Would you like to be added to our mailing list to receive updates on the development of the global action plan?* Y X N

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1 Would you like to be added to our mailing list to receive updates on the development of the global action plan?* Y X N Yes. General questions 1. From the perspective of your organization, what are the most important areas of concern in AMR? The problem is the uncontrolled use of antimicrobial in human, veterinary and food production. It is necessary to integrate information regarding the control of the use in both human and animal health, including the development of monitoring programs and risk assessment. Monitoring antimicrobial resistance in primary bloodstream infection associated with central venous catheter in patients hospitalized adult Intensive Care Unit, Pediatric and newborn. 2. Is your organization currently involved in work related to AMR? Y_X_ N If Yes, How? - Anvisa has developed an AMR monitoring program in poultry and also supports researches in this area. Since 2010, ANVISA conducts monitoring of antimicrobial resistance in primary bloodstream infection associated with use of central venous catheters in patients admitted to intensive care units adult, pediatric and neonatal. Currently there are 1887 hospitals that report monthly 33 markers of antimicrobial resistance through online form. Bulletins with 07 national analysis of these reports have been published. Questions about the draft global action plan outline document Before the WHA resolution was adopted, two WHO AMR Strategic Technical Advisory Group (STAG) meetings were held in anticipation, which included members plus a large number of representatives from other organizations. These meetings identified key issues, concerns and led to the development of a draft outline. As this consultation progresses and stakeholder meetings are held, the secretariat will harvest and incorporate the input into the draft global action plan. 1. How would you rate your understanding of WHO s intention in the development of a global action plan to address AMR?

2 Very good X Good Fair Poor Additional comments Antimicrobial resistance is a global public health problem and the development of a Global Action Plan will allow countries to join efforts to prevent and control the advancement of antimicrobial resistance worldwide. 2. From the perspective of your organization, are the major issues relating to AMR outlined in the draft global action plan? Y_X_ N If No, what additional issues need to be addressed? Questions on the Building blocks described in the draft outline. You will notice, the global action plan has been constructed around building blocks in recognition that different countries will have different starting points. In this situation, countries can choose building blocks to concentrate upon. Each building block specified has been identified as a key area where specific attention, planning and work are needed to achieve progress in addressing AMR. Through questions in this section, we would like to hear your opinions on these building blocks in more detail. I. Building block-1: Increasing awareness and understanding about AMR and of the actions and changes needed Surveillance and monitoring of antimicrobial resistance markers in health services The generation and consolidation of national data on AMR (human and animal) and an active risk communication with all involved; Training of health professionals for the rational use of antimicrobial; Orientation towards informing the general public of the risks of self-medication and the indiscriminate use of antimicrobials. b) What are the main actions that needs to be done -- and who are the main actors/stakeholders who need to take action -- to go beyond the status quo? Undertake integrated programs to encourage research in the control of infections and microbial resistance area; Conduct risk assessments and risk communications targeted to specific

3 audiences; Conduct surveillance and monitoring of antimicrobial resistance markers in health services Analyze and disseminate national data on AMR (human and animal) Promote training focused on health professionals for the rational use of antimicrobials; Orientation towards informing the general public of the risks of self-medication and the indiscriminate use of antimicrobials. Actors involved: - Ministry of Health (MOH) - National Health Surveillance Agency - ANVISA - Ministry of Agriculture, Livestock and Supply (MAPA) - Professionals responsible for the human and veterinary health - Universities and Research Centers - General population c) What steps have already been taken to address this priority? (please In the area of animal health and agriculture: ANVISA has developed programs for residues of veterinary medicines and resistant microorganisms in animal products, even though a segment basis, with samples being collected only at the stage of marketing the product. A workshop was conducted in an attempt to develop a joint work between ANVISA and MAPA. ANVISA has sought to encourage research in the area. In the area of health services: - Conduct training for prescribers to the correct prescription of antimicrobials (doctors, dentists, etc.) - ANVISA published notices for research regarding initiatives for the prevention and control of antimicrobial resistance in healthcare - ANVISA annually publishes national bulletins on Antimicrobial Resistance in Health Services with the data reported by health services. - In 2010, ANVISA published Collegiate Board Resolution RDC No. 44/2010, which provides for the control of drugs based on substances classified as antimicrobials, use under

