NURS8024 TEST 1Questions and Answers
Solved 100% Correct
The description and analysis of the costs of drug therapy to health care systems
and society, measuring and comparing costs and consequences of pharmaceutical
products and services. - ANSWER-What is pharmacoeconomics?
Cost-benefit analysis (CBA), cost-effectiveness analysis (CEA), and humanistic
(cost-utility) analysis (CUA). - ANSWER-What are the three methods for evaluating
treatment costs?
The impact of an intervention, activity, or program on general society, including the
economic value of a life or productive years. - ANSWER-What does Cost-Benefit
Analysis (CBA) evaluate?
Cost Benefit Ratio = Dollars of economic benefit / Dollar cost of program. -
ANSWER-What is the formula for the Cost-Benefit Ratio?
Wrong drug name or confusing abbreviations. - ANSWER-What is a common error
in prescribing related to drug names?
Patients may not obtain medications due to cost, lack of communication, or
premature discontinuation. - ANSWER-What is a significant issue affecting patient
compliance with medications?
Use of electronic medical records (EMR) and e-prescribing to ensure accurate
medication orders. - ANSWER-What role does technology play in reducing
prescribing errors?
Limit prescriptions to no more than 7 days of any medication that can be lethal in
overdose. - ANSWER-What should prescribers do if a patient exhibits suicidal
ideation?
An initiative to ensure medication accuracy as patients move across different care
settings, such as inpatient to outpatient. - ANSWER-What is medication
reconciliation?
Building a trusting relationship, involving patients in their care plan, and providing
clear instructions can enhance adherence. - ANSWER-What is the significance of
patient education in medication adherence?
To compare similar treatments based on their outcomes and costs. - ANSWER-What
is the primary focus of cost-effectiveness analysis (CEA)?
Illegible writing, incomplete directions, wrong or unspecified doses, and errors of
,omission. - ANSWER-What are common reasons for medication errors in
prescribing?
Age, comorbidities, clinical presentation of illness, and insurance formularies. -
ANSWER-What should prescribers consider regarding patient characteristics?
To offer reliable information and support for patients regarding their medications
and health. - ANSWER-What is the purpose of patient education resources provided
by the National Library of Medicine?
To recognize that all scarce items have a cost, and decision-makers choose
purposefully to maximize benefits. - ANSWER-What is the importance of
understanding economic principles in prescribing?
Gradual changes, teaching the purpose and timing of medications, and considering
literacy and cultural beliefs. - ANSWER-What are some strategies to encourage
patient adherence to medication?
A specific diagnosis, therapeutic objectives, appropriate drug selection, dosing
regimen, and monitoring plans. - ANSWER-What should be included in a rational
prescribing process?
Marketing to the public and providers, providing literature, and offering drug
samples, while raising ethical concerns. - ANSWER-What is the role of
pharmaceutical companies in the prescribing process?
It may involve over-reporting symptoms, multiple prescriptions from different
providers, and pressure to prescribe. - ANSWER-What are the implications of drug-
seeking behavior for prescribers?
Non-compliance can lead to treatment failure and increased healthcare costs. -
ANSWER-What is the significance of patient compliance in medication
management?
Patients may not fill prescriptions due to cost, leading to gaps in treatment and
health outcomes. - ANSWER-What is the impact of economic issues on patient
medication adherence?
To provide resources that identify confusing drug names and abbreviations to avoid
in prescribing. - ANSWER-What is the role of the Institute for Safe Medication
Practices?
Clearly document the reasons for using a drug outside its approved indications. -
ANSWER-What should prescribers do to document rationale for 'off label'
prescribing?
Identification of chemical compounds through in vitro testing. - ANSWER-What is
the first step in the drug development process?
,Investigational New Drug Application. - ANSWER-What does INDA stand for?
To assess the safety and dosage of a drug. - ANSWER-What is the purpose of Phase
I clinical trials?
To evaluate the effectiveness of the drug. - ANSWER-What is the primary goal of
Phase II clinical trials?
To confirm effectiveness, monitor side effects, and compare with standard
treatments. - ANSWER-What is the focus of Phase III clinical trials?
New Drug Application. - ANSWER-What does NDA stand for?
Monitoring the safety and effectiveness of a drug after it has been approved for
consumer use. - ANSWER-What is post-marketing surveillance?
A law that provides incentives for the development of drugs for rare diseases. -
ANSWER-What is the Orphan Drug Act of 1983?
Over 550 orphan drugs for more than 80 rare diseases. - ANSWER-How many
orphan drugs has the FDA approved since 1983?
The requirement that drug products with the same physical and chemical
composition produce comparable therapeutic effects. - ANSWER-What is
bioequivalence?
Bioequivalence refers to comparable therapeutic effects, while therapeutic
equivalence means the products are approved as safe and effective with identical
active ingredients. - ANSWER-What is the difference between bioequivalence and
therapeutic equivalence?
It lists interchangeable drug products based on bioequivalence. - ANSWER-What is
the significance of the Blue Book in drug regulation?
