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?