Pharmacy and Wellness Review
Abstract
Risk Evaluation and Mitigation Strategies (REMS) are the most recent risk management initiative put forth by the Food and Drug Administration (FDA) that decreases the risk associated with certain medications. They may be mandatory by the FDA or can be produced voluntarily by the manufacturer in order for a drug associated with significant risk to be approved. REMS may include one or multiple elements, including a Medication Guide (MedGuide), Communication Plan, Elements to Assure Safe Use (ETASU), Implementation Plan, and Timetable for Submission of Assessments. Although REMS enhance patient care by reducing risk and maintaining patient safety, an unbalanced burden is placed on the health care system to implement these elements. A stakeholder meeting with representation from a variety of health care provider groups was held in October 2010, to discuss these issues and potential resolutions. Specific to the field of pharmacy, pharmacists must be aware of REMS requirements and how they affect medication access and patient care in order to maintain adequate and appropriate therapy.