Minnesota health officials reported that 129 clinics in Minnesota have purchased drugs from the New England Compounding Center, which is now closed and under investigation for its link to a deadly national meningitis outbreak, according to the Star Tribune.
Monday, the Food and Drug Administration warned that several of the company’s drugs had been contaminated. Now the Minnesota Department of Health plans to contact each affected clinic to inform them of potential risks.
As of Wednesday, 247 cases of fungal meningitis and 19 deaths have been linked to the company’s steroids nationally; Minnesota alone has seven confirmed cases and no deaths. But nearly 1,000 Minnesotans have received spinal
injections with the steroid linked to the infections.
Five health care centers in the area — including Fairview Health Services in Minneapolis — have reported purchases of injectable drugs from the NECC and are now working on identifying and contacting patients.
Ryan Davenport, a spokesman for Fairview Health Services, told the Star Tribune the clinic was in the process Tuesday of contacting about 250 patients who received potentially contaminated drugs.
Criminal investigators from the FDA were at the Framingham, Mass., pharmacy Tuesday, looking into possible causes for the
contamination.
The drug is made without preservatives, meaning there was no alcohol or other solution used to kill germs. In addition, the NECC isn’t as tightly regulated as other drug company plants because it’s a compounding pharmacy.
There are multiple speculated causes of the contamination, ranging from batches sitting out for extended periods of time to pharmacy workers failing to properly wash up after breaks to faulty or misused sterilizing
equipment.
The two main types of fungus in the latest outbreak are the commonly found Aspergillus and a black mold called Exserohilum, the main cause of the illness. Normally, people do not get sick from exposure to these fungi, however the spinal injection of steroids for back pain provides a pathway for them to the brain.
Further controversy has emerged with the discovery of the NECC’s lack of a manufacturing and distribution license. Although NECC was only licensed to fill individual prescriptions, it mass-produced drugs and marketed to hospitals and clinics across the country.
Stephen Schondelmeyer, a University of Minnesota professor of pharmaceutical economics, said the real issue is that the NECC was manufacturing without a license to do so. He said legislative attempts to outlaw compounding don’t address the root of the problem.
Schondelmeyer also said NECC didn’t have a wholesale license to sell and hadn’t been inspected by the FDA.
Representatives across the state who purchased from the NECC continue to say they were unaware it was breaking any rules.
But Schondelmeyer insisted that they share the blame.
“Anybody buying drugs from an entity can look up on the Minnesota Board of Pharmacy and identify who has license to distribute,” he said, adding that the NECC is not licensed on this list as a wholesaler.
“There were a lot of steps along the way that could have, would have, should have prevented this,” he said.
—The Associated Press
contributed to this report.
