FDA Announces Classwide REMS for Specific Fentanyl Medications

Action Could Cut Access to These Short-acting Opioids, Say FPs

January 09, 2012 04:55 pm Matt Brown

The FDA recently announced(www.fda.gov) it has approved a single shared-system risk evaluation and mitigation strategy (REMS) for the entire class of transmucosal immediate-release fentanyl (TIRF) prescription medications. The so-called TIRF REMS Access program, which would supersede the individual TIRF medication REMS programs currently in place, is scheduled to go live in March.

[FDA News]

Under the new program -- the first-ever classwide REMS approved by the agency -- prescribers, pharmacies, distributors and outpatients will be able to enroll in one REMS program to prescribe, dispense or receive all drugs in the category. Currently, the FDA requires enrollment in a different REMS program for each individual TIRF drug, which include the brand-name medications Abstral, Actiq, Fentora, Lazanda and Onsolis.

Physicians who prescribe TIRF medications that will be used only in an inpatient setting (e.g., hospitals, long-term care facilities) will not be required to enroll in the TIRF REMS Access program. Similarly, patients who receive the medications in an inpatient setting will not be required to enroll.

According to an agency press release, the REMS is intended to mitigate the risks of misuse, abuse, addiction, overdose and serious complications associated with TIRF medications by

story highlights

  • The FDA has called for a new risk evaluation and mitigation strategy (REMS) that covers the entire class of transmucosal immediate-release fentanyl medications.
  • The REMS is the first to cover an entire category of opioids.
  • The FDA expects the program to improve patient access to the drugs.
  • Two family physicians interviewed expressed concern, however, that the move could prove burdensome for physicians and impair patient access.
  • ensuring that the medications are prescribed for and dispensed only to appropriate patients;
  • preventing inappropriate conversion between fentanyl products;
  • preventing accidental exposure to children and others for whom the drugs were not prescribed; and
  • educating prescribers, pharmacists and patients on the potential for misuse, abuse, addiction and overdose seen with these drugs.

Physicians who wish to enroll in the REMS program must review the TIRF education program, successfully complete a knowledge assessment and fill out an enrollment form. Additional information about the enrollment process will be available on the TIRF REMS Access program website(www.TIRFREMSaccess.com) when it goes live in March.

The FDA said(www.fda.gov) it does not expect the REMS to negatively affect patient access to TIRF medications and, in fact, expects the program to improve patient access to the drugs. Those already enrolled in existing product-specific TIRF REMS programs will be transitioned automatically to the new program, the agency noted.

According to Wendy Biggs, M.D., assistant director in the AAFP Medical Education Division, setting up a classwide REMS could streamline the prescribing process for family physicians, but she said she is hesitant to completely sign off on the idea.

"Doing any REMS could potentially have a negative effect on a physician's practice," said Biggs. "If the perceived effort to complete the REMS outweighs the benefit of prescribing the medicine, this could possibly prompt physicians to refuse to prescribe (drugs covered by the REMS) at all."

Ann Karty, M.D., medical director in the AAFP Continuing Medical Education Division, agreed with Biggs' reservations.

"Anything that affects the physician's ability to prescribe, be it a registry or mandatory education, has the potential for a big impact to family physicians and patients," Karty told AAFP News Now.

In this most recent announcement, the FDA also noted that it is "continuing work on another class REMS for the class of long-acting and extended-release opioids."

In April 2011, the FDA announced it would require manufacturers of long-acting and extended-release opioids to develop a REMS that would include voluntary CME for prescribers of the drugs in an effort to reduce abuse of the products. The FDA decision accompanied legislation(www.govtrack.us) sponsored by Sen. John Rockefeller, D-W.Va., that would amend the Controlled Substances Act by requiring physicians and other health care professionals seeking to obtain or renew a DEA registration number to complete CME related to responsible opioid-prescribing practices.

In August, (then) AAFP President Roland Goertz, M.D., M.B.A., of Waco, Texas, wrote in AAFP News Now about the Academy's view that requiring physicians to complete CME to prescribe opioids is unnecessary and most likely would place an additional burden on physicians that could, in turn, cut access to pain medications for some patients.

Goertz followed up with a September letter to Rockefeller citing the AAFP's policy opposing legislation or other actions that would mandate education for family physicians as a condition for prescribing specific drugs. He also suggested measures that could more effectively address opioids abuse.

Citing the extensive education FPs already complete during their medical training and as part of their continuing professional development, "The AAFP does not believe that requiring additional education (for family physicians) will solve the problem of drug diversion," Goertz said in the letter. It should be left up to state licensing boards to deal with the few physicians who prescribe opioids inappropriately, he noted. In addition, every state should have an effective tracking system capable of identifying abusers of these medications.