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article imageNECC pharmacy fungal contamination owners arrested

By Tim Sandle     Dec 18, 2014 in Health
Two co-founders along with 12 other former employees of a Massachusetts compounding pharmacy, linked to a fungal meningitis outbreak that killed 64 people, have been arrested. One charge is second-degree murder.
As Digital Journal reported back in 2012, a U.S. compounding pharmacy called the new England Compounding Center (NECC) announced a recall of all its products. This was due to a contaminated steroid product, made up of over 17,000 vials, being distributed across 23 U.S. states. The product was contaminated with a fungus and the fungus triggered meningitis. The steroid was called methylprednisolone acetate. The medicine was used to treat pain and swelling that occurs with arthritis and other joint disorders, via injection into the spinal cord.
The U.S. Centers for Disease Control and Prevention (CDC) later estimated that over 700 people nation-wide were diagnosed with fungal meningitis or other serious fungal infections. At least 64 deaths were confirmed.
The issue led to a national inquiry, together with hearings in the U.S. Senate. Earlier this year, the pharmacist who oversaw the sterile compounding at the facility was arrested at Logan Airport as he was about to board a plane for Hong Kong. He was charged with knowingly releasing a contaminated steroid product which caused several deaths.
Now the news has come in that the big arrests have been made. On December 17, Barry Cadden, a co-founder of the New England Compounding Center, and Glenn Adam Chin, a pharmacist who was in charge of the aseptic processing area were detained and accused under a federal racketeering indictment of causing the deaths of patients in several states by "acting in wanton and willful disregard of the likelihood" that their actions would cause death or great bodily harm.
Alongside the major two arrests, 12 others have also been charged with offenses. This group face charges ranging from mail fraud to the introduction of adulterated and misbranded drugs into interstate commerce.
One of the root causes for the contamination was poor hygiene. This tallies with something that emerged from the U.S Food and Drug Administration (FDA) investigation, according to CBS News, here it is alleged that pharmacy technicians were instructed to lie on cleaning logs, showing rooms were properly cleaned when they had not been. Other issues of concern were standing water, mold, water droplets and dirty equipment. With the fungus issue, according to a former NECC technician, mold was found in the cleanroom a dozen times during a span of three years.
Furthermore, according to the 73-page indictment, unsealed Wednesday, from 2008 to 2012 the pharmacy allegedly disguised expired or expiring stock solutions by mixing them with current stocks and passing off the finished solution as an up-to-date product.
The outbreak also sparked Congress to create a new voluntary regulatory category for large compounders in the 2013 Drug Quality and Security Act to bring them under GMP rules.
More about NECC, new england compounding center, Pharmacy, Meningitis
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