NUR 521Module Exam 1 Study Guide. University of Alabama. With
Accurate Solutions
Chapter 1: Issues for the Practitioner in Drug Therapy
1. How do you access packet labeling from drug inserts in order to identify must
know information and black box warnings?
a. From drug (sample), from pharmacist, online at Daily Med.NIH.gov,
online at drug website.
2. List the four phases of FDA medication trials and be able to explain to a patient.
a. Preclinical: Lab and animal studies monitoring efficacy, toxic effects
b. Phase I: Safety study 20-100 volunteers, focused on absorption,
distribution, metabolism, and elimination of the drug, and most
effective drug administration route/dosage
c. Phase II: Safety study to measure the effectiveness, identifying side
effects with 100- 300 people
d. Phase III: Begins when the drug causes no apparent serious adverse effects
and dosage is appropriate; this phase Measure effectiveness, monitor side
effects on 1000- 3000 people using a double-blind research method. After
completion, FDA evaluates data presented and accepts or rejects the
application for the drug.
e. Phase IV: once on the market, objectives are to monitor long term side
effects, analyze cost-effectiveness, compare with other drugs on the
market. During this phase, drugs can be taken off the market or restricted
due to additional findings.
3. Identify the scheduled drug classes and make sure you know the medications
associated with the schedules. ****** DRUG LIST BELOW****
Drugs on the schedule are considered controlled substances. These drugs have
the potential to induce dependency and addiction, either psychologically or
physiologically.
a. Schedule 1: high potential for abuse; no routine therapeutic use
i. (heroin and LSD)
b. Schedule 2: valid medical use; high potential for abuse, no refills. High
potential for abuse both psychological and physiologic
i. (amphetamines, barbiturates)
c. Schedule 3: potential for abuse is lower than drugs on schedule 2; no refills.
Contains a combination of controlled and non-controlled substances
i. Codeine, nonbarbiturate sedatives
NUR 521 Module 1 Study Guide
(Chapters 1,2,4,5, and 6)
Page 1 of 20
,d. Schedule 4: low potential for abuse; they can call psychological dependency,
but limited physiologic dependency
i. Non-narcotic analgesics, antianxiety agents (Ativan/lorazepam)
NUR 521 Module 1 Study Guide
(Chapters 1,2,4,5, and 6)
Page 2 of 20
, e. Schedule 5: least potential for abuse; moderate amount of opioids and
are used as antitussives and antidiarrheals
Medications
Identify why these specific drugs link to the first chapter’s concepts:
• Tamoxifen: Class: Antiestrogens, Schedule: n/a
• Valacyclovir. Class: Antiviral, Schedule: n/a
• Codeine. Class: Opiate/Narcotic, Schedule 3
• Morphine. Class: Opiate/Narcotic, Schedule 2
• Dilantin (phenytoin). Class: Anticonvulsant, Schedule: n/a?
• Valproic acid. Class: Anticonvulsant, Schedule: n/a
• Benzodiazepines. Class: CNS depressant, Schedule 4
• Steroids. Schedule 3 (if anabolic steroids)
• Progesterone. Class: hormone replacement Schedule: n/a
• Methotrexate. Class: immunosuppressant, Schedule: n/a
4. What aspects of the drug must the drug manufacturer supply evidence of prior
to a generic being allowed retail sale?
a. To ensure safety, the FDA must grant approval for these drugs, and
rigorous testing is again required to ensure that all generic drugs meet
specifications for quality, purity, strength, and potency. Generic drugs must
demonstrate therapeutic equivalence to the brand name equivalent. They must be
manufactured under the same strict standards and meet the same batch requirements
for identity, strength, purity, and quality as the brand name drug. Next, peak serum
concentration and the Area Under the plasma concentration Curve (AUC) are
measured. The values obtained for the generic drug must be within 80% to 125% of
those obtained for the brand name drug.
5. Be able to apply the four ethical concepts in prescribing and apply to a case. (2
questions)
a. Autonomy: Informed consent is needed. The pt cannot give me permission
unless they understand all the possible consequences.
b. Justice: It is against ethical standards to prescribe friends/family.
c. Beneficence: Doing for the benefit of the pt, and putting their
needs first (not experimenting with drugs)
d. Non-maleficence: obligation to not cause harm to others. We should not
cause avoidable or intentional harm, or risk of harm.(Using drugs outside of
FDA approval trial)
6. What is the difference between a side effect and an adverse effect of a medication?
a. Adverse reactions: threatens the person’s life.
i. Exaggeration of principal pharmacologic action of drug itself,
NUR 521 Module 1 Study Guide
(Chapters 1,2,4,5, and 6)
Page 3 of 20
Accurate Solutions
Chapter 1: Issues for the Practitioner in Drug Therapy
1. How do you access packet labeling from drug inserts in order to identify must
know information and black box warnings?
a. From drug (sample), from pharmacist, online at Daily Med.NIH.gov,
online at drug website.
