News Release
Date: May 11, 2012
Contact: Rich Isaacson
Number: (313) 234-4310

Omnicare in $50 Million Settlement-Largest Controlled Substance Settlement in History

--Controlled Substances Allegedly Improperly Dispensed at Nursing Homes--

May 11 (Cleveland) – The Justice Department has reached a settlement with Omnicare, Inc. in which the company will pay a $50 million civil penalty to resolve claims its various pharmacy facilities improperly dispensed controlled substances to patients at long-term care facilities across the country, said Drug Enforcement Administration Administrator Michele M. Leonhart and Steven M. Dettelbach, United States Attorney for the Northern District of Ohio.

DEA Administrator Leonhart said: “This case highlights the responsibilities of pharmacists, doctors and others when prescribing or dispensing controlled substances. DEA is committed to protecting the public health and safety by ensuring that those involved in dispensing prescription medications adhere to their responsibilities, and today’s fine demonstrates what can happen when they fail to comply with the law.”

“Federal law provides that doctors, not pharmacies, are the ones who must prescribe these highly controlled substances,” said Dettelbach. “These laws and regulations are designed to balance the need to provide for patients while preventing misuse. This case demonstrates the need to follow those rules closely throughout the industry.”

The settlement resolves civil penalty claims made by the Justice Department against Omnicare that the company violated the Controlled Substances Act between 2007 and the present by:

Routinely dispensing controlled substances to residents of long-term facilities without a prescription signed by a practitioner.
In a limited emergency situation, dispensing controlled substances without an oral prescription called in by a practitioner.
Dispensing controlled substances to residents of long-term facilities from prescriptions missing essential elements, such as drug name, dosage, strength, quantity, DEA registration number and practitioner’s name.
Not properly documenting partially filled prescriptions thus preventing DEA from conducting an audit.
Omnicare is the nation’s leading provider of pharmaceutical care for seniors, serving on a daily basis an estimated 1.4 million residents of skilled nursing, assisted living and other healthcare facilities in 50 states and the District of Columbia.

Federal law and regulations clearly prohibit long-term care pharmacies such as Omnicare from dispensing controlled substances without a valid prescription signed by a physician ordering the medication. In limited “emergency” circumstances, applicable law and regulations provide a special procedure for a prescribing practitioner to call in an oral prescription directly to the pharmacy, followed up within a week by a signed written prescription. Yet Omnicare has routinely accepted facility medical chart orders, oral orders from facility staff and other substitute documents and procedures as bases to dispense controlled substances, instead of requiring signed prescriptions or oral prescriptions directly from the prescribing physician.

“These practices are all-too-prevalent in the long-term care industry and are a violation of federal law,” Dettelbach said. “With today’s settlement, we hope Omnicare will lead industry-wide efforts to establish controls over the dispensation of controlled substances to the elderly.”

The two sides reached an agreement designed to avoid protracted litigation on these claims.

The settlement was reached by the United States Attorney’s Office for the Northern District of Ohio with assistance from the Department of Justice Criminal Division’s Narcotic and Dangerous Drug Section, following an investigation by the DEA’s Cleveland office.

Under the terms of the agreement, Omnicare will pay $50 million to the Office of the United States Attorney for the Northern District of Ohio. This settlement covers any claims across the country. The DEA, in turn, agreed to refrain from instituting, directing, or maintaining any administrative action, including denial, suspension or revocation of Omnicare’s registration.

News from DEA, Domestic Field Divisions, Detroit News Releases 05/11/12