Sixth Street Drugs, a Traverse City pharmacy that is a subsidiary of Munson Healthcare, has agreed to pay $1.5 million and enter into a “Memorandum of Agreement” with the United States Drug Enforcement Administration (DEA) to settle claims that it committed multiple violations of the Controlled Substances Act (CSA). Per a press release issued on Friday afternoon by the U.S. Attorney’s Office Western District of Michigan, Sixth Street Drugs had faced allegations of “filling numerous prescriptions for controlled substances despite red flags that the prescriptions were not valid.”

Under the CSA, a prescription can only be valid if it is “issued for legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.” Pharmacies have a responsibility to look for “red flags” – or any reasonable suspicion that a prescription may not be valid – and to deny any potentially invalid prescriptions. Additionally, in situations where a pharmacist does raise a red flag regarding a prescription, they are legally required to “conduct a further inquiry” to determine prescription validity. Failure to abide by these professional standards can lead to steep penalties for pharmacies or pharmacists, including fines of up to $72,683 per violation.

According to the U.S. Attorneys Office press release, the government launched an investigation into Sixth Street Drugs in 2019, “based on information that [the pharmacy] was an outlier in a number of categories relating to schedule II controlled substances, including its quantities of oxycodone, hydrocodone, morphine, and amphetamine.”

Specifically, the DEA alleged that Sixth Street Drugs and its pharmacists had done the following, per the press release:

·       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.

Representatives from the DEA and the U.S. Attorney’s Office said in the press release that the “overprescribing” of medications by healthcare professionals, as well as “careless behavior and negligence” on the part of pharmacists and other links in the prescription drug chain, are some of the factors that “allow for substances to be diverted and sold on the black market with no measure of accountability.” Drug diversion is one of the major problems that has contributed to the U.S. opioid epidemic.

The new Memorandum of Agreement between Sixth Street Drugs and the DEA mandates that Sixth Street Drugs go through “external controlled substance audits” and implement “a broad-based educational program focused on preventing drug diversion,” among other requirements.

The press release notes that, in reaching the settlement, the government had “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.” The release also concludes with a disclaimer stating: “The claims resolved by the settlement are allegations only and there has been no determination of liability.”