ESVAC data on consumption of veterinary antimicrobial agents in - PowerPoint PPT Presentation

ESVAC data on consumption of veterinary antimicrobial agents in 2010 from 19 EU/ EEA countries Kari Grave/ Arno Muller/ Jordi Torren/ David Mackay European Medicines Agency – Animal and Public Health ESVAC Stakeholders meeting 18 March 2013, EMA An agency of the European Union

Outline • Approach • Results 2

Countries participating in ESVAC 2010* ESVAC 1st report: 8 EU/ EEA countries provided data aggregated by class ESVAC 2nd report: 19 EU/ EEA countries provided data according to the ESVAC template implying that the 8 original countries had to change their data collection system * Italy has recently provided data for 2010. Will be included in 2011 report 3

Approach collecting and quality check of 2010 data on overall sales • ESVAC protocol, data collection form and data base/ program developed and tested in a pilot study 2010 • Training on how to fill in the template and technical support (one to one) MSs • Data checked – If standardised by application of the ESVAC data program and for harmonisation (manually) e.g. conversion factors – For validity (manually) e.g. by identification of obvious outliers; strengths different from in names

Approach cont. • The population correction unit (PCU) used as a proxy for the animal biomass of food producing species at risk for being treated in the country of question. Takes into account transport of animals for slaughter or fattening in another MS • Tablets used almost solely in companion animals - excluded from the data prior to analysis of the data together with PCU 5

Approach cont. • The main indicator used to report overall sales and sales by antimicrobial class by country in ESVAC is mg active ingredient/ PCU (1 PCU = 1 kg) 6

ESVAC 2010 report - disclaimer • It is generally agreed that it takes at least three to four years in order to establish a valid baseline for the data on sales of veterinary antimicrobial agents. Consequently, the data from countries that have collected such data for the first time should be interpreted with due caution. • It should be emphasised that the data presented in this report should not be used alone as a basis for setting management priorities, but should always be considered together with data from other sources. 7

Results PCU (in 1,000 tonnes) of the various food producing animal species, including horses, in 2010, by country Cattle Pig Poultry Sheep and goat Others* 8,000 7,000 6,000 PCU (1,000 tonnes) 5,000 4,000 3,000 2,000 1,000 0 Austria Czech Republic Denmark Estonia Finland France Iceland Ireland Latvia Lithuania Netherlands Portugal Slovenia Spain Sweden Belgium Hungary Norway Kingdom United 8 * Horse and for some countries fish and rabbit

Results cont. Net export and net import 1 , as percentage of the total PCU, of animals for fattening or slaughter in another Member State for 2010 15% Export 10% 5% 0% -5% Import -10% Austria Czech Republic Estonia Finland France Iceland Ireland Latvia Lithuania Netherlands Portugal Slovenia Spain Sweden Belgium Denmark Hungary Norway United Kingdom Net export and net import 1 , as percentage of the total PCU, of animals for fattening or slaughter in another Member State for 2010 9

Results cont. Distribution of sales of veterinary antimicrobial agents for food producing animals (including horses), in mg per population correction unit (mg/ PCU), by pharmaceutical forms by country for 2010 10

Oral solution, oral powder and premixes as percentages of total sales, in mg per population correction unit (mg/ PCU), of veterinary antimicrobial agents for food producing animals (including horses) by country in 2010 11

Sales of veterinary antimicrobial agents in 2010 in 19 countries by form, in mg/ PCU 84% for herd treatment 0.4% 3% 0.3% 0.1% 13% Prem ix Oral powder 9% Oral solution Injection Intramammaries Intrauterine prep. Oral paste 40% Bolus 12 35%

Sales for food producing species, including horses, in mg/ PCU, of the various veterinary antimicrobial classes in 2010 by country 1 1 Differences between countries can partly be explained by differences in animal demographics, 13 in the selection of antimicrobial agents and in dosage regimes, among other factors

Sales of tetracyclines, penicillins and sulfonamides as a percentage of the total sales for food-producing species, including horses, in mg/ PCU, by country, for 2010 Average 19 countries 73% Tetracyclines Penicillins Sulfonamides 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% Austria Czech Republic Denmark Estonia Finland France Hungary Iceland Ireland Latvia Lithuania Netherlands Norway Portugal Slovenia Spain Sweden Belgium United Kingdom 14

