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Background: The aim of this study was to determine the current magnitude and characteristics of intravenous patient-controlled analgesia (IV-PCA) errors, and to identify opportunities for improving the PCA modality.Methods: We conducted a descriptive analysis of IV-PCA medication errors submitted to the MEDMARX database. Events were restricted to those occurring in inpatient hospital settings between 1 January 2005 and 31 December 2015. IV-PCA errors were classified by error category, cause of error, error type, level of care rendered, and actions taken.Results: A total of 1948 IV-PCA errors were identified as potential errors (3.9%), nonharmful errors (89.5%), or harmful errors (6.7%) based on the National Coordinating Council for Medication Error Reporting and Prevention taxonomy for categorizing medication errors. Of these, 19.1% required a clinical intervention to address the deleterious effects of the error, indicating an underestimation of the risks associated with IV-PCA errors. The most frequent types of errors were improper dose/quantity (43.2%) and omission errors (19.9%). While human performance deficit was the leading cause of error (50.2%), other common causes included failure to follow procedure and protocol (42.2%) and improper use of the pump (22.7%). Although remedial actions were often taken to prevent error recurrence, actions were taken to rectify the systemic deficits that led to errors in only a minority of cases (11.8%).Conclusion: Preventable errors continue to pose unnecessary risks to patients receiving IV-PCA. Multimodal analgesic regimens and novel PCA systems that reduce human error are needed to prevent errors while preserving the advantages of PCA for the management of acute pain.

ABSTRACTBackground: The aim of this study is to determine the characteristics, magnitude, and the quality of reporting of mandated events involving intravenous patient-controlled analgesia (IV-PCA) devices in the Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database; a postmarket surveillance system.Methods: We utilized a mixed-methods approach to systematically characterize structured data and text narratives associated with IV-PCA events submitted to MAUDE between 1 January 2011 and 12 September 2016.Results: Of 1,430 IV-PCA events reported during the study period, 6.4% were adverse events (AEs) as identified via structured data fields in the MEDWATCH forms. Upon qualitative review of the narrative texts, 11.0% of events were associated with an unfavorable clinical outcome, which was 71% higher than the incidence of the adverse outcomes reported using the structured data fields. Device-related issues, which were mostly preventable, accounted for 86.9% of events. Of 65 reportable events submitted by manufacturers, 18.5% did not comply with reporting requirements as mandated by law.Conclusion: Patients on IV-PCA continue to experience serious complications as a result of preventable errors. Multi-modal interventions including educational training and the development and adoption of PCA devices with improved safety features are needed to improve safety.