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DEA Targets Retailers to Stem Rx Drug Abuse 2012-03-17
By Kristina Fiore

After targeting pill mills and unscrupulous doctors in Florida -- the epicenter of the nation's prescription painkiller epidemic, some say -- the Drug Enforcement Administration (DEA) is turning its sights on other points in the drug diversion chain: major distributors and retailers.

Last month, DEA ordered Cardinal Health's wholesale distribution facility in Lakeland, Fla., a halfway point between Tampa and Orlando, to stop dispensing controlled substances such as oxycodone (OxyContin) and hydrocodone (Vicodin) to its 2,500 customers in Florida, Georgia, and South Carolina.

At the same time in early February, it also ordered two CVS pharmacies in Sanford, Fla., just outside of Orlando, to stop distributing these medications.

The agency charged that Cardinal failed to maintain effective controls against diversion and that the CVS pharmacies were filling prescriptions far beyond the legitimate needs of their customers.

DEA spokesperson Mia Ro told MedPage Today that the organization isn't making a special push against retailers or distributors; rather, the orders were brought on by red flags raised by the agency's routine monitoring of registrants.

"We are looking at all different angles and at all different levels [of diversion]," Ro said. "A move towards distributors and pharmacies doesn't mean we're scaling back on doctors or pain clinics."

Ro wouldn't comment on whether the agency would be issuing similar orders to other distributors or retail pharmacies in the near future, but said that scrutiny of these facilities is a routine part of DEA's fight against prescription painkiller abuse.

Trickle Down

On Feb. 2, DEA ordered the two Sanford-based CVS pharmacies, which are about 5.5 miles apart, to stop dispensing controlled substances because the two had ordered unusually large amounts of oxycodone.

While the average pharmacy in the U.S. ordered 69,000 doses of the opioid painkiller in 2011, more than three million doses were ordered between the two pharmacies that year, according to DEA.

They should have known that a large proportion of these pills wasn't being dispensed for legitimate medical purposes, the agency charged.

Indeed, in court documents, two pharmacists admitted their stores dispensed controlled substances when they should have known the prescriptions "were not issued in the usual course of professional practice or for a legitimate medical purpose."

Cardinal Health was served with the stop-distribution order the following day, with DEA alleging the wholesaler wasn't doing enough to monitor its clients.

Its Lakeland, Fla., facility supplies 2,500 pharmacies in Florida, Georgia, and South Carolina, and oxycodone and other painkillers account for less than 10% of the pharmaceuticals it distributes, a Cardinal spokesperson confirmed.

Legal Wrangling

Both companies immediately appealed the DEA's order, and in the following weeks ultimately won legal approval from federal appeals courts to continue distributing oxycodone and other narcotics.

In court documents, Cardinal emphasized that it has stopped shipping controlled medications to more than 350 pharmacies it deemed to be involved in diversion; 160 of these were in Florida. It maintains that it has a "robust" anti-diversion system that involves a team of investigators who ensure customers aren't illegally dispensing medications.

It's not Cardinal's first run-in with the DEA, however. In 2007, the company had to pay $34 million for distributing hydrocodone to rogue Internet pharmacies.

Though Cardinal spokesperson Debbie Mitchell said the company is still waiting on a final decision on its appeal, at this point both Cardinal and the two CVS pharmacies can continue to sell the drugs through April 3, the date of the DEA hearing to decide whether all three will keep their DEA registrations.

Impact on Patients

Were Cardinal and the retail pharmacies to become unable to continue to sell or distribute these products, the impact on patients isn't clear.

Mitchell said Cardinal has contingency distribution plans in place, which immediately ramp up distribution from other facilities around the country -- so it would still be able to supply its clients. Nationwide, the $103 billion company has 24 distribution centers.

Still, Mitchell said that whenever the nation's "fragile healthcare supply" is disrupted, "you run the chance of legitimate patients not getting medications when they need them."

The Florida Department of Health and the Florida Medical Association both declined to comment on how clamping down on major suppliers and pharmacies could impact patients.

Erin Van Sickle, a spokesperson for the Florida Medical Association, said, however, that the organization is continuing its push to help lawmakers and the state health department shut down illegal pain clinics, which are likely to remain a key target in the state's war on prescription painkillers.

DEA spokesperson Ro said all points of diversion remain an important target for investigators: "Everybody has a role" in the epidemic. She declined to comment on whether manufacturers would ever be a target of DEA operations.


 
 
 
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