Conditions inside New England Compounding Center conducive to contamination

The drug compounding lab likely responsible for the deadly nationwide outbreak of fungal meningitis ignored many safety protocols designed to ensure sterility of its products. According to a New York Times report this week, health officials in Massachusetts released a report Tuesday which showed New England Compounding Center as a company that routinely broke safety violations and ignored the few regulations it was governed by in “a rush to ship drugs around the country.” At least 23 people have died and more than 300 others are seriously ill after receiving an epidural injection of a painkiller steroid drug process at New England Compounding Center earlier this year. Thousands of vials of methylprednisolone acetate were likely contaminated with the a fungus at the company’s Framingham, Mass., lab that led to many recipients of the drug developing serious and life-threatening illness. A report released this week from Massachusetts’ Board of Pharmacy detailed numerous safety violations at the New England Compounding Center labs, including accumulations of dirt outside so-called “clean rooms” where drugs are prepared, and even a leaking boiler, all situations that could cause a contamination of drug products there. New England Compounding Center is a drug compounding lab where other previously-approved pharmaceutical products are mixed into new formulations for other treatments. The vials of methylprednisolone acetate mixed at New England Compounding Center are prescribed in the treatment of back pain and inflammation. Places like New England Compounding Center are not regulated by the Food and Drug Administration as other pharmaceutical manufacturing and processing facilities are. Instead, these labs and pharmacies are subject to a network of state regulations and part of the company’s license prohibited the company from making drugs, methylprednisolone acetate in particular, without a prescription confirming it. More than 17,000 vials of the steroid injection were delivered to nearly 80 pain management and other healthcare facilities in 23 states. Fungal meningitis infections suffered by recipients of a contaminated vial have been reported in 17 of those states, with Tennessee experiencing the highest volume of cases. Massachusetts officials admitted to The New York Times that with so many companies like New England Compounding Center operating in the Commonwealth, it is difficult for agencies to maintain proper oversight. In the case of the contaminated methylprednisolone acetate vials, New England Compounding Center sent shipments of vials to clinics across the country without receiving an inspection report that was to determine the sterility of the vials. The company said the report eventually showed the vials to be safe but obviously that may not be the case. A previous FDA sample testing on at least 50 vials discovered traces of the fungus in each that was responsible for the meningitis outbreak. More questions continue to mount against New England Compounding Center and officials at both the state and federal levels have launched investigations into the company’s operations and its apparent ignorance to keeping a sterile environment and it not following strict protocol in the manufacture of the products it distributes.

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