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Ethics and Responsibilities of Medication Use in Food Animals

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Title: Ethics and Responsibilities of Medication Use in Food Animals


1
Ethics and Responsibilities of Medication Use in
Food Animals
  • DGriffin_at_GPVEC.UNL.EDU

2
Lets start withVet-er-in-aryETHICS
  • Our Professions
  • (AVMA) Principles

3
AVMA policy   Principles of Veterinary Medical
Ethics
  • a) PROFESSIONAL BEHAVIOR
  • Veterinarians should first consider the needs of
    the patient to relieve disease, suffering, or
    disability while minimizing pain or fear.
  • Question
  • The veterinarian should use the best, potentially
    most effective antibiotic they have available to
    treat a critically ill calf suffering from
    life-threatening septicemic bacterial scours.

http//www.avma.org/issues/policy/ethics.asp
4
AVMA policy   Principles of Veterinary Medical
Ethics
  • e) PROFESSIONAL BEHAVIOR
  • Veterinarians may choose whom they will serve.
    Both the veterinarian and the client have the
    right to establish or decline a
    Veterinarian-Client-Patient Relationship and to
    decide on treatment.
  • Question
  • Do you agree with this this AVMA policy?
  • In an emergency, should a veterinarian be
    required to treat?
  • If, Yes, should they A) 1st Aid Only, or B) best
    appropriate Tx.

http//www.avma.org/issues/policy/ethics.asp
5
AVMA policy   Principles of Veterinary Medical
Ethics
  • e) PROFESSIONAL BEHAVIOR
  • The decision to accept or decline treatment and
    related cost should be based on adequate
    discussion of clinical findings, diagnostic
    techniques, treatment, likely outcome, estimated
    cost, and reasonable assurance of payment.
  • Question
  • Does this policy contradict a)
    Veterinarians should first consider the needs of
    the patient to relieve disease, suffering, or
    disability while minimizing pain or fear.

http//www.avma.org/issues/policy/ethics.asp
6
AVMA policy   Principles of Veterinary Medical
Ethics
  • e) PROFESSIONAL BEHAVIOR
  • Once the veterinarians and the client have
    agreed, and the veterinarians have begun patient
    care, they may not neglect their patient and must
    continue to provide professional services related
    to that injury or illness within the previously
    agreed limits.
  • As subsequent needs and costs for patient care
    are identified, the veterinarians and client must
    confer and reach agreement on the continued care
    and responsibility for fees.
  • If the informed client declines further care or
    declines to assume responsibility for the fees,
    the VCPR may be terminated by either party.

http//www.avma.org/issues/policy/ethics.asp
7
AVMA policy   Principles of Veterinary Medical
Ethics
  • f) PROFESSIONAL BEHAVIOR
  • In emergencies, veterinarians have an ethical
    responsibility to provide essential services for
    animals when necessary to save life or relieve
    suffering, subsequent to client agreement. Such
    emergency care may be limited to euthanasia to
    relieve suffering, or to stabilization of the
    patient for transport to another source of animal
    care.
  • Question
  • After the veterinarian discusses the potential
    cost, if the animal owner declines should the
    practitioner still be required to administer
    treatment?

http//www.avma.org/issues/policy/ethics.asp
8
AVMA policy   Principles of Veterinary Medical
Ethics
  • k) PROFESSIONAL BEHAVIOR
  • The responsibilities of the veterinary profession
    extend beyond individual patients and clients to
    society in general.
  • What does this mean to you?
  • Questions
  • Is this reason enough to support withdrawal of
    all antibiotic use that includes labeling for
    improved feed efficiency?
  • If antibiotic use to treat calf scours is related
    to E. coli resistance that could affect humans,
    veterinarians should support not treating calves
    with scours with antibiotics?

http//www.avma.org/issues/policy/ethics.asp
9
AVMA policy   Principles of Veterinary Medical
Ethics
  • III) THE VETERINARIAN-CLIENT-PATIENT
    RELATIONSHIP
  • The veterinarian has assumed responsibility for
    making clinical judgments regarding the health of
    the animal(s) and the need for medical treatment,
    and the client has agreed to follow the
    veterinarians instructions
  • The veterinarian has sufficient knowledge of the
    animal(s) to initiate at least a general or
    preliminary diagnosis of the medical condition of
    the animal(s). This means that the veterinarian
    has recently seen and is personally acquainted
    with the keeping and care of the animal(s) by
    virtue of an examination of the animal(s), or by
    medically appropriate and timely visits to the
    premises where the animal(s) are kept.
  • The veterinarian is readily available, or has
    arranged for emergency coverage, for follow-up
    evaluation in the event of adverse reactions or
    the failure of the treatment regimen.

