By two years of age, healthy infants in the United States can receive up to 20 vaccinations to protect against 11 diseases. Although most people know that vaccines effectively protect against serious infectious diseases, approximately one-quarter of parents in a recent survey believe that infants get more vaccines than are good for them, and that too many immunizations could overwhelm an infant's immune system. The Immunization Safety Review Committee reviewed the evidence regarding the hypothesis that multiple immunizations increase the risk for immune dysfunction. Specifically, the committee looked at evidence of potential biological mechanisms and at epidemiological evidence for or against causality related to risk for infections, the autoimmune disease type 1 diabetes, and allergic disorders.

In this report, the Immunization Safety Review committee examines the hypothesis of whether or not the use of vaccines containing the preservative thimerosal can cause neurodevelopmental disorders (NDDs), specifically autism, attention deficit/hyperactivity disorder (ADHD), and speech or language delay.

Closing Evidence Gaps in Clinical Prevention, a new consensus study report from the National Academies of Sciences, Engineering, and Medicine's Board on Population Health and Public Health Practice, evaluates evidence gaps in clinical prevention recommendations described by the United States Preventive Services Task Force and other clinical practice guideline developers and presents a taxonomy of these evidence gaps for future use. This report aims to improve the coordination of efforts to describe and communicate priority evidence gaps among funders and researchers. It also proposes new opportunities for collaboration among researchers, funders, and guideline developers to accelerate research that could close evidence gaps. The authoring committee has also developed an interactive graphic that can be used as a workflow diagram for implementing the taxonomy. This workflow walks users through reviewing evidence, characterizing evidence gaps using relevant taxonomies, and developing a research agenda. Click here to view and engage with the interactive graphic. Table of Contents Front Matter Summary 1 Introduction 2 Clinical Practice Guidelines and the U.S. Preventive Services Task Force 3 Clinical Prevention Research Enterprise 4 Taxonomy and Workflow 5 Recommendations Appendix A: Topics with "I Statements" from the U.S. Preventive Services Task Force Appendix B: Research Methods Appendix C: Public Meeting Agendas Appendix D: Committee Member and Staff Biographies Appendix E: U.S. Preventive Services Task Force's Reports to Congress Appendix F: U.S. Preventive Service Task Force Research Needs Statements from I Statements Issued Between 2017 and 2021

Immunization to protect infants and children from vaccine-preventable diseases is one of the greatest achievements of public health. Immunization is not without risks, however. It is well established, for example, that the oral polio vaccine can on rare occasion cause paralytic polio.
The Immunization Safety Review Committee was established by the Institute of Medicine (IOM) to evaluate the available evidence on a series of immunization safety concerns. The committee is charged with examining three immunization safety hypotheses each year during the three-year study period (2001- 2003). While all of the committee members share the view that immunization is generally beneficial, none of them has a vested interest in the specific immunization safety issues that come before the group. In this report, which is the fourth in the series, the committee examines the hypothesis that the hepatitis B vaccine increases the risk for demyelinating disorders of the central or peripheral nervous systems, including multiple sclerosis (MS) and Guillain-Barre syndrome (GBS).

Millions of Americans use e-cigarettes. Despite their popularity, little is known about their health effects. Some suggest that e-cigarettes likely confer lower risk compared to combustible tobacco cigarettes, because they do not expose users to toxicants produced through combustion. Proponents of e-cigarette use also tout the potential benefits of e-cigarettes as devices that could help combustible tobacco cigarette smokers to quit and thereby reduce tobacco-related health risks. Others are concerned about the exposure to potentially toxic substances contained in e-cigarette emissions, especially in individuals who have never used tobacco products such as youth and young adults. Given their relatively recent introduction, there has been little time for a scientific body of evidence to develop on the health effects of e-cigarettes. Public Health Consequences of E-Cigarettes reviews and critically assesses the state of the emerging evidence about e-cigarettes and health. This report makes recommendations for the improvement of this research and highlights gaps that are a priority for future research. Table of Contents Front Matter Summary Summary Annex Report Conclusions by Level of Evidence 1 Introduction 2 Committee Approach Section I: E-Cigarette Devices, Constituents, and Exposures 3 E-Cigarette Devices, Uses, and Exposures 4 Nicotine 5 Toxicology of E-Cigarette Constituents 6 Research Needs: E-Cigarette Devices, Constituents, and Exposures Section II: Effects of E-Cigarettes on Health 7 Modes of Action 8 Dependence and Abuse Liability 9 Cardiovascular Disease 10 Cancers 11 Respiratory Diseases 12 Oral Diseases 13 Developmental and Reproductive Effects 14 Injuries and Poisonings 15 Research Needs: Effects of E-Cigarettes on Health Section III: Public Health Implications of E-Cigarettes 16 Combustible Tobacco Cigarette Smoking Among Youth and Young Adults 17 Smoking Cessation Among Adults 18 Harm Reduction 19 Modeling of E-Cigarette Use 20 Research Needs: Public Health Implications of E-Cigarettes 21 Concluding Observations Appendix A: Questions from the Center for Tobacco Products of the Food and Drug Administration Submitted for the Committee's Consideration Appendix B: Search Strategy and Quality Assessment Appendix C: Glossary of Terms Related to E-Cigarettes Appendix D: Cytotoxicity Tables Appendix E: Public Meeting Agenda Appendix F: Committee Biosketches

