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

question

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

answer

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

question

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

question

PRN

answer

As needed

question

QD

answer

Once a day

question

QID

answer

Four times a day

question

Protein binding

answer

the ability of certain drugs to bind to plasma protein.

question

TID

answer

three times a day

question

Titration

answer

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

question

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

question

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

question

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

question

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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