NAPSRx 2023 with verified questions and answers

Pharmaceuticals are arguably the most socially important healthcare product true Pharmaceutical development is a high risk undertaking, in which many promising leads prove disappointing true Pharmaceutical sales are highest in which geographical regions U.S., Western Europe, and Japan The U.S. accounts for about ____ of the world's pharmaceutical revenues 50% Which of the following has fueled recent growth in the pharmaceutical industry population growth and increased life expectancies which statement accurately describes the predicted relationship between pharmaceutical companies and research facilities partnerships between pharmaceutical companies and genomic companies will not prove immediately profitable Prescription drug therapy is not cost-effective for insurance companies and healthcare providers false The high price of healthcare is explained by the high price of medicines false One of the oldest and least effective pharmaceutical marketing techniques is DTC advertising false What influences the number of districts in a region? -the regions population What is an example of the regionalization of healthcare delivery systems -California and Florida have different prescription reimbursement policies The heart of pharmaceutical sales team is the Regional Manager false Most DMs did not start as representatives false How many territories are in a typical district 8-12 What is the most effective method of grabbing market share comparative selling Which term denotes the study of bodily functions? physiology In its broadest definition, a drug is any substance that produces a physical or psychological change in the body true 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 disease, or a substance other than food intended to affect the structure or function of the body Which statement about vitamins is correct -most of the body's required vitamins must be taken in from outside the body ADME testing measures 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 the excretes it from the body -true ADME testing is primarily used in what field -pharmacokinetics Which statement about placebos is correct -placebo effects can lead to withdrawal symptoms On average, only about 5 of 4,000 drugs studied in the laboratory are eventually studied in people true Which statement is true about drugs taken sublingually -sublingual drugs are absorbed directly and almost immediately into the bloodstream What are 3 of the 7 rights of drug administration -the right patient, the right drug, and the right dose Pro-drugs are administered in an active form, which is metabolized into an inactive form -false The kidney of an 85-year-old person excretes drugs only ____ as efficiently as that of a 35-year-old person -around 50% The normal age-related decrease in kidney function can help doctors determine an appropriate dosage based solely on a person's age -true What differentiates a caplet from a tablet -caplets are shaped like capsules and have film coatings to aid in swallowing Where will you find the legend "Caution: Federal Law prohibits dispensing without a prescription"? -on the label of all prescription drugs What happens in slow acetylators? -drugs that are metabolized by the N-acetyl transferase tend to reach higher blood levels and remain in the body longer About __ of the people in the U.S. are "slow acetylators" 5% Drug-drug interactions -duplication can involve two drugs with the same effect causing toxicity when taken together -duplication can involve two drugs with the same effect intensifying each other's therapeutic effects without any serious side effects -opposition can involve two drugs with opposing actions interacting to reduce one's effectiveness but not the other's Smoking decreases the effectiveness of some drugs -false Which of the following statements about dietary supplements is incorrect -because dietary supplements are not drugs, interactions with drugs are not a concern Which statement is correct about an ideal drug, or "magic bullet" as Ehrlich phrased it? -it does not exist -it would be aimed precisely at a disease site -it would not harm healthy tissues Which statement accurately differentiates resistance from tolerance? -tolerance refers to a person's diminished response to a drug after repeated use, whole resistance applies to microorganisms' or "cancel" cells' abilities to withstand drug effects Between 3% and 7% of hospital admissions in the United States are estimated to be for treatment of adverse drug reactions -true Which statement is true about the universal scale for quantifying the severity of an adverse drug reaction -none of these statements are true because there is no such scale Why is noncompliance a serious public health concern? -it increases the total cost of medial care Drug's trade names are often unrelated to their intended use -true Like foods and household products, generic drugs are usually lower quality than the brand name drugs for which they are marketed as equivalents -false Legally bioequivalence of different versions of a drug can very by up to ____? 20% Which of the following statements about biologics is incorrect -they do not cause immune responses "Large Molecule" products are developed and manufactured by a chemical process -false What are drugs that attract or bind to cell receptors in order to mimic or enhance activities by endogenous chemical messengers -agonists Which term denotes how an API works in the body -mechanism of action What cements the active 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 component might cause patients' different reactions to brand name and generic drugs -differences in inactive ingredients All cells have a nucleus -false Which of the following does not affect drug response -the patient's genetic makeup, age, body size, and use of other drugs and dietary supplements -the patient's other conditions or diseases -whether or not the patient takes the drug properly Drug reactions are predictable because they do not occur after a person has been previously exposed to the drug one or more times without any allergic reactions -false What is the typical relationship between a drug's 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 Which of the following is not a main concept in clinical pharmacology -pharmacokinetics Which of the following is not a route of drug administration -transfugal How are intradermal drugs delivered -by injection 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 -mouth, esophagus, stomach, liver, pancreas, gallbladder, small and large intestines Who is normally responsible for selling to distributors? NAMs How often do secondary drug wholesale distributors buy their drugs directly from manufactures? Sometimes By FDA law, large chain pharmacies are not allowed to buy directly from drug manufactures False Only 3 companies account for nearly 90% of all drug wholesale sales -true What type of sale bypasses the need for intermediary distributors? -manufacturer-direct sales What is a group purchasing organization (GPO)? -an entity