The FDA’s approval of Narcan, an over-the-counter overdose treatment, explained

Over-the-counter Narcan is a big win for slowing overdose deaths. But there is more to do.

A long-sought tool in the fight against America’s opioid crisis is becoming available later this year: Narcan, the nasal spray that can stop opioid overdoses as they are happening, will finally be sold over the counter.

The Food and Drug Administration (FDA) approved the change on Wednesday, a regulatory overhaul that patient advocates and community health groups have been pushing for. Emergent BioSolutions, the manufacturer of Narcan, said the product should be stocked on store shelves by the end of the summer.

It’s a welcome sign of progress amid America’s worsening opioid crisis. Nationally, nearly 107,000 Americans died after overdosing on some kind of drug in 2021, up from about 92,000 in 2020 and 70,600 in 2019. The majority of those overdoses involved opioids and specifically fentanyl, the synthetic opioid that is much more potent than heroin and has become ubiquitous in the country’s drug supply over the past decade, contributing to the increasing number of overdose deaths.

Narcan, the first-of-its-kind spray version of the anti-overdose medication naloxone, is remarkably effective at stopping overdoses. The drug blocks the receptors in a person’s brain that are targeted by opioids, reversing the dramatic slowdown in respiration that can lead to sudden death. It works quickly, within two to three minutes of being administered.

Nearly 17 million doses of naloxone were distributed nationwide in 2021, according to a report from the Reagan-Udall Foundation on behalf of the FDA, continuing a surge in the drug’s availability since Narcan first debuted in 2015. Previous studies have found that the expansion of naloxone access decreased opioid overdose deaths by 10 percent or more in state and local jurisdictions that tried to make the drug more available.

But despite that progress, the United States has still been struggling to get naloxone into the hands of people who really need it. According to the US Centers for Disease Control and Prevention, nearly half of overdose deaths in 2021 occurred with another person nearby who could have potentially intervened. Public health advocates have also long encouraged the co-prescribing of naloxone and prescription opioids, but that’s still extremely rare.

Two problems have stood in the way of getting Narcan to people who may depend on it to save their life: stigma and cost. The FDA’s decision to allow Narcan sales over the counter could help to address the first, but may not do much on the second — with a current retail price of $50 or more, cost is still a factor. This week’s news is a step in the right direction, but far from the end of America’s battle to prevent drug overdose deaths.

How making Narcan available over the counter could help prevent overdose deaths

Before Wednesday’s FDA decision, Narcan was already available at retail pharmacies nationwide. Almost every state had issued a standing order to pharmacists, allowing them to distribute the drug to anyone who asks for it.

But that required people to be comfortable approaching the pharmacy desk and making that request, which implies that either they or someone in their life is abusing drugs. Some people also reportedly worried about the information being shared with their health insurer if they produced an insurance card, even though most insurers have been covering Narcan at no cost to the patient. They might also need to pay for it, and 20 percent of people with substance use disorder do not have health insurance, according to the Reagan-Udall Foundation. That means they would have to pay the full price in order to get naloxone.

Tellingly, out of those 17 million naloxone doses that were distributed in 2021, only a small share, about 2.6 million, passed through retail pharmacies. The other 14 million-plus doses were provided to patients by other medical providers, such as doctors and hospitals, or other groups such as health departments, harm reduction groups, first responders, schools, and community health organizations.

Making Narcan available over the counter, instead of requiring somebody to confer with a pharmacist, should help to reduce the risk that stigma will prevent somebody from obtaining the drug in the first place. CVS and Walgreens, the country’s two largest retail pharmacy chains, said they both plan to stock their shelves with Narcan as soon as the over-the-counter version becomes available.

In addition, convenience stores, gas stations, and other retail stores will now be able to carry Narcan. New York City is planning to set up vending machines with two packs of Narcan.

That should make it easier to put Narcan in the hands of people who need it. The FDA determined, as part of its decision this week, that Narcan is simple enough to be used with appropriate instructions on its packaging. Some experts do worry that the opportunity to educate users will be missed by cutting out pharmacists, so here are some general tips:

• Signs of an overdose include a person being non-responsive, having slowed or stopped breathing, becoming purple or blue in their extremities, and their pupils becoming small
• To administer a dose of Narcan, lean the person’s head back and insert the spray plunger into one of their nostrils, then press to administer the dose
• After administering the medicine, call 9-1-1
• If the person does not respond within a few minutes of the first dose being administered, a second dose may be necessary

But while the FDA’s decision should remove some barriers to naloxone access, it has not eliminated them entirely.

