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Hepatitis B and C cause most cases of hepatitis in the United
States and the world. The two diseases account for about a million
deaths a year and 78 percent of world's hepatocellular carcinoma
and more than half of all fatal cirrhosis. In 2013 viral hepatitis,
of which hepatitis B virus (HBV) and hepatitis C virus (HCV) are
the most common types, surpassed HIV and AIDS to become the seventh
leading cause of death worldwide. The world now has the tools to
prevent hepatitis B and cure hepatitis C. Perfect vaccination could
eradicate HBV, but it would take two generations at least. In the
meantime, there is no cure for the millions of people already
infected. Conversely, there is no vaccine for HCV, but new
direct-acting antivirals can cure 95 percent of chronic infections,
though these drugs are unlikely to reach all chronically-infected
people anytime soon. This report, the first of two, examines the
feasibility of hepatitis B and C elimination in the United States
and identifies critical success factors. The phase two report will
outline a strategy for meeting the elimination goals discussed in
this report. Table of Contents Front Matter Summary 1 Introduction
2 The Elimination of Hepatitis B 3 The Elimination of Hepatitis C 4
Conclusion Appendix A: Committee Meeting 1 Agenda Appendix B:
Committee Meeting 2 Agenda Appendix C: Committee Biographies
Appendix D: Glossary
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Stronger Food and Drug Regulatory Systems Abroad (Paperback)
National Academies of Sciences, Engineering, and Medicine, Health and Medicine Division, Board on Global Health, Committee on Stronger Food and Drug Regulatory Systems Abroad; Edited by Catherine E Woteki, …
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R1,676
Discovery Miles 16 760
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Ships in 12 - 17 working days
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Ensuring the safety of food and the quality and safety of medicines
in a country is an important role of government, made more
complicated by global manufacturing and international trade. By
recent estimates, unsafe food kills over 400,000 people a year, a
third of them children under 5, mostly in low- and middle-income
countries; every year poor quality medicines cause about 70,000
excess deaths from childhood pneumonia and roughly 8,500 to 20,000
malaria deaths in sub-Saharan Africa alone. The Federal Drug
Administration (FDA) Office of Global Policy and Strategy is
charged with improving capacity of the agency's foreign counterpart
offices and increasing understanding of the importance of
regulatory systems for public health, development, and trade. At
the request of the FDA, this study sets out a strategy to support
good quality, wholesome food and safe, effective medical products
around the world. Its goal is to build on the momentum for
strengthening regulatory systems and to set a course for
sustainability and continued progress. The 2012 report Ensuring
Safe Food and Medical Products Through Stronger Regulatory Systems
Abroad outlined strategies to secure international supply chains,
emphasized capacity building and support for surveillance in low-
and middle-income countries, and explored ways to facilitate work
sharing among food and medical product regulatory agencies. This
new study assess progress made and the current regulatory
landscape. Table of Contents Front Matter Summary 1 Introduction 2
Regulatory Systems, Global Health, and Development 3 Global Efforts
to Strengthen Regulatory Systems 4 The Role of the National
Government 5 The Role of the Regulatory Agency Appendix A:
Committee Member Biographies Appendix B: Public Meeting Agendas
Appendix C: Call for Comments Appendix D: Ensuring Safe Foods and
Medical Products Through Stronger Regulatory Systems Abroad
Since the 2014 Ebola outbreak many public- and private-sector
leaders have seen a need for improved management of global public
health emergencies. The effects of the Ebola epidemic go well
beyond the three hardest-hit countries and beyond the health
sector. Education, child protection, commerce, transportation, and
human rights have all suffered. The consequences and lethality of
Ebola have increased interest in coordinated global response to
infectious threats, many of which could disrupt global health and
commerce far more than the recent outbreak. In order to explore the
potential for improving international management and response to
outbreaks the National Academy of Medicine agreed to manage an
international, independent, evidence-based, authoritative,
multistakeholder expert commission. As part of this effort, the
Institute of Medicine convened four workshops in summer of 2015 to
inform the commission report. The presentations and discussions
from the Pandemic Financing Workshop are summarized in this report.
