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DEA, Academic Pain Specialists Issue New Guidelines on Prescribing Pain Relievers 8/20/04

In response to a growing chorus of complaints from pain patients and the doctors who treat them, who say that heavy-handed drug law enforcement is leaving patients in pain and innocent doctors behind bars, the Drug Enforcement Administration (DEA) and leading pain specialists have coauthored a new set of guidelines spelling out how to prescribe opioid pain relievers such as morphine or Oxycontin without running afoul of the law. But while the guidelines are a consensus effort between drug enforcers and academics, they are not winning universal approval among pain relief advocates.

In recent years, hundreds of doctors have been prosecuted or sanctioned by state medical control boards as "Dr. Feelgoods" or drug traffickers by state or federal officials who view their prescribing practices as excessive. Those cases have become harder to prosecute as doctors have begun fighting back, and pain patient advocates have joined the fray, charging that the DEA crackdown on prescribing is leaving millions of Americans suffering needless pain. But they still have a devastating impact on physicians' willingness to prescribe pain medications.

The consensus statement was produced by experts from the DEA, the University of Wisconsin Pain and Policy Studies Group, and Last Acts (www.lastacts.org), a national coalition of consumer and professional organizations working to improve end-of-life care through the use of palliative medicine and pain management techniques. Last Acts and the DEA signed an earlier consensus statement stressing the need for "balance" between law enforcement's demand to prevent drug abuse and diversion and the medical imperative to treat the sick in 2001.

But with the White House Office of Drug Control Policy having declared war on prescription drug abuse this year and the prosecution of physicians for alleged over-prescribing continuing apace, doctors are reluctant to prescribe medically acceptable quantities of opioid pain relievers for fear of being stripped of their practices, subjected to criminal prosecutions, and possibly sentenced to decades in prison, pain relief advocates say. Thus the publication of "Prescription Pain Medications: Frequently Asked Questions and Answers for Health Care Professionals and Law Enforcement Personnel."

The document is intended to clarify matters for physicians and law enforcement alike. And it does make clear that opioids such as Oxycontin are legitimate pain medications, that they are sometimes subscribed in large quantities, that they are sometimes prescribed to large numbers of patients by one doctor or clinic, and that none of these things necessarily imply shady doctoring.

That is a critical message, study coauthor David Joranson, pain policy director at the University of Wisconsin-Madison Medical School, told the Associated Press. Fewer doctors are willing to prescribe opioid pain relievers because of fear of prosecution, he said. "In some ways, pain management and the use of pain medications has become a crime story when it really should be a healthcare story," Joranson said.

The key message for law enforcement is that opioid pain relievers, even in large quantities, are good medicine, said Dr. Russell Portenoy, head of New York's Beth Israel Medical Center pain center. "These are legitimate treatments. They're essential for good medical care," he told AP.

The DEA will distribute the document to agents and prosecutors, said Patricia Good, the agency's drug diversion head. Helping law enforcement distinguish aggressive pain management from criminal over-prescribing would help remove the "unwarranted fear that doctors who treat pain aggressively are singled out," she said in a notice announcing the document. The information should help eliminate that "aura of fear," she said.

But parts of the guidelines have pain relief advocates and doctors concerned. Some activists said medicine is being perverted by the war on drugs with recommendations such as the following, which are designed to help doctors weed out "drug abusers" and protect themselves from arrest:

"Document a medical history, physical exam, pain assessment and treatment plan in first-time patients' charts, with re-evaluations at follow-up visits.

"Records should show evidence that the doctor evaluated the nature and impact of the pain, earlier treatments, and alcohol and drug history. Measuring pain intensity and extent of relief over time 'is important evidence of the appropriateness of therapy.'

"Watch for abuse warning signs, such as a patient unwilling to allow contact with previous doctors, escalating doses, seeking early refills or requesting specific medications. These require careful evaluations -- they might merely signal unrelieved pain.

"More worrisome signs include deterioration in functioning at home or work, illegal activities such as stealing or forging prescriptions, and repeatedly 'losing' prescriptions."

"Look, let me say there are some good features in this, but it's fundamentally misguided," said Dr. Frank Fisher, a California physician who underwent a five-year legal ordeal before being exonerated of all charges -- including spurious murder charges -- after being raided by state officials over his opioid prescribing practices (www.drfisher.org). "For the last 15 years, we've been doing this sort of thing -- intractable pain acts, patients' bills of rights, medical board guidelines, consensus statements like this one -- in recognition of the terrible public health problem with chronic pain. None of that has worked," he told DRCNet, "and this is more of the same."

Guidelines seeking "balance" between law enforcement and medicine fail to get to the root of the problem, Fisher said. "This doesn't address the underlying flaw in our social policy and legal approaches to the regulation of these medicines and how that affects the treatment of pain," he argued, calling the involvement of the criminal justice system in medicine a "fundamental structural problem in the law."

And that is prohibition. "By making opioids illegal," said Fisher, "prosecutors will have to decide who to prosecute, and to do that, they will have to apply some sort of standards to medical practices, which effectively has them regulating the medical system. This document is nothing more than a reiteration of the status quo that says let's keep doing all these things, the DEA is going to play nice, and you physicians shouldn't be so scared, but I find it terrifying," he said.

There was progress in some small sense, said Siobhan Reynolds, executive director of the Pain Relief Network (www.painreliefnetwork.org), a pain patients' advocacy group. "Well, it's the first time the DEA even admitted they had created an aura of fear," she told DRCNet. "But this will not remove the aura; it will only make things worse," she said. "What this does is criminalize in writing the application of the principles of pain management in their pure form. The doctors are supposed to practice with an eye to law enforcement concerns."

"Basically, addiction medicine doctors have adopted the dual concept of being a doctor and a cop, and this document is an astonishing display of paternalism," said Reynolds. "Academic pain medicine has been co-opted. What we are really talking about here with these 'drug abuser' profiles is the denial of the autonomy and dignity of patients and their civil rights when it comes to the practice of medicine," she argued. "These doctors think they're doing the right thing," said Reynolds, "but there is such a gap between what these academics see and what is actually happening to patients. There are 50 million people in chronic pain and maybe 7-9 million in out-of-control pain, and they're worried about a handful of 'drug abusers'?"

Read the consensus FAQ on pain medication prescribing at
www.deadiversion.usdoj.gov/faq/pain_meds_faqs.pdf or
www.stoppain.org/faq.pdf online.

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