NAPSR/CNPR Exam with Complete Questions And Answers Graded A+, Exams of Advanced Education

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NAPSR/CNPR Exam with Complete Questions And Answers Graded A+ 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 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 Body's Major Systems - Correct Answer-Cardiovascular, Respiratory, nervous, musculoskeletal, reproductive, immune 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, 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 Branding - Correct Answer-pg 113 Values - Correct Answer-Function, Expressive, Central 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 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 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 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 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 SS is an abbreviation for: - Correct Answer-semis The ___________ is used to determine appropriate medical reimbursement. - Correct Answer-coding system A term used to refer to drugs that are non-biological (that is, chemical) in nature: - Correct Answer-small molecule The origin, or cause, of a disease or a patient's symptoms: - Correct Answer-Etiology Used when referring to medication dosage, means "as needed": - Correct Answer-PRN Where the tolerance of one medication may result in increased tolerance of another medication? - Correct Answer-cross tolerance The study of the effects, both beneficial and toxic, of drugs and chemicals on living cells, tissues, organisms: - Correct Answer-pharmacology A substance that enhances the action of a drug or antigen: - Correct Answer-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: - Correct Answer-receptor Refers to medication dosage, means "hour": - Correct Answer-h Outside a living body: - Correct Answer-ex vivo The meaning of subcutaneous is: - Correct Answer-beneath outer skin The acronym for effective dose is: - Correct Answer-ed ML stands for: - Correct Answer-milliliter According to the text, depression is a disease that attacks the: - Correct Answer-central nervous system