Appendix F
A Public Health Action Plan to Combat Antimicrobial Resistance

EXECUTIVE SUMMARY

This Public Health Action Plan to Combat Antimicrobial Resistance (Action Plan) was developed by an interagency Task Force on Antimicrobial Resistance that was created in 1999. The Task Force is co-chaired by the Centers for Disease Control and Prevention, the Food and Drug Administration, and the National Institutes of Health, and also includes the Agency for Healthcare Research and Quality, the Health Care Financing Administration, the Health Resources and Services Administration, the Department of Agriculture, the Department of Defense, the Department of Veterans Affairs, and the Environmental Protection Agency.

The Action Plan reflects a broad-based consensus of federal agencies on actions needed to address antimicrobial1 resistance (AR). Input from state and local health agencies, universities, professional societies, pharmaceutical companies, health care delivery organizations, agricultural producers, consumer groups, and other members of the public was important in developing the plan. While some actions are already underway, complete implementation of this plan will require close collaboration with all of these

1  

In this document, the term “antimicrobial” is used inclusively to refer to any agent (including an antibiotic) used to kill or inhibit the growth of microorganisms (bacteria, viruses, fungi, or parasites.) This term applies whether the agent is intended for human, veterinary, or agricultural applications.



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Appendix F A Public Health Action Plan to Combat Antimicrobial Resistance EXECUTIVE SUMMARY This Public Health Action Plan to Combat Antimicrobial Resistance (Action Plan) was developed by an interagency Task Force on Antimicrobial Resistance that was created in 1999. The Task Force is co-chaired by the Centers for Disease Control and Prevention, the Food and Drug Administration, and the National Institutes of Health, and also includes the Agency for Healthcare Research and Quality, the Health Care Financing Administration, the Health Resources and Services Administration, the Department of Agriculture, the Department of Defense, the Department of Veterans Affairs, and the Environmental Protection Agency. The Action Plan reflects a broad-based consensus of federal agencies on actions needed to address antimicrobial1 resistance (AR). Input from state and local health agencies, universities, professional societies, pharmaceutical companies, health care delivery organizations, agricultural producers, consumer groups, and other members of the public was important in developing the plan. While some actions are already underway, complete implementation of this plan will require close collaboration with all of these 1   In this document, the term “antimicrobial” is used inclusively to refer to any agent (including an antibiotic) used to kill or inhibit the growth of microorganisms (bacteria, viruses, fungi, or parasites.) This term applies whether the agent is intended for human, veterinary, or agricultural applications.

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partners,2 a major objective of the process. The plan will be implemented incrementally, dependent on the availability of resources. The Action Plan provides a blueprint for specific, coordinated federal actions to address the emerging threat of antimicrobial resistance. This document is Part I of the Action Plan, focusing on domestic issues. Since AR transcends national borders and requires a global approach to its prevention and control, Part II of the plan, to be developed subsequently, will identify actions that more specifically address international issues. The Action Plan, Part I (Domestic Issues), includes four focus areas: Surveillance, Prevention and Control, Research, and Product Development. A summary of the top priority goals and action items in each focus area follows. Surveillance Unless AR problems are detected as they emerge—and actions are taken quickly to contain them—the world may soon be faced with previously treatable diseases that have again become untreatable, as in the pre-antibiotic era. Priority Goals and Action Items in this focus area address ways to: Develop and implement a coordinated national plan for AR surveillance; Ensure the availability of reliable drug susceptibility data for surveillance; Monitor patterns of antimicrobial drug use; and Monitor AR in agricultural settings to protect the public’s health by ensuring a safe food supply as well as animal and plant health. A coordinated national surveillance plan for monitoring AR in microorganisms that pose a threat to public health will be developed and implemented. The plan will specify activities to be conducted at national, state, and local levels; define the roles of participants; promote the use of standardized methods; and provide for timely dissemination of data to interested parties, e.g., public health officials, clinicians, and researchers. 2   Implementation of this Action Plan requires working with a wide variety of partners, e.g., state and local health agencies, universities, professional societies, pharmaceutical and biotechnology companies, health care delivery organizations, insurers, agricultural producers, consumer groups, and the public. A wide variety of expertise is needed, e.g., from clinicians, consumers, pharmacists, microbiologists, epidemiologists, behavioral and social scientists, economists, health policy researchers, and others. Partners and expertise needed will vary with different action items.

