Part 2 Flashcards
Drugs that are considered safe for self-administration
over-the-counter drugs
Overwhelming feeling of physical need for a particular drug that must be met at all costs.
ADDICTION
Physical or psychological need for a particular drug.
DEPENDENCE
A drug has many names given to it before it becomes available for use.
These names include:
DRUGS NOMENCLATURE
Chemical name
Code number
Generic name
Trade or Proprietary name
Presents its exact chemical formula of a drug and always remains the same.
CHEMICAL NAME
Name given to the drug before its official approval for use.
Less complicated and easier remember than the chemical name.
GENERIC NAME
Assigned to a drug by a particular manufacturer of the drug.
TRADE NAME or Proprietary name
GN: Paracetamol
CN: Aceto Amino Phenol
BN: Biogesic, Tylenol, Calpol
GN: Aspirin
CN: Acetyl Salicylic Acid
BN: Ecosprin, Disprin
GN: Metformin
CN: 1-1 Dimethyl Biguanide
BN: Glucophage
GN: Ampicillin
CN: Aminobenzyl Pen
BN: Roscillin Unasyn, Sulbacin
DRUGS ARE ADMINISTERED FOR A NUMBER OF REASONS:
To relieve undesired symptoms
To prevent disease
To cure disease
To diagnose disease or pathological conditions
As this process takes place, the drug reaches a point at which it has its intended effect.
Drugs are absorbed, distributed, metabolized, and then excreted from the body.
ONSET OF ACTION
As it continues to be absorbed, the drug reaches its _____.
PEAK CONCENTRATION LEVEL
Drug is able to produce its most desired curative.
The time during which the drug attains its maximum therapeutic response.
REMEDIAL EFFECT
As the drug is excreted from the body, the concentration level subsides to a point at which there is little or no intended effect.
Time during which the drug is in the body in an amount large enough to be therapeutic
DURATION OF ACTION
All drugs must be in liquid form to be absorbed.
Drugs that are administered in solid or tablet form must go through a phase called the _______ before they can be absorbed
PHARMACEUTIC PHASE
Enteric-coated tablets do not go through the _______ of absorption until they reach the small intestine where they are dissolved in an alkaline media.
PHARMACEUTIC PHASE
Drugs that are administered orally in liquid form or drugs that are administered parenterally do not go through this phase.
PHARMACEUTIC PHASE
They serve as agency of the Department of Health and Human Services.
FOOD & DRUG ADMINISTRATION 1906
Controls whether prescription and OTC drugs may be used for therapy.
CENTER FOR DRUG EVALUATION AND RESEARCH (CDER)
Prevents marketing of drugs tested. not thoroughly
FOOD DRUG AND COSMETIC ACT 1938
Regulates safety of biologics.
CHILDHOOD VACCINE ACT 1986
Increases research and assists person dependent on drugs with rehabilitation.
CONTROLLED SUBSTANCE ACT 1971
Requires non generic drug and biologic manufacturer to pay fees to be used for improvements in drug review.
PRESCRIPTION DRUG USER FEE ACT 1992
Requires labeling of dietary supplement and allows FDA to remove those that are a risk to the public.
DIETARY SUPPLEMENT HEALTH & EDUCATION ACT 1994
Reauthorizes the Prescription Drug User Fee Act and reforms the drug review process.
FDA MODERNIZATION ACT 1997
Regulates serums, vaccine and blood products.
Center For Biologic Evaluation And Research (CBER)