BOSTON — The number of Americans falling sick or dying from fungal meningitis linked to tainted steroid continues to grow. In Massachusetts, inspectors have finished the first stage of an investigation at the compounding pharmacy that produced the steroids, New England Compounding Center in Framingham.
The inspection that began one month ago paints a picture of a pharmacy poised for problems. Floor mats showed dirt and debris at the entrance to NECC’s so-called “clean room,” where pharmacists mixed medications. Equipment used to sterilize drugs was not regularly tested. And, says Dr. Madeleine Biondolillo with the Department of Public Health, batches of the steroid linked to deaths across the country were shipped out before NECC pharmacists had confirmed they were safe.
More: U.S. Meningitis Outbreak
- 10/7/12: Mass. Pharmacy Linked To Meningitis Outbreak Issues Wide Recall
- 10/11: Mass. Pharmacy Industry Resists Call For Stricter Regulation
- 10/15: FDA: Pharmacy’s Other Drugs May Be Causing Illness
- 10/16: Former Regulator Calls For More Oversight Of Pharmacies
- 10/16: Criminal Investigators Visit Framingham Pharmacy
- 10/23: A Trail Of Complaints At Pharmacy Linked To Meningitis Deaths
- 10/24: State Moves To Revoke License Of Firm Tied To Outbreak
- 10/31: Sister Company Of Framingham Pharmacy Recalls Drugs
- 11/7: Mass. Pharmacy Board Director Is Fired
- 11/14: Sec. Bigby: Meningitis Outbreak A ‘Disaster’ That Was ‘Preventable’
- 11/28: In Outbreak Wake, Hospital Pharmacies Step Up Drug Compounding
- 1/4/13: Patrick Proposes New Compounding Pharmacy Rules
Complete Coverage: Meningitis Outbreak
“DPH investigators documented that on 13 occasions NECC staff shipped orders from the suspect lots before their own test results confirming that those lots were sterile,” Biondolillo said. “Medication was shipped as long as 11 days before the results were received.”
DPH inspectors saw black particle matter in vials of a recalled injectable steroid, but they have not yet found the root cause of this meningitis outbreak.
Biondolillo claims the pharmacy was breaking state rules by selling drugs in bulk, not just to individual patients with a tailored prescription.
“With this violation, NECC was operating beyond the scope of their compounding license, instead, acting as a manufacturer,” Biondolillo argued.
In a statement, NECC attorney Paul Cirel said “it is hard to imagine” the state didn’t know about “both the manner and scale of the company’s operations.” State inspectors have suggested they didn’t have the authority to tell NECC to stop filling bulk orders for buyers outside Massachusetts.
“Normally, interstate commerce has been a matter of federal oversight, but for various reasons there has been very little of that over the years,” Gov. Deval Patrick said Tuesday.
Patrick is creating a special commission to look into changes in state pharmacy regulations. As well, he says inspectors will begin unannounced visits to 25 pharmacies that, like NECC, make sterile, injectable drugs. And the state is moving to permanently revoke NECC’s license. The Framingham-based company says there’s no need because NECC already surrendered its license.
At a State House press conference Tuesday, Patrick addressed the victims of this fungal meningitis outbreak.
“On behalf of the entire commonwealth, I want to extend condolences to those who have lost loved ones and encouragement to those who are trying to recover,” Patrick said. “No one should live in fear that medicine is unsafe.”
But as the scope of this tragedy continues to unfold, and with no word on how fungus got into supposedly sterile vials and uncertainty about how to avoid a similar calamity, it may be a long time before patients feel complete confidence in the medicine they receive.