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Tribal pharmacy fined for violating opioid regs

by Daily Inter Lake
| November 20, 2018 5:21 PM

The Confederated Salish and Kootenai Tribes’ Pharmacy must pay a stiff penalty for failing to regulate its distribution of thousands of oxycodone pills.

According to information from the U.S. Attorney’s Office in Missoula, the pharmacy reached an agreement in which the pharmacy will pay a $95,520 civil penalty and take other steps to ensure compliance with federal law and Drug Enforcement Administration regulations, U.S. Attorney Kurt Alme said.

The settlement agreement is the result of an inspection by the federal agency for activity from March 2017 to March 2018. The DEA has the responsibility to inspect pharmacies or medical providers that dispense controlled substances to ensure they are complying with federal regulations. The regulations are designed to prevent the theft or diversion of controlled substances to unauthorized users.

The DEA conducted the inspection after it learned that approximately 2,500 oxycodone pills had been stolen or unaccounted for from the tribes’ pharmacy in St. Ignatius on the Flathead Indian Reservation. During the investigation, the agency discovered significant violations of the regulations, including failing to adequately track records of the controlled substances in the pharmacy and failing to report the missing oxycodone pills to the federal agency.

In addition to the $95,520 penalty, the pharmacy also must take numerous measures to ensure compliance in the future. The pharmacy must conduct annual evaluations of its compliance for three years and certify it is meeting all regulatory requirements. If it has future violations, the pharmacy will be subject to a judgment for the full potential penalty of $240,640 for alleged violations.

“This settlement is an important step toward ensuring that opioids are properly controlled in the CSKT Pharmacy,” Alme said. “For the safety of the community, we need to ensure that the pharmacy is managed responsibly in the future. The penalty puts every pharmacy in Montana on notice that the U.S. Attorney’s Office and DEA will vigorously enforce controlled-substance regulations to prevent diversion of the prescription opioids that are harming our communities.”

Stacy Zinn-Brittain, Drug Enforcement Administration regional agent in charge for Montana said the agency appreciates “the Confederated Salish and Kootenai Tribes taking this issue seriously.

The DEA’s Western Montana Tactical Diversion Squad investigated the case.