New Fentanyl Restrictions Call For Closer Monitoring Of Overdoses, Adverse Events

Federal health officials will be implementing a new opioid monitoring system, which is designed to specifically track trends and drug overdose deaths involving synthetic forms of fentanyl, which has been linked to an alarming increase in fatalities annually since 2011.

The U.S. Food and Drug Administration (FDA) announced the new Risk Evaluation and Mitigation Strategy (REMS) on March 27, detailing new protocols that health care professionals will be required to follow when prescribing the drugs.

Protocols for the transmucosal immediate-release fentanyl (TIRF) will include requiring prescribing doctors to document patient’s opioid tolerance concurrently with each prescription, and require inpatient pharmacies to develop internal processes to verify opioid tolerance in patients who require TIRF medicines while hospitalized.

Pharmacies will also be instructed to only dispense opioid medications if documentation is provided stating the recipient has been cleared by their physician to receive TIRF’s.

The FDA will also develop a new patient registry to monitor adverse reactions related to prescription opioid outcomes. The registry will monitor both fatal and non-fatal reactions to determine whether patients were properly screened for opioid tolerance.

Fentanyl is an opioid 50 to 100 times more powerful than morphine, and the cause of more than half of all drug overdoses in the U.S. It is delivered through lozenges, sprays, patches and tablets, and enters the bloodstream within seconds for faster pain relief, which was originally designed to reduce chronic pain for cancer patients.

Despite its original intention to serve as a chronic pain relief, the synthetic form of opioid has become increasingly popular across the medical community, especially with first responders. The U.S. Centers for Disease Control and Prevention (CDC) indicated nearly 60 opioid prescriptions were written for every 100 Americans in 2017, with more than 17% of Americans filling one opioid prescription.

Fatal drug overdoses involving fentanyl doubled each year from 2013 through 2016. The rate of all synthetic opioid deaths skyrocketed by 113% over the same time period, indicating an ever worsening opioid abuse epidemic.

The FDA currently has a REMS program in place 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.

However, recent research has called into question the effectiveness of the FDA’s REMS. Last month, the Journal of the American Medical Association (JAMA) released a new survey completed 12 months after the program began, indicating 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.

Earlier this year, FDA Commissioner, Scott Gottlieb said the FDA would be reevaluating patient prescription terms, citing new research that nearly half of all patients prescribed opioids don’t need them for pain relief.