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Fungal meningitis cases spotlight risks from custom-mixed drugs

Recent fungal meningitis cases are part of a growing concern over contaminated custom-mixed drugs from 'compounding pharmacies' that supply hospitals, clinics, and doctors. The custom-mixed drugs are not FDA approved.

By Marilyn MarchioneAssociated Press / October 5, 2012

Dr. David Reagan, chief medical officer for the Tennessee Department of Health, right, and Dr. Dr. Marion Kainer, also with the state health department tell local and national media about an outbreak of fungal meningitis infections that have been linked to the deaths of two and the illness 13 others in Nashville, Tenn.

AP Photo/The Tennessean, Shelley Mays

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Two people blinded in Washington, D.C., in 2005. Three dead in Virginia in 2006 and three more in Oregon the following year. Twenty-one dead polo horses in Florida in 2009. Earlier this year, 33 people in seven states with fungal eye infections.

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And now, at least five people dead and 35 diagnosed as sick with fungal meningitis that authorities say has been linked to steroid shots for back pain.

All these tragedies involved medicines that had been custom-mixed at what are called "compounding pharmacies" — laboratories that supply hospitals, clinics and doctors to a much wider degree in the U.S. than many people realize.

These pharmacies mix solutions, creams and other medicines used to treat everything from menopause symptoms and back pain to vision loss and cancer. Unlike manufactured drugs, these products are not subject to approval by the Food and Drug Administration. And some have turned out to be dangerously contaminated.

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Compounding pharmacies often obtain drugs from manufacturers and then split them into smaller doses, or mix ingredients sold in bulk. Any of those steps can easily lead to contamination if sterile conditions aren't maintained.

The risks from these products have long been known but are being amplified now by a national shortage of many drugs that has forced doctors to seek custom-made alternatives to the usual first-choice treatments.

"Because of the incredible number of drugs that are out of stock or back-ordered, compounding pharmacies are working with local hospitals, clinics and physicians to fill that gap," said David Miller, executive vice president of the  International Academy of Compounding Pharmacists, a trade organization.

These products have had remarkable growth. More than 7,500 compounding pharmacies operate in the U.S., up from 5,000 in 2009, Miller said. They account for a $3 billion segment of the drug market and 3 percent of all prescriptions filled.

Some say this industry needs more regulation.

"There's not a lot of oversight of compounding pharmacies" compared with drug manufacturers, said Allen Vaida, executive vice president of the Institute for Safe Medication Practices, a suburban Philadelphia advocacy group that tracks medication errors.

Dr. William Schaffner, an infectious-disease specialist at Vanderbilt University, agreed.

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