TY - BOOK AU - Institute of Medicine A2 - Clare Stroud A2 - Lori Nadig A2 - Bruce M. Altevogt TI - Medical Countermeasures Dispensing: Emergency Use Authorization and the Postal Model: Workshop Summary SN - DO - 10.17226/12952 PY - 2010 UR - https://nap.nationalacademies.org/catalog/12952/medical-countermeasures-dispensing-emergency-use-authorization-and-the-postal-model PB - The National Academies Press CY - Washington, DC LA - English KW - Health and Medicine KW - Conflict and Security Issues AB - During public health emergencies such as terrorist attacks or influenza outbreaks, the public health system's ability to save lives could depend on dispensing medical countermeasures such as antibiotics, antiviral medications, and vaccines to a large number of people in a short amount of time. The IOM's Forum on Medical and Public Health Preparedness for Catastrophic Events held a workshop on November 18, 2009, to provide an overview of current threats, recent progress made in the public health system for distributing and dispensing countermeasures, and remaining vulnerabilities. ER - TY - BOOK AU - Institute of Medicine A2 - Margie Patlak A2 - Sharyl J. Nass A2 - Erin Balogh TI - Extending the Spectrum of Precompetitive Collaboration in Oncology Research: Workshop Summary SN - DO - 10.17226/12930 PY - 2010 UR - https://nap.nationalacademies.org/catalog/12930/extending-the-spectrum-of-precompetitive-collaboration-in-oncology-research-workshop PB - The National Academies Press CY - Washington, DC LA - English KW - Health and Medicine AB - Despite spending more time and money in developing novel therapeutics, the success rate for new pharmacologic treatments has been poor. Although the research and development expenditures have grown 13 percent each year since 1970 (a 50-fold increase), the number of new drugs approved annually is no greater now than it was 50 years ago. Over the past decade, skyrocketing costs and the complexity of the scientific knowledge upon which to develop new agents have provided incentives for alternative approaches to drug development, if we are to continue to improve clinical care and reduce mortality. These challenges create opportunities for improved collaboration between industry, academia, government, and philanthropic organizations at each stage in new drug development, marketing, and implementation. Perhaps the most appropriate initial step in addressing the need for collaboration is to consider more precompetitive relationships that allow sharing of scientific information to foster drug development. While these collaborative relationships in basic and preclinical research on drug targets and the early stages of clinical testing are acknowledged to be potentially important drivers for innovation and more rapid marketing of new agents, they also raise a number of concerns that must be addressed. For example, acknowledgment of academic productivity and independence and economic competitiveness must be considered and these challenges managed to foster a culture of collaboration. At the same time, regulatory issues, the need for standardization, and intellectual property concerns must be confronted if the current models for drug development are to be refined to encourage robust participation in precompetitive collaborations. Recognizing the growing importance of precompetitive collaborations in oncology drug development, as well as the challenges these innovative collaborations pose, the National Cancer Policy Forum of the Institute of Medicine held a workshop on February 9 and 10, 2010. This book is a summary of the workshop proceedings. ER - TY - BOOK AU - Institute of Medicine A2 - Margie Patlak A2 - Laura Levit TI - Policy Issues in the Development of Personalized Medicine in Oncology: Workshop Summary SN - DO - 10.17226/12779 PY - 2010 UR - https://nap.nationalacademies.org/catalog/12779/policy-issues-in-the-development-of-personalized-medicine-in-oncology PB - The National Academies Press CY - Washington, DC LA - English KW - Health and Medicine KW - Biology and Life Sciences AB - One of the challenges in treating cancer is the disease's complexity and variation among patients. Cancer manifests differently in each patient, so treatments that are effective in one patient may not be effective in another. As cancer care becomes more personalized, subpopulations of individuals will be given preventive or therapeutic interventions based on their susceptibility to a particular disease or their predicted response to a specific treatment. However, before the use of personalized cancer care can reach its full potential, the health care system must resolve a number of technological, regulatory, and reimbursement issues. To explore these policy