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Actions & Recommendations

In October, 2015, TATFAR revised its work plan and identified 20 actions for continued collaboration through 2020.

Phase 3 actions for 2016 through 2020 are currently being implemented. This page is updated regularly to reflect progress.

Acronyms

AMR – antimicrobial resistance

ASPR – Office of the Assistant Secretary for Preparedness and Response

BARDA – Biomedical Advanced Research and Development Authority

CDC – Centers for Disease Control and Prevention

CFIA –Canadian Food Inspection Agency

CIHR – Canadian Institutes of Health Research

CLSI – Clinical & Laboratory Standards Institute

COMBACTE – Combatting Bacterial Resistance in Europe

DG RTD – Directorate-General for Research and Innovation

DG SANTE – Directorate-General for Health and Consumers

DHHS – Department of Health and Human Services

DoD – Department of Defense

EC – European Commission

ECDC – European Centre for Disease Prevention and Control

EFSA – European Food Safety Authority

EMA – European Medicines Agency

FDA – Food and Drug Administration

FHI – Norwegian Institute of Public Health (also called NIPH)

GLASS – Global Antimicrobial Resistance Surveillance System

HC – Health Canada

MDR – multi-drug resistant

NIAID – National Institute of Allergy and Infectious Diseases

NIH – National Institutes of Health

NMA –Norwegian Medicines Agency

NVI – Norwegian Veterinary Institute

OGA – Office of Global Affairs

PHAC – Public Health Agency of Canada

USDA – United States Department of Agriculture

Key Area I. Appropriate therapeutic use in human and veterinary medicine

Key Area I. Appropriate therapeutic use in human and veterinary medicine
Action Number Description Implementer Organizations
1.1 Develop guidance for assessing appropriate antibiotic use
  • Compiled a draft summary of appropriate outpatient antibiotic use in the U.S. and other TATFAR countries. This summary was shared with the working group and feedback was incorporated into the document.
  • The document was also discussed at the TATFAR meeting in Atlanta in March 2018, where feedback was incorporated from session participants and shared among members.
CDC, DoD, ECDC, FHI, PHAC
1.2 Publish a review of antibiotic reduction goals in human medicine from TATFAR partner countries
  • Distributed survey to EU member states in May 2017.
  • Drafted a manuscript summarizing survey results and finalized content for publication in a peer-reviewed journal.
CDC, ECDC, FHI, PHAC
1.3 Continue the coordination of campaigns to promote appropriate antibiotic use in human medicine
  • Work is ongoing with good collaboration among TATFAR partners, WHO, and other non-TATFAR countries.
  • Participated in the World Antibiotic Awareness Week in November 2016 and 2017, which included a global Twitter chat with partners and country-specific activities around prudent use of antibiotics and antibiotic resistance.
CDC, ECDC, FHI, PHAC
1.4 Cooperate in the development of methodology for measuring and reporting the consumption of antimicrobials per species in veterinary medicine
  • Led by EMA, 3 to 4 teleconferences are scheduled each year.
  • Agreed to focus on providing a forum for increased communication and information exchange between taskforce members on priority topics in order to enhance member contribution to these international activities.
  • Sent representative from all TATFAR member countries to the annual ESVAC Network meeting. Representatives presented on and discussed development of surveillance methodology.
  • Published draft guidance on methodology of data collection by species for consultation. This was the main topic of discussion during the workshop “Data collection on consumption of veterinary antimicrobials in Europe: achievements, challenges and way forward,” organized by the European Commission with EMA in April 2017. The workshop was attended by representatives of member states, veterinarians and farmers associations, industry, and other stakeholders.
CFIA, DG SANTE, EFSA, EMA, FDA, NVI, USDA
1.5 Collaborate on implementation of the Guidelines for Risk Analysis of Foodborne Antimicrobial Resistance prepared by Codex Alimentarius
  • Committed to engaging in discussions on the guidelines and recommendations for risk assessment for the authorization of antimicrobial drugs for use in veterinary medicine.
  • Continued previous discussions around implementation of CAC/GL 77-2011, and the development of a risk profile based on the Codex model that has applications to other drug products or purposes.
  • Discussed the development of an information inventory for use in future risk analysis, particularly in areas where country-nonspecific information is available.
CFIA, DG SANTE, EFSA, EMA, FDA, ECDC, NVI, PHAC
1.6 Enhance information sharing on approaches to promoting appropriate use in veterinary communities
  • USDA’s Animal and Plant Health Inspection Service worked with states to provide updates to the “Use of Antibiotics in Animals” module of the National Veterinary Accreditation Program to educate veterinarians in private practice about rules and regulations. Another module, Module 29 addresses requirements for issuing a veterinary feed directive and has the capability of issuing a Certificate of Completion for other stakeholders.
  • Continued education and outreach efforts related to implementation of FDA Guidance for Industry #213 and the Veterinary Feed Directive Rule.
  • Consulted with the American Veterinary Medical Association’s Committee on Antimicrobials. FDA’s Center for Veterinary Medicine, USDA’s Animal and Plant Health Inspection Service, and CDC helped to develop a definition and core principles of antimicrobial stewardship in veterinary settings.
