Responding to the Rofecoxib Withdrawal Crisis: A New Model for Notifying Patients at Risk and Their Health Care Providers

1 February 2005 | Volume 142 Issue 3 | Pages 182-186

Background: We decided to inform our patients of the withdrawal of rofecoxib, one of the largest drug withdrawals in United States history, and instruct them to contact their providers for guidance.

Objective: To identify and inform patients and providers affected by the rofecoxib withdrawal.

Design: Descriptive observational study.

Setting: Tertiary care center with an electronic medical record (EMR) system.

Patients: Patients with an active rofecoxib prescription within the EMR.

Intervention: Existing information technology and traditional communication resources were used to automate the identifying and notifying of patients and providers and to deactivate rofecoxib prescriptions in the EMR.

Measurements: Characteristics of patients receiving rofecoxib at our institution, details of their prescription and provider, number of EMR alerts, and medication discontinuations.

Results: The 11 699 patients with a rofecoxib prescription in our practice were sent notifications within 24 hours of the withdrawal.

Limitations: We did not directly measure the effect of our notification on patients or providers.

Conclusions: Information technology enabled our institution to rapidly identify and notify individual patients and their providers about an important drug withdrawal. The methods modeled a feasible way for health care organizations with EMRs to participate in notification processes that may be applicable in a variety of situations.

Editors' Notes Context The rofecoxib withdrawal on 30 September 2004 was one of the largest drug recalls in modern history. Contribution This article describes how a single institution used its electronic medical record system to immediately identify 11 699 patients with rofecoxib prescriptions. Within 1 hour of the announcement of the national withdrawal, the institution pulled rofecoxib from its medication stocks. Within 7 hours, it deactivated prescriptions in the electronic record and notified providers via e-mail. Within 22 hours, letters about the withdrawal were sent to patients. Cautions The authors did not measure the effects of the notification on patient and provider behavior and outcomes. –The Editors

 

Author and Article Information

From The Cleveland Clinic Foundation, Cleveland, Ohio.

Potential Financial Conflicts of Interest: Consultancies: J. Young (Merck & Co., Inc.; AstraZeneca; Pfizer, Inc.); Grants received: J. Young (Merck & Co., Inc.; AstraZeneca; Pfizer, Inc.).

Requests for Single Reprints: Anil Jain, MD, Cleveland Clinic Foundation, A91, 9500 Euclid Avenue, Cleveland, OH 44195.

Current Author Addresses: Drs. Jain and Atreja: Cleveland Clinic Foundation, A91, 9500 Euclid Avenue, Cleveland, OH 44195.

Dr. Lehmann: Department of Pharmacy/Hb03, Cleveland Clinic Foundation, 9500 Euclid Avenue, Cleveland, OH 44195.

Dr. Young: Cleveland Clinic Foundation, T13, 9500 Euclid Avenue, Cleveland, OH 44195.

Mr. Burns: Cleveland Clinic Foundation, CL30, 9500 Euclid Avenue, Cleveland, OH 44195.

Dr. Harris: Cleveland Clinic Foundation, H18, 9500 Euclid Avenue, Cleveland, OH 44195.