Chapter 2: Drug Approval and Regulation
Question:1
Type: MCSA
The pharmaceutical representative comes to the physician's office and says his company's pharmaceutical
laboratory is marketing a drug that does not need approval by the Food and Drug Administration (FDA). What is
the best response by the nurse?
1. "Any pharmaceutical laboratory in America must have approval from the Food and Drug Administration
(FDA) before marketing a drug."
2. "Is this an over-the-counter (OTC) drug? They do not need approval by the Food and Drug Administration
(FDA)."
3. "Is your pharmaceutical laboratory private? Only public pharmaceutical laboratories need approval from
the Food and Drug Administration (FDA)."
4. "Your pharmaceutical laboratory must be involved in academic research because they are exempt from
approval by the Food and Drug Administration (FDA)."
Correct Answer: 1
Rationale 1: Any pharmaceutical laboratory must obtain approval from the Food and Drug Administration (FDA)
before marketing a drug.
Rationale 2: Pharmaceutical laboratories that manufacture over-the-counter (OTC) drugs must obtain approval
from the Food and Drug Administration (FDA) before marketing these drugs.
Rationale 3: Private pharmaceutical laboratories must obtain approval from the Food and Drug Administration
(FDA) before marketing a drug.
Rationale 4: Pharmaceutical laboratories involved in academic research must obtain approval from the Food and
Drug Administration (FDA) before marketing a drug.
Global Rationale: Any pharmaceutical laboratory, whether private, public, or academic, must obtain approval
from the Food and Drug Administration (FDA) before marketing a drug. Private pharmaceutical laboratories
must obtain approval from the Food and Drug Administration (FDA) before marketing a drug. Pharmaceutical
laboratories involved in academic research must obtain approval from the Food and Drug Administration (FDA)
before marketing a drug. Pharmaceutical laboratories that manufacture over-the-counter (OTC) drugs must
obtain approval from the Food and Drug Administration (FDA) before marketing these drugs.
Cognitive Level: Applying
Client Need: Physiological Integrity
Client Need Sub: Pharmacological and Parenteral Therapies
,QSEN Competencies: V.B.1 Demonstrate effective use of technology and standardized practices that support
safety and quality.
AACN Essential Competencies: V.4 Examine legislative and regulatory processes relevant to the provision of
health care.
NLN Competencies: Quality and Safety: Policies and procedures.
Nursing/Integrated Concepts: Nursing Process: Implementation
Learning Outcome: 2-2 Discuss the role of the U.S. Food and Drug Administration (FDA) in the drug approval
process.
MNL Learning Outcome: 1.1.1 Apply basic concepts related to pharmacology.
Page Number: 13
Question 2
Type: MCSA
The nurse is employed by the Food and Drug Administration (FDA) and is involved in clinical investigation. What
is the primary role of the nurse in this phase of the review and approval process by the FDA?
1. To perform tests on the population-at-large
2. To perform tests on various species of animals
3. To perform tests on human cells cultured in the laboratory
4. To perform tests on human clients
Correct Answer: 4
Rationale 1: Performing tests on the population-at-large is the stage of post-marketing surveillance.
Rationale 2: Performing tests on various species of animals is the preclinical investigation stage.
Rationale 3: Performing tests on human cells cultured in the laboratory is the preclinical investigation stage.
Rationale 4: Clinical investigation includes performing tests on healthy volunteers, and later, on selected clients
with a particular disease.
Global Rationale: Clinical investigation includes performing tests on healthy volunteers, and later, on selected
clients with a particular disease. Performing tests on human cells cultured in the laboratory is the preclinical
investigation stage. Performing tests on the population-at-large is the stage of post-marketing surveillance.
Performing tests on various species of animals is the preclinical investigation stage.
Cognitive Level: Applying
Client Need: Physiological Integrity
,Client Need Sub: Pharmacological and Parenteral Therapies
QSEN Competencies: V.B.1 Demonstrate effective use of technology and standardized practices that support
safety and quality.
