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NAPSR/CNPR Certification Exam Questions with Verified Answers 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. Pharmacokinetics --*correct 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. Drug distribution & elimination --*correct answer*--Drug delivery systems, route of administration , modes of excretion. Plasma --*correct answer*--The liquid portion of the blood that carries proteins and other substances Organs --*correct answer*--Specialized cells and tissues grouped together to perform specific body function for a common purpose. (Kidney, heart, intestines, and skin) Nucleus --*correct answer*--Brain of the cell that regulates all activities. Proteins --*correct answer*--A nutrient made up of of chains of amino acids Fats --*correct answer*--A nutrient stored in special body tissues as a great source of reserve energy 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 AN AO AP AT B 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 It is important not to change the order of a sample closet --*correct answer*--True Manufacturers and distributors are required to have systems to monitor and audit the distribution of their drug samples --*correct answer*--True Meticulous records must be kept of sample inventories and reps are required to account for their samples periodically. --*correct answer*--True Representatives are required to store samples in a secure area where people cannot access them without permission and where they will not be subjected to extremes of temperature, moisture, and contamination -- *correct answer*--True A sample closet or cabinet is essentially similar to a grocery store shelf. The more visibility you can give your drug, the more likely it will be used. -- *correct answer*--True In some situations, a physician may sign the paperwork before the number of samples has been recorded --*correct answer*--True Section 503 --*correct answer*--Prohibits sale, purchase, or trade of drug samples E-sampling --*correct answer*--Pg 72 Many pharmaceutical manufacturers set expiration dates every six months (June, December) --*correct answer*--True DEA regulates the distribution and use of narcotics and other controlled substances --*correct answer*--True FTC --*correct answer*--Regulates general business practices to protect consumers against misleading claims and anticompetitive behavior AMA --*correct answer*--provides ethical guidelines to physicians about appropriate interactions with pharmaceutical companies Benefits of Government-Industry Partnerhsips --*correct answer*--Pg 79 Preclinical studies --*correct answer*--pg 81 Pinocytosis --*correct answer*--Involves the engulfing of fluids by a cell. Transport Mechanisms --*correct answer*--Passive diffusion, facilitated diffusion, active transport, pinocytosis 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, PhRMA FAQ --*correct answer*--Pg 174 Nursing Structures --*correct answer*--Pg 200 Sales techniques --*correct answer*--pg 207 Medicare part D --*correct answer*--pg 225 Organizing your day --*correct answer*--Pg 239 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 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 agency which regulates the distribution and use of narcotics and other controlled substances is _______. --*correct answer*--DEA The FDA approves storage conditions for drug products. --*correct answer*- -True The most important benefit of electronic prescribing is related to patient ______. --*correct answer*--safety Patients with leukemia have a condition in which the stem cells in the bone marrow malfunction and produce an excessive number of immature white blood cells, which interfere with normal blood cell production. --*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 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 The most effective method for grabbing market share is: --*correct answer*--comparative selling Most visits by pharmaceutical reps are to pharmacies. --*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 The heart of a pharmaceutical sales team is the Regional Manager. -- *correct answer*--false 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 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 Specialty care products are often prescribed by generalist physicians. -- *correct answer*--false In some medical cases, a therapy may be initiated by a specialist and monitored and maintained by a primary care physician. --*correct answer*- -true 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