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

J Manag Care Pharm. 2012 Apr;18(3):268-75. doi: 10.18553/jmcp.2012.18.3.268.

Abstract

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).

MeSH terms

  • Drug-Related Side Effects and Adverse Reactions
  • Humans
  • Managed Care Programs / standards*
  • Patient Safety / legislation & jurisprudence
  • Patient Safety / standards
  • Pharmaceutical Services / standards*
  • Risk Management / methods
  • Risk Management / standards*
  • United States
  • United States Food and Drug Administration / legislation & jurisprudence
  • United States Food and Drug Administration / standards