Meningitis Outbreak: Pharmacy Inspection Reveals Drug-Safety Lapses

Oct. 24, 2012— -- The compounding pharmacy at the center of a deadly meningitis outbreak had dirty floors and a leaky boiler that jeopardized the safety of its products, according to an inspection by the Massachusetts Department of Public Health.

The inspection started Sept. 26, two days after six Tennesseans were diagnosed with a rare form of fungal meningitis after receiving steroid injections for back pain.

The steroid, called methylprednisolone acetate, was made by the New England Compounding Center in Framingham, Mass. Sealed vials of the steroid contained exserohilum rostratum, a fungus found in soil and plants.

It's not clear how the fungus landed in the pharmacy's ostensibly sterile vials, some of which were shipped to clinics without sterility testing, according to the inspection report. Floor mats near sterile drug-mixing areas were "visibly soiled with assorted debris," and a leak from a nearby boiler created an "environment susceptible to contaminant growth," according to the report.

When state officials arrived for the inspection, they found pharmacy employees cleaning drug-compounding areas and "detected signs of bleach decontamination," according to the report. They also found lapses in the use and maintenance of autoclaves, machines designed to kill any potential contaminant.

As many as 14,000 patients are thought to have received injections of the suspect steroid, according to the U.S. Centers for Disease Control and Prevention. More than 300 people in 17 states have contracted fungal meningitis or joint infections from the tainted shots, and 24 have died.

For a map of cases by state, click here.

Meningitis affects the membranous lining of the brain and spinal cord. Early symptoms of fungal meningitis -- including headache, fever, dizziness, nausea, sensitivity to light, stiff neck, weakness or numbness, slurred speech and pain, and redness or swelling at the injection site -- can take more than a month to appear.

The disease is diagnosed through a spinal tap, which draws cerebrospinal fluid from the spine that can be inspected for signs of the disease. Once detected, it can be treated with high doses of intravenous antifungal medications.

Unlike bacterial meningitis, fungal meningitis is not transmitted from person to person, and only those who received the steroid injections are thought to be at risk.

The outbreak has prompted surprise inspections of other Massachusetts compounding pharmacies as well as calls for stricter regulation. The specialty pharmacies are licensed to tailor-make drugs based on individual patient prescriptions without oversight from the U.S. Food and Drug Administration, but the New England Compounding Center shipped "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.

More than 17,600 vials of the pharmacy's methylprednisolone acetate landed in 76 clinics in 23 states, according to the CDC.

For a full list of clinics receiving the recalled lots of spinal steroid injections, click here.

The New England Compounding Center has recalled all its products and shut down operations. Calls to the owners were not immediately returned, but Paul Cirel, a lawyer for the pharmacy, said state health officials have had "numerous opportunities, including as recently as last summer, to make firsthand observations of the NECC's facilities and operations. Based on that history, it is hard to imagine that the Board has not been fully apprised of both the manner and scale of the company's operations."