01antibiotics d schillinger


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01antibiotics d schillinger

  2. 2. The future of antibiotics use in Europe Moderator: Dr Sophie Randoux• The antibiotic hype and the consequences for pig production in Europe. Dr. D. Schillinger• Limiting the use of antibiotics in the Pig industry: the Danish experience. Dr M. Andreasen• PCVD control in 2012: how to design the best PCV2 vaccination programme? Dr R. Aerts
  3. 3. The Antibiotic-Hype andthe Consequences for Pig Production in Europe 4th MERIAL Swine Forum Berlin – May 30th to June 1st, 2012 Dr. Dieter Schillinger – Animal Health Consultancy
  4. 4. EFSA – Report for 2010 on the results from the monitoring of vet medicinal product residues in live and animal products418,081 targeted samples were reported underCouncil Directive 96/23/EC:• 61% were analysed for veterinary drugs and contaminants• 0,33% non-compliant• For antibacterials, 0.23% samples non-compliant• Highest frequencies on non-compliant for antibacterials were found in honey (2.9%) and rabbit meat (0.62%)• No notable variations in the frequency of non-compliant samples over the years D.Schillinger – 4th Merial Forum 4
  5. 5. “Increasing Transmission of Antibiotic Resistance from Animals to Humans“Frank M. Aarestrup & Niels Frimodt-Moller; Dänemark,Mai 2011• The importance of the animal reservoir for emergence of AMR in bacteria in humans is difficult to estimate.• It still is the human usage of antibiotics which contributes most to resistance observed in humans.• But the contribution from animals is large and larger than estimated just a few years ago.• This indicates the need to implement restriction on antimicrobial usage for both humans and animals D.Schillinger – 4th Merial Forum 5
  6. 6. One Health – The view of EFPIA European Federation of Pharmaceutical Industries and Associations• Widespread over-prescription and misuse of antibiotics triggered resistance - need of new drugs• Treatments must be affordable – few financial incentives to stimulate research• New business model – intensifying appropriate use rather than overuse (maximising sales)• Antimicrobials are not very profitable – treatment period only a few days• Risk of resistance may reduce the lifecycle• Innovation – tax credits for research, prize or award for a successfully developed drug, extension of exclusive patent rights D.Schillinger – 4th Merial Forum 6
  7. 7. ESVAC European Surveillance of Veterinary Antimicrobial Consumption • 2005-2009 Trends in the sales of vet antimicrobial agents in nine European countries (published September 2011) • www.ema.eu/docs/en_GB/document_library/Report/2011/09/WC5001123 09.pdf • Czech Republic, Denmark, Finland, France, the Netherlands, Norway, Sweden, Switzerland, UK • PCU = Population Correction Unit, a proxy for the animal biomass at risk of being treatedCommission requests the EMA to• Develop a harmonised approach for collection and reporting of data on antimicrobial veterinary medicinal products• Collect the data from MSs and manage the data base• Draft an annual report with the data from MSsD.Schillinger – 4th Merial Forum 7
  8. 8. Trends in the sales of veterinary antimicrobial agents in nine European EMA/238630/2011 Reporting period: 2005-2009 countriesD.Schillinger – 4th Merial Forum 8
  9. 9. Trends in the sales of veterinary antimicrobial agents in nine European countries Temporal trends in the sales, expressed in mg per population correction (mg/PCU), of veterinary antimicrobial agents in European countries. Note the differences in the scales. EMA/238630/2011 Reporting period: 2005-2009D.Schillinger – 4th Merial Forum 9
  10. 10. Critically important antimicrobials in vet and human medicine The Dilemma: For a number of antimicrobial classes there is an overlap of the OIE and the WHO list! • 3rd and 4th generation Cephalosporins • Quinolones (incl. Fluoroquinolones) • Macrolides • Penicillins • Aminoglycosides • …… Joint FAO/OIE/WHO Expert Meeting on Critically Important Antimicrobials (Rome, November 2007)D.Schillinger – 4th Merial Forum 10
  11. 11. AMR – Policy positions of key stakeholders (1)11/2009 – European Commission staff working paper o Loss of efficacy of antimicrobials ‘a largely unresolved issue in public health’ o 25,000 patients dying annually; € 1.5 billion costs; 4 Mio patients06/2010 – Heads of Medicines Agencies (HMA) o ‘Strategic plan on antimicrobial issues’ o Most important task in vet medicine: maintaining efficacy of antimicrobials and minimizing strategy o Responsible use – the focus of any action minimizing AMR o All antimicrobials classed as prescription-only medicines o Surveys of antimicrobial consumption and resistance (human + vet medicine) D.Schillinger – 4th Merial Forum 11
  12. 12. AMR – Policy positions of key stakeholders (2)10/2010 – Chief Veterinary Officers (CVOs) o ‘Conclusions on Antimicrobial Resistance’ o Strict enforcement of existing regulatory framework o Minimise the use of antimicrobials as preventative treatments o Alternative methods (vaccination, biosecurity, management) o Discourage cascade07/2011 – CMVP (Committee for Medicinal Products for Veterinary Use) o ‘Strategy on antimicrobials 2011-2015’ o Confirmed the importance of effective antimicrobial treatment for relevant indications in all species to alleviate pain and suffering o Fluoroquinolones and 3rd & 4th generation cephalosporins should be classed as second line antimicrobials D.Schillinger – 4th Merial Forum 12
