Prescription Drug Therapy and the Pharmaceutical Industry, Exams of Social Sciences

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CNPR EXAM QUESTIONS AND ANSWERS

Pharmaceuticals are arguably the most socially important healthcare product. - Answers-True Pharmaceutical development is a high-risk undertaking, in which many promising leads prove disappointing. - Answers-True Pharmaceutical sales are highest in which geographic regions? - Answers-The U.S., Western Europe, and Japan. The U.S. accounts for about ______ of the world's pharmaceutical revenues. - Answers- 50% What event has fueled recent growth in the pharmaceutical industry? - Answers- Population growth and increased life expectancies. According to your manual, what describes the predicted relationship between pharmaceutical companies and genomic research facilities? - Answers-Partnerships between them will not prove immediately profitable. Prescription drug therapy is not cost-effective for insurance companies and insurance providers. - Answers-False The high price of healthcare is explained by the high price of medicines. - Answers- False One of the oldest and least effective pharmaceutical marketing techniques is DTC (direct-to-consumer) advertising. - Answers-False What influences the number of districts in a region? - Answers-The regions population What is an example of the regionalization of healthcare delivery systems? - Answers- California and Florida have different prescription reimbursement policies. The heart of a pharmaceutical sales team is the Regional Manager. - Answers-False Most District Managers (DMs) did not start as representatives. - Answers-False How many territories are in a typical district? - Answers-8 to 12 What is the most effective method for grabbing market share? - Answers-Comparative selling. Pharmaceutical reps mainly visit pharmacies. - Answers-False

It usually takes about 1-2 calls to a physician before he/she commits to prescribing your product. - Answers-False The pharmacist may dispense a product other than what the physician prescribed. - Answers-True Which of the following would classify as Payers - Employers, patients, pharmacists, or physicians? - Answers-Employers. How would you define ethical pharmaceutical companies? - Answers-Ones that research and develop 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. - Answers-False Thanks to modern medicines, how long are people newly diagnosed with HIV expected to live? - Answers-Another 50 years. How much has the average American lifespan increased since 1890? - Answers-Almost 30 years What is a treatment group? - Answers-A group of patients assigned to receive a specified treatment. What is the main difference between a blinded and a double-blinded study? - Answers- In a double blind study, neither the study staff nor the study participants know which subjects are in the experimental group and which are in the control group. What does asymptomatic mean? - Answers-Not exhibiting signs or symptoms. What term denotes the study of bodily functions (as opposed to structures)? - Answers- Physiology. In its broadest definition, a drug is any substance that produces a physical or psychological change in the body. - Answers-True How does the Federal Food, Drug and Cosmetic Act (FFDCA) define a drug? - Answers-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. Most of the body's required vitamins must be taken from outside the body. - Answers- True

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. - Answers-True What field is ADME testing used in primarily? - Answers-Pharmacokinetics. Placebo effects can lead to withdrawal symptoms. - Answers-True On average, only about 5 of 4,000 drugs studied in laboratory are eventually studied in people. - Answers-True Sublingual drugs are absorbed directly and almost immediately into the bloodstream. - Answers-True What are 3 of the 7 rights of drug administration? - Answers-The right patient, the right drug, the right dose. Pro-drugs are administered in active form, which is metabolized into an inactive form. - Answers-False The kidney of an 85-year old person excretes drugs only ______ as efficiently as that of a 35-year old person. - Answers-Around 50% The normal age-related decrease in kidney function can help doctors determine an appropriate dosage based solely on a person's age. - Answers-True What differentiates a caplet from a tablet? - Answers-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."? - Answers-On the label of all prescription drugs. What happens in slow acetylators? - Answers-Drugs that are metabolized by N-acetyl transferase tend to reach higher blood levels and remain the body longer. About _______ of the people in the U.S. are slow acetylators. - Answers-50% Drug-drug interactions are always harmful. - Answers-False Smoking decreases the effectiveness of some drugs. - Answers-True Because dietary supplements are not drugs, interactions with drugs are not a concern. - Answers-False Ehrlich stated that an ideal drug (magic bullet) does not exist, would be aimed precisely at a disease site, and would not harm healthy tissues. - Answers-True

