Match the following drug development regulations with the year they were formulated:
1. Trials had to demonstrate safety
2. Trials had to demonstrate efficacy
3. Trials had to present comparative efficacy research
A. 1938
B. 1962
C. 2009
1. 1938
2. 1962
3. 2009
Which government department is responsible for protecting the health and providing essential human services to Americans?
A. Department of Health & Human Services (DHHS)
B. Department of Labor
C. Department of Human Services
D. Department of State
A
Department of Health & Human Services (DHHS) includes:
A. The Food & Drug Administration (FDA)
B. The National Institutes of Health (NIH)
C. Both A & B
C
This agency implements laws passed by congress through establishing regulations that become part of the Code of Federal Regulations AND creates guidance statements that are not enforceable by law (recommendations)?
A. FDA
B. NIH
A
Match the following sub-divisions of the FDA to their roles/function:
1. Regulates OTC and Rx drugs
2. Regulates vaccines, blood/components, gene therapy and recombinant therapeutic proteins
A. Center for Drug Evaluation & Research (CDER)
B. Center for Bi
1. A
2. B
The mission of this agency is to seek fundamental knowledge about the nature and behavior of living systems & apply that knowledge to enhance health, lengthen life and reduce illness & disability:
A. FDA
B. NIH
B
The approval process for drugs is complicated & time consuming. It takes an average of 10-15 years and costs between 1.2-1.3 billion.
Match the following phases of the drug approval process with their description.
1. Phase I
2. Phase II
3. Phase III
4. Po
1. A
2. B
3. C
4. D
Which of the following is TRUE regarding the American Recovery & Reinvestment Act (ARRA) of 2009?
A. Also known as the "stimulus act"
B. It provides funding to the DHHS for CER (Comparative Effectiveness Research)
C. It requires establishment of a federal
D
Comparative effectiveness research compares _________ of items, services and procedures used to prevent, diagnose or treat diseases.
A. Clinical outcomes
B. Effectiveness
C. Appropriateness
D. All the above
D
It encourages development and use of clinical registries & databases
Pharmaceutical manufacturers
focused on 2 points:
1. "growing reluctance by payers - health insurers, employers, and governments around the world - to reimburse for new treatments that are NOT clearly superior to those already available"
2. "drug and medical device companies will have to make a strong ar
The field of study that evaluates the behavior of individuals, firms and markets relevant to the use of pharmaceutical products, services and programs and which frequently focuses on the costs (inputs) and consequences (outcomes) of that use is known as?
A
The aim of pharmacoeconomics is to __________ a link between both resource consumption and outcomes so that relative worth of selected pharmaceutical products, programs and/or services can be established.
A. Identify
B. Measure
C. Value
D. Establish
E. Al
E
NOTE: its a form of economic evaluation limited to pharmaceutical products, programs and/or services
Pharmacoeconomics relates the 3 parts to each other. These include:
A. Costs
B. Treatment
C. Outcomes
D. All the above
D
KNOW
The 4 E's of health program evaluation include:
A. Efficacy
B. Effectiveness
C. Efficiency
D. Equity
E. All the above
E
Match the following 4 E's of evaluation to the correct description:
1. It works; positives outweigh negatives
2. It works in the real world; works for individuals for which it was intended
3. Lowest cost per unit output; best allocation of resources that
1. A
2. B
3. C
4. D
Dr. Pathak's MOST important maxim is
efficiency cannot be superimposed upon an ________ therapy or a program.
A. Ineffective
B. Effective
A
To conduct pharmacoeconomic evaluations, four methodological approaches are used. These include:
A. Cost-minimization analysis (CMA)
B. Cost-benefit analysis (CBA)
C. Cost-effectiveness (CEA)
D. Cost-utility analysis (CUA)
E. All the above
E
NOTE: a 5th approach; cost-consequence analysis (CCA) has gained acceptance
If outcomes are NOT measured, which pharmacoeconomic evaluation approach should be used?
A. Cost analysis
B. Cost minimization analysis
C. Cost effectiveness, cost utility or cost benefit analysis
A
If outcomes are measured and outcomes are equivalent, which pharmacoeconomic evaluation approach should be used?
A. Cost analysis
B. Cost minimization analysis
C. Cost effectiveness, cost utility or cost benefit analysis
B
If outcomes are measured and outcomes are NOT equivalent, which pharmacoeconomic evaluation approach should be used?
