Conclusion It is evident that costs associated with the use of prescription drug and biologic products are rising at unsustainable rates. Am- ple data exists showing that the use of generic and biosimilar products are tools that can increase competition, and effectively reduce the cost of medications, increasing their usage across a va- riety of patient populations. To this end, the U.S. government and the pharmaceutical industry has developed a robust approach to American Academy of Neurology. (2001). Substitution of Generic Drugs may Cause Problems for Epilepsy Patients. https://www.aan.com/PressRoom/Home/PressRelease/115 • American College of Cardiology. (2019). Additional ARBs Added to FDA Recall List Due to Contamination. https://www.acc.org/latest-in- cardiology/articles/2019/01/04/16/50/ additional-arbs-added-to-fda-recall-list • American Medical Association (n.d.). Procedure for USAN Name Selection. https://www.ama- assn.org/about/united-states-adopted- names/procedure-usan-name-selection • Conrad, R. & Lutter, R. (2019). Generic Competition and Drug Prices: New Evidence Linking Greater Generic Competition and Lower Generic Drug Prices. https://www.fda.gov/ media/133509/download • Daley, T.J. & Emery, A. (2019). Branding pharmaceuticals: drug naming and non-traditional trademarks. https://www.worldtrademarkreview.com/article/branding-pharmaceuticals-drug- naming-and-non-traditional-trademarks • Harvard Medical School. (2021). Do generic drugs compromise on quality? https://www. health.harvard.edu/staying-healthy/do-generic- drugs-compromise-on-quality • References • National Cancer Institute. (2020). What Are Biosimilar Drugs? https://www.cancer.org/ treatment/treatments-and-side-effects/treatment- types/biosimilar-drugs/what-are- biosimilars.html • Palmer, E. (2017). Hetero Labs plant hit with Form 483 for suspicious shredding of documents. https://www.fiercepharma.com/manufacturing/hetero-labs-plant-hit-form-483-for- suspicious-shredding-documents • PharmaEducation (n.d.). Generic drugs vs brand name drugs. https://pharmaeducation.net/ generic-vs-brand-name- drugs/#Excipients_in_generic_vs_brand_name_drugs • Privitera, M.D., Welty, T.E., Gidal, B.E., Diaz, F.J., Krebill, R., Szaflarski, J.P., Dworetzky, B.A., Pollard, J.R., Elder, E.J., Jiang, W., Jiang, X. & Berg, M. (2016). Generic-to-generic lamotrigine switches in people with epilepsy: the randomised controlled EQUIGEN trial. Lancet , 15 , pp. 365-372. https://doi.org/10.1016/S1474-4422(16)00014-4 • Rajkumar, S.V. (2020). The high cost of prescription drugs: causes and solutions. Blood Cancer Journal, 10 , p. 71. https://doi.org/10.1038/s41408-020-0338-x • Sacks, C.A., Van de Wiele, V.L., Fulchino, L.A., Patel, L., Kesselheim, A.S., & Sarpatwari, A. (2021). Assessment of Variation in State Regulation of Generic Drug and Interchangeable Biologic Substitutions. JAMA Internal Medicine, 181 (1), pp. 16–22. https://doi.org/10.1001/ jamainternmed.2020.3588 • Song, Y. & Barthold, D. (2018) The effects of state-level pharmacist regulations on generic substitution of prescription drugs. Health Economics, 27 (11), pp. 1717-1737. https://doi. org/10.1002/hec.3796 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.
providing relatively cost-effective solutions. While there are a va- riety of voices calling out the hazards of generic substitution, the breadth of available research suggests that in most cases, generic or biosimilar substitution is safe, effective and makes sense finan - cially. Although blanket statements are usually not advisable, it appears safe to state that in most cases, when available, generic, or biosimilar products should be considered. • University of California San Diego. (n.d.). Warfarin Tablet Identification. https://health. ucsd.edu/for-health-care- professionals/anticoagulation-guidelines/warfarin/Pages/tablet- identification.aspx • U.S. Food & Drug Administration (n.d.). Purple Book Database of Licensed Biological Products. https://purplebooksearch.fda.gov/about • U.S. Food & Drug Administration. (2019a). Impact Story: Addressing Concerns About the Quality of Generic Drugs for Treating Epilepsy. https://www.fda.gov/drugs/regulatory- science-action/impact-story-addressing-concerns-about-quality-generic-drugs-treating- epilepsy • U.S. Food & Drug Administration. (2019b). Statement alerting patients and health care professionals of NDMA found in samples of ranitidine. https://www.fda.gov/news-events/ press-announcements/statement-alerting-patients-and-health-care-professionals-ndma-found- samples-ranitidine • U.S. Food & Drug Administration. (2020). Frequently Asked Questions on Patents and Exclusivity. https://www.fda.gov/drugs/development- approval-process-drugs/frequently- asked-questions-patents-and-exclusivity#What_is_the_difference_between_patents_a • U.S. Food & Drug Administration. (2021). Generic Drugs: Questions & Answers. https://www. fda.gov/drugs/questions-answers/generic- drugs-questions-answers • U.S. Food & Drug Administration. (2022a). FDA Drug Competition Action Plan. https://www. fda.gov/drugs/guidance-compliance-regulatory- information/fda-drug-competition-action- plan • U.S. Food & Drug Administration. (2022b). New Drug Application (NDA). https://www.fda. gov/drugs/types-applications/new-drug- application-nda • U.S. Food & Drug Administration. (2022c). Abbreviated New Drug Application (ANDA). https://www.fda.gov/drugs/types- applications/abbreviated-new-drug-application- anda#:~:text=An%20abbreviated%20new%20drug%20application%20%28ANDA%29%20 contains%20data,cost%20alternative%20to%20t name%20drug%20it%20references • U.S. Food & Drug Administration. (2022d). Approved Drug Products with Therapeutic Equivalence Evaluations | Orange Book. https://www.fda.gov/drugs/drug-approvals-and- databases/approved-drug-products-therapeutic-equivalence-evaluations-orange-book • Vossler, D.G., Anderson, G.D., & Bainbridge, J. (2016). AES Position Statement on Generic Substitution of Antiepileptic Drugs. Epilepsy Currents, 16 (3), pp. 209–211. https://doi. org/10.5698/1535-7511-16.3.209 • White, C.M. (2020). Generic Drugs Not as Safe as FDA Wants You to Believe. Annals of Pharmacotherapy, 54(3), pp. 283–286. https://doi.org/10.1177/1060028019881692 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. 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 Self-Assessment Answers and Rationales 1. The correct answer is A.
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