Although they were the only two people in the store, she drew her head closer to his, and whispered “I have epilepsy and need brand-name Lamictal to keep from having seizures.” She then went on to state that she has been reading for years about how important it is to stick with the brand-name product, since the generic versions cause seizures. She acknowledged that although her insurance co-payment was higher than for the generic, she was certain that it was worth it and was willing to pay the differ- ence. The problem now is that not only does she not have insur- ance, even if she did, she could not afford to pay the additional money. She was almost out of both medication and money. This was not a challenging issue for Thomas. He prides himself in keeping current in the research as it relates to the practice of pharmacy. He was well aware of the controversy surrounding the generic substitution of medications for epilepsy and had plenty of experience comforting his patients regarding the bad publicity for these generic products. He was relieved when he learned that AES had changed their position on generics for epilepsy. In short, he was well-equipped to help Tina. He first acknowledged that there were concerns beginning approximately 20 years ago. Then he went on to explain how the FDA had worked with the experts to fully understand the issue. He summarized by stating that they concluded that generic drugs are not always the best for every patient, but they are often a good choice for preventing seizures. Further to that, the substitution of generics for Lamictal had been specifically addressed and given the stamp of approval of AES. Tina’s face brightened a bit, but then reminded him that she no longer had insurance and was afraid that she might not even be able to afford the generic product. Timothy walked over to the counter and tore a coupon off a pad. Handing it to her, he said “this is a coupon that you can use to bring the cost down on your medication. I could not tell you how these work but one of my patients used one today to lower their cost of lamotrigine, the generic version of Lamictal. Not sure exactly what it came to, but for a month’s supply of 100 mg tablets, I think that it was about six dollars. Could that work for you?” Tina was beside herself. She jumped up, pulled a ragged prescription from her purse, and gave Timothy a hug. “Thank you, thank you thank you!” 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
Self-Assessment Quiz Question #9 Pharmacist Timothy appears to be skilled at building patient rapport that is useful for communicating with patients. Provide an example from the case study that illustrates how he used this skill to help Tina. a. Timothy ignored Tina when she entered the store, providing her with the privacy that she needed. b. Timothy appeared to observe Tina’s behavior in an effort to surmise her general needs. Self-Assessment Quiz Question #10 Regarding the generic substitution of epilepsy medications, which of the following false statements did Pharmacist Timothy dispel? a. Timothy proved that there was never controversy regarding the use of generic seizure medications. b. AES and other professional associations have been consistently in favor of reducing patient costs through the use of generic drug products useful for the treatment of epilepsy. c. FDA worked to show that generic substitution of epilepsy medications is often appropriate. d. While some generic epilepsy products have been shown to be safe and effective, no data on the efficacy of lamotrigine is available. c. He put Tina at ease by actively confronting her. d. Timothy practiced efficiency with Tina’s time by immediately asking her what her problem was. Healthcare Professional Consideration: Litigating each of the arguments for and against generic substitution is well beyond the scope of this educational program. Nonetheless, it is likely fair to conclude that while in some cases, this exercise is not warranted, in many, if not most, this practice is critical to deliv- ering safe and effective pharmaceutical care. It is incumbent on all healthcare professionals to understand the issues at hand so that they are in a position to help their patients make the best choices to suit their individual needs. 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
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