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The FDA approves the over-the-counter sale of the drug Narcan to curb the overdose epidemic. This is what the measure implies


It will be the first over-the-counter opioid treatment medication. These are the advantages and disadvantages of the federal measure, who will benefit and how it will be applied.

By Geoff Mulvihill —

The Associated Press

The Food and Drug Administration (FDA) on Wednesday approved the sale of naloxone without a prescription in response to the fentanyl overdose epidemic;

It will thus become the first over-the-counter opioid treatment medication.

It's a move that some activists have long called for as a way to improve access to a potentially life-saving drug, though its impact remains unclear.

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What is Narcan?

The nasal spray from Emergent BioSolutions, a Gaithersburg, Maryland-based pharmaceutical company, is the best-known commercial formulation of naloxone.

It works to reverse opioid overdoses, including street drugs like heroin and fentanyl, and prescription versions like oxycodone.

[The opioid crisis is not just a white problem: deaths among Hispanics have skyrocketed]

Expanding the availability of naloxone may be a key strategy to control the overdose epidemic, linked to more than 100,000 deaths a year in the United States.

Most of those deaths are related to opioids, especially powerful synthetic versions like fentanyl, which can require multiple doses of naloxone to reverse.

Advocates believe it is important to make naloxone more accessible to people most likely to be associated with overdoses, such as drug users and their families, as well as police, fire and rescue teams, and doctors.

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What does FDA approval mean?

According to Emergent BioSolutions, Narcan will be available without a prescription by the end of the summer.

Other brands of naloxone and injectables are not yet available over the counter, but could be approved soon.

Harm Reduction Therapeutics, a nonprofit organization that receives funding from Purdue Pharma, the company that makes OxyContin (an opiate pain medication), has asked the FDA to make its aerosolized version of naloxone available without a prescription.

[Drug overdose deaths are at an all-time high, and the coronavirus pandemic isn't just to blame]

How will the naloxone be distributed?

Before the FDA approval, pharmacies were already able to sell naloxone without a prescription because authorities in every state have allowed it.

But not all do.

And buyers have to pay for the drug, either with an insurance copay or full retail price (about $50 for two doses).

The drug is also distributed by organizations that serve drug addicts, but its access is not guaranteed.

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Emergent BioSolutions has not announced its OTC pricing in pharmacies, and it is not yet clear if insurers will continue to cover it as a prescription drug.

Will selling naloxone over the counter improve access for those who need the drug?

The FDA approval will allow Narcan to be available in places without pharmacies such as convenience stores, supermarkets and online retailers.

José Benítez, director of Prevention Point Philadelphia, a group that tries to reduce the risk of people who use drugs with services that include free distribution of naloxone, said it could go a long way for people who don't see doctors or who live in places where they are not available.

[“We are the ones who die”: the pandemic triggers opioid overdoses and Latinos are the most vulnerable] 

He also said that some people have expressed concern about buying naloxone at pharmacies because their insurers will know they are using it.

"Taking it off the shelves will allow people to grab it, without stigma, and easily access this life-saving medicine," she said.

However, it is not yet known how many stores will carry it and what their prices will be.

The Centers for Medicaid and Medicare Services, which now covers prescription naloxone for people who are on government insurance programs, says that over-the-counter naloxone coverage will depend on the insurance program.

The centers have not given any official guidance.

Maya Doe-Simkins, co-director of Remedy Alliance/For The People, an initiative launched in 2023 to provide low-cost -- and sometimes free -- naloxone to community organizations, said her group will continue to distribute injectable naloxone.

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What are the drawbacks of the measure?

One concern is whether people who buy Narcan without a prescription will know how to use it correctly, said Keith Humphreys, an addiction expert at Stanford University, though the manufacturer does provide instructions and videos online.

One of the advantages of pharmacists' involvement is that they can show buyers how to use it.

There is one key thing that people should be reminded of: call an ambulance to attend to the person, after the naloxone is applied.

He also said that it is feared that if the drug is not profitable in this form, the manufacturer could stop producing it.

Source: telemundo

All news articles on 2023-03-29

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