NAPSR CNPR Exam( 100% Solved)

NAPSR CNPR Exam Pharma companies must submit extensive data to the FDA demonstrating the safety and effectiveness of new drugs before receiving approval for sale. - ANS True Average review time for a new drug - ANS 18 months Sales Team - ANS Pg 7 The "engine of innovation," focused on discovering or inventing promising new product. - ANS Research & Development This includes supply chain, manufacturing, trade, and distribution functions of the business. - ANS Manufacturing & Operations In 2012, FDA regulators approved 39 new drugs for use in the U.S. - ANS True 3,070 new meds are in development for cancer. - ANS True Define Off-label - ANS Usage of a medication for purposes other than the specific ones appearing on the label Toxicity - ANS The extent, quality, or degree to which a substance is poisonous or harmful to the body Institutional review Board (IRB) - ANS 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 - ANS Inactive pill, liquid, or powder that has no treatment value aka sugar pill Edema - ANS Swelling Asymptomatic - ANS Without signs or symptoms Clinical Pharmacology - ANS The study of the effects and movement of drugs in the human body Anatomy - ANS The study of basic structures of the body Physiology - ANS The study of how those body structures function Basic clinical pharmacology involves 3 main concepts - ANS Pharmacodynamics, Pharmacokinetics, drug distribution and elimination. Pharmacodynamics - ANS 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 - ANS 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 - ANS Drug delivery systems, route of administration , modes of excretion. Plasma - ANS The liquid portion of the blood that carries proteins and other substances Organs - ANS Specialized cells and tissues grouped together to perform specific body function for a common purpose. (Kidney, heart, intestines, and skin) Nucleus - ANS Brain of the cell that regulates all activities. Proteins - ANS A nutrient made up of of chains of amino acids Fats - ANS A nutrient stored in special body tissues as a great source of reserve energy Carbohydrates - ANS A nutrient that is the body's immediate source of energy. It's broken down to glucose and used for immediate metabolic reactions. Vitamins - ANS A nutrient substance necessary for growth, development, and normal regulation of metabolic processes. Must be taken from outside the body. Minerals - ANS A nutrient necessary for bodily purposes such as the balance of body fluid Water is NOT a nutrient - ANS True Body's Major Systems - ANS Cardiovascular, Respiratory, nervous, musculoskeletal, reproductive, immune Absorption - ANS How the drug passes from its side of administration into the bloodstream Distribution - ANS How the drug is dispersed among the organs after absorption into the blood Metabolism - ANS How the active part of a drug is metabolized into a more water-soluble compound that can be readily excreted by the kidneys Excretion - ANS 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 - ANS True Routes of drug administration - ANS Pg 26-29 Seven rights of drug administration - ANS pg 30 Bioavailability - ANS how quickly and how much of a drug reaches its intended target site of action Bioequivalent - ANS when they contain the same active ingredients and proceed virtually the same blood levels over time. Therapeutic equivalence - ANS Production of the same medicinal effect Drug elimination and Excretion - ANS pg 34 Drug Forms - ANS Pg 35-38 Patent last 20 years - ANS True Inactive ingredients - ANS Added to provide bulk, strength, aid dissolving, color, taste, etc. IAs do not affect the body Pharmaceutical Ingredients - ANS Pg 54 BID - ANS twice a day Cmax - ANS Peak plasma concentration on a measuring curve Half-life - ANS 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 - ANS As needed QD - ANS Once a day QID - ANS Four times a day Protein binding - ANS the ability of certain drugs to bind to plasma protein. TID - ANS three times a day Titration - ANS the process of adjusting drug doses to achieve the max positive therapeutic effects while minimizing adverse or side affects Tmax - ANS Time of peak plasma concentration on a measuring curve STAT - ANS Immediately Primary wholesale distributors - ANS 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 - ANS 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 - ANS Pg 60-61 Average wholesale price (AWP) - ANS Published wholesale price of list price suggested by the manufacturer. Chain drug store - ANS Company that owns and operates four or more pharmacies Drop shipment - ANS Drug manufacturer directly delivers the drugs to a dispenser, but order and payments are made through a wholesaler Group purchasing organization (GPO) - ANS 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 - ANS Percentage fee that is paid by the dispenser to the wholesaler for the cost of distribution Package Insert Info - ANS Pg 63 Drug Patents - ANS Pg 65 Terms pg 67 Orange Book ratings - ANS A AA AN AO AP AT B Hatch-Waxman Act - ANS 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 - ANS True Manufacturers and distributors are required to have systems to monitor and audit the distribution of their drug samples - ANS True Meticulous