challenges, the National Cancer Policy Forum held the workshop Policy Issues in the Development of Personalized Medicine in Oncology in June 2009. Experts provided presentations on the current state of personalized medicine technology, as well as issues in the validation of, regulation of, and reimbursement for the predictive tests that underpin personalized medicine. Participants discussed the obstacles and possible solutions to further developing and using personalized medicine technologies. This document summarizes the workshop. ER - TY - BOOK AU - Institute of Medicine TI - Secondhand Smoke Exposure and Cardiovascular Effects: Making Sense of the Evidence SN - DO - 10.17226/12649 PY - 2010 UR - https://nap.nationalacademies.org/catalog/12649/secondhand-smoke-exposure-and-cardiovascular-effects-making-sense-of-the PB - The National Academies Press CY - Washington, DC LA - English KW - Health and Medicine AB - Data suggest that exposure to secondhand smoke can result in heart disease in nonsmoking adults. Recently, progress has been made in reducing involuntary exposure to secondhand smoke through legislation banning smoking in workplaces, restaurants, and other public places. The effect of legislation to ban smoking and its effects on the cardiovascular health of nonsmoking adults, however, remains a question. Secondhand Smoke Exposure and Cardiovascular Effects reviews available scientific literature to assess the relationship between secondhand smoke exposure and acute coronary events. The authors, experts in secondhand smoke exposure and toxicology, clinical cardiology, epidemiology, and statistics, find that there is about a 25 to 30 percent increase in the risk of coronary heart disease from exposure to secondhand smoke. Their findings agree with the 2006 Surgeon General's Report conclusion that there are increased risks of coronary heart disease morbidity and mortality among men and women exposed to secondhand smoke. However, the authors note that the evidence for determining the magnitude of the relationship between chronic secondhand smoke exposure and coronary heart disease is not very strong. Public health professionals will rely upon Secondhand Smoke Exposure and Cardiovascular Effects for its survey of critical epidemiological studies on the effects of smoking bans and evidence of links between secondhand smoke exposure and cardiovascular events, as well as its findings and recommendations. ER - TY - BOOK AU - Institute of Medicine A2 - Clare Stroud A2 - Lori Nadig A2 - Bruce M. Altevogt TI - The 2009 H1N1 Influenza Vaccination Campaign: Summary of a Workshop Series SN - DO - 10.17226/12992 PY - 2010 UR - https://nap.nationalacademies.org/catalog/12992/the-2009-h1n1-influenza-vaccination-campaign-summary-of-a-workshop PB - The National Academies Press CY - Washington, DC LA - English KW - Health and Medicine AB - The 2009 H1N1 vaccination campaign was one of the largest public health campaigns in U.S. history, vaccinating one-quarter of the population in the first three months. The Institute of Medicine held three workshops in Raleigh, NC; Austin, TX; and Seattle, WA to learn from participants' experiences during the campaign and improve future emergency vaccination programs. ER - TY - BOOK AU - Institute of Medicine A2 - Bruce M. Altevogt A2 - Clare Stroud A2 - Lori Nadig A2 - Matthew Hougan TI - Medical Surge Capacity: Workshop Summary SN - DO - 10.17226/12798 PY - 2010 UR - https://nap.nationalacademies.org/catalog/12798/medical-surge-capacity-workshop-summary PB - The National Academies Press CY - Washington, DC LA - English KW - Health and Medicine AB - During natural disasters, disease pandemics, terrorist attacks, and other public health emergencies, the health system must be prepared to accommodate a surge in the number of individuals seeking medical help. For the health community, a primary concern is how to provide care to individuals during such high demand, when the health system's resources are exhausted and there are more patients than the system can accommodate. The IOM's Forum on Medical and Public Health Preparedness for Catastrophic Events held a workshop June 10-11, 2009, to assess the capability of and tools available to federal, state, and local governments to respond to a medical surge. In addition, participants discussed strategies for the public and private sectors to improve preparedness for such a surge. The workshop brought together leaders in the medical and public health preparedness fields, including policy makers from federal agencies and state and local public health departments; providers from the health care community; and health care and hospital administrators. This document summarizes the workshop. ER - TY - BOOK