New guidelines for prescribing opioid pain drugs

A prestigious panel of pain-management experts representing the American Pain Society (APS) www.ampainsoc.org and the American Academy of Pain Medicine (AAPM) has published the first comprehensive clinical practice guideline to assist clinicians in prescribing potent opioid pain medications for patients with chronic non-cancer pain.

The long-awaited guideline appears in the current issue of The Journal of Pain , www.jpain.org , the APS peer-reviewed publication.

"The expert panel concluded that opioid pain medications are safe and effective for carefully selected, well-monitored patients with chronic non-cancer pain," said Gilbert J. Fanciullo, MD, a panel co-chair and director, Section of Pain Medicine, Dartmouth Hitchcock Medical Center.

APS, AAPM and the Oregon Evidence-based Practice Center at Oregon Health and Science University collaborated for two years reviewing more than 8,000 published abstracts and non-published studies to assess clinical evidence from which their recommendations are based. The target audience is clinicians who care for adults with chronic non-cancer pain.

The panel made 25 specific recommendations and achieved unanimous consensus on nearly all. "The guidelines are based on the available evidence and also rely on an underlying assumption that chronic opioid therapy requires prescribers to have clinical skills and knowledge in both the principles of opioid treatment and the assessment and management of risks associated with opioid abuse, addiction and diversion," said Fanciullo.

Opioid prescribing has increased significantly due to growing professional acceptance that the drugs can relieve chronic non-cancer pain, and the guideline acknowledges there are widespread concerns about increases in prescription opioid abuse, addiction and diversion.

"Decisions about chronic opioid therapy must weigh the benefits of these medications against the risks, which include side effects and adverse outcomes associated with abuse," said Perry Fine, MD, panel co-chair and professor of anesthesiology, University of Utah Medical Center.

Opioids, such as morphine, oxycodone, oxymorphone and fentanyl are potent analgesics. They traditionally have been used to relieve pain following surgery, from cancer and at the end of life. Today opioids are used widely to relieve severe pain caused by chronic low-back injury, accident trauma, crippling arthritis, sickle cell, fibromyalgia, and other painful conditions.

Prior to initiating chronic opioid therapy, the guideline advises clinicians to determine if the pain can be treated with other medications. If opioids are appropriate, the clinician should conduct a thorough medical history and examination and assess potential risk for substance abuse, misuse or addiction. Fanciullo noted the strongest predictor of possible drug misuse is a personal or family history of alcohol and drug abuse. "For patients at higher risk for misuse of opioids, the guideline advises giving patients clear written rules, such as filling prescriptions at one pharmacy only, taking random drug tests, making regular physician visits, and locking their medications at home," he said.

Diligent Patient Monitoring Is Essential

A key recommendation urges clinicians to continuously assess patients on chronic opioid therapy by monitoring pain intensity, level of functioning and adherence to prescribed treatments. Periodic drug screens should be ordered for patients at risk for aberrant drug behavior.

"Regular monitoring of chronic opioid therapy patients is warranted because the therapeutic benefits of these medications are not static and can be affected by changes in the underlying pain condition, coexisting disease, or in psychological or social circumstances," said Fanciullo. "For patients at low risk for adverse outcomes and on stable doses of opioids, monitoring at least once every three to six months is sufficient, but weekly monitoring is justifiable for those at high risk for abuse and other adverse events."

Fine added that sometimes patient self reports are unreliable, so the guideline recommends that pill counts, urine drug screening, family member or caregiver interviews and prescription monitoring data be used to check for possible abuse. "Although strong evidence is lacking on the best methods for managing high-risk patients, potential risks can be minimized by more frequent and intense monitoring compared to lower risk patients," he said.

Other recommendations in the APS/AAPM clinical practice guideline include:

Methadone: Use of methadone for pain management has increased dramatically but few trials have evaluated its benefits and harms for treatment of chronic non-cancer pain. Methadone, therefore, should be started at low doses and titrated slowly. Because of its long half-life and variable pharmacokinetics, the panel recommends methadone not be used to treat breakthrough pain or as an as-needed medication.

Abusers: Chronic opioid therapy must be discontinued in patients known to be diverting their medication or in those engaging in serious aberrant behaviors.

Breakthrough Pain: As-needed opioids can be prescribed based on initial and ongoing analysis of therapeutic benefit versus risk.

High Doses: Patients who need high doses of opioids (200 mg daily of morphine or equivalent) should be evaluated for adverse events on an ongoing basis. Clinicians should consider rotating pain medications when patients experience intolerable side effects or inadequate benefit despite appropriate dose increases.

Driving and Work Safety: Patients should be educated about the greater risk for impairment when starting chronic opioid therapy and counseled not to drive or engage in potentially dangerous work if impaired.

Pregnancy: Clinicians should counsel women about risks in pregnancy and encourage minimal or no use of chronic opioid therapy unless potential benefits outweigh risks.

The guideline on opioid therapy for chronic non-cancer pain is the sixth evidenced-based, pain management clinical practice guideline published by APS. Others have covered sickle-cell disease, arthritis, cancer, fibromyalgia, and low back pain.

"This is a milestone collaboration in which two leading organizations representing pain management have developed the first comprehensive, evidence-based clinical practice guideline to assist clinicians in managing chronic opioid therapy," said APS President Charles Inturrisi, PhD. "We are grateful to the American Academy of Pain Medicine for joining forces with APS in developing this long-awaited publication."

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