December 7, 2012
Massachusetts Health Regulators Shut Down Three Compounding Pharmacies Due To Safety Concerns
Lawrence LeBlond for redOrbit.com - Your Universe Online
Massachusetts health regulators are continuing to crack down on compounding pharmacies in the wake of the deadliest meningitis outbreak due to contaminated steroidal injections in US history. On Thursday, the Department of Public Health (DPH) found problems at three more compounding facilities in the state and have ordered those pharms to cease and desist operations until further notice.
The notices came as part of the regulator´s ongoing surprise inspections of pharmacies that prepare sterile drugs used in injections. The New England Compounding Center (NECC), the pharm at the forefront of the deadly meningitis outbreak that has claimed no less than 36 lives and infected more than 540 patients, was shut down in October after state health inspectors and the FDA found evidence that the facility shipped out more than 17,000 vials of contaminated steroid injections.
Ameridose, sister pharm to NECC, was also shut down in November following concerns their drugs may also have been contaminated. The company issued a system-wide recall on all its drugs, leaving the healthcare industry with limited options for treating patients around the country.
DPH also ordered the temporary shutdown of Oncomed Pharmaceuticals on November 21 over concerns about how it stored chemotherapy drugs. Partial shutdowns have also come at Pallimed Solutions after it was found the company used improper components in preparing one of its drugs, and Whittier Pharmacist for violations in its sterile compounding operations.
All three of these pharms are working with regulators and are expected to reopen as soon as possible, said David Kibbe, a spokesman for Mass. DPH.
In light of the recent criticism of the Massachusetts Board of Pharmacy for not handling the issue appropriately, DPH is assigning three new members to the board. This move comes after Board Director James D. Coffey was fired for ignoring complaints filed at NECC by the FDA. The other two members will fill expired term positions.
The new board members are: Patrick Gannon, chief quality officer of Southcoast Health System; Jane Franke, senior director of performance improvement innovations at Blue Cross Blue Shield of Massachusetts; and Edmund Taglieri, Jr., executive director of the Beaumont Rehabilitation and Skilled Nursing Center.
"These respected health care professionals will use their experience to bring change to the Board of Pharmacy to enhance our oversight of this industry," said Interim Commissioner Lauren Smith, according to Reuters. "We expect additional changes to the board after the Commission on Pharmacy Compounding issues its recommendations to Governor Deval Patrick at the end of the month."
Smith said the issues seen at the three latest compounding pharmacies had not necessitated a mandatory recall, but were more geared toward the companies´ production approaches. “At this point, the rationale for interrupting or requiring the pharmacies to cease their operations is so the investigation can continue.”
So far, the DPH has inspected about a dozen of the state´s 25 compounding facilities that prepare sterile injectable drugs.
James Nahill, owner of Pallimed, one of the pharms in the DPH probe, said he has fully cooperated with the state; he emphasized that his pharmacy has never received a complaint about the drug. He noted that the current issue revolves around “interpretation of rules and regulations of compounding” and will work to correct any issues the state finds.
“We´re fully committed to working with the board and the inspection,” Nahill said. “Personally, I think that the board is looking at compounding as a safety issue, and every little thing that needs to be investigated should be investigated to its fullest.”
As officials continue to focus their attention on ensuring drug safety in the Massachusetts pharms, one state that has received tainted drugs from NECC said patients who had received spinal injections from these contaminated drugs are continuing to experience health problems.
Tennessee health officials on Thursday said they are now worrying about a growing number of patients who are developing localized infections at the site of their injections. The infections are causing painful swelling of the membranes around the spinal cord, which can be dangerous if left untreated, said Dr. John Dreyzehner, Tenn. Public health commissioner, during an interview with The Boston Globe. These infections can eventually progress to meningitis, he added.
Tennessee remains one of the worst hit states of the 2012 deadly meningitis outbreak, with nearly 100 infections and 13 deaths reported, according to the CDC.