NUR 521 Module 1 Study Guide
(Chapters 1,2,4,5, and 6)
Page 1 of 11
, NUR 521
Module 1 Study Guide
Each chapter has 10 questions on the quiz.
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
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 11
, 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, usually dose
dependent and predictable
ii. Unrelated to principal pharmacologic action, secondary actions of the drug.
NUR 521 Module 1 Study Guide
(Chapters 1,2,4,5, and 6)
Page 3 of 11
, b. Adverse events are unintended pharmacologic effects that occur when a medication is
administered correctly while a side effect is a secondary unwanted effect that occurs
due to drug therapy
c. Adverse events require interventions whereas most side effects spontaneously resolve
with time.
d. Side effect usually occurs within therapeutic dose range.
Chapter 2: Pharmacokinetics(movement of drug through the body, absorption, distribution,
metabolism and excretion) and Pharmacodynamics(how the drug affects the body, an initiates
its therapeutic or toxic effect at a cellular level and systematically)
1. Study the vocabulary terms in the flashcard activity within the module.
Term Definition
Affinity Attraction between a drug and a receptor
Bioavailability The fraction or percentage of a drug that reaches the systemic circulation.
Enterohepatic The process by which a drug excreted in the bile flows into the gastrointestinal tract,
recirculation where it is reabsorbed and returned to the general circulation.
First pass effect The phenomenon by which a drug first passes through the liver where it is degraded
before distribution to the tissues.
Half-life The time required for half of a total drug amount to be eliminated from the body.
Pharmacokinetics Absorption, distribution, metabolism and excretion; the process the body does to the
drug. The movement of the drug through the body and how the body affects the
drug.
Pharmacodynamics Processes through which the drug affects the body. How the drug initiates its
therapeutic or toxic effect at the cellular level and systemically.
Prodrug A drug that is transformed from an inactive parent drug into an active metabolite.
Therapeutic window The range of drug concentration in the blood between a minimally effective level and
a toxic level.
CYP hepatic system Enzymes that account for 70 to 80 percent of enzymes involved in drug metabolism.
Adverse drug event FDA defines an ADR as “Any untoward medical occurrence associated with the use
of a drug in humans, whether or not considered drug-related.”
Drug-drug interaction A change in a drug’s effect on the body when the drug is taken along with a second
drug. A drug-drug interaction can delay, decrease or enhance absorption of either
drug. This can decrease or increase the action of either or both drugs or cause
adverse effects.
Drug-food interaction A change in a drug’s effect on the body when the drug is taken together with certain
foods or beverages. A drug-food interaction can delay, decrease, or enhance
absorption of a drug. This can decrease or increase the action of the drug or cause
NUR 521 Module 1 Study Guide
(Chapters 1,2,4,5, and 6)
Page 4 of 11
(Chapters 1,2,4,5, and 6)
Page 1 of 11
, NUR 521
Module 1 Study Guide
Each chapter has 10 questions on the quiz.
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
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 11
, 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, usually dose
dependent and predictable
ii. Unrelated to principal pharmacologic action, secondary actions of the drug.
NUR 521 Module 1 Study Guide
(Chapters 1,2,4,5, and 6)
Page 3 of 11
, b. Adverse events are unintended pharmacologic effects that occur when a medication is
administered correctly while a side effect is a secondary unwanted effect that occurs
due to drug therapy
c. Adverse events require interventions whereas most side effects spontaneously resolve
with time.
d. Side effect usually occurs within therapeutic dose range.
Chapter 2: Pharmacokinetics(movement of drug through the body, absorption, distribution,
metabolism and excretion) and Pharmacodynamics(how the drug affects the body, an initiates
its therapeutic or toxic effect at a cellular level and systematically)
1. Study the vocabulary terms in the flashcard activity within the module.
Term Definition
Affinity Attraction between a drug and a receptor
Bioavailability The fraction or percentage of a drug that reaches the systemic circulation.
Enterohepatic The process by which a drug excreted in the bile flows into the gastrointestinal tract,
recirculation where it is reabsorbed and returned to the general circulation.
First pass effect The phenomenon by which a drug first passes through the liver where it is degraded
before distribution to the tissues.
Half-life The time required for half of a total drug amount to be eliminated from the body.
Pharmacokinetics Absorption, distribution, metabolism and excretion; the process the body does to the
drug. The movement of the drug through the body and how the body affects the
drug.
Pharmacodynamics Processes through which the drug affects the body. How the drug initiates its
therapeutic or toxic effect at the cellular level and systemically.
Prodrug A drug that is transformed from an inactive parent drug into an active metabolite.
Therapeutic window The range of drug concentration in the blood between a minimally effective level and
a toxic level.
CYP hepatic system Enzymes that account for 70 to 80 percent of enzymes involved in drug metabolism.
Adverse drug event FDA defines an ADR as “Any untoward medical occurrence associated with the use
of a drug in humans, whether or not considered drug-related.”
Drug-drug interaction A change in a drug’s effect on the body when the drug is taken along with a second
drug. A drug-drug interaction can delay, decrease or enhance absorption of either
drug. This can decrease or increase the action of either or both drugs or cause
adverse effects.
Drug-food interaction A change in a drug’s effect on the body when the drug is taken together with certain
foods or beverages. A drug-food interaction can delay, decrease, or enhance
absorption of a drug. This can decrease or increase the action of the drug or cause
NUR 521 Module 1 Study Guide
(Chapters 1,2,4,5, and 6)
Page 4 of 11
