A report by the Massachusetts Executive Office of Health and Human Services, Department of Public Health, said the outbreak of the non-contagious fungal meningitis originated from a medication produced at the compounding pharmacy at the New England Compounding Center, a facility licensed by the Massachusetts Board of Registration in Pharmacy Board.
The Massachusetts Department of Public Health in collaboration with investigators from the U.S. Food and Drug Administration, worked to identify the root causes of the outbreak. The complete scope and severity of this outbreak will not be fully understood for many weeks, but to ensure the utmost transparency, Department of Public Health released the preliminary findings from its ongoing investigation of NECC.
The report said final sterilization did not follow proper standards for autoclaving -- sterilization through high pressure steam. NECC records indicated a systemic failure to keep products in the autoclave for the required minimum 20-minute sterilization period necessary to ensure product sterility. The investigation also found:
-- Visible black particulate matter was seen in several recalled sealed vials of methylprednisolone acetate from Lot 08102012@51.
-- Powder hoods, intended to protect pharmacists from inhaling substances during medication preparation, within the sterile compounding area were not thoroughly cleaned.
-- Residual powder was visually observed within the hood during inspection. This contamination may subsequently lead to contamination of compounded medications.
-- "Tacky" mats, used to trap dirt, dust and other potential contaminants from shoes prior to clean room entry,
were visibly soiled with assorted debris.
-- A leaking boiler adjacent to the requisite clean room created an environment susceptible to
-- A pool of water was visually observed around the boiler and adjacent walls, creating an unsanitary condition; the culture results of this potential contaminant are still pending.
Medication compounding involves the practice of taking commercially available products and modifying them to meet the needs of an individual patient pursuant to a prescription from a licensed provider.
In Massachusetts, nearly all retail pharmacies in Massachusetts perform compounding, but only 25 compounding pharmacies meet the standards necessary to produce sterile injectable products, the report said.
Every Massachusetts pharmacy must comply with Massachusetts laws and regulations, including compliance with the U.S. Pharmacopeia Standards. Compounding pharmacies may only perform compounding upon receipt of a patient specific prescription.
"Upon beginning the joint on-site investigation of NECC early in this outbreak, the DPH and FDA investigators identified serious deficiencies and significant violations of pharmacy law and regulations that clearly placed the public's health and safety at risk," the report said.
"This report constitutes early findings that may be subject to revision as the investigation unfolds."
The CDC said Tennessee was the first state to identify the fungal meningitis and had the most cases at 70 and nine deaths, followed by 73 cases in Michigan and five deaths; 43 cases and two deaths in Virginia; 41 cases in Indiana and three deaths; 17 cases and one death in Maryland; 19 cases and three deaths in Florida; seven cases in Minnesota; 10 cases in New Hampshire; 11 cases in Ohio; two cases in North Carolina and one death; 18 cases in New Jersey, and one case each in Idaho, New York, Illinois, Texas, Pennsylvania and Georgia.
U.S. health officials confirmed the fungus Exserohilum rostratum was detected in unopened vials of a preservative-free steroid -- methylprednisolone acetate produced at the NECC.
About 17,000 doses of the steroid were shipped from the NECC and an estimated 14,000 were used in treatment to ease back and joint pain. Patients have become ill about one to four weeks following the injection, but health officials said the fungus can take time to develop so there could be cases for months.
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