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Dr. Beth P. BellDirector, National Center for Emerging and Zoonotic Infectious Diseases
FY 16-17: Agency Priority Goal
Combating Antibiotic-Resistant Bacteria (CARB)
Priority Goal
Goal Overview
Antibiotics have been a critical public health tool since the discovery of penicillin in 1928, saving the lives of millions of people around the world. Today, however, the emergence of drug resistance in bacteria is reversing the miracles of the past eighty years, with drug choices for the treatment of many bacterial infections becoming increasingly limited, expensive, and, in some cases, nonexistent. The Centers for Disease Control and Prevention (CDC) estimates that drug-resistant bacteria cause two million illnesses and approximately 23,000 deaths each year in the United States alone. Thus, combatting antibiotic resistance has become a priority for both the White House, and the Department of Health Human Services (DHHS) Secretary. In response to President Barack Obama’s Executive Order: Combating Antibiotic-Resistant Bacteria (CARB), the National Strategy and the National Action Plan for CARB were developed to provide a roadmap to guide the Nation in rising to this challenge. One of the core strategies within the action plan is improving the use of antibiotics, also known as antibiotic stewardship. This Agency Priority Goal (APG) will help advance efforts related to antibiotic stewardship in hospitals, where complications of and risk factors for antibiotic resistance are most concentrated. The APG also aligns with the strategic goals listed in the 2014-2018 HHS Strategic Plan.
Current Problem/Challenges:
At least one-third of antibiotics used in inpatient settings are either unnecessary or inappropriately prescribed. Antibiotic stewardship interventions have been proven to improve individual patient outcomes, reduce the overall burden of antibiotic resistance, and save healthcare dollars. Implementation of antibiotic stewardship programs in hospitals will help ensure that hospitalized patients receive the right antibiotic, at the right dose, at the right time, and for the right duration. Improved antibiotic use leads to reduced mortality, reduced risk of Clostridium difficile-associated diarrhea, shorter hospital stays, reduced overall antibiotic resistance within the hospital, and increased cost savings. Despite all of these benefits, the uptake of antibiotic stewardship programs and interventions among U.S. hospitals is variable. Data from 2014 show that only about 40% of US acute care hospitals report having antibiotic stewardship programs that incorporate all of the CDC Core Elements for Hospital Antibiotic Stewardship Programs.
Strategies
HHS OPDivs and STAFFDivs are exploring a variety of strategies to accelerate the implementation of high-quality antibiotic stewardship programs in hospitals. These include:
- Working with existing quality improvement efforts (e.g., Quality Improvement Networks-Quality Improvement Organizations (QIN- QIOs)) to enhance stewardship programs
- Working with state health departments to support the implementation of stewardship programs
- Conducting research to build the evidence base that will support stewardship programs and interventions and to develop improved methods for conducting stewardship and for promoting the implementation of stewardship programs.
- Developing tools and recommendations and disseminating them to help with implementation of stewardship programs and interventions, and raising awareness about the importance of implementing stewardship programs as part of the National Strategy for CARB
- Increasing data for action by expanding enrollment in the National Healthcare Safety Network’s Antibiotic Use Option.
- Exploring regulatory/accreditation mechanisms to enhance compliance with antibiotic stewardship program recommendations.
- Developing diagnostic tools to allow clinicians to swiftly determine appropriate treatments for infected individuals and use antibiotics effectively.
- Identifying new treatment strategies to optimize and preserve the use of currently available antibiotic agents for healthcare-associated and drug-resistant pathogens.
Progress Update
Progress Update for Q4 of FY 2016
Facilitating Implementation of Programs to Improve Practices to Improve Antibiotic Use and Prevent HAIs and AR infections:
• In August 2016, CDC awarded all state health department grantees with additional FY 2016 resources to implement and enhance efforts to detect and respond to emerging pathogens such as CRE, and improve antibiotic stewardship activities outlined in the National Action Plan for CARB. This work will expand on existing prevention efforts to prevent healthcare- associated infections (e.g., CLABSI, CAUTI, and C. difficile). CDC is also supporting 28 state and local health departments to develop coordinated prevention activities for addressing AR, including antibiotic stewardship across the full spectrum on healthcare, including hospitals, nursing homes and outpatient facilities.
• CDC, CMS, AHRQ, and other partners continue to work together to prevent HAIs including C. difficile infections using CDC’s Targeted Assessment for Prevention (TAP) strategy, developing guidelines and tools, innovative research to better assess and understand transmission, and improving antibiotic use (AU).
• CDC continues to work with partners on quality improvement efforts on HAI prevention and improving AU through CMS’ QINs-QIOs and Hospital Innovation Improvement Networks (HIINs), state hospital associations and state health departments promoting AS implementation across the continuum of care.
