CHATTANOOGA, TN (WRCB) -- "It was sheer horror that people died from this and were harmed, our whole purpose is to heal people and help people and make them better."
Randy Davis is the owner of the Wellness Pharmacy in East Brainerd where he gave Channel 3 an inside look at how things work in a compounding pharmacy.
"If you standardize your process and you have quality assurance and stick to the guidelines, these things would have never happened," Davis said.
He is talking about the latest health crisis to capture the country's attention. More than 200 people have been infected in a meningitis outbreak in 14 states including Tennessee, more than a dozen died, including eight from the Volunteer state.
The outbreak of fungal meningitis has been linked to steroid shots for back pain made in a Massachusetts pharmacy. Randy says that would have never had happened at his pharmacy and could have...and should have been prevented.
"We would have made a batch and quarantined it until we found it was sterile, it was potent and pyrogen free, the proper tests shows the fungus is not there," he said.
He says the medication should never have been distributed until those tests are proven. This case has once again raised the issue of federal regulations and guidelines, and is there a need for more oversight when it comes safety at compounding pharmacies?
"Would I object to FDA coming in and standardizing and regulating me, I certainly would," he said when asked. "Why? It's a federal agency, [and] they've got so much to regulate."
Just like in Massachusetts, where a State Board of Pharmacy is responsible for regulation. "We're regulated by the state boards of pharmacies, they can be hands on and see what we do," Davis points out.
But while they come every year for an inspection, such oversight didn't prevent the tragedy in Massachusetts, and many wonder how we can be sure the same thing won't happen here?
Davis points to his PCAP certificate, which shows that his pharmacy has met very strict guidelines and is in the top five percent of compounding pharmacies across the country.
So, bottom line, doctors and patients have to do their homework.
Thursday, December 5 2013 10:58 AM EST2013-12-05 15:58:22 GMT
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