POP Capstone Test Flashcards
1
Q
Post-marketing studies are an example of what phase commitment after a drug is approved
A
Phase IV
2
Q
What is an example of passive surveillance to monitor a drug after approval
A
Spontaneous reporting of adverse drug reactions
3
Q
Limitation of the FDA Adverse Event Reporting System (FAERS)
A
Inability to estimate the population of exposure
4
Q
Pharmacovigiliance is the science and activities relating to the
A
Detection, assessment, understanding, and prevention of adverse effects or other drug-related problems
5
Q
What is true regarding safety signals for drugs in post-marketing surveillance
A
Usually there are multiple case reports
6
Q
Example of an Elemnt to Assure Safe Use of a drug
A
Negative pregnancy test required before dispensing a prescription
7
Q
Primary role of the United States Pharmacopeia (USP)
A
Develop and publish standards for drugs
8
Q
USP standards are set by
A
Council of experts
9
Q
Regulatory agency primarily responsible for the small, traditional compounding of drugs
A
State Boards of Pharmacy
10
Q
When can a pharmacy compound a drug that is commercially available
A
When a shortage exists
11
Q
The regulation of “A television advertisement about a disease or condition which does not recommend a particular medication” is done by the?
A
Federal Trade Commission
12
Q
In addition to the U.S., what country allows direct to consumer advertising of prescription drugs?
A
New Zealand
13
Q
Which of the following is the best available source for current prescription drug prescribing information?
A
DailyMed
14
Q
Situations, when a drug should not be used because the risk of use outweighs any possible therapeutic benefit for the labeled indication, is found under the following section of the official label?
A
Contraindications
15
Q
Which of the following can be found in the Patient Counseling Information section of the official prescribing information:
A
Storage and Handling
NOT the labeled use, when to contact the manufacturer, or the suggested retail price
16
Q
Which of the following is an important reference regarding the off-label use of prescription drugs?
A
DrugDex
NOT DailyMed, PDR, or all of the above
17
Q
Who determines if the off-label promotion of prescription drugs is false and misleading?
A
Office of Prescription Drug Promotion
18
Q
The governmental entity that determined Amarin’s off-label promotion was “free speech?”
A
The Second Circuit Court of Appeals
19
Q
Which of the following is considered an alternative to samples that can be “prescribed” by a provider and filled in a pharmacy at no charge?
A
Voucher
20
Q
Patient Assistance Programs (PAPs) can do what?
A
Improve patient outcomes
NOT considered a kickback, cost health plans money, or accessed by billing out one form for all companies
21
Q
The following term describes an intermediary from whom a hospital would agree to purchase most of their drugs:
A
Prime Vendor
NOT Primary warehouse, repackager, or specialty distributor
22
Q
Eample of a major wholesaler
A
AmeriSource/Bergen
NOT Morris and Dickson, HD Smith, Curascript
23
Q
A statement that must accompany the distribution of a drug from a wholesaler is known as:
A
Pedigree
NOT origin, custody, heritage
24
Q
The Drug Supply Chain Security Act contains the following requirement?
A
Provides tracing information for drugs within the supply chain
25
Health-systems generally respond to shortages by doing which of the following:
Order larger quantities than usual Continue using the product until supplies are exhausted
Ration or allocate product for specific clinical situations
26
A drug category that is most likely to experience a shortage for economic reasons is
Generic Injectable
27
True/False: Shortage are an important cause of medication-related errors
True
28
Who is the "first party" in the US healthcare system?
The patient
NOT the payor, provider, none of the above
29
Iatrogenic hazards or incidents that are inherent risks of drug therapy are best described as?
Medication misadventures
NOT adverse drug events or reactions, medication errors
30
System design issues that lead to medication errors
Latent conditions
NOT lapses, active failures, medication misadventures
31
Which is considered a full economic analysis? Cost-minimization, Cost-outcome, Cost analysis, or Cost description?
Cost-minimization
32
Type of economic analysis that uses QALYs
Cost-Utility
33
Method that Medicare uses to pay hospitals for a patient's hospital stay
Inpatient Prospective Payment System
34
True/False: All hospitals receive the same payment from Medicare for the treatment of a patient based on the patient’s diagnosis.
False
35
When new expensive drugs are approved to treat new conditions, Medicare will approve an add-on payment if, the drug is:
Demonstrated to be a substantial clinical improvement over existing drugs
36
In terms of Medicare, hospitals that serve a high percentage of low-income patients are called ____________ hospitals.
