Reuters
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The prescription medication naloxone can reverse an opioid overdose and has become a key tool in the US’s deadly and prolonged opioid crisis.
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On Friday, the US Food and Drug Administration highlighted its efforts to increase availability of naloxone, including encouraging companies to create a non-prescription product.
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But experts say that the FDA has the power to make naloxone available without a prescription and should do so.
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An opioid overdose kills 130 Americans each day, on average. So why isn’t the opioid overdose antidote naloxone, which is a prescription medication, as widely available as over-the-counter products like Advil and Plan B?
That’s a question experts have been asking for years, and they’re asking it again now that the US Food and Drug Administration recently highlighted its work to make naloxone more accessible.
The FDA, which regulates medications and other products, has been working to encourage companies to make an over-the-counter naloxone product. Such a treatment would be “an important public health advancement,” FDA Acting Commissioner Dr. Ned Sharpless said in a Friday statement.
But experts have also called on the FDA itself make current naloxone products available without a prescription. One of those experts is Corey Davis, a staff attorney at the National Health Law Program, and he redoubled the call this weekend:
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The studies are complete. FDA could move one or more products OTC on its own authority, but instead it’s decided to wait for a manufacturer to request either an Rx-to-OTC switch or OTC approval for a new product. Meanwhile, 200+ ppl die every day.
Meanwhile, addiction medicine specialist Dr. Stefan Kertesz wrote:
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Naloxone MUST be made an over the counter med. In our state the Board of Pharmacy opposes community distribution unless a pharmacist directly dispenses the naloxone. They do appear to be right from a regulatory perspective but this locks down access. OTC is the only way. https://t.co/Ef134z5njG
The US has long been in the throes of a deadly opioid crisis, with overdose deaths from prescription painkillers as well as heroin and synthetic opioids like fentanyl.
US Surgeon General Jerome Adams has advised Americans who know people at risk of an overdose to carry naloxone, and said that the rescue medication is a crucial tool, since such overdoses typically happen outside of a medical setting like a hospital.
You should be able to buy naloxone without a prescription, but that doesn’t always work out in practice
Because naloxone is so widely recognized as a lifesaving product, many states have taken steps to make it more available.
In most places, you should be able to go to the pharmacy and get naloxone under what’s called a “standing order,” which works like a blanket prescription for people in that state or area. Certain states also give pharmacists power to prescribe or sell naloxone, the FDA’s Sharpless noted. But he also acknowledged the limitations.
“Still, many pharmacists may be unaware of the standing orders and direct authority in their states or are unwilling to provide all forms of naloxone to consumers without an individual prescription,” Sharpless wrote in the Friday statement.
A New York Times investigation last year found that, of 720 New York City pharmacies that were supposed to sell naloxone without a prescription, only about a third had it in stock and would sell it without a prescription.
And then there is the issue of price. Naloxone can cost up to $150 without insurance, Business Insider has previously reported, though insurance plans may cap the out-of-pocket costs at around $20. A generic version of the naloxone nasal spray Narcan was approved by the FDA earlier this year, which could help bring down the cost of the medication.
Naloxone should be available as an over-the-counter medication, and the FDA’s moves to encourage that are in the right direction, the addiction medicine specialist Kertesz told Business Insider.
He said he was moved to tweet about the issue after being at a New York City event where volunteers were about to hand out pouches containing naloxone.
But issues could still crop up even then, he noted. For instance, if the overdose antidote were made available without a prescription, insurers might stop covering it, exposing consumers to higher costs, he said.
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