Compounding is the way pharmacists combine different agents or drugs to treat a specific disorder. On Thursday, health officials in Massachusetts, where that bad batch of epidural steroids was made, made a bold move to stem future outbreaks.
"This is an extraordinary precaution," said Dr. Madeleine Biondolillo with the Bureau of Healthcare Safety.
Massachusetts Public Health officials still can't explain how tens of thousands of batches of epidural steroid vials were contaminated, causing a deadly nationwide outbreak of fungal meningitis. But Biondolillo said they aren't taking any chances.
"To be as abundantly cautious as possible, we wanted to make sure that they recalled everything," said Biondolillo.
New England Compounding Center is recalling all 17,676 vials of the medication, affecting hospitals in Middle Tennessee including Skyline and Centennial Medical Centers. In addition, the Food and Drug Administration is asking doctors to stop using drugs produced by NECC.
Dr. Roger Davis, dean of the College of Pharmacy at Lipscomb University, said even with all the precautions, nothing is fool proof.
"There's always the opportunity for human error," said Davis.
Davis admits he doesn't know specifics about the outbreak but said contamination isn't uncommon when manufacturers compound products in bulk.
"The likelihood of a large manufactured batch of products being contaminated in a single preparation is extremely high," said Davis.
Davis explained that contaminant like the Aspergillus linked to this outbreak can be found on any surface.
In fact he said people are exposed to the fungi every day. But when it's injected directly into the spine, it bypasses the body's normal defense mechanisms, as opposed to the type of compounding pharmacists across Tennessee do every day for individuals.
"They have certain standards and certain practices to follow to ensure the integrity of that product whether it's an oral, topical," said Davis.
Davis warned recalling the product could lead to a temporary shortage. But he said patients are prepared. Doctors will likely devise another method of treatment for patients until those injections are cleared for use again.
This facility linked to the outbreak has been investigated before. In March, the Massachusetts Board of Health got a complaint about the potency of an eye surgery product. That incident is still under review. There were also complaints against the facility in 2002 and 2003, involving the sterile processing of products. That resulted in an agreement with the state, and in 2011 inspectors found no deficiencies.
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