Prep Course Papers

Question 1

5 requirements of the veterinarian-client-patient relationship (VCPR)

Answer 1

A VCPR is present when all of the following requirements are met:

1. The veterinarian has assumed the responsibility for making clinical judgments regarding the health of the patient and the client has agreed to follow the veterinarians’ instructions.
2. The veterinarian has sufficient knowledge of the patient to initiate at least a general or preliminary diagnosis of the medical condition of the patient. (veterinarian is personally acquainted)
3. The veterinarian is readily available for follow-up evaluation or has arranged for the following: veterinary emergency coverage, and continuing care and treatment.
4. The veterinarian provides oversight of treatment, compliance, and outcome.
5. Patient records are maintained.

Question 2

Purpose and Practices of Public Health: Three Core functions and Ten Essential Public Health Services

Answer 2

Three core functions:

I - ASSESSMENT

1. Monitor health status to identify and solve health problems
2. Diagnose and investigate health problems and hazards in the community

II - POLICY DEVELOPMENT

3. Inform, educate and empower people about health issues 4. Mobilize community partnerships and actions to identify and solve health problems. 5. Develop policies and plans that support individual and community health efforts.

III - ASSURANCE

6. Enforce laws and regulations that protect health insurance and safety.
7. Link people to needed personal health services and assure the provision of health care
8. Assure a competent public and personal health care workforce.
9. Evaluate effectiveness, accessibility and quality of personal and population-based health services
10. Research for new insights and innovative solutions to health problems.

Question 3

Five Social Determinants of Health Inequalities (SDOH)

Answer 3

• Neighborhood and Built Environment
• Health and Health Care
• Social and Community Context
• Education
• Economic Stability

Question 4

What is “Vet shopping” and drug diversion?

Answer 4

“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.

Question 5

WAYS TO MINIMIZE DRUG DIVERSION from vet shopping:

Answer 5

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

Question 6

What is the National Public Health Performance Standards Program (NPHPSP)?

Answer 6

The National Public Health Performance Standards Program (NPHPSP) is a collaborative effort of seven national partners to enhance the Nation’s public health systems.

Question 7

What are the mission and goals of the National Public Health Performance Standards Program (NPHPSP)?

Answer 7

The stated mission and goals of the NPHPSP are to improve the quality of public health practice and the performance of public health systems by:

• Providing performance standards for public health systems and encouraging their widespread use,
• Engaging and leveraging national, state, and local partnerships to build a stronger foundation for public health preparedness,
• Promoting continuous quality improvement for public health systems, and
• Strengthening the science base for public health practice

Question 8

Describe the three NPHPSP (National Public Health Performance Standards Program) instruments:

Answer 8

The NPHPSP includes three instruments:

• The State Public Health System Assessment Instrument focuses on the “state public health system,” which includes state public health agencies and other partners that contribute to public health services at the state level. This instrument was developed by ASTHO and CDC.
• The Local Public Health System Assessment Instrument focuses on the “local public health system” or all entities that contribute to public health services within a community. The local instrument was developed by NACCHO and CDC.
• The Local Public Health Governance Assessment Instrument focuses on the governing body accountable for public health at the local level. Such governing bodies may include boards of health, councils, or county commissioners. The governance instrument was developed by NALBOH and CDC.

Question 9

Vision and Mission of Public Health in America

Answer 9

Vision: Health People in Healthy Communities Mission:

• Promote Physical and Mental Health
• Prevent Disease, Injury and Disability

Question 10

Assessment Instruments of NPHPSP

Answer 10

Assessment Instruments:

• State public health system
• Local public health system
• Local public health governance

Question 11

Partners of NPHPSP

Answer 11

• CDC
• APHA
• ASTHO
• NACCHO
• NALBOH
• NNPHI
• PHF

Question 12

Categories of antimicrobials based on AMR published by WHO following two tripartite WHO/FAO/OIE consultations on non-human antimicrobial usage and antimicrobial resistance

Answer 12

The ranking identifies three categories:

• Critically Important Antimicrobials (CIA),
• Highly Important Antimicrobials (HIA) and
• Important Antimicrobials (IA).

[further, a prioritisation has been performed among CIAs to identify the Highest Priority Critically Important Antimicrobials (HPCIA): Quinolones, 3rd and higher generation cephalosporins, macrolides and ketolides, glycopeptides and polymyxins]

Question 13

Two criteria to build the WHO list of antimicrobials

Answer 13

Criterion 1: the antimicrobial class is the sole, or one of limited available therapies, to treat serious bacterial infections in people.

Criterion 2: the antimicrobial class is used to treat infections in people caused by either:

• bacteria that may be transmitted to humans from non-human sources
• bacteria that may acquire resistance genes from non-human sources.

