Albuterol Switching to New HFA Formulation

ROUGH TRANSITION TO A NEW ASTHMA INHALER
By Laurie Tarkan
Published: May 13, 2008
The New York Times
Millions of people with asthma and other lung diseases will have to switch inhalers by the end of the year. And for many, the transition will not be smooth.
The change — mandated by the federal government in 2005, to go into effect next Jan. 1 — is to comply with the 1987 treaty to protect the earth’s ozone layer. It bans most uses of chlorofluorocarbons, or CFCs, which are used as propellants in many inhalers.

CFC-free inhalers have been available for more than a decade. But four million to five million users have yet to switch, according to the consumer advocacy group Allergy and Asthma Network Mothers of Asthmatics.

For one thing, the old inhalers cost much less — an average of $13.50, or one-third the price of a CFC-free inhaler, which uses propellants called HFAs, for hydrofluoroalkanes. (CFC inhalers are generic; HFA inhalers are brand-name.) People with asthma use an average of three or four inhalers a year, but some patients use one a month.

Moreover, the new and old inhalers differ in feel, force and taste, and how they are primed and cleaned. Advocates for people with asthma say doctors and patients have not been educated about the changes.

“What the government failed to do is to mandate anyone to tell patients and physicians this transition was happening,” said Nancy Sander, president of the asthma group. “There is no education, no monitoring of patients, no financial assistance to patients who have to pay higher prices for the new drugs.”

As a result, she and others say, there have been unnecessary fears about the newer inhalers, preventable trips to the emergency room and even some hoarding of CFC inhalers.

Callers to a hot line run by Ms. Sander’s group have complained that when they were switched to the new inhalers, the differences between the two types were never explained. Many thought that their device was broken or that their symptoms were not being relieved by the new inhalers.

The Food and Drug Administration says that since January 2007 it has received 415 complaints about HFA inhalers’ costing too much or not working properly. After a public meeting last month in which doctors and patients said most people were unaware of the transition, the agency has been stepping up educational efforts, with several public service announcements expected by the end of this month, said Deborah Henderson, an official at the Center for Drug Evaluation and Research.

Both types of inhalers use albuterol, a short-acting medication that can prevent an asthma attack when used preventively — before exercising, for example — or at the first sign of breathing trouble.

But the cost difference has meant huge gains for drug companies. As people switched to HFA inhalers in 2006 and 2007, sales of all albuterol inhalers jumped from about $500 million to $1.1 billion, according to I.M.S. Health, a health care information company. Of the 40.5 million prescriptions written for albuterol inhalers last year, it said, about half were CFC and half were HFA inhalers.

And even though there are important differences between the four brands of HFA inhalers, some insurers cover only one of the four. Advocates say the higher cost may keep patients from buying inhalers or force them to cut back on other medications or switch to a less effective over-the-counter inhaler that uses epinephrine.

Several members of Congress are asking the Bush administration to require insurers, including the Medicare and Medicaid programs, to cover the new inhalers equally. Representative Steve Kagen, a Wisconsin Democrat who is also an allergy and asthma physician, said it was important “to make sure there’s as little co-pay as possible.”

The four HFA inhalers are Ventolin by GlaxoSmithKline, ProAir by Teva, Proventil by Schering-Plough and Xopenex by Sepracor. (Xopenex uses a different chemical, levalbuterol.) All companies have give-away programs for those in need and are providing free samples that doctors give to their patients. There is also financial assistance available through the Partnership for Prescription Assistance (1-888-477-2669).

Studies show that HFA inhalers are as effective as CFC inhalers and have the same rate of side effects. But if they are not used properly, patients will not get adequate doses. There are three critical differences.

HFA inhalers must be pumped four times to prime them — a number that was not so critical with the more forgiving CFC inhalers, said Dr. Leslie Hendeles, professor of pharmacy and pediatrics at the University of Florida. And each brand of the newer inhaler requires a different frequency of priming.

HFA inhalers have a weaker spray. “It’s very soft so people think it’s not working,” Dr. Stoloff said. Where CFC inhalers deliver a powerful force that feels as if the airway is being pushed open, the newer ones provide a warm, soft mist that also has a distinct taste.

They also require a slower inhale. “You have to take a nice slow, deep breath and hold it,” Ms. Sander said. If people worry that it’s not working, they may not take the second puff, may fail to wait the necessary 30 seconds between puffs or may take too many puffs. ,And their anxiety may rise, further constricting their airways.

HFA inhalers need to be washed with warm water and air dried once a week. The medication is stickier and will clog the hole, reducing the amount of medication the spray delivers.

There are also important differences among the brands, though some doctors simply write Albuterol HFA on the prescription, leaving the pharmacist to choose the brand. Only one, Ventalin, has a dose counter, which helps users keep track of how much medication is left. ProAir appears to be on many insurance companies’ lists of approved medications, but it has the softest spray, Dr. Stoloff said.

To read the full article, go to NY Times.com

Acknowledgement: thanks to Dr. Munitz for calling our attention to this article