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NAPSR/CNPR EXAM | QUESTIONS &
ANSWERS (VERIFIED) | LATEST
UPDATE | 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
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: Pg 26- 29 Seven rights of drug administration Correct Answer: pg 30 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- 38 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 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
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- 61 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 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
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
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.
Opportunity cost Correct Answer: pg 124 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 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
