PTCB Complete Study Review with Solutions
According to the World Health Organization (WHO), a
health care system is defined as a system that consists of
Health Care system
organizations, institutions, and resources of people whose
primary purpose is to improve public health
Provides service for the elderly and disabled individuals
Medicare
(must meet a certain criteria)
Provides service for lower income individuals. Federally
Medicaid
and state funded
AKA military insurance; provides service to veterans and
Tricare
soldiers
NIH National Institute of Health
Most employers provide health insurance to full time em-
Employer Insurance
ployees
Individuals can apply and pay for health insurance. Small-
Private Insurance
er businesses otter group rates to their employees.
The remaining amount an individual must pay for their
Copay medication after insurance. This form of payment is col-
lected at the point of sale (ie the pharmacy)
Medicare A Covers inpatient hospital stays
Covers outpatient hospital stays and diabetic supplies,
DME (durable medical equipment), patients on long term
Medicare B
disabilities, X-rays, dialysis, vaccines, and respiratory neb-
ulizers
Additional coverage not covered under A or B. Often called
Medicare C
the advantage plan or choice plan.
Covers prescription medications; usually processed by pri-
Medicare Part D vate insurance but funding is provided by CMS (govern-
ment)
Medicare Part E
,Supplemental coverage; covers A, B, and D (Ditterent than
just Medicare C)
Medicare C only covers A and B
HMO Health Maintenance organization
With an HMO plan, you must select a primary care physi-
cian (PCP) from .a network of local healthcare providers
who will refer you to in-network specialists or hospitals
Health Maintenance Organization (HMO) when necessary.
All of your care is coordinated through your PCP
Lost cost to the insurance and the patient
PPO preferred provider organization
Recommended list of in-network providers and hospitals
-If you choose a provider outside of your network, your
Perferred Provider Organization (PPO)
copay may be higher
-More flexibility= pay more money per month
EPO Exclusive Provider Organization
Sort of like a combination between HMO's and PPO's
-There is a recommended list of providers and specialists
Exclusive Provider Organization (EPO) but cannot pick a provider outside of network
-You can pick any primary care physician but they must be
in-network
When a patient has been hurt at work and his/her com-
Workers Compensation
pany has agreed to pay for the cost of his/her medication
Individuals without health care coverage and have to pay
out of pocket
out of pocket expenses
Pharmacy Benefit Managers
,PBM
-Primarily responsible for developing and maintaining the
formulary, contracting with pharmacies, negotiating dis-
counts and rebates with drug manufacturers, and pro-
cessing and paying prescription drug claims.
-Working with self-insured companies and government
programs; trying to reduce pharmacy expenditures of the
plan and trying to improve health outcomes
Complex and time consuming; on average it takes 8-15
Drug Development years for a drug to be developed and approved by the
Food and Drug Administration
1. Research
3 Basic Steps of Drug Development 2. Testing
3. Approval
Can be done be pharmacologists, toxicologists, clinical
pharmacologists, pharmacists, and physicians
Research
-The objective of research is to find a new active ingredient
or to modify the structure of existing drugs
The food and drug administration was established in
1906
FDA Regulation -Charged with the regulation of medications ensuring
their safety and ettectiveness before medications are
brought to market
In the laboratory
Where does testing begin? -Stability
-Structure
-Dosage forms of the drug
Tests are done in animals to assess
, Toxicity
- A new drug must be deemed safe before used in humans
How many steps is the approval process for testing in
4
humans regulated by the FDA?
Objective: To assess the initial dose and to determine if
humans can tolerate the drug (toxicology)
Human Test Phase 1
-A new drug is tested on a few healthy individuals at the
lowest dose and is slowly increased
absorption, distribution, metabolism, biotransformation,
Pharmacokinetics
and excretion
Most drugs do not make it past phase __________________________ 2
When the drug passes the first phase
-The drug is tested on a few hundred volunteers who have
the disease the drug is intended for
Human Test Phase 2 -Extensive data on pharmacokinetic and toxicology profile
of the drug are collected in this phase
-The optimal dose of the drug is determined in this phase
-Must pass phase 2
- Drug is tested on thousands of patients in a health care
setting
Human Test Phase 3
-Must be randomized, double blind (drug or placebo)
controlled study
-Test the eflcacy of the drug
AKA Post market surveillance phase
-The drug has reached an approval by the FDA
Human Test Phase 4
-Drug interactions, use in pregnancy, and long term side
ettects are examined
According to the World Health Organization (WHO), a
health care system is defined as a system that consists of
Health Care system
organizations, institutions, and resources of people whose
primary purpose is to improve public health
Provides service for the elderly and disabled individuals
Medicare
(must meet a certain criteria)
Provides service for lower income individuals. Federally
Medicaid
and state funded
AKA military insurance; provides service to veterans and
Tricare
soldiers
NIH National Institute of Health
Most employers provide health insurance to full time em-
Employer Insurance
ployees
Individuals can apply and pay for health insurance. Small-
Private Insurance
er businesses otter group rates to their employees.
