Surprise inspections for Mass. compounding pharmacies

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October 24, 2012, 6:22 pm
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(NECN: Ally Donnelly, Waltham, Mass.) – There’s new fallout from the multi-state meningitis outbreak linked to a Framingham, Mass. compounding pharmacy.
An additional death has been reported. 
All this comes as Massachusetts begins a new effort to inspect pharmacies like the New England Compounding Center.

Standing in a press conference at State department of Health Offices, Bureau Director for Healthcare Safety and Quality, Dr. Madeliene Biondolillo addressed the room.

"This aggressive action allows us to see how pharmacies are operating without giving them a warning that we are coming," said Dr. Biondolillo

It's a new directive from the Governor, to more closely scrutinize the 25 compound pharmacies that make sterile, injectable drugs.

Dr. Madeliene Biondolillo won't say which pharmacy got the surprise visit from state inspectors Tuesday or how it went, but she did tell us what they were looking for.

"The sterility, the sanitary conditions that they find, the methods of preparing the medications, the qualifications of those preparing the medications," said Biondolillo.

The state is reacting to the fungal meningitis outbreak tied to steroid shots made by the New England Compounding Center in Framingham. The shots made 317 people sick in 17 states and have killed 24 people.

Though the state has found a number of serious violations at NECC over the last decade, they found no problems during their last inspection in 2011. Officials say they didn't know NECC was mass producing compound medications to sell out of state. The facility only had a license to make drugs for individual prescriptions.

"All an inspector had to do was look at their log and see what they made and look at their prescriptions and see what they dispensed and see if it added up," said Professor Todd Brown.

Professor Brown heads the Massachusetts Independent Pharmacists Association and is a professor at Northeastern University. He says the state has always been able to make surprise inspections and can't believe they didn't expose NECC.

"The quantity of compounding they were doing was extreme. I know of no other pharmacy that compounded in these quantities," said Brown.

Even the lawyer for NECC said in a statement that it was "hard to imagine that the board has not been fully apprised of both the manner and scale of the company's operations."

Biondalillo would not directly respond to the allegation.

"What you're asking about is part of an ongoing investigation," answered Biondalillo.
Local pharmacy owner Steve Bernard reacted.

“It's real scary."

Steve Bernard owns Johnson Compounding and Wellness Center in Waltham. He says he's been inspected several times over the last 25 years and supports unannounced inspections, but they're not a fail-safe.

"In all walks of life in all different businesses, there's people operating on the edge and the state doesn't have the resources, nor does the federal government to do all that stuff."

Tags: Ally Donnelly, Governor Deval Patrick , framingham massachusetts, New England Compounding Center, NECC, fungal meningitis, compounding pharmacy
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