ANSWER KEY FOR 16TH EDITION CNPR PHARMACEUTICAL SALES REPS EXAM/ 2022-2024

The FDA regulates the introduction of new drugs and enforces U.S. drug laws.
True

Pharma companies must submit extensive data to the FDA demonstrating the safety and effectiveness of new drugs before receiving approval for sale.
True

Average review time for a new drug
18 months

Sales Team
Pg 7

The “engine of innovation,” focused on discovering or inventing promising new product.
Research & Development

This includes supply chain, manufacturing, trade, and distribution functions of the business.
Manufacturing & Operations

In 2012, FDA regulators approved 39 new drugs for use in the U.S.
True

3,070 new meds are in development for cancer.
True

Define Off-label
Usage of a medication for purposes other than the specific ones appearing on the label

Toxicity
The extent, quality, or degree to which a substance is poisonous or harmful to the body

Institutional review Board (IRB)
A committee of physicians, staticians, community advocated, and others which ensure that a clinical trial is ethical and that the rights of the study participants are protected. All clinical trials must be approved by an IRB before they begin.

Placebo
Inactive pill, liquid, or powder that has no treatment value aka sugar pill

Edema
Swelling

Asymptomatic
Without signs or symptoms

Clinical Pharmacology
The study of the effects and movement of drugs in the human body

Anatomy
The study of basic structures of the body

Physiology
The study of how those body structures function

Basic clinical pharmacology involves 3 main concepts
Pharmacodynamics, Pharmacokinetics, drug distribution and elimination.

Pharmacodynamics
Study of the biochemical and physiological effects of drugs and their mechanisms of action i.e. the study of what a drug does to the body. It describes the therapeutic effects of drugs (pain relief, blood pressure reduction, their side effects and their sites of action.

Pharmacokinetics
Study of how a drug is processed by the body, with emphasis on the time required for absorption, duration of action, distribution, and method of excretion. The study of how the body affects drugs.

Drug distribution & elimination
Drug delivery systems, route of administration , modes of excretion.

Plasma
The liquid portion of the blood that carries proteins and other substances

Organs
Specialized cells and tissues grouped together to perform specific body function for a common purpose. (Kidney, heart, intestines, and skin)

Nucleus
Brain of the cell that regulates all activities.

Proteins
A nutrient made up of of chains of amino acids

Fats
A nutrient stored in special body tissues as a great source of reserve energy

Carbohydrates
A nutrient that is the body’s immediate source of energy. It’s broken down to glucose and used for immediate metabolic reactions.

Vitamins
A nutrient substance necessary for growth, development, and normal regulation of metabolic processes. Must be taken from outside the body.

Minerals
A nutrient necessary for bodily purposes such as the balance of body fluid

Water is NOT a nutrient
True

Body’s Major Systems
Cardiovascular, Respiratory, nervous, musculoskeletal, reproductive, immune

Absorption
How the drug passes from its side of administration into the bloodstream

Distribution
How the drug is dispersed among the organs after absorption into the blood

Metabolism
How the active part of a drug is metabolized into a more water-soluble compound that can be readily excreted by the kidneys

Excretion
How the drug is eliminated from the body. Usually drugs are eliminated via urine. They can also be excreted through the lungs, skin, or breast milk.

It takes about 10 years for a drug to hit the market
True

Routes of drug administration
Pg 26-29

Seven rights of drug administration
pg 30

Bioavailability
how quickly and how much of a drug reaches its intended target site of action

Bioequivalent
when they contain the same active ingredients and proceed virtually the same blood levels over time.

Therapeutic equivalence
Production of the same medicinal effect

Drug elimination and Excretion
pg 34

Drug Forms
Pg 35-38

Patent last 20 years
True

Inactive ingredients
Added to provide bulk, strength, aid dissolving, color, taste, etc. IAs do not affect the body

Pharmaceutical Ingredients
Pg 54

BID
twice a day

Cmax
Peak plasma concentration on a measuring curve

Half-life
Period of time it takes for a specific amount of drug in the body to be reduced, through the excretion or elimination process, to exactly one-half that original amount

PRN
As needed

QD
Once a day

QID
Four times a day

Protein binding
the ability of certain drugs to bind to plasma protein.

TID
three times a day

Titration
the process of adjusting drug doses to achieve the max positive therapeutic effects while minimizing adverse or side affects

Tmax
Time of peak plasma concentration on a measuring curve

STAT
Immediately

Primary wholesale distributors
Buy most of their drugs directly from manufacturers. Legally considered authorized distributors within the meaning of the PDMA because they usually have ongoing relationships with manufacturers

Secondary wholesale distributors
Buy from a primary and other secondary wholesalers as well as manufacturers but are not considered authorized distributors of the manufacturers within the meaning of the PDMA

Distribution Terminology
Pg 60-61

Average wholesale price (AWP)
Published wholesale price of list price suggested by the manufacturer.

Chain drug store
Company that owns and operates four or more pharmacies

Drop shipment
Drug manufacturer directly delivers the drugs to a dispenser, but order and payments are made through a wholesaler

Group purchasing organization (GPO)
An entity consisting of two or more hospitals or other healthcare entities that is formed to offer its members access to purchasing contracts for health supplies

Upcharge
Percentage fee that is paid by the dispenser to the wholesaler for the cost of distribution

Package Insert Info
Pg 63

Drug Patents
Pg 65
Terms pg 67

Orange Book ratings
A
AA
AN
AO
AP
AT
B

Hatch-Waxman Act
aka Drug Price Competition and Patent Term Restoration Act of 1984. Considered the most significant drug-related legislation affecting pharma and healthcare. H-W made it easier to bring generics to the marker by requiring FDA to only look at bioavailability studies in order to approve. Also gave protection to the research based manu’s by providing a 30 months automatic cooling off period

It is important not to change the order of a sample closet
True

Manufacturers and distributors are required to have systems to monitor and audit the distribution of their drug samples
True

Meticulous records must be kept of sample inventories and reps are required to account for their samples periodically.
True

Representatives are required to store samples in a secure area where people cannot access them without permission and where they will not be subjected to extremes of temperature, moisture, and contamination
True

A sample closet or cabinet is essentially similar to a grocery store shelf. The more visibility you can give your drug, the more likely it will be used.
True

In some situations, a physician may sign the paperwork before the number of samples has been recorded
True

Section 503
Prohibits sale, purchase, or trade of drug samples

E-sampling
Pg 72

Many pharmaceutical manufacturers set expiration dates every six months (June, December)
True

DEA regulates the distribution and use of narcotics and other controlled substances
True

FTC
Regulates general business practices to protect consumers against misleading claims and anticompetitive behavior

AMA
provides ethical guidelines to physicians about appropriate interactions with pharmaceutical companies

Benefits of Government-Industry Partnerhsips
Pg 79

Preclinical studies
pg 81

Pinocytosis
Involves the engulfing of fluids by a cell.

Transport Mechanisms
Passive diffusion, facilitated diffusion, active transport, pinocytosis

Absorption methods
Oral, Buccal, sublingual, rectal, subcutaneous, intramuscular, transdermal, topical, inhalation, intravenous

The liver is the major organ for metabolizing drugs. Secondary is kidney
True

CL= rate of drug elimination/drug concentration in blood
True

In vitro assays are increasingly being see because they are usually less expensive, offer more rapid results, and are not as prone to negative publicity.
True

Clinical Trials
pg 89

Subjects should be informed about the aims, methods, risks, and benefits of the trial
True

Four phases of clinical trials
Pg 90

Regulatory Requirement terms
Pg 92

Investigator
The person who conducts the trial. This person is normally an expert in the field. They should not be employed by the sponsor

Sponsor
The organization or individual that initiates the trial and finances the study,

Protocol
This document sets out how a trial is to be conducted

Epidemiology
The study of how factors influence disease and health in human populations.

Therapeutic
Antibodies

Vaccines
Pg 108

Toxoids
Derived from toxins secreted by a pathogen.Examples are diphtheria and tetnus vaccines.

Vector-based vaccines
Viruses and bacteria are detoxified and used as vehicles to carry vaccines. Example is the use of canary pox (a virus that infects birds but not humans) to carry envelope proteins for HIV treatment.

Peptide Vaccines
Chemically synthesized and normally consist of 8-24 amino acids

Adjuvants
pg 110

Cytokines are produced mainly by the leukocytes (white blood cells)
True

Hormones are intercellular messengers.
True

Retrovirus
Integrates genes to hose chromosomes, change of long term stability.

Adendovirus
This vector has a large capacity for foreign genes.

Liposomes
Vector does not have viral genes so they do not cause disease.