Question 14

Criteria of prioritisation among the CIA in the WHO list of antimicrobials

Answer 14

Prioritization criterion 1: High absolute number of people, or high proportion of use in patients with serious infections in health care settings affected by bacterial diseases for which the antimicrobial class is the sole or one of few alternatives to treat serious infections in humans.

Prioritization criterion 2: High frequency of use of the antimicrobial class for any indication in human medicine, or else high proportion of use in patients with serious infections in health care settings, since use may favour selection of resistance in both settings.

Prioritization criterion 3: The antimicrobial class is used to treat infections in people for which there is evidence of transmission of resistant bacteria (e.g. non-typhoidal Salmonella and Campylobacter spp.) or resistance genes (high for E. coli and Enterococcus spp.) from non-human sources.

Antimicrobial classes that meet all three prioritization criteria (1, 2, and 3) are considered the highest priority critically important antimicrobials.

Question 15

Recommendations in the WHO guidelines on use of medically important antimicrobials in food-producing animals

Answer 15

The Guideline Development Group (GDG)

1 The GDG recommends an overall reduction in use of all classes of medically important antimicrobials in food-producing animals.

2 The GDG recommends complete restriction of use of all classes of medically important antimicrobials in food-producing animals for growth promotion.

3 The GDG recommends complete restriction of use of all classes of medically important antimicrobials in food-producing animals for prevention of infectious diseases that have not yet been clinically diagnosed. Specific considerations: when a veterinary professional judges that there is a high risk of spread of a particular infectious disease, use of antimicrobials for disease prevention is justified, if such a judgement is made on the basis of recent culture and sensitivity testing results.

4 a – The GDG suggests that antimicrobials classified as critically important for human medicine should not be used for control of the dissemination of a clinically diagnosed infectious disease identified within a group of food-producing animals. b – The GDG suggests that antimicrobials classified as highest priority critically important for human medicine should not be used for treatment of food-producing animals with a clinically diagnosed infectious disease. To prevent harm to animal health and welfare, exceptions to recommendations 4a and 4b can be made when, in the judgment of veterinary professionals, bacterial culture and sensitivity results demonstrate that the selected drug is the only treatment option.

Question 16

OIE List of Antimicrobials of Veterinary Importance

Answer 16

Following two tripartite WHO/FAO/OIE consultations on non-human antimicrobial usage and antimicrobial resistance (WHO, 2003; WHO, 2004), the OIE published a list of antimicrobial agents of veterinary importance in 2007. This list was updated in 2013, 2015, 2018 and 2019 (OIE, 2019). The OIE list is based on a questionnaire sent to all OIE member countries • Criterion 1. Importance of the antimicrobial based on answers by OIE member countries. This criterion was met when a majority of the respondents (more than 50%) identified the importance of the antimicrobial class in their response to the questionnaire. • Criterion 2. Treatment of serious animal diseases and availability of alternative antimicrobial agents. This criterion was met when compounds within the class were identified as essential against specific infections and there was a lack of sufficient therapeutic alternatives. If both these criteria are fulfilled the compound or class is regarded as a veterinary critically important antimicrobial agent (VCIA). If one of these criteria is fulfilled the compound or class is regarded as a veterinary highly important antimicrobial agent (VHIA). If none of these criteria are fulfilled the compound or class is regarded as a veterinary important antimicrobial agent (VIA).

Question 17

Factors directly related to the administration of an antibiotic that affect the occurrence of AMR.

Answer 17

These include: the type and formulation of the antibiotic agent; the dose; the total animal biomass, in particular the microbiota, exposed to the antibiotic (i.e. individual treatment versus mass medication); the treatment interval and the treatment duration.

Question 18

Definition of One Health (according to AVMA)

Answer 18

One Health is the integrative effort of multiple disciplines working locally, nationally, and globally to attain optimal health for people, animals, and the environment. Because of their expertise, veterinarians play critical roles in the health of animals, humans, and even the environment, but these roles are often overlooked or unrecognized. Nonetheless, veterinary medicine is the only profession that routinely operates at the interface of these three components of One Health.

Question 19

What is the CVM (within the FDA)

Answer 19

CVM is the Center for Veterinary Medicine.

CVM is responsible for ensuring the safety and effectiveness of animal drugs, including antimicrobials.

Question 20

Actions taken by CVM (FDA) intended to combat antimicrobial resistance and preserve the effectiveness of antimicrobial drugs

Answer 20

• Applying a risk-based approach to evaluate new and currently approved antimicrobial products for animals
• collaborating with key stakeholders to support stewardship of these products by end users
• collecting data on resistance and antimicrobial use to monitor the effectiveness of the CVM actions to slow development of resistance.

