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Summary1 Acute and chronic pain affects large numbers of Americans, with ap- proximately 100 million2 U.S. adults burdened by chronic pain alone. The annual national economic cost associated with chronic pain is estimated to be $560-635 billion. Pain is a uniquely individual and subjective expe- rience that depends on a variety of biological, psychological, and social factors, and different population groups experience pain differentially. For many patients, treatment of pain is inadequate not just because of uncertain diagnoses and societal stigma, but also because of shortcomings in the availability of effective treatments and inadequate patient and clinician knowledge about the best ways to manage pain. Some answers will come from exciting new research opportunities, but changes in the care system also will be needed in order for patients’ pain journeys to be shorter and more successful. In the committee’s view, addressing the nation’s enormous burden of pain will require a cultural transformation in the way pain is understood, assessed, and treated. This report provides recommendations intended to help achieve this transformation. 1This summary does not include references. Citations for the discussion presented in the summary appear in the subsequent report chapters. 2 Because of a computational error, the initial publication of the report Relieving Pain in America contained an erroneous estimate of the number of adults who experience chronic pain in the United States. A re-analysis of the study by Tsang and colleagues (2008), as well as the independent assess - ment by Gaskins and Richards (Appendix C), yield an estimate of approximately 100 million U.S. adults who experience chronic pain and not 116 million as stated in the original report. The text of the report has been revised to show this corrected estimate. 1

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2 RELIEVING PAIN IN AMERICA Pain is a universal experience. Common chronic pain conditions affect ap- proximately 100 million U.S. adults at a cost of $560-635 billion annually in direct medical treatment costs and lost productivity. Pain’s occurrence, severity, duration, response to treatment, and disabling consequences vary from person to person because pain, like other severe chronic conditions, is much more than a biological phenomenon and has profound emotional and cognitive effects. Pain can be mild and easily handled with over-the-counter medications; it can be acute and recede with treatment; it can be recurrent over months or years; or it can be chronic and debilitating, requiring almost constant attention and accommodation. Many shortfalls in pain assessment and treatment persist despite humanity’s intimate familiarity with pain throughout history, modern appreciation for the complexity of its origins and the diversity of its effects, and the not insubstantial risk that any one person may have serious or chronic pain at some point. In gen - eral, these shortfalls arise through gaps in policy, treatment, attitudes, education, and research. Why and how these gaps might be remedied was the focus of the Institute of Medicine’s (IOM’s) Committee on Advancing Pain Research, Care, and Education. CHARGE TO THE COMMITTEE AND STUDY APPROACH Section 4305 of the 2010 Patient Protection and Affordable Care Act required the Secretary, Department of Health and Human Services (HHS), to enter into an agreement with the IOM for activities “to increase the recognition of pain as a significant public health problem in the United States.” Accordingly, HHS, through the National Institutes of Health (NIH), requested that the IOM conduct a study to assess the state of the science regarding pain research, care, and edu - cation and to make recommendations to advance the field (see Chapter 1 for the committee’s statement of task). This report responds to the committee’s charge by providing a blueprint for transforming the way pain is understood, assessed, treated, and prevented. It provides recommendations for improving the care of people who experience pain, the training of clinicians who treat them, and the collection of data on pain in the United States. The report does not provide an exhaustive review of the literature examining the science of pain and its diagnosis and treatment. Nor does the report present a clinical algorithm for the diagnosis and treatment of patients with pain. Rather, it describes the scope of the problem of pain and provides an overview of needs for care, education, and research. The committee’s recommendations are based on both scientific evidence and expert judgment. Several important underlying principles informed the committee’s approach to its charge. These principles are presented in Box S-1.

