APhA releases REMS white paper

WASHINGTON — The American Pharmacists Association has published its white paper on risk evaluation and mitigation strategies, the group said.

Published in the May/June 2011 issue of the Journal of the American Pharmacists Association, the “APhA 2011 REMS White Paper: Summary of the REMS stakeholder meeting on improving program design and implementation” focuses on designing a system that maximizes patient safety while minimizing burdens on the healthcare system. The paper was the product of a meeting the APhA sponsored in October that brought together 34 stakeholders representing organizations for pharmacists, pharmacies, physician assistants, nurses and nurse practitioners, drug makers and others, as well as observers from the Food and Drug Administration. The discussion focused on four themes: effective provider interventions, REMS standardization and communication models, using existing technology in the provider workspace for REMS implementation and ensuring a sustainable business model for REMS-related provider activities.

Recommendations included standardizing REMS programs, components and processes; utilizing effective provider interventions, such as personal consultations with patients; leveraging existing technology solutions in medical and pharmacy practice settings; establishing a central repository or clearinghouse for all REMS-related information; improving communication strategies and awareness of REMS programs and implementation requirements; and establishing compensation models to ensure providers have staff and resources to implement REMS programs.

The white paper is available at Pharmacist.com/REMS2011.

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