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Helping Patients Transition to HFA-Based Throughout the past year, the FDA has made a number of announcements regarding the supply of albuterol metered dose inhalers (MDIs). An FDA mandate requires that all albuterol MDIs with CFC propellants be phased out of the market because they are damaging to the ozone layer. Some of the manufacturers of these commonly dispensed CFC-based MDIs have decreased production – which may be resulting in changes in pharmacies’ supplies. In place of CFC-based MDIs, some manufacturers have reformulated their products with an alternate propellant, called hydrofluoroalkane (HFA), which is non-harmful to the ozone. This issue of The Practice Memo is devoted to providing pharmacists with the details of the transition from CFC-based to HFA-based albuterol MDIs so that patients continue to have access to these necessary products. Phase out of CFCs: A result of the Montreal Protocol of 1987
Although community pharmacies are more recently being impacted by the decreased supply of CFC-containing albuterol MDIs, the Montreal Protocol on Substances that Deplete the Ozone Layer, which mandates that CFC albuterol MDIs be phased out, was signed into law nearly 20 years ago in 1987. While the Protocol called for the elimination of CFCs, some pharmaceutical products, including albuterol MDIs were granted “essential use” exemptions because no feasible alternatives were available and the products were deemed to have an essential medical use. In April 2005, however, the FDA issued a final rule – establishing December 31, 2008 as the date by which production and sale of albuterol MDIs containing CFCs must cease.
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Pharmacists’ Role: Monitoring Supply and Helping Patients Make the CFC to HFA Transition With the decrease in supply of CFC-based albuterol MDIs already underway, community pharmacists are already being counted on for educating and helping patients transition to HFA-based products. Pharmacists can help their patients by being aware of the supply of CFC-based albuterol MDIs and the steps necessary to effectively and efficiently transition a patient to an HFA-containing product. Supply of CFC-containing MDIs expected to continue to decrease in 2007 Although some pharmacies may still have supplies of CFC-containing albuterol MDIs, it may become increasingly more difficult to obtain these products in 2007 since some manufacturers of these products have decreased or ceased production. Pharmacists looking to obtain additional supplies of CFC-based albuterol MDIs can check with management, wholesalers, and manufacturers to identify which products, if any, may be available. To make up for the decrease in supply of CFC-based albuterol MDIs, the supply of HFA-containing products has been increasing. Pharmacists should monitor inventory of both CFC and HFA-based albuterol MDIs closely throughout the beginning of 2007 to assure adequate supplies are in stock. Helping Patients Transition to an HFA-Based Albuterol MDI
With the transition to HFA-based albuterol MDIs already underway, pharmacists are encouraged to help asthma patients transition to an HFA-based albuterol inhaler. See box, right, for currently available albuterol HFA products. Although some prescribers are writing for HFA-based albuterol MDIs, many are still writing for “Albuterol MDI” – referring to the products containing CFCs. In the event that a prescription or refill calls for “Albuterol MDI” pharmacists should contact the prescriber to seek clarification as to which product should be dispensed. Pharmacists are encouraged to help patients transition to an HFA-based product – instead of switching back and forth between HFA-based and CFC-based albuterol MDIs. Assure patients the HFA inhaler provides the same active ingredient (albuterol sulfate). Also, see below for more information on the similarities and differences between CFC and HFA-based MDIs. Educating Prescribers to Assist with the Transition to Albuterol HFA MDIs Prescribers of albuterol MDIs are being educated to assist with the transition to environmentally friendly HFA-based products. However, as pharmacists continue to receive prescriptions for “Albuterol MDI”, make sure to remind prescribers that the transition to HFA-based albuterol products has already begun and ask prescribers to specify the HFA albuterol inhaler they would like dispensed. This will help reduce the burden placed on pharmacists if more prescribers are aware that the supply of products containing CFCs is decreasing. |
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Safety and efficacy of Albuterol HFA products is similar to CFC-based Albuterol MDIs As stated above, the albuterol HFA products are not considered by the FDA to be substitutable for each other or CFC-based albuterol formulations. However, the HFA rescue inhalers are considered to be safe and effective alternatives to CFC-based quick-relief albuterol MDIs. Similar to CFC products, each of the three currently available HFA MDIs deliver 90 mcg of albuterol base per puff and contain a total of 200 actuations per canister. Indications of HFA-based albuterol MDIs
Differences between CFC and HFA Pharmacists should inform patients that they may experience any or all of the differences below when switching to an HFA-based product. These changes are due to the propellant, not the active ingredient.
Also, the cleaning and priming procedures for these products may vary. Pharmacists should inform patients to check their product instructions.
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