The Drug Enforcement Administration and top pain specialists yesterday jointly issued detailed new guidelines designed to reassure worried doctors that they will not be prosecuted for prescribing high doses of powerful morphine-based painkillers for patients who need them for intractable pain.
The guidelines also make clear that doctors have responsibilities to ensure that their patients are not abusing prescription opioids such as OxyContin and are not doctor-shopping to collect narcotics for illicit sales.
The new document, which will be distributed to law enforcement agencies and all doctors who apply for DEA approval to prescribe controlled drugs, is an effort to resolve a controversy that has bedeviled pain specialists.
An earlier consensus paper failed to clarify the issues, leading to a situation in which many patients with severe pain have been turned away by doctors and pharmacists concerned that prescribing and dispensing opioid painkillers would get them in trouble with the law.
"We hope this is a step in the right direction, to reverse an increasingly unfriendly environment for pain management," said one of authors of the new guidelines, University of Wisconsin pain studies director David E. Joranson.
Getting the agency to publicly declare its position on prescribing opioids "will make more clear that the DEA understands good medicine and would be avoiding it in their investigations," he said. "A lot of people don't feel now that's the case."
The new guidelines spell out the steps that ensure proper prescribing, such how to diagnose severe pain and keep proper records to justify the prescribing of a narcotic painkiller. Written largely in a question-and-answer form, the document makes clear to law enforcement authorities that even heavy use of prescription opioids can be appropriate and that the physical dependence it brings is not the same as physical addiction.
The DEA and other law enforcement agencies stepped up their prosecutions of doctors, pharmacists and some of their employees after the prescription narcotic OxyContin became widely used and abused in the late 1990s, resulting in numerous overdoses. With hundreds of doctors charged in recent years, pain patients and doctors who treat them have complained of a growing climate of fear -- adding to what is widely seen as a serious nationwide problem of inadequate pain treatment.
Among the high-profile prosecutions of pain specialists is that of William E. Hurwitz, a nationally known doctor from McLean accused of drug trafficking. Hurwitz is scheduled to go on trial this fall.
"In numerous meetings over the past several years, it has become obvious that there are many misconceptions about the DEA's role and even the DEA's fundamental beliefs about the use of prescription opioids," said another author of the guidelines, DEA diversion control official Patricia M. Good.
"Many of these misconceptions lead to unwarranted fear that doctors who treat pain aggressively are singled out for enforcement actions, and that the goals of protecting the public health from drug abuse have come into direct conflict with the goals of promoting the public health through effective pain control," she said. "Undertreatment of chronic, serious pain is considered a major medical problem."
Russell K. Portenoy, another author of the guidelines and a pain specialist with New York's Beth Israel Medical Center, said opioid painkillers are appropriate treatment for serious pain from cancer and AIDS, as well as among the terminally ill. But about 40 percent of those patients are undertreated, he said.
"What this document does is make clear [that] we in pain management and DEA are on the same page, and that we're willing to endorse the same principles," Portenoy said. "We need to create a culture of respect for the policies."
Joranson, director of the Pain and Policy Studies Group at the University of Wisconsin Medical School, said the DEA's written acceptance of basic pain management principles could be useful in persuading some states to change their laws on prescription opioids. He said his group has found that 20 states have laws that could be detrimental to pain patients. He added that the new guidelines will be sent to officials in those states.
The new document was met with skepticism by some advocates for pain patients, who said it will do little to calm jittery doctors or decrease the illicit use of prescription narcotics.
"The Department of Justice and other prosecutors are misidentifying quality pain management for drug dealing and have apparently convinced academic pain medicine that these doctors were 'diverting drugs,' " said Siobhan Reynolds, founder of the Pain Relief Network. "The DEA blames doctors as the number one reason why pharmaceutical drugs are on the street, when the truth is they are smuggled in, stolen from trucks and freely bought and sold all over the Internet."
Frank Fisher, a California doctor who was tried and acquitted on charges related to prescribing opioid painkillers, said the new document "is an articulation of the status quo in the management of chronic pain. . . . The underlying problem is that our national pain policy is an expression of social concerns, rather than scientific knowledge."