Question 21

Pre-approval review process of antimicrobial drug by CVM

Answer 21

• Effectiveness (sponsor demonstrate it works as per the label)
• Target Animal/User Safety
• Environmental Safety
• Human Food safety
• AMR Risk Assessment
• Chemistry, manufacturing, and controls
• Label review.

Question 22

Post-approval surveillance and monitoring process of antimicrobial drugs by CVM

Answer 22

• Adverse event monitoring (reports by sponsor, vets, public)
• Drug labeling, promotion, and adverstising
• antimicrobial sales and distribution data (drugs for use in food-producing animals)
• antimicrobial resistance monitoring (drugs in food-producing animals: monitor resistance through NARMS)

Question 23

What is NARMS?

Answer 23

NARMS: National Antimicrobial Resistance Monitoring System.

Parternship between: FDA, CDC and USDA that tracks AMR in foodborne bacteria from:

• humans: CDC
• retail meats: FDA
• food-producing animals: USDA

Question 24

How does NARMS helps promote and protect public health?

Answer 24

NARMS helps promote and protect public health by providing information about:

• emerging bacterial resistance,
• how resistant infections differ from susceptible infections, and
• impact of interventions designed to limit the spread of resistance

Question 25

Core principles identified by AVMA for developing antimicrobial stewardship plans in veterinary practice settings

Answer 25

1. Commit to stewardship
2. Advocate for a system of care to prevent common diseases
3. Select and use antimicrobial drugs judiciously
4. Evaluate antimicrobial drug use practices
5. Educate and build expertise

Question 26

Definition of antimicrobial stewarship for veterinarians by AVMA

Answer 26

Actions veterinarians take individually and as a profession to preserve the effectiveness and availability of antimicrobial drugs through conscientious oversight and responsible medical decision making while safeguarding animal, public, and environmental health.

Question 27

CVM’s Goals for fiscal years 2019-2023

Answer 27

1. Align antimicrobial drug product product use with the principles of antimicrobial stewardship
2. Foster stewardship of antimicrobials in veterinary settings
3. Enhance monitoring of AMR and antimicrobial drug use in animals

Question 28

To align all approved medically important antimicrobial drug products with the principles of
antimicrobial stewardship, CVM is undertaking three objectives under Goal #1: ALIGN ANTIMICROBIAL DRUG PRODUCT USE WITH THE PRINCIPLES OF ANTIMICROBIAL STEWARDSHIP

Answer 28

Objective 1.1: Revise, as necessary, the use conditions for approved medically important antimicrobials in food-producing animals

Objective 1.2: Develop and implement a strategy for promoting antimicrobial stewardship in companion animals

Objective 1.3: Enhance processes to support new product development

Question 29

Three objectives that CVM is undertaking under Goal #2: FOSTER ANTIMICROBIAL STEWARDSHIP IN VETERINARY SETTINGS

Answer 29

Objective 2.1: Support outreach and education by providing information on antimicrobial stewardship

Objective 2.2: Strengthen CVM compliance program activities to support antimicrobial stewardship

Objective 2.3: Support international outreach and collaboration to foster antimicrobial stewardship in veterinary settings

Question 30

Three objectives that CVM is undertaking under Goal #3: ENHANCE MONITORING OF ANTIMICROBIAL RESISTANCE AND ANTIMICROBIAL DRUG USE IN ANIMALS

Answer 30

Objective 3.1: Collect and analyze data on antimicrobial drug use in animals

Objective 3.2: Enhance the collection and analysis of antimicrobial resistance data

Objective 3.3: Increase data sharing and reporting to aid in the monitoring of antimicrobial drug use practices and resistance

Question 31

What are Blue Bird Labels?

Answer 31

A new animal drug application (NADA) for a Type A medicated article is required to include, among other things, representative labeling proposed to be used for Type B and Type C medicated feeds containing the new animal drug.

The Center for Veterinary Medicine (CVM) uses the term Blue Bird labels to refer to such representative labeling. Blue Bird labels are created by Type A medicated article sponsors and function as a guide to manufacturers of medicated animal feeds in the preparation of final printed feed labels. The sponsor of a Type A medicated article must submit, as part of its NADA, two labeling components.

1. The specimens of labeling to be used for such new animal drug which must include adequate directions for the manufacture and use of finished feeds for all conditions for which the new animal drug is intended, recommended, or suggested in any of the labeling, including advertising, sponsored by the applicant.
2. The representative labeling proposed for use in Type B and Type C medicated feeds containing the new animal drug.