Naked DNA
they do not have viral genes and do not cause disease

Gene Therapy types
Retrovirus, adenovirus, adeno-associated virus, liposomes, naked DNA

Stem Cells
Pg 114

Managed Care
Pg 117

Formulary
List of prescription drugs approved by insurance coverage pg 118

Opportunity cost
pg 124

Branding
pg 113

Values
Function, Expressive, Central

Functional Values
Efficacy, safety, convenience, cost-effectiveness

6 stages of brand strategy
Brand positioning, brand personality, brand values, unique values of the brand that support the values, how the brand appears to its audience, internal commitment

Pharmetrics
impact, pronunciation, scriptability, confusion, symbolism and communication, fit, appeal pg 144

Brands should be:
Easy to pronounce, easy to write and read, memorable, distinctive and different from competition

Direct-to-consumer (DTC)
pg 152

Factors that influence DTC
pg 153

Gifts
Pg 162

PhRMA Code
Now prohibits pens, mugs, objects with company logo

AMA Gift guidelines
Pg 165

Any gifts accepted by physicians individually should entail a benefit to the patient and not be of substantial value
True

Individual gifts of minimal value (Under $100) are permissible as long as the gifts are related to the work
True

Subsidies should not be accepted to pay for the costs of travel, lodging, or other personal expenses. Paying for a modest meal is OK
True

PhRMA Code on relationships
Pg 167

PhRMA FAQ
Pg 174

Nursing Structures
Pg 200

Sales techniques
pg 207

Medicare part D
pg 225

Organizing your day
Pg 239

Traits of Pharma sales Rep
Passion, Go the extra mile, be a resource, be creative, invest in yourself, authentic and real, love what they do, focus on service, cultivate support, believe, focus, macro-thinking, KIT, ask, keep accurate records

Glossary
271

Exclusivity is granted for an orphan drug for __
7 years

Patents are applied for with, and granted by the FDA.
False

Patents expire after how many years from the date of filing?
20 years

Generic drugs are not regulated by the Food & Drug Administration.
False

The most reliable source of information for determining therapeutically equivalent drug products are
ORange Book

Pharmaceutical representatives will typically store and secure their own drug samples
True

Pharmaceutical representatives must always record the amount of drug samples left and obtain signature for that amount.
True

The federal government does not regulate the drug sampling for a pharmaceutical representative
False

Storage conditions for drug products are based on data and information supplied by the manufacturer
True

Drug recalls are almost always negotiated with the FDA beforehand.
True

The PDMA is the Prescription Drug Manufacturers Association.
False

Primary wholesale distributors buy most of their drugs directly from __
manufacturers

The AWP is a published __ price, suggested by drug manufacturers.
wholesale

Rebates are also referred to as after-market arrangements.
true

Drug labels must include indications and usage information, as well as contraindications.
true

A patent owner has the right to exclude others from making, using, selling or importing into the US the __ it describes.
invention

Exclusivity gives exclusive __, which is granted by the FDA, and can run concurrently with a patent or not.
marketing rights

Exclusivity is granted for an orphan drug for _ years.
7

A generic drug is __ to the originator brand-name drug in dosage, strength, safety, and quality.
bioevuivalent

Generic drugs are not regulated by the FDA.
False

The Orange Book is considered the most authoritative manual on therapeutic __.
equivalence

The Hatch-Waxman Act is considered the most significant drug-related __ affecting the pharmaceutical industry since 1962.
legislation

First pass metabolism occurs when a drug administered orally is metabolized in the __.
Liver

Pharmacological studies using animals are regulated under Good Laboratory Practice.
True

Monoclonal antibodies are created in laboratories to target the __ of patients to kill cancer.
Cancer cells

The best way to deliver health care is through a __ system.
market based

The costs for all phases of R&D for drug companies are rising, with the increase particularly acute for _.
clinical trials

The agency which regulates the distribution and use of narcotics and other controlled substances is _.
DEA

The FDA approves storage conditions for drug products.
True

The most important benefit of electronic prescribing is related to patient __.
safety

Patients with leukemia have a condition in which the stem cells in the bone marrow malfunction and produce an excessive number of immature white blood cells, which interfere with normal blood cell production.
true

There are more white blood cells than red blood cells for the same volume in the human body.
false

Unlike the small molecule drugs (pharmaceuticals) described, large molecule drugs (biopharmaceuticals) are mainly protein-based.
true

The duration for Phase III of the clinical trial can typically last 3-5 years.
true

The aim of the Phase IV clinical trial is to examine the safety and effectiveness of the drug in the targeted disease group.
false

Carcinogenicity studies are carried out to identify the tumor-causing potential of a drug.
true

Which one of the below terms is not a route for excreting a drug from the body?
heart

Which of the below terms means “to apply the drug on the skin surface”?
transdermal

Diffusion is the random movement of molecules in fluid
true

Most drugs that are administered to patients typically contains just one active pharmaceutical ingredient.
false

Toxicity information in preclinical studies provides confidence about a drugs safety aspect.
true

The aim of pharmacological studies is to obtain data on the safety and effectiveness of the lead compound.
true

Effective drug therapy typically is a cost-effective and highly valuable means of controlling total healthcare expenditures and improving quality of life.
true

Almost 98% of employed Americans are now covered by a HMO, a preferred provider organization, or a point-of-service plan.
false

DUR programs involve retrospective monitoring of physicians’ prescribing patterns.
true

The Hatch-Waxman Act made it more difficult for generic manufacturers to manufacture and distribute off-patent drugs and compete with R & D companies.
false

PBM’s tend to serve a local market through a network of pharmacies.
false

The chief motivating force in mergers and acquisitions within the pharmaceutical industry is the desire of one company to acquire and exploit more successfully the brands of another.
false

It is rare for pharmaceutical companies to explore, develop and promote expressive values with which patients might identify.
true

To be competitive, pharmaceutical brands must be distinctive. They must possess defining characteristics that are perceived by customers to be unique, attractive and relevant to their needs.
true

With the global need for new drugs, pharmaceutical brand names are not subject to regulatory approval.
false

DTC advertising has become a required tactical consideration for most pharmaceutical brands in the U.S..
true

Subjects for clinical trials are selected on the basis of _
scientific objectives

The pivotal trial is Phase __ of the clinical trial.
3

The “road map” for a clinical research paper is called the _.
abstract

Pharmaceutical reps should thoroughly read _ sections of clinical studies when results are released.
all

The three major areas in which biologics are used are prophylactic, _, and replacement therapy.
therapeutic

A formulary is a list of prescription drugs approved by insurance coverage.
true

Three primary entities fund pharmaceuticals: employer, government (Medicare and Medicaid), and __.
individuals

The more a patient is asked to pay for his/her medication, the greater likelihood that he/she will refuse to fill the prescription, pr will not take the medication properly.
true

The key areas in hospitals that require special selling tactics are __, formulary committee, and the medical education department.
pharmacy department

Opportunity Cost refers to the value of a sacrificed alternative, when making a choice using resources.
true

One of the oldest and least effective pharmaceutical marketing techniques is the direct-to-consumer advertising.
false

Typically it only takes 1-2 calls to an individual physician before you can successfully get a physician to commit to prescribing your drug or product.
false

One of the most disappointing results of the pharmaceutical industry’s continued investment in R & D is the few number of new drugs being approved and in development.
false

The extent, quality, or degree to which a substance is poisonous or harmful to the body.
toxicity

The US accounts for about __ of all the world’s pharmaceutical revenues.
1/2

The most effective method for grabbing market share is:
comparative selling

Most visits by pharmaceutical reps are to pharmacies.
false

Among the biotechnology medications under development, about _ target cancer.
50%

A _ is an inactive medication with no treatment value, used in experimental studies.
placebo

The heart of a pharmaceutical sales team is the Regional Manager.
false

Almost 98% of employed Americans are now covered by a HMO, a preferred provider organization, or a point-of-service plan.
false

DUR programs involve retrospective monitoring of physicians’ prescribing patterns.
true

The Hatch-Waxman Act made it more difficult for generic manufacturers to manufacture and distribute off-patent drugs and compete with R & D companies
false

PBM’s tend to serve a local market through a network of pharmacies.
false

The chief motivating force in mergers and acquisitions within the pharmaceutical industry is the desire of one company to acquire and exploit more successfully the brands of another.
false

It is rare for pharmaceutical companies to explore, develop and promote expressive values with which patients might identify
true

To be competitive, pharmaceutical brands must be distinctive. They must possess defining characteristics that are perceived by customers to be unique, attractive and relevant to their needs.
true

With the global need for new drugs, pharmaceutical brand names are not subject to regulatory approval.
false

DTC advertising has become a required tactical consideration for most pharmaceutical brands in the U.S..
true

Because pharmaceutical sales reps work mostly out of their home it is not important for a rep to work well in a team environment.
false

Specialty care products are often prescribed by generalist physicians.
false

In some medical cases, a therapy may be initiated by a specialist and monitored and maintained by a primary care physician.
true

