Veterinarians and Antimicrobial UseLegislative & Regulatory Update

Christine Hoang, DVM, MPH, CPHAmerican Veterinary Medical Association

choang@avma.org

Pew Health Professions Commission in Health America: Practitioners for 2005“Veterinarians are more knowledgeable about the impact of

animals and diseases on human health and the role and use of

animals in the improvement of health and well-being than any

other health professional in most communities. Thus

veterinarians should be more directly available to human

health providers for consultation on these subjects.”

Role of the Veterinarian• AVMA Role of the Veterinarian Policy: Veterinarians should be involved in

the decision-making process for the use of antimicrobials in animals regardless of the distribution channels through which the antimicrobials were obtained. – Additionally, the FDA references the veterinarian’s role in their

Guidance for Industry #209 - The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals in defining greater veterinary oversight.• “Veterinary involvement in the decision-making process associated with the

use of medically important antimicrobial drugs is an important aspect of assuring appropriate use, including judicious prevention use.”

• AVMA Judicious Use Policy: “When the decision is reached to use antimicrobials for therapy, veterinarians should strive to optimize therapeutic efficacy and minimize resistance to antimicrobials to protect public and animal health.” … “Judicious use of antimicrobials, when under the direction of a veterinarian, should meet all requirements of a veterinarian-client-patient relationship.”

VCPR = oversightThe veterinarian-client-patient relationship (or VCPR) is the basis for interaction among veterinarians, their clients, and their patients. • the veterinarian is personally acquainted with the

keeping and care of the patient• The veterinarian provides oversight of treatment,

compliance and outcome• Patient records are maintained

AVMA:

• MVPA = Model Veterinary Practice Act

• PVME = Principles of Veterinary

Medical Ethics

FDA:

• AMDUCA = Animal Medicinal Drug Use

Clarification Act (AVMA and FDA Info)

for Extra-Label Drug Use

• VFD = Veterinary Feed Directive

(currently, but is not in the proposed

draft text for VFDs)

Where does it live?

• State Practice Acts

AMDUCA• (i) A valid veterinarian-client-patient relationship is one in which:

• (1) A veterinarian has assumed the responsibility for making medical judgments regarding the health of

(an) animal(s) and the need for medical treatment, and the client (the owner of the animal or animals or

other caretaker) has agreed to follow the instructions of the veterinarian;

• (2) There is sufficient knowledge of the animal(s) by the veterinarian to initiate at least a general or

preliminary diagnosis of the medical condition of the animal(s); and

• (3) The practicing veterinarian is readily available for follow-up in case of adverse reactions or failure of the

regimen of therapy. Such a relationship can exist only when the veterinarian has recently seen and is

personally acquainted with the keeping and care of the animal(s) by virtue of examination of the

animal(s), and/or by medically appropriate and timely visits to the premises where the animal(s) are kept.

Model Veterinary Practice ActThe AVMA Model Veterinary Practice Act is to serve as a set of guiding principles for state regulation

of the practice of veterinary medicine.

• The commentary to the model act explains that states may wish to further specify that

when establishing a VCPR in the case of large operations, “sufficient knowledge” of the

patient can be supplemented by means of:

– 1) examination of health, laboratory, or production records;

– 2) consultation with owners, caretakers or supervisory staff regarding a health management

program for the patient; or

– 3) information regarding the local epidemiology of diseases for the appropriate species.

Current MVPAhttps://www.avma.org/KB/Policies/Pages/Model-Veterinary-Practice-Act.aspx

“Veterinarian-client-patient relationship” means that all of the following are required: – The veterinarian has assumed the responsibility for making medical judgments regarding the health

of the patient and the client has agreed to follow the veterinarian’s instructions.– The veterinarian has sufficient knowledge of the patient to initiate at least a general or preliminary

diagnosis of the medical condition of the patient. This means that the veterinarian is personally acquainted with the keeping and care of the patient by virtue of: • a timely examination of the patient by the veterinarian, or• medically appropriate and timely visits by the veterinarian to the operation where the patient

is managed.– The veterinarian is readily available for follow-up evaluation or has arranged for the following:

• veterinary emergency coverage, and• continuing care and treatment.

– The veterinarian provides oversight of treatment, compliance and outcome.– Patient records are maintained.

Commentary to Section 2• The definition of “veterinarian-client-patient relationship” (VCPR) in subsection 20 was changed in 2012, and is now different from that embodied

in federal regulation 21 CFR 530.3(i) relating to extralabel drug use.

• In 2012, subsection 14 was revised to define “patient” as “an animal or group of animals.” Therefore, the definition of VCPR can be applied to

individual animals as well as a group or groups of animals within an operation (production system).

• The AVMA recognizes that individual states may wish to more clearly define specific terms within the definition of VCPR. For example, a state

regulatory board may wish to include a specific time period (eg, no less frequent than 6 or 12 months) to better delineate the term “timely”

relating to examinations and visits. The term “timely” should be considered in light of the nature and circumstances of the patient (eg, species,

condition or disease, or operation).

• In 2012, subsections 20-b and 20-c were revised for purposes of clarification. Subsection 20-d was added to state that patient records must be

maintained to establish a VCPR.