AU - Institute of Medicine A2 - Ben Wheatley TI - Regionalizing Emergency Care: Workshop Summary SN - DO - 10.17226/12872 PY - 2010 UR - https://nap.nationalacademies.org/catalog/12872/regionalizing-emergency-care-workshop-summary PB - The National Academies Press CY - Washington, DC LA - English KW - Health and Medicine AB - During medical emergencies, hospital staff and emergency medical services (EMS) providers, can face barriers in delivering the fastest and best possible care. Overcrowded emergency rooms cannot care for patients as quickly as necessary, and some may divert ambulances and turn away new patients outright. In many states, ambulance staff lacks the means to determine which hospitals can provide the best care to a patient. Given this absence of knowledge, they bring patients to the closest hospital. In addition, because emergency service providers from different companies compete with each other for patients, and emergency care legislation varies from state to state, it is difficult to establish the necessary local, interstate, and national communication and collaboration to create a more efficient system. In 2006, the IOM recommended that the federal government implement a regionalized emergency care system to improve cooperation and overcome these challenges. In a regionalized system, local hospitals and EMS providers would coordinate their efforts so that patients would be brought to hospitals based on the hospitals' capacity and expertise to best meet patients' needs. In September 2009, three years after making these recommendations, the IOM held a workshop sponsored by the federal Emergency Care Coordination Center to assess the nation's progress toward regionalizing emergency care. The workshop brought together policymakers and stakeholders, including nurses, EMS personnel, hospital administrators, and others involved in emergency care. Participants identified successes and shortcomings in previous regionalization efforts; examined the many factors involved in successfully implementing regionalization; and discussed future challenges to regionalizing emergency care. This document summarizes the workshop. ER - TY - BOOK AU - Institute of Medicine A2 - Cori Vancheri TI - The Safe Use Initiative and Health Literacy: Workshop Summary SN - DO - 10.17226/12975 PY - 2010 UR - https://nap.nationalacademies.org/catalog/12975/the-safe-use-initiative-and-health-literacy-workshop-summary PB - The National Academies Press CY - Washington, DC LA - English KW - Health and Medicine AB - Every year at least 1.5 million people suffer adverse effects from medication. These problems occur because people misunderstand labels, are unaware of drug interactions, or otherwise use medication improperly. The Food and Drug Administration's Safe Use Initiative seeks to identify preventable medication risks and develop solutions to them. The IOM held a workshop to discuss the FDA's Safe Use Initiative and other efforts to improve drug labeling and safety. ER - TY - BOOK AU - Institute of Medicine A2 - Clare Stroud A2 - Bruce M. Altevogt A2 - Lori Nadig A2 - Matthew Hougan TI - Crisis Standards of Care: Summary of a Workshop Series SN - DO - 10.17226/12787 PY - 2010 UR - https://nap.nationalacademies.org/catalog/12787/crisis-standards-of-care-summary-of-a-workshop-series PB - The National Academies Press CY - Washington, DC LA - English KW - Health and Medicine AB - During a wide-reaching catastrophic public health emergency or disaster, existing surge capacity plans may not be sufficient to enable health care providers to continue to adhere to normal treatment procedures and follow usual standards of care. This is a particular concern for emergencies that may severely strain resources across a large geographic area, such as a pandemic influenza or the detonation of a nuclear device. Under these circumstances, it may be impossible to provide care according to the standards of care used in non-disaster situations, and, under the most extreme circumstances, it may not even be possible to provide basic life sustaining interventions to all patients who need them. Although recent efforts to address these concerns have accomplished a tremendous amount in just a few years, a great deal remains to be done in even the most advanced plan. This workshop summary highlights the extensive work that is already occurring across the nation. Specifically, the book draws attention to existing federal, state, and local policies and protocols for crisis standards of care; discusses current barriers to increased provider and community engagement; relays examples of existing interstate collaborations; and presents workshop participants' ideas, comments, concerns, and potential solutions to