Compounding Pharmacy Investigated Following Multiple Meningitis Cases
Compounding practices in Massachusetts went under the scanner following the widespread fungal meningitis cases that were traced back to a compounding center in the state. The production of contaminated spinal steroids by the New England Compounding Center based in Framingham, Massachusetts, has been held responsible for 45 deaths.
Government officials carried out a non-routine search of the state's compounding pharmacies and found that only four of them could be given clearance as they followed all rules and regulations laid down by the government's health department. Another 11 of them were closed indefinitely as they were in violation of the regulations, and 21 pharmacies have been reprimanded.
The investigative operation started Nov. 27, 2012 and continued till Feb. 1, 2013, during which 11 pharmacies from New Bedford to West Springfield were given cease-and-desist orders. The officials found violations in 21 other pharmacies but they were cited, as these violations were minimal. The 21 pharmacies have already implemented corrective measures to eliminate those violations since they were cited.
Of the 11 companies that have been shut down, eight of them have given proposals to the Board of Pharmacy which outlines the changes they are going to implement to correct the violations. These proposals will have to be reviewed by the board before they can take a decision on the duration of the cease-and-desist order.
"While these results are troubling, this process has led to significant corrective measures and increased compliance among sterile compounders in Massachusetts," Department of Public Health Interim Commissioner Dr. Lauren Smith was quoted as saying in Boston Herald.
Approximately 700 people fell sick and 45 died after consuming the contaminated drug. Seventeen deaths were from New England, and all these drugs were traced back to New England Compounding Center. Officials, on inspection of NECC, found that the steroid was being manufactured under unhygienic conditions. Governor Deval Patrick has put forward a plan of increasing the Department of Public Health budget by $1 million, so that 30 more positions can be included, which would lead to more inspectors being hired.