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PHAD 343 Final Exam
Final Exam
193
Pharmacology
Graduate
12/14/2010

Additional Pharmacology Flashcards

 


 

Cards

Term
What did the 1962 Kefauver-Harris amendment to the FD&C act stipulate?
Definition
Stipulated that drugs must be proved "safe" and "effective prior to marketing
Term
What separates efficacy from effectiveness?
Definition
Efficacy are the benefits of the drug in IDEAL circumstances vs effectiveness are benefits of the drug obtained in ACTUAL, real world use
Term
List the stages of NDA process in order
Definition
1. Preclinical Stage
2. Clinical Stage 1 (Phase 1)
3. Clinical Stage 2 (Phase 2)
4. Phase 3 clinical trials
5. Phase 4 - Post Marketing monitoring
Term
What happens in preclinical stage?
Definition
All activity prior to use in humans
ie Drug discovery, animal testing to determine potential uses, SE, toxicity, and safe dosage parameters
Term
What is an orphan drug?
Definition
Drug that may show therapeutic benefit but not economically promising
Term
What happens in clinical stage 1?
Definition
Drug enters IND (Investigation New Drug) status when used in humans
Term
When is first use of the drug in humans to establish the drug's action, safe dosage range, and pharmacokinetics?
Definition
Phase 1 of clinical pharmacology
Term
What is pharmacokinetics?
Definition
Study of absorption, metabolism, & excretion rates of the drug and its metabolites
Term
Who are the typical subjects in phase 1?
Definition
Typically young, healthy, male volunteers
Term
What happens in phase 2?
Definition
Drug's first use in patients with the disease of interest.
Term
What happens in phase 3?
Definition
Drug is given to patients in a "natural" setting.
Note: not enough patients are used in this stage to see rare SE (1 in 10k)
Term
What happens in phase 4?
Definition
Post market monitoring
Not a legal, required phase
Term
How long is the FDA review process suppose to take? And usually how long does it actually take?
Definition
Suppose to be 180 days following its submission but can be up to 7 years
on avg ~ 12 months in 1997
Term
What are the 2 FDA drug classification system?
Definition
Therapeutic type
Chemical type
Term
What are the 2 therapeutic types?
Definition
Type P: Priority is for REVIEW not approval
Type S: Standard
Term
What is the fee for submitting an NME?
Definition
$200k
Term
What are the 3 chemical type?
Definition
Type 1: new molecular/Chemical entity NME/MCE
Type 2: New salt, ester, or derivative
Type 3: New formulation
Term
What are some problems with new drug approval in the U.S?
Definition
1. Limited Number of subjects
2. Time Consideration
3. Expensive
4. Artificial Environment
5. Usually little formal monitoring of drug effect after approval
Term
What is the rule of thumb for the number of test subjects?
Definition
3 times the reciprocal of the incidence in order to have a 95% chance of seeing an event
Example: 1:1000 = 3k subjects needed
Term
What are the concerns with time consideration?
Definition
Too short - not enough time to observe delayed effects such as DES and uterine cancer in female offspring
Too long - depresses and discourages new drug development, limits # of developers, and keeps new drugs from patients
Term
What is the current estimated cost over 10-15 years to bring a new drug to market?
Definition
1.25 billion + dollars
Term
What is so bad about artificial environment?
Definition
Clinical studies do not duplicate "real world" use of drug
Term
What is a patent?
Definition
A grant of legal monopoly to any person who "invents or discovers a new and useful process / thing"
Term
What is a monopoly?
Definition
A market in which there is only one seller and many buyers
Term
What is another mechanism that encourages innovation?
Definition
Awards
Term
In what sense is the award system not very good?
Definition
The governing body chooses the direction of innovation
Term
How long did a patent last? How long does it last now and due to what act?
Definition
At first 17 years now 20 years due to Uruguay Agreements Act of 1994
Term
What does the patent essentially do?
Definition
Protects intellectual property
Term
What are the rights of a patent?
Definition
ONLY TO EXCLUDE all others from making, using, or selling their invention. No right for owner to make, use or sell.
Term
Patent owner's right is a ______right.
Definition
negative
Term
What is a trademark?
