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NAPSR CNPR Exam Exam With 100%|592 Correct And Verified Answers 2024 Margin of safety - Correct Answer-the difference between the usual effective dose and the dose that induces severe or life threatening side effects Rights of drug administration - Correct Answer-right patient, right medication, right does, right route of administration, and right time of delivery Injection routes - Correct Answer-intramuscular, intrathecal, intravenous, subcutaneous intramuscular - Correct Answer-drugs given by direct injection into muscle tissue intrathecal - Correct Answer-needle is inserted between to vertebrea in the lower spine an into space around the spinal cord intravenous - Correct Answer-injected directly into the veins subcutaneous - Correct Answer-needle inserted into the fatty tissue just beneath the skin Bioavailablility - Correct Answer-how quickly and how much of a drug reaches its intended target site of action Bioequivalent - Correct Answer-when drugs contain not only the same active ingredients but also produce virtually the same blood levels over time Therapeutic equivalence - Correct Answer-production of the same medicinal effects Areas of drug elimination and excretion - Correct Answer-Lungs, breast milk, sweat tears urine feces, bile, saliva, and exhaled air medication error - Correct Answer-failure to administer drug in the correct form Powders - Correct Answer-a drug that is dried and ground into fine particles pills - Correct Answer-a single dose unit of medicine made by mixing the powdered drug with liquid such as syrup and rolling it into a round or oval shape granules - Correct Answer-a small pill usually accompanied usually accompanied by many others encased within a gelatin capsule; quite often releasing medication over time tablet - Correct Answer-pharmaceutical preparation made by compressing the powdered for of a drug and bulk filling material under high pressure; commonly used for anti acids and antiflatulents Capsules - Correct Answer-medication dosage form in which the drug is contained in an external shell; can be pulled apart for access to contents sustained release - Correct Answer-several doses of a drug in special coatings that dissolve at different rates Enteric Coating - Correct Answer-dosage in special coating that doesn't digest in the stomach; only starts to digest in the intestines Lubricants - Correct Answer-ease the release of the tablets from the dies that stamp them during the manufacturing process AUC - Correct Answer-represents the extent of the drug absorption or the quantity of the drug that appears in the bloodstream following oral administration Cmax - Correct Answer-peak plasma concentration on a measuring curve First pass effect - Correct Answer-metabolizing process in the liver that suppresses the amount of drug that eventually reaches the systemic circulation and the site of action onset of action - Correct Answer-the time it takes for a drug to start having any intended affect after it is administered Protein Binding - Correct Answer-the ability of certain drugs to bind to plasma protein QD - Correct Answer-once a day QID - Correct Answer-four times a day PRN - Correct Answer-take as needed TID - Correct Answer-three times a day Tmax - Correct Answer-time of peak plasma concentration on a measuring curve BID - Correct Answer-twice a day Authorized distributor - Correct Answer-any distributor of a prescription drug that has a written agreement with the manufacturers of the prescription drug and conducts at least two transactions with the manufacturer of the prescription drug within any 24-month period Average whole price (AWP) - Correct Answer-published whole sale price or list price suggested by the manufacturer Brokerage - Correct Answer-the combination of -drop ship and dock to dock delivery services provided by wholesalers. Wholesalers do not bring the product into their warehouses Buy-side margin - Correct Answer-refers to the early payment discounts and other earned or negotiated rebates and discounts received by wholesalers from drug manufacturers; increase in the value of wholesalers' inventories ad manufacturers' prices rise chain drug store - Correct Answer-a company that owns and operates four or more pharmacies dock to dock delivery - Correct Answer-wholesaler obtains the drugs to a dispenser own warehouse without taking the drugs into its own inventory drop shipment - Correct Answer-the drug manufacturer directly delivers the drugs to a dispenser but the order and payments are made through a wholesaler Float - Correct Answer-the time differential between when a wholesaler receives payment from its customer and when the payment is due to its supplier Group Purchasing Organization GPO - Correct 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 In-state wholesaler - Correct Answer-wholesaler that distributes drug products in a state in which it is physically located independent drug store - Correct Answer-a company that owns and operates three or