NAPSRx CNPR Exam, Exams of Nursing

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NAPSRx CNPR Exam

The FDA regulates the introduction of new drugs and enforces U.S. drug laws. True 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 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. Placebo Inactive pill, liquid, or powder that has no treatment value aka sugar pill Edema Swelling Asymptomatic Without signs or symptoms Clinical Pharmacology The study of the effects and movement of drugs in the human body Basic clinical pharmacology involves 3 main concepts Pharmacodynamics, Pharmacokinetics, drug distribution and elimination. Pharmacodynamics

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 Bioavailability how quickly and how much of a drug reaches its intended target site of action Bioequivalent when they contain the same active ingredients and proceed virtually the same blood levels over time. Therapeutic equivalence Production of the same medicinal effect Patent last 20 years True Inactive ingredients Added to provide bulk, strength, aid dissolving, color, taste, etc. IAs do not affect the body BID twice a day Cmax Peak plasma concentration on a measuring curve Half-life 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 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 Tmax Time of peak plasma concentration on a measuring curve 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 Average wholesale price (AWP) Published wholesale price of list price suggested by the manufacturer. 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 Upcharge Percentage fee that is paid by the dispenser to the wholesaler for the cost of distribution Hatch-Waxman Act 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 market 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 True

The organization or individual that initiates the trial and finances the study, Protocol This document sets out how a trial is to be conducted Epidemiology The study of how factors influence disease and health in human populations. 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 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. Gene Therapy types Retrovirus, adenovirus, adeno-associated virus, liposomes, naked DNA Formulary List of prescription drugs approved by insurance coverage pg 118 Functional Values Efficacy, safety, convenience, cost-effectiveness 6 stages of brand strategy 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 impact, pronunciation, scriptability, confusion, symbolism and communication, fit, appeal pg 144 Brands should be: Easy to pronounce, easy to write and read, memorable, distinctive and different from competition Any gifts accepted by physicians individually should entail a benefit to the patient and not be of substantial value True 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 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 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 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 The federal government does not regulate the drug sampling for a pharmaceutical representative False The PDMA is the Prescription Drug Manufacturers Association. False

true 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 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 Subjects for clinical trials are selected on the basis of scientific objectives The pivotal trial is Phase of the clinical trial. 3 The three major areas in which biologics are used are prophylactic, , and replacement therapy. therapeutic One of the oldest and least effective pharmaceutical marketing techniques is the direct-to-consumer advertising. false The US accounts for about of all the world's pharmaceutical revenues. 1/ Among the biotechnology medications under development, about target cancer. 50% DUR programs involve retrospective monitoring of physicians' prescribing patterns. true 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 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 With the global need for new drugs, pharmaceutical brand names are not subject to regulatory approval. false "Pull through" refers to: generating demand for your company's product Which of the following is not a part of the Seven Step Cascade of Emotion? be a consultant, not a rep Which is a step to becoming an indispensable pharmaceutical sales rep? asking feedback Which is not a step to plan for rumors? counter attack According to the text, which of the following is considered "going to the next level?" staying focused 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 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 A low supply of oxygen due to low blood flow is:

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