Prescription fentanyl, a very powerful, immediate-release medication for people with advanced cancer who has been treated with opioids, has been inappropriately prescribed for people who do not meet the criteria, according to a new study. by researchers from Johns Hopkins University.
Researchers, using more than 4,000 pages of Federal and Drug Administration documents obtained through the Freedom of Information Act (FOIA), discovered that the drug was wrongly prescribed up to 50 % time.
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In addition, they discovered that a federal system was in place to follow these fentanyl prescribing practices and did not report any of the prescribers who mis-administered the drug. According to the study, the system was aimed at "reducing the risk of adverse effects, including abuse, abuse, addiction and overdose, resulting from the use of [the drug]"
"Because of their unique risk, they are subject to one of the most restrictive dispensing systems of the FDA," Fox News told the author of the study, Caleb Alexander, a professor of Medicine at Johns Hopkins University, Fox News. "Prescribers, pharmacists and patients must all be specially accredited to access this product. It's really a big problem. "
"The risks, when they are used unsafe, are enormous. "These products can kill," said Alexander. "The prescription monitoring system for this drug did not work as expected.The FDA and the manufacturers missed an opportunity to improve the safety of these products."
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Alexander pointed out that the number of Americans who use this type of fentanyl – which is not the one that comes in patch form but in the form of lollipops, nasal spray or lozenges – is a small fragment of millions of people who take prescription opioids.
When properly prescribed, this drug, known as immediate-release transmucosal fentanyl, or TIRF, provides relief to cancer patients with insoluble pain that is so intense that even other opioid drugs can be used. prescription do not help to help enough, explained Alexander
However, researchers discovered that prescription fentanyl for people with these serious conditions was given to them for problems such as headaches, back pain and fibromyalgia.
"Doctors and patients should be aware that they should be used for people who are already taking opioids 24 hours a day," said Alexander, "and many who do not receive opioids are not . "
Alexander pointed out that TIRFs are different from illegally manufactured fentanyl which, along with heroin, fuels the epidemic of opioid overdose.
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Dr Stefan Kertesz, addiction specialist and professor at the University of Alabama at the Birmingham School of Medicine, said the Johns Hopkins study, to which he was not associated "shows very clearly that the basic rules of the road to treat with an opioid have not been achieved and this highlights the shortcomings of American pain care and our prescription culture."
"Strong reports suggest that inappropriate marketing has contributed to an irresponsible prescription," said Kertesz. "There is no reason to prescribe a powerful, highly specialized opioid like this outside of highly specialized situations."