• CDC is working with the Joint Commission to implement new accreditation standard requiring stewardship programs in hospitals. These new standards incorporate CDC’s Core Elements and will be effective in Jan. 1, 2017.
• CDC is working with Pew Charitable Trusts and other healthcare partners (e.g. Intermountain Healthcare) to help small hospitals implement stewardship programs that implement the CDC Core Elements.
• CDC continues to expand partnerships to improve antibiotic use:
o Engaged Anthem Healthcare and American Academy of Pediatrics on a project in Virginia to promote better antibiotic use.
o Working with the American Nurses Association to engage nurses in hospital settings on improving use.
o Working with leaders in sepsis to incorporate stewardship principals as part of sepsis recognition and treatment (e.g., CDC’s Vital Signs)
o Collaborating with Pew Charitable Trusts and the urgent care and retail clinic communities to identify opportunities to improve use in those settings.
o Providing HICPAC guidance to professional organizations that develop treatment guidelines for infectious diseases.
• Recent CDC publications have highlighted the problem in the U.S. as well as key opportunities to improve antibiotic use in ambulatory and hospital settings:
o CDC published a paper in the Journal of the American Medical Association (JAMA) Internal Medicine (Sept. 2016) that provided the 1st ever national estimates of hospital antibiotic use and the 1st ever assessment of that use over time. This manuscript showed that use of “last resort” antibiotics is rising quickly in the US.
o New data in the Journal of the American Dental Association (JADA) from CDC and the Organization for Safety, Asepsis, and Prevention (OSAP) show that primary care dentists (not including dental specialists or surgeons) write approximately 10% (equates to 26 million prescriptions) of all antibiotic prescriptions filled in outpatient pharmacies each year. CDC and OSAP developed best practices to guide dentists through the entire antibiotic prescribing process, including pretreatment, prescribing, and patient and staff education.
o CDC released a vital signs publication (Aug. 2016) about educating the public and clinicians about the burden of sepsis and how to prevent and incorporate antibiotic stewardship practices and principals as part of sepsis early recognition and treatment.
• CDC and IHS are working on a memorandum of understanding (MoU) to implement antibiotic stewardship activities in certain IHS hospitals and outpatient facilities. These activities align with CDC’s Core Elements for Antibiotic Stewardship Programs for both healthcare settings.
• CDC awarded Duke University Health System to improve antibiotic use through implementation and evaluation of CDC’s Core Elements of hospital antibiotic stewardship programs.
• CDC is supporting and collaborating with the VA and DoD to increase participation of their hospitals in NHSN module for AUR and improve antibiotic use.
• CDC is working with CMS to engage nursing homes in the prevention of C difficile infections that includes improvement of antibiotic use.
• IHS National Pharmacy Council Developed Antibiotic Stewardship Guidelines and posted them on the IHS website as a starting point for facilities to develop their own local guidelines.
• IHS developed and disseminated a survey to assist in identifying barriers to local antibiogram integration to all IHS sites.
• IHS is exploring appropriate antibiotic stewardship reporting capabilities in the electronic health record.
• AHRQ’s HAI Program of research and implementation is continuing to combat antibiotic-resistant bacteria through action in all 3 AR domains:
o Promoting antibiotic stewardship;
o Reducing transmission of resistant infections;
o Preventing HAIs in the first place
• AHRQ’s HAI Prevention efforts: A strong force for antibiotic stewardship and preventing resistant infections—Every HAI prevented is one less episode of antibiotic use, and thus one less opportunity for development of resistance, as well as one less exposure to a potentially resistance infection. Recent progress in AHRQ’s HAI prevention projects includes:
o CUSP for CAUTI in Long-Term Care – the project was concluded in September – Preliminary results show:
Significant decrease in CAUTI rate
Significant decrease in urine culture orders – part of antibiotic stewardship focus – fewer unnecessary cultures means fewer unnecessary antibiotics
o CUSP to reduce CLABSI and CAUTI in ICUs with persistently elevated rates. More than 300 ICUs have been recruited from 4 HHS regions, with current implementation of Cohort 1 of 2 (187 units). This project, initiated in September 2015, is a follow-up to AHRQ’s previous nationwide projects of CUSP for CAUTI and CUSP for CLABSI. The project is a prime example of a collaborative effort by AHRQ, CDC, and CMS to prevent HAIs, which makes a major contribution to AS by avoiding the need to use antibiotics in the first place. Implementation strategies tailored to this group of ICUs are being developed, including a modified set of CUSP training resources. Activities during Q4 have included provision of technical assistance to ICUs to address CLABSI and CAUTI.
