Meningitis Investigators Eye Link To Compounding Pharmacy
By Phil Williams
Chief Investigative Reporter
NASHVILLE, Tenn. -- NewsChannel 5 has learned that investigators have a theory about the possible source of the fungal meningitis outbreak that's hit Middle Tennessee.
At the top of this list: possible contaminated drugs from an out-of-state compounding pharmacy, a facility that mixes drugs for hospitals and clinics.
It was the same sort of facility that was blamed for a similar outbreak a decade ago. And, once again, area doctors who practice this type of medicine are being told it is once again a possibility.
"Compounding is when a pharmacist prepares a product, following the instructions of a licensed prescriber, generally when the product is not available off the shelf," said pharmacist Robert DeChristoforo in a video posted on YouTube by the U.S. Food and Drug Administration.
The FDA video warns about the possible dangers of relying upon drugs from such compounding pharmacies.
"Pharmacies that are regulated as pharmacies are not subject to FDA regulations on good manufacturing practices, and they may not have the same types of controls that FDA-regulated drug manufacturers have," said Michael Levy, division director for the FDA's Office of Compliance.
In this case, investigators are concerned about a steroid injected directly into the spine, potentially giving the disease a direct path to the brain.
A similar outbreak of fungal meningitis in late 2002 was also blamed on contaminated injectable steroids prepared by a compounding pharmacy. Investigators later discovered "improper performance" of a piece of equipment at the pharmacy, "no testing for sterility" and "inadequate clean room practices."
As a result, a North Carolina woman died and three other patents became ill as a result of the very same injectable steroid drug used in these cases.
That pharmacy, which was based out of South Carolina, ended up filing for bankruptcy.
The name of the compounding pharmacy involved in this case is not known.
A spokesperson for the Tennessee Department of Health confirmed that an out-of-state compounding pharmacy is indeed getting attention from investigators and that it has voluntarily recalled the injectable drugs that it mixed.
But he also cautioned that everything else, including the wipes used to clean the injection point, is being looked at, as well.