Distribution of sales by pharmaceutical form for tetracyclines, in tonnes of active ingredient, by country, for 2010 Average 1 9 4% 2% countries Premix 32% Oral powder Oral solution Injection 61% 15

Distribution of sales by pharmaceutical form for penicillins, in tonnes of active ingredient, by country, for 2010 Average 1 9 countries 3% 3% 22% 21% Premix Oral powder Injection Oral solution Intramammaries 51% 16

Distribution of sales by pharmaceutical form for sulfonamides, in tonnes of active ingredient, by country, for 2010 4% 1% Average 1 9 countries 12% Premix Oral powder Oral solution 44% Injection Oral paste 39% 17

Results cont. Sales of macrolides, fluoroquinolones and 3rd- and 4th-generation cephalosporins, in % of total sales, for food-producing species, including horses, in mg/ PCU, by country, for 2010 Macrolides Fluoroquinolones 3-4 gen cephalosporines 14% 12% 10% 8% 6% 4% 2% 0% Austria Czech Republic Denmark Estonia Finland France Hungary Iceland Ireland Latvia Lithuania Netherlands Norway Portugal Slovenia Spain Sweden Belgium United Kingdom 18

Percentage of sales of the most important CIAs, in mg/ PCU, of total sales aggregated by 19 countries in 2010 0.2% Most important critical important antimicrobials (CIA) in human medicine 2% 3-4 gen cephalosporines Fluoroquinolones Macrolides 6% Note that the dosing used for the CIAs are usually much lower than for the most- selling antimicrobial agents: tetracyclines, penicillins and sulfonamides

Distribution of sales by pharmaceutical form for macrolides, in tonnes of active ingredient, by country, for 2010 Average 1 9 countries 9% 11% Premix Oral powder Oral solution Injection 45% 36% 20

Distribution of sales by pharmaceutical form for fluoroquinolones, in tonnes of active ingredient, by country, for 2010 Average 1 9 countries 21% Oral solution Injection 79% 21

Distribution of sales by pharmaceutical form for 3rd- and 4th- generation cephalosporins, in tonnes of active ingredient, by country, for 2010 Average 1 9 countries 41% Injection Intramammaries 59% 22

Summary • The major part of the sales of veterinary antimicrobial agents in the 19 countries is for herd treatment but considerable variations between countries • The prescribing patterns of the various antimicrobial classes, expressed as mg/ PCU, varied substantially between the countries.

Summary cont. • Of total sales tetracyclines, penicillins and sulfonamides are the most-selling veterinary antimicrobial agents, both by country (range 61-81% ) and overall (73% ) in the 19 countries • Overall in the 19 countries the sales, in mg/ PCU of the most CIAs account for 8% of total sales • The percentage of sales of the most important CIAs varies considerably between countries (range 0.2% -12% ) 24

Summary cont. • A many-fold difference in the sales, expressed as mg/ PCU, is observed between the most- and least-selling countries. • This is in part likely to be due to – differences in the composition of the animal population in the various countries – variation in terms of dosage used, length of treatment period or formulation of the various antimicrobial agents used; • However, these factors can only partly explain the differences; other factors also need to be considered. 25

Use of the ESVAC 2010 data • EC review of medicated feed legislation • CVMP prioritisation of referrals for antimicrobials • CVMP Antimicrobials Working Party reflection papers on various classes of antimicrobials • World Economic Forum, Davos 2013 http: / / reports.weforum.org/ global-risks-2013/ risk-case-1/ the-dangers-of-hubris-on- human-health/ # read • Requests from universities 26

Acknow ledgem ents • The European Medicines Agency wishes to thank Christina Greko and Gérard Moulin for their contribution to the development of this report. • Klemens Fuchs, Lionel Laurier, Jeroen Dewulf, Lucie Pokludová, Erik Jacobsen, Marju Sammul, Katrin Kurvits, Katariina Kivilahti-Mäntylä, Gérard Moulin, Ann Chevance, János Kovács, Jóhann M. Lenharðsson, Jeremiah Gabriel Beechinor, Gavin Ryan, Valda Sejane, Gatis Ozoliņš, Unge Zymantaite, Albert Meijering, Maria Helena Ponte, Teresa Mafalda Flores, Anton Svetlin, Rinaldo Zidar, Cristina Muñoz Madero, Kinfe Girma, Christina Greko, Nick Renn and Renee Sheehan are thankfully acknowledged for providing the data from their countries and for reviewing this report.