[ad_1]
Advocates say that community-run programs across the country are running short on low-cost, injectable naloxone, the opioid overdose treatment. The shortage has been ongoing since May 2021, despite early media coverage and a record-high rise in overdose deaths. And while some of the issues behind the shortage may be resolved soon, it will require systemic changes in how naloxone can be sold and distributed to ensure its widespread availability moving forward.
Naloxone is an opioid antagonist, a class of drugs that bind to the opioid receptors in our cells and prevent other opioids from activating them. When naloxone is given to someone who’s actively experiencing an opioid overdose, it can rapidly reverse life-threatening symptoms like the inability to breathe. It can be given intravenously, intramuscularly, or subcutaneously as a shot; it can also be used as a nasal spray, known by the brand name Narcan. An auto-injectable version was developed by Evzio, but the drug and its generic version were pulled from the market in 2020, following criticism over its high price.
Injectable naloxone, usually given intramuscularly, has long since become generic and is cheaper than the auto-injectable or nasal spray formulations, both of which were patented as novel drug delivery methods. In 2012, the Opioid Safety and Naloxone Network Buyers Club, a nonprofit organization founded four years earlier, negotiated a deal with pharmaceutical company Pfizer to purchase injectable naloxone at the low price of $2.50 per dose—far cheaper than even discounted Narcan, which can cost around $75 per dose. The group, led by co-directors Eliza Wheeler and Maya Doe-Simkins, has recently changed its name to Remedy Alliance/For The People.
Since its deal with Pfizer, Remedy Alliance has been one of the largest facilitators of naloxone in the country, helping purchase upwards of a million doses a year. It has established a network of over 100 programs that secure their supply of generic injectable naloxone through the organization. These programs include health departments, mutual aid networks, and syringe exchange programs, and many operate on the principle of harm reduction, an approach that tries to reduce the negative health effects of drug use without necessarily advocating for abstinence.
Last year, as first reported by Filter, Pfizer began to encounter manufacturing problems with its injectable naloxone. These disruptions, experts have said, may be related to the pandemic’s effects on the supply chain—issues that have affected many industries. In response to the Washington Post at the time, though, Pfizer denied that the shortage was in any way related to its manufacturing of the covid-19 vaccine. Regardless of the reasons, Remedy Alliance and its partners have been forced to scramble for every spare dose available during the past year.
As of early 2022, Wheeler told Gizmodo, Pfizer’s manufacturing of injectable naloxone has started to pick up again, but not consistently, and the organization is still facing supply issues. Over time, it’s gotten harder for the programs they’re in touch with to fill in the gaps.
“We’re still working on a lot of back orders—probably around 200,000 doses now. And we’re still activating the mutual aid networks, but there’s a lot less surplus floating around,” Wheeler said by phone. “We’ve done a lot of creative stuff to try to help programs survive this last year. But as the waning days of the shortage come to a close, or at least we hope, it’s still extremely difficult for programs to get the naloxone that they need.”
Pfizer did not respond to a request for comment from Gizmodo asking about the factors behind the shortage or the current status of its naloxone supply. However, the company now describes its May 2022 supply of single dose naloxone vials as being limited, with the shortage expected to last until August 2022.
Other forms of naloxone don’t appear to be in shortage, and there are programs that aren’t facing major problems in securing enough supply. But much of the current network of naloxone distribution and access in the U.S. is a patchwork mess. Some programs can use government funding to purchase the cheapest naloxone available through the Remedy Alliance, for instance, but others can’t. Many other programs, particularly mutual aid networks and other grassroots groups, have no consistent source of funding and rely on little more than community donations, so pricier options like Narcan or even undiscounted injectable naloxone are ill-suited for them. These “last mile” programs often have close, direct relationships to the people they’re helping, and they’ve been forced to exhaust their funds early or ration what little supply they have left, Wheeler said.
“The harm reduction programs who are doing the lion’s share of distribution to the people who need it—most are not getting adequate supplies, except in a handful of states. And so it’s really also a structural issue of where that naloxone goes once it’s purchased,” she said. “If you have a state that has no harm reduction infrastructure, or the harm reduction infrastructure in the state is underground, not even legally authorized, or there’s a contentious relationship between harm reduction programs and the state public health system—then those programs are not getting access to the supply that’s being purchased.”
All of this has happened against the backdrop of a worsening drug overdose crisis. Preliminary data collected by the CDC indicates more than 100,000 Americans died of overdose in 2021, which is more than double the death toll a decade earlier. The majority of these deaths have involved opioids, particularly synthetic opioids like fentanyl. When the shortage began, Nabarun Dasgupta, co-founder of Remedy Alliance and an epidemiologist at the University of North Carolina Gillings School of Public Health, estimated that it would directly lead to somewhere between 12,000 to 18,000 added deaths.