• AHRQ awarded the CUSP for Antibiotic Stewardship project to John Hopkins University. This nationwide project will adapt AHRQ’s highly successful CUSP approach to improve AU and promote AS in various settings: hospitals, long-term care, and ambulatory care. The 5-year project will promote and support implementation of AS in 250 acute care hospitals, 250 long-term care facilities, and 250 ambulatory care facilities across the country. Project interventions will be consistent with CDC’s Core Elements for AS in applicable settings and will be coordinated with CMS activities. As part of the project, a toolkit will be produced to promote implementation of AS in all of the settings beyond the life of the project and will be made publicly available at the end of the project.
• AHRQ completed the development and field testing of the Implementation Guide for Antibiotic Stewardship in Nursing Homes. The Guide aligns with CDC’s Core Elements for Nursing Homes. Wide dissemination of the Guide will begin in October 2016, and the Guide will also be presented at ID Week. The Guide comprises four sets of toolkits:
o Create an Antibiotic Stewardship Program
o Determine whether to treat with antibiotics
o Choose the right antibiotic
o Engage residents and families
• CMS’ new Conditions of Participation (CoPs) for Medicare and Medicaid-participating hospitals, including critical access hospitals, were proposed. These CoPs also require institution of infection control and antibiotic stewardship programs that comply with CDC’s Seven Core Elements for antibiotic stewardship in hospitals. These CoPs remain in the review and development stage. These CoPs also require facilities to establish designated and qualified leaders in these facilities to guide and oversee this effort.
• CMS’ Quality Improvement Networks-Quality Improvement Organizations (QIN-QIOs) recruited over 1,300 hospitals nationally to work on Clostridium difficile reduction and work in close collaboration with community partners and their states’ HAI Advisory groups to develop and implement antibiotic stewardship programs and best practice toolkits for hospitals within their states.
• CMS’ HEN 2.0 period of performance ended September 23, 2016. A total of 2,816 hospitals were reporting under the Partnership for Patients (PfP) on Clostridium difficile and 245 on Antibiotic Stewardship efforts. CMS anticipates that this number will continue to increase during this period of performance given the intention to focus on this work in the next iteration of the PfPs under the Hospital Improvement Innovation Network (HIIN) contractors.
• On September 29, 2016, CMS awarded $347 million to 16 Hospital Innovation Improvement Networks (HIINs) representing national, regional, or state hospital associations, Quality Improvement Organizations, and health system organizations to continue efforts in reducing hospital-acquired conditions and readmissions in the Medicare program. Target is to recruit 4,000 hospitals nationally for this work.
• CMS’ HIINs quality improvement contractors will work in hospitals while QIN-QIOs will focus their efforts in the long-term care and ambulatory care setting thus eliminating the potential for duplication of quality improvement work among CMS contractors.
• CMS is working on a detailed plan to transition hospital work from QINs to HIINs which includes:
o Development of 90-day checklist: for CMS contracting officers to promote a seamless transition, including contractually-obligated continuation of antibiotic stewardship and infection control prevention work in hospitals that chose to continue HAI and AS work with HIINs in this setting. Monitoring of transition throughout the contract cycle via required QIN-QIO and HIIN monthly deliverables.
o Effective communication: Between CMS and federal partners to promote continuity of collaborative programs such as the Targeted Assessment for Prevention program with the CDC; Communication between QIN and HIIN CMS contracting officers to ensure deliverables related to communication and collaboration are being met; and communication between 11th SOW QINs and HIINs to maintain state and local partnerships and share lessons learned.
o Modeling: Consideration to modeling of successful QIN-QIO and HIIN transitions and those contractors maintaining successful federal, state and local partnerships at meetings such as the 2016 CMS Quality Conference: Aligning for Innovation and Outcomes.
• As part of the National Nursing Home Quality Care Collaborative (NNHQCC) in CMS current 11th Statement of Work, QIN-QIOs have been recruiting long-term care facilities in which to provide directed technical assistance to implement antibiotic stewardship programs and reduce Clostridium difficile in this setting. As of Sept. 29, 2016, the target goal of recruiting 2,300 nursing homes nationally has been exceeded as of September 5th with 2,800 nursing homes recruited thus far.
• The Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (PACCARB) held a public meeting on September 19, 2016, dedicated to the topics of antibiotic-resistance prevention and antibiotic stewardship.
• HHS-OASH- Established new PACCARB working groups on Incentives for Vaccines, Diagnostics, and Therapeutics are currently in the process of holding recurrent monthly meetings to respond to the Secretary’s task, which includes a component on stewardship.
• The PACCARB announced the establishment of a future Prevention and Stewardship working group, which is set to be stood up in late 2016, early 2017.
