Evolution of the AMCP Format for Formulary Submissions.

DISCLOSURES: No funding was required for this project. The authors are or have been members of the Format Executive Committee.

Implications of Risk Evaluation and Mitigation Strategy (REMS) programs for managed care pharmacy.

In the last 2 decades, health care management has been challenged by more aggressive therapy, the increased number of specialty medications, and more stringent guidelines to monitor adverse events or health risk. To promote patient safety, various communication requirements are mandated to increase the risk awareness of patients and physicians. These include black-box warnings, "Dear Health Care Provider" letters, U.S. Food and Drug Administration (FDA) Talk Papers, MedGuides, and Risk Minimization Action Plans (RiskMAPs).