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01antibiotics d schillinger
1. 4TH MERIAL FORUM
HAVE WE GOT PCVD &
SWINE INFLUENZA UNDER
CONTROL?
2. The future of antibiotics use in
Europe
Moderator: Dr Sophie Randoux
โข The antibiotic hype and the consequences
for pig production in Europe.
Dr. D. Schillinger
โข Limiting the use of antibiotics in the Pig
industry: the Danish experience.
Dr M. Andreasen
โข PCVD control in 2012: how to design the
best PCV2 vaccination programme?
Dr R. Aerts
3. The Antibiotic-Hype and
the Consequences for Pig
Production in Europe
4th MERIAL Swine Forum
Berlin โ May 30th to June 1st, 2012
Dr. Dieter Schillinger โ Animal Health Consultancy
4. EFSA โ Report for 2010 on the results from
the monitoring of vet medicinal product
residues in live and animal products
418,081 targeted samples were reported under
Council Directive 96/23/EC:
โข 61% were analysed for veterinary drugs and
contaminants
โข 0,33% non-compliant
โข For antibacterials, 0.23% samples non-compliant
โข Highest frequencies on non-compliant for antibacterials
were found in honey (2.9%) and rabbit meat (0.62%)
โข No notable variations in the frequency of non-compliant
samples over the years
D.Schillinger โ 4th Merial Forum 4
5. โIncreasing Transmission of Antibiotic
Resistance from Animals to Humansโ
Frank M. Aarestrup & Niels Frimodt-Moller; Dรคnemark,
Mai 2011
โข The importance of the animal reservoir for
emergence of AMR in bacteria in humans is difficult
to estimate.
โข It still is the human usage of antibiotics which
contributes most to resistance observed in humans.
โข But the contribution from animals is large and larger
than estimated just a few years ago.
โข This indicates the need to implement restriction on
antimicrobial usage for both humans and animals
D.Schillinger โ 4th Merial Forum 5
6. One Health โ The view of EFPIA
European Federation of Pharmaceutical Industries and Associations
โข Widespread over-prescription and misuse of antibiotics
triggered resistance - need of new drugs
โข Treatments must be affordable โ few financial incentives
to stimulate research
โข New business model โ intensifying appropriate use rather
than overuse (maximising sales)
โข Antimicrobials are not very profitable โ treatment period
only a few days
โข Risk of resistance may reduce the lifecycle
โข Innovation โ tax credits for research, prize or award for a
successfully developed drug, extension of exclusive
patent rights
D.Schillinger โ 4th Merial Forum 6
7. ESVAC
European Surveillance of Veterinary Antimicrobial Consumption
โข 2005-2009 Trends in the sales of vet
antimicrobial agents in nine European
countries (published September 2011)
โข www.ema.eu/docs/en_GB/document_library/Report/2011/09/WC5001123
09.pdf
โข Czech Republic, Denmark, Finland, France,
the Netherlands, Norway, Sweden,
Switzerland, UK
โข PCU = Population Correction Unit, a proxy for
the animal biomass at risk of being treated
Commission requests the EMA to
โข Develop a harmonised approach for collection and
reporting of data on antimicrobial veterinary medicinal
products
โข Collect the data from MSs and manage the data base
โข Draft an annual report with the data from MSs
D.Schillinger โ 4th Merial Forum 7
8. Trends in the sales of veterinary
antimicrobial agents in nine European
EMA/238630/2011
Reporting period: 2005-2009
countries
D.Schillinger โ 4th Merial Forum 8
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: 2005-2009
D.Schillinger โ 4th Merial Forum 9
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!
