Question 1

A nurse is teaching a student nurse about the stages of drug approval. A drug manufacturer that is studying the effects of a drug on laboratory animals would be in which phase of the new drug development timeline?

Accepted Answer

Preclinical Investigation is the first phase of drug development, in which the drug is studied in laboratory animals to determine its safety and effectiveness. Clinical Investigation, New Drug Application Review, and Postmarketing Studies all occur later in the drug development timeline.

Question 2

A nurse is developing a time line of drug regulations and standards. The nurse should list which of the following events as the first drug regulation and/or standard?

Accepted Answer

The development of the U.S. Pharmacopoeia in 1820 was the first drug regulation and standard in the United States. The U.S. Pharmacopoeia is a book that contains standards for drug purity, strength, and quality.

Question 3

During the admission assessment, a client tells a nurse, "Sure I smoke a little weed (marijuana) to manage my stress. Doesn't everyone?" What is the nurse's best response?

Accepted Answer

D

Question 4

A nurse is participating in the New Drug Review step for a new therapeutic agent. Which activities will the nurse most likely perform during this phase of the drug approval process? Note: Credit will be given only if all correct choices and no incorrect choices are selected. Select all that apply.

Accepted Answer

The answer of A nurse is participating in the New...

Question 5

A nurse is teaching a group of nursing students about the role of the U.S. Food and Drug Administration (FDA). The nurse plans to include which of the following? Note: Credit will be given only if all correct choices and no incorrect choices are selected. Select all that apply.

Accepted Answer

The answer of A nurse is teaching a group of...

Question 6

A student nurse is taking a pharmacology course and studying about the Food and Drug Administration (FDA). Which statement indicates the student understands how the FDA has decreased the amount of time involved in bringing a new drug to the market?

Accepted Answer

The FDA has decreased the amount of time involved in bringing a new drug to the market by requiring drug manufacturers to pay yearly user fees, which allow the FDA to hire more employees to increase its efficiency. This has helped to streamline the review/approval process. Option A is incorrect because the FDA's standards have not been relaxed; in fact, they have become stricter over the years. Option B is incorrect because the FDA's decision to streamline the review/approval process was not driven by consumer demand. Option D is incorrect because the FDA does not require drug manufacturers to test more drugs on an annual basis.

Question 7

A drug is withdrawn from a client who has been taking it routinely for many years. The client has developed muscle tremors. How will the nurse document this event?

Accepted Answer

Muscle tremors are an assessment finding associated with physical dependence on a drug. Since the client has been taking the drug routinely for many years, it is likely that the body has become dependent on it, and withdrawal symptoms such as muscle tremors can occur when the drug is stopped abruptly.

Question 8

A nurse is employed by the Food and Drug Administration (FDA) and is involved in clinical investigation. The nurse's primary role in this phase of the FDA review and approval is to perform tests on which of the following?

Accepted Answer

During the clinical investigation phase of the FDA review and approval process, the primary role of a nurse would involve performing tests on human clients. This phase focuses on assessing the safety and efficacy of new drugs or treatments in humans after preclinical testing on animals and in vitro.

Question 9

A nurse is teaching a group of nursing students about the preclinical research stage of drug development. The nurse understands that the students understand the teaching by which of the following student responses? Note: Credit will be given only if all correct choices and no incorrect choices are selected. Select all that apply.

Accepted Answer

The answer of A nurse is teaching a group of...

Question 10

A nurse provides medication education to a client with terminal cancer. The physician has ordered morphine, a Schedule II drug, for the client. The nurse determines that learning has occurred when the client makes which statement?

Accepted Answer

Schedule II drugs require a new prescription for each refill, so the client needs to see the doctor before the prescription runs out to get a new one.

Question 11

A client says to a nurse, "My healthcare provider said my drug is a controlled substance; am I considered an addict?" What is the best response by the nurse?

Accepted Answer

The correct answer is B because it provides factual information about why a drug might be classified as a controlled substance by the DEA, addressing the client's concern without implying addiction.

Question 12

A client is receiving methadone (which is a Schedule II drug). The client says to the nurse,"A pharmacist told me the pharmacy must register with the Drug Enforcement Administration (DEA) to give me this drug; will DEA agents be snooping around my house?" What is the best response by the nurse?

Accepted Answer

The nurse should reassure the client by explaining that the DEA's role is to regulate drugs with high abuse potential, not to invade personal privacy.

Question 13

A nurse is teaching a medication class for parents of children with attention-deficit hyperactivity disorder (ADHD) who are receiving stimulant medications. The nurse has reviewed reasons why the medications are restricted. The nurse determines that learning has occurred when the parents make which responses? Note: Credit will be given only if all correct choices and no incorrect choices are selected. Select all that apply.

Accepted Answer

The use of stimulant medications for ADHD is restricted because of their potential for abuse and because it is currently the law. A and D are incorrect and not a valid reason for medication restriction. B may be true in certain cases, but it is not the primary reason for medication restriction.

Question 14

While reading a medication package insert, a nurse notes the information contained within the "black box." What is the significance of this information to the nurse? Note: Credit will be given only if all correct choices and no incorrect choices are selected. Select all that apply.

Accepted Answer

The "black box" contains information about extreme adverse drug reactions and "special problems" associated with the medication, making it significant for the nurse to be aware of these potential risks when administering the medication. The other options (C, D, E) are not accurate descriptions of the information contained within the "black box."

Question 15

A parent of an adolescent receiving methylphenidate (Concerta) for ADHD asks why she needs a new prescription each month. What is the best response by the nurse?

Accepted Answer

The nurse should explain that the law requires a new prescription for methylphenidate (Concerta) each month and offer to assist the parent in obtaining a new prescription. Option A does not explain the reason for the monthly prescription requirement. Option B is inappropriate and unhelpful. Option D deflects the question and does not provide a clear answer.

Question 16

A client asks a nurse how many Americans take at least one prescription drug per year. What is the nurse's best response?

Accepted Answer

According to data from the Centers for Disease Control and Prevention (CDC), about 50% of Americans take at least one prescription drug per month, indicating a high prevalence of prescription medication use in the United States.

Question 17

A nurse is teaching a client about their medications. The client is worried about "getting addicted" to their medications. The nurse explains that which of the following drugs has the highest risk for dependence?

Accepted Answer

Heroin has the highest risk for dependence among the options given. It is an opioid that is known for its high potential for addiction and abuse.

Question 18

A client who is terminally ill reports hearing about a drug that is in preclinical investigation. The client asks the nurse if the drug will be available to the public soon. What should the nurse consider when formulating an answer to this question?

Accepted Answer

The answer of A client who is terminally ill reports...

Question 19

A client has skin lesions that have not responded to prescription drugs. He tells the nurse he has heard about some research going on with a new drug and asks why he can't take it. What is the best response by the nurse?

Accepted Answer

The answer of A client has skin lesions that have...

Question 20

A pharmaceutical representative comes to the physician's office and says his company's pharmaceutical laboratory is marketing a drug that does not need approval by the Food and Drug Administration (FDA). What is the best response by the nurse?

Accepted Answer

Any pharmaceutical laboratory in America must have approval from the Food and Drug Administration (FDA) before marketing a drug. This statement is correct and acknowledges the importance of FDA approval for pharmaceuticals to ensure safety and effectiveness.

Quiz 2: Drug Approval and Regulation