Definition
Any work, name, symbol or device, or any combo thereof adopted and used by a manufacturer or merchant to identify and distinguish his product from the others
Term
What is the purpose of a trademark?
Definition
1. Indicates origin or source
2. Used to extend monopoly through identification and loyalty
3. Product differentiation through marketing
Term
Brand names are an example of what?
Definition
Trademarks
Term
What did the Drug Price Competition and Patent Term Restoration Act of 1984 do?
Definition
Made it easier for generics to be approved while it also allowed Brand company to extend patent and the first to come out with the generic
Term
What is GNP and GDP?
Definition
Gross National Product
Gross Domestic Product
Term
What is the difference between GNP and GDP?
Definition
GNP is everything the US produces in the world vs GDP is everything the US produces inside the US
Term
Which one is most often used to compare US to other countries?
Definition
GDP
Term
Which one better shows short term trends in the economy?
Definition
GDP
Term
What is CPI and its definition?
Definition
Consumer Price Index and it measures changes in the prices of goods purchased by the typical urban family of 4
Term
What is MPI and what does it do?
Definition
Medical Price Index and its a sub-index of CPI, looking at the medical field
Term
What is PPI and what does it do?
Definition
Producer Price Index and it measures changes in the prices for a manufacturer
Term
CPI is the ratio of what?
Definition
new price to the original price x 100
Term
What happened to the role of government in the 1960s?
Definition
It became the payor due to medicare and medicaid
Term
What are the 4 major factors for health care inflation?
Definition
1. Health care expenditures
2. Population increase
3. Increased utilization/intensity of services
4. Inflation/health care inflation
Term
What are the two factors we can do nothing about and the two factors we have control over?
Definition
Can't do anything about: Population increase and general inflation
We can control health care inflation and health care utilization
Term
Compare and contrast price indexes include change over time for selected health care goods and services
Definition
Term
In terms of CPI what has increased at a greater rate than all others?
Definition
Medical care
Term
What are the top two contributors to the high costs of CPI?
Definition
Hospital service is major
Rx drugs are a close second
Term
What has happened to the burden on household income over time? Burden on business and gov't?
Definition
Household: burden not changed much at all
Business and Gov't: Burden increased ALOT
Term
Who are the employers shifting the cost of premiums to?
Definition
The employees
Term
For personal health care payments the direct out of pocket payment has done what?
Definition
It has steadily dropped
Term
Where does the US lie in health spending as a % of GDP vs other countries?
Definition
US has the highest health spending of % GDP
Term
For the amount of money the US spends on health care where do we rank in Infant Mortality Rate and Male Life expectancy?
Definition
US and Cuba have nearly the same IMR and we are not the highest for MLE
Term
What two states did Victor Fuchs do his study on?
Definition
Nevada and Utah
Term
What is the primary cause of death in young americans, Middle age death, and late middle age death?
Definition
Young Americans: Accidents
Middle Age Death: Heart disease
Late Middle Age Death: Heart, cancer, stroke, liver "life style disease"
Term
What are the four hallmarks of a competitive market?
Definition
1. Many buyers and sellers in the market
2. Offerings are for a standardized product or service which has an elastic demand
3. Market entry for new firms is free from barriers and resources are easily transferable
4. Consumers have complete info on prices, quality, and other factors
Term
What is elastic demand?
Definition
A condition where there is a definite relationship between the price of a product and the quantity which would be purchased
Term
How is health care a nearly universal demand?
Definition
Everyone gets sick therefore everyone is a buyer
Term
What are the characteristics that make the health care market unique from purely competitive market?
Definition
1. Nearly universal demand
2. Unpredictability of illness
3. Inelastic demand and supply
4. Health care as a "right"
5. Variation in products/services
6. Barriers to market entry
7. Lack of consumer information/interest
8. Physician as agent
9. Third partyism/insurance
Term
Elasticity tends to be more common for what kind of items?
Health care is considered what kind of item?
Definition
Elasticity tends to be more common for luxury items while most health care is deemed a necessity
Term
How is the idea of health care as a right related to in elasticity?
Definition
Because society deems it as a right they see to it that the goods/services should be paid for by the gov't and thus ignore the price of health care being charged yet still demanding the same level of care
Term
What are the barriers to market entry for health care?