Acute medications, such as antibiotics, are used to address short-term illnesses or symptoms.
true

Side effects that might be considered merely minor annoyances in acute treatment can be a powerful barrier to adoption in chronic therapies.
true

The greatest challenge for a generics manufacturer is to replicate drug formulation factors that affect the pharmacokinetic and pharmacodynamic characteristics of the original drug.
true

What is one of the biggest time wasters for a pharmaceutical sales rep?
travel time

“Pull through” refers to:
generating demand for your company’s product

Which of the following is not a part of the Seven Step Cascade of Emotion?
be a consultant, not a rep

Which is not a rule in making the most out of your sales call?
your agenda not theirs

What do retail pharmacists do?
dispense pharmaceuticals

Which is a step to becoming an indispensable pharmaceutical sales rep?
asking feedback

Which is not a step to plan for rumors?
counter attack

Customers purchase products from people they like, trust, and respect. This is the:
likeability

According to the text, which of the following is considered “going to the next level?”
staying focused

clinical effect
The response produced by a medication

pathology
The practice of medicine dealing with the causes and nature of disease/death

New prescription drug benefits covered under the Medicare Prescription Drug Improvement & Modernization Act:
medicare part d

tertiary care
Highly specialized medical and surgical care for unusual or complex medical problems provided by a large medical center

Literally “disease producer”:
pathogen

A type of blood cell that helps the body fight infection and disease:
white blood cell

SS
Used when referring to medication dosage, means “one-half”:

Dividing a group of physicians and other potential prescribers for a certain category of drugs based on anticipated prescription volume:
declining

The substances comprising all active and inert pharmaceutical ingredients, including fillers, colors, and other excipients used to prepare dosage forms:
formulation

A low supply of oxygen due to low blood flow is:
ischemia

The acronym for pharmacokinetics is:
PK

According to the text, there are _ classes of therapeutic drugs.
US federal govt

Oral Glaucoma Therapy is classified as:
ophthalmology therapy

internist
is a physician that practices internal medicine

IDN
integrated delivery network

Another name for biologic compound is:
large molecule

SS is an abbreviation for:
semis

The _ is used to determine appropriate medical reimbursement.
coding system

A term used to refer to drugs that are non-biological (that is, chemical) in nature:
small molecule

The origin, or cause, of a disease or a patient’s symptoms:
Etiology

Used when referring to medication dosage, means “as needed”:
PRN

Where the tolerance of one medication may result in increased tolerance of another medication?
cross tolerance

The study of the effects, both beneficial and toxic, of drugs and chemicals on living cells, tissues, organisms:
pharmacology

A substance that enhances the action of a drug or antigen:
adjuvant

A site in the body which generally resides on a cell surface or within the cytoplasm. When stimulated or occupied, a biological change/activity takes place:
receptor

Refers to medication dosage, means “hour”:
h

Outside a living body:
ex vivo

The meaning of subcutaneous is:
beneath outer skin

The acronym for effective dose is:
ed

ML stands for:
milliliter

According to the text, depression is a disease that attacks the:
central nervous system

Pharmaceuticals are arguably the most socially important healthcare product.
True

Pharmaceutical development is a high-risk undertaking, in which many promising leads prove disappointing.
True

Pharmaceutical sales are highest in which geographic regions?
The U.S., Western Europe, and Japan.

The U.S. accounts for about __ of the world’s pharmaceutical revenues.
50%

What event has fueled recent growth in the pharmaceutical industry?
Population growth and increased life expectancies.

According to your manual, what describes the predicted relationship between pharmaceutical companies and genomic research facilities?
Partnerships between them will not prove immediately profitable.

Prescription drug therapy is not cost-effective for insurance companies and insurance providers.
False

The high price of healthcare is explained by the high price of medicines.
False

One of the oldest and least effective pharmaceutical marketing techniques is DTC (direct-to-consumer) advertising.
False

What influences the number of districts in a region?
The regions population

What is an example of the regionalization of healthcare delivery systems?
California and Florida have different prescription reimbursement policies.

The heart of a pharmaceutical sales team is the Regional Manager.
False

Most District Managers (DMs) did not start as representatives.
False

How many territories are in a typical district?
8 to 12

What is the most effective method for grabbing market share?
Comparative selling.

Pharmaceutical reps mainly visit pharmacies.
False

It usually takes about 1-2 calls to a physician before he/she commits to prescribing your product.
False

The pharmacist may dispense a product other than what the physician prescribed.
True

Which of the following would classify as Payers – Employers, patients, pharmacists, or physicians?
Employers.

How would you define ethical pharmaceutical companies?
Ones that research and develop novel drugs.

One of the most disappointing results of the pharmaceutical Industry’s continued investment in R&D is the few new drugs being approved and in development.
False

Thanks to modern medicines, how long are people newly diagnosed with HIV expected to live?
Another 50 years.

How much has the average American lifespan increased since 1890?
Almost 30 years

What is a treatment group?
A group of patients assigned to receive a specified treatment.

What is the main difference between a blinded and a double-blinded study?
In a double blind study, neither the study staff nor the study participants know which subjects are in the experimental group and which are in the control group.

What does asymptomatic mean?
Not exhibiting signs or symptoms.

What term denotes the study of bodily functions (as opposed to structures)?
Physiology.

In its broadest definition, a drug is any substance that produces a physical or psychological change in the body.
True

How does the Federal Food, Drug and Cosmetic Act (FFDCA) define a drug?
Any substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, or a substance other than food intended to affect the structure or function of the body.

Most of the body’s required vitamins must be taken from outside the body.
True

ADME testing measures the rate at which the body absorbs the drug, distributes it to the organs necessary to produce the desired effect, metabolizes it into waste material, and then excretes it from the body.
True

What field is ADME testing used in primarily?
Pharmacokinetics.

Placebo effects can lead to withdrawal symptoms.
True

On average, only about 5 of 4,000 drugs studied in laboratory are eventually studied in people.
True

Sublingual drugs are absorbed directly and almost immediately into the bloodstream.
True

What are 3 of the 7 rights of drug administration?
The right patient, the right drug, the right dose.

Pro-drugs are administered in active form, which is metabolized into an inactive form.
False

The kidney of an 85-year old person excretes drugs only __ as efficiently as that of a 35-year old person.
Around 50%

The normal age-related decrease in kidney function can help doctors determine an appropriate dosage based solely on a person’s age.
True

What differentiates a caplet from a tablet?
Caplets are shaped like capsules and have film coatings to aid in swallowing.

Where will you find the legend, “Caution: Federal Law prohibits dispensing without a prescription.”?
On the label of all prescription drugs.

What happens in slow acetylators?
Drugs that are metabolized by N-acetyl transferase tend to reach higher blood levels and remain the body longer.

About _ of the people in the U.S. are slow acetylators.
50%

Drug-drug interactions are always harmful.
False

Smoking decreases the effectiveness of some drugs.
True

Because dietary supplements are not drugs, interactions with drugs are not a concern.
False

Ehrlich stated that an ideal drug (magic bullet) does not exist, would be aimed precisely at a disease site, and would not harm healthy tissues.
True

What is the difference between resistance and tolerance?
Tolerance refers to a person’s diminished response to a drug after repeated use, while resistance applies to microorganism’s or cancer cell’s abilities to withstand drug effects.

Between 3% and 7% of hospital admissions in the U.S. are estimated to be for treatment of adverse drug reactions.
True

There is no universal scale for quantifying the severity of an adverse drug reaction.
True

Why is noncompliance a serious public health concern?
It increases the cost of medical care.

Name 3 items available for which patent protection is available under U.S. regulations.
The drug itself, the method of delivering and releasing the drug into the bloodstream, and the way the drug is made.

Drugs’ trade names are often unrelated to their intended use.
False

Like foods and household products, generic drugs are usually lower quality than the brand name drugs for which they are marketed as equivalents.
False

Legally, bioequivalence of different versions of a drug can vary by up to _ percent.
20

Biologics do not cause immune responses.
False

“Large molecule” products are developed and manufactured by a chemical process.
False

What are the drugs that attract or bind cell receptors in order to mimic or enhance activities by endogenous chemical messengers?
Agonists

What term denotes how an API works in the body?
Mechanism of action.

What cements the active and inert components together to maintain cohesive portions?
Binders.

What does the abbreviation BID denote?
Twice a day

What is the medical abbreviation for ‘as needed’?
PRN.

Which components might cause patient’s different reactions to brand name and generic drugs?
Differences in inactive ingredients.

All cells have a nucleus.
False

Name three things that affect drug response.
The patient’s genetic makeup, age, body size, and use of other drugs and dietary supplements. The patient’s other conditions and diseases. Whether or not the patient takes the drug properly.

