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A disturbing number of American patients are receiving prescriptions for fentanyl, not intended for them, revealed a recent study published in the journal JAMA in February 2019. The study focused on transmucosal immediate-release fentanyls or TIRFs meant for the management of intense pain in only cancer patients already on opioids, how these were prescribed, and whether these were prescribed in accordance with the specification laid out in a federal program especially set in place for its monitoring.
The findings revealed that the opioid manufacturers and the U.S. Food and Drug Administration (FDA) faltered at several levels in sufficiently monitoring the restricted use of fentanyl through the federal program and even after the officials learnt about the problems, only a few substantive changes were made. Lead author G. Caleb Alexander shared that his team found that these products were being prescribed at a worrying rate to patients who should not have received them in the first place. The prescribing of fentanyl should have been carefully scrutinized and restricted but it was not.
FDA started program to monitor prescribing patterns of fentanyl
The study reviewed 4,877 pages of FDA reports and some documents from 2012 to 2017, procured by the researchers through the Freedom of Information Act. The TIRFs were administered as lozenges, sprays and tablets, which entered the bloodstream within a few seconds. In 2011, a program was created by the FDA for monitoring the prescribing pattern of this drug. The program was initiated with an intent of alleviating the risk of adverse outcomes, misuse, addiction, and overdoses by stringently watching whom it was prescribed to and limiting prescription to cancer patients.
According to the study, the FDA quoted in its documents that the program failed to meet its goals and objectives as more than half of the patients who received this drug should not have. Further, 12,916 (51 percent) patients out of 25,322 prescribed these opioids, were opioid-intolerant. Alexander said that TIRFs should not be used on patients not on around-the-clock opioid therapy. He further added that the study was not carried out to ascertain the harm that fentanyl must have caused these patients, however, everyone should have been concerned over the lack of oversight because fentanyl is connected to a risk of fatal overdose.
Opioid manufacturers and FDA share blame for oversight
Andrew Kolodny, co-director, Opioid Policy Research Collaborative at the Brandeis University, said that the study results were very disturbing. It clearly showed that the FDA failed to guard the public against this menacing opioid and despite growing problems associated with the use of TIRFs, the FDA was doing nothing to change the manner in which it was used. He added that it was troubling to know that most of the TIRF patients did not have cancer and were not opioid tolerant.
Michael Felberbaum, spokesperson for the FDA, stated that the agency was concerned about the issues being raised and was assessing if the program was working as intended. The effectiveness of the program was being investigated through the recommendations of the advisory committee and it was looking at the necessary steps that had to be taken. He also stated that the FDA would share the steps that it intends to take including the modifications to the current program to lessen the risk of these medicines and ensuring that these were prescribed only to opioid-intolerant patients who understood the associated risks and knew how to safely use TIRF medicines.
Seeking help for opioid addiction
Fentanyl is a synthetic opioid which is 100 times more potent than morphine. It is diverted for abuse because of its powerful opioid properties. Manufacturers often mix it with heroin to increase its potency and their profitability. It can cause intense short-term high, temporary feelings of euphoria, slowed respiration, reduced blood pressure, nausea, fainting, seizures, and even death from overdose. Therefore, one must seek professional help if one gets addicted to it.
If you or someone you know is addicted to fentanyl and is looking for opioid abuse treatment centers to overcome their addiction, then the Hillside Mission can help. Our professionals can administer rapid drug detox treatment that gently helps an individual get rid of the toxins accumulated in the body with years of abuse. An inpatient opioid abuse treatment clinic can be a sure-shot way to jumpstart your journey to sobriety. For more information about our evidence-based detox program, call our helpline (866)-225-6101 and speak to a member from our Admissions Team. You can also chat online to a representative to get more information about our inpatient programs.