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

CHANGES IN ANTIMICROBIAL USE –
PRACTITIONER
Dr. Paul D. Ruen, DVM
Fairmont Veterinary Clinic, LLP
Allen D. Leman Conference
September 20, 2016
St. Paul, MN

CHANGES IN ANTIMICROBIAL USE -
PRACTITIONER
Review:
VFD Rule & Implications
Veterinary Practice
Strategy & Questions
Ruen, 2016 Leman Conference

FDA TIMELINE OF CHANGES:
Guidance #152 / 2003
Veterinary oversight
 Veterinary Feed Directive (VFD)
 Refers to 21 CFR Sec. 530.3(i) VCPR
 Appendix A – human important drugs
Judicious use
Necessary for animal health “therapeutic”
Includes veterinary oversight
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 A
GFI #120
VFD / Water Rx Implements / 2017

FDA: GUIDANCE 152, APPENDIX A
Classified important,highly important,or critical
for human health:
Beta lactam penicillin,amoxicillin,ceftiofur
Macrolides tylosin,tilmicosin,lincomycin,tulathromycin
Aminoglycosides neomycin,gentamicin
Fluroquinolones enrofloxacin
Tetracyclines tetracycline,oxytetracycline,chlortetracycline
Sulfonamides various sulfas
Streptogramins virginiamycin
Phenicols florfenicol
Not Classified
Polypeptides bacitracin BMD®
Pleuromultilin tiamulin Denagard®
Quinoxaline carbadox Mecadox®
Phosphoglycolipid bambermycin Flavomycin®
Ionophores narasin Skycis®

CLEAR MESSAGE FROM FDA & CONSUMER:
Antimicrobial Resistance
 Removal of growth promoters
 Veterinary 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 VFD RULE: PRACTITIONER PERSPECTIVE
4 objectives for VFD’s:
Legal
Accurate
Efficient
On-time

NEW VFD RULE:
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 VFD RULE:
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 – “ WORKING KNOWLEDGE”
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 VFD RULE:
Legal:
Get to know the
FEED ADDITIVE
COMPENDIUM
New labels coming
by December 2016
For feed in bins
and feeders 1-1-17

NEW VFD RULE:
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 VFD RULE:
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 VFD RULE:
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

EFFICIENT:
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 1
2 Fin 1200 Nursery 2 Neo/Terra 400g 1
Nursery 3 CTC/Den
400g/35g
1
Nursery 4 No med
Finish 1 CTC/Den
400g/35g
1
Finish 2 BMD 30g 0
Finish 3 BMD 30g 0
Finish 4 CTC 600g 1
Finish 5 No med 0
Finish 6 No med 0
Total 3 1 5

EFFICIENT:
1 sow flow w/9 producers, 8 mills
Client Flow Sites Barns # Pigs Feed
mills
# AB
Diets
Antibiotic(s) #
VFDs
Nurs RD 1 6 N 7800 1 co T 3 C/D,Tyl 3
Prod 1 RD 8 14 F 13800 1 farm
1 co LR
6 C/D,Tyl, CTC,
BMD
5
5
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 6
Prod 4 RD 2 2 1200 1 co J 5 C/D, BMD, CTC 2
Prod 5 RD 1 1 600 1 co L 5 C/D,Tyl, CTC 5
Prod 6 RD 1 2 1200 1 farm 3 C/D,Tyl, CTC,
Skycis
3
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 3
Prod 9 RD 1 2 2400 1 co T 3 C/D,Tyl, CTC,
Skycis
3
Totals 20 43 40800 8 42

EFFICIENT:
1 producer, 3 flows, 20 sites
Client Flow Sites Barns Feed
mills
# AB
Diets
Antibiotic(s) #VFDs
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*)

VFD OPTIONS – SINGLE SITE / GROUP

VFD OPTIONS - FLOW

VFD OPTIONS – FLOW SITES

NEW VFD RULE:
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
CHANGES IN ANTIMICROBIAL USE –
PRACTITIONER

Strategy:
2. Reevaluate pig flows, risks
continuous improvement
biosecurity mindset
facilities
neighborhoods – sites - barns
load outs/rooms – air filtration
transportation
flow dedicated trailers, wash / dry bays
flow adjustments – the right “fit”
AIAO for real?, still comingling?
wean/finish - sow flow size
batch, parity segregation
PRACTITIONER

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
PRACTITIONER

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
PRACTITIONER

Strategy:
5. Planning ahead
PRACTITIONER
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…
PRACTITIONER

NEW VFD RULE – FOR PRACTITIONERS
Challenges
 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 VFD RULE –
“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 Administration
Center for Veterinary Medicine
Division of Animal Feeds (HFV-220)
7519 Standish Place
Rockville, MD 20855
 Or fax to: (240) 453-6882
 Notify FDA if change in ownership, business name or address

JUDICIOUS USE REGARDLESS OF ROUTE…

Resources
 AASV
https://www.aasv.org/
 Pork BoardAntibiotic Resource Center
http://www.pork.org/production-topics/antibiotics-resource-center/
 FeedstuffsVFD Central
http://feedstuffs.com/vfd.aspx
THANKYOU!
 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

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