Download NAPSRx Study Guide questions with correct answers and more Exams Nursing in PDF only on Docsity! NAPSRx Study Guide Pharmaceuticalscorrect answerMedicines and vaccines for human and animal use. Products may have a trademark (brand) name or be generic; and they may be prescription or over-the counter. Diagnosticcorrect answerEquipment and supplies used in screening, detecting, and monitoring disease. Can range from simple home testing kits to sophisticated diagnostic imaging technologies. Medical Devicescorrect answerAdvanced instrumentation and appliances used for medical therapy, such as joint replacements, implantable defibrillators, and pacemakers. Also includes drug delivery devices such as syringes, infusion pumps, metered-dose inhalers, and transdermal patches. Medical Suppliescorrect answerCommodity, high-volume supplies such as surgical gowns and gloves. Durable Medical Equipmentcorrect answerReusable products for health-related use in the home, such as walkers, wheelchairs, oxygen equipment, prosthetics and hospital beds. What countries are pharmaceutical sales the highest?correct answerUnited States, Western Europe, and Japan. The U.S. accounts for roughly __________ of the world's pharmaceutical revenues.correct answer50% Two factors have significantly contributed to recent growth in the pharmaceutical industry are?correct answerPopulation growth and increasing life expectancies. What is the predicted relationship between pharmaceutical companies and genomic research facilities? correct answerPartnerships between pharmaceutical companies and genomic research facilities will not prove immediately profitable. Prescription drug therapy is cost effective for insurance companies and health care providers. True or False?correct answerTrue The high price of health care is explained by the high price of medicines. True or False?correct answerFalse One of the oldest and least effective pharmaceutical marketing techniques is DTC (direct-to-consumer) advertising. True or False?correct answerFalse What influences the number of districts in a region?correct answerThe region's population. What is an example of the regionalization of healthcare delivery systems?correct answerCalifornia and Florida have different prescription reimbursement policies. What is the heart of a pharmaceutical sales team?correct answerDistrict Manager. How many territories are in a typical district?correct answer8-12 What is the most effective method for grabbing market share?correct answerComparative selling. The average review time for a new drug is 18 months, down from almost 3 years in 1996. True or False? correct answerTrue What are some questions reps should ask a physician?correct answerWhy 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. Pharmaceutical reps mainly visit pharmacies. True or False?correct answerFalse. Pharmaceutical reps mainly visit/target physicians. What does the term "off label" mean?correct answerUsage of a medication for purposes other than the specific ones appearing in the labeling. What is a placebo?correct answerA 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?correct answerThe 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?correct answerThe 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.correct answerThe extent, quality, or degree to which a substance is poisonous or harmful to the body. Define "anatomy"correct answerThe study of the basic structures of the body. Define "physiology"correct answerThe study of how those body structures function Define "clinical pharmacology"correct answerThe study of the effects and movements of drugs in the human body. Define "pharmacodynamics"correct answerStudy 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"correct answerStudy 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 eliminationcorrect answerDrug 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%correct answer50% 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 correctcorrect answer(d) All of these statements are correct Which term denotes the study of bodily functions?correct answerPhysiology What is the broadest definition of a drug?correct answerAny substance that produces a physical or psychological change in the body. How does the Federal Food, Drug and Cosmetic Act (FFDCA) define a drug?correct answerAny 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?correct answerMost of the body's required vitamins must be taken in from outside the body. What does ADME testing measure?correct answerThe 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?correct answerPharmacokinetics What is true about placebos?correct answerEffects can lead to withdrawal symptoms. On average, what percent of drugs are studied in the lab are eventually studied in people?correct answer5 of 4000 What is true about drugs taken sublingually?correct answerAre absorbed directly and almost immediately into the bloodstream. What are 3 of the 7 rights of the drug administration?correct answerThe right patient, the right drug, and the right dose. Pro-drugs are administered in the active for, which is metabolized into an active form.correct answerFalse The kidney of an 85 year old person excretes drugs only _____________ as efficiently as that of a 35 year old person.correct answerAround 50% The normal age related disease in kidney function can help doctors determine an appropriate dosage based solely on a person age.correct answerTrue What differentiates a caplet from a tablet?correct answerCaplets are shaped like capsules and have film coatings to aid in swallowing. Where will you find the legend "federal law prohibits dispensing without a prescription"?correct answerOn the label of all prescription drugs. A generic drug is ____________ to the originator brand name drug in dosage, strength, safety, and quality.correct answerBioequivalent What is not required by the FDA's criteria for equivalency?correct