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VOL. 37 | NO. 5 | Friday, February 01, 2013
State board discusses more pharmacy regulation
NASHVILLE (AP) - Members of the Tennessee Board of Pharmacy discussed several options Thursday to increase oversight of sterile compounding pharmacies after last year's deadly outbreak of fungal meningitis that has sickened hundreds of people across the country.
During a meeting in Nashville, board members weighed proposals from the state Department of Health that included changes to pharmacy licenses and stressed the need for more investigators to ensure facilities were sterile.
Doctors in Tennessee were the first to link the meningitis outbreak to steroid injections prepared by a Massachusetts compounding pharmacy, which also had a pharmacy license in Tennessee until it was revoked. Across the country, 45 people, including 14 in Tennessee, have died after getting the shots.
Valerie Nagoshiner, the Tennessee Department of Health's legislation liaison, asked for the board's input on several suggestions for changes based on their work investigating the outbreak.
One suggestion was creating an alternative licensing for pharmacies that do sterile compounding and more clearly define sterile compounding pharmacies in state regulations. She said that would allow inspectors to focus their efforts on pharmacies that are doing the riskier type of compounding.
"We knew that all pharmacies were compounding to some degree, but we didn't know those that were in sterile compounding that would be falling through the cracks," Nagoshiner said.
Joyce McDaniel, a board member who is not a pharmacist, but represents consumers on the board, said that creating a new licensure wouldn't have necessarily protected patients in the case of NECC.
Compounding pharmacies traditionally create customized medications based on doctors' instructions or in forms that aren't commercially available from drug manufacturers. But NECC was acting like a manufacturer, which are federally licensed, and was producing large ba tches of steroid injections.
"We're talking about manufacturers that were the issue here, and not a local pharmacy," McDaniel said.
Kevin Eidson, a board member and pharmacist, suggested that sterile compounding pharmacies could be identified by a modifier to their license, similar to the modifier required for pharmacists who work with controlled substances.
"We do not need another piece of legislation," he said.
Nagoshiner also suggested giving the health commissioner the authority to instantly suspend sterile compounding at a pharmacy if inspectors found certain safety problems. She said it would be similar to the commissioner's ability to suspend new admissions at nursing homes until corrective action was taken.
But Eidson said he wasn't comfortable with letting Health Department Commissioner John Dreyzehner decide whether to suspend a pharmacy's operations.
"We are the experts as it relates to pharmacy," Eidson said. "Commissioner Dreyz ehner is a physician."
Andrew Holt, the executive director of the board of pharmacy who oversees enforcement state laws pertaining to pharmacy, told the board that five inspectors are responsible for inspecting about 1,900 licensed pharmacies across the state. Holt said based on a recent survey of pharmacies, he estimated there were around 300 to 400 pharmacies doing sterile compounding in the state, but that number could be higher.
"Obviously, we are way understaffed when it comes to investigators," said Charles Stephens, the board president.
Holt said his recommendation is that sterile compounding pharmacies be inspected annually at a minimum, but he said he would have to do some additional research to determine how many more inspectors would be needed to perform those inspections.