FDA Takes First Steps to Modify TIRF REMS Program

Regulatory NewsRegulatory News | 27 March 2019 |  By 

The Risk Evaluation and Mitigation Strategy (REMS) for transmucosal immediate-release fentanyl (TIRF) medicines is being strengthened by the US Food and Drug Administration (FDA) to better ensure the appropriate patients are receiving these opioids, the agency announced Wednesday.

Following an advisory committee meeting on the REMS last August, as well a recently published study in JAMA that found that “thousands of patients receiving TIRFs were opioid-nontolerant,” FDA is now requiring:
  • Prescribers to document a patient’s opioid tolerance concurrently with each prescription of a TIRF medicine for outpatient use.
  • Inpatient pharmacies to develop internal policies and procedures to verify opioid tolerance in patients who require TIRF medicines while hospitalized.
  • That a TIRF medicine be dispensed for outpatient use with evidence or other documentation of safe use conditions, including concurrent documentation of opioid tolerance.
  • The development of a new patient registry to monitor for serious adverse events including overdose (both fatal and non-fatal).
“The prescribing of these medicines for non-FDA approved uses to non-opioid-tolerant patients tells us that there may be a disconnect between prescriber knowledge and prescribing behavior,” FDA Commissioner Scott Gottlieb said.

He noted that TIRF medicines are contraindicated in opioid non-tolerant patients “due to the risk of respiratory depression and death.”

“The agency is concerned about serious adverse events that could occur if TIRF medicines are used in patients that are not opioid-tolerant,” Gottlieb added. “That’s why we’re now requiring verification of opioid tolerance with each prescription written and dispensed to provide greater assurance that only opioid tolerant patients are treated with a TIRF medicine in order to lower the risks for adverse events, including overdose and death.”

Data from FDA between 2016 and 2017 showed 569 unique cases of adverse events linked to the use of TIRF products. Most (549 or 96.7%) of the cases reported patient deaths, followed by overdoses (6%), addiction (1.8%) and pediatric exposure (0.2%).

The new patient registry will allow the agency to track adverse events and the safe use of TIRF medicines, FDA said. The agency is also issuing letters to the manufacturers of the nine TIRF products notifying them of the required changes to the REMS.

“Today’s action is the first step in the process to update the REMS over the next year. We’re committed to finalizing these meaningful modifications to the TIRF REMS program as quickly as possible. We may also take other new actions,” Gottlieb added.


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Tags: FDA, opioid, REMS, TIRF

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