An affordable antidote for opioid overdoses has become more difficult to obtain amid a fatal epidemic, in what advocates have called a “perfect storm” with deadly consequences.
After a manufacturing issue halted Pfizer’s production of the single-dose injectable naloxone in April, groups that distribute a significant amount of the lifesaving medicine say they are facing an unprecedented obstacle to reverse drug overdoses as they reach an all-time high. Organizers say the insufficient supply has been felt unequally across the country.
Pfizer, which offers naloxone at a discount to a national buyer’s club made up of harm prevention programs, said it may take until February before it can meet demand again. The community programs that rely on the buyer’s club have resorted to seeking donations to buy naloxone at market price or looking for supply from places where the antidote is sitting on shelves and expiring. A dose of generic naloxone typically costs upward of $20 wholesale. Buying the same quantity of the drug from other manufacturers isn’t attainable, activists told The Washington Post.
Without supply, organizations such as Utah Naloxone must weigh which facilities, including libraries and treatment centers, it will no longer stock, said Jennifer Plumb, the group’s founder and medical director.
“Who do you stop supplying?” Plumb said. “Who do you stop prioritizing? Who do you stop making sure has naloxone?”
Utah Naloxone has distributed the antidote for six years, recording more than 5,600 overdoses that were reversed. Plumb, who is also an associate professor of pediatrics at the University of Utah, estimated that without the lifesaving naloxone on hand, hundreds of reversals every year would end in death.
“It makes me a little teary,” Plumb said, wiping her eye. “It’s that real for me. It’s that horrifying.”
Pfizer declined to provide additional information about what led to the manufacturing issue but said it is unrelated to its production of the coronavirus vaccine it developed with German partner BioNTech. Drug policy outlet Filter was the first to report on the supply disruption.
While the Food and Drug Administration has not added naloxone to its shortage list, the Opioid Safety and Supply Network Buyer’s Club, the national consortium of more than 100 harm reduction programs that have provided millions of doses since 2012 to communities at a reduced price, says the unprecedented scarcity is expected to have deadly consequences.
Maya Doe-Simkins, an organizer for the buyer’s club, estimated that the 250,000-dose backorder so far could result in at least 11,000 overdose deaths.
The past year has already topped records for drug overdoses, more than 93,000, with opioids and the deadly synthetic opioid fentanyl driving the death toll, according to preliminary data from the Centers for Disease Control and Prevention. Overdose deaths involving opioids surpassed 69,000 in 2020.
Activists say those most likely to suffer from shortages are programs with limited funding or in communities without adequate laws and infrastructure to distribute naloxone.
In some areas, especially in the Midwest, South and Appalachian regions, programs operate under the radar, without authorities’ approval, said Eliza Wheeler, another buyer’s club organizer. Harm reduction, or efforts to minimize the harms of substance use, has faced backlash from critics who argue providing clean needles, fentanyl testing strips and naloxone enables drug use. Recent studies show such approaches save lives.
“The New Yorks and New Mexicos and Massachusetts and Californias of the world, who all have really robust infrastructure to support harm reduction programs and syringe exchange programs are hopefully going to be okay and even expand,” Wheeler said. “The focus for us is the regions not receiving that kind of support and relying on us.”
States where organizers are in “panic mode” include Louisiana, Kentucky, North Carolina, Utah and others, according to Nabarun Dasgupta, a scientist at University of North Carolina’s Gillings School of Global Public Health.
Dasgupta, who helped negotiate the buyer’s club’s deal with Pfizer, said that the programs relying on it for their naloxone supply have needed to diversify the supply and get other companies to donate the drug or sell it at a discount.
“A single source for any product makes you beholden to that source,” Dasgupta said. “That’s just never going to be a sustainable model.”
Since 2012, distribution via the buyer’s club has grown. Last year, the club accounted for about 1.3 million doses, and that was estimated to rise to 1.5 million doses in 2021 if there hadn’t been a sudden shortfall.
The disruption at Pfizer has also affected naloxone donations promised to another group. Direct Relief, a humanitarian relief nonprofit organization, has received half of the 1 million doses Pfizer committed last year but won’t receive the rest until February. The nonprofit says it’s working to provide free naloxone but has faced an uptick in requests.
“It’s hard to say at this point how we’ll adjust,” Direct Relief spokesman Tony Morain said.
The FDA told The Post that the supply available through other producers is “sufficient” to meet the national demands. Two of five drugmakers with naloxone products responded to The Post, saying their supply remains unaffected. Aside from Pfizer, only one other drugmaker, Kaléo Pharma, has donated naloxone to Direct Relief.
But Pfizer’s price was what made the group’s distribution so attainable, they said, and other companies have not matched that offer.
Less than half of the groups in the buyer’s club receive federal funding and cannot afford to pay the market cost of naloxone to make up for shortages they face, according to the club.
The Department of Health and Human Services will be able to spend $30 million allocated in the American Rescue Plan – the first federal funds designated specifically for harm reduction by Congress – on naloxone once it is available. In the meantime, according to HHS, states can seek funds through grant programs run by the Substance Abuse and Mental Health Services Administration.
State funding to distribute naloxone to government entities like police departments doesn’t help people who use drugs and the supply ends up sitting on shelves, members of the buyer’s club say.
Harm reduction groups say they are distributing a lion’s share of naloxone. From 2017 to last year, such programs distributed 3.7 million doses because of the availability of the drug at a low cost, estimated the National Alliance of State & Territorial AIDS Directors, a nonprofit group representing public health officials.
While the FDA says it has worked toward making the drug more available at pharmacies, harm reduction organizers say drug users may not feel safe seeking naloxone at a pharmacy, where they may be judged.
Utah Naloxone’s Plumb tells people that they should call for paramedics who carry naloxone when they witness an overdose, but she knows family members and friends may worry about criminal repercussions for drug possession and use. Plumb, who lost her brother to a heroin overdose in 1996, recalled her parents fearing he would get in trouble with his probation officer.
“There’s an assumption that people who don’t call 911 are monsters,” she said. “They are actually really terrified of the people they are calling 911 on or they’re really terrified for themselves or the people around them.”
For people living in marginalized communities, the threat of policing is pervasive – as is the continued health disparities that have disproportionately intensified the toll of the overdose epidemic and coronavirus pandemic.
Jack Martin, the co-founder and executive director of Southside Harm Reduction Services in Minneapolis, said about half of the clients his program serves belong to Black and Indigenous communities. Since he learned Southside would face a shortage of naloxone, he has been unsure how the group will be able to recuperate the loss, fearing the worst.
“It’s absolutely heartbreaking,” Martin said, “because the possibility is there for this to not even be an issue but we’re sitting here, and Black and brown communities are really feeling the effects the heaviest. It’s honestly very ridiculous.”
“It’s just so preventable,” he said.