NAPSRx Exam Questions and Answers Graded A+

Pharmaceuticals are arguably the most socially important healthcare product - true Pharmaceutical deveoplment is a big-risk undertaking, in which many promising leads prove disappointing - true Pharmaceutical sales are highest in which geographical regions - The U.S., Western Europe, and Japan The U.S. accounts for about ____ of the world's pharmaceutical revenues - 50% Which off the following has fueled recent growth in the pharmaceutical industry - population growth and increased life expectancies According to your manual, which statement accurately describes the predicted relationship between pharmaceutical companies and genomic research facilities - partnerships between pharmaceuitcal 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 efffective pharmaceutical marjeting techniques is DTC (direct-to-consumer) advertising - false what influences the number of districts in a region - the region's population what is an example of the regionalization off healthcare delivery systems - California and Florida have difffernet perscription reimbursment policies the heart of pharmaceutical sales is the regional manager - false most DMs did not start as representatives - false how many territories are in a typical district - 8 to 12 what is the most effective method for grabbing market share - comparative selling pharmaceutical reps mainly visit pharmacies - false it usually only takes 1-2 calls to a physician before he or she commits to prescribing your product - false the pharmacist may dispense a product other than what the physician prescribed - true according to chapter 12 of your manual, which of the following would classify as "payers" - employers according to your manual, what defines "ethical pharmaceutical companies - researching and developing novel drugs one of the most diappointing results of the pharmaceutical industry's continued investment in R & D is the few new drugs being approved and in development - false thanks to modern medicines, how long are people newly diagnosed with HIV expected to live - another 50 years how much has the average american lifespan increased since 1890 - almost 30 years what is a treatment group - A group of patients assigned to receive a specified treatment what is the main difference between a blinded and double-blinded study - in a double blinded study, neither the study staff nor the study participants know which subjects are in the experimental group and which are in the control what does "asymptomatic" mean - not exhibiting signs or symptoms what term denotes the study of bodily functions (as opposed to structures) - 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 off 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 bodys 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 then 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 off 4,000 drugs studied in the labratory 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 off the 7 rights of drug administration - the right patient, rigt drug, and 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 persion excretes drugs only ____ as efficiently as that of a 35-year-old person - around 50% the normal age-related decrease in kidney function cem help doctors determine an appropiate dosage based soley 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 scallowing what will you find the legend "Caution: federal law prohibits dispensing wihtout a prescription - on the label of all prescription drugs what happens to slow acetylators - Drugs that are metabolized by 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" - 50% which of the following statements about drug-drug interactions is incorrect - drug-drug interactions are always harmful Smoking decreases the effectiveness of some drugs - true 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/s is/are incorrect about an ideal drug, or "magic bullet" as Ehrlich phrased it - it does not exist, it would be aimed percisely 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, while 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 reactoins - true which statement is true about the universal scale for quantiffying the severity of an adverse drug reaction - there is no scale why is noncomplience a serios public healthy concern - it increases the cost of medical care which of the following is NOT eligible for patent protection under U.S. regulations - companies can be granted patents for all these things drugs' 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 vary by up to ________. - 20% which of the following statements about biologics is incorrect - they do not cause immune response "large molecules" products are developed and manuffactured 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 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 what components 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 drig response - the patients' 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 becasue 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 - Peak plasma concentration on a measuring curve which of the following is not a main concept in clinical pharmacology - pharmacoprocesses 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 - the mouth, esophagus, stomach, liver, pancreas, gallbladder, small intestine, large intestine 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 not 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 presciption 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 infformation covers the usual dosage range - indications and usage Drug labels must include indications and usage information, as well as contraindications. - true what should be included in the "description" section off a drug's package insert information - the drug's proprietary name and the 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 drug 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 off the same inactive ingredients A generic drug is ____ to the originatory brand-name drug in dosage, strength, safety, and quality - bioequivalent what list 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 prescribed - generic substitution what is the duration off 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 representatives 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 pharmaceutical representatives must alwasy record the amount of drug samples left and obtain a signature for that 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 the federal government does not regulate the drug sampling for a pharmaceutical representative - false which of the following is permitted by Section 503 of the federal food, drug and cosmetic act - cannot donate or sell prescribtion drug samples 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 medications are usually unaffected by changes in temperature, light, humidity, and other environmental factors - false In which cases can degraded drugs SOMETIMES still be used? - when the amount off 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 Which problem would NOT be improved by electronic prescribing systems? - none: patients "doctor-shopping" for controlled substances, pharmacists misreading prescriptions, physicians wasting time calling pharmacies what should you do if you recieve a shipment from your employer and you notice that there are twice as many samples as what is posted on the packing slip - call your sales manager to inform him/ her of the mistake and ask for instructions posted on the packing slip which area of drugs R&D has seen the largest cost increases - clinical trials on average, how long does it take for a new drug to be developed (I.e., from the discovery of the initial compound to FDA approval) - 10-15 years which of the following regulatory agencies is industry- based (I.c., run mainly by the companies themselves) - Pharmaceutical research and manufactures of america (PhRMA) which of the following factors has simplified the pharmaceutical R&D process - none: an intensive regulatory process, growing demand in the medical community for more complex data about pharmaceuticals, and the increasing number of precedures in Phase III trials 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 wat to deliever healthcare - a market-based system how would increased pharmaceutical price controls affect the U.S. healthcare system - increased price controls would stifle innovation which of the following invests a greater percentage of sales in research than the biotech sector - none: aerospace sector, communications sector, electronics sector what was the intent of the Bayh-Dole Act and Stevenson-Wydler Technology Innovation Act - to hasten the commercialization of technologies that otherwise might not be used according to your manual, what did the G10 medicines group recently report about the pharmaceutical industry in the european union (EU) - there is poor collaberation between publicly- and privately- funded research concerns The aim of preclinical pharmacological studies is to obtain data on the safety and effectiveness of the lead compound. - true toxicity infformation in preclinical studies helps provide confidence about a drug's safety - true pharmacological studies using animals are regulated under good laboratory practice - true Why do drugs administered to patients only contain APIs? - they don't which of the following does not affect a drug's ability to permeate membranes - the drugs 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 no 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 the following does not affect a drug's distribution to its target tissues - the drug's lipid-solubility, the drug's polarity, the vascular nature of the drug's target tissue- all these facots affect a drug's distribution to its target tissues which of these medical terms means "to apply the drug on the skin surface" - transdermal 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 studies? - scientific objectives which statement about the IRB in 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 I and IV trials 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 subject with a certain disease and a control group without the disease, and then looks to back in time (e.g. 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