NAPSR Exam - Pharmaceutical Industry Knowledge, Exams of Pharmacology

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NAPSR Exam (practice quizzes) Questions With

Correct Answers-LATEST UPDATE 2025

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% Pharmaceuticals are arguably the most socially important healthcare product. (T/F) true Pharmaceutical development is a high-risk undertaking, in which many promising leads prove disappointing. (T/F) true Which of the following has fueled recent growth in the pharmaceutical industry? population growth and increased life expectancies According to the manual, which statement accurately describes the predicted relationship between pharmaceutical companies and genomic 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. (T/F) false The high price of healthcare is explained by the high price of medicines. (T/F) false One of the oldest and least effective pharmaceutical marketing techniques is DTC (direct-to-consumer) advertising. (T/F) 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 The heart of a pharmaceutical sales team is the regional manager. (T/F) false

Most DMs did not start as representatives. (T/F) 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. (T/F) false It usually only takes 1-2 calls to a physician before he or she commits to prescribing your product. (T/F) false The pharmacist may dispense a product other than what the physician prescribed. (T/F) true According to ch. 12 of the manual, which of the following would classify as "payers"? employers According to the manual, what defines "ethical pharmaceutical companies"?

researching and developing novel drugs One of the most disappointing results of the pharmaceutical industry's continued investment in R & D is the few new drugs being approved and in development. (T/F) 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 specific 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

Which 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. (T/F) 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 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, metabolites 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 of 4,000 drugs studied in the lab are eventually studied in people. (T/F) 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. (T/F) 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. (T/F) 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 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 statements is/are INCORRECT about an ideal drug, or "magic bullet" as Ehrlich phrased it?

All are correct

• 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, while resistance applies to microorganisms' or "cancel" cells' abilities to withstand drug effects Between 3% and 7% of hospital admissions in the US are estimated to be for treatment of adverse drug reactions. (T/F) 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
• the severities of adverse drug reactions are quantified by their chronicity
• the severities of adverse drug reactions are quantified by their threat to life Why is noncompliance a serious public health concern? it increases the cost of medical care Which of the following is NOT eligible for patent protection under US regulations? companies can be granted patents for all of these things
• the drug itself

• the method of delivering and releasing the drug into the bloodstream
• the way the drug is made Drugs' trade names are often unrelated to their intended use. (T/F) true Like foods and household products, generic drugs are usually lower quality than the brand name drugs for which they are marketed as equivalents. (T/F) false Legally, bioequivalence of different versions of a drug can vary 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 cells 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? difference in inactive ingredients All cells have a nucleus. (T/F) false Which of the following does NOT affect drug response? All of these factors influence 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. (T/F) 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 of 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 injections 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. (T/F) false Only 3 companies account for nearly 90% of all drug wholesale sales. (T/F) 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? All of these are examples of non-stock sales

• 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. (T/F) 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? indications and usage Drug labels must include indications, usage information, and contradictions. (T/F) true What should be included in the "description" section of 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 a patent? 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 of the same inactive ingredients What list is generally considered the most reliable source of information on therapeutically equivalent drug products? "Approved Drug Products with Therapeutic Evidence" 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 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 representatives do not typically store and secure their own drug samples. (T/F) false Sampling is sometimes the most important factor in a pharmaceutical rep's success. (T/F) true The FDA approves storage conditions for drug products. (T/F) true Pharmaceutical representatives must always record the amount of drug samples left and obtain a signature for that amount. (T/F) 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. (T/F) false Which of the following is permitted by Section 503 of the Federal Food, Drug and Cosmetic Act? None of these

• hospitals donating their prescription drug coupons to qualified charitable organizations
• hospitals donating their prescription drug samples to qualified charitable organizations
• hospitals selling their prescription drug samples to qualified charitable organizations at reduced costs 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. (T/F) true Medications are usually unaffected by changes in temperature, light, humidity, and other environmental factors. (T/F) false 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. (T/F) true Which problem would NOT be improved by electronic prescribing systems? None of these

• patients "doctor-shopping" for controlled substances
• pharmacists misreading prescriptions
• physicians wasting time calling pharmacies 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 your sales manager to inform him/her or 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 (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.e., 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 of these

• an intensive regulatory process
• growing demand in the medical community for more complex data about pharmaceuticals
• the increasing number of procedures 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. (T/F) true According to the manual, which type of system is the best way to deliver healthcare? a market-based system How would increased pharmaceutical price controls affect the US 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 of these
• the aerospace sector
• the communications sector
• the electronics sector What was the intent of the Bayh-Dole Act and the Stevenson-Wylder Technology Innovation Act?

to hasten the commercialization of technologies that otherwise might not be used According to the manual, 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 to obtain data on the safety and effectiveness of the lead compound. (T/F) true Toxicity information in preclinical studies helps provide confidence about a drug's safety. (T/F) true Pharmacological studies using animals are regulated under Good Laboratory Practice. (T/F) true Why do drugs administered to patients only contain APIs? they dont 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 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? all of these factors affect a drug's ability to reach the target site 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. (T/F) 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 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 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 subjects with a certain disease and a control group without the disease, and then looks to back in time (i.e. 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 (i.e. lung infections per year)?

incidence 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 and Cox proportional hazards analysis? methods of survival analysis What section of a clinical paper describes subject's' entry and exclusion criteria? methods Which document sets out how a trial is to be conducted (i.e. the 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? geographic 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? vaccine development focuses on how to reduce virulence while retaining the ability to produce immunity What is an advantage of attenuated vaccines over inactivated vaccines? attenuated vaccines are less expensive to produce How are toxoids derived? from toxins secreted by a pathogen What is an estimated annual death toll for malaria? 1.5-3.5 million people There are more white blood cells than red blood cells for the same volume in the human body. (T/F) false How was insulin primarily obtained from the 1930s to the 1980s? porcine and bovine extracts

Which of the following are NOT types of cytokines? monokines, interferons, and interleukins are all types of cytokines 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. (T/F) 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