CSP EXAM TEST (SPECIALTY PHARMACY) WITH CORRECT ANSWERS 2024
!!|GUARANTEED PASS
The fastest growing segment of the pharmaceutical market and the highest priced
segment, is ______________________. - (ANSWER)specialty drugs
What is a specialty drug (According to AMCP)? - (ANSWER)a product can be classified as a
specialty pharmaceutical if:
It requires a difficult or unusual process of delivery to the patient (preparation, handling,:lkj%$^&*()
storage, inventory, distribution, Risk Evaluation and Mitigation Strategy (REMS) programs,
data collection, or administration) or,
Patient management prior to or following administration (monitoring, disease or
therapeutic support systems).
What is the Medicare Definition of Specialty Drug for Part D? - (ANSWER)Any drug costing
more than $600 per month
Describe the Health Plans' Definitions of Specialty Drug. - (ANSWER)The percentages
indicate the percentage of plans indicating the factor has impact or great impact on
whether a drug is categorized as a specialty product. Health plans, as does Medicare, have
a primary interest in paying for drugs. I suspect this is why high cost is the most frequently
mentioned part of health plans' specialty drug definition.
Most, but not all, specialty drugs are _____________; some are ____________ drugs -
(ANSWER)1.) biologics
2.) chemical
Chemical drugs fall under most definitions of specialty drugs because they are what? -
(ANSWER)1.) some combination of very expensive
2.) require special handling
3.) treat rare disease
4.) require ongoing assessment of response
5.) require patient administration training
6.) require monitoring of side effects
7.) have an FDA mandated REMS
What are some different names for biologics? - (ANSWER)1.) large molecule drug
2.) Biologic drug
What are some different names for traditional, non-biologic drugs? - (ANSWER)1.) drug
2.) small molecule
,CSP EXAM TEST (SPECIALTY PHARMACY) WITH CORRECT ANSWERS 2024
!!|GUARANTEED PASS
3.) chemical drug
According to BIO, the trade association representing biotech companies, a biologic is
what? - (ANSWER)manufactured in a living system such as a microorganism, or plant or
animal cells. Most biologics are very large, complex molecules or mixtures of molecules
:lkj%$^&*()
According to BIO, the trade association representing biotech companies, a non-biologic is
what? - (ANSWER)is typically manufactured through chemical synthesis, which means that
it is made by combining specific chemical ingredients in an ordered process
Describe the size of Non-biologic, or chemical, drugs. - (ANSWER)tend to be much smaller,
simpler molecules.
Most biologics are ______________, so they cannot be taken orally - ______________________.
- (ANSWER)1.) proteins
2.) they must be injected
Because biologics are large, complex proteins they can be made less effective by what? -
(ANSWER)1.) high temperatures
2.) excessive shaking
3.) exposure to light
Biologics are contaminated by ____________ much more easily than chemical drugs. -
(ANSWER)microbials
Because of there potential for contamination, biologics require what? - (ANSWER)require
special handling and storage
Why are biologics more expensive than chemical drugs? - (ANSWER)Because they must be
grown in organisms, they are much more expensive to produce than chemical drugs. This
accounts for at least part of their much higher cost.
Biologics (and non-biologic specialty drugs) are frequently used to treat what? -
(ANSWER)high risk conditions that if not properly treated can result in patient death or
significant deterioration in physical functioning, e.g. rheumatoid arthritis.
Biologics (and non-biologic specialty drugs) also frequently have significant ____________. -
(ANSWER)side effects
, CSP EXAM TEST (SPECIALTY PHARMACY) WITH CORRECT ANSWERS 2024
!!|GUARANTEED PASS
Biologics (and non-biologic specialty drugs) also frequently have significant side effects. As
a result, what are critical parts of therapy? - (ANSWER)patient monitoring for response to
therapy and for side effects and patient education
Because biologic drugs are so expensive, payers want to make sure that patients are what?
:lkj%$^&*()
- (ANSWER)responding to treatment
Many specialty drugs are also subject to FDA approved _____________________. -
(ANSWER)Risk Evaluation and Mitigation Strategies (REMS)
Why is harder to characterize (chemically) a biologic product than a traditional chemical
drug? - (ANSWER)The biologics are just bigger by several orders of magnitude.
Describe the relationship between specialty, chemical, and biologic drugs. - (ANSWER)
In 2012, specialty drugs accounted for ___________% of prescriptions, but for ________% of
drug sales. - (ANSWER)1.) less than 1%
2.) 25%
In 2016, specialty pharmacy was _______% of the $450 billion pharmaceutical marketa -
(ANSWER)40%
Traditional drug sales expected to *decline* ______% in the next few years while specialty
drug sales are expected to grow by ______% per year. - (ANSWER)1.) 1-2%
2.) 22%
By 2020 ESRx estimates specialty will account for _______% of US drug spending -
(ANSWER)50%
What type of disease are treated with specialty drugs? - (ANSWER)For the most part,
specialty drugs treat relatively rare conditions (those with small populations of patients).
