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Pharmaceutical Industry Review Questions and Answers, Exams of Nursing

A comprehensive review of the pharmaceutical industry, including topics such as drug development, distribution, sales, and regulations. It covers important concepts such as absorption, distribution, metabolism, and excretion of drugs, as well as the role of various government agencies in regulating the industry. The document also includes a glossary of key terms and a section on sales techniques for pharmaceutical representatives. Overall, this document is a useful resource for anyone studying or working in the pharmaceutical industry.

Typology: Exams

2023/2024

Available from 10/02/2023

Beverlyn
Beverlyn 🇺🇸

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Download Pharmaceutical Industry Review Questions and Answers and more Exams Nursing in PDF only on Docsity! NAPSR/CNPR Latest Exam review question and answers 2023 Pharma companies must submit extensive data to the FDA demonstrating the safety and effectiveness of new drugs before receiving approval for sale. - True Average review time for a new drug - 18 months. Sales Team - Pg 7 The "engine of innovation," focused on discovering or inventing promising new product. - Research & Development This includes supply chain, manufacturing, trade, and distribution functions of the business. - Manufacturing & Operations NAPSR/CNPR Latest Exam review question and answers 2023 In 2012, FDA regulators approved 39 new drugs for use in the U.S. - True 3,070 new meds are in development for cancer. - True Define Off-label - Usage of a medication for purposes other than the specific ones appearing on the label Toxicity - The extent, quality, or degree to which a substance is poisonous or harmful to the body Institutional review Board (IRB) - 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. NAPSR/CNPR Latest Exam review question and answers 2023 Plasma - The liquid portion of the blood that carries proteins and other substances Organs - Specialized cells and tissues grouped together to perform specific body function for a common purpose. (Kidney, heart, intestines, and skin) Nucleus - Brain of the cell that regulates all activities. Proteins - A nutrient made up of of chains of amino acids Fats - A nutrient stored in special body tissues as a great source of reserve energy NAPSR/CNPR Latest Exam review question and answers 2023 Carbohydrates - A nutrient that is the body's immediate source of energy. It's broken down to glucose and used for immediate metabolic reactions. Vitamins - A nutrient substance necessary for growth, development, and normal regulation of metabolic processes. Must be taken from outside the body. Minerals - A nutrient necessary for bodily purposes such as the balance of body fluid Water is NOT a nutrient - True Body's Major Systems - Cardiovascular, Respiratory, nervous, musculoskeletal, reproductive, immune NAPSR/CNPR Latest Exam review question and answers 2023 Absorption - How the drug passes from its side of administration into the bloodstream Distribution - How the drug is dispersed among the organs after absorption into the blood Metabolism - How the active part of a drug is metabolized into a more water-soluble compound that can be readily excreted by the kidneys Excretion - 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 - True NAPSR/CNPR Latest Exam review question and answers 2023 PRN - As needed QD - Once a day QID - Four times a day Protein binding - the ability of certain drugs to bind to plasma protein. TID - three times a day Titration - the process of adjusting drug doses to achieve the max positive therapeutic effects while minimizing adverse or side affects NAPSR/CNPR Latest Exam review question and answers 2023 Tmax - Time of peak plasma concentration on a measuring curve STAT - Immediately Primary wholesale distributors - 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 - 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 - Pg 60-61 NAPSR/CNPR Latest Exam review question and answers 2023 Average wholesale price (AWP) - Published wholesale price of list price suggested by the manufacturer. Chain drug store - Company that owns and operates four or more pharmacies Drop shipment - Drug manufacturer directly delivers the drugs to a dispenser, but order and payments are made through a wholesaler Group purchasing organization (GPO) - 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 NAPSR/CNPR Latest Exam review question and answers 2023 Meticulous records must be kept of sample inventories and reps are required to account for their samples periodically. - 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 - 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. - True In some situations, a physician may sign the paperwork before the number of samples has been recorded - True NAPSR/CNPR Latest Exam review question and answers 2023 Section 503 - Prohibits sale, purchase, or trade of drug samples E-sampling - Pg 72 