APhA White Paper Calls for Collaboration to Improve REMS Programs


Implementing a dynamic REMS system will improve health care delivery, increase patient safety, and improve access to medications.

As part of an ongoing effort to advance the national conversation on Risk Evaluation and Mitigation Strategies (REMS), the American Pharmacists Association (APhA) published its second white paper on the topic in the May/June 2011 issue of the Journal of the American Pharmacists Association.

Based on discussions stemming from the APhA 2010 REMS Stakeholder Meeting, hosted by the Association in Arlington, Virginia in October 2010, the white paper urged cooperative efforts by all constituents to improve REMS programs.

“Due to the increasing number of REMS programs and the lack of standardization among these programs, there is a decisive need for health care providers to work collaboratively with FDA, manufacturers, and other stakeholders to improve REMS development and implementation,” the authors wrote. “Development and implementation of a dynamic REMS system will facilitate health care delivery, decrease burden on the health care system, increase patient safety, and improve patient access to medications for optimal treatment.”

Recommendations in the white paper for facilitating a workable REMS system included the following:

  • 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
  • Viable provider compensation models needed to offset costs to implement and comply with REMS program requirements

The 2010 stakeholder meeting included 34 experts from pharmacy, medicine, nursing, physician assistant, drug wholesaler, technology, and safety organizations, and was observed by FDA representatives.

In its November/December 2009 issue, the Journal of the American Pharmacists Association published APhA’s first REMS white paper, “White paper on designing a risk evaluation and mitigation strategies (REMS) system to optimize the balance of patient access, medication safety, and impact on the health care system,” based on a REMS stakeholder meeting convened by APhA.

To download “APhA 2011 REMS white paper: Summary of the REMS stakeholder meeting on improving program design and implementation" from the APhA Web site, click here.

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