The remaining amount an individual must pay for their
Copay medication after insurance. This form of payment is col-
lected at the point of sale (ie the pharmacy)
Medicare A Covers inpatient hospital stays
Covers outpatient hospital stays and diabetic supplies,
DME (durable medical equipment), patients on long term
Medicare B
disabilities, X-rays, dialysis, vaccines, and respiratory neb-
ulizers
Additional coverage not covered under A or B. Often called
Medicare C
the advantage plan or choice plan.
Covers prescription medications; usually processed by pri-
Medicare Part D vate insurance but funding is provided by CMS (govern-
ment)
Medicare Part E
,Supplemental coverage; covers A, B, and D (Ditterent than
just Medicare C)
Medicare C only covers A and B
HMO Health Maintenance organization
With an HMO plan, you must select a primary care physi-
cian (PCP) from .a network of local healthcare providers
who will refer you to in-network specialists or hospitals
Health Maintenance Organization (HMO) when necessary.
All of your care is coordinated through your PCP
Lost cost to the insurance and the patient
PPO preferred provider organization
Recommended list of in-network providers and hospitals
-If you choose a provider outside of your network, your
Perferred Provider Organization (PPO)
copay may be higher
-More flexibility= pay more money per month
EPO Exclusive Provider Organization
Sort of like a combination between HMO's and PPO's
-There is a recommended list of providers and specialists
Exclusive Provider Organization (EPO) but cannot pick a provider outside of network
-You can pick any primary care physician but they must be
in-network
When a patient has been hurt at work and his/her com-
Workers Compensation
pany has agreed to pay for the cost of his/her medication
Individuals without health care coverage and have to pay
out of pocket
out of pocket expenses
Pharmacy Benefit Managers
,PBM
-Primarily responsible for developing and maintaining the
formulary, contracting with pharmacies, negotiating dis-
counts and rebates with drug manufacturers, and pro-
cessing and paying prescription drug claims.
-Working with self-insured companies and government
programs; trying to reduce pharmacy expenditures of the
plan and trying to improve health outcomes
Complex and time consuming; on average it takes 8-15
Drug Development years for a drug to be developed and approved by the
Food and Drug Administration
1. Research
3 Basic Steps of Drug Development 2. Testing
3. Approval
Can be done be pharmacologists, toxicologists, clinical
pharmacologists, pharmacists, and physicians
Research
-The objective of research is to find a new active ingredient
or to modify the structure of existing drugs
The food and drug administration was established in
1906
FDA Regulation -Charged with the regulation of medications ensuring
their safety and ettectiveness before medications are
brought to market
In the laboratory
Where does testing begin? -Stability
-Structure
-Dosage forms of the drug
Tests are done in animals to assess
, Toxicity
- A new drug must be deemed safe before used in humans
How many steps is the approval process for testing in
4
humans regulated by the FDA?
Objective: To assess the initial dose and to determine if
humans can tolerate the drug (toxicology)
Human Test Phase 1
-A new drug is tested on a few healthy individuals at the
lowest dose and is slowly increased
absorption, distribution, metabolism, biotransformation,
Pharmacokinetics
and excretion
Most drugs do not make it past phase __________________________ 2
When the drug passes the first phase
-The drug is tested on a few hundred volunteers who have
the disease the drug is intended for
Human Test Phase 2 -Extensive data on pharmacokinetic and toxicology profile
of the drug are collected in this phase
-The optimal dose of the drug is determined in this phase
-Must pass phase 2
- Drug is tested on thousands of patients in a health care
setting
Human Test Phase 3
-Must be randomized, double blind (drug or placebo)
controlled study
-Test the eflcacy of the drug
AKA Post market surveillance phase
-The drug has reached an approval by the FDA
Human Test Phase 4
-Drug interactions, use in pregnancy, and long term side
ettects are examined
