NAPSR/CNPR Exam

question

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

True
question

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

True
question

Average review time for a new drug
answer

18 months
question

Sales Team
answer

Pg 7
question

The \”engine of innovation,\” focused on discovering or inventing promising new product.
answer

Research & Development
question

This includes supply chain, manufacturing, trade, and distribution functions of the business.
answer

Manufacturing & Operations
question

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

True
question

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

True
question

Define Off-label
answer

Usage of a medication for purposes other than the specific ones appearing on the label
question

Toxicity
answer

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

Institutional review Board (IRB)
answer

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.
question

Placebo
answer

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

Edema
answer

Swelling
question

Asymptomatic
answer

Without signs or symptoms
question

Clinical Pharmacology
answer

The study of the effects and movement of drugs in the human body
question

Anatomy
answer

The study of basic structures of the body
question

Physiology
answer

The study of how those body structures function
question

Basic clinical pharmacology involves 3 main concepts
answer

Pharmacodynamics, Pharmacokinetics, drug distribution and elimination.
question

Pharmacodynamics
answer

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.
question

Pharmacokinetics
answer

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.
question

Drug distribution & elimination
answer

Drug delivery systems, route of administration , modes of excretion.
question

Plasma
answer

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

Organs
answer

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

Nucleus
answer

Brain of the cell that regulates all activities.
question

Proteins
answer

A nutrient made up of of chains of amino acids
question

Fats
answer

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

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

Vitamins
answer

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

Minerals
answer

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

Water is NOT a nutrient
answer

True
question

Body’s Major Systems
answer

Cardiovascular, Respiratory, nervous, musculoskeletal, reproductive, immune
question

Absorption
answer

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

Distribution
answer

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

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

Excretion
answer

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.
question

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

True
question

Routes of drug administration
answer

Pg 26-29
question

Seven rights of drug administration
answer

pg 30
question

Bioavailability
answer

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

Bioequivalent
answer

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

Therapeutic equivalence
answer

Production of the same medicinal effect
question

Drug elimination and Excretion
answer

pg 34
question

Drug Forms
answer

Pg 35-38
question

Patent last 20 years
answer

True
question

Inactive ingredients
answer

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

Pharmaceutical Ingredients
answer

Pg 54
question

BID
answer

twice a day
question

Cmax
answer

Peak plasma concentration on a measuring curve
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Half-life
answer

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
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PRN
answer

As needed
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QD
answer

Once a day
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QID
answer

Four times a day
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Protein binding
answer

the ability of certain drugs to bind to plasma protein.
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TID
answer

three times a day
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Titration
answer

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

Time of peak plasma concentration on a measuring curve
question

STAT
answer

Immediately
question

Primary wholesale distributors
answer

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
question

Secondary wholesale distributors
answer

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
question

Distribution Terminology
answer

Pg 60-61
question

Average wholesale price (AWP)
answer

Published wholesale price of list price suggested by the manufacturer.
question

Chain drug store
answer

Company that owns and operates four or more pharmacies
question

Drop shipment
answer

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

Group purchasing organization (GPO)
answer

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
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Upcharge
answer

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

Package Insert Info
answer

Pg 63
question

Drug Patents
answer

Pg 65 Terms pg 67
question

Orange Book ratings
answer

A AA AN AO AP AT B
question

Hatch-Waxman Act
answer

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
question

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

True
question

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

True
question

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

True
question

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
answer

True
question

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.
answer

True
question

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

True
question

Section 503
answer

Prohibits sale, purchase, or trade of drug samples
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E-sampling
answer

Pg 72
question

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

True
question

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

True
question

FTC
answer

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

AMA
answer

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

Benefits of Government-Industry Partnerhsips
answer

Pg 79
question

Preclinical studies
answer

pg 81
question

Pinocytosis
answer

Involves the engulfing of fluids by a cell.
question

Transport Mechanisms
answer

Passive diffusion, facilitated diffusion, active transport, pinocytosis
question

Absorption methods
answer

Oral, Buccal, sublingual, rectal, subcutaneous, intramuscular, transdermal, topical, inhalation, intravenous
question

