Preparing for Changes to Antibiotic Use

Sam Holst, DVM Swine Vet CenterWorld Pork ExpoJune 8-9, 2016

Overview of antibiotic use changes 1. Growth promotion label claims for medically important

antibiotics will be phased out

2. 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

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

Veterinary oversight of antibiotic use

Veterinary oversight• Producers will need to work with licensed veterinarian to use:

– Feed medications requiring VFD– Rx water soluble antibiotics– Rx injectable antibiotics

Veterinary oversight• Veterinarian-client-patient relationship (VCPR)

1. Veterinarian assumes responsibility for making clinical judgments regarding patient health

2. Veterinarian has sufficient knowledge of the patient by virtue of examination and/or timely visits to facility where patient is

3. Veterinarian provides any necessary follow-up evaluation/care

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

Veterinary Feed Directive

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

Changes to existing VFD format

Previous RevisedOriginal 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

Regulations that will carry over:• Retain VFD for 2 years (producer, vet, feed mill)• No extra-label use• No refills, unless on label

Issuing VFDs: electronic VFDs

Issuing VFDs: In-house VFD

How will we get VFDs implemented?

Frequently Asked Questions

Frequently Asked Questions1. Does every group of pigs need its own VFD? Will my veterinarian need to visit every site to do a VFD?

Answer: Not necessarily

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

2000 Farrow to Finish

VFD 1- N1- Pulmotilsite 1, site 2, site 3, etc

VFD 2- N2- Den/CTC site 1, site 2, site 3, etc

VFD 3- N3- Neo/OTCsite 1, site 2, site 3, etc

VFD 4- F1- Den/CTC

site 1, site 2, site 3, etc

VFD example• 1 producer, 3 flows, 30 sites, 3 feed mills

Client Flow SitesFeed mills Diets w/ Abx VFDs

Bacon Eater A 10 1 4 4  B 10 1 4 4  C 10 1 4 4

Total  3 30 3   12

3 flows- 1 feed mill per flowFeed Mill 1VFD 1- N1- PulmotilVFD 2- N2- Den/CTCVFD 3- N3- Neo/OTCVFD 4- F1- Den/CTC

Feed Mill 2VFD 1- N1- PulmotilVFD 2- N2- Den/CTCVFD 3- N3- Neo/OTCVFD 4- F1- Den/CTC

Feed Mill 3VFD 1- N1- PulmotilVFD 2- N2- Den/CTCVFD 3- N3- Neo/OTCVFD 4- F1- Den/CTC

Frequently Asked Question2. 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”

Frequently Asked Question3. 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

Frequently Asked Question4. 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

Frequently Asked Question5. 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

Frequently Asked Question6. 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)

Treatment records• Required treatment information to record:

Frequently Asked Question7. 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

Medicated feed definitions

Category I No withdrawal Category II

Require withdrawal VFD drugs

Type A Manufacture of Type A, B, or C feeds

Type B Manufacture of

Type B or C feeds Substantial quantity

of nutrients

Type C Complete feed

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

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

Category II, Type A Category II, Type B

Frequently Asked Question8. 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

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

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

• http://www.fda.gov/downloads/AnimalVeterinary/DevelopmentApprovalProcess/UCM455479.pdf

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

Frequently Asked Question9. What can producers do to prepare?

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 1100 pigs weaned per week or

26,400 pigs

N4 Non Medicated    

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, MNBacon loves me 1235 fatty rd, St Peter, MN Feed mill 2 St Peter, MN

Piggy ranch 1236 fatty rd, St Peter, MN Feed mill 3 St Peter, MN

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

Questions?