• States may also wish to further specify that when establishing a VCPR in the case of large operations, “sufficient knowledge” can be supplemented

by means of:

1. examination of health, laboratory, or production records; or

2. consultation with owners, caretakers or supervisory staff regarding a health management program for the patient; or

3. information regarding the local epidemiology of diseases for the appropriate species.

Principles of Veterinary Medical Ethics• Regardless of practice ownership, the interests of the patient, client, and public require that all

decisions that affect diagnosis, care, and treatment of patients are made by veterinarians.

• The responsibilities of the veterinary profession extend…to society in general. Veterinarians are encouraged… to provide their services for activities that protect public health.

• Dispensing or prescribing a prescription product requires a VCPR

– Without a VCPR, veterinarians merchandising or… use of any pharmaceutical is unethical...

• Veterinarians are responsible for choosing the treatment regimens for their patients.

• It is against our ethics to:

– be influenced by considerations other than the needs of the patient, the welfare of the client, and the safety of the public.

– allow medical judgment to be influenced by agreements by which they stand to profit through …products.

Prescription Requirements• 21 USC chapter 9

– Established by AMDUCA for Extra-Label Drug Use– 1994 (summary) & FRN• On pages 437 & 438 under New animal drugs in Section 360b (4)&(5)-“is

by or on the lawful written or oral order of a licensed veterinarian within the context of a veterinarian-client- patient relationship, as defined by the Secretary”

– ADAA – 1996 (summary) • On page 300 - (a) Lawful veterinary feed directive requirement - “to use

under the professional supervision of a licensed veterinarian” … “Any animal feed bearing or containing a veterinary feed directive drug shall be fed to animals only by or upon a lawful veterinary feed directive issued by a licensed veterinarian in the course of the veterinarian's professional practice.”

CFR Verbiage on VCPR and VFDs• Veterinary Feed Directive; Current Regulation

– 21 CFR Part 558.3 - “A veterinarian may issue a VFD only if a valid – veterinarian-client-patient relationship exists, as defined in § 530.3(i) of this chapter.”

– 21 CFR Part 558.6 – “You must issue a VFD only within the confines of a valid veterinarian-client- patient relationship (see definition at § 530.3(i) of this chapter)”

• Veterinary Feed Directive; Draft Text for Proposed Regulation– 21 CFR Part 558.3 - A ‘‘veterinary feed directive’’ is a written statement issued by a

licensed veterinarian in the course of the veterinarian’s professional practice that orders the use of a VFD drug in or on an animal feed. This written statement authorizes the client (the owner of the animal or animals or other caretaker) to obtain and use the VFD drug in or on an animal feed to treat the client’s animals only in accordance with the directions for use approved, conditionally approved, or indexed by the Food and Drug Administration (FDA).

– 21 CFR Part 558.6 - The veterinarian may only issue a VFD for use in animals under his or her supervision or oversight in the course of his or her professional practice, and in compliance with all applicable veterinary licensing and practice requirements.

c

c

c

c

Next…• State Practice Acts• MVPA, PVME, other AVMA policies• Species specific “BMP’s” ???

Prescription Requirements• 21 USC chapter 9

– Established by GADPTRA – 1988 (summary)• The language is in the USC in Section 353(f) Veterinary prescription drugs on

page 287 where it states “(4) A drug which is subject to paragraph (1) shall be deemed to be misbranded if at any time prior to dispensing its label fails to bear the statement "Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian." A drug to which paragraph (1) does not apply shall be deemed to be misbranded if at any time prior to dispensing its label bears the statement specified in the preceding sentence.

• On page 286-287 under veterinary prescription drugs (see highlighted section in attached doc on those pages) – This states “shall be dispensed only by or upon the lawful written or oral order of a licensed veterinarian in the course of the veterinarian's professional practice”

How Vets work with ProducersWithin the Veterinarian-Client-Patient-Relationship (VCPR) - the producer is the “client” component of that relationship. • assist producers in complying with their industry’s quality

assurance programs (that also contain the concepts below) • work closely with producers to ensure the health and welfare of

their animals• AVMA Judicious Use Policy: “Veterinarians should work with

those responsible for the care of animals to use antimicrobials judiciously regardless of the distribution system through which the antimicrobial was obtained.”

AVMA Efforts

Veterinary Foresight and Expertise in Antimicrobial Discussions AVMA Policy: AVMA recognizes that veterinarians need to be involved in discussions relative to judicious use of antimicrobials and food supply veterinary medicine… to ensure that risks and benefits to both humans and animals are given due consideration.

AVMA EffortsNumerous issue specific Task Forces and Steering Committees as well as standing Councils and Committees to provide guidance on these issues. • 2009-2010 AVMA’s Antimicrobial Use Task Force• 2010- present AVMA Steering Committee for FDA

Policy on Veterinary Oversight of Antimicrobials.

