Pharmacies accused of errors and deficiencies in dispensing controlled substances
CINCINNATI (May 11, 2012) In a settlement with the Drug Enforcement Agency, Omnicare, Inc. (NYSE:OCR) has agreed to pay $50 million, the company announced today.
The settlement relates to a previously-disclosed DEA investigation of alleged errors and deficiencies in dispensing controlled substances by certain Omnicare pharmacies.
The $50 million settlement releases Omnicare’s long-term care pharmacies from all civil penalty claims by the DEA related to the investigation. The settlement 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 press release from Omnicare.
While DEA regulations specifically address retail and hospital pharmacy operations, long-term pharmacies have historically operated in a less defined middle ground, dispensing controlled substances on instructions from long-term care facility staff after the staff’s consultation with the ordering authorized prescriber, Omnicare said in its release. 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. Further, while 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.
“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, Omnicare’s Chief Executive Officer.
Omnicare “understands and accepts” the DEA’s efforts to ensure appropriate procedures are followed during the dispensing of controlled substances, he said.
“While requiring authorized prescribers to communicate directly with the pharmacy can potentially cause delay, we have committed ourselves to shortening the time in which nursing home residents receive required medication,” he said.
A new enhancement to the company’s prescriber product, Omnicare has developed “what we believe is the first electronic prescribing application for controlled substances for the institutional market,” Figueroa said. “We believe this offering, which also transmits electronic prescription orders for other non-controlled drugs, will significantly improve the quality of care for our nation’s most vulnerable patient population while ensuring adherence to DEA regulatory interpretations.”