REMS (Risk Evaluation and Mitigation Strategies)

Inform, Educate and Warn

Utilize PDR’s multi-channel Risk Communication programs to deliver important safety alerts to physicians and other healthcare professionals that are product-related and mandated by the FDA.

• PDR’s REMS programs offer timely dissemination of important medication safety information, such as FDA-mandated black box warnings, drug recalls, and other product safety information to physicians and allied practitioners via digital media followed up with a traditional paper-based communication.
• PDR’s comprehensive distribution channels provide pharmaceutical companies with the most efficient and effective way to fulfill their FDA obligations, while helping to improve patient safety.

A sample Professional REMS Program might include:

• An immediate update to PDR.net adding label changes plus a revision of the notification message in the labeling information header on PDR.net.
• An electronic notification to the entire PDR email database via the PDR^® eAlert Program, including users logged onto our website and users of our mobilePDR application.
• A PDR Risk Communication letter to targeted prescribers – a direct mail letter that can comprise any FDA-mandated physician and/or patient education materials including an envelope clearly highlighted with Risk Communication or Urgent verbiage.
• Inclusion in the appropriate PDR Supplement reinforcing the Risk Communication message.