Over-the-Counter Naloxone: A Step in the Right Direction?


Psychiatric Times’ Substance Use Section Editor weighs in on the FDA approval of the first naloxone product for nonprescription use.




Ed. The US Food & Drug Administration (FDA) announced on March 29 that it has approved Narcan, 4 mg naloxone hydrochloride nasal spray, for nonprescription, over-the-counter (OTC) use, making Narcan the first naloxone product to receive FDA approval for nonprescription use. Is this a step in the right direction? Psychiatric Times® Substance Use Section Editor Roueen Rafeyan, MD, DFAPA, FASAM, weighs in.

The news that Narcan has been approved for nonprescription, over-the-counter (OTC) use may be interpreted in various ways by the public and health care professionals. On initial thought, it may come across as acceptance and approval of drug use. However, opiate use disorder continues to claim many lives every year here in the United States. More and more street drugs have been tainted with fentanyl, which has immensely contributed to overdose deaths.

The ideal approach to addiction treatment outcomes is complete abstinence and sobriety. Let’s keep in mind that addiction is a chronic disease. Like any chronic disease, there may—or will—be acute exacerbations that require care and stabilization. In the case of opioid use disorder, a lapse and or a relapse can be fatal.

Narcan is an effective intervention in reversing opioid/opiate overdose. It is a safe medication and does not have the potential for misuse. So, why not make it more accessible to the public? I think it should be a part of all first-aid kits. The ability to reverse an overdose will give the individual another chance to live with the hope that that person will go to treatment to establish sobriety and a meaningful, productive life.

Making Narcan more accessible is a public health intervention. It is not about approval, but acceptance. It is not about encouraging drug use—it is about giving individuals suffering from addiction a chance to live, especially if we consider the harm reduction model, which has proven effective in reducing the burden of substance use disorder.

The harm reduction model is an approach that implements core principals of direct engagement with patients to prevent overdose, reduce transmission of infectious diseases, and improve physical and mental health, along with providing social assistance and help. Through this model, access to treatment and recovery services is enhanced. Needle exchange programs are an example of a harm reduction approach. In medicine, we frequently have to meet patients where they are. This model allows us to approach treatment of individuals affected with more compassion.

The first step in this public health policy was to make Narcan available without a prescription. However, it is still difficult for many to obtain Narcan. Making it available OTC will eliminate this barrier. One issue that will need to be determined is the cost and affordability. Currently, many insurances and Medicaid programs cover the cost. Will they continue to do so now that Narcan is available OTC?

For us psychiatrists, this opens the door to having candid conversations with our patients. We need to inform our patients about OTC Narcan, educate them on how to use it, and encourage them to have it available as a lifesaving intervention for themselves, loved ones, family members, or even strangers in case they encounter an individual in need of help.

Dr Rafeyan is chief medical officer of the Gateway Foundation and an assistant professor of psychiatry at Northwestern University Feinberg School of Medicine in Chicago, Illinois.

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