  • EMA and EFSA published a joint scientific opinion (RONAFA [PDF – 245 pages]) on measures taken in the EU to reduce the need for and use of antimicrobials in food-producing animals and impacts on antimicrobial resistance.
  • Completed fact-finding missions by DG SANTE to 13 EU Member States and Norway.
  • Published mission reports summarizing findings and best practices.
  • Organized training activities within the framework of the DG SANTE “Better Training for Safer Food” (BTSF) in the context of “One Health”. Three workshops were organized in 2017 with around 100 participants from 27 Member States and Norway.
CDC, CFIA, DG SANTE, EFSA, EMA, FDA, NVI, PHAC, USDA
1.7 Cooperate in the areas of research and surveillance aiming to improve understanding of foodborne transmission of bacteria resistant to certain classes of antimicrobials
  • Continue to emphasize full implementation of whole genome sequencing (WGS) and online interactive data tools through the U.S. National Antimicrobial Resistance Monitoring System (NARMS) program to enhance surveillance of antibiotic resistance in foodborne bacteria and improve the communication of findings to EU and other partners.
  • Published an integrated report in November 2016 with WGS data for the first time, including a display of all the resistance genes detected. This work led to numerous new insights into the origins and spread of resistant foodborne pathogens in the U.S., for example emergence of blaCTX-M-65, spread of qnr genes,
  • increasing resistance in Salmonella Dublin, and more.
  • Published a study by NARMS scientists to enhance surveillance methodology. The study focused on the use of antimicrobial resistance genes as a way to help refine interpretive criteria for MIC values. Other studies include the prevalence of MRSA in retail meats, and finding a very low prevalence of mcr-1 in swine.
  • CDC is working with CLSI to assess if there are clinical failures among patients who are taking fluoroquinolones for Shigella infections and also have Shigella isolates (bacteria isolated from a specimen, like stool) with minimum inhibitory concentration (MIC) values of 0.12–1 μg/mL for ciprofloxacin (a fluoroquinolone antibiotic). Early available data suggests that Shigella isolates with ciprofloxacin MICs in this range have at least one quinolone resistance gene known to cause enteric (gut) bacteria to be less susceptible to antibiotics. CDC is also combining enhanced epidemiologic and outcome data collected in FoodNet sites, in combination with NARMS whole genome sequencing (predicted antimicrobial resistance data), to better understand antibiotic resistance in human enteric disease.
  • Update the ongoing enhancements to NARMSNow data visual displays via the website. NARMS was reviewed by an external advisory committee, and the results were presented at a public meeting in October 2017.
CDC, CFIA, DG RTD, DG SANTE, EFSA, EMA, FDA, ECDC, NVI, PHAC
USDA
1.8 Cooperate in improving understanding of the impact on public and animal health of restricting certain uses of antimicrobial drugs in food-producing animals
  • FDA awarded two grants (cooperative agreements). One grant is for on-farm antimicrobial use data collection in U.S. poultry and swine production and the other is for on-farm antimicrobial use data collection in U.S. beef feedlots and dairies. In January 2017, FDA implemented Guidance for Industry #213 (Veterinary Feed Directive for feed uses, and prescription-only for water uses). These grants will help gauge the success of these interventions,
  • FDA provided input for USDA-APHIS NAHMS antimicrobial use surveys initiated in 2017 for swine farms and feedlot cattle. Information from these data collected, along with continued monitoring of antimicrobial resistance as performed by the NARMS program, will contribute to our knowledge about the relationships between antimicrobial drug use in food-producing animals and antimicrobial resistance. It can also assist in continued support of antimicrobial stewardship efforts in veterinary medicine.
  • The European Commission requested the EMA to update its 2013 advice on the use of colistin in animals in response to the discovery of a new resistance mechanism in bacteria to colistin(caused by the mcr-1 gene). The revised advice was prepared by the Antimicrobial Advice Ad Hoc Expert Group (AMEG) and published by the EMA in July 2016. The main recommendation is that Member States minimize sales of colistin for use in animals to achieve a 65% reduction in EU-wide sales (target level of 5 mg/PCU) in the next 3 to 4 years.
  • EMA and EFSA jointly reviewed measures taken in the EU to reduce the need for and use of antimicrobials in food-producing animals and the resultant impacts on AMR. This was following a request from the European Commission. The joint scientific opinion (“RONAFA”) was published in January 2017 and provides for restrictions on the use of critically important antimicrobials and restrictions on prophylactic and metaphylactic use.
  • EMA, ECDC and EFSA adopted a joint scientific opinion on a list of outcome indicators on surveillance of AMR and antimicrobial consumption in humans and food-producing animals in September 2017. These harmonized indicators are aimed to assist EU Member States in assessing their progress made in reducing the use of antimicrobials and AMR in both humans and food-producing animals. The agencies presented the use of key outcome indicators at the EU One Health Network meeting in February 2018.
CDC, CFIA, DG RTD, DG SANTE, ECDC, EFSA, FDA, USDA

