The U.S. Food and Drug Administration on Tuesday released a corrected list of customers of a specialty pharmacy linked to the fungal meningitis outbreak.
The FDA on Monday released a list of hospitals and medical practices – including several from Northeastern Pennsylvania – that purchased products from the New England Compounding Center of Framingham, Mass. A deadly outbreak of a rare fungal form of meningitis has been tied to steroid shots made by the company.
Last month, the company recalled the steroid shots that went to clinics in 23 states. That recall was later expanded to all its products, and the lists show they went to a longer list of states. However, the lists released on Monday apparently contained some incorrect information.
Jim McGuire, spokesman for Wilkes-Barre General Hospital, which is part of Commonwealth Health, said Berwick Hospital Center, also part of Commonwealth Health, has not purchased or received any products from NECC, even though the hospital was listed as a customer on Monday's FDA lists.
The lists released on Tuesday do not list the Berwick hospital as a customer. Nor do they list Geisinger Wyoming Valley Medical Center in Plains Township, which also was on Monday's lists. Geisinger spokesman Matthew Van Stone had said the hospital purchased products from NECC last November and last June, but the lists are supposed to be current as of May 21, 2012.
And, there are some hospitals that did not appear on Monday's lists but do appear on Tuesday's. They are: Mercy Hospital and Moses Taylor Hospital, both in Scranton.
Area hospitals on both lists are Geisinger Community Medical Center in Scranton, Geisinger Medical Center in Danville, Hazleton General Hospital, Hazleton Surgery Center, Northeastern Eye Institute in Scranton and Wilkes-Barre General Hospital.
Massachusetts state officials investigating the pharmacy said Tuesday they found shoddy sterilization practices and unclean conditions there, including debris-covered floor mats and standing water from a leaking boiler.
They also said the pharmacy shipped steroids from the possibly contaminated batches suspected in the outbreak before it received its own test results confirming the drugs were sterile.
Gov. Deval Patrick said he's ordered state pharmacy regulators to conduct surprise inspections at companies similar to the NECC and take other steps to tighten oversight. The state also moved to revoke the company's operating license and the licenses of its top three pharmacists.
The outbreak of fungal meningitis, an inflammation of the lining of the brain and spinal cord, has sickened 308 people, including 23 who have died, in 17 states. The outbreak has been linked to a steroid made by the NECC and taken mainly for back pain. Compounding pharmacies like NECC custom mix solutions in doses or forms generally not commercially available.
The federal government is conducting a criminal investigation.
The state said Tuesday that its preliminary investigation, which began last month after the company was first suspected in the growing outbreak, found large batches of drugs ready for general distribution but not labeled for specific patients.
Its state license permits the company to fill prescriptions only for specific patients, and distributing drugs in bulk like a manufacturer would violate that, said Dr. Madeleine Biondolillo, director of the Mass. Department of Public Health's Bureau of Healthcare Safety.
But company attorney Paul Cirel said it's hard to imagine state regulators weren't previously aware of the scale of its operations because they've worked so closely together. The state Board of Pharmacy has always had complete access to the facility, and board members were there as recently as last summer, he said.
Besides possible state license violations, Biondolillo said the inspections also revealed several health and safety deficiencies.
Three lots of steroids produced by the company are suspected in the outbreak, and the company shipped orders from those lots 13 times before receiving the results of its own tests to confirm those lots were sterile. Some medication was shipped as many as 11 days before the company received test results, Biondolillo said.
Biondolillo also detailed signs of flawed sterilization procedures, including black specks of fungus in sealed vials of the steroids, which were returned to the company during a recall.
Investigators found the company didn't sterilize its products long enough or adequately test whether its sterilization equipment was working, she said.
Find the corrected lists at timesleader.com.