A Closer Look at Antibiotic Resistance

Description

The emerging interdisciplinary field of cognitive choice models integrates theory and recent research findings from both decision process and choice behavior.Cognitive decision processes provide the interface between the environment and brain, enabling choice behavior, and the basic cognitive mechanisms underlying decision processes are fundamental to all fields of human activity. Yet cognitive processes and choice processes are often studied separately, whether by decision theorists, consumer researchers, or social scientists. In Cognitive Choice Modeling, Zheng Joyce Wang and Jerome R. Busemeyer introduce a new cognitive modeling approach to the study of human choice behavior. Integrating recent research findings from both cognitive science and choice behavior, they lay the groundwork for the emerging interdisciplinary field of cognitive choice modeling. Contents Preface Chapter 1 Antibiotic Resistance: Additional Federal Actions Needed to Better Determine Magnitude and Reduce Impact( Abbreviations Why GAO Did This Study What GAO Recommends What GAO Found Background The National Action Plan and Federal Agency Responsibilities CDC Has Expanded Surveillance of Antibiotic Resistance, but Faces Challenges Determining the Magnitude of the Problem CDC Has Expanded Surveillance of Priority Bacteria The Precise Magnitude and Trends of Antibiotic Resistance Are Unknown, in Part Because of Challenges CDC Faces in Three Areas Challenges in Tracking Resistance Challenges in Reporting Complete and Timely Information on Magnitude and Trends Challenges in Tracking and Assessing the Global Threat Federal Agencies Have Helped Advance Diagnostic Tests and Promoted Their Use, but These Efforts Have Limitations Agency Efforts toward the Development and Use of Diagnostic Tests HHS and DOD Have Funded the Development of New Tests HHS Has Funded Some Studies of Clinical Outcomes, but Has Not Clearly Identified Leadership, Roles, and Responsibilities CMS and FDA Have Taken Steps to Advance the Use of Tests, but Experts Have Identified Challenges with Payments FDA Efforts to Advance the Development of New Tests FDA Has Taken Steps to Speed the Development of Tests for Newly Approved Antibiotics FDA Has Taken Steps to Improve Breakpoint Recognition FDA Has Taken Limited Steps to Monitor Use of Updated Breakpoints Federal Efforts Have Not Fully Addressed Challenges to Developing New Treatments for Antibiotic­Resistant Infections Economic and Other Challenges to Developing New Treatments Exist Federal Agencies Have Made Some Progress toward Addressing Treatment Development Challenges Federal Funding for Antibiotic R&D Issued Guidance to Support Clinical Trials Implemented Medicare Payment Mechanisms Federal Efforts Have Not Fully Incentivized Antibiotic Development, and HHS Lacks a Strategy to Develop New Incentives Federal Agencies Have Undertaken Several Efforts to Promote the Appropriate Use of Antibiotics, but Key Challenges Remain Federal Agencies Have Undertaken Several Efforts to Promote the Appropriate Use of Antibiotics through Stewardship Programs Published Requirements for Hospitals, Long-Term Care, and DOD and VA Facilities to Implement Antibiotic Stewardship Programs Developed Incentives for Clinicians to Implement Antibiotic Stewardship Activities Published Guidance on Implementing Antibiotic Stewardship Programs Expanded the Collection of Antibiotic Use Data Developed Antibiotic Stewardship Training for Various Health Care Settings Funded Research Continued National Public Awareness Campaign Collaborated Internationally Four Key Challenges Have Limited Federal Efforts to Promote the Appropriate Use of Antibiotics Federal Requirements and Incentives Are Limited CDC Faces Challenges in Collecting Complete Antibiotic Use Data, Limiting the Agency’s Ability to Monitor and Improve Appropriate Use The CARB Task Force Has Not Identified Plans to Address Challenges Related to Expanding Stewardship Programs and Antibiotic Use Data Collection Antibiotic Stewardship Training May Have