Lec 26 - antimicrobial resistance

Question 1

what do we know about antibiotic resistance

Answer 1

• antibiotic resistance is a natural phenomenon
• most scientists think resistance is a bacterial survival mechanism for competition
• regardless of who is responsible, exposure to antibiotics selects for resistance strains
• resistance has not developed just due to human use

Question 2

who discovered penicillin

Answer 2

alexander fleming

Question 3

how many deaths occur from antibiotic resistance each year

Answer 3

more than 35k

Question 4

Humans and their pets use ____ ______ the amount of antibiotics than what is used in food animal production

Answer 4

10 times

Question 5

t/f there is little overlap between antibiotics used in human medicine and animal agriculture

Answer 5

true

Question 6

what percent of antibiotics are used in animals but rarely/never used in human medicine

Answer 6

71%

Question 7

t/f simply using antibiotics creates resistance. these drugs should only be used to treat infections

Answer 7

true

Question 7

what antibiotic is used in animals that is never used in people

Answer 7

lonophores

Question 8

who is the regulatory oversight that approves all animal drugs (as well as human drugs)
- considers risks to human health and the environment when assessing new animal drug applications
- inspects commercial feed mill to assure animal antibiotics are used according to regulation
- has the authority to withdraw a drug if they fill there is an imminent risk to human health

Answer 8

US food and drug administration FDA

Question 9

slide 41

Question 10

what change in the FDA policy on antibiotics used in animal fed

Answer 10

eliminate use of antibiotics that are deemed medically important for human health for growth promotion purposes

Question 11

what is the veterinary feed directive (VFD)

Answer 11

• producers need to consult with veterinarian before using feed or water medication
• veterinarian required to provide written VFD with copies to feed manufacturer and client (keep another copy for personal records)
• veterinary client patient relationship mush be established

Question 12

what does the VFD final rule require

Answer 12

required vets to issue all VFDs within the context of a vet client patient relationship (VCPR) and specificizes the key elements that define a VCPR

Question 13

what are a VCPR requirements

Answer 13

• the vet has assumed the responsibility for making clinical judgements regarding the heath of the patient
• the vet has sufficient knowledge of the patient to initiate at least a general or preliminary diagnosis of the medical condition of the patient
• the veterinarian is readily available for follow-up eval
• the veterinarian provides oversight of treatment, compliance, and outcome
• patient records are maintained

Question 14

why was the veterinary feed directive made

Answer 14

for stricter federal rules that regulate how medically important antibiotics - medications that are important for treating human disease - can be administered to animals in feed and drinking water

FDA requires veterinary oversight whenever such antibiotics are administered to any food animal species via feed or water even if the animals are not intended for food production **

Question 15

from pets rabbits and pigs to backyard poultry, to large livestock farms, these restrictions apply

Answer 15

all medically important antibiotics to be used in feed or water for food animal species require a veterinary feed directive (VFD) or a prescription

Question 16

what is extra label drug use

Answer 16

the use of any drug other than as approved and described on the label
- indication
- route of administration
- species
- dosage
- duration of use

Question 17

what is the AMDUCA

Answer 17

animal medicinal drug use clarification Act

Question 18

when does the AMDUCA allow extra label drug use

Answer 18

• to treat disease
• when there is no approved food animal drug containing the needed ingredient, in the proper dosage form and labeled for the condition being treated
• the veterinarian determines the approved drug is clinically ineffective
• for prevention of disease if the vet can substantiate that the health of the animal is threatened

Question 19

what are the requirements for extra label drug use

Answer 19

• a valid VCPR
• use only as prescribed by a vet
• only FDA- approved animal and human drugs may be used
• injectable and water meds (not feed)
• prolonged withdraw
• ELDU of some drugs or drug classes may be prohibited or further restricted
• only allows for treatment not production uses
• records must be maintained for 2 years

Question 20

when is use of ELDs prohibited

Answer 20

• for production purposes
  - FDA has said reproductive use is usually no considered therapeutic
• for feed-grade antibiotics
• if there is an approved effective food-animal drug
• for cost-saving
• if the drug is unapproved or on the FDA prohibited/restricted list

Question 21

when is ELDU illegal

Answer 21

Any ELDU in the feed of food animals is illegal. there is no gray area to this part of the regulations. if it is not on the label it cannot be used in that manner

Question 22

what 3 sources does NARMS monitoring use to monitor antimicrobial resistance among enteric bacteria

Answer 22

• humans (CDC)
• retail meats (FDA)
• food animals (USDA)