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Antimicrobial
    Use in Veterinary Medicine
     Today and Tomorrow...

®




       W. Ron DeHaven, DVM, MBA
       Executive Vice President and CEO
       American Veterinary Medical Association
Definitions
®




     Microorganisms

     Antimicrobials

     Antibiotics

     Antimicrobial   Resistance
Uses of Antibiotics
®




    Animal uses currently approved by FDA
        Treatment
        Control
        Prevention
        Production Uses
         (Growth Promotion/Feed Efficiency)
Sources and Regulatory Oversight
            of Antimicrobials
®


        Over-the-Counter (OTC)
           Producers, only as approved on label; can be feed or water

           Added to feed by a feed mill or producer as directed on the
             FDA approved label
        Veterinary Feed Directive (VFD)
           Currently only 2 drugs are approved - florfenicol (Nuflor) and
             tilmicosin (Pulmotil)
           OTC => VFD medically important antimicrobials in feed

        Prescription (Rx) –
           GFI 213 transitions medically important antimicrobials in
             water from OTC to Rx and allows mechanism to seek
             therapeutic claims for production use antimicrobials
Differences in Use
®

       Human Medicine
          For treatment or prevention

          Physician determines indication and route of administration,
           dose, frequency, and duration of treatment
          No restrictions on extra-label or "off label" uses

       Food Animals
          Drug only approved for specific indications, e.g., respiratory
           disease due to Pasteurella multocida
          Only allowed at specific dosage, duration, frequency, and
           route of administration
          Extra label uses heavily regulated
A Source of Controversy…
®




       Antimicrobial use in food producing animals can serve as a
        reservoir for antimicrobial resistance, i.e., the more we
        expose the organisms to antimicrobials the more we give
        them the opportunity to develop resistance.

       Although that may be true in a very simplified, general sense,
        there is no clear scientific evidence of how, and to what
        extent such exposure affects human health.
Additional Complexity
®



       While plausible, there is no hard evidence that cases of
        human infection with a resistant bacteria have been
        caused by use of antimicrobials in food animals.

       There is little to no evidence that restricting or eliminating
        the use of antimicrobials in food-producing animals
        would improve human health or reduce the risk of
        antimicrobial resistance to humans.
Benefits vs. Risk
®


       Benefits of Antibiotics
           Animal welfare
                Prevent, control, & treat disease
           Food safety
                Healthy animals produce safer food
         Economic - Efficiency
         Environmental

       Disadvantages
           Antimicrobial resistant bacteria can develop
Impact of Animal Health on
               Foodborne Risk
®


       Healthy: Passed FSIS antemortem inspection
         (not visibly ill)
       Some (~7%) had internal adhesions from previous
        chronic infection
          Carcasses 90% more likely to be contaminated
           with Salmonella




                                        Photo credit: Hudson ISD FFA
Which is Preferred?
®




       Less Use vs. More Use
         Lower dose in more animals (today)
         Higher dose in fewer animals (tomorrow?)

            Stronger drugs?

            Or more culls?
Differing Approaches
®



       Discontinue Use
           Although we may not know the degree of risk, why
            should we take any chances?
           Let’s eliminate or reduce the use of antibiotics in animals
            on the possibility that this is jeopardizing human health.

       Continue Use
           Let’s not take any action that is not based on a scientific
            risk assessment.
           The benefits to animal health, welfare, and food safety
            outweigh the risks to human health based on risk
            assessments done to date.

       Novel Approach ?
We Need a Collaborative Approach!
®
AVMA's Current Approach
®


       Judicious use of antimicrobials
          Maximize benefit, minimize risks

       Supports veterinary involvement in any use of
        antimicrobials
       Actions to limit use should be based on:
          Available scientific research

          Risk-based assessments
Preservation of Antibiotics for Medical
              Treatment Act (PAMTA)
®



       Purpose
            Preserve the effectiveness of medically important
             antibiotics used in the treatment of human and animal
             diseases by reviewing the safety of certain antibiotics for
             nontherapeutic purposes in food-producing animals.

       Nontherapeutic Use
            Use of the drug as a feed or water additive for an animal
             in the absence of any clinical sign of disease in the
             animal for growth promotion, feed efficiency, weight gain,
             routine disease prevention, or other routine purpose.
AVMA’s Position on PAMTA
®




     Not supported by science (based on
      AVMA’s interpretation)
     Lacks risk-based assessments
     Has potential to eliminate 2 or 3 of the 4
      approved uses of antibiotics in animals
     Animal welfare implications
Greater Veterinary Oversight
®



       Some believe this is the way to go – supported
        by market research
       General agreement within AVMA (We think!)
       Workforce shortage issue (some disagree)
       VFD is primary vehicle for greater oversight in
        antimicrobials in feed
       Degree of oversight proportionate to risk
       AVMA would do all we can to make it work!
           Veterinary Oversight Steering Committee
Legislation versus Regulation
®



       Legislation
          Less opportunity for scientific input & evaluation

          Can be more politically motivated

       Regulation (rulemaking process)
          Provides months/years for input

          More of a deliberative process

          Statutory authority already exists
FDA-CVM Perspective
®




       Innovative use of VFD
       Supportive of and recognition of the importance of
        treatment, control, and prevention
       Phase in greater veterinary oversight
       Phase out growth promotion/feed efficiency
          Data needed – Is Growth Promotion really
           prevention?
So, where are we headed?
®
Pathogenesis of Baldness
®
So, where are we headed?
®




