regulates drugs and food additives (NOT supplements, vitamins or herbs).
Center of Veterinary Medicine is the authority on drugs (what is in progress, on backorder, etc.)
United States Department of Agriculture (USDA)
In charge of Biologics: vaccines, serums, antitoxins etc.
surveillance of infectious diseases, especially zoonoses. Also regulate travel (certificates).
Environmental Protection Agency (EPA)
in charge of animal topical pesticides (flea/tick)
The Green Book
Lists all animal drug products that have been approved by the FDA
Drugs are listed by NADA number or trade name.
Includes: Trade name and sponsors, NADA number, active ingredient, patient information (take with food, adverse effects, etc), exclusivity period, notice of hearing, voluntary withdrawals
any substance that causes a change in biologic function through its chemical actions
Category of Pharmacology: Health science dealing with preparing, compounding and dispensing of drugs for therapeutic use.
manipulating a drug to produce a form other than as described by FDA-approved label
FDA's Compliance Policy Guide (CPG)
Permits compounding under certain conditions
AVMA's position statement
"Compounding for non-food animals may be necessary when no approved drug exists to treat a pet's diagnosed condition or when approved drugs need to be modified to sufficiently treat the patient..."
Franck's pharmacy (2009, incorrect strength ingredient caused death of 21 polo horses)
New England Compounding Center (Oct 2012, fungal contamination of epidural steroids, 48 diet, 720 being treated as of March 2013)
Senate Bill 959
Branch of pharmacology dealing with undesirable effects of chemicals on living systems.
Therapeutic index = LD5o/ED50
Therapeutic index = LD5o/ED50
Ability to produce the desired effect vs. negative effect.
LD = lethal dose in 50% of people
ED = effective dose in 50% of people
category of pharmacology:
How is the drug introduced into the body?
absorbed into blood circulation?
distributed to its sites of action in the body?
transformed/metabolized by the body?
eliminated by the body?
category of pharmacology: study of mechanisms by which drugs produce changes in biological functions in the body
effect at tissue site, usually involves receptors.
tendency of drug to combine with receptor
degree to which drug combines with receptor and causes effect
high affinity and efficacy
high affinity without efficacy
category of pharmacology: application of drugs in diagnosis, prevention or treatment of disease (how to use and treat/prevent)
Prescription (Legend) drugs
Considered by the FDA to be unsafe for use except under supervision of licensed practitioner.
Generally FDA-approved only for specific indications, found in package insert
Veterinary drugs FDA-approved for specific indications in specific species
do not require the supervision of a licensed practitioner to be used
Do not required a prescription to be purchased
not necessarily "safer" than prescription drugs
Animal Medicinal Drug Use Clarification Act
Stipulates that veterinarians may use in companion animals any drug legally obtained in US, providing: valid veterinarian-client-patient relationship exists, required records are maintained, drug is appropriately labeled. (can be used for off-label, dif species. Must tell O it's off-label, etc.)
Many drugs are prohibited in food-producing animals (no off-label use)
Valid veterinarian-client-patient relationship
DVM agrees to assume responsibility for treating animal
client agrees to follow DVM's orders
DVM must have current knowledge of animal to issue diagnosis
DVM must have examined animal and is personally acquainted with its keeping and care
DVM must be available for follow-up eval
name that describes the precise molecular structure of a drug
Drug has only one
In practice only simple chemical names are used (KCl and NaHCO3)
Code name or Laboratory name
Name given by research and development investigators
Usually letters and code numbers (like U50)
Compendial, nonproprietary or generic name
Assigned by US adopted names council
Listed in US Pharmacopoeia-National Formulary (USP-NF) (standards and official generic name)
May begin with lower case letter
each drug has only one.
After patent expires, other companies may market and manufacture
Proprietary (Trade) Name
Selected by drug manufacturer to be easily remembered and identified
Use restricted to copyright or trademark owner
first letter capitalized
20 years of exclusive rights includes time for R&D and approval process
MANY proprietary names
Parts of a drug label (10)
National Drug Code # (unique 3-segment identifier)
USP (meet standards)
Inactive ingredients (excipients)
Adhesives (binder) - decrease crumbling
Coatings - decrease breakage and moisture absorption. Enteric prevents disintegration in stomach.
Emulsifiers - keep lipid- and water-soluble ingredients mixed together
Fillers - increase bulk
Lubricants - stop tablets from sticking to machinery
Vehicle - transporting agent for drug, especially acting as a solvent or diluent.
Measure drug action based on pharmacological effect, not drug weight.
Different for each drug.
(1 IU insulin is about 45.5 micrograms pure insulin)
drugs measured in IU include heparin, penicillin and hormones like insulin