NIH shuts down pharmacy after fungus found in vials of cancer drugs

The National Institutes of Health has shut down a pharmacy at its clinical center in Bethesda, Md., after discovering fungus in two vials of cancer medication.

Doctors don't know if any patients received medication contaminated with the fungus, which was discovered in April. But six cancer patients were given medication from the same batch, according to the NIH, which announced the closure Thursday.

"This is a distressing and unacceptable situation," said NIH director Francis Collins. "The fact that patients may have been put in harm's way because of a failure to follow standard operating procedures in the NIH Clinical Center's pharmaceutical development section is deeply troubling. I will personally oversee the steps to protect the safety of patients and remedy the situation as swiftly as possible."

Patients from around the USA travel to the NIH for experimental therapies. About 250 patients in clinical trials were scheduled to receive medication from the pharmacy. Doctors will try to get medication for these patients elsewhere, said Lawrence Tabak, the NIH's principal deputy director.

The NIH facility acts partly as a compounding pharmacy, making special orders of medications that aren't routinely available elsewhere. Concerns about the safety of compounding pharmacies were raised after a 2012 outbreak of fungal meningitis tied to a compounding pharmacy in Massachusetts. In that case, up to 14,000 people may have received the contaminated injections.

Concerns about the NIH pharmacy led someone to file a complaint to the Food and Drug Administration, which inspected the Bethesda facility in May. Inspectors documented numerous problems, including flaws in air handling systems, insufficient employee training and lack of compliance with standard operating procedures.

The shutdown of the NIH pharmacy Thursday is concerning, said Leigh Briscoe-Dwyer, the chief pharmacy and medication safety officer, North Shore-Long Island Jewish Health System.

"Because this is the NIH, the expectation is that standards are higher than you would expect from other sites," Briscoe-Dwyer said. "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."

Briscoe-Dwyer said she is encouraged that Collins will oversee efforts to fix the problems.

"When problems like this are identified, it gives you a chance to fix them," Briscoe-Dwyer said.