130 Americans die each day from opioid overdoses. Experts are asking why a lifesaving treatment isn't widely available without a prescription.
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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.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:
Meanwhile, addiction medicine specialist Dr. Stefan Kertesz wrote: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.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.
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.
- Corey Davis (@coreysdavis) September 21, 2019
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
- Stefan Kertesz (@StefanKertesz) September 21, 2019
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