NAPSR/CNPR Exam Questions With 100% Correct Answers 2024, Exams of Advanced Education

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NAPSR/CNPR Exam Questions With 100% Correct Answers 2024 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 pg. 1 professoraxe l 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. pg. 2 professoraxe l 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 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. Vitamins - Correct Answer-A nutrient substance necessary for growth, development, and normal regulation of metabolic pg. 5 professoraxe l processes. Must be taken from outside the body. Minerals - Correct Answer-A nutrient necessary for bodily purposes such as the balance of body fluid Water is NOT a nutrient - Correct Answer- True Body's Major Systems - Correct Answer- Cardiovascular, Respiratory, nervous, musculoskeletal, reproductive, immune Absorption - Correct Answer-How the drug passes from its side of administration into the bloodstream Distribution - Correct Answer-How the drug is dispersed among the organs after absorption into the blood Metabolism - Correct Answer-How the active part of a drug is metabolized into a more pg. 6 professoraxe l water-soluble compound that can be readily excreted by the kidneys Excretion - Correct 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. It takes about 10 years for a drug to hit the market - Correct Answer-True Routes of drug administration - Correct Answer-Pg 26-29 Seven rights of drug administration - Correct Answer-pg 30 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 pg. 7 professoraxe l 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 pg. 10 professoraxe l 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 pg. 11 professoraxe l 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 pg. 12 professoraxe l 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, pg. 15 professoraxe l 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 pg. 16 professoraxe l 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 pg. 17 professoraxe l Individual gifts of minimal value (Under $100) are permissible as long as the gifts are related to the work - Correct Answer- True Subsidies should not be accepted to pay for the costs of travel, lodging, or other personal expenses. Paying for a modest meal is OK - Correct Answer-True PhRMA Code on relationships - Correct Answer-Pg 167 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 pg. 20 professoraxe l 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 pg. 21 professoraxe l 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 pg. 22 professoraxe l 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 pg. 25 professoraxe l 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 one of the below terms is not a route for excreting a drug from the body? - Correct Answer-heart pg. 26 professoraxe l 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 pg. 27 professoraxe l 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 pg. 30 professoraxe l 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 pg. 31 professoraxe l 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 pg. 32 professoraxe l 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 pg. 35 professoraxe l 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 pg. 36 professoraxe l 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 pg. 37 professoraxe l