MANAGEMENT OF DRUG CHALLENGES: GENERIC VS BRANDED DRUGS, 2ND EDITION Final Examination Questions Select the best answer for each question and mark your answers on the Final Examination Answer Sheet found on page 123, or complete your test online at EliteLearning.com/Book
46. Which of the following forms the premise that the avail- ability of generic drugs can decrease prescription drug expenditures? a. Less expensive drugs provide enhanced safety. b. Increased competition should decrease prices. c. Less burdensome quality documentation will allow lower prices for generics. d. More choices should reduce demand. 47. Which of the following statements is true? a. Data suggests that the price of a medication is lowest im - mediately after introduction of the first generic version. b. FDA has stated that generic medication offers the same clinical benefit as the name-brand alternative. c. It is estimated by Conrad and Lutter that on average, when six or more generic alternatives are available a price reduction of at least 25% is expected. d. The World Health Organization is solely responsible for assigning generic medication names. 48. Which of the following statements is false? a. Both patents and exclusivity protect brand-name medi- cations from generic competition. b. Generic names are key to the commercial success of a medication. c. The U.S. Patent and Trademark Office coordinates the issuance of patents. d. FDA is not permitted to approve a generic drug for a brand-name product with an unexpired patent. 49. The Drug Competition Action Plan, issued by FDA in 2017 was designed to increase the availability of generic drug products. The key strategies employed by this approach were: a. Allow increased transparency to the review process. b. Reduce the rigor of the review process. c. Remove barriers to generic drug development. d. Both a and c. 50. Describe one difference in the development and approval of generic and brand-name medications: a. Generic drugs usually require more animal testing than brand-name medications. b. Innovator drugs generally require more documentation to support approval than generic drug products. c. While branded medications require a robust approval process, generic drugs require only a notification to FDA prior to marketing. d. Since efficacy is documented during the approval of in - novator products, a sponsor must demonstrate only safe- ty of generic drugs.
51. In many cases, rather than demonstrating efficacy, a generic drug sponsor can gain FDA approval by showing which of the following to the brand-name product? a. A similar safety profile. b. Enhanced efficacy relative. c. Bioequivalence. d. Reduced cost relative. 52. Regarding biosimilar products, which of the following is true? a. Biosimilars are almost always extracted from natural products. b. Biosimilars are identical to the brand-name product. c. Due to economies of scale, biosimilars are always sub - stantially less expensive than the brand-name product. d. Biosimilars are required to be comparable to the prede - cessor product. 53. Which of the following statements are true? a. Prescribers must always demand the use of a generic medication. b. In practice, the use of generics is common when appro - priate. c. Generic substitution is governed by federal law. d. In many cases, patient preference for brand-name or ge - neric medications can be overruled by the pharmacist. 54. Which of the following statements is true? a. The exclusive use of brand-name medications is relative- ly expensive. b. It has been acknowledged that there is a need for cost-ef - fective alternatives to brand-name products. c. The use of generics has led to some cases of controversy. d. All of the above are true. 55. Which of the following arguments have been used to op- pose the use of generic medications? a. Generic drug products lead to competitive pricing. b. There have been instances of inferior generic drug qual - ity. c. Arguments have been recently proven that FDA officials received bribes to loosen bioequivalence guidelines. d. Evidence of consistent safety issues with generic medica- tions have been confirmed.
Course Code: RPTTX01DC
EliteLearning.com/Pharmacy-Technician
Book Code: RPTTX2024
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