Massachusetts health authorities have ordered 11 compounding pharmacies to shut down operations either partially or completely in the wake of the last year’s deadly fungal meningitis outbreak, which has been traced to an injectible steroid medication produced by the New England Compounding Center (NECC) in Framingham, Massachusetts.
The Centers for Disease Control and Prevention (CDC) report that, to date, nearly 700 people in 20 states have fallen ill and 45 deaths are attributed to the tainted medication.
The state’s public health department began unannounced inspections of compounding pharmacies statewide last October following the multi-state meningitis outbreak. Serious violations of state pharmacy regulations prompted the shutdown of the 11 compounders, the Boston Globe reported, while 21 other pharmacies were cited for minor violations. Officials have said that NECC, the pharmacy that made the contaminated steroids, was making what were supposed to be sterile injections in unsanitary facilities.
NECC filed for Chapter 11 bankruptcy in December and pledged, as part of the bankruptcy filing, to establish a victims’ compensation fund.
As we’ve previously written, compounding is vital for patients who cannot be treated with U.S. Food and Drug Administration (FDA) -approved medications and who require individually formulated medicines; for example, people allergic to certain dyes or inactive ingredients, or those who need a medication in a form not commonly available. In the wake of the fungal meningitis outbreak, concerns have arisen over large-scale compounding, national distribution of compounded products, and how compounding pharmacies should be regulated. In December, the FDA convened a meeting with public health officials from all 50 states to discuss how to strengthen the rules regulating compounding pharmacies, The New York Times reported.
Madeleine Biondolillo, director of the Massachusetts Health Department’s Bureau of Health Care Safety, said many of the latest problems pinpointed by investigators relate to flaws in the design or operation of the companies’ clean rooms, where sterile products are made, the Globe said. Dr. Lauren Smith, the state’s interim public health commissioner, called the results of the surprise inspections troubling, but said that the process “has led to significant corrective measures and increased compliance among sterile compounders in Massachusetts.” Massachusetts Governor Deval Patrick has ordered stricter requirements for inspectors, including that the inspectors be pharmacists with five years of clinical experience.