Thursday, January 31, 2013

Pharmacy board: More inspectors needed for sterile compounding

Jan. 31, 2013 5:23 PM, 

Members of the state pharmacy board called for more inspectors on Thursday amid discussions of new rules and potential legislation related to the regulation of sterile compounding.
Currently the board has five inspectors to oversee 1,905 pharmacies. Lawmakers, pharmacy experts and the board have talked in recent months about adding regulations of sterile compounding, the practice of combining multiple drugs for injection. In September, tainted compounded drugs led to a national outbreak of fungal meningitis that has stricken 693 people and led to 45 deaths.
“Until we (add more inspectors), we accomplish nothing,” board member Joyce McDaniel said.
Department of Health Assistant Commissioner for Legislative Affairs Valerie Nagoshiner discussed possible legislation related to sterile compounding that the department may pursue this legislative session. Most notably, the department is considering a bill that would require a separate license for pharmacies that practice sterile compounding.
The purpose of the separate license would be so that officials could get a handle on how many such sterile compounders have a state license. Prior to the outbreak, the board of pharmacy and the Health Department did not know the answer to that question.
Pharmacy board members said legislation could be unnecessary, because the board could require pharmacies to alert the board during the application process if they practice sterile compounding.
At least 352 pharmacies practice sterile compounding in Tennessee, according to the preliminary results of a survey released earlier this month by the pharmacy board.
Nagoshiner also discussed legislation that would allow the Health Department commissioner to suspend a pharmacy from practicing sterile compounding. The commissioner already has the power to shut down nursing homes under an emergency suspension.
But board member Kevin Eidson worried that the commissioner was not a pharmacist and may lack the expertise to make such a call. Eidson, and other board members, suggested that the board already has the power to take such emergency action.
The tainted drugs were linked to Massachusetts-based New England Compounding Center. Eidson said too much time passed — 33 days — before the Tennessee health department gave the pharmacy board the information it needed to take action against NECC and its lead pharmacist, Barry J. Cadden.
“I feel very comfortable about what’s going on in Tennessee (in terms of sterile compounding),” Eidson said. “I’m not comfortable with what’s going on in other states.”
Board president Buddy Stephens said the board would like to inspect each of its pharmacies once per year, and sterile compounders possibly as often as once every six months.
But to accomplish these goals, more inspectors are needed. And those inspectors need to be properly trained regarding sterile compounding practices. Stephens said the board needed approval from the health department to create the new inspector positions.
He instructed the board of pharmacy staff to investigate how much licensure fees would need to increase in order to inspect each of its licensees, including those that operate out of state. At a legislative hearing on sterile compounding earlier this week, the state pharmacy association expressed support for such an increase if necessary.
Already the Iowa pharmacy board has signed off on inspecting its out-of-state pharmacies, and Stephens said Tennessee should consider following suit. Iowa will use the National Association of Boards of Pharmacies to conduct its out-of-state inspections.
Contact Nate Rau at 615-259-8094 or Follow him Twitter @tnnaterau.
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