Paule Carnat-Gautier French Ministry of Agriculture

1. Integrated surveillance systems for use of antimicrobials and the monitoring of antimicrobials resistance Paule Carnat-Gautier French Ministry of Agriculture

2. Introduction Antimicrobial agents represent one of the main therapeutic tools both in human and veterinary medicine to control and treat bacterial infectious diseases. However, the use and misuse of antimicrobials in both human and veterinary medicine has resulted in the emergence of strains of bacteria that no longer respond to antimicrobial therapy. This is a problem for animal health, but also for public health when transmitted to humans. As very few new antimicrobials are coming on the market, addressing the issue of antimicrobial resistance is a priority in the fields of public health today

3. Background Council Conclusions on Antimicrobial Resistance (AMR) 2876th EMPLOYMENT, SOCIAL POLICY, HEALTH AND CONSUMER AFFAIRS Council meeting Luxembourg, 10 June 2008

4. Council Conclusions on Antimicrobial Resistance (AMR) • CALLS UPON THE MEMBER STATES to: − strengthen surveillance systems and improve data quality on AMR and use of antimicrobial agents from both human health and veterinary sector, and healthcare associated infections; − further promote prudent use of antibiotics in both the human and veterinary sector − control the prevalence of pathogens that cause food-borne (potentially) resistant infections in animals and food by the application of both pre- and post-harvest risk management strategies in food production and other preventive measures, including, where appropriate according to national circumstances, vaccination, in order to reduce the burden of infection.

5. Council Conclusions on Antimicrobial Resistance (AMR) • CALLS UPON THE COMMISSION TO: • improve surveillance and control of antimicrobial resistance; • promote mutual cooperation between all Directorates General and concerned Agencies and facilitate cooperation between Member States' on all aspects of AMR, • consider further control options when appropriate; • support research on the potential impact of antimicrobial usage in food animals and crop production, on emergence and prevalence of AMR in the most common microorganisms responsible for infections in humans; • facilitate the exchange of information, best practices and experiences on reducing AMR and healthcare-associated infections, • facilitate training on prudent use of antimicrobials.

6. Council Conclusions on Antimicrobial Resistance (AMR) • CALLS UPON THE COMMISSION AND MEMBER STATES TO: − maintain and improve co-ordinated and coherent surveillance for antimicrobial resistance, consumption of antimicrobial agents and healthcare-associated infections at the European level − co-ordinate an annual European initiative to increase awareness of the general public and veterinary and healthcare professionals about the AMR, the prudent use of antibiotics on humans and animals and infection control practices."

7. Surveillance of use of antimicrobials in animals • OIE - World Organisation for Animal Health • Terrestrial animal health Code • Chapter 6.8 Monitoring of antimicrobials and usage patterns of antimicrobials used in food producing animals • Chapter 6.7 : harmonisation of national animicrobial resistance surveillance and monitoring programs • http://www.oie.int/en/international-standard-setting/terrestrial-code/access-online/

8. Surveillance of use of antimicrobials in animals • ESVAC : European surveillance of veterinary antimicrobials consumption (EVAC for human consumption) • Set up in June 2010 • Develop a harmonized approch for the collection and reporting of data on the use of antimicrobials in animals.

9. Surveillance of use of antimicrobials in animals • Collected data on a regular basis • Reported by : • Weight (kg) of active substance per animal or species • Subdivised in therapeutic use or growth promotion use • Per routes of administration : in feed, in water, injectable, oral, intramammary, intra–uterine, topical • Class of antimicrobials (nomenclature sould comply with international standards)

10. Surveillance of use of antimicrobials in animals • Data should be obtained by different sources • Pharmaceutical industry : manufacturing sales data • Wholesalers • Pharmacies, veterinarians • Data sources depend upon the national situation • Different distribution systems

11. Surveillance of use of antimicrobials in animals • Usage data should be combined with data regarding • Animal population size • Animal health status • Occurrence of different infections thus reflecting the need of using different kinds of antimicrobials

12. Surveillance of use of antimicrobials in animals • ESVAC 1 • Call for 2010 data to 23 european countries (21 Members states) aggregated by antimicrobials class • Overall sales data aggregated by class from 9 european countries (2004- 2009)

13. Figure 1b. Overall sales of veterinary antimicrobial agents in the Czech Republic in 2005-2009. Note that the values on the two y-axises are different.

