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, |
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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, |
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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), |
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2. |
Drug name (generic of trade name of active ingredient(s)), |
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3. |
Directions for use (class/species or herd/animal ID), |
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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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