The Food and Drug Administration (FDA) has approved over-the-counter sales of the opioid overdose reversal medication Narcan, a move that advocates say will reduce stigma around a lifesaving medication and increase access for people in need — if they can afford to pay for it.
Narcan is a popular nasal spray version of the drug naloxone, the antidote administered to quickly block the effects of opioids in the event of a potentially fatal overdose. Narcan and the first responders, drug users and harm reductionists who distribute and carry the medication with them have saved countless lives over the course of the overdose crisis.
The FDA’s decision only covers name-brand Narcan nasal spray, and generic naloxone typically administered by injection remains a prescription medication. The number of fatal drug overdoses and opioid-involved deaths began steadily rising more than a decade ago before exploding during the pandemic as the supply of prescription painkillers shrank and powerful synthetics such as fentanyl flooded the illicit market. (Learn to identify the signs of an overdose here).
For those on the front lines of the crisis, allowing over-the-counter sales of Narcan is a public health no-brainer. Naloxone is safe and extremely effective, and harm reductionists argue the prescription requirement should have been dropped years ago as the crisis escalated.
It’s impossible to know how many lives have been saved by naloxone, but one study in Massachusetts found that nearly 94 percent of overdose victims survived after naloxone was administered by emergency medical services. From 1996 to 2014, Narcan kits distributed to drug users and their friends and family by 600 harm reduction groups across Canada saved an estimated 27,000 lives.
Other badly needed reforms, such as the removal of unnecessary barriers to opioid addiction medication, are only now becoming official policy after years of mass death. Still, advocates say over-the-counter sales of Narcan are a major step forward and are eager to spread the word that pharmacies are expected to start offering Narcan without a prescription by the end of the summer. (Narcan is used to treat opioid overdoses, not dependence or addiction.)
While the overdose crisis has pushed most states to change their laws and make naloxone easier to access without a prescription, removing the prescription requirement at the national level will encourage more public health organizations to distribute the nasal spray, according to Claire Zagorski, a paramedic and overdose response researcher at the University of Texas at Austin.
“As someone who’s worked to get naloxone distributed in a conservative state, the over-the-counter approval is also going to be huge for the message it sends,” Zagorski said in a statement this week.
Despite being a prescription medication, naloxone has long been stockpiled and informally distributed by harm reduction groups, public health offices, first responders, librarians, opioid users, friends and family of opioid users — really anyone who may encounter an opioid overdose. Narcan is designed to be administered in life-threatening emergencies that often cannot be anticipated, so the prescription requirement was always a barrier that didn’t make sense.
Zagorski said prescription Narcan was “confusing” for community health groups and the public at large. Narcan is often associated with criminalized drug use, so can a volunteer or a concerned family member carry it without a doctor’s prescription? Police in many jurisdictions now carry Narcan, but there’s little trust between drug users and police, and possessing Narcan without a prescription remains a concern in conservative areas.
“It’s very reassuring and clarifying to organizations that may have been reticent to put [Narcan] out into the community without clinician oversight,” Zagorski said. “We can say it’s safe as many times as we want,” but the public may remain fearful “as long as it’s prescription only.”
Physicians and first responders who have seen the toll of the overdose crisis up close are jumping at the chance to demystify Narcan and show people how to use the nasal spray as it becomes available over the counter. Ryan Marino, an emergency physician in Ohio and outspoken advocate for drug policy based in science, compared Narcan to EpiPens and defibrillators, which are also used to save lives in an emergency.
“People don’t want Narcan in schools and worry it encourages drug use; that’s not true,” Marino said in a recent tweet. “This is like getting EpiPens, defibrillators to the community: it’s not something you ever want to use but should be glad it’s available because the alternative is far worse.”
Despite the stigma around drug use, experts and harm reductionists know that simply having Narcan on hand does not encourage people to use drugs and overdose, just as defibrillators do not encourage people to have heart attacks. However, the price of Narcan will determine exactly how far access expands under the FDA’s decision.
Currently, brand-name Narcan is only manufactured by one company, Emergent BioSolutions. A box of two doses purchased from a pharmacy can cost between $42 and $100 without insurance. Volunteers and harm reduction groups already hand out Narcan for free along with other safety supplies such as alcohol swabs and clean syringes, and activists say they doubt the average user can afford to go to the pharmacy to buy their own for around $50 a kit.
The FDA encouraged Emergent BioSolutions to make Narcan as affordable and widely available without a prescription, but so far the company has said little about pricing. Zagorski said there is usually a period of time when drugs remain expensive after becoming available over the counter, but there must be “rapid movement” to make Narcan as affordable and accessible as possible.
“It’s cheap to produce and easy to show people how to use and administer it,” Zagorski said. “So, I’m very hopeful that the price will drop quickly.”
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