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The adulteration and fraudulent manufacture of medicines is an old problem, vastly aggravated by modern manufacturing and trade. In the last decade, impotent antimicrobial drugs have compromised the treatment of many deadly diseases in poor countries. More recently, negligent production at a Massachusetts compounding pharmacy sickened hundreds of Americans. While the national drugs regulatory authority (hereafter, the regulatory authority) is responsible for the safety of a country's drug supply, no single country can entirely guarantee this today.The once common use of the term counterfeit to describe any drug that is not what it claims to be is at the heart of the argument. In a narrow, legal sense a counterfeit drug is one that infringes on a registered trademark. The lay meaning is much broader, including any drug made with intentional deceit. Some generic drug companies and civil society groups object to calling bad medicines counterfeit, seeing it as the deliberate conflation of public health and intellectual property concerns. Countering the Problem of Falsified and Substandard Drugs accepts the narrow meaning of counterfeit, and, because the nuances of trademark infringement must be dealt with by courts, case by case, the report does not discuss the problem of counterfeit medicines.

Over the past several decades, the public and private sectors made significant investments in global health, leading to meaningful changes for many of the world's poor. These investments and the resulting progress are often concentrated in vertical health programs, such as child and maternal health, malaria, and HIV, where donors may have a strategic interest. Frequently, partnerships between donors and other stakeholders can coalesce on a specific topical area of expertise and interest. However, to sustain these successes and continue progress, there is a growing recognition of the need to strengthen health systems more broadly and build functional administrative and technical infrastructure that can support health services for all, improve the health of populations, increase the purchasing and earning power of consumers and workers, and advance global security. In June 2015, the National Academies of Sciences, Engineering, and Medicine held a workshop on the role of public-private partnerships (PPPs) in health systems strengthening. Participants examined a range of incentives, innovations, and opportunities for relevant sectors and stakeholders in strengthening health systems through partnerships; to explore lessons learned from pervious and ongoing efforts with the goal of illuminating how to improve performance and outcomes going forward; and to discuss measuring the value and outcomes of investments and documenting success in partnerships focused on health systems strengthening. This report summarizes the presentations and discussions from the workshop.

The U.S. government supports programs to combat global HIV/AIDS through an initiative that is known as the President's Emergency Plan for AIDS Relief (PEPFAR). This initiative was originally authorized in the U.S. Leadership Against HIV/AIDS, Tuberculosis, and Malaria Act of 2003 and focused on an emergency response to the HIV/AIDS pandemic to deliver lifesaving care and treatment in low- and middle-income countries (LMICs) with the highest burdens of disease. It was subsequently reauthorized in the Tom Lantos and Henry J. Hyde U.S. Global Leadership Against HIV/AIDS, Tuberculosis, and Malaria Reauthorization Act of 2008 (the Lantos-Hyde Act). Evaluation of PEPFAR makes recommendations for improving the U.S. government's bilateral programs as part of the U.S. response to global HIV/AIDS. The overall aim of this evaluation is a forward-looking approach to track and anticipate the evolution of the U.S. response to global HIV to be positioned to inform the ability of the U.S. government to address key issues under consideration at the time of the report release.

The number of people infected with HIV or living with AIDS is increasing at unprecedented rates as various scientists, organizations, and institutions search for innovative solutions to combating and preventing the disease. At the request of the Bill & Melinda Gates Foundation, Methodological Challenges in Biomedical HIV Prevention Trials addresses methodological challenges in late-stage nonvaccine biomedical HIV prevention trials with a specific focus on microbicide and pre-exposure prophylaxis trials. This book recommends a number of ways to improve the design, monitoring, and analysis of late-stage clinical trials that evaluate nonvaccine biomedical interventions. The objectives include identifying a beneficial method of intervention, enhancing quantification of the impact, properly assessing the effects of using such an intervention, and reducing biases that can lead to false positive trial results. According to Methodological Challenges in Biomedical HIV Prevention Trials , the need to identify a range of effective, practical, and affordable preventive strategies is critical. Although a large number of promising new HIV prevention strategies and products are currently being tested in late-stage clinical trials, these trials face a myriad of methodological challenges that slow the pace of research and limit the ability to identify and fully evaluate effective biomedical interventions.

Assessing Health Professional Education is the summary of a workshop hosted by the Institute of Medicine's Global Forum on Innovation in Health Professional Education to explore assessment of health professional education. At the event, Forum members shared personal experiences and learned from patients, students, educators, and practicing health care and prevention professionals about the role each could play in assessing the knowledge, skills, and attitudes of all learners and educators across the education to practice continuum. The workshop focused on assessing both individuals as well as team performance. This report discusses assessment challenges and opportunities for interprofessional education, team-based care, and other forms of health professional collaborations that emphasize the health and social needs of communities.

