Three Pharmacies Snared By Unannounced State Inspections
The Patrick administration on Thursday replaced three members on the state Board of Pharmacy, including one member who worked at Ameridose in Westborough, and announced three new cease-and-desist orders issued to Massachusetts pharmacies for the improper preparation and storage of drugs.
Inspectors began unannounced spot checks of compounding pharmacies last month as part of the emergency response to tainted steroids traced back to a Framingham pharmacy responsible for a deadly nationwide outbreak of fungal meningitis.
The Board of Pharmacy issued a cease-and-desist notice to OncoMed Pharmaceuticals in Waltham the day before Thanksgiving due to problems found related to the storage of chemotherapy drugs, and is currently working with the lab on a corrective plan, according to the Department of Public Health.
Pallimed Solutions Pharmacy in Boston was also ordered to stop production of sildenafil citrate, a drug used in Viagra and other brand-name treatments for erectile dysfunction, after inspectors found they had been preparing and distributing the medication using improper components.
A third pharmacy – The Whittier Pharmacist in Bradford - was ordered to cease operations until changes were made to bring its sterile compounding operations into compliance with federal standards.
So far, the board has conducted spot checks on more than a dozen pharmacies, finding other "minor deficiencies" that have been corrected or are currently being addressed, according to the Department of Public Health.
Dr. Lauren Smith, the state's interim public health commissioner, also announced an expected shake up of the 11-member board, replacing two members whose terms had expired and filling a third vacancy.
Patrick Gannon, vice president and chief quality officer for Southcoast Health System, will replace Sophia Pasedis. Pasedis had been asked by Patrick to resign because she worked at Westborough-based Ameridose LLC, which is under investigation for its ties to the New England Compounding Center blamed for the meningitis outbreak.
Edmund Taglieri, executive director of the Beaumont Rehabilitation and Skilled Nursing Center, will replace George Cayer, and Jane Franke, senior director of performance improvement innovations at Blue Cross Blue Shield of Massachusetts, has been named to the open seat.
Gannon, Taglieri and Franke will bring a diversity of experience to the board that critics, including Gov. Patrick, expressed concerns about being too insular and heavily represented by pharmacists.
"These respected health care professionals will use their experience to bring change to the Board of Pharmacy to enhance our oversight of this industry. We expect additional changes to the Board after the Commission of Pharmacy Compounding issues its recommendations to Governor Patrick at the end of the month," Smith said in a statement.
The board earlier this week held a public hearing to solicit feedback on the emergency regulations passed in November, and plans a vote within the next month to finalize those changes.
Industry leaders testified that the state should require out-of-state pharmacies doing business in Massachusetts to go through a registration process, and said regulators should allow pharmacies found in violation of state rules to have a hearing a quickly as possible.
The emergency regulations also required for the first time that sterile compounding pharmacies report the volume and distribution figures of their drug operations to the state, helping the board determine whether the pharmacy should be regulated as a manufacturer, which would require an FDA license.
New England Compounding Center was found to be in violation of the state's distribution regulations, shipping large quantities of compounded steroids to other states without specific patient prescriptions.
Unsanitary conditions were also discovered at the lab, contributing to the tainted drugs infecting 541 patients to date and leading to 36 deaths in 19 states. The Board of Pharmacy permanently revoked NECC's license to operate in Massachusetts, and criminal investigations are ongoing.
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