Exam 1: Drug Development and Ethical Considerations

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?

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

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

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

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 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?

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?

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?

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?

Which are responsibilities of the FDA?

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?

Which is the characteristic of preclinical in vivo testing?

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?

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?

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

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?

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

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

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?

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?