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Parents across the United States are beginning to face a second winter of amoxicillin shortages. most prescribed Domestic antibiotics.
Liquid formulation of the drug — first-line treatment for children with strep throat, chest and sinus infections, and earaches — Still in short supply, according to the U.S. Food and Drug Administration’s Drug Shortage Database. And there is no salvation in sight.
“That’s a problem. We’re approaching respiratory disease season, and that’s going to be a big problem,” said David Margraf, a pharmaceutical researcher at the University of Minnesota’s Resilient Drug Supply Project.
Erin Hooley/Chicago Tribune/TNS/Getty Images/File
Pharmacist Selena Ko reconstitutes the fortified antibiotic amoxicillin and measures doses for pediatric patients at Rush University Medical Center in Chicago.
According to the FDA, amoxicillin capsules and tablets are not affected by the shortage, but young children are unable to swallow tablets and often rely on liquids instead.
Not all manufacturers of amoxicillin powder, which is mixed into a liquid, have disclosed the reason for the shortage. Most companies are still producing antibiotics, but customers can only order limited quantities because of quotas.
In times of drug shortages, quotas can ensure that no single purchaser can claim all available supplies. But it also means pharmacies can quickly run out of stock, leaving parents and pediatricians having to keep searching for available stock or getting prescriptions to switch to different antibiotics. This creates a frustrating situation.
“Due to the huge spike in respiratory viral illnesses and ear infections and all sorts of other illnesses associated with the winter season over the past year or two, demand is actually outstripping what the supply chain can produce. There are shortages all over the place that are impacting patients,” said Dr. Rohan Kazanchi, a pediatrician and resident at Brigham and Women’s Hospital in Boston.
Kazanci and colleague Dr. Ryan Brewster I studied recently The clinical impact of last winter’s amoxicillin shortage. Researchers found that after the FDA declared a shortage in amoxicillin in October, prescriptions for amoxicillin fell by more than 90% as doctors switched to sometimes stronger antibiotics, such as augmentin and cefdinir. discovered. These alternatives may have more severe side effects for patients and contribute to antibiotic resistance. Additionally, a domino effect can occur when a sudden change in demand eliminates the supply of substitutes.
Amoxicillin is not the worst-case scenario for drug shortages. At least doctors have other antibiotics they can prescribe.
“What we’re concerned about is kind of the generalizability of this problem,” Kazanchi said. “It’s not about amoxicillin. It’s about the fact that there is a shortage of a fairly essential drug that should be widely available in generic form.”
Some manufacturers, such as Teva Pharmaceuticals, blamed the shortage on increased demand rather than typical factors such as manufacturing delays or trouble sourcing raw materials.
Sandoz, Novartis’ generic drug manufacturing unit, said low prices were forcing manufacturers out of the market, putting further pressure on them.treatment course retail About $10 per bottle.
“If market price fluctuations are not addressed, drug shortages are likely to worsen,” Sandoz said in a statement.
Other companies reporting shortages have declined to say why supplies are tight.
“Companies are refusing to tell us what’s going on,” said Erin Fox, who tracks drug shortages at the University of Utah. “There is no doubt that we will go into the season without an adequate supply of oral fluids.”
Laura Bray, who runs Angels for Change, a nonprofit organization that works to solve drug shortages, said amoxicillin shortages continue to go unnoticed.
“From a medical perspective, there is less urgency to solve this because there are alternatives,” she says. “That’s why people don’t talk about it as much as chemotherapy drugs for which there is no alternative, but the root cause is the same.”
According to a 2022 report from the United States Pharmacopeia, antibiotics such as amoxicillin are 42% more likely to be in short supply than other types of drugs.
And like many other drugs that are susceptible to shortages, the downside to amoxicillin is its low price.
“These companies are focusing our efforts on other areas because they simply aren’t profitable. And we’re letting them make whatever they want based on the bottom line numbers. I feel kind of stuck in being able to do that,” Margraff said.
Although FDA monitors and reports drug shortages, it has limited authority to resolve them.
The FDA said in a statement that it sympathizes with those affected by the shortage and is doing everything it can to help. “While the FDA does not manufacture drugs and cannot require drug companies to make drugs, make additional drugs, or change the way drugs are distributed, the public believes that the FDA “We want you to feel safe that we are making changes to the distribution of your products. Others in your supply chain can understand, mitigate, and prevent or mitigate the impact of intermittent or increased demand for certain products.”
What the U.S. really needs, Bray and other experts say, is someone within the government who will oversee the drug supply and ensure the U.S. has an adequate supply of basic medicines when the country needs them most. He said it was an office.
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Consider the United States Department of Agriculture. “If it’s their job to know how much grain and corn is used around the world, how much corn and grain yields, and how much to keep on hand to make bread to eat sandwiches, why not?” You probably don’t have something like ‘Is it because of drugs? ” asked Bray.
Other experts agree.
“There is no single organization, political party, government agency, etc. that is individually responsible for monitoring the entire supply chain. And because there is no coordination, the lack of visibility creates problems,” US Pharmacy said. said Matt Christian, Director of Supply Chain Insights for the Pharmaceutical Supply Map Project.
Another proposed solution involves giving drug companies some kind of subsidies or financial incentives (perhaps guaranteed bulk contracts) to produce cheap and needed medicines.
“We’re doing it for the farmers. We’re giving them a lot of subsidies. And we don’t want food shortages,” Margraff said. “Now we need to do the same with drugs.”