  13. 13. AMR – Policy positions of key stakeholders (3)09/2011 – European Food Safety Authority (EFSA) o ‘Scientific opinion on the public health risks of bacterial strains producing ESBLs and/or AmpC ß-lactamases in food-producing animals’ o Recommendation: discontinuing or restricting all use of 3rd and 4th generation of cephalosporins in all food-producing animals o Resistance in cattle and pigs ‘very low to low’09/2011 – TATFAR (Transatlantic Taskforce on Antimicrobial Resistance) o Urgent antimicrobial resistance issues focused on appropriate therapeutic use of antimicrobial drugs in the medical and veterinary communities o Strategies for improving the pipeline of new antimicrobial drugs o 17 recommendations for future EU-US cooperation to ensure that antimicrobials remain effective D.Schillinger – 4th Merial Forum 13
  14. 14. AMR – Policy positions of key stakeholders (4)05/2011 and 10/2011 – European Parliament o More research (new products, alternative production systems) o Better monitoring of effects of antibiotics o Surveillance of AMR o Reduce use of antimicrobials in livestock and companion animals o EU vets retain right to sell medicines o Emphasis on responsible use, good husbandry practices, research o Commission multi-annual action plan against AMR D.Schillinger – 4th Merial Forum 14
  15. 15. AMR – Policy positions of key stakeholders (5)11/2011 – European Commission Conclusion: The increasing resistance to antimicrobial drugs represents one of the major emerging threats to human health. To address this, a holistic approach is stressed in line with the ‘One Health’ initiative. The Commission proposes to put in place a 5-year Action Plan to fight against AMR based on 12 key actions D.Schillinger – 4th Merial Forum 15
  16. 16. Communication from the Commission to the European Parliament and the Council15/11/2011 – Action Plan against the rising threats from AMR1. Strengthening the promotion of the appropriate use of antimicrobials in all Member States2. Strengthening the regulatory framework on veterinary medicines and on medicated feed3. Introduce recommendations for prudent use in veterinary medicine, including follow-up reports4. Strengthening infection prevention and control in healthcare settings5. Introduce a legal tool to enhance prevention and control of infections in animals in the new Animal Health Law6. Promote, in a staged approach, unprecedented collaborative research and development efforts to bring new antimicrobials to patients D.Schillinger – 4th Merial Forum 16
  17. 17. Communication from the Commission to the European Parliament and the Council15/11/2011 – ActionPlan against the rising threats from AMR7. Promote efforts to analyse the need for new antibioticsinto veterinary medicine8. Develop and/or strengthen multilateral and bilateral commitments forthe prevention and control of AMR in all sectors9. Strengthen surveillance systems on AMR and antimicrobialconsumption in human medicine10. Strengthensurveillance systems on AMR andantimicrobial consumption in animal medicine11. Reinforce and co-ordinate research efforts12. Survey and comparative effectiveness research D.Schillinger – 4th Merial Forum 17
  18. 18. “Combating Antimicrobial Resistance – Time for Joint Action“ Copenhagen, March 20123 Major Themes1. Decreasing general usage2. Decreasing use of critically important antimicrobials3. Monitoring and surveillanceConclusions• A ban on use of cephalosporins in veterinary medicine• Prohibition on prescribing and dispensingD.Schillinger – 4th Merial Forum 18
  19. 19. Spotlight on Antimicrobial Resistance for World Veterinary Day – 28/04/2012OIE• The global demand for proteins – healthy animals• Antibiotics are not ordinary products – specialists• Promoting the prudent use in all animals is a priority• Veterinarians around the world must prevent misuseBVA• The BVA’s 8-point plan for responsible use in veterinary practice• Vet must accept constraints on the use of certain classes of AM• Antimicrobials are a vital tool in our armoury to combat animal diseases• One HealthIFAH• Antibiotics need to be used responsibly, with care and discrimination• Innovation and R&D to find new classes and innovative ways to fight new diseases D.Schillinger – 4th Merial Forum 19
  20. 20. IFAH-Europe Activities and Recommendations• The strategic and responsible use of all antimicrobial products• Prescriptions of antimicrobial products should be made on the basis of the results of resistance testing• The use of the ‘Cascade’ system should only be under exceptional circumstances• Eliminating ‘off-label’ use other than according to the Cascade• Efforts to maintain the availability of new and existing classes, products and formulations• Support for the CVOs efforts to improve the collection of data on antimicrobial usage at farm level• Target Pathogen Monitoring Programme D.Schillinger – 4th Merial Forum 20
  21. 21. www.epruma.eu 21
  22. 22. Thank youD.Schillinger – 4th Merial Forum 22