DEA pledges balance in OxyContin debate
Concerns and education hinder progress
With federal drug enforcers promising a balance between enforcement and education on use of OxyContin, end-of-life care and palliative care experts are hoping physicians will once again feel confident in prescribing it and other pain drugs without fear of being prosecuted for aggressively treating the pain of dying patients.
And while physicians are applauding the Drug Enforcement Agency’s (DEA) Oct. 23 announcement that it would take a balanced approach in dealing with the abuse of pain medication, there is still concern regarding just what that approach entails.
"It’s just a beginning," says John Millett, spokesman for the National Hospice and Palliative Care Organization in Alexandria, VA. "It’s going to take ongoing vigilance and communication between the DEA and physicians. For now, there is a measure of reassurance that physicians can prescribe pain management drugs and not be subject to unwarranted scrutiny."
But not complete reassurance. There is still concern that overzealous agents could misconstrue a physician’s good intentions for criminal conduct. For example, a physician who prescribes higher doses of OxyContin in order to address severe pain might be a target if his or her prescribing patterns exceed the norm.
"I think the DEA’s announcement was a good first step," says James Martin, MD, a family practice physician in San Antonio, TX, and president-elect of the Leawood, KS-based American Academy of Family Physicians. "What remains to be seen is how this will all take place. For instance, how will the DEA look at prescribing patterns?"
Martin’s comments are significant because he represents the throngs of family practice, internal medicine, and general practitioners who are under the most pressure to forgo narcotics in favor of less effective drugs, such as nonsteroidal anti-inflammatory drugs.
Advocates for better end-of-life care held up as an example the case of California physician Wing Chin, MD, who failed to treat a patient’s pain with opioids. The case involved the care of an 85-year-old terminal lung cancer patient. Using a 10-point scale, with 10 being the worst, nurses charted pain levels ranging from 7 to 10 throughout the patient’s hospital stay. Mr. Bergman was later discharged to die at home, although still in agony. His family ultimately got another physician to prescribe pain medication that brought him relief before he died the next day.
Wing’s inaction caused the patient’s family to file suit in California state court, where a jury awarded his family $1.5 million for elder abuse in July 2001.
End-of-life advocates hoped the ruling would open physicians’ eyes to the need for better pain management. But instances of punishment for inadequate pain management are offset by stories of physicians running afoul of the law where narcotics are involved. While the vast majority of physicians are not engaging in illegal activity, there is a sense that physicians are wary of prescribing narcotics out of fear of being equated with physicians who have been caught doing wrong.
Recently, for instance, an Ohio physician was arrested for writing hundreds of prescriptions of OxyContin. While physicians around the country routinely write numerous prescriptions for OxyContin, police accuse Jeff Lilly, MD, of writing bogus prescriptions and pocketing hundreds of thousands of dollars.
Authorities allege that Lilly’s clients were mainly people with no need for pain management drugs and that he charged $200 to $450 for a prescription, half of which authorities say were for OxyContin. He also allegedly kept minimal, if any, patient records, and his one employee at the clinic was not a nurse but a convicted felon.
"He opened that pain management clinic, a little hole in the wall on Main Street, and almost immediately there were long lines of individuals out on the sidewalk in the mornings. We started getting calls," says Scioto County prosecutor Lynn Grimshaw.
Lilly eventually pleaded guilty to engaging in a pattern of corrupt activity. He agreed to give up his medical license and was sentenced to three years in prison.
A 2000 study done by the Oregon Health Sciences University’s Center for Ethics in Health Care sheds light on how physicians feel about prescribing pain medications for patients at the end of life. In 1998, researchers interviewed 103 families whose loved ones had died in the state’s hospitals. The study was prompted by a 1997 study that showed a rise in the number of families who reported that their hospitalized family members spent the last week of their life in "moderate to severe pain."
The study showed that:
- Although 89% of families rated the medical staff’s attention to patient comfort, including pain medication, as "good" or "excellent," 54% said their family members spent the last week of life in "moderate to severe" pain.
- In follow-up interviews with 411 doctors and nurses, researchers found that 96% said "families’ expectations of good pain management are higher than in the past."
- Sixty-six percent of doctors and nurses said "doctors are prescribing less pain medication."
- Fifty-nine percent of doctors and nurses said "nurses are administering less pain medication."
According to researchers, most physicians explained that fear of state or federal investigation was a strong reason for limiting the use of pain medication. Lesser concerns included media attention and the fear that a colleague might suspect the physician of participating in assisted suicide.
Certainly, the DEA’s message was intended to allay the fears of physicians and to encourage them to follow their clinical instincts. Efforts to control the abuse of pain medications should not obstruct their legitimate use by pain sufferers, said Asa Hutchinson, the head of the DEA, during the Oct. 23 press conference.
"I think it is significant that the DEA is joining with over 20 of the nation’s leading pain and health organizations to call for a balanced policy when it comes to pain medication," Hutchinson said. "And the DEA’s policies and regulations are not at odds with the goals of legitimate pain treatment. That is a significant point."
Still, Hutchinson warned that the DEA will keep close watch over the prescription and use of OxyContin and other pain management drugs. "Now, of course, we’re not limiting the prescriptions, per se; we’re simply trying to avoid its abuse and the misuse of the prescription process," Hutchinson said. "We get letters from doctors on both sides, and so these letters that we receive demonstrate the balance that we have to achieve in the DEA. But specifically in reference to OxyContin, figures obtained from the American Methadone Treatment Association Report that there was an increase in patients admitted to treatment programs as a direct result of OxyContin abuse."
Overdoses and pharmacy robberies
Hutchinson cited statistics from drug treatment programs in West Virginia, Pennsylvania, Kentucky, and Virginia showing that 50% to 90% of the newly admitted patients identified OxyContin as the primary drug of abuse. "We’ve received medical examiners’ reports that link deaths due to overdose or abuse to OxyContin," Hutchinson said. "There have been instances of pharmacies being robbed to obtain the supply of OxyContin."
The joint statement represents a major step in helping make OxyContin and similar drugs available for people who legitimately need them, said Russell Portenoy, MD, chairman of the Pain Medicine and Palliative Care Department at Beth Israel Medical Center in New York City.
Experts say the way to achieve that balance is through education. For their part, the American Academy of Family Physicians says it is educating its members about the drug’s potential for abuse as well as its role in alleviating moderate to severe pain.
Martin and others are concerned about whether law enforcement will itself be educated to understand why physicians prescribe powerful drugs, sometimes beyond the norm. "How will they look at prescribing patterns?" he asks.
Hopefully, Millett says, the needed education will work both ways. "Greater awareness will likely temper law enforcement," Millett says.
He also warns that progress will be incremental and fragile. Education will help physicians better understand how to prescribe the drug in specific clinical situations, but the first news of a physician being prosecuted by an overzealous agency will undermine any progress achieved.
"All it will take is a few examples of physicians acting in good faith, but still being prosecuted, to set everything back," says Martin.
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