Shocking Negligence at Compounding Pharmacies – a Continuing Story

Meningitis lawyers at Pintas & Mullins Law Firm previously warned about the horrific conditions at the now closed New England Compounding Center that was linked to a massive rare meningitis outbreak. Now, it appears that conditions at the compounding pharmacy’s sister company, Ameridose, may have been even worse.

Ameridose shut down in late October 2012 and recalled all of its products a short time later. An FDA investigation reveals that the staff did not use gloves, eye protection or sterile gowns. Their foreheads were bare when they worked inside the open-faced hoods, making sterile injectables.

Additionally, at least one bird was detected flying in a place where sterile finished products were packed and stored. Insects were also noticed in the same place, which was within about 10 feet of the controlled section of the facility where sterile products were manufactured.

The House Energy and Commerce Committee’s Oversight and Investigations Subcommittee mentioned the FDA’s report on NECC multiple times during a hearing on the fungal meningitis outbreak. However, when the subcommittee tried to question NECC’s co-owner and managing pharmacist, the latter repeatedly cited his right under the Fifth Amendment to remain silent.

Outpatient Surgery Magazine recently carried pharmacy violations of a similar kind. Operations at the Florida compounding pharmacy have been suspended by health department officials.

An emergency suspension order was issued for a number of violations. During a routine inspection, the pharmacy was found to violate rules pertaining to the compounding and dispensing of medication, record keeping, and cleanliness of the prescription department.

The Florida DOH (Department of Health) inspection documents highlight a couple of violations that came up during an October inspection. Two of these violations are listed below:

  • Invoices were possibly thrown away, the wrong pharmacist was named on the majority of prescriptions and the pharmacy was not able to furnish dispensing records.
  • In infringement of USP 797, open containers of products were noticed in the clean room, next to dustpans and brooms. Dead bugs and rodent or bug fecal matter were observed. There was also dirty sitting water in the sink.

Even worse is that an assessment of previous inspections showed that the pharmacy was aware of many of the infringements, but did not rectify them.

Inspections in 2009 revealed that expiration dates and lot numbers were missing on medications, and that daily logs were not suitably maintained. A 2010 inspection showed that compounded drugs were missing expiration dates and lot numbers. Prescriptions, pedigrees, dates, invoices and signatures were still missing on daily logs.

Recently, a single lot of cardioplegia solution and four lots of preservative-free betamethasone from the New England Compounding Center tested positive for bacterial contamination.

The commonly-found bacteria have not been proven to cause human disease, and the CDC (Centers for Disease Control and Prevention) said that it was not aware how products tainted with these varieties of bacteria could affect patients.

However, the discovery of both fungal and bacteria contamination of NECC-supplied products fuelled the FDA’s apprehension about poor product sterility at NECC’s compounding facility. The FDA has advised healthcare providers not to utilize any NECC-supplied products. What’s more, the CDC indicated that there was a possibility that more microbial organisms could possibly be discovered in recalled NECC products as additional tests were completed.

If you developed meningitis or any other health problems from a NECC-supplied product, you may be entitled to compensation. A drug recall attorney can evaluate your potential claim.

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