Drug Enforcement Agency Withdraws Support for New Controlled Substances Prescription Guidelines
The Drug Enforcement Administration has withdrawn support for new guidelines "designed to end a controversy" over the arrests and prosecutions of hundreds of pain treatment specialists who prescribe controlled substances such as OxyContin and morphine, the Washington Post reports (Kaufman, Washington Post, 10/21). After OxyContin became more commonly used and abused in the late 1990s, the federal government has prosecuted hundreds of physicians, pharmacists and some of their employees. A past DEA consensus paper did not clarify the position of the agency and prompted many physicians and pharmacists to decide not to prescribe or dispense controlled substances to patients with severe pain over concerns about prosecution. DEA and pain specialists in August issued new guidelines on the agency Web site. DEA had planned to distribute the document to law enforcement agencies and physicians who apply for approval to prescribe controlled substances. The guidelines ask physicians to:
- Include in the medical records of first-time patients medical histories, physical exam results, pain assessments and treatment plans and add reassessments to the records after subsequent visits;
- Include evidence in medical records that they have evaluated the nature and impact of the pain experienced by patients, earlier treatments they have taken and their alcohol- and drug-use histories; and
- Examine patients for indications of pain medication abuse, such as an unwillingness to provide information on previous physicians; requests for higher doses of pain medications, early refills or specific treatments; deterioration in function at home or work; illegal conduct, such as theft and prescription forgery; and repeated loss of prescriptions (California Healthline, 8/12).
The DEA Web site said that agency decided to withdraw support for the guidelines because they "contained misstatements" and were "not approved as an official statement of the agency," the Post reports. However, DEA Administrator Karen Tandy in August had praised the guidelines. She said in a statement at the time, "The medical and law enforcement communities continue to work together to carefully balance the needs of legitimate patients for pain medications against the equally compelling need to protect the public from the risk of addiction and even possible death from these medications. ... The DEA is committed to assisting the overwhelming majority of health care providers who successfully strike that balance every day, as well as the law enforcement officers investigating diversion and abuse of pain medications."
DEA officials said that they would issue a more detailed statement on the decision to withdraw support for the guidelines in one or two weeks. DEA spokesperson Ed Childress said that the agency plans to revise and republish the guidelines.
Pain treatment advocates said that DEA might have decided to withdraw support for the guidelines because defense attorneys sought to use them as evidence in the drug-trafficking trial of William Hurwitz, a Virginia physician. Several weeks after attorneys for Hurwitz in late September attempted to introduce the guidelines as evidence, DEA officials removed them from the agency Web site and said that they were not official agency policy. About two weeks later, U.S. attorney Paul McNulty, the prosecutor in the Hurwitz case, filed a motion to request the dismissal of the guidelines as evidence because they do "not have the force and effect of law."
Patrick Hallinan, an attorney for Hurwitz, said, "It seems pretty clear that they felt they had to try to get rid of the guidelines because they supported so many parts of our case. If the Justice Department followed the guidelines, there would be no reason to arrest and charge Dr. Hurwitz." Childress declined to comment on whether DEA decided to withdraw support for guidelines because of the Hurwitz case.
Pain treatment specialists who helped develop the guidelines criticized the decision by DEA to withdraw support for them and said that they received "no explanation or told whether the agency had changed its position" on when and how physicians should prescribe pain medications.
Russell Portenoy, a pain treatment specialist with Beth Israel Medical Center who helped develop the guidelines, said, "There was a real feeling that we had made significant progress, but now we have to wonder whether that progress is all gone." He added, "If they don't fix whatever problems they might have and put the document back up, that would speak very clearly that the goal of the DEA is not to collaborate with the medical community or to reassure doctors about the proper role and use of prescription opioids in pain management" (Washington Post, 10/21).