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Transcript
Responsible Use of
Livestock Drugs
Dave Sparks D.V.M
Area Extension Food Animal
Quality and Health Specialist
What’s the Big Deal?
• Residues - Drug or drug breakdown products
that remain in the meat or meat products at the
time of slaughter and may be harmful to
consumers. They may cause disease directly
such as toxins or carcinogens, or contribute to
resistance.
• Resistance – The development of the ability of
germs to tolerate antimicrobials. This makes
disease in humans harder to treat and is usually
caused by low dosages or too short duration of
treatment in livestock.
Rx vs OTC
• Prescription drugs (Rx) must be either
dispensed or prescribed by a licensed
veterinarian for use in a valid veterinarianclient-patient relationship.
• Over the counter drugs (OTC) may be
purchased and used by anyone as long as
they are used in all manners consistent
with their label.
Veterinarian/Client/Patient
Relationship
• A V/C/P relationship exists when these 3
conditions are met;
– The veterinarian has assumed the responsibility
for making clinical judgments and treatments, and
the client has agreed to follow the veterinarians
instructions.
– The veterinarian has sufficient knowledge
obtained by actual examination of the animal or
appropriate visits to the premises.
– The veterinarian is available for follow up
evaluation and/or emergency coverage.
Labeling Requirements
• The label is a legal document, either OTC
or Rx.
• The label must tell who made it, what
species it is approved for, what conditions
it is meant to treat, dosage, route of
administration, course of therapy,
withdrawal times, special considerations.
• Any deviation constitutes extra-label-use.
Extra-Label-Use
• Only allowed when used or prescribed by
veterinarian with valid V/C/P relationship. (OTC or
Rx)
• Must carry a label which addresses all of the
components of a legal label listed above, plus
contact information for the veterinarian.
(including withdrawal time)
• Only to save life or stop suffering, not to improve
performance.
• Both the veterinarian and producer are required to
keep records of all extra-label usage.
• Off label use can only be used to
save animal lives or prevent
suffering. It cannot be used to
enhance performance or
production.
Some Drugs Can’t be Used
Extra-Label
•
•
•
•
•
•
•
•
All feed additive drugs.
Flouroquinalones (Baytril)
Nitrofurazones in food animals.
Clenbuterol in food animals.
Dipyrone in food animals.
Micotil in goats
Dectomax in dairy animals.
Others.
Are There Penalties?
• Banishment from Shows.
• FDA fines for legal label violations or
residues.
• Imprisonment?? I don’t know of it ever
happening but FDA has the authority to
pursue this through the courts in the event
of serious violations.
Minor Species, Minor Use
• Under new regulations FDA is encouraging
manufacturers to apply for minor species, minor
uses approval for existing human or veterinary
drugs.
• A minor species is anything other than dog, cat,
cattle, horses, pigs, chickens, and turkeys.
• A minor use is any use other than the indication
on the existing label.
• Not much action yet.
National Research Support
Project
• USDA NRSP7 Program
– For certain drugs where there is enough
interest, but not enough economic incentive,
USDA will do the research for a company that
will agree to market the drug
• Wish list
– www.nrsp-7.org go to forms and then select
ADR for Animal Drug Request
What’s New?
• Louisiana Anaplasmosis Vaccine
– Approved by USDA for experimental use in
selected states
– Dr. Gene Luther at LSU
– Available only to licensed veterinarians.
– Cost is about $6.00 / dose.
– No problems with neonatal isoerythrolysis.
New Products from IntervetShering Plough
• Nuflor Gold (Rx)
– Same dose and active ingredient but
“formulated” to also be effective against
mycoplasma pneumonia
– Slightly more expensive than Nuflor
• Resflor Gold (Rx)
– Combination of florfenicol (Nuflor) and flunixin
(Banamine)
– Reduces inflammation and reduces fever
while combating respiratory infections.
New Product From Agrilabs
• Long acting tetracycline with flunixin in
combination coming soon.
Encourage Producers to
Develop Treatment Protocol
• Work with veterinarian
– Relationship vital
• Keep hospital records
– How do you know what works and what
doesn’t without records
• Evaluate effectiveness of protocol.
• Change as needed
Questions?