Ethics and Responsibilities of Medication Use in Food Animals

1. Ethics and Responsibilities of Medication Use in Food Animals DGriffin@GPVEC.UNL.EDU

2. Let’s start withVet-er-in-aryETHICS … Our Profession’s (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 • A careful diagnosis is made by an attending veterinarian within the context of a valid veterinarian-client-patient relationship.  • 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. • Procedures are instituted to assure that identity of the treated animal is carefully maintained. • 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 animal’s 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 • Can’t 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 FARAD (FARAD.ORG) US Pharmacopeia (USP.ORG)

23. AVMA’s 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; • Can’t use “Bulk Drug Substance” (21 CFR 207.3) http://www.fda.gov/ora/compliance_ref/cpg/cpgvet/cpg608-400.html http://www.avma.org/issues/drugs/compounding/faq_compounding.asp

25. FDA-CVM:Extra Label Drug Use (ELDU) …Questions 21 CFR 530 Synchronizing breeding cows http://beef.unl.edu/learning/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/viewtopic.php?f=8&t=3464 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 >20 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) ∞ 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/acronyms/index.cfm http://www.accessdata.fda.gov/scripts/AnimalDrugsAtFDA/ 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:

33. GPVEC

34. GPVEC Pregnancy Exam Feedlot Clinical Reproduction Calving Production Mgmt.