FDA Issues Report on Counseling Patients about Drugs with a REMS

These best practices are broken down into four domains
These best practices are broken down into four domains

The Food and Drug Administration (FDA) has created a new resource for clinicians who are considering prescribing, or are already treating patients with drugs that require a Risk Evaluation and Mitigation Strategy (REMS). 

The report, titled "A Framework for Benefit-Risk Counseling to Patients About Drugs with a REMS", offers best practice recommendations on how clinicians can effectively communicate the benefits and risks associated with medications that require REMS. These best practices are broken down into 4 domains: 

  • Evaluate and continuously re-evaluate patients to make sure treatment goals are being met, that patients understand the risks of the drug, and that they are able to adhere to the REMS requirements.
  • Educate patients about their treatment and other options, including the risks and benefits. Education should be tailored to an individual patient's health profile, treatment goals, and counseling needs.
  • Engage patients so they become active participants in healthcare decisions. Patients should be encouraged to ask questions about their treatment and clinicians should ask patients to demonstrate their understanding.
  • Monitor and counsel patients to reinforce key risk information and help them understand the steps needed to mitigate these risks.

The Agency notes that these recommendations will be most effective if they are learned and implemented consistently across all healthcare settings. "Thus, the framework has been designed to provide broad educational considerations when developing and/or implementing benefit-risk counseling."

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Medications that have approved REMS can be found here.

For more information visit FDA.gov.