An outside firm that the state of Massachusetts hired to do an assessment found problems at a pharmacy linked to a deadly meningitis outbreak, CBS reports.
According to Massachusetts state documents from 2006, investigators found inadequate contamination control and no written standard operating procedures for using equipment, among other problems, at the New England Compounding Center. The NECC corrected the problems that year, and a state inspection in 2011 found no such issues.
The NECC is a compounding pharmacy, meaning that it makes specialized treatments for patients from drug ingredients provided by other manufacturers. It’s the source of contaminated steroid medication, which has sickened 308 people with fungal meningitis in 17 states. Twenty-three of them have died.
Meningitis is the potentially deadly inflammation of tissue surrounding the brain and spinal cord.
In response to several complaints, the NECC signed a consent agreement with state regulators in 2006, in which it agreed to a full inspection of its drug compounding practices.
The report says the newly released state documents “include dozens of complaints from as early as April 1999, less than a year after the company began as a compounding pharmacy in Framingham, Mass.”
Problems included allowing doctors’ offices to fax orders for medicine without names of specific patients, which is prohibited under state law. Also, the company was repeatedly cited for not providing the appropriate data to support its medicines’ expiration dates.
The report says an outside firm hired to do an assessment, the Illinois-based Pharmaceutical Systems Inc. found “significant gaps” in procedures and a lack of required documentation at the NECC.
The report quotes a letter to pharmacist Barry Cadden, who co-founded NECC in 1998, which states it was “the opinion of the auditors that your operation needs to be upgraded and enhanced to be in substantial compliance” with federal pharmacy regulations.
According to the PSI report, inspectors found insufficient documentation that proper sterilization procedures had been followed.
Inspectors who looked at the company’s non-sterile compounding procedures also found potential contamination problems ranging from uncovered and unlabeled containers to a large hole in a ceiling panel above a workbench. In addition, the exteriors of some equipment were visibly dirty with buildups of residue.
Lopez McHugh is investigating cases related to this outbreak. If you or a loved one had an injection and were diagnosed with meningitis, you should consult with a Lopez McHugh lawyer for a free consultation.
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