Oct. 28, 2012 at 7:01 PM ET
Massachusetts officials said Sunday they had closed another pharmacy as part of a crackdown after an outbreak of fungal disease that has killed 25 people and made 344 sick.
They said a surprise inspection turned up unsanitary conditions at Infusion Resource, a compounding pharmacy in Waltham, Massachusetts that prepares sterile, injectable medications. The facility was also administering injections, something it wasn’t licensed to do, said Dr. Madeleine Biondolillo, director of the state department of health’s Bureau of Healthcare Safety and Quality. Biondolillo did not say any products from the pharmacy were in any way linked to the ongoing outbreak linked to pain injections.
The Centers for Disease Control and Prevention reported six new cases of fungal disease on Saturday in the outbreak traced to steroid injections made by the New England Compounding Center in Massachusetts, bringing the total to 344 cases of infection in 18 states, with 25 deaths. Officials have closed NECC and a separate pharmacy with common ownership, Ameridose, has also closed.
The fungus causes an unusual type of meningitis in some patients who got injections directly into their spines, and patients must undergo weeks or months of treatment with antifungal drugs that themselves can be dangerous, with severe side-effects. State and federal regulators are working to find out how the drugs got contaminated and how the pharmacy managed to operate at such a large scale for so long.
“As our joint investigation with our federal partners into NECC and Ameridose continues, we have launched a series of immediate, on-site inspections of other compounding pharmacies in Massachusetts that prepare sterile injectable medications,” Dr. Lauren Smith, interim commissioner of the Massachusetts Department of Public Health, told a news conference Sunday.
“We will continue our aggressive unannounced inspections of compounding pharmacies while also focusing on our ongoing investigations of NECC and Ameridose.” Smith said the department was adding inspectors and other staff to help take on the workload.
NECC was licensed as a compounding pharmacy, which is supposed to custom-make drugs to order on a per-prescription basis. Instead, officials say, it was mass-producing and distributing drugs to hundreds of clinics treating tens of thousands of patients in two dozen states.
On Friday, the Food and Drug Administration released details of some of its inspections of NECC, and said it found greenish black matter growing in some of the products. The FDA doesn’t regulate compounding pharmacies like it does drug manufacturers, but can look for unclean conditions. The FDA said it found dirt, puddles of water and improper sterilization practices at NECC.
State health agencies are supposed to regulate compounding pharmacies but Massachusetts officials say they didn’t have the power they needed to keep tabs on NECC, which had received several state and federal warnings in recent years. Smith said her department was preparing regulations to require compounding pharmacies to submit frequent reports about sterile, injectable medications -- especially how much they are making and distributing. “This reporting will allow us to better identify large-scale operations acting more as a manufacturer, which requires federal licensure and additional scrutiny,” she said.
“We are also launching a special commission to examine best practices in other states and potential changes to state law or regulations to help us keep pace with an evolving industry and close the regulatory gray area that exists between state and federal oversight."
Infusion Resource, the pharmacy that was closed Sunday, has a branch in Rhode Island, also. "Our patients’ infusion solution needs are being serviced out of our Rhode Island pharmacy located within our main headquarters building in East Providence," Infusion Resource LLC CEO Bernard Lambrese said in a statement.
Biondolillo said inspectors found “significant issues with the environment in which medications were being compounded, which has called into question the company's compliance with nationally accepted pharmacy standards and Massachusetts regulations.” She said while no products have been found to be contaminated, the state has closed the facility because of worries about sterility.
“Additionally, there was an adjacent space set up for giving patients intravenous medications on-site. Infusion Resource does not have an appropriate clinic license to conduct these activities, which is a violation of state regulations,” Biondolillo said.
Infusion Resource said the issues uncovered by the inspectors did not involve its products.
"The compliance issues involve such physical plant issues as a hairline crack discovered in a 4-pane window caused by settling of the anteroom, the condition of the standard clean room flooring, and a leak in a refrigerator drain hose," the company said in a statement.
"The company provides infusion therapy services to patients in home, ambulatory suite or hospital locations, with approximately 80 patients in Massachusetts served from its Waltham location. It does not provide batch compounding services -- rather it compounds for individual patient dosing needs." A spokeswoman added that the on-site space flagged by the researchers was for education, not for delivering infusions.
In a separate matter, Smith also said state pharmacy board member Sophia Pasedis, who is also a manager at Ameridose, had been asked to resign but said she had refused. Smith said Pasedis should have recused herself from any matters concerning Ameridose and NECC but it wasn’t in fact clear that she had. “Given the ongoing investigation, we believe it is in the best interest of the board to have Ms. Pasedis step down," Smith said. “We are considering what actions to take in the interim. “