records must be kept of sample inventories and reps are required to account for their samples periodically. - ANS 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 - ANS 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. - ANS True In some situations, a physician may sign the paperwork before the number of samples has been recorded - ANS True Section 503 - ANS Prohibits sale, purchase, or trade of drug samples E-sampling - ANS Pg 72 Many pharmaceutical manufacturers set expiration dates every six months (June, December) - ANS True DEA regulates the distribution and use of narcotics and other controlled substances - ANS True FTC - ANS Regulates general business practices to protect consumers against misleading claims and anticompetitive behavior AMA - ANS provides ethical guidelines to physicians about appropriate interactions with pharmaceutical companies Benefits of Government-Industry Partnerhsips - ANS Pg 79 Preclinical studies - ANS pg 81 Pinocytosis - ANS Involves the engulfing of fluids by a cell. Transport Mechanisms - ANS Passive diffusion, facilitated diffusion, active transport, pinocytosis Absorption methods - ANS Oral, Buccal, sublingual, rectal, subcutaneous, intramuscular, transdermal, topical, inhalation, intravenous The liver is the major organ for metabolizing drugs. Secondary is kidney - ANS True CL= rate of drug elimination/drug concentration in blood - ANS 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. - ANS True Clinical Trials - ANS pg 89 Subjects should be informed about the aims, methods, risks, and benefits of the trial - ANS True Four phases of clinical trials - ANS Pg 90 Regulatory Requirement terms - ANS Pg 92 Investigator - ANS The person who conducts the trial. This person is normally an expert in the field. They should not be employed by the sponsor Sponsor - ANS The organization or individual that initiates the trial and finances the study, Protocol - ANS This document sets out how a trial is to be conducted Epidemiology - ANS The study of how factors influence disease and health in human populations. Therapeutic - ANS Antibodies Vaccines - ANS Pg 108 Toxoids - ANS Derived from toxins secreted by a pathogen.Examples are diphtheria and tetnus vaccines. Vector-based vaccines - ANS 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 - ANS Chemically synthesized and normally consist of 8-24 amino acids Adjuvants - ANS pg 110 Cytokines are produced mainly by the leukocytes (white blood cells) - ANS True Hormones are intercellular messengers. - ANS True Retrovirus - ANS Integrates genes to hose chromosomes, change of long term stability. Adendovirus - ANS This vector has a large capacity for foreign genes. Liposomes - ANS Vector does not have viral genes so they do not cause disease. Naked DNA - ANS they do not have viral genes and do not cause disease Gene Therapy types - ANS Retrovirus, adenovirus, adeno-associated virus, liposomes, naked DNA Stem Cells - ANS Pg 114 Managed Care - ANS Pg 117 Formulary - ANS List of prescription drugs approved by insurance coverage pg 118 Opportunity cost - ANS pg 124 Branding - ANS pg 113 Values - ANS Function, Expressive, Central Functional Values - ANS Efficacy, safety, convenience, cost-effectiveness 6 stages of brand strategy - ANS 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 - ANS impact, pronunciation, scriptability, confusion, symbolism and communication, fit, appeal pg 144 Brands should be: - ANS Easy to pronounce, easy to write and read, memorable, distinctive and different from competition Direct-to-consumer (DTC) - ANS pg 152 Factors that influence DTC - ANS pg 153 Gifts - ANS Pg 162 PhRMA Code - ANS Now prohibits pens, mugs, objects with company logo AMA Gift guidelines - ANS Pg 165 Any gifts accepted by physicians individually should entail a benefit to the patient and not be of substantial value - ANS True Individual gifts of minimal value (Under $100) are permissible as long as the gifts are related to the work - ANS 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 - ANS True PhRMA Code on relationships - ANS Pg 167 PhRMA FAQ - ANS Pg 174 Nursing Structures - ANS Pg 200 Sales techniques - ANS pg 207 Medicare part D - ANS pg 225 Organizing your day - ANS Pg 239 Traits of Pharma sales Rep - ANS 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 - ANS 271 Exclusivity is granted for an orphan drug for ____ - ANS 7 years Patents are applied for with, and granted by the FDA. - ANS False Patents expire after how many years from the date of filing? - ANS 20 years Generic drugs are not regulated by the Food & Drug Administration. - ANS False The most reliable source of information for determining therapeutically equivalent drug products are - ANS ORange Book Pharmaceutical representatives will typically store and secure their own drug samples - ANS True Pharmaceutical representatives must always record the amount of drug samples left and obtain signature for that amount. - ANS True The federal government does not regulate the drug sampling for a pharmaceutical representative - ANS False Storage conditions for drug products are based on data and information supplied by the manufacturer - ANS True Drug recalls are almost always negotiated with the FDA beforehand. - ANS True The PDMA is