As part of a crackdown after the fungal meningitis outbreak that has killed 25 people, including three in Indiana, Massachusetts officials confirmed Sunday they had closed another compounding pharmacy, Infusion Resource located in Waltham, Massachusetts.
According to state officials, a surprise inspection at Infusion Resource revealed unsanitary conditions where it prepares sterile, injectable medications.
Dr. Madeleine Biondolillo, Director of the Burea of Healthcare Safety and Quality with the Massachusetts Department of Health, said the facility was also administering injections, which it wasn’t licensed to do. However, she did not say any products from the pharmacy were in any way linked to the ongoing outbreak linked to pain injections.
Meanwhile, on Saturday, the Centers for Disease Control and Prevention reported six new cases of fungal disease in the outbreak linked to steroid injections made by the New England Compounding Center in Massachusetts; thus, bringing the total number of cases of infection to 344 in 18 states, with 44 of them being in Indiana as of Sunday, according to the CDC meningitis website. Officials have closed NECC. A separate pharmacy with common ownership, Ameridose, has also closed.
The fungus causes an unusual type of meningitis, which has been found in patients who received steroid injections directly into their spines. Such patients often need months of anti-fungal drug treatment, which can be dangerous and have many 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, said Sunday at a news conference.
“We will continue our aggressive unannounced inspections of compounding pharmacies while also focusing on our ongoing investigations of NECC and Ameridose,” Smith said. She also said the department was adding inspectors and other staff to help take on the workload.
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.