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3 SUMMARY BOX S-1 Underlying Principles • moral imperative. Effective pain management is a moral imperative, a A professional responsibility, and the duty of people in the healing professions. • hronic pain can be a disease in itself. Chronic pain has a distinct pathology, C causing changes throughout the nervous system that often worsen over time. It has significant psychological and cognitive correlates and can constitute a serious, separate disease entity. • alue of comprehensive treatment. Pain results from a combination of bio- V logical, psychological, and social factors and often requires comprehensive approaches to prevention and management. • eed for interdisciplinary approaches. Given chronic pain’s diverse effects, N interdisciplinary assessment and treatment may produce the best results for people with the most severe and persistent pain problems. • mportance of prevention. Chronic pain has such severe impacts on all I aspects of the lives of its sufferers that every effort should be made to achieve both primary prevention (e.g., in surgery for a broken hip) and secondary prevention (of the transition from the acute to the chronic state) through early intervention. • ider use of existing knowledge. While there is much more to be learned W about pain and its treatment, even existing knowledge is not always used effectively, and thus substantial numbers of people suffer unnecessarily. • he conundrum of opioids. The committee recognizes the serious problem T of diversion and abuse of opioid drugs, as well as questions about their long- term usefulness. However, the committee believes that when opioids are used as prescribed and appropriately monitored, they can be safe and effective, especially for acute, postoperative, and procedural pain, as well as for patients near the end of life who desire more pain relief. • oles for patients and clinicians. The effectiveness of pain treatments de- R pends greatly on the strength of the clinician–patient relationship; pain treat- ment is never about the clinician’s intervention alone, but about the clinician and patient (and family) working together. • alue of a public health and community-based approach. Many features V of the problem of pain lend themselves to public health approaches—concern about the large number of people affected, disparities in occurrence and treat- ment, and the goal of prevention cited above. Public health education can help counter the myths, misunderstandings, stereotypes, and stigma that hinder better care. THE NEED FOR A CULTURAL TRANSFORMATION IN THE WAY PAIN IS VIEWED AND TREATED Pain serves a vital function as a warning sign of injury or infection, but once its warning role is over, continued pain is maladaptive. Chronic pain results in many changes in the peripheral and central nervous systems that aid in its per-

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4 RELIEVING PAIN IN AMERICA sistence. Because of those physiological changes, some types of chronic pain are diseases in their own right. All people are at risk of chronic pain. It can come about with age (e.g., arthritis), from genetic predisposition (e.g., migraine), as a component of another chronic disease (e.g., cancer, heart disease), as a result of surgery (e.g., severed nerves), or following an injury (e.g., low back pain, neck pain). Pain is a uniquely individual, subjective experience. Why one person suffers an injury and reports modest pain and another with a similar injury reports serious pain depends on many factors: genetic characteristics, general health status and comorbidities, pain experiences from childhood on, the brain’s processing system, the emotional and cognitive context in which pain occurs, and cultural and social factors. Because pain often produces psychological and cognitive effects—anxiety, depression, and anger among them—interdisciplinary, biopsychosocial ap- proaches are the most promising for treating patients with persistent pain. But for most patients (and clinicians), such care is a difficult-to-attain ideal, impeded by numerous structural barriers—institutional, educational, organizational, and reimbursement-related. Costly procedures often are performed when other actions should be considered, such as prevention, counseling, and facilitation of self-care, which are common features of successful treatment. In addition, adequate pain treatment and follow-up may be thwarted by a mix of uncertain diagnosis and societal stigma consciously or unconsciously applied to people reporting pain, particularly when they do not respond readily to treatment. In the committee’s view, remediating the mismatch between current knowl- edge and its application will require a cultural transformation in the way clinicians and the public view pain and its treatment. Understanding chronic pain as a disease means that it requires direct treatment, rather than being sidelined while clinicians attempt to identify some underlying condition that may have caused it. It also means that health professions education programs should include a substantial amount of learning about pain and its diversity, and that people with chronic pain should be recognized by family, employers, health insurers, and others as having a serious condition. It means that people with chronic pain have an important role to play in managing their disease in an informed, productive way. And finally, it means that the biomedical research community should pursue pain research with the same vigor expended on other serious and disabling chronic conditions. FINDINGS AND RECOMMENDATIONS The findings and recommendations presented in this report revolve around a single conclusion: Chronic pain alone affects the lives of approximately 100 million Americans, making its control of enormous value to individuals and society. To reduce the impact of pain and the resultant suffering will require a transformation in how