Information on therapeutic equivalence of drug products. - ANSWER-What does the
Orange Book provide?
Randomized, Double-Blind, Placebo Controlled Trials (RCT). - ANSWER-What is the
gold standard for clinical trials?
The U.S. Pharmacopeia of 1820. - ANSWER-What major legislation established the
first compendium of standard drugs in the U.S.?
It prohibited mislabeling and adulteration of drugs. - ANSWER-What did the Pure
Food and Drug Act of 1906 address?
Proof of efficacy as well as safety for new drugs. - ANSWER-What requirement was
, established by the Kefauver-Harris Amendments of 1962?
To outline strict controls in the manufacture, distribution, and prescribing of habit-
forming drugs. - ANSWER-What is the purpose of the Comprehensive Drug Abuse
Prevention and Control Act of 1970?
To approve consumer marketing of legend drugs and ensure safety and efficacy. -
ANSWER-What is the role of the FDA in drug marketing?
It allows healthcare providers to substitute generic drugs for brand-name drugs
that are therapeutically equivalent. - ANSWER-What is the significance of
therapeutic equivalence in healthcare?
Poorly understood pathology, cost prohibitive development, and limited patient
populations for studies. - ANSWER-What challenges exist in the development of
drugs for rare diseases?
2 to 6 years. - ANSWER-What is the average time required for toxicity testing
before human trials?
Variable natural history of diseases, co-morbidities, subject and observer bias, and
placebo response. - ANSWER-What are major confounding factors in clinical trials?
As a 'nontoxic' hypnotic and for morning sickness treatment during pregnancy. -
ANSWER-What was thalidomide marketed for?
Phocomelia, a condition involving shortening or complete absence of limbs. -
ANSWER-What rare birth defect was linked to thalidomide?
1961. - ANSWER-What year did reports suggest thalidomide caused birth defects?
Approximately 10,000 children. - ANSWER-How many children were estimated to
be born with birth defects due to thalidomide?
Thalidomide was never approved for sale in the U.S. - ANSWER-What was the FDA's
stance on thalidomide in the U.S.?
A warning issued by the FDA when a drug presents a unique risk/benefit concern
compared to others in the same class. - ANSWER-What is a Black Box Warning?
Information on treatment risks, benefits, and warnings, which should be
documented in the patient's record. - ANSWER-What must prescribers provide to
patients regarding drugs with a Black Box Warning?
Guides that must be given to patients for drugs with a Black Box Warning,
approved by the FDA. - ANSWER-What are Patient Medication Guides?
Information included in the medication container for drugs that are not as risky but
Solved 100% Correct
The description and analysis of the costs of drug therapy to health care systems
and society, measuring and comparing costs and consequences of pharmaceutical
products and services. - ANSWER-What is pharmacoeconomics?
Cost-benefit analysis (CBA), cost-effectiveness analysis (CEA), and humanistic
(cost-utility) analysis (CUA). - ANSWER-What are the three methods for evaluating
treatment costs?
The impact of an intervention, activity, or program on general society, including the
economic value of a life or productive years. - ANSWER-What does Cost-Benefit
Analysis (CBA) evaluate?
Cost Benefit Ratio = Dollars of economic benefit / Dollar cost of program. -
ANSWER-What is the formula for the Cost-Benefit Ratio?
Wrong drug name or confusing abbreviations. - ANSWER-What is a common error
in prescribing related to drug names?
Patients may not obtain medications due to cost, lack of communication, or
premature discontinuation. - ANSWER-What is a significant issue affecting patient
compliance with medications?
Use of electronic medical records (EMR) and e-prescribing to ensure accurate
medication orders. - ANSWER-What role does technology play in reducing
prescribing errors?
Limit prescriptions to no more than 7 days of any medication that can be lethal in
overdose. - ANSWER-What should prescribers do if a patient exhibits suicidal
ideation?
An initiative to ensure medication accuracy as patients move across different care
settings, such as inpatient to outpatient. - ANSWER-What is medication
reconciliation?
Building a trusting relationship, involving patients in their care plan, and providing
clear instructions can enhance adherence. - ANSWER-What is the significance of
patient education in medication adherence?
To compare similar treatments based on their outcomes and costs. - ANSWER-What
is the primary focus of cost-effectiveness analysis (CEA)?
Illegible writing, incomplete directions, wrong or unspecified doses, and errors of
,omission. - ANSWER-What are common reasons for medication errors in
prescribing?
Age, comorbidities, clinical presentation of illness, and insurance formularies. -
ANSWER-What should prescribers consider regarding patient characteristics?
To offer reliable information and support for patients regarding their medications
and health. - ANSWER-What is the purpose of patient education resources provided
by the National Library of Medicine?
To recognize that all scarce items have a cost, and decision-makers choose
purposefully to maximize benefits. - ANSWER-What is the importance of
understanding economic principles in prescribing?
Gradual changes, teaching the purpose and timing of medications, and considering
literacy and cultural beliefs. - ANSWER-What are some strategies to encourage
patient adherence to medication?