Streamlining the VFDThe AVMA’s Steering Committee for Veterinary Oversight:

– engaged with the FDA as it proposed changes to the Veterinary Feed Directive (VFD) to

make it more workable and to gain greater veterinary oversight. Much of the feedback

provided by the Steering Committee was incorporated into the FDA’s VFD Draft Text for

Proposed Regulation published in July 2012

• The Veterinary Feed Directive (VFD) is the primary vehicle for greater veterinary

oversight of antimicrobials in feed

– continues to collaborate with the FDA to provide guidance from the veterinary

perspective and clarify veterinarians’ role in the oversight of antimicrobial use in animals

as regulatory changes are made to address antimicrobial resistance.

Listening Sessions • The FDA has organized, in conjunction with USDA, 5 listening

sessions to be held throughout the country to hear input on the implementation of its initiative for the judicious use of antimicrobials in medicated feed or drinking water of food-producing animals.

• AVMA is participating in these sessions given the importance and role of the veterinary workforce in implementing changes.

• Information gleaned from these listening sessions will be provided to AVMA decision makers (in addition to FDA and USDA) to enhance understanding of the concerns associated with the FDA’s initiative as we all continue working to enhance veterinary oversight.

Legislation• Preservation of Antibiotics for Medical Treatment Act (PAMTA) - To amend

the Federal Food, Drug, and Cosmetic Act to preserve the effectiveness of medically important antimicrobials.

• Delivering Antimicrobial Transparency in Animals (DATA Act) - To amend the Federal Food, Drug, and Cosmetic Act to enhance the reporting requirements pertaining to use of antimicrobial drugs in food animals.

• Animal Drug User Fee Act (ADUFA) - To amend the Federal Food, Drug, and Cosmetic Act to reauthorize user fee programs relating to new animal drugs and generic new animal drugs.

PAMTA• The 113th Congressional version of the bill several changes from previous iterations.

• The legislation now covers cephalosporins, bringing the total to eight classes of medically important antibiotics that would be banned from “non-therapeutic” uses (any kind of penicillin, tetracycline, macrolide, lincosamide, streptogramin, aminoglycoside, sulfonamide, or cephalosporin).

• The measure also clarifies what is considered non-therapeutic “to ensure that any use of medically important antibiotics outside of treatment of a sick animal is not permitted,” according to Slaughter’s office.

PAMTA - Definitions• ‘therapeutic use’, with respect to a medically important antimicrobial, means the use of

antimicrobials for the specific purpose of treating an animal with a documented disease or infection. Such term does not include the continued use of such an antimicrobial in the animal after the disease or infection is resolved.

• ‘nontherapeutic use’—– “(i) means administration of antibiotics to an animal through feed and water (or, in poultry hatcheries,

through any means) for purposes (such as growth promotion, feed efficiency, weight gain, or disease prevention) other than therapeutic use or nonroutine disease control; and

– “(ii) includes any repeated or regular pattern of use of medically important antimicrobials for purposes other than therapeutic use or nonroutine disease control.

• ‘noncustomary situation’ does not include normal or standard practice and conditions on the premises that facilitate the transmission of disease.

• ‘nonroutine disease control’ means the use of antibiotics on an animal that is not sick but where it can be shown that a particular disease or infection is present, or is likely to occur because of a specific, noncustomary situation, on the premises at the barn, house, pen, or other level at which the animal is kept.

PAMTA - ProhibitionsIt shall be unlawful to administer (including by means of animal feed) a medically important antimicrobial to a food-producing animal for

nonroutine disease control unless—

– (1) there is a significant risk that a disease or infection present on the premises will be transmitted to the food-producing

animal;

– (2) the administration of the medically important antimicrobial to the food-producing animal is necessary to prevent or

reduce the risk of transmission of the disease or infection described in paragraph (1);

– (3) the medically important antimicrobial is administered to the food-producing animal for nonroutine disease control for the

shortest duration possible to prevent or reduce the risk of transmission of the disease or infection described in paragraph (1)

to the animal; and

– (4) the medically important antimicrobial is administered—

• (A) at a scale no greater than the barn, house, or pen level; and

• (B) to the fewest animals possible to prevent or reduce the risk of transmission of the disease or infection described in

paragraph (1).

DATA Act• enhanced reporting requirements• to increase collaboration and coordination with the Secretary of

Agriculture to expand and coordinate the collection of data on the use of antimicrobial drugs in or on cattle, swine, chickens, turkeys, and such other food-producing animal species.

• to publish a final version of draft guidance #213• to conduct a study evaluating

– (A) the voluntary approach used by the Food and Drug Administration to eliminate injudicious use of antimicrobial drugs in food-producing animals; and

– (B) the effectiveness of the data collection activities conducted by the FDA regarding antimicrobial resistance.

ADUFA• authorizes the FDA to collect fees from animal health companies to enable the Center for

Veterinary Medicine (CVM) to meet performance standards.

• ADUFA II will sunset in September 2013 and is scheduled to be reauthorized this year

Legislative Changes

• FDA will allow for multiple conditional approved indications on a single product label and

remove the requirement that indexed drugs be labeled “not FDA approved” for Minor

Use/Minor Species products

• Require notification of drug approvals on FDA’s website with the option to publish in the

Federal Register

AVMA

• www.avma.org• www.kofs.orgConnect with us on

choang@avma.org

@AVMAvets@ DrCHoang