Tennessee health officials warn about drugs from Cleveland pharmacy

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AFFECTED CLINICSThese clinics are known to have received injectable medications from Wellness Store Compounding Pharmacy in Cleveland after Jan. 1:• Associates in Spine and Joint Medicine, Cleveland, Tenn.• Cleveland Medical Associates, Cleveland, Tenn.• East Tennessee Vein Clinic, Knoxville, Tenn.• Hollywood Body Spa, Athens, Tenn.• Internal Medicine Group, Cleveland, Tenn.• Kennedy Clinic, Ooltewah, Tenn.• Lynn Garden Weight Loss, Kingsport, Tenn.• Premier Weight Management, LaFollette, Tenn.• Voytik Center for Orthopedics, Cleveland, Tenn.Source: Tennessee Department of HealthWHAT TO DOIf you have drugs produced by the Wellness Store Compounding Pharmacy, do not use them.Do not throw the drugs away. Instead, arrange collection with the Tennessee Department of Health by calling 615-741-2718.If you have used injectable drugs made by the Wellness Store, and you notice pain, swelling or redness at or near an injection site, call your doctor immediately.Source: Tennessee Department of Health

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State health officials are warning patients not to use drugs made in a Cleveland, Tenn., pharmacy after an investigation found a series of major violations in its drug-making process.

The state has suspended the license of the Wellness Store Compounding Pharmacy, located at 3555 Keith St. NW, after investigators found that the pharmacy was using "outdated, deteriorated or otherwise unsafe" ingredients to make eye drops and injectable drugs like steroids and the hormone hCG.

The pharmacist in charge at the Wellness Store, Robin Terrero, also had her license suspended after an investigator found that she "intentionally falsified records," frequently left the pharmacy unattended and illegally dispensed controlled substances using forged prescriptions in her son's name.

At least nine clinics in East Tennessee have received injectable drugs from the Wellness Store since the beginning of this year, and the pharmacy may have supplied some injectable drugs directly to pharmacy customers.

The state has not received word of complications from the drugs, but officials said they were issuing a warning "out of an abundance of caution."

Compounding pharmacies specialize in making small-batch, customized drugs.

There has been increased state and federal scrutiny of compounding pharmacies since a deadly fungal meningitis outbreak in 2012, which killed 16 Tennesseans.

In that case, contaminated drugs came from a large compounding pharmacy in New England.

"That in itself is the obvious reason why we have to have this tremendous oversight in sterile compounders," said Dr. Reggie Dilliard, executive director of the state's Board of Pharmacy, "If it's not done with the most sterile of techniques, there is a severe risk to the patient. Infections can develop from the smallest amount of bacterial contamination."

Still, Dilliard said, such suspensions are "extremely rare."

The Nashville-based attorney hired by the Wellness Store, Frank J. Scanlon, declined to comment on the case Tuesday afternoon, saying the final decision about the pharmacy's license will be decided at a hearing later this fall.

Meanwhile, the pharmacy reopened the retail section of its store this week.

State records show that the Wellness Store has had its pharmacy license since 1997, and that Terrero has had her pharmacist license since 1979.

The investigation began with a complaint in August that the pharmacy was not being supervised properly.

When Tennessee Board of Pharmacy Investigator Rebecca Moak showed up at the Wellness Store, no pharmacist was present, even though prescription drugs were bagged and ready for patient pickup. She later found that this was routinely the case, the state's suspension order says.

The investigation also found that drugs were being made with "outdated" ingredients in an area that had an unsealed floor, exposed wallboard and an unsealed door.

Moak discovered that the store's staff "routinely and systematically altered records ... in order to override software safeguards designed to prevent the dispensing of expired products."

In addition, the report said, Moak found that Terrero has forged prescriptions for benzphetamine -- a weight loss drug -- in the name of her son, then dispensed them from the store over the past four years.

State officials say the "questionable medications" made at the store include prescription eye drops and both injectable and implantable products. They include steroids, vitamin B12, amino acids, and hormones like hCG. Most were provided directly to physicians.

The pharmacy was ordered to stop making medicines on Aug. 28, and its license was suspended in an emergency hearing on Sept. 10. That action was upheld by the state's full board one week later. The Board of Pharmacy will meet later this fall to determine the final status of the pharmacy's license.

State records show Terrero has been penalized once before, in 2013, for practicing on an expired license.

Contact staff writer Kate Harrison Belz at kbelz@timesfreepress.com or 423-757-6673.

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