioids, Dr. Hertz noted. "There is a separate REMS under development for the more commonly used extended-release and long-acting opioids," she said.

Although the TIRF class program requires prescribers, patients, and pharmacies to enroll, the REMS program for the extended-release and long-acting opioids has no such requirement for prescribers, she pointed out. "The requirement will be for the companies to make appropriate educational programs available based on a blueprint that we worked on and approved for the educational materials."

The "blueprint" for education modules was released in November. The program should be available in early 2012, Dr. Hertz said.


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