Regulators Could Have Stopped Meningitis Outbreak

Tennessee’s top health official today described the steroid contamination that lead to a meningitis outbreak as preventable. But when it comes to tightening regulations on the kind of facility that made them, he urged state legislators to leave those changes to national groups.

Knowing what he does now about the New England Compounding Center, Health Commissioner John Dreyzehner says it’s amazing that only three lots of injections were bad. The job of catching those mistakes belonged to Massachusetts regulators, since that’s where the NECC is located. Which lead to the question at a hearing of the Senate Health Committee: how can Tennessee be sure other states are doing their job?

When asked if he thought Tennessee should vet other state’s policies before allowing their drugs to be used in clinics here, Dreyzehner said he wouldn’t recommend it.

“Practically, that would be very difficult to do and very expensive.”

Instead, he pointed to a proposal from a national organization of state health officials that want to bring the federal government into the process. As important as it is to make targeted improvements to the oversight of compounders, Dreyzehner says going too far could lead to shortages of vital medications.

As talk turned to compounders within the state, the head of the Tennessee Pharmacist Association said her members are willing to pay for more frequent inspections.

Bettina Black said most druggists want their industry to be held to high standards. She praised Tennessee’s policy that says inspectors must themselves be fully trained pharmacists. But she also pointed out that the number of inspectors in the state has stayed the same even as the number of pharmacies has grown.

“Back when I practiced, those inspections were occurring at least annually. Now, because of the increasing number of pharmacies, it’s a little longer between inspections.”

Oversight of Tennessee’s druggists comes from the Pharmacy Board. That’s funded not by taxes, but by the fees pharmacies pay to keep their licenses. Black says her members would welcome higher fees to cover the cost of new inspectors.