Creve Coeur Pharmacy and Owner to Pay $1.4 Million for Ignoring Signs of Illegal Drug Prescriptions
ST. LOUIS – Olive Street Pharmacy, LLC, and pharmacy technician Irina Shlafshteyn, agreed to pay $1,507,808.50 to resolve a civil complaint bringing claims under the False Claims Act and Controlled Substances Act related to the unlawful dispensing of controlled substances, including some that were submitted to Medicaid or Medicare for reimbursement.
According to the civil complaint, Olive Street, a retail pharmacy located in Creve Coeur, Missouri, and Shlafshteyn, partial owner and managing employee, repeatedly dispensed prescriptions for controlled substances while disregarding warning signs of diversion, or “red flags,” indicating the prescriptions were not legitimate. The types of red flags that Olive Street and Shlafshteyn ignored included clear instances of tampering with written prescriptions; dangerous combinations of drugs commonly sought after for recreational purposes; and amounts of opioids that exceeded CDC guidance by as much as 17.5 times the recommended maximum daily dosage.
The complaint also accused Olive Street of routinely dispensing prescriptions for Subsys, an oral fentanyl spray, which is subject to heightened FDA restrictions and indicated only for opioid-tolerant patients experiencing breakthrough pain due to cancer. Olive Street and Shlafshteyn knowingly dispensed high dosages of Subsys to patients who did not qualify for the drug, and that the vast majority of the Subsys Olive Street dispensed was prescribed by Philip Dean, M.D., a Warrenton, Missouri, neurologist, who pleaded guilty to illegally distributing prescription opioids in 2018, including to women with whom he had lived and with whom he had had personal relationships.
Shlafshteyn knew Dean was having intimate relationships with at least one of the women for whom he was prescribing controlled substances. Shlafshteyn and others at her direction continued to dispense Dean’s controlled substance prescriptions to that patient and to other patients of Dean. As the managing employee of Olive Street, Shlafshteyn had the control and authority to effect compliance with the federal regulations.
“Medical professionals have the legal obligation to ensure the dispensing of prescriptions are for legitimate medical purposes,” said Inez Davis, the Drug Enforcement Administration’s Diversion Program Manager for the states of Missouri and Kansas, and southern Illinois. “In this case, the pharmacy abandoned its corresponding responsibility and ignored the clear signs that powerful medications, like oral fentanyl spray, were being prescribed far beyond the recommended guidance. This settlement sends a message that DEA will not accept actions that put people’s lives at risk.”
Shlafshteyn surrendered her Missouri pharmacy technician license effective Sept. 30, 2021, and Olive Street terminated its enrollment in the Transmucosal Immediate Release Fentanyl Risk Evaluation and Mitigation Strategy (TIRF REMS) Program, the FDA-mandated program that had allowed Olive Street to dispense immediate-release fentanyl drugs like Subsys.
Under the settlement agreement, Shlafshteyn is excluded from participating in the federal healthcare programs for a period of 10 years, and Olive Street is bound by the terms of a corporate integrity agreement governing its ability to continue participating in the federal programs.
The DEA investigated this case with the Office of Inspector General of the Department of Health and Human Services, the Federal Bureau of Investigation and the Missouri Attorney General’s Medicaid Fraud Control Unit.