AACN Essential Competencies: V.4 Examine legislative and regulatory processes relevant to the provision of
health care.
NLN Competencies: Quality and Safety: Policies and procedures.
Nursing/Integrated Concepts: Nursing Process: Implementation
Learning Outcome: 2-5 Identify the nurse’s role in the drug approval process and in maintaining safety practices.
MNL Learning Outcome: 1.1.1 Apply basic concepts related to pharmacology. Page Number: 13
Question 3
Type: MCSA
The student nurse is taking a pharmacology course and studying about the Food and Drug Administration (FDA).
What has the student learned about how the FDA has decreased the amount of time involved in bringing a new
drug to the market?
1. The Food and Drug Administration (FDA) is not as strict as it once was with regard to drug approval.
2. Since consumers have demanded more drugs, the Food and Drug Administration (FDA) has streamlined the
review/approval process.
3. Drug manufacturers are required to pay yearly user fees, which allow the Food and Drug Administration (FDA)
to hire more employees to increase its efficiency.
4. Drug manufacturers are required by the Food and Drug Administration (FDA) to test more drugs on an annual
basis.
Correct Answer: 3
Rationale 1: The Food and Drug Administration (FDA) is just as strict now as it always was with regard to drug
approval.
Rationale 2: The Food and Drug Administration (FDA) has not streamlined the review/approval process.
Rationale 3: In 1992, the Prescription Drug User Fee Act was passed. This required drug manufacturers to
provide yearly product user fees so the Food and Drug Administration (FDA) could restructure, hire more
employees, and operate more efficiently.
Rationale 4: The Food and Drug Administration (FDA) does not require drug manufacturers to test more drugs
on an annual basis.
Global Rationale: In 1992, the Prescription Drug User Fee Act was passed. This required drug manufacturers to
provide yearly product user fees so the Food and Drug Administration (FDA) could restructure, hire more
employees, and operate more efficiently. The Food and Drug Administration (FDA) is just as strict now as it
, always was with regard to drug approval. The Food and Drug Administration (FDA) has not streamlined the
review/approval process. The Food and Drug Administration (FDA) does not require drug manufacturers to test
more drugs on an annual basis.
Cognitive Level: Applying
Client Need: Physiological Integrity
Client Need Sub: Pharmacological and Parenteral Therapies
QSEN Competencies: V.B.1 Demonstrate effective use of technology and standardized practices that support
safety and quality.
AACN Essential Competencies: V.4 Examine legislative and regulatory processes relevant to the provision of
health care.
NLN Competencies: Quality and Safety: Policies and procedures.
Nursing/Integrated Concepts: Nursing Process: Implementation
Learning Outcome: 2-4 Discuss how the FDA has increased the speed with which new drugs reach consumers.
MNL Learning Outcome: 1.1.1 Apply basic concepts related to pharmacology. Page Number: 15
Question 4
Type: MCSA
The client has skin lesions that have not responded to prescription drugs. He tells the nurse he has heard about
some research going on with a new drug and questions why he can't take it. What is the best response by the
nurse?
1. "I know it is frustrating, but the Food and Drug Administration (FDA) approval process is in place to ensure
that drugs are safe."
2. "The Food and Drug Administration (FDA) has very strict rules about new drugs; it is important to be patient
regarding the review/approval process."
3. "Your skin lesions really aren't that bad, but maybe the new drug will be available soon."
4. "Maybe you could contact the drug company about becoming involved in a clinical trial." Correct Answer: 1
Rationale 1: Although the public is anxious to receive new drugs, the fundamental priority of the Food and Drug
Administration (FDA) is to ensure that drugs are safe. Also, telling the client that the nurse knows he is frustrated
is therapeutic because it communicates that the nurse recognizes what he is feeling.
Rationale 2: Telling the client to be patient is a condescending response; the client wants relief from the skin
condition.
Rationale 3: Telling the client his skin lesions "aren't that bad" is a non-therapeutic response; the client's
perception is his reality.
Rationale 4: The client could contact the drug company, but this response fosters false hope as he may not be a
viable candidate for this drug.
