Pharmacology is the study of:
OTC drugs do not require:
a physicians order
What did the Pure Food& Drug Act do?
gave the gov't power to control the labeling of meds
What did the Shirley Amendment prohibit?
sale of drugs labeled with false therapeutic claims intended to cheat the customer
Food, Drug and Cosmetic Act is the 1st_____ that ______?
Law; that prevents the marketing of drugs that had not been thoroughly tested prior to marketing
What are the four stages of approval for therapeutic & biologic drugs?
1) preclinical investigation 2) clinical investigation 3)submission of a new drug application(NDA) 4) post marketing studies
Therapeutic Classification is:
organization of medicine by therapeutic usefulness
Pharmacologic Classification is:
Organization of medicine by how they work pharmacologically
What is a prototype drug?
The original, well understood drug model from which other medications in a pharmacologic class have been developed
A chemical name is assigned by:
standard nomenclature established by International Union of Pure and Applied Chemistry (IUPAC)
What is a preclinical investigation?
Basic science research
What is a clinical investigation?
Longest part of drug approval process. Involves clinical pharmacology that evaluates drugs used for human benefit
Explain submission of an NDA with review:
3rd stage of drug approval, trials and animal testing may continue depending on preclinical testing
Post marketing studies are:
4th stage of drug approval, testing in humans is done to check for any new harmful effects in a larger and more diverse population.
Define generic name:
name of drug assigned by the U.S. adopted name council
Whats a trade name:
name assigned by the company marketing the drug
Whats the difference between brand name & generic equivalents:
price, formulations & bioavailability
What is bioavailability?
the physiologic ability of the drug to reach its target cells and produce its effect
What is a teratogen?
any substance that will harm a developing fetus or embryo
What are the five pregnancy categories?
A(lowest risk), B, C, D, X (highest risk)
Pregnancy Category A:
No shown risk to women or the fetus
Pregnancy Category B:
Animal studies have not shown a risk to fetus & studies in women show no risk
Pregnancy Category C:
Animal studies show risk to fetus, but controlled studies have not been done in women
Pregnancy Category D:
use can cause harm to fetus but can benefit mother in life threatening situation.
Pregnancy Category X:
studies show high risk to women and fetus!
Six rights of administration:
patient, medication, does, route, time, documentation
Three checks for drug administration:
-Check the MAR, -Check when preparing drug, pouring it, taking it out of unit dose, container or connecting IV tubing to the bag -check before administering to patient
med that should be given immediately and only once!
should be available for administration within 30 mins of the written order
A single order:
Drug that is to be given only once at a specific time
administration is required by the pt's condition
orders not written as STAT, ASAP, NOW or prn
written in advance of a situation & should be carried out under specific circumstances
drugs given orally and those administered through the nasogastric (NG) or gastrostomy tubes.
Enteric Coated tablets:
designed to dissolve in the alkaline environment of the small intestine. DO NOT CRUSH
Sustained- Release tablets:
designed to dissolve very slowly, increases the drugs duration of action
Sublingual (SL) route:
medication is placed under the tongue and allowed to dissolve slowly
tablet, capsule, lozenge, or torche is placed in the mouth between gum and cheek
applying drugs locally to the skin or the membraneous linings of the eye, eat, nose, respiratory tract, urinary tract, vagina and rectum
drugs applied to skin using formulations of creams, lotions, powders and sprays
Instillation's and Irrigations:
drugs applied into body cavities or orifices including the eyes, ears, nose, urinary bladder, rectum and vagina
inhalors, nebulizers, or positive pressure apparatuses for respiratory tract.
delivers drug via a needle into the skin layers, subcutaneous tissue, muscles or veins
Intradermal (ID) route:
injection administered into the dermis layer of the skin, usually used for allergy and disease screening for local anesthetic delivery (Tb; 10-15 degrees)
Subcutaneous (SC/ SQ) route:
delivered into the deepest layers of the skin (insulin, heparin, vitamins; 45 degrees)
Intramuscular (IM) route:
delivers medication into specific muscles (90 degrees)
Intravenous (IV) route:
enables administration of medications & fluids directly into the bloodstream and allows for immediate use for the body
how drugs move within the body in 4 processes (absorption, distribution, metabolism, excretion)
movement of a substance from its site of administration across one or more body membranes
process by which drugs are transported after they have been absorbed or administered into the bloodstream
drug binds with a plasma protein and is held in the bloodstream, where its unable to reach its target cells
3 important organs contain barriers that prevent some drugs from gaining access:
brain, placenta, testes
total of all chemical reactions in the body. (liver is primary site for metabolism of medication)
individual chemical reactions of metabolism
substances absorbed across the intestinal wall enter blood vessels known as the hepatic portal circulation
Hepatic Portal Circulation:
carries blood directly to the liver
Main organ of excretion is the:
Half life (t 1/2) of a drug:
length of time required for a drug's concentration in teh plasma to decrease by 1/2. Indicator of how long a drug will produce its effect in the body
When a patient has a renal/hepatic disease the plasma half-life of a drug:
mechanisms of drug action or how the drug exerts its effects
drugs capable of binding with receptors and causing a cellular response (facilitators of cell action)
drugs that inhibit or block the responses of agonists (aka blockers)
drugs strength at a certain concentration/dose
ability of a drug to produce a more intense response as its concentration is increased.
systemic collection, organization, validation, and documentation
what the patient says or perceives (pain, anxiety, nausea)
data observed, medical history, lab tests, other diagnostic resources
Dietary Supplement Health and Education Act (DSHEA)
regulates dietary supplements. BUT does not regulate the accuracy of the label.