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New guidelines from the American Pain Society and the American Academy of Pain Medicine offer clinicians advice for managing treatment and assessing risk for abuse with chronic opioid therapy.

Neurologists now have specific guidelines for the use of chronic opioid therapy (COT) in a host of common conditions, with practical steps for selecting appropriate patients for treatment, risk stratification, and treatment management over time.

The new clinical guidelines were formulated by a 21-member panel convened by the American Pain Society and the American Academy of Pain Medicine, and published in the February issue of The Journal of Pain. The paper includes 25 recommendations in fourteen areas.

Neurologist Kathleen Foley, MD, a panel member who is professor of neurology, neuroscience, and clinical pharmacology at Weill Medical College of Cornell University, said the new guidelines will help clinicians in a difficult area fraught with complex clinical, ethical, and even legal implications due to the risk for abuse associated with opioids and the uncertain long-term effects.

“The guidelines provide very practical guidance on how to evaluate a patient, assess risks, and follow a patient through treatment,” she said. “The hard issue for clinicians is that we don't have good treatments for patients with major pain. The opioids may be the best approach for the patient but the long-term effects are not clear.”


So how might neurologists find the new guidelines useful? Dr. Foley cited examples of patients who have pain from severe acute herpes zoster, diabetic neuropathy, or postherpetic neuropathy as instances in which the new guidelines would provide some assurance of the safety of COT and guidance for assessing and minimizing risks.

“These are conditions for which there are clinical trials that have supported use of opioids, but which don't provide clear cut guidelines on how to use them,” she said.

Misha-Miroslav Backonja, MD, professor of neurology, anesthesiology, and rehabilitation medicine at the University of Wisconsin School of Medicine, said the guidelines could be especially reassuring to neurologists who may not regularly prescribe opioids.

“Family physicians and primary care physicians have more likely made opioids a part of their general practice, but neurologists have been apprehensive,” said Dr. Backonja, who was not a member of the guidelines panel. “Many who are used to working with patients who are paralyzed are skeptical about so-called ‘soft signs’ of pain and suspect that some patients could be abusing drugs.

“But while there is a minority of patients who abuse drugs, they should not be the reason to punish all patients who might legitimately benefit from opioid treatment.”

Dr. Backonja cited neuropathic pain peripheral to spinal cord injury from trauma or work-related injuries as among those chronic conditions that neurologists could now look to the guidelines for support and guidance in the use of COT.



Herpes zoster (left) and diabetic neuropathy are among those chronic pain conditions that may be treated with opioids.

The first step, in considering use of COT for these and other conditions, is patient selection and risk stratification. This means conducting a history and physical examination that includes an assessment of risk of substance abuse, misuse or addiction; and it may include consultation with a mental health or addiction specialist in cases of high-risk patients.

The guidelines name specific risk screening tools that neurologists may use in considering COT. These include the Screener and Opioid Assessment for Patients with Pain (SOAPP) Version 1; the Opioid Risk Tool (ORT); and the Diagnosis, Intractability, Risk, Efficacy (DIRE) instrument. DIRE is clinician-administered and is designed to assess potential efficacy as well as harms. [For more information about these assessment methods, see “Screening Tools for Opioid Assessment.”]

The guideline on patient selection noted also that the factor that appears to be most strongly predictive of drug abuse, misuse, or other aberrant drug-related behaviors after initiation of COT is a personal or family history of alcohol or drug abuse. Younger age and presence of psychiatric conditions are also associated with aberrant drug-related behaviors in some studies.

The patients most likely to experience a good response to COT, based on research evidence, are those with moderate or more severe pain who have not responded to non-opioid therapies. Evidence is less compelling for conditions that have a strong psychosocial component, such as some types of chronic low back pain, daily headache, or fibromyalgia.

Other areas addressed in the guidelines are initiation and titration of COT; use of methadone; monitoring of patients; high-risk patients; dose escalations; high dose opioid therapy and opioid rotation; opioid-related adverse effects; use of psychotherapeutic co-interventions; driving and work safety; identifying a medical home and when to obtain consultation; breakthrough pain; opioids in pregnancy; and opioid policies.

Dr. Foley emphasized that the guidelines are especially important because much of the research base in the area of COT— especially on long-term effects— is thin, and neurologists need practical guidance.

“Some of the evidence is weak, and probably the most important recommendation is that we really need more and better research to understand the role of opioids in treatment,” said Dr. Foley. “These guidelines are a stop-gap approach, representing the best evidence we have to guide our clinical approach to chronic non-cancer pain. But the reality is that we need more research at every level.”

Because of the lack of research evidence and the uncertainty about long-term effects of opioids, Dr. Foley said the guidelines tend to be conservatively cautious. “But they should not be construed to mean that patients should not be treated with opioids, even high-risk patients,” she said.


The expert panel comprised 21 individuals who reviewed evidence and formulated recommendations. Chairing the panel were Gilbert J. Fanciullo, MD, associate professor of anesthesiology at Dartmouth Medical School and an anesthesiologist with the Pain Management Center department of anesthesiology at Dartmouth-Hitchcock Medical Center in Lebanon, NH, and Perry G. Fine, MD, professor in the Pain Research Center department of anesthesiology at the University of Utah in Salt Lake City.


DR. KATHLEEN FOLEY: “The guidelines provide very practical guidance on how to evaluate a patient, assess risks, and follow a patient through treatment. The hard issue for clinicians is that we dont have good treatments for patients with major pain. The opioids may be the best approach for the patient but the long-term effects are not clear.”

All of the recommendations had to be approved by a two-thirds majority vote, and all are flagged for whether they were strongly, moderately, or weakly recommended, and for whether the evidence base was strong or weak. As evidence of the scarcity of research in the area, not one of the 25 recommendations was considered to be supported by high-quality evidence, and only four recommendations were viewed as supported by even moderate-quality evidence.

Dr. Backonja stressed that the guidelines should give clinicians confidence that opioids can be safely used in patients with a variety of conditions. “The guidelines are important because they assure clinicians that opioids and analgesics can be safely prescribed to patients who have moderate to severe pain that is not relieved otherwise,” said. “This is the most comprehensive set of guidelines on this topic by any professional society. It is an excellent resource and provides answers to most relevant and common issues and questions when opioids are prescribed for treatment of chronic non-cancer pain.”


Descriptions of the screening tools for pain — including The Screener and Opioid Assessment for Patients with Pain; the Opioid Risk Tool; and the Diagnosis, Intractability, Risk, Efficacy (DIRE) — are all available along with free downloads of the tests by registering at this site: www.emergingsolu–


Chou R, Fanciullo GH, Miaskowsi, et al, for the American Pain Society and the American Academy of Pain Medicine Opioids Guidelines Panel. Clinical guidelines for the use of chronic opioid therapy in chronic noncancer pain. J Pain 2009;10(2):113–130.