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Commentary

Pharmacy Pays $1.5 Million to Resolve Controlled Substances Allegations

Ann W Latner, JD

The Department of Justice announced an agreement whereby Sixth Street Drugs, Inc—a Michigan pharmacy—will pay $1.5 million to the United States “to resolve allegations that it violated the Controlled Substances Act by filling numerous prescriptions for controlled substances despite red flags that the scripts were not valid.”

The pharmacy first came to the attention of the government for being an outlier in several categories related to schedule II controlled substances, including oxycodone, hydrocodone, morphine, and amphetamine. After an administrative inspection in 2019, the Drug Enforcement Administration (DEA) alleged the pharmacy had failed to identify and fix red flags before filling prescriptions.

Per the press release, the allegations against the pharmacy included that it:

  • filled hundreds of prescriptions resulting in dangerous “drug cocktails” for patients, including opioids with benzodiazepines, muscle relaxants, and stimulants;
  • filled prescriptions resulting in patients receiving extraordinarily high opioid doses, far exceeding federal dosage guidance;
  • filled prescriptions for patients who had prescriptions from numerous providers and at numerous pharmacies (patients who were doctor- or pharmacy-shoppers);
  • provided early refills of opioid prescriptions hundreds of times;
  • lacked policies and procedures related to to dispensing controlled substances;
  • filled prescriptions for hundreds of patients who travelled long distances; and
  • filled prescriptions from suspicious providers.

To settle the allegations without an admission of guilty, the pharmacy entered a 3-year agreement with the DEA that lays out the pharmacy’s medication-handling responsibilities, mandates external controlled substances audits, and requires the pharmacy to institute a program for preventing drug diversion. The pharmacy also agreed to a $1.5 million fine (the Controlled Substances Act provides penalties for each violation of over $72,000).

“Prescription drug abuse and diversion—and the overprescribing that often enables them—have caused tremendous damage throughout the Western District of Michigan,” said US Attorney Mark Totten.

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