Drug reactions are predictable because they do not occur after a person has been previously exposed to the drug one or more times without any allergic reactions.
False

What is the typical relationship between a drug’s site of administration and site of action?
They are usually somewhat removed from one another.

What is CMAX?
The peak plasma concentration on a measuring curve.

Pharmacoprocesses are a main concept of clinical pharmacology.
False

Which is not a route of drug administration – buccal, intramuscular, sublingual, or transfugal?
Transfugal

How are intradermal drugs delivered?
By injection under the skin.

An injection of anesthetic directly into the bloodstream is an example of intravenous drug delivery.
True

What are the major organs of the gastrointestinal system?
The mouth, esophagus, stomach, liver, pancreas, gallbladder, small and large intestines.

Who is normally responsible for selling to distributors?
NAMs.

How often do secondary drugs wholesale distributors buy their drugs directly from manufacturers?
Sometimes

By FDA law, large chain pharmacies are not allowed to buy directly from drug manufacturers.
False

Only 3 companies account for nearly 90% of all wholesale drug sales.
True

What type of sale bypasses the need for intermediary distributors?
Manufacturer direct sales.

What is a group purchasing organization (GPO)?
An entity consisting of two or more hospitals or other health care entities that negotiates contracts on behalf of its members.

Prescriptions dispensed by mail-order pharmacies are, on average, around _ than those dispensed by retail pharmacies.
3 times larger

Which of the following is NOT a type of non-stock sale –
a) brokerage sales
b) dock-to-dock sales
c) drop shipments
d) all of these are types of non-stock sales
D) all of these are types of non-stock sales

What is another term for rebates?
After market arrangements.

The PDMA is the Prescription Drug Manufacturers Association.
False.

A company that owns and operates three or fewer pharmacies is an ___.
Independent drug store.

Which section of a drug’s package insert information covers the usual dosage range?
Indications and usage.

Drug labels must include indications, usage information, and contraindications.
True

What should be included in the description section of a drug’s package insert information?
The drug’s proprietary name and the established name.

Exclusivity gives exclusive _, is granted by the FDA, and can run concurrently with a patent or not.
Marketing rights.

What differentiates exclusivity from a patent?
Exclusivity is only granted upon the drug’s FDA approval.

What is required of an invention for it to be worthy of patent protection?
It must be novel, useful, and not obvious.

A generic drug is __ to the originator brand-name drug in dosage, strength, safety, and equality.
bioequivalent

The FDA’s Criteria for Equivalency requires the drugs contain identical amounts of the same inactive ingredients.
True

What list is generally considered the most reliable source of information on therapeutically equivalent drug products?
“Approved Drug Products with Therapeutic Equivalence”

Which of the following is an Orange Book rating
a) AZ
b) B
c) BZ
d) CZ
b) B

What is the term for chemical equivalents which, when administered in the same amounts, will provide the same biological or physiological availability as measured by blood and urine levels?
Biologic equivalents.

What term denotes a drug that is identical or bioequivalent to the originator brand-name drug in dosage form, safety, strength, route, quality, performance?
Generic

What term denotes the dispensing of an unbranded generic product for the product prescribed?
Generic substitution.

What is the duration of a patent challenge?
180 days (6 months)

How is a drug sample closet or cabinet like a grocery store shelf?
The more visibility you can give your drug, the more likely it will be prescribed.

Pharmaceutical reps do not typically store and secure their own drug samples.
False

Sampling is sometimes the most important factor in a pharmaceutical rep’s success.
True

The FDA approves storage conditions for drug products.
True

Pharmaceutical reps must always record the amount of drug samples left and obtain a signature for that amount.
True

What is prohibited by Section 503 of the Federal Food, Drug, and Cosmetic Act, as amended by the Prescription Drug Marketing Act?
The sale, purchase, or trade or offer to sell, purchase, or trade prescription drug samples.

The federal government does not regulate the drug sampling for a pharmaceutical rep.
True

Section 503 of the Federal Food, Drug, and Cosmetic Act permits hospitals to donate their prescription drug samples to qualified charitable organization.
False

Which entity issues monographs that define how drugs should be stored, and what variance is allowed in their shared contents?
United States Pharmacopoeial Convention.

Storage conditions for drug products are based on information supplied by the manufacturer.
True

Medications are usually unaffected by changes in temperature, light, humidity, and other environmental factors.
False

In which cases can degraded drugs sometimes still be used?
When the amount of the remaining drug has not fallen lower than 85-90% of that stated on the label.

Drug recalls are almost always negotiated with the FDA beforehand.
True

Electronic prescribing systems would improve patients doctor-shopping for controlled substances, pharmacists misreading prescriptions, and physicians wasting time calling pharmacies.
True

What should you do if you receive a shipment from your employer and you notice that there are twice as many samples as what is posted on the packing slip?
Call your Sales Manager and inform him/her of the mistake, and ask for instructions on proper procedure.

Which area of drug R&D has seen the largest cost increases?
Clinical trials.

On average, how long does it take for a new drug to be developed (i.e. from the discovery of the initial compound to FDA approval)?
10-15 years

Which of the following agencies is industry-based (i.e. run mainly by the companies themselves)?
a) Drug Enforcement Administration
b) European Medicines Agency
c) Pharmaceutical Research and Manufacturers of America (PhRMA)
d) the FDA?
C) PhRMA.

Growing demand in the medical community for more complex data about pharmaceuticals has simplified the pharmaceutical R&D process?
False

The landmark FDA Modernization Act of 1997 was a major step forward in enabling safe and effective new drugs and biologics to be made available sooner to patients.
True

Which type system is the best way to deliver healthcare?
A market-based system.

How would increased pharmaceutical price controls affect the U.S. healthcare system?
Increased price controls would stifle innovation.

Which invests a greater percentage of sales in research than the biotech sector
a) aerospace
b) communications
c) electronics
d) none of these
d) none of these

What was the intent of the Bayh-Dole Act and the Stevenson-Wydler Technology Innovation Act?
To hasten the commercialization of technologies that otherwise might not be used.

What did the G10 Medicines Group recently report about the pharmaceutical industry in the European Union (EU)?
There is poor collaboration between publicly- and privately-funded research centers.

The aim of preclinical pharmacological studies is to obtain data on the safety and effectiveness of the lead compound.
True

Toxicity information in preclinical studies helps provide confidence about a drug’s safety.
True

Pharmacological studies using animals are regulated under Good Laboratory Practice.
True

Why do drugs administered to patients only contain APIs?
They don’t.

A drug’s vesicles affect it’s ability to permeate membranes.
True

Through which barriers can lipid-soluble drugs usually pass?
Cell membranes.

How are weak acid drugs generally absorbed by the stomach?
More quickly than weak basic drugs.

Which route of administration does not completely bypass the liver?
Rectal administration.

Why are intravenous drug dosages easier to control than drugs administered transdermally?
The entire dose is available in the bloodstream to be distributed to the target site.

A drug’s lipid-solubility, polarity, and the _ __ of the drug’s target tissue affect it’s distribution.
vascular nature

What medical term means “to apply the drug on the surface of the skin”?
Transdermal.

Carcinogenicity studies are carried out to identify the tumor-causing potential of a drug.
True

According to NIH ethical guidelines, what is the most important criteria in selecting subjects for clinical studies?
Scientific objectives

The members of the IRB/IEC must be experts in the topic of study.
True

Which phases of clinical studies are open label and which are blinded?
Phase I and IV trials are often open label, but Phase II and III are double-blinded or at least blinded.

If it is not possible to measure the direct effects of a drug, what is used instead?
Surrogate markers such as blood pressure and cholesterol levels.

What is the name of an observational study that first identifies a group of subjects with a certain disease and a control group without the disease, and then looks back in time (e.g. via chart reviews) to find exposure to risk factors?
Case-control study.

Which measure of central tendency is the sum of all observations divided by the number observations?
Mean.

Which measurement describes the number of new events that occur during a specified period of time in a population at risk for the event (e.g. lung infections per year)?
Incidence.

____ is used to describe the variability of the population mean.
Standard error of the mean

What term denotes the extent to which a test actually measures what it is supposed to be measuring, or what we think it is measuring?
Validity.

What are the Kaplan-Meier analysis and Cox proportional hazards analysis?
Methods of survival analysis.

What section of a clinical paper describes subjects’ entry and exclusion criteria?
Methods.

Which document sets out how a trial is to be conducted (i.e. the study’s general design and operating features)?
Protocol.

When designing and performing clinical trials, several ethical constraints must be considered. Which one of the following is NOT one of these ethical restraints
a) geographic variations
b) independent review
c) scientific validity
d) social value?
Geographic variations.

What is one way in which large molecule drugs differ from small molecule drugs?
Large molecule drugs are mainly protein-based drugs that develop in biological systems such as living cells.

