Food Animal terapeutics and extra-label drug use

Extra-label drug use

• Use of a drug in a manner other than that listed on its label

• Governed by AMDUCA

AMDUCA

Animal Medicinal Drug Use clarification act

REquirements for Extra-Label Drug use

1. Valid Veterinarian-Client-Patient-Relationship (VCPR)

1. For Therapeutic purposes only

2. A careful diagnosis of the condition has been made

3. A determination is made that there is no marketed drug specifically labeled to treat the condition diagnosed, or drug therapy with the approved product at the dosage recommended has been found to be clinically ineffective

4. A significantly extended time period is assigned for drug withdrawal prior to marketing meat or milk and steps are taken to assure that the assigned time frames are met, and no illegal residues occur

5. Procedures are instituted to assure that the identity of treated animals is adequately maintained

6. All drugs dispensed to the producer by the veterinarian bear label information which is adequate to assure proper use of the product

7. Extra-label drug use of feed additives is not permitted under any circumstances

Valid VCPR

This means the vet has examined the patient or has adequate knowledge of the patient - and has agreed to assume responsibility for veterinary care- Vet can't prescribe if they haven't seen the patient

FDA Drug Classification

• Over-the-Counter Drugs

• Veterinary prescription drugs

• Veterinary Feed Directive

Over-the-Counter Drugs

• Drugs that can be purchased and used without veterinary supervision

• Label directions must be clear and understandable by the producer

• When used without veterinary supervision, these drugs used must comply with the product label or it is extra-label drug use

Veterinary Prescription Drugs

• Drug use that requires supervision by a licensed veterinarian

• Access to veterinary prescription drugs are dependent on a valid VCPR

• All veterinary prescription drugs must bear the statement: "CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian"

• January 1, 2017 - Antimicrobials delivered via the water require a veterinary prescription

Veterinary Feed Directive

• Provided greater control over the use of new antimicrobial feed additives

• January 1, 2017

  • Inclusion of antimicrobials at sub-therapeutic levels in feed is prohibited

  • Feed-grade antimicrobials require oversight of a licensed veterinarian in the form of a VFD request to feed mills

  • Antimicrobials not requiring a VFD

    1. BMD (Bacitracin Methylene Disalicylate)

    2. Denagard (Tiamulin)

    3. Flavomycin (Bambermycin)

    4. Mecadox (Carbadox)

    5. Skycis (Narasin - Rumensin, ionophore fed to cattle, pigs)

Antimicrobials

substance that kills or stops the growth of microoganisms

• Antibiotics

• Antivirals

• Antifungals

• Antiparastitics

Compounding

• Alteration of approved drugs to obtain a therapeutic product

• You are bringing 2 different drugs together

• Illegal is an approved animal drug is available that is comparable to the compounded preparation

• Must be performed by a licensed pharmacist or licensed veterinarian

• Compound ONLY is necessary

Example of compounding

• Combining Dexamethasone + Draxxin (Tulathromycin) for localized treatment of conjunctivitis in pigs

Prohibited and/or restricted drugs in FOOD ANIMALS

• Diethylstilbestrol

• Chloramphenicol

• Nitroimidazoles/Nitrofurans

• Clenbuteral

• Dipyrone

• Fluoroquinolones

• Glycopeptides

• Medicated Feeds

• Chephalosporins

• Aspirin

Diethylstilbestrol

• potent reproductive carcinogen

  • With humans treated with this can affect them badly, so we don’t want to risk humans ingesting this

Chloramphenicol

• can be toxic to bone marrow (aplastic anemia)

  • Is an antibiotic

Nitroimidzaoles/Nitrofurans

•  carcinogen concerns

  • If you dress a wound with this it can be absorbed and risk it being in the animal systemically

Clenbuterol

• can cause tachycardia and death

  • People has died eating meat that contained this.

  • Causes them to become more lean, more muscular

Dipyrone

• depress white blood cell production in bone marrow (myelotoxicity)

  • It does help with fevers

Fluoroquinolones

• use in poultry assumed to induce Salmonella resistance (approved for cattle and pigs)

  • Cannot use in poultry

Glycopeptides

•  one of only 2 drugs for treating resistant staphylococcus (MRSA) and clostridial (C. Diff) infections in humans

  • It's an antibiotic

Medicated Feeds

NO EXTRA-LABEL PRIVILEGES, EVER

Cephalosporins

• restrictions enacted in January 2012, requires that the dosing instructions on the label to be followed in all cases (dose, frequency of administration)

Aspirin

• the use of this in food animals was prohibited as of October 2024. This was in response to the use of aspirin to treat dairy cows infected with bird flu (H5N1 influenza). The aspirin products on the market were never approved by the FDA

Prohibited and/or restricted drugs in FOOD ANIMALS - Poultry

Adamantanes, Neuraminidase inhibitors - influenza antiviral drugs, misuse of adamantanes has led to resistance worldwide

Prohibited and/or restricted drugs in FOOD ANIMALS - Dairy

DMSO, Fluroquinolones, Phenylbutazone, Sulfa drugs - drugs with very limited or no approval for use in dairy cows