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What is an OTC veterinary drug?
recognized among experts to be safe and effective for use and have been labeled with directions for the layman
What does "safe use" for veterinary OTC include?
safety to the animal
the person administering it
food products derived from the animals treated
the environment
What does effective lay use assume?
adequate diagnosis can be made
the drug can be properly administered
course of disease can be followed to determine lack of success or success
What are ethical products?
given a different name and packaged differently
can say "sold only through licensed veterinarians" but this is a marketing ploy and has no legal basis
What are grooming aids?
veterinary cosmetics not subject to FDA control unless therapeutic claim
What are nutraceuticals?
not classified as a drug
not regulated by the FDA
cannot make therapeutic claim
What are pesticides?
includes topical flea and tick products and other pesticides used on animate and inanimate objects
Topical pesticides are regulated under ?
environmental protection agency
Oral or paternal pesticides are regulated under the ?
FDA
What are veterinary biologics regulated by?
USDA
How do EPA products differ from FDA products?
EPA extra label use is prohibited
What is a legend drug?
prescription only (found on human approved prescription drugs)
What legend must prescription veterinary products bear?
"Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian"
A practitioner must be licensed by the state where ?
the drug is prescribed
What is required for a prescription to be given by a veterinarian?
agreement
examination
follow up
What are the types of drugs that require a prescription when used in veterinary patients?
all veterinary prescription products
all human prescription drugs used extra label in animals
veterinary OTCs when used extra label
all human OTC
all compounded products
Refills for a non-controlled prescription drug may be authorized by the veterinarian for a maximum of _________ from date on the original prescription.
1 year
What does prn mean?
refill as needed
What package must a prescription drug be given to the owner in?
a child-resistant, moisture and light resistant container
What is included on a prescription label?
prescriber information
ID of animal
date issued
name of drug, strength, quality
precise instructions of administration
precautionary statements
withdrawal information
lot # and expiration date
state requirements
What are the federal regulatory agencies for drug use in veterinary patients?
FDA
USDA
EPA
DEA
What are the state regulatory agencies for drug use in veterinary patients?
boards of veterinary medicine
boards of pharmacy
What does the FDA regulate?
food, drugs, and cosmetics
What does the USDA regulate?
veterinary biologics (vaccines)
What does the EPA regulate?
pesticides
What does the DEA regulate?
enforces controlled substances act of 1970 and subsequent amendments
What does the FTC regulate?
prevents unfair methods of competition and deceptive acts or practices
enforces price fixing
What does AMDUCA do?
legalizes extra-label drug use in animals under certain circumstances
What is a food producing animal?
animals that are intended to produce food for human consumption
What determines food animal vs non food animal status?
intended use rather than species
Must a veterinarian choose a veterinary-approved product over a human-approved product when prescribing for non-food animals?
no
When an OTC product is used extra-label in animals, it must be treated as a ______________ in accordance with the provisions of AMDUCA
prescription drug
What is the purpose of compounding?
meeting the individual patient needs that cannot be met through approved products in their commercially available form
All products compounded for use in veterinary patients require a ?
prescription
What is a compounded product?
based upon individual need
reformulated from either a commercial product or a from an API (active pharmaceutical ingredient)
What is not approved for compounded products?
resale
duplication of a commercially available product
a commercial product that must be reconstituted prior to use
Who can legally compound for veterinary patients?
Veterinarians and pharmacists
The CSA places controlled substances into a hierarchy of 5 schedules determined by:
potential for abuse
dependence-producing potential
What enforces the CSA?
DEA
What are schedule I drugs?
chemical substances that have a high potential for abuse and have no legitimate medical use in the US
What are schedule II drugs?
drugs that have a current accepted medical use in the US but have a high potential for abuse
What are examples of schedule I drugs?
heroin
LSD
marihuana
What are examples of schedule II drugs?
morphine
fentanyl
What are schedule III drugs?
drugs accepted in medical use in the US and have less potential for abuse than schedule I and II
What are examples of schedule III drugs?
codeine combinations
What are schedule IV drugs?
drugs with a lower potential for abuse than schedule III
What are examples of schedule IV drugs?
opioids
propofol
What are schedule V drugs?
drugs with the lowest potential for abuse
What are examples of schedule V drugs?