Definition
Education
Certification
Licensure
Term
What can explain third-party insurance taking an active role in patient's health care?
Definition
Limited information for both price and quality
Term
What are the factors that can affect the demand and/or supply for health care?
Definition
Change in per capita income
Change in tastes of preference
Change in relative price
Change in financial system
Supply of manpower/facilities
Term
Describe how change in per capita income affects health care demand and supply
Definition
More $ = more demand
If health insurance covers it...why not?
Term
Describe how change in tastes and preference affects health care demand and supply
Definition
Individuals decide they want more or less Health care, preference- preventative vs acute MD vs non-MD
Term
Describe how change in relative price affects health care demand and supply
Definition
price increase = demand decrease
Term
Describe how change in financing system affects health care demand and supply
Definition
Patient increased out of pocket cost
Physicians: HMO can put them at risk
Term
What is the idea about risk in insurance?
Definition
To spread risk
Term
What are the 4 basic elements which constitutes an "insurable hazard"?
Definition
Probabilistic event over a population
Irregular event on an individual basis
Event must result in substantial loss
Loss must be measurable
Term
To be insurable what must be possible?
Definition
The ability to determine the probability of an event or hazard occurring.
Term
For individuals, the insurable event has what 2 things?
Definition
Low frequency
poor predictability
Term
What are the 2 basic functions of insurance?
Definition
1. Transfer risk
2. Pooling of risk
Term
How do you calculate a premium?
Definition
Premium = [(Probability of loss)(amount of loss)(risk factor)]+administrative costs
Term
What are the 4 terms that all relate to patient cost-sharing?
Definition
Premium
Deductible
Copayment
Coinsurance
Term
What is a premium?
Definition
The periodic payment required to keep a health insurance policy active
Term
What is a copayment?
Definition
An amount that must be paid by the insured to the provider for each visit
Term
What is a deductible?
Definition
An amount that must be paid by the insured before benefits will kick in. This amount is renewalable over a specific time frame
Term
What is coinsurance
Definition
An occurrence where both the insured person and the insurance company share the covered cost in a specific ratio 20:80
Term
What are the advantages of cost sharing?
Definition
Makes the patient be aware of the price of health care, decreases the cost of the insurer
Term
What is persons covered?
Definition
Individual(s) covered on the insurance policy
Term
What is defining the peril?
Definition
Seeing what is covered, what kind of events you are being insured against
Term
What are exclusions on an insurance policy?
Definition
Things and events that your insurance will not cover
Term
What are covered expenses?
Definition
The conditions and services that your insurance police will cover. Lots of stipulations like generics only or step therapy
Term
What is waiting period?
Definition
Also known as elimination period, refers to the time between the date on which you apply for insurance and when the insurance is effective
Term
What is cancellation and renewability?
Definition
Cancellation is when the insurance company voids your policy and Renewability refers to whether insured has the right to continue coverage
Term
What is the ideal policy called?
Definition
Non cancelable guaranteed renewable
Term
What is incontestability?
Definition
Refers to a clause that states that after a certain period of time no misstatements on your application will void the policy, unless they can prove you did it on purpose
Term
What are coordination of benefits?
Definition
Refers to the fact that a claim will not be double paid if there are two insurance
Term
What is indemnity?
Definition
Refers to situations in which benefits are paid, often to the patient, predetermined amount to cover the loss.
Term
What is hospitalization insurance?
Definition
Covers specifically services which patients receive while hospitalized. (lab work) Excludes physician care
Term
What is physician/medical insurance?
Definition
Covers physician care
Term
What is major medical insurance? Sometimes referred to as catastrophic insurance
Definition
Idea that covers very expensive illness
Term
What are the 2 basic types of major medical plans?
Definition
1. Supplement to a "basic" hospital-physician-surgeon expense policy
2. Combination of "basic" and "supplemental" policies into one which provides comprehensive protection, esp. for large, unpredictable medical expenses.
Term
What is medicare supplement "medigap" insurance?
Definition
Policies designed specifically for the elderly/ for medicare
Term
What is long term care insurance?
Definition
Designed to provide a range of maintenance and health services for the chronically ill, disabled, or mentally retarded
Term
What are the 3 major problems with the traditional health insurance system?
