Question 1

Which is the characteristic of preclinical in vivo testing?

Accepted Answer

Preclinical in vivo testing is performed in animals or other living organisms.In vitro studies occur in test tubes.Safe therapeutic dose studies are part of clinical research.Prior to clinical trials,an assessment is made of the disease and its seriousness.

Question 2

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

Accepted Answer

The U.S.Food and Drug Administration (FDA)Modernization Act of 1997 requires that drugs intended for use in children be tested on children.

Question 3

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?

Accepted Answer

Phase I drug trials are performed to assess safety and to identify the pharmacokinetics,such as metabolism and elimination,of drugs in healthy subjects.

Question 4

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?

Accepted Answer

The Pediatric Research Equity Act requires drug manufacturers to test drugs on children.

Question 5

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?

Accepted Answer

Beneficence is the duty to do good and to not harm others.Once a serious adverse effect is noted in a majority of subjects,researchers have an ethical obligation to stop the study.

Question 6

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

Accepted Answer

Each state's Nurse Practice Act identifies how nurses administer medications.The other acts govern how drugs are marketed and tested.

Question 7

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

Accepted Answer

Drug research was historically done only with Caucasian males,causing uncertainty as to the validity of the research results.

Question 8

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?

Accepted Answer

The principle of justice requires that all people be treated fairly,including equal access to health care for all.Once a benefit is demonstrated,it should be available to all participants.

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

After Phase I studies demonstrating drug safety and pharmacokinetics have been completed,the drug is tested on subjects who have the disease the drug will treat.

Question 10

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

All participants have the right to autonomy,which is the right to self-determination.Patients have the right to refuse to participate or to withdraw from a study at any time without penalty even if the health care provider disagrees with that choice.

Question 11

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

Accepted Answer

The generic name is the official,nonproprietary name for a drug.The brand name is the trademark name and is always capitalized.The chemical name describes the chemical structure of the drug.

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

The experimental group in a drug trial is the group that receives the drug being tested.The control group may receive no drug,a different drug,a placebo,or the same drug with a different dose,route,or frequency of administration.Dependent and independent are not terms to describe groups in a study; they denote the variables.

Question 13

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?

Accepted Answer

Veracity requires health care professionals to tell the truth.

Question 14

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

Generic drugs are approved by the FDA if they are proved to be bioequivalent to the brand-name drug.They tend to be less expensive because manufacturers of these drugs do not have to do the extensive testing required of brand-name drugs before marketing.They are not identical to brand-name drugs and often have different inert ingredients.

Question 15

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

In a double-blind experimental study,subjects in the experimental group receive the treatment or drug under study.They are randomly assigned and not selected.They should have similar baseline characteristics to those in the control group.They do not receive a placebo.

Question 16

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

All participants have the right to autonomy,which is the right to self-determination.Patients have the right to refuse to participate or to withdraw from a study at any time without penalty.Patients generally are not allowed to choose participation in either the treatment or the control group.

Question 17

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

Schedule II drugs are controlled substances,and all must be accounted for.When wasting a portion of a drug,another nurse should observe and cosign that a drug was wasted.

Question 18

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

The "USP" designation is given to drugs that have met high standards for therapeutic use,patient safety,quality,purity,strength,packaging safety,and dosage form by the United States Pharmacopoeia National Formulary.The FDA classifies controlled substances with Roman numerals from I to V.The USP designation does not indicate FDA approval.The USP designation does not indicate generic availability.

Question 19

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

If a nurse suspects that a patient is being coerced to participate in the study,the nurse should report this to the party named on the informed consent.When a patient verbalizes participation based on a financial reward,there is an element of coercion.

Question 20

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

Phase IV studies are performed to examine potential new indications for approved drugs.

Quiz 1: Drug Development and Ethical Considerations