In 2003, Congress passed the United States Leadership Against HIV/AIDS, Tuberculosis, and Malaria Act, which established a 5-year, $15 billion initiative to help countries around the world respond to their AIDS epidemics. The initiative is generally referred to by the title of the 5-year strategy required by the act-PEPFAR, or the President's Emergency Plan for AIDS Relief. PEPFAR Implementation evaluates this initiative's progress and concludes that although PEPFAR has made a promising start, U.S. leadership is still needed in the effort to respond to the HIV/AIDS pandemic. The book recommends that the program transition from its focus on emergency relief to an emphasis on the long-term strategic planning and capacity building necessary for a sustainable response. PEPFAR Implementation will be of interest to policy makers, health care professionals, special interest groups, and others interested in global AIDS relief.

Biomedical advances have made it possible to identify and manipulate features of living organisms in useful ways-leading to improvements in public health, agriculture, and other areas. The globalization of scientific and technical expertise also means that many scientists and other individuals around the world are generating breakthroughs in the life sciences and related technologies. The risks posed by bioterrorism and the proliferation of biological weapons capabilities have increased concern about how the rapid advances in genetic engineering and biotechnology could enable the production of biological weapons with unique and unpredictable characteristics. Globalization, Biosecurity, and the Future of Life Sciences examines current trends and future objectives of research in public health, life sciences, and biomedical science that contain applications relevant to developments in biological weapons 5 to 10 years into the future and ways to anticipate, identify, and mitigate these dangers.

Cardiovascular disease (CVD), once thought to be confined primarily to industrialized nations, has emerged as a major health threat in developing countries. Cardiovascular disease now accounts for nearly 30 percent of deaths in low and middle income countries each year, and is accompanied by significant economic repercussions. Yet most governments, global health institutions, and development agencies have largely overlooked CVD as they have invested in health in developing countries. Recognizing the gap between the compelling evidence of the global CVD burden and the investment needed to prevent and control CVD, the National Heart, Lung, and Blood Institute (NHLBI) turned to the IOM for advice on how to catalyze change.In this report, the IOM recommends that the NHLBI, development agencies, nongovernmental organizations, and governments work toward two essential goals:creating environments that promote heart healthy lifestyle choices and help reduce the risk of chronic diseases, andbuilding public health infrastructure and health systems with the capacity to implement programs that will effectively detect and reduce risk and manage CVD.To meet these goals, the IOM recommends several steps, including improving cooperation and collaboration; implementing effective and feasible strategies; and informing efforts through research and health surveillance. Without better efforts to promote cardiovascular health, global health as a whole will be undermined.

Globally, between 15-71 percent of women will experience physical and/or sexual abuse from an intimate partner at some point in their lifetime. Too often this preventable form of violence is repetitive in nature, occurring at multiple points across the lifespan. The prevalence of intimate partner violence is on the higher end of this spectrum in East Africa, with in-country demographic and health surveys indicating that approximately half of all women between the ages of 15-49 in Uganda, Kenya, and Tanzania having experienced physical or sexual abuse within a partnership. It is now widely accepted that preventing intimate partner violence is possible and can be achieved through a greater understanding of the problem; its risk and protective factors; and effective evidence-informed primary, secondary, and tertiary prevention. To that end, on August 11-12, 2014, the Institute of Medicine's Forum on Global Violence Prevention, in a collaborative partnership with the Uganda National Academy of Sciences, convened a workshop focused on informing and creating synergies within a diverse community of researchers, health workers, and decision makers committed to promoting intimate partner violence-prevention efforts that are innovative, evidence-based, and crosscutting. This workshop brought together a variety of stakeholders and community workers from Uganda, Kenya, and Tanzania to engage in a meaningful, multidirectional dialogue regarding intimate partner violence in the region. Preventing Intimate Partner Violence in Uganda, Kenya, and Tanzania summarizes the presentations and discussion of the workshop.

The COVID-19 pandemic has laid bare the fragility of the global system of preparedness and response to pandemics and the fragmentation of our research and development ecosystem. The pandemic has provided a disruptive moment to advance new norms and frameworks for influenza. It also has demonstrated how innovative global public-private partnerships and coordination mechanisms can lead to rapid successes in viral vaccine research, manufacturing, and risk pooling. Countering the Pandemic Threat Through Global Coordination on Vaccines identifies ways to strengthen pandemic and seasonal influenza global coordination, partnerships, and financing. This report presents seven overarching recommendations for how the urgent influenza threat should be conceptualized and prioritized within the global pandemic preparedness and response agenda in the future.