The National Institutes of Health suspended operations at a specialized pharmacy in its clinical center in Bethesda, Md., Thursday. Here are five things to know about the shut-down so far.
1. Six patients may have been exposed to a contaminated drug prepared by the NIH for use in at least 46 clinical trials. That number may rise since 250 individuals are scheduled to participate in the study, although most were not due for immediate treatment, according to the NIH.
2. Following a weeks-long investigation, inspectors from the FDA declared significant operational failures at the NIH pharmacy tasked with drug production. Discovery of fungal contamination in two vials of blood protein albumin produced for testing of the drug interleukin has resulted in an order for the pharmacy to freeze manufacturing immediately, according to the Washington Post.
3. Inadequate quality control, unsanitary conditions and insufficient employee training were among the issues cited by the FDA at the NIH pharmacy.
4. Francis Collins, MD, director of the NIH, called the situation deeply troubling, distressing and unacceptable.
5. The event is sounding the alarm for other healthcare providers and pharmacies. "Because this is the NIH, the expectation is that standards are higher than you would expect from other sites," Leigh Briscoe-Dwyer, the chief pharmacy and medication safety officer of North Shore-Long Island Jewish Health System, told USA Today. "It shows that no one is immune to failing to adhere to standard operating procedures. All of us involved in pharmacy need to pay attention. If it can happen at NIH, it can happen anywhere."
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