The Massachusetts Department of Public Health (MDH) has released preliminary findings of its investigation of New England Compounding Center (NECC), the compounding pharmacy responsible for a multistate outbreak of fungal meningitis that has affected people in 17 states and caused at least 23 deaths. The outbreak originated from a steroid medication compounded by NECC, which was licensed by the Massachusetts Board of Registration in Pharmacy (Board). Patients with questions about their legal right to sue NECC can contact Attorney Fred Pritzker for a free consultation here. Fred has filed a meningitis lawsuit against NECC and is representing patients from several states.
Medication compounding involves the practice of taking commercially available products and modifying them to meet the needs of an individual patient pursuant to a prescription from a licensed provider. Nearly all retail pharmacies in Massachusetts perform compounding, however only 25 compounding pharmacies meet the standards necessary to produce sterile injectable products. By terms of their license with the Board, every Massachusetts pharmacy must comply with Massachusetts laws and regulations, including compliance with the United States Pharmacopeia Standards. Compounding pharmacies may only perform compounding upon receipt of a patient-specific prescription. These requirements and restrictions are consistent with the rules in place in other states.
According to MDH, early in the outbreak, DPH and FDA officials investigating NECC “identified serious deficiencies and significant violations of pharmacy law and regulations that clearly placed the public’s health and safety at risk.”
MDH and FDA found the following:
- NECC distributed large batches of compounded sterile products directly to facilities apparently for general use rather than requiring a prescription for an individual patient. Manufacturing and distributing sterile products in bulk was not allowed under the terms of its state pharmacy license. If NECC was appropriately licensed as a manufacturer with the FDA the company would have been subject to additional levels of scrutiny.
- NECC did not conduct patient-specific medication history and drug utilization reviews as required by regulations.
- NECC distributed two of the recalled lots of methylprednisolone acetate (PF) 80 MG/ML prior to receiving results of sterility testing. Lot 06292012@26 was prepared on June 29, 2012. Final sterility testing was completed on July 17, 2012. Two shipments of product were made prior to the final sterility tests results being received. Lot 08102012@51 was prepared on August 10, 2012. Final sterility testing was completed on August 28, 2012. Eleven shipments of product were made prior to the final sterility tests results being received.
- Final sterilization of product did not follow proper standards for autoclaving (sterilization through high pressure steam) pursuant to United States Pharmacopeia Standard 797 (USP 797) and NECC’s own Standard Operating Procedures. Examination of NECC records indicated a systemic failure to keep products in the autoclave for the required minimum 20-minute sterilization period necessary to ensure product sterility. NECC did not conduct proper validation of autoclaves pursuant to USP 797. NECC failed to test their autoclaves to ensure proper function.
- Visible black particulate matter was seen in several recalled sealed vials of methylprednisolone acetate from Lot 08102012@51.
- Powder hoods, intended to protect pharmacists from inhaling substances during medication preparation, within the sterile compounding area were not thoroughly cleaned pursuant to USP 797.
- Residual powder was visually observed within the hood during inspection. This contamination may subsequently lead to contamination of compounded medications.
- Condition of “Tacky” mats, which are used to trap dirt, dust, and other potential contaminants from shoes prior to clean room entry, violated the USP 797.
- Mats were visibly soiled with assorted debris.
Pritzker Hageman attorneys have won millions for clients, including over $40,000,000 for clients injured by another unsafe medical product. They are representing patients in several states. Contact them for a free consultation here regarding a personal injury or wrongful death lawsuit.
