DS / Zactran Forum ‐ Cascais ‐ 30 Sept 2010 1
3
ANTIBIOTIC
VOLUMES AND
DISTRIBUTION
4
RESISTANCE
MONITORING
5
RESPONSIBLE
...
DS / Zactran Forum ‐ Cascais ‐ 30 Sept 2010 2
Animal Health and Food Security/Food Safety
• WORLD POPULATION
• FOOD SECURI...
DS / Zactran Forum ‐ Cascais ‐ 30 Sept 2010 3
AH – FOOD SECURITY/FOOD SAFETY
Animal medicines incl. antibiotics
have a ver...
DS / Zactran Forum ‐ Cascais ‐ 30 Sept 2010 4
AH – FOOD SECURITY/FOOD SAFETY
A very important future?
• “20% of animal pro...
DS / Zactran Forum ‐ Cascais ‐ 30 Sept 2010 5
AH – FOOD SECURITY/FOOD SAFETY
• Data provided by the 27 EU Member States fo...
DS / Zactran Forum ‐ Cascais ‐ 30 Sept 2010 6
AH – FOOD SECURITY/FOOD SAFETY
Animals need medicines too!
• The need for an...
DS / Zactran Forum ‐ Cascais ‐ 30 Sept 2010 7
The war of “bugs vs. drugs”
• HISTORY OF ANTIBIOTIC AND RESISTANCE DEVELOPME...
DS / Zactran Forum ‐ Cascais ‐ 30 Sept 2010 8
THE WAR OF « BUGS vs. DRUGS »
Resistance is inherent to us
Fleming: Nobel Pr...
DS / Zactran Forum ‐ Cascais ‐ 30 Sept 2010 9
THE WAR OF “BUGS vs. DRUGS”
• 20% of Europeans said they had taken ABs to tr...
DS / Zactran Forum ‐ Cascais ‐ 30 Sept 2010 10
T. ISHIBASHI– 17/01/2008; Brussels
Antibiotic Classification
* Also on the ...
DS / Zactran Forum ‐ Cascais ‐ 30 Sept 2010 11
Antibiotic Volumes
• IFAH-Europe: ANTIBIOTICS & CONTEXT
• MEMBER STATE SYST...
DS / Zactran Forum ‐ Cascais ‐ 30 Sept 2010 12
Decreased antibiotic use in animals? –
Yes, sort of!
COLLECTING VOLUME DATA
DS / Zactran Forum ‐ Cascais ‐ 30 Sept 2010 13
COLLECTING VOLUME DATA
ESVAC – European Surveillance of
Veterinary Antimicr...
DS / Zactran Forum ‐ Cascais ‐ 30 Sept 2010 14
Antimicrobial Resistance (AMR)
Monitoring
• EU - JOINT OPINION ON AMR/ZOONO...
DS / Zactran Forum ‐ Cascais ‐ 30 Sept 2010 15
RESISTANCE MONITORING
AMR challenge today
• Salmonella resistance to Fluoro...
DS / Zactran Forum ‐ Cascais ‐ 30 Sept 2010 16
RESISTANCE MONITORING
Commission – staff working
paper on AMR (2009)
• Purp...
DS / Zactran Forum ‐ Cascais ‐ 30 Sept 2010 17
RESISTANCE MONITORING
Possible consequences
• Prohibition/limitations of ve...
DS / Zactran Forum ‐ Cascais ‐ 30 Sept 2010 18
• WHAT NEEDS TO BE DONE
• EPRUMA
• CONCLUSIONS
DS / Zactran Forum ‐ Cascais ‐ 30 Sept 2010 19
RESPONSIBLE USE
How to address AMR in
humans by vet medicine?
• Reducing th...
DS / Zactran Forum ‐ Cascais ‐ 30 Sept 2010 20
RESPONSIBLE USE
“Best-practice framework for the use of
antimicrobials in f...
DS / Zactran Forum ‐ Cascais ‐ 30 Sept 2010 21
DS / Zactran Forum ‐ Cascais ‐ 30 Sept 2010 22
CONCLUSIONS
Conclusions
• We face a food supply challenge
• Animals need me...
DS / Zactran Forum ‐ Cascais ‐ 30 Sept 2010 23
THANK YOU
A happy end?