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5 SUMMARY pain is perceived and judged both by people with pain and by the health care providers who help care for them. The overarching goal of this transformation should be gaining a better understanding of pain of all types and improving ef - forts to prevent, assess, and treat pain. The committee’s recommendations and the findings that support them fall into four areas that serve to structure the main chapters of the report: pain as a public health challenge, care of people with pain, education challenges, and research challenges.3 Pain as a Public Health Challenge Pain affects millions of Americans; contributes greatly to national rates of morbidity, mortality, and disability; and is rising in prevalence. Substantial dis - parities exist in the prevalence, seriousness, and adequate treatment of pain that affect the vulnerable populations of traditional public health concern. Pain exacts enormous costs both economically and in the toll it takes on people’s lives. Analy- sis performed for the committee revealed that the annual economic cost of chronic pain in the United States is at least4 $560-635 billion. This estimate combines the incremental cost of health care ($261-300 billion) and the cost of lost productivity ($297-336 billion) attributable to pain. The federal Medicare program bears fully one-fourth of U.S. medical expenditures for pain; in 2008, this amounted to at least $65.3 billion, or 14 percent of all Medicare costs. In total, federal and state programs—including Medicare, Medicaid, the Department of Veterans Affairs, TRICARE, workers’ compensation, and others—paid out $99 billion in 2008 in medical expenditures attributable to pain. Lost tax revenues due to productivity losses compound that expense. Finding 2-1. Pain is a public health problem. Pain is a significant public health problem. Chronic pain alone affects approximately 100 million U.S. adults. Pain reduces quality of life, affects specific population groups disparately, costs society at least $560-635 billion annually (an amount equal to about $2,000 for everyone living in the United States), and can be appropriately addressed through population health-level interventions. 3 The findings and recommendations are numbered according to the chapter of the report in which they appear. Thus, for example, recommendation 2-1 is the first recommendation in Chapter 2. Note that some of the findings and recommendations are presented here in abbreviated form. The full ver- sions are included in the respective chapters. 4 The $560-635 billion range is a conservative estimate because it excludes the cost of pain affecting institutionalized individuals (including nursing home residents and corrections inmates), military personnel, children under age 18, and personal caregivers (such as spouses who miss work while caring for people with pain), as well as the lost productivity of workers younger than 24 and older than 65. The estimate also excludes the emotional cost of pain.

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6 RELIEVING PAIN IN AMERICA Finding 2-2. More consistent data on pain are needed. While it is known that pain affects millions of Americans, the committee acknowledges the lack of consistent data with which to describe the nature and extent of the problem or to identify subpopulations that will benefit most from future interventions. Improvements in state and national data are needed to (1) monitor changes in the incidence and prevalence of acute and chronic pain; (2) document rates of treat - ment or undertreatment of pain; (3) assess the health and societal consequences of pain; and (4) evaluate the impact of related changes in public policy, pay - ment, and care. Pain data need to be based on standardized questions, preferably using existing international standards, to facilitate comparisons over time and across populations. These data would be useful for a wide range of stakeholders, including policy makers, health care providers, health professions educators, professional licensing authorities, pain advocacy and awareness organizations, and researchers. Recommendation 2-1. Improve the collection and reporting of data on pain. The National Center for Health Statistics, the Agency for Health- care Research and Quality, other federal and state agencies, and private organizations should improve and accelerate the collection and reporting of data on pain. Data should be collected in the following domains: • t he incidence and prevalence of pain; • i nterference with activities of daily living and work, as well as dis- ability, related to pain; • u tilization of clinical and social services as a result of pain; • c osts of pain and pain care, including indirect costs of lost employ- ment and public- and private-sector costs for disability payments; and • t he effectiveness of treatment in reducing pain and pain-related disability, determined through research on the comparative effec- tiveness of alternative treatments (including in different patient populations), to identify people most likely to benefit (or not) from specific treatment approaches. Standardized questions, fields, and protocols for surveys and electronic health records should be developed, and pain-related data should be col- lected at regular intervals. Finding 2-3. A population-based strategy for reducing pain and its conse - quences is needed. The committee finds that, to effect changes that will reach the millions of American adults living with pain, account for differences in the experience of pain among population groups, and address selected environmental

