A multicenter record review of in-hospital adverse drug events requiring a higher level of care

Abstract

Objective: Adverse drug events (ADEs) are a worldwide concern, particularly when leading to a higher level of care. This study defines a higher level of care as an unplanned (re)admission to an intensive care unit or an intervention by a Medical Emergency Team. The objectives are to describe the incidence and preventability of ADEs leading to a higher level of care, to assess the types of drug involved, and to identify the risk factors.

Methods: A three-stage retrospective review was performed in six Belgian hospitals. Patient records were assessed by a trained clinical team consisting of a nurse, a physician, and a clinical pharmacist. Descriptive statistics, univariate, and multiple logistic regressions were used.

Results: In this study, 830 patients were detected for whom a higher level of care had been needed. In 160 (19.3%) cases, an ADE had occurred; 134 (83.8%) of these were categorized as preventable adverse drug events (pADEs). The overall incidence rate of patients transferred to a higher level of care because of a pADE was 33.9 (95% CI: 28.5–39.3) per 100,000 patient days at risk. Antibiotics and antithrombotic agents accounted both for one-fifth of all pADEs. Multivariate analysis indicated American Society of Anaesthesiologists physical status score as a risk factor for pADEs.

Conclusions: The high number of pADE with patient harm shows that there is a need for structural improvement of pharmacotherapeutic care. Detection of these pADEs can be the basis for the implementation of these improvements.

Keywords:

• Adverse drug events
• Adverse drug reaction
• Preventable adverse drug event
• Drug safety
• Intensive care unit
• Record review

Acknowledgments

The authors are grateful to the six participating hospitals for their cooperation. We gratefully thank all patient safety departments, the head nurses, and intensivists of ICUs for the coordination and collection of patients’ records. We thank the expert panel for their advice. Ms. Nele Geurden is acknowledged for her linguistic advice.