November 8, 2012
State Pharmacy Director Fired For Ignoring Complaint Over NECC Drug Shipments
Lawrence LeBlond for redOrbit.com - Your Universe Online
Massachusetts Board of Pharmacy director James D. Coffey has been fired after allegedly ignoring complaints that Framingham-based New England Compounding Center (NECC) had illegally shipped bulk orders of drugs to Colorado hospitals, reports Boston.com's Kay Lazar.
The shipments were in direct violation of Colorado´s state licenses, according to MA state health officials. Yet, the long-time director of the pharmacy board failed to take action on the complaint, which had been reported back in July.
NECC, blamed for the deadly meningitis outbreak that has so far claimed 31 deaths and has sickened hundreds, was shut down in October after federal officials learned the company had shipped some 17,000 vials of contaminated drugs to 76 medical facilities in 23 states.
However, if the July complaint was handled appropriately, it stands to reason that at least a third of the fungal meningitis cases may have been avoided.
The Colorado Board of Pharmacy had contacted Coffey on July 26 about the problem, and Coffey had forwarded the information to board attorney Susan Manning, who has been placed on administrative leave, and other department inspectors. Despite contacting officials, he failed to order an investigation into the issue, Dr. Lauren Smith, interim commissioner of the Mass Dept of Public Health, said in a statement.
Smith said since the director is the one person responsible for ordering an investigation, Coffey was the sole person fired.
“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.
Even once the outbreak became public, the Pharmacy Board staff failed to disclose the existence of the complaint to the Dept of Public Health, the agency that oversees the board, according to Smith, adding there was no evidence either Coffey or Manning made any attempt to alert the board itself.
Colorado´s complaint stated NECC had distributed manufactured drugs to many hospitals in the state between 2010 and 2012 without patient-specific prescriptions, a violation of both Colorado and Massachusetts licenses, according to Smith.
The Colorado board had issued NECC a cease and desist order in April of 2011 after its investigators discovered the company had distributed prescription drugs unlawfully in that state. A routine inspection in July of this year revealed NECC had still been shipping bulk orders to at least one Colorado hospital.
It was then, on July 26, that Colorado authorities had decided to notify the Mass. Pharmacy Board, assuming the issue would be dealt with.
Coffey, on July 27, issued a response to the Colorado board, writing: “Please be advised that I am in receipt of the special report. The Massachusetts Board of Pharmacy will respond as soon as possible following a thorough review and analysis” and told Colorado officials he would provide any additional information they needed.
At the time Coffey received the Colorado complaint, two of the three contaminated lots of steroid injectables produced by NECC had already been shipped to medical facilities around the country; The third tainted lot was not produced until August 10.
“I find the actions of New England Compounding reprehensible,” Smith said, adding citizens have a right to expect that drug companies will comply with laws to ensure patient safety. “But I also expect the staff charged with oversight to perform their duties to the highest standards. That failed to happen here,” she concluded.