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Healthy Populations > Pharmacology and Drug Use > Flashcards

Pharmacology and Drug Use Flashcards

1
Q

Define extra lable drug use (ELDU).

A

Administration of a different Dose, Interval, Volume, Indication, Duration, Route, and Species/animal use class than what is stated on the drug label.

DIVIDRS

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2
Q

What are the major non-food animal species?

A

Dogs, cats, and horses

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3
Q

What are the minor non-food animal species?

A

Pocket pets (rats, mice, ferrets) and ornamental fish

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4
Q

What are the major food animal species?

A

Beef and dairy cattle, swine, chickens, and turkeys (poultry)

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5
Q

What are the minor food animal species?

A

Sheep and goats, wildlife, game birds, honeybees, rabbits, lobsters, fish, camelids

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6
Q

What are the limitations on ELDU as stated in AMDUCA for non-food animals?

A

If their is an approved product in that species that contains the needed ingredient in the proper doage form, labeld for the idication and is clinically effective, you must use it. Economic reasons are not valid. However, ith human drugs, economic reasons are valid.

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7
Q

What are the lmitations on ELDU as stated in AMDUCA for food animals (6)?

A
  • There must be no licensed/marketed drug for that species that would be considered effective (i.e. flunixin meglumine and meloxicam)
  • Veterinary drugs should be used prior to human drugs
  • Extralabel use in an animal of an approved or human drug by a lay person (except when under the supervision of a licensed vet) - includes owners of pet animals as well as producers, includes OTC drugs
  • Extralabel use of a drug for non-therapeutic purposes (i.e. estrus synchronization, growth propotion, feed efficiency)
  • Extralabel use resulting in any residue which may present a risk to the public health (i.e. can’t administer known arcinogen such as rifampin)
  • Extralabel use resulting in any residue above an established safe level, safe concentration or tolerance (TOL/MRL)
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8
Q

What is the list of drugs that are baned for all uses in food animals (9)?

A
  1. Chloramphenicol
  2. Clenbuterol
  3. Diethylstilbestrol
  4. Nitroimidazoles (includes metronidazole)
  5. Nitrofurans
  6. Glycopeptides
  7. Gentian violet
  8. Phenylbutazone (dairy cattle)
  9. Antiviral compounds (poultry)
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9
Q

What is the list of drugs that are banned from being used extra-label in food animals (4)?

A
  1. Cephalosporins (major species)
  2. Sulfonamid drugs (dairy cattle)
  3. Fluoroquinolones
  4. Medicated feeds
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10
Q

Which drugs are banned in food animals due to aplastic anemia in people?

A

Chloramphenicol and phenylbutazone (dairy cattle)

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11
Q

Which drugs are banned in food animals due to antimicrobial resistance (4)?

A

Glycopepties, antiviral compounds (poulty), cephalosporins (major species) and fluoroquinolones.

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12
Q

What drugs are banned in food animals due to mutagenic/carcinogenic properties at some doses (4)?

A

Diethylstilbestrol, nitroimidazoles, nitrofurans, and sulfonamide drugs (dairy cattle)

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13
Q

What drugs are banned in food animals due to CV side effects in people?

A

Clenbuterol

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14
Q

What drugs are banned in food animals due to insufficient residue avoidance data?

A

Gentian violte and medicated feeds.

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15
Q

Describe AMDUCA and it’s rule regarding compounded drugs in food animals.

A
  • Needs to be from FDA approved formulation
  • Not prohibited but not recommended
  • Not regulated by the FDA –> concentration and stability issues, adequate withdrawl time cannot be calculated
  • Compounding from bulk substances is illegal
  • Any legal compounding should be done using approved animal or human drugs
  • CVM GFI # 256 EXCEPTIONS - antiotes in food animals (i.e. Cu glycinate for molybdenum toxicity), and sedation/capture drugs in free-ranging wildlife species
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16
Q

What are the most common causes of illegal residues in food animals?

A
  1. Poor record keeping/animal identification
  2. Inadvertent administration of the wrong drug or dose
  3. Failure to adhere to recommened WDT
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17
Q

What are the most common animals with illegal drug residues?