Limited Success in Improving Prescribing Behavior Conclusion Recommendations for Executive Action Agency Comments and Our Evaluation Appendix I: Objectives, Scope, and Methodology Appendix II: Expert Meeting Participant List Appendix III: Additional Examples of Federal Efforts to Support Antibiotic Research and Development Appendix IV: Additional Information on Federal Efforts to Promote Appropriate Antibiotic Use Appendix V: Comments from the Department of Health and Human Services Chapter 2 Combating Superbugs: U.S. Public Health Responses to Antibiotic Resistance( Opening Statement of Hon. Tim Murphy, a Representative in Congress from the Commonwealth of Pennsylvania Prepared Statement of Hon. Tim Murphy Opening Statement of Hon. Diana Degette, a Representative in Congress from the State of Colorado Opening Statement of Hon. Fred Upton, a Representative in Congress from the State of Michigan Opening Statement of Chairman Fred Upton Subcommittee on Oversight and Investigations Hearing on “Combatting Superbugs: U.S. Public Health Responses to Antibiotic Resistance,” June 14, 2016 Opening Statement of Hon. David B. Mckinley, a Representative in Congress from the State of West Virginia Opening Statement of Vice Chairman McKinley Subcommittee on Oversight and Investigations Hearing on “Combatting Superbugs: U.S. Public Health Responses to Antibiotic Resistance,” June 14, 2016 Opening Statement of Hon. Frank Pallone, Jr., a Representative in Congress from the State of New Jersey Statements of Dr. Beth Bell, Director, National Center for Emerging and Zoonotic Infectious Disease, Centers for Disease Control; Dr. Janet Woodcock, Director, Center for Drug Evaluation and Research, Food and Drug Administration; Dr. Richard J. Hatc... Statement of Dr. Beth Bell Witness: Beth Bell, MD, MPH; Testimony: House Energy and Commerce Committee, Subcommittee on Oversight and Investigations Threat of Antibiotic Resistance CDC’s Antibiotic Resistance Solutions Initiative Detect and Respond Prevent Innovate Collaborate Additional Investments Public Health Response to Discovery of mcr-1 Conclusion Statement of Dr. Janet Woodcock Statement of Janet Woodcock, M.D., Director, Center for Drug Evaluation and Research Food and Drug Administration, Department of Health and Human Services, before the Subcommittee on Oversight and Investigations Committee on Energy and Commerce, U.S. ... Introduction The Challenges Impacting Antibacterial Drug Development Use of Common Clinical Trial Protocols to Encourage Antibacterial Drug Development What FDA Is Doing to Address the Current Challenges Encouraging the Development of New Antibacterial Drugs Accelerating Development of Rapid Diagnostic Tests for Antibiotic Resistance Expedited Updating of Susceptibility Test Interpretive Criteria (Breakpoints) to Maximize the Effective Use of Antimicrobial Products Solution for Updating Breakpoint Information Faster Conclusion Statement of Dr. Richard J. Hatchett Written Testimony, House Committee on Energy and Commerce, Subcommittee on Oversight and Investigations, “Combatting Superbugs: U.S. Public Health Responses to Antibiotic Resistance” Statement of Dennis M. Dixon Department of Health and Human Services National Institutes of Health, The Role of the National Institute of Allergy and Infectious Diseases Research in Combating Antibiotic Resistance, Testimony before the House Energy and Commerce Committee, Subcomm... Antibiotic Resistance White House Initiative on Combating Antibiotic-Resistant Bacteria NIAID Research Addressing Antibiotic Resistance Basic Research and Research Resources to Facilitate Product Development Diagnostics Therapeutics Vaccines Conclusion U.S. House of Representatives, Committee on Energy and Commerce, June 10, 2016 Witnesses Background Understanding the Superbug and Antibiotic Resistance Overuse of Antibiotics Development of New Antibiotics The Federal Response to Antibiotic Resistance Mapping the Spread of Antibiotic-Resistant Bacteria Antibiotic Stewardship Programs New Antibiotic Development Issues Index Blank Page Blank Page