Table of Contents Front Matter 1 Introduction 2 International
Cooperative Action on Pandemics 3 Pandemic Emergency Funds 4
Adapting Insurance Products for Pandemic Risk 5 Innovative
Financing Mechanisms for Preparedness and Response 6 Identifying
Triggers and Modeling Risk 7 Financing Challenges In-Country 8
Donor Considerations and Crowding-In 9 The Role of the Private
Sector 10 Incentives and Preparedness Appendix A: References
Appendix B: Workshop Agenda Appendix C: Participant Biographies
The United States has been a generous sponsor of global health
programs for the past 25 years or more. This investment has
contributed to meaningful changes, especially for women and
children, who suffer the brunt of the world's disease and
disability. Development experts have long debated the relative
merits of vertical health programming, targeted to a specific
service or patient group, and horizontal programming, supporting
more comprehensive care. The U.S. government has invested heavily
in vertical programs, most notably through the President's
Emergency Plan for AIDS Relief (PEPFAR), its flagship initiative
for HIV and AIDS. PEPFAR and programs like it have met with good
success. Protecting these successes and continuing progress in the
future depends on the judicious integration of vertical programs
with local health systems. A strong health system is the best
insurance developing countries can have against a disease burden
that is shifting rapidly and in ways that history has not prepared
us for. Reaching the poor with development assistance is an
increasingly complicated task. The majority of the roughly 1
billion people living in dire poverty are in middle-income
countries, where foreign assistance is not necessarily needed or
welcome. Many of the rest live in fragile states, where political
volatility and weak infrastructure make it difficult to use aid
effectively. The poorest people in the world are also the sickest;
they are most exposed to disease vectors and infection.
Nevertheless, they are less likely to access health services.
Improving their lot means removing the systemic barriers that keep
the most vulnerable people from gaining such access. Investing in
Global Health Systems discusses the past and future of global
health. First, the report gives context by laying out broad trends
in global health. Next, it discusses the timeliness of American
investment in health systems abroad and explains how functional
health systems support health, encourage prosperity, and advance
global security. Lastly, it lays out, in broad terms, an effective
donor strategy for health, suggesting directions for both the
manner and substance of foreign aid given. The challenge of the
future of aid programming is to sustain the successes of the past
25 years, while reducing dependence on foreign aid. Investing in
Global Health Systems aims to help government decision makers
assess the rapidly changing social and economic situation in
developing countries and its implications for effective development
assistance. This report explains how health systems improvements
can lead to better health, reduce poverty, and make donor
investment in health sustainable.
Antimicrobial resistance is a health problem that threatens to
undermine almost a century of medical progress. Moreover, it is a
global problem that requires action both in the United States and
internationally. Combating Antimicrobial Resistance and Protecting
the Miracle of Modern Medicine discusses ways to improve detection
of resistant infections in the United States and abroad, including
monitoring environmental reservoirs of resistance. This report sets
out a strategy for improving stewardship and preventing infections
in humans and animals. The report also discusses the strength of
the pipeline for new antimicrobial medicines and steps that could
be taken to bring a range of preventive and therapeutic products
for humans and animals to the market. Table of Contents Front
Matter Summary 1 Introduction 2 The Scope of the Problem 3 The
Health and Economic Burden of Resistance 4 Strengthening
Surveillance 5 Stewardship and Infection Prevention 6 Bringing New
Products to Market and Ensuring Their Reach 7 The National Action
Plan for Combating Antibiotic-Resistant Bacteria 8 A Role for the
United States in Coordinated Global Action Appendix A: Committee
Member Biographies Appendix B: Disclosure of Unavoidable Conflict
of Interest Appendix C: Open Session Agendas
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. Table of
Contents Front Matter Summary 1 Introduction 2 Core Elements of
Regulatory Systems 3 Critical Issues 4 A Strategy to Building Food
