Extra-Label Drug Use Flashcards
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
What is the difference between regulations and guidelines?
- regulations: FDA writes specifics of regulations (legally binding)
- guidelines: produced from regulations that are more practical, but not legally binding
What is the number 1 condition for extra-label use?
There is no approved animal drug that contains the same active ingredient in the required dosage form and concentration that is labeled for such use, OR all approved animal drugs are clinically ineffective for its intended use
Prior to prescribing an approved animal/human drug for extra-label use in food animals, the vet must
- make a diagnosis that warrants extra-label use
- diagnosis and treatment are within limits of accepted practice
- make sure animals are identified to prevent accidental entry into food chain
- make sure measures are in place to adhere to withdrawal times
- establish an appropriate withdrawal period based on scientific evidence
If no scientific evidence exists on which to base a withdrawal time, the animal _____
Must not enter the human food chain
A human drug can be used only if _____
There is no approved vet drug that could be used instead, even if in an extra-label manner
Extra-label use to enhance _____ is prohibited
Production
- only used when health of animal is threatened, or suffering/death may result if animal is not treated
Compliance policy guide for extra-label use of medicated feeds for minor species
Directs FDA field personnel to make the use of medicated feeds for minor species a low enforcement priority under the stated conditions
- ex: ionophores in goats and sheep to control coccidiosis is done because there is no slaughter and milk withdrawal times
Compounded drug
Extra-label practice when no formulation exists to meet the demands of the patient, a pharmacist is allowed to create a new formulation from an existing approved drug
Does the Drug Quality and Security Act apply to vet med?
No
- strictly voluntary
Present status of AMDUCA and compunding
Compounding for use in animals is not allowed when an approved animal or human drug will appropriately treat the condition
Is compounding allowed when suffering or death of the animal is not likely to result from failure to treat?
No
Is compounding from a human drug for use in food animals allowed?
Not if an approved animal drug can be used for compounding
When is compounding from bulk drugs allowed?
Used for herd poisoning outbreaks
Is compounding of drugs in anticipation of future prescriptions allowed?
No
Is labeling a compounded drug with a withdrawal time established by the pharmacist allowed?
No, withdrawal times can only be established by the vet
Is compounding at a commercial scale (manufacturing) allowed?
No
Who assumes liability with compounded drugs?
- pharmacist assumes liability for quality of product (strength, purity)
- vet assumes liability for safety and efficacy
Does the Accreditation by the Pharmacy Compounding Accreditation Board ensure safety and efficacy of the product?
No, ensures quality control of compounded product
Compounded drugs are regulated by
State Board of Pharmacy
______ and _____ have no regulatory oversight
Nutraceuticals and normal serum
- falls under FDA but is not enforced
