Albuterol inhalers that use chlorofluorocarbons (CFCs) are being phased out and will no longer be available for sale after December 31, 2008. Patients who now use albuterol inhalers containing CFCs will need to switch to alternative albuterol inhalers that contain a propellant called hydrofluoroalkane (HFA). By participating in the Montreal Protocol on Substances that Deplete the Ozone Layer, the United States has agreed to phase out the production and importation of ozone depleting substances such as CFCs. During this transition, FDA intends to ensure that therapeutic options and supplies are available for the public so that patient health is not put at risk.
What is available for patients
Three FDA-approved HFA-propelled albuterol inhalers are currently available for the treatment or prevention of bronchospasm in patients with reversible obstructive airway disease:
- ProAir HFA Inhalation Aerosol
- Proventil HFA Inhalation Aerosol
- Ventolin HFA Inhalation Aerosol
In addition, an HFA-propelled inhaler containing levalbuterol, an enantiomer of albuterol, is available as Xopenex HFA Inhalation Aerosol. Albuterol HFA inhalers are used in the same way as albuterol CFC inhalers and deliver the same dose of albuterol with each actuation as the CFC inhalers. Any of the three HFA propelled products containing the active moiety albuterol (ProAir HFA Inhalation Aerosol, Proventil HFA Inhalation Aerosol, and Ventolin HFA Inhalation Aerosol) are acceptable replacements for CFC propelled products containing albuterol, even though they are not generically equivalent to CFC-propelled products.
Education is key
Pharmacists should be aware of several differences between HFA and CFC inhalers, and this important information should be conveyed to patients when they receive the HFA product. HFA inhalers may taste and feel different from CFC inhalers. Notably, the force of the spray of an HFA-propelled inhaler may feel softer than that of a CFC-propelled inhaler. Patients should be reassured of the drug’s effectiveness, even though the spray may taste different or not feel as strong as that from a CFC inhaler.
HFA inhalers have to be cleaned and primed to work in the right way and give the right dose of medicine. The HFA inhaler should be primed before initial use. Each HFA inhaler has different priming instructions; therefore, patients should read and understand the instructions that accompany each of the HFA inhalers before use.
The actuator of an HFA inhaler must be cleaned under warm running water once a week; if it is not kept clean, it can become clogged, affecting the amount of albuterol in each spray. Each HFA inhaler has different cleaning and drying instructions, so instruct patients to read and make sure they understand the instructions that accompany each of the HFA inhalers before use (see Table 1).
Because no generic products are available, patients may also have concerns about the higher cost of HFA propelled albuterol inhalers. Some drug companies have patient assistance programs that make medicines available to patients at no cost or at a lower cost. In addition, some patients may be able to get help paying for medicines from CMS.
Still have questions?
To learn more about the phase-out of CFC-propelled albuterol inhalers and the transition to HFA inhalers, a podcast, a question and answer sheet, consumer article, and public service announcement can be found on FDA’s website. The question and answer sheet and consumer article, which may be helpful for educating patients, are available in English and Spanish. For additional information about the transition and answers to many frequently asked questions, you can also visit the Environmental Protection Agency website at www.epa.gov/ozone/title6/exemptions/inhalers.htm.
|Albuterol and Levalbuterol HFA Inhalers|
|ProAir HFA||Proventil HFA||Ventolin HFA||Xopenex HFA|
|Active ingredient||Albuterol sulfate||Albuterol sulfate||Albuterol sulfate||Levalbuterol tartrate|
|Inactive ingredients||HFA propellant|
|HFA propellant||HFA propellant|
- Janelle Derbis, PharmD, Public Health Specialist, FDA
- Connie T. Jung, BPharm, PhD, Senior Advisor for Pharmacy Affairs, FDA
- Ilisa B.G. Bernstein, PharmD, JD, Director of Pharmacy Affairs, FDA
The authors would like to acknowledge Carrie Deierlein (pharmacy intern, University of Michigan) for her contributions to this article.
This article was featured in the November 2008 issue of Pharmacy Today, the official publication of the American Pharmacists Association.