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Patients & Consumers Online Tools Find an Allergist / Immunologist Pollen Counts Diseases 101 Drug Guide Featured Resources » AAAAI Tips Brochures Topic of the Month New Research Information Request Form Donate Now En Español Just for Kids Seniors Contact Us Search by Condition (A-Z) Request a Speaker Smoke Free Homes Referral Guidelines Other Resources En Español Just for Kids Seniors		For Physicians The U.S. Food and Drug Administration (FDA) is requiring that manufacturers of metered-dose inhalers (MDIs) reformulate these inhalers to no longer use chlorofluorocarbons (CFCs) and instead use hydrofluoroalkane (HFA), by December 31, 2008. Up until December 31, 2008, the supply of CFC-based asthma inhalers will gradually decline and the supply of HFA-based asthma inhalers are expected to increase. Physicians are encouraged to talk to their patients now about transitioning to HFA-based asthma inhalers early so they can successfully make the switch. Several non-CFC products are currently approved and/or marketed for a range of different drugs (including non-CFC MDI versions for albuterol, beclomethasone, fluticasone, and ipratropium, as well as dry powder versions of fluticasone, formoterol, and salmeterol. Several more non-CFC products are in the latter stages of development according to the FDA. All HFA products had to undergo extensive clinical development and full new drug applications to the FDA. Thus, there are no generic HFA albuterol products on the market, nor will there be until the branded HFA products lose their patents. Available HFA albuterol products include ProAir HFA, Proventil HFA, Ventolin HFA and Xopenex HFA. Many patients have expressed concern that the medicines they need to treat their asthma or chronic obstructive pulmonary disease (COPD) will be removed from the market. CFC-based inhalers will not be removed by action of the FDA until sufficient alternative medicines exist to serve the needs of patients. However, the amount of CFC allotted by the EPA for drug manufacturing in 2008 may impact the amount of CFC inhalers available for manufacture in 2008 independent of any action by the FDA. Download a patient handout to help your patient's transition here. What should physicians do now? 1. Begin transitioning your patients now by writing prescriptions as Albuterol HFA or as a specific branded albuterol HFA product. Making the switch before patients' medications become unavailable will protect them from sudden changes and help identify potential problems early. 2. Use transition as an opportunity to improve asthma management for your patients. 3. Inform your patients of the numerous patient assistance programs to help people who cannot afford their medications. Patients in need of financial assistance should contact The Partnership for Prescription Assistance by calling 1-888-477-2669 or visiting http://www.pparx.org. Why should my patients switch now? 1. CFC-based inhalers are harmful to the environment. 2. CFC-based inhalers will not be available after December 31, 2008 and switching your patients early will protect them from sudden changes and help identify potential problems early. 3. Many HFA-based inhalers are currently available and contain the same medicine as CFC-based inhalers. 4. The supply of CFC-based inhalers will gradually decrease. 5. Making the transition to an HFA-based inhaler is an opportunity to review your patients overall asthma management plan. 6. Making the switch to HFA inhalers now will, through the law of supply and demand, result in a gradual increase of HFA inhalers so that by the end of 2008 there will be enough HFA albuterol to meet the demand. Are there any differences that my patients will notice with the HFA-based inhaler? After switching to a HFA inhaler, your patients will notice many similarities to the CFC inhalers, but there are also a few differences. Similarities Differences Safe and effective for the same FDA-approved uses Ozone-friendly to the environment Shape is similar Might be slightly different in smell and taste Size is similar Mist is less forceful and warmer Convenient to use May need to be cleaned and cared for differently (These should not get wet, don't use the float test!) Will there be a shortage of CFC-based inhalers? The supply of CFC-based inhalers will decrease gradually and the HFA-based inhaler's supply will increase. You can check on current drug shortages here. What is the HFA inhaler cost and are there assistant programs available for my patients? If your patients currently have prescription drug coverage through their employer or through Medicare or Medicaid, they will need to confirm the copay that applies to the HFA quick-relief albuterol inhaler. If they self-pay for prescription drug coverage, the cost of HFA quick-relief asthma inhalers will be higher than what they currently pay since there are no generic versions of HFA quick-relief inhalers. Patients in need of financial assistance should contact The Partnership for Prescription Assistance by calling 1-888-477-2669 or visit www.pparx.org. <back>
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