Chapter 7: Management Of Drug Challenges: Generic vs Branded Drugs, 2nd Edition 1 Contact Hour
By: Bradley K. Gillespie, PharmD Author Disclosure: Bradley K. Gillespie, and Colibri Healthcare, LLC do not have any actual or potential conflicts of interest in relation to this lesson. Universal Activity Number UAN: 0607-0000-22-042-H01-P Target Audience: Pharmacists in a community-based setting. To Obtain Credit: A minimum test score of 75 percent is needed to obtain a credit. Please submit your answers either by mail, fax, or online at EliteLearning.com/Book Questions regarding statements of credit and other customer ser- vice issues should be directed to 1-888-666-9053. This lesson is $9.95. Activity Type: Knowledge-based Initial Release Date: 10/31/2022 Expiration Date: 10/31/2025 Learning objectives After completing this course, the learner should be able to: Identify a potential driver of increased costs for prescription drug products. Distinguish between the processes of determining generic and brand medication names. Identify attributes of generic drugs as they relate to brand- name medications. Introduction In an effort to stabilize the rapidly growing costs associated with prescription drug use, government, industry, and professional or- ganizations have made great efforts to facilitate the availability of generic drug products. As measured by the high proportion of generic drug usage relative to all prescription drugs, and asso- ciated cost savings, it is likely fair to call these efforts successful. Nonetheless, the use of generic drugs is not universally appro- priate or accepted. Both of these observations’ present oppor- tunities to healthcare professionals. It is incumbent on all parties
Colibri Healthcare, LLC is accredited by the Accredita- tion Council for Pharmacy Education (ACPE) as a pro- vider of continuing pharmacy education. Participants of the session who complete the evaluation and provide accurate NABP e-Profile information will have their credit for 1 contact hour (0.1 CEU) submitted to CPE Monitor as early as within 10 business days after course completion and no later than 60 days after the event. Please know that if accurate e-Profile information is not provided within 60 days of the event, credit cannot be claimed after that time. The participant is ac- countable for verifying the accurate posting of CE credit to their CPE Monitor account within 60 days.
Describe the difference between the development of generic and brand-name products. Compare and contrast generic drugs and biosimilars. Summarize a universal guideline governing generic substitution across all U.S. jurisdictions. Provide an overview of the evolving concepts regarding the generic substitution of anti-seizure medications. involved in pharmaceutical care to best understand the generic drug environment, recognize when substitution is warranted, and work with their patients to fully understand and appreciate the process. The overarching objective of this educational program is to provide the information needed for a general overview of the tradeoffs involved in the decision to prescribe and dispense both generic and brand-name medications. This course is intended as an introduction to the topic. Development of a full understanding is beyond its intended scope.
STATEMENT OF PROBLEM
Rajkumar noted in a 2020 publication that worldwide spending on prescription drugs in that year was projected to be approxi- mately $1.3 trillion. Of that total, the United States (U.S.) share might be as much as $3.5 billion. Further, it was expected that these costs would continue to rise at a rate of 3-6% annually. In an effort to try and understand these large outlays, he notes that drug manufacturing companies justify the expense as the cost of sustained innovation. He offers a variety of reasons for the high cost of medications: 1. Monopoly : For many new drugs there are no alternatives available. Even for some older medications, there may be limited competition. 2. Seriousness of the disease : In some cases, high costs can be maintained because drugs required to treat some diseases are not luxury items, rather they are required for survival. In these cases, high costs may be less of a barrier. 3. Lobbying power of pharmaceutical companies : Massive sums of money invested by the pharmaceutical industry Potential solution The United States Food & Drug Administration (FDA) defines generic drugs as a medication that is made to be the same as originally developed and approved drug products in terms of
appear to have limited regulatory and legislative reform focused on high prescription drug prices (Rajkumar, 2020). Self-Assessment Quiz Question #1 Which of the following are not likely to be drivers of the high cost of prescription medications? a. It is well established in multiple peer-reviewed scientific journals, that brand-name medications are considered a status symbol. b. In many cases, there is no alternative to recently approved drugs. c. The pharmaceutical industry invests large sums of money lobbying to limit reforms on high drug prices. d. In the case of some disease states, the patients have no choice but to purchase expensive medications.
its dosage form, safety, strength, route of administration, qual- ity, performance characteristics, and intended use. FDA states that the generics work in the same way, offering the same clinical
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