What is the difference between resistance and tolerance? - Answers-Tolerance refers to a person's diminished response to a drug after repeated use, while resistance applies to microorganism's or cancer cell's abilities to withstand drug effects. Between 3% and 7% of hospital admissions in the U.S. are estimated to be for treatment of adverse drug reactions. - Answers-True There is no universal scale for quantifying the severity of an adverse drug reaction. - Answers-True Why is noncompliance a serious public health concern? - Answers-It increases the cost of medical care. Name 3 items available for which patent protection is available under U.S. regulations. - Answers-The drug itself, the method of delivering and releasing the drug into the bloodstream, and the way the drug is made. Drugs' trade names are often unrelated to their intended use. - Answers-False Like foods and household products, generic drugs are usually lower quality than the brand name drugs for which they are marketed as equivalents. - Answers-False Legally, bioequivalence of different versions of a drug can vary by up to _____ percent. - Answers- 20 Biologics do not cause immune responses. - Answers-False "Large molecule" products are developed and manufactured by a chemical process. - Answers-False What are the drugs that attract or bind cell receptors in order to mimic or enhance activities by endogenous chemical messengers? - Answers-Agonists What term denotes how an API works in the body? - Answers-Mechanism of action. What cements the active and inert components together to maintain cohesive portions?

• Answers-Binders. What does the abbreviation BID denote? - Answers-Twice a day What is the medical abbreviation for 'as needed'? - Answers-PRN. Which components might cause patient's different reactions to brand name and generic drugs? - Answers-Differences in inactive ingredients.

All cells have a nucleus. - Answers-False Name three things that affect drug response. - Answers-The patient's genetic makeup, age, body size, and use of other drugs and dietary supplements. The patient's other conditions and 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. - Answers-False What is the typical relationship between a drug's site of administration and site of action? - Answers-They are usually somewhat removed from one another. What is CMAX? - Answers-The peak plasma concentration on a measuring curve. Pharmacoprocesses are a main concept of clinical pharmacology. - Answers-False Which is not a route of drug administration - buccal, intramuscular, sublingual, or transfugal? - Answers-Transfugal How are intradermal drugs delivered? - Answers-By injection under the skin. An injection of anesthetic directly into the bloodstream is an example of intravenous drug delivery. - Answers-True What are the major organs of the gastrointestinal system? - Answers-The mouth, esophagus, stomach, liver, pancreas, gallbladder, small and large intestines. Who is normally responsible for selling to distributors? - Answers-NAMs. How often do secondary drugs wholesale distributors buy their drugs directly from manufacturers? - Answers-Sometimes By FDA law, large chain pharmacies are not allowed to buy directly from drug manufacturers. - Answers-False Only 3 companies account for nearly 90% of all wholesale drug sales. - Answers-True What type of sale bypasses the need for intermediary distributors? - Answers- Manufacturer direct sales. What is a group purchasing organization (GPO)? - Answers-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. - Answers-3 times larger Which of the following is NOT a type of non-stock sale - a) brokerage sales b) dock-to-dock sales c) drop shipments d) all of these are types of non-stock sales - Answers-D) all of these are types of non- stock sales What is another term for rebates? - Answers-After market arrangements. The PDMA is the Prescription Drug Manufacturers Association. - Answers-False. A company that owns and operates three or fewer pharmacies is an _______________.

• Answers-Independent drug store. Which section of a drug's package insert information covers the usual dosage range? - Answers-Indications and usage. Drug labels must include indications, usage information, and contraindications. - Answers-True What should be included in the description section of a drug's package insert information? - Answers-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. - Answers-Marketing rights. What differentiates exclusivity from a patent? - Answers-Exclusivity is only granted upon the drug's FDA approval. What is required of an invention for it to be worthy of patent protection? - Answers-It must be novel, useful, and not obvious. A generic drug is ________ to the originator brand-name drug in dosage, strength, safety, and equality. - Answers-bioequivalent The FDA's Criteria for Equivalency requires the drugs contain identical amounts of the same inactive ingredients. - Answers-True What list is generally considered the most reliable source of information on therapeutically equivalent drug products? - Answers-"Approved Drug Products with Therapeutic Equivalence" Which of the following is an Orange Book rating

