Deck 1: Introduction to Pharmacology: Drug Regulation and Approval

Question 1

The nurse is caring for a client with migraine headaches.The client asks why she has been prescribed a medication for seizures.Which legislation allows drug companies to share off-label drug use information with healthcare practitioners to allow such a prescription to occur?
1)Therapeutic Products Programme
2)Food and Drugs Act
3)Prescription Drug User Fee Act
4)Health Products and Food Branch

Answer 1

3

Question 2

Which science is known for preparing and dispensing drugs?
1)Pharmacology
2)Pharmaceutics
3)Traditional drug therapy
4)Therapeutics

Answer 2

2

Question 3

In addition to physicians,which healthcare providers are able to prescribe medications? (Select all that apply.)Note: Credit will be given only if all correct choices and no incorrect choices are selected.
1)Physician's assistants
2)Advanced nurse practitioners
3)Dentists
4)Medical assistants
5)Registered nurses

Answer 3

1,2,3

Question 4

Which statement best describes the advantages of prescription drugs versus over-the-counter (OTC)drugs? (Select all that apply.)Note: Credit will be given only if all correct choices and no incorrect choices are selected.
1)The cost of the drug is always less than the cost of an OTC drug.
2)The practitioner can maximize therapy by ordering the proper medication for the client's condition.
3)There are fewer side effects of prescription drugs than of OTC drugs.
4)The practitioner is able to control the dose and frequency of dosing of the drug.
5)Prescription drugs do not require a practitioner order.

Question 5

Which statement best describes how a traditional drug is different from a biologic agent?
1)Biologics and traditional drugs are identical chemically.
2)Traditional drugs are naturally produced by the body or in animal cells,whereas biologic agents are chemically produced in a laboratory.
3)Traditional drugs are chemically produced in a laboratory,whereas biologic agents are naturally produced by the body or in animal cells.
4)Biologics include herbs,natural extracts,vitamins,minerals,and dietary supplements.

Question 6

A nurse educator wants to define the term pharmacology for the student.Which definition is most appropriate?

A)The study of medicine
B)The use of medicine to treat disease
C)The branch of medicine concerned with the treatment of disease and suffering
D)The use of herbs,natural extracts,vitamins,minerals,or dietary supplements to treat diseases

Question 7

Which branch of the FDA is responsible for the use of biologics,including serums,vaccines,and products found in the bloodstream?
1)The Center for Biologics Evaluation and Research (CBER)
2)The Center for Drug Evaluation and Research (CDER)
3)The Center for Food Safety and Applied Nutrition (CFSAN)
4)The FDA does not have a branch responsible for the use of biologics.

Question 8

Insulin would fall into which therapeutic drug category?
1)Biologics
2)Alternative therapies
3)Natural therapy
4)Traditional therapeutic drug

Question 9

A client expresses concerns about a newly prescribed medication.The nurse explains that the safety and effectiveness of the medication have been proven,according to the statutes of which law?
1)Public Health Service Act
2)FDA Modernization Act
3)Food,Drug,and Cosmetic Act
4)Pure Food and Drug Act

Question 10

A client asks the nurse if all herbal supplements undergo the same testing that prescription drugs undergo.Which statement is the best response by the nurse?
1)"Herbal and dietary supplements may not be marketed without prior approval from the FDA."
2)"The Center for Food Safety and Applied Nutrition (CFSAN)regulates use of herbal supplements,which means the medication must be safe."
3)"Herbal products and dietary supplements are regulated by the Dietary Supplement Health and Education Act of 199
4)This act does not require the same research for herbal or dietary supplements."
4)"All medications and herbal supplements undergo the same testing before being made available for purchase."

Question 11

The nurse is discussing a medication with a patient.This approved medication is discovered to have serious problems.Which FDA response does the nurse expect?
1)Require the medication to have additional clinical trials conducted
2)Issue a warning to practitioners to watch for side effects in clients taking the drug
3)Continue to monitor the medication in postmarketing studies
4)Require that the drug be withdrawn from the market and its use discontinued

Question 12

Which definition best describes the term pharmaceutics?
1)The science of preparing and dispensing drugs,and a very important part of pharmacotherapy
2)The use of medicine to treat disease
3)Agents naturally produced in animal cells,in microorganisms,or by the body itself
4)Herbs,natural extracts,vitamins,minerals,and dietary supplements

