The FDA approves over-the-counter Narcan. Here’s What It Means – NBC Chicago
The U.S. Food and Drug Administration on Wednesday approved the sale of naloxone without a prescription, putting the anti-overdose drug on track to become the first opioid treatment drug to be sold without a prescription.
It’s a move some advocates have long sought as a way to improve access to a lifesaving drug, though the exact impact isn’t immediately clear.
Here is an overview of the issues involved.
WHAT IS NARCAN?
Gaithersburg, Maryland’s approved brand nasal spray, Emergent BioSolutions, is the best-known form of naloxone.
It can reverse opioid overdoses, including street drugs like heroin and fentanyl and prescription versions, including oxycodone.
Making naloxone more widely available is seen as a key strategy to control the national overdose crisis, which has been linked to more than 100,000 deaths in the United States annually. The majority of these deaths are related to opioids, primarily potent synthetic versions such as fentanyl which can take multiple doses of naloxone to reverse.
Proponents believe it is important to provide naloxone to those most likely to face overdoses, including people who use drugs and their loved ones.
Police and other first responders often wear it as well.
DOES FDA APPROVAL MEAN I CAN BUY IT FROM CVS, WALGREENS OR RITEAID?
Yes. Narcan will be available over the counter in pharmacies by the end of the summer, the company said.
Other brands of naloxone and injectable forms will not yet be available over-the-counter, but may be soon.
The nonprofit organization Harm Reduction Therapeutics Inc., which receives funding from OxyContin maker Purdue Pharma, has filed an application with the FDA to distribute its version of naloxone spray without a prescription.
HOW IS NALOXONE DISTRIBUTED NOW?
Even before the FDA action, pharmacies could sell naloxone without a prescription because state authorities allowed it.
But not all pharmacies sell it. And buyers have to pay for the drugs – either with an insurance copayment or for the full retail price. The cost varies, but two doses of Narcan often cost around $50.
The drug is also distributed by community organizations that serve people who use drugs, although it is not readily available to everyone who needs it.
Emergent has not announced its price and it is not yet clear whether insurers will continue to cover it as a prescription drug if it is available over the counter.
DOES MANUFACTURE OF ENHANCED NALOXONE FOR SALE IMPROVE ACCESS?
This paves the way for Narcan to be made available in places without pharmacies – convenience stores, supermarkets and online retailers, for example.
Jose Benitez, the chief executive of Prevention Point Philadelphia, an organization that tries to reduce harm to people who use drugs with services such as free naloxone distribution, said it could be a big help for people who aren’t looking for of services – or who live in places where they are not available.
Now, he said, some people fear getting naloxone from pharmacies because their insurers will know they’re getting it.
“Removing it from the shelves will allow people to simply pick it up, not be stigmatized and easily access this life-saving medicine,” he said.
But it remains to be seen how many stores will carry it and what the prices will be. The US Centers for Medicaid and Medicare Services, which now covers prescription naloxone for people on government insurance programs, says coverage for over-the-counter naloxone would depend on the insurance program. The centers did not provide any formal guidance.
Maya Doe-Simkins, co-director of Remedy Alliance/For The People, which was launched last year to provide low-cost — and sometimes free — naloxone to community organizations, said her group would continue to distribute naloxone injectable.
ARE THERE ANY CONCERNS ABOUT OTC SALES?
One concern is whether people who buy Narcan over the counter will know how to use it correctly, said Keith Humphreys, a Stanford University addiction expert, although the manufacturer is responsible for clear instructions and online videos about it.
One of the benefits of involving pharmacists, he said, is that they can show shoppers how to use it. One key thing people need to remember: call an ambulance for the person who receives naloxone after giving it.
He also said he fears that if the drug is unprofitable as an over-the-counter option, the drugmaker might stop producing it.