http//www.avma.org/issues/policy/ethics.asp
10
AVMA policy   Principles of Veterinary Medical
Ethics
  • V) INFLUENCES ON JUDGEMENT VI) THERAPIES
  • Attending veterinarians are responsible for
    choosing the treatment regimens for their
    patients.
  • It is the attending veterinarians
    responsibility to inform the client of the
    expected results and costs, and the related risks
    of each treatment regimen.
  • Question
  • Would the potential of a drug residue be a
    related risk of a treatment regimen?

http//www.avma.org/issues/policy/ethics.asp
11
AVMA policy   Principles of Veterinary Medical
Ethics
  • V) INFLUENCES ON JUDGEMENT VI) THERAPIES
  • It is unethical for veterinarians to prescribe or
    dispense prescription products in the absence of
    a VCPR.
  • Questions
  • What do you think constitutes a VCPR?
  • Must a veterinarian see and examine each animal
    (individual or group) to prescribe a drug to be
    used for a medical condition?
  • If not, how often should a veterinarian see the
    animal(s) to qualify as having a VCPR? a)
    weekly, b) monthly, c) quarterly, d) yearly

http//www.avma.org/issues/policy/ethics.asp
12
AVMA policy   Principles of Veterinary Medical
Ethics
  • V) INFLUENCES ON JUDGEMENT VI) THERAPIES
  • It is unethical for veterinarians to promote,
    sell, prescribe, dispense, or use secret remedies
    or any other product for which they do not know
    the ingredient formula.
  • Question
  • Have you ever seen a medication dispensed by a
    veterinarian that would fit this description?

http//www.avma.org/issues/policy/ethics.asp
13
AVMA policy   Principles of Veterinary Medical
Ethics
  • V) INFLUENCES ON JUDGEMENT VI) THERAPIES
  • It is unethical for veterinarians to use or
    permit the use of their names, signatures, or
    professional status in connection with the resale
    of ethical products in a manner which violates
    those directions or conditions specified by the
    manufacturer to ensure the safe and efficacious
    use of the product.
  • Questions
  • Have any of you ever attended a client
    appreciation dinner?
  • Frequently, the sponsor of these occasions are
    pharmaceutical or biologic company Does this
    violate this policy?

http//www.avma.org/issues/policy/ethics.asp
14
AVMA policy   Principles of Veterinary Medical
Ethics
  • XII - 1) PHARMACEUTICAL PRODUCTS
  • Ethical Product A product the manufacturer
    voluntarily limits sale to veterinarians as a
    marketing decision. Identical OTC products often
    given a different product name and are packaged
    differently.
  • Over the Counter (OTC) Drug Any drug that with
    FDA approval, can be labeled with adequate
    direction to enable it to be used safely and
    properly by a consumer who is not a medical
    professional.
  • Prescription Drug / Legend Drug A drug that
    cannot be labeled with adequate direction to
    enable its safe and proper use by
    non-professionals.
  • Veterinary Prescription Drug / Legend Drug A
    drug that is restricted by federal law to use by
    or on the order of a licensed veterinarian,
    according to section 503(f) of the federal Food,
    Drug, and Cosmetic Act. The law requires that
    such drugs be labeled with the statement
    "Caution, federal law restricts this drug to use
    by or on the order of a licensed veterinarian.

http//www.avma.org/issues/policy/ethics.asp
15
A Little On Drug Use The FACTS You Must Know To
Pass Your Board Exam To Legally Practice
  • Antibiotic Use Guidelines
  • AMDUCA
  • (Animal Medicinal Drug Use Clarification Act)
  • ELDU
  • (Extra Label Drug Use)

