The FDA is working quickly to address shortages of the form used in nebulizers.
Pediatric hospitals across the United States are facing a shortage of albuterol sulfate inhalation solution, a fast-acting drug used to treat patients with asthma and other respiratory conditions, including COVID-19 and respiratory syncytial virus. According to the FDA, the drug has been on the agency’s shortage list since October 2022.1 In addition, in February 2023, one of the main suppliers of the drug, Akorn Pharmaceuticals, filed for Chapter 7 bankruptcy and closed major manufacturing plants in New Jersey, New York, and Illinois, worsening an already-flaring shortage of the medication nationwide.2
Explaining the consequences of albuterol shortage, Vivian Hernan-dez-Trujillo, MD, FAAP, FAAAAI, FACAAI, director of the Division of Allergy and Immunology and fel-lowship training program director of allergy and immunology at Nicklaus Children’s Hospital in Miami, Florida, said, “The shortage can result in asthma exacerbations and worse health outcomes for patients who may need the medication and not have access. This could…lead to increased emergency [department] visits and hospitalizations because patients may not have access to the treatment they need at home, and they may present sicker to the hos-pital setting.”
The FDA posted on Twitter on March 9, 2023, that it is working to address a shortage of a particular form of albuterol. The agency went on to note that this shortage does not affect albuterol inhalers for personal use, but only the particular form of drug used in nebulizers.3
Findings from a 2018 study listed albuterol among the top 10 prescribed drugs in the United States.4 With the Akorn Pharmaceuticals shutdown, there remains only 1 major domestic supplier of liquid albuterol, Nephron Pharmaceuticals, which is already facing a backlog of orders because of manufacturing issues.2 As of May 2, 2023, 8 albuterol inhalation solutions were unavailable, according to the American Soci-ety of Health-System Pharmacists.5
Experts have warned that the shortage will likely get worse in as spring allergy symptoms spike. “The increase in viral infections, often multiple, has been difficult for patients with asthma, [because] this is the most common trigger for asthma exacerbations,” Hernandez-Trujillo explained, “The spring pollen season also started early in many parts of the United States and has been a challenge for patients with seasonal allergies. If a patient [has] allergic forms of asthma, the need for asthma rescue medications [such as] albuterol increases. This may be 1 reason the shortage will worsen. A need also exists for increased manufacturing of albuterol products; if this does not happen, the shortage is likely to worsen further.”
Brenda Laughlin, PharmD, operations director of pharmacy at Ann & Robert H. Lurie Children’s Hospital of Chicago in Illinois said, “At our hospital, staff—pharmacy, nursing, respiratory therapy—have had to squeeze out the contents from small 0.5-mL albuterol 0.5% nebules, which is time consuming and labor intensive [because] it takes opening 40 containers to equal 20 mL; each patient on continuous albuterol requires 3 to 5 syringes per day. Nephron [Pharmaceuticals] is the sole manufacturer of the albuterol 0.5% 0.5-mL [nebules], and in mid-February, they were unable to meet demand [because of] manufacturing issues. As a result, we had to make temporary switches to a different concentration of albuterol liquid and alternative liquid bronchodilator, levalbuterol [Xopenex].”
The shortage has highlighted the fragile domestic supply of some vital generic drugs that have few manufacturers because of low proﬁt margins; hence, a single failure has a huge impact on the health care system.6 A recent report published by FDA listed “lack of incentives to produce less-proﬁtable drugs” as the ﬁrst root cause of drug shortages.7
According to the CDC, approximately 6 million individuals aged 0 to 17 years in the United States have asthma,8 which makes this shortage a huge concern for the medical community. To cope with the drug shortage, experts must encourage parents of children with asthma to take necessary precautions, such as reducing their exposure to cigarette smoke, dust, and pollens with an at-home asthma air puriﬁer and reducing outdoor activities during high pollen season to help them avoid asthma triggers. Also, health care professionals must advise parents of toddlers and young children with asthma to use an albuterol metered-dose inhaler with a spacer as an alterna-tive because it is equally effective and a more portable option.9 Hernandez-Trujillo also suggests leval-buterol as an alternative, although she warned, “Depending on the insurance and the formulation of the medication––nebulized versus inhaler––the cost of the medication will vary. The price of levalbuterol, in general, is higher than albuterol. Increased production by the manu-facturers of albuterol and its alterna-tives is needed.”
Laughlin added, “Levalbuterol is the more active (R)-enantiomer of the albuterol racemic mixture and can be used as an alternative. It is not approved for continuous administration, but there are [data from] studies that show it can be administered continuously. Leval-buterol cost can range anywhere from 5 [to] 10 times more expensive than albuterol depending on the formulation and strength.”
Meanwhile, the federal government is working with Nephron Pharmaceuticals to increase the production and supply of liquid albuterol. The government is also looking into importing the drug from foreign suppliers to get through the shortage.10
There are alternative options for hospitals and pharmacies. Some hospitals are using compounding methods to make medications tailored to the needs of individual patients, as well as levalbuterol, despite the expensive price point.
Most recently, the Children’s Hospital Association (CHA) found an alternative supply of liquid albuterol from a new producer, STAQ Pharma. Because the organization is a new producer of liquid albuterol, it produces the drug with an expiration date of 32 days, which requires careful planning and frequent deliveries. According to the CHA, STAQ Pharma plans to run at full capacity starting in May 2023 and will likely provide hospitals with a stable supply by the next respiratory season.10
This article originally appeared in the May issue of Contemporary Pediatrics® and has been lightly edited.