The University of Michigan Health System has agreed to pay $4.3 million to resolve allegations of mishandling prescription drugs. The claim came after two opioid overdoses involving hospital employees, one of which who died.
The overdoses, which occurred in December 2013, involved use of fentanyl at a U-M health facility.
The settlement, which is the largest of its kind at a hospital in the United States, came after a years-long probe by the Drug Enforcement Administration (DEA) into the hospital’s handling of controlled substances.
The DEA cited the hospital for multiple issues, including failure to report drug thefts to the DEA in a timely manner and poor record keeping of its drug inventory. The DEA also found that many of the facility’s prescription drug practices were in violation of the Controlled Substance Act.
No criminal charges were filed. The settlement is part of a civil lawsuit, and there has been no determination of liability.
“We were not where we needed to be as a regulatory matter and, equally important, as measured against our own high standards,” the hospital said in a statement. “We’ve made multiple, substantial improvements to our pharmacy and controlled substance processes over the last several years and expect to continue those efforts in the future.”
The DEA’s investigation also found that the hospital failed to secure DEA registration for 15 ambulatory care locations in southeast Michigan. These facilities all received narcotics from U-M’s hospital pharmacy, which were dispensed to patients. Failure to register the facilities means that all of the drugs that were distributed from the hospital to the off-site locations were unlawful, according to the DEA.
The investigation revealed that the hospital committed several record-keeping violations, including failure to keep accurate records of certain drugs it acquired, sold and delivered.
As part of the settlement agreement, U-M will enter a three-year agreement with the DEA.