• HHS led the USG position on antibiotic resistance and the need for national and international action is currently under development. In addition, the U.S. delegation hosted a side event related to AR prevention and stewardship on Sept. 21, 2016. The U.S. side event included Secretary Burwell and the Ministers of Health from Cuba and Thailand.
Education for Patients and Providers:
• CMS is heading an educational pilot program, now in Phase II, to develop antibiotic stewardship worksheets for surveyors based on the proposed CoPs for hospitals and long-term care facilities.
• CDC awarded a contract to revamp the Get Smart About Antibiotics Campaign to further promote awareness of AS across the continuum of care.
• CDC released a patient fact sheet about antibiotics aimed primarily at hospitalized patients. This fact sheet will help better inform patients and will help hospitals meet educational requirements on antibiotics.
• CDC launched the Sepsis Awareness Campaign and integrate stewardship efforts to prevent infections which can lead to sepsis. The Sept. 2016 campaign emphasized that preventing infections and the spread of resistant organisms is an important part of preventing sepsis and also that AS is an important part of making sure that patients with sepsis get prompt and effective antibiotic treatment.
• IHS created an Antibiotic Stewardship list- serve to allow for easy dissemination of information and collaboration across IHS facilities.
• IHS is performing multiple education sessions on Appropriate Antibiotic use. The audience is IHS providers, pharmacists, and nurses. Education will be ongoing as ASP implementation and guidelines are moving targets.
Innovation and Research:
• CDC is taking new approaches to improve prescribing for adults, including a project with the University of Utah that will scale up and test interventions to improve outpatient prescribing.
• CDC continues to support innovation (Epicenters, Emerging Infections Program) to prevent HAI, AR and improve antibiotic use.
• CDC is accelerating innovations to combat antibiotic resistance, including research on how microorganisms naturally present in the human body (referred to as a person’s microbiome) can be used to predict and prevent infections caused by drug-resistant organisms. CDC awarded over $23.5 million to over 35 organizations (e.g., private, industry, health systems, and academic) across the U.S. through CDC’s Broad Agency Announcement (BAA) and Safe Healthcare, Epidemiology, and Prevention Research Development (SHEPheRD) Program to support activities in CDC’s Antibiotic Resistance Solutions Initiative. These awards will fund research on and implementation of innovative approaches to prevent infections, stop spread of drug-resistant organisms, and improve antibiotic use, such as:
o How antibiotics disrupt a healthy microbiome
o How a disrupted microbiome puts people at risk
o How to improve antibiotic use through implementation and evaluation of core elements of antibiotic stewardship across healthcare settings
• AHRQ completed the funding of new FY 2016 HAI grants – 18 studies are currently funded under existing HAI Prevention Funding Opportunity Announcements (FOAs) to combat AR and promote antibiotic stewardship in all CARB domains and in all healthcare settings.
• AHRQ published two new CARB-specific FOAs for R01 and R18 research studies, which will help stimulate research grant applications in all CARB domains. These two new CARB FOAs are in addition to AHRQ’s long-standing HAI Prevention FOAs, which have been renewed.
• NIH is supporting research on the potential of host biomarker signatures to distinguish viral and bacterial respiratory infections, which could revolutionize the diagnosis and treatment of potential infections. For example, the NIH-supported Antibacterial Resistance Leadership Group (ARLG) is building on NIH-funded discoveries and strategies in this area. Through the RADICAL study, ARLG investigators are collecting clinical samples for assay validation and identifying potential diagnostics platforms that could be used to translate the assay into a clinical diagnostic tool. The study is now focusing on participants <18 years of age in an effort to validate the host signature response in this population. By the end of FY16 Q4, a total of 703 participants were enrolled in the study.
• NIH is supporting a study to assess a diagnostic tool that could inform appropriate treatment and guide use of Ciprofloxacin to treat uncomplicated urogenital gonococcal infection. The study is being conducted through the NIH-funded Sexually Transmitted Infections Clinical Trials Group. In FY16 Q4, one study site began screening subjects for enrollment.
• NIH is supporting a clinical trial (TRAP-LRTI) to demonstrate the clinical utility of using the procalcitonin bioassay to identify a sub-set of patients with lower respiratory tract infections who are unlikely to benefit from antibiotics. In FY16 Q4, the ARLG, bioMerieux, and NIH-funded Vaccine and Treatment Evaluation Units initiated protocol development for this study and sites have been selected.
• NIH, in collaboration with ASPR/BARDA (HHS) announced the Antimicrobial Resistance Diagnostic Challenge. The competition seeks diagnostic tests that identify and characterize antibiotic resistant bacteria and that distinguish between viral and bacterial infections to reduce unnecessary uses of antibiotics. Submissions are due in January 2017.