answerThe 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?correct answerApproved Drug products with therapeutic equivalence Exclusivity gives exclusive ____________, is granted by the FDA and can run concurrently with a patent or not.correct answerMarketing rights What is an orange book rating?correct answerB 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?correct answerBiological equivalents What term denotes the dispensing of an unbranded generic product for the product prescribed?correct answerGeneric 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?correct answerGeneric What is the duration of a patent challenge?correct answer180 days How is a drug sample closet or cabinet like a grocery store shelf?correct answerThe 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?correct answerYes What is sometimes the most important factor in a pharmaceutical representatives success?correct answerSampling What approves storage conditions for drug products?correct answerFDA Pharmaceutical representatives must always record the amount of drug samples left and obtain a signature for the amount.correct answerTrue What is prohibited by section 503 of the Federal food drug and cosmetic act as amended by the prescription drug marketing act?correct answerThe 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?correct answerUnited States Pharmaceutical Convention Who regulates the drug sampling for a pharmaceutical representative?correct answerThe federal government Stores conditions for drug products or based on information supplied by who?correct answerThe manufacturer In which cases can degraded drugs sometimes still be used?correct answerWhen the amount of remaining drug has not fallen lower than 85-90% of that stated on the label. Drug recalls are almost always negotiated with the FDA before hand.correct answerTrue What should you do if you receive a shipment from your employer and you noticed that there are twice as many samples as what is posted on the packing slip?correct answerCall your sales manager to inform them of the mistake and ask for instructions on proper procedure. Which of the following drug R & D has seen the largest cost increases?correct answerClinical trials On average, how long does it take for a new drug to be developed (from the discovery of the initial compound to FDA approval)?correct answer10-15 years Which of the following regulatory agencies is industry based (run mainly by the companies themselves)? correct answerPharmaceutical Research and Manufacturers of America The landmark FDA modernization act of 1997 was a major step forward and enabling safe and effective new drugs and Biologics to be made available sooner to patients.correct answerTrue According to your manual which type of system is the best way to deliver healthcare?correct answerA market bases system How would increased pharmaceutical price controls affect the US healthcare system?correct answerIncreased price controls would stifle innovation. What was the intent of the Bayh-Dole act and the Stevenson-Wydler technology innovation act?correct answerTo hasten the commercialization of technologies that otherwise might not be used. According to your manual what did the G 10 medicines group recently report about the pharmaceutical industry in the European Union?correct answerThere is poor collaboration between publicly and privately funded research centers. What is the aim of preclinical pharmacological studies?correct answerTo obtain data on the safety and effectiveness of the lead compound. Toxicity information in preclinical studies helps provide what?correct answerConfidence about a drugs safety. Pharmacological studies using animals are regulated under what?correct answerGood laboratory practice Why do drugs administered to patients only contain API's?correct answerThey don't What is an advantage of attenuated vaccines over inactivated vaccines?correct answerAttenuated vaccines are less expensive to prepare. How are toxoids derived?correct answerFrom the toxins secreted by a pathogen. What is the estimated annual death toll for malaria?correct answer1.5 to 3.5 million people How was insulin primarily obtained from the 1930's to the 1980's?correct answerPorcine and bovine extracts Name the types of cytokines.correct answerLymphokines, monokines, and growth factors Which of the following is not a type of hormone?correct answerBlood glucose Which of the following is a basic gene therapy technique?correct answerIn 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?correct answerPluripotent 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.correct answerTrue Which of the following are types of vectors used in gene therapy?correct answerRetroviruses Which of the following is not a type of stem cell?correct answerSemipotent Traditional vaccines are prepared in a number of ways. Which of the following is not one of them?correct answerInsulin Effective drug therapy is cost effective and highly valuable means of controlling total healthcare expenditures and improving quality of life.correct answerTrue Drug utilization review (DUR) programs...correct answerHave traditionally been used to ensure the appropriate, safe, and effective use if prescription drugs, but are increasingly shifting their focus to minimizing costs. DUR programs involve retrospective monitoring of physicians prescribing patterns.correct answerTrue What is a formulary?correct answerA list of prescription drugs approved by insurance coverage. The history of drug formularies in the US extends back to...correct answerThe American Revolution Which of the following is not a recent formulary trend?correct answerThe repeal of Hatch-Waxman What did the Hatch-Waxman act do?correct answerMake it easier for generic manufacturers to compete with R & D companies. What is opportunity cost?correct answerThe value of a sacrificed alternative According to your manual, the