Federal agents investigate the offices of New England Compounding Center in Framingham, Mass., Tuesday, Oct. 16, 2012. The company's steroid medication has been linked to a deadly meningitis outbreak. FDA spokesman Steven Immergut says the visit is part of the investigation into the outbreak, which has killed at least 15 people and sickened more than 200 others in 15 states. (AP Photo/The Boston Globe, Barry Chin) BOSTON HERALD OUT, QUINCY OUT (AP)
The New England Compounding Center isn’t the only specialty pharmacy to be shut down due to the growing meningitis outbreak throughout the country.
Massachusetts state officials have closed another compounding pharmacy over sterility concerns after an inspection prompted by the outbreak linked to a different company, they said.
According to Dr. Madeleine Biondolillo of the state Department of Public Health, inspectors went to the Waltham location of Rhode Island-based Infusion Resource last week and found significant issues where the drugs were being mixed.
She said the manager of record at the company was a former employee at Ameridose, which is owned by the same people who ran the New England Compounding Center.
Dr. Biondolillo would not identify the drugs or say which specific issues were found at Infusion Resource. She is also saying there is no indication any medication the company compounded is unsafe.
The company was first inspected in December 2009 when it opened.
There have been no complaints since. Infusion Resource mixes sterile injective drugs for people who have been released from hospitals. It has agreed to contact its 40 patients and their doctors, asking them to return any unused medication. The company voluntarily surrendered its pharmacy license this weekend.
“No issues were cited relating to the integrity of our products nor to the quality of our compounding practices,” said company Chief Executive Officer Bernard F. Lambrese. “I want to reassure our patients and the general public of the safety, purity and efficacy of our solutions produced at our Waltham pharmacy since we were first licensed in 2009. Patient safety is something we take very seriously.”
Lambrese also stated the company will take immediate action to fix any issues identified by investigators, including a window crack, the conditioning of flooring in a clean room and a refrigerator drain hose leak.
Patient needs are being served out of the company’s pharmacy in its main headquarters in East Providence, Rhode Island.
Currently, there are 344 cases of fungal meningitis and 25 deaths throughout the country The outbreak has been linked to a steroid shot made by the New England Compounding Center, which is taken mainly for back pain.
Dr. Lauren Smith, interim commissioner of the state Department of Public Health, said Sunday that the department is adding five inspectors to review all compounding pharmacies in the state by the end of the year.
Smith also stated the Department of Public Health is taking other steps to improve conditions, including proposing regulations to require frequent reports from compounding pharmacies, as well as forming a commission to investigate best practices in other states.
Based on reporting by the Associated Press.
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