Mass. Acts Against 3 Pharmacies After Inspections
BOSTON (AP) -- Public health officials announced action Thursday against three compounding pharmacies following unannounced inspections that were ordered amid a nationwide fungal meningitis outbreak that was linked to another specialty pharmacy in Massachusetts.
The Department of Public Health said board notices were sent last week to OncoMed Pharmaceutical Services of Waltham; Pallimed Solutions of Woburn; and The Whittier Pharmacist of Haverhill.
However, the agency noted that the board action against the three was not connected to the New England Compounding Center in Framingham, which was linked to the outbreak that federal health officials say killed 36 people and sickened more than 500. The outbreak was linked to contaminated steroid injections from the Framingham pharmacy, which has since closed.
Also Thursday, the department named three new members to the state board that regulates compounding pharmacies. The pharmacies traditionally mix customized medications based on doctors' instructions, turning out specialized products for patients with unusual medical needs. Gov. Deval Patrick had expressed a desire for changes to the board makeup, saying too many members were pharmacists themselves.
In a statement, the health department said OncoMed had problems with the storage of chemotherapy drugs and was issued a cease-and-desist order. OncoMed said the problems pertained to a "workplace management issue" involving the storage of non-compounded medications.
"The integrity and condition of the medications were never compromised, and were never in danger of being compromised," the company said in a statement, adding that it has suspended operations at its Waltham facility and plans to brief state regulators Friday.
Pallimed was ordered to stop production of sildenafil citrate for human use after inspectors found it had been prepared with improper components, the health department said. Sildenafil citrate is sold as Viagra.
But Pallimed owner Jim Nahill said no patient complaints or safety issues have surfaced and the matter may be a question of interpretation on the part of the board.
"We believe we were using appropriate ingredients and we still do, and we want to have a collaborative hearing with the board," Nahill said.
The health department said Whittier was issued a partial cease-and-desist order to halt sterile compounding operations. The agency did not specify any violations. The order is to remain in effect until changes are made to comply with federal standards. A message left with Whittier was not immediately returned.
With the outbreak last fall, Massachusetts officials announced in October that they would begin unannounced inspections. Previously, pharmacies were inspected only when they opened, relocated or were the subject of complaints.
Health officials said on Oct. 28 that the Waltham location of Rhode Island-based Infusion Resources was shut down after a surprise inspection found problems with the environment in which drugs were being produced.
The three new members of the 11-member Massachusetts pharmacy board fill the positions of two members whose terms expired and another that has been vacant.
Patrick Gannon, vice president and chief quality officer for Southcoast Health System, replaces Sophia Pasedis, whose term expired last week. Pasedis declined a request from state officials in October to resign from the board because she worked for Ameridose, a Westborough-based company with the same owners as New England Compounding Center.
Edmund Taglieri, executive director of the Beaumont Rehabilitation and Skilled Nursing Center, will replace long-time board member George Cayer. Jane Franke, senior director of performance improvement innovations at Blue Cross Blue Shield of Massachusetts, will fill the vacant seat.