the Prescription Drug Manufacturers Association. - ANS False Primary wholesale distributors buy most of their drugs directly from ______ - ANS manufacturers The AWP is a published ______ price, suggested by drug manufacturers. - ANS wholesale Rebates are also referred to as after-market arrangements. - ANS true Drug labels must include indications and usage information, as well as contraindications. - ANS true A patent owner has the right to exclude others from making, using, selling or importing into the US the ____ it describes. - ANS invention Exclusivity gives exclusive ______, which is granted by the FDA, and can run concurrently with a patent or not. - ANS marketing rights Exclusivity is granted for an orphan drug for _______ years. - ANS 7 A generic drug is ______ to the originator brand-name drug in dosage, strength, safety, and quality. - ANS bioevuivalent Generic drugs are not regulated by the FDA. - ANS False The Orange Book is considered the most authoritative manual on therapeutic ______. - ANS equivalence The Hatch-Waxman Act is considered the most significant drug-related ______ affecting the pharmaceutical industry since 1962. - ANS legislation First pass metabolism occurs when a drug administered orally is metabolized in the ________. - ANS Liver Pharmacological studies using animals are regulated under Good Laboratory Practice. - ANS True Monoclonal antibodies are created in laboratories to target the ________ of patients to kill cancer. - ANS Cancer cells The best way to deliver health care is through a ________ system. - ANS market based The costs for all phases of R&D for drug companies are rising, with the increase particularly acute for _____. - ANS clinical trials The agency which regulates the distribution and use of narcotics and other controlled substances is _______. - ANS DEA The FDA approves storage conditions for drug products. - ANS True The most important benefit of electronic prescribing is related to patient ______. - ANS 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. - ANS true There are more white blood cells than red blood cells for the same volume in the human body. - ANS false Unlike the small molecule drugs (pharmaceuticals) described, large molecule drugs (biopharmaceuticals) are mainly protein-based. - ANS true The duration for Phase III of the clinical trial can typically last 3-5 years. - ANS true The aim of the Phase IV clinical trial is to examine the safety and effectiveness of the drug in the targeted disease group. - ANS false Carcinogenicity studies are carried out to identify the tumor-causing potential of a drug. - ANS true Which one of the below terms is not a route for excreting a drug from the body? - ANS heart Which of the below terms means "to apply the drug on the skin surface"? - ANS transdermal Diffusion is the random movement of molecules in fluid - ANS true Most drugs that are administered to patients typically contains just one active pharmaceutical ingredient. - ANS false Toxicity information in preclinical studies provides confidence about a drugs safety aspect. - ANS true The aim of pharmacological studies is to obtain data on the safety and effectiveness of the lead compound. - ANS true Effective drug therapy typically is a cost-effective and highly valuable means of controlling total healthcare expenditures and improving quality of life. - ANS true Almost 98% of employed Americans are now covered by a HMO, a preferred provider organization, or a point-of-service plan. - ANS false DUR programs involve retrospective monitoring of physicians' prescribing patterns. - ANS 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. - ANS false PBM's tend to serve a local market through a network of pharmacies. - ANS 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. - ANS false It is rare for pharmaceutical companies to explore, develop and promote expressive values with which patients might identify. - ANS 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. - ANS true With the global need for new drugs, pharmaceutical brand names are not subject to regulatory approval. - ANS false DTC advertising has become a required tactical consideration for most pharmaceutical brands in the U.S.. - ANS true Subjects for clinical trials are selected on the basis of _____ - ANS scientific objectives The pivotal trial is Phase ______ of the clinical trial. - ANS 3 The "road map" for a clinical research paper is called the _______. - ANS abstract Pharmaceutical reps should thoroughly read _______ sections of clinical studies when results are released. - ANS all The three major areas in which biologics are used are prophylactic, _______, and replacement therapy. - ANS therapeutic A formulary is a list of prescription drugs approved by insurance coverage. - ANS true Three primary entities fund pharmaceuticals: employer, government (Medicare and Medicaid), and ______. - ANS 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. - ANS true The key areas in hospitals that require special selling tactics are ______, formulary committee, and the medical education department. - ANS pharmacy department Opportunity Cost refers to the value of a sacrificed alternative, when making a choice using resources. - ANS true One of the oldest