Exam 2: Drug Development and Ethical Considerations

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

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:

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

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?

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?

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

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?

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?

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?

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?

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?

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:

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

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?

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?

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:

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

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?

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?

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: