Wed, 2012-10-17 09:22 AM
Meningitis outbreak
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The company that made the pain relieving steroid at the center of a growing fungal meningitis outbreak should face a deeper investigation into its activities with federally-controlled drugs, said a U.S. lawmaker.
Rep. Edward Markey (D-MA) on Oct. 16 urged the Department of Justice to begin a wider investigation into the Framingham, MA-based New England Compounding Center (NECC), to see it the firm violated laws and regulations for controlled prescription drugs. Markey said the company may have been improperly distributed nearly 1,000 controlled substances, including cocaine, morphine and ketamine that come under the purview of the Drug Enforcement Administration.
3 comments:
why wont this die. I have been reading about this incident with NECC everyday all these years. I agree that this is a misfortunate incident that should have never been allowed to happen. But , it dide and for God's sake Lets move on. Compounders are facing a huge issue right now with PBM's. Hey Markey !? lets talk about Express Scripts and big Pharma!
You do realize this is a flashback that is probably meant to give compounders an idea of why the DEA may be inspecting them.
The incident with NECC is a sentinel event--immortalized like other public health disasters--it is tip-of-the-iceberg for a practice area that otherwise escapes our surveillance and may buried in background. Exposed patients continue to be at risk, and those that have diagnosed morbidity are in a chronic disease state. We should continue follow-up.
[excerpt]
In a December 2013 “lessons learned” opinion, Pappas noted that while the overall (known) mortality associated with the outbreak remains low, “morbidity relating to persistent symptoms and treatment associated toxicity is high”71 indicating that clinical manifestations of the early outbreak have shifted to a less-well characterized, chronic disease setting. The overall cost to human health caused by the 2012 outbreak is immeasurable, as is the total financial impact to healthcare systems. For a single hospital health system, the identification of particulate in an outsourced compounded product triggered an investigation costing nearly 1 million dollars for 5 lots of compounded medication totaling 1090 units, at an added cost of $802.74 per unit purchased.72 The research letter notes “Fungal contamination of MgSO4 required extensive pharmacy, laboratory, infection control, and hospital administrative support; substantial hospital resources for patient and physician notification; ongoing surveillance; and prophylactic treatment of high-risk patients”.72 Remarkably, as the early publications on the outbreak were being published, pharmacies that would later recall products due to identified contamination or lack of assurance of sterility continued to supply the market with non-FDA approved medicines for sterile use, including methylprednisolone acetate suspension.
See submission at http://www.regulations.gov/#!documentDetail;D=FDA-2013-N-1523-0006
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