Government-mandated inhaler switch goes into effect January 1, 2009 - - Drug Topics

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Government-mandated inhaler switch goes into effect January 1, 2009


Drug Topics


Key iconKey Points

  • After December 31, 2008, it will be illegal to manufacture, deliver, or sell CFC-driven albuterol inhalers.
  • HFA inhalers cost more and there are no generic equivalents yet.
  • Pharmacists must take the lead in helping patients switch prescriptions, adjust to the different "taste" and "feel," and learn proper priming and use.

One thing is certain: albuterol MDIs containing CFCs will no longer be manufactured, delivered, or sold in the United States after Dec. 31. Less clear is how smooth or rocky the long-anticipated transition will be for pharmacists and the millions of patients who use metered-dose albuterol inhalers.

The Food and Drug Administration (FDA) has said there is an adequate supply of the new, environmentally friendly inhalers, but some pharmacists are already complaining of shortages of the product. Others are concerned that poor lines of communication with doctors could hamper the process, as patients will need new prescriptions for an HFA albuterol MDI or the HFA levalbuterol MDI (Xopenex, Sepracor).

There is also the question of cost. The new HFA inhalers cost significantly more and have no cheaper generic equivalents, which means that patients will have to dig deeper into their pockets and retail pharmacists will be forced to deal with the backlash.

The FDA is advising consumers not to wait until next year before switching to the new inhaler, and a majority of inhaler users have taken that advice, but a sizable number of patients are likely to use the less-expensive product as long as possible. For their part, pharmacists would be wise to switch patients prior to the deadline.

"[The first thing] I think pharmacists really need to focus on is the fact that every time they see a prescription for CFC albuterol, they need to get that patient switched to HFA," Kristen Binaso, RPh, director of strategic alliances and business development for APhA, said.

The switch is bound to cause some confusion and frustration, but it will provide pharmacists the opportunity to educate patients about the new inhaler drugs and proper inhalation technique. Most pharmacists, wisely, have already begun the process.

Huge opportunity to educate

Despite the efforts of various agencies and manufacturers to make people aware of the impending phase-out of CFC albuterol MDIs, many patients still have not been converted to the HFA products. According to Badrul Chowdhury, MD, director of the Division of Pulmonary and Allergy Products for CDER, about 52 million prescriptions for albuterol MDIs are written each year in the United States.

So far, he said, about 65 percent of patients have been switched to HFA albuterol MDIs. While encouraging, that still leaves over a third of patients who have not. Also, the percentage does not seem to be evenly distributed across the country. Binaso noted that the percentage of patients still using CFC albuterol MDIs in Southern states, for example, could be much higher than 35 percent.

Converting patients to HFA MDIs provides the perfect opportunity to ensure that these patients receive proper counseling. "It's becoming more and more important for pharmacists to review things," Binaso said. When filling new prescriptions for HFA inhalers, pharmacists should go over the proper use and maintenance of the inhalers, as well as the differences from CFC inhalers that patients might notice. This is also a good time to see how often patients are using their SABAs and refer them for re-evaluation when warranted. When dispensing a different MDI, pharmacists should discuss proper inhalation technique. "Correct inhalation technique is very important," Nancy Sander, president and founder of Allergy and Asthma Network Mothers of Asthmatics (AANMA), said.

She said whether people have been using MDIs for days or decades, they could benefit from a refresher course, as most patients have the misconception that the MDI device should be depressed before inhaling. "What patients need to do is inhale, and then, a split-second later, press the device," she said. "It's the inhalation that carries the medication into the lungs, not the spray."


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