At the conclusion of this knowledge-based educational activity, participants should be able to

• Describe recent trends in the number of new and existing drugs with REMS requirements.
• Identify the challenges and opportunities REMS present health system pharmacists and other stakeholders.
• Explain the intent and impact of REMS on patients and health systems including factors that influence the success of these systems.
• Explain practical approaches to proactively and effectively implement REMS in health systems, including the role of the P&T committee and training pharmacists for REMS that require certification or special training.
• Identify potential changes to REMS by FDA based on stakeholder feedback, including recent draft guidance on the distribution of medication guides.