Veterinary drugs and residues Flashcards

1
Q

What can chloramphenicol cause?

A

aplastic anemia

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2
Q

what can diehtylstilbsetrol cause?

A

bone marrow toxicity

carcinogen

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3
Q

What can metronidazole cause?

A

carinogen

teratogen

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4
Q

what can nitrofurazone cause

A

carcinogen

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5
Q

what can phenylbutasone cause?

A

blood dyscrasias

carcinogen

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6
Q

what can sulfonamides cause?

A

hypersensitivity

thyroid tumors

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7
Q

What can penicillin cause?

A

hypersensitivity

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8
Q

What are 4 issues with antimicobial use in food animals?

A
  1. resistance in pathogens
  2. resistence in commensal bacteria
  3. changes in food animal flora (more enteric pathogens)
  4. effect of drug residues on human enteric flora
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9
Q

What was the issue with diclofenac?

A

it killed vultures. was cheap and used for cattle that are not slaughtered (NSAID). vultures are uniquely suscpetible

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10
Q

Who approves drugs for veterinary use?

A

Health Canada
Health products and food branch
veterinary drugs directorate

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11
Q

Does the veterinary drugs directorate regulate drug use?

A

no. but performs human health risk assessments?

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12
Q

What does the CFIA do with respect ti drugs?

A
  1. tests drug residues in food

2. approves biologics (vaccines, antibodies etc)

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13
Q

What are 6 pre-market steps in approval of vet drugs?

A
  1. human safety
  2. clinical efficacy
  3. safety in intended species
  4. safety to the environmetn
  5. manufacturing and quality control!
  6. labelling
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14
Q

What are subchronic toxicity studies?

A
  1. 2 species of lab animals used (rodent and non-rodent)
  2. drug administered orally every day) 3-12 months
  3. low, medium and high dose groups
  4. minimum 2 animals (10 of each sex) per group
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15
Q

What are chronic toxicity studies?

A

like subchornic but >12 months

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16
Q

What are examples of special studies

A
  1. carcinogenicity tests
  2. reproductive tests
  3. teratogenicity tests
  4. genetic toxicity tests
    (others: immunotoxicity, neurotoxicity, endocrine changes)
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17
Q

What are three studies for human safety testing?

A
  1. subchronic
  2. chronic
  3. special
    tests
18
Q

What are three studies for human safety testing?

A
  1. subchronic
  2. chronic
  3. special
    tests
19
Q

What does human safety (microbiology) evaluate?

A
  1. spectrum of activity
  2. antimicrobial resistance
  3. effect on target animal gut flora
  4. effects on human gut flora
  5. impact on human medicine
20
Q

What are three aspects of human safety testing?

A
  1. toxicology and pharmacology
  2. microbiology
  3. drug residues and metabolism
21
Q

What aspects of spectrum of activity of a drug are considered?

A

activity to

  1. target animal pathogens
  2. food-borne pathogens
  3. commensal bacteria
22
Q

What aspects of antimicrobial resistance are examined in new drugs?

A
  1. mechanism of AMR
  2. mechanism of AMR transfer
  3. rate of AMR development
  4. cross resistance to other antimicrobials
23
Q

What affects on animal gut flora are evaluated?

A

if zoonotic pathogens in gut increase
if there are changes in fecal shedding
(changes usually transient)

24
Q

What is the microbiological acceptable daily intake?

A

the concentration of drug in food residues that is required to cause changes in the gut flora (human)

25
Q

What is the acceptable daily intake?

A

the amount of drug that can be consumed by a human over a lifetime with no adverse effects

all drug residues in food (parent compond + metabolites must result in human intake

26
Q

How is the ADI (acceptable daily intake) determined?

A
  1. toxicology and microbiology data
27
Q

What is NOEL

A

No observable effect level (NOEL)

28
Q

What is NOEL

A

No observable effect level (NOEL)

29
Q

what is the no observable effect level (NOEL)

A

highest dose in the most susceptible species that does not cause any adverse effects (rabbits or rats)

30
Q

How do you calculate ADI

A

NOEL divided by a safety factor (usually 100)–10 for intraspecies variability, 10 for interspecies variability

31
Q

What is microbial ADI?

A

for antimicrobial only

the lowest concentration of drug that can cause changes in the human gut flora

32
Q

What is the maximum residue limit?

A

determines how much drug residue is allowed in food

33
Q

How is the total residue limit determined?

A

total residue limit=ADI/food consumption factor

34
Q

What is the maximum residue limit?

A

the maximum amount of drug MARKER RESIDUE allowed in tissue

35
Q

What is the maximum residue limit based on?

A

based on a ratio of the marker residue to the total residue limit

36
Q

What is the maximum residue limit based on?

A

based on a ratio of the marker residue to the total residue limit

37
Q

What is a withdrawal period

A
  1. period of time from last treatment until an animal can be slaughtered/milk/eggs used for consumption
38
Q

What is the withdrawal period determined to be?

A

amount of time for the marker residue coencentration in the slowest animals treated with that drug to fall below the maximum residue limit

39
Q

What is an issue with the withdrawal period?

A

have to follow the label!

40
Q

What might make a carcass suspect?

A
  1. injection site lesions

2. evidence of pathology or illness

41
Q

Who determines if the processing plant will take the milk?

A

processing plant and they can have different levels-even if the residue is below the MRI is may not be accepted

42
Q

what are some factors that ensure that drugs are very safe?

A
  1. extensive testing
  2. 100x safety factor
  3. very high food consumption assumed
  4. withdrawal periods are based on residues from slowest depleting animals