Metered-Dose-Inhalers Changing

Metered-Dose Inhalers Will Be Changing

Here Are The Facts

Metered-dose inhalers (MDIs) are devices that people with asthma and chronic obstructive pulmonary disease (chronic bronchitis and emphysema) use to deliver medicine to their lungs. The medication is delivered by a propellant in the MDI whenever it is used. For most MDIs, the propellant is one or more gases called chlorofluorocarbons (CFCs).

Over the next few years, MDIs that contain CFCs are expected to be replaced by new inhaler devices that do not contain CFCs (non-CFC inhalers). This change has just begun and will continue for several years as more non-CFC options become available.

Patients and health care providers need to learn about the change to non-CFC inhalers. This fact sheet will help answer many of the questions that you may have about the change.

Why Will CFC MDIs Be Changing?

Although CFCs in medicines are safe for patients to inhale, CFCs are harmful to the environment. Scientists have found that when CFCs get into the upper regions of the earth's atmosphere (stratosphere), they reduce the amount of ozone in the ozone layer that surrounds the earth. The ozone layer acts as a shield to protect the earth against the sun's harmful rays. With less ozone in the ozone layer, too many of these harmful rays reach the earth and can increase the risk of potentially serious health problems, such as skin cancer and cataracts, as well as other health and environmental problems. To lower the risk of health and environmental problems caused by ozone depletion and to help restore the ozone layer, most countries have agreed to stop using CFCs. The agreement was made in 1987 and is known as the Montreal Protocol.

CFCs are used in many types of products (such as air conditioners, refrigerators, etc.), not just MDIs. However, in response to the Montreal Protocol, the manufacture of CFCs for these purposes has already been stopped. Nonetheless, CFC MDIs have been given a special exemption because they are so important for treating asthma and chronic obstructive pulmonary disease. The manufacture of CFCs for use in MDIs will not be stopped until safe and effective replacements are available. But the goal is to one day replace CFC MDIs with alternatives that do not contain CFCs.

What Are the Benefits of Changing to Non-CFC Inhalers?

The change to non-CFC inhalers is one of many steps being taken worldwide to restore the ozone layer. A clear benefit of these efforts will be to help reduce the health and environmental risks caused by the sun's harmful rays.

The change is stimulating the development of many new types of non-CFC inhalers. Some of these will be new MDIs that have non-CFC propellants. Other inhalers are being developed that do not use propellants, such as dry powder inhalers and mini-nebulizers. This means that physicians may have several options to prescribe and patients may have additional choices in how their medicine is delivered. The safety and effectiveness of every new non-CFC inhaler will be reviewed by the U.S. Food and Drug Administration (FDA) before it is approved.

What Steps Have Been Taken to Change from CFC to Non-CFC Inhalers?

Many professional, public, and private groups are working to ensure that medicines are available to properly care for patients during the change from CFC to non-CFC inhalers. Although the conversion has been challenging, there has been a worldwide drive to develop non-CFC inhalers.

The pharmaceutical industry has been working very hard to develop non-CFC MDIs. Companies around the world are testing inhalers containing new propellants instead of CFCs. These new propellants have been shown to be just as safe for patients as CFCs.

        Other non-CFC options not requiring propellants are being developed, including dry powder inhalers, mini-nebulizers, and other devices.

        The FDA and the U.S. Environmental Protection Agency (EPA) are working together to ensure that CFC MDIs remain available until safe and effective replacements are available.

        The National Asthma Education and Prevention Program (NAEPP), in collaboration with the International Pharmaceutical Aerosol Consortium, is developing educational materials regarding the change to non-CFC inhalers. Several NAEPP member organizations are also involved in patient education efforts, including the Allergy and Asthma Network/Mothers of Asthmatics, Inc.; the American Academy of Allergy, Asthma, and Immunology; the American Lung Association; the Asthma and Allergy Foundation of America; and representatives from the FDA and the EPA.

Which MDIs Will Be Available to Patients During the Change to Non-CFC Inhalers?

Concerns about patient health are important in the change from CFC to non-CFC inhalers. In order for patients and health care providers to have time to prepare for these changes, CFC MDIs will remain available until an adequate number of safe and effective non-CFC inhalers are available. However, we do not know how long this will take. All patients should have adequate choices of medicines during the change.

How Will the New Inhalers Differ from CFC MDIs?

There may be some differences in how CFC and non-CFC MDIs work, look, taste, or feel. Many new products will be produced and approved over time. It will be important for patients to talk with their doctor, nurse, pharmacist, respiratory therapist, or other health care provider when they get a new inhaler to make sure they know the correct way to use it. One non-CFC MDI for the medicine albuterol is available. Although patients may notice some minor differences in the feel or taste of the new product, the FDA has found it comparable in safety and effectiveness to the albuterol CFC MDIs. As with any change in therapy, patients should talk to their health care provider about non-CFC medication and other alternatives when they become available.

Will All Patients Have to Use Non-CFC Inhalers?

Yes. The goal is to phase out and ultimately eliminate the use of CFCs in MDIs. Although it will likely take a few years for this to happen, the process has already begun. It is important for patients and their health care providers to start making plans for the change now.

For information about asthma, other respiratory diseases, the Montreal Protocol, and the change to non-CFC inhalers, contact:

Allergy and Asthma Network/Mothers of Asthmatics, Inc.
American Academy of Allergy, Asthma, and Immunology
American Association for Respiratory Care
American College of Allergy, Asthma, and Immunology
American College of Chest Physicians
American Lung Association
American Pharmaceutical Association
American Society of Health-System Pharmacists
American Thoracic Society
Asthma and Allergy Foundation of America
European Federation of Asthma and Allergy Associations
International Pharmaceutical Aerosol Consortium
National Association of School Nurses
National Asthma Education and Prevention Program
U.S. Environmental Protection Agency
U.S. Food and Drug Administration

Source: U.S. National Heart, Lung and Blood Institute (NHLBI), U.S. National Institutes of Health (NIH)