• NIH is conducting research to identify new treatment strategies to optimize and preserve antibiotics. The NIH-supported ARLG has completed enrollment of a Phase 1 trial, known as the PROOF study, to generate safety and pharmacokinetic data to inform future research on the expanded use of Monurol (oral fosfomycin) for outpatient treatment of complicated UTI (cUTI). The data generated by these studies will provide information on optimal dosing of Monurol for cUTIs, where rising fluoquinolone resistance rates are limiting oral treatment options.
Next Steps
Q1 of FY 2017
Facilitating Implementation of Programs to Improve Practices:
• CDC will publish its Core Elements for stewardship programs in outpatient settings (Nov. 2016). The release of CDC’s Core Elements for Outpatient Settings is one step in achieving the objectives set out in the National Action Plan for CARB and improve AS across all settings are part of CDC’s AR Solutions Initiative.
• Release CDC’s Assessment tool to help hospitals look for opportunities to improve use (Nov. 2016).
• AHRQ will begin implementation in Cohort 2 of the CUSP project to reduce CLABSI and CAUTI in ICUs with persistently elevated rates.
• IHS’ Antibiotic Stewardship Program Workgroup will identify and report best practices for data collection with current data reporting capabilities and identify any gaps in current reporting capabilities.
• IHS will evaluate the data from the antibiogram survey to determine the major barriers to integration and determine the best way to overcome those barriers.
• CMS will release the final Conditions of Participation in long-term care facilities (Oct. 4, 2016), which require infection prevention and control programs to have an antibiotic stewardship program. These antibiotic stewardship programs should conform to antibiotic use protocol and create a system to monitor antibiotic use in alignment with the CDC Core Elements for antibiotic stewardship in this setting.
• After a technical expertise panel (TEP) sponsored by Survey and Certification is conducted, CMS will complete antibiotic stewardship worksheets.
• CMS will release the final rule for the Medicare Access and CHIP Reauthorization Act (MACRA) which repeals the Sustainable Growth Rate, replacing it with the Quality Payment Program which rewards high-quality, cost-efficient patient care through two avenues: 1) the Merit-Based Incentive System (MIPs) or Advanced Alternative Payment Models (APMs) for eligible clinicians or 2) provider groups that fall under the Physician Fee Schedule. Among the high priority measures which providers and/or provider groups can choose to report beginning January 1, 2017 and affecting payment incentives in January 2019, will include those addressing the misuse or overuse of antibiotics in certain clinical conditions such as:
– Acute otitis externa: Systematic Antimicrobial Therapy-Avoidance of Inappropriate Use
– Overuse of antibiotics prescribed for Acute Sinusitis
– Acute Sinusitis: Appropriate Choice of Antibiotics (percentage of patients over 18 prescribed amoxicillin with or without clavulanate as first-line therapy for acute bacterial sinusitis)
– Avoidance of treatment of adults with antibiotics for acute bronchitis (overuse measure)
• CMS’ QIN-QIOs will begin recruiting community facilities to provide direct technical assistance to develop and implement AS programs in the outpatient setting to include but not limited to:
– Primary Care and Specialty Clinics
– Emergency Departments
– Retail and pharmacy-based Clinics
Education for Patients and Providers:
• Expanding CDC’s Annual education/outreach campaign- Get Smart About Antibiotics Week. CDC will launch the 9th annual Get Smart About Antibiotics Week November 14-20, 2016 in collaboration with the World Health Organization, the European Centre for Disease Prevention and Control, and numerous other international and domestic partners to increase general public and provider awareness of AR and the importance of appropriate antibiotic use.
• CDC will develop a public education campaign on antibiotic use.
• AHRQ will begin wide dissemination of the Guide for Antibiotic Stewardship in Nursing Homes
• IHS has developed multiple ASP education sessions and will begin presenting them as a series of webinars across the IHS.
Innovation and Research:
• CDC will complete a study of antibiotic selection and duration for the treatment of community acquired pneumonia, a leading cause of antibiotic prescriptions, using a large proprietary database.
• NIH: Sites will be selected and protocol development will begin for an NIH-supported study of oral step-down therapy for complicated UTI (FOCUS). The study builds on the fully enrolled oral fosfomycin trial (PROOF).
• NIH: Protocol development will continue for an NIH-supported study to demonstrate the clinical utility of using the procalcitonin bioassay to identify a sub-set of patients with lower respiratory tract infections who are unlikely to benefit from antibiotics (TRAP-LRTI).