fewer pharmacies Integrated Delivery Network IDN - Correct Answer-a financial management structure that unites hospitals, physicians ambulatory care site and managed care plans through ownership or exclusive formal agreements to provide a system to deliver a continuum of healthcare services Mail order pharmacy - Correct Answer-a pharmacy that dispenses prescriptions to patients who submit their prescriptions by mail or fax manufacturer direct sale - Correct Answer-the type of sale that bypasses the need for any intermediary distributor mass merchandiser - Correct Answer-Department stores with a pharmacy non-stock sales - Correct Answer-brokerage sales, dock to dock sales, drop shipments, and any form of sale not placed in inventory AT - Correct Answer-topical products B - Correct Answer-drug products requiring further FDA investigation and review to determine equivalence ANDA - Correct Answer-abbreviated new drug application How many days does a brand name company have to sue - Correct Answer-45 Generic drug first to file exclusivity - Correct Answer-the first generic drug manufacturer to file an ANDA with the FDA on a new off-patent drug receives a six-month marketing exclusivity Single-source drug products - Correct Answer-there is only one approved product available for that active ingredient and dosage form Multi-source drug prodcuts - Correct Answer-pharmaceutically equivalent products are available from more than one manufacturer Hatch Waxman act - Correct Answer-also known as the drug price competition and patent tem restoration act of 1984 most significant drug related legislation affecting pharmaceutical and healthcare industries since 1962 HW Act - Correct Answer-made it easier to bring generic drugs to the market by requiring the FDA to only look at bioavailability studies in order to approve an ANDA chemical equivalents - Correct Answer-multi-source products which contain essentially the same amounts of identical active ingredients in identical dosage forms which meet existing physical chemical standards Biological equivalents - Correct Answer-chemical equivalents which when administered in the same amount will provide same biological or physiological availability as measured by blood and urine levels therapeutic equivalents - Correct Answer-chemical equivalents which when administered in the same amount will provide same therapeutic effect as measured by the control of a symptom or disease generic substitution - Correct Answer-the act of dispensing a different brand for the product prescribed pharmaceutical alternatives - Correct Answer-drug products that have the same therapeutic effect and strength but differ in the salt, ester or dosage form and are administered by the same rout pharmaceutical substitution - Correct Answer-the act of dispensing a pharmaceutical alternative for the product prescribed Therapeutic alternatives - Correct Answer-drug products containing different therapeutic moieties but of the same pharmacological or therapeutic class can be expected to have similar therapeutic effects when administered in therapeutically equivalent doses PDMA - Correct Answer-product development and management association drug sample - Correct Answer-unit of drug not intended to be sold but to promote the sale Section 503 of Federal food drug and cosmetic act - Correct Answer-prohibits the sale, purchase, trade or offer to sell, purchase or trade prescription drug samples and coupons USP US pharmacopoeia - Correct Answer-the first comprehensive publication of drug standards USP-UF US Pharmacopoeia - National Formulary - Correct Answer-current annual publication of certified drug standards verifying purity and ingredients Office of inspector general - Correct Answer-an arm of the department of health and human services that investigates regulatory infractions, provides compliance advice and bring enforcement actions Federal trade commision - Correct Answer-regulates general business practices to protect consumers against misleading and anti-competitive behavior Drug enforcement administration - Correct Answer-regulates the distribution and use of narcotics and other controlled substances A patent owner has the right to exclude others from making, using, selling or importing into the US the it describes. - Correct Answer-invention Which is not a rule in making the most out of your sales call? - Correct Answer-your agenda not theirs Functional Values - Correct Answer-Efficacy, safety, convenience, cost-effectiveness Branding - Correct Answer-strengthens bond between buyer and seller; competition differentiation pg 198 PhRMA Code on relationionships - Correct Answer-pg 233 Brand values - Correct Answer-functional values, expressive values, central value Functional values - Correct Answer-what the brand does for me Expressive values - Correct Answer-what the brand says about me central values - Correct Answer-what the brand and I share at a fundamental level gene therapy types - Correct Answer-Retrovirus, adenovirus, adeno-associated virus, liposomes, naked