Pharmacist says meningitis not caused by lack of standards

Knoxville pharmacist says meningitis outbreak not caused by lack of standards

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Dr. Tim Smith says an extremely sterile, controlled environment is used to prepare medicines Dr. Tim Smith says an extremely sterile, controlled environment is used to prepare medicines
"There was a process breakdown somewhere. There had to be. If not, there's no reason fungus should have been introduced into the sterile product," Dr. Smith said. "There was a process breakdown somewhere. There had to be. If not, there's no reason fungus should have been introduced into the sterile product," Dr. Smith said.

By MONA NAIR
6 News Reporter

KNOXVILLE (WATE) – The Tennessee Department of Health says six people have died from fungal meningitis in the state.

The outbreak has extended to10 states, but Tennessee has the highest number of cases.

Federal authorities tracked the outbreak to possibly contaminated vials of a steroid that is injected into patients for back pain.

The steroid has been traced to New England Compounding Center, a compounding pharmacy based in Massachusetts.

There are similar specialty pharmacies across the country, like P3 Compounding Pharmacy in Knoxville. Pharmacists there custom-make medicines for patients' needs.

The use of compound pharmacies is growing in popularity.

"Typically most folks get in because they have a dosage they need, or they want to avoid preservatives," explained Dr. Tim Smith, the pharmacist who runs the Knoxville facility.

P3 Compounding Pharmacy serves close to a hundred patients a day.

New England Compounding Center shipped tens of thousands of doses across the country.

Dr. Smith says an extremely sterile, controlled environment is used to prepare medicines. In addition to disinfecting all surfaces, even the air is purified to be germ free.

Compounding pharmacies are not regulated by the Food and Drug Administration.

A New York Times article says federal inspectors found a sealed vial at the New England center that contained so much foreign matter it could be seen with the naked eye.

Dr. Smith says compounding pharmacy operations are watched over by an organization called the United States Pharmacopeia, as well as the state.

"They tell us exactly what we need to do from a good practice point of view. Things like testing and training," Dr. Smith explained.

He believed whatever contamination that may have happened at the Massachusetts pharmacy likely did not happen from a lack of standards.

"If you do those things, then you should not have any mistakes or be surprised. The product, if it's sterile, should be clear. There should be nothing on there," Dr. Smith said.

If a sterile setting was used at New England Compounding Center, Smith says, there is no obvious reason for why the outbreak happened.

"There was a process breakdown somewhere. There had to be. If not, there's no reason fungus should have been introduced into the sterile product," he said.

Federal officials say the Massachusetts pharmacy shipped more than 17,000 vials of the potentially contaminated solution to 75 clinics in 23 states.

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