MANAGEMENT OF DRUG CHALLENGES: GENERIC VS BRANDED DRUGS, 2ND EDITION Self-Assessment Answers and Rationales 1. The correct answer is A.
6. The correct answer is C. Rationale: While both biosimilars and generics usually require clinical testing, generics often rely on bioequivalence testing, while biosimilars are typically required to show safety and efficacy comparable to the branded product. 7. The correct answer is C. Rationale: Unfortunately, while laws governing generic substitu - tion are inconsistent across jurisdiction, in all cases, patients are empowered to make the final decision of whether they are dis - pensed brand-name or generic medication products. It is import- ant that pharmacists respect this important patient right. 8. The correct answer is B. Rationale: Due to reduced development costs and increased competition; generic drugs have the potential to reduce health- care costs, while working as well, or comparable to brand-name medications. 9. The correct answer is B. Rationale: It appeared that Tina had a problem on her mind that she needed help with. Timothy through passive observation sus- pected this and provided her the space and opportunity to bring her problem to him on her own time, when she felt comfortable to do so. 10. The correct answer is C. 79. 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. 80. 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. 81. 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.
Rationale: While some people may prefer to use branded medi- cations, and there is likely some evidence of this preference, it is an overstatement of facts to claim that there is a significant body of research indicating that brand-name medications are a status symbol. 2. The correct answer is D. Rationale: Drug development sponsors work with INN to gener - ate an appropriate generic name for novel products, and WHO evaluates the resultant name to ensure that it complies with their guidelines. 3. The correct answer is D. Rationale: Patients administered generic drugs can expect that their medication has a similar safety and efficacy profile as the Rationale: Due to warfarin’s narrow therapeutic index; it is critical that patients’ dose of medication remain constant. As a result, the color of the tablet is approximately consistent across all brand name and generic tablets to assist patients with dose level con- firmation. 5. The correct answer is B. Rationale: Bioequivalence testing of candidate generic drug products is often used to demonstrate that the same blood levels of an active drug can be achieved after administration of a generic drug product relative to the branded version. brand-name alternative product. 4. The correct answer is C. 76. 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. 77. 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. 78. 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.
Rationale: Although FDA requirements for the approval of gener- ic epilepsy medications were at one time facing significant scruti - ny, FDA collaborated on research conducted supporting the FDA position that generic substitution was appropriate and can be used to provide safe and effective therapy for seizure prevention. MANAGEMENT OF DRUG CHALLENGES: GENERIC VS BRANDED DRUGS, 2ND EDITION Final Examination Questions Select the best answer for each question and then proceed to EliteLearning.com/Book to complete your final examination.
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