Extra-Label Drug Use Flashcards
(44 cards)
Extra-label use
Use of a drug in an animal in a manner that is not in accordance with approved labeling
- off label is not an appropriate term
ELDU
Veterinary extra-label use was overlooked by the FDA according to guidelines that allowed enforcement discretion
- AMDUCA legalized extra-label drug use by vets in context of a VCPR
Veterinarian-client-patient relationship
Required for prescription, VFDs, and ELDU
- vet has assumed responsibility for care of animal and owner has agreed to follow guidance
- vet is knowledgeable of situation to make a prelim diagnosis
- vet has personally seen animal recently
- vet is available for follow ups
- valid VCPR cannot be established online, by email, or over the phone
What drugs are banned from extra-label use
Pesticides
Extra-label use is only applied to _____
Drugs
- things governed by the FDA
Why are drugs banned from use in food animals?
They were abused, or they have high health risk for humans
- can never be used in food animals under any circumstances!
Drugs banned from use in any food animal
- chloramphenicol
- clenbuterol
- diethylstilbestrol
- dimetridazole, ipronidazole, other nitroimidazoles (metronidazole)
- nitrofurans (furazolidone)
- sulfonamide in lactating dairy cattle
- phenylbutazone in lactating dairy cattle
- fluoroquinolones
- cephalosporin
- glycopeptides (vancomycin)
- adamantane, neuraminidase
Labeling of the extra-label product must include
- name and address of vet and/or name and address of dispensing pharmacy
- established name of ingredients and their strengths
- directions for use
- precautions if applicable
- withdrawal times
Directions for use should include:
- class/species/identification of the animal or herd being treated
- dosage, frequency, and route of administration
- duration of therapy
Can medicated feed be used extra-label?
No, neither OTC or VFD
Extra-label use record keeping
Readily retrievable records must be kept for 2 years or as mandated by state law (whichever is greater)
Records must contain
- animal identification
- name of drug and active ingredients
- condition treated
- species of treated animals
- dosage administered
- duration of the treatment
- number of animals treated
- specified withdrawal or discard times
What reasons are valid to allow for ELDU and which ones are not
- pain: yes
- suffering: yes
- performance enhancement: no
- production: no
FARAD
Food animal residue avoidance and depletion program
- supported by USDA, provides science-based advice to help mitigate unsafe chemicals residues in products derived from food animals
Described the antemortem screening tests for detection of antimicrobial residues using milk
or urine
Take uninoculated broth that contains bacteria and pH color indicator –> add milk
- no antibiotic present: bacterial growth, acid production, color change
- antibiotic present: no bacterial growth, no color change
When is cost allowed as a reason for ELDU?
In non-food animals, you may use a human drug extralabelly, even when an animal drug exists if cost is lower
Companion animal heirarchy
Few restrictions on extra-label use in non-food animals
- use vet drug if it: contains needed ingredient, is in the proper dosage, labeled for indication, and is clinically effective
- if not: use extralabel vet drug
- OR: human drug if more cost effective
Food animal heirarchy
If there is a vet drug that fills all of the requirements, then you must use it per label!
- if not: use extralabel vet drug and establish extended withdrawal time
- if no vet drug exists use human drug ONLY if there is adequate scientific info on withdrawal time
When is compounding a drug allowed for food animals?
If there is no vet or human drug available for the condition
- can only be done to prevent pain and suffering
Surveillance of meat
USDA (FSIS) –> FDA
- if any use results in a residue in a food animal, the FDA has regulatory authority to intervene
Surveillance of milk
Pasteurized milk ordinance
- state department of health
Scheduled sampling
- continuous baseline: random tissue sampling from food animals that have passed ante-mortem inspection
- targeted sampling: react to the violations obtained from previous baseline assessments and intelligence info
Post-mortem antimicrobial screening
- FAST (fast antimicrobial screen test): swab into muscle to collect tissue fluid
- KIS (kidney inhibition swab): sample just the kidney
- look for zone of inhibition after 24 hrs*
Import reinspection sampling
- normal sampling
- increased sampling: result of agency management decision
- intensified sampling: when previous sample failed to meet US requirements
