veterinary drug residues and food safety Flashcards

1
Q

what is clenbuterol classified as

A

B1 and B2 agonist

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2
Q

what do B1 and B2 agonists cause

A

tachycardia, bronchodilation, tocolytic, repartitioning agents

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3
Q

what is the concern to people with chloramphenicol residues

A

aplastic anemia

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4
Q

what is the concernt o people with diethystilbestrol residues

A

bone marrow toxicity and carcinogen

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5
Q

what is the concern to people with metronidazole residues

A

carcinogen and teratogen

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6
Q

what is the concern to people with nitrofurazone residues

A

carcinogen

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7
Q

what is the concern to people with phenylbutazone residues

A

blood dyscrasias, possible carcinogen

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8
Q

what is the concern to people with sulfonamide residues

A

hypersensitivity and thyroid tumors

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9
Q

what is the concernt o people with penicillin residues

A

hypersensitivity

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10
Q

what are the concerns regarding antimicrobial use in food animals

A

resistance in both target bacteria and in commensal bacteria (enteric), changes in food animal normal flora (increased enteric pathogens), drug residues that can effect human enteric flora

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11
Q

why is antibiotic resistance in commensal enteric bacteria of food animals a concern

A

those bacteria can spread to people

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12
Q

which enteric commensal bacteria are we concerned about resistance occuring in

A

E. coli, salmonella, campylobacter

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13
Q

who does the veterinary drugs directorate work under

A

health products and food branch of health canada

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14
Q

what is the VDDs function

A

approve drugs for veterinary use in Canada (does not regulate drug use) and performs human health risk assessments

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15
Q

what is the CFIAs role in veterinary drugs

A

tests for drug residues in food and approves biologics (vaccines, antibodies)

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16
Q

what legislation does inappropriate drug use fall under

A

provincial

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17
Q

what is involve in the pre-market approval of veterinary drugs

A

human safety, clinical efficacy, safety in intended species, safety to environment, manufacturing/quality control, labelling

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18
Q

what is involved in looking at human safety of food animal drugs

A

toxicology and pharmacology, microbiology, drug residues and metabolism

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19
Q

who takes care of examing drugs for quality control

A

analytical chemists

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20
Q

what is done to measure clinical efficacy and safety in intended species for a drug

A

clinical evaluation

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21
Q

what 3 types of studies are done to evaluate tox/pharm regarding human safety of a food animal drug

A

subchronic toxicity studies; chronic oral toxicity studies; special studies

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22
Q

what species are used for subchronic toxicity studies

A

2 species of lab animals; one rodent (rat) and one non-rodent (rabbit)

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23
Q

how is the drug administered in subchronic toxicity studies and why

A

orally (because people will be ingesting residues)

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24
Q

how is the drug administered in subchronic toxicity studies and why

A

orally (because people will be ingesting residues)

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25
Q

how long do subchronic toxicity studies last

A

3-12 months

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26
Q

how many different dose groups are used for subchronic toxicity studies

A

low, medium and high (3)

27
Q

minimum number of animals for subchronic toxicity studies

A

20 (10 of each sex) per group

28
Q

what are chronic oral toxicity studies

A

same as subchronic but longer – 12 months up to 2 years

29
Q

what are examples of special studies

A

carcinogenicity, reproductive and teratogenicity studies; genetic toxicity (mutagenicity) tests, immunotoxicity, neurotoxicity and endocrine changes

30
Q

what do carcinogenicity tests look for

A

increased incidence of tumors; required if drug is a suspected carcinogen or if chronic toxicity studies show histopathology

31
Q

what methods of testing do special studies use

A

lab animals or in vitro tests

32
Q

what do reproductive studies look for

A

if the drug causes spermatogenesis/estrus cycling/conception/parturition problems

