This issue focuses on the challenge of managing chronic pain. Commentaries present various treatment options, including opioids, nonopioid medications, surgery, and alternative therapies. Authors also address the problems of opioid misuse and abuse and discuss ways to lessen these risks. Original articles examine health professionals’ communication with adolescents about smoking, as well as children's immunization status as verified by practice records and by the North Carolina Immunization Registry.
Challenges of Chronic Pain Management: Public Health Consequences and Considered Responses
Prescribing rates for opioid medications have risen dramatically over the past 15 years, doubling or even quadrupling depending on the particular analgesic. The total amount of opioids prescribed in the United States measured in morphine-equivalent doses (MEDs) increased more than 600% between 1997 and 2007 , and more than 200 million opioid prescriptions are now written every year. With the increased availability of opioids, diversion of these medications to nonmedical use has also increased. In 2010 more than 12 million individuals in the United States were estimated to have used opioid analgesics nonmedically during the previous year, and approximately 1.8 million people had abused or had been dependent on these drugs . As a consequence of this trend, health care providers in clinical practice are more commonly observing medical and traumatic complications of opioid use. Between 2004 and 2010, the number of emergency department visits for hydrocodone misuse or abuse more than doubled, and the number of visits related to oxycodone tripled .
Accidental overdose deaths underscore the seriousness of this problem. Nationally, the rate of unintentional deaths due to prescription drug overdoses has nearly tripled over the past 10 years . In 2010 approximately 16,000 overdose deaths were attributed to prescription opioids, while only 2,000 were related to heroin . While opioids are the primary cause for concern, other controlled medications also have potentially serious overdose risks. In 2010 there were almost 400,000 emergency department visits and approximately 6,000 overdose deaths involving benzodiazepines . Nationally, deaths due to drug poisoning are now the primary cause of accidental deaths, exceeding traffic fatalities [2, 4]. The North Carolina Office of the Chief Medical Examiner reports that deaths due to overdoses of controlled medications—primarily opioid analgesics—have more than doubled over the past 10 years in North Carolina, with almost 900 such deaths reported in 2011 (William Bronson, written communication).
These numbers provide only a broad outline of the more obvious public health consequences of opioid misuse. Mean annual direct health care costs are nearly 8.7 times higher for individuals who abuse these medications than for those who do not . Along with these economic effects on individuals, there are also incalculable emotional consequences for families and communities. Prescription medications, primarily opioid analgesics and benzodiazepines, have surpassed marijuana to become the new gateway drugs—the first illicit drugs used by teenagers —which hints at their broad impact and foreshadows the continuation of this societal and clinical problem for many years to come.
An Evolving Standard of Care
Each year, a large majority of the global supply of opioid analgesics is consumed in the United States, including more than 80% of the global opioid supply and 99% of the global supply of hydrocodone . This imbalance reflects sociocultural and economic factors as well as clinical standards. Therapeutic decisions, including the decision to prescribe opioids, are based not only on the clinician’s knowledge base but also on patient preference, availability of nonmedical treatment modalities, complexities and biases in third-party reimbursement, aggressive pharmaceutical marketing, and medicolegal concerns. These and other factors have tended to skew the standard of care in the United States toward an overreliance on opioids for long-term management of chronic pain.
Viewed in a historical context, the standard of care for the management of chronic noncancer pain has changed dramatically over the past 20 years. The United States has long had high rates of chronic pain and associated suffering, disability, and impaired quality of life. Approximately 15–20 years ago, physicians were seen as being unresponsive to this pressing clinical need, and they were accused of ignoring pain or treating it inadequately . At that time a concerted effort was made to respond to this unmet need with educational and regulatory initiatives, such as the “pain as the fifth vital sign” campaign. In addition, the Model Policy for the Use of Controlled Substances for the Treatment of Pain was developed by the Federation of State Medical Boards in an attempt to alleviate physicians’ concerns about regulatory oversight .
Clinical practice subsequently shifted to include more widespread use of opioid analgesics. Previously opioids had typically been used only for acute, time-limited pain. Successful use of opioids for chronic cancer-related pain led to increasing use of these drugs to treat chronic noncancer pain as well. Although well intended, this expansion in the use of opioids was made without adequate attention to potential risks and despite the paucity of clinical research supporting such a change .
There is now a need for a more balanced, evidence-based standard of care for management of chronic pain—one that assures access to needed treatment while minimizing the potential for overuse and abuse of medications. This effort will require paying attention to 2 parallel, overlapping imperatives. First, there is a need for training in effective, multidimensional pain management strategies with a more proscribed role for opioids, particularly high-dose opioids. Second, new standards of care will need to define and apply safer prescribing practices through adequate risk stratification, appropriate treatment planning, and conscientious monitoring.
US medical schools report devoting an average of only 9 hours of curricular time to pain, and a majority of primary care physicians report that they do not feel confident about managing chronic pain . There is thus a clear need for more education on topics such as how to differentiate categories of pain (such as nociceptive, inflammatory, and neuropathic pain), how to identify which treatment modalities are likely to be effective for these types of pain, and how to determine when pain is likely to be responsive to opioids. Currently, most clinical protocols list opioids as indicated for moderate to severe pain, and they state that these drugs are to be used only after other modalities have proven inadequate . Yet primary care clinicians and specialists at times use opioids as first-line treatment for a broad range of chronic pain syndromes.
Dosing is another important area in which training is needed. Specific topics that should be addressed include safe and effective dose initiation and titration; when and how to use different opioids, including short-acting and long-acting formulations; how to establish when an adequate dose has been reached; and when and how to stop prescribing opioids. Achieving the optimal dose for each patient is particularly important because there is an escalation in risk with increasing dosages of opioids. In a study of opioid overdoses among patients with chronic noncancer pain , the hazard ratio for serious overdose events was 1.0 at a daily MED up to 20 mg, 3.11 at a daily MED of 50–99 mg, and 11.18 at a daily MED of 100 mg or greater. Clinicians also need to know what constitutes an adequate trial of opioid therapy. When faced with complaints of inadequate pain management or requests for higher doses, the clinician may decide—rather than increasing the dose—to discontinue opioid therapy, rotate among opioids, or use these drugs with greater attention to other pharmacologic or behavioral interventions.
More broadly, a recent Institute of Medicine report, Relieving Pain in America , reinforced the importance of framing chronic pain as a unique chronic disease state with complex neurophysiological, emotional, and social components—all of which make its management quite distinct from that of acute pain. The “suffering” aspects of chronic pain require a different level of attention and intervention than that available through medications alone. Traumatic experiences, depression, changes in self-image, disruptions in employment and other social roles, stresses on family caregivers, and a host of other subtle aspects of chronic pain clearly point to the need for a biopsychosocial treatment model. Cognitive behavioral therapies and the development of coping skills have demonstrated effectiveness in pain management, and patients’ motivation and engagement are important in establishing realistic goals for the management of their pain. A collaborative model of care is thus critically important to a successful outcome .
Implementing a Safer and More Balanced Approach to Prescribing
Many of the current proposals for adapting prescribing practices to minimize the potential for misuse and addiction are not really new. Rather, they reapply guidelines for conscientious medical practice to this particular clinical area [8, 14]. The emphasis is now on the need to apply these guidelines universally and to routinely use newer tools such as the North Carolina Controlled Substances Reporting System (NCCSRS) as part of ongoing risk assessment and monitoring . Applying these strategies to all patients, regardless of age or other demographic characteristics, is crucial, as overdoses are not just occurring among young, naïve street addicts. One review  found that overdose rates in 2008 were actually highest among those 45–54 years of age, while those 15–24 years of age had some of the lowest reported overdose rates (25 deaths per 100,000 and 5 deaths per 100,000, respectively). Some guidelines also recommend wider use of abuse-resistant formulations of pain medications. Whether such formulations will have a significant impact on misuse and abuse is not yet clear; while they may indeed provide some added safety, they are no substitute for conscientious clinical care.
Most of the evolving protocols for safer prescribing share certain features, even if specific applications or tools vary [11, 16]. One important feature of these protocols is risk stratification. Specifically, deciding whether or how to use opioids should be dictated by risk assessment that is based not only on the patient’s self-report but also on information obtained from prior clinicians or medical records, from the NCCSRS, and from the results of preliminary drug screening.
Treatment agreements are another common feature of prescribing protocols. These are written, signed agreements that educate the patient about risks, set realistic collaborative goals, and define the parameters for safe use that must be maintained in order for patients to have continued access to their medication [11, 17].
Ongoing monitoring is also commonly imposed. Treatment effectiveness should be determined by improvement in functionality and adequate pain management, not by pain eradication . Safety is gauged through the absence of impairment or aberrant behaviors, use of recurrent drug screening, and review of NCCSRS data.
Most protocols also call for adapting the treatment plan when necessary. Inadequate pain relief calls for reevaluation of multimodal treatment options and for active engagement with the patient, rather than simply an increase in dosage. Referrals for evaluation or additional treatment may also be indicated, particularly if higher doses are to be considered.
In addition, most safe-prescribing protocols recommend intervening when the patient’s behaviors appear to be risky or aberrant. Further assessment is often required to determine what type of intervention is needed, after which clinicians may choose to increase their frequency of contact with the patient, discontinue refills, refer the patient for mental health or substance abuse evaluation, or discontinue the use of controlled substances.
Implementation of these recommendations will depend on how they are adapted to various primary care, specialty, or emergency settings. Methodologies must be time-efficient, take advantage of electronic medical records and other information system technologies, make use of personnel in team-based models, and link patients with available mental health and substance abuse services in the community.
