Visible fungal specks found in NECC steroid vials

Robin Wulffson MD's picture
fungal meningitis, NECC, contamination, sterility, deaths, strokes, lawsuits
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An inspection by Massachusetts Public Health Department officials of the shuttered New England Compounding Center (NECC) unearthed disturbing findings in regard to sterility. On October 23, they reported that they had found unsanitary conditions at the facility including visible black specks of fungus in steroid vials. They noted that mats used to trap dust and dirt just outside the facility’s clean room were “visibly soiled with assorted debris.” In addition, a leaking boiler was located adjacent to the clean room.

One particularly troublesome finding of the inspection was that NECC shipped some orders of vials of methylprednisolone acetate, which may have been contaminated with the fungus without waiting for the final results of sterility testing. NECC records indicate the tests found no contamination; however, regulators said they were skeptical of the company’s methods. The records suggest that the company failed to sterilize products for “even the minimum amount of time necessary to ensure sterility,” noted Dr. Madeleine Biondolillo, director of the Bureau of Health Care Safety and Quality at the Massachusetts Public Health Department. State officials said a preliminary investigation found that the NECC shipped orders from the lots of steroid vials suspected in the outbreak before its own tests came back confirming the lots were sterile. In some cases, they said, drugs went out up to 11 days before test results came back.

The findings raise the issue of whether the meningitis outbreak could have been averted, or at least reduced in magnitude, had proper procedures been followed. “This was preventable,” noted Eric S. Kastango, president of Clinical IQ, a consulting firm that counsels compounding pharmacies. He added. “They failed to properly sterilize this medicine that had to be sterilized. That’s huge.” State officials also said that NECC operated as a drug manufacturer by producing drugs for broader use, rather than filling out specific prescriptions for specific physicians, which is all its license allowed.

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To date, 308 cases have been reported, including 23 deaths in 17 states. A total of 14,000 individuals in 23 states received methylprednisolone acetate steroid injections produced by the now-shuttered New England Compounding Company (NECC). All of them are still at risk for fungal meningitis from a contaminated vial.

Governor Deval Patrick noted the state of Massachusetts has moved to revoke the licenses of the New England Compounding Center and three pharmacists there. In addition, he has ordered the state pharmacy board that oversees similar companies to conduct surprise inspections and take other steps to tighten oversight. Revocation of the licenses will probably have little impact; the likelihood of NECC surviving a flurry of lawsuits is virtually impossible.

References:
Massachusetts Department of Public Health
FDA
CDC

See also:
CDC stresses continued vigilance for fungal meningitis
FDA now scrutinizing other NECC products for contamination
Federal criminal investigators raid tainted steroid maker NECC
FDA warns of risk from other tainted drugs produced by NECC
Company responsible for fungal meningitis cases skirted state and federal laws

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