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VOL. 36 | NO. 41 | Friday, October 12, 2012

Pharmacy suspected in outbreak surrenders license

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NASHVILLE (AP) - The Tennessee Board of Pharmacy on Monday effectively revoked the license of the pharmacy that distributed injectable steroids suspected of causing a deadly outbreak of fungal meningitis.

At the emergency meeting, board members questioned why action was not taken sooner. They also expressed concern that the pharmacist in charge of the New England Compounding Center, Barry Cadden, is still licensed in Tennessee.

"Theoretically, he could come to Tennessee and go to work in Tennessee," board member Kevin Eidson said.

Department of Health attorney John Smith said that was highly unlikely. He said Cadden, through his attorney, has agreed to surrender his Tennessee license, and Smith expects to call another emergency meeting once the details of that agreement are worked out.

Meanwhile, the board voted 7-0 to accept the voluntary surrender of the New England Compounding Center's license.

Smith said the action has the same effect as a revocation and is understood to be a formal disciplinary action against the Framingham, Mass., pharmacy.

The board still has the right to seek financial penalties.

After the meeting, Smith called the meningitis outbreak a "catastrophe" and said the Health Department is considering whether there are safeguards it can put in place to better prevent something like this from happening. That includes enforcing rules that any business operating as a drug manufacturer have a manufacturer's license.

Smith said the Massachusetts pharmacy was operating "under the radar as a manufacturer" by providing bulk shipments of drugs to clinics. Pharmacies are supposed to fill individual prescriptions, he said.

"We will make sure now that compounding pharmacies comply with the law," he said.

Also on Monday, a Hendersonville woman who was sickened after receiving a steroid injection sued the New England Compounding Center, claiming the pharmacy allowed the steroid to be contaminated by fungi through negligence.

Janet Russell and her husband, Robert Russell, are seeking $15 million in Davidson County Circuit Court.

According to the suit, Janet Russell's injuries have caused her to suffer horribly and include stroke, disfigurement and permanent disability. The 71-year-old has been hospitalized at Saint Thomas Hospital in Nashville since Sept. 18

A spokesman for the New England Compounding Center, Andrew Paven, said in an email that the company had no comment on the suit.

According to the Centers for Disease Control and Prevention, fungal meningitis has sickened 212 people in 15 states, including 53 in Tennessee where the Saint Thomas Outpatient Neurosurgery Center in Nashville received 2,000 vials of the suspect steroid, by far the largest shipment in the U.S.

So far 15 people have died around the country, including six in Tennessee.

Unlike bacterial or viral meningitis, this rare f ungal meningitis is not contagious.