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

  1. Anil Jain, MD;
  2. Ashish Atreja, MD, MPH;
  3. C. Martin Harris, MD, MBA;
  4. Meghan Lehmann, PharmD;
  5. Jon Burns, BS; and
  6. James Young, MD
  1. From The Cleveland Clinic Foundation, Cleveland, Ohio.

    Abstract

    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.

    Article and Author Information

    • 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.

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