Federal agency issues new guidelines for transmucosal immediate-release fentanyl (TIRF) drugs.
The federal Food and Drug Administration (FDA) has issued new prescribing guidelines for synthetic opioid painkillers, which specifically focus on transmucosal immediate-release fentanyl (TIRF) drugs. TIRF medications contain the powerful synthetic opioid that is supposed to be reserved for pain management in patients with terminal cancer. To be prescribed a TIRF drug, patients have to be opioid tolerant.
In recent years, there has been growing evidence that fentanyl has made its way to the streets and is commonly being mixed with other deadly drugs, including cocaine and heroin. This has caused the overdose rate to skyrocket. Thus, it is important to regulate more closely how this synthetic is being distributed legally to patients in order to also get it off the streets.
According to its prescribing guidelines overview, the FDA’s new rules for TIRF drugs involve: “Requiring prescribers to document patients’ opioid tolerance with each TIRF prescription; Requiring outpatient pharmacies that dispense TIRF drugs to document and verify patients’ opioid tolerance before dispensing; Requiring inpatient pharmacies to develop policies and procedures to verify opioid tolerance in patients who are prescribed TIRF drugs; (and) Requiring a new patient registry to monitor for accidental exposure, misuse, abuse and overdose.”
“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,” the agency said. “While our efforts to combat COVID-19 remain at the forefront of our day-to-day activities, the U.S. Food and Drug Administration also continues its work on a number of important public health issues and, in particular, the opioid crisis. 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. “
In fall of 2020, U.S. Senators Rob Portman (R-OH) and Jeanne Shaheen (D-NH) joined Reps. Michael McCaul (R-TX) and David Trone (D-MD) to roll out a bill designed to increase worldwide cooperation in fighting synthetic drug trafficking called Fighting Emerging Narcotics Through Additional Nations to Yield Lasting (FENTANYL) Results Act. The act aimed to require the Secretary of State to prioritize efforts to combat the international flow of fentanyl, fentanyl analogues, other synthetic drugs.
“My nephew Ian Trone died of a fentanyl overdose at the age of 24 alone in a hotel room, and since his passing, we’ve seen a dramatic and alarming increase in fentanyl and other synthetic opioid deaths across this country,” Trone, a member of the Commission to Combat Synthetic Opioid Trafficking and founder of the Freshmen Working Group on Addiction, said. “We need to tackle the opioid crisis from every angle.”
The FDA is now calling for more advanced Risk Evaluation and Mitigation Strategies (REMS) for various opioid analgesics to help eliminate serious complications.
“In addition to the modifications to fortify the TIRF REMS program, the FDA also continues efforts to evaluate the opioid analgesic (OA) REMS,” the agency announced, which furthers the efforts of the previously introduced FENTANYL Act. The efforts are focused on “educating prescribers and other health care providers on the treatment and monitoring of patients with pain.”