16
Extralabel Antibiotic UseMust follow FDA
Regulations
  • Prescriptions, including extra label use of
    medications must meet the AMDUCA (Animal
    Medicinal Drug Use Clarification Act) amendments
    to the Food, Drug, and Cosmetic Act and its
    regulations.
  • Meet FDA criteria for
  • ELDU (Extra Label Drug Use)
  • a valid VCPR (Veterinary Client Patient
    Relationship)

17
FDA criteria for ELDU
  1. A careful diagnosis is made by an attending
    veterinarian within the context of a valid
    veterinarian-client-patient relationship. 
  2. A determination is made that 1) there is no
    marketable drug specifically labeled to treat the
    condition diagnosed, or 2) treatment at the
    dosage recommended by the labeling was found
    clinically ineffective.
  3. Procedures are instituted to assure that identity
    of the treated animal is carefully maintained.
  4. A significantly extended period is assigned for
    drug withdrawal prior to marketing the treated
    animal and steps are taken to assure the assigned
    time frames are met so that no violative residue
    occurs. The Food Animal Residue Avoidance
    Databank (FARAD) can aid the veterinarian in
    making these estimates.

18
FDA criteria for VCPR
  • Veterinarian-Client-Patient Relationships Exist
    When
  • A.  The veterinarian has assumed the
    responsibility for making clinical judgments
    regarding the health of the animal and the need
    for medical treatment, and the client has agreed
    to follow the veterinarian's instructions.
  • B.  The veterinarian has sufficient knowledge of
    the animal to initiate at least a general or
    preliminary diagnosis of the medical condition of
    the animal. This means the veterinarian has
    recently seen and is personally acquainted with
    the keeping and care of the animal by virtue of
    an examination of the animal or the medically
    appropriate and timely visits to the premises
    where the animal is kept.
  • C.  The veterinarian is readily available for
    follow-up evaluation in the event of adverse
    reactions or failure of the treatment regimen.

19
Animal Medicinal Drug Use Clarification Act
(AMDUCA) Scope
  • Applies only to approved animal human
    drugs
  • Valid VCPR
  • Lay ELDU not allowed
  • Does not allow ELDU of feed additives
  • BY ANYONE !!! However ? Veterinary Feed
    Directive
  • ELDU of Water medications is OK.

VFD 21CFR 510,514 558
AVMA AMDUCA Algorithm
AMDUCA.PDF
20
AMDUCA Scope
  • ELDU permitted only when animals health is
    threatened or animal is suffering.
  • Therapeutic only.
  • No ELDU allowed for production purposes
  • Implants reproductive etc

21
ELDU in Food Animals
  • No approved animal drug for such use with same
    ingredient, dosage form, concentration
  • VCPR
  • Extended withdrawal time to ensure no illegal
    residues occur
  • Ensure identity of animal
  • If an approved drug is shown to be ineffective,
    ELDU may be used

22
ELDU of Human Non-food Animal Drugs
  • Cant use human drug if there is an approved
    animal drug available !!!
  • Scientific information on the human food safety
    aspect of the use of the drug can obtain this
    info from
  • FARAD or US Pharmacopeia

US Pharmacopeia (USP.ORG)
FARAD (FARAD.ORG)
23
AVMAs ELUD Algorithm
24
Sec. 608.400 - Compounding of Drugs for Use in
Animals  (CPG 7125.40)ELDU Drug Compounding
  • Extralabel use from compounding of approved new
    animal and approved human drugs (21CFR530.13)
  • There is no approved new animal or approved new
    human drug that, when used as labeled or in
    conformity with criteria established in this
    part, will, in the available dosage form and
    concentration, appropriately treat the condition
    diagnosed. Compounding from a human drug for use
    in food-producing animals will not be permitted
    if an approved animal drug can be used for the
    compounding
  • Cant use Bulk Drug Substance (21 CFR 207.3)

http//www.fda.gov/ora/compliance_ref/cpg/cpgvet/c
pg608-400.html
http//www.avma.org/issues/drugs/compounding/faq_c
ompounding.asp
25
FDA-CVM   Extra Label Drug Use (ELDU) Questions
  • 21 CFR 530
  • Synchronizing breeding cows http//beef.unl.edu/le
    arning/estrussynch.shtml
  • Synchronizing mares CIDR (vaginal progesterone)
  • Teaser cow Testosterone or Implant
  • example Veterinary Pharmacology and
    Therapeutics, Richard Adams pg 613
  • Flunixin ELDU Transport Stress?
    http//jas.fass.org/cgi/reprint/jas.2006-587v1.pdf
  • Calf diarrhea http//www.cattletoday.com/forum/v
    iewtopic.php?f8t3464
  • Penicillin dosing decisions Indication, Dose,
    Route
  • Feed additive dosing

http//beef.unl.edu/learning/estrussynch.shtml
http//www.fda.gov/AnimalVeterinary/default.htm
26
AMDUCA Labeling Requirements
  • Name and Address of Vet
  • Name of drug
  • Directions for use with animal ID
  • Cautionary Statements
  • Withdrawal time