The barriers that still exist to getting Narcan to the people who need it

The primary obstacle remaining to naloxone access is cost. Emergent BioSolutions did not immediately say what price it would set for over-the-counter Narcan, but the drug currently retails between $50 and $100, according to news reports.

Previous research has found that costs as low as $10 can prevent people from buying medications that they need. That may prove especially true for people who are using — and therefore purchasing — illicit substances.

As one recovery specialist in Minnesota who himself was in recovery told the Associated Press: “There was no way I would spend $10 for something to save my life when I needed that money to buy drugs.”

Stakeholders convened by the Addiction Policy Forum suggested a top-end price of $20 per unit, with a suggested retail price between $5 and $20, in order to prevent cost from being a barrier to people obtaining the medication.

Health insurance generally covers Narcan for free or a minimal copay with a prescription, but health insurance does not typically cover over-the-counter medications. Public health advocates are urging insurers to continue covering the over-the-counter version at zero cost, but it remains to be seen whether they will. That would still raise the possibility that people will choose not to purchase the drug rather than alert their health insurer that they or somebody in their household is using drugs.

Ultimately, cheaper versions of Narcan and other forms of naloxone would help to solve the cost crisis and this week’s FDA decision may open the door for their approval.

Harm Reduction Therapeutics has already asked the FDA to approve its naloxone spray for over-the-counter sales, and experts said the agency’s decision on Narcan likely opened the door for that product’s approval. Generic competition would also help to reduce the sticker prices for people purchasing the drug directly off the shelf.

Public health experts are also urging the government to make other forms of naloxone available over the counter. Liquid vials of the medication, sold with syringes, can often be much cheaper (as little as $4) than the spray version and, according to people who work in recovery, are sometimes preferred by people familiar with syringe use because of their drug abuse.

So there is still work to be done to make naloxone as widely available as possible. And the need is only growing more urgent.

Narcan is more important than ever as fentanyl rips through the US

Drug overdose deaths have been steadily rising for the past two decades. About 20,000 Americans died of overdoses in 2000, a fifth of the lives lost by 2021. Part of the problem is the proliferation of dependency, something that began with the over-prescription of opioids starting in the 1990s.

But the other problem is the increased potency of the drugs that people are taking.

In the mid-2000s, most overdose deaths were from commonly prescribed opioids, the most well-known version of which is OxyContin. People either took too many pills after getting a prescription because of an injury or chronic pain, or those drugs entered into the black market.

But by the 2010s, the opioid crisis started to change. Between the high costs associated with prescription opioids and government efforts to begin restricting their supply, heroin started to become the drug of choice. Criminal drug gangs seized on the opportunity to bring that cheaper alternative to America, as was chronicled in Sam Quinones’s 2016 book Dreamland.

By the middle of the last decade, commonly prescribed opioids and heroin were almost even in the number of overdose deaths attributed to them. But another culprit was quickly picking up momentum: synthetic opioids, the best known of which is fentanyl. Over the past 10 years, those drugs have become by far the most common cause of overdose death in the US.

Reagan-Udall Foundation

Fentanyl is now the leading cause of death for Americans ages 18 to 49. On the same day as the FDA’s Narcan decision, Homeland Security Secretary Alejandro Mayorkas told a Senate committee that fentanyl was the “single greatest challenge we face as a country.” The drug is 50 times more potent than heroin but cheap to manufacture. Mexican drug cartels have been producing fentanyl and smuggling it into the US in increasing quantities since 2015, sometimes selling illicit pills for as little as $5 each.

That increase in supply has coincided with a growing number of overdose deaths every year, which accelerated even further during the Covid-19 pandemic, according to research from the Kaiser Family Foundation.

Slowing that loss of life will be a long and multi-pronged project, covering everything from border security to criminal justice to public health. This week’s FDA decision is an important step in the right direction. But the work goes on.

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