4 prescription drugs, alone or in combination. d) What are concrete and measurable indicators of progress for this priority? (Including, for example, global and national goals to be achieved within 2, 5 and 10 years) The indicators were not set yet. II. Building block-2: Identifying the most important approaches for preventing development of infections and the steps needed to move beyond guidance to more effective implementation of such approaches Control and restrict the use of antimicrobials in human medicine and animal development of harmonized surveillance systems use and the prevalence of resistance in human medicine and animal feed (focus on bacteria). - Harmonized surveillance systems HAI - Related Infections at Health Care and resistance antimicrobianade seamlessly between MAPA and ANVISA. - ANVISA published and widely disseminated manuals for professionals with guidelines for the prevention of HAI - Related Infections at Health Care (prevention of respiratory infections, primary bloodstream infections and surgical site infections) b) What are the main actions that needs to be done -- and who are the main actors/stakeholders who need to take action -- to go beyond the status quo? In isolation the ANVISA and MAPA institutions have specific programs. If ANVISA Program Analysis of Residues of Veterinary (PAMVET) Medicines and when this institution resized the monitoring program on the prevalence and antimicrobial susceptibility in Enterococcus sp and Salmonella isolates from chicken carcasses sold in the frozen profile Brazil (PREBAF). Set of priority actions for AMR. The proposal is to create the Program for Integrated Surveillance of Antimicrobial Resistance will come from shared between ANVISA and MAPA with the following objectives: 1. larger transparency about national governance and measures to combat AMR; 2. Strengthen the prevention and control of infections; 3. Specify, control and restrict the use of antimicrobials in human and veterinary medicine;

5 4. Ensure harmonized surveillance systems use and the prevalence of resistance in human medicine and animal feed (focus on bacteria); 5. Improve the management of antimicrobials under the supervision of trained professionals; 6. Ensure access and availability of effective drugs, improving the systems of regulation and surveillance; 7. Wedge 6 position on the reserve for human health of new and those who are last therapeutic antimicrobials also on human health; 8. Engage and support the primary production of food of animal origin and other links in the chain to the adoption and implementation of best practices to reduce the use of antibiotics in animal production. 9. Strengthen risk communication strategies; 10. Encourage the development of new antimicrobials, alternative therapies and better diagnostic methods; 11. Promoting research on the magnitude, epidemiology and economic impact of AMR and effectiveness of control measures. 12. Qualification of microbiology health service laboratories and national reference for more effective identification of multiresistant microorganisms. c) What significant work has already been done to address this? (please The workshop was held in May 2013, where the main objectives Were designed. The integrated between ANVISA and MAPA work is still a proposal, Which in this design by the two government agencies ANVISA and MAPA. ANVISA Increased control in the sale of drugs targeted to human health and has participated with the Ministry of Agricutura, Livestock and Supply of working groups, Which resulted in the prohibition of some antimicrobials the growth performance enhancers. Entretando there is still a lack of control actions and monitoring more integrated. ANVISA and the Ministry of Health created a sub-network of microbiology laboratories for identification and confirmation of infections by multiresistant microorganisms in their situations of outbreaks in health services. d) What are concrete and measurable indicators of progress for this priority? (Including, for example, global and national goals to be achieved within 2, 5 and 10 years) The indicators will be constructed on the basis of commitments made by the two bodies, database sharing, and information exchange and communication management.