โข 3rd and 4th generation Cephalosporins
โข Quinolones (incl. Fluoroquinolones)
โข Macrolides
โข Penicillins
โข Aminoglycosides
โข โฆโฆ
Joint FAO/OIE/WHO Expert Meeting on Critically Important
Antimicrobials (Rome, November 2007)
D.Schillinger โ 4th Merial Forum 10
11. AMR โ Policy positions of key
stakeholders (1)
11/2009 โ European Commission staff working paper
o Loss of efficacy of antimicrobials โa largely unresolved issue in
public healthโ
o 25,000 patients dying annually; โฌ 1.5 billion costs; 4 Mio patients
06/2010 โ Heads of Medicines Agencies (HMA)
o โStrategic plan on antimicrobial issuesโ
o Most important task in vet medicine: maintaining efficacy of
antimicrobials and minimizing strategy
o Responsible use โ 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 โ 4th Merial Forum 11
12. AMR โ Policy positions of key
stakeholders (2)
10/2010 โ Chief Veterinary Officers (CVOs)
o โConclusions on Antimicrobial Resistanceโ
o Strict enforcement of existing regulatory framework
o Minimise the use of antimicrobials as preventative treatments
o Alternative methods (vaccination, biosecurity, management)
o Discourage cascade
07/2011 โ CMVP (Committee for Medicinal Products for Veterinary Use)
o โStrategy on antimicrobials 2011-2015โ
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 โ 4th Merial Forum 12
13. AMR โ Policy positions of key
stakeholders (3)
09/2011 โ European Food Safety Authority (EFSA)
o โScientific opinion on the public health risks of bacterial strains
producing ESBLs and/or AmpC ร-lactamases in food-producing
animalsโ
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 โvery low to lowโ
09/2011 โ 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 โ 4th Merial Forum 13
14. AMR โ Policy positions of key
stakeholders (4)
05/2011 and 10/2011 โ 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 โ 4th Merial Forum 14
15. AMR โ Policy positions of key
stakeholders (5)
11/2011 โ 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 โOne Healthโ initiative.
The Commission proposes to put in
place a 5-year Action Plan to fight
against AMR based on 12 key actions
D.Schillinger โ 4th Merial Forum 15
16. Communication from the Commission to
the European Parliament and the Council
15/11/2011 โ Action Plan against the rising threats from AMR
1. Strengthening the promotion of the appropriate use of antimicrobials
in all Member States
2. Strengthening the regulatory framework on veterinary
medicines and on medicated feed
3. Introduce recommendations for prudent use in veterinary
medicine, including follow-up reports
4. Strengthening infection prevention and control in healthcare settings
5. Introduce a legal tool to enhance prevention and control
of infections in animals in the new Animal Health Law
6. Promote, in a staged approach, unprecedented collaborative
research and development efforts to bring new antimicrobials to
patients
D.Schillinger โ 4th Merial Forum 16
17. Communication from the Commission to
the European Parliament and the Council
15/11/2011 โ ActionPlan against the rising threats from AMR
7. Promote efforts to analyse the need for new antibiotics
into veterinary medicine
8. Develop and/or strengthen multilateral and bilateral commitments for
the prevention and control of AMR in all sectors
9. Strengthen surveillance systems on AMR and antimicrobial
consumption in human medicine
10. Strengthensurveillance systems on AMR and
antimicrobial consumption in animal medicine
11. Reinforce and co-ordinate research efforts
12. Survey and comparative effectiveness research
D.Schillinger โ 4th Merial Forum 17
18. โCombating Antimicrobial Resistance โ
Time for Joint Actionโ
Copenhagen, March 2012
3 Major Themes
1. Decreasing general usage
2. Decreasing use of critically important antimicrobials
3. Monitoring and surveillance
Conclusions
โข A ban on use of cephalosporins in veterinary medicine
โข Prohibition on prescribing and dispensing
D.Schillinger โ 4th Merial Forum 18
19. Spotlight on Antimicrobial
Resistance for World Veterinary Day โ
28/04/2012
OIE
โข The global demand for proteins โ healthy animals
โข Antibiotics are not ordinary products โ specialists
โข Promoting the prudent use in all animals is a priority
โข Veterinarians around the world must prevent misuse
BVA
โข The BVAโs 8-point plan for responsible use in veterinary practice
โข Vet must accept constraints on the use of certain classes of AM
โข Antimicrobials are a vital tool in our armoury to combat animal diseases
โข One Health
IFAH
โข Antibiotics need to be used responsibly, with care and discrimination
โข Innovation and R&D to find new classes and innovative ways to fight
new diseases
D.Schillinger โ 4th Merial Forum 19
20. IFAH-Europe
Activities and Recommendations
โข The strategic and responsible use of all antimicrobial
products
โข Prescriptions of antimicrobial products should be made
on the basis of the results of resistance testing
โข The use of the โCascadeโ system should only be under
exceptional circumstances
โข Eliminating โoff-labelโ use other than according to the
Cascade
โข Efforts to maintain the availability of new and existing
classes, products and formulations
โข Support for the CVOs efforts to improve the collection of
data on antimicrobial usage at farm level
โข Target Pathogen Monitoring Programme
D.Schillinger โ 4th Merial Forum 20