Prescription fentanyl, a highly potent and immediate-release drug for people with advanced cancer who have been on opioid therapy, has been inappropriately prescribed to people who did not meet the criteria, says a new study. by Johns Hopkins University researchers.
The researchers, using more than 4,000 pages of Federal and Drug Administration documents they obtained through the Freedom of Information Act, or FOIA, found that the drug was wrongly prescribed up to 50 percent of the time.
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What's more, they found, a federal system was set up to track these fentanyl prescriptions practices did not flag one of the prescribers who had been giving the drug incorrectly. The system, the study said, aims to "reduce the risk of adverse outcomes, including misuse, abuse, addiction and overdose arising from the use of [the drug]"
"Because of their unique risk, they are subject to one of the most restrictive distribution systems that the FDA has, "said study author Caleb Alexander, professor of medicine at Johns Hopkins University, to Fox News. "Prescribers, pharmacists and patients all have to be especially certified to access this product. It's a really big deal. "
" The risks, when used unsafely, are enormous. These products can kill, "Alexander said." The prescription monitoring system for this drug did not function as intended. "
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Alexander stressed that the number of Americans who use this type of fentanyl ̵
When properly prescribed, this drug, known as transmuccosal immediate release fentanyl, or TIRFs Alexander brings relief to cancer patients with intractable pain that is so intense that even other prescription opioids do not help enough, Alexander said.
However, researchers found that the prescription fentanyl meant for people with these severe conditions was given to people for such things as headaches, back pain and fibromyalgia.
"Doctors and patients should be aware that they should be used for people who are already on the ar Alexander said, "And many receiving it were not."
Alexander wanted to stress that TIRFs are different from the illicitly produced fentanyl that, along with heroin, fuel the opioid overdose epidemic. 19659004] CLICK HERE TO GET THE FOX NEWS APP
Dr. Stefan Kertesz, an addiction specialist and professor at the University of Alabama at Birmingham School of Medicine, said the Johns Hopkins study, with which he was not involved, "makes it very clear that the basic rules of the road for dealing with highly specialized opioids were "
" Solid reporting suggests that inappropriate marketing contributed to irresponsible prescribing, "Kertesz said. "There is no reason to prescribe highly specialized and potent opioid like this outside of very specialized situations."