What you need to know about the albuterol shortages

What you need to know about the albuterol shortages | Image Credit: © galaganov - © galaganov - stock.adobe.com.

Pediatric hospitals across the United States are facing a shortage of albuterol sulfate inhalation solution, a fast-acting drug used to treat asthma and other respiratory conditions, including COVID-19 and respiratory syncytial virus. According to the FDA, the drug has been running scarce since the autumn of 2022 and has been on the agency’s shortage list since October.¹ However, 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 Hernandez-Trujillo, MD, FAAP, FAAAAI, FACAAI, director of the Division of Allergy and Immunology, and fellowship 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 hospital setting.”

The FDA posted on Twitter on March 9 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 impact albuterol inhalers for personal use, but only the particular form of drug used for nebulizers.³

Findings from a study published in 2018 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 due to manufacturing issues.² Almost 11 albuterol inhalation solutions are unavailable, according to an update from the American Society of Health-System Pharmacists on March 23, 2023.⁵

Experts have warned that the shortage will likely get worse in the spring season with a spike in allergy symptoms. “The increase in viral infections, often multiple, has been difficult for patients with asthma, as this is the most common trigger for asthma exacerbations. The spring pollen season also started early in many parts of the United States and has been a challenge for patients with seasonal allergies; and if a patient suffers from allergic forms of asthma, the need for asthma rescue medications, like albuterol, increases. This may be one reason the shortage will worsen. A need also exists for increased manufacturing of albuterol products, so that “if this does not happen, the shortage is likely to worsen further,” Hernandez-Trujillo explained.

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, as it takes opening 40 containers to equal 20 mL (each patient on continuous albuterol requires 3-5 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 due to manufacturing issues. As a result, we had to make temporary switches to a different concentration of albuterol liquid and alternative liquid bronchodilator, levalbuterol.”

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, around 6 million children 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 as much as possible. 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 alternative because it is equally effective and a more portable option.⁹ Hernandez-Trujillo also suggests levalbuterol as an alternative, although she warns, “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 manufacturers of albuterol and its alternatives 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. Levalbuterol cost can range anywhere between 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. It is also looking into importing the drug from foreign suppliers to get through the shortage.¹⁰

Besides Nephron Pharmaceuticals, 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 found an alternative supply of liquid albuterol from a new producer, STAQ Pharma. As the organization is a new producer of liquid albuterol, it produces the drug with an expiration date of 32 days, requiring careful planning and frequent deliveries. According to the association, STAQ Pharma plans to run at full capacity from May 2023 and will likely provide hospitals with a stable supply by the next respiratory season.¹⁰

To read more from the May, 2023, issue of Contemporary Pediatrics®, click here.

References:

1. Sunny S. Albuterol in short supply? FDA works closely with manufacturers to mitigate scarcity. International Business Times. March 10, 2023. Accessed April 5, 2023. https://www.ibtimes.com/albuterol-short-supply-fda-works-closely-manufacturers-mitigate-scarcity-asthma-drug-3675677

2. Becker Z. Bankrupt Akorn Pharma calls it quits and closes all US sites, laying off entire workforce. Fierce Pharma. February 23, 2023. Accessed April 6, 2023. https://www.fiercepharma.com/manufacturing/akorn-pharma-bankrupt-calls-it-quits-closes-all-us-sites-and-cuts-entire

3. @US_FDA. FDA is working to address a shortage of a particular form of albuterol – a medication that is used to treat breathing conditions. It is important to note that this shortage does not impact albuterol inhalers for personal use. March 9, 2023. Accessed April 5, 2023. https://twitter.com/US_FDA/status/1633649223936753665?lang=en

4. Fuentes AV, Pineda MD, Venkata KCN. Comprehension of top 200 prescribed drugs in the US as a resource for pharmacy teaching, training and practice. Pharmacy (Basel). 2018;6(2):43. doi:10.3390/pharmacy6020043

5. Albuterol inhalation solution. American Society of Health-System Pharmacists. March 23, 2023. Accessed April 5, 2023. https://www.ashp.org/drug-shortages/current-shortages/drug-shortage-detail.aspx?id=820&loginreturnUrl=SSOCheckOnly

6. Rowland C. The albuterol shortage is about to get worse. Washington Post. March 2, 2023. Accessed April 5, 2023. https://www.washingtonpost.com/business/2023/03/01/drug-shortages-manufacturing-albuterol/

7. Drug shortages: root causes and potential solutions. FDA. Updated March 11, 2020. Accessed April 5, 2023. https://www.fda.gov/drugs/drug-shortages/report-drug-shortages-root-causes-and-potential-solutions

8. Asthma in children. CDC. Updated May 10, 2018. Accessed April 5, 2023. https://www.cdc.gov/vitalsigns/childhood-asthma/index.html

9. What does the albuterol shortage mean for people with asthma? Asthma and Allergy Foundation of America. March 23, 2023. Accessed April 5, 2023. https://community.aafa.org/blog/what-does-the-albuterol-shortage-mean-for-people-with-asthma

10. Heiman G. Creating a new supply chain for continuous albuterol. Children’s Hospital Association. February 21, 2023. Accessed April 5, 2023. https://www.childrenshospitals.org/news/childrens-hospitals-today/2023/02/creating-a-new-supply-chain-for-continuous-albuterol