Pharmaceutical Industry Exam Questions and Answers, Exams of Pharmacology

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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

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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

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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)

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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 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

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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 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- Seven rights of drug administration - correct answer pg 30

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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- 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

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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

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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- 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

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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

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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

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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

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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

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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.

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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

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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

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Branding - correct answer pg 113 Values - correct answer Function, Expressive, Central Functional Values - correct answer Efficacy, safety, convenience, cost- effectiveness 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 Pharmetrics - correct answer impact, pronunciation, scriptability, confusion, symbolism and communication, fit, appeal pg 144 Brands should be: - correct answer Easy to pronounce, easy to write and read, memorable, distinctive and different from competition Direct-to-consumer (DTC) - correct answer pg 152 Factors that influence DTC - correct answer pg 153

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Gifts - correct answer Pg 162 PhRMA Code - correct answer Now prohibits pens, mugs, objects with company logo AMA Gift guidelines - correct answer Pg 165 Any gifts accepted by physicians individually should entail a benefit to the patient and not be of substantial value - correct answer True 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

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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

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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

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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

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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

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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

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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 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

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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 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

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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