Disproportinate Share Hospitals
NOT Critical Access, Title II, or Charity Care
37
Medicare can reduce payments to hospitals who display:
High 30-day readmissions for heart failure patients
38
Section 340B of the Public Health Serve Act allows:
Covered entities to purchase outpatient drugs at a discount
39
Which of the following is an example of a drug that could be designated high-priority non-formulary?
An expensive medication for a metabolic deficiency disorder that has a short shelf-life
NOT
B. An affordable oral antihypertensive available as brand only and is used as add-on therapy
C. An expensive antidote for anticoagulants approved in patients with life-threatening hemorrhage
D. An affordable injectable medication for psoriatic arthritis that requires administration by a healthcare professional
40
Which of the following are recommended by the Institute for Safe Medication Practice to assess an institution’s Formulary?
The Formulary includes almost no duplication of generic equivalents
NOT The Formulary restricts access to expensive medications, The Formulary provides at least one alternative therapeutic equivalent for applicable drugs
41
Which of the following is the biggest type of insurance provider in the US (i.e., insures the highest number of people)?
Commercial/employer
42
Which plan type has high premiums but offers great network flexibility, meaning that members can see any provider they choose?
PPO
43
Which of the following is typically a fixed dollar amount of a pharmacy or medical bill paid for by the patient?
Copay
44
As monthly premiums go up, other patient out of pocket costs (deductibles, copays, and coinsurance):
Go down
45
Which utilization management tool requires doctors to provide additional information to determine if the patient meets the eligibility criteria for the prescribed drug?
Prior Authorization
46
Which of the following books of business differs from others because members typically stay with the plan for less than 5 years and a group purchases the plan rather than an individual?
Commercial/employer
47
According to the assigned reading, “Health Affairs: Pharmacy Benefit Mangers,” what is the share of invoice prices that go to rebates, according to a report by the brand-name drug sector (2015)?
26%
48
According to the assigned reading “AMCP Guide to Pharmaceutical Payment Methods,” which of the following best describes average sales price (ASP)?
Calculated as volume of weighted average of manufacturer’s reported total sales, only applicable to physician-administered drugs
49
According to the assigned reading “AMCP Guide to Pharmaceutical Payment Methods,” which of the following best describes average wholesale price?
Sticker price, used as point of negotiation for PBM ingredient cost payment to the pharmacy
50
Which stakeholder in the drug supply chain provides negotiated rebates to pharmacy benefit managers (PBMs) in exchange for volume, market share, or favorable formulary placement?
Drug manufacturers
51
The discipline in medicine of the coordinated effort to prevent harm caused by the provision of health care is?
Patient Safety
52
Which of the following best describes the relationship between patient safety and quality?
Patient safety is a subset of quality
53
Which of the following is an example of a countervailing influence that may limit the acceptance of new evidence of a best practice?
Marketing
54
What does the acronym PDSA represent
An iterative approach to testing improvement processes
55
Measurement of quality intended for internal use within an organization
Quality indicator
56
Who publishes the National Health Quality Report?
Agency for Healthcare Research and Quality
57
According to a Commonwealth Fund assessment of health care quality in 11 developed countries, the country that ranks first is?
The United Kingdom
58
A factor that has been shown to influence hospital re-admissions for inpatient psychiatric facilities?
Follow-up after discharge
59
An example of a type of outcome as defined by the National Quality Forum?
Patient Reported Outcomes
NOT
A. Appropriate use of a medication consistent with an established standard
B. Adequate physician to patient ratios to provide quality care
60
Which of the following represents the difference between a patient safety event and a sentinel event?
All sentinel events are patient safety events
61
A category of drugs that bear a heightened risk of causing significant harm when used in error
High-alert medications
62
An example of a category or drug often involved in harmful errors in the acute care setting
Neuromuscular blockers
63
A common drug or category of drugs involved with harmful errors in the acute-care, ambulatory-care, and long-term-care settings.
Insulin
64
An approach to using drugs whose exposure is variable based on standard dosages and can be individualized based on the measurement of blood levels.
Therapeutic drug monitoring
65
An example of a drug category that can be individualized commonly by measuring blood levels is:
Immunosuppressive drugs post organ transplantation
66
A term coined by critics of the precision movement critical of emphasizing the genetic pathways of biomedical conditions:
Genetic reductionism
NOT Genetocentrism, Genomism, Gene dominance
67
A commercial product used in an institutional setting to render waste opioids non-retrievable.
