NU 578 Unit 1 Exam (2026/2027 Update): Advanced
Pharmacology | University of South Alabama | 100
Questions with Answers & Explanations | Instant Pdf
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COVERAGE BY TOPIC
Topic Questions
Drug Development & FDA Regulations 1–15
Pharmacokinetics (Absorption, Distribution, 16–35
Metabolism, Excretion)
Pharmacodynamics (Receptors, Agonists, 36–50
Antagonists, Dose-Response)
Drug Safety, Adverse Effects & Individual Variation 51–65
Autonomic Nervous System & Cholinergic Drugs 66–80
Neuromuscular Blockers & Malignant Hyperthermia 81–90
Medication Administration & Nursing Considerations 91–100
Total Questions: 100 | Passing Score: 90% | Course: NU 578 – Advanced
Pharmacology | Institution: University of South Alabama
Section 1: Drug Development & FDA Regulations (Questions 1–15)
1. N-acetyl-para-aminophenol is an example of which type of drug name?
a) Trade name
b) Generic name
,c) Brand name
d) Chemical name
The chemical name describes the drug using nomenclature of chemistry. It is long,
hard to pronounce, and not good for regular use. The generic name is assigned by
the US Adopted Names Council, and the trade name is created by the manufacturer
for marketing purposes .
2. A new medication becomes available for treatment of a debilitating neurologic
disease. What would the nurse expect about the safety of the drug?
a) The drug has been tested only on animals
b) The drug is known to be 100% safe
c) The drug has no adverse effects
d) The drug has passed the FDA approval process
Before a new drug can be marketed, it must undergo rigorous testing and receive
FDA approval. The FDA reviews data from preclinical and clinical trials to determine
safety and effectiveness. No drug is 100% safe or free from adverse effects .
3. Why are trade names much easier to say and remember than generic names?
a) Trade names are assigned by the US Adopted Names Council
b) Trade names are always shorter
c) Companies have a marketing advantage when the trade name is easier to
recognize
d) Trade names are required by federal law to be simple
Pharmaceutical companies create trade (brand) names that are catchy, easy to
remember, and marketable. Generic names are assigned by the US Adopted Names
Council and may be more complex. The marketing advantage encourages brand
recognition and loyalty .
4. Which term is commonly used for nonprescription drugs?
a) Prescription medications
b) Controlled substances
c) Legend drugs
d) Over the counter (OTC)
,Over-the-counter (OTC) drugs are available without a prescription. They are
considered safe for self-use when taken as directed. Prescription drugs require a
healthcare provider's order and are monitored by the FDA .
5. Which is a true statement about new drug development? (Select all that apply)
a) Drug trials allow subjects to choose whether they receive the drug or placebo
b) Drug trials require that those involved don't know which subjects are receiving the
drug or control
c) Preclinical testing is performed on human volunteers
d) During preclinical testing, drugs are evaluated for toxicities, kinetic properties, and
useful effects
Double-blind studies ensure that neither the subjects nor the researchers know who
is receiving the active drug versus placebo, reducing bias. Preclinical testing is
performed on animals, not humans, to evaluate toxicity, pharmacokinetics, and
potential efficacy before human trials begin .
6. Which statements about over-the-counter (OTC) drugs would the nurse identify as
true? (Select all that apply)
a) Most illnesses initially are treated with an OTC agent
b) OTC drugs are only used for chronic conditions
c) Forty percent of Americans take at least one OTC drug every 2 days
d) Some drugs that originally were sold by prescription are now OTC
*OTC drugs are widely used for self-treatment of minor illnesses. Many drugs have
switched from prescription to OTC status (e.g., loratadine, omeprazole) after proving
safety for non-prescription use. Approximately 40% of Americans use OTC
medications regularly .*
7. Which statements about the Family Smoking Prevention and Tobacco Control Act
(2009) would the nurse identify as true? (Select all that apply)
a) All ingredients in tobacco products must be listed on the warning label
b) A gradual reduction of nicotine to nonaddictive levels is required
c) Marketing to youth is prohibited
d) Harmful additives are restricted
, The Family Smoking Prevention and Tobacco Control Act of 2009 gave the FDA
authority to regulate tobacco products. Key provisions include ingredient disclosure,
nicotine reduction goals, restrictions on marketing to youth, and regulation of
harmful additives. This was a major expansion of FDA authority .
8. The Federal Pure Food and Drug Act of 1906:
a) Required proof of drug effectiveness
b) Required FDA approval before marketing
c) Established drug schedules for controlled substances
d) Required that drugs be free of adulterants
The Federal Pure Food and Drug Act of 1906 was the first federal drug legislation. It
was weak by modern standards—it only required that drugs be free of adulterants
(contaminants). It did not address safety or effectiveness. The Food, Drug, and
Cosmetic Act of 1938 first addressed safety .