three primary entities that fund pharmaceuticals are employers, the government (Medicare and Medicaid), and _____________.correct answerIndividuals Which of these members would not be a member of a P & T committee?correct answerA company's medical liaison Almost 98% of employed Americans are now covered by a HMO, a preferred provider organization, or a point of service plan,correct answerFalse Ideally, when should brand strategy development for a new drug begin?correct answerDuring phase 2 clinical trials Which of the following is an example of an expressive value?correct answerI own a BMW because I want people to know that I am a serious driving enthusiast. According to your manual, which of the following is not an example of s functional value?correct answerUniqueness It is rare for pharmaceutical companies to explore, develop, and promote expressive values with which patients might identify.correct answerTrue 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.correct answerTrue How has DTC advertising changed over the last few decades?correct answerDTC advertising has become an essential marketing tactic for both large and small brands. Which of the following most strongly influences physicians prescribing habits?correct answerDoctors personal experience, and their patients unique situations. Pharmaceutical companies spend more on promotional activities than on R & D.correct answerFalse Which of the following would be most well served by mass market print and tv ads?correct answerA brand that treats a very common chronic condition. How do companies use prescriber data?correct answerTo conduct research Under PhRMA code, which of the following is acceptable?correct answerModest meals for staff members attending educational events. Under the AMA guidelines on gifts to physicians from industry, which gifts are not permitted?correct answerGifts that are only given to doctors with high prescribing volumes. When a physician visits your hospital display, you should begin conversion by asking, can i help you? correct answerFalse Which of the following is not a rule in making the most out of your sales calls?correct answerYour agenda, not theirs Specialty care products are more often prescribed by generalist physicians.correct answerFalse Side effects that might be considered merely minor annoyances in acute treatment can be a powerful barrier to adoption in chronic therapies.correct answerTrue Acute medications such as antibiotics are used to address short term illnesses and symptoms.correct answerTrue In some medical cases therapy may be initiated by a specialist and monitored by a primary care physician.correct answerTrue Blockbuster drug status typically translates into sales of just under $10 million annually.correct answerFalse A generic drug manufacturers greatest challenge is often to replicate drug formulation factors that affect the pharmacokinetic and pharmacodynamic characteristics of the original drug.correct answerTrue What differentiates an orphan drug from a blockbuster drug?correct answerOrphan drugs typically treat rare conditions. How long are most calls and visits to physicians offices (excluding waiting and driving time)?correct answerOnly a few minutes Which of the following is not a step in managing tumors?correct answerCounter attack According to the text, which of the following is considered going to the next level?correct answerStaying focused What is one of the primary job responsibilities of a retail pharmacist?correct answerDispensing pharmaceuticals What is not one of the ways in pharmaceutical companies and representatives categorize their customers?correct answerCompanies in agents categorize your patience and all these ways. Which of the following are relatively new prescription drug benefits covered under the Medicare prescription drug improvement and modernization act?correct answerMedicare Part D Which term means disease producer?correct answerPathogen Which type of blood cell please the most prominent role in fighting infection and disease?correct answerWhite blood cell Which of the following generally resides on a cell surface (or in the cytoplasm) and causes a biological change or activity when stimulated?correct answerReceptor Renal pertains to...correct answerKidneys What term denotes the practice of locating genes on a chromosome?correct answerGene mapping What field is most concerned with drug affects due to slight genetic difference?correct answerPharmacogenomics Which entity funds the National Institutes of Health (NIH)?correct answerUnited States federal government With respect to material in your manual, what does IDN stand for?correct answerIntegrated delivery network What is SS an abbreviation for?correct answerSemis What term is used to denote drugs that are non-biological (chemical) in nature?correct answerSmall molecule When referring to medication dosage, which medical abbreviation denotes hair?correct answerH Which of the following terms denotes the study of drugs beneficial and toxic effects on living cells, tissues, and organs?correct answerPharmacology What are specialized cells and tissues that work together to perform a specific body function for a common purpose?correct answerOrgans What is the mechanism of action?correct answerThe method by which a medication produces it's therapeutic effects. What is plasma?correct answerThe fluid portion of the blood. What is anaphylaxis?correct answerAn extreme sensitivity and reaction to a foreign substance including medications. How do cholinergic agonists work?correct answerBy mimicking the actions of acetylcholine. Which of the following is considered a sympathominetic drug that stimulates the alpha-adrenergic receptors?correct answerDecongestant Which of the following is not a type of gastrointestinal agent?correct answerProlactin inhibitors What is one of the main functions of a tocolytic agent?correct answerTo suppress labor