Use of Antibiotics in Cattle: Changes Coming Dr Use of Antibiotics in Cattle: Changes Coming Dr. Dee Whittier Virginia-Maryland Regional College of Veterinary Medicine

FDA Antibiotic Changes Changes coming in the way antibiotics are used in food animals. December, the Food and Drug Administration (FDA) published a final “guidance for industry” that starts the clock running on some of these changes. Initially: Animal health companies Adjustments that will eventually make their way down to the people who prescribe and use the drugs: veterinarians and livestock producers.

Antibiotic Changes The role of livestock antibiotics in contributing to resistant bacterial infections in humans is complex and has been long-debated. Producer associations have seen the writing on the wall for a couple of years now that these changes were coming. But what do they actually mean for producers?

The Development of Antibiotic Resistance Antibiotics

The Development of Antibiotic Resistance Antibiotics

Antibiotic Usage Over the Counter Prescription Extra-Label

Antibiotic Usage Prescription

Antibiotic Usage Over the Counter??? Extra-Label

Extra-Label Any species, any condition, any route, any dose other than label Conditions: Direction of a Veterinarian Proper Veterinary-Client-Patient-Relationship (VCPR) Exaggerated withdrawal times Proper labeling

Antibiotic Changes What will change? The labeled uses of “medically important” antibiotics for growth promotion and improvements in feed efficiency have gone away. Extra-label use of feed grade antibiotics is illegal, these uses will continue to be illegal.

Antibiotic Changes Before a producer can obtain (for example) CTC (chlortetracycline- Aureomycin) crumbles for his calves or pigs, he will have to obtain a VFD form filled out by his veterinarian. The form will specify the farm and animals to be treated, the duration of treatment, and which drug is to be used. The feed mill or distributor would need to have a properly completed VFD before they could supply the feed.

Antibiotic Changes Before a producer can obtain (for example) CTC (chlortetracycline- Aureomycin) crumbles for his calves or pigs, he will have to obtain a VFD form filled out by his veterinarian. In to Effect December 2016!

Vets VFD Rules Veterinarians’ Responsibilities must be licensed to practice veterinary medicine; must be operating in the course of the veterinarian’s professional practice and in compliance with all applicable veterinary licensing and practice requirements; must write VFD orders in the context of a valid client-patient-relationship (VCPR); must issue a VFD that is in compliance with the conditions for use approved, conditionally approved, or indexed for the VFD drug or combination VFD drug; must prepare and sign a written VFD providing all required information; may enter additional discretionary information to more specifically identify the animals to be treated/fed the VFD feed; must include required information when a VFD drug is authorized for use in a drug combination that includes more than one VFD drug; must restrict or allow the use of the VFD drug in combination with one or more OTC drug(s); must provide the feed distributor with a copy of the VFD; must provide the client with a copy of the VFD order; must retain the original VFD for 2 years, and must provide VFD orders for inspection and copying by FDA upon request.

Vets VFD Rules must be licensed to practice veterinary medicine; Veterinarians’ Responsibilities must be licensed to practice veterinary medicine; must be operating in the course of the veterinarian’s professional practice and in compliance with all applicable veterinary licensing and practice requirements;

Vets VFD Rules Veterinarians’ Responsibilities must write VFD orders in the context of a valid client-patient-relationship (VCPR);

Vets VFD Rules Veterinarians’ Responsibilities must be licensed to practice veterinary medicine; must be operating in the course of the veterinarian’s professional practice and in compliance with all applicable veterinary licensing and practice requirements; must write VFD orders in the context of a valid client-patient-relationship (VCPR); must issue a VFD that is in compliance with the conditions for use approved, conditionally approved, or indexed for the VFD drug or combination VFD drug; must prepare and sign a written VFD providing all required information; may enter additional discretionary information to more specifically identify the animals to be treated/fed the VFD feed; must include required information when a VFD drug is authorized for use in a drug combination that includes more than one VFD drug; must restrict or allow the use of the VFD drug in combination with one or more OTC drug(s); must provide the feed distributor with a copy of the VFD; must provide the client with a copy of the VFD order; must retain the original VFD for 2 years, and must provide VFD orders for inspection and copying by FDA upon request.

VFD : Veterinary Feed Directive

VFD

Client’s Responsibilities As the client, a producer must: only feed animal feed bearing or containing a VFD drug to animals based on a VFD issued by a licensed veterinarian; not feed a VFD feed to animals after the expiration date on the VFD; provide a copy of the VFD order to the feed distributor if the issuing veterinarian sends the distributor’s copy of the VFD through you, the client maintain a copy of the VFD order for a minimum of 2 years; and provide VFD orders for inspection and copying by FDA upon request.

A little Math 0.5 mg / lb body wt per day 1200 lb cow (0.5 mg/lb) = 0.6 gm/hd/day 1200 lb cow (2 mg/lb) = 2.4 gm/hd/day If cows eat 4 oz per head per day 4800 gm / ton of mineral 2.4 gm/ lb of mineral

Medicated mineral

Medicated mineral

Medicated mineral

Antibiotic Changes The VFD won’t be able to come from just any veterinarian. Right now VFD’s have to be issued in the midst of a valid veterinary-client-patient relationship (VCPR) that’s spelled out by federal regulation.

VCPR The veterinarian has assumed the responsibility for making clinical judgments regarding the health of the patient and the client has agreed to follow the veterinarians' instructions.

VCPR The veterinarian has sufficient knowledge of the patient to initiate at least a general or preliminary diagnosis of the medical condition of the patient.  This means that the veterinarian is personally acquainted with the keeping and care of  the patient by virtue of a timely examination of the patient by the veterinarian, or medically appropriate and timely visits by the veterinarian to the operation where the patient is managed.

VCPR The veterinarian is readily available for follow-up evaluation or has arranged for the following: veterinary emergency coverage, and continuing care and treatment. The veterinarian provides oversight of treatment, compliance, and outcome. Patient records are maintained

Antibiotic Changes What won’t change: The ability to use feed-grade antibiotics to treat, control, or prevent bacterial diseases. The term “prevention” is used in the situation where there is a very high risk of illness if you don’t administer the antibiotic. However, producers will need to obtain a VFD for these products as explained above.

Antibiotic Changes The Kind’a Good News: The FDA doesn’t have many resources for enforcement But they will monitor VFD’s Now only act if there is a complaint or residue But: Do we really want to live having to always look over our shoulder?

Antibiotic Changes What won’t change: How one uses and obtains non-“medically important” feed grade products. Examples of these include ionophores like Rumensin®, Bovatec®, most coccidiosis medications, and certain growth-promoting medications like bacitracin (BMD). Since they’re not used very often if at all in human medicine, there will be no changes in their use.

Antibiotic Changes What won’t change: Uses of injectable antibiotics. However, this proposal would also move over-the-counter medically-important water medications to “prescription” status like many injectable antibiotics. Extra label uses of feed-grade medications. Any use of feed grade medications not in accordance with their label is illegal now, and it will remain so.

Bulletin!!

Antibiotic Changes Antibiotic resistance is a complex and sometimes contentious topic among animal and human health professionals. The complexity of the issue means that a “silver bullet” solution is not going to present itself any time soon.

Antibiotic Changes All of us involved in using these products—in animals and people alike—play a role in ensuring that they continue to work for the sake of our animals and our family members. Understanding these proposed changes and proactively deciding how they will work into your operation is a great first step that we can all take.

Thank You! Questions? Veterinary Medicine