After Dec. 31, albuterol asthma inhalers that contain chlorofluorocarbons, or CFCs will no longer be made or sold in the U.S.

Asthma inhalers deliver life-saving medicine directly into the lungs during an asthma attack. The inhalers relax the airways during asthma attacks, allowing patients to breath easier.

The Statistics
Albuterol, one of the medicines that relieves asthma attacks, is the seventh most commonly prescribed drug in the United States.
About 52 million prescriptions are filled for albuterol each year in the United States, with most containing a generic version of CFC.

The Food and Drug Administration wants anyone using the discontinued type of inhaler to make the switch sooner rather than later.

Production of CFC Inhalers to Stop before Deadline

The CFC-inhaler ban doesn't officially go into effect until Jan. 1, 2009, but most pharmaceutical manufacturers have stopped producing them. According to the FDA, Armstrong Pharmaceuticals is the sole remaining maker of CFC inhalers and is expected to stop production even before the deadline. A spokesman for Armstrong's parent company wouldn't say when production would stop, but sales of remaining inventory will continue until Dec. 31.

Why the Ban?
Although the CFC inhalers are convenient, portable and allow many asthma suffers to lead a normal life the US made a commitment to the world community to stop using the product. Why you may ask? The CFC propellant used in the inhaler. Most manufacturers stopped using them in other products long ago, but until recently, an exception has been made for asthma inhalers (the product was classified as "medically essential" but are now finally joining a list of banned products that started in 1978).

Although CFC inhalers release negligible amounts of the propellant, and do not pose a significant threat to ozone depletion, the United States joined more than 185 other countries in signing the Montreal Protocol, an international treaty requiring complete withdrawal of all CFC products and this final rule fulfills the FDA's obligations under both the federal Clean Air Act and the Montreal Protocol on Substances that Deplete the Ozone Layer.

• GlaxoSmithKline's Ventolin HFA,
• Schering Plough's Proventil HFA and
• Teva Specialty Pharmaceuticals' ProAir HFA.
• Sepracor's Xopenex HFA is also CFC-free, but it contains levalbuterol, a similar medication.
  

According to the Food and Drug Administration (FDA,) the new generation of asthma inhalers is environmentally friendly and as effective as the older generation that used ozone-harming ingredients. However, some users of the new inhalers disagree. They said the new one's called HFA inhalers don't taste or feel the same and are used differently.

The FDA admits the new inhalers are not a direct alternative but may work as a replacement for some with asthma and other lung diseases.

Warning Not New
Patients have been warned of the change for several years, but the Food and Drug Administration issued an advisory May 30th, 2008 stating anyone still using CFC inhalers should ask their doctor about switching now.

Cost Implications
The new inhalers cost roughly $30 to $50 in local pharmacies. The older style, which is increasingly hard to find, cost about $15. Furthermore because the Earth-friendly inhalers are relatively new, there is no generic alternative for them. Current HFA inhalers most likely won't lose patent protection until the next decade, leaving insured patients with much higher co-payments and the uninsured footing the entire bill. Someone with moderate to severe asthma would typically go through six to eight of the inhalers in a year, therefore costing them an average of an extra $250 a year or more.Because these inhalers are so widely used its is estimated that Americans will spend an additional $1.2 billion a year on three patented inhaler brands containing the new propellant (Ventolin, ProAir and Proventil) until generic versions reach the market.

While the new inhalers are said to be just as effective as their traditional CFC counterparts, a few differences have been reported. One brand, for example, comes sealed in a protective pouch. After that pouch is opened, the drug carries a shelf life of just two months, while most inhalers can typically be stored for 15 to 24 months.

Cost May Effect Health
The new inhalers' cost may prompt some patients to decide to try to do without them, putting them at risk when they have an asthma attack, which, in turn, can lead to more costly emergency room visits.

Help Available for the Poor and Uninsured…If You Qualify
There are prescription assistance programs for people who qualify.

Insurance Implications
It is important to check which, if at all, HFA brands are covered or make your insurers "preferred" brand-name drug tier offering a lower co-payment.

