QUESTIONS AND ANSWERS 100%
RATED CORRECT WITH 100% SURE
PASS|GRADED A+
7 rights of medication administration - CORRECT ANSWERS Right drug, right dose, right
patient, right route, right time, right reason, right documentation
Drugs - CORRECT ANSWERS any chemical that alters the an organisms functions or
processes
pharmacy - CORRECT ANSWERS the preparation and dispensing of drugs
Pharmacogenetics - CORRECT ANSWERS study of interrelationship of genetic differences and
drug effects
Pharmacognosy - CORRECT ANSWERS Identification of sources of drugs, from plants and
animals. (
pharmacokinetics - CORRECT ANSWERS Time course and disposition of a drug in the body,
based on its absorption, distribution, metabolism, and elimination
Therapeutics - CORRECT ANSWERS art of treating disease with drugs
Toxicology - CORRECT ANSWERS study of toxic substances and their pharmacologic actions
(antidotes and poison control)
,Naming Drugs
Chemical name - CORRECT ANSWERS indicates the chemical structure
Naming Drugs: Code Name - CORRECT ANSWERS assigned by manufacturer to experimental
chemical
Naming Drugs
Generic Name - CORRECT ANSWERS Name assigned by US Adopted Name council when
found to be therapeutic
Naming Drugs: Official - CORRECT ANSWERS once experimental drug becomes approved and
admitted- generic-official
Naming Drugs: Trade name - CORRECT ANSWERS Brand name or proprietary name given by
manufacturer
Sources of Drug info - CORRECT ANSWERS United States Pharmacopeia-National Formulary
Physician's Desk Reference
Goodman & Gilman's The Pharmacological Basis of Therapeutics, edition 11
Basic & Clinical Pharmacology, edition 11
Drug Facts and Comparisons
Sources of drugs: animals - CORRECT ANSWERS Thyroid hormone, insulin, pancreatic
dornase
Sources of drugs include - CORRECT ANSWERS animal, plant, mineral , chemical
synthesis,(most common)
,Sources of Drugs: Plants - CORRECT ANSWERS Khellin, atropine, digitalis, reserpine, volatile
oils of eucalyptus, pine oil, anise
Sources of drugs: Minerals - CORRECT ANSWERS Copper sulfate, magnesium sulfate (Epsom
salts), mineral oil
Most common source of drug preparation - CORRECT ANSWERS Chemical synthesis
Plants, minerals, and animals contribute
Process of Drug approval in the united states - CORRECT ANSWERS Chemical isolation and
identification
Animal studies
Investigational New Drug approval
New Drug Application
Food and Drug Administration new drug classification system
Orphan drugs
Investigation new drug approval - CORRECT ANSWERS Phase 1 Studies: Small number,
healthy subjects
Phase 2 Studies: Small number, subjects with disease
Phase 3 Studies: Large, multicenter studies
Phase 1 of drug approval - CORRECT ANSWERS involves 20 - 100 study participants and lasts
several months. This phase is used to determine the safety and dosage of the drug, and about 70% of
these drugs move on to the next clinical research phase.
Phase 2 of drug approval - CORRECT ANSWERS involves up to several hundred people, who
must have the disease or condition the drug supposes to treat. This phase can last from a few months to
, two years, and its purpose is to monitor the efficacy of the drug, as well as note side effects that may
occur. Only around 30% of these drugs move on to the next clinical research phase.
Phase 3 of New drug approval - CORRECT ANSWERS involves 300 - 3000 volunteers and can
last up to four years. It is used to continue monitoring the efficacy of the drug, as well as exploring any
longer-term adverse reactions. About 25% to 30% of these drugs move on to the last phase of clinical
research.
Phase 4 drug approval - CORRECT ANSWERS involves several thousands of volunteers who
have the disease or condition and continues to monitor safety and efficacy. If a drug passes this phase, it
goes on to FDA review.
FDA review - CORRECT ANSWERS Once the pharmaceutical company can prove (through
preclinical research and clinical trials) that a drug is safe and is effective in treating a condition, they can
file an application to allow marketing of the drug. The application contains clinical results, labeling
information, safety information, drug abuse potential, patient information, and directions for use.
The FDA review team ensures that each application is complete, and then takes the next 6 - 10 months
to make a decision.
Post market monitoring - CORRECT ANSWERS Some issues may only arise after marketing
and prolonged usage
Changes by manufacturer must be approved
Formulation, new use, advertising
Fast track - CORRECT ANSWERS this process is designed to speed up development and
expedite the review of drugs that treat serious conditions and "fill an unmet medical need".
Breakthrough Therapy - CORRECT ANSWERS this process expedites drugs that are found to
be substantially more effective for a certain condition than others on the market.