consisting of two or more hospitals or other health care entities that negotiates contracts on behalf of its members Prescriptions dispensed by mail-order pharmacies are, on average, around ______ than those dispensed by retail pharmacies 3 times larger Which of the following is a type of non-stock sale -brokerage sales -dock-to-dock sales -drop shipments What is another term for rebates After-market arrangements The PDMA is the Prescription Drug Manufacturers Association -false A company that owns and operates three or fewer pharmacies is an ____ -independent drug store Which section of a drug's package insert information covers the usual dosage range -indication and usage Drug labels must include indications, usage information, and contraindications -true What should be included in the "description" section of a drug's package insert information -the drug's proprietary name and established name Exclusivity gives exclusive ____, is granted by the FDA, and can run concurrently with a patent or not -marketing rights What differentiates exclusivity from a patent -exclusivity is only granted upon the drug's 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 drugs is ______ to the originator brand-name drug in dosage, strength, safety, and quality bioequivalent Which of the following is NOT required by the FDA's criteria for equivalency -the drugs contain identical amounts of the same inactive ingredients What is generally considered the most reliable source of information on therapeutically equivalent drug products? -"Approved Drug Products with Therapeutic Equivalence" Which of the following is an Orange Book rating? -AA 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 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 term denotes the dispensing of an unbranded generic product for the product prescribes? -generic substitution 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 Pharmaceutical reps do not typically store and secure their own drug samples -false Sampling is sometimes the most important factor in a pharmaceutical rep's success -true The FDA approves storage conditions for drug products -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 The federal government does not regulate the drug sampling for a pharmaceutical rep -false Which entity issues monographs that define how drugs should be stored, and what variance is allowed in their stated contents -United States Pharmacopoeial Convention Storage conditions for drug products are based on information supplied by the manufacturer -true In which cases can degraded drugs sometimes still be used -when 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 beforehand -true What should you do if you receive a shipment from your employer and you notice that there are twice as many samples as what is posted on the packing slip? -Call you Sales Manager to inform him/her of the mistake and ask for instructions on proper procedure Which area of drug R&D has seen the largest cost increases? -clinical trials On average, how long does it take for a new drug to be developed -10-15 years Which of the following regulatory agencies is industry based -Pharmaceutical Research and Manufactures of America (PhRMA) The landmark FDA modernization Act of 1997 was a major step forward in enabling safe and effective new drugs and biologics to be made available sooner to patients -true According to your manual which type of system is the best way to deliver healthcare? -market-based system How would increased pharmaceutical price controls affect the U.S. healthcare system -increased price controls would stifle innovation What was the intent of the Bayh-Dole Act and the Stevenson-Wydler Technology Innovation Act? -to hasten the commercialization of technologies that otherwise might not be used What did the G10 Medicines Group recently report about the pharmaceutical industry in the European Union (EU) -there is poor collaboration between publicly- and privately- funded research centers The aim of preclinical pharmacological studies is to obtain data on the safety and effectiveness of the lead compound -true Toxicity information in preclinical studies helps provide confidence about a drug's safety -true Pharmacological studies using animals are regulated under Good Laboratory Practice -true Which of the following does NOT affect a drug's ability to permeate membranes? -the drug's vesicles Through which barriers can lipid-soluble drugs usually pass? -cell membranes How are weak acid drugs generally absorbed by the stomach? -more quickly than weak basic drugs Which of the following routes of administration do NOT completely bypass the liver -rectal administration 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 Which of these medical terms means "to apply the drug on the skin surface"? -trandermal Carcinogenicity studies are carried out to identify the tumor-causing potential of a drug? -true According to NIH ethical guidelines, which of the following is the most important criteria in selecting subjects for clinical trials? -scientific objectives Which statement about the IRB is INCORRECT? -THe members of the IRB/IEC must be experts in the topic of the study Which phases of clinical studies are "open label" and which are blinded -Phase I and IV are often open label, but phase II and III 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 the disease, and then looks to back in time to find exposure to risk factors? Case-control study 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? -protocol 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 to 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 There are more white blood cells than red blood cells for the same volume in the human body -false How was insulin primarily obtained from the 1930s to the 1980s? -porcine and bovine extracts Cytokines -interferons -interleukins -monokines Which of the following is NOT a type of hormones? -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 a 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 of prescription drugs, but are increasingly shifting their focus to minimizing costs DUR programs involve retrospective monitoring of physicians' prescribing patterns -true The history of drug formularies in the U.S. extends back to -the American revolution Which of the following is NOT a recent formulary trend? -the repeal of Hatch-Waxman What did the Hatch-Waxman act do? -make it easier for generic manufacturers to compete with R&D companies Which of these individuals would NOT be a member of a P&T committee? -a 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 -false Pharmaceutical companies are more interested in acquiring and exploiting another's brands than in acquiring another's R&D and sales marketing assets -false Ideally, when should brand strategy development for a new drug begin -during phase II clinical trials Which of the following is an example of a "expressive" value "I own a BMW because I want people to know that I'm a serious driving enthusiast" Which of the following is NOT an example of a "functional" value? -uniqueness