Meningitis Outbreak Highlights Compounding Pharmacy Safety Lapses

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October 24, 2012 – The Framingham, Mass.-based compounding pharmacy at the center of a rapidly growing nationwide meningitis outbreak had dirty floors and a dangerously leaky boiler, according to a recent inspection by the Massachusetts Department of Public Health. The inspection started on Sept. 26, two days after a half dozen Tennesseans were diagnosed with a rare form of fungal meningitis after being inoculated with pain medications that were processed by the New England Compounding Center (NECC). So far, the outbreak has sickened over 300, including at least 23 people who died from their illness.

Compounding Pharmacy Recall Update 8/12/13: Texas-based compounding pharmacy Specialty Compounding, LLC, has issued a nationwide recall for all lots of medications it has processed since May 9. To date, at least 15 people have been diagnosed with a rare bacterial infection after being administered injections of calcium gluconate at a pair of Texas hospitals. In response to this and a number of other recent compounding pharmacy recalls, the FDA is asking Congress for increased oversight and authority over these operations.

Fungal Meningitis Update 1/30/13: This week, a federal judge ruled that assets of the company at the center of last year’s unprecedented fungal meningitis outbreak will be frozen indefinitely. An emergency injunction was placed on the New England Compounding Center (NECC) after the owners were accused of funneling more than $21 million out of the company’s assets before filing for bankruptcy in December.

What’s the problem?

Federal health regulators have still not determined how the steroid blamed for the outbreak, methylprednisolone acetate, became tainted with exserohilum rostratum, a fungus commonly found in soil and plant matter. What is clear is that some shipments of the drug were distributed to medical clinics without sterility testing. Additionally, floor mats at the NECC plant were ‘visibly soiled with assorted debris,’ and a leaky nearby boiler created an ‘environment susceptible to contaminant growth,’ according to Massachusetts health authorities.

When state officials arrived at NECC’s facility to conduct the inspection, they found employees busy cleaning work areas and ‘detected signs of bleach contamination.’ They also found that autoclaves, machines designed to kill contaminants, had not been properly used or maintained at the plant.

According to the Centers for Disease Control and Prevention (CDC), as many as 14,000 patients around the country may have been administered methylprednisolone acetate that was processed and distributed by NECC. So far, more than 300 people in 17 states have contracted fungal meningitis associated with the outbreak, including at least 24 people who died.

Meningitis is a rare disease that attacks the membranous lining of the brain and spinal cord. Signs and symptoms, which may take three months or more after the injection to manifest, include:

  • headache
  • fever
  • stiff neck / neck ache
  • weakness
  • numbness
  • slurred speech
  • pain
  • redness or swelling at the injection site

The disease must be conclusively diagnosed with a spinal tap, a procedure that draws cerebrospinal fluid from the spine. Once detected, fungal meningitis is typically treated with powerful intravenous antifungal medications. It is important to note that unlike bacterial meningitis, fungal meningitis is non-communicable, which means that it cannot be transmitted from person to person. The only way an individual can contract this variety of the disease is to be injected with the contaminated steroid from NECC.

The nationwide outbreak has prompted a number of surprise inspections at other Massachusetts compounding pharmacies, as well as calls for tighter regulations on the industry as a whole. These companies are licensed to manufacture custom drug orders for individual patient prescriptions, but NECC was shipping “large batches of compounded sterile products directly to facilities apparently for general use rather than requiring a prescription for an individual patient,” according to the inspection report. In all, the company distributed more than 17,600 vials of methylprednisolone acetate to 76 clinics in 23 states around the country.

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