14. Monitoring of antimicrobials resistance • Provisions for monitoring of antimicrobial resistance in zoonotic bacteria : • Directive 2003/99 • Commission decision 2007/407/EC • EFSA Manuel for reporting on Zoonoses + Resistance

15. Monitoring of antimicrobials resistance • Directive 2003/99/EC on the monitoring and reporting of antimicrobial resistance in zoonotic bacteria • Article 7 Monitoring of antimicrobials resistance 1. Member states shall ensure, in accordance with the requirements set out in annex II that monitoring provides comparable data on the occurrence of antimicrobial resistance in zoonotic agents and, in so far as they present a threat to public health other agents

16. Monitoring of antimicrobials resistance • Directive 2003/99/EC on the monitoring and reporting of antimicrobial resistance in zoonotic bacteria • Annexe II B Specific requirements Member States must ensure that the monitoring system provides relevant information at least with regards to a relevant number of isolates of Salmonella spp., Campylobacter jejuni and Campylobacter coli from cattle, pigs and poultry and food of animal origin derived from those species

17. Monitoring of antimicrobials resistance COMMISSION DECISION 2007/407/EC on a harmonised monitoring of antimicrobial resistance in Salmonella in poultry and pigs Article 1 This decision lays down detailed rules for monitoring antimicrobial resistance in accordance with Article 7(3) and Annex II(B) of Directive 2003/99/EC to be carried out in the Member States. It shall cover Salmonella spp. in fowl (Gallus gallus), turkeys, and slaughter pigs without prejudice to additional antimicrobial resistance monitoring in accordance with the requirements in Article 7(1) of Directive 2003/99/EC. Decision 2007/407/EC applies from 1 January 2008

18. COMMISSION DECISION 2007/407/EC on a harmonised monitoring of antimicrobial resistance in Salmonella in poultry and pigs Table 1 Per year 170 Salmonella isolates per study population shall be included in the antimicrobial resistance monitoring

19. COMMISSION DECISION 2007/407/EC on a harmonised monitoring of antimicrobial resistance in Salmonella in poultry and pigs Table 2 Resistance against an antimicrobial is considered to be present if the Minimum Inhibitory Concentration (MIC) exceeds the breakpoint or the epidemiological cut-off value.

20. Manual for reporting on Zoonoses, Zoonotic Agents and Antimicrobial resistance in the framework of Directive 2003/99/EC The EFSA Journal (2009) 255, 1-90 …and of some other pathogenic microbiological agents for information derived from the reporting year 2009 The EFSA Journal (2010) 8(4):1579 The manuals are on the course CD

21. Manual for reporting on Zoonoses, Zoonotic Agents and Antimicrobial resistance in the framework of Directive 2003/99/EC Chapter 8: Reporting on antimicrobial resistance For the purpose of following trends, every yearor at regular intervals (e.g. every 2. or 3. year) the following information on antimicrobial resistance needs to be reported: • Resistance in Salmonella Enteritidis, S. Typhimurium, • Campylobacter jejuni, and C. coli isolates from broiler flocks • Resistance in Campylobacter jejuni, and C. coli isolates from • broiler meat • Resistance in S. Typhimurium isolates from pigs

22. Manual for reporting on Zoonoses, Zoonotic Agents and Antimicrobial resistance in the framework of Directive 2003/99/EC Diagnostic / analytical methods typically used Three types of methods are used in antimicrobial resistance testing for Salmonella bacteria: disk diffusion, agar dilution and broth dilution. For Campylobacter, only dilution methods are considered reproducible.

24. Figure CA13. Spatial distribution of ciprofloxacin resistance among Campylobacter jejuni from Gallus gallus in countries reporting quantitative data in 2008

25. Guidelines on Laboratory methodologies for bacterial antimicrobial susceptibility testing (AST)

26. Laboratory methodologies for AST testing Recommendations for validated methods and proficiency testing Need for every country to start a program aiming at “monitoring AMR and consumptions of antibiotics”

27. World Health Day – 7 April 2011 Antimicrobial resistance: no action today, no cure tomorrow Antimicrobial resistance is not a new problem but one that is becoming more dangerous; urgent and consolidated efforts are needed to avoid regressing to the pre-antibiotic era. On World Health Day 2011, WHO will introduce a six-point policy package to combat the spread of antimicrobial resistance.