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Preparing for Changes to Antibiotic Use

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Presentation on theme: "Preparing for Changes to Antibiotic Use"— Presentation transcript:

1 Preparing for Changes to Antibiotic Use
Sam Holst, DVM Swine Vet Center World Pork Expo June 8-9, 2016

2

3 Overview of antibiotic use changes
Growth promotion label claims for medically important antibiotics will be phased out Increased veterinary oversight for therapeutic uses: Medically important feed grade antibiotics will require a veterinary feed directive (VFD) Medically important antibiotics administered via the drinking water will require a veterinary prescription

4 Not classified medically important
Bacitracin (BMD)* Carbadox (Mecadox) Narasin (Skycis) Bambermycin (Flavomycin) Tiamulin (Denagard)* * Considered medically important by WHO Will remain available for growth promotion and/or over-the-counter (OTC) in feed and water

5 Veterinary oversight of antibiotic use

6 Veterinary oversight Producers will need to work with licensed veterinarian to use: Feed medications requiring VFD Rx water soluble antibiotics Rx injectable antibiotics

7 Veterinary oversight Veterinarian-client-patient relationship (VCPR)
Veterinarian assumes responsibility for making clinical judgments regarding patient health Veterinarian has sufficient knowledge of the patient by virtue of examination and/or timely visits to facility where patient is Veterinarian provides any necessary follow-up evaluation/care

8 Veterinary oversight Regular veterinary visits
“Medically appropriate and timely visits to the premises where the animal is kept” Prescriptions and VFDs = 6 month expiration (at most) Additional components to prove sufficient knowledge: Necropsies and diagnostic testing Treatment protocols Production records Service team reports

9 Veterinary Feed Directive

10 Veterinary feed directive
VFD written statement from licensed veterinarian Authorizes client to obtain and use VFD antibiotic In or on animal feed According to label directions FDA does not allow extra-label use of feed grade antibiotics

11 Changes to existing VFD format
Regulations that will carry over: Retain VFD for 2 years (producer, vet, feed mill) No extra-label use No refills, unless on label Previous Revised Original document to mill Electronic copy ok Approx. tons of feed to be fed Approx. # pigs to be fed Written for one group on a premise Attach list of premises (same mill, same owner) VCPR required Satisfy state-specific VCPR 6 month expiration max

12 Issuing VFDs: electronic VFDs

13 Issuing VFDs: In-house VFD

14 How will we get VFDs implemented?
Frequently Asked Questions

15 Frequently Asked Questions
Does every group of pigs need its own VFD? Will my veterinarian need to visit every site to do a VFD? Answer: Not necessarily

16 VFD example 1 producer, 1 flow, 12 sites, 1 feed mill

17 2000 Farrow to Finish VFD 1- N1- Pulmotil site 1, site 2, site 3, etc
VFD 2- N2- Den/CTC VFD 3- N3- Neo/OTC VFD 4- F1- Den/CTC

18 VFD example 1 producer, 3 flows, 30 sites, 3 feed mills Client Flow
Diets w/ Abx VFDs Bacon Eater A 10 1 4 B C Total  3 30 12

19 3 flows- 1 feed mill per flow
VFD 1- N1- Pulmotil VFD 2- N2- Den/CTC VFD 3- N3- Neo/OTC VFD 4- F1- Den/CTC Feed Mill 2 VFD 1- N1- Pulmotil VFD 2- N2- Den/CTC VFD 3- N3- Neo/OTC VFD 4- F1- Den/CTC Feed Mill 3 VFD 1- N1- Pulmotil VFD 2- N2- Den/CTC VFD 3- N3- Neo/OTC VFD 4- F1- Den/CTC

20 Frequently Asked Question
Can video/photos count as “sufficient knowledge” with an operation to establish a VCPR? Answer: A VCPR cannot be established by video/photos “have sufficient knowledge of the patient by virtue of patient examination and/or visits to facility where patient is managed”