• NIH: The NIH-funded Vaccine and Treatment Evaluation Units will begin enrollment of a Phase IV trial to compare a short course of therapy (5 days) to standard of care (10 days) in children with community acquired pneumonia (SCOUT-CAP). The study utilizes an innovative trial design, as described in a 2015 paper from ARLG investigators, to assess the optimal use of new antibiotic treatment strategies. (Desirability of outcome ranking (DOOR) and response adjusted for duration of antibiotic risk (RADAR). Evans SR, et al; Clin Infect Dis. Jun 2015).
Q2 of FY 2017
Facilitating Implementation of Programs to Improve Practices:
• CDC will launch a prevalence survey in approximately 150 nursing homes to help identify opportunities to prevent HAIs and improve AU in nursing homes.
• AHRQ will convene the first meeting of the Technical Expert Panel for the CUSP for AS nationwide project.
• AHRQ will begin implementation of CUSP for AS in integrated delivery systems (first cohort).
• PACCARB will establish a future Prevention and Stewardship working group
• The next PACCARB public meetings are due to be held on January 25-26, 2017.
• CMS plans to finalize the proposed rule requiring hospitals and critical access hospitals support an antibiotic stewardship program as an effective means to improve hospital antibiotic-prescribing practices and curb patient risk for infections and adverse events.
Innovation and Research:
• AHRQ will receive the first wave of grant applications submitted in response to the new CARB FOAs.
Expand All
Performance Indicators
Increasing the percent of hospitals that report implementation of antibiotic stewardship programs that comply with all of the CDC Core Elements for Hospital Antibiotic Stewardship Programs by 50%
Contributing Programs & Other Factors
Goal lead: Centers for Disease Control and Prevention
CDC has long played a lead role in efforts to prevent healthcare associated infections and antibiotic resistance. This work has expanded since Congress recognized the large and growing threat of antibiotic resistance (AR) and appropriated $160 million to CDC to work with federal, state and other partners to implement the National Action Plan for Combating Antibiotic-Resistant Bacteria (CARB) activities: To detect and respond to resistant pathogens; prevent the spread of resistant infections; and collaborate with partners to encourage innovation for new prevention strategies. These resources are transforming how our nation tackles and slows antibiotic resistance comprehensively, efficiently, and systematically.
CDC’s CARB activities focuses in 4 major areas:
CDC has long played a lead role in efforts to prevent healthcare associated infections and antibiotic resistance. This work has expanded since Congress recognized the large and growing threat of antibiotic resistance (AR) and appropriated $160 million to CDC to work with federal, state and other partners to implement the National Action Plan for Combating Antibiotic-Resistant Bacteria (CARB) activities: To detect and respond to resistant pathogens; prevent the spread of resistant infections; and collaborate with partners to encourage innovation for new prevention strategies. These resources are transforming how our nation tackles and slows antibiotic resistance comprehensively, efficiently, and systematically.
CDC’s CARB activities focuses in 4 major areas:
Prevent healthcare associated infections- many infections that arise as a result of healthcare are caused by antibiotic resistant organisms. Hence preventing these infections (like central line associated blood stream infections, catheter associated urinary tract infections and surgical site infections) will help prevent the development of antibiotic resistance.
Prevent the transmission of antibiotic resistant organisms- many of these pathogens (like Clostridium difficile, methicillin-resistant Staphylococcus aureus [MRSA], and Carbapenem-resistant Enterobacteriaceae [CRE]) can be spread easily from one patient to another. Preventing this transmission will reduce antibiotic resistance.
Improve antibiotic use- unnecessary antibiotic use is an important driving factor of antibiotic resistance. By improving antibiotic use through antibiotic stewardship we can lower rates of resistance while improving patient outcomes.
Detect and respond to resistant threats- CDC operates the National Healthcare Safety Network (NHSN), a monitoring system used by more than 17,000 healthcare facilities. NHSN provides “data for action” to healthcare facilities, systems as well as state and federal partners on healthcare associated infections and antibiotic resistance. NHSN is the system to measure national and local progress and identify prevention gaps for HAIs and AR. Through the new Antibiotic Use option of NHSN, hospitals can also electronically monitor and compare antibiotic use to look for opportunities for improvement. The Antibiotic Use option allows hospitals to calculate the only National Quality Forum endorsed standardized measure of antibiotic use, the Standardized Antimicrobial Administration Ratio or SAAR. The SAAR measure was developed by CDC and endorsed by NQF in 2016 as an important benchmarking tool to help hospitals improve antibiotic use. CDC is also providing support to public health laboratories to expand their capacity to detect important antibiotic resistance.
CDC will invest the largest extramural portion of its CARB funding in the 50 state health departments, the six largest local health departments, and Puerto Rico. This Antibiotic Resistance Solutions Initiative supports comprehensive and coordinated public health action to minimize the spread of antibiotic resistance across states, counties, and cities.
