Download NAPSR Study Guide Exam Questions with Complete Solutions 2023 and more Exams Nursing in PDF only on Docsity! NAPSR STUDY GUIDE EXAM QUESTIONS WITH COMPLETE SOLUTIONS 2023A+ Pharmaceuticals - Medicines/ vaccines /human and animal use. / trademark (brand) name or generic/and prescription or over-the counter. Diagnostic - All Equipment /supplies- screening/detecting, and monitoring disease./ Medical Devices - Advanced instrument /medical therapy, / joint replacements, defibrillators, and pacemakers./includes drug delivery devices such as syringes, infusion pumps, metered- dose inhalers, and transdermal patches. Medical Supplies - Commodity, supplies such /surgical gowns and gloves. Durable Medical Equipment - Reusable products/ walkers, wheelchairs, oxygen equipment, prosthetics and hospital beds. What countries are pharmaceutical sales the highest? - United States, Western Europe, and Japan. The U.S. accounts for roughly____of the world's pharmaceutical revenues. - 50% Two factors have significantly contributed to recent growth in the pharmaceutical industry are? - Population growth/ increasing life expectancies. What is the predicted relationship between pharmaceutical companies and genomic research facilities? - Partnership will not prove immediately profitable. NAPSR STUDY GUIDE EXAM QUESTIONS WITH COMPLETE SOLUTIONS 2023A+ Prescription drug therapy is cost effective for insurance companies and health care providers. True or False? - True The high price of health care is explained by the high price of medicines. True or False? - False One of the oldest and least effective pharmaceutical marketing techniques is DTC (direct-to- consumer) advertising. True or False? - False What influences the number of districts in a region? - The region's population. What is an example of the regionalization of healthcare delivery systems? - California and Florida have different prescription reimbursement policies. What is the heart of a pharmaceutical sales team? - District Manager. How many territories are in a typical district? - 8-12 What is the most effective method for grabbing market share? - Comparative selling. The average review time for a new drug is 18 months, down from almost 3 years in 1996. True or False? - True What are some questions reps should ask a physician? - Why do you prefer the competitor's drug to ours? What do they like and dislike about it? Which patient types is the drug being used for? What are the results and side effects, if any? Note: Careful questioning and listening enables reps to craft effective messages based on each physician's specific needs. NAPSR STUDY GUIDE EXAM QUESTIONS WITH COMPLETE SOLUTIONS 2023A+ What is indication in terms of drug approval? - The exact cause or purpose for which the FDA has approved that a new drug can be prescribed. What is the institutional review board (IRB)? - A committee of physicians, statisticians, community advocates, and others which ensures that a clinical trial is ethical and that the rights of the study participants are protected. All clinical trials in the U.S. must be approved by the IRB before they begin. What does the term "off label" mean? - Usage of a medication for purposes other than the specific ones appearing in the labeling. What is a placebo? - A placebo is an inactive pill, liquid, or powder that has no treatment value. In clinical trials, experimental treatments are often compared with placebos to assess the treatment's effectiveness. What is the placebo effect? - The effect produced by a placebo due to the expectations of the patient. The effect in placebo-controlled clinical trials is generally measured by comparing the effect observed in patients receiving the placebo treatment to the effect observed in patients receiving the active treatment. What is study protocol? - The general design and operating features of a trial. It is distinguished from the study manual operations by its generality and absence of specific details needed for day-to-day execution of the trial. Define toxicity. - The extent, quality, or degree to which a substance is poisonous or harmful to the body. Define "anatomy" - The study of the basic structures of the body. Define "physiology" - The study of how those body structures function Define "clinical pharmacology" - The study of the effects and movements of drugs in the human body. NAPSR STUDY GUIDE EXAM QUESTIONS WITH COMPLETE SOLUTIONS 2023A+ Define "pharmacodynamics" - Study of biochemical and physiological effects of drugs and their mechanisms of action, i.e., the study of what a drug does to the body. Drug dynamics (pharmacodynamics) describes the therapeutic effects of drugs (e.g., pain relief, blood pressure reduction), their side effects, their sites of action (i.e., which tissues they act on), and their mechanisms of action (i.e., how they act on those tissues). A drug's effects on the body may be influenced by many factors, such as a person's age and genetic makeup and disorders the person has other than the one being treated. Define "pharmacokinetics" - 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, i.e., the study of how the body affects drugs. Drug distribution and elimination - Drug delivery systems, route of administration, modes of excretion (passing from the body). About __ people in the U.S are slow acetylators? (a) 1% (b) 5% (c) 25% (d) 50% - 50% of people are slow acetylators. Where