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GREENSBORO, N.C. 鈥� Louise Vincent figures her group, the North Carolina Survivors Union, saves at least 1,690 lives a year.
The distributes the opioid overdose reversal medication naloxone to people who use drugs. Research suggests , since people who use drugs are to witness an overdose and .
The 1,690 number refers to how many times participants in the Survivors Union reported using the medication between July 2020 and June 2021. But the true number of lives saved could be higher: The program distributed nearly 9,400 doses of naloxone during that time.
Now, as overdose deaths nationwide reach , the Biden administration has made increasing access to naloxone a key part of its . It has allotted an in federal funds for harm-reduction groups and announced the that state legislatures can pass to improve access.
But Vincent and her peers say the administration has not addressed their greatest barrier to obtaining the lifesaving medication: naloxone鈥檚 prescription-only status.
鈥淭his designation is the root of all evil,鈥� said , a scientist at the University of North Carolina鈥檚 school of public health and co-founder of , a collective of more than 100 harm-reduction programs in the U.S.
The Food and Drug Administration approved naloxone as a prescription drug to treat opioid overdose in 1971, when it was only an injectable drug. That remains the cheapest form and the one used most by harm-reduction groups, which have long relied on a deal with Pfizer to buy the medication for less than $5 a dose. However, newer, nasal spray versions of naloxone 鈥� including the brand-name drug Narcan, which has a discounted price of 鈥� are available in many police stations, libraries and schools.
allow individuals to buy naloxone at the pharmacy without a prescription. States don鈥檛 have the authority to designate it as an over-the-counter medication, but they鈥檝e created workarounds 鈥� such as a state health official writing one prescription that can be used for every resident. But these workarounds don鈥檛 apply to organizations that purchase naloxone in bulk from drugmakers. When a hospital, harm-reduction group or any other organization orders naloxone from pharmaceutical companies, the companies are required to treat naloxone the way the federal government sees it: as a prescription medication, Dasgupta said. As a result, the companies impose a series of requirements on buyers.
For example, an organization that orders naloxone must have a doctor sign for the order, and that doctor must be someone who has not signed for another group. The organization must also have an address that is not a private home to receive shipments, a medical or pharmacy license and the ability to comply with regulations for storing and dispensing the drugs.
Hospitals and health departments can easily fulfill these requirements. But they can be onerous for smaller, grassroots groups, many of which are led by volunteers and operate out of makeshift home or car offices, said Eliza Wheeler and Maya Doe-Simkins, and co-authors of a with Dasgupta on this subject.
When these groups can鈥檛 order naloxone, the people they serve can die, Wheeler and Doe-Simkins said.
Those clients won鈥檛 necessarily turn to pharmacies. Indeed, as overdose deaths surged in 2020, pharmacy sales of naloxone . The cost of the medication, requirements to show ID, a fear of and an inability to naloxone are all barriers, said West Virginia University researcher , who studies naloxone distribution.
So harm-reduction groups are calling on the FDA to allow naloxone to be sold over-the-counter so they can order it more easily and distribute it to the people at the greatest risk of overdosing.
The product has long been deemed safe and effective for community use, harm-reduction groups say, even by . Other advocates have suggested that the Department of Health and Human Services issue an order allowing manufacturers to sell naloxone to organizations buying in bulk without a prescriber鈥檚 signoff.
鈥淗aving more naloxone on the street can only do good. It can鈥檛 do harm,鈥� said , an epidemiologist and substance use researcher at Tufts University School of Medicine. 鈥淲e need to pull out all the stops and consider a bunch of different avenues to address this issue of supply.鈥�
The concern was highlighted this year when a manufacturing problem depleted Pfizer鈥檚 stock of naloxone and the company for harm-reduction groups. Hikma, another company that makes naloxone, offered to donate 50,000 injectable doses to the affected groups. But because of naloxone鈥檚 prescription status and Hikma鈥檚 associated paperwork requirements, only three harm-reduction programs qualified, Dasgupta said. (Pfizer said that the manufacturing issue has been resolved and that shipments resumed this fall.)
In Oklahoma, Stop Harm on Tulsa Streets (SHOTS) didn鈥檛 qualify for Hikma鈥檚 donation because the group didn鈥檛 have a doctor who could sign for its order, co-founder Hana Fields said. The doctor the group had previously worked with retired in January, and SHOTS had yet to find a replacement. Many doctors are worried about liability or simply don鈥檛 return her calls, she said. In the meantime, SHOTS relies on naloxone donations from other programs.
鈥淭he stakes are so high. My friends are dying,鈥� said Fields, whose life has been saved by naloxone and who has been in recovery for seven years.
In a statement to KHN, the FDA laid responsibility on the companies making naloxone, saying it has encouraged pharmaceutical manufacturers to apply for over-the-counter designation for years, even that are typically the purview of companies.
鈥淲e continue to hope that one or more sponsors will submit an application, as this would be the most direct regulatory path for the FDA to be able to approve a non-prescription naloxone,鈥� the agency said.
But when, or if, that鈥檒l happen is unclear.
Pfizer and Hikma told KHN that they do not have current plans to pursue an over-the-counter designation. Emergent BioSolutions, which makes Narcan, said it is 鈥渆valuating the potential for OTC naloxone鈥� but warned of 鈥渦nintended consequences鈥� from the switch, such as insurers no longer covering the cost and consumers having to pay out-of-pocket. (Experts say products typically are cheaper when sold over the counter.)
Harm Reduction Therapeutics, a nonprofit pharmaceutical company, said it plans to apply for an over-the-counter naloxone nasal spray next year, with the goal that it be on shelves in 2023. CEO said the company will donate most of its product to harm-reduction groups and raise funds to offset the cost to consumers at retail pharmacies. Currently, the bulk of the company鈥檚 funding comes from Purdue Pharma, the .
But advocates say the FDA should make the switch itself.
鈥淲e have this lifesaving tool available throughout the whole time of this crisis, and the federal government has just been sitting on its hands,鈥� said , a professor of law and health sciences at Northeastern University in Boston.
Some pharmaceutical companies in the past have argued that the government doesn鈥檛 have the to designate a prescription drug as over-the-counter, but others point to a that allows a drug鈥檚 prescription status to be removed 鈥渨hen such requirements are not necessary for the protection of the public health.鈥� In 1982, the FDA without the company鈥檚 request, though it later rescinded that status because of widespread criticism that the inhalers would be overused.
Meanwhile, harm-reduction organizations, like the North Carolina Survivors Union in Greensboro, see the demand for naloxone daily. Vincent, who runs the program, said cost and regulatory burdens prevent her from ordering naloxone directly. Instead, she relies on donations from other groups. But she fears the day her group doesn鈥檛 have enough.
鈥淚 can鈥檛 look someone in the eye and tell them I can鈥檛 give them medicine that鈥檚 going to save their lives,鈥� Vincent said.