Life-Threatening and Fatal Adverse Drug Events in a Danish University Hospital

J Patient Saf. 2021 Sep 1;17(6):e562-e567. doi: 10.1097/PTS.0000000000000411.


Objectives: Detection of adverse drug events (ADEs) in Danish hospitals relies on health care professionals' incident reporting to a national database for adverse events, but the method is incomplete; thus, fatal and life-threatening ADEs may remain unrecognized.The objectives of this study were to examine the occurrence of life-threatening and fatal ADEs in population of hospitalized patients with suspected adverse outcome and to compare these findings with the actual number of reported ADEs in the study period of 3 months.

Methods: Study was designed as a cross-sectional study of adult population, hospitalized for more than 24 hours, having an unplanned transfer to an intensive care unit (ICU), or having unexpected death. Medical records were retrospectively screened by the Global Trigger Tool. All positive triggers were assessed for ADEs by a clinical pharmacologist.

Results: Of the 26,176 patients admitted in the study period, 105 had an unplanned transfer to the ICU and 36 died unexpectedly. In total, 15 positive triggers were identified in 10 patients. Life-threatening ADEs accounted for 7.6% (8/105) of patients transferred to the ICU, and fatal ADEs constituted 5.5% (2/36) of the deceased patients. Life-threatening and fatal ADEs corresponded to an overall prevalence of 0.04% (10/26,176). Most ADEs were related to hemorrhages and respiratory problems. No serious or fatal ADEs were reported in the incident reporting system in the study period.

Conclusions: Ten life-threatening and fatal ADEs were uncovered as not reported in the incident reporting system. Further steps are needed for recognition and prevention of this patient safety challenge.