Make a careful diagnosis and evaluation of the conditions for which the drug is to be us
Take appropriate measures to assure that assigned time frames for withdrawal are met and no illegal
drug residues occur in any food producing animal subjected to extra-label treatment. - ANSWER:
Before prescribing or dispensing an approved animal drug or approved human drug for an extralabel
use infood animals, the veterinarian must:
an animal drug approved for use in food producing animals can be used in an extralabel manner for
the particular use. - ANSWER: Extralabel use of an approved human drug in a food producing animal
is not permitted if...
three components or "pillars": an official animal identification with a specific location at a point in
time. - ANSWER: What are the three "pillars" of ADT?
ICVIs document veterinary visual inspection, not health examination.-An inspection is defined under
9 CFR §160.1 as the "visual study of the physical appearance, physical condition, and behavior of
animals (singly or in groups) that enables an accredited veterinarian to determine whether any
abnormality in physical condition or bodily function is evident."-
An examination is defined under 9 CFR §160.1 as the "physical study of an individual animal to
determine if an abnormality in physical condition or bodily function is suggestive of clinical signs of
communicable disease."
•ICVIs are intended for interstate movement. - ANSWER: In terms of ICVI's what is the difference
between and examination and inspection?
Swine are the only species that can be identified by ear notching. Some swine breed registries allow
the use of ear notches. Ear notches must be readable and accompanied by the breed registration
certificate. Ear notching is official ID for swine. - ANSWER: What is offical id for swine in the ADT
Rule?
official eartag - ANSWER: Your dairy client is shipping a load of replacement heifers to a breeder in
another State and needs official identification along with an ICVI.
Which form of official ID could be used without approval and agreement from the animal health
officials in both the shipping and receiving States?
5 years - ANSWER: Official identification device distribution records must be maintained for...
,•2 years for swine and poultry; and
•5 years for cattle, bison, sheep, goats, cervids, and equines. - ANSWER: The AV must keep a copy of
each ICVI or other movement document issued as follows:
State Animal Health Official in both the shipping and receiving States - ANSWER: Regarding ADT and
ICVIS's, Who do you contact to find out if certification statements are needed?
7 days - ANSWER: As an accredited veterinarian, how many calendar days do you have to submit the
designated pages to the shipping State?
5 years;
2 years - ANSWER: As an accredited veterinarian, how many years must you keep a copy of this ICVI
for cattle movement? Swine and Poultry?
Minor Use and Minor Species Act
The law is intended to make more medications legally available to veterinarians and animal owners
for the treatment of minor animal species and uncommon diseases in the major animal species.
This law provides innovative ways to bring products to market for these small populations and is
designed to help pharmaceutical companies overcome the financial roadblocks they face in providing
limited-demand animal drugs. Before this legislation, pharmaceutical companies would rarely
attempt to bring such drugs to market, because the markets were too small to generate an adequate
financial return. - ANSWER: What is MUMS and what does it do?
CONDITIONAL APPROVAL: A sponsor of a veterinary drug for a minor use or minor species can apply
for "conditional approval," which allows the sponsor to make the drug available before collecting all
necessary effectiveness data, but after proving the drug is safe in accordance with the full FDA
approval standard and showing that there is a reasonable expectation of effectiveness. The drug
sponsor can keep the product on the market for up to five years, through annual renewals, while
collecting the remaining required effectiveness data. This provision is managed by the Office of New
Animal Drug Evaluation (ONADE), not by the Office of Minor Use & Minor Species Animal Drug
Development (OMUMS).
DESIGNATION: This provision was modeled on the "Orphan Drug Act" for humans, which encourages
pharmaceutical sponsors to develop drugs for rare diseases in people, by providing incentives for
approval. Sponsors of "designated" ne - ANSWER: MUMS Act: The law modifies the Federal Food,
Drug and Cosmetic Act in three key ways to provide for:
,Food Drug and Cosmetic Act - ANSWER: AMDUCA amended what act?
1) dispense veterinary prescription drugs only in quantities required for the treatment of the
animal(s) for which the drugs are dispensed, and 2) avoid unlimited refills of prescriptions or any
other activity that might result in misuse of drugs. - ANSWER: OPIOIDS: Veterinarians should follow
the AVMA Guidelines for Veterinary Prescription Drugs, which recommend that veterinarians
Recognize the potential for DIVERSION of opioid prescriptions for animals. Drug diversion occurs
when prescription medicines are obtained or used illegally. Veterinarians should recognize that
various individuals, including animal owners, family members, handlers, and practice staff, may
engage in diversion of opioid and other controlled substance prescriptions intended for animals.
Recognize signs of opioid misuse among animal ownersand others.
