Dr. Paul Ruen - Hanson Lecture: Changes in Antimicrobial Use - Practitioner

CHANG E S IN ANTIM ICRO B IAL USE –

PRACT IT IO NE R

Dr. Paul D. Ruen, DVMFairmont Veterinary Clinic, LLP

Allen D. Leman ConferenceSeptember 20, 2016St. Paul, MN

CHANG E S IN ANTIM ICRO B IAL USE -P RACT IT IO NE R

Review:

VFD Rule & Implications

Veterinary Practice

Strategy & Questions

Ruen, 2016 Leman Conference


F DA T IM E L INE O F CHANG E S:Guidance #152 / 2003 Veterinary oversight Veterinary Feed Directive (VFD) Refers to 21 CFR Sec. 530.3(i) VCPR Appendix A – human important drugs

Guidance #209 / 2012 Judicious use

Necessary for animal health “therapeutic”Includes veterinary oversight

Guidance #213 / 2013 Process to implement #209

Voluntary label changes Phase out production uses Moves OTC to VFD & Rx (feed & water) 3-year timeline VFD Final Rule / 2015

Veterinary oversight – all Appendix AGFI #120

VFD / Water Rx Implements / 2017


F DA : G UIDANCE 152, AP P E ND IX AClassified important, highly important, or critical

for human health:

Beta lactam penicillin,amoxicillin,ceftiofurMacrolides tylosin,tilmicosin,lincomycin,tulathromycinAminoglycosides neomycin,gentamicinFluroquinolones enrofloxacinTetracyclines tetracycline,oxytetracycline,chlortetracyclineSulfonamides various sulfasStreptogramins virginiamycinPhenicols florfenicol

Not ClassifiedPolypeptides bacitracin BMD®Pleuromultilin tiamulin Denagard®Quinoxaline carbadox Mecadox®Phosphoglycolipid bambermycin Flavomycin®Ionophores narasin Skycis®


CL E AR M E SSAG E F ROM F DA & CO NSUMER :

Antimicrobial ResistanceRemoval of growth promotersVeterinary oversight for all antimicrobial use

Injectable - Feed - Water

New regulations will take effort Time and Cost: planning, paperwork

Swine industry is more ready than others 1989 Pork Quality Assurance® / PQA Plus® Producers already following labels Pulmotil® & Nuflor® - 283 affected feed products

NEW VF D RUL E : P RACT IT IO NE R P E RSP E CT IVE

4 objectives for VFD’s:

Legal

Accurate

Efficient

On-time



NEW VF D RUL E :

Legal:

licensed in the state where pigs are

valid VCPR

written VFD and signature

copy to client & distributor

retain VFD for 2 years, for FDA inspection

one time registering of all distributors with FDA


NEW VF D RUL E :Legal:

What is a valid VCPR?

FDA defers to State’s practice act

unless no appropriate VCPR, then to Federal VCPR

Federal definition for VCPR

1. engage w/client to assume responsibility for making clinical judgments about patient health & client agrees to follow instructions

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

3. provide for any necessary follow-up evaluation or care & maintain records

VCPR – “ WORK ING KNOWL E DG E ”

Legal:

Many components describe

veterinary oversight -

Site visits (within a flow)

Clinical observations

Post-mortems and diagnostics

Production records

Service team reports

“VCPR = Partnership”


NEW VF D RUL E :

Legal:Get to know the

FEED ADDITIVE COMPENDIUM

New labels comingby December 2016

For feed in bins and feeders 1-1-17



NEW VF D RUL E :Accurate:

vet’s & client’s name, address, phone

premise where pigs are

issuance & expiration dates

drug name, level, & duration of use

instructions regarding usage, +/- combination

species & production class of animals

approximate # of animals to be treated

withdrawal, special instructions & precautions

number of reorders, if permitted

statement: “extra label use is not permitted”


NEW VF D RUL E :Accurate:

Two categories of VFD’s –

1st targeted to farm’s normal disease challenges

2nd for disease outbreaks/emergency

Right feed medication

to the right pig

at the right time


NEW VF D RUL E :

Efficient:

6 months max. expiration ~ wean/finish turn

lead time

option for VFD to “flow” (1 owner & 1 distributor)

list approximate # of animals, not tons of feed

not required to deliver hard copy

electronic with secure “e-signature”

Personal experience: *10-15 minutes/VFD

vet time, office staff, software, records system

client information/sites/flows/feed mills

E F F ICIE NT:


1 producer, 1 site, 3 barns, VFD’s by diet

Client Flow Sites Barns # Pigs

Feed mills

Diets w/ AB

Antibiotic(s) # VFDs

Ole A 1 1 Nur 625 1 co E Nursery 1 Neo/Terra 600g 12 Fin 1200 Nursery 2 Neo/Terra 400g 1

Nursery 3 CTC/Den 400g/35g

1

Nursery 4 No medFinish 1 CTC/Den

400g/35g1

Finish 2 BMD 30g 0Finish 3 BMD 30g 0Finish 4 CTC 600g 1Finish 5 No med 0Finish 6 No med 0

Total 3 1 5

E F F ICIE NT:


