State halts drug production at Woburn pharmacy
Firm recalls products deemed tainted
Government inspectors found foreign matter in vials of injectable drugs made by a Woburn compounding pharmacy that regulators had previously cited for a series of problems, prompting the state last week to order a halt to production and request a recall of products, state officials announced Monday.
After the inspection found the contamination Friday, the company, Pallimed Solutions Inc., immediately recalled more than a dozen products distributed in 15 states since Jan. 1.
No reports of patient injuries have been received in the latest incident, but Pallimed was cited last year for producing an overly potent painkiller that caused two patients to be hospitalized, a top state health regulator said. The company also was ordered to stop making a generic form of Viagra last November after a surprise inspection found it was being made with “improper components.”
The latest action, coming a week after wide-scale recalls by two compounders in other states, highlights the continuing concerns about lack of oversight of these specialty pharmacies after 51 deaths and hundreds of cases of fungal meningitis and other serious infections were linked to New England Compounding Center of Framingham.
The state Department of Public Health issued a statement Monday saying the state pharmacy board issued a cease-and-desist order to Pallimed Friday “after foreign matter was observed in vials of injectable drugs.”
State regulators called in the US Food and Drug Administration Friday after waiting months for Pallimed to submit acceptable plans to correct the problems uncovered at the facility in November, which included substandard equipment for producing sterile medications. Each submission, nine in total, was “very flimsy,” said Dr. Madeleine Biondolillo, the state’s director of health care safety and quality.
“In addition to the obvious problems with the site, there were increasing concerns about what they were producing, how they were producing it, and if they were using standards in accordance with the regulations,” Biondolillo said.
She said investigators are trying to figure out how many patients may have received the recalled products. The company was licensed to do business in 13 states, including Massachusetts, Connecticut, Maine, New Hampshire, and Rhode Island, Biondolillo said, but apparently was shipping without a license to at least two others, Nebraska and Vermont.
The recalled drugs, which were supposed to be made using processes to ensure sterility, are used for a number of purposes, including erectile dysfunction and eye conditions. The company promotes one of the recalled products, human chorionic gonadotropin, as part of a fad diet, and others as unproven therapies for children with autism.
Officials said the pharmacy will be allowed to continue making compounded products that do not require sterile processing.
The company said on its website that the drugs were recalled as a precaution. “Please note that we have no indication that any product made by Pallimed is unsafe or that any recalled product has been contaminated,” it said.
Investigators also are trying to determine whether Pallimed was violating its state license by mass-producing drugs, operating more like a manufacturing facility subject to licensing by the FDA.
Chronic shortages of various medications nationwide have forced many hospitals and doctors to rely on compounding companies to produce hard-to-find drugs, but the recent spate of recalls has prompted many to rethink that policy, said Michael Cohen, president of the Institute for Safe Medication Practices, a Pennsylvania nonprofit that has long tracked compounders.
“Just in the last couple of days, I have heard from pharmacists that have written to us letting us know that their hospital leadership has banned them from using outside compounders,” Cohen said. “We need better oversight, and something has to be done quickly.”
State legislative and congressional hearings last fall after the nationwide fungal meningitis outbreak underscored gaps in regulatory oversight between state pharmacy boards and the FDA, which allowed companies like New England Compounding to operate largely unnoticed.
Massachusetts lawmakers plan a State House hearing next Tuesday to review proposals submitted by Governor Deval Patrick and others for improving state oversight of compounders, said Representative Jeffrey Sanchez, a Jamaica Plain Democrat and chairman of the legislature’s Joint Committee on Public Health.
“This conundrum that exists is pretty profound,” said Sanchez, who has been meeting with industry and regulatory officials. “Whatever we do can have an adverse reaction on the patient drug supply.”
The Globe reported in December that the state had ordered Pallimed to stop producing one drug, sildenafil citrate, known by the brand name Viagra, because the product was being made with “improper components.”
Prior to that, state regulators cited Pallimed for producing a super-potent batch of the painkiller lidocaine, which resulted in two patients being hospitalized, Biondolillo disclosed for the first time Monday. State regulators have still not resolved that issue, and recently requested more information from the company, she said.
The FDA said little Monday about the nature and scope of the recall. It was unclear, for example, how many patients could be affected or precisely where the drugs were distributed. FDA spokesman Steven Immergut said the inspection of Pallimed is ongoing.
Pallimed spokesman Scott Farmelant declined to answer specific questions about the recall.
Working with the FDA, companies often issue recall notices that include detailed information about the drugs affected, including lot numbers or the states in which drugs were distributed, information that patients or doctors would need in order to know whether the drug they received should be used. None of that information was included in Pallimed’s news release.
In August, a post on the company’s blog portrayed Pallimed as the state’s largest sterile compounding pharmacy accredited by the national Pharmacy Compounding Accreditation Board. The board suspended Pallimed’s accreditation March 8. Douglas Hoey, the accrediting group’s president, said the board had decided to reexamine Pallimed’s practices after a pharmacist at the company reported receiving a cease-and-desist order.
Hoey said the problems did not present a threat to patients.