some of the most difficult challenges. ER - TY - BOOK AU - Institute of Medicine TI - Priorities for the National Vaccine Plan SN - DO - 10.17226/12796 PY - 2010 UR - https://nap.nationalacademies.org/catalog/12796/priorities-for-the-national-vaccine-plan PB - The National Academies Press CY - Washington, DC LA - English KW - Health and Medicine AB - Vaccination is a fundamental component of preventive medicine and public health. The use of vaccines to prevent infectious diseases has resulted in dramatic decreases in disease, disability, and death in the United States and around the world. The current political, economic, and social environment presents both opportunities for and challenges to strengthening the U.S. system for developing, manufacturing, regulating, distributing, funding, and administering safe and effective vaccines for all people. Priorities for the National Vaccine Plan examines the extraordinarily complex vaccine enterprise, from research and development of new vaccines to financing and reimbursement of immunization services. Priorities for the National Vaccine Plan examines the extraordinarily complex vaccine enterprise, from research and development of new vaccines to financing and reimbursement of immunization services. The book makes recommendations about priority actions in the update to the National Vaccine Plan that are intended to achieve the objectives of disease prevention and enhancement of vaccine safety. It is centered on the plan's five goals in the areas of vaccine development, safety, communication, supply and use, and global health. ER - TY - BOOK AU - Institute of Medicine A2 - Elizabeth Haytmanek A2 - Katherine McClure TI - Mitigating the Nutritional Impacts of the Global Food Price Crisis: Workshop Summary SN - DO - 10.17226/12698 PY - 2010 UR - https://nap.nationalacademies.org/catalog/12698/mitigating-the-nutritional-impacts-of-the-global-food-price-crisis PB - The National Academies Press CY - Washington, DC LA - English KW - Food and Nutrition KW - Agriculture AB - In 2007 and 2008, the world witnessed a dramatic increase in food prices. The global financial crisis that began in 2008 compounded the burden of high food prices, exacerbating the problems of hunger and malnutrition in developing countries. The tandem food price and economic crises struck amidst the massive, chronic problem of hunger and undernutrition in developing countries. National governments and international actors have taken a variety of steps to mitigate the negative effects of increased food prices on particular groups. The recent abrupt increase in food prices, in tandem with the current global economic crisis, threatens progress already made in these areas, and could inhibit future efforts. The Institute of Medicine held a workshop, summarized in this volume, to describe the dynamic technological, agricultural, and economic issues contributing to the food price increases of 2007 and 2008 and their impacts on health and nutrition in resource-poor regions. The compounding effects of the current global economic downturn on nutrition motivated additional discussions on these dual crises, their impacts on the nutritional status of vulnerable populations, and opportunities to mitigate their negative nutritional effects. ER - TY - BOOK AU - Institute of Medicine A2 - David A. Relman A2 - Eileen R. Choffnes A2 - Alison Mack TI - The Domestic and International Impacts of the 2009-H1N1 Influenza A Pandemic: Global Challenges, Global Solutions: Workshop Summary SN - DO - 10.17226/12799 PY - 2010 UR - https://nap.nationalacademies.org/catalog/12799/the-domestic-and-international-impacts-of-the-2009-h1n1-influenza-a-pandemic PB - The National Academies Press CY - Washington, DC LA - English KW - Health and Medicine AB - In March and early April 2009, a new, swine-origin 2009-H1N1 influenza A virus emerged in Mexico and the United States. During the first few weeks of surveillance, the virus spread by human-to-human transmission worldwide to over 30 countries. On June 11, 2009, the World Health Organization (WHO) raised the worldwide pandemic alert level to Phase 6 in response to the ongoing global spread of the novel influenza A (H1N1) virus. By October 30, 2009, the H1N1 influenza A had spread to 191 countries and resulted in 5,700 fatalities. A national emergency was declared in the United States and the swine flu joined SARS and the avian flu as pandemics of the 21st century. Vaccination is currently available, but in limited supply, and with a 60 percent effectiveness rate against the virus. The story of how this new influenza virus spread out of Mexico to other parts of North America and then on to Europe, the Far East, and now Australia and the Pacific