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Waltham pharmacy closed after breach of sanitary regulations

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Section: News

November 2, 2012

A Waltham specialty pharmacy was shut down on Oct. 23 after a surprise inspection in which state inspectors found multiple sanitary violations. Infusion Resource closed after being found in violation of national pharmaceutical standards and Massachusetts regulations. The conditions, officials said, could affect the sterility of the intravenous medications they provide.

The manager of the Infusion Resource was a former employee of Ameridose, according to Dr. Madeleine Biondolillo from the Massachusetts Department of Public Health. Ameridose is owned by the same individuals who ran New England Compounding Center, the Framingham-based pharmacy involved in the recent fungal meningitis outbreak.

“Because there appears to be a business relationship between Ameridose and NECC, and as a precautionary measure … [the] FDA will review whether Ameridose has procedures and facilities necessary to assess the firm’s ability to safely produce and provide sterile drug products,” Commissioner for Global Regulatory Operations and Policy, Deborah Autor said.

The fungal meningitis outbreak, caused by unsanitary lab conditions in the Framingham pharmacy, prompted the inspection. The Waltham pharmacy is not linked to the meningitis outbreaks. Its closure resulted from an inspection prompted by the digressions of NECC.

Governor Deval Patrick announced last week that the state would begin surprise inspections of all Massachusetts pharmacies as well as require annual reports on what they produce and distribute.

The Waltham pharmacy mixed intravenous antibiotic and nutritional IV medication for patients recently released from hospitals or prescriptions in forms or doses not usually on the market. While there is no indication that the medications distributed by the company are unsafe, its 40 patients have been asked to return any unused prescriptions as the company recalls all compounded products produced in the last month.

Upon inspection of the Waltham pharmacy, officials “expressed concern for the sterility of products,” according to Biondolillo, who also said inspectors observed an unlicensed area in the lab meant for giving patients intravenous injections on site. Officials issued a cease-and-desist letter on Oct. 23 and the pharmacy voluntarily surrendered its license a few days later.

Biondolillo noted that the measures were precautionary and there was no evidence that any of the medications distributed by Infusion Resource were contaminated.
The Chief Executive Officer of Infusion Resource, Bernard F. Lambrese, released a statement last week that claimed the company would take immediate action to repair the transgressions identified by Massachusetts investigators.

Although investigators declined to state what the exact issues were, they noted the transgressions did not include any contaminated medication. Lambrese includes on his to-do list a crack in a window, the condition of flooring in a clean room where drugs are mixed and a leak in a refrigerator drain hose. “No issues were cited relating to the integrity of our product,” Lambrese said.

Patients of the Waltham pharmacy are now being served from the company headquarters in Rhode Island.

The surprise inspection followed the discovery of a severely contaminated Framingham lab, which was responsible for a nationwide outbreak of fungal meningitis. The outbreak was linked to a medicinal steroid made by the New England Compounding Company and taken mainly for back pain.

NECC was shut down after contaminated intravenous steroids from their pharmacy killed 25 people. Preservative-free methylprednisolone acetate, used to treat back pain, was shipped to pain clinics in 23 states. More than 14,000 patients were exposed to the potentially contaminated injection.

In the month of October, during seven inspections, investigators found more than 83 of 321 vials of the steroid linked to the nationwide outbreak of fungal meningitis, containing “what appeared to be greenish black foreign matter,” investigators wrote in a recently released report on the pharmacy.

“Seventeen vials from the same bin … were observed to contain what appeared to be white filamentous material,” investigators wrote in their report.

According to the FDA report, there was also a clean room with “reddish-brown and cloudy substances,” a “greenish yellow” and “tarnished discoloration,” as well as “dark particulate” and “white, filamentous substances” lining and covering sterilization surfaces. The ground surrounding a leaking boiler was “soiled with thick white debris and thick black, granular material.”

According to the Legal Examiner, NECC personnel told FDA inspectors that the air conditioning was shut off during non-working hours overnight, which increases the risk of bacteria.

There was no record of NECC decontaminating or keeping its facility clean. Internal NECC clean room records noted the presence of bacteria and mold for some time.

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