Asthma med inhalers to have no CFCs by 2008

A government-ordered switch to more environmentally friendly albuterol metered dose inhalers means that physicians will have to help patients adjust to the change but also will give doctors the opportunity to stress the importance of asthma control.

The official countdown for this transition began March 31 with a Food and Drug Administration final rule directing that albuterol MDIs containing chlorofluorocarbon propellants must no longer be produced, marketed or sold in the United States after Dec. 31, 2008.

"To a large extent, the transition has already begun -- at least with inhaled asthma controller medications," explained Paul V. Williams, MD, a member of the American Academy of Allergy, Asthma and Immunology Pharmacotherapeutics Committee. Some commonly used controller medicines, for example, are only available in HFA or dry powder inhalers. Albuterol is the only asthma treatment largely still used in a CFC preparation even though HFA alternatives have been available for years.

With a date certain now set, physicians will find themselves doing more and more patient education on the topic. "It [also] means rewriting a lot of prescriptions," said Dr. Williams, a clinical allergist in Mt. Vernon, Wash.

No longer medically essential

The use of CFCs in consumer aerosols has been banned in the United States since 1976 as part of the Montreal Protocol on Substances that Deplete the Ozone Layer and the Clean Air Act. But newly produced CFCs have been allowed for certain essential medical uses, such as albuterol MDIs.

This status is now changing, though, because the FDA and the Dept. of Health and Human Services determined that certain conditions had been met.

For instance, at least two non-CFC products with the same active drug and route of administration for the same indication and with approximately the same level of convenience are now being marketed. The agencies determined that there would be sufficient supply and production capacity for environmentally friendly alternatives and adequate postmarketing use data to meet patient needs. They also concluded that patients who are required to use the CFC product for medical reasons will be adequately served by available alternatives.

The albuterol MDIs meeting these criteria currently being marketed are proventil HFA by Schering-Plough, GlaxoSmithKline's Ventolin HFA and a similar product from IVAX. Only the first two are officially considered alternatives because IVAX has only recently marketed its product.

Overall, these HFA inhalers have been well-accepted by patients, said Nancy Ostrom, MD, a San Diego-based asthma specialist. "As a clinician, I have not had a great deal of patient concern."

But many patients still use CFC-containing inhalers, she said. It is important to tell them they should not be unduly concerned and that the alternatives are well-tested, she added.

With regard to patient safety, HFA albuterols are the same, noted Ira Finegold, MD, a past president of the American College of Allergy, Asthma and Immunology. "HFA has been around for six or seven years. Technically, it's a better product and better for the environment."

Still, one of the biggest transition issues involves cost.

"Although we don't know what the cost of the medications will be by 2008, currently generic albuterol, the most common inhaler used by asthmatics, costs about one-fifth to one-third the cost of the branded HFA alternatives," Dr. Williams said. "For those people ... whose asthma is poorly controlled and who use these medications frequently, that will increase the cost about $360 or more a year."

The expense could be an added incentive for achieving better control.

Dr. Finegold's message to physicians: Remind patients that albuterol is "a Band-Aid" and that the aim is to manage the condition so they don't need the rescue medication as often. This goal, he added, requires identifying asthma triggers and treating its inflammatory component with the best available medications. If successful, patients will feel far less of a financial pinch.

Meanwhile, manufacturers of the three environmentally friendly albuterol inhalers are implementing programs -- including coupons, giveaways and other means of assistance -- to help patients for whom price could be a hardship, according to an FDA fact sheet.

For now, the agency advises patients to begin their own planning and move to the HFA product in advance of the final date, since HFA supplies will be increasing over this time and CFC supplies will be diminishing.

"We have been assured by the pharmaceutical industry that they should be able to handle the change well before the new FDA transition date," Dr. Williams said. It will not mean albuterol MDIs no longer will be available, just that they will change.

Both AAAAI and ACAAI are involved in national programs and coalitions with other medical societies to raise awareness among primary care physicians and patients that the phaseout is final in less than 40 months.