Many pharmaceutical manufacturers set expiration dates every six months (June, December) - True DEA regulates the distribution and use of narcotics and other controlled substances - True FTC - Regulates general business practices to protect consumers against misleading claims and anticompetitive behavior NAPSR/CNPR Latest Exam review question and answers 2023 AMA - provides ethical guidelines to physicians about appropriate interactions with pharmaceutical companies Benefits of Government-Industry Partnerhsips - Pg 79 Preclinical studies - pg 81 Pinocytosis - Involves the engulfing of fluids by a cell. Transport Mechanisms - Passive diffusion, facilitated diffusion, active transport, pinocytosis Absorption methods - Oral, Buccal, sublingual, rectal, subcutaneous, intramuscular, transdermal, topical, inhalation, intravenous NAPSR/CNPR Latest Exam review question and answers 2023 Therapeutic - Antibodies Vaccines - Pg 108 Toxoids - Derived from toxins secreted by a pathogen.Examples are diphtheria and tetnus vaccines. Vector-based vaccines - 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 - Chemically synthesized and normally consist of 8-24 amino acids Adjuvants - pg 110 NAPSR/CNPR Latest Exam review question and answers 2023 Cytokines are produced mainly by the leukocytes (white blood cells) - True Hormones are intercellular messengers. - True Retrovirus - Integrates genes to hose chromosomes, change of long term stability. Adendovirus - This vector has a large capacity for foreign genes. Liposomes - Vector does not have viral genes so they do not cause disease. NAPSR/CNPR Latest Exam review question and answers 2023 Naked DNA - they do not have viral genes and do not cause disease Gene Therapy types - Retrovirus, adenovirus, adeno- associated virus, liposomes, naked DNA Stem Cells - Pg 114 Managed Care - Pg 117 Formulary - List of prescription drugs approved by insurance coverage pg 118 Opportunity cost - pg 124 Branding - pg 113 NAPSR/CNPR Latest Exam review question and answers 2023 Individual gifts of minimal value (Under $100) are permissible as long as the gifts are related to the work - 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 - True PhRMA Code on relationships - Pg 167 PhRMA FAQ - Pg 174 Nursing Structures - Pg 200 Sales techniques - pg 207 Medicare part D - pg 225 NAPSR/CNPR Latest Exam review question and answers 2023 Organizing your day - Pg 239 Traits of Pharma sales Rep - 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 - 271 Exclusivity is granted for an orphan drug for ____ - 7 years Patents are applied for with, and granted by the FDA. - False Patents expire after how many years from the date of filing? - 20 years NAPSR/CNPR Latest Exam review question and answers 2023 Generic drugs are not regulated by the Food & Drug Administration. - False The most reliable source of information for determining therapeutically equivalent drug products are - ORange Book Pharmaceutical representatives will typically store and secure their own drug samples - True Pharmaceutical representatives must always record the amount of drug samples left and obtain signature for that amount. - True The federal government does not regulate the drug sampling for a pharmaceutical representative - False NAPSR/CNPR Latest Exam review question and answers 2023 A generic drug is ______ to the originator brand-name drug in dosage, strength, safety, and quality. - bioevuivalent Generic drugs are not regulated by the FDA. - False The Orange Book is considered the most authoritative manual on therapeutic ______. - equivalence The Hatch-Waxman Act is considered the most significant drug-related ______ affecting the pharmaceutical industry since 1962. - legislation First pass metabolism occurs when a drug administered orally is metabolized in the ________. - Liver NAPSR/CNPR Latest Exam review question and answers 2023 Pharmacological studies using animals are regulated under Good Laboratory Practice. - True Monoclonal antibodies are created in laboratories to target the ________ of patients to kill cancer. - Cancer cells The best way to deliver health care is through a ________ system. - market based The costs for all phases of R&D for drug companies are rising, with the increase particularly acute for _____. - clinical trials The agency which regulates the distribution and use of narcotics and other controlled substances is _______. - DEA The FDA approves storage conditions for drug products. - True NAPSR/CNPR Latest Exam review question and answers 2023 The most important benefit of electronic prescribing is related to patient ______. - 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. - true There are more white blood cells than red blood cells for the same volume in the human body. - false Unlike the small molecule drugs (pharmaceuticals) described, large molecule drugs (biopharmaceuticals) are mainly protein- based. - true NAPSR/CNPR Latest Exam review question and answers 2023 Almost 98% of employed Americans are now covered by