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Congress to Curb OxyContin Abuse?

Federal lawmakers introduce new legislation against OxyContin, but workers' comp and pharma experts say the bill isn't the right solution to tackle off-label prescribing and drug abuse.

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By JOSHUA CLIFTON, a Chicago-based writer who covers workers' comp and disability issues

Insurers, workers' compensation experts and the medical community have long been concerned about the growing rate of prescription drug abuse in America. To address the issue, federal lawmakers recently introduced legislation that takes aim at OxyContin, the powerful narcotic painkiller that has become the poster boy of this alarming trend.

The Stop Oxy Abuse Act of 2010, sponsored by Rep. Mary Bono Mack, R-Calif., and Rep. Hal Rogers, R-Ky., would revise the U.S. Food and Drug Administration classification of the drug to ensure that it is prescribed for only severe pain.

Under the current code, OxyContin is classified as a treatment method for moderate to severe pain. The bill is intended to keep the drug out of the hands of young people and ensure that OxyContin is limited to only those who need it--individuals dealing with late stages of cancer and other severe illnesses--according to Rogers.

"In the face of mounting drug overdoses, federal indictments for misbranding and burgeoning illegal trafficking, the FDA has simply looked the other way and shirked its responsibility," he said.

The bill has raised eyebrows within the workers' comp world, where questions of potential abuse have been raised along with concerns about OxyContin's role as a pharmaceutical cost driver. The painkiller has consistently ranked among the top 10 most expensive drugs prescribed in the workers' comp system over the past decade. According to a report issued late last year by the National Council on Compensation Insurance (NCCI), narcotics now account for a quarter of all workers' comp drug costs. Oxycodone, the active ingredient found in OxyContin, represents the largest share of narcotics costs at 37.4 percent.

Overall workers' comp pharmacy spending, according to the latest data from PMSI, a pharmacy benefit manager and provider of specialty services for the comp market, increased by 5.4 percent in 2008, with pharmacy costs now representing approximately 14 percent of the total medical spending in workers' comp.

OFF-LABEL PROBLEMS

"We have observed the growth of OxyContin that has moved far beyond the original recommended usage and the basis of the drug's FDA approval," said Barry Llewellyn, senior divisional executive of NCCI's regulatory services. "I think this legislation is a good start, but I question if it goes far enough. In workers' comp, there aren't a lot of cancer claims. We certainly know that there is a lot of off-label prescribing involved."

Physicians who are prescribing OxyContin for a host of medical maladies that don't typically fall within the realm of severe pain conditions have been driving use of the drug, Llewellyn said. While few members of the medical community would object to the use of narcotics to treat severe, chronic, cancer-related pain, some physicians are prescribing narcotics for minor conditions such as sprained ankles, "despite the serious risks associated" with their usage, Llewellyn said.

RESTRICTION RAISES CONCERN

On the other hand, some experts have commented that allowing Congress to restrict a physician's ability to legally prescribe drugs they deem necessary for a patient, even if that includes off-label use, sets a dangerous precedent. Phil Walls, chief clinical and compliance officer for myMatrixx, a Tampa, Fla.-pharmacy and ancillary medical services company that specializes in workers' comp, said pain is a subjective issue.

"Historically, Congress has steered clear of telling physicians how to practice medicine," he said. "The bill focuses on the drug's intended use, but what might be considered severe pain to one person might be considered as tolerable to another. I think they are raising some relevant concerns, and we certainly support any legislation aimed at curbing drug abuse, but this is a very subjective way of going about it. Anything that might restrict a physician's ability to make a judgment call with a patient will have implications downstream."

Walls added that there are better approaches available in the workers' comp world to ensure that OxyContin and other powerful narcotics don't fall into the wrong hands and are being used safely and effectively. His company, he said, advocates the use of step therapy, a tool which is available to myMatrixx clients but largely goes unused because of the fear of "denial of care" litigation. Through this method, which is often used in group health to control costs, physicians will initiate therapy in an "opioid-naive patient" with a lower-dose, short-acting drug, only stepping up the treatment to include drugs such as OxyContin if the individual does not experience relief from pain.

"I came out of an environment at Cigna where a pharmacist could work directly with physicians, and it was very routine to make recommendations," he said. "Through step therapy, you can accomplish a lot in terms of cost savings and clinical oversight."

Another issue, Walls said, stems from direction of care. In nearly every other setting outside of the comp system, an individual would be required to visit a physician within a network, which has the ability to impose certain standards and expel a doctor if he doesn't achieved desired outcomes. Without the ability to direct care, Walls explained, it is incredibly difficult to successfully curb inappropriate prescribing.

The ability to refer someone to a specialist is another issue, he added.

EDUCATION, DATA-MINING KEY

Wall said education remains a critical element to improving the prescribing habits of physicians. He noted that the FDA recently launched its Risk Evaluation Mitigation Strategy, which is aimed at getting educational materials on several high-risk drugs into the hands of physicians and patients alike.

"I've looked at what they have put together for OxyContin," he said. "If every patient and physician were to follow the program, we wouldn't have a problem."

At myMatrixx, the firm also places a significant focus on data-mining to identify physicians who exhibit aberrant or inappropriate prescribing patterns. In addition, the firm regularly reports drug dispensing data to 31 states that have already implemented prescription-drug monitoring programs. Because all of those databases are separate, though, it is hard to trace a drug from its source to eventual consumer, Walls added.

"Ultimately, I think the solutions will be a national database," he said.

Jim Andrews, senior vice president of pharmacy services at HealthCare Solutions, agreed that technology and education is key, noting that many pharmacy benefit managers such as his firm are already effective in helping companies identify and isolate problem issues.

"We need more education, more making sure, and less of a focus on whether OxyContin is better or worse than other Class II narcotics," he said.

As to the fate of the OxyContin legislation, many experts aren't convinced that it will muster enough support to pass.

"The legislation looks like a call to arms," Andrews said. "And while it is true that we have a serious issue with OxyContin in America and I think the bill is well-intentioned, it isn't viable. We still support physicians' rights to manage their patients' plans within certain boundaries."

May 20, 2010

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