VCPR’s and Prescription Drug Use

Battenkill Veterinary Bovine

April 2012

A Little Quiz

Not graded Not submitted to the FDA or USDA or NYS Be honest

Drug Classes- OTC

Over-the Counter (OTC)– can be sold by any person or establishment

without a prescription from a veterinarian. – Examples:

Penicillin LA 200 Today, Tomorrow

– Sufficient label directions for correct use.

Drug Classes - Rx

Prescription (RX)– can only be sold by a veterinarian or pharmacist– “Caution: Federal law restricts this drug to use by

or on the order of a licensed veterinarian.”– Examples: Naxcel , Cystorelin– Need further diagnostics or directions to be able

to properly use the medication.

Drug Classes - VFD

Veterinary Feed Directive (VFD) - a drug intended for use in or on feed, which is limited by an approved application to use under the professional supervision of a licensed veterinarian.– Examples: Pulmotil in swine or beef or non-

lactating dairy cattle feed

Extra Label Use (ELU)

Any use of a drug not specifically listed on the label is called “extra-label drug use” and is regulated by the Food and Drug Administration (FDA) under the Animal Medicinal Drug Use Clarification Act (AMDUCA) of 1994. Using a prescription or over-the-counter drug in an extra-label manner is illegal unless it is specifically recommended under the guidance of a veterinarian working in the context of a Veterinary-Client-Patient Relationship (VCPR).

Examples of ELU

A. Changing the dosea) giving more penicillin than is listed on

the label. B. Changing the route of administration

a) giving Banamine IM instead of IV.C. Changing the frequency of use

a) giving Spectramast LC twice a day instead of once a day.

Examples of ELU

Examples of Illegal Use

Feed additives – Cannot alter dose, duration, indication– Cannot use more than two additives at once

Ceftiofur – Cannot alter dose, duration, route of

administration

Baytril, Sulfa drugs– ELU use prohibited

Drugs Illegal to Use in Food Animals

– • Chloramphenicol– • Clenbuterol – • Colloidal Silver – • Diethylstilbestrol (DES) – • Dimetridazole (Flagyl®) – • Estradiol Cypionate (ECP) – • Glycopeptides (Vancomycin) – • Furazolidone (Furacin Ointment) – • Ipronidazole (Flagyl®) – • Nitrofurans (Nitrofurazone paste or – Furazone aerosol spray) – • Other Nitroimidazoles (Flagyl® {Metronidiazole}) – Gentian violet (Blue Coat ®)

Drugs Prohibited from ELU use

Sulfonamide drugs in lactating dairy cattle (Albon ®) Fluoroquinolones (Baytril ®) Phenylbutazone in female dairy cattle 20 months of

age or older Ceftiofur (Excenel®, Naxcel®, Excede®,

Spectramast®, Ceftiflex®)- cannot use extra-label dose, duration, frequency, or route of administration or for disease prevention

Feed additives – ELU prohibited ELU is not allowed if it results in a violative food

residue ZERO tolerance for any drug residues not listed as

OTC, Rx, or prohibited

Aminoglycosides not to be used in cattle

Amikacin Gentamicin Kanamycin Neomycin- except as approved by FDA

– This drug is a leading cause of violative residues in bob veal calves.

Drug Holdouts

Neomycin is tolerated at 7.2 ppm Gentamicin is not tolerated.

MONTHS

Tail never comes down to 0 ppm. Stays in the kidneys for years.

Calculating Withholding Times

Not an exact science because we don’t always have all the information needed.

Veterinarians can use FARAD. Err on the side of waiting to sell a food

product. Need to know basic info:

– Animal, Age, Drug, Amount, Route, Duration, Health of animal.

Examples

Draxxin Treatment of pneumonia with 1.1ml under

the skin for 100 pound bull calf to be sold.

Treated 2/20/2012 and got better.

Can we sell him today (3/12/2012)?

Milk Antibiotic Residue Testing

The Grade “A” Pasteurized Milk Ordinance (PMO), requires that all bulk milk tankers be sampled and analyzed for beta-lactam drug residues.

