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Pharmacology
Exam 1 notes
65
Pharmacology
Not Applicable
01/19/2012

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Cards

Term
Pure Food And Drug Act
Definition
1906 Standards of drug purity, not drug safety
Term
Federal Food, Drug, And Cosmetic Act
FDA
Definition
1938 Drug use/ safety
Term
Durham-Humphrey Amendment
Definition
1952 required prescriptions
Term
Kefauver-Harris Amendment
Definition
1962 Thalidomide
Proof of effectivness, safety, animal research, labeling of drugs
Term
Controlled Substances Act
Definition
1970 regulated addictive potential drugs
established schedules of drugs
regulated by DEA Drug enforcment agency
Term
DEA Schedules
Schedule 1
Definition
heroin
Term
Schedule 2
Definition
morphine
meperidine/demerol
Term
schedule 3
Definition
codine w acetaminophen
Term
schedule 4
Definition
diazepam/valium
Term
schedule 5
Definition
codine cough prep
Term
Poison Prevention Act
Definition
1970 Child proof containers
Term
Hatch-Waxman Act
Definition
1984 generics of brand w/o additional testing
data submitted as ANDA
Term
FDA Modernization Act
Definition
1997 allow faster review of drugs that may be useful in life threatening disease
Term
Drug Safety Oversight Board
Definition
2005 resulted from Vioxx problems
monitor potential adverse reports for a drug after marketed
Term
Six centers of FDA
Definition
Drug Evaluation
Biologics Evaluation
Food Safety
Devices
Veterinary Medicine
Toxicology
Term
Phases of Drug Development
1
Definition
Synthesis of discovery
Term
Phases of Drug Development
2
Definition
Safety evaluation (animals and humans)
Term
Phases of Drug Development
3
Definition
Effectivness evaluation (humans)
Term
Phases of Drug Development
4
Definition
Review of NDA
Term
Phases of Drug Development
5
Definition
Post-Marketing surveillance
Term
IND Approval
Definition
submitted if impressive margin of safety in mice, if approved can begin human testing
Term
Clinical Studies
Phase I
Definition
begins after IND approval

establishes effects of predetermined dose and toxicity dose
Term
Clinical Studies
Phase 2
Definition
Dose-response studies
Term
Clinical Studies
Phase 3
Definition
verify drug efficacy

initiated after effective dose range established
Term
NDA Process
Definition
submitted after 8 years of testing
5ft high papers
if approved can sell drug for 17 years from date of phase I clinical testing
Term
Post Marketing Surveillance
Phase 4
Definition
After FDA aprroval
collect data to define side effects
Term
Solution
Definition
no alcohol
Term
Syrup
Definition
sugar
Term
Suspension
Definition
drug wont dissolve
shake well
Term
emulsion
Definition
oil
emulsifier
external prep
Term
tincture
Definition
pure alcohol
Term
elixir
Definition
sweetened water alcohol solution
Term
Teratogenic effect
Definition
monster
birth defects
Term
therapeutic effect
Definition
clinically desirable action
Term
Adverse rxn
Definition
undesirable action
Term
toxicity
Definition
intolerable damage
Term
side effect
Definition
undesired tolerable effect
Term
First pass effect/metabolism
Definition
significant portion of drug metabolized into inactive products prior to entering systemic circulation
Term
Brand name
Definition
manufacturer
Term
Generic Name
Definition
FDA
usually shortened chemical name
Term
local anesthetic/ vasoconstrictor precautions
Definition
Specific info to prevent potential drug interactions related to anesthesia
Term
Effects on Dental Treatment
Definition
Significant side effects of drug therapy which my directly or indirectly affect dental treatment or diagnosis
Term
Mechanism of Action
Definition
How the drug works in the body to elicit a response
Term
Contraindications
Definition
info pertaining to inappropriate use of drug as dictated by the approved labeling
Term
Warnings/Precautions
Definition
Precautionary considerations, hazaurdous conditions related to use of drug, and disease states or patient population in which drug should be cautiously used
Term
Use
Definition
Approved labeling by FDA based on accepted clinical evaluation on safety and efficacy of the drug submitted in the NDA. FDA considers new drug "safe and effective"
Term
Dental Use
Definition
When a drug has an established use specific to dentistry and/or oral medicine
Term
Drug Hypersensitivities
Type I
Definition
IgE
Asthma, anaphylaxis, dermatitis
Term
Drug Hyper.
Type II
Definition
IgG, IgM
hemolysis of RBC
Term
Drug Hyper
Type III
Definition
IgG
Term
a.c.
Definition
before meals
Term
p.c.
Definition
after meals
Term
h.s.
Definition
at bedtime
Term
p.r.n.
Definition
as needed
Term
q3h
Definition
every 3 hours
Term
stat
Definition
at once
Term
b.i.d.
Definition
twice daily
Term
t.i.d.
Definition
3 times daily
Term
q.i.d.
Definition
4 times daily
Term
Parts of a prescription
Definition
1. Name, address of patient, date
2. Rx
3. Name of medicine, dose form, strength
4. Directions to Pharmacist
5. Directions to patient "sig"
6. prescribers signature
7. Refill info
Term
Pregnancy Risk
A
Definition
Human Studies no fetal risk
Term
Pregnancy Risk
B
Definition
Animal studies no fetal risk
Term
Pregnancy Risk
C
Definition
Animal fetal risk, no human data
Term
Pregnancy Risk
D
Definition
Human risk, benefits acceptable
Term
Pregnancy Risk
X
Definition
Animal/Human abnormalities
Contraindicated in pregnant/may become pregnant women
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