Topic 1 Pharma QUIZ

Sad- ang, John Daryl P.
BSN-2B
A 1. The nurse is preparing to give a medication to a child. The child’s parent asks whether the
drug is safe for children. How will the nurse respond to the parent?
“Drugs are tested on adults and safe doses for children are based on weights compared to
adult weights.”
“Drugs are deemed safe for children over time when repeated use proves effectiveness and
safety.”
“Drugs are tested for both efficacy and safety in children in order to be marketed for
pediatric use.”
“Drugs are tested on children in postmarketing studies and on a limited basis.”
C 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
are selected for participation in that group.
have unique baseline characteristics.
receive a placebo.
receive the treatment being evaluated.
B 3. 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?
C-II
C-III
C-IV
C-V
D 4. 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
is a controlled substance.
is approved by the FDA.
is available in generic form.
meets quality and safety standards.
A 5. Many drugs marketed in the 1980s may not be effective in a majority of the population.
The nurse understands that this is because these drugs
did not pass through the appropriate phases of clinical trials.
did not require human subject protections and are invalid.
were not tested on women, minorities, or children.
were tested on healthy subjects only.
A 6. 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?
Ask the patient to clarify concerns.
Reinforce that cash is given to all subjects equally.
Report this statement to the party named on the consent.
Review the elements of the study and obtain consent.
C 7. Which law(s) govern all drug administration by nurses?
Drug Regulation and Reform Act

FDA Amendments Act
Nurse Practice Acts
The Controlled Substances Act

C 8. 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?
They contain the same inert ingredients as brand-name drugs.
They have chemical structures that are identical to proprietary drugs.
They tend to be less expensive than brand-name drugs.
They undergo extensive testing before they are marketed.
A 9. The nurse is assisting with data collection in a study of drug effects in healthy subjects. The
nurse assists with blood and urine collection to determine serum drug levels and the presence
of metabolites in the urine. Which phase of a drug study does this represent?
Phase I
Phase II
Phase III
Phase IV
C 10. Which statement about the safety and efficacy of medications in children is accurate?
Children cannot give consent, so clinical drug trials are not performed on children.
Children can only be subjects in quasi-experimental clinical studies.
Data from adult clinical drug trials can be extrapolated to children.
Federal law requires that drugs for children be tested on children.

C 11. 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?
“Participation for the duration of the study is required.”
“Participation may end at any time without penalty.”
“Withdrawal from the study may end at any time, but the gift certificate will not be given.”
“You can request placement in the treatment group.”
A 12. During a clinical drug trial for a new medication, researchers note a previously unknown
serious adverse effect occurring in more than 50% of subjects. The study is discontinued. Which
ethical principle is being exercised?
Beneficence
Justice
Respect for persons
Veracity
A 13. 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
autonomy.
beneficence.
justice.
veracity.
B 14. Which is the characteristic of preclinical in vivo testing?
A comparison of experimental and control data in animals
A study conducted in a test tube in a laboratory
A study that determines the effects of the placebo in human participants
A study to assess the seriousness of the disease to be treated

A 15. Which is the characteristic of preclinical in vivo testing?
A comparison of experimental and control data in animals
A study conducted in a test tube in a laboratory
A study that determines the effects of the placebo in human participants
A study to assess the seriousness of the disease to be treated
C 16. 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. The lead researcher elects to continue the study. Which ethical principle is being
violated?
Beneficence
Justice
Respect for persons
Veracity
A, D, E 17. Which are responsibilities of the FDA?

Select all that apply.
To ensure a drug has accurate labeling.
To ensure a drug is affordable.

To ensure a drug is effective.
To ensure a drug is free from adverse reactions.
To ensure a drug is tested for harmful effects.
D 18. 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
control group.
experimental group.
dependent group.
independent group.
C 19. 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?
Healthy subjects
Healthy and ill subjects
Subjects with the disease the drug will treat
Subjects with other diseases
D 20. 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 medication will have a name that
is a registered trademark.
is always capitalized.
is related to the drug’s chemical structure.

is nonproprietary.
D 21. The nurse is assisting with a clinical drug trial to test the safe dose of an analgesic
medication and learns that subjects have been told that the study is about measuring the
analgesic effects. Which ethical principle has been violated?
Beneficence
Justice
Respect for persons
Veracity
B 22. 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?
C-I
C-II
C-III
C-V
C 23. 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?
Ask another nurse to observe and cosign wasting the remaining drug from the vial.
Keep the remaining amount in the patient’s drawer to give at the next dose.
Record the amount unused in the patient’s medication record.
Dispose of the vial with the remaining drug into a locked collection box.

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Sad- ang, John Daryl P.

“Drugs are tested on children in postmarketing studies and on a limited basis.”

are selected for participation in that group.

have unique baseline characteristics.

receive the treatment being evaluated.

B 3. The nurse is preparing to administer a combination drug containing acetaminophen and

is approved by the FDA.

is available in generic form.

meets quality and safety standards.

did not pass through the appropriate phases of clinical trials.

did not require human subject protections and are invalid.

were not tested on women, minorities, or children.

were tested on healthy subjects only.

Ask the patient to clarify concerns.

Reinforce that cash is given to all subjects equally.

Report this statement to the party named on the consent.

Review the elements of the study and obtain consent.

C 7. Which law(s) govern all drug administration by nurses?

Drug Regulation and Reform Act

Nurse Practice Acts

The Controlled Substances Act

They contain the same inert ingredients as brand-name drugs.

They have chemical structures that are identical to proprietary drugs.

They tend to be less expensive than brand-name drugs.

They undergo extensive testing before they are marketed.

Children can only be subjects in quasi-experimental clinical studies.

Data from adult clinical drug trials can be extrapolated to children.

Federal law requires that drugs for children be tested on children.

“Participation for the duration of the study is required.”

“Participation may end at any time without penalty.”

“You can request placement in the treatment group.”

Respect for persons

A comparison of experimental and control data in animals

A study conducted in a test tube in a laboratory

A study that determines the effects of the placebo in human participants

A study to assess the seriousness of the disease to be treated

A comparison of experimental and control data in animals

A study conducted in a test tube in a laboratory

A study that determines the effects of the placebo in human participants

A study to assess the seriousness of the disease to be treated

Respect for persons

A, D, E 17. Which are responsibilities of the FDA?

To ensure a drug has accurate labeling.

To ensure a drug is affordable.

To ensure a drug is free from adverse reactions.

To ensure a drug is tested for harmful effects.

Healthy and ill subjects

Subjects with the disease the drug will treat

Subjects with other diseases

is related to the drug’s chemical structure.

Respect for persons

Record the amount unused in the patient’s medication record.

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