One of the nation's largest pharmaceutical distributors has agreed to pay $44 million to resolve federal claims that it did not report suspicious orders of the prescription painkiller oxycodone from pharmacies in Maryland, Florida and New York.
Dublin, Ohio-based Cardinal Health Inc.'s civil settlement is one of the largest ever in a drug diversion case, according to the U.S. Department of Justice.
The settlement comes as federal law enforcement works to curb a stubborn opioid epidemic that was linked to almost 1,100 overdose deaths in Maryland last year. More than 350 were linked directly to prescription painkillers.
The monetary settlement stems from an agreement reached in 2012 that barred the health care services and products company from distributing such prescription painkillers for two years.
"Pharmaceutical suppliers violate the law when they fill unusually large or frequent orders for controlled substances without notifying the DEA," said Rod J. Rosenstein, U.S. attorney for Maryland. "Abuse of pharmaceutical drugs is one of the top federal law enforcement priorities."
The U.S. Drug Enforcement Administration has worked with local authorities to reduce illegal supplies of oxycodone and other addictive prescription painkillers on the streets.
Most states now have prescription drug monitoring programs that doctors and pharmacists can use to see how many prescriptions a patient has obtained. And the U.S. Centers for Disease Control and Prevention has issued guidance for doctors aimed at reducing how much is prescribed.
"These agreements allow us to move forward and continue to focus on working with all participants in addressing the epidemic of prescription drug abuse," Craig Morford, chief legal and compliance officer for Cardinal Health, said in a statement.
"To combat the scourge of opioid abuse successfully, this must be a collaborative effort that includes all parties — the regulators, who set and license supply; the manufacturers, who produce medications; the physicians, who treat patients and prescribe medications; and the pharmacists, who fill those prescriptions," he said.
"Collectively, we must focus on combating the ever-changing tactics employed by those determined to divert medications for illegitimate use."
DEA licenses distributors and pharmacies under the Controlled Substances Act and regulates drugs based on their accepted medical use and their abuse potential. Oxycodone and other opioids are considered Schedule II, which means they have a high potential for abuse and can lead users to become dependent.
As authorities have cracked down on opioid misuse, addicts have increasingly turned to heroin because it has become cheaper and easier to access, said Todd Edwards, a spokesman for the DEA's Baltimore district office.
Overdose deaths related to heroin and fentanyl, a more powerful opioid often mixed with heroin, now cause more deaths than prescription painkillers.
"Many people start their addictions with prescription painkillers, so there is still a big link," Edwards said. "Settlements like the one with Cardinal do send a message. Really the only way the DEA and government can get the message across is to hit a company where it hurts, and that means taking their money."
All large companies, including Cardinal, have so-called anti-diversion programs, where they aim to stop legal drugs from entering the illicit market. Still, Edwards said, many distributors get caught from time to time for failing to maintain effective controls.
Justice officials said Cardinal agreed to implement better security measures as part of the 2012 agreement.
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Cardinal's website reports that it supplies 25,000 pharmacies nationwide and has several distribution facilities. The federal claims stemmed from activity at a facility in Lakeland, Fla.
According to the settlement agreement, Cardinal admitted that from January 2009 to May 2012, it failed to report suspicious orders to the DEA.
The company said in a statement that its anti-diversion program uses "advanced analytics, technology and the deployment of teams of anti-diversion specialists and investigators embedded within our supply chain."
The settlement did not disclose which pharmacies were involved in the suspicious orders, but Justice officials said in Maryland most were CVS pharmacies. CVS Pharmacy Inc. reached its own federal settlement in February.
That settlement claims some CVS stores in Maryland were dispensing oxycodone, fentanyl and hydrocodone without proper prescriptions.
CVS said it has implemented enhanced procedures to ensure that its pharmacists exercise their responsibility to determine whether a controlled substance prescription was issued for a legitimate medical purpose before filling it.