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CNPR EXAM | QUESTIONS & ANSWERS
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Which term denotes how an API works in the body? Correct Answer: mechanism of 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 to brand name and generic drugs? Correct Answer: differences in inactive ingredients All cells have a nucleus (T/F) Correct Answer: False
Which of the following does NOT affect drug response? Correct Answer: All of these factors influence drug response. A. the patient's genetic makeup, age, body size, and use of other drugs and dietary supplements. B. the patient's other conditions or diseases. C. 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 (T/F) Correct Answer: False 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: Peak plasma concentration on a measuring curve Which of the following is NOT a main concept in clinical pharmacology? Correct Answer: Pharmacoprocesses Which of the following is NOT a route of drug administration?
Only 3 companies account for nearly 90% of all drug wholesale sales. Correct Answer: True What type of sale bypasses the need for intermediary distributors? Correct Answer: manufacturer-direct sales What is a group purchasing organization (GPO)? Correct Answer: 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. Correct Answer: 3 times larger Which of the following is NOT a type of non-stock sale? Correct Answer: All of these are examples of non-stock sales. What is another term for rebates? Correct Answer: after-market arrangements The PDMA is the Prescription Drug Manufacturers Association Correct Answer: False
A company that owns and operates three or fewer pharmacies is an ____________. Correct Answer: independent drug store Which section of a drug's package insert information covers the usual dosage range? Correct Answer: indications and usage Drug labels must include indications and usage information, as well as contraindications. Correct Answer: True What should be included in the "description" section of a drug's package insert information Correct Answer: the drug's proprietary name and the established name Exclusivity gives exclusive ______, which is granted by the FDA, and can run concurrently with a patent or not. Correct Answer: marketing rights What differentiates exclusivity from a patent? Correct Answer: Exclusivity is only granted upon the drug's FDA approval. What is required of an invention for it to be worthy of patent protection? Correct Answer: It must be novel, useful, and not obvious.
Correct Answer: 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? Correct Answer: generic What term denotes the dispensing of an unbranded generic product for the product prescribed? Correct Answer: generic substitution What is the duration of a patent challenge? Correct Answer: 180 days (6months) How is a drug sample closet or cabinet like a grocery store shelf? Correct Answer: 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 Correct Answer: False Sampling is sometimes the most important factor in a pharmaceutical rep's success.
Correct Answer: True The FDA approved storage conditions for drug products Correct Answer: True Pharmaceutical representatives must always record the amount of drug samples left and obtain a signature for that amount Correct Answer: True What is prohibited by Section 503 of the Federal Food, Drug and Cosmetic Act, as amended by the Prescription Drug Marketing Act? Correct Answer: the sale, purchase, or trade or offer to sell, purchase, or trade prescription drug samples The government does not regulate the drug sampling for a pharmaceutical rep Correct Answer: False Which of the following is permitted by Section 503 of the Federal Food, Drug and Cosmetic Act? Correct Answer: none of these Which entity issues monographs that define how drugs should be stored, and what variance is allowed in their stated contents?
Correct Answer: A. Call your Sales Manager to inform him/her of the mistake and ask for instructions on proper procedure. Which area of drug R&D has seen the largest cost increases? Correct Answer: 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)? Correct Answer: 10 - 15 years Which of the following regulatory agencies is industry-based (i.e. run mainly by the companies themselves)? Correct Answer: Pharmaceutical Research and Manufactures of America (PhRMA) Which of the following factors has simplified the pharmaceutical R&D process? Correct Answer: none of these 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 Correct Answer: True According to your manual, which type of system is the best way to deliver healthcare? Correct Answer: a market-based system
How would increased pharmaceutical price controls affect the U.S. healthcare system? Correct Answer: Increased price controls would stifle innovation. Which of the following invests a greater percentage of sales in research than the biotech sector? Correct Answer: none of these: A. the aerospace sector B. the communications sector C. the electronics sector 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 G10 Medicines Group recently report about the pharmaceutical industry in the European Union (EU)? Correct Answer: 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.
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. Which of the following does NOT affect a drug's distribution to its target issues? Correct Answer: All of these factors affect a drug's distribution to its target tissues Which of these medical terms means "to apply the drug on the skin surface"? Correct Answer: Transfermal Carcinogenicity studies are carried out to identify the tumor-causing potential of a drug Correct Answer: True According to NIH ethical guidelines, which of the following is the most important criteria in selecting subjects for clinical studies? Correct Answer: scientific objectives Which statement about the IRB is incorrect? Correct Answer: 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? Correct Answer: 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? 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 the disease, and then looks to back in time 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 (e.h. 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 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 What is the estimated annual death toll for malaria? Correct Answer: 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 Correct Answer: False How was insulin primarily obtained from the 1930s to the 1980s? Correct Answer: porcine and bovine extracts Which of the following are NOT types of cytokines? Correct Answer: All of these are types of cytokines: interferon, interleukins, monokines
Which of the following is not a type of hormone? Correct Answer: blood glucose Which of the following is a basic gene therapy technique Correct Answer: 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? Correct Answer: 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. Correct Answer: True Which of the following are types of vectors used in gene therapy? Correct Answer: retroviruses Which of the following is NOT a type of stem cell? Correct Answer: semipotent Traditional vaccines are prepared in a number of ways. What way is NOT one of them? Correct Answer: insulin
