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Wednesday, October 10, 2012

Fungal Meningitis Outbreak Renews Scrutiny Of Pharmacy Rules, Regulators

A pharmacist mixes medication at a compounding pharmacy in West Palm Beach, Fla. Thousands of these pharmacies operate nationwide. A compounding pharmacy in Massachusetts has been blamed for a deadly outbreak of fungal hepatitis. (AP/Brian Skoloff)

Congressional committee leaders are asking health officials for briefings on the fungal meningitis outbreakthat has now killed 12 people in 10 states. In Tennessee, where six patients given contaminated steroid injections for back pain have died, Gov. Bill Haslam says the state will not rush to implement new rules.

A vial of injectable steroids from the New England Compounding Center is displayed in the Tennessee Department of Health in Nashville. (AP/Kristin M. Hall)

But The Tennessean reports that California is already taking steps to tighten standards, even though no deaths have been reported there, and California already has some of the nation’s strictest rules for compounding pharmacies.

Questions are also being asked about regulators themselves. The Boston Globe reports that owners of the New England Compounding Center, implicated in the outbreak, also own another pharmacy and one of the executives there is a board member of the state agency that regulates pharmacies.

Dr. Sarah Sellers, a licensed pharmacist who has been working in compounding pharmacies and testified before Congress in 2003 about her concerns about them, tells Here & Now‘s Robin Young that physicians and patients are not aware of the risks of products made at compounding pharmacies and, in her opinion, “we are only beginning to scratch the surface” of deaths and other health complications caused by drugs made there.

In an opinion piece published in the journal Drugs, she argues that there is not enough mandatory reporting of problems associated with compounding pharmacies.

Guest:

  • Dr. Sarah Sellers, pharmacist and former FDA compliance regulator

Please follow our community rules when engaging in comment discussion on this site.
  • http://twitter.com/mem_somerville mem_somerville

    I am saddened by this incident. But I’m kinda glad this is getting some scrutiny. I think this could become more and more important in medicine, actually. We are going to start getting more personalized cocktails of compounds to treat individuals as we learn more about their genomes. And we will get more unusual combos with cancer treatment cocktails as we get tumor sequence data too.

    This is a service we’ll need, but it does need to be regulated properly. 

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