Chapter 2

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? - "What other ways do you think you might use to help you to manage your stress?" - "Aren't you afraid of going to jail for a long time if you get caught?" - "Do you really believe that everyone smokes marijuana to manage stress?" - "How often do you smoke marijuana, and how much each time?"

"How often do you smoke marijuana, and how much each time?"

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? - "The Food and Drug Administration (FDA) is not as strict as it once was with regard to drug approval." - "Since consumers have demanded more drugs, the Food and Drug Administration (FDA) has streamlined the review/approval process." - "Drug manufacturers are required to pay yearly user fees, which allow the Food and Drug Administration (FDA) to hire more employees to increase its efficiency." - "Drug manufacturers are required by the Food and Drug Administration (FDA) to test more drugs on an annual basis."

"Drug manufacturers are required to pay yearly user fees, which allow the Food and Drug Administration (FDA) to hire more employees to increase its efficiency."

A client asks a nurse how many Americans take at least one prescription drug per year. What is the nurse's best response? 1. 50% 2. 10% 3. 40% 4. 25%

50

The nurse is reviewing prescription refill request messages. The nurse understands that a prescription for which of the following drugs can be sent to the pharmacy by telephone? - Morphine - Cannabis - Meperidine - An anabolic steroid

An anabolic steroid

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? - "Any pharmaceutical laboratory in America must have approval from the Food and Drug Administration (FDA) before marketing a drug." - "Is this an over-the-counter (OTC) drug? They do not need approval by the Food and Drug Administration (FDA)." - "Is your pharmaceutical laboratory private? Only public pharmaceutical laboratories need approval from the Food and Drug Administration (FDA)." - "Your pharmaceutical laboratory must be involved in academic research because they are exempt from approval by the Food and Drug Administration (FDA)."

Any pharmaceutical laboratory must obtain approval from the Food and Drug Administration (FDA) before marketing a drug.

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? - An adverse effect - Evidence that the client had psychological dependence on the drug - An expected therapeutic effect of no longer taking the drug - Assessment finding associated with physical dependence on a drug

Assessment finding associated with physical dependence on a drug

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. - Attend meetings to finalize the brand name for the drug. - Check on the results of animal testing. - Survey for harmful effects in a larger population. - Evaluate the results of the drug on cultured cells. - Provide the medication to large groups of people with a particular disease.

Attend meetings to finalize the brand name for the drug. Check on the results of animal testing.

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? - Passage of the Sherley Amendment - Passage of the Childhood Vaccine Act - Development of the U.S. Pharmacopoeia - Passage of the Biologics Control Act

Development of the U.S. Pharmacopoeia

A nurse is administering a medication to a group of volunteers and is assessing for the development of adverse effects. The nurse is working in which phase of the development of this drug? - Clinical Phase I Trials - Preclinical Investigation - Clinical Phase II trials - Clinical Phase III trials

Clinical Phase I Trials

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. - Most drugs do not proceed past the preclinical stage because they are found to be too toxic or just ineffective. - At the end of the preclinical research stage, client variability is determined and potential drug-to-drug interactions are examined. - The preclinical stage of research involves extensive testing on animals in the laboratory to determine if the drug will cause harm to humans. - Preclinical research results are always inconclusive. - The Food and Drug Administration (FDA) is responsible for extensive testing for safety before the pharmaceutical company can begin the preclinical research stage of development.

Most drugs do not proceed past the preclinical stage because they are found to be too toxic or just ineffective. The preclinical stage of research involves extensive testing on animals in the laboratory to determine if the drug will cause harm to humans. Preclinical research results are always inconclusive.

A student nurse asks an advanced practice nurse (APRN) about the role of APRNs in prescribing medications. Which of the following is the best response by the nurse? - The ability to prescribe drugs is regulated by federal law. - All advanced practice nurses can prescribe medications. - Nurse practitioners are an example of an advanced practice nurse. - Advanced practice nurses may increase the cost of healthcare.

Nurse practitioners are an example of an advanced practice nurse.

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? - Clinical Investigation - Preclinical Investigation - New Drug Application Review - Postmarketing Studies

Preclinical Investigation

A student nurse asks a nurse why some medications get approved by the Federal Drug Administration (FDA) faster. What is the nurse's best response? - The FDA collects a user fee from pharmaceutical companies and uses it to hire more employees to speed up the process. - Pharmaceutical companies are allowed to skip the Preclinical Investigation phase if they are developing a chemotherapy drug. - The Accelerated Approval Program allows earlier approval of a medication if it is a commonly used drug. - A smaller group of patients with a particular disease are selected for the clinical phase trials.

The FDA collects a user fee from pharmaceutical companies and uses it to hire more employees to speed up the process.

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? - After preclinical investigation the drug has one more step before being released for public use. - The average length of preclinical investigation is 18 months. - When the drug reaches the clinical investigation stage it is usually released within 2 years. - The drug will not be available until after the postmarketing studies are done.

The average length of preclinical investigation is 18 months.

A nurse suspects a client has had an allergic reaction to a recently prescribed antibiotic. The nurse is responsible for providing emergency treatment and for reporting this suspected reaction to which persons? Note: Credit will be given only if all correct choices and no incorrect choices are selected. Select all that apply. - Federal Drug Administration (FDA) - Healthcare provider - Hospital pharmacist - Medicare - Hospital risk management

Healthcare provider Hospital pharmacist Hospital risk management

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? - The population-at-large - Various species of animals - Human cells cultured in the laboratory - Human clients

Human clients

A client has been chosen to participate in the clinical trial of a medication to treat chemotherapy-induced nausea. When the nurse takes the informed consent form to the bedside, the client says, "I am glad there is finally a medication to cure my cancer." How should the nurse respond? Note: Credit will be given only if all correct choices and no incorrect choices are selected. Select all that apply. - "Who told you the medication would cure your cancer?" - "What questions do you have about this medication?" - "Let me explain how this medication works." - "Has anyone explained the research trial to you?" - "So am I. This research has been intense."

