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Chronic pain costs the nation up to $635 billion each year in medical treatment and lost productivity. The 2010 Patient Protection and Affordable Care Act required the Department of Health and Human Services (HHS) to enlist the Institute of Medicine (IOM) in examining pain as a public health problem. In this report, the IOM offers a blueprint for action in transforming prevention, care, education, and research, with the goal of providing relief for people with pain in America. To reach the vast multitude of people with various types of pain, the nation must adopt a population-level prevention and management strategy. The IOM recommends that HHS develop a comprehensive plan with specific goals, actions, and timeframes. Better data are needed to help shape efforts, especially on the groups of people currently underdiagnosed and undertreated, and the IOM encourages federal and state agencies and private organizations to accelerate the collection of data on pain incidence, prevalence, and treatments. Because pain varies from patient to patient, healthcare providers should increasingly aim at tailoring pain care to each person's experience, and self-management of pain should be promoted. In addition, because there are major gaps in knowledge about pain across health care and society alike, the IOM recommends that federal agencies and other stakeholders redesign education programs to bridge these gaps. Pain is a major driver for visits to physicians, a major reason for taking medications, a major cause of disability, and a key factor in quality of life and productivity. Given the burden of pain in human lives, dollars, and social consequences, relieving pain should be a national priority.

Mental health and substance use disorders affect approximately 20 percent of Americans and are associated with significant morbidity and mortality. Although a wide range of evidence-based psychosocial interventions are currently in use, most consumers of mental health care find it difficult to know whether they are receiving high-quality care. Although the current evidence base for the effects of psychosocial interventions is sizable, subsequent steps in the process of bringing a psychosocial intervention into routine clinical care are less well defined. Psychosocial Interventions for Mental and Substance Use Disorders details the reasons for the gap between what is known to be effective and current practice and offers recommendations for how best to address this gap by applying a framework that can be used to establish standards for psychosocial interventions. The framework described in Psychosocial Interventions for Mental and Substance Use Disorders can be used to chart a path toward the ultimate goal of improving the outcomes. The framework highlights the need to (1) support research to strengthen the evidence base on the efficacy and effectiveness of psychosocial interventions; (2) based on this evidence, identify the key elements that drive an intervention's effect; (3) conduct systematic reviews to inform clinical guidelines that incorporate these key elements; (4) using the findings of these systematic reviews, develop quality measures - measures of the structure, process, and outcomes of interventions; and (5) establish methods for successfully implementing and sustaining these interventions in regular practice including the training of providers of these interventions. The recommendations offered in this report are intended to assist policy makers, health care organizations, and payers that are organizing and overseeing the provision of care for mental health and substance use disorders while navigating a new health care landscape. The recommendations also target providers, professional societies, funding agencies, consumers, and researchers, all of whom have a stake in ensuring that evidence-based, high-quality care is provided to individuals receiving mental health and substance use services.

Collaborations of physicians and researchers with industry can provide valuable benefits to society, particularly in the translation of basic scientific discoveries to new therapies and products. Recent reports and news stories have, however, documented disturbing examples of relationships and practices that put at risk the integrity of medical research, the objectivity of professional education, the quality of patient care, the soundness of clinical practice guidelines, and the public's trust in medicine. Conflict of Interest in Medical Research, Education, and Practice provides a comprehensive look at conflict of interest in medicine. It offers principles to inform the design of policies to identify, limit, and manage conflicts of interest without damaging constructive collaboration with industry. It calls for both short-term actions and long-term commitments by institutions and individuals, including leaders of academic medical centers, professional societies, patient advocacy groups, government agencies, and drug, device, and pharmaceutical companies. Failure of the medical community to take convincing action on conflicts of interest invites additional legislative or regulatory measures that may be overly broad or unduly burdensome. Conflict of Interest in Medical Research, Education, and Practice makes several recommendations for strengthening conflict of interest policies and curbing relationships that create risks with little benefit. The book will serve as an invaluable resource for individuals and organizations committed to high ethical standards in all realms of medicine.

In the realm of health care, privacy protections are needed to preserve patients' dignity and prevent possible harms. Ten years ago, to address these concerns as well as set guidelines for ethical health research, Congress called for a set of federal standards now known as the HIPAA Privacy Rule. In its 2009 report, Beyond the HIPAA Privacy Rule: Enhancing Privacy, Improving Health Through Research, the Institute of Medicine's Committee on Health Research and the Privacy of Health Information concludes that the HIPAA Privacy Rule does not protect privacy as well as it should, and that it impedes important health research.

