AMA Asks to Remove Prescription Status from Naloxone
By Jonathan Springston, Editor, Relias Media
The American Medical Association (AMA) this week sent a letter to the Office of National Drug Control policy asking regulators to remove the prescription status from naloxone so the opioid reversal agent can be accessed easier over the counter (OTC), possibly saving more lives.
“As the overdose epidemic has worsened, given the FDA’s clear guidance, there is no moral, medical, or safety-related reason for these life-saving overdose reversal agents to remain locked under prescription regulations,” the AMA wrote. “The AMA urges removing the prescription status of naloxone as an essential step to save lives from opioid-related overdose because it will help make naloxone more readily available to patients everywhere."
The group praised the manufacturers who have provided discounts to state and local governments purchasing naloxone, and others who have given some supplies of the agent for free to appropriate organizations. “These efforts have helped, but they are not enough,” the letter reads. “The AMA has tried repeatedly to urge naloxone manufacturers to further reduce costs and take actions more consistent with the needs of the drug overdose epidemic, but manufacturers claim they are doing all they can.”
In 2017, the FDA backed the idea of offering naloxone OTC. More recently, the notion appears to be gaining traction among other agencies. For example, in December 2021, Health and Human Services Secretary Xavier Becerra said the Biden administration is working on how to make naloxone available OTC. On Feb. 10, the CDC opened for public comment the draft updated Clinical Practice Guideline for Prescribing Opioids. In the draft, the agency floated the idea that clinicians could consider co-prescribing naloxone with opioids in certain circumstances. This, instead of prescribing the reversal agent well after the fact or leaving patients to their own devices to find the solution.
Overall, among all parties, there appears to be a consensus that naloxone is a vital life-saving agent; these groups just have to figure out how to push the ball across the goal line. Meanwhile, the clock is ticking. The authors of a study published last week concluded “the extent of naloxone distribution … warrants substantial expansion in nearly every U.S. state.” Click here to read more about their modeling study and suggestions for expanding naloxone access.