A Little On Drug Use

Antibiotic Use Guidelines

AMDUCA

(Animal Medicinal Drug Use Clarification Act)

ELDU

(Extra Label Drug Use)

Great Plains Veterinary Educational Center

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) 2

Great Plains Veterinary Educational Center

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: 3

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Extralabel Antibiotic Use Must 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) 4

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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 !!!

ELDU of Water medications is OK.

AMDUCALG.doc

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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

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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

•

Can’t use human drug if there is an approved animal drug available

10 •

Scientific information on the human food safety aspect of the use of the drug … can obtain this info from

–

FARAD or US Pharmacopeia Great Plains Veterinary Educational Center

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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Great Plains Veterinary Educational Center

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 13

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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 Great Plains Veterinary Educational Center

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