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11. political and regulatory aspects of veterinary antibiotics use in europe

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11. political and regulatory aspects of veterinary antibiotics use in europe

  1. 1. DS / Zactran Forum ‐ Cascais ‐ 30 Sept 2010 1 3 ANTIBIOTIC VOLUMES AND DISTRIBUTION 4 RESISTANCE MONITORING 5 RESPONSIBLE USE Political and Regulatory Aspects of Veterinary Antibiotic use in Europe DIETER SCHILLINGER 1 ANIMAL HEALTH AND FOOD SECURITY/ FOOD SAFETY 2 THE WAR OF « BUGS vs. DRUGS »
  2. 2. DS / Zactran Forum ‐ Cascais ‐ 30 Sept 2010 2 Animal Health and Food Security/Food Safety • WORLD POPULATION • FOOD SECURITY/FOOD SAFETY • RESIDUES
  3. 3. DS / Zactran Forum ‐ Cascais ‐ 30 Sept 2010 3 AH – FOOD SECURITY/FOOD SAFETY Animal medicines incl. antibiotics have a very important future! • Saving agricultural resources will be essential for food security Green et al. (2005) “Farming and the Fate of Wild Nature.” Science Tilman et al. (2002) “Agricultural sustainability and intensive production practices.” Nature UN-FAO (2002) “World Agriculture: toward 2015/2030”
  4. 4. DS / Zactran Forum ‐ Cascais ‐ 30 Sept 2010 4 AH – FOOD SECURITY/FOOD SAFETY A very important future? • “20% of animal production is lost because of animal diseases” Univ. Leuven • “Without veterinary medicines we would need 89% more cattle in Europe to produce the same amount of meat and milk”
  5. 5. DS / Zactran Forum ‐ Cascais ‐ 30 Sept 2010 5 AH – FOOD SECURITY/FOOD SAFETY • Data provided by the 27 EU Member States for 2008 • Over 750,000 targeted meat/milk samples - less than 2,000 (0.27%) results were found to be over the legal limits • The highest proportion of the non-compliant results: Antimicrobials (46%) Hormones (19%) Other veterinary medicinal products (18%) • Fact = only 0.12% (46% of 0.27%) of 750,000 samples contained levels of antibiotics above legal limits. Animals are not “stuffed full of antibiotics” EFSA report on residues (2010)
  6. 6. DS / Zactran Forum ‐ Cascais ‐ 30 Sept 2010 6 AH – FOOD SECURITY/FOOD SAFETY Animals need medicines too! • The need for antimicrobials to treat animal bacterial diseases will remain - Ethical reasons - Economical reasons - Environmental reasons - Food safety reasons
  7. 7. DS / Zactran Forum ‐ Cascais ‐ 30 Sept 2010 7 The war of “bugs vs. drugs” • HISTORY OF ANTIBIOTIC AND RESISTANCE DEVELOPMENT • EUROBAROMETER • CRITICAL LISTS OF ANTIBIOTICS
  8. 8. DS / Zactran Forum ‐ Cascais ‐ 30 Sept 2010 8 THE WAR OF « BUGS vs. DRUGS » Resistance is inherent to us Fleming: Nobel Prize lecture - 1945 “If a specific antibiotic is frequently applied, selection of resistant individuals among the target bacteria will normally result” If a bacterium develops resistance against a specific antibiotic, other antibiotics of the same class with a similar mode of action may also lose their effectiveness (cross resistance). In 1947 physicians observed the first case of clinical resistance (Staphylococcus aureus/Penicillin).
  9. 9. DS / Zactran Forum ‐ Cascais ‐ 30 Sept 2010 9 THE WAR OF “BUGS vs. DRUGS” • 20% of Europeans said they had taken ABs to treat flu • 53% of Europeans said ABs kill viruses • 83% were aware that the unnecessary use of ABs makes them ineffective Eurobarometer (2010) ECDC Report 2008 Consuming few antibiotics: Dutch (1), Germans, Scandinavians and Baltics - 5% penicillin resistance in Streptococcus pneumonia Main users: Greece (1), Cyprus, France, Italy and Spain - 25% penicillin resistance in Streptococcus pneumonia
  10. 10. DS / Zactran Forum ‐ Cascais ‐ 30 Sept 2010 10 T. ISHIBASHI– 17/01/2008; Brussels Antibiotic Classification * Also on the critical list of WHO Tetracyclines* Sulfonamides* StreptograminsPolypeptidesQuinolones* QuinoxalinesPleuromutilinePhenicols OrthosomycineLincosamidesPenicillins* NovobiocineIonophoresMacrolides* Fusidic AcidFosfomycineCephalosporins* BicyclomycineRifamycineAminoglycosides* importanthighly importantcritically important
  11. 11. DS / Zactran Forum ‐ Cascais ‐ 30 Sept 2010 11 Antibiotic Volumes • IFAH-Europe: ANTIBIOTICS & CONTEXT • MEMBER STATE SYSTEMS • EMA PROPOSAL - ESVAC
  12. 12. DS / Zactran Forum ‐ Cascais ‐ 30 Sept 2010 12 Decreased antibiotic use in animals? – Yes, sort of! COLLECTING VOLUME DATA
  13. 13. DS / Zactran Forum ‐ Cascais ‐ 30 Sept 2010 13 COLLECTING VOLUME DATA ESVAC – European Surveillance of Veterinary Antimicrobial Consumption • Broad agreement on the value of collecting volume data (interpretation of AMR monitoring over time). • The data should be collected in a reliable, efficient, consistent and verifiable manner yet providing for confidentiality. • The cumulative data should be presented in a format that makes it scientifically useful for researchers, risk assessors and stakeholders yet balances the level of detail with the resources necessary to obtain it. • Data collection together with context data (animal production, food production, disease prevalence, other external factors that my influence antimicrobial usage). • Risk managers should consult with stakeholders in interpretation of the data.