What questions do you have about this medication?" "Has anyone explained the research trial to you?"

A nurse is providing preconception teaching to a group of women who wish to become pregnant. The nurse informs the group that which classifications of medications have shown no confirmed risk for fetal abnormalities if taken while pregnant? Note: Credit will be given only if all correct choices and no incorrect choices are selected. Select all that apply. Category A Category B Category C Category D Category X

a b

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? 1. Acetaminophen 2. Codeine 3. Heroin 4. Diazepam

heroin

A nurse teaches a client that the newly prescribed medication has a very high risk of causing fetal abnormalities and that reliable measures to prevent pregnancy are essential while taking the medication. The nurse has described a medication that falls into which category? 1. A 2. B 3. D 4. X

x

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? - "I know it is frustrating, but the Food and Drug Administration (FDA) approval process is in place to ensure that drugs are safe." "- The Food and Drug Administration (FDA) has very strict rules about new drugs; it is important to be patient regarding the review/approval process." - "Your skin lesions really aren't that bad, but maybe the new drug will be available soon." - "Maybe you could contact the drug company about becoming involved in a clinical trial."

"I know it is frustrating, but the Food and Drug Administration (FDA) approval process is in place to ensure that drugs are safe."

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? - "I need to call the office for a refill before my medication runs out." - "This drug is addictive so I should only take it when my pain becomes severe." - "Maybe my physician could change me to a Schedule IV drug." - "I need to see my doctor before my prescription runs out so I can get a refill."

"I need to see my doctor before my prescription runs out so I can get a refill."

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? - "It is probably unlikely that Drug Enforcement Administration (DEA) agents will be bothering you." - "No, the Drug Enforcement Administration (DEA) restricts drugs that have a high potential for abuse." - "No. I think our system should be more like Europe; they have fewer controlled drugs." - "That's an interesting question. Are you worried about the Drug Enforcement Administration (DEA)?"

"No, the Drug Enforcement Administration (DEA) restricts drugs that have a high potential for abuse."

A client says, "This morning's nurse told me that my pain medication is a scheduled drug. Aren't all drugs given on a schedule?" How should the nurse respond? - "What time would you like to schedule your pain medication?" - "Medications are usually scheduled every 4 hours." - "Scheduled medications have a significant potential for abuse." - "During preclinical investigation, scheduled medications are tested."

"Scheduled medications have a significant potential for abuse."

A client at 14-weeks gestation is seen in the clinic with a sprained ankle. The healthcare provider prescribes a mild analgesic, rest, compression, and application of an ice bag. The client is very concerned about taking the prescribed medication, telling the nurse, "I don't want to hurt my baby." How should the nurse respond? Note: Credit will be given only if all correct choices and no incorrect choices are selected. Select all that apply. - "The most dangerous time for birth defects is probably in the first semester and you are past that now." - "You are wise to avoid all drugs. I would only use the rest, compression, and ice." - "Let me check with the physician to see if he remembered you are pregnant." - "This is a category A drug, so there is very little risk to your baby." - "Don't worry, it will all be okay. You need to take care of yourself first."

"The most dangerous time for birth defects is probably in the first semester and you are past that now." "This is a category A drug, so there is very little risk to your baby."

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. - "The use of these medications is restricted so that the pharmacies can track the rate of drug abuse in our city." - "The use of these medications is restricted because the physician needs to evaluate our child more often." - "The use of these medications is restricted because they have the potential for abuse." - "The use of these medications is restricted so that the drug companies can make a bigger profit." - "The use of these medications is restricted because this is the current law."

"The use of these medications is restricted because they have the potential for abuse." "The use of these medications is restricted because this is the current law."

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? "- Are you concerned about becoming an addict? We can discuss this in more detail if you would like to." - "You are not an addict; the Drug Enforcement Administration (DEA) restricts the use of drugs with a high potential for abuse." - "Why do you ask about becoming an addict? Not many of our clients have asked this question." - "You are not an addict, but the Drug Enforcement Administration (DEA) will monitor you for this."

"You are not an addict; the Drug Enforcement Administration (DEA) restricts the use of drugs with a high potential for abuse."

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. - Responsible for improving the health of Americans. - Publishes a summary of the standards of drug purity and strength. - Ensures the availability of effective drugs. - Takes action against any supplement that is deemed to be unsafe. - Facilitates the availability of safe drugs.

Responsible for improving the health of Americans. Ensures the availability of effective drugs. Takes action against any supplement that is deemed to be unsafe. Facilitates the availability of safe drugs.

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. - The drug can cause "special problems." - It identifies extreme adverse drug reactions. - It differentiates a prescribed medication from an over-the-counter medication. - It highlights the cost of the medication. - It signifies the medication is generic.

The drug can cause "special problems." It identifies extreme adverse drug reactions.

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? - "Just drop by and I will get you a prescription." - "We can't do that; maybe you can find another doctor's office that will do it." - "The law does not allow us to give you refills on this medication." - "How do you feel about having to get a new prescription each month?"

The law does not allow us to give you refills on this medication."