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PULMONARY DISORDERS                                                                       DEVRA K. DANG, SECTION ADVISOR


HFA inhalers replacing generic albuterol inhalers, driving up costs

Inhalers with CFC propellent being replaced by more expensive branded products.

Key point: Branded albuterol inhalers containing the newer and more environmentally friendly propellant hydrofluoroalkane (HFA) are as safe and effective as generic inhalers that contain the propellant chlorofluorocarbon (CFC), but they cost nearly three times as much.

Finer points: In 2005, FDA ruled that U.S. sales of CFC albuterol inhalers would be prohibited after 2008 due to growing concerns regarding the detrimental effects of CFCs on stratospheric ozone levels and American obligations under an international treaty, the Montreal Protocol. This decision led manufacturers to reformulate their products using the propellant HFA.

Currently, three branded HFA albuterol inhalers are available in the U.S.: Proventil HFA (Schering-Plough), Ventolin HFA (GlaxoSmithKline), and ProAir HFA (IVAX). In addition, Xopenex HFA (Sepracor), which contains levalbuterol, uses HFA as a propellent. Currently, all generic forms of albuterol contain CFC. Generic versions of the albuterol HFA inhalers are not expected to reach U.S. markets until after 2012.

Each year about 52 million prescriptions are dispensed in the U.S. for albuterol inhalers, making it the seventh most prescribed drug in the U.S. The majority of these prescriptions are dispensed using generic albuterol products. Because generic albuterol is so widely used, the authors of a review article recently published in the New England Journal of Medicine predicted that Americans will spend an additional $1.2 billion a year for the new HFA products. Those who pay for their own medications will be most affected by the increased costs—seeing average increases of $26 per prescription and spending an additional $312 per year. For those with prescription benefit plans, copayments are likely to increase.

What you need to know: There are pros and cons associated with the various HFA formulations. Ventolin HFA is currently the only HFA inhaler that comes with a counter to track how much active drug remains. Ventolin HFA also comes sealed in a protective pouch since it is susceptible to moisture penetration. After the Ventolin HFA pouch is opened, the inhaler expires in 60 days, unlike the other HFA inhalers, which can be stored for 15–24 months. Proventil HFA contains small amounts of ethanol, and patients with religious objections to use of alcohol may not want to use this formulation. This product can temporarily cause a false elevation in results of breath alcohol tests (up to 35 mcg/mL for up to 5 minutes after 2 puffs). Remind patients who use inhalers other than Ventolin HFA to always have a backup inhaler since it is impossible to predict when the inhalers will become empty. Finally, remind patients to never immerse HFA inhalers in water to determine if the canisters are empty. This method is not only unreliable but can also damage inhalers.

What your patients need to know: Differences in price are not the only changes patients will encounter with the “newer” HFA inhalers. Many patients report that the actuations from the HFA inhalers feel and taste differently. This is not surprising since the HFA inhalers use a different propellant and sprays emitted from the actuators have less force. Clogging of HFA actuators has also been reported. Remind patients to clean their inhalers at least once a week by removing the metal canister, running water through the plastic actuator for 30 seconds, shaking the actuator to remove excess water, and allowing it to dry. Finally, HFA inhalers typically require less frequent repriming than CFC inhalers.

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Contact the editor: L. Michael Posey, BPharmAPhA DrugInfoLine

Posted May 1, 2007, 3:46 pm EST