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Fungal meningitis outbreak raises safety issues regarding compounding pharmacies

Robin Wulffson MD's picture
fungal meningitis, compounding pharmacies, regulation, fatalities, strokes

The contaminated steroid injections have now sickened 137 people with fungal meningitis, killing 12 of them, in 10 states. On October 10, a compounding pharmacy that “shares principal ownership” with the New England Compounding Center, the company at the center of the deadly outbreak has voluntarily ceased operations. In addition, the outbreak is prompting some physicians and medical groups to reconsider the use if compounding pharmacies.

Compounding pharmacies create specific pharmaceutical product to fit the unique needs of a patient. To do this, they combine or process appropriate ingredients utilizing various tools. This may be done for medically necessary reasons, such as to change the form of the medication from a solid pill to a liquid, to avoid a non-essential ingredient that the patient is allergic to, or to obtain the exact dose needed. It may also be done to flavor a medicine to increase its patient acceptability. These facilities are overseen by state boards of pharmacy rather than regulated like drug companies are by the US Food and Drug Administration (FDA). In recent years, hospitals have started outsourcing compounding to compounding pharmacies as advances in medications made blending and assembling them more complex, requiring more training and expensive equipment. In addition, shortages have appeared among a range of drugs, from steroid injections to chemotherapy medications, and anesthesia drugs. The situation created opportunities for new large-scale compounding pharmacies to emerge and fill specific needs. In 2011, there were 267 reports of drug shortages, nearly four times the 70 reported in 2006. To date for 2012, 151 shortages have been reported.

The fungal meningitis outbreak has caused healthcare professionals to reconsider the use of compounding pharmacies. An example is MedStar Health, which owns nine hospitals in Maryland and the District of Columbia. The hospital chain uses compounding centers to a limited extent (1%); however, the meningitis outbreak has caused the administration to cease using them altogether.

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On October 6, the New England Compounding Pharmacy announced a recall of all its products. On October 10, Ameridose LLC of Westborough, Massachusetts, a compounding pharmacy that “shares principal ownership” with the company at the center of the deadly meningitis outbreak voluntarily ceased operations, pending an inspection of its facilities by Massachusetts health officials. Ameridose said that it agreed to halt operations “out of an abundance of caution,” and that the action “was taken proactively and cooperatively” with state officials.

Ameridose shares ownership with New England Compounding Center of Framingham, Mass., the suspected source of contaminated steroid injections that have now sickened 137 people with fungal meningitis, killing 12 of them, in 10 states. NECC has ceased operations and recalled all of its products.

Dr. Madeleine Biondolillo, director of the Massachusetts Department of Public Health's Bureau of Healthcare Safety and Quality, noted that the state had seen no evidence of any “direct concern” tied to Ameridose products, and said it hadn’t requested a recall. She added that investigators are probing, among other things, whether NECC violated state law by mass-producing spinal steroid injections instead of making them for individuals in conjunction with a patient-specific prescription. She explained, “There is a gray area where some organizations may have operated contra to the licensing regulations.”


See also:
CDC reports that thousands received tainted epidural injections
More deaths, strokes reported from fungal meningitis
Fatalities reported from rare fungal meningitis