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DEA's September 2006 Actions Regarding Pain Management

The US Drug Enforcement Administration published two notices regarding pain management in the Federal Register on September 6, 2006.

The first is a policy statement titled "Dispensing Controlled Substances for the Treatment of Pain." According to the Summary, "On January 18, 2005, DEA published in the Federal Register a solicitation of comments on the subject of dispensing controlled substances for the treatment of pain. Many of the comments that DEA received asked the agency to elaborate on the legal requirements and agency policy relating to this subject. This document provides such information."

According to DEA, "One of the chief purposes of this document is to make clear that the longstanding requirement under the law that physicians may prescribe controlled substances only for legitimate medical purposes in the usual course of professional practice should in no way interfere with the legitimate practice of medicine or cause any physician to be reluctant to provide legitimate pain treatment. DEA also wishes to dispel the mistaken notion among a small number of medical professionals that the agency has embarked on a campaign to 'target' physicians who prescribe controlled substances for the treatment of pain (or that physicians must curb their legitimate prescribing of pain medications to avoid legal liability)."

DEA makes very clear that they are not issuing a set of guidelines by clarifying federal policies with this statement. They state:
"Many commenters expressed the view that it would be beneficial if physicians had a single document providing clear guidelines on the use of controlled substances for the treatment of pain. Some believe such a document would remedy their concerns about the undertreatment of pain by giving physicians assurance that they can avoid scrutiny by Federal and State regulatory authorities as long as they follow those guidelines when prescribing opioids. More specifically, it has been suggested that these guidelines should take the form of a series of questions and answers to be adopted by DEA. Among the questions that have been proposed for inclusion in these guidelines are:

  • What should be the goals of pain management?
  • How can a clinician assess a patient's pain?
  • When should a primary care physician turn to a pain medicine specialist to manage a patient's pain?
  • How are opioids used to manage chronic pain?

"It is certainly appropriate for physicians and medical oversight boards to explore these types of questions. However, for the following reasons, it is not appropriate for DEA to address these questions in the form of a guidance document (or to endorse such a guidance document prepared by others).
"First, one cannot provide an exhaustive and foolproof list of 'dos and don'ts' when it comes to prescribing controlled substances for pain or any other medical purpose. As discussed above, the fundamental principle under both Federal and State law is that a controlled substance must be dispensed by a physician for a legitimate medical purpose in the usual course of professional practice. Throughout the 90 years that this requirement has been a part of United States law, the courts have recognized that there are no definitive criteria laying out precisely what is legally permissible, as each patient's medical situation is unique and must be evaluated based on the entirety of the circumstances. DEA cannot modify or expand upon this longstanding legal requirement through the publication or endorsement of guidelines.
"Second, as stated earlier in this document, DEA's authority under the CSA is not equivalent to that of a State medical board. DEA does not regulate the general practice of medicine. The responsibility for educating and training physicians so that they make sound medical decisions in treating pain (or any other ailment) lies primarily with medical schools, post-graduate training facilities, State accrediting bodies, and other organizations with medical expertise. Some states also have continuing medical education requirements for licensing. Physicians also keep abreast of the latest findings by reading peer-reviewed articles published in medical and scientific journals. DEA, however, has neither the legal authority nor the expertise to provide medical training to physicians or issue guidelines that constitute advice on the general practice of medicine.
"For these reasons, DEA is not proposing any medical guidelines on prescribing controlled substances for the treatment of pain."

The second notice issued by DEA on Sept. 6, 2006, is a notice of proposed rule, titled "Issuance of Multiple Prescriptions for Schedule II Controlled Substances.". According to the Summary, "DEA is hereby proposing to amend its regulations to allow practitioners to provide individual patients with multiple prescriptions, to be filled sequentially, for the same schedule II controlled substance, with such multiple prescriptions having the combined effect of allowing a patient to receive over time up to a 90-day supply of that controlled substance. DEA is requesting public comment on this proposed rule." (Written comments to DEA must be postmarked, and electronic comments must be sent, on or before November 6, 2006.)

Reaction to the DEA's move has been somewhat mixed. The Washington Post reported on Sept. 7, 2006 ("DEA Revises Rule On Prescribing Painkillers,") that "Agency officials had earlier worked for two years with pain and hospice experts on a 'frequently asked questions' guideline to advise doctors on how to prescribe controlled drugs in a way that would not get them into trouble with law enforcement. The agency briefly posted the guidelines on its Web site in 2004 but then pulled them down and disavowed them. One of the doctors involved with writing the guidelines -- who became a critic of the DEA when they were abruptly discarded -- called Tandy's actions yesterday "a very positive step forward in restoring that necessary cooperation between practicing physicians and the DEA." Howard Heit, a Fairfax County pain and addiction specialist, also said the new policy will help patients get better care by allowing doctors more flexibility in prescribing controlled drugs. But Siobhan Reynolds, who created the Pain Relief Network several years ago to help defend pain doctors who she said were being unfairly arrested and prosecuted, disagreed and said the new DEA policy has changed little. 'Ms. Tandy states here, as she has on many occasions, that doctors need not fear criminal prosecution as long as they practice medicine in conformity with what these drug cops think is 'appropriate,'' Reynolds said. 'If that isn't a threat, it will certainly pass for one within the thoroughly intimidated medical community.'"

According to the Post, "While defending its efforts to aggressively investigate doctors who officials conclude are writing painkiller prescriptions for no 'legitimate medical purpose,' the agency agreed with the protesting experts that it had gone too far in limiting how doctors prescribe the widely used medications. The unusual turnaround was welcomed by relieved doctors, who said it will help restore "balance" in government policy between the needs of pain patients and the effort to control prescription drug abuse and diversion. Specifically, the DEA proposed a formal rule that would allow doctors with patients who need a constant supply of morphine-based painkillers to write multiple prescriptions in a single office visit. Under the new rule, a doctor can write three 30-day prescriptions at a time -- two of them future-dated -- to be filled a month apart."

The Post noted that "Two years ago, the agency clamped down on the common practice of writing such multi-month prescriptions, which it said were probably illegal and were contributing to the growing abuse of prescription painkillers. As a result of the DEA's position, many doctors began requiring patients to come in each month for a new prescription -- office visits many doctors considered medically unnecessary but essential to keep them out of trouble with the DEA. Yesterday, DEA Administrator Karen Tandy said the agency had been wrong in limiting the multiple prescriptions and had made the tough decision to reverse course. She said the DEA received more than 600 comments from doctors, patients and others about its policies on narcotic painkillers, many of them strongly opposed to the agency's position on limiting refills."

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