Affordable naloxone will be easier to access, reversing opioid overdoses


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The first shipment of naloxone as part of a new national effort to reverse overdoses has arrived without ceremony.

Delayed by shipping wait times and packed in some nondescript cardboard box, 100,000 doses of Pfizer’s injectable drug were delivered Wednesday by a driver, who steered two huge pallets into an unassuming warehouse that houses the new organization in non-profit Remedy Alliance, which is expected to distribute mass quantities of cheap naloxone to smaller community groups. Co-founder Eliza Wheeler took the stacks scene at shoulder height.

“It’s going to save a lot of lives,” she told the delivery man, explaining that there was an opioid overdose antidote in the boxes. Already, 43,000 of these doses have been pre-ordered by more than 100 harm reduction groups across the country. In total, the first shipment alone could save thousands of lives, according to the nonprofit organization.

“Oh, shit,” the driver said. “OK.”

Researchers found that no state had enough naloxone to meet demand, even as drug overdoses hit an all-time high. But Remedy Alliance organizers Wheeler, Maya Doe-Simkins and Nabarun Dasgupta say they’ve found a new solution, saying “the affordable naloxone shortage is officially over.” Their success, say drug policy experts, underscores how far behind governments are in unofficial efforts to build up a satisfying and affordable supply.

Organizers, who previously operated an informal naloxone buying club, say they will be able to get more of the antidote into the hands of people who use drugs. They attribute two major developments: agreements with drugmakers to buy the drug at a reduced price; and a restructured system that allows local groups to order naloxone directly through an online store, bypassing a complex web of federal regulations that has restricted the flow of naloxone in the past.

“We believe this will totally change the landscape of naloxone in the United States,” said Dasgupta, chairman of the nonprofit organization’s board of directors and a scientist at the Gillings School of Global Public Health in the United States. University of North Carolina at Chapel Hill.

Affordable naloxone is running out, creating a perfect storm for more overdose deaths, campaigners say

Organizers believe their efforts, formerly called Opioid Safety and Naloxone Network Buyers Club, have reversed thousands of opioid overdoses. The club distributed 1.3 million doses in one year. Now, in the form of a non-profit organization, they expect rapid growth, projecting a new total of 1.8 to 2 million doses over the next 12 months.

That could represent tens of thousands of lives saved in a year, according to Remedy Alliance, at a time when the country has eclipsed 100,000 drug overdose deaths every 12 months, disproportionately killing blacks and Native Americans.

These doses are more likely to reach those who need naloxone because people who use drugs depend on groups that practice harm reduction, a method of dealing with the consequences of drug use by providing clean needles and other vital accessories, according to Remedy Alliance and Kendall LaSane. , a UNC-CH PhD student conducting independent research on the association’s efforts.

Remedy Alliance accounts for “a substantial portion” of the naloxone that is distributed across the country, said Reagan-Udall Foundation executive director Susan Winckler, particularly to community groups that drug users trust more, rather than ‘to pharmacies or law enforcement, which users avoid for fear of stigma or arrest.

“I think Remedy Alliance has come up with an elegant solution,” said Winckler, whose foundation compiles data on how much naloxone is produced.

The creation of Remedy Alliance overcomes a critical issue with the distribution of naloxone, which for years operated in a legal gray area.

Current Food and Drug Administration rules state that only licensed wholesale distributors can dispense prescription drugs, unless the drugs are for “emergency medical reasons.” Naloxone makers said they were unsure if harm reduction groups were eligible for the exception and turned down groups trying to buy naloxone directly, including the few operating in communities. hard-to-reach rural areas hardest hit by overdoses and addiction.

Last month, the senses. Maggie Hassan (DN.H.) and Rand Paul (R-Ky.) asked the FDA in a letter to clarify its “ambiguous regulations” and “minimize obstacles that still impede its purchase, distribution or use” . of naloxone.

But Remedy Alliance isn’t waiting for that to happen.

After the Washington Post published an article in August 2021 about the buyers’ club struggling to meet demand for naloxone, Hikma Pharmaceuticals approached the organizers.

Hikma originally donated 50,000 vials to the buyers’ club when it learned of the supply issue last summer and began to strike a deal to provide custom-produced, discounted naloxone on a long-term basis. , said company spokesman David Belian.

Pfizer said its stock of single-dose vials was back to normal in late July and it was fulfilling all of its orders, spokeswoman Sharon Castillo said.

Buyers’ club organizers at the time met with senators, the FDA and the White House to lobby for increased access to naloxone, pushing for it to be designated as an over-the-counter drug and an over-the-counter drug. ’emergency. At the same time, they decided to go ahead with the creation of a non-profit organization, allowing them to receive naloxone when other groups are refused and becoming a kind of umbrella for the national harm reduction organizations.

“There was all this rushing and jostling and trying to come up with a solution and get it on a flag pole and get a ‘this won’t work’ or get a ‘this sounds interesting, but I can’t say yes’ and “you should talk to so-and-so,” Doe-Simkins said. “All of this was happening against the backdrop of a naloxone shortage.”

Organizers hope governments can direct funding to provide more naloxone in other ways, especially as settlements in the nationwide opioid epidemic litigation are expected to bring more than $32 billion to national and local funds.

Even as more people die and the supply of illegal drugs becomes increasingly dangerous, the cost of naloxone has continued to rise, rising more rapidly over the past decade, said Sarah Evans , Global Director of Harm Reduction at Open Society Foundations.

Governments pay more than Remedy Alliance for naloxone, and they don’t distribute it either, Evans said. Even though Remedy Alliance has made progress on both fronts, cost and delivery, governments need to think about how they can replicate and scale this success.

“We have to decide as a community and as a society, is it okay to just let people who use drugs die,” Evans said. “Are we comfortable with this?”

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