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Antibiotic Use in Swine ProductionTimes, they are a changin’
Harry Snelson, DVMAmerican Association of Swine Veterinarians
What’s driving the change?Concerns about antibiotic
resistance in the human population
Antibiotic use will select for a population of resistant bacteria
Antibiotic ResistanceA naturally occurring
phenomenonAbtic use can select for a
population of resistant bacteria◦Resistant bacteria can thrive in the
absence of sensitive bacteria◦Can share resistance genes
What role does antibiotic use in livestock play?
No definitive linkRisk assessments for resistance
development have demonstrated the risk is negligible
European experience would not show a significant decline in resistance following restrictions on abtic use in vet medicine
Global Effort to Battle ResistanceWhite House called for a strategy
to address abtic resistanceUSDA has developed a plan to
explore on-farm use and collect data to study use trends – needs to be funded
FDA is working to improve stewardship and veterinary oversight
FDA Guidelines & Regulations#152 identified “medically
important” antibiotics#209/#213 directed elimination
of AGP claims and transition to VFD/Rx
VFD revisions increased vet oversight on feed abtics
Antibiotic RegulationUS Food and Drug Administration
regulates animal and human antibiotics◦OTC◦RX◦VFD
State pharmacy boards have authority over veterinary prescribing
Antibiotic Label ClaimsDisease TreatmentDisease ControlDisease Prevention
◦Treatment, Control and Prevention are considered therapeutic
◦FDA has said they are necessary for animal health and welfare
Growth Promotion or Improvement of Nutritional Efficiency
Definitions• Treatment
o Defined as the use of an antibiotic for the treatment of animals showing clinical signs of disease.
• Controlo Defined as the use of an antibiotic for the treatment of a group of animals where
a percentage are sick and the remainder of the group are not showing clinical signs (yet).
• Preventiono Defined as the use of an antibiotic in a group of healthy animals that are known
to be at risk for, or exposed to, disease agents.• Growth Promotion
o Improves growth or feed efficiency
FDA considers treatment, control and prevention to be therapeutic uses
Route vs Indication
Route Growth Prevention
Control Treatment
Injectable ++ +++
Water +++ +++ ++
Feed +++ +++ ++ +
Veterinary Feed DirectiveImplemented in 1996Provides for veterinary oversight
without requiring a prescription3 swine products
◦Nuflor◦Pulmotil◦Avilamycin
Antibiotic ClassesMedically important (as defined
by FDA)◦Same, or in same classes, as
antibiotics used to treat humans◦Most antibiotics approved for use in
animal feed are medically important with possible exceptions: Swine: bacitracin, mecadox, narasin,
bambermycin, and tiamulin
FDA GoalEliminate GP uses of medically
important abticsIncrease veterinary oversight of
antibiotic use in food producing animals for therapeutic purposes (prevention, control and treatment)
Two Key ChangesRemoval of growth promotion
claims◦“voluntary”◦Achieved through Guidance for
Industry 209 & 213Transition from OTC to VFD
◦Regulatory changes to Code of Federal Regulations (CFR)
Guidance for Industry“voluntary”? – well sort ofGFI are not legally bindingRepresent the agency’s
interpretation of a regulation or how they plan to address certain issues◦GFI #152 ◦GFI #209◦GFI #213
Guidance for Industry #209“Production uses” (growth promotion and
nutritional efficiency) of antibiotics in classes used in human medicine are injudicious◦ Does not call them unsafe
Requires other uses of these same classes of antibiotics be under “veterinary oversight”
“Voluntarily” working with sponsors to discontinue claims or migrate production claims to disease prevention◦ All sponsors agreed to remove GP claims ◦ Guidance #213 gives roadmap on
implementation
Effect of 209/213There is no ELDU for feed grade
abtics thus once removed from the label, these products can no longer be used for GP
Removal of GP claims was voluntary but label compliance is mandatory by both vets and producers
Due to be completed by Jan. 1, 2017
FDA medically importantAll swine antibiotics will be
affected under Guidance 209 except◦Bacitracin◦Carbadox◦Bambermycin◦Ionophores ◦Tiamulin
These antibiotics will remain available for growth promotion and/or over-the-counter (OTC) in feed and water
Feed-grade Antibiotics Affected
Courtesy of FDA
Water Medications Affected
Courtesy of FDA
Veterinary Feed DirectiveVFD final rule went into effect
October 1, 2015Growth Promotion and Nutritional
Efficiency Labels will be removed by Dec. 2016◦“Medically Important”
Disease Prevention, Control and Treatment will be VFD in feed, Rx in water
What does this really mean?Significant regulatory step that
will result in changes on how antibiotics are used on the farm
Once those labels are changed, it will be illegal to utilize these antibiotics to promote growth
Producers will need a VFD or prescription to use these products in feed and water
How will this affect pork producers?Producers are going to lose some
antibiotics, or uses of antibioticsPotentially increased costs and
increased timeProducers will need a close
relationship with their veterinarian
Veterinary Feed Directive
Veterinary ResponsibilitiesMust write VFD orders in the context of a
VCPR;◦Minimum requirements:
the veterinarian engage with the client to assume responsibility for making clinical judgments about patient health,
have sufficient knowledge of the patient by virtue of patient examination and/or visits to the facility where the patient is managed, and
provide for any necessary follow-up evaluation or care.
