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Antibiotic / Antimicrobial Resistance

Actions & Recommendations

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

Actions for 2016 through 2020 are currently being implemented.

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

Action Number Description Implementer Organizations
1.1 Develop guidance for assessing appropriate antibiotic use
  • Determined current ongoing work in this area, how TATFAR can best contribute, and working to finalize a scope of work.
 CDC, DoD, ECDC, FHI, PHAC
1.2 Publish a review of antibiotic reduction goals in human medicine from TATFAR partner countries
  • Agreed to collect information via survey based on a teleconference between TATFAR partners.
  • Finalized the survey content with input from TATFAR partners and circulated to the EU MS relevant contact points in March 2017 with a deadline for reply of May 2017.
  • Scheduled the next teleconference for late August 2017.
 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, November 14-20, 2016, which included a global Twitter chat with partners. The Twitter chat had higher results when compared to previous years.
 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.
  • Initiated discussions based on presentations during the February 2016 teleconference from EMA, FDA and PHAC that can be addressed in future sub-group meetings and could lead to further collaboration.
  • 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.
  • Participated in the ESVAC Annual Network Meeting in March 2017. FDA presented an update on work related to U.S. animal drug metrics, specifically regarding U.S. domestic sales and distribution of medically important antimicrobials used in food-producing animals. As of calendar year 2016, drug sponsors are required to provide estimates of use by species when reporting annual sales data for food animal antimicrobials. These data will be incorporated in FDA’s 2017 Annual Summary Report on Antimicrobials Sold or Distributed in Food-Producing Animals. FDA will also be seeking public comment on a proposed method to calculate a biomass denominator that best fits the circumstances of animal production in the U.S. The proposed method utilizes the annually reported antimicrobial sales and distribution data by species, and takes into account the annual U.S. domestic food animal species populations and weights.
 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.
  • Discussed risk analysis project conducted in Canada at a meeting in March 2017, including the development of a risk profile using the Codex CAC/GL 77-2011 for a specific resistant microorganism and implementing this aspect of the Codex Framework.
  • Discussed the possibility of shifting focus from providing feedback on CAC/GL 77-2011 to aspects of CAC/GL 77-2011 implementation. Initial discussions in October 2015 were focused on CAC/GL 77-2011, but Codex may not presently be seeking input on this guideline. Several potential areas of focus were discussed and will be explored.
  • Provide a venue for sharing ideas on how to effectively conduct risk analyses for AMR, and met again in May, 2017.
 CFIA, DG SANTE, EFSA, EMA, FDA, ECDC, NVI, PHAC
1.6 Enhance information sharing on approaches to promoting appropriate use in veterinary communities
  • Circulated a preparatory questionnaire by SANTE Directorate F to competent authorities of all EU Member States, Iceland, Norway, Switzerland plus veterinary and industry stakeholder organizations.
  • Completed fact-finding missions by SANTE Directorate F to 10 EU Member States plus Norway.
  • Published six mission reports and an interim overview report summarizing the questionnaire responses. Best practices from initial missions were identified and expected to be published during 2017.
  • Organized training activities within the framework of the DG SANTE “Better Training for Safer Food” (BTSF) program to further harmonize the approaches and practices of the Member States, and to increase the efficacy of the competent authorities to verify compliance with the legal requirements on the veterinary use of antimicrobials and on prevention and monitoring of AMR in the food chain. The training covered Commission guidelines on prudent use of antimicrobials in veterinary medicine and examples of good practices. Four workshops were organized in 2016 with around 80 participants from all Member States and Norway. Additionally, a BTSF workshop on AMR with emphasis on the “One Health” approach was organized for Asian region in 2016, covering the prudent use of antimicrobials in animals and humans.
  • FDA collaborated with veterinary, animal producer, and feed industry organizations, plus various local, state and federal agencies, to prepare veterinarians and animal producers the implementation of FDA Guidance for Industry #213. FDA disseminated information, particularly about the Veterinary Feed Directive final rule, as part of the outreach and education efforts. This includes presentations, website updates, meetings, calls, and other opportunities for FDA-CVM to address questions.
 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 S. 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 announced a SHEPheRD grant to gather information on antibiotic use practices and resistance in aquaculture, is working with CLSI to change the breakpoint for Shigella, and developed core data elements to improve collection of epidemiologic data and outcome measures associated with antibiotic resistance in human enteric disease.
  • Update the ongoing enhancements to NARMSNow data visual displays via the website. NARMS is currently being reviewed by an external advisory committee, the results of which will be presented at a public meeting in October.
 CDC, CFIA, DG RTD, DG SANTE, EFSA, EMA, FDA, ECDC, NVI, PHAC
USDA
1.8 Cooperatein 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 are developing a list of harmonized outcome indicators to enable Member States to assess the progress made in implementation of their action plans against AMR including, among others, monitoring and detection of reductions in the use of antimicrobials in humans and food-producing animals. This is on the request of the European Commission.
 CDC, CFIA, DG RTD, DG SANTE, ECDC, EFSA, FDA, USDA