1 sow flow w/9 producers, 8 mills

Client Flow Sites Barns # Pigs Feed mills

# AB Diets


Nurs RD 1 6 N 7800 1 co T 3 C/D, Tyl 3Prod 1 RD 8 14 F 13800 1 farm

1 co LR6 C/D, Tyl, CTC,

BMD55

Prod 2 RD 1 2 4800 1 farm 7 C/D, Tyl, CTC, BMD

4

Prod 3 RD 1 5 3600 1 farm 6 C/D, Tyl, CTC 6Prod 4 RD 2 2 1200 1 co J 5 C/D, BMD, CTC 2Prod 5 RD 1 1 600 1 co L 5 C/D, Tyl, CTC 5Prod 6 RD 1 2 1200 1 farm 3 C/D, Tyl, CTC,

Skycis3

Prod 7 RD 3 7 4200 1 co J 5 Pul, C/D, BMD, CTC

3

Prod 8 RD 1 2 1200 1 co J 5 C/D, BMD, CTC 3Prod 9 RD 1 2 2400 1 co T 3 C/D, Tyl, CTC,

Skycis3

Totals 20 43 40800 8 42

E F F ICIE NT:


1 producer, 3 flows, 20 sites

Client Flow Sites Barns Feed mills

# AB Diets


Sven CC 6 6 WF 1 farm 8 C/D, Tyl, CTC, BMD 6

CC 2 8 WF 1 com LR 8 C/D, Tyl, CTC, BMD 6

RD 7 12 F 1 farm 6 C/D, Tyl, CTC 5

RD 1 2 F 1 com LR 6 C/D, Tyl, CTC 5

PC 2 2 N 1 farm 3 C/D, Tyl 3*

PC 3 4 F 1 farm 6 C/D, Tyl, CTC 5*

Total 3 20 34 2 30 (22*)

VF D O P T IO NS – SING L E SITE / GRO UP


VF D O PT IO NS - F L OW


VF D O PT IO NS – F L OW SITE S



NEW VF D RUL E :

On-time:

communication

need to begin preparing now – trial runs

client information and pig sites

pig flows and feed mills

paper or electronic

sponsors

Global VetLINK® --- FeedLINK®

in-house systems

can not feed after expiration date

December start for January 1st inventory


Strategy:

1. Reevaluate health programs for clients

are we focused on the right things?

is the antimicrobial plan targeted?

is it working? for pig, producer, processor

does antimicrobial use fit new regulations?

what about other inputs –

water diets vaccines

right product(s)

right dose

right timing

CHANGE S IN ANTIM ICRO B IAL USE –PRACTIT IO NE R


Strategy:2. Reevaluate pig flows, risks

continuous improvementbiosecurity mindsetfacilities

neighborhoods – sites - barnsload outs/rooms – air filtration

transportationflow dedicated trailers, wash / dry bays

flow adjustments – the right “fit”AIAO for real?, still comingling?wean/finish - sow flow sizebatch, parity segregation

CHANGE S IN ANTIM ICRO B IAL USE -P RACT IT IO NE R


Strategy:

3. Define health profiles for client farms

do we have the right information to make decisions?

investigations & monitoring programs

partnering with diagnostic center

right samples

completing history

new inputs – premise ID, flow nomenclature

treatment decisions

data queries

global v. flow v. age

new consumer & retail demands



Strategy:

4. Health upgrades

does new regulatory era change what we can live with?

is there greater value today for health?

options -

herd closure

depop / repop

siting & biosecurity maintenance

new value propositions



Strategy:

5. Planning ahead


Plan:

Meet/discuss ahead of time

Example – Post-wean E. coli

Review Health hx, dx, tx Previous performance

Short & Long-term Plans Key ingredients, +/- meds Water quality, vaccines Pen/barn management Individual treatments Evaluate, Backup Plan B

Process:

Communicate

Target

Educate

Options


Some VFD questions from producers & vets:

source / flow changes - fluid nature of filling barns & sites

registering as a distributor –

do I need to?

does it put me on a “list”?

FDA oversight – what’s it mean? inspections?

level of VFD detail – feed mill perspective

medication inventories – “stockpiling”

What’s next?

FDA Notice (9-14-16): Establishing “targeted durations of use”

Antibiotic usage data…


NEW VF D RUL E – F O R PRACT IT IO NE RSChallenges

Getting the process right Legal Accurate Efficient On-time Staffing, costs

Animal care

Next Trial runs with farms

Opportunities

Improve relationships Real VCPR Communication, follow-up Better medical information

Better decisions Teaching Evidence-based

Demand for higher health


NEW VF D RUL E –“ONE-TIME” DISTRIBUTOR NOTIFICATION

What information to include?

The distributor's complete name and business address

The distributor's signature or signature of distributor's authorized agent

The date the notification was signed

Where should the notification be sent?

Mail to: Food and Drug AdministrationCenter for Veterinary MedicineDivision of Animal Feeds (HFV-220)7519 Standish PlaceRockville, MD 20855

Or fax to: (240) 453-6882

Notify FDA if change in ownership, business name or address


JUD ICIO US USE RE GARDL E SS O F RO UTE…



Resources AASV

https://www.aasv.org/ Pork Board Antibiotic Resource Center

http://www.pork.org/production-topics/antibiotics-resource-center/ Feedstuffs VFD Central

http://feedstuffs.com/vfd.aspx

THANK YOU!

Dr. Jim Dick

Dr. Clark Huinker

Dr. Brian Roggow

Dr. Mark Wagner

Dr. Jeff Kurt

Dr. Steve Stone

Dr. Andrea Pitkin

Dr. Chase Stahl

Dr. Andy Kryzer

Dr. Paul Ruen - Hanson Lecture: Changes in Antimicrobial Use - Practitioner

Health & Medicine

Transcript of Dr. Paul Ruen - Hanson Lecture: Changes in Antimicrobial Use - Practitioner