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

True
question

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

True
question

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.
answer

True
question

Clinical Trials
answer

pg 89
question

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

True
question

Four phases of clinical trials
answer

Pg 90
question

Regulatory Requirement terms
answer

Pg 92
question

Investigator
answer

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

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

Protocol
answer

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

Epidemiology
answer

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

Therapeutic
answer

Antibodies
question

Vaccines
answer

Pg 108
question

Toxoids
answer

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

Vector-based vaccines
answer

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.
question

Peptide Vaccines
answer

Chemically synthesized and normally consist of 8-24 amino acids
question

Adjuvants
answer

pg 110
question

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

True
question

Hormones are intercellular messengers.
answer

True
question

Retrovirus
answer

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

Adendovirus
answer

This vector has a large capacity for foreign genes.
question

Liposomes
answer

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

Naked DNA
answer

they do not have viral genes and do not cause disease
question

Gene Therapy types
answer

Retrovirus, adenovirus, adeno-associated virus, liposomes, naked DNA
question

Stem Cells
answer

Pg 114
question

Managed Care
answer

Pg 117
question

Formulary
answer

List of prescription drugs approved by insurance coverage pg 118
question

Opportunity cost
answer

pg 124
question

Branding
answer

pg 113
question

Values
answer

Function, Expressive, Central
question

Functional Values
answer

Efficacy, safety, convenience, cost-effectiveness
question

6 stages of brand strategy
answer

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

Pharmetrics
answer

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

Brands should be:
answer

Easy to pronounce, easy to write and read, memorable, distinctive and different from competition
question

Direct-to-consumer (DTC)
answer

pg 152
question

Factors that influence DTC
answer

pg 153
question

Gifts
answer

Pg 162
question

PhRMA Code
answer

Now prohibits pens, mugs, objects with company logo
question

AMA Gift guidelines
answer

Pg 165
question

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

True
question

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

True
question

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

True
question

PhRMA Code on relationships
answer

Pg 167
question

PhRMA FAQ
answer

Pg 174
question

Nursing Structures
answer

Pg 200
question

Sales techniques
answer

pg 207
question

Medicare part D
answer

pg 225
question

Organizing your day
answer

Pg 239
question

Traits of Pharma sales Rep
answer

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
question

Glossary
answer

271
question

Exclusivity is granted for an orphan drug for ____
answer

7 years
question

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

False
question

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

20 years
question

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

False
question

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

ORange Book
question

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

True
question

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

True
question

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

False
question

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

True
question

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

True
question

The PDMA is the Prescription Drug Manufacturers Association.
answer

False
question

Primary wholesale distributors buy most of their drugs directly from ______
answer

manufacturers
question

The AWP is a published ______ price, suggested by drug manufacturers.
answer

wholesale
question

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

true
question

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

true
question

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

invention
question

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

marketing rights
question

Exclusivity is granted for an orphan drug for _______ years.
answer

7
question

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

bioevuivalent
question

Generic drugs are not regulated by the FDA.
answer

False
question

The Orange Book is considered the most authoritative manual on therapeutic ______.
answer

equivalence
question

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

legislation
question

First pass metabolism occurs when a drug administered orally is metabolized in the ________.
answer

Liver
question

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

True
question

Monoclonal antibodies are created in laboratories to target the ________ of patients to kill cancer.
answer

Cancer cells
question

The best way to deliver health care is through a ________ system.
answer

market based
question

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

clinical trials
question

The agency which regulates the distribution and use of narcotics and other controlled substances is _______.
answer

