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Early Warning Signs Revealed in Meningitis Outbreak

An investigation into a deadly fungal meningitis outbreak reveals a history of problems at the Massachusetts specialty pharmacy which made the contaminated steroid shots that killed 23 and sickened 300 across the country. The New England Compounding Center (NECC) has a history of problems which stretch back to 1999, about a year after it opened. The pharmacy is now at the center of a growing scandal and a wave of pharmaceutical product liability lawsuits.

Recently publicized federal investigation records reveal that regulators avoided giving the mixing lab the harshest punishments despite receiving growing numbers of complaints regarding the practices at NECC. In 2004, a state inspector recommended that the pharmacy be publically reprimanded for its inadequate safety practices. An evaluation by an outside firm in 2006 found that NECC had inadequate sterilization and documentation controls.

“Although your facility has seen significant upgrades in facility design for the sterile compounding operation, there were numerous significant gaps identified during the assessment,” said a letter from the evaluation firm Pharmacy Support Inc.

Other complaints include that the pharmacy improperly solicited business from pharmacists and physicians, and that the pharmacy improperly violated standards for compounding the same steroid at the center of the current fungal meningitis outbreak.