and Medical Product Regulatory Systems 5 International Action 6
Domestic Action 7 Conclusions and Priorities Appendix A: Glossary
Appendix B: A Review of Tort Liability's Role in Food and Medical
Product Regulation Appendix C: Food and Medical Product Regulatory
Systems of South Africa, Brazil, India, and China Appendix D:
Chinese Food Regulatory System Appendix E: Meeting Agendas Appendix
F: Committee Member Biographies Appendix G: Analyzing Food Safety
Alerts in European Union Rapid Alerts Systems for Food and Feed
Appendix H: Strengthening Core Elements of Regulatory Systems in
Developing Countries: Identifying Priorities and an Appropriate
Role for the U.S. Food and Drug Administration
Hepatitis B and C cause most cases of hepatitis in the United
States and the world. The two diseases account for about a million
deaths a year and 78 percent of world's hepatocellular carcinoma
and more than half of all fatal cirrhosis. In 2013 viral hepatitis,
of which hepatitis B virus (HBV) and hepatitis C virus (HCV) are
the most common types, surpassed HIV and AIDS to become the seventh
leading cause of death worldwide. The world now has the tools to
prevent hepatitis B and cure hepatitis C. Perfect vaccination could
eradicate HBV, but it would take two generations at least. In the
meantime, there is no cure for the millions of people already
infected. Conversely, there is no vaccine for HCV, but new
direct-acting antivirals can cure 95 percent of chronic infections,
though these drugs are unlikely to reach all chronically-infected
people anytime soon. This report, the second of two, builds off the
conclusions of the first report and outlines a strategy for
hepatitis reduction over time and specific actions to achieve them.
Table of Contents Front Matter Summary 1 Introduction 2 Targets for
Elimination 3 Public Health Information 4 Essential Interventions 5
Service Delivery 6 Financing Elimination 7 Research Appendix A:
Population Health Impact and Cost-Effectiveness of Chronic
Hepatitis B Diagnosis, Care, and Treatment in the United States
Appendix B: Modeling the Elimination of Hepatitis C in the United
States Appendix C: Public Meeting Agenda Appendix D: Committee
Biographies
Quality of care is a priority for U.S. Agency for International
Development (USAID). The agency's missions abroad and their host
country partners work in quality improvement, but a lack of
evidence about the best ways to facilitate such improvements has
constrained their informed selection of interventions. Six
different methods - accreditation, COPE, improvement collaborative,
standards-based management and recognitions (SBM-R), supervision,
and clinical in-service training - currently make up the majority
of this investment for USAID missions. As their already substantial
investment in quality grows, there is demand for more scientific
evidence on how to reliably improve quality of care in poor
countries. USAID missions, and many other organizations spending on
quality improvement, would welcome more information about how
different strategies work to improve quality, when and where
certain tools are most effective, and the best ways to measure
success and shortcomings. To gain a better understanding of the
evidence supporting different quality improvement tools and clarity
on how they would help advance the global quality improvement
agenda, the Institute of Medicine convened a 2-day workshop in
January 2015. The workshop's goal was to illuminate these different
methods, discussing their pros and cons. This workshop summary is a
description of the presentations and discussions. Table of Contents
Front Matter 1 Introduction 2 An Overview of Quality of Care in
Low- and Middle-Income Countries 3 Six Widely Used Methods to
Improve Quality 4 Reviewing the Evidence for Different Quality
Improvement Methods 5 Synthesizing Evidence, Identifying Gaps 6
Cross-Cutting Approaches to Improve Quality References Appendix A:
Workshop Agenda Appendix B: Participant Biographies
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Countering the Problem of Falsified and Substandard Drugs (Paperback)
Committee on Understanding the Global Public Health Implications of Substandard, Falsified, and Counterfeit Medical Products, Board on Global Health, Institute of Medicine; Edited by Lawrence O. Gostin, Gillian J. Buckley
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R1,928
Discovery Miles 19 280
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Ships in 12 - 17 working days
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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.
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