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7 SUMMARY factors that contribute to the consequences of pain, a population health-level strategy is needed. Recommendation 2-2. Create a comprehensive population health- level strategy for pain prevention, treatment, management, and research. The Secretary of the Department of Health and Human Ser- vices should develop a comprehensive, population health-level strategy for pain prevention, treatment, management, education, reimbursement, and research that includes specific goals, actions, time frames, and re - sources. This strategy should • D escribe how efforts across government agencies, including public– private partnerships, can be established, coordinated, and integrated to encourage population-focused research, education, communica - tion, and community-wide approaches that can help reduce pain and its consequences and remediate disparities in the experience of pain among subgroups of Americans. • I nclude an agenda for developing physiological, clinical, behav- ioral, psychological, outcomes, and health services research and appropriate links across these domains (consistent with Recom - mendations 5-1 through 5-4). • I mprove pain assessment and management programs within the service delivery and financing programs of the federal government. • P roceed in cooperation with the Interagency Pain Research Coordi- nating Committee and the National Institutes of Health’s Pain Con - sortium and reach out to private-sector participants as appropriate. • I nvolve the relevant federal agencies and departments (National Institutes of Health, Centers for Disease Control and Prevention, Food and Drug Administration, Centers for Medicare and Medi- caid Services, Agency for Healthcare Research and Quality, Health Resources and Services Administration, Indian Health Service, De - partment of Defense, and Department of Veterans Affairs); private- sector entities (pain advocacy and awareness organizations; health professions associations; health care providers; health professions educators; private insurers; and accreditation, certification, and ex - amination organizations); and state-level entities. • I nclude ongoing efforts to enhance public awareness about the ature n of chronic pain and the role of self-care in its management. The development of this strategy should be completed by the end of 2012.

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8 RELIEVING PAIN IN AMERICA Care of People with Pain Currently, large numbers of Americans receive inadequate pain prevention, assessment, and treatment, in part because of financial incentives that work against the provision of the best, most individualized care; unrealistic patient expectations; and a lack of valid and objective pain assessment measures. Clini- cians’ role in chronic pain care is often a matter of guiding, coaching, and assist- ing patients with day-to-day self-management, but many health professionals lack training in how to perform this support role, and there is little reimbursement for their doing so. Primary care is often the first stop for patients with pain, but primary care is organized in ways that rarely allow clinicians time to perform comprehensive patient assessments. Sometimes patients turn to, or are referred to, pain specialists or pain clinics, although both of these are few in number. Unfortu- nately, patients often are not told, or do not understand, that their journey to find the best combination of treatments for them may be long and full of uncertainty. Finding 3-1. Pain care must be tailored to each person’s experience. Pain management takes place through self-management, primary care, specialty care, and pain centers. However, the majority of care and management should take place through self-management and primary care, with specialty services being focused on recalcitrant or more complex cases. Accordingly, individualization of pain management is necessary throughout the health care system. Health care providers need to foster pain care that is patient-centered and, when necessary, comprehensive and interdisciplinary. Financing, referral, records management, and other systems need to support this flexibility. Recommendation 3-1. Promote and enable self-management of pain. Health care provider organizations should take the lead in developing educational approaches and materials for people with pain and their families that promote and enable self-management. These materials should include information about the nature of pain; ways to use self- help strategies to prevent, cope with, and reduce pain; and the benefits, risks, and costs of various pain management options. Approaches and materials should be culturally and linguistically appropriate and avail - able in both electronic and print form. Finding 3-2. Significant barriers to adequate pain care exist. The committee finds that multiple and significant barriers to pain care and management exist in the primary care setting. • E nhanced continuing education and training are needed for health care professionals to address gaps in knowledge and competencies related to pain assessment and management, cultural attitudes about pain, negative

