By: Celestine Van Sertima, PharmD Candidate c/o 2027

Addressing the Issue

As the spring season leads the way to respiratory challenges, there have been growing concerns over the shortage of respiratory medications which have raised many problems for people’s health. Specifically, a lack of albuterol metered-dose inhalers (MDIs) has heavily impacted the asthmatic community. Albuterol is a life-saving drug that became available in 1972 to treat early forms of asthma.¹ In light of the recent dilemma, what impact could the albuterol shortage have on developing forms of chronic lung diseases, efficiency in the pharmaceutical markets, and quality of healthcare in hospitals and clinical settings?

Albuterol Impact on COPD and Health-Related Diseases

Albuterol is one of many bronchodilators, specifically an adrenergic bronchodilator. It works to relax the smooth muscles of the bronchial tubules in our lungs.² Albuterol is a beta 2-adrenergic agonist and is known as a rescue or quick-relief inhaler used to relieve bronchospasm, shortness of breath, chest tightness, and coughing.³ Beta 2 agonists are bronchodilators that improve airflow in cases of lung disease, like chronic obstructive pulmonary disease (COPD).³  COPD is a chronic inflammatory lung disease involving obstruction to airflow and breathing-related health. Albuterol products commonly used by patients include Accuneb, Proair Respiclick, Proventil, Proventil HFA, Ventolin, and Ventolin HFA.

Albuterol is typically administered as an aerosol powder, aerosol solution, or nebulizing solution. Proair Respiclick is a dry-powder formulation taken orally by adults and children 2 years and older.Proair, Proventil, and Ventolin are MDIs that provide 90mcg of albuterol per pump. Accuneb is a liquid solution that is inhaled by mouth using a jet nebulizer machine that vaporizes the solution. The typical frequency for use of an inhaler is 3 to 4 times a day.³ Albuterol medication, despite its form, should be used appropriately by patients who actively adhere to the dosage amount prescribed by doctors. Each inhaler provides 60 to 200 inhalations and is discarded once the number of inhalations is complete.  The specific measures that attain the proper use of albuterol demonstrate its impact and constant need and supply to patients.

Shortages of Albuterol Metered-Dose Inhalers

Since October 2022, albuterol has been on the Food and Drug Administration (FDA) medication shortage list. According to the American Society of Health-System Pharmacists (ASHP), it was significantly limited in June 2022.⁴ Individuals with asthma and breathing-related issues commonly use albuterol; however, the introduction of coronavirus disease-2019 (COVID-19) in early 2020 has recently increased medication consumption. It is widely used to mitigate the impacts of respiratory-related COVID-19 symptoms.

Akron Operating Company, LLC., a significant production factory in the United States (U.S.) shut down production in February 2023, significantly reducing the supply and distribution of medication being supplied to hospitals and clinics.⁵ Nephron Pharmaceuticals, another U.S. manufacturer, is facing an increase in demand for albuterol medication which it is unable to meet due to manufacturing and production issues.⁵

According to the American Lung Association, the most prevalent complication concerning the albuterol shortage is its effect on people who have respiratory issues and are at risk of developing chronic lung disease.⁵ Hospitals across the country have been monitoring and maintaining their supply chain by making appropriate protocols, stock inventory, compounding, and knowing who their suppliers are. They fear that the recent shortage can affect discharging patients or require patients to visit the emergency room due to the lack of access to medication.

Impact on the Pharmaceutical Market

While medication shortage has the most drastic impact on patients, they have also been shown to hurt pharmaceutical companies. Since several major manufacturing plants and pharmaceutical factories have shut down, there has been a significant impact on hospital medication shortages. The most prominent reasons for a company’s drug shortage are price, quality regulations, or drug unavailability. During the height of the COVID-19 pandemic, pharmaceutical companies could not effectively reach the unexpected growing demands, resulting in the capacity exceeding the control costs.

Stakeholders across the pharmaceutical world, healthcare providers, and the legal system have hinted at a new innovative approach to relieving shortages. This concept includes the cooperation of generic and brand medication manufacturers to increase the production and availability of drugs. In addition, the pharmacy benefit managers (PBMs) model has also received some attention as it will provide pharma excellent access while maintaining business objectives.⁶ PBMs can help address medication shortages by working with drug manufacturers, wholesalers, and pharmacies to identify alternative sources of medication treatments and manage inventory to ensure that medications are available when needed. Furthermore, through the collaboration of different sectors and groups within the healthcare system, pharmaceutical markets can be restored, and the impact of the albuterol shortage can be minimized.

The Prospective Outlook of Albuterol and Its Significance

Albuterol is an essential drug for many patients and the idea of it being on shortage is daunting. While the recent shortage of albuterol has drastically impacted the productivity of hospitals and clinics already, the pharmaceutical market has shown the appropriate actions to address these types of changes previously. Thus, we must remain hopeful for the success of managing and treating patients with lung diseases despite this setback.

References

1. Stein SW, Thiel CG. The History of Therapeutic Aerosols: A Chronological Review. J Aerosol Med Pulm Drug Deliv. 2017;30(1):20-41. doi:10.1089/jamp.2016.1297
2. Hanania NA, Moore RH. Anti-inflammatory activities of beta2-agonists. Curr Drug Targets Inflamm Allergy. 2004;3(3):271-277.
3. Albuterol oral inhalation. MedlinePlus. Last Revised 02/15/2016. https://medlineplus.gov/druginfo/meds/a682145.html.
4. Albuterol inhalation solution. ASHP Drug Shortages. Last Updated June 16, 2023. Accessed July 12, 2023. https://www.ashp.org/drug-shortages/current-shortages/drug-shortage-detail.aspx?id=820
5. American Lung Association Editorial Staff. How the albuterol shortage will impact your chronic lung disease. American Lung Association. Published March 13, 2023. https://www.lung.org/blog/albuterol-shortage-lung-health-impacts.
6. Strongin RJ. The ABCs of PBMs. Issue Brief Natl Health Policy Forum. 1999;(749):1-12.

Published by Rho Chi Post