Question:1
Type: MCSA
The pharmaceutical representative comes to the physician's office and says his company's pharmaceutical
laboratory is marketing a drug that does not need approval by the Food and Drug Administration (FDA). What is
the best response by the nurse?
1. "Any pharmaceutical laboratory in America must have approval from the Food and Drug Administration
(FDA) before marketing a drug."
2. "Is this an over-the-counter (OTC) drug? They do not need approval by the Food and Drug Administration
(FDA)."
3. "Is your pharmaceutical laboratory private? Only public pharmaceutical laboratories need approval from
the Food and Drug Administration (FDA)."
4. "Your pharmaceutical laboratory must be involved in academic research because they are exempt from
approval by the Food and Drug Administration (FDA)."
Correct Answer: 1
Rationale 1: Any pharmaceutical laboratory must obtain approval from the Food and Drug Administration (FDA)
before marketing a drug.
Rationale 2: Pharmaceutical laboratories that manufacture over-the-counter (OTC) drugs must obtain approval
from the Food and Drug Administration (FDA) before marketing these drugs.
Rationale 3: Private pharmaceutical laboratories must obtain approval from the Food and Drug Administration
(FDA) before marketing a drug.
Rationale 4: Pharmaceutical laboratories involved in academic research must obtain approval from the Food and
Drug Administration (FDA) before marketing a drug.
Global Rationale: Any pharmaceutical laboratory, whether private, public, or academic, must obtain approval
from the Food and Drug Administration (FDA) before marketing a drug. Private pharmaceutical laboratories
must obtain approval from the Food and Drug Administration (FDA) before marketing a drug. Pharmaceutical
laboratories involved in academic research must obtain approval from the Food and Drug Administration (FDA)
before marketing a drug. Pharmaceutical laboratories that manufacture over-the-counter (OTC) drugs must
obtain approval from the Food and Drug Administration (FDA) before marketing these drugs.
Cognitive Level: Applying
Client Need: Physiological Integrity
Client Need Sub: Pharmacological and Parenteral Therapies
,QSEN Competencies: V.B.1 Demonstrate effective use of technology and standardized practices that support
safety and quality.
AACN Essential Competencies: V.4 Examine legislative and regulatory processes relevant to the provision of
health care.
NLN Competencies: Quality and Safety: Policies and procedures.
Nursing/Integrated Concepts: Nursing Process: Implementation
Learning Outcome: 2-2 Discuss the role of the U.S. Food and Drug Administration (FDA) in the drug approval
process.
MNL Learning Outcome: 1.1.1 Apply basic concepts related to pharmacology.
Page Number: 13
Question 2
Type: MCSA
The nurse is employed by the Food and Drug Administration (FDA) and is involved in clinical investigation. What
is the primary role of the nurse in this phase of the review and approval process by the FDA?
1. To perform tests on the population-at-large
2. To perform tests on various species of animals
3. To perform tests on human cells cultured in the laboratory
4. To perform tests on human clients
Correct Answer: 4
Rationale 1: Performing tests on the population-at-large is the stage of post-marketing surveillance.
Rationale 2: Performing tests on various species of animals is the preclinical investigation stage.
Rationale 3: Performing tests on human cells cultured in the laboratory is the preclinical investigation stage.
Rationale 4: Clinical investigation includes performing tests on healthy volunteers, and later, on selected clients
with a particular disease.
Global Rationale: Clinical investigation includes performing tests on healthy volunteers, and later, on selected
clients with a particular disease. Performing tests on human cells cultured in the laboratory is the preclinical
investigation stage. Performing tests on the population-at-large is the stage of post-marketing surveillance.
Performing tests on various species of animals is the preclinical investigation stage.
Cognitive Level: Applying
Client Need: Physiological Integrity
,Client Need Sub: Pharmacological and Parenteral Therapies
QSEN Competencies: V.B.1 Demonstrate effective use of technology and standardized practices that support
safety and quality.
AACN Essential Competencies: V.4 Examine legislative and regulatory processes relevant to the provision of
health care.
