Automating Individualized Notification of Drug Recalls to Patients: Complex Challenges and Qualitative Evaluation

Area of Science:

• Health Informatics
• Patient Safety
• Drug Regulation

Background:

• Consumer drug recalls often require individual patient action.
• The Food and Drug Administration (FDA) provides public recall information, but awareness is limited.
• No current system notifies prescribers about patients affected by specific drug recalls.

Purpose of the Study:

• To leverage the FDA's Healthy Citizen platform for automated patient recall notifications.
• To develop and evaluate an electronic notification system for relevant drug recalls.

Main Methods:

• An electronic notification system was developed and tested in primary care and cardiology practices.
• The system scanned the FDA Healthy Citizen API for new recalls and identified affected patients via EHR medication lists.
• Patients received notifications through the EHR patient portal, linking to FDA information.

Main Results:

• The notification system was technically functional.
• An electronic audit trail from prescription to specific dispensed medication lot numbers could not be established.
• Patient feedback from interviews highlighted key themes regarding the system and portal messaging.

Conclusions:

• The absence of an accurate electronic audit trail from prescription to dispensed medication prevents clinical deployment of automated drug recall notifications.
• Further development is needed to bridge the gap between electronic health records and dispensed medication data for patient safety systems.