2. List the four phases of FDA medication trials and be able to explain to a patient.
a. Preclinical: Lab and animal studies monitoring efficacy, toxic effects
b. Phase I: Safety study 20-100 volunteers, focused on absorption,
distribution, metabolism, and elimination of the drug, and most
effective drug administration route/dosage
c. Phase II: Safety study to measure the effectiveness, identifying side
effects with 100- 300 people
d. Phase III: Begins when the drug causes no apparent serious adverse effects
and dosage is appropriate; this phase Measure effectiveness, monitor side
effects on 1000- 3000 people using a double-blind research method. After
completion, FDA evaluates data presented and accepts or rejects the
application for the drug.
e. Phase IV: once on the market, objectives are to monitor long term side
effects, analyze cost-effectiveness, compare with other drugs on the
market. During this phase, drugs can be taken off the market or restricted
due to additional findings.
3. Identify the scheduled drug classes and make sure you know the medications
associated with the schedules. ****** DRUG LIST BELOW****
Drugs on the schedule are considered controlled substances. These drugs have
the potential to induce dependency and addiction, either psychologically or
physiologically.
a. Schedule 1: high potential for abuse; no routine therapeutic use
i. (heroin and LSD)
b. Schedule 2: valid medical use; high potential for abuse, no refills. High
potential for abuse both psychological and physiologic
i. (amphetamines, barbiturates)
c. Schedule 3: potential for abuse is lower than drugs on schedule 2; no refills.
Contains a combination of controlled and non-controlled substances
i. Codeine, nonbarbiturate sedatives
NUR 521 Module 1 Study Guide
(Chapters 1,2,4,5, and 6)
Page 1 of 20
,d. Schedule 4: low potential for abuse; they can call psychological dependency,
but limited physiologic dependency
i. Non-narcotic analgesics, antianxiety agents (Ativan/lorazepam)
NUR 521 Module 1 Study Guide
(Chapters 1,2,4,5, and 6)
Page 2 of 20
, e. Schedule 5: least potential for abuse; moderate amount of opioids and
are used as antitussives and antidiarrheals
Medications
Identify why these specific drugs link to the first chapter’s concepts:
• Tamoxifen: Class: Antiestrogens, Schedule: n/a
• Valacyclovir. Class: Antiviral, Schedule: n/a
• Codeine. Class: Opiate/Narcotic, Schedule 3
• Morphine. Class: Opiate/Narcotic, Schedule 2
• Dilantin (phenytoin). Class: Anticonvulsant, Schedule: n/a?
• Valproic acid. Class: Anticonvulsant, Schedule: n/a
• Benzodiazepines. Class: CNS depressant, Schedule 4
• Steroids. Schedule 3 (if anabolic steroids)
• Progesterone. Class: hormone replacement Schedule: n/a
• Methotrexate. Class: immunosuppressant, Schedule: n/a
4. What aspects of the drug must the drug manufacturer supply evidence of prior
to a generic being allowed retail sale?
a. To ensure safety, the FDA must grant approval for these drugs, and
rigorous testing is again required to ensure that all generic drugs meet
specifications for quality, purity, strength, and potency. Generic drugs must
demonstrate therapeutic equivalence to the brand name equivalent. They must be
manufactured under the same strict standards and meet the same batch requirements
for identity, strength, purity, and quality as the brand name drug. Next, peak serum
concentration and the Area Under the plasma concentration Curve (AUC) are
measured. The values obtained for the generic drug must be within 80% to 125% of
those obtained for the brand name drug.
5. Be able to apply the four ethical concepts in prescribing and apply to a case. (2
questions)
a. Autonomy: Informed consent is needed. The pt cannot give me permission
unless they understand all the possible consequences.
b. Justice: It is against ethical standards to prescribe friends/family.
c. Beneficence: Doing for the benefit of the pt, and putting their
needs first (not experimenting with drugs)
d. Non-maleficence: obligation to not cause harm to others. We should not
cause avoidable or intentional harm, or risk of harm.(Using drugs outside of
FDA approval trial)
6. What is the difference between a side effect and an adverse effect of a medication?
a. Adverse reactions: threatens the person’s life.
i. Exaggeration of principal pharmacologic action of drug itself,
NUR 521 Module 1 Study Guide
(Chapters 1,2,4,5, and 6)
Page 3 of 20