Learn how to talk with animal owners and others about opioid misuse. Instruct clients to store
prescriptions in a locked cabinet or container, if possible, to prevent accidental exposure or
unauthorized use. Veterinarians could consider implementing a drug take back program in their clinic
(for clients to drop off unused medications) or should direct clients to the established prescription
drug take back sites
Know how to take action if misuse of opioids is suspected. - ANSWER: Veterinarians can help reduce
opioid misuse in several ways:
1. Requests for early refills of prescriptions.
2. Requests for refills of prescriptions while missing appointments.
3. Requests for opioid medications by name.
4. Few signs of improvement in a pet's condition.
5. Clients claim that medications were lost or stolen.
6. The pet's condition does not match the owner's description.
7. New clients with seriously injured animals. - ANSWER: Signs of potential opioid misuse by animal
owners and others include:
"Vet shopping" refers to the practice of soliciting multiple veterinarians under false pretenses to
obtain prescriptions for controlled substances. Drug diversion is the illegal distribution or abuse of
prescription drugs. - ANSWER: What is "vet shopping"?
, New clients bringing in seriously injured animals with vague histories
• Old, incomplete, or missing veterinary care records
• Describing clinical signs that are inconsistent with findings on examination of the patient
• Describing clinical signs that require specific medications
• Requesting medications by name (e.g., Tramadol or Xanax)
• Refusing medications as prescribed and suggesting alternatives
• Requesting early refills of medication
• Claiming medications were lost or stolen
• Requesting refills, while missing appointments
• Uncooperative and aggressive behavior - ANSWER: HOW TO RECOGNIZE A VET SHOPPER????
WAYS TO MINIMIZE DRUG DIVERSION
• Be thorough about documentation when using or prescribing narcotics
• Restrict access to prescription pads
• Maintain strict refill policies
• Remind clients to turn in unused portions of medications to a controlled substance disposal
location
• Minimize the use of commonly abused drugs, if possible
• Strictly control access, and regularly check inventory
• Look for signs of animal abuse during physical exams
• Contact police if you see suspicious behavior - ANSWER: What are some ways to minimize opioid
drug diversion?
Farm animals are not covered by the AWA - ANSWER: What animals are not covered by the AWA?
Pet Safety and Protection Act (H.R. 2849) - ANSWER: What ACT would amend the AWA to ensure
that all cats and dogs used in research were properly obtained?
The Animal Welfare Act (AWA; 7 U.S.C. 2131 et seq.) is intended to ensure the humane treatment of
animals that are intended for research, bred for commercial sale, exhibited to the public, or
commercially transported. Under the AWA, businesses and others with animals covered by the law
must be licensed or registered, and they must adhere to minimum standards of care. Farm animals
are among those not covered by the act, which nonetheless provides a broad set of statutory
protections for animals. - ANSWER: Describe the AWA
Take appropriate measures to assure that assigned time frames for withdrawal are met and no illegal
drug residues occur in any food producing animal subjected to extra-label treatment. - ANSWER:
Before prescribing or dispensing an approved animal drug or approved human drug for an extralabel
use infood animals, the veterinarian must:
an animal drug approved for use in food producing animals can be used in an extralabel manner for
the particular use. - ANSWER: Extralabel use of an approved human drug in a food producing animal
is not permitted if...
three components or "pillars": an official animal identification with a specific location at a point in
time. - ANSWER: What are the three "pillars" of ADT?
ICVIs document veterinary visual inspection, not health examination.-An inspection is defined under
9 CFR §160.1 as the "visual study of the physical appearance, physical condition, and behavior of
animals (singly or in groups) that enables an accredited veterinarian to determine whether any
abnormality in physical condition or bodily function is evident."-
An examination is defined under 9 CFR §160.1 as the "physical study of an individual animal to
determine if an abnormality in physical condition or bodily function is suggestive of clinical signs of
communicable disease."
•ICVIs are intended for interstate movement. - ANSWER: In terms of ICVI's what is the difference
between and examination and inspection?
Swine are the only species that can be identified by ear notching. Some swine breed registries allow
the use of ear notches. Ear notches must be readable and accompanied by the breed registration
certificate. Ear notching is official ID for swine. - ANSWER: What is offical id for swine in the ADT
Rule?
official eartag - ANSWER: Your dairy client is shipping a load of replacement heifers to a breeder in
another State and needs official identification along with an ICVI.
Which form of official ID could be used without approval and agreement from the animal health
officials in both the shipping and receiving States?
5 years - ANSWER: Official identification device distribution records must be maintained for...
,•2 years for swine and poultry; and
•5 years for cattle, bison, sheep, goats, cervids, and equines. - ANSWER: The AV must keep a copy of
each ICVI or other movement document issued as follows:
State Animal Health Official in both the shipping and receiving States - ANSWER: Regarding ADT and
ICVIS's, Who do you contact to find out if certification statements are needed?
7 days - ANSWER: As an accredited veterinarian, how many calendar days do you have to submit the
designated pages to the shipping State?
5 years;
2 years - ANSWER: As an accredited veterinarian, how many years must you keep a copy of this ICVI
for cattle movement? Swine and Poultry?
Minor Use and Minor Species Act
The law is intended to make more medications legally available to veterinarians and animal owners
for the treatment of minor animal species and uncommon diseases in the major animal species.
