Louise Vincent, chief executive officer of the North Carolina Survivors Union, holds a vial of naloxone overdose reversal medication. “Almost everyone who comes here survives on naloxone,” says Vincent.
Aneri Pattani / KHN
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Louise Vincent, chief executive officer of the North Carolina Survivors Union, holds a vial of naloxone overdose reversal medication. “Almost everyone who comes here survives on naloxone,” says Vincent.
Aneri Pattani / KHN
Louise Vincent says her group, the North Carolina Survivors Association, saves at least 1,690 lives each year.
The Harm reduction service program and syringe in Greensboro, NC, distributes the opioid overdose reversal aid naloxone to drug users. Research to show that This approach works, because of drug users likely witness an overdose and naloxone administration.
The 1,690 number refers to the number of times Coalition Survivors reported taking the drug between July 2020 and June 2021. But the actual number of lives saved may be higher: Program distributed nearly 9,400 doses of naloxone during that time.
Addiction treatment is available. For help, call the free and confidential treatment referral hotline (1-800-662-HELP), or visit findtreatment.gov.
Now, when drug overdose deaths across the country all-time high, the Biden administration has increased access to naloxone becoming an important part of the Overdose prevention strategy. It allocated a Unprecedented 30 million dollars in federal funds for harm reduction groups and announced create a model rule that state legislatures can pass to improve accessibility.
But Vincent and her colleagues say the administration has failed to address their biggest barrier to obtaining the life-saving drug: the prescription-only status of naloxone.
“This designation is the root of all evil,” Nabarun Dasgupta, a scientist at the University of North Carolina school of public health and a co-founder Buyer’s Club, a collection of more than 100 harm reduction programs in the United States
The Food and Drug Administration approved naloxone as a prescription drug to treat opioid overdoses in 1971, when it was only an injectable drug. It’s still the cheapest form and the form most used by harm reduction groups, which have long relied on agreements with Pfizer to buy drugs for less than $5 a dose. However, newer, nasal spray versions of naloxone – including the brand-name Narcan, have a discounted price of about $38 a dose – Available in many police stations, libraries and schools.
Although all 50 states allow individuals to purchase naloxone, more commonly known as Narcan, organizations that order the drug from drug manufacturers are subject to federal rules that designate the drug. prescription only. The rules make access to lifesaving drugs difficult for people at high risk of overdose.
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All 50 states allows individuals to buy naloxone at the pharmacy without a prescription. States do not have the authority to designate it as an over-the-counter drug, but they have created alternatives — such as a state health official writing a prescription that can be used by all residents. But these workarounds do not apply to organizations that buy naloxone in bulk from drug manufacturers.
When a hospital, harm reduction group, or any other organization orders naloxone from pharmaceutical companies, those companies must treat naloxone the way the federal government sees it: as a prescription drug. single, Dasgupta said. As a result, companies place a wide range of requirements on buyers.
For example, an organization that orders naloxone must have a physician sign the order, and that physician must be a non-signer for the other group. The organization must also have a non-home address to receive shipments, a medical or pharmaceutical license, and the ability to comply with drug storage and dispensing regulations.
Hospitals and health departments can easily fulfill these requests. But they can make it difficult for smaller, grassroots groups, many of which are led by volunteers and operate outside of shelters or car offices, said Eliza Wheeler and Maya Doe-Simkins, Buyers Club co-founders and co-authors of a paper with Dasgupta on the subject.
When these groups can’t order naloxone, the people they serve can die, says Wheeler and Doe-Simkins.
Those customers won’t necessarily go to the pharmacy. Indeed, as drug overdose deaths soar in 2020, pharmacy sales of naloxone reduction. Drug costs, identification requirements, fear of Discrimination from pharmacists and not able Find a pharmacy that sells it naloxone are all barriers, says West Virginia University researcher Robin Pollini, who studies naloxone distribution.
So harm reduction groups are calling on the FDA to allow over-the-counter sale of naloxone so they can more easily order and distribute to those most at risk of overdose.
