The New England Compounding Center (NECC), the compounding pharmacy at the heart of the nationwide meningitis outbreak, has been shut down since late September and it's products recalled.
But Indiana Attorney General Greg Zoeller is taking no chances, filing an emergency petition asking the Indiana Board of Pharmacy to suspend the license of the Massachusetts pharmacy.
Indiana, along with Tennessee, has been particularly hard hit by the outbreak. The Indiana State Department of Health (ISDH) has confirmed at least 43 cases of fungal meningitis and three deaths stemming from a tainted steroid injection produced by NECC. As a licensed non-resident pharmacy whose products are distributed and sold in Indiana, NECC is legally responsible for the "proper and safe storage and distribution of drugs and devices."
Immediate danger
"It is tragically clear that this out-of-state pharmacy presents an immediate danger to public health and safety," Zoeller said. "Our office will use all available resources to ensure Indiana patients are protected from any more harm and to pursue a formal administrative action against the company's ability to operate in our state."
The Indiana Board of Pharmacy will consider the petition for summary suspension at its next meetingon Nov. 5. If the suspension is granted, the NECC could not operate in Indiana for 90 days which would give the Attorney General's Office time to file a formal licensing complaint before the pharmacy board. Once an administrative complaint is filed, the board could then determine the appropriate disciplinary action.
According to ISDH, there are now 1,502 Indiana residents have been exposed to the contaminated medication through an epidural or joint injection. Patients exposed in Indiana have been contacted by their healthcare provider.
Uncharted waters
"These are uncharted waters, but we are learning more about these infections every day," said Joan Duwve, M.D., Chief Medical Officer at ISDH. "The State Health Department has been working diligently with the Centers for Disease Control and Prevention to assist Indiana medical providers with the screening, diagnosis, and treatment of infections related to use of these contaminated products. We will continue to do so until this outbreak is resolved."
In September, the CDC in coordination with the Food and Drug Administration (FDA) identified the NECC as the compounding pharmacy that produced the epidural steroid injections that caused the onset of meningitis in certain patients. Shortly after, NECC ceased production and initiated a recall of the drugs.
As of Oct. 29, the CDC had identified 354 cases of fungal meningitis across 19 states stemming from NECC's tainted steroid injections. The cause of contamination of the steroid injections is still under investigation.
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