DNA Exclusivity is granted for an orphan drug for - Correct Answer-7 years Nursing Structures - Correct Answer-pg 268 Director of nursing - Correct Answer-BSN MSN Unit manager with 24 hour responsibility for unit - Correct Answer-RN, BSN Case Manager risk manager/infection control - Correct Answer-RN, BSN House supervisor, works off shift - Correct Answer-RN Charge Nurse oversees shift in unit - Correct Answer-RN Clinical Care - Correct Answer-RN Oral medication - Correct Answer-LPN Protocol - Correct Answer-This document sets out how a trial is to be conducted Exclusivity is granted for an orphan drug for years. - Correct Answer-7 Absorption methods - Correct Answer-Oral, Buccal, sublingual, rectal, subcutaneous, intramuscular, transdermal, topical, inhalation, intravenous Transport Mechanisms - Correct Answer-Passive diffusion, facilitated diffusion, active transport, pinocytosis The agency which regulates the distribution and use of narcotics and other controlled substances is . - Correct Answer-DEA The most important benefit of electronic prescribing is related to patient . - Correct Answer-safety Which one of the below terms is not a route for excreting a drug from the body? - Correct Answer-Heart The Hatch-Waxman Act made it more difficult for generic manufacturers to manufacture and distribute off-patent drugs and compete with R & D companies. - Correct Answer- False Bioavailability - Correct Answer-how quickly and how much of a drug reaches its intended target site of action Fats - Correct Answer-A nutrient stored in special body tissues as a great source of reserve energy Carbohydrates - Correct Answer-A nutrient that is the body's immediate source of energy. It's broken down to glucose and used for immediate metabolic reactions. travel time - Correct Answer-What is one of the biggest time wasters for a pharmaceutical sales rep? Metabolism - Correct Answer-How the active part of a drug is metabolized into a more water-soluble compound that can be readily excreted by the kidneys Monoclonal antibodies are created in laboratories to target the of patients to kill cancer. - Correct Answer-cancer cells The best way to deliver health care is through a system. - Correct Answer- market based The costs for all phases of R&D for drug companies are rising, with the increase particularly acute for . - Correct Answer-clinical trials The FDA approves storage conditions for drug products. - Correct Answer-true 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 - Correct Answer-true There are more white blood cells than red blood cells for the same volume in the human body. - Correct Answer-false Unlike the small molecule drugs (pharmaceuticals) described, large molecule drugs (biopharmaceuticals) are mainly protein-based. - Correct Answer-true The duration for Phase III of the clinical trial can typically last 3-5 years. - Correct Answer- true The aim of the Phase IV clinical trial is to examine the safety and effectiveness of the drug in the targeted disease group. - Correct Answer-false Carcinogenicity studies are carried out to identify the tumor-causing potential of a drug. - Correct Answer-true Which of the below terms means "to apply the drug on the skin surface"? - Correct Answer-transdermal Diffusion is the random movement of molecules in fluid - Correct Answer-true Most drugs that are administered to patients typically contains just one active pharmaceutical ingredient. - Correct Answer-false Toxicity information in preclinical studies provides confidence about a drugs safety aspect. - Correct Answer-true The aim of pharmacological studies is to obtain data on the safety and effectiveness of the lead compound. - Correct Answer-true Effective drug therapy typically is a cost-effective and highly valuable means of controlling total healthcare expenditures and improving quality of life. - Correct Answer- true Almost 98% of employed Americans are now covered by a HMO, a preferred provider organization, or a point-of-service plan. - Correct Answer-false DUR programs involve retrospective monitoring of physicians' prescribing patterns. - Correct Answer-true PBM's tend to serve a local market through a network of pharmacies. - Correct Answer- 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. - Correct Answer-false Exclusivity gives exclusive , which is granted by the FDA, and can run concurrently with a patent or not. - Correct Answer-marketing rights Drug labels must include indications and usage information, as well as contraindications. - Correct Answer-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. - Correct Answer-true Traits of Pharma sales Rep - Correct 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 Storage conditions for drug products are based on data and information supplied by the manufacturer - Correct Answer-True Drug recalls are almost always negotiated with the FDA beforehand. - Correct Answer- true The PDMA is the Prescription Drug Manufacturers Association. - Correct Answer-False Primary wholesale distributors buy most of