NLN Competencies: Quality and Safety: Policies and procedures.
Nursing/Integrated Concepts: Nursing Process: Implementation
Learning Outcome: 2-5 Identify the nurse’s role in the drug approval process and in maintaining safety practices.
MNL Learning Outcome: 1.1.1 Apply basic concepts related to pharmacology. Page Number: 13
Question 3
Type: MCSA
The student nurse is taking a pharmacology course and studying about the Food and Drug Administration (FDA).
What has the student learned about how the FDA has decreased the amount of time involved in bringing a new
drug to the market?
1. The Food and Drug Administration (FDA) is not as strict as it once was with regard to drug approval.
2. Since consumers have demanded more drugs, the Food and Drug Administration (FDA) has streamlined the
review/approval process.
3. Drug manufacturers are required to pay yearly user fees, which allow the Food and Drug Administration (FDA)
to hire more employees to increase its efficiency.
4. Drug manufacturers are required by the Food and Drug Administration (FDA) to test more drugs on an annual
basis.
Correct Answer: 3
Rationale 1: The Food and Drug Administration (FDA) is just as strict now as it always was with regard to drug
approval.
Rationale 2: The Food and Drug Administration (FDA) has not streamlined the review/approval process.
Rationale 3: In 1992, the Prescription Drug User Fee Act was passed. This required drug manufacturers to
provide yearly product user fees so the Food and Drug Administration (FDA) could restructure, hire more
employees, and operate more efficiently.
Rationale 4: The Food and Drug Administration (FDA) does not require drug manufacturers to test more drugs
on an annual basis.
Global Rationale: In 1992, the Prescription Drug User Fee Act was passed. This required drug manufacturers to
provide yearly product user fees so the Food and Drug Administration (FDA) could restructure, hire more
employees, and operate more efficiently. The Food and Drug Administration (FDA) is just as strict now as it
, always was with regard to drug approval. The Food and Drug Administration (FDA) has not streamlined the
review/approval process. The Food and Drug Administration (FDA) does not require drug manufacturers to test
more drugs on an annual basis.
Cognitive Level: Applying
Client Need: Physiological Integrity
Client Need Sub: Pharmacological and Parenteral Therapies
QSEN Competencies: V.B.1 Demonstrate effective use of technology and standardized practices that support
safety and quality.
AACN Essential Competencies: V.4 Examine legislative and regulatory processes relevant to the provision of
health care.
NLN Competencies: Quality and Safety: Policies and procedures.
Nursing/Integrated Concepts: Nursing Process: Implementation
Learning Outcome: 2-4 Discuss how the FDA has increased the speed with which new drugs reach consumers.
MNL Learning Outcome: 1.1.1 Apply basic concepts related to pharmacology. Page Number: 15
Question 4
Type: MCSA
The client has skin lesions that have not responded to prescription drugs. He tells the nurse he has heard about
some research going on with a new drug and questions why he can't take it. What is the best response by the
nurse?
1. "I know it is frustrating, but the Food and Drug Administration (FDA) approval process is in place to ensure
that drugs are safe."
2. "The Food and Drug Administration (FDA) has very strict rules about new drugs; it is important to be patient
regarding the review/approval process."
3. "Your skin lesions really aren't that bad, but maybe the new drug will be available soon."
4. "Maybe you could contact the drug company about becoming involved in a clinical trial." Correct Answer: 1
Rationale 1: Although the public is anxious to receive new drugs, the fundamental priority of the Food and Drug
Administration (FDA) is to ensure that drugs are safe. Also, telling the client that the nurse knows he is frustrated
is therapeutic because it communicates that the nurse recognizes what he is feeling.
Rationale 2: Telling the client to be patient is a condescending response; the client wants relief from the skin
condition.
Rationale 3: Telling the client his skin lesions "aren't that bad" is a non-therapeutic response; the client's
perception is his reality.
Rationale 4: The client could contact the drug company, but this response fosters false hope as he may not be a
viable candidate for this drug.
