Via CIDRAP, a report by Lisa Schnirring: CIDRAP >> Report airs problems at firm linked to fungal meningitis outbreak. Excerpt:
Massachusetts officials yesterday said New England Compounding Center (NECC), the firm linked to a multistate fungal meningitis outbreak, sent shipments from two of the recalled lots before it received sterility testing results.
Investigators also found black particulate matter in several unopened vials of the recalled methylprednisolone acetate, which was used in epidural injections for back pain and injections for peripheral joint problems, according to a report of preliminary investigation findings.
Federal officials have said that as many as 14,000 patients could have been exposed to the recalled injections.
Nine more infections have been reported in the outbreak, raising the number of infections to 317, the US Centers for Disease Control and Prevention (CDC) said today in its latest update. One more death was reported, putting that total at 24, and the number of affected states held steady at 17.
The CDC reported one more joint infection linked to the contaminated steroids, raising that number to five, and it said 54 cases have now been confirmed with lab tests. So far all but two of the infections involve Exserohilum rostratum, a type of black mold that hadn't previously been known to cause meningitis.
In a press conference with reporters yesterday, Madeleine Biondolillo, MD, who directs the Massachusetts Department of Public Health's Bureau of Health Care Safety and Quality, said the investigation began on Sep 25 and involves collaboration with their colleagues at the US Food and Drug Administration (FDA) since Oct 1. She said the investigation is ongoing and that authorities have obtained evidence, reviewed NECC's standard operating procedures, probed the company's records, and interviewed its employees.
NECC didn't label the medications for specific patients, a violation of Massachusetts licensing regulations for compounding pharmacies, Biondolillo said.
According to the Massachusetts Department of Public Health (MDPH) investigation report, NECC's sterility tests on the shipments sent before results came in didn't show contamination. However, investigators said they were still exploring the adequacy of NECC's testing methods.