Technologies collectively called omics enable simultaneous measurement of an enormous number of biomolecules; for example, genomics investigates thousands of DNA sequences, and proteomics examines large numbers of proteins. Scientists are using these technologies to develop innovative tests to detect disease and to predict a patient's likelihood of responding to specific drugs. Following a recent case involving premature use of omics-based tests in cancer clinical trials at Duke University, the NCI requested that the IOM establish a committee to recommend ways to strengthen omics-based test development and evaluation. This report identifies best practices to enhance development, evaluation, and translation of omics-based tests while simultaneously reinforcing steps to ensure that these tests are appropriately assessed for scientific validity before they are used to guide patient treatment in clinical trials.

Pharmaceutical companies, academic researchers, and government agencies such as the Food and Drug Administration and the National Institutes of Health all possess large quantities of clinical research data.

In 2006 the National Institutes of Health (NIH) established the Clinical and Translational Science Awards (CTSA) Program, recognizing the need for a new impetus to encourage clinical and translational research. At the time it was very difficult to translate basic and clinical research into clinical and community practice; making it difficult for individual patients and communities to receive its benefits. Since its creation the CTSA Program has expanded, with 61 sites spread across the nation's academic health centers and other institutions, hoping to provide catalysts and test beds for policies and practices that can benefit clinical and translation research organizations throughout the country. The NIH contracted with the Institute of Medicine (IOM) in 2012 to conduct a study to assess and provide recommendations on appropriateness of the CTSA Program's mission and strategic goals and whether changes were needed. The study was also address the implementation of the program by the National Center for Advancing Translational Sciences (NCATS) while exploring the CTSA's contributions in the acceleration of the development of new therapeutics. A 13-member committee was established to head this task; the committee had collective expertise in community outreach and engagement, public health and health policy, bioethics, education and training, pharmaceutical research and development, program evaluation, clinical and biomedical research, and child health research. The CTSA Program at NIH: Opportunities for Advancing Clinical and Translational Research is the result of investigations into previous program evaluations and assessments, open-session meetings and conference class, and the review of scientific literature. Overall, the committee believes that the CTSA Program is significant to the advancement of clinical and translational research through its contributions. The Program would benefit from a variety of revisions, however, to make it more efficient and effective.

The Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) were designed to encourage more pediatric studies of drugs used for children. The FDA asked the IOM to review aspects of pediatric studies and changes in product labeling that resulted from BPCA and PREA and their predecessor policies, as well as assess the incentives for pediatric studies of biologics and the extent to which biologics have been studied in children. The IOM committee concludes that these policies have helped provide clinicians who care for children with better information about the efficacy, safety, and appropriate prescribing of drugs. The IOM suggests that more can be done to increase knowledge about drugs used by children and thereby improve the clinical care, health, and well-being of the nation's children.

A very high portion of the seafood we eat comes from abroad, mainly from China and Southeast Asia, and most of the active ingredients in medicines we take originate in other countries. Many low- and middle-income countries have lower labor costs and fewer and less stringent environmental regulations than the United States, making them attractive places to produce food and chemical ingredients for export. Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad explains that the diversity and scale of imports makes it impractical for U.S. Food and Drug Administration (FDA) border inspections to be sufficient to ensure product purity and safety, and incidents such as American deaths due to adulterated heparin imported from China propelled the problem into public awareness. The Institute of Medicine Committee on Strengthening Core Elements of Regulatory Systems in Developing Countries took up the vital task of helping the FDA to cope with the reality that so much of the food, drugs, biologics, and medical products consumed in the United States originate in countries with less-robust regulatory systems. Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad describes the ways the United States can help strengthen regulatory systems in low and middle income countries and promote cross-border partnerships - including government, industry, and academia - to foster regulatory science and build a core of regulatory professionals. This report also emphasizes an array of practical approaches to ensure sound regulatory practices in today's interconnected world.

Disasters and public health emergencies can stress health care systems to the breaking point and disrupt delivery of vital medical services. During such crises, hospitals and long-term care facilities may be without power; trained staff, ambulances, medical supplies and beds could be in short supply; and alternate care facilities may need to be used. Planning for these situations is necessary to provide the best possible health care during a crisis and, if needed, equitably allocate scarce resources. Crisis Standards of Care: A Toolkit for Indicators and Triggers examines indicators and triggers that guide the implementation of crisis standards of care and provides a discussion toolkit to help stakeholders establish indicators and triggers for their own communities. Together, indicators and triggers help guide operational decision making about providing care during public health and medical emergencies and disasters. Indicators and triggers represent the information and actions taken at specific thresholds that guide incident recognition, response, and recovery. This report discusses indicators and triggers for both a slow onset scenario, such as pandemic influenza, and a no-notice scenario, such as an earthquake. Crisis Standards of Care features discussion toolkits customized to help various stakeholders develop indicators and triggers for their own organizations, agencies, and jurisdictions. The toolkit contains scenarios, key questions, and examples of indicators, triggers, and tactics to help promote discussion. In addition to common elements designed to facilitate integrated planning, the toolkit contains chapters specifically customized for emergency management, public health, emergency medical services, hospital and acute care, and out-of-hospital care.