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NURS 316 Unit 1 questions with correct answer1.
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NURS 316 Unit 1 questions with correct answersPharmacology Correct Answer-the study of the biological effects of
chemicals
Outline the steps involved in developing and approving a new drug in
the United States? Correct Answer-Approved by the Food and Drug
Administration: federal agency responsible for the regulation and
enforcement of drug evaluation and distribution policies.
Preclinical trials: chemicals that have therapeutic value are tested on
laboratory animals for two main purposes: 1) to determine whether they
have the presumed effects in living tissue and 2) to evaluate any adverse
effects
-the chemical lacks therapeutic activity when used with living animals
-the chemical is too toxic to living animals to be worth the risk of
developing into a drug
-the chemical is highly teratogenic
-the safety margins are so small that the chemical would not be useful in
the clinical setting
Phase 1 Study: a pilot study of a potential drug using a small number of
selected, usually healthy human volunteers
Phase 2 Study: a clinical study of a proposed drug by selected physicians
using actual patients who have the disorder the drug is designed to treat;
the patients must provide informed consent.
Phase 3: use of a proposed drug on a wide scale in the clinical setting
with patients who have the disease the drug is thought to treat
,Phase 4: continuous evaluation of a drug after it has been released for
marketing
Describe the federal controls on drugs that have abuse potential? Correct
Answer-Teratogenic Effects: High-Low risk with fertility, pregnancy,
and breastfeeding.
Category A: Adequate studies in the pregnant woman, no evidence of
harm in the first trimester and later pregnancy.
Category B: animal studies have not demonstrated a risk to the fetus, and
no studies in pregnant women or animal studies of adverse effects.
Category C: animal studies have shown an adverse effect on the fetus,
but no studies on humans. Use in pregnant women may be used despite
its potential risks.
Category D: there is evidence of human fetal risk, may be used in
pregnant women despite its potential risks.
Category X: studies in animals and humans demonstrate fetal
abnormalities of the fetus. If the risk outweighs the reward, the drug
should not be given.
The Controlled Substances act of 1970: control over drugs by the FDA
and Drug Enforcement Agency (DEA), US Department of Justice.
Schedule 1: High abuse potential and no accepted medical use (heroin,
marijuana, LSD)
Schedule 2: High abuse potential with severe dependence liability
(narcotics, amphetamines, and barbiturates)
,Schedule 3: Less abuse potential than schedule 2 drugs and moderate
dependence liability (nonbarbiturate sedatives, nonamphetamine
stimulants, limited amounts of certain narcotics)
Schedule 4: less abuse than schedule 3 and limited dependence liability
(some sedatives, antianxiety agents, and nonnarcotic analgesics).
Schedule 5: Limited abuse potential. Primarily small amounts of
narcotics (codeine) are used as antitussives or antidiarrheals. Under
federal law, limited quantities of certain schedule 5 drugs may be
purchased without a prescription 18years<, transaction recorded by
pharmacist.
Differentiate between generic and brand name drugs and over-the-
counter and prescription drugs? Correct Answer-Generic name: the
original designation that a drug is given when the drug company that
developed it applies for the approval process, straight print, same dose,
route, contain safe ingredients and packaging, the inactive ingredients do
not have to be the same ex. minoxidil
Brand name: name given to a drug by the pharmaceutical company that
developed it; also called a trade name or proprietary name, usually
capitalized and italicized ex. Rogaine
Over-the-Counter drugs: drugs that are available without a prescription
for self-treatment of a variety of complaints; deemed to be safe when
used as directed; often formerly only available by prescription ex.
tylenol
Prescription: drugs that can be potentially harmful and need to be
approved by a physician
Explain the benefits and risks associated with the use of over-the-
counter drugs? Correct Answer-The FDA is currently testing
, "grandfather" drugs, drugs that have shown effectiveness and safety, but
some problems are
-taking these drugs could mask the signs and symptoms of underlying
disease, making diagnosis difficult
-taking these drugs with prescription medications could result in drug
interactions and interfere with drug therapy
-not taking these drugs as directed could result in serious overdoses.
Chapter 1 Summary Correct Answer--Clinical pharmacology is the
study of drugs used to treat, diagnose, or prevent a disease
-Drugs are chemicals that are introduced into the body and affect the
body's chemical processes.
-Drugs can come from natural sources, including plants, foods, animals,
salts of inorganic compounds, or synthetic sources.
-The FDA carefully regulates the testing and approval of all drugs in this
country
-To be approved for marketing, a drug must pass through animal testing,
testing on healthy humans, selected testing on people with the disease
being treated, and then broad testing on people with the disease being
treated.
-Generic drugs are drugs no longer protected by a patent and can be
produced by companies other than the one that developed it
-OTC drugs are available without a prescription and are deemed safe
when used as directed
-Orphan drugs have a limited market or a narrow margin of safety.
These drugs may have then been adopted for development by a drug
company in exchange for tax incentives.
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