Vaccines are types of small molecule drugs.
False

What is an advantage of attenuated vaccines over inactivated vaccines?
Attenuated vaccines are less expensive to prepare.

How are toxoids derived?
From the toxins secreted by a pathogen.

What is the estimated annual death toll in Malaria?
1.5 to 3.5 million people.

There are more white blood cells than red blood cells for the same volume in the human body.
False

How was insulin primarily obtained from the 1930s to the 1980s?
Porcine and bovine extracts.

Which of the following are not types of cytokines
a) interferons
b) interleukins
c) monokines
d) all of these are types of cytokines
All of these are types of cytokines.

Which of the following is not a type of hormones
a) amino acid derivatives
b) blood glucose
c) polypeptides
d) steroids?
Blood glucose.

Describe the ‘in vitro’ gene therapy technique.
Patients’ genetically faulted tissues are removed, loaded with normal genes in vectors, and returned to the patients’ bodies.

Pluripotent stem cells can develop into many cell types, but not a new individual.
True.

Leukemia is a condition in which the stem cells in the bone marrow malfunction and produce an excessive number of immature white blood cells.
True.

Retroviruses are types of vectors used in gene therapy.
True.

Which of the following is not a type of stem cell
a) multipotent
b) pluripotent
c) semipotent
d) totipotent
Semipotent.

Traditional vaccines are prepared in a number of ways. Which of the following is not one of them
a) attenuated
b) insulin
c) inactivated
d) toxoids
Insulin

Effective drug therapy is a cost-effective and highly valuable means of controlling total healthcare expenditures and improving quality of life.
True

Drug utilization review (DUR) programs have traditionally been used to ensure the appropriate, safe, and effective use of prescription drugs, but are increasingly shifting their focus to minimize costs.
True

DUR programs involve retrospective monitoring of physicians’ prescribing patterns.
True

A formulary is a list of prescription drugs approved by insurance coverage.
True

The history of drug formularies in the U.S. extends back to _.
The American Revolution

Which of these is not a type of formulary
a)closed three-tier in which generic drugs are listed on Tier 1
b) five-tier that is supplemented by a step therapy program
c) open that replaces few restrictions on coverage or access
d) all of these are types of formularies
All of these are types of formularies.

The repeal of Hatch-Waxman is a recent formulary trend.
False

What did the Hatch-Waxman Act do?
Make it easier for generic manufacturers to compete with R&D companies.

What is opportunity cost?
The value of a sacrificed alternative.

The three primary entities that fund pharmaceuticals are employers, the government, and __.
Individuals.

A company’s medical liaison can be a member of a P&T committee.
False

Almost 98% of employed Americans are now covered by a HMO, a preferred provider organization, or a point-of-service plan.
False

Pharmaceutical companies are more interested in acquiring and exploiting another’s brands than in acquiring another’s R&D and sales marketing assets.
False

Ideally, when should brand strategy development for a new drug begin?
During Phase II clinical trials.

An example of an expressive value is, “I own a BMW because I like feeling the road.”
False

Which of the following is not an example of a functional value
a) convenience
b) efficacy
c) safety
d) uniqueness
Uniqueness

It is rare for pharmaceutical companies to explore, develop, and promote expressive value with which patients might identify.
True

To be competitive, pharmaceutical brands must be distinctive. They must possess defining characteristics that are perceived by customers to be unique, attractive, and relevant to their needs.
True

With the global need for new drugs, pharmaceutical brand names are not subject to regulatory approval.
False

Over the last few decades, DTC advertising has become an essential marketing tactic for both large and small brands.
True

Which of the following most strongly influences physicians’ prescribing habits
a) doctors’ personal experiences, and their patients’ unique situations, b) DTC advertising
c) other types of pharmaceutical marketing
d) patients’ opinions about DTC advertising?
Doctors’ personal experiences, and their patients’ unique situations.

Pharmaceutical companies spend more on promotional activities than on R&D.
False

A brand that treats a very common chronic condition would be well-served by mass-market print and TV ads.
True

How do companies use prescriber data?
To conduct research.

Under PhRMA Code, it is acceptable for modest meals to be provided for staff members attending educational events.
True

Under AMA Guidelines on Gifts to Physicians from Industry, it is acceptable to only give gifts to doctors with high prescribing volumes.
False

According to PhRMA Code, sales reps are allowed to provide modest meals to staff members attending educational events.
True

The PhRMA Code on Interactions with Healthcare Professionals is only voluntary and not mandatory.
True

Pens and clipboards designed to be used by patients in doctors’ offices is considered acceptable under PhRMA Code.
False

Under PhRMA Code, what is one example of an acceptable patient education item?
An anatomical model valued under $100.

A company is never to provide entertainment or recreational activities to healthcare practitioners.
True

Under PhRMA Code, may a company sponsor a lunch at a 3-day conference if part of it includes an educational program for which attendees may choose to receive CME credit?
Yes, but only if the lunch is clearly separate from the CME portion of the conference.

What is the name of the arm of the Department of Health and Human Services that investigates regulatory infractions, provides compliance advice, and brings enforcement actions?
Office of Inspector General.

It is illegal to ask receptionists for personal information about your clients such as home phone numbers, birthdays, or hobbies.
False

A primary goal of the P&T committee is to educate sales representatives on legal and ethical guidelines for professional behavior.
False

A major challenge facing family medicine is managed care policies are eroding patient-doctor relationships.
True

Family physicians diagnose and treat approximately what proportion of patients they see (as opposed to referring them to specialists)?
95%

Adoption, awareness, and _ are all steps on the Product Adoption Continuum.
Evaluation.

__ would be classified as a type of somatic psychiatric treatment.
Drug therapy

Why is the last 10 minutes of each hour usually the best time to make office visits to psychiatrists?
They often see their patients on the hour for 45 minutes.

One of the advantages of selling to residents is that they are often more open-minded.
True

What is drug utilization review (DUR)?
An MCO’s practice of monitoring prescribing patterns.

are used in the treatment of manic-depressive illness and schizoaffective disorder.
Mood Stabilizers

What is the focus of the short call protocol?
Beginning with a specific patient type.

Who is the Medical Science Liaison (MSL)?
Someone employed by a pharmaceutical company who builds relationships with thought leaders and acts as an informational resource.

What type of education do MSLs typically have?
Master’s Degrees

How do companies typically judge the MSL team’s contributions?
Return on education.

What differentiates push through programs from pull through programs?
Sales reps are more involved in pull through programs.

Adherence/persistency, educational support, and _ __ are all types of pull through programs.
Therapeutic intervention.

Because pharmaceutical sales reps work mostly out of their homes, it is not important that they work well in a team environment.
False.

What is a likely reason a doctor would lack interest in one of your clinical studies?
He/she does not like the way you are presenting it.

Effective methods for reaching the 65+ market are being a Medicare Part D information resource, knowing the physician-payer mix, and taking advantage of _ ______.
Partnership programs.

When a physician visits your hospital display, you should begin conversation by asking, “Can I help you?”.
False

One of the rules in making the most out of your sales calls is forcing your agenda, not theirs.
False

Specialty care products are more often prescribed by generalist physicians.
False

Side effects that might be considered merely minor annoyances in acute treatment can be a powerful barrier to adoption in chronic therapies.
True

Acute medications, such as antibiotics, are used to address short-term illnesses or symptoms.
True

In some medical cases, a therapy may be initiated by a specialist and monitored and maintained by a primary care physician.
True

Blockbuster drug status typically translates into sales of just under $10 million annually.
False

A generic drug manufacturer’s greatest challenge is often to replicate drug formulation factors that affect the pharmacokinetic and pharmacodynamic characteristics of the original drug.
True

What differentiates an orphan drug from a blockbuster drug?
Orphan drugs typically treat rare conditions.

How long are most calls and visits to physicians’ offices (excluding waiting and driving time)?
Only a few minutes.

Which is not a step in managing rumors
a) confirm
b) counter attack
c) search
d) transition
Counter attack

Which of the following is considered going to the next level
a) becoming a micro-thinker
b) meeting the clients’ every need
c) minimizing rumors
d) staying focused
Staying focused

What is one of the primary job responsibilities of a retail pharmacist?
Dispensing pharmaceuticals.