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9 SUMMARY and ill-informed attitudes about people with pain, and stereotyping and biases that contribute to disparities in pain care. • O ther barriers include the magnitude of the pain problem, including its extremely high prevalence, which makes effective action difficult on a national scale; certain provider attitudes and training, which impede the delivery of high-quality care; insurance coverage, because fully one- third of all Americans are uninsured or underinsured; cultural attitudes of patients, many of whom do not recognize the need to address pain early on; and geographic barriers, which place residents of rural com - munities at a disadvantage. • S ystem and organizational barriers, many of them driven by current re- imbursement policies, obstruct patient-centered care. Examples of these barriers are minimal capacity for frequent visits when necessary; lim- ited time for conduct of comprehensive assessments; inadequate patient education initiatives; difficulties in accessing specialty care; and lack of reimbursement for needed specialty care services, interdisciplinary prac- tice, psychosocial and rehabilitative services, in-depth patient interviews and education, and time spent planning and coordinating care. • A comprehensive, strategic approach can succeed in addressing these barriers and help close the gap between empirical evidence regarding the efficacy of pain treatments and current practice. • R egulatory, legal, educational, and cultural barriers inhibit the medically appropriate use of opioid analgesics. Recommendation 3-2. Develop strategies for reducing barriers to pain care. The population health-level strategy referred to in Recommendation 2-2 should include identifying and developing comprehensive approaches to overcoming existing barriers to pain care, especially for populations that are disproportionately affected by and undertreated for pain. Strate- gies also should focus on ways to improve pain care for these groups. Recommendation 3-3. Provide educational opportunities in pain as- sessment and treatment in primary care. Health professions education and training programs, professional associations, and other groups that sponsor continuing education for health professionals should develop and provide educational opportunities for primary care practitioners and other providers to improve their knowledge and skills in pain assessment and treatment, including safe and effective opioid prescribing. Recommendation 3-4. Support collaboration between pain specialists and primary care clinicians, including referral to pain centers when appropriate. Pain specialty professional organizations and primary care professional associations should work together to support the collabora-

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10 RELIEVING PAIN IN AMERICA tion of pain specialists with primary care practitioners and teams when primary care providers have exhausted their expertise and the patient’s pain persists. Recommendation 3-5. Revise reimbursement policies to foster coor- dinated and evidence-based pain care. Payers and health care orga- nizations should work to align payment incentives with evidence-based assessment and treatment of pain. Optimal care of the patient should be the focus. Recommendation 3-6. Provide consistent and complete pain assess- ments. Health care providers should provide pain assessments that are consistent and complete and documented so that patients will receive the right care at the right place and the right time. Education Challenges The optimal timing, content, and goals of patient education about pain vary with individual circumstances. Fundamental to treatment is education regarding self-management to minimize flare-ups, decrease day-to-day discomfort, and maximize functioning. In addition, public education about pain can be highly beneficial in promoting • i ndividual and community actions to prevent injuries, • a dvocacy for appropriate acute and chronic pain treatment, and • s upport for improved pain prevention and control policies. Educational programs for the many types of health care professionals who play a role in pain prevention and treatment—nurses, psychologists, physicians, dentists, pharmacists, physical therapists, and complementary and alternative medicine practitioners—vary in the amount and quality of information on pain they contain. In medical education, pain generally has received little attention, which has contributed to the problem of undertreatment. The need for improved education about pain is especially acute for primary care providers—the front- line clinicians for most people’s acute or chronic pain problems. Finding 4-1. Education is a central part of the necessary cultural transforma - tion of the approach to pain. The committee finds that the federal government is in a position to contribute to substantial improvements in patient and professional education about pain. Recommendation 4-1. Expand and redesign education programs to transform the understanding of pain. Federal agencies and other