What are examples of rare diseases treated with specialty drugs? - (ANSWER)1.) Multiple
sclerosis
2.) Cancers
3.) Gaucher's Disease
4.) Hemophelia
!!|GUARANTEED PASS
The fastest growing segment of the pharmaceutical market and the highest priced
segment, is ______________________. - (ANSWER)specialty drugs
What is a specialty drug (According to AMCP)? - (ANSWER)a product can be classified as a
specialty pharmaceutical if:
It requires a difficult or unusual process of delivery to the patient (preparation, handling,:lkj%$^&*()
storage, inventory, distribution, Risk Evaluation and Mitigation Strategy (REMS) programs,
data collection, or administration) or,
Patient management prior to or following administration (monitoring, disease or
therapeutic support systems).
What is the Medicare Definition of Specialty Drug for Part D? - (ANSWER)Any drug costing
more than $600 per month
Describe the Health Plans' Definitions of Specialty Drug. - (ANSWER)The percentages
indicate the percentage of plans indicating the factor has impact or great impact on
whether a drug is categorized as a specialty product. Health plans, as does Medicare, have
a primary interest in paying for drugs. I suspect this is why high cost is the most frequently
mentioned part of health plans' specialty drug definition.
Most, but not all, specialty drugs are _____________; some are ____________ drugs -
(ANSWER)1.) biologics
2.) chemical
Chemical drugs fall under most definitions of specialty drugs because they are what? -
(ANSWER)1.) some combination of very expensive
2.) require special handling
3.) treat rare disease
4.) require ongoing assessment of response
5.) require patient administration training
6.) require monitoring of side effects
7.) have an FDA mandated REMS
What are some different names for biologics? - (ANSWER)1.) large molecule drug
2.) Biologic drug
What are some different names for traditional, non-biologic drugs? - (ANSWER)1.) drug
2.) small molecule
,CSP EXAM TEST (SPECIALTY PHARMACY) WITH CORRECT ANSWERS 2024
!!|GUARANTEED PASS
3.) chemical drug
According to BIO, the trade association representing biotech companies, a biologic is
what? - (ANSWER)manufactured in a living system such as a microorganism, or plant or
animal cells. Most biologics are very large, complex molecules or mixtures of molecules
:lkj%$^&*()
According to BIO, the trade association representing biotech companies, a non-biologic is
what? - (ANSWER)is typically manufactured through chemical synthesis, which means that
it is made by combining specific chemical ingredients in an ordered process
Describe the size of Non-biologic, or chemical, drugs. - (ANSWER)tend to be much smaller,
simpler molecules.
Most biologics are ______________, so they cannot be taken orally - ______________________.
- (ANSWER)1.) proteins
2.) they must be injected
Because biologics are large, complex proteins they can be made less effective by what? -
(ANSWER)1.) high temperatures
2.) excessive shaking
3.) exposure to light
Biologics are contaminated by ____________ much more easily than chemical drugs. -
(ANSWER)microbials
Because of there potential for contamination, biologics require what? - (ANSWER)require
special handling and storage
Why are biologics more expensive than chemical drugs? - (ANSWER)Because they must be
grown in organisms, they are much more expensive to produce than chemical drugs. This
accounts for at least part of their much higher cost.
Biologics (and non-biologic specialty drugs) are frequently used to treat what? -
(ANSWER)high risk conditions that if not properly treated can result in patient death or
significant deterioration in physical functioning, e.g. rheumatoid arthritis.
Biologics (and non-biologic specialty drugs) also frequently have significant ____________. -
(ANSWER)side effects
, CSP EXAM TEST (SPECIALTY PHARMACY) WITH CORRECT ANSWERS 2024
!!|GUARANTEED PASS
Biologics (and non-biologic specialty drugs) also frequently have significant side effects. As
a result, what are critical parts of therapy? - (ANSWER)patient monitoring for response to
therapy and for side effects and patient education
Because biologic drugs are so expensive, payers want to make sure that patients are what?
:lkj%$^&*()
- (ANSWER)responding to treatment
Many specialty drugs are also subject to FDA approved _____________________. -
(ANSWER)Risk Evaluation and Mitigation Strategies (REMS)
Why is harder to characterize (chemically) a biologic product than a traditional chemical
drug? - (ANSWER)The biologics are just bigger by several orders of magnitude.
Describe the relationship between specialty, chemical, and biologic drugs. - (ANSWER)
In 2012, specialty drugs accounted for ___________% of prescriptions, but for ________% of
drug sales. - (ANSWER)1.) less than 1%
2.) 25%
In 2016, specialty pharmacy was _______% of the $450 billion pharmaceutical marketa -
(ANSWER)40%
Traditional drug sales expected to *decline* ______% in the next few years while specialty
drug sales are expected to grow by ______% per year. - (ANSWER)1.) 1-2%
2.) 22%
By 2020 ESRx estimates specialty will account for _______% of US drug spending -
(ANSWER)50%
What type of disease are treated with specialty drugs? - (ANSWER)For the most part,
specialty drugs treat relatively rare conditions (those with small populations of patients).
What are examples of rare diseases treated with specialty drugs? - (ANSWER)1.) Multiple
sclerosis
2.) Cancers
3.) Gaucher's Disease
4.) Hemophelia
