Foundations II focuses on the drug use system after a drug is marketed. Foundations of Pharmaceutical Outcomes and Policy II is the second course in a two-course series designed to provide students in the Master of Science in Pharmaceutical Sciences with a Focus on Pharmaceutical Outcomes & Policy an overview of drug discovery, development, approval, marketing, regulation, and use in the United States. The Foundations courses are designed to show how the “US medication system” pieces fit together and introduces issues that are developed in detail in the Master of Science tracks (i.e., Applied Pharmacoeconomics, Managed Care Pharmacy Systems, Medication Safety and Quality Systems, Pharmaceutical Regulation, and Pharmaceutical Value Assessment and Communications). The Foundation courses can be taken in any order.
In addition to recorded video lectures and online weekly class meetings, this course will include mandatory readings from various sources and perspectives. It provides a balanced view of controversial topics and invites discussion using the presented content, supplemental information posted to the Discussion Boards, and students and faculty experiences. This course’s concepts and principles will provide perspectives for students’ various chosen specialty areas, which will be addressed in courses that follow this foundational course.
Upon completion of this course, the student will:
- Identify and discuss the components and effectiveness of post-marketing surveillance in the US.
- Identify and describe the current framework used to mitigate drug risk post-approval.
- Recognize and explain the purpose and related regulations of a drug label and its various components; and the importance of off-label drug use.
- Identify and describe the fundamental limits placed on drug promotion.
- Recognize factors that affect the cost of various pharmaceuticals.
- List the most important USP standards and their effects on the production and use of drugs.
- List reasons for drug shortages and their potential consequences.
- Describe the drug use process in various health care settings.
- Recognize the influence of governmental programs, health insurance, and managed care on the use of drugs.
- Identify high-alert medications, hazardous drug substances, and proper methods of disposal of drugs.
- Explain the current infrastructure to improve the safe and effective use of drugs.
- Recognize the role of personalized medicine and individualized drug dosing in health care
*Please note that this syllabus is subject to change. Use the updated syllabus in Canvas as the official course syllabus.