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Fungal Meningitis Outbreak Focuses Scrutiny On Drug Compounders

The fungal meningitis outbreak has now claimed 23 lives and triggered around 300 reported cases in Florida and around the country. As many as 14,000 other patients could be at risk after receiving contaminated steroid injections. One facility is at the center of the outbreak: the New England Compounding Center.

As the outbreak continues, attention has focused on what might have gone wrong at this facility. Current indications suggest that victims' families may be able to pursue wrongful death claims based on the company's apparent negligence.

Much of the scrutiny is looking at how compounding facilities function. According to some industry experts, NECC operated very differently from more legitimate compounding companies.

While NECC recalled 17,000 vials of contaminated steroids from clinics in 23 states around the country, most other compounding laboratories produce only small batches. Instead of manufacturing large volumes, these companies only fulfill small orders for individual patients. For example, one company quoted in a recent news report said that they make only custom drugs made for individual patients based on specific prescriptions from a doctor.

This contrasts dramatically with NECC's practice of mass producing steroids for shipment to numerous clinics. The same company said that it does not make spinal injection products specifically because of the risk of contamination. These steroids cannot include preservatives and are therefore highly vulnerable to infection from outside sources. The steroids need to be kept in a perfectly sterile environment at all times.

As government investigations continue, more information will likely reveal how NECC allowed fungal contaminants to get into its steroid products. If an employee failed to follow sterilization procedures to the letter, the company could find itself taken to task for this outbreak.

Source: ABC News, "Compounding Pharmacists Defend Their Trade After Meningitis Outbreak," Sydney Lupkin, Oct. 22, 2012

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