Mass. Regulators Say Pharmacy Ignored Safety Precautions
By Phil Williams
Chief Investigative Reporter
NASHVILLE, Tenn. -- A Massachusetts pharmacy blatantly ignored safety precautions that could have prevented that deadly fungal meningitis outbreak, regulators said Tuesday.
It marks the first time we're hearing how bad conditions really were inside the New England Compounding Center and what may have led to the deaths of almost two dozen people.
Now, as a result of what they've found, Massachusetts authorities have voted to permanently revoke NECC's pharmacy license, as well as the licenses of its principal pharmacists.
"Immediately following the meningitis outbreak at the end of September, our department of health took decisive steps to isolate and remove the contaminated substances," Massachusetts Gov. Deval Patrick said during a late afternoon news conference.
The governor and state regulators painted a devastating portrait of conditions inside NECC. That facility -- the source of the contaminated drugs in the fungal meningitis outbreak -- was recently raided by federal agents as part of what has now become a criminal investigation.
"Our investigators documented several health and safety deficiencies related to the practice of pharmacy at NECC," said Dr. Madeleine Biondolillo, director of the Massachusetts Department of Public Health's bureau of healthcare safety.
Regulators said that, while Massachusetts law allows pharmacists there to mix up drugs for individual patients, they found evidence confirming that NECC was essentially engaged in mass production.
"Investigators demonstrated that compounded medications ready for distribution were not labeled with patient specific identifiers, as is required under Massachusetts licensing regulations," Biondolillo said.
"With this violation, NECC was operating beyond the scope of their compounding license, instead acting as a manufacturer."
Even more disturbing were the conditions they found inside the facility, including dirty floor mats and all sorts of other debris.
"And a leaking boiler was located next to the clean room which created an environment in which contaminations could have occurred," Biondolillo added.
While NECC was supposed to be testing batches of drugs before they were shipped out -- to make sure there was no contamination -- regulators said those protections were blatantly ignored.
"Investigators documented that, on 13 occasions, NECC staff shipped orders from the suspect lots before receiving their own test results confirming that those lots were sterile," Biondolillo said. "Medication was shipped as long as 11 days before results were received."
Now, in the wake of an outbreak that has sickened hundreds, the governor promised tough actions against companies like NECC.
"Those whose laboratory practices caused this outbreak should never practice pharmacy or manufacture in Massachusetts again," Patrick said.
The governor said that the pharmacy board there will start immediate unannounced visits to pharmacies like NECC. Compounding pharmacies -- those that mix up drugs for patients -- must also begin submitting reports on the volumes of medications they are producing.
As for NECC, the company's lawyer released a statement Tuesday afternoon, essentially suggesting that regulators knew what they were doing at that facility.
Here is the statement:
"NECC has had a long standing practice of working closely and cooperatively with the Massachusetts Board of Registration in Pharmacy and the Massachusetts Department of Public Health. It has always been the company's practice to provide the Board with full and complete access to its facility and its records. As is standard practice in the health care industry, the Board had numerous opportunities, including as recently as last summer, to make first-hand observations of the NECC's facilities and operations. Based on that history, it is hard to imagine that the Board has not been fully apprised of both the manner and scale of the company's operations. NECC's transparency in dealing with the Board since inception in 1998 demonstrates its good faith intention to operate in compliance with the requirements of its license. Furthermore, the company's intention and best efforts at compliance are equally applicable in every other state in which it has been licensed."
- 10/2/12: Meningitis Investigators Eye Link To Compounding Pharmacy
- 10/3/12: Meningitis Outbreak Traced To MassaChusetts Pharmacy
- 10/4/12: 17,676 Vials At Center Of Meningitis Investigation
- 10/5/12: Statement Suggests Pharmacy May Have Violated Law
- 10/16/12: Federal Agents Raid Pharmacy Linked To Meningitis Outbreak
- 10/22/12: NECC Argued Reprimand Would Be 'Fatal'