Questions raised about meningitis pharmacy

Published: Oct. 10, 2012 at 5:26 PM

BOSTON, Oct. 10 (UPI) -- Massachusetts officials said an executive of a sister company of the pharmacy linked to the meningitis outbreak recused herself as a state regulator.

Sophia Pasedis, vice president of regulatory affairs and compliance at Ameridose, which shares the same owner as that of the New England Compounding Center in Framingham, Mass., was appointed to the 11-member Massachusetts Board of Registration in Pharmacy in June 2004 and reappointed in 2008, The Boston Globe reported.

The New England Compounding Center is at the center of the fungal meningitis outbreak that has killed 12 and sickened 137 in 10 states. The compounding pharmacy in Framingham, Mass., produced about 13,000 doses of the injectable steroid methylprednisolone acetate used to treat back pain.

The investigation into the exact cause of the outbreak is ongoing locally and nationally. The Centers for Disease Control and Prevention in Atlanta said its preliminary analyses showed all infected patients received an injection of preservative-free methylprednisolone acetate, a steroid prepared by the New England Compounding Center.

"The compounding center voluntarily surrendered its license at the request of the state of Massachusetts and at the direction of public health officials, announced a recall of all products that were distributed from its facility in Framingham," Dr. Madeleine Biondolillo of the Massachusetts Department of Public Health said in a statement.

"Massachusetts regulations stipulate that licensed compounding pharmacies are only permitted to prepare and dispense medications pursuant to a prescription from a registered practitioner for an individual patient. If a compounding pharmacy manufactures without a patient-specific prescription, it would be a violation of the terms of its licensure with the Board of Pharmacy."

State health officials have said the New England Compounding Center was licensed only to dispense and mix medications for individual patients. This raises questions about how and why it produced and shipped thousands of vials of the drugs to facilities nationwide, the Globe said.

The U.S. Food and Drug Administration and the Massachusetts Board of Pharmacy conducted joint inquiries for more than a decade at the New England Compounding Center, Biondolillo said.

Compounding pharmacies are regulated primarily by state agencies as pharmacies, not drug manufacturers, therefore they are not regulated as strictly as drug manufacturers, which are regulated by the U.S. Food and Drug Administration.

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Questions raised about meningitis pharmacy