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CRITICAL CARE

Adverse Drug Event Reporting in Intensive Care Units: A Survey of Current Practices

Assistant Professor, University of Pittsburgh, Center for Pharmacoinformatics and Outcomes Research, Pittsburgh, PA

John W Devlin, PharmD BCPS FCCP FCCM

Associate Professor, Department of Pharmacy Practice, Northeastern University School of Pharmacy; Adjunct Associate Professor, Tufts University School of Medicine; Clinical Pharmacist, Medical Intensive Care Unit, Tufts-New England Medical Center, Boston, MA

Reprints: Dr. Kane-Gill, University of Pittsburgh, Center for Pharmacoinformatics and Outcomes Research, 918 Salk Hall, 3501 Terrace St., Pittsburgh, PA 15261-0001, fax 412/624-1850, KaneSL{at}upmc.edu

BACKGROUND: With the incidence of adverse drug events (ADEs) and adverse drug reactions (ADRs) higher in the intensive care unit (ICU) than other areas of the hospital, it is suspected that ADE/ADR surveillance systems differ between ICU and non-ICU areas. However, there is a lack of information about ADE/ADR identification, reporting, and evaluation strategies in the ICU. Understanding the frequency with which institutions incorporate standardized operational ADE/ADR definitions, triggers, and evaluation tools in this population will facilitate benchmarking between hospitals.

OBJECTIVE: To determine whether ADE/ADR identification, reporting, and evaluation strategies differ between ICU and non-ICU populations and to characterize ADE/ADR reporting strategies in the ICU.

METHODS: A validated survey was mailed to pharmacy directors at 590 randomly selected hospitals in the US having at least one ICU. A reminder was sent one week after the surveys were mailed. Five weeks later, a second survey was mailed to hospitals that did not respond.

RESULTS: The response rate was 22% (132/590); institutions were predominantly community (68.2%), with 199 or fewer (54.5%) operational beds and 19 or fewer (60.6%) ICU beds. ICU types included mixed medical/surgical (62.1%), medical (48.5%), surgical (31.8%), coronary (29.5%), neonatal (22.7%), and cardiothoracic (15.2%). Operational definitions for ADEs and ADRs varied little between ICU and non-ICU areas, as 92.4% of institutions used the same term for both settings. Triggers were used to identify ADE/ADRs hospital-wide (75%) and were usually the same between ICU and non-ICU areas (88.6%). ADE reporting was nearly always voluntary (94.7%), using paper reports (88.6%), phone calls (22.7%), e-mail (12.1%), Intranet (12.1%), Web-based/Internet (10.6%), or PDA (1.5%). Only 22% of hospitals tracked ICU-specific data.

CONCLUSIONS: ADE identification, reporting, and evaluation strategies are similar between ICU and non-ICU areas. Few institutions currently track ICU-specific ADE/ADR data. The institution of ICU-specific ADE detection and prevention strategies may improve the safety of critically ill patients.

Key Words: adverse drug event, adverse drug reaction reporting systems, critical care, intensive care units

Published Online, July 18, 2006. www.theannals.com, DOI 10.1345/aph.1H088