Antibiotic use, regulation, and

record keeping

Matt S. Anderson, DVM

Suidae Health and Production

Algona, Iowa

When Fleming discovered

penicillin, do you think he ever

envisioned such a debate?

Tools of the veterinarian

Vaccine

Antibiotics

Host of other medications

Physicians recognize the value too

The Perceived Problem

1. Antibiotics are used in animals

2. Results in the development of resistant

bacteria

3. Resistant bacteria remain on meat through

packing process

4. Resistant bacteria remains on meat through

transport and to the retailer

The Perceived Problem

5. Consumer buys meat and resistant bacteria

remains viable through preparation

6. Resistant bacteria is transmitted to

human/human becomes infected

7. Human goes to doctor and is prescribed an

antimicrobial

8. Human does not recover

(Dr. Scott Hurd)

Manifestations

All kinds of groups with specific agendas

and initiatives

PAMPTA

GFI 209

GFI 213

VFD

GFI 209 Final Guidance for Industry

Medically important antimicrobial drugs

will be limited to uses assuring animal

health

– Loss of growth promotant claims

– Expanded carbon footprint

– Economically detrimental to producers

Decreased ADG

Increased F/G

GFI 209

Medically important antimicrobial drugs

will be limited to uses that include

veterinary oversight and consultation

– Loss of OTC drugs

– Expanded role for veterinarians in oversight

May be an opportunity but may also cost more

GFI 213

Draft GFI 213

Implementation of principles espoused in

GFI 209

Veterinary Feed Directive

Draft text

Marketing status changes

Judicious Use of Antibiotics The right antimicrobial

At the right time

At the right concentration

With the correct amount of treatment time

With the correct amount of withdrawal time

observed

With the proper records completed and

maintained

Judicious Use

Have a herd health management plan

– Supported by current diagnostics

– With a demonstrated VCPR

– Maintain accurate records for the appropriate

amount of time

Judicious Use

Producers

– We care

– PQA Plus

Veterinarians

– VCPR

– ELDU

– AMDUCA

We Care Program

Produce safe food

Protect and promote animal well-being

Ensure practices to protect public health

Safeguard natural resources in all of our practices

Provide a work environment that is safe and

consistent with our other ethical principles

Contribute to a better quality of life in our

communities

PQA Plus GPP1 Herd health management plan

GPP2 Appropriate VCPR

GPP3 Use antibiotics responsibly

GPP4 ID, track, and maintain medication

and treatment records

GPP5 Adhere to withdrawal times

GPP6 Properly store, label, and account for

all drugs

PQA Plus

GPP7 Use proper administration techniques,

etc.

GPP8-10

VCPR

21 CFR part 530

1. Vet assumes responsibility for making

medical judgments

2. Vet has sufficient knowledge of the

animals in question

3. Vet is readily available for follow up

VCPR

Non-OTC Swine labeled products requiring

a prescription (Baytril or Naxcel)

Non-swine labeled products

– ELDU

ELDU

ELDU is permitted only by or under the supervision of a veterinarian.

ELDU is allowed only for FDA approved animal and human drugs.

A valid Veterinarian/Client/Patient Relationship is a prerequisite for all

ELDU.

ELDU for therapeutic purposes only (animal's health is suffering or

threatened). Not drugs for production use.

Rules apply to dosage form drugs and drugs administered in water.

ELDU in feed is prohibited.

ELDU is not permitted if it results in a violative food residue, or any

residue which may present a risk to public health.

FDA prohibition of a specific ELDU precludes such use

AMDUCA record keeping

Identify the animals, either as individuals or a group.

Animal species treated.

Numbers of animals treated.

Conditions being treated.

The established name of the drug and active ingredient.

Dosage prescribed or used.

Duration of treatment.

Specified withdrawal, withholding, or discard time(s), if applicable, for

meat, milk, eggs, or animal-derived food.

Keep records for 2 years.

FDA may have access to these records to estimate risk to public health.

AMDUCA label requirements

Name and address of the prescribing veterinarian.

Established name of the drug.

Any specified directions for use including the class/species

or identification of the animal or herd, flock, pen, lot, or

other group; the dosage frequency, and route of

administration; and the duration of therapy.

Any cautionary statements.

Your specified withdrawal, withholding, or discard time

for meat, milk, eggs, or any other food.

FDA Inspection Great way to test your knowledge and skill

in the areas of prescription and record

keeping

These inspectors are

professional, polite, incredibly

thorough, and have a very limited sense of

humor

FDA inspection can be initiated without any

notice and for not much in the way of a

reason

FDA Inspection Pre-emptive residue avoidance??????

Demonstration of VCPR

Looked at every product in every dark

corner of the farm---2 day effort

Every label was scrutinized

Every expiration date was studied

Many questions were asked

If you don’t break the rules you’ll be fine

The Veterinarian’s Oath

Being admitted to the profession of veterinary medicine, I solemnly swear to

use my scientific knowledge and skills for the benefit of society through the

protection of animal health, the relief of animal suffering, the conservation of

livestock resources, the promotion of public health, and the advancement of

medical knowledge.

I will practice my profession conscientiously, with dignity, and in keeping with

the principles of veterinary medical ethics.

I accept as a lifelong obligation the continual improvement of my professional

knowledge and competence.

Adopted by AVMA HOD in 1954

– Revised in 1969 and 1999

The Veterinarian’s Oath

Being admitted to the profession of veterinary medicine, I solemnly swear to

use my scientific knowledge and skills for the benefit of society through the

protection of animal health and welfare, the prevention and relief of animal

suffering, the conservation of animal resources, the promotion of public

health, and the advancement of medical knowledge.

I will practice my profession conscientiously, with dignity, and in keeping with

the principles of veterinary medical ethics.

I accept as a lifelong obligation the continual improvement of my professional

knowledge and competence.

Revised by the AVMA executive board in late 2010

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