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

Background: Consumer-level drug recalls usually require action by individual patients. The Food and Drug Administration (FDA) has public-facing outlets to inform the public about drug safety information, including all recalls, but individual consumers may not be aware of them. And there is no system in place to notify individual prescribers which of their patients are affected by a specific recall. Objective: We aimed to leverage the FDA's Healthy Citizen prototype web-based software platform, which provides users with information about recalls, to automatically notify patients of relevant recalls. Methods: We developed and evaluated an electronic notification system in the primary care and cardiology practices at a large, urban, academic medical center. The health care portal scanned the FDA Healthy Citizen application programming interface nightly to detect new recalls, identified patients who had those medications in their electronic health record (EHR) medication list, and sent them a message through the EHR patient portal with a link to a customized FDA information display. Using structured interviews, we assessed qualitative feedback on the system and portal messaging from a convenience sample of 9 patients. Results: The system was technically functional, but it was not possible to trace a medication prescription from the EHR to specific lot numbers dispensed to that patient by a community pharmacy. The qualitative feedback obtained from patients showed convergence of topics. Conclusions: Lack of an accurate electronic audit trail from prescription to dispensed medication precludes clinical deployment of automated drug recall notification.