and least effective pharmaceutical marketing techniques is the direct-to-consumer advertising. - ANS 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. - ANS 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. - ANS false The extent, quality, or degree to which a substance is poisonous or harmful to the body. - ANS toxicity The US accounts for about ____ of all the world's pharmaceutical revenues. - ANS 1/2 The most effective method for grabbing market share is: - ANS comparative selling Most visits by pharmaceutical reps are to pharmacies. - ANS false Among the biotechnology medications under development, about _____ target cancer. - ANS 50% A _____ is an inactive medication with no treatment value, used in experimental studies. - ANS placebo The heart of a pharmaceutical sales team is the Regional Manager. - ANS false Almost 98% of employed Americans are now covered by a HMO, a preferred provider organization, or a point-of-service plan. - ANS false DUR programs involve retrospective monitoring of physicians' prescribing patterns. - ANS 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 - ANS false PBM's tend to serve a local market through a network of pharmacies. - ANS 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. - ANS false It is rare for pharmaceutical companies to explore, develop and promote expressive values with which patients might identify - ANS 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. - ANS true With the global need for new drugs, pharmaceutical brand names are not subject to regulatory approval. - ANS false DTC advertising has become a required tactical consideration for most pharmaceutical brands in the U.S.. - ANS 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. - ANS false Specialty care products are often prescribed by generalist physicians. - ANS false In some medical cases, a therapy may be initiated by a specialist and monitored and maintained by a primary care physician. - ANS true Acute medications, such as antibiotics, are used to address short-term illnesses or symptoms. - ANS true Side effects that might be considered merely minor annoyances in acute treatment can be a powerful barrier to adoption in chronic therapies. - ANS 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. - ANS true What is one of the biggest time wasters for a pharmaceutical sales rep? - ANS travel time "Pull through" refers to: - ANS generating demand for your company's product Which of the following is not a part of the Seven Step Cascade of Emotion? - ANS be a consultant, not a rep Which is not a rule in making the most out of your sales call? - ANS your agenda not theirs What do retail pharmacists do? - ANS dispense pharmaceuticals Which is a step to becoming an indispensable pharmaceutical sales rep? - ANS asking feedback Which is not a step to plan for rumors? - ANS counter attack Customers purchase products from people they like, trust, and respect. This is the: - ANS likeability According to the text, which of the following is considered "going to the next level?" - ANS staying focused clinical effect - ANS The response produced by a medication pathology - ANS 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: - ANS medicare part d tertiary care - ANS Highly specialized medical and surgical care for unusual or complex medical problems provided by a large medical center Literally "disease producer": - ANS pathogen A type of blood cell that helps the body fight infection and disease: - ANS white blood cell SS - ANS 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: - ANS declining The substances comprising all active and inert pharmaceutical ingredients, including fillers, colors, and other excipients used to prepare dosage forms: - ANS formulation A low supply of oxygen due to low blood flow is: - ANS ischemia The acronym for pharmacokinetics is: - ANS PK According to the text, there are ___ classes of therapeutic drugs. - ANS US federal govt Oral Glaucoma Therapy is classified as: - ANS ophthalmology therapy internist - ANS is a physician that practices internal medicine IDN - ANS integrated delivery network Another name for biologic compound is: - ANS large molecule SS is an abbreviation for: - ANS semis The ___________ is used to determine appropriate medical reimbursement. - ANS coding system A term used to refer to drugs that are non-biological (that is, chemical) in nature: - ANS small molecule The origin, or cause, of a disease or a patient's symptoms: - ANS Etiology Used when referring to medication dosage, means "as needed": - ANS PRN Where the tolerance of one medication may result in increased tolerance of another medication? - ANS cross tolerance The study of the effects, both beneficial and toxic, of drugs and chemicals on living cells, tissues, organisms: - ANS pharmacology A substance that enhances the action of a drug or antigen: - ANS 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: - ANS receptor Refers to medication dosage, means "hour": - ANS h Outside a living body: - ANS ex vivo The meaning of subcutaneous is: - ANS beneath outer skin The acronym for effective dose is: - ANS ed ML stands for: - ANS milliliter According to the text, depression is a disease that attacks the: - ANS central nervous system