CDC recognizes that partnerships are critical to the success of the CARB effort. This Agency Priority Goal builds on the past APG success of the collaboration between CDC, AHRQ, CMS and ODPHP in preventing central-line associated bloodstream infections (CLABSI) and catheter associated urinary tract infections (CAUTI). For this APG, federal partners have expanded to included NIH and IHS. In addition, CDC is partnering with many other types of organizations to implement CARB, for example: VA, large, non-government healthcare systems, professional organizations (e.g. American Nurses Association, American Hospital Association), academic institutions, accreditation organizations and consumer groups. These partnerships will be essential not only for implementing currently known best practices, but also for exploring innovative ways to combat resistance.
Improving antibiotic use, the focus of this CARB APG, has been a focus for CDC since the early 2000s with the launch of the “Get Smart: Know When Antibiotics Work” campaign. While, this APG is focused on antibiotic stewardship programs in hospitals, CDC’s efforts to improve antibiotic use span the full spectrum of healthcare. The development and release of the “Core Elements for Antibiotic Stewardship Programs” series of best practice documents is helping drive national progress in improving antibiotic use. CDC has also launched a key strategic partnership with the Pew Charitable Trusts to improve antibiotic use.
Contributing Agencies
Agency for Healthcare Research and Quality (AHRQ)
AHRQ is making significant contributions to the national effort on CARB. AHRQ’s Healthcare-Associated Infections (HAI) Program is working with various federal partners to slow the emergence of antibiotic resistance and combat the spread of resistant infections. The HAI Program is supporting a broad portfolio of research and implementation projects on antibiotic stewardship and the prevention of HAIs. In support of the CARB National Action Plan, AHRQ has more than doubled its funding for research to develop improved methods for combating antibiotic-resistant infections and for conducting and promoting the implementation of antibiotic stewardship activities. Although the current APG is focused on hospitals, this body of research is helping to build the evidence base for fighting antibiotic resistance and carrying out stewardship programs across the healthcare system – in hospitals, ambulatory, and long-term care settings. Examples of antibiotic-focused projects include several studies aimed at using health information technology to personalize antibiotic stewardship for the hospital patient with healthcare-associated pneumonia and with community-acquired pneumonia and other infections; promoting appropriate antibiotic use in dialysis units; developing and disseminating effective methods of antibiotic stewardship in nursing homes; and promoting appropriate antibiotic use for urinary tract infections in nursing homes. AHRQ plans to translate the results of this research into antibiotic-resistance prevention tools that help clinicians and healthcare providers implement the findings widely. In keeping with this role, AHRQ has created an implementation guide for antibiotic stewardship in nursing homes, which is based on the results of four previous AHRQ-supported studies in long-term care. Field testing of this guide has been completed. Data from the testing are being reviewed, and the guide is expected to be available for wide dissemination in late CY 2016. Previous AHRQ-supported research has produced a hospital toolkit for reducing Clostridium difficile infections (CDI) through antibiotic stewardship, which is being made available on the AHRQ website. In addition to this work that directly targets stewardship and resistant infections, other HAI prevention projects in AHRQ’s overall HAI Program are also making a significant contribution to the CARB effort. Every HAI prevented is one less episode of antibiotic use, and thus one less opportunity for development of resistance, as well as one less exposure to a potentially resistant infection. AHRQ will adapt the effective implementation methods it has used in successful HAI prevention projects to accelerate the adoption of stewardship programs in hospitals.
Center for Medicare and Medicaid Services (CMS)
CMS has worked through large-scale quality improvement programs to improve patient safety and quality of care through direct education and outreach to participating hospitals in every state, D.C., Puerto Rico and the Virgin Islands. Over the past several years, with these programs and programs that link performance to payment such as Hospital Value Based Purchasing, CMS has worked to reduce and prevent HAIs occurring in our health systems. CMS has, like its partners, spread evidence-based strategies and interventions for infection prevention, in non-ICU and ICU settings. CMS will embark on strengthening programs that actively concentrate on the more judicious and appropriate use of antibiotics. CMS also supports through programmatic contributions and proposed regulatory authority, implementing antibiotic stewardship programs in healthcare settings as part of a comprehensive plan of combating antibiotic-resistant bacteria and as aligned with the priorities of the CARB National Plan.
CMS’ contractors work with hospitals that have an antibiotic stewardship (AS) program to ensure their programs contain the “Core Elements of Antimicrobial Stewardship” as released by the CDC in 2014.