Recent health care payment reforms aim to improve the alignment of Medicare payment strategies with goals to improve the quality of care provided, patient experiences with health care, and health outcomes, while also controlling costs. These efforts move Medicare away from the volume-based payment of traditional fee-for-service models and toward value-based purchasing, in which cost control is an explicit goal in addition to clinical and quality goals. Specific payment strategies include pay-for-performance and other quality incentive programs that tie financial rewards and sanctions to the quality and efficiency of care provided and accountable care organizations in which health care providers are held accountable for both the quality and cost of the care they deliver. Accounting For Social Risk Factors in Medicare Payment is the fifth and final report in a series of brief reports that aim to inform ASPE analyses that account for social risk factors in Medicare payment programs mandated through the IMPACT Act. This report aims to put the entire series in context and offers additional thoughts about how to best consider the various methods for accounting for social risk factors, as well as next steps. Table of Contents Front Matter Summary 1 Introduction 2 Social Risk Factors: Definitions and Data 3 Methods to Account for Social Risk Factors 4 Moving Forward Appendix A: Identifying Social Risk Factors AS: Summary A1: Introduction A2: Social Risk Factors AA: Overview of Medicare Value-Based Payment Programs Appendix B: Systems Practices for the Care of Socially At-Risk Populations BS: Summary B1: Introduction B2: Improving Care for Socially At-Risk Populations BA: Example Implementation Strategies and Case Studies Appendix C: Criteria, Factors, and Methods CS: Summary C1: Introduction C2: Criteria for Selecting Social Risk Factors for Application in Medicare Quality Measurement and Payment C3: Applying Selection Criteria to Social Risk Factors and Health Literacy C4: Methods to Account for Social Risk Factors in Medicare Value-Based Payment CA: Criteria for Selecting Risk Factors Reviewed by the Committee Appendix D: Data DS: Summary D1: Introduction D2: Potential Data Sources D3: Data Sources and Data Collection for Social Risk Factors Appendix E: Prior Conclusions and Recommendations Appendix F: Committee Biosketches Index

A particularly valuable opportunity to improve public health arises when an urban area is being redesigned and rebuilt following some type of serious disruption, whether it is caused by a sudden physical event, such as a hurricane or earthquake, or steady economic and social decline that may have occurred over decades. On November 10, 2014, the Institute of Medicine's Roundtable on Environmental Health Sciences, Research, and Medicine held a workshop concerning the ways in which the urban environment, conceived broadly from factors such as air quality and walkability to factors such as access to fresh foods and social support systems, can affect health. Participants explored the various opportunities to reimagine the built environment in a city and to increase the role of health promotion and protection during the process of urban revitalization. Bringing Public Health into Urban Revitalization summarizes the presentations and discussions from this workshop. Table of Contents Front Matter 1 Introduction 2 Utilizing Green Technologies in Washington, DC 3 Rebuilding Efforts in Detroit, Michigan 4 Transforming New York City 5 Cross-Cutting Issues That Face All Urban Environments 6 Closing Remarks Appendix A: Workshop Agenda Appendix B: Speaker and Moderator Biographical Sketches

