NAPSRx Study Guide Questions and Answers: A Guide to Pharmaceuticals and Healthcare, Exams of Community Corrections

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Pharmaceuticals - CORRECT ANSWER-✔✔✅Medicines 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. Diagnostic - CORRECT ANSWER-✔✔✅Equipment and supplies used in screening, detecting, and monitoring disease. Can range from simple home testing kits to sophisticated diagnostic imaging technologies. Medical Devices - CORRECT ANSWER-✔✔✅Advanced 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 Supplies - CORRECT ANSWER-✔✔✅Commodity, high-volume supplies such as surgical gowns and gloves. Durable Medical Equipment - CORRECT ANSWER-✔✔✅Reusable 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 ANSWER-✔✔✅United States, Western Europe, and Japan. The U.S. accounts for roughly __________ of the world's pharmaceutical revenues. - CORRECT ANSWER- ✔✔✅50% Two factors have significantly contributed to recent growth in the pharmaceutical industry are? - CORRECT ANSWER-✔✔✅Population growth and increasing life expectancies. What is the predicted relationship between pharmaceutical companies and genomic research facilities? - CORRECT ANSWER-✔✔✅Partnerships 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 ANSWER-✔✔✅True The high price of health care is explained by the high price of medicines. True or False? - CORRECT ANSWER- ✔✔✅False One of the oldest and least effective pharmaceutical marketing techniques is DTC (direct-to-consumer) advertising. True or False? - CORRECT ANSWER-✔✔✅False What influences the number of districts in a region? - CORRECT ANSWER-✔✔✅The region's population. What is an example of the regionalization of healthcare delivery systems? - CORRECT ANSWER- ✔✔✅California and Florida have different prescription reimbursement policies. What is the heart of a pharmaceutical sales team? - CORRECT ANSWER-✔✔✅District Manager. How many territories are in a typical district? - CORRECT ANSWER-✔✔✅8- What is the most effective method for grabbing market share? - CORRECT ANSWER-✔✔✅Comparative selling. The average review time for a new drug is 18 months, down from almost 3 years in 1996. True or False? -

CORRECT ANSWER-✔✔✅True What are some questions reps should ask a physician? - CORRECT ANSWER-✔✔✅Why 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 ANSWER-✔✔✅False. Pharmaceutical reps mainly visit/target physicians. It usually takes only 1-2 calls on a physician before he or she prescribes your product. True or False? - CORRECT ANSWER-✔✔✅False. Your success ultimately depends on your relationship with the physician. This takes time. Persistence is key. The pharmacist may dispense a product other than what the physician prescribed. True or False? - CORRECT ANSWER-✔✔✅True. The pharmacist can either (1) dispense a generic; (2) The pharmacist calls the doctor and requests permission to dispense a different medication. According to chapter 2 of your manual which of the following classifies as payers? (a) employers (b) patients (c) pharmacists (d) physicians - CORRECT ANSWER-✔✔✅(a) employers Some third party payers include the insurance company, the employer, managed care organization, or the U.S. government (Medicare/Medicaid). What defines ethical pharmaceutical companies? - CORRECT ANSWER-✔✔✅Pharmaceutical companies that research and develop novel drugs. Thanks to modern medicine how long are people newly diagnosed with HIV expected to live? - CORRECT ANSWER-✔✔✅Another 50 years. How much has the average American lifespan increased since 1890? - CORRECT ANSWER-✔✔✅30 years What is a treatment group? - CORRECT ANSWER-✔✔✅A group of patients assigned to receive specific treatment. What is the main difference between a blinded and double-blinded study? - CORRECT ANSWER-✔✔✅In a double blinded study, neither the staff nor the study participants know which subjects are in the experimental group and which subjects are in the control group. What does asymptomatic mean? - CORRECT ANSWER-✔✔✅Without signs or symptoms of disease. What is an approvable letter? - CORRECT ANSWER-✔✔✅Letters sent by the FDA to the applicant indicating whether the new drug application (NDA) or abbreviated new drug application (ANDA) for a product meets the necessary requirements and whether or not the agency believes that it can approve the application or abbreviated application if specific additional information or material is submitted or specific conditions (e.g., certain changes in labeling) are agreed to by the applicant. What is a blinded or masked study? - CORRECT ANSWER-✔✔✅A study in which participants do not know whether they are in the experimental or control group of a research study. Those in the experimental group get the medications or treatments being tested, while those in the control group get standard treatment or no treatment. What is a control or control group? - CORRECT ANSWER-✔✔✅The standard by which experimental observations are evaluated. In many clinical trials, one group of patients will be given an experimental drug or

About __ people in the U.S are slow acetylators? (a) 1% (b) 5% (c) 25% (d) 50% - CORRECT ANSWER-✔✔✅50% 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 correct - CORRECT ANSWER-✔✔✅(d) All of these statements are correct Which term denotes the study of bodily functions? - CORRECT ANSWER-✔✔✅Physiology What is the broadest definition of a drug? - CORRECT ANSWER-✔✔✅Any 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 ANSWER-✔✔✅Any 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 ANSWER-✔✔✅Most of the body's required vitamins must be taken in from outside the body. What does ADME testing measure? - CORRECT ANSWER-✔✔✅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. ADME testing is primarily used in what field? - CORRECT ANSWER-✔✔✅Pharmacokinetics What is true about placebos? - CORRECT ANSWER-✔✔✅Effects can lead to withdrawal symptoms. On average, what percent of drugs are studied in the lab are eventually studied in people? - CORRECT ANSWER-✔✔✅5 of 4000 What is true about drugs taken sublingually? - CORRECT ANSWER-✔✔✅Are absorbed directly and almost immediately into the bloodstream. What are 3 of the 7 rights of the drug administration? - CORRECT ANSWER-✔✔✅The 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 ANSWER- ✔✔✅False The kidney of an 85 year old person excretes drugs only _____________ as efficiently as that of a 35 year old person. - CORRECT ANSWER-✔✔✅Around 50% The normal age related disease in kidney function can help doctors determine an appropriate dosage based solely on a person age. - CORRECT ANSWER-✔✔✅True What differentiates a caplet from a tablet? - CORRECT ANSWER-✔✔✅Caplets 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 ANSWER-✔✔✅On the label of all prescription drugs. What happens in slow acetylators? - CORRECT ANSWER-✔✔✅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 Unites States are slow acetylators. - CORRECT ANSWER-✔✔✅50% Smoking decreases the effectiveness of some drugs. - CORRECT ANSWER-✔✔✅True What about drug-drug interaction is not correct? - CORRECT ANSWER-✔✔✅Drug interaction are always harmful. What about dietary supplements is incorrect? - CORRECT ANSWER-✔✔✅Because dietary supplements are not drugs, interacting with drugs is not a concern. Between what percent of hospital admissions in the Unites States are estimated to be for treatment of adverse drug reactions? - CORRECT ANSWER-✔✔✅Between 3% and 7% Why is noncompliance a serious public health concern? - CORRECT ANSWER-✔✔✅Increasing medical care cost. Legally bioequivalence of different versions od a drug can vary by up to what? - CORRECT ANSWER- ✔✔✅20% What is no true about biologies? - CORRECT ANSWER-✔✔✅They do not cause an immune response. What are the drugs that attract or bind to cell receptors in order to mimic or enhance activities by endogenous channel messages? - CORRECT ANSWER-✔✔✅Agonists Which term denotes how an API works in the body? - CORRECT ANSWER-✔✔✅Mechanism for action. What cements the active and inert components together to maintain cohesive portions? - CORRECT ANSWER- ✔✔✅Binders What does the medical abbreviation BID denote? - CORRECT ANSWER-✔✔✅Twice a day. What is the medical abbreviation for as needed? - CORRECT ANSWER-✔✔✅PRN Which components might cause patients different reactions to brand name and generic drugs? - CORRECT ANSWER-✔✔✅Differences in inactive ingredients. Do all cells have a nucleus? - CORRECT ANSWER-✔✔✅No What is the typical relationship between a drugs site of administration and site of action? - CORRECT ANSWER- ✔✔✅They are usually somewhat removed from each other. What is CMAX? - CORRECT ANSWER-✔✔✅The peak plasma concentration on a measuring curve. What is not a main concept in pharmacology? - CORRECT ANSWER-✔✔✅Pharmacoprocesses What is not a route of drug administration? - CORRECT ANSWER-✔✔✅Transfugal How are intradermal drugs delivered? - CORRECT ANSWER-✔✔✅By injecting under the skin. What is an example of intravenous drug delivery? - CORRECT ANSWER-✔✔✅An injection of anesthetic directly into the bloodstream. What are the major organs of the gastrointestinal system? - CORRECT ANSWER-✔✔✅The mouth, esophagus, stomach, liver, pancreas, gallbladder, small and large intestines. What differentiates exclusivity from a patent? - CORRECT ANSWER-✔✔✅Exclusivity is only granted upon the

In which cases can degraded drugs sometimes still be used? - CORRECT ANSWER-✔✔✅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 before hand. - CORRECT ANSWER-✔✔✅True 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 ANSWER-✔✔✅Call 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 ANSWER-✔✔✅Clinical 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 ANSWER-✔✔✅10-15 years Which of the following regulatory agencies is industry based (run mainly by the companies themselves)? - CORRECT ANSWER-✔✔✅Pharmaceutical 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 ANSWER-✔✔✅True According to your manual which type of system is the best way to deliver healthcare? - CORRECT ANSWER- ✔✔✅A market bases system How would increased pharmaceutical price controls affect the US healthcare system? - CORRECT ANSWER- ✔✔✅Increased price controls would stifle innovation. What was the intent of the Bayh-Dole act and the Stevenson-Wydler technology innovation act? - CORRECT ANSWER-✔✔✅To 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 ANSWER-✔✔✅There is poor collaboration between publicly and privately funded research centers. What is the aim of preclinical pharmacological studies? - CORRECT ANSWER-✔✔✅To obtain data on the safety and effectiveness of the lead compound. Toxicity information in preclinical studies helps provide what? - CORRECT ANSWER-✔✔✅Confidence about a drugs safety. Pharmacological studies using animals are regulated under what? - CORRECT ANSWER-✔✔✅Good laboratory practice Why do drugs administered to patients only contain API's? - CORRECT ANSWER-✔✔✅They don't Which of the following does not affect a drugs ability to permeate membranes? - CORRECT ANSWER-✔✔✅The drugs vesicles Through which barriers can lipid soluble drugs usually pass? - CORRECT ANSWER-✔✔✅Cell membranes How are weak acid drugs generally absorbed by the stomach? - CORRECT ANSWER-✔✔✅More quickly than weak basic drugs. Which of the following routes of administration do not completely bypass the liver? - CORRECT ANSWER- ✔✔✅Rectal administration Why are intravenous drug dosages easier to control than drugs administered transdermally? - CORRECT

ANSWER-✔✔✅The entire dose is available in the bloodstream to be distributed to the target site. What medical term means to apply the drug on the skin surface? - CORRECT ANSWER-✔✔✅Transdermal Carcinogenicity studies are meant to identify the tumor causing potential of a drug. - CORRECT ANSWER- ✔✔✅True According to NIH ethical guidelines, which of the followers is the most important criteria in selecting subjects for clinical studies? - CORRECT ANSWER-✔✔✅Scientific objects Which statement about the IRB is incorrect? - CORRECT ANSWER-✔✔✅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? - CORRECT ANSWER-✔✔✅Phase 1 and 4 trials are often open label, but phase 2 and 3 are double blinded or at least blinded. If it is not possible to measure the direct effects of a drug, what is used instead? - CORRECT ANSWER- ✔✔✅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 that disease, and then looks to back in time (via chart reviews) to find exposure to risk factors? - CORRECT ANSWER-✔✔✅Case control study Which measure of central tendency is the sum of all observations divided by the number of observations? - CORRECT ANSWER-✔✔✅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 (lung infections per year)? - CORRECT ANSWER-✔✔✅Incidence Which of the following measures is used to describe the variability of the population mean? - CORRECT ANSWER-✔✔✅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? - CORRECT ANSWER-✔✔✅Validity What are the Kaplan-Meier analysis and Cox proportional hazards analysis? - CORRECT ANSWER- ✔✔✅Methods of survival analysis What section of a clinical paper describes subjects entry and exclusion criteria? - CORRECT ANSWER- ✔✔✅Methods Which document sets out how a trial is to be conducted (study's general design and operating features)? - CORRECT ANSWER-✔✔✅Protocol When designing and performing clinical trials, several ethical constraints must be considered. Which of the following is not one of these ethical constraints? - CORRECT ANSWER-✔✔✅Geographical variations What is one way in which large molecule drugs differ from small molecule drugs? - CORRECT ANSWER- ✔✔✅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? - CORRECT ANSWER-✔✔✅Vaccines are types of small molecule drugs. What is an advantage of attenuated vaccines over inactivated vaccines? - CORRECT ANSWER-✔✔✅Attenuated vaccines are less expensive to prepare. How are toxoids derived? - CORRECT ANSWER-✔✔✅From the toxins secreted by a pathogen.

Ideally, when should brand strategy development for a new drug begin? - CORRECT ANSWER-✔✔✅During phase 2 clinical trials Which of the following is an example of an expressive value? - CORRECT ANSWER-✔✔✅I 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 ANSWER-✔✔✅Uniqueness It is rare for pharmaceutical companies to explore, develop, and promote expressive values with which patients might identify. - CORRECT ANSWER-✔✔✅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. - CORRECT ANSWER-✔✔✅True How has DTC advertising changed over the last few decades? - CORRECT ANSWER-✔✔✅DTC advertising has become an essential marketing tactic for both large and small brands. Which of the following most strongly influences physicians prescribing habits? - CORRECT ANSWER- ✔✔✅Doctors personal experience, and their patients unique situations. Pharmaceutical companies spend more on promotional activities than on R & D. - CORRECT ANSWER- ✔✔✅False Which of the following would be most well served by mass market print and tv ads? - CORRECT ANSWER- ✔✔✅A brand that treats a very common chronic condition. How do companies use prescriber data? - CORRECT ANSWER-✔✔✅To conduct research Under PhRMA code, which of the following is acceptable? - CORRECT ANSWER-✔✔✅Modest meals for staff members attending educational events. Under the AMA guidelines on gifts to physicians from industry, which gifts are not permitted? - CORRECT ANSWER-✔✔✅Gifts that are only given to doctors with high prescribing volumes. The PhRMA code on interactions with healthcare professionals is only voluntary bed not mandatory. - CORRECT ANSWER-✔✔✅True Which of the following would not be considered acceptable promotional items under PhRMA code? - CORRECT ANSWER-✔✔✅Pens and clipboards designed to be used by patients in the doctors offices. Under PhRMA code, what is one example of an acceptable patient education item? - CORRECT ANSWER- ✔✔✅An anatomical model valued under $100. Under what circumstances does PhRMA code permit a company to provide entertainment or recreational activities to healthcare practitioners? - CORRECT ANSWER-✔✔✅Under no circumstances 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? - CORRECT ANSWER-✔✔✅Yes, but only if the lunch is clearly separate from the CME portion of the conference. Which of the following is an arm of the department of health and human services that investigates regulatory infractions, provides compliance advice, and brings enforcement actions? - CORRECT ANSWER-✔✔✅Office of inspector general Is it illegal to ask receptionists for personal information about your clients charts such as home phone numbers, birthdays, or hobbies? - CORRECT ANSWER-✔✔✅No

Which of the following is not a primary goal or function of the P & T committee? - CORRECT ANSWER- ✔✔✅To educate sales representatives on legal and ethical guidelines for professional behavior. Which of the following is a major challenge facing family medicine? - CORRECT ANSWER-✔✔✅Managed care policies eroding patient - doctor relationships. According to your manual, Family physicians diagnose and treat approximately what proportion of patients they see (as opposed to referring then to specialists)? - CORRECT ANSWER-✔✔✅95% Which of the following would be classified as a type of somatic psychiatric treatment? - CORRECT ANSWER- ✔✔✅Drug therapy Why is the last 10 minutes of each hour usually the best time to make office visits to psychiatrists? - CORRECT ANSWER-✔✔✅Psychiatrists often see patients on the hour for 45 minutes. What is an advantage of selling to residents? - CORRECT ANSWER-✔✔✅Residents are often more open- minded. What is drug utilization review (DUR)? - CORRECT ANSWER-✔✔✅An MCO's practice of monitoring prescribing patterns. What is used in treatment of manic depression illness and schizoaffective disorder? - CORRECT ANSWER- ✔✔✅Mood stabilizers What is the focus of the short call protocol? - CORRECT ANSWER-✔✔✅Beginning with a specific patient type. Who is the medical science liaison (MSL)? - CORRECT ANSWER-✔✔✅Someone employed by pharmaceutical companies who build relationships with thought leaders and acts as an information resource. What type of education do MSL's usually have? - CORRECT ANSWER-✔✔✅Graduate level science degrees How do companies typically judge the MSL team's contributions? - CORRECT ANSWER-✔✔✅Return on edication What differentiates push through programs from pull through programs? - CORRECT ANSWER-✔✔✅Sales representatives are more involved in pull through programs. Because pharmaceutical sales representatives work mostly out of their homes, it is not important that they work well in a team environment. - CORRECT ANSWER-✔✔✅False What is the most likely reason that a doctor would lack interest in one of your clinical studies? - CORRECT ANSWER-✔✔✅The doctor does not like the way you are presenting it. When a physician visits your hospital display, you should begin conversion by asking, can i help you? - CORRECT ANSWER-✔✔✅False Which of the following is not a rule in making the most out of your sales calls? - CORRECT ANSWER- ✔✔✅Your agenda, not theirs Specialty care products are more often prescribed by generalist physicians. - CORRECT ANSWER-✔✔✅False Side effects that might be considered merely minor annoyances in acute treatment can be a powerful barrier to adoption in chronic therapies. - CORRECT ANSWER-✔✔✅True Acute medications such as antibiotics are used to address short term illnesses and symptoms. - CORRECT ANSWER-✔✔✅True In some medical cases therapy may be initiated by a specialist and monitored by a primary care physician. -

What are specialized cells and tissues that work together to perform a specific body function for a common purpose? - CORRECT ANSWER-✔✔✅Organs What is the mechanism of action? - CORRECT ANSWER-✔✔✅The method by which a medication produces it's therapeutic effects. What is plasma? - CORRECT ANSWER-✔✔✅The fluid portion of the blood. What is anaphylaxis? - CORRECT ANSWER-✔✔✅An extreme sensitivity and reaction to a foreign substance including medications. How do cholinergic agonists work? - CORRECT ANSWER-✔✔✅By mimicking the actions of acetylcholine. Which of the following is considered a sympathominetic drug that stimulates the alpha-adrenergic receptors? - CORRECT ANSWER-✔✔✅Decongestant Which of the following is not a type of gastrointestinal agent? - CORRECT ANSWER-✔✔✅Prolactin inhibitors What is one of the main functions of a tocolytic agent? - CORRECT ANSWER-✔✔✅To suppress labor Which of these conditions is not treated with antiandrogens? - CORRECT ANSWER-✔✔✅Dyspepsia Which types of patients are most likely to receive immune globulins? - CORRECT ANSWER-✔✔✅Patients with weakened immune systems. What is iron's primary function in the body? - CORRECT ANSWER-✔✔✅Carrying oxygen Which of the following is not a type of anti-infectant? - CORRECT ANSWER-✔✔✅Antimetabolisms What is one difference between entry level and experienced resumes? - CORRECT ANSWER-✔✔✅Entry level resumes are more likely to begin with the education section than the experience section. Which statement about targeted cover letters is true? - CORRECT ANSWER-✔✔✅Targeted cover letters are always tailored to specific companies.