Rim countries has its origins in the global interconnectedness of travel, trade, and tourism. Given the rapid spread of the virus, the international scientific, public health, security, and policy communities had to mobilize quickly to characterize this unique virus and address its potential effects. The World Health Organization and Centers for Disease Control have played critical roles in the surveillance, detection and responses to the H1N1 virus. The Domestic and International Impacts of the 2009-H1N1 Influenza A Pandemic: Global Challenges, Global Solutions aimed to examine the evolutionary origins of the H1N1 virus and evaluate its potential public health and socioeconomic consequences, while monitoring and mitigating the impact of a fast-moving pandemic. The rapporteurs for this workshop reported on the need for increased and geographically robust global influenza vaccine production capacities; enhanced and sustained interpandemic demand for seasonal influenza vaccines; clear "triggers" for pandemic alert levels; and accelerated research collaboration on new vaccine manufacturing techniques. This book will be an essential guide for healthcare professionals, policymakers, drug manufacturers and investigators. ER - TY - BOOK AU - Institute of Medicine AU - National Research Council A2 - Robert B. Wallace A2 - Maria Oria TI - Enhancing Food Safety: The Role of the Food and Drug Administration SN - DO - 10.17226/12892 PY - 2010 UR - https://nap.nationalacademies.org/catalog/12892/enhancing-food-safety-the-role-of-the-food-and-drug PB - The National Academies Press CY - Washington, DC LA - English KW - Food and Nutrition KW - Health and Medicine AB - Recent outbreaks of illnesses traced to contaminated sprouts and lettuce illustrate the holes that exist in the system for monitoring problems and preventing foodborne diseases. Although it is not solely responsible for ensuring the safety of the nation's food supply, the U.S. Food and Drug Administration (FDA) oversees monitoring and intervention for 80 percent of the food supply. The U.S. Food and Drug Administration's abilities to discover potential threats to food safety and prevent outbreaks of foodborne illness are hampered by impediments to efficient use of its limited resources and a piecemeal approach to gathering and using information on risks. Enhancing Food Safety: The Role of the Food and Drug Administration, a new book from the Institute of Medicine and the National Research Council, responds to a congressional request for recommendations on how to close gaps in FDA's food safety systems. Enhancing Food Safety begins with a brief review of the Food Protection Plan (FPP), FDA's food safety philosophy developed in 2007. The lack of sufficient detail and specific strategies in the FPP renders it ineffectual. The book stresses the need for FPP to evolve and be supported by the type of strategic planning described in these pages. It also explores the development and implementation of a stronger, more effective food safety system built on a risk-based approach to food safety management. Conclusions and recommendations include adopting a risk-based decision-making approach to food safety; creating a data surveillance and research infrastructure; integrating federal, state, and local government food safety programs; enhancing efficiency of inspections; and more. Although food safety is the responsibility of everyone, from producers to consumers, the FDA and other regulatory agencies have an essential role. In many instances, the FDA must carry out this responsibility against a backdrop of multiple stakeholder interests, inadequate resources, and competing priorities. Of interest to the food production industry, consumer advocacy groups, health care professionals, and others, Enhancing Food Safety provides the FDA and Congress with a course of action that will enable the agency to become more efficient and effective in carrying out its food safety mission in a rapidly changing world. ER - TY - BOOK AU - Institute of Medicine A2 - Eileen R. Choffnes A2 - David A. Relman A2 - Alison Mack TI - Antibiotic Resistance: Implications for Global Health and Novel Intervention Strategies: Workshop Summary SN - DO - 10.17226/12925 PY - 2010 UR - https://nap.nationalacademies.org/catalog/12925/antibiotic-resistance-implications-for-global-health-and-novel-intervention-strategies PB - The National Academies Press CY - Washington, DC LA - English KW - Health and Medicine KW - Food and Nutrition AB - Years of using, misusing, and overusing antibiotics and other antimicrobial drugs has led to the emergence of multidrug-resistant 'superbugs.' The IOM's Forum on Microbial Threats held a public workshop April 6-7 to discuss the