Pharmaceutical companies and representatives categorize their customers as 1) acute care vs. chronic care, 2) office-based vs. hospital-based, and 3) vs. _.
Primary care vs. specialty care

T/F: Pharmaceuticals are arguably the most socially important healthcare product.
True Pg 1

T/F: Pharmaceutical development is a high-risk undertaking, in which many promising leads prove disappointing.
True Pg 2

Pharmaceutical sales are highest in which geographical regions?
The U.S., Western Europe, and Japan (Pg3)

The U.S. accounts for about __ of the world’s pharmaceutical revenues.
B. 50% (pg3)

What has fueled recent growth in the pharmaceutical industry?
population growth and increased life expectancies (pg4)

According to your manual, which statement accurately describes the predicted relationship between pharmaceutical companies and genomic research facilities?
partnerships between pharmaceutical companies and genomic companies will not prove immediately profitable. (pg4)

T/F: Prescription drug therapy is not cost-effective for insurance companies and healthcare providers.
False (pg4)

T/F: The high price of healthcare is explained by the high price of medicines.
False (pg5)

T/F: One of the oldest and least effective pharmaceutical marketing techniques is DTC (direct-to-consumer) advertising.
False (pg5)

What influences the number of districts in a region?
the region’s population

What is an example of the regionalization of healthcare delivery systems?
California and Florida have different prescription reimbursement policies.

T/F: The heart of a pharmaceutical sales team is the Regional Manager.
False

T/F: Most DMs did not start as representatives.
False (pg7)

How many territories are in a typical district?
B. 8 to 12 (pg6)

What is the most effective method for grabbing market share?
A. comparative selling (pg10)

T/F: Pharmaceutical reps mainly visit pharmacies.
False (pg11)

T/F:It usually only takes 1-2 calls to a physician before he or she commits to prescribing your product.
False (pg12)

T/F: The pharmacist may dispense a product other than what the physician prescribed
True (pg12)

Who classifies as payers?
Employers

What defines ethical pharmaceutical companies?
researching and developing novel drugs

T/F: One of the most disappointing results of the pharmaceutical industry’s continued investment in R & D is the few new drugs being approved and in development.
False (pg15)

How long are people newly diagnosed with HIV expected to live?
another 50 years (pg16)

How much has the average American lifespan increased since 1890?
almost 10 years (pg17)

What is a treatment group?
a group of patients assigned to receive a specified treatment (pg18)

What is the main difference between a blinded and double-blinded study?
In a double blind study, neither the study staff nor the study participants know which subjects are in the experimental group and which in the control. (pg18)

What does asymptomatic mean?
not exhibiting signs or symptoms (pg18)

Which term denotes the study of bodily functions (as opposed to structures)?
physiology (pg 19)

T/F: In its broadest definition, a drug is any substance that produces a physical or psychological change in the body.
True (pg20)

How does the Federal Food, Drug and Cosmetic Act (FFDCA) define a drug?
any substance intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease, or a substance other than food intended to affect the structure or function of the body (pg20)

Which statement about vitamins is CORRECT?
Most of the body’s required vitamins must be taken in from outside the body. (pg21)

T/F: ADME testing measures the rate at which the body absorbs the drug, distributes it to the organs necessary to produce the desired effect, metabolizes it into waste material and then excretes it from the body.
True (pg22)

ADME testing is primarily used in what field?
pharmacokinetics (pg22)

Which statement about placebos is CORRECT?
Placebo effects can lead to withdrawal symptoms. (pg 24)

T/F: On average, only about 5 of 4,000 drugs studied in the laboratory are eventually studied in people.
True (pg24)

Which statement is TRUE about drugs taken sublingually?
Sublingual drugs are absorbed directly and almost immediately into the bloodstream. (pg 28)

What are 3 of the 7 rights of drug administration?
the right patient, the right drug, and the right dose (pg30)
{the right of patient, the right of drug, the right dose, the right route, the right time, the right technique, the right documentation}

T/F: Pro-drugs are administered in an active form, which is metabolized into an inactive form.
True

The kidney of an 85-year-old person excretes drugs only _ as efficiently as that of a 35-year-old person.
around 50% (pg 35)

T/F: The normal age-related decrease in kidney function can help doctors determine an appropriate dosage based solely on a person’s age.
True (pg35)

What DIFFERENTIATES a caplet from a tablet?
Caplets are shaped like capsules and have film coatings to aid in swallowing. (pg36)

Where will you find the legend “Caution: Federal Law prohibits dispensing without a prescription”?
on the label of all prescription drugs (pg39)

What happens in slow acetylators?
Drugs that are metabolized by N-acetyl transferase tend to reach higher blood levels and remain in the body longer.

About _ of the people in the U.S. are slow acetylators.
50%

Which of the following statements about drug-drug interactions is INCORRECT?
Drug-drug interactions are always harmful

T/F: Smoking decreases the effectiveness of some drugs.
True

Which of the following statements about dietary supplements is INCORRECT?
Because dietary supplements are not drugs, interactions with drugs are not a concern.

Which statement/s is/are INCORRECT about an ideal drug, or magic bullet as Ehrlich phrased it?
all are correct:
A. It does not exist.
B. It would be aimed precisely at a disease site.
C. It would not harm healthy tissues.

Which statement accurately differentiates resistance from tolerance?
Tolerance refers to a person’s diminished response to a drug after repeated use, while resistance applies to microorganisms’ or cancel cells’ abilities to withstand drug effects.

T/F: Between 3% and 7% of hospital admissions in the United States are estimated to be for treatment of adverse drug reactions.
true

Which statement is true about the universal scale for quantifying the severity of an adverse drug reaction?
None of these statements are true because there is no such scale
A. The severities of adverse drug reactions are quantified by their chronicity.
B. The severities of adverse drug reactions are quantified by their threat to life.

Why is noncompliance a serious public health concern?
It increases the cost of medical care.

Which of the following is NOT eligible for patent protection under U.S. regulations?
Companies can be granted patents for all of these things

T/F: Drugs’ trade names are often unrelated to their intended use.
False

T/F: Like foods and household products, generic drugs are usually lower quality than the brand name drugs for which they are marketed as equivalents.
False

Legally, bioequivalence of different versions of a drug can vary by up to __.
20%

Which of the following statements about biologics is INCORRECT?
They do not cause immune responses.

T/F: “Large molecule” products are developed and manufactured by a chemical process.
False

What are drugs that attract or bind to cell receptors in order to mimic or enhance activities by endogenous chemical messengers?
agonists

Which term denotes how an API works in the body?
mechanism of action

What cements the active and inert components together to maintain cohesive portions?
binders

What does the medical abbreviation BID denote?
twice a day

What is the medical abbreviation for as needed?
PRN

Which components might cause patients’ different reactions to brand name and generic drugs?
differences in inactive ingredients

T/F: All cells have a nucleus.
False

Which of the following does NOT affect drug response?
All of these factors influence drug response.
A. the patient’s genetic makeup, age, body size, and use of other drugs and dietary supplements.
B. the patient’s other conditions or diseases.
C. whether or not the patient takes the drug properly

T/F: Drug reactions are predictable because they do not occur after a person has been previously exposed to the drug one or more times without any allergic reactions.
False

What is the typical relationship between a drug’s site of administration and site of action?
They are usually somewhat removed from each other.

What is CMAX?
the peak plasma concentration on a measuring curve

Which of the following is NOT a main concept in clinical pharmacology?
Pharmacoprocesses

Which of the following is NOT a route of drug administration?
transfugal

How are intradermal drugs delivered?
by injection under the skin

What is an example of intravenous drug delivery?
an injection of anesthetic directly into the bloodstream

What are the major organs of the gastrointestinal system?
the mouth, esophagus, stomach, liver, pancreas, gallbladder, small and large intestines

Who is normally responsible for selling to distributors?
NAMs

How often do secondary drug wholesale distributors buy their drugs directly from manufactures?
sometimes

T/F: By FDA law, large chain pharmacies are not allowed to buy directly from drug manufactures.
False

T/F: Only 3 companies account for nearly 90% of all drug wholesale sales.
True

What type of sale bypasses the need for intermediary distributors?
manufacturer-direct sales

What is a group purchasing organization (GPO)?
an entity consisting of two or more hospitals or other health care entities that negotiates contracts on behalf of its members

Prescriptions dispensed by mail-order pharmacies are, on average, around __ than those dispensed by retail pharmacies.
3 times larger

What are examples of non-stock sales?
-brokerage sales
-dock-to-dock sales
-drop shipments

What is another term for rebates?
sell-side arrangements

T/F: The PDMA is the Prescription Drug Manufacturers Association.
False

A company that owns and operates three or fewer pharmacies is an __.
independent drug store

Which section of a drug’s package insert information covers the usual dosage range?
indications and usage

T/F: Drug labels must include indications, usage information, and contraindications.
True

What should be included in the description section of a drug’s package insert information?
the drug’s proprietary name and the established name

Exclusivity gives exclusive _, is granted by the FDA, and can run concurrently with a patent or not.
marketing rights

What differentiates exclusivity from a patent?
Exclusivity is only granted upon the drug’s FDA approval.

What is required of an invention for it to be worthy of patent protection?
It must be novel, useful, and not obvious.

