title: APhA 2011 REMS white paper: Summary of the REMS stakeholder meeting on improving program design and implementation.
abstract: OBJECTIVE
  To develop an improved risk evaluation and mitigation strategies (REMS) system for maximizing effective and safe patient medication use while minimizing burden on the health care delivery system.
  
  
  METHODS
  34 stakeholders gathered October 6-7, 2010, in Arlington, VA, for the REMS Stakeholder Meeting, convened by the American Pharmacists Association (APhA). Participants included national health care provider associations, including representatives for physicians, physician assistants, nurses, nurse practitioners, and pharmacists, as well as representatives for patient advocates, drug distributors, community pharmacists (chain and independent), drug manufacturer associations (brand, generic, and biologic organizations), and health information technology, standards, and safety organizations. Staff from the Food and Drug Administration (FDA) Center for Drug Evaluation and Research participated as observers. The meeting built on themes from the APhA's 2009 REMS white paper.
  
  
  CONCLUSIONS
  The current REMS environment presents many challenges for health care providers due to the growing number of REMS programs and the lack of standardization or similarities among various REMS programs. A standardized REMS process that focuses on maximizing patient safety and minimizing impacts on patient access and provider implementation could offset these challenges. A new process that includes effective provider interventions and standardized tools and systems for implementing REMS programs may improve patient care and overcome some of the communication issues providers and patients currently face. Metrics could be put in place to evaluate the effectiveness of REMS elements. By incorporating REMS program components into existing technologies and data infrastructures, achieving REMS implementation that is workflow neutral and minimizes administrative burden may be possible. An appropriate compensation model could ensure providers have adequate resources for patient care and REMS implementation. Overall, stakeholders should continue to work collaboratively with FDA and manufacturers to improve REMS program design and implementation issues.
  
  
  CONCLUSIONS
  A workable REMS system will require effective patient interventions, standardized elements that limit barriers to implementation for both patients and providers, standardized yet flexible implementation strategies, use of existing technologies in practice settings, increased opportunities for provider input early in REMS design processes, improved communication strategies and awareness of program requirements, and viable provider compensation models needed to offset costs to implement and comply with REMS program requirements.
authors.affiliation: mbough@aphanet.org
authors.lastname: American Pharmacists Association
authors.forename: Marcie
authors.initials: M
authors.lastname: Bough
mesh_terms: D003695:Delivery of Health Care / Q000592:standards*; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D005791:Patient Care / Q000379:methods / Q000592:standards*; D004364:Pharmaceutical Preparations / Q000008:administration & dosage; D016730:Program Development; D018570:Risk Assessment / Q000379:methods; D012308:Risk Management / Q000379:methods*; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D004364:Pharmaceutical Preparations