Towards a Systematic Approach to REMS Design. Adam Kroetsch Office of Program and Strategic Analysis OSP, CDER, FDA September 25, 2013
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1 Towards a Systematic Approach to REMS Design Adam Kroetsch Office of Program and Strategic Analysis OSP, CDER, FDA September 25, 2013
2 Why do we need a systematic approach to REMS design? A systematic approach to REMS design could help us Document and communicate a rationale for each REMS. Comprehensively identify and anticipate failures. Address complexity of drug risk management. Reduce unnecessary variation in REMS design and tools. Increase predictability of review process. September 25, 2013 Expert Workshop: Strengthening REMS 2
3 REMS Design: Future State Establish the Scope Characterize the risk that the REMS is trying to address and conditions for safe use of the drug. Establish the likely context of use for the drug. Analyze the Problem Identify failures in safe use that might lead to patient harm. Identify underlying causes of those failures. Specify Interventions Specify key information / desired behaviors /process changes to address underlying causes. Develop interventions to convey information/ behaviors. September 25, 2013 Expert Workshop: Strengthening REMS 3
4 Characterize the risk and safe use of the drug How do patients become exposed to the risk? What is the relationship between exposure and the adverse reaction of concern? Can exposure be managed to reduce the likelihood of an adverse reaction? How? What is the adverse reaction (ADR) of concern? Can it be prevented, detected, or treated? How? What risk factors affect the likelihood of an ADR? Can they be prevented, detected, or treated? How? What are adverse outcomes that can result and how likely/severe are they? What factors affect their likelihood/severity? Can they be prevented, detected, or treated? How? September 25, 2013 Expert Workshop: Strengthening REMS 4
5 Establish the context of use Which patient populations that are likely to use the drug? In which healthcare settings is the drug likely to be prescribed? Which stakeholders will be involved in the patient s care? What is the process by which the patient is treated? September 25, 2013 Expert Workshop: Strengthening REMS 5
6 Identify possible failures What are the potential failures that could lead to unsafe use and patient harm? Where in the medication use process could these failures occur? September 25, 2013 Expert Workshop: Strengthening REMS 6
7 Identify underlying causes of failure How does the medication use process contribute to the failure? How do the knowledge, attitudes, beliefs, and behaviors of stakeholders contribute to the failure? September 25, 2013 Expert Workshop: Strengthening REMS 7
8 Identify key information, desired behaviors, interventions What information, behavior changes, or process changes are needed to address the underlying causes of failure? What interventions can effectively convey information and implement changes? September 25, 2013 Expert Workshop: Strengthening REMS 8
9 Develop tools When is it possible to use engineering or administrative controls? How do we balance tool intensity against access and burden considerations? September 25, 2013 Expert Workshop: Strengthening REMS 9
10 Use tools from a standard REMS toolkit What tools can we use from our REMS toolkit? How should they be customized to the individual REMS? September 25, 2013 Expert Workshop: Strengthening REMS 10
11 Practical Considerations An effective approach should 1. Work within the regulatory review process Build an evidence base that permits informed decision-making Consider time/resource and regulatory constraints 2. Focus on what s most important Prioritize most important failures, root causes Prioritize most effective/feasible interventions 3. Streamline to enhance efficiency Share tools across programs (e.g., for similar risks, failures, and/or contexts of use) Re-use analysis across programs 4. Design with evaluation in mind September 25, 2013 Expert Workshop: Strengthening REMS 11
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