US liquid albuterol shortage expected to worsen after major supplier shuts down

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The United States is bracing for a worsening of the shortage of the liquid form of albuterol, an essential generic drug used to treat breathing problems caused by conditions such as asthma and respiratory syncytial virus (RSV).

The Food and Drug Administration (FDA) first noted the shortage in October after Akorn Pharmaceuticals, one of the last major albuterol suppliers, stopped shipping its 20-milliliter (mL) formulation. Last month, the company abruptly shuttered all three of its US plants amid its second bankruptcy proceeding in 3 years. The generics manufacturer had been plagued with regulatory and financial problems for the past 5 years.

Of the three other pharma firms supplying albuterol to the US market—Nephron, Mylan, and Sun—only Nephron provided a reason for the shortage, in this case, a "manufacturing issue," according to the American Society of Health-System Pharmacists.

Nephron, the only US albuterol manufacturer, restarted shipping the drug last week, but it is still on backorder, Paula Gurz, senior director of pharmacy contracting with a major group purchasing firm, told CNN. "It's going to be an uphill climb," she said.

The history of each drug shortage is unique, but there are trends toward more shortages of low-profit generic drugs such as albuterol, said David Margraf, PharmD, PhD, pharmaceutical research scientist at the Resilient Drug Supply Project (RDSP), part of the University of Minnesota's Center for Infectious Disease Research and Policy (CIDRAP), publisher of CIDRAP News.

"Over time, profits tend to decline, which leads to fewer producers in the market, and ultimately points of failure arise in the drug supply chain," he said. "Albuterol is an essential critical medicine. We need robust, high-quality manufacturing of this and many other critical medicines that are produced on or near US soil."

No cheap alternative

Liquid albuterol is used in nebulizers to treat children too young to use an inhaler, which requires simultaneous activation and inhalation. A nebulizer is a drug-delivery device that turns liquid medicine into a mist for easy inhalation via a face mask or mouthpiece, either in the hospital or at home. So far, inhaler formulations, which use aerosolized or powdered albuterol, haven't been affected by the shortage.

Albuterol is an essential critical medicine. We need robust, high-quality manufacturing of this and many other critical medicines that are produced on or near US soil.

David Margraf, PharmD, PhD

In the absence of liquid albuterol, hospitals have had to compound the drug themselves or seek it from a third-party compounder. Angela Folger, director of pharmacy at Nemours Children's Hospital in Orlando, told the Washington Post that staff have had to squeeze out the contents of 40 0.5-mL albuterol containers to make a single dose.

That's because there is no cheap alternative to albuterol, Margraf said: "Levalbuterol is also available as a solution, but it is much more expensive than albuterol. Additionally, the production volume of levalbuterol is far less than that of albuterol, so there will be downstream shortages of levalbuterol if the shortage of albuterol continues."

But there may be a light at the end of the tunnel. The Children's Hospital Association (CHA) told CNN that it has been working with STAQ Pharma, which provides compounded pediatric medicines, to start manufacturing batches of albuterol in the dosages children's hospitals need. Earlier this month, the CHA said STAQ should be running at full capacity by May.

In the meantime, parents of children who rely on liquid albuterol should ask their pediatrician for suitable alternatives specifically for their child's needs and discuss the availability of products with their community pharmacist, Margraf said.