In 2008, millions of patients with asthma, COPD (chronic obstructive pulmonary disease) and other respiratory conditions face a critical change in lifesaving medications. The problem: Many are not aware of the change or how to safely go about making it.

Overview
For more than 50 years, respiratory patients have relied on metered-dose inhalers (MDIs) that contain CFC propellants, a man-made chemical known to destroy the earths' protective stratospheric ozone layer.

In 1978, the federal government banned CFC use in spray cans (such as aerosol hairspray) as part of an effort to reverse environmental damage. In 1987, the United States signed on to the Montreal Protocol to eliminate use of CFCs worldwide and the federal government began implementing further bans on CFCs.

MDIs were given a temporary exemption from the CFC ban until manufacturers could develop safe and effective non-CFC MDIs. That time has come for albuterol inhalers. After December 31, 2008, it will be unlawful to manufacture, sell or distribute albuterol MDIs made with CFCs. We now have four distinct non-CFC alternatives.

The federal mandate to eliminate CFCs in medications charged the U.S. Food and Drug Administration with approving alternate medications and removing CFC MDIs from the market. The Environmental Protection Agency was ordered to manage and phase out use of CFCs in all U.S. products.

But no federal mandate was issued to inform patients the transition was happening, provide education for medical professionals and patients, monitor the impact of the transition on patient health outcomes and care, or provide financial assistance for higher priced drugs.

This 20-year-old oversight has created potentially serious health issues for more than 40 million people affected by respiratory disease.

• Inhalers are changing and why
• The change is mandatory
• There are important decisions to make about treatment options that require thoughtful consideration of the patient's medical history and current respiratory health status
• CFC and HFA metered-dose inhalers are distinctly different
• HFA MDIs cost significantly more than generic CFC MDIs, which may present a barrier to effective health care
• HFA MDIs are not interchangeable – one HFA medication cannot be substituted for another without a new prescription, and HFAs cannot be substituted for a CFC inhaler without a new prescription
• Patient assistance, medication discounts and rebate programs are available from pharmaceutical manufacturers

• Many patients have been switched to new medications at the pharmacy counter – without instructions on how to use HFA MDIs correctly
• Many patients switched at the pharmacy do not know their medication is different until they are home or in the throes of a life-threatening emergency
• Higher out-of-pocket prices and co-pays create a huge financial burden, causing many families to ration MDI use, share one MDI among family members or make choices between medications to breathe vs. medications for other conditions (e.g., mental health, cardiac health, diabetes)
• Health insurance plans force patients to switch to the HFA MDI on their formularies – a decision based on cost, not which medication works best for patients or is recommended by prescribers
• Some pharmacies dispense to patients HFA MDIs other than what was prescribed for them

More than 40 million respiratory patients in the U.S. are affected by this medication change. Exactly how many are already using non-CFC MDIs or are even unaware of the need to switch medications is unclear. Market data suggest that 5 million respiratory patients have yet to make the transition to HFA bronchodilators. The consequences of inaction include needless suffering and anxiety, missed work days, hospitalizations, emergency department visits . . . and death.

Patients across the country just want to breathe. With education and access to effective medications, they can.

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