a) AZ b) B c) BZ d) CZ - Answers-b) B 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? - Answers-Biologic 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? - Answers-Generic What term denotes the dispensing of an unbranded generic product for the product prescribed? - Answers-Generic substitution. What is the duration of a patent challenge? - Answers-180 days (6 months) How is a drug sample closet or cabinet like a grocery store shelf? - Answers-The more visibility you can give your drug, the more likely it will be prescribed. Pharmaceutical reps do not typically store and secure their own drug samples. - Answers-False Sampling is sometimes the most important factor in a pharmaceutical rep's success. - Answers-True The FDA approves storage conditions for drug products. - Answers-True Pharmaceutical reps must always record the amount of drug samples left and obtain a signature for that amount. - Answers-True What is prohibited by Section 503 of the Federal Food, Drug, and Cosmetic Act, as amended by the Prescription Drug Marketing Act? - Answers-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. - Answers-True Section 503 of the Federal Food, Drug, and Cosmetic Act permits hospitals to donate their prescription drug samples to qualified charitable organization. - Answers-False Which entity issues monographs that define how drugs should be stored, and what variance is allowed in their shared contents? - Answers-United States Pharmacopoeial Convention.

Storage conditions for drug products are based on information supplied by the manufacturer. - Answers-True Medications are usually unaffected by changes in temperature, light, humidity, and other environmental factors. - Answers-False In which cases can degraded drugs sometimes still be used? - Answers-When the amount of the 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. - Answers-True Electronic prescribing systems would improve patients doctor-shopping for controlled substances, pharmacists misreading prescriptions, and physicians wasting time calling pharmacies. - Answers-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? - Answers-Call your Sales Manager and 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? - Answers-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)? - Answers- 10 - 15 years Which of the following agencies is industry-based (i.e. run mainly by the companies themselves)? a) Drug Enforcement Administration b) European Medicines Agency c) Pharmaceutical Research and Manufacturers of America (PhRMA) d) the FDA? - Answers-C) PhRMA. Growing demand in the medical community for more complex data about pharmaceuticals has simplified the pharmaceutical R&D process? - Answers-False 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. - Answers-True Which type system is the best way to deliver healthcare? - Answers-A market-based system. How would increased pharmaceutical price controls affect the U.S. healthcare system? - Answers-Increased price controls would stifle innovation.

Which invests a greater percentage of sales in research than the biotech sector a) aerospace b) communications c) electronics d) none of these - Answers-d) none of these What was the intent of the Bayh-Dole Act and the Stevenson-Wydler Technology Innovation Act? - Answers-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)? - Answers-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. - Answers-True Toxicity information in preclinical studies helps provide confidence about a drug's safety.

• Answers-True Pharmacological studies using animals are regulated under Good Laboratory Practice. - Answers-True Why do drugs administered to patients only contain APIs? - Answers-They don't. A drug's vesicles affect it's ability to permeate membranes. - Answers-True Through which barriers can lipid-soluble drugs usually pass? - Answers-Cell membranes. How are weak acid drugs generally absorbed by the stomach? - Answers-More quickly than weak basic drugs. Which route of administration does not completely bypass the liver? - Answers-Rectal administration. Why are intravenous drug dosages easier to control than drugs administered transdermally? - Answers-The entire dose is available in the bloodstream to be distributed to the target site. A drug's lipid-solubility, polarity, and the __________ ___________ of the drug's target tissue affect it's distribution. - Answers-vascular nature What medical term means "to apply the drug on the surface of the skin"? - Answers- Transdermal.

Carcinogenicity studies are carried out to identify the tumor-causing potential of a drug.

• Answers-True According to NIH ethical guidelines, what is the most important criteria in selecting subjects for clinical studies? - Answers-Scientific objectives The members of the IRB/IEC must be experts in the topic of study. - Answers-True Which phases of clinical studies are open label and which are blinded? - Answers- 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? - Answers-Surrogate markers such as blood pressure and cholesterol levels. What is the name of an observational study that first identifies a group of subjects with a certain disease and a control group without the disease, and then looks back in time (e.g. via chart reviews) to find exposure to risk factors? - Answers-Case-control study. Which measure of central tendency is the sum of all observations divided by the number observations? - Answers-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 (e.g. lung infections per year)? - Answers-Incidence. ________________ is used to describe the variability of the population mean. - Answers-Standard error of the mean What term denotes the extent to which a test actually measures what it is supposed to be measuring, or what we think it is measuring? - Answers-Validity. What are the Kaplan-Meier analysis and Cox proportional hazards analysis? - Answers- Methods of survival analysis. What section of a clinical paper describes subjects' entry and exclusion criteria? - Answers-Methods. Which document sets out how a trial is to be conducted (i.e. the study's general design and operating features)? - Answers-Protocol. When designing and performing clinical trials, several ethical constraints must be considered. Which one of the following is NOT one of these ethical restraints a) geographic variations b) independent review c) scientific validity

d) social value? - Answers-Geographic variations. What is one way in which large molecule drugs differ from small molecule drugs? - Answers-Large molecule drugs are mainly protein-based drugs that develop in biological systems such as living cells. Vaccines are types of small molecule drugs. - Answers-False What is an advantage of attenuated vaccines over inactivated vaccines? - Answers- Attenuated vaccines are less expensive to prepare. How are toxoids derived? - Answers-From the toxins secreted by a pathogen. What is the estimated annual death toll in Malaria? - Answers-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. - Answers-False How was insulin primarily obtained from the 1930s to the 1980s? - Answers-Porcine and bovine extracts. Which of the following are not types of cytokines a) interferons b) interleukins c) monokines d) all of these are types of cytokines - Answers-All of these are types of cytokines. Which of the following is not a type of hormones a) amino acid derivatives b) blood glucose c) polypeptides d) steroids? - Answers-Blood glucose. Describe the 'in vitro' gene therapy technique. - Answers-Patients' genetically faulted tissues are removed, loaded with normal genes in vectors, and returned to the patients' bodies. Pluripotent stem cells can develop into many cell types, but not a new individual. - Answers-True. Leukemia is a condition in which the stem cells in the bone marrow malfunction and produce an excessive number of immature white blood cells. - Answers-True. Retroviruses are types of vectors used in gene therapy. - Answers-True. Which of the following is not a type of stem cell

a) multipotent b) pluripotent c) semipotent d) totipotent - Answers-Semipotent. Traditional vaccines are prepared in a number of ways. Which of the following is not one of them a) attenuated b) insulin c) inactivated d) toxoids - Answers-Insulin Effective drug therapy is a cost-effective and highly valuable means of controlling total healthcare expenditures and improving quality of life. - Answers-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 minimize costs. - Answers-True DUR programs involve retrospective monitoring of physicians' prescribing patterns. - Answers-True A formulary is a list of prescription drugs approved by insurance coverage. - Answers- True The history of drug formularies in the U.S. extends back to _________. - Answers-The American Revolution Which of these is not a type of formulary a)closed three-tier in which generic drugs are listed on Tier 1 b) five-tier that is supplemented by a step therapy program c) open that replaces few restrictions on coverage or access d) all of these are types of formularies - Answers-All of these are types of formularies. The repeal of Hatch-Waxman is a recent formulary trend. - Answers-False What did the Hatch-Waxman Act do? - Answers-Make it easier for generic manufacturers to compete with R&D companies. What is opportunity cost? - Answers-The value of a sacrificed alternative. The three primary entities that fund pharmaceuticals are employers, the government, and ______________. - Answers-Individuals. A company's medical liaison can be a member of a P&T committee. - Answers-False

Almost 98% of employed Americans are now covered by a HMO, a preferred provider organization, or a point-of-service plan. - Answers-False Pharmaceutical companies are more interested in acquiring and exploiting another's brands than in acquiring another's R&D and sales marketing assets. - Answers-False Ideally, when should brand strategy development for a new drug begin? - Answers- During Phase II clinical trials. An example of an expressive value is, "I own a BMW because I like feeling the road." - Answers-False Which of the following is not an example of a functional value a) convenience b) efficacy c) safety d) uniqueness - Answers-Uniqueness It is rare for pharmaceutical companies to explore, develop, and promote expressive value with which patients might identify. - Answers-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. - Answers-True With the global need for new drugs, pharmaceutical brand names are not subject to regulatory approval. - Answers-False Over the last few decades, DTC advertising has become an essential marketing tactic for both large and small brands. - Answers-True Which of the following most strongly influences physicians' prescribing habits a) doctors' personal experiences, and their patients' unique situations, b) DTC advertising c) other types of pharmaceutical marketing d) patients' opinions about DTC advertising? - Answers-Doctors' personal experiences, and their patients' unique situations. Pharmaceutical companies spend more on promotional activities than on R&D. - Answers-False A brand that treats a very common chronic condition would be well-served by mass- market print and TV ads. - Answers-True How do companies use prescriber data? - Answers-To conduct research.