their drugs directly from - Correct Answer- Manufacturers The AWP is a published price, suggested by drug manufacturers. - Correct Answer- wholesale It is rare for pharmaceutical companies to explore, develop and promote expressive values with which patients might identify. - Correct Answer-true With the global need for new drugs, pharmaceutical brand names are not subject to regulatory approval. - Correct Answer-false Brands should be: - Correct Answer-Easy to pronounce, easy to write and read, memorable, distinctive and different from competition formulation - Correct Answer-The substances comprising all active and inert pharmaceutical ingredients, including fillers, colors, and other excipients used to prepare dosage forms: The greatest challenge for a generics manufacturer is to replicate drug formulation factors that affect the pharmacokinetic and pharmacodynamic characteristics of the original drug. - Correct Answer-true "Pull through" refers to: - Correct Answer-generating demand for your company's product Which of the following is not a part of the Seven Step Cascade of Emotion? - Correct Answer-be a consultant, not a rep Which is a step to becoming an indispensable pharmaceutical sales rep? - Correct Answer- asking feedback Which is not a step to plan for rumors? - Correct Answer-counter attack According to the text, which of the following is considered "going to the next level?" - Correct Answer-staying focused clinical effect - Correct Answer-The response produced by a medication tertiary care - Correct Answer-Highly specialized medical and surgical care for unusual or complex medical problems provided by a large medical center Literally "disease producer": - Correct Answer-pathogen A type of blood cell that helps the body fight infection and disease: - Correct Answer- white blood cell Dividing a group of physicians and other potential prescribers for a certain category of drugs based on anticipated prescription volume: - Correct Answer-declining A low supply of oxygen due to low blood flow is - Correct Answer-ischemia Acute medications, such as antibiotics, are used to address short-term illnesses or symptoms. - Correct Answer-true The acronym for pharmacokinetics is: - Correct Answer-PK According to the text, there are classes of therapeutic drugs - Correct Answer-US federal govt Another name for biologic compound is: - Correct Answer-large molecule SS is an abbreviation for: - Correct Answer-semi doses The is used to determine appropriate medical reimbursement. - Correct Answer- coding system The origin, or cause, of a disease or a patient's symptoms: - Correct Answer-etiology 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. - Correct Answer-false The extent, quality, or degree to which a substance is poisonous or harmful to the body. - Correct Answer-toxicity The US accounts for about of all the world's pharmaceutical revenues. - Correct Answer-50% Specialty care products are often prescribed by generalist physicians. - Correct Answer- false Among the biotechnology medications under development, about target cancer. - Correct Answer-50% A is an inactive medication with no treatment value, used in experimental studies. - Correct Answer-placebo Almost 98% of employed Americans are now covered by a HMO, a preferred provider organization, or a point-of-service plan. - Correct Answer-false DUR programs involve retrospective monitoring of physicians' prescribing patterns. - Correct Answer-true PBM's tend to serve a local market through a network of pharmacies. - Correct Answer- 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. - Correct Answer-false It is rare for pharmaceutical companies to explore, develop and promote expressive values with which patients might identify - Correct Answer-true DTC advertising has become a required tactical consideration for most pharmaceutical brands in the U.S.. - Correct Answer-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. - Correct Answer-false 6 stages of brand strategy - Correct 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 Edema - Correct Answer-swelling Hatch-Waxman Act - Correct 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 Manufacturers and distributors are required to have systems to monitor and audit the distribution of their drug samples - Correct Answer-true Institutional review Board (IRB) - Correct 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. 