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11 SUMMARY relevant stakeholders should expand education programs to transform patient and public understanding of pain. In concert with Recommenda- tion 2-2, federal agencies, in partnership with health professions asso - ciations, payers, pain advocacy and awareness organizations, and other relevant stakeholders, should develop education programs for patients, the public, and health care providers that are designed to promote a transformation in their expectations, beliefs, and understanding about pain, its consequences, its management, and its prevention. Recommendation 4-2. Improve curriculum and education for health care professionals. The Centers for Medicare and Medicaid Services, the Health Resources and Services Administration, accrediting or- ganizations, and undergraduate and graduate health professions train - ing programs should improve pain education curricula for health care professionals. Recommendation 4-3. Increase the number of health profession- als with advanced expertise in pain care. Educational programs for medical, dental, nursing, mental health, physical therapy, pharmacy, and other health professionals who will participate in the delivery of pain care should have increased capacity to train providers who can offer advanced pain care. Research Challenges In recent years, biomedical research has made remarkable strides in under- standing of the basic biological and psychological underpinnings of pain. A principal current opportunity may be to use what has been learned across a broad spectrum of fields—from genomic and cellular through behavioral mechanisms— to develop innovative therapies that are simultaneously more targeted to the individual and more comprehensive in meeting patient needs. From a scientific standpoint, the future of pain research is exciting because of advances in a number of relevant and diverse research fields and the devel- opment of new research techniques. This excitement is tempered, however, by knowledge that federal research dollars to address the problem of pain are in short supply and likely to decrease. Pain is a topic of interest to virtually every NIH institute and center, but not a central concern of any one of them. The committee believes one of the existing NIH institutes should be designated the lead institute for pain. The committee further believes that the NIH Pain Consortium needs to take a stronger leadership role in effecting the necessary transformation in how pain research is conducted by fostering coordination across institutes and centers, by ensuring that study section decision making on pain proposals is improved, and by exploring a range of potential public–private initiatives.

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12 RELIEVING PAIN IN AMERICA Pain research should not be confined to NIH. As this report details, pain- related research is needed across public health entities, involving, for example, the Centers for Disease Control and Prevention’s epidemiological and public education expertise, the Agency for Healthcare Research and Quality’s quality improvement initiatives, the Health Resources and Services Administration’s ex - pertise in professional education and service delivery for vulnerable populations, and the Centers for Medicare and Medicaid Services’ research and demonstration programs related to reimbursement policies. Finding 5-1. Research to translate advances into effective therapies for pain is a continuing need. The committee finds that significant advances have been made in understanding the basic mechanisms of nociception and pain, leading to new potential targets for future pain assessment and treatment strategies. Furthermore, recent advances in the neurosciences, biomarkers, and the behavioral sciences have validated a comprehensive approach to the management of pain that includes the individual’s inherent biology, behavior, and psychological makeup and reactions, as well as environmental influences. However, data and knowledge gaps in pain research remain that have prevented such research advances from being translated into safe and effective therapies. Addressing these gaps will require a cultural transformation in the view of and approach to pain research, involving basic, translational, and clinical researchers; federal funding and regulatory agencies; and private organizations. This cultural transformation is reflected in the following recommendations. Recommendation 5-1. Designate a lead institute at the National Institutes of Health responsible for moving pain research forward, and increase the support for and scope of the Pain Consortium. The National Institutes of Health should designate a specific institute to lead efforts in advancing pain research. At the same time, the National Institutes of Health should increase financial resources and staffing support for and broaden the scope of the Pain Consortium and engage higher-level staff from the institutes and centers in the consortium’s efforts. The Pain Consortium should exert more proactive leadership in effecting the necessary transformation in how pain research is conducted and funded. Recommendation 5-2. Improve the process for developing new agents for pain control. Academia and industry should develop novel agents for the control of pain. This does not mean simply recycling current drugs. What is required is basic and clinical science research to discover new classes of pain therapeutics and more efficient ways of developing them. Also required is that regulatory agencies, especially the Food and Drug

