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State wants pharmacist to resign as a regulator

Surprise inspection closes another facility

The Ameridose firm in Westborough and NewEngland Compounding Center share the same owners.

MARSHALL WOLFF/METROWEST DAILY NEWS/AP

The Ameridose firm in Westborough and NewEngland Compounding Center share the same owners.

The Patrick administration has demanded that Sophia Pasedis, lead pharmacist of a sister company to the Framingham pharmacy at the center of the national meningitis outbreak, resign from the state board that oversees pharmacies, saying board minutes “call into question” whether she recused herself from matters concerning both companies.

State health officials said at a Sunday news conference that Pasedis has refused to step down.

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In a related development, state officials said Sunday another pharmacy, Infusion Resource, a Waltham specialty pharmacy, has been shut down after inspectors found “significant issues” where sterile, injectable medications were being made.

The facility was the first to receive one of the surprise inspections that state officials launched last week of the roughly 25 other compounders that produce sterile injectable medications, similar to New England Compounding Center in Framingham. Officials said there is no evidence of contaminated products at Infusion.

A contaminated steroid made by New England Compounding is suspected of sickening 344 people across 18 states, most of them with fungal meningitis, and killing 25.

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Pasedis, vice president of regulatory affairs and compliance at Ameridose in Westborough, is a member of the state Board of Registration in Pharmacy,which regulates pharmacies, and she is a former president of the board. Ameridose and New England Compounding share the same owners. State pharmacy board records show that New England Compounding repeatedly violated state regulations since 2002, yet received little disciplinary action, raising questions about whether Pasedis may have influenced state oversight of the two companies.

State officials previously said that Pasedis recused herself in any New England Compounding or Ameridose dealings with the board.

“Although Ms. Pasedis has claimed that she did, in fact, recuse herself, which is consistent with the Board staff’s recollection, there is no definitive proof that she did so on certain occasions,” said Dr. Lauren Smith, interim state public health commissioner.

“Given the ongoing investigation, we believe it is in the best interest of the board to have Ms. Pasedis step down,” Smith said. “Thus far, she has declined to do so. Ms. Pasedis’ term expires next month. We are considering what actions to take in the interim.”

Pasedis’ attorney Tom Kiley said that Pasedis, whose term expires in late November, does not intend to step down.

“The reality is that her term is about to expire,” Kiley said. “There isn’t a practical need for her to resign so she is not going to. There is no possibility that she is going to act on [New England Compounding] matters, as she has not” in the past.

Late Sunday, the state released copies of minutes of pharmacy board meetings during the last 10 years in which members discussed New England Compounding, Ameridose or a sister company, Alaunus Pharmaceutical.

The pharmacy board appears to have violated the state’s Open Meeting Law by not releasing the minutes earlier. State law requires boards to release minutes of meetings within 10 days of a request, and the Globe originally requested the minutes of any meetings mentioning New England Compounding, Ameridose, and Alaunus Pharmaceutical on Oct. 11.

A spokesman for the Patrick administration said state investigators are looking into why minutes for two meetings are missing. At one meeting in May 2006, New England Compounding was on the agenda, and the missing minutes appear related to a discussion by the board on whether to revise discipline against New England Compounding for a slew of violations and complaints.

The agenda also shows that Pasedis planned to represent Ameridose before the board — while she was a member — along with co-owner Gregory Conigliaro. Pasedis, who was at that time the proposed manager of record for Ameridose, was applying for a pharmacy license for the company. The company asked for a waiver from regulations that would free Ameridose from having to fill commonly prescribed prescriptions for patients.

Overall, the minutes paint a mixed picture of Pasedis’s involvement in discussions about New England Compounding and Ameridose.

The minutes clearly say she left the room for a number of discussions, including one in September 2004, when the board talked about complaints against New England Compounding and voted to reprimand the company and place it on three years probation — a decision that apparently was later reversed. But during a meeting two months later, on Nov. 23, there is no record that Pasedis recused herself when the board voted unanimously not to weaken the terms of probation against the New England Compounding.

Pasedis was appointed to the pharmacy board in June, 2004, during the height of the first round of state investigations into New England Compounding following several complaints about the company. At that time, she was working at Massachusetts Eye and Ear Infirmary. The minutes show Pasedis was recusing herself from pharmacy board action involving New England Compounding as early as 2004. Kiley said Pasedis was paid by New England Compounding before Ameridose was formed in 2006 to consult on forming Ameridose. Kiley said he did not know how long this consulting arrangement lasted.

Pasedis worked as manager of clinical pharmacy at Mass. Eye and Ear from February 2000 to April 2005. She left that job to become director of pharmacy at South Shore Hospital on April 4, 2005, but she resigned just seven months later, according to the hospitals.

Pasedis has worked at Ameridose since 2005, according to documents reviewed by the state.

She is in her second term on the state pharmacy board, first appointed by former Governor Mitt Romney, and reappointed by Patrick.

A report released Friday by the US Food and Drug Administration depicts lax safety practices at New England Compounding and widespread contamination. The company closed earlier this month.

The state has sought permanent surrender of New England Compounding’s license and that of its three primary pharmacists. It has also temporarily shut down Ameridose as officials investigate its business and operations practices.

State health officials said Sunday that an unannounced inspection Oct. 23 of Infusion Resource in Waltham called into question the company’s compliance with nationally accepted pharmacy standards and Massachusetts regulations.

“Due to the variety of notable findings regarding the conditions of the medication production areas, inspectors expressed concern for the sterility of products,” said Dr. Madeleine Biondolillo, director of the state health department’s Bureau of Healthcare Safety and Quality.

Biondolillo said inspectors also observed an adjacent space in the lab set up for giving patients intravenous medications onsite. She said the company does not have an appropriate clinic license to conduct these activities, and that it is a violation of state regulations.

State health officials issued an immediate cease-and-desist order Oct. 23, she said, preventing the company from dispensing any more medications, and this weekend received the voluntary surrender of Infusion’s license.

Infusion’s primary business is supplying specialized medications for patients after they have been discharged from the hospital, and Biondolillo said the company has agreed to contact all of its approximately 40 patients and their physicians to request any outstanding medications patients have on hand be returned.

“Please note that these actions are precautionary and there is no current evidence of contaminated products at Infusion Resource,” she said.

In a written statement, Bernard Lambrese, chief executive of Infusion Resource, said that the state did not find any issues “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 which has been without incident since 2009,’’ he said. “Patient safety is something we take very seriously.’’

The compliance issues included a hairline crack in a 4-pane window, the condition of the clean room flooring, and a leak in a refrigerator drain hose, he said. Lambrese said the company would work to correct these problems and apply to be relicensed, he said.

The company also said that patients will no longer receive infusions at the Waltham pharmacy.

Smith, the state’s interim health commissioner, said her agency is in the process of adding five inspectors to the pharmacy board to ensure it has enough resources to conduct its new unannounced inspections of compounders, to be completed by Jan. 1.

Smith said they would make the findings publicly available “as part of our larger efforts to ensure that the board maintains the trust of the public.”

Massachusetts congressman Edward J. Markey planned to release a report Monday outlining the roles of state and federal regulators and how the industry “has historically resisted a federal role” in their oversight. A review by his office of pharmacy board records, FDA compliance records, and news reports since 2001 found 23 deaths and 86 serious illnesses linked to compounding pharmacy products, excluding the latest meningitis cases.

Chelsea Conaboy can be reached at cconaboy@ globe.com. Kay Lazar can be reached at klazar@globe.com. Liz Kowalczyk can be reached at kowalczyk@globe.com.
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