       More Veterinary Oversight
         Workforce concerns
         More responsibility and more credit - yet also
          more blame
       Role of Veterinarians? Huge!
®

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Dr. Ron DeHaven - Antimicrobial Use in Veterinary Medicine Today and Tomorrow

  • 1. Antimicrobial Use in Veterinary Medicine Today and Tomorrow... ® W. Ron DeHaven, DVM, MBA Executive Vice President and CEO American Veterinary Medical Association
  • 2. Definitions ®  Microorganisms  Antimicrobials  Antibiotics  Antimicrobial Resistance
  • 3. Uses of Antibiotics ® Animal uses currently approved by FDA  Treatment  Control  Prevention  Production Uses (Growth Promotion/Feed Efficiency)
  • 4. Sources and Regulatory Oversight of Antimicrobials ®  Over-the-Counter (OTC)  Producers, only as approved on label; can be feed or water  Added to feed by a feed mill or producer as directed on the FDA approved label  Veterinary Feed Directive (VFD)  Currently only 2 drugs are approved - florfenicol (Nuflor) and tilmicosin (Pulmotil)  OTC => VFD medically important antimicrobials in feed  Prescription (Rx) –  GFI 213 transitions medically important antimicrobials in water from OTC to Rx and allows mechanism to seek therapeutic claims for production use antimicrobials
  • 5. Differences in Use ®  Human Medicine  For treatment or prevention  Physician determines indication and route of administration, dose, frequency, and duration of treatment  No restrictions on extra-label or "off label" uses  Food Animals  Drug only approved for specific indications, e.g., respiratory disease due to Pasteurella multocida  Only allowed at specific dosage, duration, frequency, and route of administration  Extra label uses heavily regulated
  • 6. A Source of Controversy… ®  Antimicrobial use in food producing animals can serve as a reservoir for antimicrobial resistance, i.e., the more we expose the organisms to antimicrobials the more we give them the opportunity to develop resistance.  Although that may be true in a very simplified, general sense, there is no clear scientific evidence of how, and to what extent such exposure affects human health.
  • 7. Additional Complexity ®  While plausible, there is no hard evidence that cases of human infection with a resistant bacteria have been caused by use of antimicrobials in food animals.  There is little to no evidence that restricting or eliminating the use of antimicrobials in food-producing animals would improve human health or reduce the risk of antimicrobial resistance to humans.
  • 8. Benefits vs. Risk ®  Benefits of Antibiotics  Animal welfare  Prevent, control, & treat disease  Food safety  Healthy animals produce safer food  Economic - Efficiency  Environmental  Disadvantages  Antimicrobial resistant bacteria can develop
  • 9. Impact of Animal Health on Foodborne Risk ®  Healthy: Passed FSIS antemortem inspection (not visibly ill)  Some (~7%) had internal adhesions from previous chronic infection  Carcasses 90% more likely to be contaminated with Salmonella Photo credit: Hudson ISD FFA
  • 10. Which is Preferred? ®  Less Use vs. More Use  Lower dose in more animals (today)  Higher dose in fewer animals (tomorrow?)  Stronger drugs?  Or more culls?
  • 11. Differing Approaches ®  Discontinue Use  Although we may not know the degree of risk, why should we take any chances?  Let’s eliminate or reduce the use of antibiotics in animals on the possibility that this is jeopardizing human health.  Continue Use  Let’s not take any action that is not based on a scientific risk assessment.  The benefits to animal health, welfare, and food safety outweigh the risks to human health based on risk assessments done to date.  Novel Approach ?
  • 12. We Need a Collaborative Approach! ®
  • 13. AVMA's Current Approach ®  Judicious use of antimicrobials  Maximize benefit, minimize risks  Supports veterinary involvement in any use of antimicrobials  Actions to limit use should be based on:  Available scientific research  Risk-based assessments
  • 14. Preservation of Antibiotics for Medical Treatment Act (PAMTA) ®  Purpose  Preserve the effectiveness of medically important antibiotics used in the treatment of human and animal diseases by reviewing the safety of certain antibiotics for nontherapeutic purposes in food-producing animals.  Nontherapeutic Use  Use of the drug as a feed or water additive for an animal in the absence of any clinical sign of disease in the animal for growth promotion, feed efficiency, weight gain, routine disease prevention, or other routine purpose.
  • 15. AVMA’s Position on PAMTA ®  Not supported by science (based on AVMA’s interpretation)  Lacks risk-based assessments  Has potential to eliminate 2 or 3 of the 4 approved uses of antibiotics in animals  Animal welfare implications
  • 16. Greater Veterinary Oversight ®  Some believe this is the way to go – supported by market research  General agreement within AVMA (We think!)  Workforce shortage issue (some disagree)  VFD is primary vehicle for greater oversight in antimicrobials in feed  Degree of oversight proportionate to risk  AVMA would do all we can to make it work!  Veterinary Oversight Steering Committee
  • 17. Legislation versus Regulation ®  Legislation  Less opportunity for scientific input & evaluation  Can be more politically motivated  Regulation (rulemaking process)  Provides months/years for input  More of a deliberative process  Statutory authority already exists
  • 18. FDA-CVM Perspective ®  Innovative use of VFD  Supportive of and recognition of the importance of treatment, control, and prevention  Phase in greater veterinary oversight  Phase out growth promotion/feed efficiency  Data needed – Is Growth Promotion really prevention?
  • 19. So, where are we headed? ®
  • 21. So, where are we headed? ®  More Veterinary Oversight  Workforce concerns  More responsibility and more credit - yet also more blame  Role of Veterinarians? Huge!
  • 22. ®