The Federal Register is the official journal of the U.S. Federal government. It’s a publication that contains government agency rules, proposed rules, public notices, and any government communication, especially Presidential documents, press conference info, and new and amended federal regulations. It is prepared and published by the Office of the Federal Register every day the Federal government is in operation. When Congress enacts and issues laws, the Federal Register publishes a small pamphlet that explains the acts. Each session of Congress is summarized, as are all Presidential communications, including executive orders. It follows, then, that agencies of the executive branch would report their policy changes or major decisions in the Register.
Such it was on November 16, 2022, when the Food and Drug Administration (FDA) announced they were considering dispensing certain forms of naloxone (Narcan) without a prescription. Naloxone is the drug used to counteract the effects of opioid overdoses. It has been used successfully for decades and is innocuous. Many lives have been saved by the immediate IV administration of naloxone to patients presenting with coma or unresponsiveness.
The FDA is announcing the safety of naloxone nasal spray 4mg and naloxone autoinjector up to 2mg warrants them being available over-the-counter without a prescription. They are saying they believe these low-dose forms of naloxone are effective, safe, no longer require a prescription to obtain, and clearly would improve the state of public health. That also admits the opioid epidemic is so pervasive that to lessen its devastation on the populace, drugs that counteract the effects of opioid abuse and overdose should be readily available to the public. It is hoped that ready availability of this opioid overdose antidote will have positive effects on overdose deaths which have, as I’ve reported recently, shortened life expectancy to the lowest level in 25 years. They state “prescription requirements for these naloxone products might not be necessary for the protection of public health.” Higher dose naloxone in vials, ampoules, and syringes that are not autoinjectors would still require a prescription.
Making naloxone OTC is an amazing admission that the war on drugs has been lost. I don’t object to this change in policy because naloxone is safe and greater access will save lives. However, emphasis is being placed on chasing the horse after it has escaped rather than keeping him locked up in the barn. Efforts to stop the flood of drugs into this country and educating people about drugs have failed, and overdose deaths are far too common. Increasing access to naloxone is easier to accomplish than stopping the flow and use of illicit drugs, and shifts responsibility for deaths away from failed preventive programs and on to the individual abusers themselves. Making naloxone OTC forces drug users and their friends to recognize the risk they’re taking and at least be prepared for the many problems that can happen. They must be responsible and mature enough to react properly in potentially tragic circumstances. My hope would be OTC naloxone would not make opioid abuse a bigger problem than it is already.
References: News From the Food and Drug Administration, “Some Naloxone Products Could Be Sold Without a Prescription.” JAMA 2022 December 20;328(23):2296.
“Safety and Effectiveness of Certain Naloxone Hydrochloride Drug Products for Non-prescription Use; Requests for Comments” The Federal Register 2022 November 16;87(220):68702-68713.