Despite overwhelming evidence of tobacco's harmful effects and pressure from anti-smoking advocates, current surveys show that about one-quarter of all adults in the United States are smokers. This audience is the target for a wave of tobacco products and pharmaceuticals that claim to preserve tobacco pleasure while reducing its toxic effects. Clearing the Smoke addresses the problems in evaluating whether such products actually do reduce the health risks of tobacco use. Within the context of regulating such products, the committee explores key questions: Does the use of such products decrease exposure to harmful substances in tobacco? Is decreased exposure associated with decreased harm to health? Are there surrogate indicators of harm that could be measured quickly enough for regulation of these products? What are the public health implications? This book looks at the types of products that could reduce harm and reviews the available evidence for their impact on various forms of cancer and other major ailments. It also recommends approaches to governing these products and tracking their public health effects. With an attitude of healthy skepticism, Clearing the Smoke will be important to health policy makers, public health officials, medical practitioners, manufacturers and marketers of "reduced-harm" tobacco products, and anyone trying to sort through product claims. Table of Contents Front Matter Executive Summary 1 Introduction 2 Principles of Harm Reduction 3 Historical Perspective and Lessons Learned 4 Products for Tobacco Exposure Reduction 5 The Scientific Basis for PREP Assessment 6 Surveillance for the Health and Behavioral Consequences of Exposure Reduction 7 Implementation of a Science-Based Policy of Harm Reduction 8 Principal Conclusions 9 Nicotine Pharmacology 10 Tobacco Smoke and Toxicology 11 Exposure and Biomarker Assessment in Humans 12 Cancer 13 Cardiovascular Disease 14 Nonneoplastic Respiratory Diseases 15 Reproductive and Developmental Effects 16 Other Health Effects A Presentations and Submissions B Committee Biographical Sketches C Time Line of Tobacco Events Index

It sounds simple: Women who drink while pregnant may give birth to children with defects, so women should not drink during pregnancy. Yet in the 20 years since it was first described in the medical literature, fetal alcohol syndrome (FAS) has proved to be a stubborn problem, with consequences as serious as those of the more widely publicized "crack babies." This volume discusses FAS and other possibly alcohol-related effects from two broad perspectives: diagnosis and surveillance, and prevention and treatment. In addition, it includes several real-life vignettes of FAS children. The committee examines fundamental concepts for setting diagnostic criteria in general, reviews and updates the diagnostic criteria for FAS and related conditions, and explores current research findings and problems associated with FAS epidemiology and surveillance. In addition, the book describes an integrated multidisciplinary approach to research on the prevention and treatment of FAS. The committee: Discusses levels of preventive intervention. Reviews available data about women and alcohol abuse and treatment among pregnant women. Explores the psychological and behavioral consequences of FAS at different ages. Examines the current state of knowledge about medical and therapeutic interventions, education efforts, and family support programs. This volume will be of special interest to physicians, nurses, mental health practitioners, school and public health officials, policymakers, researchers, educators, and anyone else involved in serving families and children, especially in high risk populations. Table of Contents Front Matter Executive Summary 1 Introduction 2 Issues in Research on Fetal Drug Effects 3 Vignettes 4 Diagnosis and Clinical Evaluation of Fetal Alcohol Syndrome 5 Epidemiology and Surveillance of Fetal Alcohol Syndrome 6 Epidemiology of Women's Drinking 7 Prevention of Fetal Alcohol Syndrome 8 The Affected Individual: Clinical Presentation, Intervention, and Treatment 9 Integration and Coordination: A Concluding Comment and Recommendation Appendix: Biographies Index

To mitigate the risks posed by microbial threats of public health significance originating abroad, the Centers for Disease Control and Prevention (CDC) places small groups of staff at major U.S. airports. These staff, their offices, and their patient isolation rooms constitute quarantine stations, which are run by CDC's Division of Global Migration and Quarantine (DGMQ). Congress began to allocate funds in fiscal 2003 for the establishment of new quarantine stations at 17 major U.S. ports of entry that comprise airports, seaports, and land-border crossings. In a significant departure from the recent past, both the preexisting 8 quarantine stations and the new 17 are expected to play an active, anticipatory role in nationwide biosurveillance. Consequently, DGMQ asked the Institute of Medicine (IOM) to convene an expert committee to assess the present CDC quarantine stations and recommend how they should evolve to meet the challenges posed by microbial threats at the nation's gateways. DGMQ specifically requested "an assessment of the role of the federal quarantine stations, given the changes in the global environment including large increases in international travel, threats posed by bioterrorism and emerging infections, and the movement of animals and cargo." To conduct this assessment and provide recommendations, IOM convened, in October 2004, the Committee on Measures to Enhance the Effectiveness of the CDC Quarantine Station Expansion Plan for U.S. Ports of Entry. At the sponsor's request, the committee released the interim letter report Human Resources at U.S. Ports of Entry to Protect the Public's Health in January 2005 to provide preliminary suggestions for the priority functions of a modern quarantine station, the competences necessary to carry out those functions, and the types of health professionals who have the requisite competences (Appendix A). This, the committee's final report, assesses the present role of the CDC quarantine stations and articulates a vision of their future role as a public health intervention. Table of Contents Front Matter Executive Summary 1 Introduction 2 Context and Content of the CDC Quarantine Station Expansion Plan 3 Today's CDC Quarantine Stations at U.S. Ports of Entry 4 Bridge from Present to Future: Vision and Recommendations Appendix A: Human Resources at U.S. Ports of Entry to Protect the Public's Health: Interim Letter Report Appendix B: Agendas of Open Sessions of Committee Meetings Appendix C: Methodology Used by the Division of Global Migration and Quarantine to Select Sites for New Quarantine Stations Appendix D: Commissioned Paper on US Seaports and the CDC Quarantine Station System Appendix E: Microbial Threats of Public Health Significance Originating in Animals or Animal Products at U.S. Ports of Entry Appendix F: International Legal Considerations for the Quarantine Station Expansion Appendix G: Excerpts from a Standard Memorandum of Agreement Between CDC and Local Hospitals Appendix H: Committee Biographies