5 rights of drug administration - Correct Answer-Right dose, right patient, right medication, right route of administration, right time of delivery Minerals - Correct Answer-A nutrient necessary for bodily purposes such as the balance of body fluid Water is NOT a nutrient - Correct Answer-true Hormones are intercellular messengers. - Correct Answer-true Many pharmaceutical manufacturers set expiration dates every six months (June, December) - Correct Answer-true Toxoids - Correct Answer-Derived from toxins secreted by a pathogen.Examples are diphtheria and tetnus vaccines. Vector-based vaccines - Correct 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. The liver is the major organ for metabolizing drugs. Secondary is kidney - Correct Answer- true Pinocytosis - Correct Answer-Involves the engulfing of fluids by a cell. In 2012, FDA regulators approved 39 new drugs for use in the U.S. - Correct Answer- 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. - Correct Answer- true Investigator - Correct Answer-The person who conducts the trial. This person is normally an expert in the field. They should not be employed by the sponsor Subjects should be informed about the aims, methods, risks, and benefits of the trial - Correct Answer-true clinical trials - Correct Answer-research study conducted with human patients Four phases of clinical trials - Correct Answer-pg 125 Regulatory Requirement terms - Correct Answer-Pg 126 The FDA regulates the introduction of new drugs and enforces U.S. drug laws. - Correct Answer-True Pharma companies must submit extensive data to the FDA demonstrating the safety and effectiveness of new drugs before receiving approval for sale. - Correct Answer- True Average review time for a new drug - Correct Answer-18 months Sales Team - Correct Answer-Pg 7 The "engine of innovation," focused on discovering or inventing promising new product. - Correct Answer-Research & Development This includes supply chain, manufacturing, trade, and distribution functions of the business. - Correct Answer-Manufacturing & Operations In 2012, FDA regulators approved 39 new drugs for use in the U.S. - Correct Answer- True 3,070 new meds are in development for cancer. - Correct Answer-True Define Off-label - Correct Answer-Usage of a medication for purposes other than the specific ones appearing on the label Toxicity - Correct Answer-The extent, quality, or degree to which a substance is poisonous or harmful to the body Institutional review Board (IRB) - Correct 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. Placebo - Correct Answer-Inactive pill, liquid, or powder that has no treatment value aka sugar pill Edema - Correct Answer-Swelling Asymptomatic - Correct Answer-Without signs or symptoms Clinical Pharmacology - Correct Answer-The study of the effects and movement of drugs in the human body Anatomy - Correct Answer-The study of basic structures of the body Physiology - Correct Answer-The study of how those body structures function Basic clinical pharmacology involves 3 main concepts - Correct Answer- Pharmacodynamics, Pharmacokinetics, drug distribution and elimination. Pharmacodynamics - Correct 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. Bioavailability - Correct Answer-how quickly and how much of a drug reaches its intended target site of action Bioequivalent - Correct Answer-when they contain the same active ingredients and proceed virtually the same blood levels over time. Therapeutic equivalence - Correct Answer-Production of the same medicinal effect Drug elimination and Excretion - Correct Answer-pg 34 Drug Forms - Correct Answer-Pg 35-38 Patent last 20 years - Correct Answer-True Inactive ingredients - Correct Answer-Added to provide bulk, strength, aid dissolving, color, taste, etc. IAs do not affect the body Pharmaceutical Ingredients - Correct Answer-Pg 54 BID - Correct Answer-twice a day Cmax - Correct Answer-Peak plasma concentration on a measuring curve Half-life - Correct 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 PRN - Correct Answer-As needed QD - Correct Answer-Once a day QID - Correct Answer-Four times a day Protein binding - Correct Answer-the ability of certain drugs to bind to plasma protein. TID - Correct Answer-three times a day Titration - Correct Answer-the process of adjusting drug doses to achieve the max positive therapeutic effects while minimizing adverse or side affects Tmax - Correct Answer-Time of peak plasma concentration on a measuring curve STAT - Correct Answer-Immediately Primary wholesale distributors - Correct 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 Secondary wholesale distributors - Correct 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 Distribution Terminology - Correct Answer-Pg 60-61 Average wholesale price (AWP) - Correct Answer-Published wholesale price of list price suggested by the manufacturer. Chain drug store - Correct Answer-Company that owns and operates four or more pharmacies Drop shipment - Correct Answer-Drug manufacturer directly delivers the drugs to a dispenser, but order and payments are made through a wholesaler Group purchasing organization (GPO) - Correct 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 Upcharge - Correct Answer-Percentage fee that is paid by the dispenser to the wholesaler for the cost of distribution Package Insert Info - Correct Answer-Pg 63 Drug Patents - Correct Answer-Pg 65 Terms pg 67 Orange Book ratings - Correct Answer-A AA Absorption methods - Correct Answer-Oral, Buccal, sublingual, rectal, subcutaneous, intramuscular, transdermal, topical, inhalation, intravenous The liver is the major organ for metabolizing drugs. Secondary