Definition
1. Ineffective at cost control
2. Often results in overutilization of health care
3. Some remain uninsured or underinsured
Term
What are possible solutions to ineffective cost control?
Definition
1. Increase cost sharing to decrease utilization and make consumers more cost conscious
2. Standardize payment schedules, rather than basing payments on historic provider changes
3. Place health care providers at financial risk
Term
What are the possible solutions to overutilization?
Definition
1. Increase cost sharing
2. Institute prior approval mechanism
3. Encourage substitution of outpatient for inpatient care when appropriate
Term
What are some possible solutions to those who are uninsured or underinsured?
Definition
1. Encourage use of comprehensive HMOs
2. Set "higher" minimum standards of health ins.
3. Expand government programs/NHI
Term
What is the approx % of American who don't have health insurance?
Definition
Approx 16% or 45-48 million people
Term
What are the 4 particular characteristics of the uninsured American?
Definition
1. Young - many uninsured are children
2. Not terribly poor
3. Working
4. Work for small companies
Term
What are the two segments of the health industry?
Definition
1. Public
2. Private
Term
Where is most of the money spend in the public sector?
Definition
Medicare and Medicaid
Term
What are the 3 basic forms of private ins?
Definition
Commercial ins
Blue Cross/Blue Shield
Self-insured employers
Term
What is adverse selection?
Definition
Refers to situations where an insurer has a group of very ill patient ie expensive patients
Term
What are the 3 cost advantages of group contracts over individual contracts for health insurance?
Definition
1. Decrease chance of adverse selection
2. Lower administrative costs
3. Tax advantage for employees
Term
What are the 2 reasons why there is lower administrative costs for a group contract?
Definition
1. 1 salesman for a group contract of 1000 vs 20 or 30 sales for 1000 individual contracts
2. Less paperwork / individual check up to determine premium ie less work overall
Term
What type of coverage has the most expensive administrative costs?
Definition
Private individual
Term
What is title 18 and 19 known as?
Definition
Medicare and Medicaid respectively
Term
Medicare is based on what philosophy?
Definition
Insurance philosophy that people have paid taxes into Social Security, so now they're receiving the benefits they paid for previously
Term
Medicaid is based on what philosophy?
Definition
Welfare philosophy, designed to redistribute the wealth from the have to the have nots
Term
Medicare is administered by whom?
Definition
Entirely the federal government
Term
Medicaid is administered by whom?
Definition
funded jointly by the state and the federal govt.
Term
In this joint force to regulate medicaid what does the feds do and what does the state do?
Definition
Fed - establishes the regulations and guidelines
State - responsible for the actual direction and day-to-day operations
Term
What are the key points in defining the term managed care?
Definition
integration of financing and provision of care
Term
What are the 4 primary types of managed health care plans?
Definition
1. HMOs (health maintenance organizations)
2. PPOs (preferred provider organizations)
3. Managed fee-for-service
4. Point of service
Term
What are the characteristics that an be used to define an HMO?
Definition
1. Serves a voluntarily enrolled population
2. Assumes responsibility for assuring delivery of a stated range of comprehensive health care services
3. Receives fixed payments from enrollees which are relatively independent of use of services
4. Assumes much of the financial risk or gain in the provision of health care services
Term
What is the key to the second characteristic of HMOs?
Definition
The responsibility for delivery of services

The comprehensive nature of those health care services
Term
How are HMOs different than traditional health care in the sense of receiving payments?
Definition
HMOs only require a minimum cost-sharing
Term
What happens when HMOs assume much of the financial risk?
Definition
HMOs demand for a higher quality of care and better utilization because their money is at risk. Prevention vs treatment
Term
Name the 4 HMO models
Definition
Staff model
Group model
Independent practice association
Network model
Term
What is the staff model?
Definition
HMO employs the physicians
Physicians paid a flat rate and fixed hours
Term
What is the group model?
Definition
HMO contracts with existing medical groups to serve the HMO's membership.
Medical groups are paid usually on capitation
Term
What is the IPA model?
Definition
HMOs contract with individual physicians
Physicians may be paid on a fee-for-basis or a capitation basis
Term
What is the network model?
Definition
Groups models with contract with more than one group practice and groups models with contract with independent practitioners
Term
What is to be said about HMOs statistically?
