Three compounding pharmacies found to have problems in how they prepared or stored drugs have received cease-and-desist notices from the state Department of Public Health, as part of its ongoing surprise inspections of pharmacies that prepare sterile drugs used in injections. But none of their products has been recalled.
At the same time, the state announced Thursday the appointment of three new pharmacy board members from a variety of health care backgrounds and said a commission that plans to make recommendations to Governor Deval Patrick by the end of the month is considering changes in the board’s structure that could ensure that more members come from outside the pharmacy industry.
“The issues that were identified did not necessitate a recall; it was more around some of the production approaches,” said Dr. Lauren Smith, interim commissioner of the Department of Public Health. “At this point, the rationale for interrupting or requiring the pharmacies to cease their operations is so the investigation can continue.”
The state began the unannounced inspections after contaminated steroids produced by New England Compounding Center of Framingham were blamed for the national meningitis outbreak, which has resulted in at least 36 deaths. In October, regulators issued a cease-and-desist order to Infusion Resource, a Waltham compounding pharmacy. That company is still closed, and the investigation is ongoing, a spokesman for the state health agency said.
Todd Brown, executive director of the Massachusetts Independent Pharmacists Association, said only a small number of his members do sterile compounding.
“The ones I do know that have been inspected, the inspections have gone fairly well,” Brown said. “That doesn’t mean the inspections for everybody or the actions taken by inspectors can’t go over the line and be a little bit overzealous. But I think, given the currrent situation, the Board of Pharmacy is really required to try to make sure the standards are met as much as possible.”
More than a dozen of the state’s 25 compounding pharmacies that prepare sterile injectable drugs have been inspected so far.
OncoMed Pharmaceutical Services of Massachusetts in Waltham received a cease-and-desist order Nov. 21, because of problems with storage of chemotherapy drugs. In a statement, the company said that the problem is a “workplace management issue involving the method of storage for noncompounded medications” and that there was no problem with the drugs.
“The integrity and condition of the medications were never compromised and were never in danger of being compromised,” the statement said.
OncoMed has suspended operations in Waltham and is working to redesign physical space to fix the storage problem. The company is planning renovations with a general contractor, and on Friday morning, company officials will inform the state about those plans.
Pallimed Solutions Pharmacy in Woburn received a partial cease-and-desist order to stop production of one drug, sildenafil citrate, which is known by the brand name Viagra. Regulators said the drug was being made with “improper components.”
James Nahill, the owner of Pallimed, said that he has fully cooperated with the state and emphasized that his pharmacy has never received a complaint about the drug. He added that the issue stems from differing “interpretation of rules and regulations of compounding” and said he is awaiting a hearing date with the state.
“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.”
The Whittier Pharmacist Inc. in Bradford received a partial cease-and-desist order on Nov. 28, to stop sterile compounding. The state said there were “violations in the pharmacy’s sterile compounding operations.” A voicemail left for the company’s management was not returned Thursday.
The three new members of the 11-member pharmacy board include executives from an insurer, a rehabilitation center, and a major hospital system. The new 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.
They fill a vacancy and replace two members whose terms expired, including Sophia Pasedis, an executive with Ameridose, a company that shares ownership with New England Compounding.
As Massachusetts officials focused on ensuring the safety of sterile compounded drugs, one of the states that received drugs linked to fungal infections said patients who received tainted injections from New England Compounding continue to experience problems.
Tennessee officials said Thursday they are worried about the growing number who are developing infections at the site of their steroid injection. These infections — which include arachnoiditis, a painful swelling of membranes that surround the spinal cord — can be dangerous if not treated, Dr. John Dreyzehner, Tennessee public health commissioner, said in a call with reporters.
The infections can eventually progress to meningitis, he said. So far, 107 people in Tennessee have been sickened, and 13 have died.Liz Kowalczyk contributed to this report. Carolyn Y. Johnson can be reached at cjohnson@
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Correction: Because of an editing error, a headline on an earlier version of this story was incorrect. Only one pharmacy has suspended operations. Two others have received partial cease-and-desist orders from the state.