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Needed core capacities at state and local levels will be defined and supported. When possible, the plan will coordinate, integrate, and build on existing disease surveillance infrastructure. All surveillance activities will be conducted with respect for patient and institutional confidentiality. The availability of reliable drug susceptibility data is essential for AR surveillance. The accuracy of AR detection and reporting will be improved through training and proficiency testing programs for diagnostic laboratories and by promoting and further refining standardized methods for detecting drug resistance in important pathogens, including bacteria, parasites, fungi, and viruses. Public and private sector partners will address barriers to AR testing and reporting, e.g., barriers due to changes in health care delivery. A plan to monitor patterns of antimicrobial drug use will be developed and implemented as an important component of the national AR surveillance plan. This information is essential to interpret trends and variations in rates of AR, improve our understanding of the relationship between drug use and resistance, identify and anticipate gaps in availability of existing drugs, and identify interventions to prevent and control AR. Improved surveillance for AR in agricultural settings will allow early detection of resistance trends in pathogens that pose a risk to animal and plant health, as well as in bacteria that enter the food supply. Agricultural surveillance data will also help improve understanding of the relationship between antimicrobial drug and pesticide use and the emergence of drug resistance. Prevention and Control The prevention and control of drug-resistant infections requires measures to promote the appropriate use3 of antimicrobial drugs and prevent the transmission of infections (whether drug-resistant or not). Priority Goals and Action Items in this focus area address ways to: Extend the useful life of antimicrobial drugs through appropriate use policies that discourage overuse and misuse; Improve diagnostic testing practices; 3   In this Action Plan, appropriate antimicrobial drug use is defined as use that maximizes therapeutic impact while minimizing toxicity and the development of resistance. In practice, this means prescribing antimicrobial therapy when and only when beneficial to a patient; targeting therapy to the desired pathogens; and using the appropriate drug, dose, and duration.

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Prevent infection transmission through improved infection control methods and use of vaccines; Prevent and control emerging AR problems in agriculture and human and veterinary medicine; and Ensure that comprehensive programs to prevent and control AR involve a wide variety of nonfederal partners and the public so these programs become a part of routine practice nationwide. Appropriate drug-use policies will be implemented through a public health education campaign on appropriate antimicrobial drug use as a national health priority. Other actions in support of appropriate drug use will include reducing inappropriate prescribing through development of clinical guidelines and computer-assisted decision support, considering regulatory changes, supporting other interventions promoting education and behavior change among clinicians, and informing consumers about the uses and limitations of antimicrobial drugs. Improved diagnostic practices will be promoted by encouraging the use of rapid diagnostic methods to guide drug prescribing, facilitating direct consultation between clinicians and laboratory personnel with appropriate expertise and authority, and promoting the use of appropriate laboratory testing methods. Guidelines, training, and regulatory and reimbursement policies will be utilized to promote improved diagnostic practices. Reduced rates of infection transmission will be addressed through public health campaigns that promote vaccination and hygienic practices such as hand washing, safe food handling, and other behaviors associated with prevention of infection transmission. Infection control in health care settings will be enhanced by developing new interventions based on rapid diagnosis, improved understanding of the factors that promote cross-infection, and modified medical devices or procedures that reduce the risk of infection. The prevention and control of AR in agriculture and veterinary medicine requires 1) improved understanding of the risks and benefits of antimicrobial use and ways to prevent the emergence and spread of resistance; 2) development and implementation of principles for appropriate antimicrobial drug use in the production of food animals and plants; 3) improved animal husbandry and food production practices to reduce the spread of infection; and 4) a regulatory framework to address the need for antimicrobial drug use in agriculture and veterinary medicine while ensuring that such use does not pose a risk to human health. Comprehensive, multifaceted programs involving a wide variety of nonfederal partners and the public are required to prevent and control AR. The AR Task Force agencies will ensure ongoing input from, review by, and collaboration with nonfederal partners. The appropriate agencies will

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support demonstration projects that use multiple interventions to prevent and control AR (e.g., through surveillance, appropriate drug use, optimized diagnostic testing, immunization practice, and infection control). The Task Force agencies will encourage the incorporation of effective programs into routine practice by implementing model programs in federal health care systems and promoting the inclusion of AR prevention and control activities as part of quality assurance and accreditation standards for health care delivery nationwide. Research Understanding the fundamental processes involved in antimicrobial resistance within microbes and the resulting impact on humans, animals, and the environment forms an important basis for influencing and changing these processes and outcomes. Basic and clinical research provides the fundamental knowledge necessary to develop appropriate responses to antimicrobial resistance emerging and spreading in hospitals, communities, farms, and the food supply. Priority Goals and Action Items in this focus area address ways to: Increase understanding of microbial physiology, ecology, genetics, and mechanisms of resistance; Augment the existing research infrastructure to support a critical mass of researchers in AR and related fields; and Translate research findings into clinically useful products, such as novel approaches to detecting, preventing, and treating antimicrobial-resistant infections. Needs in the field of AR research will be identified and addressed through a government-wide program review with external input. Additional research is needed, for example, on the epidemiology of resistance genes; on mechanisms of AR emergence, acquisition, spread, and persistence; and on the effects of antibiotics used as agricultural growth promoters on microbes that live in animals, humans, plants, soil, and water. Further study is also required to determine whether variations in drug use regimens may stimulate or reduce AR emergence and spread. Improved understanding of the causes of AR emergence will lead to the development of tools for reducing microbial resistance, as well as for predicting where AR problems are likely to arise. A comprehensive research infrastructure will help ensure a critical mass of AR researchers who will interact, exchange information, and stimulate new discoveries. This aim will be achieved through the appropriate strategies and scientific conferences that promote research on AR. The AR Task

