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How
will my metered dose inhaler be changing?
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. In the United States, 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.
Where
Can I Get More Information?
For information about asthma, other respiratory diseases, the Montreal
Protocol, and the change to non-CFC inhalers, contact:
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