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Key Area II. Prevention of drug-resistant infections

 Key Area II. Prevention of drug-resistant infections
Action Number Description Implementer Organizations
2.1 Consultation and collaboration on a point-prevalence survey (PPS) for healthcare-associated infections (HAIs)
  • Conducting validation surveys in almost all countries. The second ECDC PPS (2016-2017) is currently in the 3rd wave of survey dates, with a 4th wave to occur September-November. Publication is planned for November 2018 (Antibiotic Awareness day or week). Most EU/EEA countries have participated or committed to participating and there are 5 EU candidate countries as well. A few countries opted not to participate or complete all components of the survey work.
  • Presented first validation results at ECCMID in Vienna (22-25/4) in a meet-the-expert session on reliability of HAI surveillance data.
  • Conducting additional survey – an ongoing HALT-3 survey during the same 4 waves as for the hospital PPS, in 2016-2017. Participation there is less so far. Fifth wave might be needed because of the overlap with the hospital PPS and work overload for the national HAI surveillance teams.
  • CDC worked with the Emerging Infections Program (EIP) to complete a second, full-scale survey in hospitals between May and September 2015, prioritizing engagement of hospitals that participated in the previous survey in 2011.
  • Collected data (by EIP site staff) to make HAI determinations using the National Healthcare Safety Network (NHSN) HAI definitions used in the 2011 survey as well as the “new” NHSN HAI definitions implemented in 2015. Staff also collected data to inform a description of the quality of hospital antimicrobial prescribing, focusing on 4 scenarios: community-acquired pneumonia, present-on-admission UTI, IV vancomycin, and fluoroquinolones. Sites continue to work on finalizing data entry and cleaning. Overall, data were received from 199 hospitals, many of which had also participated in the 2011 survey.
  • CDC will be working on the primary manuscripts (one on HAIs, and one on antibiotic use) in the coming months, with a goal of being ready to submit at least one for publication by the end of 2017.
  • CDC is beginning a nursing home point prevalence survey of HAIs and antimicrobial use this year, also done with the EIP and involving up to 200 nursing homes and 15,000 patients.
CDC, ECDC, FHI, PHAC
2.2 Develop a common system for sharing and analyzing bacterial resistance patterns for pathogens identified as urgent and serious threats
  • Discussed scope, objectives, and timeline in January 2018.
CDC, DoD, ECDC, FHI, PHAC
2.3 Develop a rapid alert system for communication of new or novel antimicrobial resistance findings
  • Revised the draft of the Emerging AMR reporting and risk assessment framework after the WHO GLASS meeting in December 2016. The revised version will be shared with the participants of the 2nd High Level Technical Meeting on surveillance of antimicrobial resistance for local and global actions in April 2017. The purpose of this system (GLASS Emerging Antimicrobial Resistance Reporting, GLASS-EAR) is defined as timely communication of any newly detected antimicrobial resistance findings that may influence surveillance and control practices. The framework addresses detection and reporting of emerging resistance, as well as guidance on risk assessment.
  • Scheduled regular calls to communicate new findings and concerning trends.
CDC, DoD, ECDC, FHI, PHAC
2.4 Encourage efforts to harmonise interpretive criteria for susceptibility reporting of bacterial isolates for contribution of data to the WHO Global Antimicrobial Resistance Surveillance System (GLASS)
  • Working on harmonization of breakpoints. Agreed upon a document that describes the scope of work and the items that should be addressed first. Specifically, representatives from CLSI reported that an ongoing fluoroquinolone breakpoint decision will likely result in harmonization with the EUCAST breakpoint. Similarly, EUCAST reported that an ongoing carbapenem breakpoint decision may result in harmonization with CLSI breakpoints.
  • Worked to focus on harmonization of the Streptococcus pneumoniae method/breakpoints and on the Neisseria gonorrhoeae breakpoints. Next steps are to review with CLSI and EUCAST.
CDC, ECDC, FDA, FHI, PHAC, other partners
2.5 Coordinate guidance for detection of outbreaks or concerning resistance trends and appropriate response
  • Discussed scope, objectives, and timeline in January 2018. Partners will review a draft project definition addressing detection and response of emerging resistance and concerning resistance trends, and identifying gaps, barriers, and lessons learned.
CDC, ECDC, FHI, PHA

