Despite FDA REMS Program, Large Number Of Patients Prescribed Fentanyl, Study Finds

More than half of patients prescribed the powerful and fast-acting painkiller fentanyl do not need the medication, and do not meet the federal requirements put in place to restrict use due to the potentially fatal side effects, according to the findings of a new study. 

Researchers from Johns Hopkins published a study in the Journal of the American Medical Association (JAMA) on February 19, indicating that many doctors are still prescribing transmucosal immediate-release fentanyl (TIRF) off-label for patients who do not have cancer pain or other types of severe pain.

The data raises questions about the effectiveness of the U.S. Food and Drug Administration (FDA) Risk Evaluation and Mitigation Strategy (REMS) for the transmucosal immediate-release fentanyl. The program was designed to help prevent inappropriate use of fast-acting fentanyl products, like prescribing them to patients without a tolerance to opioid painkillers. It’s designed to help reduce the risk of side effects, including misuse and abuse.

Fentanyl is an opioid that is 50 to 100 times more powerful than morphine and the cause of more than half of drug overdoses. It is delivered through lozenges, sprays, and tablets. It goes into the bloodstream in seconds.

Fast-acting fentanyl is approved by the FDA to be used for severe cancer pain that isn’t effectively reduced with round-the-clock opioids. It is also approved to treat patients who are tolerant to opioids, but still experience severe pain.

Fast-acting fentanyl products are potent and fast acting but have a higher risk of fatal overdose for patients who don’t need them, like those that are not tolerant to the effects of traditional opioids. Last year, the CDC issued a warning about fentanyl, and it is now considered the most dangerous drug in America.

Researchers reviewed FDA documents from 2012 to 2017, including nearly 5,000 pages of data from six annual REMS reports. The reports included surveys of patients, doctors, and pharmacists.

Surveys completed 12 months after the program began indicate that 86% of pharmacists, 87% of doctors, and 91% of patients knew the fentanyl products are not recommended for patients who do not have opioid tolerance or severe untreatable cancer pain. However, after a four-year period, 51% of patients who did not have an opioid tolerance were prescribed fentanyl by their doctor.

Roughly 34%  of doctors continued to prescribe the fentanyl products to patients who didn’t need the drugs, or non-tolerant patients, at the four year mark. By five years, anywhere from 35% to 55% of patients who received the fentanyl products did not need them.

Similarly, at the five-year mark, 18% of doctors and nearly 50% of patients inaccurately said it was okay to take fentanyl for non-cancer or non-severe pain.

Despite the purpose of the program, many doctors and patients are still receiving incorrect information that can put them at risk for abuse or overdose, the researchers determined.

Lack Of Oversight

Not only was there inappropriate prescribing to patients who don’t need the fentanyl products, but there was a lack of oversight by the agency regarding the potent products and its use for patients, the researchers warned.

The data indicates fast-acting fentanyl products were prescribed off-label in many cases. While doctors are usually allowed to prescribe drugs for any purpose they see fit, drugs that are part of a REMS program are different. Doctors must be enrolled and their access to that drug is dependent upon close adherence of the rules of the REM program, which does not allow off-label prescribing.

Despite the widespread misuse and inappropriate prescribing, the FDA did not disenroll doctors who did this from the REMS program. In fact, much of the time it is prescribed for many different conditions other than cancer pain, such as arthritis, which is not an approved use.


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