Friday, the U.S. Food and Drug Administration announced that it was taking further steps to combat the opioid crisis through risk evaluation and mitigation strategy programs.
FDA Commissioner Stephen M. Hahn announced that while the FDA’s day-to-day focus continues to be the COVID-19 pandemic, the agency continues to work on other public health issues, like the opioid epidemic.
“We remain committed to using all facets of our regulatory authority to lessen the impact of opioid addiction, misuse, and abuse while also striking a careful balance between patient access and safety to ensure that patients suffering from significant pain have access to appropriate medication,” he said in a statement.
To do that, he said, the agency has worked to decrease unnecessary exposure to prescription opioids and prevent new addictions, supported the treatment of those with opioid use disorder, fostered the development of new pain therapies, and taken action against those who contribute to illegal import and sale of opioids.
The agency took further steps to strengthen the risk evaluation and mitigation strategies for opioid analgesics by looking at transmucosal immediate-release fentanyl (TIRF) products and toughening the requirements for prescribing practices.
These changes include requiring prescribers to document a patient’s opioid tolerance; requiring outpatient pharmacies dispensing TIRF medicines to document a patient’s opioid tolerance; requiring inpatient pharmacies to develop internal policies and procedures to very opioid tolerance in patients requiring TIRF medicines while hospitalized, and requiring a new patient registry for use, along with other sources, in monitoring accidental exposure, misuse, abuse, addiction, and overdose.
“Today, we took further steps to strengthen the REMS program for transmucosal immediate-release fentanyl (TIRF) products to help ensure that the benefits of these drugs continue to outweigh the risks,” Hahn said. “TIRF medicines contain fentanyl, a powerful opioid, and are used to manage breakthrough pain in adults with cancer who are routinely taking other opioid pain medicines around-the-clock for pain. To use the TIRF medicines safely, these patients must be opioid tolerant based on concurrent regular use of another opioid medication.