Albuterol Solution Shortage Spot Report

March 28, 2023

Situation Update
Shortages of albuterol inhalation solution, first seen in October 2022, are continuing to impact the healthcare supply chain. As of March 23, 2023, there remains a shortage of albuterol sulfate inhalation solutions across numerous companies listed in the ASHP and FDA drug shortage lists Healthcare facilities are beginning to report impacts, with some health systems implementing conservation protocols. Wildfires and hurricanes events may further impact albuterol supply, with a variety of albuterol formulations potentially rising in demand in response to natural hazards over the next several months. There is currently no estimated timeframe for restoring albuterol inhalation solution supply to typical levels, and current impacts to domestic manufacturers (Akorn Pharmaceuticals closure and other companies) may further worse the situation. Some entities are working together to develop a continuous domestic supply of albuterol for pediatric patients (see section on Recommendations and Potential Solutions) but coordinated response from industry and government is yet to be seen. Healthcare Ready will continue to monitor the situation and stands ready to coordinate discussions between public and private sector partners.

Background

Albuterol is used as a quick-relief medication to reverse or prevent bronchospasm, a narrowing of the airways (bronchial tubes) in the lungs that causes breathing problems. Bronchospasm is often seen in viral and bacterial infections such as bronchitis, RSV, influenza, and COVID-19, as well as asthma, COPD, emphysema, and other diseases of the lungs.

Two primary reasons for the ongoing shortage are likely the rise in a confluence of respiratory illnesses (COVID-19, flu, and RSV) as well as supply chain issues, such as the closure of Akorn Pharmaceuticals domestic manufacturing sites. You can find more information regarding the respiratory illness surge and the Akorn Pharmaceutical closure in our most recent situation reports and threat assessments. Briefly:

• Since October 2022, there has been an unprecedented spike in three respiratory illnesses – COVID-19, flu, and RSV. Along with the rise in cases, there has been a rise in hospitalizations where common drugs such as albuterol are being used up and shortages across the nation are being seen.
• In late February 2023, a major US generic pharmaceutical manufacturer, Akorn Pharmaceuticals, abruptly filed for bankruptcy and ceased all US operations. The company produced an albuterol sulfate inhalation solution that is currently in shortage, and the shutdown has exacerbated the shortages.

Albuterol Formulations

Albuterol comes in a variety of formulations: powder, aerosol, and solution. Currently, the albuterol shortage is affecting the albuterol inhalation solution. Albuterol inhalation solution is used with a jet nebulizer that turns the solution into a fine mist that the patient inhales using a face mask connected to the machine. It is typically used in children and adults ages two years and older. Young children and those with severe asthma who are reliant on nebulizers and unable to take other forms of albuterol are most at risk if albuterol solution is not available.

Both albuterol inhalation powder and albuterol inhalation aerosol are used with a special inhaler. The aerosol formulation is typically used for children and adults ages four years and older while the powder form is used for children and adults ages 12 years and older.
 
Facilities, including children’s hospitals, are implementing conservation methods to protect limited supply of albuterol solution for patients that need it most. Aerosol and dry power inhaler formulations of albuterol are not in shortage. Some facilities are evaluating which patients may be able to use those formulations instead of solution as part of conservation strategies.

While both powder and aerosol formulations of albuterol are not currently in shortage, if the inhalation solution form supply continues to falter, then those other forms of albuterol could potentially see an impact. In turn, this would create a trickle-down effect that could impact a larger population of people that rely on metered dose inhalers.

Forecasting Supply Chain Impacts

Supply chain implications to monitor as the albuterol situation continues to unfold:

• There is no estimated timeframe as to when the albuterol inhalation solution supply will rise to meet demand. This puts a strain on health care providers as they will have to allocate supplies as well as search for appropriate medical substitutes.
• Akorn Pharmaceuticals’ abrupt shutdown has left customers needing to find alternative sources for generic pharmaceuticals which means other manufacturers will have to bolster production levels to fill the additional demand.
• Wildfire and hurricane seasons may further strain albuterol supply.

While albuterol inhalation solution has been listed on the ASHP and FDA drug shortage lists since October 2022, they have always had expected restoration dates. The previous dates implied that albuterol production would catch up to demand anywhere from mid-March into July of 2023. However, recently, these restoration timetables have been removed from the drug shortage lists; manufacturers of albuterol are unable to give estimated timeframes on when albuterol production will increase. Uncertainty around when restoration will occur has put healthcare providers in a difficult situation. Healthcare providers will be unable to allocate supplies properly and will probably rely heavily on substitutes of albuterol to ensure access to health care for their patients. This, in turn, could cause shortages of similar remedies –already being seen in ipratropium bromide and albuterol sulfate combination solution, a drug used when using a single inhalation solution does not yield results. As of March 23, 2023, ASHP’s drug shortage list have listed additional agents, such as levalbuterol hydrochloride inhalation solution, which may be used as an alternative to albuterol inhalation solution. If providers start relying heavily on substitutes for albuterol solution, there could be an uptick in use of similar APIs which could exacerbate the albuterol shortage.

Another supply chain implication to monitor is the ability of Akorn Pharmaceuticals' clients to find replacement product. As stated above, Akorn is a major generic pharmaceutical company in the US and holds a 1.1% market share within the generic pharmaceutical industry. Since ceasing domestic operations, Akorn's customers must procure supplies from other companies. Nephron Pharmaceuticals Corporation, now the only domestic manufacturer of albuterol, is also on the ASHP and FDA drug shortage list which means they probably will not be able to absorb additional demand from Akorn’s customers. Beyond Nephron, the US relies heavily on overseas manufacturers for generic pharmaceuticals so we will have to see whether or not they are able to fill that gap. Again, this is a situation that should be monitored closely because those global companies serve more than just the US and our visibility into their supply chain is not as clear – so any impacts to the regions they have production facilities in or global supply chain impacts could further worsen the situation.

Lastly, as we enter spring and summer, not only are allergies and other respiratory-related illnesses becoming more prevalent, but wildfire and hurricane season are also right around the corner. As we have seen over the past few years, it is important for supply chain stakeholders to be aware of the potential impacts that compounding hazards might have on the communities they serve. With albuterol being such a common drug used in hospitals, if wildfires or hurricanes start impacting locations and hospitalization rates increase, there could very well be a sharper increase in albuterol demand – further stretching the supply. This was seen first-hand during the wildfire season in 2020, where prescription fills for inhalers increased 30% along the west coast. Although the COVID-19 virus was the most prevalent illness at that time; we are currently seeing a confluence of three respiratory illnesses impacting the nation – which is impacting both the adult and pediatric population.

Recommendations and Potential Solutions