The first few months of 2007 will mark the halfway point for asthma
stakeholders in the transition from chlorofluorocarbon (CFC)-propelled
quick-relief albuterol inhalers to hydrofluoroalkane (HFA) versions. The switch
will continue to be one of the most important issues in asthma care in 2007.
This article discusses the important role of patients and clinicians in this
transition, as well as additional asthma management, and marketplace and cost
considerations.

Since 1978, CFCs have been removed from almost every product where they have
been used in the past because of their harmful effect on the environment
– they destroy the Earth’s protective ozone layer. Most of these
products – car air conditioners and hair spray canisters, for example
– have been redesigned and are now CFC free. Other products that are
deemed essential, including many medicines such as quick-relief albuterol
inhalers, have also been redesigned, but for a limited time they are still
available with CFCs.

While it might not seem that the small amount of CFCs in a typical
quick-relief asthma inhaler could pose a threat to the ozone layer, these CFCs
are exhaled intact into the atmosphere. They eventually find their way to the
stratosphere, where ultraviolet light breaks them down, causing ozone
depletion. With approximately 50 million albuterol inhalers being prescribed
each year in the US, the effect on the environment is significant.

HALFWAY TO HFA

HFA quick-relief albuterol inhalers contain exactly the same medication as
their CFC counterparts, but have no environmental impact. And because several
HFA versions are now available, in 2005 the US Food and Drug Administration
(FDA) mandated that CFC-propelled inhalers be entirely removed from the US
market by 1 January 2009. Consumers in Canada, Australia, Japan and Europe have
already successfully completed this transition to HFA inhalers.

Although the transition to HFA is almost half complete in the US, the
success of the switch still depends on providing key stakeholders with
information and guidance.

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Doctors and other healthcare providers should encourage their patients to
switch to HFA inhalers now, to allow plenty of time for all patients to make
the transition. According to Dr Clifford Bassett, a practising allergist in New
York: “An early transition is essential. Patients should learn from their
healthcare team that HFA quick-relief albuterol inhalers are FDA-approved and
are as safe and effective as their old CFC-propelled medicine.”

Prescriptions should be written specifically for HFA inhalers, and the
doctor’s office should be ready to assist the patient if there are
problems filling the prescription at the local pharmacy. Physicians, nurses and
pharmacists can be the best advocates for HFA and help ensure that their
communities are adequately supplied with HFA inhalers.

Patients making the switch should know that, although the medicine is the
same, there are differences in the taste and feel of HFA-propelled albuterol,
while specific directions for the proper use, storage and maintenance of the
HFA devices should be followed. Chris Ward, an asthma patient and current
president of the Asthma and Allergy Foundation of America, says: “The HFA
inhaler produces a finer mist for better distribution in the airways, but
patients may misinterpret the lack of spray force in the back of the throat and
believe they are not getting enough medicine.”

LEARNING CURVE

For many patients, it can be several weeks before they are comfortable with
their new inhaler. Maintaining an HFA inhaler requires care and attention, and
patients must closely follow the cleaning directions for their product.

The exit port on an HFA tends to accumulate faster and requires more
cleaning than a CFC inhaler to keep the medicine flowing freely. Some HFAs also
need priming and shaking before use – again, patients should regularly
refer to the instructions that come with their inhaler. Patients should also be
aware that HFAs typically have different expiration dates, and their storage
requirements may be different from the older inhalers. The bathroom medicine
cabinet may not be ideal for HFA inhalers, for example, because of its high
humidity.

Perhaps most important of all, until the transition is complete, patients
that have already made the switch to HFA should be vigilant to make sure their
local pharmacy does not inadvertently switch them back to a CFC-propelled
inhaler.

ASTHMA MANAGEMENT

“Doctors and other healthcare providers should encourage their patients to switch to HFA inhalers now.”

As clinicians and patients make the switch to HFA, this is an opportune time
for both parties to discuss the proper role of quick-relief albuterol inhalers
in asthma management and to initiate and/or update asthma action plans.

Comprehensive asthma care guidelines stipulate that if a patient is using
their quick-relief inhaler more than twice a week because of symptoms, their
asthma is not well controlled and the healthcare team should consider
prescribing a long-term asthma medication, such as an inhaled corticosteroid.
This long-term daily medication helps keep airway inflammation in check and
reduces reliance on short-term quick-relief albuterol.

The transition to HFA is also a great opportunity for clinicians and
patients to review strategies for avoiding or eliminating common asthma
triggers at home, work and school. Because the condition can be highly variable
over time, asthma action plans require frequent updating to ensure that the
disease has the minimum negative impact on everyday activities and quality of
life.

AVAILABILITY ISSUES

When the transition was originally announced almost two years ago, the
pharmaceutical companies had insufficient manufacturing capacity to ensure a
consistent supply of HFA quick-relief albuterol inhalers to replace the CFC
version. Since the transition announcement, however, HFA inhalers have become
more readily available, while the supply of CFC inhalers has decreased
correspondingly. This trend will continue until the phase-out is complete.

Schering-Plough Corporation has announced that its subsidiary will stop
production of generic CFC inhalers in March 2007. IVAX/TEVA stopped making CFC
inhalers in July 2006. This leaves Armstrong Pharmaceuticals as the only
remaining manufacturer of CFC-propelled quick-relief albuterol inhalers.

Although the transition is proceeding relatively smoothly at the
manufacturing level, the supply of HFA quick-relief inhalers today is patchy.
If their local pharmacy does not currently have HFA inhalers, patients should
contact other pharmacies in their area, or contact their health insurance plan
and doctor’s office for advice on where they can get the HFA inhaler
prescription filled. Again, patients who have already moved to HFA need to
guard against being switched back to a CFC inhaler.

US COST CONSIDERATIONS

Unfortunately, in the US there is no reliable way for patients and their
carers to predict how much the HFA inhalers will cost, since each health payor
will make co-pay decisions independently.

Patients with prescription drug coverage through an employer or through
Medicare or Medicaid will need to confirm the co-pay that will apply to their
HFA quick-relief albuterol inhaler prescription. If patients self-pay for
prescription drugs, the cost of HFA inhalers may be higher than CFC inhalers,
since no generic versions of the product are available. How much HFA inhalers
will cost will depend on the patient’s health insurance plan policy on
prescription drug coverage.

HFA makers are currently distributing coupons and free products, which may
be available through many physicians’ offices or clinics. In addition,
patients that meet certain low-income and other requirements may be eligible to
receive discounted or free HFA inhalers through The Partnership for
Prescription Assistance.