Attention Opioid Prescribers: Change Is Coming

The Federation of State Medical Boards (FSMB) has published the 2013 version of the Model Policy on the Use of Opioid Analgesics in the Treatment of Chronic Pain. The FSMB is “committed to assisting state Medical Boards in protecting the public and improving the quality and integrity of health care in the United States.” The FSMB first developed and published guidelines encouraging “safe and effective treatment of patients with pain, including, if indicated, the use of opioid analgesics” in 1998, revising them in 2004.

The 2013 version, “recognizing that adequate evidence is currently lacking as to the effectiveness and safety of long-term opioid therapy,” encourages “state medical boards to adopt consistent policy regarding the treatment of pain, particularly chronic pain, and to promote patient access to appropriate pain management and, if indicated, substance abuse and addiction treatment.” The 2013 Model Policy “emphasizes the professional and ethical responsibility of physicians to appropriately assess and manage patients’ pain, assess the relative level of risk for misuse and addiction, monitor for aberrant behaviors and intervene as appropriate.”

The 2013 Model Policy continues to acknowledge that many Americans suffer from chronic pain, much of which is “inadequately and ineffectively treated.” Since the 2004 revisions, the FSMB notes that the “evidence for risk associated with opioids has surged, while evidence for benefits has remained controversial and insufficient.” As opioid prescribing increased over the past decade, there has also been an increase in morbidity and mortality associated with opioid therapy. The 2013 Model Policy primarily aims to improve “appropriate prescribing and mitigate risks” associated with the treatment of chronic pain when using opioid analgesics.

The 2013 Model Policy continues to raise concern about the inadequate treatment of pain and the inappropriate prescribing of opioids by physicians, noting for the first time that “patients share with physicians a responsibility for appropriate use of opioids analgesics.” The new Model Policy specifically mentions that patients have a responsibility to provide physicians with “complete and accurate information” and to adhere to their treatment plan. Patients have a duty not to share their drugs with others (even if trying to help a friend or loved one alleviate their pain), deliberately misuse opioids, or mislead their physicians or fail to disclose information in order to obtain opioids to sustain their addiction and avoid withdrawal. Patients must safeguard their medications and not leave them “unsecured where they can be stolen by visitors, workers and family members.”

For the first time, the 2013 Model Policy describes the “more problematic individual… the criminal patient, whose primary purpose is to obtain drugs for resale.” Readers are advised to be vigilant for “doctor shoppers” and patients who “travel from one geographic area to another... in search of unsuspecting targets.” The Model Policy advises “physicians’ attention to patient assessment and the routine use of state prescription drug monitoring programs.”

The 2013 Model Policy makes it clear that the state medical board will consider inappropriate management of pain, in particular chronic pain, “to be a departure from accepted best clinical practices, including, but not limited to the following:”

• Inadequate attention to initial assessment to determine if opioids are clinically indicated and to determine the risks associated with their use in a particular individual with pain
• Inadequate monitoring during the use of potentially abusable medications
• Inadequate attention to patient education and informed consent
• Unjustified dose escalation without adequate attention to risks or alternative treatments
• Excessive reliance on opioids, particularly high-dose opioids for chronic pain management
• Not making use of available tools for risk mitigation

Additionally, the Model Policy reminds physicians that “lawful prescribing” can only be done for a legitimate medical purpose by a practitioner acting in the usual course of professional practice.

The Model Policy’s “guidelines section” lists several criteria for use in evaluating a physician’s management of a patient with pain:

• Understanding pain
• Patient evaluation and risk stratification
• Informed consent and treatment agreement
• Initiating an opioid trial
• Ongoing monitoring and adopting the treatment plan
• Periodic drug testing
• Consultation and referral
• Discontinuing opioid therapy
• Medical records
• Compliance with Controlled Substance laws and regulations

The definitions provided in the Model Policy clarify abuse, addiction, controlled substance, diversion, misuse, opioid, pain, prescription drug monitoring program, tolerance, trial period, and Universal Precautions. Many of the terms used have additional definitions to make certain there is no ambiguity about what is meant in the Model Policy.

The original 1998 Model Policy has grown from a few pages to a 29-page document. Anyone prescribing opioids is encouraged to obtain this publication -- read it seriously -- and adapt their practice style to conform to it. Basically, these are the 2013 “rules of engagement.” Failure to comprehend what is contained in the Model Policy will not be an excuse for substandard practice.

B. Eliot Cole, MD, MPA, is a member of the Pain Management editorial advisory board. He has served in executive positions for several prominent pain management organizations and societies, including the American Society of Pain Educators and the American Academy of Pain Management. He has been a pain management fellow, clinician, educator, and advocate for nearly 30 years and has practiced in a variety of settings serving a wide range of patients.