State shuts down Waltham specialty pharmacy

By Kay Lazar, Globe Staff

A Waltham specialty pharmacy, similar to the Framingham pharmacy at the center of the national fungal meningitis outbreak, has been shut down, after inspectors found “significant issues” in the area where sterile, injectable medications were being made, Massachusetts health officials announced at a news conference Sunday afternoon.

They said 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 on 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.

Biondolillo said the investigation into Infusion is in its preliminary stages and the state is working with the company’s manager of record, who is a former employee of Ameridose, a sister company to New England Compounding Center in Framingham, the company at the center of the meningitis outbreak.

A contaminated steroid at New England Compoundin is suspected of sickening 344 people across 18 states and killing 25.

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 in Westborough, which shares the same owners, as officials investigate its business and operations practices.

Sophia Pasedis, pharmacy manager at Ameridose, is also a member of the state Board of Registration in Pharmacy, which regulates pharmacies, and she is a former president of the 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 have said that Pasedis recused herself in any New England Compounding or Ameridose dealings with the board, but after repeated requests for copies of board minutes by The Globe, officials said today that those minutes “call into question” whether Pasedis did in fact recuse herself from New England Compounding and Ameridose matters before the board.

“Although Ms. Pasedis has claimed that she did, in fact, recuse herself , which is consistent with the Board’s staff 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.”

Smith said the state is in the process of adding five additional inspectors to the Board of Pharmacy to ensure it has enough resources to conduct unannounced inspections of the state’s roughly 25 other compounders that produce sterile injectable medications, similar to New England Compounding.

Governor Deval Patrick last week said the state would be conducting surprise inspections of the compounders, and officials said Sunday they intended to have these inspections completed by January 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.”