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Food and Drug Administration
- 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)
- Public property
- 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)
- Trade name
- generic name
- 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
measure of solutions, usually electrolytes