Responding to the rofecoxib withdrawal crisis: a new model for notifying patients at risk and their health care providers

Ann Intern Med. 2005 Feb 1;142(3):182-6. doi: 10.7326/0003-4819-142-3-200502010-00008.

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.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Anti-Inflammatory Agents, Non-Steroidal / adverse effects*
  • Cyclooxygenase Inhibitors / adverse effects*
  • Drug and Narcotic Control*
  • Female
  • Humans
  • Information Dissemination / methods*
  • Lactones / adverse effects*
  • Male
  • Medical Records Systems, Computerized
  • Middle Aged
  • Patient Care / methods*
  • Sulfones / adverse effects*
  • Time Factors
  • United States

Substances

  • Anti-Inflammatory Agents, Non-Steroidal
  • Cyclooxygenase Inhibitors
  • Lactones
  • Sulfones
  • rofecoxib