Compounded Drugs Mix Benefits With Possible Risk In the past few years, a battle has raged over how to regulate the 3,500 U.S. pharmacies that mix medications to individual specifications on site. Many patients say compounded drugs are their only option. But the FDA has safety concerns.
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Compounded Drugs Mix Benefits With Possible Risk

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Compounded Drugs Mix Benefits With Possible Risk

Compounded Drugs Mix Benefits With Possible Risk

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  • <iframe src="" width="100%" height="290" frameborder="0" scrolling="no" title="NPR embedded audio player">
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OK, new subject. There are thousands of pharmacies where the pharmacists can mix drugs right there. They're called compounding pharmacies. Some federal regulators are worried that the onsite mixed drugs aren't safe. NPR's Meghan Collins Sullivan reports.

MEGHAN COLLINS SULLIVAN: At Village Green Apothecary in Bethesda, Maryland, people squeeze into a tiny space by the door waiting to pick up their prescriptions.

Ms. SHARON LEWIS: Hi. It's for Katherine Fianeed(ph).

Unintelligible Woman: Are you picking up a prescription?

Ms. LEWIS: Picking up, yeah. It's in the refrigerator.

Unidentified Woman: OK.

Ms. LEWIS: Compound.

COLLINS SULLIVAN: Sharon Lewis comes here every month to pick up a compound prescription for her granddaughter Katherine.

Ms. LEWIS: This is only place that she can get it. It's a special compound. She's six years old now, but she was born with a liver disease.

COLLINS SULLIVAN: Part of Katherine's liver was missing when she was born. The special medicine helps digest food, but she can't get it at your average pharmacy. Some drug stores can mix simple compounds now and then, but not more complicated medicines like this one. Village Green is one of a few thousand pharmacies across the U.S. known for specializing in uncommon mixtures.

Ms. LEWIS: It would be a problem if we didn't have an apothecary. It's very difficult to get this prescription other than at an apothecary that will do this mixture.

Mr. RON KEACH (Senior Pharmacist, Village Green): We do topical products. We've got some analgesic things and some hormonal creams. We'll do some liquid products for children.

SULLIVAN: That's Ron Keach, Village Green's senior pharmacist. He says half of the pharmacy's sales come from compounding medications. Keach and his team of pharmacists create drugs for people who can't tolerate dyes or additives. They also mix them in different forms for patients whose bodies won't absorb them in the traditional way or for people who need experimental drugs, and they can combine many pills into one. That's why Kathy Rivers gets prescriptions at Village Green.

Ms. KATHY RIVERS: If we took all the different B vitamins and all the different antioxidants and the carnitine and creatine and CoQ10 and took them all as individual pills, we'd be taking probably 100 pills a day.

SULLIVAN: Taking that much medicine everyday would be impossible for Rivers' 16-year-old daughter, Emily. She's bedridden from complications related to a metabolic genetic disorder. Her body cannot turn food into energy to run her cells and organs. Rivers and her three children all have this mitochondrial disease, and she spent hours upon hours researching options for herself and her children.

Ms. RIVERS: I stay home with my kids now, and that's made it easier for me to look all this up as well. It's challenging, but you'd be amazed what parents will do for their kids.

SULLIVAN: Rivers eventually found some help. Dr. Richard Layton is one of the family's physicians. He says he uses compounding pharmacies a lot.

Dr. RICHARD LAYTON (Family Physician): The value I have with specific compounding pharmacies is not only can I have things made up preservative free, but they can make it up the way I want it made up,in certain dilutions.

SULLIVAN: Dr. Layton treats both adults and children with issues like allergies, gastrointestinal aliments, fatigue, autism, and hyperactivity. He says close to 90 percent of the prescriptions he writes must be compounded. But he's not the norm. Many doctors don't even think to try something that's not mass-manufactured. As for doctors who use compounding pharmacies, the FDA's Steve Silverman says they should do so with caution.

Mr. STEVE SILVERMAN (Assistant Director, Food and Drug Administration Office of Compliance): There are people who will tell you that the risks to patients are low to nonexistent. And I don't want to be alarmist. I will tell you, though, that we regularly see reports of adverse events associated with compounded drugs.

SULLIVAN: Recently, there have been several instances where patients have been seriously harmed or have even died because of mistakes with compounded drugs. Silverman told me about a pharmacy in Texas that made an injectable compound for neck and back pain that allegedly killed three people in the spring of 2007. He was frustrated by the pharmacist's reaction.

Mr. SILVERMAN: He was quoted as saying: You know what people say? Stuff happens. And we view that kind of cavalier attitude, especially with respect to drugs that can kill patients if they're not prepared properly, as very troubling.

SULLIVAN: The FDA does not regulate pharmacies. The state Boards of Pharmacy do. But they do regulate the compounds used in the mixtures, and Silverman says that the FDA supports compounding pharmacies that go through the appropriate channels, but that...

Mr. SILVERMAN: Only in situations where FDA-approved drugs are either unavailable or in the opinion of a health-care provider inappropriate for treatment of a specific condition should patients resort to compounded drugs.

SULLIVAN: However, many, like pharmacist Ron Keach, say safety issues and abuse are rare and that the FDA is mostly concerned with making sure the big drug companies are protected.

Ms. SILVERMAN: A lot of this is simply about power and dollars, in my opinion.

SULLIVAN: And he worries what some patients would do if they couldn't get tailored drugs.

Mr. SILVERMAN: You know, in some cases, you know, it would definitely affect their quality of life. I think in a few cases, it might affect their life all together.

SULLIVAN: Meghan Collins Sullivan, NPR News.

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