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 bulk distribution complaints, and Coffey forwarded the information to Manning and department inspectors but failed to order an investigation, said Dr. Lauren Smith, interim commissioner of the Massachusetts Department of Public Health.
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.
Coffey and Manning could not be reached for comment.
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 its licenses in Colorado and Massachusetts.
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 in July found 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.
Susan Martin, an inspector with the Colorado Pharmacy Board, sent an e-mail to Coffey on July 26 with details about her state’s investigation of New England Compounding’s mass distribution of medications.
“I would appreciate any information that the Massachusetts Board could provide concerning if this practice is allowed under Massachusetts pharmacy law,” Martin wrote in the e-mail, according to documents made public Wednesday.
Coffey e-mailed Martin back at 7:33 a.m. the next day acknowledging receipt of the material.
“The Massachusetts Board of Pharmacy will respond as soon as possible following a thorough review and analysis of the same,” he wrote. A minute after sending that e-mail, the records show that Coffey forwarded the material to Manning, the department’s attorney, and four board inspectors and wrote, “FYI for follow up discussion.”
Smith said that officials looking into the meningitis outbreak learned only this past weekend of Coffey’s communications with Colorado and his lack of follow-up, which led to his firing Tuesday.
Cory Everett-Lozano, spokeswoman for the Colorado Department of Regulatory Agencies, said her state reported its disciplinary action against New England Compounding in May 2011 to a national database that tracks actions taken against health care professionals’ licenses and to the National Association of Boards of Pharmacy.
New England Compounding closed early last month and recalled all its products. A steroid produced at the company has been linked to 424 fungal meningitis cases and joint infections and 31 deaths, the US Centers for Disease Control and Prevention said Wednesday.
At the time Coffey received the Colorado complaint in July, two of three lots of contaminated steroids from New England Compounding had already been shipped to health care facilities around the country; the third tainted lot was not produced until Aug. 10.
Smith said it is hard to know whether the widespread misery from the contamination might have been blunted if Coffey and Manning had acted on Colorado’s information.
“I understand that people are going to wonder if inspectors had been instructed to go visit New England Compounding after the receipt of this report, would they have found then the conditions and violations that they found later in September, when it was brought to the attention of the department that the company was potentially related to the meningitis outbreak,” Smith said. “That is hard to know. But certainly we thought that it was a serious lapse in judgment.”
Smith said investigators continue to review the board’s actions.
“It is absolutely essential that we understand what happened and that we hold people responsible for their actions,” she said. “But it’s also important to identify what can be done in the future to prevent something like this from happening again.”
She said the investigation will include a review of “potential organizational improvements” and whether the pharmacy board has sufficient staffing.
Smith is one of a half-dozen industry executives who have been called to testify next Thursday before the US Senate Committee on Health, Education, Labor, and Pensions, which is investigating the meningitis outbreak. The committee has also asked Dr. Margaret Hamburg, commissioner of the Food and Drug Administration, and New England Compounding co-owner Barry Cadden to appear.