Commissioner of the FDA determines frequency of screening of other drug residues through a random sampling program.

Customers may also require additional testing for quality assurance purposes.

Milk Antibiotic Residue Testing

Tankers testing positive:

1996 – 0.104% 3520 loads 2008 – 0.028% 942 loads 2009 – 0.026%

2011 – 0.028% 1079 loads out of 3.787 million tested

26.874 million pounds dumped

Milk Antibiotic Residue Testing

Flunixin (Banamine) milk with hold = 36 hrs after IV administration.

test available now for milk Neogen Corporation product #8475 800-234-5333 1hr 15 minutes/ test. Uses wells with

chemical reagent bottles.

Draxxin Example

This is Extra-Label Use because it is not intended for veal calves.

Tolerance level is now 0, not X ppm as it would be for a non-lactating dairy animal.

Need longer to hit 0. FARAD recommended 35 days, not 18 days. Sale date permissible : 3/27/12

FDA Milk Drug Residue Testing

List of ~1600 farms where beef residues have been found in last year.

Choose 900 of these farms. Choose 900 of their neighbors without

residues. Test all for several drugs using special

testing methods.

Drugs Included in Plan

Ampicillin Penicillin G Cloxacillin Cephapirin Sulfamethazine Sulfadiazine Sulfadimethoxine Sulfathiazole Sulfaquinoxaline Sulfapyridine Sulfachloropyridazine Sulfamerazine Oxytetracycline

Tetracycline Chlortetracycline Doxycycline Tylosin Tilmicosin Erythromycin Sarafloxacin Enrofloxacin Ciprofloxacin Flunixin Bacitracin Thiabendazole Virginiamycin Tripelennamine

FDA Testing

Blinded – no producer information included – Avoids recalls and dumping milk

Hypothesis is that the drug violators will have higher level of milk residues as well.

Testing done on samples from the plant– You won’t know you are being tested

Meat Antibiotic Residue Testing

The United States Department of Agriculture (USDA) Food Safety Inspection Services (FSIS) conducts tests for antibiotics in meat destined for human consumption.

Random sampling plans from healthy cows Packing plant sampling of “sick” animals

Who Makes the Residues?

Injection-Damaged BeefInjection-Damaged Beef

MastitiMastitiss

Metritis

Peritonitis Injection Site

Post Mortem Conditions

Residue Violator List

FSIS maintains a “Residue Violator List” -names and addresses of producers who have more than one meat residue violation in a 12-month period on the web

Most are dairy beef and bob veal 27 farms in US/Canada 11 veal, 37 bob, 18 dairy, 3 pigs, 2 sheep, 1

beef cow (from a dairy)

Repeat Violator List

FDA follow up & Repeat Violators

FDA at Battenkill recently. Summer 2011 problem – came in February Repeat violations can occur without chance

to know and correct. One California farm – 10 violations in 2 days

17 days apart.

Definitions of cattle classification

Lactating cattle = cattle greater than 20 months

Non-lactating cattle = only those who have never lactated. Dry cows are Lactating cows.

Non-ruminating calves = calves on milk Some variation in labels due to FDA

changing definitions.

Causes of Antibiotic Residues

Not following vet prescription or manufacturer label

Accidentally milking treated cow to bulk tank Inadequate animal identification Long term residue following treatment as a

calf Use of medicated milk replacers in calves

Some Key Issues Leading to Residues

The person(s) in charge of treating the cows are not working under a valid veterinary/client/patient relationship.

Employees are not trained properly and continuously in treatment protocols and maintaining written records.

The producer does not review all treatment records for veterinarian-recommended withdrawal times prior to marketing milk or meat.