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13 SUMMARY Administration, develop new and expeditious ways to evaluate and ap- prove new pain therapies. Recommendation 5-3. Increase support for interdisciplinary re- search in pain. Federal agencies, such as the National Institutes of Health, Agency for Healthcare Research and Quality, Centers for Dis - ease Control and Prevention, Department of Defense, and Department of Veterans Affairs, as well as private funders of pain research, should increase support for interdisciplinary research and research training— across agencies and professions—on pain-related diseases and the defi- ciencies noted in Finding 5-1. Recommendation 5-4. Increase the conduct of longitudinal research in pain. Public and private funders should increase support for longitu- dinal research in pain, including comparative effectiveness research and novel randomized controlled trials, to help ensure that patients receive care that works best in both the short and long terms. Recommendation 5-5. Increase the training of pain researchers. With the support of training grants from the National Institutes of Health, academic institutions should increase the training of basic, translational, behavioral, population, and clinical pain researchers. This training should recognize the interdisciplinary benefits of research on pain and pain man- agement. Agencies such as the National Center for Health Statistics, the Agency for Healthcare Research and Quality, and the Centers for Medi- care and Medicaid Services should support the training of researchers interested in secondary analysis of pain-related data collected by these agencies. CONCLUSION With the goal of providing relief for pain in America, the committee concludes this report by offering a blueprint for action toward transforming prevention, care, education, and research (Chapter 6 and Table S-1 below). This blueprint organizes the committee’s recommendations into two categories. Recommendations categorized as immediate are those the committee believes should be initiated now and completed before the end of 2012. Recommenda - tions categorized as near-term and enduring build on these immediate actions, should be completed before the end of 2015, and should be maintained as on - going efforts. The comprehensive population health-based strategy set forth in Recommendation 2-2 should inform actions taken in response to, or consistent with, all of the other recommendations.

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14 RELIEVING PAIN IN AMERICA TABLE S-1a Blueprint for Transforming Pain Prevention, Care, Education, and Research IMMEDIATE: Start now and complete before the end of 2012 Recommendation Actors Key Elements of Recommendation 2-2. Create a Secretary of Health and Involve multiple federal, state, and comprehensive Human Services (HHS) private-sector entities, such as the population health- National Institutes of Health (NIH), level strategy for Food and Drug Administration pain prevention, (FDA), Centers for Disease Control treatment, and Prevention (CDC), Agency for management, and Healthcare Research and Quality research (AHRQ), Health Resources and Services Administration (HRSA), Centers for Medicare and Medicaid Services (CMS), Department of Defense (DoD), Department of Veterans Affairs (VA), outcomes research community and other researchers, credentialing organizations, pain advocacy and awareness organizations, health professions associations (including pain specialty professional organizations), private insurers, health care providers, state health departments, Medicaid programs, and workers’ compensation programs 3-2. Develop HHS Secretary, AHRQ, CMS, Key part of the strategy envisioned in strategies for HRSA, Surgeon General, Recommendation 2-2 reducing barriers to Office of Minority Health, pain care Indian Health Service, VA, DoD, large health care providers (e.g., accountable care organizations) 3-4. Support CMS, VA, DoD, health care The pain specialist role includes collaboration between providers, pain specialists, serving as a resource for primary care pain specialists pain centers, primary care practitioners and primary care practitioners, pain specialty clinicians, including professional organizations, referral to pain primary care professional centers when associations, private insurers appropriate

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15 SUMMARY TABLE S-1 Continued Recommendation Actors Key Elements of Recommendation 5-1. Designate a NIH Involve pain advocacy and awareness lead institute at the organizations; foster public–private National Institutes of partnerships Health responsible for moving pain research forward, and increase the support for and scope of the Pain Consortium NEAR-TERM AND ENDURING: Build on immediate recommendations, complete before the end of 2015, and maintain as ongoing efforts Recommendation Actors Key Elements of Recommendation 2-1. Improve the National Center for Health Based on Recommendation 2-2; foster collection and Statistics (NCHS) (part public–private partnerships; includes reporting of data on of CDC), AHRQ, CMS, subpopulations at risk for pain and pain VA, DoD, state and local undertreatment of pain, characteristics health departments, private of acute and chronic pain, and health insurers, outcomes research consequences of pain (morbidity, community, other researchers, mortality, disability, related trends) large health care providers, designers of electronic medical records 3-1. Promote Health professions Requires the development of better and and enable self- associations (including more evidence-based patient education management of pain pain specialty professional products organizations), pain advocacy and awareness organizations, health care providers 3-3. Provide CMS, VA, DoD, graduate Improved health professions education educational medical education (GME) requires a stronger evidence base opportunities in and continuing medical on clinical effectiveness and more pain assessment and education (CME) primary interdisciplinary training and care treatment in primary care programs (backed by care accreditation, licensure, and certification authorities and examiners), nurse practitioner and physician assistant training programs, researchers, health care providers continued