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Key Area III. Strategies for improving the pipeline of new antimicrobial drugs

Key Area III. Strategies for improving the pipeline of new antimicrobial drugs 
Action Number Description Implementer Organizations
3.1 Communicate on the development of a package of economic incentives that could effectively incentivize antibacterial therapy development
  • Published second incentives paper (Ardal et al., 2017, Clinical Infectious Diseases) in June 2017, which examined various pull incentives to potentially incentivize antibacterial drug development. At present, there are few pull incentives implemented. Many experts argue that this is the remaining piece that requires action to create an ecosystem of incentives to mobilize industry to re-enter antibacterial drug discovery and development.
  • The U.S. Presidential Advisory Council on Combatting Antibiotic-Resistant Bacteria made recommendations for incentivizing the development of vaccines, diagnostics, and therapeutics to combat antibiotic resistance in September 2017.
  • The European Commission, through the Innovative Medicines Initiative and in collaboration with the European Federation of Pharmaceutical Industries and Associations, funded the DRIVE-AB project to transform the way policymakers stimulate innovation, sustainable use, and equitable availability of novel antibacterial products to meet public health needs. The final report was delivered in January 2018 with recommendations on a package of economic incentives to incentivize antibacterial therapy development.
  • Discussed recommendations in regards to a pull incentive at the TATFAR meeting in March 2018.
  • No additional plans for this Action
BARDA, CIHR, DG RTD, DG SANTE, FHI, Industry Canada
3.2 Feasibility assessment of options for pull incentives and development of a coordinated approach
  • The working group will develop proposals to move forward and are considering coordination with outside stakeholders.
BARDA, CIHR, DG RTD, DG SANTE, FHI, Industry Canada
3.3 Foster international research and product development to address challenging problems in the management of AR
  • NIH, which leads this working group, holds regular conference calls to share information on planned and ongoing research activities. NIH-funded clinical trials are forming partnerships with Combating Bacterial Resistance in Europe (COMBACTE). A key clinical trial in the U.S. that has a parallel counterpart in the EU has leveraged the TATFAR interactions, and the COMBACTE network to add 12 new clinical trial sites in the EU to the US trial for linking these important studies. When the COMBACTE trial was completed, the highest enrolling sites joined an NIH/NIAID-supported Phase III trial evaluating colistin, alone or with a carbapenem (NCT01597973), in patients with MDR gram-negative infections.
  • In May 2017, NIH officials participated in bilateral meetings with the Minister of Health from Japan, the Minister of Science from Canada, and a delegation from the Swedish Royal Technology Mission that was headed by the King of Sweden. In each of these meetings, challenges and opportunities in antimicrobial resistance were examined, with discussion of NIH’s role in advancing CARB National Action Plan goals, the NIH/NIAID-supported ARLG, and clinical trial opportunities through NIH.
  • NIH/NIAID co-sponsored a workshop with the Chinese Academy of Medical Sciences in Beijing, China that brought together governmental representatives, academic researchers, and biomedical companies from both countries to identify potential opportunities for partnerships to advance development of new medical countermeasures to address antimicrobial resistance.
  • NIAID awarded six milestone-driven grants under RFA AI-16-034, Partnerships for Countermeasures Against Select Pathogens, for research on immunotherapeutics, therapeutics, and vaccines for C. difficile, N. gonorrhea, and Gram-negative bacteria. NIAID also awarded four grants under RFA-AI-16-081, Partnerships for the Development of Tools to Advance Therapeutic Discovery for Select Antimicrobial-Resistant Gram-Negative Bacteria. These grants will help advance the development of new therapeutic products, diagnostics and vaccines against antibiotic-resistant pathogens.
  • An antibiotic supported by BARDA, Vabomere, received FDA approval for the treatment of cUTI in August 2017.
  • Canada issued its Pan-Canadian Framework in September 2017. It focused on four pillars: surveillance, stewardship, infection prevention and control, and research and innovation. It was developed using a One Health approach in collaboration with federal, provincial and territorial governments. The development of the action plan to support this framework is underway.