OTC codeine cough preparations
What form are schedule II drugs ordered with?
form DEA-222 preprinted with the registrants name and address
How are schedule III-V drugs aquired?
written purchase order, FAX, phone calls, or off the web
What are the rules for a DEA-222 form?
no liquid paper
no strikeouts
ink or typewriter
description must be exact
Prescriptions for CS must be issued by a qualified prescriber and for a ?
legitimate medical purpose
What schedule drugs cannot be refilled?
schedule II
What schedule drugs can be refilled a maximum of five times and are valid for 6 months?
schedule III and IV
What schedule drugs can be refilled as authorized by the practitioner and are valid for one year by federal law?
schedule V
What is the exception for schedule V drugs in mississippi?
the maximum refill is 5 times and it is valid for 6 months only
Separate records for Schedule ____ drugs must be kept.
II
Schedule III-V drugs records may be maintained together if ?
use of each individual drug can be identified
A vet that only _______________ CS is not required to keep records of the transactions
prescribes
A vet who _________________ CS is required to keep records of each transaction
dispenses
According to the DEA, records must be kept for ?
2 years
____________ statute of limitation on CSA.
5 year
___________ statute of limitation on IRS.
10 year
What must controlled substances be kept in?
a securely locked, substantially constructed cabinet or safe
What form must be filed if the veterinarian is involved in loss or theft?
DEA form-106
Veterinarians involved in any "significant" loss or theft of CS must notify in __________ the nearest DEA field office within _____________ of discovery
writing
one business day
What form is filed for disposal of controlled substances?
DEA form-41
Up to ___________ for a misdemeanor by a corporation or individual not resulting in death
$100,000
Up to _________________ for a misdemeanor by an individual resulting in death or for a felony
$250,000
Up to _______________ for a misdemeanor by a corporation or individual resulting in death or for a felony
$500,000
Up to _______ in prison for a misdemeanor
1 year
Up to ________ in prison for a felony
10 years
What is a separate and complementary health-care profession concerned with collection, preparation, standardization, and dispensing of drugs?
pharmacy
What is a science dealing with the properties of drugs and their effects on living systems?
pharmacology
What is a branch of pharmacology that deals directly with the effectiveness and safety of drugs in the clinical setting?
clinical pharmacology
What is a drug?
a substance that when taken into the body alters its physiology
a substance used in the treatment, diagnosis, prevention, or mitigation of disease
What is a dose?
the amount of drug given at one time
What is a dosage?
the amount of drug given (dose), the route of administration, the interval between doses, and the duration of therapy
What is potency?
relative measurement of biological activity
What is efficacy?
the ability of a drug to control or cure an illness
What is the loading dose?
larger than the maint. dose; it is used to increase drug concentrations to therapeutic levels in a short time period
What is the maintenance dose?
periodic, smaller drug doses to maintain therapeutic concentrations
What is the peak concentration?
highest drug concentration in a dosing interval
What is the trough concentration?
lowest drug concentration in a dosing interval
Always occurs immediately before the next dose
What is the minimum inhibitory concentration (MIC)?
lowest concentration that produces the desired effect
Concentrations below the MIC are considered ?
subtherapeutic
What is the dosing interval?
The frequency of intermittent drug administration
What is LD50?
lethal dose in 50% of animals (toxicity study)
What is ED50?
dose that was effective in 50% of animals (efficacy study)
What is the maximum nontoxic dose (MNTC)?
largest dose (concentration) that does not cause toxicity
What is the therapeutic index?
measure of the relative desirability of a drug for attaining a particular medical end versus its risk of toxicity
What is the therapeutic range?
the drug concentrations associated with efficacy and not toxicity
The low end of the therapeutic range is ?
MEC
The high end of the therapeutic range is ?
MNTC
What is the chemical name?
describes the chemical composition of a drug; little practical use in the clinical setting
What is the nonproprietary name?
a more concise name given to the drug (generic name)
What is the proprietary name?
unique name that the manufacturer gives to its specific brand of a drug (trade name)
What name is always capitalized?
proprietary name
What is a Type A adverse reaction?
an adverse event that can be anticipated based on the known mechanism of the drug. Usually dose-dependent