Pharmacology (AMR monitoring and ELDU) Flashcards
It is estimated that 4.95 million deaths are associated with bacterial AMR and 1.27 million of those are directly attributable. In what area of the globe are attributable deaths HIGHEST?
western sub-sarahran africa
which 2 bacterial organisms are MOST commonly causing death due to AMR?
e. coli
staph aureus (MRSA)
why do we see variations in bacterial types, antibiotic types, and geographical location for bacterial AMR infections and deaths in humans?
there are differences in …
1. antibiotic use and stewardship practices
2. healthcare infrastructure and systems
3. sanitation systems
4. regulations on antibiotic use
5. surveillance systems
T/F: AMR requires a one health approach
true
T/F: wastewater can pollute surface and ground water if not properly managed.
true
T/F: most of the wastewater is discharged UNTREATED globally
true
what is environmental mediation of AMR?
the role of the environment in AMR development and the environmental pathways of exposure that lead to AMR colonization and infection in humans and animals
what is the difference between direct and indirect transmission of AMR from animals to humans?
direct – focuses on AMR pathogens that develop in animals and are transmitted to people through food, water, or direct contact
indirect – occurs through environmental mediation (AMR bacteria shed from animals into env. and these bacteria serve as a source of AMR genes that can be shared between bacteria in the env. Humans are exposed to the bacteria in the environment and now contain the animal-origin resistance genes
what are the 2 most common zoonotic foodborne AMR pathogens to total AMR infections in the United States?
- campylobacter
- non-typhoidal salmonella
these two pathogens are responsible for 14% of AMR illnesses and 0.17% deaths
What type of illness does salmonella enterica dublin (a cattle host-adapted salmonella) cause in humans?
severe illness – sepsis, hospitalization, and death
this bacterial organism has shown to be resistant to >7 classes of antimicrobials.
What are the duties of the NARMS (national antimicrobial resistance monitoring system)? (4 total)
- monitor trends in Ab resistance among common foodborne bacteria
- disseminate timely info on Ab resistance to promote interventions that reduce resistance
- conduct research to better understand emergence, persistance, and spread of Ab resistance
- assist FDA in making decisions related to approval of safe and effective Ab drugs for animals
match the following NARMS data collections:
1. FDA a. human data
2. USDA-FSIS b. food animal isolates
3. CDC c. retail meats
- FDA = c. retail meats
- USDA-FSIS = b. food animal isolates
- CDC = a. human data
There are 14 specific antibiotics the NARMS are resistance testing for, why are these antibiotics chosen?
these are the medically important antibiotics for HUMANS
T/F: pharmaceutical companies are required to report to the FDA the amount of each antimicrobial active ingredient in drug products sold or distributed for use in food-producing animals
true
Most medically important antimicrobial drugs approved for use in food animals are administered in what two ways?
feed and water
T/F: sales of antimicrobials in food producing animals are equivalent to the antimicrobials used in food producing animals
false
T/F: currently, there are good systems in place to monitor AMR pathogens and to track direct and indirect transmission pathways
false – we have good systems in place, but we have a lot more understanding to do in regard to indirect transmission pathways (environmental mediation)
Monitoring data on AMR in animals is controlled by what 3 systems?
- NARMS
- Vet-LIRN
- NAHLN
T/F: we currently have data for antimicrobial sales and distribution in livestock and companion animals
false not companion animals
what is extralabel drug use?
hint: dividers
administration of a compound in a different…
1. dose
2. interval
3. volume
4. indication
5. duration
6. route
7. species or animal use class
T/F: ELDU is necessary because we have lack of approved drug formulations for every vet species
true
what act passed in 1994 allowed ELDU and allowed the FDA to regulate the ELDU?
Animal Medicinal Drug Use Clarification Act (AMDUCA)
what species are classified as “non-food animals”?
dogs, cats, horses, pocket pets, ornamental fish
what species are classified as “major” food animal species?
cattle (beef and dairy)
swine
poultry (chickens and turkeys)
what species are classified as “minor” food animal species?
sheep and goats
wildlife
game birds
honeybees
rabbits
lobsters
fish
camelids
AMDUCA requires valid vet-client-patient relationship. What does this mean?
it means that the vet is assuming responsibility for medical judgements (the health of the animal, the need for medical treatment, and that the client has agreed to follow instructions given)
it also means that the vet has suff knowledge to give a preliminary Dg and is readily available for follow-up.
all of which can only exist is the vet has recently seen and is acquainted with the care of the animal
You can use ELDU in non-food animals if …
you dont have a labeled product for that species to use.
so… if there is a drug that…
1. contains needed ingredient
2. in proper dosage form
3. labeled for the indication
4. is clinically effective
you are required to use it.
T/F: you are allowed to use a drug labeled for dogs in horses because it is cheaper.
false – economic reasons are not valid
ONLY human formulations are allowed to be used in veterinary species for economic reasons
T/F: in order to use ELDU in food animals, there must be NO licensed/marketed drug for that species that would be considered effective.
true
T/F: lay persons can use approved drugs extralabel without specific direction to do so.
false – they are not allowed to do this UNLESS under the supervision of a licensed vet.
