Board probed pharmacy tied to meningitis

By Richard Weir
Friday, October 5, 2012

The Framingham specialty pharmacy linked to a nationwide meningitis outbreak that has claimed five lives was under the spotlight of a Bay State licensing board as far back as 2002 after complaints over its sterilization procedures, state health officials revealed yesterday.

The New England Compounding Center is now at the center of a growing health calamity after Food and Drug Administration officials said investigators this week found contamination in a sealed vial of the firm’s preservative-free steroid methylprednisolone acetate — the same injectable medication given to 35 people in six states who contracted the rare form of fungal meningitis.

At the urging of federal officials, the company last week recalled three lots of the steroid used to treat back and joint pain shipped since July to 23 states, including Rhode Island, New Hampshire and Connecticut. None of the recalled product was distributed in Massachusetts, but nine clinics have received other batches of the same steroid, officials said.

“All nine facilities were contacted by DPH today to quarantine that product as a precaution,” said Dr. Madeleine Biondolillo, head of the state Department of Public Health’s Bureau of Healthcare Safety.

Ilsa Bernstein of the FDA said “out of an abundance of caution” the agency is urging health care providers to stop using any products from the company.

In a statement yesterday, NECC said it has voluntarily suspended operations while assisting in the investigation. Biondolillo said in 2006 NECC entered into a consent agreement with the state Board of Pharmacy stemming from two complaints in 2002 and 2003 over “concerns about the sterile processing procedures.”

She said an independent review verified NECC no longer had “deficient practices” — the same finding produced in 2011 after NECC moved.