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FAQs on CFC-to-HFA transition of albuterol
inhalers
Counseling tips for pharmacists to
share with patients as new products are phased in.
Albuterol inhalers are relied on by many of the
20 million Americans with asthma and the 24 million with chronic
obstructive pulmonary disease to stop potentially life-threatening
bronchospasms and restore easier breathing. Regulations banning the use
of chlorofluorocarbons (CFCs) as propellants in albuterol metered-dose
inhalers (MDIs) and the onset of brand-name hydrofluoroalkane (HFA)
products will have far-reaching effects for not only health care, but
also for the environment.
Why are CFCs being phased out?
CFCs consist of chlorine, fluorine, and carbon
and are commonly used as refrigerants, cleaning solvents, and
propellants. Research has shown that when CFCs enter the stratosphere,
they are broken down by strong ultraviolet light, thereby releasing
ozone-depleting chlorine atoms. An international agreement established
through the Montreal Protocol on Substances that Deplete the Ozone Layer
and U.S. Clean Air Act called for the elimination of CFCs and a number
of other substances that threaten the ozone. CFCs in MDIs have not been
shown to have any direct adverse effects on patient health.
What is the timeline for the phaseout of CFC
inhalers?
FDA ruled in 2005 that after December 31, 2008,
production, marketing, and sale of CFC-containing albuterol MDIs will no
longer be permitted. The Environmental Protection Agency called for a
gradual decrease of CFC production in the early 1990s, but the timeline
for elimination of albuterol MDIs using CFCs was extended by FDA because
of the lack of alternative products. While other propellants could
easily be substituted for nonmedical uses of CFCs, t his
“essential use” exemption stems from the fact that
manufacturers have had difficulty developing new propellants for use in
MDIs. FDA has waited for there to be more than one non-CFC alternative
for each moiety before proposing to ban that particular CFC MDI. Warrick
Pharmaceuticals, a division of the Schering-Plough Corporation, has been
the primary supplier of CFC inhalers but has been gradually slowing
production. The company will cease manufacturing of CFC MDIs in early
2007.
What albuterol MDI alternatives are now
available?
MDI products that use HFA as a propellant are
now available: ProAir HFA (albuterol sulfate—IVAX Laboratories),
Proventil HFA (albuterol sulfate—Schering-Plough), Ventolin HFA
(salbutamol sulphate—GlaxoSmithKline), and Xopenex HFA
(levalbuterol tartrate—Sepracor). If the patents are upheld on
these branded products, no generic HFA-propelled albuterol MDIs will be
on the U.S. market until 2010. Also, although proven safe and effective,
these HFA MDIs are not therapeutically interchangeable according to the
FDA Orange Book. Patients will generally need to obtain a new
prescription to transition to an HFA product.
What are the cost implications of the transition
to brand-name HFAs?
The exit of generic CFC inhalers combined with
the lack of generic HFA equivalents is expected to cause the price of
inhaled albuterol to escalate over the next couple of years. The cost
disparity is already high: the American Lung Association (ALA) Web page
notes that HFA MDIs cost $30 to $60, whereas generic CFC inhalers are $5
to $25. As a result, PBMs and patients are likely to stick with
CFC-containing generics as long as possible.
What role do pharmacists play?
Patients may be concerned about the new look,
feel, and taste of HFA inhalers. ALA advises that the mist from HFA
inhalers may be less forceful and warmer than that from CFC inhalers.
Pharmacists can reassure patients that extensive trials have proven the
new HFA inhalers to be safe and effective. Displaying and distributing
brochures on the CFC-to-HFA transition can help foster patient
education. Pharmacists can also guide patients to the ALA program,
CFC-Free Inhalers: Time to Make the Switch, at the link below. This Web
page also provides information on prescription-assistance programs. To
ensure appropriate use, pharmacists should also provide patient
counseling on the long-term use of controller medications and
short-acting “rescue” inhalers.
Web Links
Related Resources on
pharmacist.com
Contact the writer: Joe Sheffer, Pharmacy Today
Posted January 16th, 2007, 4:00 pm EST
| Counseling tips for pharmacists to share with patients as new products are phased in. |
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