NU 343- Exam 1 Study Questions And 100% Verified Correct Answers Guaranteed A+.
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Module
NU 343
Institution
NU 343
7/14 lecture - correct answer
This drug law enforces *standards of drug strength and purity* & prohibits *misleading* or *adulteration* (the action of making something poorer in quality by the addition of another substance) What is this drug? - correct answer pure food and drug act
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This drug law enforces *standards of drug strength and purity* & prohibits *misleading* or
*adulteration* (the action of making something poorer in quality by the addition of another substance)
What is this drug? - correct answer pure food and drug act
Informs of off-label uses - Ex: Aspirin started off for pain etc, but its' off-label use is for blood thinning -
correct answer Food and Drug Administration Modernization Act
This drug law is enforced by the FDA through *registration* & the drug must be *safe*. What is this
drug? - correct answer food, drug & cosmetic act
This drug law separated drugs into *legend* (prescription) & non legend (nonprescription, over-the
counter) categories.ex: Caution: Federal law prohibits dispensing without prescription." What is this
drug law? - correct answer durham-humphrey admendments
This drug law requires proof of *efficacy* (the power or capacity to produce a desired effect). What drug
law is this? - correct answer Kefauver-Harris admendment
This drug law *established control (registration) and enforcement (DEA)* in order for use. -- These were
for drugs that show liking, that can be addictive and will give off a euphoric feel). What is this drug law? -
correct answer comprehensive drug abuse and control (controlled substances act)
Designed to monitor drugs once they are on the market - speed up the process of getting drugs on the
market, risk surveillance mandated to include *100 million patients. What is this drug law? - correct
answer FDA Amendments Act
Promote drug studies in children -- set up pediatric drug trials - correct answer Best Pharmaceuticals
Act for Children
,What is a controlled substance? - correct answer - a drug that requires a prescription
-potentially addictive
-psychologically addicting
-can be -reinforcing (ex: "anytime I take this drug it makes me feel ready for the day")
-use is controlled by the federal gov. and monitored by both federal and state govs.
High abuse potential and no accepted medical use drugs in the U.S. are considered schedule __ control
substance. Ex: investigational; opiates; heroin - correct answer schedule I controlled substances
Currently accepted medical use in U.S. with high abuse potential resulting in severe physical or
psychological dependence drugs are considered schedule __ control medicine. Ex: meth, oxycodone,
morphine, cocaine, codeine, fentanyl, hydrocodone - correct answer schedule II controlled
substances
THERE ARE NO VERBAL ORDERS ALLOWED FOR SCHEDULE II PRESCRIPTIONS IN ALABAMA.
*COME BACK*
Abuse potential less than Schedule II that Rules for Prescriptionsa. written or verbal prescriptions
allowed; valid for 6 months from the date writtenb. limit of 5 refills Ex: codeine/Acetaminophen (Tylenol
#3); Anabolic steroids; Sedatives like Secobarbital - correct answer schedule III controlled substances
Abuse potential less than schedule III (same rules) are considered schedule __ controlled substance. Ex:
Benzodiazepines, e.g., diazepam (Valium), Alprazolam (Xanax); Drugs for weight loss (Qsymia);. Drugs for
sleep (Ambien) - correct answer schedule IV controlled substances
Lowest abuse potential drugs are considered schedule __ control subtstances. - correct answer
schedule V controlled substances
This drug law regulates certain "household substances" and requires that they be packaged for
consumer use in a manner that will make them significantly difficult for children < 5yr to open. What is
this drug law? - correct answer poison prevention packaging act
, This drug law *informs of "off-label" uses (meaning there is no indication for the drug to be used for a
certain reason but it does work for that reason -- ex: I took melatonin to relieve my headache but it was
originally used to help with sleep). What is this drug law? - correct answer food and drug
administration modernization act
This drug law both promotes drug studies in children, see how existing drugs work in children &
determine safety. It *set up pediatric drug trials*. What is this drug law? - correct answer pediatric
research equity act/ best pharmaceuticals for children act
Drug safety legislation designed to monitor drugs once they are on the market. Post-marketing safety,
risk surveillance mandated to include *100 million patients -- puts drug on the market and see how ppl
react to it & determine if it stays on the market or gets withdrawn. It spread up the process of drugs
hitting the market). What is this drug law? - correct answer FDA amendments act
Contains:
- Black Box Warnings—high risk!!
- Risk Evaluation Mitigation Strategies
- Dear Prescriber Letters
- Removal of unsafe drugs from the market quickly
The strongest safety warning a drug can have and still be on the market is known as ____________.
- Ex: Acetaminophen causes liver toxicity• Compare to side effect• Compare to adverse drug reaction -
correct answer black box warning -- gets name from black box surrounding warning
Fact: New Drug Development
• May take years
• Preclinical phase done in animals
• Phase I: Done in healthy volunteers
• Phases II and III: Done in small cohorts with the disease. Groups are randomized and studies are
typically double blinded
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