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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
  • Work on this Action has not started.
 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.
  • Planned future work to focus on harmonization of the Streptococcus pneumoniae method/breakpoints and on the Neisseria gonorrhoeae breakpoints. Next steps are to develop a work plan and a process for proceeding.
 CDC, ECDC, FDA, FHI, PHAC, other partners
2.5 Coordinate guidance for detection of outbreaks or concerning resistance trends and appropriate response
  • Work on this Action has not started.
 CDC, ECDC, FHI, PHA

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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 in 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.
  • Examining the work products of other groups that have been examining this topic. TATFAR aims to publish its third and final paper on this topic to provide a final recommendation on a set of economic incentives that should be considered for implementation.
 BARDA, CIHR, DG RTD, DG SANTE, FHI, Industry Canada
3.2 Conduct a feasibility assessment of options for pull incentives and development of a potential joint incentive mechanism
  • See Action 3.1 for updates on Action 3.2.
 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.
  • IMI members of TRANSLOCATION project participated in NIAID’s workshop on Gram-negative entry
  • CARB-X, a public-private product development partnership involving BARDA, NIH and the Wellcome Trust, awarded up to $48 million in funding for their first group of projects: the CARB-X portfolio.
  • Canada will publish its Pan-Canadian framework and Action Plan on AMR which has four pillars: surveillance, stewardship, infection prevention and control, and research and innovation. It has been developed using a One Health approach in collaboration with federal, provincial and territorial governments.
  • 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.
  • Launched strategic funding through the JPIAMR call “Comparison of prevention, control and intervention strategies for AMR infections through multidisciplinary studies, including One Health approaches” in January 2017 ($3M for 3years, 3-5 grants).
  • Awarded Transmission Dynamics calls in October 2016 (6 team grants for 3 years, $3.6M). These grants will address transmission of antibiotic resistance following a One Health Approach while fostering multinational research collaborations to improve the control of resistant bacterial infections of clinical and/or veterinary importance only.
  • Awarded funding for JPIAMR Transnational Network/Working groups (8 participating countries) for two 1-year grants ($110,000). This will bring together leading experts and establish working groups to enhance resource alignment and maximize existing and future efforts to combat AMR by producing white papers, guidelines, best practices, etc.
  • CIHR is working with Antimicrobial Stewardship (AMS) Canada and hosted, in collaboration with Merck, a forum entitled “Current and Future Directions for Innovation and Research in AMS in Canada” in November 2016. This forum brought together researchers, industry, government, scientific organizations and patient groups to develop strategies to encourage doctors, pharmacists, and patients to use antimicrobials more responsibly, in order to maintain their effectiveness. A report will be released in the near future.
  • Canada is engaged in a number of international efforts in the area of AMR, and has supported declarations focused on AMR and framed Canada’s position at the international table of the WHO, World Health Assembly, United Nations General Assembly, G7 and G20, and is developing action plans and frameworks.
  • NIAID released RFA-AI-16-081, Partnerships for the Development of Tools to Advance Therapeutic Discovery for Select Antimicrobial-Resistant Gram-Negative Bacteria (R01), in November 2016. This funding opportunity will support the development of novel predictive assays, models and/or research tools based on penetration, and efflux of small molecules to facilitate therapeutic discovery for carbapenem-resistant Enterobacteriaceae (CRE), MDR Acinetobacter and/or MDR Pseudomonas aeruginosa. Visit the NIH grants website for additional details. Additionally, NIAID and the Pew Charitable Trusts Antibiotics Innovation Program co-sponsored a meeting titled “Challenges in the Discovery of Gram-negative Antibacterials: The Entry & Efflux Problem” in February 2017. The workshop brought together academic and industry investigators to discuss barriers to Gram-negative antibiotic discovery. The group identified the following action items to advance the field:
    • Create a platform that enables the scientific community to better access, share, and use information.
    • Establish an antibiotic discovery “society” or virtual consortium.
    • Build momentum by tackling key research priorities in a systematic way.
  • 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 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.
 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
  • TATFAR partners have regular calls to discuss ongoing work.
 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
  • TATFAR partners have regular calls to discuss ongoing work.
 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
  • TATFAR partners have regular calls to discuss ongoing work.
 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 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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