New Rules for Inhalers Start With New Year

Chlorofluorocarbon inhalers are down to their last gasps -- literally.

Changes mandated by the federal government in 2005 take effect Jan. 1, meaning physicians are running out of time to transition patients from albuterol metered-dose inhalers that use chlorofluorocarbons, or CFCs, as propellants to inhalers that use the more ozone-friendly propellant hydrofluoroalkane, or HFA.

To date, the FDA has approved three HFA-propelled albuterol inhalers: Proair HFA Inhalation Aerosol, Proventil HFA Inhalation Aerosol and Ventolin HFA Inhalation Aerosol. Xopenex HFA Inhalation Aerosol, which contains levalbuterol, a drug similar to albuterol, also is available in the United States.

Supply is not expected to be an issue, says the FDA, thanks to manufacturers' earlier efforts to ramp up production of these agents.

This most recent change has been a long time coming, originally prompted by a 1987 international treaty that called for the United States and other nations to phase out production and importation of ozone-depleting substances, including CFCs. During that time, several non-CFC products have been approved and/or are being marketed for a range of different drugs, including CFC-free versions of beclomethasone, fluticasone and ipratropium inhalers.

The FDA issued a public health advisory in May to alert patients and physicians to switch to HFA-propelled albuterol inhalers. However, millions of CFC inhaler prescriptions have yet to be transitioned to HFA inhalers, according to the Allergy & Asthma Network Mothers of Asthmatics, or AANMA, a nonprofit membership organization based in Fairfax, Va.

AANMA works with medical professional organizations and the pharmaceutical industry and has advised Congress on issues related to asthma and allergies. Recently, the organization posted video offerings and other resources on its Web site to help patients manage the transition away from CFC-propelled inhalers, including information on the differences between the two types of inhalers, comparative costs and how to use HFA inhalers.

In addition to the AANMA Web site, physicians can direct their patients to a program of the American Lung Association, or ALA, that offers information about albuterol inhalers that use HFA propellant and how they stack up against the CFC-propelled inhalers.

For example, says the ALA site, HFA inhalers cost $30 to $60, compared with $5 to $25 for a generic CFC inhaler. And according to the FDA, generic HFA inhalers won't be available until at least 2010. However, patients may qualify for prescription assistance programs; they can call the ALA HelpLine at (800) LUNG-USA, or (800) 586-4872, and press "2" to speak to a nurse or respiratory therapist about this opportunity.