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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.)
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United States Department of Agriculture (USDA)
- In charge of Biologics: vaccines, serums, antitoxins etc.
- surveillance of infectious diseases, especially zoonoses. Also regulate travel (certificates).
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Environmental Protection Agency (EPA)
in charge of animal topical pesticides (flea/tick)
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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
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Drug
any substance that causes a change in biologic function through its chemical actions
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Pharmacy
Category of Pharmacology: Health science dealing with preparing, compounding and dispensing of drugs for therapeutic use.
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Compounding
manipulating a drug to produce a form other than as described by FDA-approved label
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FDA's Compliance Policy Guide (CPG)
Permits compounding under certain conditions
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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..."
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Compounding controversies
- 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
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Toxicology
- Branch of pharmacology dealing with undesirable effects of chemicals on living systems.
- Therapeutic index = LD5o/ED50
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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
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Pharmacokinetics
- 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?
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Pharmacodynamics
- category of pharmacology: study of mechanisms by which drugs produce changes in biological functions in the body
- effect at tissue site, usually involves receptors.
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affinity
tendency of drug to combine with receptor
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efficacy
degree to which drug combines with receptor and causes effect
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agonist
high affinity and efficacy
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antagonist
high affinity without efficacy
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Pharmacotherapeutics
category of pharmacology: application of drugs in diagnosis, prevention or treatment of disease (how to use and treat/prevent)
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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
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OTC drugs
- 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
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AMDUCA
- 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)
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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
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Chemical name
- 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)
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Code name or Laboratory name
- Name given by research and development investigators
- Usually letters and code numbers (like U50)
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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
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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
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Parts of a drug label (10)
- Trade name
- generic name
- National Drug Code # (unique 3-segment identifier)
- barcode
- strength
- dosage
- USP (meet standards)
- Storage
- expiration
- manufacturer
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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.
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International units
- 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
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milliequivalents (mEq)
measure of solutions, usually electrolytes
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