Pharmacy at Center of Fungal Meningitis Outbreak Knew of Contamination Issues
Federal regulators revealed over the weekend that the Massachusetts compounding pharmacy at the center of a multistate outbreak of fungal meningitis was aware of contamination issues at its facility. Yet, there is little evidence that anyone at the New England Compounding Center (NECC) did anything to correct the problems.
Epidural steroid injections supplied by NECC are suspected of causing a multistate outbreak of fungal meningitis that has sickened 337 people in 18 states, killing five. Seven peripheral joint infections that occurred in people who received steroid shots in their hips, knees, shoulders and other joints are also suspected of being linked to the tainted steroid injections, according to the U.S. Centers for Disease Control (CDC).
NECC recalled 17,000 vials of epidural steroid injections back on September 26th. On October 6th, the company recalled all of its products and voluntarily surrendered its license to operate to Massachusetts health authorities. According to the CDC, NECC’s recalled steroids were shipped to 76 facilities in 23 states, and some 14,000 patients are known to have received the potentially-contaminated shots.
Compounding pharmacies like NECC are supposed to prepare custom medications for specific patients only. But in recent days it has become clear that NECC was acting as a large-scale pharmaceutical manufacturer in violation of that license. According to a recent report from The New York Times, some of the nation’s most prestigious hospitals had been supplied by NECC prior to the outbreak, including some connected with Harvard, Yale and the Mayo Clinic. Compounding pharmacies are only lightly regulated by the U.S. Food & Drug Administration (FDA), and they are not subjected to the agency’s good manufacturing practices standards.
According to a report from the Associated Press, documents obtained by the FDA during the agency’s inspection of NECC revealed four dozen reports stretching back to January of possible contamination in rooms that were supposed to be sterile. The FDA inspection also uncovered a host of potentially unsanitary conditions in and around NECC’s clean rooms, including green and yellow residues, water droplets and standing water from a leaking boiler.
“The entire pharmacy was an incubator of bacteria and fungus,” Sarah Sellers, a former FDA officer, told the Associated Press. “The pharmacy knew this through monitoring results, and chose to do nothing.” According to the Associated Press report, Sellers left the FDA in 2008, after failing in her push to have compounding facilities subjected to stricter regulation.
According to the FDA report, inspectors visiting the NECC facility also discovered 83 vials out of a bin containing 321 vials of preservative-free methylprednisolone acetate — the injectable steroid tied to the outbreak – that contained a “greenish black foreign matter.” Another 17 vials in the same bin contained a “white filamentous material.” Microbial growth was confirmed in all 50 vials from the bin that the FDA sent out for analysis.
The FDA inspections also found problems with NECC’s air conditioning and ventilation systems. According to The New York Times, employees said NECC switched off the air conditioning between 8 p.m. and 5:30 a.m. in the room where sterile drugs were made, even though maintaining proper temperatures and humidity levels is required to prevent microbial growth.
According to the Times, federal officials are also looking at a recycling facility adjacent to NECC that is owned by the same people that own the pharmacy. In recent years, neighbors have complained about dust, debris and smells coming from the recycling plant. NECC’s rooftop units for the its air-conditioning system were located about 100 feet away from where large trucks and excavators were moving mattresses and plastic, the Times said.