The deadly outbreak of fungal meningitis last year may have been caused by the illegal actions of a Massachusetts pharmacy, which used patient lists from a Nashville clinic to mislead regulators, according to the former Saint Thomas Outpatient Neurosurgical Center medical director.
Reports indicated that contaminated medicines made by the New England Compounding Center (NECC) were behind the meningitis outbreak that caused 55 deaths, including 15 in Tennessee. The dangers inherent in improper and tainted drug administration have come to the forefront of health care.
Dr. John Culclasure, who was the then medical director of Saint Thomas Outpatient Neurosurgical Center, says that the Massachusetts pharmacy board was insisting on patient names because NECC was legally required to have patient-specific prescriptions, according to reports.
It is becoming increasingly clear that the New England Compounding Center routinely shipped thousands of drug vials without legally required patient-specific prescriptions, and in the process putting human lives in harm's way. As regulators dig into the murky affairs of pharmacy management, it is apparent that the insistence of Massachusetts pharmacy board on patient names, despite the lack of any, was to blame.
According to the reports, it is not clear when the clinic began ordering methylprednisolone acetate, the steroid blamed for the outbreak, from NECC. However, the investigation into the phone calls about pricing reveals the drug purchase from NECC was completed by February 2012.
As the report suggests, based on the filings, NECC ordered at least 500 vials at a time to sell at $6.50 a piece, and the clinic "ordered 500 vials from that point on." Three lots of preservative-free methylprednisolone acetate manufactured by the New England Compounding Center in Framingham, Mass., were tied to an outbreak of fungal meningitis last year. Following the incidence of several cases of fungal meningtitis in six states and subsequent deaths seventeen thousand doses were recalled, eventually.
The investigation back then, looked into the possibilities of fungal meningitis, which is not contagious, localized spinal or paraspinal infections, and infections involving injections in a peripheral joint space, such as a knee, shoulder, or ankle. Investigations now revealed compromised sterility procedures at NECC, including unopened vials of fungus-tainted steroids, according to the reports available.
The real problem and challenge relates to the lack of a policy of openness, and procedures that exempt officials from full disclosure by taking shelter behind a veil of federal and provincial laws. The ongoing investigation by the congressional committee should shed light on the less than desirable clinical practices at some of these centers, and hopefully a comprehensive national strategy designed to prevent any such recurrence.
