WorksheetsIPP Exam 2 - Drug Use, Access, and Role of Pharm Industry
Total questions: 32
Worksheet time: 16mins
Name
Class
Date
1.
What are some characteristics of brand name drugs
a)
the original product
b)
carries a trademark name
c)
exclusivity
d)
a drug manufactured after patent expiration
e)
multiple companies may compete
2.
What are some characteristics of generic drugs
a)
the original product
b)
not protected by a trademark
c)
exclusivity
d)
a drug manufactured after patent expiration
e)
multiple companies may compete
3.
What are some characteristics of specialty pharmaceuticals
a)
high cost
b)
prescribe by a specialist physician
c)
supply chain concerns
d)
safety issues require unique monitoring
e)
self-administered drugs
4.
Biological pharmaceutical products are
a)
isolated from natural sources
b)
composed of sugars, proteins, and nucleic acids
c)
potentially sensitive to heat and susceptible to microbial contamination
d)
isolated from synthetic sources
e)
are themostable and resistent to bacteria
5.
Medications are valuable because they are
a)
the most cost effective
b)
the least invasive
c)
the preferred option for most medical conditions
d)
the most basic solution
6.
What is the insruance company who is offering a policy for coverage of medication considered
a)
Payor
b)
Provider
c)
Manufacturer
d)
Distributor
e)
Pharmacy benefit manager
7.
What is the health care entity that prescribes medications
a)
Payor
b)
Provider
c)
Manufacturer
d)
Distributor
e)
Pharmacy benefit manager
8.
What is the company that makes pharmaceuticals
a)
Group purchasing organization
b)
Pharmacy services adminsitration organization
c)
Manufacturer
d)
Distributor
e)
Pharmacy benefit manager
9.
What is the group that purchases products from manufacturers, stores the products, and transports it
a)
Group purchasing organization
b)
Pharmacy services adminsitration organization
c)
Manufacturer
d)
Distributor
e)
Pharmacy benefit manager
10.
Who aggregates purchasing volume of multiple providers and pharmacies to negotiate discounds with manufactuers
a)
Group purchasing organization
b)
Pharmacy services adminsitration organization
c)
Manufacturer
d)
Distributor
e)
Pharmacy benefit manager
11.
Who negoiates formularies for medication coverage and cost with providers and pharmacies
a)
Group purchasing organization
b)
Pharmacy services adminsitration organization
c)
Manufacturer
d)
Distributor
e)
Pharmacy benefit manager
12.
Who provides consulting services and negotiaton of contract with PBMs and payors for smaller pharmacies
a)
Group purchasing organization
b)
Pharmacy services adminsitration organization
c)
Manufacturer
d)
Distributor
e)
Pharmacy benefit manager
13.
What does the Drug Supply Chain Security Act do
a)
aims to protect against counterfeit, contaminated, or stolen drugs
b)
requires end-to-end traceability of prescription pharmaceuticals through interoperable electronic systems
c)
all trading partners must be authorized
d)
enables saleable returns
14.
What are some ways a pharmacy can protect again counterfeit drugs
a)
pedigree system
b)
drug traceability
c)
bar code
d)
RFID
e)
block chain
15.
What type of counterfeit protection involves having a record of each prior sale, purchase, or trade of medications
a)
pedigree system
b)
drug traceability
c)
bar code
d)
RFID
e)
block chain
16.
What type of counterfeit protection involves "track and trace" transactions throughout the supply chain
a)
pedigree system
b)
drug traceability
c)
bar code
d)
RFID
e)
block chain
17.
What type of counterfeit protection involves a decentralized and distributed ledger system
a)
pedigree system
b)
drug traceability
c)
bar code
d)
RFID
e)
block chain
18.
What are some centers within the FDA that regulate different aspects
a)
drugs
b)
biologics
c)
medical devices
d)
animal and veterinary
e)
radio-emitting products
19.
What are some responsibilities of the FDA
a)
approves drugs, ensures safety of drugs and manufacturers, recalls drugs
b)
communicates safety information to providers and public
c)
communicates shortages, provides drug information
d)
regulates labeling and advertising
e)
conducts postmarketing surveillance for unanticipated problems after approval
20.
Why would there be a drug recall
a)
a drug is not making enough profit in a specified time frame
b)
protect the public from defective or harmful products
c)
a drug is being manufactured at a different facility and therefore the old facility's product must be taken back
21.
Who can initiate a drug recall
a)
drug company
b)
FDA
c)
public
d)
news stations
22.
What is the correct order of the FDA drug recall classification from most dangerous to least dangerous
a)
I, II. III
b)
III, II, I
c)
I, III, II
d)
II, I, III
23.
During FDA recalls, which class is a dangerous or defective product that could cause serious health problems or death
a)
I
b)
II
c)
III
24.
During FDA recalls, which class is a product that might cause a temporary health problem, or pose slight threat of a serious nature
a)
I
b)
II
c)
III
25.
During FDA recalls, which class is a product that is unlikely to cause any adverse health reaction, but that violates FDA labeling or manufacturing laws
a)
I
b)
II
c)
III
26.
How are drug recalls announced
a)
lot numbers are used to find the affected products
b)
public notice depends on the extent of the recall
c)
FDA website includes specific details of each recall
d)
each patient with the affected product will be contacted
27.
What are some reasons why there are drug shortages
a)
lack of incentives for manufacturers to produce drugs that are less profitable
b)
no market incentive for companies to have risk management and back-up manufacturing capabilities
c)
no incentive for early recognition of supply chain issues
d)
logistical and reguatory challenges to recovering after a disruption
28.
What are some areas of potential improvement for drug shortages
a)
lengthened expiration dates
b)
improved data sharing
c)
risk management plans
d)
quantification of shortages and the harm caused
e)
changes to contract terms and ratings of quality proceses
29.
What may a REMS require to reduce a specific serious risk listed in the labeling of a drug
a)
prescribers have specific training/experience or special certifications
b)
pharamcies, practitioners or healthcare settings that dispense the drug must be specially certified
c)
drug must be dispensed with evidence of safe-use conditions such as laboratory test results
d)
each patient is subject to monitoring and must be enrolled in a registry
e)
drug can only be dispensed in specific healthcare settings
30.
What are some contributions to high drug prices
a)
companies can charge what the market will bear
b)
specialty drugs are increasing
c)
lobbyists influence lawmakers
d)
mergers and acquisitions of drug companies
e)
pay to delay
31.
What are some marketing strategies that drug companies employ
a)
advertise products to prescribers
b)
provide incentives for managed care organizations to add the drugs to formularies
c)
provide samples to prescribers to get patients on the medication
d)
direct to consumer advertising
32.
What is pay for delay
a)
brand manufactuers pay generic company not to market generic
b)
stifle competition and maintain market share
c)
drug companies pay patients to delay reporting any adverse effects
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