A federal judge ruled that a Cardinal Health facility must stop distributing controlled substances based on massive shipments of oxycodone to 4 pharmacies.
A federal judge ruled yesterday that the Drug Enforcement Administration (DEA) can suspend distribution of controlled substances from Cardinal Health Inc’s facility in Lakeland, Florida, based on allegations that it failed to exert the required level of control over distribution of the narcotic painkiller oxycodone. The DEA initially ordered the suspension on February 3, but Judge Reggie Walton of the US District Court for the District of Columbia had issued a temporary restraining order to allow the company to argue its case.
The DEA-ordered suspension was based on extremely large shipments of oxycodone from the facility to 4 Florida pharmacies: Gulf Coast Medical Pharmacy in Fort Myers, Brooks Pharmacy in Bonita Springs, and 2 CVS pharmacies, both in Sanford. According to the DEA, the CVS pharmacies, which are 5.5 miles apart, prescribed more than 3 million dosage units of oxycodone combined in 2011, when the average US pharmacy ordered approximately 69,000 dosage units of the drug. USA Today
reports that Cardinal Health’s shipments of oxycodone to Gulf Coast Pharmacy skyrocketed to 2 million pills in 2011, up 868% from 2009. Shipments to Brooks Pharmacy grew as well, tripling from 231,740 pills in 2009 to 724,500 pills in 2010.
The DEA argued that the size of Cardinal Health’s shipments to these pharmacies was “staggeringly high” and that the company ignored clear signs that something was amiss. Among the indications of inappropriate prescribing practices at the CVS pharmacies, according to USA Today
, included an unusually high portion of patients paying cash for oxycodone prescriptions (over 40% at each, compared with 7% for all prescriptions nationwide), multiple prescriptions from a single doctor using the same diagnosis code, and frequent prescriptions from a single doctor for multiple people at the same address.
Cardinal Health has argued that it has one of the best drug diversion control systems in the pharmaceutical distribution industry and that it rebuilt its systems and hired new personnel after the DEA suspended its license to distribute controlled substances from the Lakeland facility in December 2007. (That suspension was due to distribution of hydrocodone to Internet pharmacies, which along with other actions led to the company paying a $34 million fine.)
The company has also pointed out that it halted distribution of controlled substances to Brooks Pharmacy and Gulf Coast Medical Pharmacy late last year and halted distribution to the CVS pharmacies immediately after the DEA issued its suspension order. Over the last 4 years, the company has stopped shipping controlled substances to at least 340 pharmacies nationwide, including at least 140 in Florida alone. In addition, the company has argued that the sheer quantity of oxycodone shipped to the 4 pharmacies is not conclusive evidence of inappropriate distribution, given that the needs of pharmacies vary.
Nonetheless, the DEA argued that allowing Cardinal Health’s Lakeland facility to continue distributing controlled substances constituted “an imminent danger to public safety,” and Judge Walton agreed. “The government has a particular interest in ensuring that the public is not harmed by these types of dangerous substances,” Walton said after a 2-hour hearing, according to Bloomberg
A DEA administrative hearing to help determine whether the Lakeland facility will retain its license to distribute controlled substances is scheduled to begin April 3 and could last up to a year. In the meantime, Cardinal Health announced yesterday that it would appeal Walton’s ruling to the US Court of Appeals for the District of Columbia Circuit.
“We have genuine respect for the work of the DEA, but effectively addressing prescription drug abuse requires a very different approach than does the war on illicit drugs,” the company said in a statement. “We want to work collaboratively with all participants in the drug supply chain—including regulators, pharmaceutical manufacturers, distributors, pharmacists, doctors, and boards of pharmacy— to combat this serious nationwide issue.”
Florida has been at the epicenter of the nation’s prescription drug abuse problem, with the state Medical Examiner’s Office recording 4,048 deaths from hydrocodone, hydromorphone, oxycodone and oxymorphone in 2010, up 24% from 2009, according to USA Today
. Up until last year, doctors in the state could distribute painkillers from their offices, although they now have to write prescriptions to be filled at a pharmacy.
Check out more of our coverage of Florida’s prescription drug abuse problem here:
Is Florida's Oxycodone Problem Under Control?
Drug Diversion and Abuse: Florida's Prescription Drug Epidemic