This law provides innovative ways to bring products to market for these small populations and is
designed to help pharmaceutical companies overcome the financial roadblocks they face in providing
limited-demand animal drugs. Before this legislation, pharmaceutical companies would rarely
attempt to bring such drugs to market, because the markets were too small to generate an adequate
financial return. - ANSWER: What is MUMS and what does it do?
CONDITIONAL APPROVAL: A sponsor of a veterinary drug for a minor use or minor species can apply
for "conditional approval," which allows the sponsor to make the drug available before collecting all
necessary effectiveness data, but after proving the drug is safe in accordance with the full FDA
approval standard and showing that there is a reasonable expectation of effectiveness. The drug
sponsor can keep the product on the market for up to five years, through annual renewals, while
collecting the remaining required effectiveness data. This provision is managed by the Office of New
Animal Drug Evaluation (ONADE), not by the Office of Minor Use & Minor Species Animal Drug
Development (OMUMS).
DESIGNATION: This provision was modeled on the "Orphan Drug Act" for humans, which encourages
pharmaceutical sponsors to develop drugs for rare diseases in people, by providing incentives for
approval. Sponsors of "designated" ne - ANSWER: MUMS Act: The law modifies the Federal Food,
Drug and Cosmetic Act in three key ways to provide for:
,Food Drug and Cosmetic Act - ANSWER: AMDUCA amended what act?
1) dispense veterinary prescription drugs only in quantities required for the treatment of the
animal(s) for which the drugs are dispensed, and 2) avoid unlimited refills of prescriptions or any
other activity that might result in misuse of drugs. - ANSWER: OPIOIDS: Veterinarians should follow
the AVMA Guidelines for Veterinary Prescription Drugs, which recommend that veterinarians
Recognize the potential for DIVERSION of opioid prescriptions for animals. Drug diversion occurs
when prescription medicines are obtained or used illegally. Veterinarians should recognize that
various individuals, including animal owners, family members, handlers, and practice staff, may
engage in diversion of opioid and other controlled substance prescriptions intended for animals.
Recognize signs of opioid misuse among animal ownersand others.
Learn how to talk with animal owners and others about opioid misuse. Instruct clients to store
prescriptions in a locked cabinet or container, if possible, to prevent accidental exposure or
unauthorized use. Veterinarians could consider implementing a drug take back program in their clinic
(for clients to drop off unused medications) or should direct clients to the established prescription
drug take back sites
Know how to take action if misuse of opioids is suspected. - ANSWER: Veterinarians can help reduce
opioid misuse in several ways:
1. Requests for early refills of prescriptions.
2. Requests for refills of prescriptions while missing appointments.
3. Requests for opioid medications by name.
4. Few signs of improvement in a pet's condition.
5. Clients claim that medications were lost or stolen.
6. The pet's condition does not match the owner's description.
7. New clients with seriously injured animals. - ANSWER: Signs of potential opioid misuse by animal
owners and others include:
"Vet shopping" refers to the practice of soliciting multiple veterinarians under false pretenses to
obtain prescriptions for controlled substances. Drug diversion is the illegal distribution or abuse of
prescription drugs. - ANSWER: What is "vet shopping"?
, New clients bringing in seriously injured animals with vague histories
• Old, incomplete, or missing veterinary care records
• Describing clinical signs that are inconsistent with findings on examination of the patient
• Describing clinical signs that require specific medications
• Requesting medications by name (e.g., Tramadol or Xanax)
• Refusing medications as prescribed and suggesting alternatives
• Requesting early refills of medication
• Claiming medications were lost or stolen
• Requesting refills, while missing appointments
• Uncooperative and aggressive behavior - ANSWER: HOW TO RECOGNIZE A VET SHOPPER????
WAYS TO MINIMIZE DRUG DIVERSION
• Be thorough about documentation when using or prescribing narcotics
• Restrict access to prescription pads
• Maintain strict refill policies
• Remind clients to turn in unused portions of medications to a controlled substance disposal
location
• Minimize the use of commonly abused drugs, if possible
• Strictly control access, and regularly check inventory
• Look for signs of animal abuse during physical exams
• Contact police if you see suspicious behavior - ANSWER: What are some ways to minimize opioid
drug diversion?
Farm animals are not covered by the AWA - ANSWER: What animals are not covered by the AWA?
Pet Safety and Protection Act (H.R. 2849) - ANSWER: What ACT would amend the AWA to ensure
that all cats and dogs used in research were properly obtained?
The Animal Welfare Act (AWA; 7 U.S.C. 2131 et seq.) is intended to ensure the humane treatment of
animals that are intended for research, bred for commercial sale, exhibited to the public, or
commercially transported. Under the AWA, businesses and others with animals covered by the law
must be licensed or registered, and they must adhere to minimum standards of care. Farm animals
are among those not covered by the act, which nonetheless provides a broad set of statutory
protections for animals. - ANSWER: Describe the AWA
