Deck 2: Drug Approval and Regulation

Question 1

The mother of an adolescent receiving methylphenidate (Concerta) for attention-deficit hyperactivity disorder tells the nurse that her son is better and asks why she can't just get refills on the prescription. What is the best response by the nurse?

A) "Just drop by and I will get a prescription for you without seeing your son."
B) "We can't do that; maybe you can find another doctor's office that will do it."
C) "The law does not allow us to give you refills on this medication."
D) "The medication can be addictive so your son needs a monthly medical evaluation."

Answer 1

"The medication can be addictive so your son needs a monthly medical evaluation."

Question 2

The nurse reviewing prescription refill request messages would collaborate with the physician regarding a request for which drug?

A) Morphine
B) Cannabis
C) Meperidine
D) An anabolic steroid

Answer 2

An anabolic steroid

Question 3

The 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?

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

Answer 3

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

Question 4

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

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

Question 5

While reading a medication package insert, the nurse notes the information contained within the "black box." What is the significance of this information to the nurse?

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

Question 6

A drug is withdrawn from a client who has been taking it routinely for many years.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

A) As an adverse effect
B) As evidence that the client had psychological dependence on the drug
C) As an expected therapeutic effect of no longer taking the drug
D) As an assessment finding associated with physical dependence on a drug

Question 7

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

A) The Food and Drug Administration (FDA) is not as strict as it once was with regard to drug approval.
B) Since consumers have demanded more drugs, the Food and Drug Administration (FDA) has streamlined the review/approval process.
C) 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.
D) Drug manufacturers are required by the Food and Drug Administration (FDA) to test more drugs on an annual basis.

Question 8

The client is receiving methadone (Dolophine), 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?

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

Question 9

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

A) "What other ways do you think you might use to help you to manage your stress?"
B) "That is a Schedule I drug; aren't you afraid of going to jail for a long time?"
C) "Do you really believe that everyone smokes marijuana to manage stress?"
D) "How often do you smoke marijuana, and how much each time?"

Question 10

Which statements regarding the role of the U.S. Food and Drug Administration (FDA) are true?

A) The FDA is responsible for improving the health of Americans.
B) The FDA publishes a summary of the standards of drug purity and strength.
C) The FDA ensures the availability of effective drugs.
D) The FDA takes action against any supplement that is deemed to be unsafe.
E) The FDA facilitates the availability of safe drugs.

Question 11

Which statements regarding the preclinical research stage of drug development are true?

A) Most drugs do not proceed past the preclinical stage because they are found to be too toxic or just ineffective.
B) At the end of the preclinical research stage, client variability is determined and potential drug-to-drug interactions are examined.
C) The preclinical stage of research involves extensive testing on animals in the laboratory to determine if the drug will cause harm to humans.
D) Preclinical research results are always inconclusive.
E) 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.

Question 12

What percentage of Americans takes at least one prescription drug per year?

A) 50%
B) 10%
C) 40%
D) 25%

Question 13

Uencing The nurse developing a time line of drug regulations and standards would list the following events in which chronological order?

A) Passage of the Sherley Amendment
B) Passage of the Childhood Vaccine Act
C) Development of the U.S. Pharmacopoeia
D) Passage of the Prescription Drug User Fee Act
E) Passage of the Biologics Control Act

Question 14

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?

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

Question 15

The nurse is employed by the Food and Drug Administration (FDA) and is involved in clinical investigation. What is the primary role of the nurse in this phase of the review and approval process by the FDA?

A) To perform tests on the population-at-large
B) To perform tests on various species of animals
C) To perform tests on human cells cultured in the laboratory
D) To perform tests on human clients

Question 16

Which drug has the highest dependency potential?

A) Acetaminophen
B) Codeine
C) Heroin
D) Diazepam

Question 17

The nurse is teaching a medication class for parents of children with attention-deficit hyperactivity disorder 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?

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

Question 18

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

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

Question 19

A drug manufacturer that is performing the effects of a drug on laboratory animals would be in which phase of the new drug development timeline?

A) Clinical Investigation
B) Preclinical Investigation
C) New Drug Application Review
D) Post-marketing Studies

Question 20

The 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 questions why he can't take it. What is the best response by the nurse?

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

Question 21

A nurse teaches the 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) C
4) D

Question 22

A client at 14-weeks gestation is seen in the clinic with a sprained ankle. The physician 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?

A) "The most dangerous time for birth defects is probably in the first semester and you are past that now."
B) "You are wise to avoid all drugs. I would only use the rest, compression, and ice."
C) "Let me check with the physician to see if he remembered you are pregnant."
D) "This is a category A drug, so there is very little risk to your baby."
E) "Don't worry, it will all be okay. You need to take care of yourself first."

Question 23

While the nurse is completing a medication history the older adult client says, "My medication costs so much. I am in the doughnut hole right now. Can't the government do something to help?" The nurse replies, "I understand how difficult this can be. There are plans under way to close the doughnut hole completely by ________."
Standard Text: Record your answer rounding to the nearest whole number.

Question 24

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?
1) A
2) B
3) C
4) D

Question 25

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?" The nurse explains that in the United States controlled substances such as some common pain medications are classified into one of _______ categories or schedules.

Question 26

All nurses who administer medications participate in which portion of the drug development and approval timeline?

A) A
B) B
C) C
D) D

Question 27

The 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?

A) Category A
B) Category B
C) Category C
D) Category D
E) Category X

Question 28

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?

A) FDA
B) The prescriber
C) Hospital pharmacist
D) Medicare
E) Hospital risk management

Question 29

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?

A) "Who told you the medication would cure your cancer?"
B) "What questions do you have about this medication?"
C) "Let me explain how this medication works."
D) "Has anyone explained the research trial to you?"
E) "So am I. This research has been intense."