Question 1

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 generic drug name is nonproprietary and not a brand name or registered trademark. It is related to the drug's chemical structure and is not always capitalized.

Question 2

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

The statement indicates that the subject may be under the impression that they are obligated to continue participation for the full 6 months even if the drug does not work. The nurse should clarify that participation can end at any time without penalty. Option A is incorrect because the subject already knows the study lasts 6 months, and this option does not address the subject's concern. Option C implies that the gift certificate is more important than the subject's health and well-being, which is not ethical. Option D is not applicable because the subject's statement does not suggest a desire to switch treatment groups.

Question 3

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, also known as post-marketing surveillance, are conducted after a drug has been approved for use and marketed. These studies aim to monitor the drug's performance in the general population, investigate long-term effects, and explore potential new uses or indications for the drug.

Question 4

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

The answer of In a 5-year experimental clinical trial to...

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

The ethical principle being exercised in this scenario is beneficence, which refers to the obligation of researchers to act in the best interest of their study participants. By discontinuing the study after noting a serious adverse effect occurring in more than 50% of the subjects, the researchers are fulfilling their duty to protect the participants from harm.

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

Autonomy refers to the patient's right to make decisions about their own healthcare, including the right to withdraw from a clinical trial at any time. The nurse is respecting the patient's autonomy by assisting with the paperwork to facilitate their withdrawal from the study. Beneficence refers to the duty to do good and act in the patient's best interest, which may or may not be relevant in this situation. Justice refers to equal access and fair distribution of healthcare resources, which is also not directly relevant in this situation. Veracity refers to truth-telling and honesty with patients, which is not directly relevant in this situation either.

Question 7

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 is the group that receives the intervention (in this case, the drug being tested). The treatment group is also sometimes used interchangeably with the experimental group. The control group, on the other hand, does not receive the intervention and is used as a comparison group to the experimental group. The dependent group and independent group are not commonly used terms in clinical research.

Question 8

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

The nurse should report the patient's statement to the lead investigator because it indicates that the patient may not be fully informed or voluntarily consenting, which is a requirement for ethical participation in clinical trials.

Question 9

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 initials "United States Pharmacopeia (USP)" after a drug's official name indicate that the drug meets USP quality and safety standards. This means that the drug has been tested and meets minimum standards for purity, strength, and quality. It does not indicate that the drug is a controlled substance, approved by the FDA, or available in generic form.

Question 10

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

Drugs approved for use in children are required to be tested for both efficacy and safety in pediatric populations in order to be marketed for pediatric use. This is done through clinical trials specifically designed for children. The dosages and formulations are then carefully determined based on age, weight, and body surface area in order to ensure their safety and efficacy in pediatric populations. Therefore, the nurse can confidently reassure the parent that the medication has been extensively tested for safety and effectiveness in children.

Question 11

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

Accepted Answer

The Nurse Practice Acts in each state govern the scope of practice for nurses, including drug administration. The other options listed refer to specific laws related to drug regulation and control, but do not directly govern nursing practice.

Question 12

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

The next phase after studying pharmacokinetics and safety in healthy individuals typically involves subjects with the disease that the drug is intended to treat. This helps in understanding the drug's efficacy and side effects in the target population.

Question 13

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

Accepted Answer

The answer of Respect for Persons is a core ethical...

Question 14

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

Many drugs marketed in the 1980s were not tested in women, minorities, or children, leading to potential biases that may affect the efficacy and safety of the drugs in these populations. This highlights an important issue of generalizability and applicability of research findings to diverse populations.

Question 15

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

Accepted Answer

Federal law (specifically the Pediatric Research Equity Act) requires that drugs for children be tested on children, as children often respond differently to medications than adults do. This is done to ensure the safety and efficacy of medications in children. While data from adult clinical trials may be helpful in certain cases, it is not enough to guarantee safety and efficacy in children, and children cannot give consent for research studies without the involvement of their parents or guardians. Quasi-experimental studies may be used in some cases, but randomized controlled trials are preferable for determining safety and efficacy.

Question 16

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 tend to be less expensive than brand-name drugs as they are not marketed under a proprietary name and do not have research and development costs associated with them. While they may have different inactive ingredients, generic drugs have the same active ingredient and are required to undergo the same testing and regulatory review as brand-name drugs. Therefore, option A and D are incorrect. Option B is incorrect as the chemical structures of generic drugs are identical to their brand-name counterparts.

Question 17

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

Subjects in the experimental group receive the experimental treatment being evaluated.

Question 18

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

This phase involves testing new drugs in a small group of healthy subjects to determine their safety, pharmacokinetics, and pharmacodynamics. Collection of blood and urine samples to determine serum drug levels and the presence of metabolites is a common part of Phase I clinical trials.

Question 19

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

The correct nursing action when drawing up half of the contents of a single-use vial of a schedule II injectable drug is to ask another nurse to observe and cosign wasting the remaining drug from the vial. This is required for accountability and to prevent diversion of the remaining drug. Keeping the remaining amount in the patient's drawer or recording it in the medication record is not recommended because it can lead to errors or misuse. Disposing of the vial with the remaining drug into a locked collection box is also not recommended because it may not allow for accurate documentation of the wasted drug.

Question 20

Which is the characteristic of preclinical in vivo testing?

Accepted Answer

Preclinical in vivo testing involves testing a drug or treatment in animals to determine its safety and efficacy before moving to human clinical trials. This typically involves comparing experimental and control data in the animals to assess the potential benefits and risks of the treatment.

Quiz 2: Drug Development and Ethical Considerations