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Force agencies will work with the academic and industrial research communities to attract AR researchers, prioritize needs, identify key opportunities, and optimize the utilization of resources to address AR problems. The translation of research findings into innovative clinical products to treat, prevent, or diagnose drug-resistant infections is an area in which the federal government can play an important role, focusing on gaps not filled by the pharmaceutical industry or by other nongovernment groups. Special efforts will be placed on the identification, development, and testing of rapid, inexpensive, point-of-care diagnostic methods to facilitate appropriate use of antimicrobials. The AR Task Force agencies will also encourage basic research and clinical testing of diagnostic methods, novel treatment approaches, new vaccines, and other prevention approaches for resistant infections. Product Development As antimicrobial drugs lose their effectiveness, new products must be developed to prevent, rapidly diagnose, and treat infections. The Priority Goals and Action Items in this focus area address ways to: Ensure that researchers and drug manufacturers are informed of current and projected gaps in the arsenal of antimicrobial drugs, vaccines, and diagnostics and of potential markets for these products (designated here as “AR products”); Stimulate the development of priority AR products for which market incentives are inadequate, while fostering their appropriate use; and Optimize the development and use of veterinary drugs and related agricultural products that reduce the transfer of resistance to pathogens that can infect humans. Current and projected gaps in the arsenal of AR products and potential markets for these products will be reported to researchers and drug manufacturers through an interagency working group convened to identify and publicize priority public health needs. The development of urgently needed AR products will be stimulated throughout the process from drug discovery through licensing. The regulatory process for AR products will continue to be streamlined, and incentives that promote the production and appropriate use of priority AR products can be evaluated in pilot programs that monitor costs and assess the return on the public investment. The production of veterinary AR products that reduce the risk of development and transfer of resistance to drugs used in human clinical

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medicine will be expedited through a streamlined regulatory and approval process. As with drugs for the treatment of human infections, pilot programs can be initiated to evaluate incentives that encourage the development and appropriate use of priority products that meet critical animal and plant health needs. Private and public partners will also evaluate ways to improve or reduce the agricultural use of particular antimicrobial drugs, as well as ways to prevent infection, such as the use of veterinary vaccines, changes in animal husbandry, and the use of competitive exclusion products (i.e., treatments that affect the intestinal flora of food animals). TOP PRIORITY ACTION ITEMS TO COMBAT ANTIMICROBIAL RESISTANCE (All 13 items have top priority, regardless of their order in the list.) Surveillance With partners, design and implement a national AR surveillance plan that defines national, regional, state, and local surveillance activities and the roles of clinical, reference, public health, and veterinary laboratories. The plan should be consistent with local and national surveillance methodology and infrastructure that currently exist or are being developed. (Action Item #2) Develop and implement procedures for monitoring patterns of antimicrobial drug use in human medicine, agriculture, veterinary medicine, and consumer products. (Action Item #5) Prevention and Control Conduct a public health education campaign to promote appropriate antimicrobial use as a national health priority. (Action Item #25) In collaboration with many partners, develop and facilitate the implementation of educational and behavioral interventions that will assist clinicians in appropriate antimicrobial prescribing. (Action Item #26) Evaluate the effectiveness (including cost-effectiveness) of current and novel infection-control practices for health care and extended care settings and in the community. Promote adherence to practices proven to be effective. (Action Item #39) In consultation with stakeholders, refine and implement the proposed FDA framework for approving new antimicrobial drugs for use in

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food-animal production and, when appropriate, for re-evaluating currently approved veterinary antimicrobial drugs. (Action Item #58) Support demonstration projects to evaluate comprehensive strategies that use multiple interventions to promote appropriate drug use and reduce infection rates, in order to assess how interventions found effective in research studies can be applied routinely and most cost-effectively on a large scale. (Action Item #63) Research Provide the research community genomics and other powerful technologies to identify targets in critical areas for the development of new, rapid diagnostics methodologies, novel therapeutics, and interventions to prevent the emergence and spread of resistant pathogens. (Action Item #70) In consultation with academia and the private sector, identify and conduct human clinical studies addressing AR issues of public health significance that are unlikely to be studied in the private sector (e.g., novel therapies, new treatment regimens, and other products and practices). (Action Item #75) Identify, develop, test, and evaluate new rapid diagnostic methods for human and veterinary uses with partners, including academia and the private sector. Such methods should be accurate, affordable, and easily implemented in routine clinical settings (e.g., tests for resistance genes, point-of-care diagnostics for patients with respiratory infections and syndromes, and diagnostics for drug resistance in microbial pathogens, including in nonculture specimens). (Action Item #76) Encourage basic and clinical research in support of the development and appropriate use of vaccines in human and veterinary medicine in partnership with academia and the private sector. (Action Item #77) Product Development Create an Interagency AR Product Development Working Group to identify and publicize priority public health needs in human and animal medicine for new AR products (e.g., innovative drugs, targeted spectrum antibiotics, point-of-care diagnostics, vaccines and other biologics, anti-infective medical devices, and disinfectants). (Action Item #79) Identify ways (e.g., financial and/or other incentives or investments) to promote the development and/or appropriate use of priority AR products, such as novel compounds and approaches, for human and veterinary medicine for which market incentives are inadequate. (Action Item #80)