Cincinnati, Ohio-based Omnicare Inc. has agreed to pay the federal government $15.3 million in civil penalties to settle allegations it violated federal law by allowing opioids to be dispensed without a valid prescription, among other charges.
A subsidiary of CVS Health, the company provides “closed-door” pharmacy services, meaning they are not open to the public, to long-term care facilities and nursing homes. As part of its services, the company makes daily deliveries of prescription medicines to residents in long-term care facilities as well as providing limited stockpiles of controlled substances in “emergency kits” for patients to have on an emergency basis.
Those emergency kits contained opioids and other controlled substances, which, according to federal law, required a valid prescription in order to be dispensed.
The federal government alleges that Omnicare violated the federal Controlled Substances Act in the way it handled those emergency prescriptions, in the amount of control it had over the emergency kits and in its processing of the prescriptions for those kits. According to the Drug Enforcement Administration (DEA), some of those prescriptions were written after the long-term care facilities had removed the opioids. Some of the prescriptions lacked the prescriber’s signature or DEA number. The federal government’s investigation into Omnicare also found that it repeatedly failed to document and report emergency prescriptions of Schedule II controlled substances.
“Omnicare failed in its responsibility to ensure proper controls of medications used to treat some of the most vulnerable among us,” said DEA Acting Administrator Uttam Dhillon. “DEA is committed to keeping our communities safe by holding companies like Omnicare accountable for such failures, while ensuring continuity of care and necessary access to emergency prescription drug supplies.”
While the company did not admit to any liability in the settlement, it did agree to pay the penalty and to enter into a Memorandum of Agreement with the DEA that requires the company to increase its auditing and monitoring of emergency kits in long-term care facilities.