Definition
Over the years the number of HMOs has decreased due to mergers but the amount of people covered has increased
Term
What are the advantages to IPA model?
Definition
More acceptable to physicians
Lower capital investment
easier to cover a large geographic area
patient preferences
Term
What are the disadvantages to IPA?
Definition
Less physician loyalty to HMO
Uncertainty about ability of IPA to control cost
Term
What are the 3 basic HMO pharmacy services?
Definition
1. In house pharmacies
2. Closed network
3. Open network
Term
What is the distinguishing feature of an in-house pharmacy? And what model is associated with it?
Definition
Distinguishing feature is that the pharmacy is owned by the HMO and it is most commonly affiliated with staff model HMOs
Term
What is said about closed network pharmacies?
Definition
HMO is only contracted to a limited number of community pharmacies
Term
How do HMOs lower health care costs?
Definition
1. Promoting health
2. Reduce Utilization
3. Putting providers at risk
4. Quality Incentives
Term
What are some things that HMOs usually do to promote health?
Definition
Routine physicals
Immunizations
Well-baby care
ie preventive care, prevention programs
Term
HMO members tend to be more satisfied with what aspect of care?
Definition
The technical aspect of care such as coverage of preventive care, lower out-of-pocket costs, less paper, etc
Term
Based on mortality rates and disability days what is the general finding of quality of care from HMOs?
Definition
Just as good and very often better than traditional , fee-for-service plans
Term
What are the 5 distinguishing characteristics of PPOs?
Definition
1. Discounted services
2. Patient freedom-of-choice
3. Provider risk
4. Utilization review
5. Provider benefits
Term
Describe the freedom-of-choice in PPOs
Definition
Patients can seek physicians for health care at their own choice. Will have coverage regardless of the doc. but if out of network they will pay more
Term
What are the 2 benefits providers get for enrolling in PPOs?
Definition
1. Allows for the potential for what could be a substantial increase in provider's patient base
2. PPOs guarantee rapid payment of claims
Term
What are the benefits of PPO for consumers?
Definition
out-of-pocket cost savings
freedom-of-choice
increased access to care
Term
What are the benefits of PPO for insurers?
Definition
Reduced health care expenses
Counters cost shifting
utilization is monitored
Term
What are the benefits of PPO for pharmacies?
Definition
Maintain or expand patient base
Relatively quick claims payment
Still paid on a fee-for-service basis
Term
What did the 1935 Flood Control Act state?
Definition
Projects should only be pursued if the benefits outweigh the costs
Term
What is the medical model?
Definition
That it is assumed that if an intervention is available to help the patient it will be applied no matter what the cost
Term
What is the great failure to the medical model?
Definition
By logic all of a society's resources would go to health care (not possible)
Term
What is the ECHO model refer to?
Definition
Refers to Economics, Humanistic, and Clinical Outcomes
Term
What is the H to the ECHO model?
Definition
Refers to humanistic ie the quality of life of the patient.
Term
What is the goal of the ECHO model?
Definition
To give the best possible outcome achievable within the economic constraints
Term
What are the 4 key concepts of economics?
Definition
1. Resources are limited
2. There must be competing alternatives
3. The costs of inputs must be available
4. The consequences of inputs must be known
Term
What are the 4 E's of Economic evaluation?
Definition
1. Efficacy
2. Effectiveness
3. Equity
4. Efficiency
Term
What are the parameters to effectiveness?
Definition
How well the drug does in the real world
ie patient non compliance, SE, multiple disease
Term
What are the parameters to efficacy?
Definition
How the drug performs under ideal conditions, defines the upper limits of the drug's ability to treat the drug ie perfectly used
Term
What are the parameters of equity?
Definition
Can patient get access to it
ie Barriers such as cost, geographical, knowledge or cultural restrictions
Term
What are the parameters of efficiency?
Definition
In the end is this drug worth doing.
Are all the resources put into this drug worth it
Term
What is the primary reason of utilizing pharmacoeconomic analysis?
Definition
Efficiency
Term
What is pharmaceutical economics?
Definition
A sub-specialty of micro economics
Used to analyze pharmaceutical industry with micro econ tools
Term
What are macro and micro economics?