is this in the book? Which statements are/is INCORRECT about an ideal drug or magic bullet as Ehrlich phrased it? (a) it does not exist (b) it would be aimed precisely at the disease site (c)it would not harm healthy tissues (d) All of these statements are correct - (d) All of these statements are correct Which term denotes the study of bodily functions? - Physiology NAPSR STUDY GUIDE EXAM QUESTIONS WITH COMPLETE SOLUTIONS 2023A+ What is the broadest definition of a drug? - Any substance that produces a physical or psychological change in the body. How does the Federal Food, Drug and Cosmetic Act (FFDCA) define a drug? - Any substance intended for use in the diagnosis, cure, mitigation, treatment or prevention of a disease or a substance other than food intended to affect structure of function of the body. What is true about vitamins? - Most of the body's required vitamins must be taken in from outside the body. What does ADME testing measure? - The rate at which the body absorbs the drug, distributes it to the organs necessary to produce the desired effect, metabolizes it into waste material and then excretes it from the body. ADME testing is primarily used in what field? - Pharmacokinetics What is true about placebos? - Effects can lead to withdrawal symptoms. On average, what percent of drugs are studied in the lab are eventually studied in people? - 5 of 4000 What is true about drugs taken sublingually? - Are absorbed directly and almost immediately into the bloodstream. What are 3 of the 7 rights of the drug administration? - The right patient, the right drug, and the right dose. Pro-drugs are administered in the active for, which is metabolized into an active form. - False The kidney of an 85 year old person excretes drugs only__as efficiently as that of a 35 year old NAPSR STUDY GUIDE EXAM QUESTIONS WITH COMPLETE SOLUTIONS 2023A+ What is no true about biologies? - They do not cause an immune response. What are the drugs that attract or bind to cell receptors in order to mimic or enhance activities by endogenous channel messages? - Agonists Which term denotes how an API works in the body? - Mechanism for action. What cements the active and inert components together to maintain cohesive portions? - Binders What does the medical abbreviation BID denote? - Twice a day. What is the medical abbreviation for as needed? - PRN Which components might cause patients different reactions to brand name and generic drugs? - Differences in inactive ingredients. Do all cells have a nucleus? - No What is the typical relationship between a drugs site of administration and site of action? - They are usually somewhat removed from each other. What is CMAX? - The peak plasma concentration on a measuring curve. What is not a main concept in pharmacology? - Pharmacoprocesses What is not a route of drug administration? - Transfugal NAPSR STUDY GUIDE EXAM QUESTIONS WITH COMPLETE SOLUTIONS 2023A+ How are intradermal drugs delivered? - By injecting under the skin. What is an example of intravenous drug delivery? - An injection of anesthetic directly into the bloodstream. What are the major organs of the gastrointestinal system? - The mouth, esophagus, stomach, liver, pancreas, gallbladder, small and large intestines. What differentiates exclusivity from a patent? - Exclusivity is only granted upon the drugs FDA approval. What is required of an invention for it to be worthy of patent protection? - It must be novel, useful, and not obvious. A generic drug is________to the originator brand name drug in dosage, strength, safety, and quality. - Bioequivalent What is not required by the FDA's criteria for equivalency? - The drugs contain identical amounts of the same inactive ingredients. What list is generally considered the most reliable source of information on the therapeutically equivalent drug products? - Approved Drug products with therapeutic equivalence Exclusivity gives exclusive_______, is granted by the FDA and can run concurrently with a patent or not. - Marketing rights What is an orange book rating? - B NAPSR STUDY GUIDE EXAM QUESTIONS WITH COMPLETE SOLUTIONS 2023A+ What is the term for chemical equivalents which when administered in the same amounts will provide the same biological or physiological availability as measured by blood and urine levels? - Biological equivalents What term denotes the dispensing of an unbranded generic product for the product prescribed? - Generic substitution What term denotes a drug that is identical or bioequivalent to the originator brand name drug in dosage form, safety, strength, route, quality, performance, characteristics, and intended use? - Generic What is the duration of a patent challenge? - 180 days How is a drug sample closet or cabinet like a grocery store shelf? - The more visibility you can give your drug the more likely that it will be prescribed. Do pharmaceutical representatives typically store and secure their own drug samples? - Yes What is sometimes the most important factor in a pharmaceutical representatives success? - Sampling What approves storage conditions for drug products? - FDA Pharmaceutical representatives must always record the amount of drug samples left and obtain a signature for the amount. - True What is prohibited by section 503 of the Federal food drug and cosmetic act as amended by the prescription drug marketing act? - The sale, purchase, or trade