Florida, which had lax laws governing pain clinics until last year, is at the focal point of prescription painkiller abuse. The state Medical Examiner's Office recorded 4,048 deaths from hydrocodone, hydromorphone, oxycodone and oxymorphone in 2010, up 24% from 2009. Until last year, doctors could dispense the painkillers from their offices. Now doctors must write prescriptions to be filled at pharmacies.
Watching the supply chain
Under the federal Controlled Substances Act, the DEA regulates every link in the supply chain for controlled substances such as oxycodone and hydrocodone, including manufacturers, distributors, doctors and pharmacies. About 1.4 million entities have DEA licenses, called registrations, to handle the controlled pharmaceuticals.
Within the closed system, each license holder has responsibilities to maintain control of the drugs and keep them from getting to illegitimate players, DEA Special Agent Gary Boggs said.
The law requires distributors, such as Cardinal Health, to have systems to detect suspicious orders, which must then be reported to the DEA. The agency repeatedly warns distributors that the size of an order alone triggers the distributor's responsibility to report it to the DEA, Boggs said. Distributors must cut sales to those drugstores with suspicious orders even if they have a valid DEA license, he said.
"If all those players involved are either complicit or not doing their due diligence correctly, that whole system comes tumbling down," Boggs said.
In court documents filed in response to Cardinal's challenge, the DEA calls the company's sales to the four pharmacies "staggeringly high" and says Cardinal ignored red flags raised within its own system to detect suspicious orders.
"Our system did raise questions with these four pharmacies," said Cardinal spokeswoman Debbie Mitchell. "We took decisive action and voluntarily suspended shipments of controlled medicines to two late last year. As for the two national chain pharmacies, we raised questions with their corporate headquarters, which they addressed. CVS subsequently took action to stop filling prescriptions for 22 doctors."
Cardinal argues that volume alone is not enough to determine whether a pharmacy is diverting the drugs, because it does not account for a pharmacy's location, the age and health of the population, and the proximity to hospitals, nursing homes and cancer centers.
"If the problem were that simple, DEA could solve it simply by setting volume limits" on the pharmacies, Cardinal says in a document posted on its website.
Cardinal notes in court papers that it has a robust detection system and has cut off more than 330 pharmacies, including 140 in Florida, over the past four years that it determined posed an unreasonable risk of diversion. Although the company reported the pharmacies to the DEA, most still hold DEA licenses and continue to operate, the company said.
Distributors can act more quickly than law enforcement if they know something is wrong, Boggs said.
"We have to investigate things in a different manner than a company (that) can act on a suspicious order. We have to meet constitutional and legal requirements. They don't have to sell to someone," Boggs said. "They have a moral obligation as keepers of powerful and dangerous substances to make sure those substances are used for legitimate medical purposes."
Looking for 'blatant signs'
According to court papers filed by the DEA and Cardinal, the four pharmacies sold thousands more pills than the average drugstore and had a high proportion of customers paying in cash. An average pharmacy in the USA dispenses 69,000 oxycodone pills a year of varying doses, the DEA said. Fewer than 7% of the patients nationwide pay for their prescriptions with cash.
"You can have the ostrich approach. You can stick your head in the sand and ignore blatant signs," Boggs said. "This company is sitting in a state that has been the epicenter of the problem. It's no secret that the drug of choice is oxycodone. I don't think you have to be that strong of an investigator to put two and two together."
The DEA says Cardinal's Lakeland distribution center shipped 50 times as much oxycodone to its top four customers than it has shipped to its other Florida retail customers. Specifically: