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U.S. Department of Health and Human Services

Advisory Committees

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Discussion Topics for the December 17, 2013 Meeting of the Risk Communication Advisory Committee


On December 17, 2013, the Agency will ask the RCAC to Identity tools to use when communicating information about a drug’s risks to healthcare providers (HCPs) as part of a Risk Evaluation and Mitigation Strategy (REMS) and new strategies for the dissemination of REMS-related materials. The committee will also discuss the assessments of REMS communications. In addition, the committee will discuss existing and future strategies to support effective counseling by healthcare providers when they review benefit and risk information with patients as part of REMS programs.

Listed below are the agency’s proposed questions for the committee. Where relevant, examples or links are provided to briefly describe or illustrate the discussion topic or key concepts that may assist the committee in better understanding some of the agency's perspectives and challenges. More information will also be shared during the FDA’s presentations.

Discussion Questions:

  1. What are some best practices in communicating information about a drug’s risks to HCPs as part of a REMS?
  2. REMS Communication Tools: Currently approved REMS included a variety of communication tools for HCPs (e.g., DHCP letters, drug fact sheets, slide decks, etc) and tools for HCPs to counsel patients (e.g., PPAs). In light of the tools currently used, consider the following:
    • What tools should be used to communicate directly to HCPs or through professional societies?
    • How should the information in the REMS materials be formatted and organized to make sure that the target audience understands the message? (e.g., logos, colors, standard look, and length)
    • How many risk messages should be communicated at a time?
      • What is a reasonable number of risk messages to be communicated that will lead to successful retention of knowledge?
  3. Dissemination of REMS information: Currently approved REMS include the following methods to disseminate REMS information or REMS materials: mail, email, website, journal information pieces, distribution through professional societies mailings and/or meetings and conventions, and distribution by pharmaceutical sales representatives, etc. In light of these methods, consider the following:
    • What other methods might be used to disseminate REMS information or REMS materials?
    • What are some innovative methods to disseminate information that sponsors and professional societies can use to disseminate REMS information to HCPs? (i.e. more electronic media using smart phones, podcasts, etc.)
    • Which methods of dissemination do HCPs prefer and are most effective?
    • What is the optimal frequency and duration for disseminating REMS information?
    • How can we help distinguish REMS materials for HCPs from other information they receive about a drug from the sponsor?
  4. Assessment of REMS Communication
    • What tools other than KAB surveys, should be used to evaluate REMS materials - in terms of awareness, understanding, and behavior change?
  5. REMS Patient Counseling Tools: Currently some approved REMS include tools for HCPs to counsel patients (e.g., PPAs).
    • What counseling tools, practices and techniques are most effective for supporting healthcare providers when counseling patients about the benefits and risks of medications?
    • What metrics of effectiveness would you advise FDA consider when assessing the effectiveness of provider to patient counseling tools, practices, and techniques? Consider metrics related to:
      • Reach (e.g. distribution)
      • Effectiveness (e.g., helping HCPs convey knowledge to patients)
      • Adoption (e.g., documented utilization of tools)
      • Implementation (e.g., compliance with counseling being delivered in steps or phases)
      • Maintenance (e.g., persistency of utilization of tools and sustained impact)
  6. Will the proposed project work plan and report generate sufficient useful information from which FDA could then implement impactful improvements to existing counseling approaches and tools for providers to use when counseling patients about benefit and risk information? If not, what recommendations do you have for altering the proposed project work plan so that it generates useful information?


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