By Jan. 1, 2009, millions of Americans with asthma and those with chronic obstructive pulmonary disease will have to make the switch from CFC-propelled inhalers to HFA-propelled inhalers, if they haven't already.
The change comes as a result of a federal ban on CFC (chlorofluorocarbons) albuterol inhalers that goes into effect Dec. 31, 2008.
For some asthma patients, like 35-year-old Shelby Rothrock of Silver Spring, Md., the new inhalers are a big improvement. She says she prefers the feel of the HFA (hydrofluoroalkane) inhalers. Albuterol is a short-acting bronchodilator, which helps open up airways to provide quick relief from wheezing and shortness of breath. Albuterol inhalers are often referred to as "rescue" inhalers because they can help stop asthma attacks. Albuterol is dispensed by both CFC and HFA inhalers in metered doses.
"Before, I felt like the medication worked but that most of it ended up in the back of my throat. It was a nice switch for me to have something that didn't blow out quite so hard," says Rothrock, whose job it is to run clinical trials for pharmaceutical companies.
Jim Brisko of Bloomfield Township, Mich., is similarly satisfied. He didn't even notice that his pharmacy gave him an HFA inhaler when he filled a prescription in February until his doctor pointed it out at his last visit in September.
The retired General Motors engineer says the HFA inhaler works just as well for him as the old CFC ones, but for others, the contrast between them is dramatic. They're pushing back with an online petition asking Congress to lift the ban on CFC inhalers, which was put in place in 2005 by the Environmental Protection Agency and the FDA to comply with the 1987 Montreal Protocol. That treaty was adopted globally to protect the earth's ozone layer, the thinning of which has been attributed in part to CFCs.
The National Campaign to Save CFC Inhalers is asserting that CFC-propelled inhalers are an insignificant source of pollution and that they are safer and more effective than HFA-propelled inhalers. As of late September, more than 2,800 people had signed the petition.
Patient advocates, however, say there is no turning back from the CFC inhaler ban. Their focus now is on educating health professionals and patients about using the HFA inhalers, and they've urged the FDA to do the same.
Confused about the switch? WebMD went to several experts to learn about the new inhalers, how they're different, and what's being done to make the transition between CFC and HFA inhalers easier. Read on for their answers.
1. What are the differences between CFC and HFA inhalers?
The primary difference is the way albuterol is propelled from the canister into the lungs, but some patients will notice that the "blast" of spray is gentler with HFA devices.
"The feel is a little different, so if somebody is switching, if they're not aware that the HFA jet is more gentle, they might feel they're not getting the same amount. It's just as effective, but people's expectations need to match what they're receiving," says Martha White, MD, an allergist in Wheaton, Md.
Three of four inhalers available - Proventil HFA, ProAir HFA, and Ventolin HFA - dispense albuterol. The fourth HFA inhaler, Xopenex, carries levalbuterol -- another bronchodilator agent of the same class as albuterol. White says her patients on the Xopenex report that it feels "cleaner."
The HFA propellant also is "gummier" than the CFC propellant, so it's important to clean the plastic sleeve that holds the canister, ideally after each use, but at least once a week. Users may also notice a difference in taste.
2. Is one HFA inhaler more effective than another?
No. In studies with children and adults, the effects of HFA albuterol on lung function tests have been shown to be similar to CFC albuterol. With Xopenex HFA, some people get less jittery than with other albuterol inhalers, White tells WebMD. Ventolin HFA has a dose counter so you know how many doses are left, whereas Proventil HFA and ProAir HFA do not have dose counters.
3. So what's the major difference between CFC and HFA inhalers?
CFC inhalers run about $5-$25 apiece, whereas the HFA inhalers cost $30 to $60, according to the American Academy of Allergy Asthma & Immunology.
The HFA inhalers that have been available for about two years are brand-name, and it could be five years before patents expire, allowing less expensive generics to enter the market.
Sandra Fusco-Walker, director of patient advocacy for the Allergy and Asthma Network Mothers of Asthmatics, points out that the cost can be especially burdensome if parents need to buy inhalers their children can keep at home and in school. AANMA is part of a MDI (metered dose inhaler) working group that went to Congress last spring to ask lawmakers to consider subsidizing the cost of the HFA inhalers, to no avail.
