FDA News

FDA takes steps to limit use of fentanyl products

Scott Gottlieb 
Scott Gottlieb
Caleb Alexander 
Caleb Alexander

The FDA recently announced several new requirements meant “to drive more judicious prescribing” of transmucosal immediate-release fentanyl products used for the management of breakthrough cancer pain in patients tolerant to these products.

“An estimated 35% to 55% of patients treated with a [transmucosal immediate-release fentanyl (TIRF)] medicine were not opioid-tolerant and many received a TIRF prescription for an unapproved use to treat other types of pain,” former FDA Commissioner Scott Gottlieb, MD, said in a statement.

The new requirements for TIRFs include:

  • Prescribers record a patient’s opioid tolerance at the same time they prescribe a TIRF medicine for outpatient use.
  • Inpatient pharmacies create internal policies and procedures to certify opioid tolerance in patients who require TIRFs during hospitalization.
  • Distribution of TIRFs for outpatient use can only occur with evidence or other documentation of safe use conditions, including concurrent documentation of opioid tolerance.
  • Creation of a new patient registry, which is added to the Risk Evaluation Management Strategy (REMS), to watch for serious adverse events, both fatal and non-fatal, tied to TIRF.

The requirements were an “important piece of the puzzle” and a “great place to start” in turning the tide of the opioid epidemic, Caleb Alexander, MD, MS, co-director, Johns Hopkins Center for Drug Safety and Effectiveness, told Healio Primary Care Today.

“Far too many opioids, including TIRFs, have been prescribed for the treatment of chronic, non-cancer pain in patients who haven’t exhausted much safer and more effective alternatives,” he continued.

Alexander was one of the authors of a JAMA study that found “few substantive changes” were made to an FDA REMS to acknowledge the evidence of high rates of off-label TIRF use.

Prescription 
The FDA recently announced several new requirements meant “to drive more judicious prescribing” of transmucosal immediate-release fentanyl products used for the management of breakthrough cancer pain in patients tolerant to these products.

Source:Adobe

He also offered a few suggestions on additional steps the FDA could mitigate the opioid crisis.

“The FDA should play a more active role in designing REMS programs, and the FDA should play a more assertive role in ensuring that these programs include meaningful and timely assessments of their function and impact,” Alexander said in the interview.

“Such evaluations need to be more timely, with rapid cycle evaluations to allow for iterative risk management,” he continued. “Also, REMS assessments that drug companies submit to the FDA should be publicly available. Any arguments in favor of withholding these are outweighed by the benefits of greater transparency, which would help to promote much greater accountability on the part of both manufacturers producing the reports and the FDA responding to them.”

In response to Alexander’s remarks, an FDA official said the agency is using “all facets of [its] regulatory authority to confront the [opioid] crisis” while trying to strike a balance between helping those patients who need TIRF for their pain management needs, ensuring the products’ safe use and alleviating the risk tied to their use.

The official added that the new TIRF requirements outlined in this story is “part of our ongoing commitment to the safe use of these products.” – by Janel Miller

Disclosures: Gottlieb was FDA commissioner at the time of his remarks. Alexander is chair of the FDA’s Peripheral and Central Nervous System Advisory Committee; serves as a paid advisor to IQVIA; holds equity in Monument Analytics, a health care consultancy whose clients and is a member of OptumRx’s National Pharmacy and Therapeutics Committee.

 

Scott Gottlieb 
Scott Gottlieb
Caleb Alexander 
Caleb Alexander

The FDA recently announced several new requirements meant “to drive more judicious prescribing” of transmucosal immediate-release fentanyl products used for the management of breakthrough cancer pain in patients tolerant to these products.

“An estimated 35% to 55% of patients treated with a [transmucosal immediate-release fentanyl (TIRF)] medicine were not opioid-tolerant and many received a TIRF prescription for an unapproved use to treat other types of pain,” former FDA Commissioner Scott Gottlieb, MD, said in a statement.

The new requirements for TIRFs include:

  • Prescribers record a patient’s opioid tolerance at the same time they prescribe a TIRF medicine for outpatient use.
  • Inpatient pharmacies create internal policies and procedures to certify opioid tolerance in patients who require TIRFs during hospitalization.
  • Distribution of TIRFs for outpatient use can only occur with evidence or other documentation of safe use conditions, including concurrent documentation of opioid tolerance.
  • Creation of a new patient registry, which is added to the Risk Evaluation Management Strategy (REMS), to watch for serious adverse events, both fatal and non-fatal, tied to TIRF.

The requirements were an “important piece of the puzzle” and a “great place to start” in turning the tide of the opioid epidemic, Caleb Alexander, MD, MS, co-director, Johns Hopkins Center for Drug Safety and Effectiveness, told Healio Primary Care Today.

“Far too many opioids, including TIRFs, have been prescribed for the treatment of chronic, non-cancer pain in patients who haven’t exhausted much safer and more effective alternatives,” he continued.

Alexander was one of the authors of a JAMA study that found “few substantive changes” were made to an FDA REMS to acknowledge the evidence of high rates of off-label TIRF use.

Prescription 
The FDA recently announced several new requirements meant “to drive more judicious prescribing” of transmucosal immediate-release fentanyl products used for the management of breakthrough cancer pain in patients tolerant to these products.

Source:Adobe

He also offered a few suggestions on additional steps the FDA could mitigate the opioid crisis.

“The FDA should play a more active role in designing REMS programs, and the FDA should play a more assertive role in ensuring that these programs include meaningful and timely assessments of their function and impact,” Alexander said in the interview.

“Such evaluations need to be more timely, with rapid cycle evaluations to allow for iterative risk management,” he continued. “Also, REMS assessments that drug companies submit to the FDA should be publicly available. Any arguments in favor of withholding these are outweighed by the benefits of greater transparency, which would help to promote much greater accountability on the part of both manufacturers producing the reports and the FDA responding to them.”

In response to Alexander’s remarks, an FDA official said the agency is using “all facets of [its] regulatory authority to confront the [opioid] crisis” while trying to strike a balance between helping those patients who need TIRF for their pain management needs, ensuring the products’ safe use and alleviating the risk tied to their use.

The official added that the new TIRF requirements outlined in this story is “part of our ongoing commitment to the safe use of these products.” – by Janel Miller

Disclosures: Gottlieb was FDA commissioner at the time of his remarks. Alexander is chair of the FDA’s Peripheral and Central Nervous System Advisory Committee; serves as a paid advisor to IQVIA; holds equity in Monument Analytics, a health care consultancy whose clients and is a member of OptumRx’s National Pharmacy and Therapeutics Committee.

 

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