is kidney - Correct Answer- True CL= rate of drug elimination/drug concentration in blood - Correct Answer-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. - Correct Answer- True Clinical Trials - Correct Answer-pg 89 Subjects should be informed about the aims, methods, risks, and benefits of the trial - Correct Answer-True Four phases of clinical trials - Correct Answer-Pg 90 Regulatory Requirement terms - Correct Answer-Pg 92 Investigator - Correct Answer-The person who conducts the trial. This person is normally an expert in the field. They should not be employed by the sponsor Sponsor - Correct Answer-The organization or individual that initiates the trial and finances the study, Protocol - Correct Answer-This document sets out how a trial is to be conducted Epidemiology - Correct Answer-The study of how factors influence disease and health in human populations. Therapeutic - Correct Answer-Antibodies Vaccines - Correct Answer-Pg 108 Toxoids - Correct Answer-Derived from toxins secreted by a pathogen.Examples are diphtheria and tetnus vaccines. Vector-based vaccines - Correct 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. Peptide Vaccines - Correct Answer-Chemically synthesized and normally consist of 8- 24 amino acids Adjuvants - Correct Answer-pg 110 Cytokines are produced mainly by the leukocytes (white blood cells) - Correct Answer- True Hormones are intercellular messengers. - Correct Answer-True Retrovirus - Correct Answer-Integrates genes to hose chromosomes, change of long term stability. Adendovirus - Correct Answer-This vector has a large capacity for foreign genes. Liposomes - Correct Answer-Vector does not have viral genes so they do not cause disease. Naked DNA - Correct Answer-they do not have viral genes and do not cause disease Gene Therapy types - Correct Answer-Retrovirus, adenovirus, adeno-associated virus, liposomes, naked DNA Stem Cells - Correct Answer-Pg 114 Managed Care - Correct Answer-Pg 117 Formulary - Correct Answer-List of prescription drugs approved by insurance coverage pg 118 Opportunity cost - Correct Answer-pg 124 Traits of Pharma sales Rep - Correct 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 Glossary - Correct Answer-271 Exclusivity is granted for an orphan drug for - Correct Answer-7 years Patents are applied for with, and granted by the FDA. - Correct Answer-False Patents expire after how many years from the date of filing? - Correct Answer-20 years Generic drugs are not regulated by the Food & Drug Administration. - Correct Answer- False The most reliable source of information for determining therapeutically equivalent drug products are - Correct Answer-ORange Book Pharmaceutical representatives will typically store and secure their own drug samples - Correct Answer-True Pharmaceutical representatives must always record the amount of drug samples left and obtain signature for that amount. - Correct Answer-True The federal government does not regulate the drug sampling for a pharmaceutical representative - Correct Answer-False Storage conditions for drug products are based on data and information supplied by the manufacturer - Correct Answer-True Drug recalls are almost always negotiated with the FDA beforehand. - Correct Answer- True The PDMA is the Prescription Drug Manufacturers Association. - Correct Answer-False Primary wholesale distributors buy most of their drugs directly from - Correct Answer- manufacturers The AWP is a published price, suggested by drug manufacturers. - Correct Answer- wholesale Rebates are also referred to as after-market arrangements. - Correct Answer-true Drug labels must include indications and usage information, as well as contraindications. - Correct Answer-true A patent owner has the right to exclude others from making, using, selling or importing into the US the it describes. - Correct Answer-invention Exclusivity gives exclusive , which is granted by the FDA, and can run concurrently with a patent or not. - Correct Answer-marketing rights Exclusivity is granted for an orphan drug for years. - Correct Answer-7 A generic drug is to the originator brand-name drug in dosage, strength, safety, and quality. - Correct Answer-bioevuivalent Generic drugs are not regulated by the FDA. - Correct Answer-False The Orange Book is considered the most authoritative manual on therapeutic . - Correct Answer-equivalence The Hatch-Waxman Act is considered the most significant drug-related affecting the pharmaceutical industry since 1962. - Correct Answer-legislation First pass metabolism occurs when a drug administered orally is metabolized in the . - Correct Answer-Liver Pharmacological studies using animals are regulated under Good Laboratory Practice. - Correct Answer-True Monoclonal antibodies are created in laboratories to target the of patients to kill cancer. - Correct Answer-Cancer cells Effective drug therapy typically is a cost-effective and highly valuable means of controlling total healthcare expenditures and improving quality of life. - Correct Answer- true