Shortages of the drug albuterol, used to treat asthma and other respiratory illnesses, are expected to worsen after one of the only two U.S. makers of the drug has shut down.
Akorn Pharmaceuticals, a Gurnee, Illinois manufacturer of liquid albuterol used in hospitals, filed for Chapter 7 bankruptcy Feb. 23, closing its plants in Illinois, New Jersey and New York. The company had been operating under a Chapter 11 bankruptcy filing from 2020.
That leaves one U.S. maker of liquid albuterol, Nephron Pharmaceuticals of West Columbia, South Carolina, which recently began production. The company is producing the drug "as fast as possible to deliver to the market – and to patients – to address this shortage,” CEO Lou Kennedy told The Washington Post.
Hospitals had been facing a shortage of the drug, used to treat patients for respiratory syncytial virus (RSV), influenza and COVID-19 symptoms. In hospitals, liquid albuterol is administered with a nebulizer, which creates a mist inhaled through a mask or mouthpiece.
The Food and Drug Administration has been monitoring a shortage of albuterol sulfate inhalational solution since Oct. 25, 2022. On Wednesday, the FDA said it has been "working closely with manufacturers and others in the supply chain for months to understand, mitigate and prevent or reduce any related impacts."
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The situation has the medical community "super-concerned," said Dr. Juanita Mora, an allergist and immunologist at the Chicago Allergy Center and national spokesperson for the American Lung Association. "It's a medication to save lives and allow people to breath, especially when children, the elderly and also the very sick, can't really use an inhaler."
What does the drug albuterol do?
Albuterol is used to treat respiratory illnesses including asthma, bronchitis, RSV, emphysema, and chronic obstructive pulmonary disease (COPD), as well as symptoms of those with influenza and COVID-19.
Albuterol sulfate is also used in handheld inhalers to treat asthma and other respiratory issues, but those products are not facing a shortage, experts say.
Why is there an albuterol shortage?
The hospital-administered version of the drug faces a shortage because the combination of RSV, flu and COVID-19 cases overloaded supplies.
"We had millions of children hospitalized with respiratory infections, needing albuterol nebulized for wheezing and coughing," Mora said. "And then you add long-haul COVID and you have an extra population that also uses it."
With the onset of spring, the 20 million adults and 5 million children with asthma face potential issues, she said.
"Pollen is one of the big triggers when it comes to asthma," Mora said. "So that's the biggest concern. Liquid albuterol is being sent over to emergency departments and hospitals so that the sickest patients get it."
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Albuterol, patented in 1972 and available as a generic, is not a big profit generator, which led to a dwindling of drug manufacturers. Akorn had not been shipping 20-millilter bottles of liquid albuterol for several months, hospital group purchasing company Premier told The Washington Post.
With Akorn officially closed, the shortages could persist, Soumi Saha, senior vice president for government affairs at Premier, told The Post.
“A sole manufacturer, whether or not it’s domestic, is still a sole manufacturer and creates immense risk” that a disruption could wipe out supply, she said. “The downstream effects are the same as if the manufacturer were foreign."
What should asthma patients do?
Patients with breathing issues should not panic, Mora said.
Patients with asthma, COPD and emphysema should consult with caregivers to make sure they have an action plan including, if needed, an inhaler (and a spacer, which is used with child patients).
Are there alternatives to albuterol during this shortage?
With Nephron unable to meet demand due to manufacturing issues, Lurie Children’s Hospital in Chicago made a temporary switch to a different concentration and used an alternative drug, levalbuterol, hospital spokesperson Julianne Bardele told CNN.com.
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What can medical personnel do?
At Miami (Ohio) Valley Hospital, where albuterol supply has grown tight, “we’ve kind of held back on using it as much for those acute conditions to save it for those folks with asthma that we really need to use it for in emergency situations,” Dr. Joseph Allen, regional medical director for Premier Health, told WDTN, a Dayton, Ohio NBC TV station.
Previously, if a patient was wheezing and "they looked a little bit kind of on edge, we’d go ahead and hit them with albuterol and get them taken care of,” Allen said. “But now we have to kind of question that or think of other things that we can use.”
Staff at Lurie Children’s Hospital have also squeezed albuterol out of smaller packages, Bardele told CNN. The process, she said, is “time-consuming and labor-intensive as it takes opening 40 containers to equal 20 mL (each patient on continuous albuterol requires 3-5 syringes per day).”
Meanwhile, the Children’s Hospital Association worked with outsourcing facility STAQ Pharma to begin making albuterol in late 2022. “STAQ plans to ramp up to full production by May 2023 so that hospitals have a stable supply ahead of the next respiratory season,” says company president Mark Spiecker.
What can the government do?
The FDA said Wednesday the agency "continues to explore all available regulatory levers to help assure supply – including exercising discretion for potential temporary importation by foreign suppliers."
The FDA continues to explore all available regulatory levers to help assure supply -- including exercising discretion for potential temporary importation by foreign suppliers.
— U.S. FDA (@US_FDA) March 9, 2023
The agency cannot "require a pharmaceutical company to make a drug, make more of a drug, or change the distribution of a drug," the FDA said.
Follow Mike Snider on Twitter: @mikesnider.
This article originally appeared on USA TODAY: Albuterol shortage: Respiratory drug supply low at asthma season start