Because there are no generic versions out yet, your co-payment will be higher. Companies will likely have patent protection through 2019, so expect the cost to remain high.

New FDA Advisory
The government is urging patients not to wait until the last minute to switch to newer alternatives for several reasons; one of the most important being:
some inactive ingredients in the new inhalers will differ from product to product and therefore you may need to try various types to find one that works best.

The FDA Warns About Patient Learning Curve

• HFA inhalers may taste and feel different (some patients say it feels weak).
•  Some of the newer inhalers are dry powder inhalers (DPI's) where the medicine is not sprayed out, but simply inhaled (Advair and Pulmicort are both DPI's). Therefore the spray may feel softer.  
• Inhalers must be primed and cleaned in a specific way to prevent clogs.
• The new inhalers tend to cost more.    
• Shelf life is less.
• Most of the new inhalers are not metered, so you may not have an indication that the inhaler is running near empty. Research has shown that many asthmatic patients incorrectly estimate how much medication is left in their inhaler. Most inhalers will continue to spray propellant even when the active ingredient has been used up.
• Patient may need to try different replacement medicines to find out what works best for them.

• Some inactive ingredients in the new inhalers differ from product to product.  Therefore patients may find themselves with a less effective replacement until they are able to try other types to find one that works best. This will result in more doctor visits, lost time, and perhaps a dangerous situation when the patient reaches for an emergency inhaler that they expect to work when they need it to.    
• The spray from the HFA inhalers is weaker. Inhalers require more priming (wasting the first few pumps) before the first use. Patients may feel a difference in the force and taste of the spray ( and confuse this for the medication not working). The HFA inhalers also require a slower and deeper inhalation.    
• Two brands of HFA inhalers contain ethanol. It may not be an appropriate therapy choice depending on the patient's religious beliefs, and can temporarily cause a false reading on breath alcohol tests performed by law enforcement agencies.
• HFA inhalers spew slower and warmer plumes of medicine. Asthma patients may fear their new inhalers aren't strong enough and may take too much of it then needed.  This can be a safety issue.
• Only the Ventolin brand of HFA inhaler comes with a counter to track how much medicine is left. Therefore it is possible for the inhaler to run out of the active ingredient without realizing it. Most inhalers will continue to spray propellant even when the active ingredient has been used up. A scary thought when you cannot breath, therefore keeping a backup inhaler handy is prudent if your physician prescribes a device without a counter.
• It has also been reported that HFA inhalers tend to clog more easily. To prevent clogging in HFA inhalers, patients should remove the devices' metal canister once a week and clean the plastic actuators with warm water. Public Awareness Campaign is Beginning Public awareness efforts about the transition are under way, including an American Lung Association public service announcement airing nationally.  

• If you have asthma, discus the CFC to HFA conversion with your doctor to make sure you are getting the right medication.
• Pay Attention to the prescriptions being filled now. Some doctors will write prescriptions for the new inhalers without telling their patients about the change. Additionally, if the physician writes albuterol HFA, since this product does not exist, the pharmacist will likely substitute one of the 3 branded products (ProAir, Ventolin HFA, and Proventil HFA).  You should confirm with the pharmacist which one is filled because each insurance company has a different policy regarding the CFC to HFA transition.    
• Know the co-pay level that your insurance will charge you for ProAir, Ventolin HFA, Proventil HFA and Xopenex HFA. If any of these are generic co-pay, switch now. All things being equal, Ventolin (dose counter) and Xopenex (fewer side effects) may be preferred.
• Recognize the differences between the HFA and CFC inhalers. As above, the spray will feel different, and will require some adjustments (priming, slower inhalations) than your previous albuterol CFC Inhaler.
• Use these medications for rescue only. The medications are really only for bad symptoms and emergencies. Current guidelines state that if you are using these medications more that two times a week, your asthma is not well controlled, and you need a better maintenance inhaler, which is an inhaler you take every day to control your asthma.    
• Do not use over the counter asthma inhaler, such as an Primatene Mist to save a few bucks. This could be dangerous, since active ingredient is epinephrine which studies have shown to have a lot of side effects for some individuals.