Sarasota, FL (WorkersCompensation.com) – The Food And Drug Administration (FDA) has announced new rules for a certain class of painkillers known as transmucosal immediate-release fentanyl, or TIRF. Part of the focus in this new set of rules is to address the specific risks associated with TIRF use.
Transmucosal drugs are medications that are administered and absorbed through the mucous membranes via inhalation, nasal passages, ocular, and sublingual means. TIRF drugs are often in the form of sublingual tablets, nasal sprays, or soluble film and contain the opioid fentanyl. They are typically used in cancer patients who are taking other opioid pain medicines for constant pain.
The Risk Evaluation and Mitigation Strategy (REMS) was created in 2007 by the FDA as a drug safety program to address opioid use. Part of the purpose of the program was to minimize risk and provide standards of prescribing powerful medications. Part of the REMS guidelines were created to ensure that the only patients prescribed TIRF drugs were those that are opioid tolerant. However, that objective was not fully met.
TIRF Data from the American Pharmacists Association from 2019 shows that 34.6 percent to 55.4 percent of patients were prescribed TIRF drugs when they were opioid nontolerant. Additionally, 48 months after the FDA created REMS to address opioid use, 34.2 percent of providers were prescribing TIRF for chronic pain not related to cancer. At 60 months after the inception of the program, 18.4 percent of providers continued to prescribe TIRF drugs inappropriately.
To address the previous gaps in guidelines, the new rules include requiring providers and pharmacies to document and verify a patient’s opioid tolerance with each TIRF prescription for outpatient use. Additionally, hospital pharmacies are required to develop policies to monitor opioid tolerance in admitted patients given TIRF drugs. The new guidelines also require a new patient registry to monitor addiction and overdose, as well misuse and accident exposure.
In addition to the new rules, the FDA is holding workshops which include discussion for continual evaluation of the REMS program. Information on the new guidelines is available on the FDA website.