New England Compounding did not follow sterility procedures, investigators find; state orders regular inspections of similar pharmacies
Drugs produced by the New England Compounding Center were not put through the minimum procedures required to ensure sterility and were shipped to customers before the pharmacy’s own safety tests were completed, a state health official said Tuesday in announcing preliminary results of an inspection of the pharmacy at the heart of the nationwide meningitis outbreak.
Inspectors who visited the pharmacy in recent weeks found dirty lab equipment, a leaking boiler near the pharmacy’s “clean room,” and records that showed the pharmacy failed to properly maintain important sterilization tools, such as an autoclave, Madeleine Biondolillo, director of the state Bureau of Health Care Safety and Quality, said during a press conference Tuesday afternoon.
Officials also announced that the state board of pharmacy is seeking the permanent surrender of New England Compounding’s pharmacy license, as well as permanent revocation of the licenses of the company’s three pharmacists, including Barry Cadden and Lisa Conigliaro Cadden, the husband-and-wife team at the center of the pharmacy operations.
“Those whose lab practices caused this outbreak should never practice pharmacy or manufacturing in Massachusetts again,” Massachusetts Governor Deval Patrick said.
Patrick said he had directed the pharmacy board to conduct regular, unannounced inspections of other compounding pharmacies in the state, at least once a year.
A steroid produced at New England Compounding has been linked to more than 300 fungal meningitis and joint infections and 23 deaths. Tests have matched the fungus found in most of the patients with a type found in unopened vials of the steroid shipped from New England Compounding, but investigators have not yet determined how the fungus got into the vials.
On Oct. 2, investigators found that vials of medication returned to the pharmacy by customers after a recall contained visible black particulate matter, Biondolillo said. Many of the infections have been linked to a kind of black mold.
The pharmacy was regularly shipping drugs to customers without having a patient-specific prescription in hand, in violation of state law. “With this violation, NECC was operating beyond the scope of it’s compounding license, instead operating as a manufacturer,” Biondolillo said.
Patrick said he wants to see strengthened penalties for compounding pharmacies that violate state rules and to require them to file regular reports about the type and quantity of drugs they produce.
It is “clear that our own rules here in Massachusetts governing compounding pharmacies have not kept pace with an industry that’s changing rapidly,” he said.Chelsea Conaboy can be reached at email@example.com. Follow her on Twitter @cconaboy. Kay Lazar can be reached firstname.lastname@example.org.