  14. 14. DS / Zactran Forum ‐ Cascais ‐ 30 Sept 2010 14 Antimicrobial Resistance (AMR) Monitoring • EU - JOINT OPINION ON AMR/ZOONOTIC INFECTION • STAFF WORKING PAPER OF THE COMMISSION • CONSEQUENCES FOR VETERINARY MEDICINE
  15. 15. DS / Zactran Forum ‐ Cascais ‐ 30 Sept 2010 15 RESISTANCE MONITORING AMR challenge today • Salmonella resistance to Fluoroquinolones & Cephalosporins • Campylobacter resistance to Fluoroquinolones & Macrolides • MRSA (Methicillin Resistant Staphylococcus aureus) presence in swine • ESBL (Extended Spectrum Beta-Lactamase) in Gram negative bacteria (most commonly E. coli and Klebsiella pneumoniae) • Direct transfer from animals to humans via zoonotic pathogens • In-direct transfer of resistance genes from animal bacteria non-pathogenic for humans to human pathogenic species
  16. 16. DS / Zactran Forum ‐ Cascais ‐ 30 Sept 2010 16 RESISTANCE MONITORING Commission – staff working paper on AMR (2009) • Purpose: serve as a basis for discussion and further reflections • AMR is an unresolved issue in public health • Each year 25,000 patients die in the EU/costs of 1.5bn € • Decreasing pace of introduction of new classes of AM • EARSS (European Antimicrobial Resistance Surveillance System) in human medicine • Harmonised monitoring for MRSA on intensively reared animals; AMR of Campy in poultry; AMR in commensals and ESBL • Applicants are requested to address the issue of AMR and propose measures to limit its development • Recommendations and tools to improve responsible use
  17. 17. DS / Zactran Forum ‐ Cascais ‐ 30 Sept 2010 17 RESISTANCE MONITORING Possible consequences • Prohibition/limitations of veterinary use of certain critically important antimicrobials for human medicines • Change of dispensing rights of veterinary medicines from veterinarians to pharmacies • Harmonisation of risk assessment methodologies • Mandatory collection of usage at species level • Resistance as a pharmacovigilance adverse event • Prohibition of the advertising of veterinary antimicrobials • Legal enforcement of responsible veterinary use of antibiotics
  18. 18. DS / Zactran Forum ‐ Cascais ‐ 30 Sept 2010 18 • WHAT NEEDS TO BE DONE • EPRUMA • CONCLUSIONS
  19. 19. DS / Zactran Forum ‐ Cascais ‐ 30 Sept 2010 19 RESPONSIBLE USE How to address AMR in humans by vet medicine? • Reducing the use of antibiotics in vet medicine? Difficult: 80% of animal medicines are related to infectious diseases (less than 10% in human medicine) • New antimicrobial classes/pathogen-specific (narrow- spectrum/disease-focused) antibiotics • Alternative means (e.g. probiotics, bacteriophages, efflux pump inhibitors, biofilm disrupters, virulence factors,) • New vaccines; state-of-the-art on-site diagnostics • Responsible use of antibiotics
  20. 20. DS / Zactran Forum ‐ Cascais ‐ 30 Sept 2010 20 RESPONSIBLE USE “Best-practice framework for the use of antimicrobials in food-producing animals in the EU” – www.epruma.eu • COPA/COGECA (farmers and co-operatives), • EISA (European Initiative for Sustainable Development in Agriculture), • FEFAC (feed manufacturers), • FESASS (animal-health farmer organizations), • FVE (veterinary surgeons) • IFAH-Europe (animal health industry)
  21. 21. DS / Zactran Forum ‐ Cascais ‐ 30 Sept 2010 21
  22. 22. DS / Zactran Forum ‐ Cascais ‐ 30 Sept 2010 22 CONCLUSIONS Conclusions • We face a food supply challenge • Animals need medicine too – we cannot eliminate diseases • Innovation needs to be encouraged • Susceptibility surveillance needs to be harmonized and volume collection needs to be rolled out • Responsible use must be promoted “The right antibiotic applied correctly” “As little as possible, but as much as necessary”
  23. 23. DS / Zactran Forum ‐ Cascais ‐ 30 Sept 2010 23 THANK YOU A happy end?

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