Antibiotic use, regulation, and        record keeping         Matt S. Anderson, DVM       Suidae Health and Production    ...
When Fleming discoveredpenicillin, do you think he ever envisioned such a debate?
Tools of the veterinarian Vaccine Antibiotics Host of other medications   Physicians recognize the value too
The Perceived Problem1.   Antibiotics are used in animals2.   Results in the development of resistant     bacteria3.   Res...
The Perceived Problem5. Consumer buys meat and resistant bacteria   remains viable through preparation6. Resistant bacteri...
Manifestations All kinds of groups with specific agendas  and initiatives PAMPTA GFI 209 GFI 213 VFD
GFI 209 Final Guidance for Industry Medically important antimicrobial drugs  will be limited to uses assuring animal  he...
GFI 209   Medically important antimicrobial drugs    will be limited to uses that include    veterinary oversight and con...
GFI 213 Draft GFI 213 Implementation of principles espoused in  GFI 209
Veterinary Feed Directive Draft text Marketing status changes
Judicious Use of Antibiotics The right antimicrobial At the right time At the right concentration With the correct amo...
Judicious Use   Have a herd health management plan    – Supported by current diagnostics    – With a demonstrated VCPR   ...
Judicious Use   Producers    – We care    – PQA Plus   Veterinarians    – VCPR    – ELDU    – AMDUCA
We Care Program   Produce safe food   Protect and promote animal well-being   Ensure practices to protect public health...
PQA Plus GPP1 Herd health management plan GPP2 Appropriate VCPR GPP3 Use antibiotics responsibly GPP4 ID, track, and m...
PQA Plus GPP7 Use proper administration techniques,  etc. GPP8-10
VCPR    21 CFR part 5301.   Vet assumes responsibility for making     medical judgments2.   Vet has sufficient knowledge ...
VCPR Non-OTC Swine labeled products requiring  a prescription (Baytril or Naxcel) Non-swine labeled products    – ELDU
ELDU   ELDU is permitted only by or under the supervision of a veterinarian.   ELDU is allowed only for FDA approved ani...
AMDUCA record keeping   Identify the animals, either as individuals or a group.   Animal species treated.   Numbers of ...
AMDUCA label requirements   Name and address of the prescribing veterinarian.   Established name of the drug.   Any spe...
FDA Inspection Great way to test your knowledge and skill  in the areas of prescription and record  keeping These inspec...
FDA Inspection Pre-emptive residue avoidance?????? Demonstration of VCPR Looked at every product in every dark  corner ...
The Veterinarian’s Oath   Being admitted to the profession of veterinary medicine, I solemnly swear to    use my scientif...
The Veterinarian’s Oath   Being admitted to the profession of veterinary medicine, I solemnly swear to    use my scientif...
Suidae Health and Production                 Veterinary Clinic                 Research                 Management     ...
Dr. Matt Anderson - Antibiotic use and future records necessary to keep the government and our customers happy
Dr. Matt Anderson - Antibiotic use and future records necessary to keep the government and our customers happy
Dr. Matt Anderson - Antibiotic use and future records necessary to keep the government and our customers happy
Dr. Matt Anderson - Antibiotic use and future records necessary to keep the government and our customers happy
Dr. Matt Anderson - Antibiotic use and future records necessary to keep the government and our customers happy
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Dr. Matt Anderson - Antibiotic use and future records necessary to keep the government and our customers happy

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Antibiotic use and future records necessary to keep the government and our customers happy - Dr. Matt Anderson, from the 2012 Allen D. Leman Swine Conference, September 15-18, St. Paul, Minnesota, USA.

More presentations at http://www.swinecast.com/2012-leman-swine-conference-material

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Dr. Matt Anderson - Antibiotic use and future records necessary to keep the government and our customers happy

