Tennessee's Health Department is hiring special investigators to keep tabs on the state's compounding pharmacies, which make small-batch, custom drugs. The move is partially in response to the deadly fungal meningitis outbreak of 2012.
Before the situation became a nationwide emergency, the first case of fungal meningitis was discovered in Tennessee, when moldy steroids were being injected into the backs of pain patients. More than 150 were sickened and 16 died in the state.
The compounding pharmacy deemed responsible was in Massachusetts and has since gone bankrupt. The owner was convicted of conspiracy and a pharmacist was cleared of murder charges. But scrutiny has increased on sterile dosages made in Tennessee.
Health Commissioner John Dreyzehner said two specialized investigators will be hired to perform inspections.
"They go on the ground, not only checking facilities, but actually watching how the process is actually done to make sure it's done correctly. So it's time and labor intensive," he said in a recent budget hearing.
Dreyzehner said the opioid epidemic has also dominated the schedules of the state's other pharmacy investigators, which is why he wants dedicated compounding specialists. If approved by the legislature, they'll cost the state a total of $385,000 per year, and would bring the number of pharmacy inspectors to 10. Three were added in 2013 immediately after the fungal meningitis outbreak.
There are also new rules to enforce. As of 2014, compounding pharmacies in Tennessee are required to disclose what drugs they're mixing and to maintain records of the patients to which they were shipped. They also must submit quarterly reports to the state Board of Pharmacy.
The board's executive director, Reginald Dilliard, said inspections of the state's more than 200 sterile compounding pharmacies can last an entire day in some cases. And each one is supposed to get an inspection every year.
"It really does take longer. It was naive on my part," Dilliard said. "We're not just walking into a pharmacy and saying 'everybody good?' "