A. Cost analysis
B. Cost minimization analysis
C. Cost effectiveness, cost utility or cost benefit analysis
C
The outcome of cost-minimization and cost-effectiveness outcome is:
A. Clinical measure
B. Dollars
C. Quality-adjusted life years (QALYs)
D. A combination of clinical measure, dollars or QALYs
A
The outcome of cost-benefit analysis is:
A. Clinical measure
B. Dollars
C. Quality-adjusted life years (QALYs)
D. A combination of clinical measure, dollars or QALYs
B
The outcome of cost-utility analysis is:
A. Clinical measure
B. Dollars
C. Quality-adjusted life years (QALYs)
D. A combination of clinical measure, dollars or QALYs
C
The outcome of cost-consequence is:
A. Clinical measure
B. Dollars
C. Quality-adjusted life years (QALYs)
D. A combination of clinical measure, dollars or QALYs
D
Costs are NOT always dollars.
A. True
B. False
A
1. __________ is the consumption of a resource that could otherwise be used for another purpose.
2. ________ is the value of benefits foregone because the resources were not available for the best alternative use
A. Economic cost
B. Opportunity cost
1. A
2. B
The value of the next highest valued alternative use of that resource AND the value if the resources were spent on the alternative is known as?
A. Opportunity cost
B. Economic cost
A
Example: going to the movie or staying home for Netflix & chill
Trade-off
Benefits are normally defined in terms of patient health outcomes. The emphasis should be on final health outcomes such as improved functioning and well-being of the patient.
A. True
B. False
A
NOTE: final health outcomes could be economic as well as noneconomic
KNOW
What does
ECHO
stand for?
Economic
Clinical
Humanistic
Outcomes
Steps for conducting a
pharmacoeconomic analysis include:
1. Define the problem and state the objective
2. Identify the perspective and the alternative interventions to be compared
3. Identify and measure the outcomes of each alternative
4. Identify, measure and value costs
A _______ is one that would not have been incurred if it were not for the product or service that is being studied
A. Relevant cost
B. Opportunity cost
C. Economic cost
A
Costs are categorized as:
A. Direct medical costs
B. Direct non-medical costs
C. Indirect costs
D. Intangible costs
E. All the above
E
Match the following description to the correct pharmacoeconomic evaluation approach.
-Equivalent outcomes (clinically)
-Choose least costly alternative
-Costs must be compared equivalently
A. Cost-minimization analysis (CMA)
B. Cost-Effectiveness Analysis
A
Match the following description to the correct pharmacoeconomic evaluation approach.
-MOST commonly used in pharmacy literature
-Outcomes or consequences are not monetary
-Outcomes MUST be on the same scale (ex: mmHg decrease in BP)
-Decision can be subje
B
Match the following description to the correct pharmacoeconomic evaluation approach.
-Can compare outcomes of different units
-Presented in terms of dollars
-How to spend your money
-Willingness to pay, human capital
-Presented as net benefit or benefit-t
C
Net benefit?
Net benefit = Benefit - Costs
if either benefits or costs extend for more than 1 year, they need to be discounted by a rate of interest over time
1. Net benefit/total cost is?
A. Benefit-to-cost ratio
B. Cost-to-benefit ratio
2. Total cost/net benefit is?
A. Benefit-to-cost ratio
B. Cost-to-benefit ratio
1. A
2. B
Match the following description to the correct pharmacoeconomic evaluation approach.
-Brings patient preferences into equation
-Measured in Quality Adjusted Life Years (QALYs)
A. Cost-minimization analysis (CMA)
B. Cost-Effectiveness Analysis (CEA)
C. Cos
D
Match the following description to the correct pharmacoeconomic evaluation approach.
-All costs together
-All effects or outcomes together
A. Cost-minimization analysis (CMA)
B. Cost-Effectiveness Analysis (CEA)
C. Cost-Benefit Analysis (CBA)
D. Cost-Util
E
Approaches to conducting pharmacoeconomic studies include:
A. Randomized controlled trials
B. Naturalistic designs
C. Retrospective analysis
D. Decision analysis
E. All the above
E
Match the following approaches to conducting pharmacoeconomic studies:
1. Patients are still randomly assigned but the patients recruited and the care delivered are representative of those seen in routine practice
2. Uses observational data (ex: actual cl
1. A
2. B
3. C
A decision tree shows the flow of options & events that occur over time. It begins with decision options (choice), then moves into consequences of the options then probabilities & costs of the options.
A. True
B. False
A
Which of the following is TRUE regarding the Markov modeling?
A. Simulates more complicated aspects of diseases
B. Divides the disease or condition into mutually exclusive states (Markov states)
C. Simulates patients transitioning through the states
D. Us
E
Quiz q
Pharmacoeconomics does not tell you the "right" answer, but makes all of the issues that go into the decision......
A. Transparent
B. Opaque
C. Totalitarian
D. Occlusive
A
Mathematical equation fo value is?
Value = Benefits/Costs
Not everything that can be counted counts, and not everything that counts can be counted.
A. True
B. False
A