Monday, October 29, 2012

Massachusetts Orders Another Pharmacy to Close

Massachusetts shut down another compounding pharmacy after a surprise inspection last week found conditions that called into question the sterility of its products, state officials said Sunday.

The pharmacy, Infusion Resource in Waltham, voluntarily surrendered its license over the weekend, said Dr. Madeleine Biondolillo, director of the Bureau of Health Care Safety and Quality at the Massachusetts Public Health Department. Inspectors who visited Infusion Resource on Tuesday found “significant issues with the environment in which medications were being compounded,” Dr. Biondolillo said during a news conference here. She would not disclose details, but said that in another troubling discovery, patients had apparently been receiving intravenous medications at the pharmacy, against state regulations.

The findings led the state to immediately issue a cease-and-desist order, Dr. Biondolillo said, preventing Infusion Resource from dispensing any drugs. But she added that as of yet, there was no evidence of any contaminated drugs produced there. The latest shutdown comes amid a continuing investigation of New England Compounding Pharmacy, the company believed responsible for a national meningitis outbreak in which 25 people have died, at least 344 others have fallen ill and as many as 14,000 people are thought to have been exposed. State and federal inspections in recent weeks found unsanitary conditions at New England Compounding, from surfaces coated with mold and bacteria to residue on sterilization equipment. New England Compounding has suspended operations and laid off most of its employees.

Gov. Deval Patrick last week directed the state’s Board of Registration in Pharmacy to immediately start unannounced inspections of compounding pharmacies that prepare sterile, injectable medications. There are 25 such pharmacies in Massachusetts, and Mr. Patrick has acknowledged that the state rules governing them were insufficient. Although the Food and Drug Administration can inspect compounding pharmacies and issue warnings, the agency says states have ultimate jurisdiction.

At the news conference on Sunday, Dr. Lauren Smith, the interim commissioner of the Massachusetts Department of Public Health, said the state was bringing on five additional inspectors to help with unannounced visits to compounding pharmacies. The goal is to inspect all of them by Jan. 1, she added. Dr. Smith also said the state had asked Sophia Pasedis, a member of the pharmacy board who works at Ameridose, a sister company to New England Compounding that is also under investigation and currently shut down, to resign from the board. State officials said earlier this month that Ms. Pasedis had recused herself from any board actions concerning New England Compounding and Ameridose. But on Sunday, Dr. Smith said there was “no definitive proof” that Ms. Pasedis, the vice president of regulatory affairs and compliance at Ameridose, had consistently done so.

Ms. Pasedis has so far declined to step down, Dr. Smith said, but her term expires next month. She has been on the pharmacy board since 2004. Dr. Biondolillo said the manager of record at Infusion Resource used to work at Ameridose. Infusion Resource was last inspected by the state when it opened in December 2009, she said, and was found to be in compliance at the time. The state has not received any complaints about the pharmacy since then, she added.

In an e-mailed statement, Bernard F. Lambrese, the chief executive of Infusion Resource, said, “No issues were cited relating to the integrity of our products nor to the quality of our compounding practices.” He added that the pharmacy was working to address concerns cited by the inspectors, including the condition of the flooring in the room where the pharmacy mixes drugs, and would then seek to be relicensed.

Dr. Biondolillo said that Infusion Resource supplies specialized medications to patients after they have been discharged from a hospital. According to its Web site, Infusion Resource is part of a company based in East Providence, R.I. Also on Sunday, Representative Edward J. Markey, a Massachusetts Democrat in whose district New England Compounding is located, issued a report on the practice of compounding that stated there had been “adverse medical incidents” related to compounding in at least 34 states.

Citing F.D.A. records, the report said there had been 23 deaths and at least 86 serious illnesses associated with the practice of compounding. The statistics did not include the current meningitis outbreak. The report also included a review of state pharmacy boards and found that they do not generally undertake enforcement actions that relate to the safety or scope of compounding. Instead, the report said, their focus tends to be more on traditional pharmacy activities, including licensing and controlled substances.

Massachusetts officials have said that tracking volume from compounding pharmacies was not part of their regulatory mandate. But Dr. Smith said the state would soon issue emergency rules requiring compounding pharmacies to submit frequent reports on production and distribution of injectable drugs. “I know that we face great challenges,” she said. “At the same time, though, we have a rare opportunity to create meaningful change.”

NY Times

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