A
  1. Veal calves
  2. Cull dairy cattle
  3. Swine
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18
Q

Chloramphenicol in food animals…

A
  • No approved products, no use allowed - includes topical or ocular formulations
  • Can cause aplastic anemia in susceptible species –> 70% fatality in humans, survivors experience high incidence of acute leukemia
  • Can cause reversible anemia in any species (cats, neonates)
  • Florfenicol is okay for label and extra-label use

Florfenicol does not have the peri-nitro group that relates to aplastic anemia

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19
Q

Clenbuterol in food animals…

A
  • B-2 agonist (bronchodilator) used as a “repartitioning agent” to increased lean muscle mass
  • No approved products for food animals, no use allowed - included inhaled formulations
  • Albuterol is okay for label and extra-label use
  • Drug of abuse in humans and horses
  • Residues in meta can cause adverse effects in people –> CNS signs, cardiac issues, death
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20
Q

Diethylstilbesterol (DES) in food animals…

A
  • Mutagenic/carcinogenic
  • No approved products, no use allowed
  • Dipyrone injection for horses can be legally used in food animals
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21
Q

Nitroimidazoles in food animals…

A
  • Deimetridazole, ipronidazole, metronidazole
  • Mutagenic/carcinogenic
  • No approved product for food animals, no use allowed
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22
Q
A
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23
Q

Nitrofurans in food animals…

A
  • Furazolidone, nitrofurazone (topical), Nitrofurantoin (systemic)
  • No approved products, not use allowed - includes topical formulations
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24
Q

Glycopeptides in food animals…

A
  • Vancomycin
  • Medically important in humans for enterococci and MRSA
  • No approved product, no use allowed
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25
Q

Gentian violet in food animals…

A
  • Feed additive/mold inhibitor - increases feed efficiency
  • No info on safety
  • Topical use okay IF the animal cannot lick it
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26
Q

Phenylbutazone in food animals…

A
  • No label uses, ELDU only prohibited in adult dairy cattle, not recommended for other dairy animals
  • Blood dyscrasias - possible aplastic anemia in people
  • Prolonged withdrawl intervals in ruminants (~90 days)
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27
Q

Antiviral drugs in food animals…

A
  • No label uses, ELDU only prohibited in poultry
  • Includes adamantanes (rimantadine and amantadine) and neurominidase inhibitors (oseltamivir)
  • Association with resistant avian influenza strains in China
  • Not recommended for use in other species
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28
Q

Cephalosporins in food animals…

A
  • Label use is allowed, concern is development of antimicrobial resistance in Salmonell and E. coli
  • The ban DOES NOT APPLY TO cephaprin (1st gen, intrammammary) and minor food animals species (in these, ELDU and label use is fine)
  • In major species, not allowed if: intended use deviates from approved dose, tx duration, frequency, admin route of product label & if unapproved for major species or animal production class & intended use of product is for the purpose of disease prevention

Naxel

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29
Q

Sulfonamides in food animals…

A
  • ELDU prohibited in adult dairy cattle only, label use is okay
  • Mutagenic/carcinogenic, hypersensitivity reaxtions
  • Labeled products: sulfadimethoxine OTC, sulfabromomethazine OTC, Sulfaethoxypyridazine water additive
  • If product is given off-label even if it is OTC it is illegal
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30
Q

Fluoroquinolones in food animals…

A
  • Water additive in poultry linked with resistant Camplyobacter strains
  • 2 marketed - Baytril100 in beef cattle, non-lactating dairy callt, and swine for tx of RDC, in the cattle also for control of BRDC & Advocin in beef cattle for the treatment of BRDC
  • ELDU not permitted - no exceptions
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31
Q

Whay is the new antimicrobial drug for cattle and swine?

A
  • Pradalex - prodofloxacin injection
  • BRD and SRD
  • Cattle intended for slaughter and cattle intended for breeding that are < 1 yo
  • Weaned swine intended for slaughter
  • ELDU prohibited
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32
Q

Medicated feeds in food animals…

A
  • ELDU is prohibited
  • Exceptions - farmed wildlife and other minor species: medication approved for use in animal feed, use in minor species similar to approved species (mammals and mammals, birds and birds, etc.), non-promotional use, all other aspects of AMDUCA
  • VFD and OTC laws
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33
Q

What are the 2 main goals of judicious use of antimicrobial drugs in food animals?

A
  1. Limit medically important antimicrobials to uses necessary for
  2. Limit uses that include veterinary oversight or consultation (VFD)
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34
Q

What is a VFD and what does it do?

A

A VFD is a written (nonverbal) statement issued by a licensed veterinarian in the course of practice. It authorizes the use of a CFD/combination VFD drug in or on an animal feed. It also authorizes the client to obtain and use animal feed bearing or containing a VFD/combination VFD drug. This is for treatment purposes only and needs to be done in accordance with FDA approved conditions for use.

35
Q

What is required for a VFD?

A

The issuing veterinarian must be licensed to practice in the state in which the animals reside. The VFD must also be issued in the context of a valid VCPR.

36
Q

Who does VFD apply to?

A

Major species: cattle, swine, chickens, turkeys, dogs, cats, and horses
Minor species: animals, other than humans, that are not major species

37
Q

VFD applies to…

A

Medically important antibiotics - products deemed important to human medicine and are used in both human and veterinary medicine.

