A lifesaving drug used to treat opioid overdoses may soon be sold at your pharmacy.
Two advisory panels that make recommendations to the Food and Drug Administration voted in mid-February in favor of making a Narcan (naloxone) nasal spray available without a prescription. The FDA, which isn’t required to follow the panel’s guidance but often does, is expected to make a decision by the end of March.
If approved, Narcan would become the first naloxone nasal spray that can be purchased over the counter in the United States, according to Emergent BioSolutions, the drug’s manufacturer.
The rise of opioid overdose deaths due to prescription drugs took off in the 1990s and accelerated with rising heroin use around 2010. In 2013, when fentanyl made its way into fake prescription drugs and counterfeit pills, the incidence of opioid deaths skyrocketed — so much so that it’s now the leading cause of accidental deaths in the U.S.
If approved, it would be much easier for people to obtain the lifesaving drug, especially for those who live in rural areas without community-based programs that offer overdose rescue kits.
“Making naloxone OTC can help normalize the medication as something everyone person should have available — in the medicine cabinet, in the car, backpack, at work, in parks and other community settings,” Alex Bennett, a research associate professor and director of the Opioid Overdose Prevention Program at New York University’s School of Global Public Health, told HuffPost.
How does Narcan work?
The drug, which comes in two forms — a nasal spray and an injectable — binds to the receptors in the brain that opioids attach to and quickly blocks the effects of drugs like heroin, fentanyl, oxycodone, hydrocodone, codeine and morphine.
Administering Narcan is simple: You peel open the package, place the device into either nostril and press the plunger firmly. In most cases, the person experiencing the overdose won’t be able to administer it themselves and will need someone to give the drug to them.
Narcan must be given within the first few minutes of an overdose or suspected overdose. Some signs that someone is experiencing an overdose include unresponsiveness, a slow heartbeat, blue lips and slow or stalled breathing.
The drug quickly restores normal breathing in people whose breathing has slowed or stopped. Occasionally, if the person hasn’t responded after a few minutes, a second dose is needed.
Narcan “reverses the respiratory depressing effect of the opioid and provides the lifesaving benefit when a patient has overdosed from an opioid,” said Jonathan Watanabe, the associate dean of pharmacy assessment and quality at the University of California, Irvine, School of Pharmacy and Pharmaceutical Sciences. Narcan isn’t a cure-all, and people experiencing an overdose will still need emergency medical care after receiving the drug.
According to Bennett, Narcan is one of the safest medications available: “If a person does not have opioids in their system, it doesn’t have any effect.” There are some minor side effects — body aches, diarrhea, fever, runny nose — but those pale in comparison to the benefits, Watanabe added.
What will change if Narcan is approved for over-the-counter sales.
In most states, people can access Narcan only by going to a pharmacy and speaking with a pharmacist — though the process varies a bit from state to state.
Most commonly, pharmacists can prescribe Narcan through a state “standing order.” Bennett likened this to how you get the flu shot. You don’t need to get a prescription from your doctor, but there’s “a sort of blanket prescription that basically allows it to be dispensed under a broad range of circumstances,” he explained.
In other states, such as Iowa and Michigan, pharmacists can prescribe Narcan as long as they’ve completed specialized training. Many areas also have opioid prevention programs that have found innovative ways to distribute Narcan free or at a low cost — also via standing orders — at community centers, vending machines, libraries and hospitals, Bennett said.
The current rules create speed bumps that delay and in some cases prevent people from accessing lifesaving care, Watanabe said. If the FDA approves OTC Narcan, a health care provider would no longer need to write or sign prescription paperwork. People could order the drug online or pick it up at their local pharmacy.
If all goes as planned, OTC Narcan could be on the shelves in a matter of months, an Emergent spokesperson said. “Production of Narcan for the over-the-counter market will not begin until after the FDA approves our application, so our anticipated timing is around late summer of this year,” the spokesperson said, adding that distribution planning with retailers is already underway.
Bennett hopes there wouldn’t be restrictions, such as an age limit, that would create unnecessary barriers, given that the medication is so safe. The cost is up in the air, too. Watanabe expects that the price for overdose treatments will always be somewhat of a barrier, especially since opioid use disorder disproportionally affects people living in poverty. “Making it available but unaffordable to impacted groups will stifle the benefit to society,” Watanabe said.
According to Emergent’s spokesperson, the price won’t be revealed until the FDA has taken action on the application. However, the company said it is working with government officials to ensure the drug will be affordable and accessible.
Narcan could prevent thousands of deaths.
As Watanabe points out, that’s looking only at the deaths. The toll of the opioid crisis runs far deeper. An estimated 2.7 million Americans are suffering from opioid use disorder — and that figure is likely severely underestimated. Non-fatal opioid overdoses have lifelong implications: They’re associated with subsequent overdoses, permanent brain damage, higher rates of depression and suicidal ideation.
A study published in 2018 found that opioid-related overdose deaths dropped by 14% in states that enacted opioid access laws. Analytic models have projected that increasing naloxone distribution among laypeople and first responders could prevent 21% of opioid overdose deaths.
Dropping the prescription requirement for Narcan will dramatically increase the availability of this lifesaving medication and ultimately help prevent many fatal overdoses.
“Making it OTC increases access as you would be able to provide it on the shelves not just at pharmacies but also at supermarkets and other stores,” Watanabe said.