A specific diagnosis, therapeutic objectives, appropriate drug selection, dosing
regimen, and monitoring plans. - ANSWER-What should be included in a rational
prescribing process?
Marketing to the public and providers, providing literature, and offering drug
samples, while raising ethical concerns. - ANSWER-What is the role of
pharmaceutical companies in the prescribing process?
It may involve over-reporting symptoms, multiple prescriptions from different
providers, and pressure to prescribe. - ANSWER-What are the implications of drug-
seeking behavior for prescribers?
Non-compliance can lead to treatment failure and increased healthcare costs. -
ANSWER-What is the significance of patient compliance in medication
management?
Patients may not fill prescriptions due to cost, leading to gaps in treatment and
health outcomes. - ANSWER-What is the impact of economic issues on patient
medication adherence?
To provide resources that identify confusing drug names and abbreviations to avoid
in prescribing. - ANSWER-What is the role of the Institute for Safe Medication
Practices?
Clearly document the reasons for using a drug outside its approved indications. -
ANSWER-What should prescribers do to document rationale for 'off label'
prescribing?
Identification of chemical compounds through in vitro testing. - ANSWER-What is
the first step in the drug development process?
,Investigational New Drug Application. - ANSWER-What does INDA stand for?
To assess the safety and dosage of a drug. - ANSWER-What is the purpose of Phase
I clinical trials?
To evaluate the effectiveness of the drug. - ANSWER-What is the primary goal of
Phase II clinical trials?
To confirm effectiveness, monitor side effects, and compare with standard
treatments. - ANSWER-What is the focus of Phase III clinical trials?
New Drug Application. - ANSWER-What does NDA stand for?
Monitoring the safety and effectiveness of a drug after it has been approved for
consumer use. - ANSWER-What is post-marketing surveillance?
A law that provides incentives for the development of drugs for rare diseases. -
ANSWER-What is the Orphan Drug Act of 1983?
Over 550 orphan drugs for more than 80 rare diseases. - ANSWER-How many
orphan drugs has the FDA approved since 1983?
The requirement that drug products with the same physical and chemical
composition produce comparable therapeutic effects. - ANSWER-What is
bioequivalence?
Bioequivalence refers to comparable therapeutic effects, while therapeutic
equivalence means the products are approved as safe and effective with identical
active ingredients. - ANSWER-What is the difference between bioequivalence and
therapeutic equivalence?
It lists interchangeable drug products based on bioequivalence. - ANSWER-What is
the significance of the Blue Book in drug regulation?
Information on therapeutic equivalence of drug products. - ANSWER-What does the
Orange Book provide?
Randomized, Double-Blind, Placebo Controlled Trials (RCT). - ANSWER-What is the
gold standard for clinical trials?
The U.S. Pharmacopeia of 1820. - ANSWER-What major legislation established the
first compendium of standard drugs in the U.S.?
It prohibited mislabeling and adulteration of drugs. - ANSWER-What did the Pure
Food and Drug Act of 1906 address?
Proof of efficacy as well as safety for new drugs. - ANSWER-What requirement was
, established by the Kefauver-Harris Amendments of 1962?
To outline strict controls in the manufacture, distribution, and prescribing of habit-
forming drugs. - ANSWER-What is the purpose of the Comprehensive Drug Abuse
Prevention and Control Act of 1970?
To approve consumer marketing of legend drugs and ensure safety and efficacy. -
ANSWER-What is the role of the FDA in drug marketing?
It allows healthcare providers to substitute generic drugs for brand-name drugs
that are therapeutically equivalent. - ANSWER-What is the significance of
therapeutic equivalence in healthcare?
Poorly understood pathology, cost prohibitive development, and limited patient
populations for studies. - ANSWER-What challenges exist in the development of
drugs for rare diseases?
2 to 6 years. - ANSWER-What is the average time required for toxicity testing
before human trials?
Variable natural history of diseases, co-morbidities, subject and observer bias, and
placebo response. - ANSWER-What are major confounding factors in clinical trials?
As a 'nontoxic' hypnotic and for morning sickness treatment during pregnancy. -
ANSWER-What was thalidomide marketed for?
Phocomelia, a condition involving shortening or complete absence of limbs. -
ANSWER-What rare birth defect was linked to thalidomide?
1961. - ANSWER-What year did reports suggest thalidomide caused birth defects?
Approximately 10,000 children. - ANSWER-How many children were estimated to
be born with birth defects due to thalidomide?
Thalidomide was never approved for sale in the U.S. - ANSWER-What was the FDA's
stance on thalidomide in the U.S.?
A warning issued by the FDA when a drug presents a unique risk/benefit concern
compared to others in the same class. - ANSWER-What is a Black Box Warning?
Information on treatment risks, benefits, and warnings, which should be
documented in the patient's record. - ANSWER-What must prescribers provide to
patients regarding drugs with a Black Box Warning?
Guides that must be given to patients for drugs with a Black Box Warning,
approved by the FDA. - ANSWER-What are Patient Medication Guides?
Information included in the medication container for drugs that are not as risky but
