Question 1

Which statement about the safety and efficacy of medications in children is accurate?

Accepted Answer

A)   Children cannot give consent, so clinical drug trials are not performed on children.
B)   Children can only be subjects in quasi-experimental clinical studies.
C)   Data from adult clinical drug trials should be extrapolated to children.
D)   Federal law requires that drugs for children be tested on children. D

Question 2

The nurse is enrolling subjects for a double-blind experimental study. One patient asks the nurse to explain the role of the experimental group. The nurse will explain that subjects in the experimental group in this type of study:

Accepted Answer

A)   are selected for participation in that group.
B)   have unique baseline characteristics.
C)   receive a placebo.
D)   receive the experimental treatment being evaluated. D

Question 3

Which law(s) govern all drug administration by nurses?

Accepted Answer

A)   Drug Regulation and Reform Act
B)   FDA Amendments Act
C)   Nurse Practice Acts
D)   The Controlled Substances Act C

Question 4

The nurse is assisting with data collection in a study of drug effects in as mall group of healthy subjects. The nurse assists with blood and urine collection to determine serum drug levels and the presence of metabolites in urine. Which phase of drug development does this represent?

Accepted Answer

A)   Phase I
B)   Phase II
C)   Phase III
D)   Phase IV

Question 5

The nurse is preparing to administer a combination drug containing acetaminophen and codeine. The nurse knows that this drug is classified as which drug schedule?

Accepted Answer

A)   C-II
B)   C-III
C)   C-IV
D)   C-V

Question 6

The nurse is assisting with a clinical drug trial in which the side effects of two effective drugs are being compared. A patient who would benefit from either drug has elected to withdraw from the study, and the nurse assists with the paperwork to facilitate this. This is an example of

Accepted Answer

A)   autonomy.
B)   beneficence.
C)   justice.
D)   veracity.

Question 7

A patient receives a prescription on which the provider has noted that a generic medication may be given. The patient asks the nurse what this means. What will the nurse tell the patient about generic drugs?

Accepted Answer

A)   They contain the same inert ingredients as brand-name drugs.
B)   They have chemical structures that are different from proprietary drugs.
C)   They tend to be less expensive than brand-name drugs.
D)   They undergo extensive testing before they are marketed.

Question 8

Before marketing a new drug that has been approved for use based on clinical effectiveness and safety, the manufacturer wishes to study the potential new uses for the drug. This is an example of which phase of study?

Accepted Answer

A)   Phase I
B)   Phase II
C)   Phase III
D)   Phase IV

Question 9

A clinical drug trial is concluding a study of pharmacokinetics and safety of a drug in healthy individuals. The nurse will assist enrollment of participants into the next phase of the study and will include which subjects?

Accepted Answer

A)   Healthy subjects
B)   Healthy and ill subjects
C)   Subjects with the disease the drug will treat
D)   Subjects with other diseases

Question 10

The nurse is preparing to administer a schedule II injectable drug and is drawing up half of the contents of a single-use vial. Which nursing action is correct?

Accepted Answer

A)   Ask another nurse to observe and cosign wasting the remaining drug from the vial.
B)   Keep the remaining amount in the patient's drawer to give at the next dose.
C)   Record the amount unused in the patient's medication record.
D)   Dispose of the vial with the remaining drug into a locked collection box.

Question 11

The nurse is obtaining signatures on consent forms for participation in a clinical drug trial. One patient says, "I'm not sure I want to do this, but I need the cash." The nurse will take which action?

Accepted Answer

A)   Ask the patient to clarify concerns.
B)   Reinforce that cash is given to all subjects equally.
C)   Report this statement to the lead investigator.
D)   Review the elements of the study and obtain consent.

Question 12

The nurse is enrolling subjects for a clinical drug trial in which subjects will be randomly assigned to either a treatment or a placebo group. The pills in both groups will be in identical packaging with identical appearance. The group that receives the intervention is the:

Accepted Answer

A)   control group.
B)   experimental group.
C)   dependent group.
D)   independent group.

Question 13

Which are responsibilities of the FDA? (Select all that apply.)

Accepted Answer

A)   To ensure a drug has accurate labeling.
B)   To ensure a drug is affordable.
C)   To ensure a drug is effective.
D)   To ensure a drug is free from adverse reactions.
E)   To ensure a drug is tested for harmful effects.

Question 14

In a 5-year experimental clinical trial to investigate a new cancer treatment, researchers in the second year note overwhelming improvement in almost all of the subjects in the treatment group. It is decided to stop the trial early and report the findings due to the overwhelmingly beneficial effects. This decision was made based on which ethical principle?

Accepted Answer

A)   Beneficence
B)   Justice
C)   Respect for persons
D)   Veracity

Question 15

The nurse is preparing to give a medication to a child. The medication is approved for use in children. The child's parent asks whether the drug is safe for children. How will the nurse respond to the parent?

Accepted Answer

A)   "Drugs approved for use in children are tested on adults and safe doses for children are based on weights compared to adult weights."
B)   "Drugs approved for use in children are deemed safe for children over time when repeated use proves effectiveness and safety."
C)   "Drugs approved for use in children are tested for both efficacy and safety in children in order to be marketed for pediatric use."
D)   "Drugs approved for use in children are tested on children in post-marketing studies and on a limited basis."

Question 16

A patient is prescribed a medication and asks the nurse if the drug is available in a generic form. The nurse understands that a generic drug name is:

Accepted Answer

A)   a registered trademark.
B)   always capitalized.
C)   related to the drug's chemical structure.
D)   nonproprietary.

Question 17

Respect for Persons is a core ethical principle of human subjects research. Which of the following best describes this principle?

Accepted Answer

A)   Duty to protect research subjects from harm.
B)   Fair selection of research subjects.
C)   Right to self-determination
D)   Patients are independent and capable of making decisions in their own best interests.

Question 18

A patient is taking methadone as part of a heroin withdrawal program. The nurse understands that, in this instance, methadone is classified as which drug schedule?

Accepted Answer

A)   C-I
B)   C-II
C)   C-III
D)   C-V

Question 19

The nurse is obtaining consent from a subject newly recruited for a clinical drug trial that will last for 6 months. All subjects will be given gift certificates for participating. One subject says, "Well, I guess if the drug doesn't work, I'll just have to put up with the symptoms for 6 months." What will the nurse tell the subject?

Accepted Answer

A)   "Participation for the duration of the study is required."
B)   "Participation may end at any time without penalty."
C)   "Withdrawal from the study may end at any time, but the gift certificate will not be given."
D)   "You can request placement in the treatment group."

Question 20

The nurse reviews information about a drug and notes the initials "United States Pharmacopeia (USP)" after the drug's official name. The nurse understands that this designation indicates the drug:

Accepted Answer

A)   is a controlled substance.
B)   is approved by the FDA.
C)   is available in generic form.
D)   meets USP quality and safety standards.

Exam 2: Drug Development and Ethical Considerations