Program Objectives

At the conclusion of this activity, attendees should be able to:

• Highlight the important elements of the FDA Amendments Act (FDAAA) of 2007 and describe their implications to pharmacists and health-system pharmacy departments.
• List and discuss key factors that must be present for a restricted drug distribution system to be successful and to not impede patient access to medications.
• Explain the rationale and potential components of a risk evaluation and mitigation strategy (REMS) for a new or existing medication.
• When provided with a hypothetical REMS that requires special training or certification for pharmacists and pharmacies involved in dispensing the drug, design a sample training program that would meet the requirements.