Between 34.6% and 55.4% of patients prescribed TIRF were opioid-intolerant
Many patients who were prescribed fentanyl should not have received it at all, a new study says.
The study, published in the Feb. 19 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 met its goal of preventing inappropriate use of TIRF products.
They found that, after 60 months, between 34.6% and 55.4% of patients prescribed TIRF were opioid-intolerant.
“Over the 60-month period examined, there were few substantive changes made to the REMS to address evidence of high rates of off-label TIRF use, and, although the REMS program had a noncompliance plan, there was no report of prescribers being disenrolled for inappropriate prescribing,” the researchers wrote.
In related news, the FDA is looking for evidence-based ways to fight opioid addiction by reducing the flow of prescription opioid products into patients’ homes, according to ASHP .
The FDA asked a National Academies committee to develop a framework for evaluating existing clinical practice guidelines on the prescribing of opioids to treat acute pain resulting from specific conditions or medical procedures. The committee will also identify acute pain conditions for which opioid prescribing guidelines are needed and outline a future research agenda for opioid use in acute pain.