This is NOT required by the FDA’s Criteria for Equivalency.
The drugs are adequately labeled.

A generic drug is __ to the originator brand-name drug in dosage, strength, safety, and quality.
bioequivalent

What list is generally considered the most reliable source of information on therapeutically equivalent drug products?
The Blue Book

Which of the following is an Orange Book rating?
B

What is the term for chemical equivalents which, when administered in the same amounts, will provide the same biological or physiological availability as measured by blood and urine levels?
biological equivalents

What term denotes a drug that is identical or bioequivalent to the originator brand-name drug in dosage form, safety, strength, route, quality, performance, characteristics, and intended use?
OTC

What term denotes the dispensing of an unbranded generic product for the product prescribed?
chemical substitution

What is the duration of a patent challenge?
180 Days

How is a drug sample closet or cabinet like a grocery store shelf?
The more visibility you can give your drug, the more likely that it will be prescribed.

T/F: Pharmaceutical representatives do not typically store and secure their own drug samples.
False

T/F: Sampling is sometimes the most important factor in a pharmaceutical rep’s success.
True

T/F: The FDA approves storage conditions for drug products.
True

T/F: Pharmaceutical representatives must always record the amount of drug samples left and obtain a signature for that amount.
True

What is prohibited by Section 503 of the Federal Food, Drug and Cosmetic Act, as amended by the Prescription Drug Marketing Act?
the sale, purchase, or trade or offer to sell, purchase, or trade prescription drug samples

T/F: The federal government does not regulate the drug sampling for a pharmaceutical representative.
False

What is not permitted by Section 503 of the Federal Food, Drug and Cosmetic Act?
-hospitals donating their prescription drug coupons to qualified charitable organizationss
-hospitals donating their prescription drug samples to qualified charitable organizationss
-hospitals selling their prescription drug samples to qualified charitable organizations at reduced costs

Which entity issues monographs that define how drugs should be stored, and what variance is allowed in their stated contents?
United States Pharmacopoeial Convention

T/F: Storage conditions for drug products are based on information supplied by the manufacturer.
True

T/F: Medications are usually unaffected by changes in temperature, light, humidity, and other environmental factors.
False

In which cases can degraded drugs SOMETIMES still be used?
when the amount of remaining drug has not fallen lower than 85-90% of that stated on the label

T/F: Drug recalls are almost always negotiated with the FDA beforehand.
True

Which problem would NOT be improved by electronic prescribing systems?
A. patients doctor-shopping for controlled substances
B. pharmacists misreading presciptions
C. physicians wasting time calling pharmacies

What should you do if you receive a shipment from your employer and you notice that there are twice as many samples as what is posted on the packing slip?
A. Call your Sales Manager to inform him/her of the mistake and ask for instructions on proper procedure.

Which area of drug R&D has seen the largest cost increases?
clinical trials

On average, how long does it take for a new drug to be developed (i.e., from the discovery of the initial compound to FDA approval)?
10-15 years

Which of the following regulatory agencies is industry-based (i.e., run mainly by the companies themselves)?
Pharmaceutical Research and Manufactures of America (PhRMA)

Which of the following factors has simplified the pharmaceutical R&D process?
none of these:
A. an intensive regulatory process
B. growing demand in the medical community for more complex data about pharmaceuticals
C. the increasing number of procedures in Phase III trials

T/F: The landmark FDA Modernization Act of 1997 was a major step forward in enabling safe and effective new drugs and biologics to be made available sooner to patients.
True

What type of system is the best way to deliver healthcare?
a market-based system

How would increased pharmaceutical price controls affect the U.S. healthcare system?
Increased price controls would stifle innovation.

Which of the following invests a greater percentage of sales in research than the biotech sector?
none of these:
A. the aerospace sector
B. the communications sector
C. the electronics sector

What was the intent of the Bayh-Dole Act and the Stevenson-Wydler Technology Innovation Act?
to hasten the commercialization of technologies that otherwise might not be used

What did the G10 Medicines Group recently report about the pharmaceutical industry in the European Union (EU)?
There is poor collaboration between publicly- and privately-funded research centers.

T/F: The aim of preclinical pharmacological studies is to obtain data on the safety and effectiveness of the lead compound.
True

T/F: Toxicity information in preclinical studies helps provide confidence about a drug’s safety.
True

T/F: Pharmacological studies using animals are regulated under Good Laboratory Practice.
true

Why do drugs administered to patients only contain APIs?
They don’t.

What does NOT affect a drug’s ability to permeate membranes?
the drug’s vesicles

Through which barriers can lipid-soluble drugs usually pass?
cell membranes

How are weak acid drugs generally absorbed by the stomach?
more quickly than weak basic drugs

What route of administration does NOT completely bypass the liver?
rectal administration

Why are intravenous drug dosages easier to control than drugs administered transdermally?
The entire dose is available in the bloodstream to be distributed to the target site.

Which of the following does NOT affect a drug’s distribution to its target tissues?
All of these factors affect a drug’s distribution to its target tissues.

Which of these medical terms means “to apply the drug on the skin surface”?
transdermal

T/F: Carcinogenicity studies are carried out to identify the tumor-causing potential of a drug.
True

According to NIH ethical guidelines, which of the following is the most important criteria in selecting subjects for clinical studies?
scientific objectives

Which statement about the IRB is INCORRECT?
The members of the IRB/IEC must be experts in the topic of the study

Which phases of clinical studies are open label and which are blinded?
Phase I and IV trials are often open label, but Phase II and III are double-blinded or at least blinded.

If it is not possible to measure the direct effects of a drug, what is used instead?
surrogate markers such as blood pressure and cholesterol levels

Which of the following is an observational study that first identifies a group of subjects with a certain disease and a control group without the disease, and then looks to back in time (e.g., via chart reviews) to find exposure to risk factors?
case-control study

Which measure of central tendency is the sum of all observations divided by the number of observations?
mean

Which measurement describes the number of new events that occur during a specified period of time in a population at risk for the event (e.g., lung infections per year)?
incidence

Which of the following measures is used to describe the variability of the population mean?
standard error of the mean

Which of the following terms denotes the extent to which a test actually measures what it is supposed to be measuring, or what we think it is measuring?
validity

What are the Kaplan-Meier analysis and Cox proportional hazards analysis?
methods of survival analysis

What section of a clinical paper describes subjects’ entry and exclusion criteria?
methods

Which document sets out how a trial is to be conducted (i.e., the study’s general design and operating features)?
protocol

When designing and performing clinical trials, several ethical constraints must be considered. Which of the following is NOT one of these ethical constraints?
geographic variations

What is one way in which large molecule drugs DIFFER from small molecule drugs?
Large molecule drugs are mainly protein-based drugs that develop in biological systems such as living cells.

Which of the following statements about vaccines is INCORRECT?
Vaccines are types of small molecule drugs.

What is an advantage of attenuated vaccines over inactivated vaccines?
Attenuated vaccines are less expensive to prepare.

How are toxoids derived?
from the toxins secreted by a pathogen

What is the estimated annual death toll for malaria?
1.5 to 3.5 million people

T/F: There are more white blood cells than red blood cells for the same volume in the human body.
False

How was insulin primarily obtained from the 1930s to the 1980s?
porcine and bovine extracts

Which of the following are NOT types of cytokines?
monokines

Which of the following is NOT a type of hormones?
steroids

Which of the following is a basic gene therapy technique?
in vitro, in which patients’ genetically faulted tissues are removed, loaded with normal genes in vectors, and returned to the patients’ bodies

Which statement about stem cells is CORRECT?
Pluripotent stem cells can develop into many cell types, but not a new individual.

T/F: Leukemia is a condition in which the stem cells in the bone marrow malfunction and produce an excessive number of immature white blood cells
True

Which of the following are types of vectors used in gene therapy?
retroviruses

What is NOT a type of stem cell?
semipotent

Traditional vaccines are prepared in a number of ways. What way is NOT one of them?
insulin

T/F: Effective drug therapy is a cost-effective and highly valuable means of controlling total healthcare expenditures and improving quality of life.
True

Drug utilization review (DUR) programs…
have traditionally been used to ensure the appropriate, safe, and effective use of prescription drugs, but are increasingly shifting their focus to minimizing costs.

T/F: DUR programs involve retrospective monitoring of physicians’ prescribing patterns.
true

T/F: A formulary is a list of prescription drugs approved by insurance coverage.
True

The history of drug formularies in the U.S. extends back to…
…the American Revolution.

