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The Family Practice Newsletter
The Ohio University College of Osteopathic Medicine
The Ohio Northern University Raabe College of Pharmacy
Doctors Hospital Family Practice
Volume 6, Issue 12
July 2007
Update: new HFA inhalers
Tim Ulbrich, Ohio Northern University Doctor of Pharmacy Candidate
In 2005, the Food and Drug Administration (FDA) determined that all inhalers containing the propellant
chlorofluorocarbon (CFC) would be discontinued after 2008. The ruling by the FDA was a result of the known
damage that CFCs can do on the ozone levels and the responsibility America has internationally to help prevent
furthering this problem. In the US alone, this primarily affects the utilization of albuterol inhalers, of which 52
million prescriptions are filled annually. However, all inhalers which contain CFCs are affected by this ruling.
HFA inhalers will not only be more expensive, but the new devices may be unreliable in determining the
remaining medication, as well as decreased expiration dates.
Due to the extensive use of albuterol inhalers containing CFCs, hydrofluoroalkane (HFA) inhalers were
introduced as an environmentally safe option. The newer HFA inhalers have shown similar efficacy and safety to
CFC inhalers, when used at FDA approved doses. Currently there are three brand name albuterol inhalers
available that contain the more environmentally friendly HFAs: Proventil HFA®, Ventolin HFA®, and ProAir
HFA®. All generic forms of albuterol currently contain the propellant CFC which are being phased out and will
not be available after 2008.
While the new HFA inhalers provide an environmentally friendly option, the generic versions of the HFA
inhalers are not expected to hit the market until after 2012. This will result in an expected 4 year gap in which no
generic albuterol products are available. Since this medication is so widely used, it has been predicted that an
additional $1.2 billion per year will be spent by Americans using the new HFA inhalers. Patients who pay for
their medications out of pocket are most likely to be affected by the absence of a generic HFA inhaler, but the
insured can also expect to see an increase in co-pay for the new HFA inhalers.
With the exception of Ventolin HFA, the newer HFA inhalers will not come with an inhalation counter
which tracks how much of the medication remains available in the canister. This may be troubling to some
patients who forget how many doses have been used, leading to patients unexpectedly running out of and using an
inhaler that does not have any active medication available. Therefore, patients should be counseled on doing their
best to estimate how much they use so they can obtain refills in a timely manner. This is also a good time to
remind patients to carry a backup inhaler if using Proventil HFA® or ProAir HFA®.
Although the Ventolin HFA® brand provides the advantage of keeping track of how much medication
remains in the inhaler, a disadvantage of this product is that it has a much shorter expiration time frame. Because
the Ventolin HFA brand has a higher affinity for moisture and water vapor can enter the canister decreasing the
efficacy of the medication, it expires in 60 days from the first use. This expiration date is significantly shorter
than the other two brands of albuterol HFA inhalers, which typically expire in approximately 15-24 months.
Also, Proventil HFA® contains a small amount of ethanol and prescribers should be made aware of using
this product in patient populations where there is objection to alcohol use. Since there is a small amount of
ethanol in Proventil HFA®, use of this inhaler can cause a false alcohol breath test when administered shortly
after inhaler use.
With the FDA’s ruling to remove all CFC inhalers from the market by 2008, it is expected the long term
environmental benefits of switching to HFA inhalers will be advantageous. However, the short term financial
effects of the HFA inhalers may be detrimental to patient adherence with short acting beta-2 agonists that are used
frequently for acute management of asthma and COPD. Other short acting beta-2 agonists that can be used in
place of albuterol include: pirbuterol (Maxair Autoinhaler). It is a breath acutated device that does not contain a
propellant. However, pirbuterol is not currently approved for use in children less than 12 years old.
Physicians and other health care professionals can play a vital role by properly counseling their patients
on the new HFA inhalers and of the expected increase in cost. Any patient assistance programs that are available
to patients should be explored in qualifying patients.
References:
Hendeles L, Colice G, Meyer R. Withdrawal of albuterol inhalers containing chlorofluorocarbon propellants. N Engl J Med
2007;356:1344-51.
Langley SJ, Sykes AP, Batty EP, Masterson CM, Woodcock A. A comparison of the efficacy and tolerability of single doses
of HFA 134a albuterol and CFC albuterol in mild-to-moderate asthmatic patients. Ann Allergy Asthma Immunol
2002;88:488-93.
Continuous Oral Contraceptive, Lybrel® Approved by the FDA
Timothy R. Ulbrich, Ohio Northern University Doctor of Pharmacy Candidate
Wyeth Pharmaceuticals announced a new oral contraceptive, Lybrel®, was approved on May 22nd of this
year. This product is the first continuous-use, low dose oral contraceptive supplied as a 28 day pack with all
active tablets. Each Lybrel tablet, containing 90mcg of levonorgestrel and 20mcg of ethinyl estradiol, is designed
to eliminate menstrual periods all together.
During a one year study evaluating the efficacy and safety of Lybrel®, 59% of patients achieved
amenorrhea (defined as an absence of all bleeding and spotting), 20% of women experienced spotting not
requiring any sanitary protection and 21% of women experienced breakthrough bleeding that required sanitary
protection. The incidence of spotting and breakthrough bleeding was noted to decrease over the year and was
worse during the initial months of Lybrel use.
Since menstrual periods are eliminated with Lybrel® and failure is possible with any contraceptive,
patients should be counseled properly on the importance of compliance and pregnancy testing if one is suspected.
As with all contraceptives, patients should be assessed appropriately for risk factors including blood clotting,
heart attacks and/or strokes. Additionally, patients should be counseled that smoking while taking Lybrel®
should be avoided, as this increases the risk of a cardiovascular and embolic events. As with all oral
contraceptives, Lybrel® does not protect against HIV or other sexually transmitted diseases.
References:
Archer DF, Jensen JT, Johnson JV, Borisute H, Gruff GS, Constantine GD. Evaluation of a continuous regimen of
levonorgestrel/ethinyl estradiol: phase 3 study results. Contraception 2006;74;439-45.
New Drug: Lybrel (levonorgestrel and ethinyl estradiol). Pharmacist’s Letter/Prescriber’s Letter 2007;23(7):230709.
The Family Practice Newsletter is edited by Stephanie Gibson, Pharm.D., Director of Clinical Pharmacy Services at Doctors Hospital Family
Practice. Address questions and/or comments to [email protected].