6 III. Building block-3: Optimizing the use of existing antimicrobials for human and animal health and in agriculture Indiscriminate use of antimicrobials important and critically important, which will reduce future therapeutic possibilities. b) What are the main actions that needs to be done -- and who are the main actors/stakeholders who need to take action -- to go beyond the status quo? Implement best practices for the rational use of antimicrobials for both human use and for veterinary and agricultural use. Control the sale of antimicrobials, with the adoption of the mandatory prescription and recipe control. Key stakeholders Doctors, Veterinarians, Agronomists, Pharmacists, drug sellers. c) What steps have already been taken to address this priority? (please Controle dos medicamentos antimicrobianos usados em saúde humana. Nos anos de 2007 e 2008 foram realizados vários cursos relacionados a prevenção e controle da resistência microbiana, tais como: Curso Medidas de Prevenção e Controle da Resistência Microbiana e Programa de Uso Racional de Antimicrobianos em Serviços de Saúde Conducted in 2007 with 6,263 professionals registered higher level (doctors, nurses, microbiologists, biologists, pharmacists, physiotherapists etc.), working in the hospital infection control, and, of the total enrolled, 1,080 were selected (119 in the Northern Region, 149 in the Midwest Region, 378 in the Northeast, 121 in the South and 313 in the Southeast). Curso "Uso Racional de Antimicrobianos para Prescritores" Conducted in 2008, signed up for the course and 2,856 health professionals were selected 809 physicians and 108 dentists. The course objective was to promote the training of doctors and dentists involved in the care of patients with acquired infections in both community and health care-related infections. The choice of this topic was due to the shortage of courses related to the rational use of antimicrobials and the treatment of community-acquired infections and related health care due to multiresistant microorganisms. Curso Boas Práticas Microbiologia Clínicas - MC Boas Práticas Course divided into two stages: the distance with 300 participants and attendance with 150 participants. The step distance occurred from November 3

7 to December 14, 2008 In May 2009, the stage presence was performed. Was selected at least one participant from each of the participating institutions of the MRI Network. The course objective was to promote the upgrading of professionals working in the area of Clinical Microbiology and standardization of processes performed in microbiology laboratories. d) What are concrete and measurable indicators of progress for this priority? (Including, for example, global and national goals to be achieved within 2, 5 and 10 years) The indicators were not set yet. IV. Building block-4: Identifying and closing critical gaps in knowledge needed to address AMR The management of integrated areas between the MAPA and ANVISA information. Research in the areas of prevention and control of antimicrobial resistance. b) What are the main actions that needs to be done -- and who are the main actors/stakeholders who need to take action -- to go beyond the status quo? University researchers d) What steps have already been taken to address this priority? (please c) What are concrete and measurable indicators of progress for this priority? (Including, for example, global and national goals to be achieved within 2, 5 and 10 years) The indicators will be constructed within the PROVIRA and can be framed in the medium term horizon of 05 years or term of 10 V. Building block-5: Developing an innovative and sustainable approach to develop and distribute critical products and technologies needed to address AMR b) What are the main actions that needs to be done -- and who are the main actors/stakeholders who need to take action -- to go beyond the status quo? c) What steps have already been taken to address this priority? (please

8 d) What are concrete and measurable indicators of progress for this priority? (Including, for example, global and national goals to be achieved within 2, 5 and 10 years) VI. Building block-6: Assessing the long term economic, developmental and social costs and implications of AMR as a basis for sustainable investment and action b) What are the main actions that needs to be done -- and who are the main actors/stakeholders who need to take action -- to go beyond the status quo? d) What steps have already been taken to address this priority? (please d) What are concrete and measurable indicators of progress for this priority? (Including, for example, global and national goals to be achieved within 2, 5 and 10 years) Concluding questions 3. What contribution would your organization be able to make in implementing the global action plan? Provide information on the risks and impact of actions implemented with will come for the monitoring and control of Antimicrobial Resistance in the field of animal health and consequent correlation to sustained use on human health. 4. Additional input that you feel would be facilitate development of the GAP.