38
Q
A
38
Q
A
39
Q

VFD does not apply to…

A

Non-medically important antibiotics:
* Ionophores (monensin, salinomycin, lasalocid - growth promotion)
* Polypeptides (bacitracin - not absorbed orally)
* Carbadox (no longer marketed due to carcinogenic metabolites)
* Bambermycin
* Pleuromutilin (tiamulin)

40
Q

What is a VFD drug?

A
  • Drug intended for use in or on animal feed (POMF)
  • Combination VFD drugs (at least 1 of the drugs is a VFD drug)
  • ELDU not allowed (exceptions for minor species)!!!
41
Q

What is NOT a VFD drug?

A
  • Prescription (drug in water is now prescription)
  • OTC drugs
  • Pills ground up and added to individual animals feed (top dressing) - does apply to top-dress in group feed
42
Q

VFD and third parties

A

Feed mills
Need appropriate licenses for manufacture

43
Q

Type A medicated article

A

Concentrated form of drug used to make type B/C drugs. Not fed directly to animals.

44
Q

Type B medicated feeds

A

Less concentrated than type A but more concentrated than type C. Used to make other type B/C drugs. Not fed directly to animal.

45
Q

Type C medicated feeds

A

Least concentrated. Fed directly to animals

46
Q

VFD category I

A

Require no withdrawl period at the lowest use level in each major species for which they are approved or are approved for use only in minor species.

47
Q

VFD category II

A

Require a withdrawl period at the lowest use level for at least one species for which they are approved or regulated on a no-residue, zero tolerance because of a carcinogenic concern regardless of withdrawl period.

48
Q

How long do you need to keep VFD records?

A

2 years

49
Q

VFD and use for disease prevention

A

Veterinary involvement is required. There must be a medical rationale for use. It must be appropriately targeted at a specific etiologic agent and appropriately timed relative to the disease.

50
Q

Are VFDs working?

A

Yes. The amount of medically important drugs being used in food animals is decreasing. The use of drugs for reasons other than therapeutics is also decreasing.

51
Q

Judicious antibiotic use: first line

A
  • Cheap, safe, and effective
  • Common, non-life-threatening infections
  • Little impact on human medicine
52
Q

Judicious antibiotic use: second line

A
  • Assumption of resistance (either culture or failure to respond to treatment)
  • More severe infections
  • Benefits outweight the impact
53
Q

Judicious antibiotic use: third line/reserved

A

Carbapenems, linezolid, vancomycin

54
Q

PROTECTME

A

Prescribe only when necessary
Reduce prophylaxis
Offer other options
Treat effectively
Employ narrow spectrum
Culture appropriately
Tailor your practice policy
Monitor
Educate others

55
Q

PROTECTME

A

Prescribe only when necessary:
* Viral infection, nutritional imbalance, metabolic disorders
* Bacterial infections that will resolve without antibiotics?
* Offer a no prescription necessary form

56
Q

PROTECTME

A

Reduce prophylaxis:
* Perioperative antibacterial drugs not a substitue for surgical asepsis
* Only appropriate in some immnuocompromised patients
* Secondary infections <1000 neutrophils
* Surgical prophylaxis when needed

57
Q

PROTECTME

A

Offer other options:
* Therapeutic alternatives i.e. lavage and debridement, cough suppressants, fluid therapy, nutritional modification, NSAIDS for LUTD
* Using topical preparations reduces selection pressure on resident intestinal flora
* Use effective hygiene techniques and antiseptics to prevent infections

58
Q

PROTECTME

A

Treat effectively:
* Consider bacteria likely to be involved
* Consider drug penetration to target site
* Use shorted effective course, avoid underdosing
* Ensure compliance with appropriate forumation and provide clear instructions

59
Q

PROTECTME

A

Employ narrow specturm:
* Narrow spectrum limit effects on commensal bacterial
* Culture results to support de-escalation

60
Q

PROTECTME

A

Culture appropriately
* Samples before starting therapy when indicated
* Essential for prolonged treatment anticipated (> 1w), resistance is likely, and in life-threatening infections
* First-line fails - do not use other antibiotics without supportive culture and sensitivity results (avoid cycling drugs)

61
Q

PROTECTME

A

Tailor your practice policy:
Guide antibacterial selection to address the bacterial infections and resistance patterns that you encounter, minimizing inappropriate use.

62
Q

PROTECTME

A

Monitor:
* Track and record culture profiles, update practice policy accordingly
* Monitor for preventable infections and alter practices if needed
* Audit own antimicrobial use, particularly of critically important antibacterial drugs (fluoroquinolones, 3rd generation cephalosporins)

63
Q

PROTECTME

A

Educate others

64
Q

What is the human concern of antibiotic residues in food animals?

A

Consuption of an animal sourced food product that contains a drug in quantities higher than the approved safe limit determined by the FDA can result in allergies and conditions that are uknown due to lack of testing in humans.