December 13, 2002, the president of the United States announced that smallpox vaccination would be offered to some categories of civilians and administered to members of the military and government representatives in high-risk areas of the world. The events that precipitated that historic announcement included a series of terrorist attacks during the 1990s, which culminated in the catastrophic events of 2001. Although preparedness for deliberate attacks with biologic weapons was already the subject of much public health planning, meetings, and publications as the twentieth century neared its end, the events of 2001 led to a steep rise in bioterrorism-related government policies and funding, and in state and local preparedness activities, for example, in public health, health care, and the emergency response and public safety communities. The national smallpox vaccination program is but one of many efforts to improve readiness to respond to deliberate releases of biologic agents. The Institute of Medicine (IOM) Committee on Smallpox Vaccination Program Implementation was convened in October 2002 at the request of the Centers for Disease Control and Prevention (CDC), the federal agency charged with implementing the government's policy of providing smallpox vaccine first to public health and health care workers on response teams, then to all interested health care workers and other first responders, and finally to members of the general public who might insist on receiving the vaccine. The committee was charged with providing "advice to the CDC and the program investigators on selected aspects of the smallpox program implementation and evaluation." The committee met six times over 19 months and wrote a series of brief "letter" reports. The Smallpox Vaccination Program: Public Health in an Age of Terrorism constitutes the committee's seventh and final report, and the committee hopes that it will fulfill three purposes: 1) To serve as an archival document that brings together the six reports addressed to Julie Gerberding, director of CDC, and previously released on line and as short, unbound papers; 2) To serve as a historical document that summarizes milestones in the smallpox vaccination program, and; 3) To comment on the achievement of overall goals of the smallpox vaccination program (in accordance with the last item in the charge), including lessons learned from the program.

Immunization is widely regarded as one of the most effective and beneficial tools for protecting the public's health. In the United States, immunization programs have resulted in the eradication of smallpox, the elimination of polio, and the control and near elimination of once-common, often debilitating and potentially life-threatening diseases, including measles, mumps, rubella, diphtheria, pertussis, tetanus, and Haemophilus influenza type b.
Along with the benefits of widespread immunization, however, have come concerns about the safety of vaccines. No vaccine is perfectly safe or effective, and vaccines may lead to serious adverse effects in some instances. Furthermore, if a serious illness is observed after vaccination, it is often unclear whether that sequence is coincidental or causal, and it can be difficult to determine the true nature of the relationship, if any, between the vaccination and the illness. Ironically, the successes of vaccine coverage in the United States have made it more difficult for the public to weigh the benefits and complications of vaccines because the now-controlled diseases and their often-serious risks are no longer familiar. However, because vaccines are so widely used-and because state laws require that children be vaccinated before entering daycare and school, in part to protect others-it is essential that safety concerns be fully and carefully studied.
Immunization Safety Review: Measles-Mumps-Rubella Vaccine and Autism, the first of a series from the Institute of Medicine (IOM) Immunization Safety Review Committee, presents an assessment of the evidence regarding a hypothesized causal association between the measles-mumps-rubella (MMR) vaccine and autism, an assessment of the broader significance for society of the issues surrounding the MMR-autism hypothesis, and the committee's conclusions and recommendations based on those assessments.

