Ch 1 Principles of Pharmacy
Introduction to Pharmacy
Hippocratic oath started with ancient greeks still used used today. One major pledge is
*
Created in the First century A.D. this standard text on drugs was used 15 centuries
• *
Ch 2 Pharmacy Laws
1st US laws in pharmacy is *
-make sure drug is no harmful and no false labeling
Food, Drug, and Cosmetic Act of 1938 later created the *
NDA abbreviation is *
so before marketing manufacturers needed to submit
FDC act only required drugs to be safe for consumption not that they be effective or
useful
Durham-Humphrey Amendment of 1951
-*
Kefauver-Harris Amendment of 1962
-drug not only be safe but also effective
-created *
-takes avg. 7 years before reaching marketplace to proof safe and effective
Compensate for research costs government allowed
*
to protect brand names of drugs
What created controlled substance drugs?
*
Schedule
Medical Use
Examples
I
For research only
Heroin, LSD
II
Dispensing severely restricted
*
III
Prescriptions can be refilled
up to 5 times in 6 months
Codeine with aspirin, anabolic steroids
IV
Same as for Schedule III
Benzodiazepines, meprobamate
V
Some sold w/o a prescription;
must be 18
Liquid codeine combination preps.
National drug code has 10 characters that identify
-*
*
is intended for use in few patients with rare diseases
How many names for one drug
*
name
like isobutylhydratropic acid
*
name
like ibuprofen
*
name
like advil, motrin
Generic drugs are comparable to brand names in dosage, safety, strength, quality,
performance, and intended use
some drugs don't have generic
About three-quarters of FDA-approved drugs have generic
equivalents. If you can buy a drug in generic form,
Omnibus budget reconciliation act of 1990
pharmacist or tech must offer to counsel patient on drugs
Dietary Supplement Health and Education act 1994
supplements monitor for safety and review false claims
*
-protect confidentiality of patient medical records
-employee continue medical coverage after they leave work
-move health insurance from one employer to another
FDA or Food and Drug administration main job is
*
DEA
is under the department of health or justice department?
DEA main duties is to regulate what kind of substances?
*
Is there a federal law what regulates refilling of prescriptions?
*
remember schedule III, IV, V drug are refillable for up to 6 months
*
only has the right to suspend or revoke a license
*is form of negligence in which the standard of care was not
met
*
effect
ingredient is active ingredient of the drug that exerts therapeutic
Vaccine is substance given in order to produce immunity to a disease
Penicillin - is a mold that kills growth of bacteria
*
is substance that kills bacteria
Legend drug
*
is *
drugs - small does stimulate body immune system to target
When a drug is created artificially in a lab is *synthesized drug
*
drug is a drug that is created artificially in imitation of naturally
occurring substances
A drug is therapeutic if it
maintain health
relieve symptoms
combat illness
try reverse disease process
Drug approval review
1st try to purify compound and study on animal
Clinical studies1st submit INDA (investigational)
gives intent to experiment on human
small group of healthy people then #small with disease then large patient
groups
If pass then submit NDA (new drug application) to FDA
cost almost $1 billion for Crestor a new cholesterol drug
Solid dosage form:
Tablets
*most
Capsules
active ingredate in shell
CR abbreviation is for *
CR designed not to release the active drug immediately
Extended release
allow the frequency of dosing reduced & best compliance
Suppositories are given *
Inhalation has two forms
Spray *
dispersion of material
aerosol that is *
MDI abbreviation *
administration
1. Shake well
2.Prime canister
3.spacer when inserting drug
4.breath out then make a seal
5. Acitvate taking a deep breath
6. Hold the breath and slowly exhale
IV abbreviated intravenous infusion
IM abbre for *
Syringe is device to draw up and deliver medication through a needle