ESVAC (European Surveillance of Veterinary Antimicrobial Consumption)

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ESVAC (European Surveillance of Veterinary Antimicrobial Consumption) Present and future activities 60th Meeting of the EFSA advisory forum Presented J. Torren, Scientific Administrator, Animal and Public Health, Veterinary Medicines Department on 8 June 2016 An agency of the European Union

Content of the presentation History Objectives Method Results Caveats of the ESVAC project Future activities Conclusions 1 ESVAC

European Commission request to EMA on collecting consumption data To develop harmonised approach for collection and reporting of data on use of antimicrobial agents based on national sales figures, as well as estimates on consumption in at least the major groups of animal species. Fifth report of the ESVAC series, all the reports available from: www.ema.europa.eu 2 ESVAC

Intended use of surveillance data on antimicrobial consumption:. To aid interpretation of patterns and trends regarding antimicrobial resistance (AMR); As input to risk profiling and risk assessment regarding AMR; For setting risk management priorities; To evaluate the effectiveness of measures being implemented to promote prudent use; To identify changing patterns of use of veterinary antimicrobial agents; To aid comparison of use of veterinary antimicrobial agents between human and veterinary medicine, time periods and countries; As a basis for focused and targeted research and development. 3 ESVAC

The ESVAC technical approach Data sets Sales data provided at package level (name, pharmaceutical from, pack size ingredient(s) and strength(s). Calculated to express tonnes of active ingredient Animal population data from Eurostat, TRACES and national (horses). The main indicator applied to express the consumption of veterinary antimicrobials is mg active ingredient normalised by the population correction unit (mg/pcu): 4 ESVAC Amount sold in metric tonnes 10 9 PCU in kg

ESVAC indicators The ESVAC main indicator is: mg active ingredient sold per population correction unit mg/pcu. Other indicators: Tonnes sold for food producing species, of the various antimicrobial veterinary classes, per country, per year (Table A1). Sales for food producing species, in milligrams active substance per Population Correction Unit (mg/pcu), of the various antimicrobial veterinary classes, per country, per year. (Figure 9). Sales for food producing species, in milligrams active substance per Population Correction Unit (mg/pcu), by form, per country, per year (Fig 7). * Refers to the 2013 ESVAC report figures and tables 5 ESVAC

ESVAC indicators (cont.) Changes in sales (mg/pcu) for the countries and years for which data are available. 6 ESVAC

Results: Sales for food-producing species, including horses, in mg/pcu, of the various veterinary antimicrobial classes, for 26 countries, in 2013 Differences likely to be partially due to differences in the composition of the animal population in the various countries 7 ESVAC

Spatial distribution of overall sales of all antimicrobials for food-producing animals, in mg/pcu, for 26 countries, for 2013 8 ESVAC

Changes by 23 EU/EEA countries, 2011-2013 10% 5% 0% -5% -10% -15% -7.9% -2.8% -10.5% PCU Tonnes sold mg/pcu Percentage changes in PCU, in tonnes sold and in sales of veterinary antimicrobial agents for food-producing species, including horses, in mg/pcu, from 2011 to 2013, aggregated by 23 EU/EEA countries 9 ESVAC

Distribution of sales, in mg/pcu, of the various pharmaceutical forms of veterinary antimicrobial agents for food-producing animals, including horses, aggregated by the 26 EU/EEA countries for 2013 10 ESVAC

Sales of antimicrobial agents by antimicrobial class as percentage of the total sales for food-producing species, including horses, in mg/pcu, aggregated by 26 countries, for 2013 11 ESVAC

Caveats of the ESVAC data It takes at least three to four years in order to establish a valid baseline for the data on sales of veterinary antimicrobial agents. Data provided at package level, but not by animal species. Data reported as tonnes. 80% of the data are provided by the pharmaceutical industry. Heterogeneous source of data (pharmaceutical industry, wholesalers, pharmacies, prescription data). No benchmarking within the country. Data from Greece and Malta missing. 12 ESVAC

AWP Antimicrobial Working Party AMEG Antimicrobial Advice ad hoc Expert Group Expert Groups JIACRA Joint Interagency Antimicrobial Consumption and Resistance Animal and Public Health RONAFA Reduction of the Need of Antimicrobials in Food Producing Animals TATFAR Trans-Atlantic Task Force on Antimicrobial Resistance 13 ESVAC ESVAC European Surveillance of Veterinary Antimicrobial Consumption Sales Advisory Group Species Advisory Group Units of Measurement Advisory Group Use antimicrobials Stratification

Future of ESVAC project Overall sales data will continue in the future. EC review of legislation likely to require antimicrobial consumption data per species from Member States. Consumption data per species is resource demanding and requires time and experience. ESVAC dedicating careful considerations on how to achieve systems at national level that are comparable at international (EU) level. Automated collection of continuous data will facilitate the collection of such data, but it will take years to be implemented in the EU. Complementary systems (stratification) will be explored by ESVAC. DDDvet and DCDvet now published. 14 ESVAC

Conclusions of ESVAC Until now we have observed a reduction on antimicrobial use in the EU/EEA. Considerable heterogeneity on the trends of antimicrobial use is observed. The overall reduction in sales is mainly accounted for by a few countries suggesting that there it is a potential for reduction in the others as well. The sales of fluoroquinolones and 3rd- and 4th-generation cephalosporins were stable during the period of 2010-2013. The most sold antimicrobials are tetracyclines, penicillins and sulfonamides administered orally. Data on sales of antimicrobials are powerful tools to encourage countries to take action on the use of antimicrobials in animals. 15 ESVAC

Conclusions (cont.) ESVAC data allows for targeted objectives. Reduction of use of colistin below 5 mg/pcu No increase in use of fluoroquinolones or 3 rd and 4 th generation cephalosporins No increase in overall antimicrobial use 16 ESVAC

Thank you for your attention Further information ESVAC@ema.europa.eu European Medicines Agency 30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact Follow us on @EMA_News