Minnesota patients and providers navigate ‘historical peak’ of drug shortages
For months, providers and patients across the U.S. and in Minnesota have been dealing with a shortage of a medication commonly used to treat people with breathing issues.
Liquid albuterol supplies have been on the Food and Drug Administration’s shortage list since October. A situation that became more challenging after a manufacturer of the drug, Akorn Pharmaceuticals, shut down all of its U.S. production sites and reportedly laid off hundreds of workers.
The company recently announced a voluntary recall for numerous products, since it no longer can provide quality assurance on them. Mayo Clinic, CentraCare and Essentia Health have confirmed that they’re complying with the recall.
Patients and providers have been navigating the shortage of albuterol as well as low supplies of cancer treatments, common antibiotics and children’s flu medications, among other things. And while drug shortages aren’t a new phenomenon, they do seem to be getting worse.
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“We are at a little bit of a peak, a historical peak,” said Eric Tichy, division chair for supply chain management at Mayo Clinic and chair of the End Drug Shortages Alliance board. “But unfortunately, it never gets to like zero or anywhere close to zero. Which is, I think, very frustrating. And there's a really long tail on shortages.”
While people have been generally able to find alternatives, the process can be stressful and frustrating.
Like winning the lottery
Jane Snyder said her dad, Tim, has chronic obstructive pulmonary disease, or COPD. The condition causes difficulty breathing and, to manage it, he takes liquid albuterol through a nebulizer. The drug relaxes the muscles around his airways to make breathing easier.
“He has to do his nebulizers three times a day, so he needs a lot of it,” she said.
But for months, the drug was tough to find. Snyder said they couldn’t find it in Hastings, where her dad lives and, at one point, had a family member travel to North Dakota to get the medication from a pharmacy there.
“We called pharmacies all day long trying to see where we could get it,” she said. “It was like we won the lottery, when we could find it.”
While some pharmacists say supplies of albuterol have improved from the height of the shortage, when one type of drug is unavailable, it can have ripple effects on other products.
“There is a shortage right now of a kind of a cousin [of albuterol], where it's a combination of albuterol and ipratropium, which is another medication used for chronic obstructive pulmonary disease. That is very difficult to get right now,” said Todd Lemke, director of the rural pharmacy division, medication therapy management and anticoagulation services at CentraCare.
Shortages can also be a challenge for doctors. While they can often pivot to other medications if something's unavailable or in short supply, they might be more expensive or harder to use. For example, while liquid albuterol is in shortage, it’s still readily available for use with an inhaler. But making that switch can be difficult for some patients.
“The nebulized version is not better than the puffer version. If you do a puffer well, it's as good as doing a nebulizer. But to get an 18-month-old to do a puffer well is an act of heroic parenting, or nursing or medicine. And so that's a very vulnerable person,” said Dr. Andrew Stiehm, a pulmonary and sleep medicine physician for Allina Health.
That’s also true, he said, for patients who use a ventilator and can’t use an inhaler well. “Those are patients who are uniquely susceptible or vulnerable to this liquid albuterol shortage.”
As for why manufacturing companies don’t just stockpile albuterol, Stiehm said it’s all about the bottom line.
“Albuterol, for my understanding, is like one of the top 10 most commonly consumed medications and prescribed medications. It's been around forever. And it's really inexpensive. It's wonderful for a patient to rely on that medicine,” Stiehm said. “But while that's a wonderful thing as a patient, that's a terrible thing as a manufacturer.”
Stiehm said manufacturers do not have an incentive to make these kinds of generic medications, since they don’t see a huge return on investment.
A recent majority report from the U.S. Senate Homeland Security and Governmental Affairs Committee says that shortages “predominantly affect older generic drug products,” which account for about 90 percent of the drugs sold in the U.S. but less than a fifth of all drug costs.
Speaking to the Senate committee in March, Vimala Raghavendran with the nonprofit U.S. Pharmacopeia said the narrow profit margins on lower-cost drugs make it more difficult for manufacturers to enter the market since they’re only making “pennies on the dollar” for some drugs. Especially if they’re complicated to make.
A 2019 report from the FDA also says that, due to market challenges, “some generic drugs have low profit margins or are even selling for less than they cost to produce.”
A new way to combat shortages?
Shortages can be triggered by global events, like the pandemic, Tichy said. Or by increases in disease, like the spikes of influenza and RSV last fall. Factories can also be shut down temporarily or permanently by the FDA for noncompliance.
Plus, since so much drug manufacturing happens overseas, events like the COVID-19 shutdowns in Shanghai, China in 2022 can dramatically impact the supply chain. These fluctuations mean that pharmacies big and small have to be nimble.
“I spend probably half of my week, maybe a little less, just battling these things out,” said Jennifer Schreiner, pharmacy procurement analyst at CentraCare’s St. Cloud hospital.
She says they have regular meetings to talk about the supplies that are harder to get. “And I would say weekly, we have between 23 and 25 items on that list.”
The Senate committee report found that new drug shortages increased by nearly 30 percent between 2021 and 2022.
“At the end of 2022, drug shortages experienced a record five-year high of 295 active drug shortages,” the report read.
“Sometimes … it's a shortage because there's only one manufacturer, and there's a raw materials issue. But things like this albuterol one, it's bigger than that, because there's probably a good handful of different suppliers, and they're all having the same issue,” Schreiner said.
Some generic drugs may appear to have diverse suppliers but actually rely on the same source or manufacturer, so “the universe of actual suppliers for a particular drug may be much smaller than it appears,” according to the report.
And it can be challenging to determine the exact cause of shortages because “[n]either the federal government nor industry has end-to-end visibility of the pharmaceutical supply chain” which limits the government’s ability to “proactively identify and address drug shortages.”
Slim margins also mean there may be less drugs on hand. If a company like Akorn Pharmaceuticals goes out of business, there aren’t always other manufacturers that can quickly step in and fill the void.
Tichy said, when it comes to Akorn, the federal government should’ve stepped in with more urgency, like they did for Silicon Valley Bank earlier this year.
“Overnight, [Akorn] just closed their doors and they stopped manufacturing. There was no warning whatsoever,” he said. “Why wasn't that treated with more urgency, given all the drug shortages that we have? But there was this urgency around like these banks. I know it was very distressing for the big investors in Silicon Valley, but at the end of the day that's not necessarily critical infrastructure.”
To deal with ongoing shortages, Tichy said some health care providers are taking it upon themselves to find solutions. In 2018, Mayo Clinic and other health care organizations invested in the creation of Civica Rx, a 501(c)(4) social welfare organization designed to address shortages and price hikes.
The company has a manufacturing facility in Virginia that Tichy says is currently undergoing inspections, and Mayo should be able to start sourcing supplies from them next year.
“We'll be able to work with them and say, ‘Hey, we have a shortage of this specific product, can you make it?’” he said.
For Jane Snyder and her dad, things have gotten better. They've been able to secure the liquid albuterol he needs through a pharmacy in Cottage Grove, and even have some extras on hand just in case. But the shortage created “a very stressful situation.”
“I don't even know how the shortage happened, why there was a shortage,” Snyder said. “I just hope that the medical providers can keep up with the demand of people, because I'm assuming there's a lot more than just my dad.”