65
Q

What are the important antibiotics used in food animals with strict laws?

A
  • All ceftiofur products (Naxel, Excenel, and Exceed) - Federal law prohibits ELDU in cattle, swine, chickens, and turkeys for disease prevention purposes at unapproved dose, frequencies, durations, or routs and in unapproved major food producing species/production classes.
  • Baytril - federal law prohibits the ELDU of drug in food-producing animals. Labeled for tx and control of respiratory diseases in cattle (except dairy) and swine and control of colibacillosis in swiine.
  • Penicillin procaine G
66
Q

What is important to remember about the use of Penicillin Procaine G in food animals?

A

The labeled dose and withdrawl periods are WRONG. Dose in cattle should be 3.5-5.5mL/100lbs IM, 1x/day for 5 days. The withdrawl times are dose dependent - in milk 2-7 days, < 20 mLs in site, in beed 15-25 days, < 30 mLs in site

67
Q

Which injection methods gives you the shortest withdrawl period?

A

IV

68
Q

When giving an IM drug in food animals, which drug do you absolutely need to draw back to ensure you do not get blood?

A

Procaine pencillin G

69
Q

What happens if you administer a large volume in an injection site than stated on the label?

A

Withdrawl time increases

70
Q

What are the tolerances for florfenicol in cattle?

A

Liver 3.7 ppm
Muscle 0.3 ppm

Lower level detection of test = 0.0005ppm

71
Q

Describe the role of FSIS in food animal residues.

A
  • New sampling strategy and restructuring of slguther residue program
  • Increased # of schedules sampling across all classes (300-800), increased sample size from 1-2lbs for further testing, sampling of ALL animals that pass antemortem insepction
  • Kidney Inhibiton Swab test followed w multi-residue analytic screening (5 differen classes, 3 hrs)
  • Increased targeting of cull dairy cows and bob veal calves
72
Q

2023 National Residue Program of FSIS - service sampling: what percentage where veterinary drugs? What percentage of those were antibiotics?

A

63% veterinary drugs, of which 58% were antibiotics

73
Q

2023 NRP of FSIS - inspector generated smaplign of suspicious animals: How much were antibiotics?

A

85%

74
Q

Synovex on grower

A
  • New growth implant
  • Extended release
  • Up to 200 days
  • Growing beed steers and heifers on pasture or fed in confinement for slaughter
75
Q

What is the new clarification from the FDA in terms of production phases for the use of growth implants?

A

Defined 3 production phases:
1. Nursing calves from 2mnth to weaning
1. Growing beef steers and heifers on pasture whose diet is mostly forage
1. Growing beef steers and heifers fed in confinement for slaughter whose diet is mostly grain (include grow yards or backgrounders)

76
Q

In May 2023, the FDA stressed new rules in terms of the use of growth implants in food animals that says:

A
  • Unless a cattle ear implant clearly states on the label that they are approved for reimplantation within a prpoduction phase, they are not approved for reimplantation.
  • Beginning July 1st 2023, cattle ear implants that are not labeled for use in a reimplantation program for that production phase may not be used in a reimplantation program
77
Q

Which production phase(s) has ear implants that are labeled for use in reimplantation?

A

Really only growing beef steers and heifers fed in confinement for slaughter

78
Q

What effect does the new FDA guidance regarding implants and hormones in terms of the producers ability to use implants effectively?

A
  • There is only 1 brand that is labeled for reimplantion - only in growing beed being fed in confinement for slaughter
  • Synovex S for growing beed steers- follow C or S
  • Synovex plus for growing beef steers/heifers - follow synovex choice only
  • Synovex one feedlot for steers/heifers - follow synovex choice only
79
Q

What are the other hormones approved by the FDA for use in food animals?

A
  • Melengestrol acetate (MGA) for increased wight gain, improved feed efficiency, and suppression of estrus in beef heifer feeders. breeders for synchonization in beef heifers
  • Progesterone to regulate estrus in sheep/beef
  • Bovine somatotropin (bST) increased milk production in dairy cows
  • B-agonist as repartitioning agent to refocus energy from feed conversion to continue to add lean muscle in 20-40 day prior to harvest rather than back fat
80
Q

Why is production efficiency so important for the food industry?

A

The population is increasing and the amount of agricultural land we have is decreasing. Improving efficiency allows us to make more with less.

81
Q

What are some ways we can increase efficiency in the food industry?

A
  • Advances in nutrition (i.e. GMOs)
  • Advances in reproduction
  • Advances in production
  • Advances in growth
82
Q

In the study that looked at environmental performance of commercial beef production systems utilizing conventional productivity enhancing technologies (PETs), what was concluded?

A

The use of conventional PETs increases animal performance while reducing the environmental impacts of beef production. Restricting use would increase the environmental footprint of beef produced for both domestic and international markets.

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