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Standards Of Practice

Purpose

To provide an outline of standards or ethics that we believe veterinarians in food animal practice should ascribe to while:
  a. Helping assure a continuing supply of wholesome and safe meat,
  b. Practicing humane and effective medicine, and
  c. Assisting producers to attain the most cost-effective product possible within accepted standards of animal husbandry.
1.
AVC encourages veterinary supervision of licensed and approved animal health products for use in disease prevention and treatment programs and will not condone the use of any federally banned or ethically unacceptable products or procedures.
2. AVC encourages the union of veterinarians and livestock producers in designing complete quality animal health programs. Emphasis should be placed on prevention of disease through education, genetics, nutrition, parasite control, animal husbandry practices, biosecurity, immune enhancement, and responsible drug and chemical utilizations in treating diseased animals.
3. AVC encourages veterinarians and producers to work together in designing and maintaining quality assurance programs.
4. AVC believes there is no economic justification for jeopardizing the food supply.
5. AVC does not encourage extra label drug use (ELDU). If found to be necessary such use should be within the Animal Medicinal Usage Clarification Act (AMDUCA) criteria. These criteria include:
a. An adequate veterinarian/client/patient relationship exists,

b. Approved treatments have been documented to be inadequate or inappropriate,
  c. Adequate treatment records and animal identification are maintained,
  d. Utilize significantly extended withdrawal (WD) times or other methodologies to assure the safety of the food supply.
6. AVC encourages veterinary cooperation with the Food and Drug Administration Center for Veterinary Medicine (FDA-CVM), United States Department of Agriculture (USDA), Environmental Protection Agency (EPA) and state and local health authorities in providing a safe and whole food supply.

Discussion

1.

Under no circumstances use illegal or grossly unsafe products. The FDA-CVM has banned (declared illegal) the following medications for use in food animals: chloramphenicol, clenbuterol, diethylstilbestrol, dimetridazole, ipronidazole, nitroimidazoles, furazolidone (non-topical or non-approved), glycopeptides, and dipyrone. Additionally, FDA-CVM considers the ELDU of Sulfonamides in lactating dairy cattle and the ELDU of fluoroquinolones in any food animal to be illegal.
  The FDA-CVM AMDUCA regulation strictly defines the guides for compounding in veterinary medicine. AVC does not condone the practice of home mixing or compounding of unapproved drugs, whether by livestock producers, veterinarians, or other parties. Examples would include the practice of mixing the so-called “Bloody Mary Mixes,” and the routine systemic use of aminoglycosides. Such compounds do not have adequate quality control, sterility guarantees, adequate labeling, or pharmacological information, and, therefore considered unsafe and inappropriate. The FDA-CVM considers compounding of bulk drugs or an unapproved drug illegal. FDA-CVM defines “bulk drug” as an active pharmaceutical ingredient (in unfinished form) intended for manufacturing finished dosage form drug products.
2. The AVC has emphasized for many years the benefits of preventative herd-health programs, and will continue to do so. Such programs should be developed by working closely with producers in utilizing management techniques and practices which are beneficial to animal health, the economic well-being of the producer, and to the wholesomeness and safety of the food product being produced. The AVC does not consider a true animal health program as something that comes only in a bottle or syringe.
  Education begins with personal continuing education in order to stay abreast of new developments. It also includes client education, and may include methods and benefits of disease prevention, recognition of disease symptoms, proper treatment of disease, and many others. Veterinarians have a responsibility to stress to their clientele the necessity of responsible drug and chemical use along with the maintenance of animal identification regarding drug use.
  Genetics determine the potential for reproduction, growth, mothering ability, mature size, disease resistance, etc. Genetics appears to be an area of immense opportunity for improving animal health and performance. The technology of genetic engineering has already produced some valuable new animal health products, and with proper monitoring should be encouraged.
 

Nutrition is an integral part of an animal health program. Inadequate nutrition reduces disease resistance and production efficiency. If excessive, it is neither economically correct for the producer nor healthy for the animal.

