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A Closer Look At Compounding Pharmacies

CBS DFW (con't)

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FORT WORTH (CBS 11 NEWS) – A deadly meningitis outbreak linked to steroid shots has grown. 105 people have become sick. Eight people have died.

Two North Dallas clinics received a back pain steroid: Dallas Back Pain Management and Texas Health Southlake.

So far, none of their patients report any symptoms.

But the deadly outbreak shines a spotlight on compounding pharmacies. What are they? And are they safe?

Lorena Williams started buying Chlorambucil from a compounding pharmacy a year and a half ago. Chlorambucil is an older chemotherapy drug.

She could buy it from one of the big pharmacy chains, but she doesn’t want to. Not even now.

“When you can use this drug that helped me so much and save 50% off? I don’t have any kind of health insurance. That’s a big savings,” she said.stero

Compounding Pharmacies provide tailor made prescription drugs. Not all of them are as inexpensive as Lorena Williams’ medication.

Chris Esparza, a pharmacist at Trinity Pharmacy in Carrollton says compounding pharmacies fill a niche. They make prescription drugs the big chains don’t or won’t.

“Sometimes it (the drug) is even something similar to a manufacturer or they’re not able to make it or it’s not made anymore,” Esparza said.

Trinity Pharmacy services individuals, making a single prescription for a single patient. That’s different from the New England Company linked to the meningitis outbreak which made thousands of vials of a steroid and shipped them to 23 states.

Some of the vials were contaminated by a fungus now blamed for sickness and death.

“Bacteria can grow in one or two days or overnight. Funguses can be slow growing. You may not see them for 10-14 days,” Esparza said.

“Things can grow when there’s no preservatives in there to keep out those microbes,” he said.

“It comes down to having protocols in place and making sure you do what you have to do, safety wise, and following USP guidelines to make sure that type of thing doesn’t happen,” Esparza said.

Compounding Pharmacies in Texas are regulated.

The Texas Board of Pharmacy oversees them. But, compounding pharmacies don’t have to meet the FDA standards big drug companies do.

Nationwide changes will depend on whether the New England pharmacy, linked to the meningitis outbreak, followed protocol.

“As you make more, you have to be more protocol driven to make sure those types of issues don’t come up,” Esparza said.

To ensure the Trinity Pharmacy Lab is sterile, Esparza conducts routine tests.

“We do in house sterility testing here and we send it off for testing to an analytical lab as well,” he said.

From now on, Lorena Williams says she’ll ask how her drug are made.

“He can reassure me or not reassure me. I make my decision from that point,” she said.

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