Almost 98% of employed Americans are now covered by a HMO, a preferred provider organization, or a point-of-service plan. - Correct Answer-false DUR programs involve retrospective monitoring of physicians' prescribing patterns. - Correct Answer-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. - Correct Answer- false PBM's tend to serve a local market through a network of pharmacies. - Correct Answer- 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. - Correct Answer-false It is rare for pharmaceutical companies to explore, develop and promote expressive values with which patients might identify. - Correct Answer-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. - Correct Answer-true With the global need for new drugs, pharmaceutical brand names are not subject to regulatory approval. - Correct Answer-false DTC advertising has become a required tactical consideration for most pharmaceutical brands in the U.S.. - Correct Answer-true Subjects for clinical trials are selected on the basis of - Correct Answer-scientific objectives The pivotal trial is Phase of the clinical trial. - Correct Answer-3 The "road map" for a clinical research paper is called the . - Correct Answer- abstract Pharmaceutical reps should thoroughly read sections of clinical studies when results are released. - Correct Answer-all The three major areas in which biologics are used are prophylactic, , and replacement therapy. - Correct Answer-therapeutic A formulary is a list of prescription drugs approved by insurance coverage. - Correct Answer-true Three primary entities fund pharmaceuticals: employer, government (Medicare and Medicaid), and . - Correct Answer-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. - Correct Answer-true The key areas in hospitals that require special selling tactics are , formulary committee, and the medical education department. - Correct Answer-pharmacy department Opportunity Cost refers to the value of a sacrificed alternative, when making a choice using resources. - Correct Answer-true One of the oldest and least effective pharmaceutical marketing techniques is the direct- to-consumer advertising. - Correct Answer-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. - Correct Answer-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. - Correct Answer-false The extent, quality, or degree to which a substance is poisonous or harmful to the body. - Correct Answer-toxicity The US accounts for about of all the world's pharmaceutical revenues. - Correct Answer-1/2 Acute medications, such as antibiotics, are used to address short-term illnesses or symptoms. - Correct Answer-true Side effects that might be considered merely minor annoyances in acute treatment can be a powerful barrier to adoption in chronic therapies. - Correct Answer-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. - Correct Answer-true What is one of the biggest time wasters for a pharmaceutical sales rep? - Correct Answer- travel time "Pull through" refers to: - Correct Answer-generating demand for your company's product Which of the following is not a part of the Seven Step Cascade of Emotion? - Correct Answer-be a consultant, not a rep Which is not a rule in making the most out of your sales call? - Correct Answer-your agenda not theirs What do retail pharmacists do? - Correct Answer-dispense pharmaceuticals Which is a step to becoming an indispensable pharmaceutical sales rep? - Correct Answer- asking feedback Which is not a step to plan for rumors? - Correct Answer-counter attack Customers purchase products from people they like, trust, and respect. This is the: - Correct Answer-likeability According to the text, which of the following is considered "going to the next level?" - Correct Answer-staying focused clinical effect - Correct Answer-The response produced by a medication pathology - Correct Answer-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: - Correct Answer-medicare part d tertiary care - Correct Answer-Highly specialized medical and surgical care for unusual or complex medical problems provided by a large medical center Literally "disease producer": - Correct Answer-pathogen A type of blood cell that helps the body fight infection and disease: - Correct Answer- white blood cell SS - Correct Answer-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: - Correct Answer-declining The substances comprising all active and inert pharmaceutical ingredients, including fillers, colors, and other excipients used to prepare dosage forms: - Correct Answer- formulation A low supply of oxygen due to low blood flow is: - Correct Answer-ischemia The acronym for pharmacokinetics is: - Correct Answer-PK According to the text, there are classes of therapeutic drugs. - Correct Answer-US federal govt Oral Glaucoma Therapy is classified as: - Correct Answer-ophthalmology therapy internist - Correct Answer-is a physician that practices internal medicine IDN - Correct Answer-integrated delivery network Another name for biologic compound is: - Correct Answer-large molecule