Those hospitals that do not have an antibiotic stewardship program in place will work through direct assistance with QIN-QIOs to establish one appropriate for their operations and regional environment. As CMS already has programs in place working to reduce and prevent facility-wide CDI, CMS will be utilizing the CDC-led NHSN AS system survey already in place to report hospital-wide existence of AS programs and to get an idea of their level of maturation and efficacy. CMS quality improvement contractors will provide support to hospitals across the nation on this topic as well as other forms of preventable harm. Through the implementation of best practices and facilitation of rapid-cycle quality improvement efforts, CMS quality improvement programs strive to facilitate high quality, evidence-based care across the care continuum. Fostering engagement of subject matter experts (such as the CDC) along with the inclusion of patients and families in understanding the need for the judicious management of antibiotic use will further support these efforts. Although the current APG will focus on hospitals, CMS will play a role in monitoring proper infection prevention and control protocol across the healthcare system.
Indian Health Service (IHS)
The Indian Health Service is responsible for providing federal health services to American Indians and Alaska Natives. The provision of health services to members of federally recognized tribes grew out of the special government-to-government relationship between the federal government and Indian tribes. IHS is the principle federal health care provider and health advocate for the Indian people, with the goal of raising Indian health status to the highest possible level. IHS provides a comprehensive health service delivery system for approximately 2.2 million American Indians and Alaska Natives who belong to 567 federally recognized tribes in 35 states. IHS is comprised of 45 hospitals and 634 health centers, school health centers, health stations and Alaska village clinics.
IHS is making significant contributions to the national effort on CARB. In 2014, the IHS formed a workgroup with the goal of helping all IHS hospitals and ambulatory clinics develop and implement an Antimicrobial Stewardship Program (ASP). Initial efforts focused on educating the clinical workforce on antibiotic stewardship through national clinical rounds, creating and implementing an ASP email Listserv, creating IHS ASP Clinical Guidelines, developing an ASP tracking tool and ASP framework for the purpose of providing a written framework to help guide sites in the development and implementation of ASP from the ground up.
National Institutes of Health (NIH)
The antibiotic resistance research and product development supported by NIH has the potential to play a significant role in the success of AS programs, especially in light of the long-term race to “outsmart” bacteria as they evolve and develop resistance to antibiotic drugs. Relevant NIH activities include ongoing efforts to develop diagnostics that will allow clinicians to swiftly determine appropriate treatments for infected individuals. Such diagnostic tools will facilitate AS by reducing the use of broad-spectrum agents. For example, in April 2015, NIH awarded more than $11 million in first-year funding for nine research projects supporting enhanced diagnostics to rapidly detect antibiotic resistant bacteria. The awardee institutions will develop tools to identify certain pathogens that frequently cause infections in healthcare settings and, specifically, those that are resistant to most antibiotics. In addition, NIH supports research grants and contracts to identify new treatment strategies to optimize and preserve the use of currently available antibiotic agents for healthcare-associated and drug-resistant pathogens. Optimizing dosing levels, duration, route of administration, and use of combination drug therapy according to current pharmacokinetic and pharmacodynamic principles can suppress the emergence of resistance.
Office of the Assistant Secretary for Health (OASH)
As part of a strategic, coordinated, and sustained effort to combat antibiotic-resistant infections, the Secretary for Health and Human Services (Secretary), in consultation with the Secretaries of Defense and Agriculture, established the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (PACCARB), per Executive Order 13676 (EO). Administratively supported by the Office of the Assistant Secretary for Health (OASH), National Vaccine Program Office (NVPO), the PACCARB will provide advice, information, and recommendations to the Secretary regarding programs and policies intended to support and evaluate the implementation of the EO, including the National Strategy for CARB (Strategy) and the National Action Plan for CARB (Action Plan).
Additionally, within OASH, the Office of Disease Prevention and Health Promotion (ODPHP) is leading national efforts to improve patient safety and health care quality. ODPHP led the development of the National Action Plan to Prevent HealthCare- Associated Infections: Road Map to Elimination (HAI Action Plan) which underscores the burden of infections caused by organisms that are becoming increasingly resistant to widely used antibiotics. In an effort to align with and support the HAI Action Plan and this APG, ODPHP has initiated research to identify, understand, and help reduce racial, ethnic, and other disparities in preventable adverse healthcare-associated outcomes, including HAIs. As progress towards this APG is made, it will be critical to ensure that the benefits from HAI prevention are realized across different patient demographic groups and that any vulnerable populations are identified and targeted for interventions. This will allow antibiotic stewardship programs to target high risk populations. An environmental scan of the literature has been conducted to identify racial, ethnic, and other disparities in preventable adverse healthcare-associated outcomes. In addition, preliminary studies have investigated systemic factors that may influence the incidence of HAIs and ADEs in hospital settings.
Findings from the literature review will be used to conduct analysis of data obtained from federal and non-federal partners and to identify promising intervention strategies for reducing disparities in preventable adverse health care-associated outcomes.
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