Failure Mode and Effects Analysis: A Tool for Identifying Risk in Community Pharmacies

Abstract

CANADIAN HEALTH CARE LEADERS HAVE BEGUN TO LOOK AT SAFE practices in other industries to identify those with applicability to health care. A key characteristic of high-reliability industries, such as nuclear power, aviation, automobile manufacturing, and chemical processing, is acceptance of the fact that errors will occur, that the impact of errors can be devastating, and that efforts should be made to discover system weaknesses before harm occurs. A tool that has been a cornerstone of safety efforts in these organizations is a proactive risk assessment process called failure mode and effects analysis (FMEA). Using FMEA, multidisciplinary teams first identify potential failures and their effects, and then develop strategies for improvement. FMEA focuses on how and when a system will fail, not if it will fail. The US Veterans Affairs (VA) National Center for Patient Safety has developed an FMEA model for health care environments called Healthcare Failure Mode and Effect Analysis (HFMEA). 1 As part of its role in the Canadian Medication Incident Reporting and Prevention System, the Institute for Safe Medication Practices Canada (ISMP Canada) has adapted the VA model to develop a similar FMEA framework for use in Canada.