This is not food related, but the issues seen at this facility that made the contaminated epidurals that led to the fungal meningitis outbreak provide lessons in product and environmental control.
· Firm shipped product before receiving sterility results (results were negative however).
· Firm didn't follow established standards for autoclaving and didn't keep products in the autoclave for the minimum 20 minutes needed to ensure sterility
· Firm didn't thoroughly clean powder hoods used to protect pharmacists while they prepare compounded substances. Investigators observed residual powder within the hood, which could lead to contamination of medications
· Mats designed to trap dirt and other contaminants were visibly soiled, and a leaking boiler next to the clean room caused water to pool around it and adjacent walls, creating conditions that could support contaminant growth, according to the findings.
In the report below, Massachusetts Governor Patrick states that over the years, some pharmacies have evolved from neighborhood drug stores to large-scale manufacturers that sell products across state lines, and that regulations in Massachusetts and at the federal level have not kept pace with the changes. He said that he had directed the pharmacy board to start making unannounced inspections of compounding pharmacies that make sterile injectable medications and strengthen penalties for pharmacies that don't comply with rules.
Not sure I want my local pharmacy making medicine, especially ones that can be injected in me. Dispensing medicine is one thing, but making it, no thanks.
We see this type of thing in food companies as well…the firm expands into a niche outside of their core competency and grow the business, but never become technically competent in that new business. They fail to spend the capital on the facility needed to meet the requirements of producing that product. Then, as more product is shipped, the inevitable production error occurs, impacting far too many.
Report airs problems at firm linked to fungal meningitis outbreakLisa Schnirring Staff Writer
http://www.cidrap.umn.edu/cidrap/content/other/news/oct2412fungal2-jw.htmlOct 24, 2012 (CIDRAP News) – Massachusetts officials yesterday said New England Compounding Center (NECC), the firm linked to a multistate fungal meningitis outbreak, sent shipments from two of the recalled lots before it received sterility testing results.
Investigators also found black particulate matter in several unopened vials of the recalled methylprednisolone acetate, which was used in epidural injections for back pain and injections for peripheral joint problems, according to a report of preliminary investigation findings.
Federal officials have said that as many as 14,000 patients could have been exposed to the recalled injections.
Nine more infections have been reported in the outbreak, raising the number of infections to 317, the US Centers for Disease Control and Prevention (CDC) said today in its latest update. One more death was reported, putting that total at 24, and the number of affected states held steady at 17.
The CDC reported one more joint infection linked to the contaminated steroids, raising that number to five, and it said 54 cases have now been confirmed with lab tests. So far all but two of the infections involve Exserohilum rostratum, a type of black mold that hadn't previously been known to cause meningitis.
In a press conference with reporters yesterday, Madeleine Biondolillo, MD, who directs the Massachusetts Department of Public Health's Bureau of Health Care Safety and Quality, said the investigation began on Sep 25 and involves collaboration with their colleagues at the US Food and Drug Administration (FDA) since Oct 1. She said the investigation is ongoing and that authorities have obtained evidence, reviewed NECC's standard operating procedures, probed the company's records, and interviewed its employees.
NECC didn't label the medications for specific patients, a violation of Massachusetts licensing regulations for compounding pharmacies, Biondolillo said.
According to the Massachusetts Department of Public Health (MDPH) investigation report, NECC's sterility tests on the shipments sent before results came in didn't show contamination. However, investigators said they were still exploring the adequacy of NECC's testing methods.
In addition, authorities found that the company didn't follow established standards for autoclaving and didn't keep products in the autoclave for the minimum 20 minutes needed to ensure sterility.
The report also says NECC didn't thoroughly clean powder hoods used to protect pharmacists while they prepare compounded substances. Investigators observed residual powder within the hood, which could lead to contamination of medications.
Mats designed to trap dirt and other contaminants were visibly soiled, and a leaking boiler next to the clean room caused water to pool around it and adjacent walls, creating conditions that could support contaminant growth, according to the findings.
At the media briefing, Massachusetts governor Deval Patrick said federal officials have launched a criminal investigation into NECC's actions and he announced more steps the state and its Board of Pharmacy have taken in response to the steroid contamination, including permanently revoking NECC's operating license and those of its three principal pharmacists.
"Those whose laboratory practices caused this outbreak should never practice pharmacy or manufacture in Massachusetts again," he said.
Patrick said that, over the years, some pharmacies have evolved from neighborhood drug stores to large-scale manufacturers that sell products across state lines, and that regulations in Massachusetts and at the federal level have not kept pace with the changes. He said that he had directed the pharmacy board to start making unannounced inspections of compounding pharmacies that make sterile injectable medications and strengthen penalties for pharmacies that don't comply with rules.
The state will now require compounding pharmacies in Massachusetts to submit annual production, volume, and distribution reports to make it easier for authorities to flag operations that are acting more like manufacturers, which require federal licensing and extra scrutiny, Patrick said. He added that the state will require compounding pharmacies to report interactions with federal regulators and will form a special commission to examine best practices in other states and what changes may be needed at the federal level.