"People are having to make a choice between a bronchodilator and controller medications, but we need these bronchodilators on us if we have symptoms," Fusco-Walker tells WebMD.
The drug companies that make the four HFA inhalers offer assistance programs to patients who cannot afford them. For information, call the Partnership for Prescription Assistance at 1-888-477-2669 or visit the web site at www.pparx.org.
4. How many quick-relief inhalers do people with asthma need in the course of a year?
Norman Edelman, MD, a pulmonologist and chief medical officer of the American Lung Association, says two to three inhalers should be enough to last a year. Canisters contain somewhere between 180 and 200 "puffs."
He says many people with asthma use the rescue inhalers far more than they should. People whose asthma is under control might need to use the inhaler once or twice a week, or if they exercise, a few times more.
"Many use more because, let's face it, a large percentage of asthmatics are not being optimally controlled," he says. "It's the patient, the doctor, the system, the cost - it's everything."
According to the Asthma and Allergy Foundation of America, a typical drug regimen for someone with asthma includes a rescue inhaler along with two controller medications, usually an inhaled steroid and a long-acting bronchodilator or a drug that combines both of the latter.
5. How many people are already using the HFA inhalers?
The FDA isn't tracking the number of people using the HFA inhalers, which have been on the market for a varying number of years, agency spokesman Christopher Kelly said during a May 30 news conference on the switch to HFA-propelled albuterol inhalers.
The FDA's director of the division of pulmonary and allergy products, Badrul Chowdhury, MD, did say during the same new conference that 65% of the 52 million albuterol prescriptions written annually are for HFA inhalers. Albuterol is one of the top 10 medications prescribed in the U.S.
That means that more than one third of albuterol inhalers prescribed are still in CFC form.
6. With only a few months to go before the CFC inhalers disappear from the market, how is the transition going?
Not as smoothly as it should. Although the EPA and FDA made the decision to make the change in 2005, there is an urgent need to get the word out about the switch to HFA inhalers, says Charlotte Collins, director of public policy and advocacy at the Asthma and Allergy Foundation of America in Washington, D.C.
"We're hearing from patients who are getting newer inhalers saying they don't work for them, but they haven't had training from their doctors, who may be prescribing them without telling patients. It takes a different patient training process to use them properly," she tells WebMD. "I'm very concerned we're going to have people as of Jan. 1 who aren't going to be able to refill prescriptions and they'll panic. That's not good for asthmatics."
Patients are also reporting they don't like the taste and smell of the HFA inhalers and don't know how to prime them.
"Until patients get an opportunity to try them several times and get some real training, it's hard to assess whether there are across-the-board issues. That's a major undertaking that hasn't been done yet, and it's a real shame. We really haven't road-tested this product among a 'real' patient community," Collins says.
Three years ago, the AAFA issued a statement called Transition Now (available at www.transitionnow.org) to alert patients to the change and explain the difference between the two inhalers. And earlier this year, the AAFA joined a working group that includes the Allergy and Asthma Network Mothers of Asthmatics and the American Lung Association to press the FDA to ramp up efforts to educate the public about the change.
"We told them things weren't going well and they needed to do a lot more," Collins says. "They gathered us to tell us things were going well, but their definition of success is different from a patient's definition of success. Their definition is getting products on the shelves."
In response, the FDA issued a statement in June urging consumers to make the change to HFA inhalers, but the AAFA and its partners would like to see a far more wide-ranging campaign that would include doctor training and online video training for patients.
"I think the FDA is in a much better position to get the information out to providers," Collins says. "If anything comes from the FDA, that gets their attention."
7. What other resources are available to educate the public?
The Allergy and Asthma Network Mothers of Asthmatics offers a free phone consultation service in which patients may talk to a nurse practitioner about using HFA inhalers and financial assistance available. That number is 800-315-8056.
Other organizations offer information on their web sites about the transition. They include the Allergy and Asthma Foundation of America, American Academy of Allergy, Asthma & Immunology, and the American Lung Association.