Which of these is NOT a type of formulary?
All of these are types of formularies:
A. a closed three-tier formulary in which generic drugs are listed on Tier 1
B. a five-tier formulary that is supplemented by a step therapy program
C. an open formulary that places few restrictions on coverage or access

Which of the following is NOT a recent formulary trend?
the repeal of Hatch-Waxman

What did the Hatch-Waxman Act do?
make it easier for generic manufacturers to compete with R&D companies

What is opportunity cost?
the value of a sacrificed alternative

According to your manual, the three primary entities that fund pharmaceuticals are employers, the government (Medicare and Medicaid), and __.
individuals

Which of these individuals would NOT be a member of a P&T committee?
a company’s medical liaison

T/F: Almost 98% of employed Americans are now covered by a HMO, a preferred provider organization, or a point-of-service plan.
FALSE

T/F: Pharmaceutical companies are more interested in acquiring and exploiting another’s brands than in acquiring another’s R&D and sales and marketing assets.
False

Ideally, when should brand strategy development for a new drug begin?
during Phase II clinical trials

Which of the following is an example of a expressive value?
I own a BMW because I want people to know that I’m a serious driving enthusiast.

According to your manual, which of the following is NOT an example of a functional value?
uniqueness

T/F: It is rare for pharmaceutical companies to explore, develop, and promote expressive values with which patients might identify.
True

T/F: To be competitive, pharmaceutical brands must be distinctive. They must possess defining characteristics that are perceived by customers to be unique, attractive, and relevant to their needs.
True

T/F: With the global need for new drugs, pharmaceutical brand names are not subject to regulatory approval.
True

How has DTC advertising changed over the last few decades?
DTC advertising has become an essential marketing tactic for both large and small brands.

Which of the following MOST strongly influences physicians’ prescribing habits?
doctors’ personal experiences, and their patients’ unique situations

T/F: Pharmaceutical companies spend more onpromotional activities than on R&D.
False

Which of the following would be MOST well-served by mass-market print and TV ads?
a brand that treats a very common chronic condition

How do companies use prescriber data?
to conduct research

Under PhRMA Code, which of the following is acceptable?
modest meals for staff members attending educational events

Under the AMA Guidelines on Gifts to Physicians from Industry, which gifts are NOT permitted?
gifts that are only given to doctors with high prescribing volumes

Under PhRMA Code, which of the following actions by sales reps are permitted?
providing modest meals to staff members attending educational events

T/F: The PhRMA Code on Interactions with Healthcare Professionals is only voluntary and not mandatory.
True

Which of the following would NOT be considered acceptable promotional items under PhRMA Code?
pens and clipboards designed to be used by patients in doctors’ offices

Under PhRMA Code, what is one example of an acceptable patient education item?
an anatomical model valued under $100

Under what circumstances does PhRMA Code permit a company to provide entertainment or recreational activities to healthcare practitioners?
under none of these circumstances

Under PhRMA Code, may a company sponsor a lunch at a 3-day conference if part of it includes an educational program for which attendees may choose to receive CME credit?
yes, but only if if the lunch is clearly separate from the CME portion of the conference

Which of the following is an arm of the Department of Health and Human Services that investigates regulatory infractions, provides compliance advice, and brings enforcement actions?
Office of Inspector General

It is illegal to ask receptionists for personal information about your clients such as home phone numbers, birthdays, or hobbies. A. TRUE
B. FALSE
False

Which of the following is NOT a primary goal or function of the P&T committee?
to educate sales representatives on legal and ethical guidelines for professional behavior

Which of the following is a major challenge facing family medicine?
managed care policies eroding patient-doctor relationships

According to your manual, family physicians diagnose and treat approximately what proportion of patients they see (as opposed to referring them to specialists)?
95%

Which of the following is NOT one of the steps on the Product Adoption Continuum?
These are all steps on the continuum.
A. adoption
B. awareness
C. evaluation

Which of the following would be classified as a type of somatic psychiatric treatment?
A. drug therapy

Why is the last 10 minutes of each hour usually the best time to make office visits to psychiatrists?
Psychiatrist often see patients on the hour for 45 minutes.

What is/are an advantage/s of selling to residents?
Residents are often more open-minded.

What is drug utilization review (DUR)?
an MCO’s practice of monitoring prescribing patterns

Used in the treatment of manic-depressive illness and schizoaffective disorder:
Mood stabilizers

What is the focus of the short call protocol?
beginning with a specific patient type

Who is the Medical Science Liaison (MSL)?
someone employed by a pharmaceutical company who builds relationships with thought leaders and acts as an informational resources

What type of education do MSLs typically have?
graduate-level science degrees

How do companies typically judge the MSL team’s contributions?
return on education

What differentiates push through programs from pull through programs?
Sales representatives are more involved in pull through programs.

Which of these is NOT a type of pull through program?
All of these are types of pull through programs.
A. adherence/persistency
B. educational support
C. therapeutic intervention

T/F: Because pharmaceutical sales reps work mostly out of their homes, it is not important that they work well in a team environment.
Fasle

What is the MOST LIKELY reason that a doctor would lack interest in one of your clinical studies?
The doctor does not like the way you are presenting it.

Which of the following is NOT an effective method for reaching the 65+ market?
All of these are effective methods for reaching the 65+ market.
A. being a Medicare Part D information resource
B. knowing the physician-payer mix
C. taking advantage of partnership programs

T/F: When a physician visits your hospital display, you should begin conversation by asking, “Can I help you?”?
False

Which of the following is NOT a rule in making the most out of your Which of the following is NOT a rule in making the most out of your sales calls?
your agenda, not theirs

T/F: Specialty care products are more often prescribed by generalist Specialty care products are more often prescribed by generalist physicians.
False

T/F: Side effects that might be considered merely minor annoyances in acute treatment can be a powerful barrier to adoption in chronic therapies.
True

T/F: Acute medications, such as antibiotics, are used to address short-term illnesses or symptoms.
True

T/F: In some medical cases, a therapy may be initiated by a specialist and monitored and maintained by a primary care physician.
True

T/F: Blockbuster drug status typically translates into sales of just under $10 million annually.
False

T/F: A generic drug manufacturer’s greatest challenge is often to replicate drug formulation factors that affect the pharmacokinetic and pharmacodynamic characteristics of the original drug.
True

What differentiates an orphan drug from a blockbuster drug?
Orphan drugs typically treat rare conditions.

How long are most calls and visits to physicians’ offices (excluding waiting and driving time)?
A. only a few minutes

Which of the following is NOT a step in managing rumors?
counter attack

According to the text, which of the following is considered going to the next level?
staying focused

What is one of the primary job responsibilities of a retail pharmacist?
A. dispensing pharmaceuticals

What is NOT one of the ways in pharmaceutical companies and representatives categorize their customers?
Companies and agents categorize their patients in all of these ways.

Which of the following are relatively new prescription drug benefits covered under the Medicare Prescription Drug Improvement & Modernization Act?
Medicare Part D

Which term means “disease producer”?
pathogen

Which type of blood cell plays the most prominent role in fighting infection and disease?
white blood cell

Which of the following generally resides on a cell surface (or in the cytoplasm) and causes a biological change or activity when stimulated?
receptor

Renal pertains to:
kidneys

What term denotes the practice of locating genes on a chromosome?
gene mapping

What field is MOST concerned with drug effects due to slight genetic differences?
pharmacogenomics

Which entity or entities fund/s the National Institutes of Health (NIH)?
United States Federal Government

With respect to the material in your manual, what does IDN stand for?
integrated delivery network

What is SS an abbreviation for?
semis

What term is used to denote drugs that are non-biological (i.e., chemical) in nature?
small molecule

When referring to medication dosage, which medical abbreviation denotes “hour”?
H

Which of the following terms denotes the study of drugs’ beneficial and toxic effects on living cells, tissues, and organisms?
pharmacology

What are specialized cells and tissues that work together to perform a specific body function for a common purpose?
organs

What is the mechanism of action?
the method by which a medication produces its therapeutic effects

What is plasma?
The fluid portion of the blood

What is anaphylaxis?
An extreme sensitivity and reaction to a foreign substance, including medications

Which of the following is NOT a way in which CNS agents are used?
They are used in all these ways.
A. as analgesics
B. as anesthetics
C. as anti-convulsants

How do cholinergic agonists work?
by mimicking the actions of acetylcholine

Which of the following is considered a sympathomimetic drug that stimulates the alpha-adrenergic receptors?
Decongestant

Which of the following is NOT a type of gastrointestinal agents?
prolactin inhibitors

What is one of the main functions of a tocolytic agent?
to suppress labor

Which of these conditions is NOT treated with antiandrogens?
dyspepsia

which types of patients are MOST likely to receive immune globulins?
patients with weakened immune systems

What is iron’s primary function in the body?
carrying oxygen

Which of the following is NOT a type of anti-infectant?
antimetabolites

What is one difference between entry-level and experienced résumés?
A. Entry-level résumés are more likely to begin with the education section than the experience section.

Which statement about targeted cover letters is true?
Targeted cover letters are always tailored to specific companies.