Drugs With a REMS: A Framework for Benefit/Risk Counseling to Patients

Interviewer: Lauri R. Graham; Interviewee: Gary Slatko, MD


February 20, 2018

Editorial Collaboration

Medscape &

Key Takeaways and Best Practices

Medscape: What do you hope are the key takeaways of the framework for HCPs?

Dr Slatko: This framework, and the publication that describes it, were developed specifically with the busy HCP in mind. To be useful and have practical value, FDA worked with HCPs and other counseling experts throughout its development.

The framework outlines desired outcomes, principles, and best practices that help underscore the importance of taking an individualized and collaborative counseling approach when prescribing drugs with REMS. This approach is one that educates and engages the patient, helps ensure a balanced conversation about both potential benefits and risks of a drug, and continually reinforces the patient's role in mitigating the risks when using such drugs.

To help support HCPs, examples used to help implement these approaches in daily clinical practice were also developed and provided.

Medscape: What are the best practices for counseling patients?

Dr Slatko: Best practices were prioritized and organized into a series of steps, with memory aids and graphics, to help support HCP recall. Examples were offered to encourage implementation.

While these steps are described sequentially, HCPs should consider this to be an iterative counseling process, with ongoing reassessment of the patient as to whether further assessment and/or additional counseling is required.

The four counseling steps (or "4E" steps) are:

  1. Evaluate the patient health profile, treatment options, and counseling needs (and re-evaluate)

  2. Educate the patient on his/her health condition and treatment options, treatment benefits and risks, and steps to minimize risks

  3. Engage the patient in treatment decision-making to the extent possible and desired by the patient

  4. Ensure that the patient understands the risks and is able to adhere to the REMS

A graphic is included in the framework, together with an example tool, for HCPs to download and print out (Figure).

Figure. Example tool for patient counseling.

Additional details about assessments to conduct and information to convey and/or reinforce are described further in the document. Suggested techniques that HCPs may wish to consider employing at each of the "4E" steps are also provided to help effective counseling.

Medscape: How can this framework translate into the real world of healthcare practice?

Dr Slatko: While developing the framework, FDA considered the challenges HCPs face when implementing benefit-risk counseling in their practice and described some of these challenges in the document.

To encourage and help support HCPs in addressing some of these challenges in their practice, examples of tools were also included for those who are interested in implementing this framework in their practice.

These examples include:

  • Counseling guide. This example describes the types of assessments, topics, and questions that could be addressed using the framework.

  • Mock discussion guide. This example illustrates the types of questions HCPs may find useful using during the process of counseling to help ensure patient adherence to the REMS.

  • Techniques to consider. The four counseling elements with techniques that HCPs may consider employing with each of the "4E" steps to help support implementation and effectiveness are highlighted.

Medscape: Where can HCPs get more information about REMS, the provider's role, and answers to potential questions that they may have?

Dr Slatko: FDA has provided a Risk Evaluation and Mitigation Strategies (REMS) website with general information about REMS, as well as more specific information about the roles of different participants in REMS. HCPs can learn more about their role in REMS by opening the drop-down box "What Health Care Providers (HCPs) who Prescribe Medications with REMS Need to Know" on the website.