(Uncommon) Intentional, malicious contamination

Steps to Prevent Antbiotic Residues:

Establish VCPR Reduce necessary treament:

– Implement preventative health program– Maintain milk quality

Implement and maintain employee training of animal drug usage

Use only approved OTC and Rx antibiotics

Steps to Prevent Antbiotic Residues:

KEEP RECORDS of antibiotic use Establish and maintain a low-risk treated animal

identification system. Examples:– Use two or more methods to ID treated cows– Brightly colored leg bands that don’t fall off– Segregate treated animals– Paint/chalk animal– Treatment board– Other methods?

Steps to Prevent Antbiotic Residues:

Use drug residue screening test specific for the drug utilized.

If in doubt – do not market. MeatSafe test from Silver Lakes Research 1-888-438-1942 Beta Lactam, Gentamicin, Sulfa

Treatment Records

FDA requires records be maintained for 2 years Records should be permanent

– Not a chalk board!!!

Keep records of drug purchases– FDA will look for drug purchases versus use recorded– Do they match?

Treatment records for preventative treatments (???)– Vaccinations– Deworming

Treatment Records

Signature page for persons administering treatments All treatments recorded should include:

– Treatment date– Animal ID– Indication/Reason (mastitis, metritis, etc)– Drug used– Dosage (ie. ml)– Route of administration (ie. IM, SQ, IV)– Initial of person administrating drug

Establish a Valid VCPR

Veterinarian assumes responsibility for medical judgments regarding animal health

Veterinarian makes routine visits to farm to gain sufficient knowledge of animals

Veterinarian available for emergency care

Establish a Valid VCPR

Employees aware that it is policy to follow instructions of veterinarian

Veterinarian and producer establish an approved drug list

Veterinarian and producer establish treatment protocols for commonly occurring medical conditions.

Precautions while administering drugs

Discard milk from all four quarters even when treating only one quarter with an IMM infusion.

Thoroughly wash all equipment (inflations, hoses, weigh jars, etc.) that has come in contact with milk from treated cows.

Keep medicated feeds separated from non-medicated feeds. Ensure that calves fed antibiotic waste milk are not sent to

slaughter until withdrawal times are met. Train employees on proper injection site selection. Record the treatment information!

Drug Residue Testing

Make certain that drug residue test being used is appropriate for drug administered.– Ie – tetracycline and beta-lactam tests.

Test milk from dry cows that freshen early Test milk from newly purchased animals Test milk when treating with ELU

Bob Veal Calves and Colostrum

Establish a protocol for colostrum feeding of bull calves for bob veal– Use stored, untreated heifer colostrum– Use dry treat with labelled neonatal calf pre-

slaughter with hold (Spectramast DC - 0 days)– Use dry treat with short recommended neonatal

pre-slaughter with hold (Tomorrow - 7days)– Selective dry treatment

NAIS and USDA

June 1 – new requirements for animal identification effective

New requirements not defined yet!– Permanently Id all cows?– Permanently Id all animals?– Likely one of the above– Tags may need to have USDA symbol

Battenkill Recommends Today

Permanently ID ALL CALVES, including bulls WHY?

– Slaughter facilities testing 2 out of 3 bob veal calves slaughtered

– Non-permanent id’s can (and do!) get mixed up– Prevent residues from incorrectly being associated

with your animals

Silver tags available for permanent ID

NYS – fill out order form or call 457-3502– Free tags, you buy tagger 7S or 49 style HASCO– “21P” tags– Scrapie – Anna Draisey 858-1424 or 218-7540

VT - ? Not sure yet– Probably free tags and tagger

MA - Tags available through clinic

VCPR Form

Formal agreement:– Veterinarian assumes responsibility for the health

and treatment of animals– Veterinarian will be available to examine,

diagnose and prescribe treatment and to provide emergency service if needed

VCPR Form

Formal agreement:– Producer agrees to follow instructions of

veterinarian for medical treatment– Producer will keep complete records of all

treatments given to animals on the farm that may incur a food residue

– Producer will apply permanent, unique identification to all animals intended for food production on the farm

Take Home Points

Have a VCPR Follow directions – call if they are not clear Wait extra time if questioning Permanently identify with UNIQUE ID each

animal Write down all treatments in a notebook. Do not throw away any drug records