Lab that made tainted steroid shots to get 'CSI' treatment (+video)
Investigators are trying to determine how fungus-tainted steroid shots, produced in a Massachusetts lab, have caused 23 deaths. The lab's safety record is under scrutiny.
Investigators are sifting through records and testing a Massachusetts lab to determine how a fungus associated with a form of meningitis worked its way into products that should have been sterile.Skip to next paragraph
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"It's really 'CSI' stuff," says Eric Kastango, president and owner of ClincalIQ, a New Jersey-based consulting firm that aims to help the industry meet safety standards. "The microoganism in the vials is the same microoganism in the patients. The question is: How did it get in the vials in the pharmacy?"
The incident involves the New England Compounding Center (NECC) in Framingham, Mass., which is no stranger to regulator scrutiny. Records released Monday by the Massachusetts Department of Public Health indicate that the company has been the subject of several complaints and inspections since 1999.
In the current case, large shipments of injectable steroid formulated by NECC have sickened 308 people in 17 states and killed at least 23, according to figures updated on Tuesday by the US Centers for Disease Control in Atlanta. Some 14,000 patients in all may have received contaminated injections.
Compounding pharmacies typically produce limited quantities of medicines whose formulation or dose is tailored to patients – pets as well as people – whose doctors deem as inappropriate treatment standard doses of mass-produced medicine. In addition, hospital pharmacies can tap advanced compounding pharmacies for some of the sterile medicines the hospitals use.
The US hosts more than 7,500 pharmacies that provide advanced compounding services, according to the International Academy of Compounding Pharmacies. Of those, some 3,000 produce sterile compounds.
Contamination incidents involving sterile compounds from compounding pharmacies are rare, but they do happen. Between 1990 and early 2012, at least 21 incidents involving contaminated sterile medicines from compounding pharmacies have occurred, killing 25 patients and leaving more than 120 others with serious side effects, according to a list compiled for the Institute of Safe Medication Practices, based in Horhsam, Pa.
In some ways, the potential for at least tiny amounts of contamination comes with any compounding, acknowledges Kara Weatherman, a pharmacist and clinical assistant professor of pharmacy practice at Purdue University in West Lafayatte, Ind.
"You try to avoid the potential for contamination," she says. "But unless you're working in an environment where there are no particles, there's always a chance that something is going to end up in your product."
In the case of microorganisms such as the fungus in the NECC products, the longer a vial sits around waiting to be shipped or used, the longer the microorganisms have to expand their colony. Testing a product before it leaves the pharmacy to ensure it's sterile can in some cases take up to 14 days – which can be impractical if the shipment is urgent.