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.