More information about the fungal meningitis outbreak that left 14 dead and 200 sickened has come to light. A recent article in CNN reports that the Massachusetts pharmacy responsible for the outbreak, the New England Compounding Center, has demanded that its cleaning contractor share responsibility for the outbreak. UniFirst Corp. replied to the letter, acknowledging that it provided cleaning services once per month for the pharmacy; however, it claims that the pharmacy’s demand is “without merit.”
As we discussed in an earlier post, this outbreak could have been caused by producing the drugs in unsterile conditions. This now seems to have been the case, as health agencies found that the pharmacy did not adhere to sterilization procedures and recklessly distributed the dangerous drug without knowing if it had undergone sterility tests.
The Massachusetts Board of Pharmacy reported that the pharmacy distributed vials that had “visible black particulate matter,” which was later found to be fungus. The FDA and CDC have also stated that they found contamination (which could be either fungus or bacteria) in unopened vials from the pharmacy.
A criminal investigation has been initiated against the New England Compounding Center. In addition, the state pharmacy board voted to permanently remove both the license of the pharmacy as well as the licenses of the pharmacy’s three top pharmacists. The U.S. House Energy and Commerce Committee’s Subcommittee on Oversight and Investigations is investigating why the pharmacy was permitted to operate despite their “history of problems.”
The New England Compounding Center recalled three lots of the drug in September voluntary; however, this was not soon enough to prevent the outbreak and tragic deaths. CNN reports that the patients who contracted fungal meningitis will have to be treated for many months, which will likely result in staggering medical costs as well as lost wages.