Deck 1: Introduction to Pharmacology: Drug Regulation and Approval

Question 1

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?
1)The Food and Drug Administration (FDA)is not as strict as it once was with regard to drug approval.
2)Since consumers have demanded more drugs,the Food and Drug Administration (FDA)has streamlined the review/approval process.
3)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.
4)Drug manufacturers are required by the Food and Drug Administration (FDA)to test more drugs on an annual basis.

Answer 1

3

Question 2

The nursing instructor is teaching a pharmacology class to student nurses.The current focus is pharmacology and therapeutics.The nursing instructor determines that learning has occurred when the students make which comments? Credit will be given only if all correct choices and no incorrect choices are selected.
1)"Pharmacology is the use of drugs to relieve suffering."
2)"Pharmacology is the study of medicines."
3)"Therapeutics is the study of the therapeutic use of drugs."
4)"Therapeutics is the study of drug interactions."
5)"Pharmacology is the study of drugs to prevent disease."

Answer 2

1,2

Question 3

The application of drugs for the purpose of disease prevention and treatment of suffering is known as
1)biologics.
2)pharmacotherapeutics.
3)alternative therapies.
4)therapeutics.

Answer 3

2

Question 4

The client comes to the emergency department with a myocardial infarction.The client's husband tells the nurse that his wife has been taking calcium carbonate (Tums)for years for what she thought was indigestion.What is the best response by the nurse?
1)"Your wife should not have self-diagnosed herself.I hope she will be okay."
2)"Why did you let her do that? She should have seen a doctor."
3)"Well,I am glad she is here,as it certainly wasn't indigestion."
4)"Your wife was self-diagnosing,which is generally not a good idea."

Question 5

The nurse is teaching a class for clients about over-the-counter (OTC)medications.The nurse determines that education has been effective when the clients make which statement?
1)"We should not take any over-the-counter (OTC)medicine without first calling and checking with the doctor's office."
2)"We should always ask the pharmacist about how to take the over-the-counter (OTC)medicine."
3)"We must read all the directions on the label and call the doctor's office if they are not clear."
4)"Medicines that are available over-the-counter (OTC)are really safe,or they would be prescription medicines."

Question 6

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

Question 7

The nurse is categorizing a client's list of medications completing a health history.Which agents would be categorized as complementary and alternative medicine? Credit will be given only if all correct choices and no incorrect choices are selected.
1)Garlic
2)Vitamin C
3)Zinc
4)Aspirin
5)Benadryl

Question 8

The elderly client has gastrointestinal bleeding.The client says to the nurse "I don't understand this.All I did was take ibuprofen (Advil)for my arthritis." Which plan would be best as it relates to the nurse's education of this client?
1)A plan to teach the client to use drugs that bypass the gastrointestinal system,like topical drugs
2)A plan to teach the client to substitute safer drugs like acetaminophen (Tylenol)
3)A plan to teach the client to obtain physician approval prior to the use of over-the-counter (OTC)medications
4)A plan to teach the advantages and disadvantages of ibuprofen (Advil)

Question 9

The student nurse has completed an initial pharmacology course and tells the nursing instructor that it was difficult and she is glad it is over.What is the best response by the nursing instructor?
1)"It may be over,but now you must apply what you have learned to patient care."
2)"Learning is gradual and continuous;we never completely master all areas of pharmacology."
3)"Learning is always painful,but we must continue anyway."
4)"It really isn't over;you should take a graduate course next."

Question 10

A patient with chronic back pain informs the nurse he has been receiving therapeutic touch in addition to his medications.This type of therapy is best classified as
1)pharmacotherapy.
2)drug-absence therapy.
3)complementary therapy.
4)biologic therapy.

Question 11

How many years does it generally take to research and develop a drug before it is submitted to the FDA for review?
1)6 years
2)5 years
3)11 years
4)9 years

Question 12

The client says to the nurse,"My wife and I take the same drug,but we have different side effects.Are we doing something wrong?" What is the best response by the nurse?
1)"No.Differences such as your sex can result in different side effects."
2)"I'll have to check.What is the name of the drug you were using?"
3)"Possibly.This could happen if one uses generic or brand name drugs."
4)"I'm not sure.Maybe the drug is not the same;you should check it."

