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Cardinal Health reaches settlement with DEA
May 15th, 2012
DUBLIN, Ohio – In a settlement with the Drug Enforcement Agency (DEA), Cardinal Health Inc. has agreed to a two-year suspension of its Lakeland, Fla., distribution center's registration to ship controlled substances.
The pharmaceutical distributor said Tuesday that under the settlement it also has agreed to improve certain anti-diversion procedures.
Cardinal noted that the agreement ends ongoing litigation and that the DEA confirmed it plans no further administrative actions at other Cardinal facilities.
The Lakeland distribution center will stay open, and all other operations at the facility will proceed, according to Cardinal.
"This agreement allows us to put this matter behind us and, just as important, will clear the way for a more productive dialogue about how we and others in the health care and regulatory community can work together to prevent the abuse and misuse of prescription drugs," George Barrett, chairman and chief executive officer of Cardinal Health, said in a statement.
In early February, the DEA issued immediate suspension orders (ISOs) to Cardinal's Lakeland facility and four of its pharmacy customers, including two CVS drug stores in Sanford, Fla. The agency claimed that the distribution center failed to control the diversion of controlled substances into other than legitimate channels and didn't perform due diligence to ensure that those drugs weren't diverted.
The DEA alleged in its ISO that Cardinal knew or should have known that the pharmacies were improperly filling prescriptions for nonmedical reasons, citing higher volumes of oxycodone shipments to those pharmacies. The agency reported that the pharmacies were filling prescriptions "far in excess of the legitimate needs of its customers."
According to the DEA, the two CVS stores — located about 5.5 miles apart — together ordered more than 3 million dosage units of oxycodone in the same year, whereas the average U.S. pharmacy in 2011 ordered roughly 69,000 oxycodone dosage units.
The U.S. District Court for the District of Columbia denied Cardinal's Feb. 3 motion for a preliminary injunction against the license suspension for the Lakeland center. But in March the U.S. Court of Appeals for the District of Columbia Circuit agreed to consider an appeal from Cardinal, which temporarily lifted the DEA license suspension.
Cardinal said Tuesday that it will continue its efforts to fight prescription drug abuse. For example, in April, the Cardinal Health Foundation invited nonprofit groups in seven U.S. cities and Puerto Rico to apply for grants to support local efforts to prevent prescription drug abuse and misuse. The foundation also announced a collaboration with The Partnership at Drugfree.org on "Wake Up to Medicine Abuse," a national campaign to curb the abuse of prescription medications.
And for the past two years Cardinal has offered the GenerationRx tool kit, a communications package that pharmacists, educators and local leaders can use to help raise awareness of prescription drug abuse in their communities.