Chances to avert meningitis outbreak possibly missed

• The FDA and state regulators failed to pass along information about Massachusetts drug compounder
• Tainted drugs have infected some 469 patients with fungal meningitis; 33 dead
• New England Compounding has been shut down

NASHVILLE, Tenn. -- On May 10, 2011, long before the current deadly meningitis outbreak, an official in the FDA regional office in Denver sent an e-mail to a colleague in Boston detailing allegations that a Massachusetts drug compounder was illegally shipping drugs to Colorado hospitals.

The information came from Colorado state inspectors who had then passed the concerns along to the U.S. Food and Drug Administration.

But there the information stopped.

The allegations, congressional investigators have concluded, were never passed along to the Massachusetts Board of Registration in Pharmacy, the agency that licensed the New England Compounding Center in the first place.

"I wish in retrospect that we had notified Massachusetts at that time," FDA Commissioner Margaret A. Hamburg told a congressional committee last week as the panel tried to dissect the ongoing outbreak.

State and federal officials say that New England Compounding shipped out more than 17,000 vials of methylprednisolone acetate that were tainted with fungus, infecting some 469 patients with fungal meningitis and killing 33. New England Compounding has been shut down, and Ameridose, a sister compounding firm with common ownership, has agreed to shut down through Dec. 31.

The hearings, briefing papers and the hundreds of pages of documents generated by the hearing provide a map of missteps and missed opportunities by state and federal regulators that prompted some senators to openly question whether the entire tragedy could have been avoided.

The FDA wasn't alone in failing to pass along the information. It would be more than a year and a cease-and-desist order later before the Colorado board told the Massachusetts board about its discoveries and action against New England Compounding.

"We historically have not reported actions to other state boards because in most states the registrants are required to report the actions (themselves)," said Cory Everett, spokeswoman for the Colorado board, in an e-mail response to questions.

Currently, there is no central national repository for disciplinary actions involving licensed pharmacies, although there is a national database, the federal government's National Practitioner Data Bank, that includes disciplinary and other adverse actions against physicians, pharmacists and other health care professionals.

A private association, the Illinois-based National Association of Boards of Pharmacy, is developing a proposal to collect such data and to focus particularly on drug compounders, said Carmen Catizone, executive director of the group. He said the plan is now in development and the association expects to soon formally present the proposal to congressional leaders.

He said the association already has contracted with the state of Iowa to inspect out-of-state pharmacies with Iowa licenses. He said as many as 200 licensees could be inspected under that program alone.

"We're not a government agency, but if a pharmacy refuses to let us inspect, we can go back to the licensing state to get enforcement power," he said.

The lack of a central data bank on licensed pharmacies is apparent in the records compiled by the congressional committees.

Records made public by the Senate Commerce Committee show that it was in early April 2011 that a Colorado state inspector came across evidence that New England Compounding had shipped drugs to the Sky Ridge Medical Center in Lone Tree, Colo. (part of the Nashville-based HCA hospital chain), without patient-specific prescriptions, a requirement of state law.

She took pictures of the vials and copied the records that showed the drugs had been ordered on Jan. 17 and March 24, 2011.

Subsequently, on April 15 of last year, the Colorado pharmacy board issued a cease-and-desist order against New England Compounding. The Colorado board did not inform its Massachusetts colleagues of either the inspection report or the cease-and-desist order.

Woody McMillin, spokesman for the state Health Department, said New England Compounding never reported the cease-and-desist order to Tennessee officials, although health department officials said that it should have.

"The way the cease-and-desist order is written, our staff believes this formal discipline should have been reported to us," McMillin said.

Colorado officials did, however, inform the regional office of the FDA, which in turn sent the information on May 11, 2011, to its Boston office, where, congressional investigators determined, the trail ended.

"I know that you have some previous reg history with this firm and they were the recipient of at least one warning letter," the Denver FDA official wrote in an e-mail to the Boston office.

"This is just FYI but if you have any questions, please feel (free) to give me a call to discuss."

Everett, the Colorado board spokeswoman, said the FDA was advised because of concerns over the manufacturing process being utilized by the Massachusetts drug compounder.

More than a year would pass before another Colorado inspector found new evidence that New England Compounding, despite the cease-and-desist order, was still shipping drugs into the state without a prescription for a specific patient.

On July 17, 2012, Colorado Inspector Susan S. Martin visited Delta County Memorial Hospital in Delta, Colo., and while reviewing hospital drug billing records came across an invoice from New England Compounding. There was no record of a patient-specific prescription. She copied the records and took pictures of the vial.

This time, Colorado officials contacted the Massachusetts Pharmacy Board.

"We reached out to the Massachusetts board in 2012 because of the repeated actions of NECC," Everett said, adding that officials there wanted to know if there was some provision in Massachusetts that would allow New England to ship drugs into another state without a prescription.

According to the federal Centers for Disease Control and Prevention, no cases of fungal meningitis from the tainted steroid have been reported in Colorado.

But the information, including a detailed description of the earlier actions, was sidetracked again when the then-administrator of the Massachusetts board shared the information with a legal counsel and other staff members but not with the board itself. James D. Coffey was fired when his superiors learned of his inaction.

By then, shipments of the tainted methylyprednisolone had been sent to three Tennessee locations, including the St. Thomas Outpatient Neurosurgery Center, where dozens of unsuspecting patients were injected.

Joyce McDaniel, the consumer member of the Tennessee pharmacy board, said that while she feels Tennessee board investigators have done a good job of investigating complaints within the state, "where we need to have more oversight is in our dependence on other states providing accurate and thorough information."

Dr. Michael Carome of Public Citizen, a nonprofit advocacy group, said one solution to the problems uncovered in the aftermath of the outbreak would be the establishment of a federal requirement that state pharmacy boards notify other regulators, particularly those in the home state of the licensee, whenever disciplinary or other adverse action is taken against a pharmacy or pharmacist.

He said that, under a federal law that went into effect in 2010, state boards and health providers are required to file reports on disciplinary actions against pharmacists to the National Health Practitioner Database. That information is not available to the general public and does not apply to pharmacies.

Catizone said his group's proposal could serve the same purpose. He said that if the inspections showed that a pharmacy was operating beyond the scope of its license by manufacturing drugs, the association would report that to both the relevant state board and the FDA.