Definition
The examination of the allocation of resources every. Macro is applied to large economies such as nations which micro is applied to ideal competitive markets to predict behavior
Term
What is health economics?
Definition
Analysis of the market in the health sector since it is is different than normal competitive markets
Term
What is pharmacoeconomics?
Definition
Looks at the very special case of pharmaceutical products
Term
What 2 things does pharmacoeconomics allow us to do?
Definition
1. Allows us to see if an action is worth doing
2. Allows us to determine which purchase or policy or action gives us the most value.
Term
What is the 6 general steps to the pharmacoeconomic process?
Definition
1. Define problem
2. Select the perspective
3. Identify relevant alternatives
4. Establish framework and scope of analysis
5. Identify, Measure and Value Cost and Consequences
6. Analyze, interpret and derive conclusions
Term
To define a problem it must be what?
Definition
It must be in an answerable form
It must be measurable
The key is to be very specific and define a narrow problem
Term
What are the common perspectives to chose from during the process?
Definition
Payer - direct cost that must be paid
Provider -Direct cost that impact budget
Public (society)- All direct and indirect cost regardless of who pays them
Patient - direct cost (out of pocket) and indirect cost (loss of work or travel expenses)
Term
What is the goal to establish framework and scope of analysis?
Definition
To make the alternative courses of action/treatments and the consequences of each explicit
Term
By establishing framework and scope of analysis what should be defined?
Definition
The who
The what
The when and how of data collection
Term
What is our best estimate of the cost of the resource?
Definition
The lost opportunity cost
Term
What is the economic definition of cost?
Definition
The consumption of a resource that could otherwise have been used for something else
Term
What are factors that influence cost?
Definition
1. influenced by the perspective that is adopted
2. Common costs that are dropped
3. The magnitude of costs (too small not considered, too big will dominate analysis)
Term
The most important costs should be subject to what?
Definition
To sensitivity analysis
Term
What are the cost classifications?
Definition
Direct
Indirect
Medical
Nonmedical
Term
Define direct medical costs
Definition
Those resources consumed due to illness or intervention.
Can be clinical or therapeutic
Term
Define direct non-medical costs
Definition
non-clinical resources consumed in response to illness or treatment
Best example: costs to travel to get treatment
Term
Define indirect medical costs
Definition
Things such as lost earnings or lower productivity of the patient
Term
Define indirect non-medical costs
Definition
Costs like pain and suffering of patient
Term
How do we know know if indirect is more important that direct and vice versa?
Definition
Depends on the perspective we take at the beginning of the process
Term
What is capital cost?
Definition
Costs involving the financing of buildings, land, and equipment etc.
Term
What are operating costs?
Definition
Costs involved in the resources being used during care or service
Term
What are fixed costs?
Definition
Costs that are consumed regardless of whether a product or service will be provided ie mortgage on building, electric
Term
What are variable costs?
Definition
Costs that are related to the amount of production or services provided
Term
What are total costs?
Definition
Sum of all resources consumed
Term
What is average costs?
Definition
Cost of the resources used per unit of production
Term
What is marginal cost aka incremental cost?
Definition
Incremental increase in resources consumed to produce one more unit of product
Term
In economics what is considered the most efficient level of production?
Definition
The lowest marginal cost
Term
What is most important in cost effective analysis?
Definition
Marginal cost
Term
What is cost description?
Definition
The simple determination or measurement of the cost of a single alternative
Term
What is COI?
Definition
It is the Cost of illness also known when an entire disease state is examined
Term
What do COI's assess?
Definition
How and where resources are being used
Term
What is cost analysis?
Definition
When two or more alternatives are compared only on cost
Term
What is CMA?
Definition
Cost Minimization Analysis, it compares 2 or more alternatives when the effect has been proven to be equal
Term
What is CBA?
Definition
Cost-benefit Analysis
The first and most formal economic analysis where everything is converted to monetary value
Term
What are some CBA limitations?
Definition
Since everything is converted to a monetary value it is difficult to accurately assess direct benefits like improved standard of living
Term
What is CEA?
Definition
Cost Effectiveness Analysis, intent is to determine which alternative produces units of change at the lowest cost per unite of change
Term
What is CUA?
Definition
Cost utility analysis, a variant of CEA, it expresses the consequence in terms of utility
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