Many patients who were prescribed fentanyl should not have received the drug, a new study said.
The study, published in the February 19 issue of JAMA, was based on documents obtained via public records requests. Researchers set out to determine whether the FDA’s Transmucosal Immediate-Release Fentanyl (TIRF) Risk Evaluation and Mitigation Strategy (REMS) program meet its goal of preventing inappropriate use of TIRF products.
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They found that, 60 months after initiation of the TIRF REMS, between 34.6% and 55.4% of patients prescribed TIRFS were opioid-intolerant.
Twelve months after initiation of the program, 11.6% of prescribers, 7.9% of pharmacists, and 2.6% of patients incorrectly reported that TIRFs can be prescribed to opioid-nontolerant patients, with similar levels of misunderstanding maintained in subsequent reports.
In the 48-month survey, 34.2% of prescribers reported prescribing TIRFs for opioid-tolerant patients with chronic, noncancer pain. At 60 months, 18.4% of prescribers and 47.7% of patients erroneously reported that TIRFs were FDA-approved for such use.
While pharmacists, prescribers, and patients generally had high levels of knowledge regarding proper TIRF prescribing, claims-based analyses and some survey responses indicated “substantial rates of inappropriate TIRF use,” the researchers wrote. “Despite these findings, the FDA did not require substantive changes to the program.”
And, even though the REMS program had a noncompliance plan, there was no report of prescribers being disenrolled for inappropriate prescribing, the researchers wrote.