  Facilities are an important consideration and include environmental conditions such as shelter, protection, space, etc. Appropriate handling facilities are required to safely and efficiently perform preventative measures, required treatment(s) or other procedures.
  Parasite control is necessary for proper animal health, as parasites can be very detrimental, and can offset many positive factors in animal health.
  Immune enhancement for preventing disease includes the use of vaccines or other immune enhancing agents. With proper timing, this is an accepted practice with respect to animal health. It is important to remember that this is only a portion of a total health program.
  Proper therapy is obviously an important part of animal health. Though the goal of a herd-health program is to prevent disease, there is always going to be some need for treatment. Veterinarians have a responsibility to play a leading role in helping producers keep treatments reasonable and justifiable. The AVC supports Antibiotic Judicious Use Principles. Examples include those adopted by the American Veterinary Medical Association (AVMA) and American Association of Bovine Practitioners (AABP). They include:
  a. Emphasize preventive strategies, such as appropriate husbandry and hygiene, routine healthy examinations, and vaccinations.
  b. Judicious antimicrobial use, when under the direction of a veterinarian, should be within a veterinarian-client-patient relationship (VPCR).
  c. Consider therapeutic alternatives before considering antimicrobial therapy.
  d. Avoid use of certain antimicrobials for initial therapy considered important in treating refractory infections in human or veterinary medicine.
  e. Utilize culture and susceptibility results to aid in the selection of antimicrobials, whenever possible.
  f.

Confine therapeutic antimicrobial use to proven clinical indications. Avoid inappropriate uses such as for viral infections without bacterial complication.

  g. Optimize regimens for therapeutic antimicrobial use by using current pharmacological information and principles.
  h. Use narrow spectrum antimicrobials, whenever possible.
  i.

Minimize therapeutic exposure to antimicrobials by treating for the shortest period possible.

  j. Limit therapeutic antimicrobial treatment to ill or at risk animals, treating the fewest number of animals possible.
  k. Steps should be taken to minimize environmental contamination with antimicrobials due to their use, whenever possible.
  l. Use accurate records of treatment and outcome to evaluate therapeutic regimens.
  m. Follow label instruction explicitly except as revise in accordance with the ELDU guidelines provided by in AMDUCA.
  n. Prescribe antimicrobial ELDU only in accordance with AMDUCA amendments to the Food, Drug, and Cosmetic Act and its regulations.
3. The American meat industry has long provided the consumer with very safe and wholesome products. Unfortunately, there is a strong public concern about the safety of animal products, even though the record demonstrates that the incidence of drug residues is very low. Quality assurance programs are a positive way to lessen consumer concern, and to assure continued high quality and safety. Veterinarians should work closely with producers initiating and maintaining such programs, especially with respect to drug and chemical residue avoidance.
  Quality assurance programs define an action program that avoids chemical, physical and microbiological defects. Implications are production under some specific guidelines and controls that allow some kind of certification of the product in addition to safety. For example, a product can be safe but no necessarily high in quality; however, a product cannot be of high quality if it is not safe. The AVC strongly supports scientifically based food safety initiatives. This includes, but is not limited to, the USDA Food Safety Inspection Service (FSIS) Hazard Analysis Critical Control Points (HACCP) based programs used in packing plants. HACCP offers concepts useful in a pre-harvest setting to control safety and quality defects. HACCP attempts to identify critical points in production in which a hazard can be reduced, controlled or eliminated. USDA-FSIS HACCP addresses biological, chemical and physical food safety hazards. Our profession and the beef industry are successfully addressing chemical and physical food safety hazards. Some biological hazards are much harder if not presently impossible to address in the pre-harvest production. AVC encourages adoption of management systems that improve the quality and safety of food products.
4.

Veterinarians engaged in food animal medicine are sometimes under considerable pressure to utilize drugs, chemicals, or procedures that are illegal, unethical, or dangerous for the purpose of finding more economical treatments or achieving improved results. Veterinarians must not jeopardize food safety and public health. Economic advantage afforded though drugs and chemicals is never an acceptable argument for their use.

 

The AVC supports the approval of generic equivalent products for use in food producing animals. The availability of such products would allow more cost effective treatment of animals without jeopardizing the food supply. One current example would be dexamethasone.