Trouble with naloxone access isn’t a new phenomenon by any means. In a study published this February, co-authored by Wheeler and Doe-Simkins, researchers analyzed data from 12 states to estimate the nationwide need for naloxone in 2017. One only state, Arizona, was estimated to have enough of a supply that year to meet the goal of having the drug on hand in at least 80% of witnessed overdoses annually.
In recent years, the federal government and states have taken steps to improve that access. These steps include policies in all 50 states that allow individuals to obtain naloxone from pharmacies directly without a prescription. And in late April this year, the Biden administration released a detailed agenda for tackling the overdose crisis and explicitly namechecked harm reduction as one of the four pillars of its plan. Last year, the White House even allotted $30 million to harm reduction programs.
But many people who use opioids may not feel comfortable obtaining naloxone at a pharmacy or potentially hostile places where the supply is plentiful, particularly police departments. And the drug technically remains prescription-only, meaning that distribution programs are still required to get permission from a doctor (who may also need registration from the Drug Enforcement Administration) to buy it in bulk. That’s a tall task for many community-run groups, according to Dasgupta, who has studied and detailed the many hurdles that these groups face in obtaining cheap naloxone.
“Each program on the ground has to jump through huge hoops in order to even purchase naloxone. And so that’s not something that’s going to get fixed by state legislators piecemeal, in any timeframe that’s reasonable for the level of crisis we’re in,” he told Gizmodo by phone.
Many advocates have been in conversation with the Food and Drug Administration to make naloxone over-the-counter, a policy that lawmakers on both sides of the political aisle now support. The FDA has considered that option for the auto-injectable and nasal spray versions of the drug—even doing some of the labeling paperwork for companies to use in their OTC application— but it is more wary of approving the injectable version, according to Dasgupta. Most companies that produce naloxone also haven’t taken the FDA up on its offer, with Pfizer recently telling NPR last December that it wasn’t currently pursuing an OTC approval of its naloxone products (at least one nonprofit company, Harm Reduction Therapeutics, is working on an application for a OTC nasal spray, which may be submitted this year, NPR reported).
Notably, Emergent BioSolutions, the makers of Narcan, made $120 million in its Narcan sales during the fourth quarter of 2021, a 56% rise over the same period last year. And it will profit even from the recent approval of a generic version of the spray, having secured a deal with Sardoz to formally authorize its product in exchange for a cut of the sales (it remains in litigation with Teva, the other makers of an approved generic nasal naloxone spray). The wholesale price of these generic sprays, so far at least, isn’t much cheaper than Narcan.
Even without a change in OTC status, Dasgupta and others have pushed for other regulatory moves that would make naloxone access less of a challenge. In 2013, Congress passed the Drug Supply Chain Security Act, which updates how the FDA tracks the production of prescription drugs and creates national standards for wholesale drug distributors. Under that law, the distribution of drugs during a public health emergency is exempt from rules that otherwise apply to wholesale drug distribution. Remedy Alliance wants the FDA to clarify that the exception applies to its organization as well as local groups that distribute naloxone. They’re also asking the FDA to push states to recognize the exemption even though the law won’t require them to do so until federal regulations are finalized, which may take several years (the law is scheduled to fully phase in by 2023).
“The whole system needs to be modernized. And this is the moment to do it, when the stress from the shortage has really uncovered the weak points in the chain,” Dasgupta said.
Remedy Alliance’s own model is changing. It’s applying for 501(c)(3) status and has already worked out deals with two other naloxone manufacturers to diversify its supply chain, which will allow it to distribute naloxone to other community groups with a simple click online. An updated website has gone live this week, complete with a link for groups to apply for eligibility. And if all goes according to plan, the group will be able to start shipments in June.
“It’s really about leveraging our collective power—professionalizing the whole enterprise and making it more resilient to these kinds of shocks in the future,” Dasgupta said.
Whatever ends up happening nationally, advocates like Wheeler know that access to cheap and readily available naloxone is only one part of the challenge to tackling the overdose crisis.
“I never want to be misinterpreted that I think that naloxone alone is going to solve this problem, right? We need structural change, we need an end to prohibition and the war on drugs; we need safe supply; we need so much more infrastructure to support harm reduction programs in this country,” Wheeler said. “But I just want to be clear that naloxone is one piece that is still fraught with difficulty all these years later. Twenty-five years after [members of the Chicago Recovery Alliance] first gave out naloxone to someone out of a van—we are still struggling with access. So part of me thinks that if we can solve this one, it may open the door to really scaling up some of the other creative and innovative solutions that harm reductionists have come up with.”
Some of those creative solutions involve making naloxone available through places like barbershops and vending machines, the latter of which is already being trialed in Philadelphia. De-stigmatizing this lifesaving treatment is a crucial step, advocates say, but none of these ideas can fully get off the ground until the supply issues are solved.
[ad_2]
Source link