a HMO, a preferred provider organization, or a point-of-service plan. - false DUR programs involve retrospective monitoring of physicians' prescribing patterns. - 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. - false PBM's tend to serve a local market through a network of pharmacies. - false The chief motivating force in mergers and acquisitions within the pharmaceutical industry is the desire of one company to NAPSR/CNPR Latest Exam review question and answers 2023 acquire and exploit more successfully the brands of another. - false It is rare for pharmaceutical companies to explore, develop and promote expressive values with which patients might identify. - 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. - true With the global need for new drugs, pharmaceutical brand names are not subject to regulatory approval. - false DTC advertising has become a required tactical consideration for most pharmaceutical brands in the U.S.. - true NAPSR/CNPR Latest Exam review question and answers 2023 Subjects for clinical trials are selected on the basis of _____ - scientific objectives The pivotal trial is Phase ______ of the clinical trial. - 3 The "road map" for a clinical research paper is called the _______. - abstract Pharmaceutical reps should thoroughly read _______ sections of clinical studies when results are released. - all The three major areas in which biologics are used are prophylactic, _______, and replacement therapy. - therapeutic NAPSR/CNPR Latest Exam review question and answers 2023 The US accounts for about ____ of all the world's pharmaceutical revenues. - 1/2 The most effective method for grabbing market share is: - comparative selling Most visits by pharmaceutical reps are to pharmacies. - false Among the biotechnology medications under development, about _____ target cancer. - 50% A _____ is an inactive medication with no treatment value, used in experimental studies. - placebo The heart of a pharmaceutical sales team is the Regional Manager. - false NAPSR/CNPR Latest Exam review question and answers 2023 Almost 98% of employed Americans are now covered by a HMO, a preferred provider organization, or a point-of-service plan. - false DUR programs involve retrospective monitoring of physicians' prescribing patterns. - 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 - false PBM's tend to serve a local market through a network of pharmacies. - false NAPSR/CNPR Latest Exam review question and answers 2023 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. - false It is rare for pharmaceutical companies to explore, develop and promote expressive values with which patients might identify - 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. - true With the global need for new drugs, pharmaceutical brand names are not subject to regulatory approval. - false NAPSR/CNPR Latest Exam review question and answers 2023 Which of the following is not a part of the Seven Step Cascade of Emotion? - be a consultant, not a rep Which is not a rule in making the most out of your sales call? - your agenda not theirs What do retail pharmacists do? - dispense pharmaceuticals Which is a step to becoming an indispensable pharmaceutical sales rep? - asking feedback Which is not a step to plan for rumors? - counter attack Customers purchase products from people they like, trust, and respect. This is the: - likeability NAPSR/CNPR Latest Exam review question and answers 2023 According to the text, which of the following is considered "going to the next level?" - staying focused clinical effect - The response produced by a medication pathology - 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: - medicare part d tertiary care - Highly specialized medical and surgical care for unusual or complex medical problems provided by a large medical center NAPSR/CNPR Latest Exam review question and answers 2023 Literally "disease producer": - pathogen A type of blood cell that helps the body fight infection and disease: - white blood cell SS - 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: - declining The substances comprising all active and inert pharmaceutical ingredients, including fillers, colors, and other excipients used to prepare dosage forms: - formulation NAPSR/CNPR Latest Exam review question and answers 2023 Where the tolerance of one medication may result in increased tolerance of another medication? - cross tolerance The study of the effects, both beneficial and toxic, of drugs and chemicals on living cells, tissues, organisms: - pharmacology A substance that enhances the action of a drug or antigen: - adjuvant 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: - receptor Refers to medication dosage, means "hour": - h NAPSR/CNPR Latest Exam review question and answers 2023 Outside a living body: - ex vivo The meaning of subcutaneous is: - beneath outer skin The acronym for effective dose is: - ed ML stands for: - milliliter According to the text, depression is a disease that attacks the: - central nervous system