All of the above:
A. Cactus Smart Sink
B. RxDestroyer
C. Drug Dispose All
68
Can ultimate users dispose of illicit drugs through a collection receptacle?
No
69
The Drug Enforcement Agency allows controlled substances to be dropped off at a pharmacy when they are:
An authorized collector
NOT reverse distributor, secure deposit location, or able to co-mingle the drug with their controlled substance inventory
70
An alternative to an FDA-compliant sharps disposal container for the disposal of used syringes by consumers:
Used laundry detergent container
71
When learning more about the underlying disease pathway and identifying potential targets, researchers narrow the field of candidates to one compound. This promising molecule that may eventually become a drug is known as the:
Lead compound
72
According to PhRMA, a reasonable estimate of the percentage of drug development conducted by the private sector is:
67-97%
73
Which of the following development steps is in the "gap" that is forming in the drug development process?
Assay Development
74
The discovery of cimetidine was an example of which type of drug discovery:
Logical Drug Design
75
The discovery of tetracycline was an example of which type of drug discovery:
Chemical modification of a natural product
76
The Laboratory for Genomic Research is a collaboration between two biologist experts on CRISPR and which of the following companies?
GlaxoSmithKline
77
Where was the strain of Penicillium discovered that was mass produced and the used to treat soldiers in WWII?
Northern Regional Research Laboratory, Peoria, IL, USA
78
Who discovered the protein erythropoietin?
Eugene Goldwasser
79
Which of the following best describes public-sector research institutions?
Universities, Research Hospitals, and Federal Laboratories
80
What was the most prolific public sector research institution for discovering new drugs from 1970 to 2009?
NIH
81
The number of new drugs [i.e., new molecular entities] approved by FDA per billion U.S. dollars spent on research and development [adjusted for inflation] has halved every 9 years from the 1950s to 2010. This has observation has been described as:
Eroom's Law
82
True or False. An orphan drug can receive orphan drug status and approval for more than one approved indication?
True
83
Critics of the Bayh-Dole Act claim which of the following?
Profit motive deters basic science research
84
What is the most important incentive that is received when a drug is designated an orphan drug?
Market exclusivity for 7 years
85
The federal government allows government-funded researchers and their institutions to patent and license a drug discovery. In rare instances, the government may regain control of that license. This is referred to as:
March-In Rights
86
What is the length of the exclusivity extension for a drug awarded to a manufacturer for a pediatric indication according to the Pediatric Exclusivity Extension?
6 months
87
True or False: The Bayh-Dole Act contains language that allows the federal government to recoup the public investment in commercialized technologies.
False
An early draft contained this language but was removed in order to obtain passage of the legislation
88
According to a Tufts University estimate done in 2013, the estimate of the pre-approval total capitalized costs per drug approval is:
$2.6 billion
89
A controversial cost accounting method used by Tufts University to estimate the cost of drug development
Lost opportunity costs by not using development money for other purposes
From the Cost of Drug Discovery, Development, & Approval Lecture. Avorn mentioned that nearly half of the total estimate ($1.2 billion of the $2.6 billion estimate was ascribed to this accounting method. These capital costs were assessed at 10.6%, despite drug company bonds that only pay 1 to 5%.
90
True or False. Important drugs marketed by large pharmaceutical and biotechnology manufacturers are developed by biotechnology firms that are often spinoffs based on discoveries of NIH-funded university laboratory laboratories.
True
91
Which of the following is NOT considered a protected population that requires additional safeguards to prevent abuse or exploitation during drug research?
A. Older People
B. Human Fetuses
C. Pregnant Women
D. Prisoners
Older People
92
An example of a drug approved by FDA that was not recommended for approval by an FDA advisory panel.
Exondys 51
93
Early dose-response studies to evaluate efficacy in a select group of patients with the disease or condition intended to be treated
Phase IIa
94
True or false? If a company submits an Investigational New Drug application and receives no response from FDA within 30 days, the company may begin clinical trials.
True
95
What percentage of drugs that enter preclinical trials fail?
90-95%
96
Studies that are done pre-approval, but after the submission for approval has been submitted to the FDA is called.
Phase IIIb
97
Preclinical research that uses advanced computer-modeling techniques is referred to as what type of method.
In silico
98
True/False: Manufacturers must have a minimum of two Phase III trials to receive FDA approval.
False
99
The type of clinical trial research done on drugs as part of the information submitted to the FDA for approval would fall under what level of IRB review.
Full Board Review
100
For which of the following reasons can the FDA deny approval of a New Drug Application for a drug treating diabetes.