DEA
question

The FDA approves storage conditions for drug products.
answer

True
question

The most important benefit of electronic prescribing is related to patient ______.
answer

safety
question

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.
answer

true
question

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

false
question

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

true
question

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

true
question

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

false
question

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

true
question

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

heart
question

Which of the below terms means \”to apply the drug on the skin surface\”?
answer

transdermal
question

Diffusion is the random movement of molecules in fluid
answer

true
question

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

false
question

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

true
question

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

true
question

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

true
question

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

false
question

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

true
question

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

false
question

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

false
question

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.
answer

false
question

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

true
question

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.
answer

true
question

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

false
question

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

true
question

Subjects for clinical trials are selected on the basis of _____
answer

scientific objectives
question

The pivotal trial is Phase ______ of the clinical trial.
answer

3
question

The \”road map\” for a clinical research paper is called the _______.
answer

abstract
question

Pharmaceutical reps should thoroughly read _______ sections of clinical studies when results are released.
answer

all
question

The three major areas in which biologics are used are prophylactic, _______, and replacement therapy.
answer

therapeutic
question

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

true
question

Three primary entities fund pharmaceuticals: employer, government (Medicare and Medicaid), and ______.
answer

individuals
question

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.
answer

true
question

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

pharmacy department
question

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

true
question

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

false
question

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.
answer

false
question

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.
answer

false
question

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

toxicity
question

The US accounts for about ____ of all the world’s pharmaceutical revenues.
answer

1/2
question

The most effective method for grabbing market share is:
answer

comparative selling
question

Most visits by pharmaceutical reps are to pharmacies.
answer

false
question

Among the biotechnology medications under development, about _____ target cancer.
answer

50%
question

A _____ is an inactive medication with no treatment value, used in experimental studies.
answer

placebo
question

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

false
question

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

false
question

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

true
question

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

false
question

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

false
question

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.
answer

false
question

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

true
question

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.
answer

true
question

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

false
question

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

true
question

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

false
question

Specialty care products are often prescribed by generalist physicians.
answer

false
question

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

true
question

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

true
question

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

true
question

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

true
question

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

travel time
question

\”Pull through\” refers to:
answer

generating demand for your company’s product
question

Which of the following is not a part of the Seven Step Cascade of Emotion?
answer

be a consultant, not a rep
question

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

your agenda not theirs
question

What do retail pharmacists do?
answer

dispense pharmaceuticals
question

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

asking feedback
question

Which is not a step to plan for rumors?
answer

counter attack
question

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

likeability
question

According to the text, which of the following is considered \”going to the next level?\”
answer

staying focused
question

clinical effect
answer

The response produced by a medication
question

pathology
answer

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

New prescription drug benefits covered under the Medicare Prescription Drug Improvement & Modernization Act:
answer

medicare part d
question

tertiary care
answer

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

Literally \”disease producer\”:
answer

pathogen
question

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

white blood cell
question

SS
answer

Used when referring to medication dosage, means \”one-half\”:
question

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

declining
question

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

formulation
question

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

ischemia
question

The acronym for pharmacokinetics is:
answer

PK
question

According to the text, there are ___ classes of therapeutic drugs.
answer

US federal govt
question

Oral Glaucoma Therapy is classified as:
answer

ophthalmology therapy
question

internist
answer

is a physician that practices internal medicine
question

IDN
answer

integrated delivery network
question

Another name for biologic compound is:
answer

large molecule
question

SS is an abbreviation for:
answer

semis
question

The ___________ is used to determine appropriate medical reimbursement.
answer

coding system
question

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

small molecule
question

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

Etiology
question

Used when referring to medication dosage, means \”as needed\”:
answer

PRN
question

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

cross tolerance
question

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

pharmacology
question

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

adjuvant
question

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:
answer

receptor
question

Refers to medication dosage, means \”hour\”:
answer

h
question

Outside a living body:
answer

ex vivo
question

The meaning of subcutaneous is:
answer

beneath outer skin
question

The acronym for effective dose is:
answer

ed
question

ML stands for:
answer

milliliter
question

According to the text, depression is a disease that attacks the:
answer

central nervous system

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