Clinical Conundrums: Functional Addiction and Functional Dependency
One looming challenge is how to deal with the large number of individuals who are currently dependent on prescribed opioids, many of whom have been taking these drugs for long periods of time, sometimes at high dosages. This is generally a poorly delineated group: Some patients may still have severe pain that requires opioids at some dose. Others may be continuing opioid therapy primarily to avoid rebound pain or withdrawal. Many may be using opioids not to treat physical pain but to ameliorate emotional or situational distress, which is called “chemical coping.” Finally, since many patients have not been monitored adequately for functionality, impairment, or aberrant behaviors, some patients may be “functional addicts”—people who are addicted but have not yet been identified as such—while other patients who show no evidence of impairment or aberrant behaviors could be referred to as “functionally dependent” rather than addicted. Patients in different categories will clearly require very different clinical approaches.
One obvious approach would be to try to decrease opioid doses to safer levels while attempting or reattempting a more multidimensional treatment approach. However, successfully transitioning these patients from opioid therapy to an alternative therapy—or even significantly lowering the dosage they are receiving—will likely be challenging. Long-term maintenance therapy with opioids induces a complex set of neuroadaptations, often making the opioid necessary for the individual to feel normal or at ease; thus it is difficult to decrease the patient’s dosage or to discontinue therapy. Studies have shown that attempts to discontinue methadone after long-term maintenance therapy for opioid addiction have generally been unsuccessful. Even after prolonged periods of stability, up to 80% of these individuals return to opioid use after stopping methadone therapy . Patients who are taking methadone for opioid addiction could be said to represent a very different clinical and demographic cohort than most other patients with chronic pain. However, studies of buprenorphine for the treatment of opioid dependence, which have been conducted in cohorts that overlap significantly with the population of chronic pain patients, show the same high tendency for relapse after discontinuation of buprenorphine therapy, even when the drug is tapered over a period of several months .
If chemical coping is involved, then decreasing or discontinuing opioid use is likely to be especially difficult, making the utilization of mental health services essential. Distress management and alternative coping skills are necessary for those who have become emotionally as well as physically dependent on opioids. Likewise, access to addiction services is critically important for patients who are at high risk for aberrant use, such as those with current or prior substance abuse problems or those who have demonstrated an inability to use opioids safely. In particular, access to buprenorphine or to a combination of buprenorphine and naloxone will likely improve addiction-related treatment outcomes, provide some analgesia if needed, and reduce addiction-related mortality . In France, widespread use of medication-assisted therapy, primarily buprenorphine treatment, was found to be associated with an 80% decrease in overdose deaths from heroin or cocaine .
Many medical practitioners, health care systems, regulatory boards, and medical societies are showing a great deal of initiative in responding to this public health challenge. The Federation of State Medical Boards is currently revising its guidelines for chronic pain management to balance access to care with safeguards to avoid misuse. Specialty societies and other organizations are also developing educational resources related to safe opioid prescribing. The American Academy of Family Practice and the American Society of Addiction Medicine have both been awarded grants to support the nationwide availability of free training regarding risk mitigation strategies, and physicians who attend this training can earn Continuing Medical Education credit. In North Carolina, the Governor’s Institute on Substance Abuse has taken a lead role in making similar training available within the state. [Editor’s note: For more information on the work of the Governor’s Institute on Substance Abuse, please see the sidebar by Finch and McEwen on pages 233-234.]
An example of an innovative health systems approach to chronic pain management is the Chronic Pain Initiative of Community Care of North Carolina (CCNC). [Editor’s note: Lancaster and colleagues discuss this initiative in more detail on pages 237-241.] Building on the successful communitywide approach taken by Project Lazarus , CCNC is using its patient-centered medical homes and systems of care pathways to implement many of the recommendations outlined above. Using clinical training provided through the Governor’s Institute, CCNC is working in collaboration with local pain, mental health, and substance abuse practitioners to change the standard of care for chronic pain management among its several thousand prescribers across the state.
Implementing more training in medical schools and residency programs will be essential for long-term change. Chronic pain management will continue to be a major clinical need, as a large cohort of patients are already dependent on these medications. Primary care specialists must continue to provide the majority of chronic pain management, but they will need the help of a broad range of specialists. There are not enough pain management or addiction medicine specialists to meet this need, so clinicians in all areas of medicine need to be informed and involved if the pendulum of care is to be pushed toward the common goal of available, effective, and safe management of chronic pain.
Potential conflicts of interest. J.W.F. was formerly on the speakers’ bureau of Reckitt-Benckiser Pharmaceuticals.
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James W. Finch, MD director, Physician Education, Governor’s Institute on Substance Abuse, Raleigh, North Carolina; adjunct associate professor, Department of Family Medicine, School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina; and codirector, Changes By Choice, Durham, North Carolina.
Address correspondence to Dr. James W. Finch, Changes by Choice, 909 Broad St, Durham, NC 27705 (firstname.lastname@example.org).