The nation has made tremendous progress in reducing tobacco use during the past 40 years. Despite extensive knowledge about successful interventions, however, approximately one-quarter of American adults still smoke. Tobacco-related illnesses and death place a huge burden on our society. Ending the Tobacco Problem generates a blueprint for the nation in the struggle to reduce tobacco use. The report reviews effective prevention and treatment interventions and considers a set of new tobacco control policies for adoption by federal and state governments. Carefully constructed with two distinct parts, the book first provides background information on the history and nature of tobacco use, developing the context for the policy blueprint proposed in the second half of the report. The report documents the extraordinary growth of tobacco use during the first half of the 20th century as well as its subsequent reversal in the mid-1960s (in the wake of findings from the Surgeon General). It also reviews the addictive properties of nicotine, delving into the factors that make it so difficult for people to quit and examines recent trends in tobacco use. In addition, an overview of the development of governmental and nongovernmental tobacco control efforts is provided. After reviewing the ethical grounding of tobacco control, the second half of the book sets forth to present a blueprint for ending the tobacco problem. The book offers broad-reaching recommendations targeting federal, state, local, nonprofit and for-profit entities. This book also identifies the benefits to society when fully implementing effective tobacco control interventions and policies. Table of Contents Front Matter Summary Introduction 1 Epidemiology of Tobacco Use: History and Current Trends 2 Factors Perpetuating the Tobacco Problem 3 Containing the Tobacco Problem 4 Reducing Tobacco Use: A Policy Framework 5 Strengthening Traditional Tobacco Control Measures 6 Changing the Regulatory Landscape 7 New Frontiers of Tobacco Control Index Appendix A: Comprehensive Smoking Cessation Policy for All Smokers: Systems Integration to Save Lives and Money Appendix B: Clean Air Laws Appendix C: Warning Labels and Packaging Appendix D: The Long-Term Promise of Effective School-Based Smoking Prevention Programs Appendix E: Adolescents' and Young Adults' Perceptions of Tobacco Use: A Review and Critique of the Current Literature Appendix F: Interventions for Children and Youth in the Health Care Setting Appendix G: Reducing and Preventing Tobacco Use Among Pregnant Women, Parents, and Families Appendix H:Smoking in the Movies: Its Impact on Youth and Youth Smoking Appendix I: State Statutes Governing Direct Shipment of Alcoholic Beverages to Consumers: Precedents for Regulating Tobacco Retail Shipments Appendix J: The Role of Public Policies in Reducing Smoking Prevalence: Results from the SimSmoke Tobacco Policy Simulation Model Appendix K: Commissioned Simulation Modeling of Smoking Prevalence as an Outcome of Selected Tobacco Control Measures Appendix L: Controlling the Retail Sales Environment: Access, Advertising, and Promotional Activities Appendix M: Sales and Marketing of Cigarettes on the Internet: Emerging Threats to Tobacco Control and Promising Policy Solutions Appendix N: Media Campaigns and Tobacco Control Appendix O: Advocacy as a Tobacco Control Strategy Appendix P: Special Populations with Higher Rates of Cigarette Smoking: Identification and Implications for Tobacco Control

In the wake of publicity and congressional attention to drug safety issues, the Food and Drug Administration (FDA) requested the Institute of Medicine assess the drug safety system. The committee reported that a lack of clear regulatory authority, chronic underfunding, organizational problems, and a scarcity of post-approval data about drugs' risks and benefits have hampered the FDA's ability to evaluate and address the safety of prescription drugs after they have reached the market. Noting that resources and therefore efforts to monitor medications' risk?benefit profiles taper off after approval, The Future of Drug Safety offers a broad set of recommendations to ensure that consideration of safety extends from before product approval through the entire time the product is marketed and used. Table of Contents Front Matter Summary 1 Introduction 2 Natural History of a Drug 3 A Culture of Safety 4 The Science of Safety 5 Regulatory Authorities for Drug Safety 6 Communicating About Safety 7 Resources for the Drug Safety System Appendix A Moving Target--The Shifting Landscape of Drug Safety in the United States Appendix B Acronyms Appendix C PDUFA Performance Goals-All Years Appendix D Committee on the Assessment of the US Drug Safety System Meeting Agendas Appendix E Summary: Preventing Medication Errors: Quality Chasm Series, Institute of Medicine Appendix F Committee Biographies Index

Infection with the influenza virus can have a serious effect on the health of people of all ages, although it is particularly worrisome for infants, the elderly, and people with underlying heart or lung problems. A vaccine exists (the a /flua shot) that can greatly decrease the impact of influenza. Because the strains of virus that are expected to cause serious illness and death are slightly different every year, the vaccine is also slightly different every year and it must be given every year, unlike other vaccines. The Immunization Safety Review committee reviewed the data on influenza vaccine and neurological conditions and concluded that the evidence favored rejection of a causal relationship between influenza vaccines and exacerbation of multiple sclerosis. For the other neurological conditions studied, the committee concluded the evidence about the effects of influenza vaccine is inadequate to accept or reject a causal relationship. The committee also reviewed theories on how the influenza vaccine could damage the nervous system. The evidence was at most weak that the vaccine could act in humans in ways that could lead to these neurological problems.