Pharmaceutical Industry and Drug Development, Exams of Nursing

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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- 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- 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-

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/ 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