  1. 1. Antibiotic use, regulation, and record keeping Matt S. Anderson, DVM Suidae Health and Production Algona, Iowa
  2. 2. When Fleming discoveredpenicillin, do you think he ever envisioned such a debate?
  3. 3. Tools of the veterinarian Vaccine Antibiotics Host of other medications Physicians recognize the value too
  4. 4. The Perceived Problem1. Antibiotics are used in animals2. Results in the development of resistant bacteria3. Resistant bacteria remain on meat through packing process4. Resistant bacteria remains on meat through transport and to the retailer
  5. 5. The Perceived Problem5. Consumer buys meat and resistant bacteria remains viable through preparation6. Resistant bacteria is transmitted to human/human becomes infected7. Human goes to doctor and is prescribed an antimicrobial8. Human does not recover (Dr. Scott Hurd)
  6. 6. Manifestations All kinds of groups with specific agendas and initiatives PAMPTA GFI 209 GFI 213 VFD
  7. 7. GFI 209 Final Guidance for Industry Medically important antimicrobial drugs will be limited to uses assuring animal health – Loss of growth promotant claims – Expanded carbon footprint – Economically detrimental to producers  Decreased ADG  Increased F/G
  8. 8. GFI 209 Medically important antimicrobial drugs will be limited to uses that include veterinary oversight and consultation – Loss of OTC drugs – Expanded role for veterinarians in oversight  May be an opportunity but may also cost more
  9. 9. GFI 213 Draft GFI 213 Implementation of principles espoused in GFI 209
  10. 10. Veterinary Feed Directive Draft text Marketing status changes
  11. 11. Judicious Use of Antibiotics The right antimicrobial At the right time At the right concentration With the correct amount of treatment time With the correct amount of withdrawal time observed With the proper records completed and maintained
  12. 12. Judicious Use Have a herd health management plan – Supported by current diagnostics – With a demonstrated VCPR – Maintain accurate records for the appropriate amount of time
  13. 13. Judicious Use Producers – We care – PQA Plus Veterinarians – VCPR – ELDU – AMDUCA
  14. 14. We Care Program Produce safe food Protect and promote animal well-being Ensure practices to protect public health Safeguard natural resources in all of our practices Provide a work environment that is safe and consistent with our other ethical principles Contribute to a better quality of life in our communities
  15. 15. PQA Plus GPP1 Herd health management plan GPP2 Appropriate VCPR GPP3 Use antibiotics responsibly GPP4 ID, track, and maintain medication and treatment records GPP5 Adhere to withdrawal times GPP6 Properly store, label, and account for all drugs
  16. 16. PQA Plus GPP7 Use proper administration techniques, etc. GPP8-10
  17. 17. VCPR 21 CFR part 5301. Vet assumes responsibility for making medical judgments2. Vet has sufficient knowledge of the animals in question3. Vet is readily available for follow up
  18. 18. VCPR Non-OTC Swine labeled products requiring a prescription (Baytril or Naxcel) Non-swine labeled products – ELDU
  19. 19. ELDU ELDU is permitted only by or under the supervision of a veterinarian. ELDU is allowed only for FDA approved animal and human drugs. A valid Veterinarian/Client/Patient Relationship is a prerequisite for all ELDU. ELDU for therapeutic purposes only (animals health is suffering or threatened). Not drugs for production use. Rules apply to dosage form drugs and drugs administered in water. ELDU in feed is prohibited. ELDU is not permitted if it results in a violative food residue, or any residue which may present a risk to public health. FDA prohibition of a specific ELDU precludes such use
  20. 20. AMDUCA record keeping Identify the animals, either as individuals or a group. Animal species treated. Numbers of animals treated. Conditions being treated. The established name of the drug and active ingredient. Dosage prescribed or used. Duration of treatment. Specified withdrawal, withholding, or discard time(s), if applicable, for meat, milk, eggs, or animal-derived food. Keep records for 2 years. FDA may have access to these records to estimate risk to public health.
  21. 21. AMDUCA label requirements Name and address of the prescribing veterinarian. Established name of the drug. Any specified directions for use including the class/species or identification of the animal or herd, flock, pen, lot, or other group; the dosage frequency, and route of administration; and the duration of therapy. Any cautionary statements. Your specified withdrawal, withholding, or discard time for meat, milk, eggs, or any other food.
  22. 22. FDA Inspection Great way to test your knowledge and skill in the areas of prescription and record keeping These inspectors are professional, polite, incredibly thorough, and have a very limited sense of humor FDA inspection can be initiated without any notice and for not much in the way of a reason
  23. 23. FDA Inspection Pre-emptive residue avoidance?????? Demonstration of VCPR Looked at every product in every dark corner of the farm---2 day effort Every label was scrutinized Every expiration date was studied Many questions were asked If you don’t break the rules you’ll be fine
  24. 24. The Veterinarian’s Oath Being admitted to the profession of veterinary medicine, I solemnly swear to use my scientific knowledge and skills for the benefit of society through the protection of animal health, the relief of animal suffering, the conservation of livestock resources, the promotion of public health, and the advancement of medical knowledge. I will practice my profession conscientiously, with dignity, and in keeping with the principles of veterinary medical ethics. I accept as a lifelong obligation the continual improvement of my professional knowledge and competence. Adopted by AVMA HOD in 1954 – Revised in 1969 and 1999
  25. 25. The Veterinarian’s Oath Being admitted to the profession of veterinary medicine, I solemnly swear to use my scientific knowledge and skills for the benefit of society through the protection of animal health and welfare, the prevention and relief of animal suffering, the conservation of animal resources, the promotion of public health, and the advancement of medical knowledge. I will practice my profession conscientiously, with dignity, and in keeping with the principles of veterinary medical ethics. I accept as a lifelong obligation the continual improvement of my professional knowledge and competence. Revised by the AVMA executive board in late 2010
  26. 26. Suidae Health and Production  Veterinary Clinic  Research  Management  Laboratory Services  Distribution  Building distributorship  Production
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