  • CIHR’s investigator-initiated funding competitions are ongoing. CIHR continues to use Federal Budget 2015 committed envelope of $1.8M per year to support AMR research.
  • Awarded the Point-of-Care Diagnostics in Human Health Initiative in AMR (Phase 1) in March 2017 ($1.4M over 2yrs), which leveraged in-kind contributions from industry partners. These grants will support the development, evaluation, and/or implementation of point-of-care diagnostic tools for viral/bacterial discrimination or for specific priority pathogens, and aims to facilitate linkages between academic researchers and industry to help advance the translation of knowledge into products.
  • CIHR is a founding member of Joint Programming Initiative on Antimicrobial Resistance (JPIAMR) and sits on the management board and steering committee of JPIAMR, and continues to be a top funder within this network. CIHR is also leading the JPIAMR Virtual Research Institute (VRI) task with 8 other member states. The VRI concept aims to be modelling a dynamic network for AMR research that would increase AMR research capacity, facilitate and increase scientific interactions, and develop a research program in alignment with JPIAMR’s research agenda. The VRI mandate encompasses the One Health approach.
  • CIHR launched a call on the Global Governance of AMR, which focuses on activities to support the eventual creation of an international network of intersectoral and interdisciplinary researchers studying the global governance arrangements, structures, and institutions in the areas of AMR and related infectious disease threats.
  • Canada has agreed to endorse the Statement of Intent issued by the German Presidency of the G20 in creating the Global AMR R&D Hub and is now part of the interim Board that will initiate the first steps alongside 11 other G20-countries, 3 non-G20 countries and 2 research funders.
  • NIH and ASPR/BARDA announced the Antimicrobial Resistance Diagnostic Challenge in September 2016. The competition seeks diagnostic tests that identify and characterize antibiotic resistant bacteria or that distinguish between viral and bacterial infections to reduce unnecessary uses of antibiotics. Submissions for Step 1 were received in January 2017. Ten Challenge semi-finalists for this stage of the Challenge competition were announced in March 2017. Each received $50,000 to develop their concepts into prototypes. NIAID supported earlier work for three of the semi-finalists. Step 2 submissions are due in September 2018. NIH and ASPR/BARDA each contributed $10 million to the challenge.
  • Norway committed to finance six research projects for a total of NOK 40 million (about 4.9 million USD) regarding AMR in collaboration with the Indian Council of Medical Research. Projects include new leads for antibiotics, diagnostics for prediction of AMR, among others. They will start in 2018.
BARDA, CIHR, DG RTD, FHI, NIH
3.4 Regulatory agencies discuss common issues in refining and furthering the science of antibacterial drug development and regulation, including clinical trial design to facilitate the development of antibacterial drugs and maintain a single development program that can be utilized by both regulatory authorities
  • Discussed antibacterial drug development programs, clinical trial designs for studying new antibacterial drugs, emerging safety issues, and coordinating efforts on scientific meetings to facilitate antibacterial drug development among TATFAR partners.
  • FDA and EMA have shared information on emerging safety issues that have resulted in regulatory actions.
EMA, FDA, HC, NMA
3.5 Continue regular meetings between FDA and EMA to discuss common issues in the area of antibacterial drug development and regulation
  • EMA and FDA have discussed vaccines for healthcare associated infection during regular teleconferences.
  • NIH and FDA held a workshop on bacteriophage as an alternative approach for treating bacterial infections in July 2017.
EMA, FDA, HC, NMA
3.6 Exchange information on possible regulatory approaches to the development of alternatives for managing bacterial infections, such as bacteriophage therapy and vaccines for healthcare-associated infections
  • Activities under this action are included under actions 3.4 and 3.5 and are ongoing.
EMA, FDA, HC, NMA
3.7 Veterinary regulatory agencies will discuss the particular challenges related to authorisation of novel veterinary therapies presented as alternatives to antimicrobials
  • EMA, which leads this working group, organizes 3 to 4 teleconferences each year.
  • Bilateral exchanges between EMA and FDA to support development and regulatory approval of products that reduce the need for antimicrobials within the wider context of cooperation on the subject of innovative veterinary medicines.
CFIA, DG SANTE, EMA, FDA, HC, Norway, USDA

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