Tennessee pharmacists would be willing to pay higher licensing fees so that the state pharmacy board could hire more qualified inspectors to inspect drug stores across the state, an industry representative told a state Senate panel Wednesday.
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“Yes, we are willing to pay for quality,” Baeteena M. Black, executive director of the Tennessee Pharmacists Association, told the Senate Health and Welfare Committee.
She made the comments as the Senate panel wrapped up a 90-minute hearing on the nationwide fungal meningitis outbreak that has taken the lives of 45 people nationwide, including 14 who were treated in Tennessee.
Several members of the panel expressed interest in tightening regulation of compounding pharmacies and requiring physicians to record lot numbers of drugs they inject in their patients. The lack of that requirement became apparent as state and federal officials tried to pin down the precise source of the recent outbreak.
Sen. Douglas Henry questioned whether the requirement could be set by regulation or whether a new statute would be necessary.
“We’ve had lots of conversations about how we can do this better,” state Health Commissioner John Dreyzehner told the panel, but he expressed doubts about one member’s suggestion that Tennessee send its own inspectors to out-of-state drug compounders such as the New England Compounding Center, the firm blamed for the meningitis outbreak.
“Something we’ve never done is go outside our borders,” the commissioner said. “Practically, that would be very difficult and expensive.”
Dreyzehner said a partnership between state and federal regulators would be a more favorable approach. He warned that overregulation of the compounding industry could lead to drug shortages.
“We don’t want to create unintended consequences,” he said.
Walking the legislators through a timeline of the fatal outbreak, Dreyzehner said that the use of electronic health records was “critical” in figuring out what was causing the outbreak and how to best treat its victims.
Dr. Donald Reagan, chief medical officer for the health department, said access to the electronic health records allowed state investigators to get a lot more information a lot more quickly.
“Previously, we would have to go on site to review the records,” he said.
Dreyzehner said one difficulty was locating all of the patients who were injected with the methylprednisolone acetate. He noted that 147 of those patients came from Kentucky and several were overseas when the outbreak was discovered. The last patient of the more than 1,000 tracked down was located on Oct. 20, he said.
The commissioner, citing the inspection reports on the conditions at the Framingham, Mass., drug compounding firm, said it was “astounding” that only three lots of the steroid were found to be tainted with the fatal fungus. Citing “a cascade of events” that led to the outbreak, Dreyzehner said, “it could have been entirely avoided.”
Walter F. Roche Jr. can be reached at 615-259-8086 orwroche@tennessean.com.
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