Risk evaluation and mitigation strategies (REMS): educating the prescriber

Area of Science:

• Pharmacovigilance
• Regulatory Science
• Drug Safety

Background:

• The US FDA Amendments Act of 2007 empowered the FDA to mandate Risk Evaluation and Mitigation Strategies (REMS).
• REMS are required for drugs where benefit-risk balance is uncertain, enhancing safety oversight.
• These strategies represent an evolution from prior risk minimization plans, with increased FDA enforcement capabilities.

Purpose of the Study:

• To review current FDA-mandated Risk Evaluation and Mitigation Strategies (REMS) policy.
• To illustrate REMS components using romiplostim as a case study.
• To enhance prescriber understanding of FDA drug safety programs.

Main Methods:

• Review of the US FDA Amendments Act of 2007 and its REMS provisions.
• Case study analysis of romiplostim (Nplate®) and its comprehensive REMS.
• Examination of REMS components: medication guide, communication plan, safe use elements, and implementation system.

Main Results:

• REMS are mandatory for new and existing drugs, including generics and biologics.
• Romilostim's REMS utilized all available components to manage significant safety risks.
• REMS implementation impacts prescribers, pharmacists, and patients.

Conclusions:

• REMS are a critical FDA tool for managing drug risks and ensuring patient safety.
• Understanding REMS is essential for healthcare providers to navigate drug safety protocols.
• The romiplostim case highlights the practical application and importance of REMS in clinical practice.