NURS 316 Exam – Accurate Solutions For Every
Question
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Terms in this set (109)
Pharmacology the study of the biological effects of chemicals
Outline the steps involved in Approved by the Food and Drug Administration:
developing and approving a new drug federal agency responsible for the regulation and
in the United States? 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 Teratogenic Effects: High-Low risk with fertility,
drugs that have abuse potential? 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 Generic name: the original designation that a drug is
brand name drugs and over-the- given when the drug company that developed it
counter and prescription drugs? 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 The FDA is currently testing "grandfather" drugs,
associated with the use of over-the- drugs that have shown effectiveness and safety, but
counter drugs? 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.
Question
Save
Terms in this set (109)
Pharmacology the study of the biological effects of chemicals
Outline the steps involved in Approved by the Food and Drug Administration:
developing and approving a new drug federal agency responsible for the regulation and
in the United States? 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 Teratogenic Effects: High-Low risk with fertility,
drugs that have abuse potential? 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 Generic name: the original designation that a drug is
brand name drugs and over-the- given when the drug company that developed it
counter and prescription drugs? 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 The FDA is currently testing "grandfather" drugs,
associated with the use of over-the- drugs that have shown effectiveness and safety, but
counter drugs? 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.
