For more than half a decade, the United States has seen an incredible rise of an opioid epidemic within its borders. Fatal overdoses have claimed the lives of many as the result of rampant and unwarranted prescriptions. transmucosal immediate-release fentanyl (TIRF) drugs make up a significant piece of this drug pie. According to a recent study, drug makers and federal regulators are the ones to blame for this crisis.
Note that TIRF drugs are approved for use in cancer patients who’ve developed tolerance against the around-the-clock opioids normally used to treat their pain.
As many as 55% of patients prescribed TIRFs did not meet these criteria and should never have been prescribed them, according to a new report published in the Journal of American Medical Association.
In a statement responding to the study, the U.S. Food and Drug Administration (FDA) said it “shares the concerns about how TIRF products are being used and whether the Risk Evaluation and Mitigation Strategy (REMS) program is working as intended.”
However, this misuse had revealed itself between 2012 and 2017, but the drug makers failed to report any errant prescribers to the FDA, and no prescribers had their special certification revoked. In 2017, the U.S. opioid epidemic claimed the lives of nearly 50,000 through fatal overdoses.
Dr. Caleb Alexander, co-director of the Center for Drug Safety and Effectiveness at the Johns Hopkins Bloomberg School of Public Health, commented:
What’s alarming is it’s taken so long. Serious deficiencies in the program have been known for some time, and the pace of change has not been faster. We’re more than six years out from the program’s inception, and there have been many opportunities that have been missed on the part of opioid manufacturers and [the] FDA.
The FDA held a public advisory committee meeting on the matter in August 2018, and “has been actively assessing the recommendations of our advisory committee on the effectiveness of the REMS and necessary changes,” the FDA statement says.