Nearly half of all patients who were prescribed fentanyl should have been denied the drug, according to a new report.
A report published Tuesday in the Journal of the American Medical Association (JAMA) is alleging widespread failure to keep the extremely potent opioid fentanyl out of the hands of patients who were ineligible to receive it.
Using the Freedom of Information Act, researchers obtained around 5,000 pages of documents from the US government that they say show that nearly half of all patients who were prescribed fentanyl should have been denied the drug.
Fentanyl is a relatively new opioid painkiller that is 50 to 100 times more powerful than morphine. It is meant only for patients experiencing severe pain, including “breakthrough” pain so bad that opioids such as OxyContin or even morphine cannot control, and who have already developed a tolerance to these drugs. Without an established tolerance to opioids, taking fentanyl presents a high risk of overdose due to its extreme potency.
Due to the dangers of fentanyl, the US government has established a strict protocol that was supposed to prevent anyone other than opioid-tolerant patients with severe pain, such as cancer patients, from being prescribed this drug.
The researchers of this new report claim that this protocol has not been followed across the system, implicating the Food and Drug Administration, drug companies, and doctors.
“The whole purpose of this distribution system was to prevent exactly what we found,” said study leader and co-director of the Center for Drug Safety and Effectiveness at Johns Hopkins Caleb Alexander. “It should never happen. It’s a never event. And yet we found it was happening in 50% [of cases reviewed].”
According to the report, between 34.6% and 55.4% of patients surveyed who were given fentanyl were “opioid-nontolerant.” Researchers also found that a substantial amount of pharmacists and drug prescribers (7.9% and 11.6%, respectively) reported believing that they were allowed to give fentanyl to patients who had not developed a tolerance to opioids 12 months after the protocol was put in place.
This number increased as time went on, reaching 18.4% among prescribers and close to 50% among patients.
In spite of this, no substantial changes were made to the protocol by the FDA.
“What we found was that several years after the program was started, there were alarming deficiencies identified, and yet little was done by the FDA and drug manufacturers to effectively address these problems,” said Alexander.
Researchers and addiction experts are finding that fentanyl has played a large role in the opioid epidemic. A 2018 study found that deaths related to fentanyl use increased by 520% from 2009 to 2016, while deaths from other prescription opioids increased by 18% in the same time frame.
The fentanyl deaths were primarily from illicit use, but the high rates of death from fentanyl overdose demonstrate just how dangerous the drug is to those who are not approved for its use.
“These drugs are dangerous enough, they should never be used in patients who aren’t already on around-the-clock opioids,” said Alexander.