Tainted medicine: Mass. moves to revoke pharmacists' licenses

• Mats designed to collect soil, dust, and other contaminants from the workers' shoes before they enter the clean room were darkened with filth and debris, suggesting the mats weren't changed as frequently as standards require.

• Tabletop boxes known as powder hoods, designed to prevent powders used in formulating a sterile drug from contaminating a product, were not thoroughly cleaned – providing a potential source of contamination.

This is not the first time that NECC has been in trouble with regulators. The company has been the target of special inspections several times over the past 13 years.

"It is tragic that these conditions were allowed to exist," writes Eric Kastago, president and owner of ClinicalIQ, in an e-mail. "There were lots of missed opportunities."

ClinicalIQ is a New Jersey-based consulting firm that focuses on compliance with sterile-compounding standards. 

Looking over the particulars in the interim report, many of the problems investigators identified appear to be the result of the "normalization of deviance," a term coined after the space shuttle Challenger accident to describe the way departures from normal procedures become routine when the departures don't lead to consequences.

In NECC's case, many of the items the investigators found appear to be shortcuts the company "took many times before, without consequence," and so they became the new "normal" procedures, suggests Edmund Elder Jr., director of the Zeeh Pharmaceutical Experiment Station at the University of Wisconsin at Madison and a participant in several investigations into compounding-pharmacy practices.

As the probe continues, investigators still are trying to determine how contaminants found their way into the steroid vials. Possible pathways include the raw materials used to make the drugs or additives introduced to ensure any powdered ingredients say dissolved in the liquid after the initial mixing, suggests Stephen Byrn, professor in the college of pharmacy at Purdue University in West Lafayette, Ind.

Since the investigation began Sept. 26, it has expanded to two other pharmaceutical companies affiliated with NECC.

Massachusetts Gov. Deval Patrick announced Monday that the state's pharmacy board would begin immediate, unannounced inspections of compounding pharmacies that produce sterile medicines. It would require yearly reports on the quantities of medicines they produce and the extent of their distribution. Companies would have to report to the state any dealings with federal regulators, such as the FDA.

The Patrick administration also aims to set up a commission to seek out "best practices" among other states' regulators and present recommendations on improvements to Massachusetts' regulatory approach.

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