Sixth Street Drugs settles $1.5M opiate case

May 29—TRAVERSE CITY — Officials with Munson Healthcare's Sixth Street Drugs, Inc. agreed to pay a $1.5 million settlement and enter into a three-year monitoring agreement with the U.S. Drug Enforcement Administration, following allegations pharmacy staff filled hundreds of prescriptions the DEA called "dangerous drug cocktails."

The DEA began investigating Sixth Street Drugs sometime in or before 2019, after receiving information the pharmacy was an "outlier" in filling prescriptions for a number of controlled substances, including oxycodone, hydrocodone, morphine and amphetamine, according to the U.S. Department of Justice.

While the agreement references allegations of wrongdoing, there has been no determination of liability on Sixth Street Drugs' behalf, though records show Munson officials have agreed to remit two $750,000 payments — the first by June 26, the second within one year — and allow unannounced, warrantless inspections by DEA representatives.

Rachel Roe, Munson Healthcare's chief legal officer, said Friday pharmacists at Sixth Street Drugs filled prescriptions in good faith.

"They believed them to be valid," Roe said. "However, the Department of Justice alleged the pharmacy's practices did not keep pace with the evolving understandings and interpretations of the Federal Controlled Substance Act and how it applies to opioids."

No criminal charges have been announced, though Sixth Street Drugs agreed to cooperate with any ongoing or subsequent investigation of individuals and entities whose potential liability was not released in the agreement, records show.

Sixth Street Drugs must also within 90 days, account for any unallowable costs previously billed to Medicare or Medicaid and agree the U.S. government can recoup any overpayment plus penalties and fees, the agreement states.

Roe declined to confirm whether any Sixth Street Drugs staff were fired as a result of the DEA's investigation, but did say there had been a change in leadership at the pharmacy in 2020. Munson also made a voluntary decision to suspend opioid prescribing at Sixth Street Drugs until further notice, Roe said.

On Aug. 28, 2019, documents show DEA officers executed an administrative inspection warrant at the pharmacy and accessed dispensing records, the results of which were provided to an unnamed consultant pharmacist for review.

As of June 1, 2018, prescribers in Michigan are required to obtain and review a report from the Michigan Automated Prescriber System, known as "MAPS," on a patient prior to prescribing or dispensing that patient more than a three-day supply of a controlled substance.

Yet the consultant pharmacist's review showed the pharmacy routinely filled monthly methadone prescriptions of up to 450 tablets.

Methadone is an opioid used to treat substance use disorder. Information on the U.S. Dept. of Health and Human Services website shows tablets are available in 5, 10 and 40 milligrams and a maintenance dose is generally between 40 and 80 milligrams per day.

"One of the changes that got put into policy was a requirement for the pharmacist to check MAPS before dispensing a prescription," said Dr. Christine Nefcy, Munson Healthcare's chief medical officer. "We do now require that as policy when filling an opioid prescription."

The DEA in summarizing the outside pharmacist's review stated some patients showed up with prescriptions from numerous providers and that the pharmacy regularly provided early refills of opioid prescriptions.

For example, one patient received early refills 74 times, 53 of which were for oxycodone, the review stated. Records reviewed also showed Sixth Street Drugs dispensed prescription medication to patients with prescriptions written by 47 different out-of-state prescribers.

"The presence of red flags of diversion was evident to the pharmacy and its staff but they continued to fill the prescriptions," the review states.

Separate prescriptions of opioids and benzodiazepine were dispensed to 479 patients who received them in a single day; 661 patients received such combinations in the same month, the review found.

U.S. Attorney for the Western District of Michigan, Mark Totten, said overprescribing enables prescription drug abuse and pledged to hold accountable those who do not live up to their legal responsibilities, including pharmacies and physicians.

Kent R. Kleinschmidt, DEA acting special agent in charge for the Detroit Field Division, expressed concerns about how mis-prescribing can allow prescription medication to end up on the black market.

"This is the type of reckless behavior that fuels the opioid epidemic gripping the nation," Kleinschmidt said, in a statement released Thursday by the DOJ.

Approximately 500,000 people died between 1999 and 2019 after overdosing on various forms of opioids, records from the Centers for Disease Control and Prevention show.

Roe said she was not aware of any direct link of an overdose or overdose death tied to Sixth Street Drugs prescribing activity.

The DEA's national opioid prescribing data collected between 2006 and 2014 and first made public by The Washington Post in 2019, shows Sixth Street Drugs received more opioid pills — 4,712,700 — from manufacturers than any other pharmacy in Grand Traverse County.

Of the 4,910 pharmacies in Michigan included in the DEA's data, only 51 received more opioid pills from manufacturers during that same timeframe than Sixth Street Drugs, the data shows.

The DOJ said the government began investigating the pharmacy after data showed it was an outlier in a number of categories relating to schedule II controlled substances, though Roe said the location of the pharmacy helped make those numbers appear more logical.

"Our working assumption was always that was because it is right across the street from the emergency department," Roe said. "The DEA has lots of data available to them. We don't know why they focused on Sixth Street Drugs."

Information included in the three-year agreement from the consultant pharmacist states many patients from Muskegon made repeated five-hour round-trip drives to Sixth Street Drugs to have prescriptions filled. The agreement does not list any other out-of-town location by name.

Roe said Sixth Street pharmacy staff have undergone new training and Sixth Street Drugs continues to follow a policy of not prescribing opioids, at least for the time being.

Nefcy said opioid use disorder is a disease, it is not a personal weakness and the community had a responsibility to eradicate stigma for those who need, and seek, treatment.

"There is absolutely a responsibility on behalf of providers to be careful and thoughtful about what they prescribe," Nefcy said. "It is the responsibility of the pharmacy to ensure that prescriptions they dispense are legitimate and warranted."

Nefcy suggested patients should ask questions of their providers about pain relief dosage and possible alternatives to opioids. She encouraged people to use Munson's medication drop boxes to dispose of unused opioids safely.