Mass. pharmacy board director fired for allegedly ignoring complaint about Framingham pharmacy linked to meningitis outbreak
The director of the state pharmacy board, James D. Coffey, has been fired and the board’s attorney, Susan Manning, has been placed on administrative leave for allegedly ignoring a complaint in July that New England Compounding Center was distributing bulk shipments of drugs to hospitals in Colorado, in violation of its state licenses, Massachusetts health officials announced Wednesday.
New England Compounding is the Framingham pharmacy blamed for a national outbreak of fungal meningitis caused by contaminated steroids it produced between May and August of this year.
The Colorado Board of Pharmacy contacted Coffey on July 26 about the problem, and Coffey forwarded the information to Manning and department inspectors but failed to order an investigation, Dr. Lauren Smith, interim commissioner of the Massachusetts Department of Public Health, said in a statement.
She said the director is the person responsible for ordering investigations.
“It is incomprehensible that Mr. Coffey and Ms. Manning did not act on the Colorado complaint given NECC’s past, and their responsibility to investigate complaints,” Smith said.
Following the outbreak, staff also failed to disclose the existence of Colorado’s complaint to leadership at the Department of Public Health, the agency that oversees the pharmacy board, Smith said. And there is no evidence that Coffey or Manning alerted the board itself, she said.
“I expect the staff charged with oversight to perform their duties to the highest standards,” Smith said. “That failed to happen here.”
The information shared by Colorado officials showed that New England Compounding had distributed manufactured drugs to many hospitals in that state between 2010 and 2012 without patient-specific prescriptions, in violation of the New England Compounding’s Colorado and Massachusetts licenses, Smith said.
The Colorado board had issued New England Compounding a cease and desist order in April 2011, after its investigators discovered the company’s “unlawful distribution of prescription drugs” in that state. But a routine inspection of a Colorado hospital this July revealed that it had received a bulk shipment of a drug from New England Compounding in June. That’s when Colorado authorities notified their Massachusetts counterparts.
New England Compounding closed early last month and recalled all of its products. A steroid produced at the company has been linked to 424 fungal meningitis cases and joint infections and 31 deaths, the Centers for Disease Control and Prevention said Wednesday.
At the time Coffey received the Colorado complaint, two of the three lots of contaminated steroids from New England Compounding had already been shipped to health care facilities around the country, but the third tainted lot was not produced until Aug. 10.Kay Lazar can be reached at firstname.lastname@example.org. Follow her on Twitter @GlobeKayLazar.