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Catching Up with the Opioid Epidemic: Over-the-Counter Naloxone Is Finally Here

Banner on pharmacy counter against narcotic overdose, with "naloxone dispensing pharmacy" listed.

Nowadays, it seems like everything is sold over the counter. From pain medications like Tylenol, to Benadryl, Nyquil and even diet pills. There seems to be no limit to what one can buy. However, until recently, there was one very specific item you couldn’t buy over the counter: naloxone.

Known commonly by the brand name Narcan, naloxone is an opioid antagonist, meaning it blocks the opioid receptor, which reverses the effects of an opioid overdose from prescription opioids such as morphine, fentanyl and heroin. Importantly, naloxone only treats the symptoms of overdose, not the addiction itself. Not only is naloxone a lifesaving treatment in opioid overdoses, but it is not detrimental to those who have overdosed on other drugs. In an emergency, naloxone can help restore normal breathing; however, Narcan can only save a life if it is available.

A CDC report on drug overdose deaths from 2001–2021 states that drug overdoses are continuing to increase, and are now responsible for an estimated 32.4 deaths per 100,000 in the U.S. Furthermore, from 2020–2021, deaths from overdose rose an astronomical 14%. Even more alarming, one study shows that in greater than a third of overdose cases, there was a bystander present during the event. However, as alarming as this fact is, it brings to light an opportunity to decrease mortality and morbidity.

The U.S. Food and Drug Administration (FDA) approved naloxone spray as a prescription drug in 2015. The spray is easy to administer as a bystander; however, not all bystanders had a prescription or easy access to naloxone. A model created by the Stanford Lancet Commission on the North American Opioid Crisis estimated the expansion of naloxone to over-the-counter access would be the most effective policy to lessen the opioid crisis morbidity and mortality.

To further improve access, in March 2023, the FDA approved the sale of over-the-counter Narcan (4-milligram naloxone hydrochloride nasal spray), which was shipped to stores in September of this year. Thus far, it will be carried at Walgreens, CVS, Walmart, Rite Aid and Kroger, and will be priced at an estimated $45 for two doses. Increased availability will allow more community members to help prevent opioid overdoses.

The American Medical Association has voiced wide support for making naloxone publicly available to save lives as the opioid crisis rages on. In July 2023, the FDA approved a second over-the-counter naloxone product, ReVive, 3-milligram naloxone hydrochloride nasal spray. Approval of over-the-counter naloxone was a step in the Substance Abuse and Mental Health Services Administration Strategic Plan. Furthermore, the plan calls for access to other medications to treat opioid use disorder, which are buprenorphine and dispensing methadone, as well as access to treatment services after release from prison.

Even with these changes, there are still concerns about barriers to access. One concern is the out-of-pocket cost may be too expensive for many individuals. Medicaid and private insurance coverage of naloxone will vary by state, and has not yet been fully decided. Furthermore, stigmatization around naloxone remains a barrier to promoting increased utilization. Lastly, which stores carry naloxone and the product location within these stores will be central to the ability of this monumental policy change to have concrete community impact.

Overall, while the availability of naloxone does not solve the opioid crisis, it will allow the reduction of adverse health outcomes secondary to opioid overdose. “Naloxone is a critical tool in addressing opioid overdoses, and today’s approval underscores the extensive efforts the agency has undertaken to combat the overdose crisis,” states Patrizia Cavazoni, director of the FDA Center for Drug Evaluation and Research.

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