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Omnicare today said it will pay the U.S. government $50 million in a civil settlement over the Drug Enforcement Administration?s claims that certain Omnicare pharmacies had errors and deficiencies in dispensing controlled substances.
Omnicare today said it will pay the U.S. government $50 million in a civil settlement over the Drug Enforcement Administration’s (DEA) claims that certain Omnicare pharmacies had errors and deficiencies in dispensing controlled substances.
The settlement releases Omnicare’s long-term care pharmacies from all civil penalty claims by the DEA related to the investigation and “contains no allegation or finding that any controlled substances were unlawfully diverted from the intended patient or that any patient was harmed,” according to a statement from Omnicare. “We believe this settlement provides long-term care pharmacies, long-term care facilities, and prescribers with clear direction regarding the procedures that must be followed when dispensing controlled substances,” said John Figueroa, CEO of Omnicare.
The U.S. Department of Justice originally brought charges against Omnicare after the DEA conducted a criminal investigation of the long-term care pharmacy and several of its current and former employees. The DEA alleged errors and deficiencies in paperwork requirements for controlled substance dispensing at several of Omnicare’s pharmacies in Ohio.
Long-term care pharmacies have historically operated in a less-defined environment for dispensing controlled substances than retail and hospital pharmacy operations, according to Omnicare. “This civil settlement makes it clear that DEA interprets its regulations to require the ordering authorized prescriber to either sign an order containing all of the elements of a valid prescription prior to dispensing, or in limited emergency circumstances for Schedule II controlled substances, to speak directly with the pharmacy prior to dispensing,” according to the Omnicare statement.
While the DEA has approved Omnicare’s use of a reminder letter containing a blank prescription template for emergency and expiring orders, long-term care pharmacies are prohibited from providing the authorized prescriber a template prescription that has been filled out in whole or in part by the pharmacy, according to the settlement.