Just 4 of 37 Massachusetts compounding pharmacies passed surprise health inspections
Surprise state inspections at 37 specialty pharmacies in Massachusetts show that only four have been fully complying with industry safety standards, health officials announced Tuesday, a finding that underscores concerns about the risk of drug contamination.
All 37 are similar to the Framingham compounding pharmacy blamed for the fatal outbreak of fungal meningitis last year.
Serious violations of state pharmacy regulations were found in 11 compounders, prompting the state to temporarily shut down all or part of their operations, while 21 others were cited for more minor violations. The state previously announced that Infusion Resource of Waltham surrendered its license in October after inspectors found “significant issues” in the clean rooms where sterile injectable drugs were prepared.
The Department of Public Health began the inspections in October after New England Compounding Center’s tainted steroids were linked last fall to meningitis and other infections that have sickened nearly 700 people across the country and been blamed for 45 deaths.
Patient safety specialists, who have long advocated for stricter oversight of the industry nationwide, say they are not surprised that only a fraction of the state’s sterile compounding pharmacies, which make injectable and intravenous medications, were obeying all the rules.
“I am sure the same things would be found in other states, not just Massachusetts,” said Michael Cohen, president of the Institute for Safe Medication Practices, a Pennsylvania-based nonprofit.
“If any good can come of this tragedy at all, it is that people have awakened to the risks now.”
Yet, unlike Massachusetts, many states do not require compounding pharmacies to follow nationally accepted safety guidelines, Cohen added.
Compounding pharmacies are supposed to prepare doses and formulations of drugs for individual patients that are not available from drug manufacturers, and sterile compounders make medications that must meet the highest standards of purity.
But state officials have said that New England Compounding Center, the pharmacy that made the contaminated steroids, was mass-producing drugs and making what were supposed to be sterile injections in unsanitary facilities.
New England Compounding shut down in October, and two sister companies with common owners remain closed under temporary orders.
The state did not release reports Tuesday detailing the problems at the more recently cited facilities.
But Madeleine Biondolillo, director of the Health Department’s Bureau of Health Care Safety and Quality, said there is no evidence that patients have been harmed by the pharmacies’ products.
She said the range of problems discovered were not as serious as those uncovered at New England Compounding, where investigators found widespread mold in the clean rooms that produced the supposedly sterile medications.
“It’s not rocket science,” she said in an interview. “You can’t say you are a sterile compounder if you are not comporting to the guidelines.”
Biondolillo said many of the latest problems pinpointed by investigators relate to flaws in the design or operation of the companies’ clean rooms. The state historically had inspected pharmacies only when they open, expand, or receive a complaint, a process that allowed outdated designs or practices to fester until a major problem was reported.
“We are now going at it proactively,” Biondolillo said.
She noted that additional money for inspections was included in Governor Deval Patrick’s proposed budget. He recommended adding $1 million for the Public Health Department to hire more staff to conduct routine inspections of compounding pharmacies.
The governor has also ordered stricter requirements for inspectors, including that all of them be pharmacists with five years of clinical experience.
Dr. Lauren Smith, interim public health commissioner, called the results of the surprise inspections troubling, but said in a statement that the process “has led to significant corrective measures and increased compliance among sterile compounders in Massachusetts.”
Biondolillo said investigators must approve plans to correct problems, which were submitted by each of the 11 compounders issued cease-and-desist orders, before they are allowed to resume operations.
Todd Brown — executive director of the Massachusetts Independent Pharmacists Association, a group that represents many compounders— said that national standards for the pharmacies are open to interpretation, and he believes state inspectors are now cracking down on minor deficiencies that may have been overlooked in the past.
“I can’t fault them for taking the strictest of interpretations,” Brown said. “I totally understand it. But there could be some interpretations that are too strict.”
No products were recalled as a result of the state inspections, although the state did not conduct its own tests of medications produced in the facilities. A number of the facilities produce medications for nursing homes and other long-term care facilities, which could complicate efforts to trace infections or other health issues if a problem was uncovered, said Cohen, the patient safety specialist.
The four Massachusetts sterile compounding pharmacies that fully met state rules, state regulators say, are: Freedom Fertility Pharmacy in Byfield; Coram Healthcare in Norwood; BioRX in Woburn; and Critical Care Systems in Shrewsbury.
Among the pharmacies ordered to shut down all sterile compounding is Home Infusion Solutions in Falmouth.
Pharmacy manager Jim Hermansen said the Dec. 27 order noted that the pharmacy’s clean room was outdated, and that the company needed to replace Formica counters and shelves with more state-of-the-art stainless steel.
He said the state also requires doors that open automatically, to avoid pharmacists having to touch doors while they are preparing sterile medications.
“They may be a little picky in some cases, but the public good is the most important thing,” Hermansen said. “I think it’s a good thing in the long run.”
He said the company has submitted a plan to correct the problems and is awaiting state approval.
Also cited was Baystate Home Infusion and Respiratory Services in Springfield, which is owned by the parent company of Baystate Medical Center, but does not supply compounded drugs for the hospital.
Baystate Health said that the Dec. 12 shutdown of its sterile compounding “was not triggered by any indication of contamination, product-quality issues, or adverse events.”
It said the problems related to “general documentation, standardization of workflow, and infrastructure” and that state regulators approved its plan for corrections in January.Kay Lazar can be reached at email@example.com. Follow her on Twitter @GlobeKayLazar.
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|White Coat Notes covers the latest from the health care industry, hospitals, doctors offices, labs, insurers, and the corridors of government. Chelsea Conaboy previously covered health care for The Philadelphia Inquirer. Write her at firstname.lastname@example.org. Follow her on Twitter: @cconaboy.|
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