T/F: extralabel use of drug for non-therapeutic purposes is not allowed under AMDUCA
true
this includes drugs for estrus synchronization, growth promotion, and feed efficiency
T/F: extralabel use of drugs that could result in any residues that are risks to public health or above any established safe levels/concentrations/tolerance is not allowed under AMDUCA
true
ex. rifampin in companion animals (carcinogen), not allowed in food animals
According to AMDUCA, when are you allowed to give compounded drugs to food animals?
when they are from FDA approved formulations
T/F: compounding bulk substances is efficient and economical, so under AMDUCA it is recommended.
false – it is illegal!
exceptions: copper glycinate and sedation/capture drugs in free-range wildlife species
what are the 3 most common causes of illegal residues?
- poor record keeping or animal identification
- inadvertent administration of wrong drug or dose
- failure to adhere to recommended WDT
According to AMDUCA, the FDA can add drugs to the “Prohibited drugs list” which means …
these drugs should NOT be used in food animal species under any circumstances
why is chloramphenicol not allowed to be used in food animals?
it can cause aplastic, irreversible anemia in susceptible people with a high mortality rate
T/F: chloramphenicol and closely-related drug florfenicol are both prohibited drugs in food animals
false – florfenicol is ok.
Clebuterol has been used as a repartitioning agent to increase lean muscle mass in animals. Why is clenbuterol not allowed to be used in food animals?
residues within meat cause CNS signs, cardiac issues, and death in humans.
T/F: while clenbuterol is prohibited for use in food animals, albuterol is ok.
true
why is diethylstilbesterol (DES) not allowed to be used in food animals?
mutagenic/carcinogenic
why is dipyrone not allowed to be used in food animals?
possible teratogen/carcinogen and is associated with blood dyscarasias (aplastic anemia) in humans.
why are nitroimidazoles (ex. metronidazole) and nitrofurans (ex. furazolidone) not allowed to be used in food animals?
mutagenic/carcinogenic
why are we not allowed to use glycopeptides (ex. vancomycin) in food animals?
medically important antimicrobial in humans for treatment of entercocci and MRSA.
T/F: gentian violet is a feed additive/mold inhibitor that is prohibited in food animals unless you can place it topically in a location that cannot be licked.
true
In what food animals is phenylbutazone prohibited and why?
female adult dairy cattle (> 20 months)
why? because it causes aplastic anemia in people
T/F: when using phenylbutazone in ruminants, there are prolonged withdrawal times
true
in what species are antiviral drugs (adamantine and neuraminidase inhibitors) prohibited in and why?
poultry (chickens, turkey, ducks)
why? because they are assoc. with resistant avian influenza strains.
why is ELDU of cephalosporins (except cephapirin) prohibited in major food animal species (unless for therapeutic indications not included on label)?
concern for development of antimicrobial resistance
why is ELDU of sulfonamide antibiotics prohibited in adult dairy cattle?
mutagenic / carcinogenic
hypersensitivity reactions
in humans
why is ELDU of fluoroquinolones prohibited?
development of resistance and making its way into the human food chain contributing to food-borne illnesses.
No extralabel use of medicated feeds is allowed in animals, EXCEPT…
farmed wildlife and other minor species
what is the basic purpose of the basic purpose of the VFD (Veterinary Feed Directive)?
the VFD is a written statement issued by a licensed vet that authorizes use of VFD drugs in or on an animal feed, authorizes the client to obtain and use animal feed containing a VFD drug for treatment purposes only and in accordance with FDA-approved conditions for use.
purpose: increase veterinary oversight and decrease use for non-therapeutic indications
T/F: ELDU of a VFD drug is illegal
true
T/F: to issue a VFD, you must be licensed in the state for which the animal resides and must have a valid VCPR
true
T/F: VDF drugs are prescriptions
false
VFD drug category was specifically created to provide vet supervision without invoking state pharmacy laws for rx drugs that were unworkable for dist. of medicated feed.
T/F: VFD drugs are OTC
false
T/F: VFDs are not the same as pills ground up and added to individual animal feed
true
Which drugs are NOT VFD drugs?
- ionophores
- polypeptides (bacitracin)
- carbadox
- bambermycin
- pleuromutilin
Feed mills are mixing medicated feeds. What is the problem with feed mills?
contamination
Describe (briefly) the difference between type A medicated articles, type B medicated feeds, and type C medicated feeds.
type A – concentrated form, not fed directly to animals
type B – less concentrated, not fed directly to animals
type C – least concentrated, fed directly to animals
_____________ are drugs that require NO withdrawal period at the lowest use level in the species in which they are approved. they can be purchased OTC, but req VFD to be fed.
category 1
__________ are drugs that require a withdrawal period at the lowest use level for at least one species in which they are approved. They are VFD drugs.
category 2
what are the elements of antimicrobial stewardship?
hint: protectme
- prescribe only when necessary
- reduce prophylaxis
- offer other options
- treat effectively
- employ narrow spectrum
- culture appropriately
- tailor your practice policy
- monitor
- educate others