nature and sources of drug-resistant pathogens, the implications for global health, and the strategies to lessen the current and future impact of these superbugs. ER - TY - BOOK AU - Institute of Medicine A2 - Pierre L. Yong A2 - Robert S. Saunders A2 - LeighAnne Olsen TI - The Healthcare Imperative: Lowering Costs and Improving Outcomes: Workshop Series Summary SN - DO - 10.17226/12750 PY - 2010 UR - https://nap.nationalacademies.org/catalog/12750/the-healthcare-imperative-lowering-costs-and-improving-outcomes-workshop-series PB - The National Academies Press CY - Washington, DC LA - English KW - Health and Medicine AB - The United States has the highest per capita spending on health care of any industrialized nation but continually lags behind other nations in health care outcomes including life expectancy and infant mortality. National health expenditures are projected to exceed $2.5 trillion in 2009. Given healthcare's direct impact on the economy, there is a critical need to control health care spending. According to The Health Imperative: Lowering Costs and Improving Outcomes, the costs of health care have strained the federal budget, and negatively affected state governments, the private sector and individuals. Healthcare expenditures have restricted the ability of state and local governments to fund other priorities and have contributed to slowing growth in wages and jobs in the private sector. Moreover, the number of uninsured has risen from 45.7 million in 2007 to 46.3 million in 2008. The Health Imperative: Lowering Costs and Improving Outcomes identifies a number of factors driving expenditure growth including scientific uncertainty, perverse economic and practice incentives, system fragmentation, lack of patient involvement, and under-investment in population health. Experts discussed key levers for catalyzing transformation of the delivery system. A few included streamlined health insurance regulation, administrative simplification and clarification and quality and consistency in treatment. The book is an excellent guide for policymakers at all levels of government, as well as private sector healthcare workers. ER - TY - BOOK AU - National Academy of Sciences AU - National Academy of Engineering AU - Institute of Medicine TI - Rising Above the Gathering Storm, Revisited: Rapidly Approaching Category 5 SN - DO - 10.17226/12999 PY - 2010 UR - https://nap.nationalacademies.org/catalog/12999/rising-above-the-gathering-storm-revisited-rapidly-approaching-category-5 PB - The National Academies Press CY - Washington, DC LA - English KW - Policy for Science and Technology KW - Education KW - Engineering and Technology KW - Industry and Labor AB - In the face of so many daunting near-term challenges, U.S. government and industry are letting the crucial strategic issues of U.S. competitiveness slip below the surface. Five years ago, the National Academies prepared Rising Above the Gathering Storm, a book that cautioned: "Without a renewed effort to bolster the foundations of our competitiveness, we can expect to lose our privileged position." Since that time we find ourselves in a country where much has changed--and a great deal has not changed. So where does America stand relative to its position of five years ago when the Gathering Storm book was prepared? The unanimous view of the authors is that our nation's outlook has worsened. The present volume, Rising Above the Gathering Storm, Revisited, explores the tipping point America now faces. Addressing America's competitiveness challenge will require many years if not decades; however, the requisite federal funding of much of that effort is about to terminate. Rising Above the Gathering Storm, Revisited provides a snapshot of the work of the government and the private sector in the past five years, analyzing how the original recommendations have or have not been acted upon, what consequences this may have on future competitiveness, and priorities going forward. In addition, readers will find a series of thought- and discussion-provoking factoids--many of them alarming--about the state of science and innovation in America. Rising Above the Gathering Storm, Revisited is a wake-up call. To reverse the foreboding outlook will require a sustained commitment by both individual citizens and government officials--at all levels. This book, together with the original Gathering Storm volume, provides the roadmap to meet that goal. While this book is essential for policy makers, anyone concerned with the future of innovation, competitiveness, and the standard of living in the United States will find this book an ideal tool for engaging their government representatives, peers, and community about this momentous issue. ER -