5. The foremost goal of the food animal industry must be to provide the consumer with a safe and wholesome food product. ELDU stands as a threat to that goal if not carefully monitored. As the primary health professional working in the food animal industry, veterinarians must assume a strong and positive role in assuring that drugs are used carefully and wisely. ELDU requires following AMDUCA guidelines.
  For the anticipated future, some ELDU is inevitable so long as veterinarians practice humane, effective medicine and producers allowed to protect themselves from financial hardship. However, veterinarians should ensure that any ELDU is justifiable and within the guidelines as outlined in the FDA-CVM AMDUCA regulations.
  a. Components of a valid VCPR
    1. has assumed the responsibility for making medical judgments regarding the health of the animal(s) and the need for medical treatment, and the client (owner 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). 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), and/or by medically appropriate and timely visits to the premises where the animal(s) are kept.

    3. The practicing veterinarian is readily available for follow-up in case of adverse reactions or failure of the regimen of therapy.
AMDUCA – ELDU requirements
  1. Only permitted where a valid VCPR exists,
  2. Therapeutic purposes only (not for reproduction),
  3. Economic justification for ELDU is not an appropriate consideration,
  4. ELDU applies to individual and water dosage forms(not feed medications),
  5. Must not lead to violative residues,
  6. Used only for FDA approved drugs,
  7. Veterinarian(s) required to make a careful diagnosis in the presence of a valid VCPR,
  8. All animals within a group may be considered for ELDU if all AMDUCA guidelines are met and treated individually or via their water.
  9. There is strict prohibition of ELDU of feed additives/medications unless the FDA has issued a Veterinary Feed Directive (VFD) and there is strict adherence to VFD guidelines.
AMDUCA labeling requirements for ELDU medications
  1. Veterinarian’s contact information (name, address, and phone),
  2. Drug name (generic of trade name of active ingredient(s)),
  3. Directions for use (class/species or herd/animal ID),
  4. Dosage (amount, frequency, route, duration),
  5. Cautionary statements,
  6. The veterinarians specified withdrawal time.
The AVC emphasizes the importance of justification of ELDU consideration. Document approved treatments as inadequate or inappropriate before considering ELDU.
  a. The means the attending veterinarian has evaluated approved treatments on the animal(s) and concluding the results unacceptable. This might vary considerably even within the context of an adequate VCPR according to the type of client, type of animal, area of country, background of the animal(s), type of problem, etc. Documentation might include sensitivity testing, clinical response, or other valid measures. The food animal industry needs this to remain flexible in order to enable veterinarians to practice effective medicine, as long as this does not sacrifice food safety and the ethics of the profession.
  b. Maintain adequate treatment records and animal identification. The type of records system that would be adequate will vary according to the type and size of operation. The important thing is that the records and animal identification be sufficient to enable the producer and/or attending veterinarian to ensure treated animals are not allowed to enter the food chain until assigned withdrawal times have been met. AMDUCA regulations outline the ELDU record requirements. As previously noted, these include: ID of herd/animal, species, number treated, diagnosis, drug name, dosage, duration, and withdrawal time. Additionally, the records must be accessible to the FDA for 2 years.
  c.

Observe significantly extended withdrawal times or other methodology utilized to assure the safety of the food supply.

The amount of information available to help determine safe withdrawal times for extra label treatment is unfortunately somewhat limited. Many treatments found to be clinically effective have no well researched withdrawal times to assist practitioners. There is a large need for input from the scientific community, drug manufacturers, and regulatory agencies toward establishing some withdrawal guidelines for extra-label treatments. This would serve to protect the entire meat industry in those instances when extra-label treatments are required.

“Other methodology” might include pre-slaughter testing for potential residues. As the technology and acceptance of such tesst improve, these may represent a valuable method to assure a residu- free food product.

6.
The intent of the statements and discussions contained in this document are to help our members, and all veterinarians, interpret FDA-CVM guidelines, not to contradict them.
  The goal of the federal regulations governing drug and chemical usage is to protect the public safety by assuring a safe food supply. AVC supports and shares this goal while at the same time attempting to practice reasonable, cost-effective food animal medicine for our producer clients. The AVC feels veterinarians, producers, and regulatory agencies should work cooperatively toward the goal of providing the consumer a desirable, safe, and wholesome product at a reasonable price.
 

 

 

 

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