The application fails to present substantial evidence of effectiveness
101
Which of the following is a drawback to expedited drug approvals?
A drug might offer less benefit to patients than originally perceived
102
Which FDA center has the regulatory responsibility for the approval of therapeutic biologics?
CBER and CDER
Center for Biologic Evaluation and Research and the Center for Drug Evaluation and Research both have regulatory oversight for the approval of biological drugs
103
What percentage of applications for investigational use of drugs under the FDA’s expanded access program are approved?
>99%
104
True/False: The National Organization for Rare Disorder supported Right-to-Try Laws as a method to get unapproved treatments for desperate patients with diseases for which there is no currently available treatment.
False
105
Most generic drugs are approved under which of the following FDA pathways.
Abbreviated NDA
106
The FDA approval pathway that relies on evidence from studies not conducted by the sponsor.
505(b)(2) NDA
107
The law that established a pathway for an abbreviated pathway for the approval of “equivalent” biological drugs.
Biologics Price Competition and Innovation Act
108
Which of the following is a hallmark of the accelerated approval pathway, but NOT the fast-track program?
The use of surrogate measures only "reasonably likely" to predict clinical benefit
109
This “faster” drug approval pathway is allowed because there is preliminary evidence of superiority over existing therapies.
Breakthrough therapy
110
Which of the following gets five years of market exclusivity?
New Chemical Entities
111
Which of the following best describes the available data on the efficacy and safety of using prescription drugs beyond their expiration dates?
Most drugs maintain their safety and potency long past the expiration date
112
An example of collaboration between the FDA and other regulatory bodies around the world to inspect manufacturing facilities
Mutual Recognition Agreement
113
Which entity determines the expiration date for a drug product when the FDA approves it?
The Sponsor
114
True/False: The Pharmaceutical Research and Manufacturer’s of America (PhRMA) is a trade organization that represents most of the biotechnology companies in the United States.
False
From the Pharmaceutical Companies [Manufacturers] lecture
115
The most common method of drug manufacturing today:
Batch Manufacturing
116
Avara Pharmaceutical Services is an example of a:
Contract manufacturing organization
117
True/False: While most generic drugs are made outside of the United States, most brand name drugs are made in the U.S.
False
from the Making Finished Drug Products and FDA Oversight lecture
118
Where are most active pharmaceutical ingredients for drugs used in the U.S. made?
China and India
119
A book that exposes quality issues with Indian manufacturers.
Bottle of Lies
120
An example of a large generic pharmaceutical company.
Hikma
121
What organization determines nonproprietary names for drugs approved in the U.S.?
The United States Adopted Names Council
122
What organization determines the correct pronunciation of nonproprietary names for drugs approved in the U.S.?
The United States Pharmacopoeia Convention
123
The gederal last that created categories of prescription and non-prescription (OTC) drugs
Durham-Humphrey Amendment
124
How are vitamins available in the US?
By prescription and without a prescription
125
Which of the following is a fat-soluble vitamin?
Vitamin D
126
The FDA regulation that governs the content and format of prescribing information for human drugs and biologics.
Physician Labeling Rule
127
Which of the following is a common reason for drugs to switch from prescription to OTC status?
Life cycle management to extend revenue generation
128
Packaging requirements established by the Poison Prevention Act of 1972.
Child-resistant packaging
129
Which of the following claims could appear on a dietary supplement label?
Improve the function of the lungs
130
Dietary supplements that are manufactured according to the United States Pharmacopeial Convention standards may display this seal: “USP ___________”
Verified
131
True or False. Labels for medical foods must display “Rx only.”
False
132
Which of the following is a basic principle of homeopathy?
Law of minimum dose
133
Which of the following represents homeopathic doses/concentrations?
C
134
Homeopathic remedies are available:
Both over-the-counter and by prescription
135
The scientific review used to determine whether a new molecular entity should be a controlled substance is called:
8-Factor Analysis
136
True/False:There are prescription drugs on the U.S. market in 2019 that are unapproved drugs.
True
137
Which of the following is a device?
Sodium hyaluronate
138
When a new drug is approved, the Drug Enforcement Agency determines the schedule for a drug with abuse potential according to which of the following Acts?
Controlled Substances Act
139
Drugs with no currently accepted medical use and a high potential for abuse are placed in which schedule:
C-I
140
True or False. Medical foods are exempt from labeling, health claims, and nutrient content claims required by the Nutrition Labeling and Education Act.
True
