Ethics and Responsibilities of Medication Use in Food Animals

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Ethics and Responsibilities of Medication Use in
Food Animals

• DGriffin_at_GPVEC.UNL.EDU

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Lets start withVet-er-in-aryETHICS

• Our Professions
• (AVMA) Principles

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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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)

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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)

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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.

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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.

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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
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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

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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

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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)
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AVMAs ELUD Algorithm
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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
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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
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AMDUCA Labeling Requirements

• Name and Address of Vet
• Name of drug
• Directions for use with animal ID
• Cautionary Statements
• Withdrawal time

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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.

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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

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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

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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/
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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)

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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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