9. The Food, Drug, and Cosmetic Act of 1938:
a) Required proof of drug effectiveness
b) First required that drugs undergo testing for toxicity and be approved by the FDA
for safety
c) Established the five schedules of controlled substances
d) Required child-proof packaging
*The 1938 Act was enacted after a mass poisoning from a sulfanilamide elixir containing
toxic diethylene glycol. For the first time, manufacturers had to prove drug safety to the FDA
before marketing. Effectiveness was not required until the Harris-Kefauver Amendment of
1962 .*
10. The Harris-Kefauver Amendment to the FDA Cosmetic Act (1962):
a) Required drugs to be free of adulterants
b) Established the FDA
c) Required that a drug must be proved effective before marketing
d) Allowed accelerated approval for AIDS drugs
*The Harris-Kefauver Amendment was enacted in response to the thalidomide tragedy. It
required that drugs be not only safe but also effective for their intended uses. It also
Pharmacology | University of South Alabama | 100
Questions with Answers & Explanations | Instant Pdf
Download
COVERAGE BY TOPIC
Topic Questions
Drug Development & FDA Regulations 1–15
Pharmacokinetics (Absorption, Distribution, 16–35
Metabolism, Excretion)
Pharmacodynamics (Receptors, Agonists, 36–50
Antagonists, Dose-Response)
Drug Safety, Adverse Effects & Individual Variation 51–65
Autonomic Nervous System & Cholinergic Drugs 66–80
Neuromuscular Blockers & Malignant Hyperthermia 81–90
Medication Administration & Nursing Considerations 91–100
Total Questions: 100 | Passing Score: 90% | Course: NU 578 – Advanced
Pharmacology | Institution: University of South Alabama
Section 1: Drug Development & FDA Regulations (Questions 1–15)
1. N-acetyl-para-aminophenol is an example of which type of drug name?
a) Trade name
b) Generic name
,c) Brand name
d) Chemical name
The chemical name describes the drug using nomenclature of chemistry. It is long,
hard to pronounce, and not good for regular use. The generic name is assigned by
the US Adopted Names Council, and the trade name is created by the manufacturer
for marketing purposes .
2. A new medication becomes available for treatment of a debilitating neurologic
disease. What would the nurse expect about the safety of the drug?
a) The drug has been tested only on animals
b) The drug is known to be 100% safe
c) The drug has no adverse effects
d) The drug has passed the FDA approval process
Before a new drug can be marketed, it must undergo rigorous testing and receive
FDA approval. The FDA reviews data from preclinical and clinical trials to determine
safety and effectiveness. No drug is 100% safe or free from adverse effects .
3. Why are trade names much easier to say and remember than generic names?
a) Trade names are assigned by the US Adopted Names Council
b) Trade names are always shorter
c) Companies have a marketing advantage when the trade name is easier to
recognize
d) Trade names are required by federal law to be simple
Pharmaceutical companies create trade (brand) names that are catchy, easy to
remember, and marketable. Generic names are assigned by the US Adopted Names
Council and may be more complex. The marketing advantage encourages brand
recognition and loyalty .
4. Which term is commonly used for nonprescription drugs?
a) Prescription medications
b) Controlled substances
c) Legend drugs
d) Over the counter (OTC)
,Over-the-counter (OTC) drugs are available without a prescription. They are
considered safe for self-use when taken as directed. Prescription drugs require a
healthcare provider's order and are monitored by the FDA .
5. Which is a true statement about new drug development? (Select all that apply)
a) Drug trials allow subjects to choose whether they receive the drug or placebo
b) Drug trials require that those involved don't know which subjects are receiving the
drug or control
c) Preclinical testing is performed on human volunteers
d) During preclinical testing, drugs are evaluated for toxicities, kinetic properties, and
useful effects
Double-blind studies ensure that neither the subjects nor the researchers know who
is receiving the active drug versus placebo, reducing bias. Preclinical testing is
performed on animals, not humans, to evaluate toxicity, pharmacokinetics, and
potential efficacy before human trials begin .
6. Which statements about over-the-counter (OTC) drugs would the nurse identify as
true? (Select all that apply)
a) Most illnesses initially are treated with an OTC agent
b) OTC drugs are only used for chronic conditions
c) Forty percent of Americans take at least one OTC drug every 2 days
d) Some drugs that originally were sold by prescription are now OTC
*OTC drugs are widely used for self-treatment of minor illnesses. Many drugs have
switched from prescription to OTC status (e.g., loratadine, omeprazole) after proving
safety for non-prescription use. Approximately 40% of Americans use OTC
medications regularly .*
7. Which statements about the Family Smoking Prevention and Tobacco Control Act
(2009) would the nurse identify as true? (Select all that apply)
a) All ingredients in tobacco products must be listed on the warning label
b) A gradual reduction of nicotine to nonaddictive levels is required
c) Marketing to youth is prohibited
d) Harmful additives are restricted
, The Family Smoking Prevention and Tobacco Control Act of 2009 gave the FDA
authority to regulate tobacco products. Key provisions include ingredient disclosure,
nicotine reduction goals, restrictions on marketing to youth, and regulation of
harmful additives. This was a major expansion of FDA authority .
8. The Federal Pure Food and Drug Act of 1906:
a) Required proof of drug effectiveness
b) Required FDA approval before marketing
c) Established drug schedules for controlled substances
d) Required that drugs be free of adulterants
The Federal Pure Food and Drug Act of 1906 was the first federal drug legislation. It
was weak by modern standards—it only required that drugs be free of adulterants
(contaminants). It did not address safety or effectiveness. The Food, Drug, and
Cosmetic Act of 1938 first addressed safety .
9. The Food, Drug, and Cosmetic Act of 1938:
a) Required proof of drug effectiveness
b) First required that drugs undergo testing for toxicity and be approved by the FDA
for safety
c) Established the five schedules of controlled substances
d) Required child-proof packaging
*The 1938 Act was enacted after a mass poisoning from a sulfanilamide elixir containing
toxic diethylene glycol. For the first time, manufacturers had to prove drug safety to the FDA
before marketing. Effectiveness was not required until the Harris-Kefauver Amendment of
1962 .*
10. The Harris-Kefauver Amendment to the FDA Cosmetic Act (1962):
a) Required drugs to be free of adulterants
b) Established the FDA
c) Required that a drug must be proved effective before marketing
d) Allowed accelerated approval for AIDS drugs
*The Harris-Kefauver Amendment was enacted in response to the thalidomide tragedy. It
required that drugs be not only safe but also effective for their intended uses. It also
