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Textbook of Pharmacoepidemiology, Second Edition, provides an
introduction to pharmacoepidemiology and the methodologies, data
sources and applications used in clinical practice, the
pharmaceutical industry and regulatory agencies. This second
edition includes new and updated learning features, case examples
and key points, as well as information on the new
pharmacoepidemiology databases and how to use them.
This volume is a summary of material presented in the course given
in the International School of Phannacology on "Drug Epidemiology
and Post-Marketing Surveillance" between September 27 and October
8, 1990, at the "Ettore Majorana Center for Scientific Culture" in
Erice, Sicily. The course, which was a NATO Advanced Study
Institute, included lectures and workshops presented by experts in
the new field of phannacoepidemiology. The material covered
includes various approaches to spontaneous reporting of adverse
drug reactions, including aggregate approaches, such as those used
in France, and detailed analyses of individual reports, such as
that done in The Netherlands and in Sweden. Also, included are
studies using traditional epidemiology methods. In addition, modern
pharmacoepidemiology makes considerable use of automated databases.
As such, information is presented on their use as well.
Phannacoepidemiology started in hospitals and some of the newest
work in the field is returning to the hospital as a site for
studies. Material on these topics was presented as well. Finally,
selected new methodologic developments were outlined in specific
examples presented that were of regulatory and commercial
importance. This new field of phannacoepidemiology is exploding in
interest internationally. Evidence of this is the increasing
development of pharmacoepidemiology programs in industry, medical
schools, pharmacy schools, and schools of public health. Also,
there is a new International Society ofPhannacoepidemiology.
Practitioners in this field tend to specialize in either analyses
of spontaneous reporting or the use of formal epidemiologic
techniques.
This volume is a summary of material presented in the course given
in the International School of Phannacology on "Drug Epidemiology
and Post-Marketing Surveillance" between September 27 and October
8, 1990, at the "Ettore Majorana Center for Scientific Culture" in
Erice, Sicily. The course, which was a NATO Advanced Study
Institute, included lectures and workshops presented by experts in
the new field of phannacoepidemiology. The material covered
includes various approaches to spontaneous reporting of adverse
drug reactions, including aggregate approaches, such as those used
in France, and detailed analyses of individual reports, such as
that done in The Netherlands and in Sweden. Also, included are
studies using traditional epidemiology methods. In addition, modern
pharmacoepidemiology makes considerable use of automated databases.
As such, information is presented on their use as well.
Phannacoepidemiology started in hospitals and some of the newest
work in the field is returning to the hospital as a site for
studies. Material on these topics was presented as well. Finally,
selected new methodologic developments were outlined in specific
examples presented that were of regulatory and commercial
importance. This new field of phannacoepidemiology is exploding in
interest internationally. Evidence of this is the increasing
development of pharmacoepidemiology programs in industry, medical
schools, pharmacy schools, and schools of public health. Also,
there is a new International Society ofPhannacoepidemiology.
Practitioners in this field tend to specialize in either analyses
of spontaneous reporting or the use of formal epidemiologic
techniques.
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
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
The vaccine used to protect humans against the anthrax disease,
called Anthrax Vaccine Adsorbed (AVA), was licensed in 1970. It was
initially used to protect people who might be exposed to anthrax
where they worked, such as veterinarians and textile plant workers
who process animal hair. When the U. S. military began to
administer the vaccine, then extended a plan for the mandatory
vaccination of all U. S. service members, some raised concerns
about the safety and efficacy of AVA and the manufacture of the
vaccine. In response to these and other concerns, Congress directed
the Department of Defense to support an independent examination of
AVA. The Anthrax Vaccine: Is It Safe? Does It Work? reports the
study's conclusion that the vaccine is acceptably safe and
effective in protecting humans against anthrax. The book also
includes a description of advances needed in main areas: improving
the way the vaccine is now used, expanding surveillance efforts to
detect side effects from its use, and developing a better vaccine.
Table of Contents Front Matter Executive Summary 1 Introduction 2
Background 3 Anthrax Vaccine Efficacy 4 Safety: Introduction 5
Safety: Case Reports 6 Safety: Epidemiologic Studies 7 Anthrax
Vaccine Manufacture 8 Future Needs Appendix A Statement of Task
Appendix B Biographical Sketches Appendix C Information-Gathering
Meeting Agendas Appendix D Anthrax Vaccine Adsorbed Package Inserts
Appendix E Vaccine Adverse Event Reporting System (VAERS) Form
Appendix F Anthrax Vaccine Expert Committee (AVEC) Case Assessment
Form Appendix G DMSS Analyses Requested by the IOM Committee to
Assess the Safety and Efficacy of the Anthrax Vaccine Appendix H An
Assessment of the Safety of the Anthrax Vaccine: A Letter Report
Despite efforts over the past several decades to reduce sodium
intake in the United States, adults still consume an average of
3,400 mg of sodium every day. A number of scientific bodies and
professional health organizations, including the American Heart
Association, the American Medical Association, and the American
Public Health Association, support reducing dietary sodium intake.
These organizations support a common goal to reduce daily sodium
intake to less than 2,300 milligrams and further reduce intake to
1,500 mg among persons who are 51 years of age and older and those
of any age who are African-American or have hypertension, diabetes,
or chronic kidney disease. A substantial body of evidence supports
these efforts to reduce sodium intake. This evidence links
excessive dietary sodium to high blood pressure, a surrogate marker
for cardiovascular disease (CVD), stroke, and cardiac-related
mortality. However, concerns have been raised that a low sodium
intake may adversely affect certain risk factors, including blood
lipids and insulin resistance, and thus potentially increase risk
of heart disease and stroke. In fact, several recent reports have
challenged sodium reduction in the population as a strategy to
reduce this risk. Sodium Intake in Populations recognizes the
limitations of the available evidence, and explains that there is
no consistent evidence to support an association between sodium
intake and either a beneficial or adverse effect on most direct
health outcomes other than some CVD outcomes (including stroke and
CVD mortality) and all-cause mortality. Some evidence suggested
that decreasing sodium intake could possibly reduce the risk of
gastric cancer. However, the evidence was too limited to conclude
the converse-that higher sodium intake could possibly increase the
risk of gastric cancer. Interpreting these findings was
particularly challenging because most studies were conducted
outside the United States in populations consuming much higher
levels of sodium than those consumed in this country. Sodium Intake
in Populations is a summary of the findings and conclusions on
evidence for associations between sodium intake and risk of
CVD-related events and mortality. Table of Contents Front Matter
Summary 1 Introduction 2 Approach to Evidence Review 3 Sodium
Intake and Intermediate Markers for Health Outcomes 4 Sodium Intake
and Health Outcomes 5 Findings and Conclusions Appendix A: Acronyms
and Abbreviations Appendix B: Committee Member Biographical
Sketches Appendix C: Open Session Agendas Appendix D: Biomarkers
Figure Appendix E: Literature Search Strategy Appendix F:
Presentation of Results - Evidence Tables
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.
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