VCPR’s and Prescription Drug
Use
Battenkill Veterinary
Bovine
April 2012
A Little Quiz
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Not graded
Not submitted to the FDA or USDA or NYS
Be honest
Drug Classes- OTC
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Over-the Counter (OTC)
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can be sold by any person or establishment
without a prescription from a veterinarian.
Examples:
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Penicillin
LA 200
Today, Tomorrow
Sufficient label directions for correct use.
Drug Classes - Rx
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Prescription (RX)
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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
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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.
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Examples: Pulmotil in swine or beef or nonlactating dairy cattle feed
Extra Label Use (ELU)
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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-thecounter 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.
B.
C.
Changing the dose
a) giving more penicillin than is listed on
the label.
Changing the route of administration
a) giving Banamine IM instead of IV.
Changing the frequency of use
a) giving Spectramast LC twice a day
instead of once a day.
Examples of ELU
D. Giving a drug to a different production class of
animal
a) using Nuflour® in a lactating cow
E. Giving a drug for an indication (disease) not listed
on the label
a) using Excede® for diarrhea
F. Changing the amount of drug per injection site
a) giving 20 cc penicillin in one spot
Examples of Illegal Use
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Feed additives
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Ceftiofur
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Cannot alter dose, duration, indication
Cannot use more than two additives at once
Cannot alter dose, duration, route of
administration
Baytril, Sulfa drugs
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ELU use prohibited
Drugs Illegal to Use in Food Animals
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• 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
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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
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Amikacin
Gentamicin
Kanamycin
Neomycin- except as approved by FDA
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This drug is a leading cause of violative residues
in bob veal calves.
Drug Holdouts
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Neomycin is tolerated at 7.2 ppm
Gentamicin is not tolerated.
Tail never comes down to
0 ppm. Stays in the
kidneys for years.
MONTHS
Calculating Withholding Times
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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:
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Animal, Age, Drug, Amount, Route, Duration,
Health of animal.
Examples
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Draxxin
Treatment of pneumonia with 1.1ml under
the skin for 100 pound bull calf to be sold.
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Treated 2/20/2012 and got better.
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Can we sell him today (3/12/2012)?
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Milk Antibiotic Residue Testing
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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:
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loads
2008 – 0.028% 942 loads
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2009 – 0.026%
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2011 – 0.028% 1079
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26.874 million pounds dumped
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1996 – 0.104% 3520
loads out of
3.787 million tested
Milk Antibiotic Residue Testing
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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
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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
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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
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Ampicillin
Penicillin G
Cloxacillin
Cephapirin
Sulfamethazine
Sulfadiazine
Sulfadimethoxine
Sulfathiazole
Sulfaquinoxaline
Sulfapyridine
Sulfachloropyridazine
Sulfamerazine
Oxytetracycline
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Tetracycline
Chlortetracycline
Doxycycline
Tylosin
Tilmicosin
Erythromycin
Sarafloxacin
Enrofloxacin
Ciprofloxacin
Flunixin
Bacitracin
Thiabendazole
Virginiamycin
Tripelennamine
FDA Testing
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Blinded – no producer information included
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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
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You won’t know you are being tested
Meat Antibiotic Residue Testing
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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?
900
800
700
600
500
400
300
200
100
0
2005 2006
2007 2008
2009 2010
Bob Veal
Cows Dairy
Steers
Sows
Non FFV
Market Hogs
Heifers
Heavy Calves
FFV
Cows Beef
Bulls/Stags
Bovine
Injection-Damaged Beef
Post Mortem Conditions
Mastitis
Peritonitis
Metritis
Injection Site
Residue Violator List
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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
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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
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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
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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
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Steps to Prevent Antbiotic Residues:
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Establish VCPR
Reduce necessary treament:
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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:
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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:
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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
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FDA requires records be maintained for 2 years
Records should be permanent
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Keep records of drug purchases
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Not a chalk board!!!
FDA will look for drug purchases versus use recorded
Do they match?
Treatment records for preventative treatments (???)
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Vaccinations
Deworming
Treatment Records
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Signature page for persons administering treatments
All treatments recorded should include:
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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
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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
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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
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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
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Make certain that drug residue test being
used is appropriate for drug administered.
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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
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Establish a protocol for colostrum feeding of
bull calves for bob veal
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Use stored, untreated heifer colostrum
Use dry treat with labelled neonatal calf preslaughter 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
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June 1 – new requirements for animal
identification effective
New requirements not defined yet!
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Permanently Id all cows?
Permanently Id all animals?
Likely one of the above
Tags may need to have USDA symbol
Battenkill Recommends Today
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Permanently ID ALL CALVES, including bulls
WHY?
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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
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NYS – fill out order form or call 457-3502
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VT - ? Not sure yet
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Free tags, you buy tagger 7S or 49 style HASCO
“21P” tags
Scrapie – Anna Draisey 858-1424 or 218-7540
Probably free tags and tagger
MA - Tags available through clinic
VCPR Form
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Formal agreement:
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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
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Formal agreement:
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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
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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