The Massachusetts Department of Public Health has ordered the full or partial shutdown of 11 compounding pharmacies in the wake of last year’s deadly fungal meningitis outbreak.
The outbreak was traced to an injectable steroid medication produced by the New England Compounding Center (NECC) in Framingham, Massachusetts. The Centers for Disease Control and Prevention (CDC) most recently reported that 696 people in 20 states had been sickened and 45 deaths had been attributed to the tainted medication. State officials have said that the NECC was making what were supposed to be sterile injections in unsanitary facilities.
Unannounced inspections of the state’s compounding pharmacies began last October following the multi-state fungal meningitis outbreak. Serious violations of state pharmacy regulations prompted the shutdown of the 11 compounders, the Boston Globe reported; 21 other pharmacies were cited for lesser violations. NECC filed for Chapter 11 bankruptcy in December.
Pharmaceutical compounding is important for patients who need individually formulated medicines. Some patients, for example, are allergic to certain dyes or inactive ingredients found in standard U.S. Food & Drug Administration (FDA) -approved medications. Others require medication in a form not commonly available–a liquid, for instance–rather than a pill. Compounding pharmacies produce these medications. But in the wake of the meningitis outbreak, concerns have arisen over the scale of compounding operations and how they should be regulated. The FDA convened a meeting in December of public health officials from all 50 states to discuss strengthening regulations for compounding pharmacies, The New York Times reported.
According to the Globe, Madeleine Biondolillo, director of the Massachusetts Health Department’s Bureau of Health Care Safety and Quality, said many of the problems seen by inspectors relate to flaws in the design or operation of the companies’ clean rooms, where sterile products are made. Dr. Lauren Smith, the state’s interim public health commissioner, called the inspection results 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 the requirement that inspectors must be pharmacists with five years of clinical experience.