WASHINGTON--The day before a consumer coalition filed a petition with the Food and Drug Administration advocating stronger oversight of compounding pharmacies, the issue hit the headlines in a front-page story that ran last week in USA Today.

"When you can know more about a box of Cheerios than you can about products some of these pharmacies are making, that's wrong," Nancy Sander told the national newspaper in a story published March 23. Sander heads the Allergy & Asthma Network of Mothers of Asthmatics, which spearheaded the consumer effort calling on the FDA to address the mass production of unapproved drugs.

The Consumer Health Alliance for Safe Medication (CHASM), a coalition of patients, nurses, physicians and respiratory therapists, wants to make sure that respiratory patients "have access to safe and effective medications and are protected from products that may pose unwarranted risks," according to a press release from the group.

"Consumers generally believe that all prescription medications are approved by the FDA as safe and effective. However, an increasing number of pharmacy businesses are manufacturing, promoting and dispensing unapproved respiratory drugs as substitutes for FDA-approved medications. Without their knowledge, patients with asthma, emphysema and other respiratory conditions are increasingly exposed to unnecessary health risks associated with these medications," Sander said in the release.

The USA Today article also detailed safety concerns regarding pharmacy-mixed drugs. "Because the state-regulated pharmacies are not held to the same quality and safety rules as FDA-regulated drug companies, they don't have to test their ingredients," the article said, adding that in a majority of states, pharmacies don't have to check the final products for potency or sterility, or "to report problems with their drugs."

In the article, Mickey Letson, president of Decatur, Ala., drug distributor The Letco Companies, responded, saying, "There has not been one recorded death associated with nebulizer medications, to my knowledge, of the hundreds of millions of doses that have been compounded."

At issue, observers say, is jurisdiction. Traditionally, pharmacy boards have had jurisdiction over compounding pharmacies while FDA has held oversight over manufacturers.

But Lisa Smith, a health attorney with Amarillo, Texas-based Brown & Fortunato, said that safety concerns have been addressed by rules already in place. Since January of 2004, the FDA has been able to enforce safety standards set by the United States Pharmacopeia, an independent standards organization. Some state pharmacy boards have adopted similar standards, she said, along with accrediting bodies like the Joint Commission on Accreditation of Healthcare Organizations (JCAHO).

"These requirements do address end-product testing for sterility and potency," Smith said, "which are the primary concerns of [the coalition]."

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