NURS 3400
Introduction to Pharmacology and Drug Approval Process Chapter 1 & 2
The Initial intention of pharm was to relieve suffering; new emphasis is on controlling disorders
Drug Sources
Plants- plants and herbs in early cultures were used to relieve symptoms; some early drugs produced by
plants and some are still used today
oex: opium (poppy plant), atropine
plant exudates: when they absorb water, they become a mass (ex: sillium aka metamucil-
prevents constipation or diarrhea to absorb excess fluids)
Animals- includes humans, originally extracted from body fluids and glands
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fish oil lowers cholesterol
calcium- from oyster shells
Biologics- produced in living tissue (ex: eggs, e. coli); naturally produced
o Their chemical structure can vary based on the producing agent (ex: vaccines,
GDGAIVE TOOTHACHE DROPS
hormones)- this is why you are asked about egg allergy before vaccine
o Premarin- estrogen drug for women to reduce menopause symptoms comes from
urine of pregnant mare
.
also includes natural blood products
Manufactured compounds- drugs are manufactured compounds (very complex);
organic compounds are far more complex- includes steroids
Some are simple like iodine, saline
Herbal agents- natural plant extracts (vitamins, minerals, dietary supplements)
have to meet some standards but not the same as prescription drugs
PAREGORIC
History of Pharmacology
Few standards/guidelines existed to protect public- people used to experiment on themselves (big no no
now)
Reviewed 8/2019
NURS 3400
Introduction to Pharmacology and Drug Approval Process Chapter 1 & 2
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As a result many drugs available to the public contained dangerous/addictive subjects
ex: heroin was sold OTC as a substitute for morphine or to treat child cough
cocaine was in a lot of stuff- treat children with toothache
paregoric (tincture of opium)- used to dose 5 drops to 5 day old baby and adults could
take a whole teaspoon
Drug Safety
Standardization
0 USP-NF
USP (US pharmacopeia)- published in 1820; verified purity and exact strength of a
particular drug; still used today
NF (national formulary)- focuses on drug ingredients, chemical structure, and what
providers needed to know about drugs
These two were merged into one publication around 1975
o Drug monograph- what everyone throws away in the drug; what is published in the USP-NP; what
protects the manufacturer of the drug from lawsuits
Goal of Laws, Acts, and Amendments
FDCA and amendments (Timetable Adams pg. 12)-Food Drug and Cosmetic Act; intended to
protect the public from false advertising from drug manufacturers
o Amendments- because harm was still reaching the public; all new drug applications eventually
had to demonstrate data that their drug worked (proof of efficacy and safety)
The FDA: Food and Drug Administration
: Prevents sale of drugs that have not been tested
protect the public from new drugs
Can halt drug availability whenever they see fit
Reviewed 8/2019
NURS 3400
Introduction to Pharmacology and Drug Approval Process Chapter 1 & 2
monitor all new drug development
:FDA funded by the pharmaceutical industry (sketchy)
Does not oversee herbal agents to the extent that prescription and OTC drugs