FDA takes further steps to confront opioid crisis through REMS programs

FDA is continuing to work on combating the opioid crisis during the pandemic by taking steps to curb unnecessary exposure to prescription opioids. The agency hopes to strengthen its Risk Evaluation and Mitigation Strategies (REMS) program that is used for various opioid analgesics, including transmucosal immediate-release fentanyl (TIRF). To use TIRF appropriately for adults with cancer, for instance, patients must be opioid-tolerant based on the concurrent regular use of another opioid medication. Research indicates that prescribing TIRF still occurs in patients who are not opioid tolerant, which prompted FDA to finalize modifications to require that prescribers document a patient’s opioid tolerance with each prescription of TIRF for outpatient use. Other REMS changes include requiring outpatient pharmacies dispensing TIRF to document and verify a patient’s opioid tolerance before dispensing, requiring inpatient pharmacies to develop internal policies and procedures to verify opioid tolerance in patients who require TIRF while hospitalized, and mandating a new patient registry for use, along with other data sources, to monitor for accidental exposure, misuse, abuse, addiction, or overdose. FDA also hosted a workshop inviting scientific discussions about methods to evaluate the effect of the opioid analgesic (OA) REMS on prescriber behavior and patient outcomes. The OA REMS seeks to educate prescribers, pharmacists, and other health care providers on the treatment and monitoring of patients with pain.