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16 RELIEVING PAIN IN AMERICA TABLE S-1 Continued Recommendation Actors Key Elements of Recommendation 3-5. Revise CMS, VA, DoD, Medicaid Requires the development of more reimbursement programs, private insurers, evidence on clinical effectiveness and policies to foster health care providers, health collaboration between payers and coordinated and professions associations providers evidence-based pain (including pain specialty care professional organizations), pain advocacy and awareness organizations 3-6. Provide Health care providers, WHO should add pain to the consistent and primary care practitioners, International Classification of complete pain pain specialists, other health Diseases, Tenth Edition (ICD-10) assessments professions, pain clinics and programs, World Health Organization (WHO) 4-1. Expand and FDA, CDC, AHRQ, CMS, Focus is on patient education and redesign education Surgeon General, DoD, VA, public education; includes pain programs to pain advocacy and awareness prevention transform the organizations, health understanding of professions associations pain (including pain specialty professional organizations), private insurers, health care providers 4-2. Improve CMS, HRSA Bureau CMS’s role is that of payer for GME; curriculum and of Health Professions, include interdisciplinary training accrediting organizations,b education for health care professionals undergraduate and graduate health professions training programs (backed by licensure and certification authorities and examiners) 4-3. Increase the Pain medicine fellowship Requires more effort to attract young number of health programs and graduate health professionals to pain programs; professionals with education programs in also requires collaboration between advanced expertise in dentistry, nursing, psychology educators and clinicians pain care and other mental health fields, rehabilitation therapies, pharmacy, and other health professions

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17 SUMMARY TABLE S-1 Continued Recommendation Actors Key Elements of Recommendation 5-2. Improve FDA, NIH, pharmaceutical Based on Recommendation 5-1; the process for manufacturing and research involves developing new and faster developing new industry, academically ways to evaluate and approve new pain agents for pain based biomedical research therapies, e.g., novel forms of patient control community, private funders of stratification in clinical trials and novel pain research investigative endpoints 5-3. Increase support NIH, AHRQ, CDC, DoD, Based on Recommendation 5-1; basic, for interdisciplinary VA, pharmaceutical translational, and clinical studies research in pain manufacturing and research should involve multiple agencies and industry, private funders of disciplines; focus on knowledge gaps pain research, academically based biomedical research community, pain advocacy and awareness organizations 5-4. Increase NIH, AHRQ, CDC, DoD, Based on Recommendation 5-1; the conduct of VA, pharmaceutical includes translational, population longitudinal research manufacturing and research health, and behavioral aspects of pain in pain industry, Patient-Centered care (social and multimodal aspects, Outcomes Research Institute, not just medications and other single private funders of pain modalities); focus is on real-world research, academically situations (comparative effectiveness, based biomedical research not just efficacy); foster public–private community, outcomes partnerships research community, pain advocacy and awareness organizations 5-5. Increase the NIH, NCHS, AHRQ, CMS, Includes more interdisciplinary training training of pain academic medical institutions researchers a The committee prepared this table based on the recommendations but with a focus on their imple - mentation. The table lists a range of potential actors and key elements of each recommendation. b Accrediting organizations include the Liaison Committee on Medical Education, Commission on Osteopathic College Accreditation, Accreditation Council for Graduate Medical Education, Com - mission on Dental Accreditation, Commission on Collegiate Nursing Education, National League for Nursing Accreditation Commission, American Psychological Association Committee on Accredita - tion, Council on Education for Public Health, Council on Social Work Education, and Council for Higher Education Accreditation (Perez et al., 2007).

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