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What are we learning about antibiotic use
after implementation of FDA Guidances
Chris J. Rademacher, DVM
Clinical Associate Professor
ISU Swine Extension Veterinarian
2017 FDA Antimicrobial Sales and
Distribution
Background
• Each year, the Food and Drug Administration (FDA) reports
the amounts of antimicrobials (by class) that were sold or
distributed
– Does not reflect actual usage
• Metrics reported include drug class, medical importance,
route of administration, indication, and dispensing status, as
well as species-specific estimates of these sales and
distribution
– This is the 2nd year that the report was reported by livestock species.
2017 Antimicrobial Sales by
Class of Antibiotics for all
Livestock Species
Livestock Tetracycline Use
over past 9 years
15% decrease
40%
decrease
2016-2017 Antimicrobial
Sales by Classes
2016-2017 Antimicrobial
Sales by Species
33% reduction in medically important
antibiotic use in livestock over past year
Swine Medically
Important Antibiotics
2016-2017
37% decrease
44% decrease
Livestock Medically
Important Antibiotic
Use by route of
administration over
past 9 years
Non-Medically Important
Antibiotics Use by Species
2016-2017
2017 Report Summary
• Domestic sales and distribution of medically important
antimicrobials approved for use in food-producing animals:
o Decreased by 33% from 2016 through 2017.
o Decreased by 43% from 2015 (the year of peak sales)
o Tetracyclines, which represent the largest volume of these domestic
sales (3,535,701 kg in 2017), decreased by 40% from 2016 through
2017.
• Water soluble medically important antibiotics also saw a
decrease
GVL VFDs by Species 2017-2018
Bovine
68%
Swine
30%
Ovine
1%
Other
1%
3,076 veterinarians
5.345 feed mills
Slide courtesy of Global Vet Link
GVL Average Head per VFD 2017 vs. 2018
7,409
976
638
8,732
2,219
727
-
1,000
2,000
3,000
4,000
5,000
6,000
7,000
8,000
9,000
10,000
Swine Bovine Ovine
NumberHead
Average Head Count
Year 2017 Year 2018
Poultry 3,101,073 9,941,889
Aquaculture 297,668 141,519
Honey Bees 18,064,668 49,398,490
Slide courtesy of Global Vet Link
GVL Swine VFDs by Number Head 2017-2018
0%
5%
10%
15%
20%
25%
30%
35%
40%
45%
< 2,000 2,000 - 4,999 5,000 - 9,999 10,000 - 24,999 25,000+
PercentageSwineVFDs
Head Count
Slide courtesy of Global Vet Link
GVL Swine VFDs by Indication 2017-2018
Enteritis &
Pneumonia
62%
Ileitis & Dysentery
17%
Pneumonia
12%
Cervical abscesses
3%
Leptospirosis
3%
Othe
Slide courtesy of Global Vet Link
GVL Swine VFDs by Active Ingredient 2017-2018
Chlortetracycline
59%
Tylosin
9%
Tilmicosin
9%
Oxytetracycline
7%
Chlortetracycline -
Sulfamethazine
2%
Other
14%
Slide courtesy of Global Vet Link
VFD Frequently Asked Questions
• Iowa Pork Industry Center Website
– https://www.ipic.iastate.edu/info/VFDfaq.pdf
• Examples of questions from industry
on how to write VFD with answers
from FDA directly.
How close does the client have to be to the intended
duration of feeding (number of days fed)?
• VERY CLOSE
– Must be fed according to the duration listed on the
label
• Aureo: “For not more than 14 days”
• Pulmotil: “shall not be fed to pigs for more than 21 days
• Linco/Tylan: “..feed for disease X for 21 days at 100
grams and then at 40 grams to market….”
– Regulator comments indicate they expect it to be
close to duration stated on VFD (i.e. within 1-2 days)
Prescription Frequently Asked Questions
• Iowa Pork Industry Center Website
– https://www.ipic.iastate.edu/info/IPBFAQ0217.pdf
– Examples of questions from industry on
prescriptions and labeling with answers
from Iowa Board of Pharmacy directly.
FAQ from Iowa Board of Pharmacy
• For product labeling, can you label
the container or do you have to
label each individual
bottle/packet?
• Unopened Containers can be
labeled, not individual packets
Questions??