or offer to sell, purchase, or trade prescription drug samples. Which entity issues monographs that define how drugs should be stored and what variance is allowed in their states contents? - United States Pharmaceutical Convention NAPSR STUDY GUIDE EXAM QUESTIONS WITH COMPLETE SOLUTIONS 2023A+ Why are intravenous drug dosages easier to control than drugs administered transdermally? - The entire dose is available in the bloodstream to be distributed to the target site. What medical term means to apply the drug on the skin surface? - Transdermal Carcinogenicity studies are meant to identify the tumor causing potential of a drug. - True According to NIH ethical guidelines, which of the followers is the most important criteria in selecting subjects for clinical studies? - Scientific objects Which statement about the IRB is incorrect? - The members of the IRB/IEC must be experts in the topic of study. Which phases of clinical studies are open label and which are blinded? - Phase 1 and 4 trials are often open label, but phase 2 and 3 are double blinded or at least blinded. If it is not possible to measure the direct effects of a drug, what is used instead? - Surrogate markers such as blood pressure and cholesterol levels. Which of the following is an observational study that first identifies a group of subjects with a certain disease and a control group without that disease, and then looks to back in time (via chart reviews) to find exposure to risk factors? - Case control study Which measure of central tendency is the sum of all observations divided by the number of observations? - Mean Which measurement describes the number of new events that occur during a specified period of time in a population at risk for the event (lung infections per year)? - Incidence NAPSR STUDY GUIDE EXAM QUESTIONS WITH COMPLETE SOLUTIONS 2023A+ Which of the following measures is used to describe the variability of the population mean? - Standard error of the mean Which of the following terms denotes the extent to which a test actually measures what it is supposed to be measuring, or what we think it is measuring? - Validity What are the Kaplan-Meier analysis and Cox proportional hazards analysis? - Methods of survival analysis What section of a clinical paper describes subjects entry and exclusion criteria? - Methods Which document sets out how a trial is to be conducted (study's general design and operating features)? - Protocol When designing and performing clinical trials, several ethical constraints must be considered. Which of the following is not one of these ethical constraints? - Geographical variations What is one way in which large molecule drugs differ from small molecule drugs? - Large molecule drugs are mainly protein based drugs that develop in biological systems such as living cells. Which of the following statements about vaccines is incorrect? - Vaccines are types of small molecule drugs. What is an advantage of attenuated vaccines over inactivated vaccines? - Attenuated vaccines are less expensive to prepare. How are toxoids derived? - From the toxins secreted by a pathogen. What is the estimated annual death toll for malaria? - 1.5 to 3.5 million people NAPSR STUDY GUIDE EXAM QUESTIONS WITH COMPLETE SOLUTIONS 2023A+ How was insulin primarily obtained from the 1930's to the 1980's? - Porcine and bovine extracts Name the types of cytokines. - Lymphokines, monokines, and growth factors Which of the following is not a type of hormone? - Blood glucose Which of the following is a basic gene therapy technique? - In vitro, in which patients genetically faulted tissues are removed, loaded with normal genes in vectors, and returned to the patients bodies. Which statement about stem cells is correct? - Pluripotent stem cells can develop into many cell types, but not a new individual. Leukemia is a condition in which the stem cells in the bone marrow malfunction and produce an excessive number of immature white blood cells. - True Which of the following are types of vectors used in gene therapy? - Retroviruses Which of the following is not a type of stem cell? - Semipotent Traditional vaccines are prepared in a number of ways. Which of the following is not one of them? - Insulin Effective drug therapy is cost effective and highly valuable means of controlling total healthcare expenditures and improving quality of life. - True Drug utilization review (DUR) programs... - Have traditionally been used to ensure the appropriate, safe, and effective use if prescription drugs, but are increasingly shifting their focus to minimizing costs. NAPSR STUDY GUIDE EXAM QUESTIONS WITH COMPLETE SOLUTIONS 2023A+ It is rare for pharmaceutical companies to explore, develop, and promote expressive values with which patients might identify. - 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. - True How has DTC advertising changed over the last few decades? - DTC advertising has become an essential marketing tactic for both large and small brands. Which of the following most strongly influences physicians prescribing habits? - Doctors personal experience, and their patients unique situations. Pharmaceutical companies spend more on promotional activities than on R & D. - False Which of the following would be most well served by mass market print and tv ads? - A brand that treats a very common chronic condition. How do companies use prescriber data? - To