33
Q

what do teratogenicity studies look for

A

if the drug affects fetal development

34
Q

how are genetic toxicity studies done

A

in vitro to look for DNA damage

35
Q

when will immunotoxicity, neurotoxicity or endocrine studies be required

A

depends on family of drug, structure and relationship

36
Q

what areas are evaluated regarding microbiology of food animal drugs (specifically antimicrobials)

A

spectrum of activity (MIC), antimicrobial resistance (AMR), effect on target species gut flora, effect on human gut flora

37
Q

what pathogens are considered regarding antimicrobial spectrum of activity

A

target animal pathogens, food-borne pathogens and commensal bacteria (esp. with oral antimicrobials)

38
Q

what areas are looked at when evaluating AMR

A

mechanism of AMR, mechanism of AMR transfer, rates of AMR development, cross-resistance to other antimicrobials

39
Q

what areas are looked at when evaluating effect on target species gut flora of antimicrobials

A

do zoonotic pathogens increase, are there changes in fecal shedding (enteric flora changes are usually transient)

40
Q

what areas are evaluated regarding microbiology of food animal drugs (specifically antimicrobials)

A

spectrum of activity (MIC), antimicrobial resistance (AMR), effect on target species gut flora, effect on human gut flora, impact on human medicine

41
Q

what areas are looked at when evaluating effect on target species gut flora of antimicrobials

A

do zoonotic pathogens increase, are there changes in fecal shedding (enteric flora changes are usually transient)

42
Q

what is looked at when evaluating effect of food animal antimicrobial on human gut flora

A

do residues of drug in food cause changes in human gut flora; if so, what concentration of drug is required

43
Q

what is the concern regarding impact on human medicine with antimicrobials

A

if AMR to this drug would directly effect human medicine

44
Q

what does acceptable daily intake mean (ADI)

A

amount of drug that can be consumed by a human over a lifetime (every day for whole life) with no adverse effects

45
Q

how is ADI determined

A

toxicology and microbiology data

46
Q

what is the “no observable effect level” (NOEL)

A

highest dose in the most susceptible species that does not cause any adverse effects

47
Q

toxicological ADI

A

= NOEL/safety factor

48
Q

what is the usual safety factor

A

100 (10x for intra species variability and 10x for inter species variability)

49
Q

what is the safety factor if there are special toxicity concerns

A

can be up to 1000x

50
Q

when is the microbiological ADI used

A

for antimicrobials only

51
Q

what is the microbiological ADI

A

must be lower than the lowest concentration of drug that can cause changes in human gut flora (can be lower than toxicological ADI)

52
Q

what does maximum residue limit determine (MRL)

A

how much drug residue is allowed in food (maximum amount of drug marker residue allowed in tissue)

53
Q

how is MRL determined

A

by the total residue limit allowed

54
Q

what is the calculation for total residue limit

A

ADI/food consumption factor

55
Q

what can the marker residue be

A

either parent compound or metabolite (or combination)

56
Q

what are withdrawal periods

A

period of time from last treatment until an animal can be slaughtered or milk/eggs used for consumption

57
Q

who determines withdrawal periods and how

A

determined by the Drug Residues and Metabolism team using MRLs

58
Q

what does the withdrawal period equal

A

amount of time for marker residue concentration in the 99th percentile (slowest) animal treated with the drug to fall below the MRL

59
Q

what does the withdrawal period equal

A

amount of time for marker residue concentration in the 99th percentile (slowest) animal treated with the drug to fall below the MRL

60
Q

the withdrawal period is exceptionally conservative if what occurs

A

drug label is followed (proper species, dose, route, health status)

61
Q

what makes a carcass a “suspect” carcass to be tested for residues

A

injection site lesions, evidence of pathology or illness

62
Q

what are processing plants residue limits for milk

A

if they can detect it, it’s not acceptable (even if residue is BELOW the MRL) – processing plants set different standards

63
Q

what safety factors are applied to determining the MRL

A

minimum of 100X safety factor for calculating ADI and very high food consumption values assumed