Sixth Street Drugs to Pay $1.5 Million to Resolve Alleged Controlled Substances Act Violations
Sixth Street Drugs in Traverse City has agreed to pay $1.5 million and enter a three-year memorandum of agreement with the Drug Enforcement Administration to resolve claims that they violated the Controlled Substances Act by filling invalid prescriptions for controlled substances, according to the United States Department of Justice.
Sixth Street Drugs is a subsidiary of Munson Healthcare.
This comes after the government began investigating Sixth Street Drugs based on information that it was an outlier in a number of categories related to schedule II controlled substances, including quantities of oxycodone, hydrocodone, morphine and amphetamine.
In 2019, the DEA alleged that Sixth Street Drugs failed to identify and resolve many red flags before filling prescriptions, as well as the following:
- Filled hundreds of prescriptions that resulted in patients receiving dangerous drug cocktails (such as opioids with benzodiazepines, muscle relaxants, and/or stimulants);
- Filled prescriptions that resulted in patients receiving extraordinarily high opioid doses that far exceeded federal dosage guidance;
- Filled prescriptions for hundreds of individuals who were traveling long distances to receive prescriptions and to fill them at Sixth Street Drugs;
- Filled prescriptions for many patients who had prescriptions from numerous prescribers and used multiple pharmacies (physician-shopper and pharmacy-shopper patients)
- Filled prescriptions for patients of several 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 dispensing controlled substances.
Under CSA and DEA regulations, for a prescription to be effective, it must be issued for a legitimate medical purpose by an individual practitioner. Pharmacies and pharmacists have a responsibility, according to the United States Department of Justice, to not fill an invalid prescription and are prohibited from dispensing pursuant to an invalid prescription.
When circumstances around a prescription raise a red flag, the pharmacist must conduct further inquiry to ensure the prescription is valid. According to the United States Department of Justice, the CSA has penalties of up to $72,683 for each violation.
As part of the settlement, Sixth Street Drugs has entered into a three year memorandum of agreement with the DEA that prescribes their drug-handling responsibilities, mandates external controlled substance audits and requires Sixth Street Drugs to institute a broad-based educational program with a focus on preventing drug diversion.
“Prescription drug abuse and diversion—and the overprescribing that often enables them—have caused tremendous 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 live up to their legal responsibilities and contribute to this crisis, including pharmacies and physicians.”
In a statement, Dr. Christine Nefcy, MD, FAAP, Chief Medical Officer with Munson Healthcare, said:
“We fully own and acknowledge that we did not meet our own high standards and have continued to learn and evolve our practices as a result. We took immediate action in 2020 to suspend dispensing of all opioid medications at Sixth Street Drugs, which is still in place today, and change leadership at that location. We also engaged two independent third parties to conduct audits of all pharmacies across the entire healthcare system and have implemented new pharmacy processes and protocols based on those audits, and fully retrained all pharmacy staff.
As part of the DEA’s investigation, MHC’s overall hospital pharmacy operations were reviewed and found to be compliant, making this an isolated situation. However, we continue to monitor all pharmacy operations to ensure full compliance and to ensure that this situation never happens again.
…The DOJ has publicly acknowledged our efforts by stating: ‘In reaching this settlement, the government recognized the substantial steps Munson Healthcare took in response to DEA’s investigation to address problems relating to Sixth Street Drugs’ handling of controlled substances.’
Munson Healthcare is, and always has been, committed to filling only legitimate prescriptions and is dedicated to educating our pharmacists and giving them tools to help exercise their professional judgment as they decide whether to fill controlled-substance prescriptions.
For many years, MHC has been at the forefront of combating the opioid crisis in northern Michigan and is committed to increasing our active leadership and participation in a variety of programs to continue to address controlled substance abuse in our community.”