conduct research Under PhRMA code, which of the following is acceptable? - Modest meals for staff members attending educational events. Under the AMA guidelines on gifts to physicians from industry, which gifts are not permitted? - Gifts that are only given to doctors with high prescribing volumes. The PhRMA code on interactions with healthcare professionals is only voluntary bed not mandatory. - True Which of the following would not be considered acceptable promotional items under PhRMA code? - Pens and clipboards designed to be used by patients in the doctors offices. NAPSR STUDY GUIDE EXAM QUESTIONS WITH COMPLETE SOLUTIONS 2023A+ Under PhRMA code, what is one example of an acceptable patient education item? - An anatomical model valued under $100. Under what circumstances does PhRMA code permit a company to provide entertainment or recreational activities to healthcare practitioners? - Under no circumstances Under PhRMA code, may a company sponsor a lunch at a 3 day conference if part of it includes an educational program for which attendees may choose to receive CME credit? - Yes, but only if the lunch is clearly separate from the CME portion of the conference. Which of the following is an arm of the department of health and human services that investigates regulatory infractions, provides compliance advice, and brings enforcement actions? - Office of inspector general Is it illegal to ask receptionists for personal information about your clients charts such as home phone numbers, birthdays, or hobbies? - No Which of the following is not a primary goal or function of the P & T committee? - To educate sales representatives on legal and ethical guidelines for professional behavior. Which of the following is a major challenge facing family medicine? - Managed care policies eroding patient - doctor relationships. According to your manual, Family physicians diagnose and treat approximately what proportion of patients they see (as opposed to referring then to specialists)? - 95% Which of the following would be classified as a type of somatic psychiatric treatment? - Drug therapy NAPSR STUDY GUIDE EXAM QUESTIONS WITH COMPLETE SOLUTIONS 2023A+ Why is the last 10 minutes of each hour usually the best time to make office visits to psychiatrists? - Psychiatrists often see patients on the hour for 45 minutes. What is an advantage of selling to residents? - Residents are often more open-minded. What is drug utilization review (DUR)? - An MCO's practice of monitoring prescribing patterns. What is used in treatment of manic depression illness and schizoaffective disorder? - Mood stabilizers What is the focus of the short call protocol? - Beginning with a specific patient type. Who is the medical science liaison (MSL)? - Someone employed by pharmaceutical companies who build relationships with thought leaders and acts as an information resource. What type of education do MSL's usually have? - Graduate level science degrees How do companies typically judge the MSL team's contributions? - Return on edication What differentiates push through programs from pull through programs? - Sales representatives are more involved in pull through programs. Because pharmaceutical sales representatives work mostly out of their homes, it is not important that they work well in a team environment. - False What is the most likely reason that a doctor would lack interest in one of your clinical studies? - The doctor does not like the way you are presenting it. When a physician visits your hospital display, you should begin conversion by asking, can i help you? - False NAPSR STUDY GUIDE EXAM QUESTIONS WITH COMPLETE SOLUTIONS 2023A+ What term is used to denote drugs that are non-biological (chemical) in nature? - Small molecule When referring to medication dosage, which medical abbreviation denotes hair? - H Which of the following terms denotes the study of drugs beneficial and toxic effects on living cells, tissues, and organs? - Pharmacology What are specialized cells and tissues that work together to perform a specific body function for a common purpose? - Organs What is the mechanism of action? - The method by which a medication produces it's therapeutic effects. What is plasma? - The fluid portion of the blood. What is anaphylaxis? - An extreme sensitivity and reaction to a foreign substance including medications. How do cholinergic agonists work? - By mimicking the actions of acetylcholine. Which of the following is considered a sympathominetic drug that stimulates the alpha- adrenergic receptors? - Decongestant Which of the following is not a type of gastrointestinal agent? - Prolactin inhibitors What is one of the main functions of a tocolytic agent? - To suppress labor Which of these conditions is not treated with antiandrogens? - Dyspepsia NAPSR STUDY GUIDE EXAM QUESTIONS WITH COMPLETE SOLUTIONS 2023A+ Which types of patients are most likely to receive immune globulins? - Patients with weakened immune systems. What is iron's primary function in the body? - Carrying oxygen Which of the following is not a type of anti-infectant? - Antimetabolisms What is one difference between entry level and experienced resumes? - Entry level resumes are more likely to begin with the education section than the experience section. Which statement about targeted cover letters is true? - Targeted cover letters are always tailored to specific companies.