Legal risk for prescribing painkillers is small, study says

Primary care doctors say the greatest obstacle they face in prescribing opioids to treat chronic pain is scrutiny from regulators and law enforcement, according to a survey released earlier this year.

But that fear is misguided, says a study in the September issue of Pain Medicine, the journal of the American Academy of Pain Medicine.

Researchers reviewed nine years of medical board and local, state and federal law enforcement charges against doctors for improperly prescribing opioid analgesics. They found that 725 doctors were accused of criminal or administrative offenses from 1998 to 2006. The figure represents about one-tenth of 1% of practicing physicians, or one of every 954 doctors.

"The conclusion of our study is that there is risk [in prescribing opioids]; we're not denying that," said study co-author Myra Christopher. "But the risk is manageable and the risk has been exaggerated."

Physicians have long worried that the U.S. Drug Enforcement Administration's fight against prescription drug diversion has had a chilling effect on doctors' willingness to appropriately treat severe chronic pain.

The DEA responded to these concerns in October 2006 with guidance for physicians. The agency declined to issue a list of do's and don'ts for doctors but said a red flag is "prescribing an inordinately large quantity of controlled substances or writing large numbers of prescriptions, compared with other physicians in an area."

Research for the new study was conducted over two years with the help of the Federation of State Medical Boards and state and federal law enforcement officials. "This is probably the largest repository of information on this matter that exists in this country today," said Christopher, CEO of the Center for Practical Bioethics, a Kansas City, Mo.-based think tank that led the investigative effort.

Richard Payne, MD, a study co-author and director of the Duke University Institute on Care at the End of Life, said the findings are "reassuring and provide some facts about how really small a proportion of physicians" get into trouble for prescribing opioids.

Perry G. Fine, MD, professor of anesthesiology at the University of Utah School of Medicine and treasurer of the American Academy of Pain Medicine, said the figures are not surprising. He said physicians who follow standards of care spelled out by the academy, the American Pain Society and the FSMB should have little to fear from authorities. He added that doctors' fear "does not constitute a justifiable reason to deprive patients of indicated therapies."

About 9% of U.S. adults experience moderate to severe chronic noncancer pain, the American Pain Society said. Most patients with severe chronic pain do not have it under control.

The AMA has called for pain policies that balance legitimate access to treatment with the need to stop recreational use and black-market diversion of drugs. The Association says "physicians who appropriately prescribe and/or administer controlled substances to relieve intractable pain should not be subject to the burdens of excessive regulatory scrutiny, inappropriate disciplinary action, or criminal prosecution."

Some critical of findings

Physicians, patient advocates and experts critical of what they call a "war on doctors" attacked the study as highly misleading.

Alexander DeLuca, MD, MPH, a New York City addiction and pain medicine specialist, said the study is a "misuse of statistics" because it compares the number of doctors charged to the total pool of practicing doctors.

"It's what I call denominator abuse," said Dr. DeLuca, a senior consultant to the Pain Relief Network, which advocates for patients with severe chronic pain and the physicians who care for them. "You should only count doctors who could possibly come to the attention of authorities, not doctors who don't prescribe opioids or who occasionally prescribe them. The only doctors who will get attention are the doctors who prescribe a lot."

Ronald T. Libby, PhD, professor of political science and public administration at the University of North Florida, similarly said the DEA could provide data about the highest opioid prescribers in each area, and then researchers could investigate how many of them faced charges. Libby, who authored the 2007 book, The Criminalization of Medicine: The War on Doctors, said another major problem with the study is that it does not measure the risk that physicians will be investigated but not charged.

The authors acknowledged the study has shortcomings. The DEA told them it had done more than 650 investigations per year, though it is unclear how many physicians were targeted. And study researchers had no access to data for state law enforcement and medical board investigations.

"There is little doubt that the number of physicians investigated greatly exceeds the numbers subsequently charged," the study said.

Siobhan Reynolds, president of the Pain Relief Network, said the study authors "want to wave a magic wand and say doctors shouldn't be feeling scared." But she said that it is, sadly, reasonable for physicians to avoid prescribing high doses of opioids for patients with severe chronic pain.

"There is one thing doctors can do to not get busted, and that is not to prescribe," Reynolds said. "It's rational, and it's predictable."