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As drug overdose deaths hover near record levels in the United States, naloxone is reaching more people than ever, and possible policy shifts could make it more accessible this year. But experts say the overdose-reversing medication is not a panacea for the country’s opioid epidemic.

About 1.2 million doses of naloxone were dispensed by retail pharmacies in 2021, according to data published by the American Medical Association – nearly nine times more than were dispensed five years earlier. Nearly all states have standing orders that allow pharmacists or other qualified organizations to provide the medication without a prescription to people who are at risk of an overdose or are helping someone at risk.

But research suggests that the naloxone supply needs to be much more prevalent and saturated throughout the population to make a significant difference in reducing overdose deaths.

More than 107,000 people died of a drug overdose in the 12-month period ending August 2022, according to the latest data from the US Centers for Disease Control and Prevention, dropping only slightly from the record reached in March. Synthetic opioids, primarily fentanyl, were involved in more than two-thirds of those deaths.

Fentanyl is potent and fast-acting, and it’s bringing people into the emergency room with greater needs than before, said Dr. Edward Boyer, an emergency medical physician specializing in medical toxicology at The Ohio State University Wexner Medical Center.

“They require greater amounts of naloxone than they did in the past, and that’s because of the presence of fentanyl,” he said. “I’ve had overdose [patients] that come in that just don’t respond to naloxone at all because of either the amount or the potency of the opioid that they have on board.”

Some key changes are on deck at the federal level this year that may help improve access to the life-saving drug nationwide – including a move to make naloxone available over-the-counter, which could happen as early as March.

The US Food and Drug Administration will meet next month to review the first application for a naloxone nasal spray that would be available over-the-counter. The application, which is for a generic version of Narcan from drugmaker Emergent BioSolutions, was granted priority review in December after the FDA signaled that it would support submissions to improve access.

Still, experts say that improving access to naloxone is just one step down a long road. Making the medication available over-the-counter will help make it more accessible, but experts say it’s important that it gets to the right people.

Most people who overdose are around others who can help. But the people around them are more likely to be fellow opioid users, rather than anonymous bystanders.

“There’s been an unfounded emphasis on the ‘worried well.’ It’s a term we use in public health for people who are not necessarily at risk for a disease or a condition but who take up a lot of resources,” said Nabarun Dasgupta, a scientist at the University of North Carolina’s Injury Prevention Research Center who studies drugs and infectious diseases.

“Giving out more naloxone to just anybody isn’t the solution, right? Giving it out to people who don’t interact with people who use drugs – that’s kind of a waste of resources.”

The price of naloxone has inhibited its accessibility to people who need it most. And although the cost will probably drop if it becomes available over-the-counter, experts say it will probably still be out of reach for many.

“We’re not going to be able to ramp up naloxone distribution in a game-changing way until we get a better handle on the price,” Dasgupta said. “There’s the promise on paper vs. on the street, and it’s going to come down to the dollars and cents.”

Separate changes to grant funding by both the CDC and the Substance Abuse and Mental Health Services Administration will make it easier for states and local health departments to buy naloxone, he said.

However, experts said the most meaningful work in the fight against the devastating outcomes of the drug overdose epidemic will come with ongoing emphasis on treatment for opioid use disorder and other harm-reduction strategies.

“While enabling people to access quality treatment for substance use disorders is critical, we must also acknowledge that people need to survive in order to have that choice,” said Dr. Nora Volkow, director of the National Institute on Drug Abuse.

“Decades of research have shown beyond a doubt that harm-reduction strategies can be effective, such as syringe service programs, and can be lifesaving, such as the opioid overdose reversal drug, naloxone. But these strategies are not enough, and we know that they are not reaching everyone who needs them.”

Caleb Banta-Green, principal research scientist at the University of Washington’s Addictions, Drug & Alcohol Institute, calls naloxone the “gateway drug” to a conversation about what substance use disorder is.

“It’s a conversation starter. It’s life-saving for the individual. It’s not a game-changer at the population level,” he said. “We need to do more. And we need to use treatment medications – methadone and buprenorphine – which are far higher overdose preventive approaches.

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