FDA Updates REMS For Close Monitoring of Fentanyl Overdoses

Introduction

The U.S. Food and Drug Administration (FDA) declared that the Risk Evaluation and Mitigation Strategy (REMS) for transmucosal immediate-release fentanyl (TIRF) medications was updated on March 27, in view of implementing a new opioid monitoring system particularly for tracking trends and drug overdose deaths due to synthetic forms of fentanyl.

The FDA outlined new protocols for health care professionals to follow while prescribing the drugs. The protocols for TIRF will include prescribing doctors to track patient's opioid tolerance during each prescription and requires inpatient pharmacies to verify opioid tolerance in patients who need TIRF medicines for treatment. Pharmacies will be advised to give opioid medications to only those patients who provide documented proof approved by their physician that they can receive TIRFs. The FDA will be maintaining a new patient directory to monitor adverse reaction, both fatal and non-fatal, related to prescription opioids, to figure out whether patients were properly screened for opioid tolerance.

TIRF medicines contain fentanyl which is 50 to 100 times more powerful than morphine and was the cause of half of all drug overdose cases in the U.S. Scott Gottlieb, FDA Commissioner, told earlier this year that the agency will be reevaluating the prescription criteria, indicating that nearly half of all patients who were prescribed opioids didn't need them for pain relief.

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