Under PhRMA Code, it is acceptable for modest meals to be provided for staff members attending educational events. - Answers-True Under AMA Guidelines on Gifts to Physicians from Industry, it is acceptable to only give gifts to doctors with high prescribing volumes. - Answers-False According to PhRMA Code, sales reps are allowed to provide modest meals to staff members attending educational events. - Answers-True The PhRMA Code on Interactions with Healthcare Professionals is only voluntary and not mandatory. - Answers-True Pens and clipboards designed to be used by patients in doctors' offices is considered acceptable under PhRMA Code. - Answers-False Under PhRMA Code, what is one example of an acceptable patient education item? - Answers-An anatomical model valued under $100. A company is never to provide entertainment or recreational activities to healthcare practitioners. - Answers-True 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? - Answers-Yes, but only if the lunch is clearly separate from the CME portion of the conference. What is the name of the arm of the Department of Health and Human Services that investigates regulatory infractions, provides compliance advice, and brings enforcement actions? - Answers-Office of Inspector General. It is illegal to ask receptionists for personal information about your clients such as home phone numbers, birthdays, or hobbies. - Answers-False A primary goal of the P&T committee is to educate sales representatives on legal and ethical guidelines for professional behavior. - Answers-False A major challenge facing family medicine is managed care policies are eroding patient- doctor relationships. - Answers-True Family physicians diagnose and treat approximately what proportion of patients they see (as opposed to referring them to specialists)? - Answers-95% Adoption, awareness, and ___________ are all steps on the Product Adoption Continuum. - Answers-Evaluation.

_________ ___________ would be classified as a type of somatic psychiatric treatment. - Answers-Drug therapy Why is the last 10 minutes of each hour usually the best time to make office visits to psychiatrists? - Answers-They often see their patients on the hour for 45 minutes. One of the advantages of selling to residents is that they are often more open-minded. - Answers-True What is drug utilization review (DUR)? - Answers-An MCO's practice of monitoring prescribing patterns. _______ ___________ are used in the treatment of manic-depressive illness and schizoaffective disorder. - Answers-Mood Stabilizers What is the focus of the short call protocol? - Answers-Beginning with a specific patient type. Who is the Medical Science Liaison (MSL)? - Answers-Someone employed by a pharmaceutical company who builds relationships with thought leaders and acts as an informational resource. What type of education do MSLs typically have? - Answers-Master's Degrees How do companies typically judge the MSL team's contributions? - Answers-Return on education. What differentiates push through programs from pull through programs? - Answers- Sales reps are more involved in pull through programs. Adherence/persistency, educational support, and _____________ ____________ are all types of pull through programs. - Answers-Therapeutic intervention. Because pharmaceutical sales reps work mostly out of their homes, it is not important that they work well in a team environment. - Answers-False. What is a likely reason a doctor would lack interest in one of your clinical studies? - Answers-He/she does not like the way you are presenting it. Effective methods for reaching the 65+ market are being a Medicare Part D information resource, knowing the physician-payer mix, and taking advantage of __________ _______________. - Answers-Partnership programs. When a physician visits your hospital display, you should begin conversation by asking, "Can I help you?". - Answers-False

One of the rules in making the most out of your sales calls is forcing your agenda, not theirs. - Answers-False How long are most calls and visits to physicians' offices (excluding waiting and driving time)? - Answers-Only a few minutes. Which is not a step in managing rumors a) confirm b) counter attack c) search d) transition - Answers-Counter attack Which of the following is considered going to the next level a) becoming a micro-thinker b) meeting the clients' every need c) minimizing rumors d) staying focused - Answers-Staying focused Specialty care products are more often prescribed by generalist physicians. - Answers- False Side effects that might be considered merely minor annoyances in acute treatment can be a powerful barrier to adoption in chronic therapies. - Answers-True Acute medications, such as antibiotics, are used to address short-term illnesses or symptoms. - Answers-True In some medical cases, a therapy may be initiated by a specialist and monitored and maintained by a primary care physician. - Answers-True Blockbuster drug status typically translates into sales of just under $10 million annually.

• Answers-False A generic drug manufacturer's greatest challenge is often to replicate drug formulation factors that affect the pharmacokinetic and pharmacodynamic characteristics of the original drug. - Answers-True What differentiates an orphan drug from a blockbuster drug? - Answers-Orphan drugs typically treat rare conditions. What is one of the primary job responsibilities of a retail pharmacist? - Answers- Dispensing pharmaceuticals.

Pharmaceutical companies and representatives categorize their customers as 1) acute care vs. chronic care, 2) office-based vs. hospital-based, and 3) ___________ vs. ____________. - Answers-Primary care vs. specialty care