Thursday, September 25, 2014

TN Drug Compounder Forged Prescriptions for Diet Drugs, State Charges

By Walter F. Roche Jr.

The owner of a Cleveland, Tenn. drug compounding pharmacy repeatedly forged prescriptions for a diet drug in her son's name, the state Pharmacy Board has charged.
The forgeries, which took place over a nearly four year period, were just one of several charges that led the state board to summarily suspend the license of Robin Terrero and her pharmacy, The Wellness Store Compounding Center.
In a 13-page order made public Thursday, the board spelled out multiple violations noted by a state inspector in three separate August visits to the pharmacy. The inspections, according to the state, were triggered by a complaint alleging multiple violations filed earlier that month.
The pharmacy did not respond to a request for comment.
While state Health Department officials released the suspension orders, they declined to release the inspection report leading to the regulatory action.
The order of summary suspension states that the inspector found that prescriptions, both new and refills, were left lying on an open counter for customers to retrieve. The pharmacy routinely operated when no pharmacist was present, the order states.
Other allegations include the dispensing of prescription drugs compounded from outdated and deteriorated products, preparation of prescriptions by staffers not licensed or trained to do so and failure to maintain sanitary conditions, even for drugs required to be sterile.
According to the complaint Terrero forged prescriptions for a drug called benzphetamine "in the name of her son and dispensed them herself from The Wellness Store."
In addition, the state charged Terrero, the chief pharmacist and owner, was often absent from the store and even when she was present she failed to provide proper supervision for the staff.
The investigator observed that "Terrero also failed to verify prescriptions being dispensed to patients" or to counsel customers on the use of the drugs being dispensed.
  Other charges include dispensing prescription drugs without a valid prescription and allowing unlicensed staffers to take prescription orders by phone.
"Wellness Store's staff routinely and systematically altered records, including the beyond-use dates on dispensing labels and compounding logs, in order to override software safeguards designed to prevent the use or dispensing of expired products," the order states.
Though state health officials say there have been no reports of illness from injectable drugs dispensed by the Cleveland pharmacy, they are urging consumers not to use any unused remaining doses.
The suspension comes on the second anniversary of a fungal meningitis outbreak caused, according to state and federal regulators, by tainted spinal steroids shipped around the country by a now defunct Massachusetts compounder.
Tennessee was one of the hardest hit in the outbreak with 16 patients dying and 153 sickened.  The outbreak triggered changes in both state and federal laws and regulations governing drug compounders.

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