Question 13

While reading a medication package inserts the nurse notes the information contained within the "black box." What is the significance of this information to the nurse? Credit will be given only if all correct choices and no incorrect choices are selected.
1)The drug can cause "special problems."
2)It identifies extreme adverse drug reactions.
3)It differentiates a prescribed medication from an over-the-counter medication.
4)It highlights the cost of the medication.
5)It signifies the medication is generic.

Question 14

The student nurse asks the nursing instructor why he needs to take anatomy and physiology,as well as microbiology,when he only wants to learn about pharmacology.What is the best response by the instructor?
1)"Because pharmacology is an outgrowth of those subjects."
2)"You must learn all,since those subjects,as well as pharmacology,are part of the curriculum."
3)"Knowledge of all those subjects will prepare you to provide the best patient care,including the administration of medications."
4)"Because an understanding of those subjects is essential to understanding pharmacology."

Question 15

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?
1)Clinical Investigation
2)Preclinical Investigation
3)New Drug Application Review
4)Postmarketing Studies

Question 16

The nurse administers a vaccine to a child.What is the best understanding of the nurse as it relates to the manufacture of this vaccine?
1)The vaccine is produced by natural plant extracts in the laboratory.
2)The vaccine is naturally produced in animal cells or microorganisms.
3)The vaccine is produced by a combination of animal and plant products.
4)The vaccine is most commonly synthesized in a laboratory.

Question 17

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?
1)To perform tests on the population-at-large
2)To perform tests on various species of animals
3)To perform tests on human cells cultured in the laboratory
4)To perform tests on human clients

Question 18

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

Question 19

The nurse is teaching a pharmacology class to student nurses.What does the nurse include as key events in the history of pharmacology? Credit will be given only if all correct choices and no incorrect choices are selected.
1)Initial drugs included morphine,cocaine,and penicillin.
2)Early researchers used themselves as test subjects.
3)The initial intention of pharmacology was to relieve human suffering.
4)Modern pharmacology began in the early 1600s.
5)Pharmacologists synthesized drugs in the laboratory in the twentieth century.

Question 20

The elderly client has gastrointestinal bleeding.The client says to the nurse "I don't understand this.All I did was take ibuprofen (Advil)for my arthritis." Which plan would be best as it relates to the nurse's education of this client?
1)A plan to teach the client to use drugs that bypass the gastrointestinal system,like topical drugs.
2)A plan to teach the client to substitute safer drugs like acetaminophen (Tylenol).
3)A plan to teach the client to obtain physician approval prior to the use of over-the-counter (OTC)medications.
4)A plan to teach the advantages and disadvantages of ibuprofen (Advil).

Question 21

A client says to the admitting nurse,"Why do you need to know the names of all the over-the-counter supplements I take? They aren't drugs." Which of the nurse's responses are appropriate? Credit will be given only if all correct choices and no incorrect choices are selected.
1)"The admitting physician needs to know everything you are taking."
2)"You're right.I'm not sure why the admitting paperwork asks for this information.Would you mind listing them anyway?"
3)"The law requires us to keep a list of over-the-counter drugs and supplements that you are taking."
4)"It is true that supplements are not considered drugs;however,some of these products can cause adverse effects with prescribed drugs."
5)"We need to know if you are having an allergic reaction to one of them."

Question 22

Which statements regarding the preclinical research stage of drug development are true? Credit will be given only if all correct choices and no incorrect choices are selected.
1)Most drugs do not proceed past the preclinical stage because they are found to be too toxic or just ineffective.
2)At the end of the preclinical research stage,client variability is determined and potential drug-to-drug interactions are examined.
3)The preclinical stage of research involves extensive testing on animals in the laboratory to determine if the drug will cause harm to humans.
4)Preclinical research results are always inconclusive.
5)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 23

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? Credit will be given only if all correct choices and no incorrect choices are selected.
1)Attend meetings to finalize the brand name for the drug.
2)Check on the results of animal testing.
3)Survey for harmful effects in a larger population.
4)Evaluate the results of the drug on cultured cells.
5)Provide the medication to large groups of people with a particular disease.

Question 24

Which statements regarding the role of the U.S.Food and Drug Administration (FDA)are true? Credit will be given only if all correct choices and no incorrect choices are selected.
1)The FDA is responsible for ensuring the security of human drugs.
2)The FDA publishes a summary of the standards of drug purity and strength.
3)The FDA ensures the availability of effective drugs.
4)The FDA takes action against any supplement that is deemed to be unsafe.
5)The FDA facilitates the availability of safe drugs.