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Rhode Island compounding pharmacy shuttered in wake of fungal meningitis outbreak

Robin Wulffson MD's picture
fungal meningitis, NECC, deaths, contamination, steroid injection

Massachusetts Department of Public Health inspectors shuttered another compounding pharmacy as part of its ongoing investigation of the deadly fungal meningitis outbreak. The Waltham location of Rhode Island-based Infusion Resource was shut down by Massachusetts health officials after inspectors found significant issues with the environment in which the drugs were being mixed. To date, 344 cases of fungal meningitis have been reported, including 25 deaths. Seven of those cases were the result of an injection into a joint rather than the spine. None of those cases have resulted in death. Healthcare facilities across the nation have received steroid vials, which may have been contaminate. A link below provides a complete listing.

According to Dr. Madeleine Biondolillo of the Massachusetts Department of Public Health, the Rhode Island facility was inspected when it first opened in December 2009 and there had been no complaints since the opening. The manager of record at the company was a former employee at Ameridose, which is owned by the same individuals who managed the New England Compounding Center (NECC), the company linked to the fungal meningitis outbreak. The outbreak is due to contaminated vials of the steroid methylprednisolone acetate.

Dr. Biondolillo did not identify the pharmaceuticals or say what specific issues investigators found at Infusion Resource; however, she explained that they were concerned about sterility. The company mixes sterile injectable drugs for patients who have been released from hospitals. Infusion Resource officials have agreed to contact its 40 patients and their physicians and ask them to return any unused medication. Dr. Biondolillo notes that at present that there is no indication any medication the company compounded is unsafe. She added that the facility also had an area to administer intravenous drugs, which it was not licensed to do. She noted that the company voluntarily surrendered its pharmacy license this weekend.

Infusion Resource CEO Bernard F. Lambrese said in a statement that the company will take immediate action to fix issues identified by Massachusetts investigators, including a crack in a window, the condition of flooring in a clean room, and a leak in a refrigerator drain hose. He added, “No issues were cited relating to the integrity of our products nor to the quality of our compounding practices. 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.” He noted that while the Waltham facility is closed, patient needs are being served out of the company’s pharmacy in its main headquarters in East Providence, Rhode Island.

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The surprise inspections were conducted in the wake of the nationwide outbreak of fungal meningitis, an inflammation of the lining of the brain and spinal cord. Dr. Lauren Smith, interim commissioner of the state Department of Public Health, said Sunday that the department is adding five inspectors to help review all compounding pharmacies in the state by the end of the year. Previously pharmacies were inspected only when they opened or if they moved or were the subject of complaints. Smith added that the state pharmacy board, which oversees compounding pharmacies, has asked member Sophia Pasedis to step down. Pasedis, a pharmacy manager for Ameridose, has been on the board since 2004. The state previously said she had recused herself from all matters related to Ameridose and the NECC; however, Smith said minutes from pharmacy board meetings raise questions about whether that is true. She said Pasedis has so far declined to leave the board. Her term ends next month.

Click on this link for a completed list of healthcare facilities that received recalled lots of methylprednisolone acetate from NECC on September 26, 2012.

Massachusetts Department of Public Health

Map Credit: CDC

See also:
FDA reports shocking findings at facility implicated in fungal meningitis cases
Visible fungal specks found in NECC steroid vials
CDC stresses continued vigilance for fungal meningitis
FDA now scrutinizing other NECC products for contamination