Default to state if requirements are met – FDA online list
Information Required on VFD• The veterinarian’s name, address, and telephone number; • the client’s name, business or home address, and telephone number; • the premises at which the animals specified in the VFD are located; • the date of VFD issuance; • the expiration date of the VFD; • the name of the VFD drug(s); • the species and production class of animals to be fed the VFD feed; • the approximate number of animals to be fed the VFD feed by the expiration date of the VFD; • the indication for which the VFD is issued; • the level of VFD drug in the feed and duration of use;
• the withdrawal time, special instructions, and cautionary statements necessary for use of the drug in conformance with the approval; • the number of reorders (refills) authorized, if permitted by the drug approval, conditional approval, or index listing; • the statement: “Use of feed containing this veterinary feed directive (VFD) drug in a manner other than as directed on the labeling (extralabel use), is not permitted”; • an affirmation of intent for combination or substitution VFD drugs as described in 21 CFR 558.6(b)(6); and • the veterinarian’s electronic or written signature.
Expiration DateNot the date the drug expiresVFD Expiration Date –
◦Specifies the period of time for which the VFD authorization is valid
◦A VFD feed should not be fed after the expiration date (i.e., after VFD authorization expires)
◦May be specified on the product label; if not – it cannot exceed 6 months after the date of issuance.
◦The veterinarian can use his or her medical judgment to determine whether a more limited period is warranted
Number of animalsOld VFD required estimating
amount of feedNew VFD requires estimating the
number of animals receiving the feed
Duration of UseThe Duration of Use –
◦A separate concept from the expiration date ◦The length of time that the feed containing
the VFD drug is allowed to be fed to the animals
◦Established as part of the approval, conditional approval, or index listing process
◦ If the VFD order will expire before completing the duration of use on the order, the client should contact his/her veterinarian to request a new VFD order
RefillsMeant to apply to when the feed
authorized under the VFD has been exhausted.
Provide authorization to obtain and feed additional VFD feed in the same total quantity and under the same conditions of the existing VFD by the expiration date of the VFD.
Refills (con’t)Refills (reorders) – Are only permitted
to be authorized by veterinarians if the drug approval, conditional approval, or index listing expressly permits a refill (or reorder) ◦If a label is silent on refills, a refill may
not be authorized ◦Currently, there are no approved VFD
drugs that allow refills or reorders as a condition of their approval, conditional approval, or index listing
Veterinary Responsibilities(con’t)must provide the distributor and
client with a copy of the VFD order;
all must retain the original VFD for 2 years; and
must provide VFD orders for inspection and copying by FDA upon request
Producer ResponsibilitiesDevelop and maintain a good
working relationship with your veterinarian – VCPR
Critical as drugs transition to VFD◦Currently 3 VFD drugs – pulmotil,
Avilamycin and nuflor◦All medically important feed grade
abtics will require a VFD on January 1, 2017
Evaluate herd health protocolsSit down with your veterinarian
to evaluate all animal-health management protocols and herd vaccination programs. ◦Veterinarians can work with
producers to develop strategies to minimize disease risk through facility design, pig flows, vaccination protocols, herd health monitoring, disease surveillance and appropriate diagnostics.
Understand product changesReview all swine medications
currently being used within the operation.
Discuss which products are affected by veterinary feed directives and prescriptions and how the process will work on the farm. ◦Veterinarians can provide guidance on
judicious antibiotic use and help ensure compliance with the new guidelines and regulations.
Record-keeping
THE JOB’S NOT FINISHED ‘TILTHE PAPERWORK’S DONE
Record-keeping is a BIG dealWalk through the record-keeping
requirements and strategies◦Record-keeping is, and will continue
to be, a key aspect of on-farm antibiotic use
◦VFD final rule requires veterinarians, distributors and producers to retain the VFD for 2 years and prescriptions for 1 year
Future IssuesDuration of use
◦Some products do not have a defined duration of use on the label
◦FDA issued a Request for Comment in the FR asking for public input
Prevention usesRaising pigs without abtics
◦AASV position statement
AASV Position Statement: Raising Pigs without Antibiotics
Any pork production system that is marketing pigs raised without the use of antibiotics should closely involve veterinarians in the management of herd health. If a pig is sick, or is at risk of getting sick, it is our responsibility as swine veterinarians to prevent or treat illness in a judicious manner to maintain animal health and welfare. Farmers should have an alternative marketing plan in place for pigs that need to be treated with an antibiotic.1,2 It is important that the decision to treat or euthanize is made in a timely manner so as to minimize the pig's pain or distress.
1If an animal has been treated with antibiotics and proper withdrawal times are followed, the meat is safe for consumption.2Marketing programs should not prevent a farmer from treating or preventing illness.Approved by the AASV Board of Directors on March 21, 2016
Educational Resources
Checkoff Stewardship Plan
Checkoff Research
• NPB to allocate up to $1.4 million in Checkoff funding for scientific research, producer education and consumer awareness programs
Producer Antibiotic Resource Center
• Antibiotic Resource Center located at: www.pork.org/antibiotics– All resources– FAQs– Additional clarifications from FDA
AASV brochure distributed to our members.
Available on the www.AASV.orgweb site.
One final point….
Extra-label use of feed grade antimicrobials remains ILLEGAL for both veterinarians and producers
Questions?