Chris J. Rademacher, DVM| Swine Extension
Veterinarian
Iowa State University2225 Lloyd Veterinary Medical Center | Ames, IA 50011
(: (515) 294-8792 | *: cjrdvm@iastate.edu
Follow on Twitter: @cjrdvm
www.ipic.iastate.edu

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What Are We Learning About Antibiotic Use After Implementation Of FDA Guidances

  • 1. What are we learning about antibiotic use after implementation of FDA Guidances Chris J. Rademacher, DVM Clinical Associate Professor ISU Swine Extension Veterinarian
  • 2. 2017 FDA Antimicrobial Sales and Distribution
  • 3. Background • Each year, the Food and Drug Administration (FDA) reports the amounts of antimicrobials (by class) that were sold or distributed – Does not reflect actual usage • Metrics reported include drug class, medical importance, route of administration, indication, and dispensing status, as well as species-specific estimates of these sales and distribution – This is the 2nd year that the report was reported by livestock species.
  • 4. 2017 Antimicrobial Sales by Class of Antibiotics for all Livestock Species
  • 5. Livestock Tetracycline Use over past 9 years 15% decrease 40% decrease
  • 7. 2016-2017 Antimicrobial Sales by Species 33% reduction in medically important antibiotic use in livestock over past year
  • 9. Livestock Medically Important Antibiotic Use by route of administration over past 9 years
  • 11. 2017 Report Summary • Domestic sales and distribution of medically important antimicrobials approved for use in food-producing animals: o Decreased by 33% from 2016 through 2017. o Decreased by 43% from 2015 (the year of peak sales) o Tetracyclines, which represent the largest volume of these domestic sales (3,535,701 kg in 2017), decreased by 40% from 2016 through 2017. • Water soluble medically important antibiotics also saw a decrease
  • 12. GVL VFDs by Species 2017-2018 Bovine 68% Swine 30% Ovine 1% Other 1% 3,076 veterinarians 5.345 feed mills Slide courtesy of Global Vet Link
  • 13. GVL Average Head per VFD 2017 vs. 2018 7,409 976 638 8,732 2,219 727 - 1,000 2,000 3,000 4,000 5,000 6,000 7,000 8,000 9,000 10,000 Swine Bovine Ovine NumberHead Average Head Count Year 2017 Year 2018 Poultry 3,101,073 9,941,889 Aquaculture 297,668 141,519 Honey Bees 18,064,668 49,398,490 Slide courtesy of Global Vet Link
  • 14. GVL Swine VFDs by Number Head 2017-2018 0% 5% 10% 15% 20% 25% 30% 35% 40% 45% < 2,000 2,000 - 4,999 5,000 - 9,999 10,000 - 24,999 25,000+ PercentageSwineVFDs Head Count Slide courtesy of Global Vet Link
  • 15. GVL Swine VFDs by Indication 2017-2018 Enteritis & Pneumonia 62% Ileitis & Dysentery 17% Pneumonia 12% Cervical abscesses 3% Leptospirosis 3% Othe Slide courtesy of Global Vet Link
  • 16. GVL Swine VFDs by Active Ingredient 2017-2018 Chlortetracycline 59% Tylosin 9% Tilmicosin 9% Oxytetracycline 7% Chlortetracycline - Sulfamethazine 2% Other 14% Slide courtesy of Global Vet Link
  • 17. VFD Frequently Asked Questions • Iowa Pork Industry Center Website – https://www.ipic.iastate.edu/info/VFDfaq.pdf • Examples of questions from industry on how to write VFD with answers from FDA directly.
  • 18. How close does the client have to be to the intended duration of feeding (number of days fed)? • VERY CLOSE – Must be fed according to the duration listed on the label • Aureo: “For not more than 14 days” • Pulmotil: “shall not be fed to pigs for more than 21 days • Linco/Tylan: “..feed for disease X for 21 days at 100 grams and then at 40 grams to market….” – Regulator comments indicate they expect it to be close to duration stated on VFD (i.e. within 1-2 days)
  • 19. Prescription Frequently Asked Questions • Iowa Pork Industry Center Website – https://www.ipic.iastate.edu/info/IPBFAQ0217.pdf – Examples of questions from industry on prescriptions and labeling with answers from Iowa Board of Pharmacy directly.
  • 20. FAQ from Iowa Board of Pharmacy • For product labeling, can you label the container or do you have to label each individual bottle/packet? • Unopened Containers can be labeled, not individual packets
  • 21. Questions?? Chris J. Rademacher, DVM| Swine Extension Veterinarian Iowa State University2225 Lloyd Veterinary Medical Center | Ames, IA 50011 (: (515) 294-8792 | *: cjrdvm@iastate.edu Follow on Twitter: @cjrdvm www.ipic.iastate.edu