21 Frequently Asked Question
My VFD expires tomorrow but have 4 days worth of feed left, can I feed it? Answer: Need to have a valid VFD issued in order to feed it Solution: Timely vet visits to establish VCPR and oversight will allow vets to have little to no delay in re-issuing VFDs

22 Frequently Asked Question
My pigs are sick, am I going to have to wait to medicate them? Answer: There will be no delays on water medications if VCPR/oversight is established Solution: Water medications can be a good choice until feed can get delivered Talk through the problem with your veterinarian and in the event of an emergency should be able to get VFD generated in a timely matter

23 Frequently Asked Question
Do I have to remember when my VFD or VCPR will expire? Answer: Responsibility lies on the producer and veterinarian Solution: Most VFD software, such as GVL, will have a reminder that will alert when VFD will expire

24 Frequently Asked Question
What records am I required to keep as a producer? Answer: Producer, veterinarian, and distributor required to retain VFD for 2 years (veterinarian retains original)

25 Treatment records Required treatment information to record:

26 Frequently Asked Question
If a producer conducts on farm mixing of medicated feed, do they need a medicated feed mill license? Answer: Depends on the category and article used to produce the medicated feed

27 Medicated feed definitions
Category I Category II No withdrawal Require withdrawal VFD drugs Type A Type B Type C Manufacture of Type A, B, or C feeds Manufacture of Type B or C feeds Complete feed Substantial quantity of nutrients

28 Medicated feed mill license
Feed manufacturing facility must have license to manufacture Type B or Type C medicated feed from a Category II, Type A medicated article

29 Exemptions… Manufacture of the following types of feed are exempt from the required license: Type B or C medicated feed using Category II, Type B or C articles Type B or C medicated feed using Category I, Type A, B, or C articles

30 Category II, Type A Category II, Type B

31 Frequently Asked Question
For a producer who mills their own feed, do they need a VFD to purchase medicated product? Answer: Depends if the producer is also a distributor or not If the producer IS NOT a distributor, need to have a VFD to purchase VFD medicated product If the producer IS a distributor, can provide VFD or acknowledgement letter to purchase VFD medicated feed

32 Distributor classification
Distributor = any person who distributes a medicated feed containing a VFD drug to another person Producer delivers feed to producer-owned sites… NOT considered to be a distributor Producer delivers feed to contract production sites… IS considered to be a distributor

33 Distributors’ responsibilities
“One-time” distributor notification to FDA Distributor’s complete name and business address Distributor’s signature Date notification signed Notify FDA within 30 days of change in: Ownership Business name Business address

34 Acknowledgement letter
Written communication between distributors Includes following statements: Distributor will not ship VFD feed to site that does not have a VFD Distributor will not ship VFD feed to another distributor without receiving acknowledgement letter Distributor has complied with notification requirements VFD still required to feed VFD medicated feed

35 Frequently Asked Question
What can producers do to prepare?

36 1100 pigs weaned per week or 26,400 pigs
Producer name Bacon Maker Address 12345 Piggy Rd. Diet Name Medication Level # pigs on VFD (approx. # in 6 mo period) N1 CTC + Denagard 400g/T + 35g/T 1100 pigs weaned per week or 26,400 pigs N2 Non Medicated N3 Pulmotil 181g/T N4 Site Name Address, City, State Feed mill Name Feed Mill location I love Bacon 1234 fatty rd, St Peter, MN Feed mill 1 St Peter, MN Bacon loves me 1235 fatty rd, St Peter, MN Feed mill 2 Piggy ranch 1236 fatty rd, St Peter, MN Feed mill 3

37 Summary Antibiotic use isn’t going away, but it is changing
Countdown to January 1, 2017 is on All VFD feed in bins on Jan 1, 2017 will need VFDs in place Communication will be key to smooth transition Preparation will help prevent gap or delay in treatment

38 Questions?


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