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Table of Contents
ADE Home
ADE Reports
ADE Report Description
Annual/Cumulative Report
Reporting an ADE
How to Report an ADE
Form 1932a
Pharmacovigilance Broc
Additional Information
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What is included
in the veterinary ADE database?
Veterinary ADEs appearing in the database:
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To see if a drug is approved for animals please
search the FDA
Approved Animal Drug Products Database
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Include some, but not all topical flea products.
If the product is delivered systemically (goes
beyond the skin and is distributed throughout
the body), FDA regulates it. Otherwise it is regulated
by EPA
Examples of FDA-regulated products include Revolution™
(Pfizer), Dectomax™(Pfizer) or search the above
database
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Accepted in writing to:
ADE Reporting System
Center for Veterinary Medicine
U.S. Food & Drug Administration
7500 Standish Place
Rockville, MD 20855-2773
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Or by telephone at 1-888-FDA-VETS
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Those ADEs that score positive for possible through
probable or definite
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Signs and clinical findings; each scored independent of
another in a single episode
What is not included
in the ADE reporting system?
Veterinary ADE’s are not:
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Complaints regarding human drugs unless administered
to animals
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Accepted via e-mail
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For animal biologics or vaccines
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For topical insecticides.
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Complaints regarding attending veterinary prescribing
or dispensing errors.
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Complaints regarding company or veterinary reimbursement
of costs associated with a pet’s illness.
My vet prescribed a
human drug for my dog. Can he do that?
The Animal
Medicinal Drug Use Clarification Act of 1994 (AMDUCA)
allows veterinarians to prescribe extralabel uses
of certain approved animal drugs and approved human
drugs for animals under certain conditions. Extralabel
(or extra-label or off label) use refers to the use
of an approved drug in a manner that is not in accordance
with the approved label directions. The key constraints
of AMDUCA are that any extralabel use must be by,
or on the order of, a veterinarian within the context
of a veterinarian-client-patient relationship, must
not result in violative residues in food-producing
animals, and the use must be in conformance with the
implementing regulations published at 21 CFR Part
530.
What kind of
information should be included in my complaint?
The ADE scoring system uses a modified Kramer scoring
system (Keller et al., Vet Clin North Am, Food Anim
Pract, March 1999,15(1):13-30). In this system, each
sign is separated from the other signs and scored
according to previous experience with the drug, alternative
etiologic candidates (other causes), timing of the
event, whether there was an overdose, whether the
reaction continued or subsided with withdrawal of
the drug, and whether a reaction recurred on re-introduction
of a drug. The scores are most accurate when there
is sound clinical information about an animal. This
means that the report should include
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a good medical history,
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all concomittent drugs the animal has been given,
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any recent surgical procedures,
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veterinary exam results,
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clinical chemistries,
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complete blood counts,
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urinalysis,
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fecal exams,
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radiographic results,
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hemodynamic data such as blood pressure, any
other pressure measurements in or around the heart,
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and neurologic assessments.
Updated
Friday, July 16, 2004 at 3:58 PM ET - swd
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