AARC Applauds FDA Warnings on Unapproved Inhalation Drugs

August 11, 2006

The AARC and its partners in the Consumer Health Alliance for Safe Medication (CHASM) were pleased to learn the Food and Drug Administration (FDA) has taken new steps to protect respiratory patients from unapproved inhalation medications.

The FDA has just issued warning letters to three national pharmacies — Rotech Healthcare Inc., CCS Medical, and Reliant Pharmacy Services — instructing them to stop compounding aqueous-based drugs for inhalation that are already on the market as FDA approved medications.

“Compounded inhalation drugs are not reviewed by the FDA for safety and effectiveness, often are not produced according to good drug manufacturing practice, and typically are not sterile. This may expose patients to unnecessary risk,” says Dr. Steven Galson, director of the FDA’s Center for Drug Evaluation and Research. “To avoid these risks, we encourage patients to use FDA-approved drugs whenever possible.”

Cheryl West, AARC director of government affairs, explains pharmacy compounding of medications is generally intended for use only in cases where there is no FDA approved medication on the market to treat the special needs of individual patients. “For example, a pharmacy might take a pill and crush it and put it into liquid form for a patient who cannot swallow a pill, or they might compound a medication for a patient who is allergic to a particular component of that medication.”

The practice was never intended to allow pharmacies to mass produce their own versions of FDA approved medications. “That’s essentially what has been happening with respiratory meds,” says West. “Pharmacies are compounding unapproved medications and then selling them through the Internet or other means to patients nationwide.”

In most cases, she continues, neither patients nor their physicians are aware they are receiving unapproved respiratory drugs.

CHASM was formed in 2005 by respiratory-related organizations interested in curtailing the practice, and the AARC has been an active member of the group since its inception. While the group has welcomed the FDA warnings, it believes more work is needed to ensure patients are protected from unapproved inhalation drugs.

“While we commend the FDA for sending out these warning letters, we need the agency to go one step further and force these companies to notify patients who are in receipt of unlawful and potentially unsafe medications,” says Nancy Sander, president and founder of the Allergy & Asthma Network Mothers of Asthmatics (AANMA), a CHASM alliance member. “Millions of doses have been manufactured and distributed, but patients and prescribers alike are often unaware that their prescriptions for FDA approved medications were substituted with unapproved, unlawful medications made by Rotech, Reliant, and CCS Medical.”

In the meantime, Cheryl West encourages respiratory therapists to get involved by informing their patients and the physicians they work with about resources available to report problems and identify the unapproved medications.

Consumers and health care professionals may notify the FDA of any complaints or problems associated with compounded drugs via the FDA’s voluntary reporting program, MedWatch, either by phone at 1-800-FDA-1088 or online at the MedWatch web site.

To learn how to distinguish pharmacy compounded medications from FDA approved medications, visit this resource set up by AANMA.