Question 13

A client asks the nurse whether the claims made regarding a new medication are true.The nurse responds based on which act or amendment passed in 1912 that prevents the sale of drugs with false therapeutic claims intended to cheat the consumer?
1)Food,Drug,and Cosmetic Act
2)FDA Modernization Act
3)The Sherley Amendment
4)Pure Food and Drug Act

Question 14

Which medication change often occurs when a drug demonstrates a wide margin of safety and is used over long periods of time?
1)Prescription-only to over-the-counter (OTC)drug
2)One classification to a lower,less restrictive one
3)Traditional drug therapy classification to biologics classification
4)Therapeutic to effective

Question 15

Which government agency has control over which prescription or OTC drugs may be used for therapy?
1)The Center for Biologics Evaluation and Research (CBER)
2)The Center for Food Safety and Applied Nutrition (CFSAN)
3)The Center for Drug Evaluation and Research (CDER)
4)The National Institutes of Health (NIH)

Question 16

The nurse is discussing the advantages of over-the-counter (OTC)medications with a client.Which statements are disadvantages of OTC drugs versus prescription drugs? (Select all that apply.)Note: Credit will be given only if all correct choices and no incorrect choices are selected.
1)OTC drugs can react with foods,herbal products,and prescriptions,or with other OTC drugs.
2)A client can obtain OTC drugs more easily than prescription drugs.
3)Self-treatment is sometimes ineffective.
4)Choosing the proper medication for a specific problem can be challenging.
5)OTC drugs are more expensive than prescription drugs.

Question 17

Which items are considered medically therapeutic? (Select all that apply.)Note: Credit will be given only if all correct choices and no incorrect choices are selected.
1)Traditional drugs
2)Sunscreens
3)Biologics
4)Natural alternative therapies
5)Antiperspirants

Question 18

A client has been selected as a participant in the approval process of a particular drug.The client's dose and any effects from the medication are being monitored.Which phase of drug approval is this client participating in?
1)Postmarketing study
2)Clinical phase trial
3)Postclinical investigation
4)Preclinical investigation

Question 19

Which branch of medicine is concerned with the treatment of disease and suffering?
1)Pharmacology
2)Therapeutics
3)Pathophysiology
4)Pharmacotherapeutics

Question 20

Nurses are responsible for administering medications.Nurses do not prescribe medications.Which best explains the reason why nurses study pharmacology?
1)To educate and advise patients regarding their healthcare needs
2)To clarify the reasons why a prescriber may prescribe a certain medication to the patient
3)To understand how adverse effects of medications can be avoided
4)To generate research for medications

Question 21

Which phase of clinical research involves basic science research?
1)Submission of NDA
2)Clinical phase trials
3)Postmarketing study
4)Preclinical investigation

Question 22

Why do healthcare providers study pharmacology and pharmacotherapeutics? (Select all that apply.)Note: Credit will be given only if all correct choices and no incorrect choices are selected.
1)To understand how drugs improve the health of the human body
2)To educate clients
3)To gather medical data regarding results of drug therapy
4)To classify medications based on how they are produced

Question 23

A public health nurse is seeking information on bioterrorist agents to present education regarding security and defense in case of attack.Which resource is the most appropriate?
1)U.S.Department of Homeland Security
2)FEMA
3)U.S.Armed Forces
4)U.S.National Guard

Question 24

The nurse is providing care to a client who is taking several different medications,both prescribed and over-the-counter (OTC).The nurse is consulting with the charge nurse about possible interactions.Which statement by the nurse explains the increased potential for adverse drug-drug and drug-herbal interactions?
1)"The restrictions placed by the FDA are stricter."
2)"People are using more herbs,so the risk for interaction is greater."
3)"Drugs are being developed at a faster rate than their risk can be assessed."
4)"Managed care has made a greater number of drugs available to consumers."

Question 25

Which are considered infectious diseases that have impacted healthcare providers in the United States?
1)Influenza
2)Human immunodeficiency virus
3)Food poisoning
4)Tuberculosis
5)Asthma

Question 26

Certain drugs are produced and prescribed with a faster process of review.Why did this occur?
1)There was limited knowledge of certain diseases and people were dying.
2)There existed faster authorization of therapeutic drugs that met medical need.
3)Drug development was stagnant and time consuming.
4)The benefits outweighed the risks.

Question 27

A nurse is discussing how drugs are approved with a healthcare provider.Place the stages of approval for therapeutic and biological drugs in the appropriate sequence.

A)NDA submission with review
B)Preclinical investigation
C)Clinical investigation
D)Postmarketing studies