REMS Effectiveness Management
REMS Effectiveness Management is a ParagonRx approach to effective and efficient REMS program implementation, evaluation, and success.
Many sponsors are quick to declare victory when their REMS program is approved, but REMS approval is only half the battle. Achieving REMS program effectiveness through targeted implementation tactics and evaluation planning is just as important to meet the goals of the REMS.
To achieve program effectiveness, risk managers should:
- Create detailed implementation plans (the prepared REMS document is not the implementation plan).
- Track fulfillment of the implementation plan by functional groups.
- Measure "interim metrics" to determine if REMS results are on a trajectory to achieve REMS assessment commitments.
- Adjust implementation planning as necessary.
At ParagonRx, we believe the overall goal of REMS is appropriate use of medications. And sometimes the REMS alone are not enough to reach that goal. In order to achieve success, supplemental or non-REMS activities are essential to improve safety and minimize burdens.
Some non-REMS activities and tactics include:
- Innovative education techniques, e.g., simulations, checklists
- Contextual benefit/risk messages providing insight to stakeholders
- Certified Nurse Educators deployed to demonstrate appropriate product use
- End-user best practices identified via ethnographic research
- Supplemental tools to promote appropriate use created with end-users
REMS Effectiveness Management provides a robust approach to REMS implementation and goes beyond REMS requirements to achieve appropriate medication use. By striving for appropriate medication use, all stakeholders involved in REMS are protected - the patients, the physicians, the pharmacists, and sponsors themselves.
