Sixth Street Drugs agrees to pay $1.5 million to resolve allegations that it filled illegitimate prescriptions for controlled substances | USAO-WDMI
The pharmacy will also be subject to a three-year memorandum of understanding with the Drug Enforcement Administration.
BIG RAPIDS – Sixth Street Drugs, Inc., a subsidiary of Munson Healthcare located in Traverse City, Michigan, has agreed to pay US$1.5 million and enter into a three-year memorandum of understanding with the Drug Enforcement Administration (DEA) to resolve allegations that it violated the Controlled Substances Act (CSA) by filling numerous prescriptions for controlled substances despite red flags that the prescriptions were invalid.
According to CSA and DEA regulations, for a prescription to be valid, it must be issued for a legitimate medical purpose by an individual practitioner acting within the usual scope of his or her professional practice. Pharmacies and pharmacists are responsible for not filling an invalid prescription and are prohibited from dispensing under an invalid prescription. When the circumstances surrounding a prescription trigger a red flag, i.e. a reasonable suspicion that the prescription is invalid, the pharmacist should investigate further to ensure that the prescription is valid. The CSA provides significant penalties, currently up to $72,683.00 for each violation.
The government began investigating Sixth Street Drugs based on information that it was an outlier in a number of Schedule II controlled substance categories, including its amounts of oxycodone. , hydrocodone, morphine and amphetamine. Following an administrative inspection in 2019, the DEA alleged that Sixth Street Drugs failed to identify and resolve numerous red flags before filling prescriptions. Among other things, the DEA argued that Sixth Street Drugs:
- filled hundreds of prescriptions that resulted in patients receiving dangerous drug cocktails (such as opioids with benzodiazepines, muscle relaxants and/or stimulants);
- prescriptions filled that allowed patients to receive extraordinarily high doses of opioids that far exceeded federal dosing recommendations;
- filled prescriptions for hundreds of people who traveled long distances to receive prescriptions and fill them at Sixth Street Drugs;
- filled prescriptions for many patients who had prescriptions from many prescribers and used multiple pharmacies (doctor-buyer and pharmacy-buyer patients);
- filled prescriptions for patients from multiple providers who issued suspicious prescriptions and have since been sanctioned by state and federal authorities;
- provided early refills of opioid prescriptions on hundreds of occasions; and
- lacked appropriate written policies and procedures relating to the distribution of controlled substances.
As part of the settlement, Sixth Street Drugs entered into a three-year memorandum of understanding with the DEA that, among other things, prescribes Sixth Street Drugs’ drug handling responsibilities, mandates external substance audits controlled and requires Sixth Street Drugs to implement a comprehensive educational program focused on the prevention of drug diversion. In reaching this settlement, the government recognized the important steps taken by Munson Healthcare in response to the DEA investigation to address issues related to the handling of substances controlled by Sixth Street Drugs.
“The abuse and diversion of prescription drugs — and the overprescribing that often allows them — has caused enormous damage throughout the Western District of Michigan,” said U.S. Attorney Mark Totten. “My office will continue to investigate and hold accountable those who fail to meet their legal responsibilities and contribute to this crisis, including pharmacies and doctors.”
Kent R. Kleinschmidt, DEA Acting Special Agent in Charge of the Detroit Field Division, said, “Reckless behavior and negligence allow substances to be diverted and sold on the black market without measure of accountability. It’s the type of reckless behavior that’s fueling the country’s opioid epidemic. The DEA is committed to prosecuting anyone who fails to meet its obligations to protect controlled substances.
The resolutions achieved in this case are the result of a coordinated effort between the US Attorney’s Office for the Western District of Michigan and the DEA. The case was investigated by the DEA’s Grand Rapids District Office Tactical Diversion Squad. The United States was represented by Assistant United States Attorney Ryan Cobb.
The claims resolved by the settlement are allegations only and no liability has been determined.