Pubdate: Tue, 21 Feb 2012 Source: Wall Street Journal (US) Copyright: 2012 Dow Jones & Company, Inc. Contact: http://www.wsj.com/ Details: http://www.mapinc.org/media/487 Authors: Timothy W. Martin and Devlin Barrett Bookmark: http://www.mapinc.org/oxycontin.htm (Oxycontin/Oxycodone) RED FLAGS IGNORED, DEA SAYS Agency Says CVS and Cardinal Health Knew of Hefty Painkiller Orders The federal government alleges Cardinal Health Inc. and CVS Caremark Corp. were aware of high-volume orders of prescription painkiller oxycodone shipped to two pharmacies in Florida, in a closely watched case probing how much responsibility companies bear for a growing drug-abuse problem. The allegations were made in written declarations filed in federal court earlier this month by the Drug Enforcement Administration. The declarations allege that drug distributor Cardinal repeatedly overlooked escalating oxycodone orders placed by the two Central Florida pharmacies. Cardinal failed to conduct on-site visits and frequently delivered more pills per month than the company's own limits allowed, the DEA said. The agency monitors production, sales and distribution of oxycodone because the drug is widely abused and can be highly addictive. The DEA moved earlier this month to revoke controlled-medication licenses at one Cardinal distribution facility and four pharmacies - including two Sanford, Fla., stores owned by drugstore chain CVS. Two other, independent pharmacies in Sanford that came under scrutiny in the same case voluntarily surrendered their controlled-substance licenses. The two CVS pharmacies and Cardinal won a temporary injunction against the agency's effort to pull their licenses. The DEA is hoping the evidence detailed in its filings will persuade a federal judge to remove the injunction. Judge Reggie Walton at the U.S. district court in Washington didn't make any final decisions in the civil case after a hearing last week. He scheduled a follow-up hearing for later this month. According to the DEA declarations, one of the CVS stores in Sanford reported that 58% of oxycodone prescriptions were paid for in cash between January 2010 and mid-October 2011, including some totaling more than $200. That proportion is more than eight times the 6.9% rate at which all prescriptions nationwide are paid for in cash, according to IMS Health Inc., which tracks drug sales. Law-enforcement officials say a high percentage of cash payments may signal potential diversion of a drug for nonmedical use. A pharmacist at the same CVS told the DEA that its oxycodone customers were "shady," and said some prescriptions were probably not legitimate, according to the DEA declarations. Cardinal approved a ninefold increase in its supply of the drug to the other CVS store over a one-year period in 2009. The next year, it shot up 63% to more than two million dosages, the DEA declarations said. A Cardinal "site visit would have revealed that a significant portion" of CVS customers were "not using [oxycodone] for legitimate purposes," according to the DEA declarations. During the DEA's own on-site investigation at one CVS, "approximately every third car" through the drive-through lane carried scrips for painkillers, according to the declarations. A pharmacist at the same pharmacy interviewed by DEA agents said customers often requested certain brands of oxycodone "using street slang." The DEA declarations don't include proof that the painkillers were used illegally, but claim that there was a lack of scrutiny of the high-volume purchases. Cardinal, the nation's No. 2 drug distributor with more than $100 billion in revenue last year, has denied wrongdoing. In an emailed statement Wednesday, Cardinal Chief Executive George Barrett said, "We want to work collaboratively with all participants in the drug-supply chain - to help stop abuse, not legitimate use." A spokeswoman for CVS Caremark said the company is "unwavering in our support of the measures taken by federal and state law-enforcement officials to combat drug abuse." CVS said the two pharmacies stopped filling prescriptions signed by "a small number of Florida physicians," starting last fall, leading to a drop of "at least" 86% in their oxycodone sales. CVS said it has voluntarily stopped dispensing oxycodone from the two Sanford stores. Cardinal's Lakeland, Fla., distribution facility is still supplying pharmacies and hospitals with oxycodone, a narcotic that produces effects similar to morphine and has more than four times as many abusers as cocaine, according to the DEA. CVS said it has developed "strengthened and reinforced" guidelines for its pharmacies in recent months on dispensing pain medications and has improved its prescription-drug monitoring. "Allegations regarding past conduct do not reflect the pharmacies' practices today," the CVS spokeswoman said. Cardinal said the DEA has targeted just four of more than 2,500 pharmacies and hospitals served by its Lakeland facility. The company said it can adequately police itself, adding that it has terminated more than 375 pharmacy customers - including more than 180 in Florida - since 2008. The majority of those pharmacies, according to Cardinal's court filings, still have DEA licenses, allowing them to continue operating by turning to other distributors. Aside from its four biggest purchasers of oxycodone - the four pharmacies involved in the investigation - Cardinal said in court documents that it supplied other customers served from the Lakeland facility "about half the amount" of the painkillers purchased by the average Florida pharmacy. The case involving Cardinal and CVS is the latest example of the DEA's strategy of targeting large corporations in its efforts to tame the nation's prescription drug-abuse problem. The DEA investigation of the Cardinal facility "revealed a persistent failure to exercise due diligence to ensure that controlled substances were not being diverted," according to a declaration signed by Joseph Rannazzisi, a deputy assistant administrator for the agency's office of diversion control. According to an internal Cardinal email attached to the DEA filing, a CVS pharmacy corporate employee told the distributor that the rising purchase orders for oxycodone were no cause for alarm. Soaring demand for the painkiller, the CVS employee explained to Cardinal, stemmed from Florida authorities' crackdown on illicit suppliers, or "pill mills," leading to an increase in legitimate traffic at CVS. Cardinal never conducted an on-site visit to the two CVS pharmacies, according to the DEA declarations, which said the distributor "improperly relied on CVS's assurances." Drug distributors say the DEA doesn't outline clearly what it wants them to do and doesn't share information that would make it easier to police pharmacies and patients. The DEA says disclosure of such information, such as customer data and details of other distributors' sales to pharmacies, would reveal proprietary data, and adds that it meets frequently with companies to discuss compliance issues. Critics of the government's strategy call the efforts misguided. "The DEA is treating pharmaceutical manufacturers and wholesalers as if they are the Medellin cartel," said Adam Fein, president of Pembroke Consulting Inc., a pharmaceutical industry consultant, referring to the South American drug organization. "These guys are not the manufacturers of heroin." Some seven million people use prescription drugs for nonmedical reasons, the DEA says, dwarfing the 1.5 million addicted to cocaine. Annual deaths from painkillers, which have quadrupled in a decade to nearly 15,000, now surpass those from heroin and cocaine combined, according to the Centers for Disease Control and Prevention. The Obama administration, which has made fighting prescription drug abuse a priority, applauded the DEA's recent actions in Florida. "Law-enforcement authorities are making tremendous progress in combating the illegal diversion of painkillers," said Gil Kerlikowske, the White House's drug czar, in a statement. He has called prescription painkillers the nation's No. 1 drug problem. - --- MAP posted-by: Jay Bergstrom