Harm reduction groups say the product has long been considered safe and effective for public use FDA. Other advocates have suggested that the Department of Health and Human Services issue an order that would allow manufacturers to sell naloxone to organizations that buy in bulk without a prescriber’s signature.
“Having a lot of naloxone on the street can only do good. It can’t do harm” Thomas Stopka, an epidemiologist and substance use researcher at Tufts University School of Medicine. “We need to get rid of all the backstops and look at a bunch of different avenues to solve this supply problem.”
Concerns were raised this year when a manufacturing problem depleted Pfizer and company stockpiles of naloxone. Unable to fulfill the order for harm reduction groups. Hikma, another naloxone maker, has offered to donate 50,000 doses of the injection to affected groups. But because of the prescribing status of naloxone and Hikma’s related paperwork requirements, only three harm reduction programs qualify, Dasgupta said. (Pfizer says the production issue has been resolved and shipments have resumed this fall.)
Hana Fields is the co-founder of Stop Harm on Tulsa Streets (SHOTS), a harm reduction organization in Oklahoma. Since the team’s doctor retired in January, SHOTS has relied on naloxone donations from other programs statewide and nationally.
Rosa Hernandez
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Hana Fields is the co-founder of Stop Harm on Tulsa Streets (SHOTS), a harm reduction organization in Oklahoma. Since the team’s doctor retired in January, SHOTS has relied on naloxone donations from other programs statewide and nationally.
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In Oklahoma, SHOTS (Stop Harm on Tulsa Street) is ineligible for Hikma to donate because the group doesn’t have a doctor who can sign the order, said co-founder Hana Fields. The doctor the team worked with previously retired in January and SHOTS has yet to find a replacement . Many doctors worry about liability or simply don’t return her calls, she said. Meanwhile, SHOTS relies on naloxone donations from other programs.
“The stakes are too high. My friend is dying,” said Fields, who was saved by naloxone and has been recovering for seven years.
In a statement to KHN, the FDA blamed the companies that make naloxone, saying it has encouraged drug manufacturers to apply for over-the-counter indications for many years, even do legitimate work to develop consumer-friendly labels that is often the goal of companies.
“We continue to expect that one or more donors will submit an application, as this would be the most direct regulatory route for FDA to approve over-the-counter naloxone,” the agency said.
But when, or if, that will happen is unclear.
Pfizer and Hikma told KHN they have no current plans to pursue an over-the-counter drug. Narcan said it was “assessing the potential of OTC naloxone” but warned of “unexpected consequences” from the switch, such as insurers no longer covering the costs and consumers use pay out of pocket. (Experts say the products are often cheaper when sold over-the-counter.)
A nonprofit pharmaceutical company says it plans to sign up for an over-the-counter naloxone nasal spray next year with a goal of hitting shelves in 2023. Michael Hufford said the company will donate the majority of its products to harm reduction groups and raise funds to offset costs to consumers at retail pharmacies. Currently, the majority of the company’s funding comes from Purdue Pharma, Manufacturer OxyContin.
But advocates say the FDA should switch itself.
“We have this lifesaver at our disposal during this crisis, and the federal government is just sitting around,” he said. Leo Beletsky, professor of law and health sciences at Northeastern University in Boston.
Some pharmaceutical companies have in the past argued that the government has no authorization to designate a prescription drug as an over-the-counter drug, but other drugs indicate Regulation allows for the removal of the prescribing status of a drug “when such requirements are not necessary to protect public health.” In 1982, FDA prescribed an asthma inhaler as an over-the-counter medicine without the company’s request, though it later rescinded that status because of widespread criticism that the inhaler would be overused.
Meanwhile, harm reduction organizations, like the North Carolina Survivors Association of Greensboro, see a need for naloxone on a daily basis. Vincent, who runs the program, said the burden of costs and regulations made it impossible for her to order naloxone directly. Instead, she relies on contributions from other groups. But she fears a day when her team won’t have enough.
“I can’t look someone in the eye and tell them I can’t give them a drug that will save their life,” Vincent said.
KHN (Kaiser Health News) is an editorially independent newsroom and an active program of KFF (Kaiser Family Foundation). The KFF is a nonprofit organization privileged to provide information on health issues to the nation.