27
AMDUCA Records
  • Identify the animals, either as individuals or a
    group.
  • Animal species treated.
  • Number of animals treated.
  • Condition being treated.
  • The established name of the drug and active
    ingredient(s).
  • Dosage prescribed or used.
  • Duration of treatment.
  • Specified withdrawal, withholding, or discard
    time(s), if applicable, for meat, milk, eggs or
    animal-derived food.
  • Keep records for a minimum of 2 years.
  • FDA may have access to these records to estimate
    risk to public health.

28
AMDUCA Records
  • Records access applies only when determined a
    particular use poses a risk to public health.
  • Information maintained in records
  • Identification of animals treated
  • name of drug and active ingredient
  • condition and species treated
  • dosage, duration number of animals treated
  • Withdrawal time

29
Prohibited Drugs
  • Chloramphenicol
  • Clenbuterol
  • Diethyl stilbesterol (DES)
  • Dimetridazole, Ipronidazole (All Nitroimidazoles)
  • Furazolidones, Nitrofurazone (All Nitrofurans)
  • Phenylbutazone (female dairy cattle gt20 months)
  • Sulfonamide drugs in lactating dairy cattle
    (except approved use of sulfadimethoxine,
    sulfabromomethazine, sulfaethoxypyridazine)
  • ELDU of Fluoroquinolones glycopeptides
  • Dipyrone (does not NADA, ANADA or NDC)
  • 8 FUTURE PROHIBITED DRUGS ? ELDU of Ceftiofur

30
FDA What Is AnNADA, ANADA NDC?
  • FDA Abbreviations
  • NADA (New Animal Drug Application)
  • ANADA (Abbreviated New Animal Drug Application)
  • NDC (National Drug Code)

http//www.accessdata.fda.gov/scripts/cder/acronym
s/index.cfm
http//www.accessdata.fda.gov/scripts/AnimalDrugsA
tFDA/
http//www.fda.gov/cder/ndc/
31
Rx Basic Information for Records (R),
Prescriptions (P), Labels (L)
  • Name, address, telephone number of
    veterinarians (RPL)
  • Name (L), address, telephone number of clients
    (RP)
  • Identification of animal(s) treated, species
    numbers of animals treated, when possible (RPL)
  • Date of treatment, prescribing, or dispensing of
    drug (RPL)
  • Name, active ingredient, quantity of the drug
    (or drug preparation) to be prescribed or
    dispensed (RPL)
  • Drug strength (if more than one strength
    available) (RPL)
  • Dosage duration
  • Route of administration (RPL)
  • Number of refills (RPL)
  • Any cautionary statements (RPL)
  • Expiration date if applicable (L)
  • Slaughter withdrawal /or milk withholding times,
    if applicable (RPL)
  • Signature or equivalent (P)

32
Producer Antibiotic Use Guidelines
  • Prevent Problems
  • Select and Use Antibiotics Carefully
  • Avoid Abs Important In Human Medicine As First
    Line Therapy
  • Use the Laboratory to Help You Select
    Antibiotics
  • Avoid Using Combinations of Antibiotics
  • Avoid Inappropriate Antibiotic Use
  • Treatment Programs Should Reflect Best Use
    Principles
  • Treat the Fewest Number of Animals Possible
  • Treat for the Recommended Time Period
  • Avoid Environmental Contamination with
    Antibiotics
  • Keep Records of Antibiotic Use
  • Follow Label Directions
  • Extralabel Antibiotic Use Must follow FDA
    Regulations
  • Subtherapeutic antibiotic use is discouraged

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GPVEC
Pregnancy Exam
Feedlot
Clinical
Reproduction
Calving
Production Mgmt.
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