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 lifethreatening ADEs may remain unrecognized. The objectives of this study were to examine the occurrence of lifethreatening 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.

In Denmark, reporting of safety incidents to the nationwide Danish Patient Safety Database (DPSD) is mandatory. Medication incident reports constitute the largest category of safety reports. We aimed to provide numbers and characteristics of medication incidents and MEs reported to DPSD focusing on medication, their severity and the trends therein. This is a cross-sectional study of medication incident reports for individuals ≥18, submitted to DPSD in 2014-2018. We performed analyses on the (1) medication incident and (2) ME levels. Out of 479 814 incident reports, 61.18% (n = 293 536) were related to individuals ≥70 and 44.6% (n = 213 974) to nursing homes. Most of the events were harmless (70.87%, n = 340 047) and 0.8% (n = 3859) had caused severe harm or death. ME-analysis (n = 444 555) revealed that paracetamol and furosemide were the most frequently reported drugs. The most common drugs for severe and fatal MEs were warfarin, methotrexate, potassium chloride, paracetamol and morphine. When the reporting ratio for all MEs and harmful MEs was considered, other drugs than the most frequently reported ones were found to be associated with harm. We found a large proportion of harmless medication incident reports and reports from community healthcare services and identified high-risk medicines associated with harm.

IntroductionMedication errors (MEs) are associated with patient harm and high economic costs. Healthcare authorities and pharmacovigilance organisations in many countries routinely collect data on MEs via reporting systems to improve patient safety and for learning purposes. Different approaches have been developed and used for the ME analysis, but an overview of the scope of available methods currently is lacking. This scoping review aimed to identify, explore and map available literature on methods used to analyse MEs in reporting systems.Methods and analysesThis protocol describes a scoping review, based on the Joanna Briggs Institute methodological framework. A systematic search will be performed in MEDLINE (Ovid), Embase (Ovid), Cinahl (EBSCOhost), Cochrane Central, Google Scholar, websites of the major pharmacovigilance centres and national healthcare safety agencies, and citation search in Scopus in August 2022. All retrieved records are to be independently screened by two researchers on title, abstract and full text, involving a third researcher in case of disagreement. Data will be extracted and presented in descriptive and tabular form. The extraction will be based on information about methods of ME analyses, type of reporting system and information on MEs (medication name, ATC codes, ME type, medication–event categories and harm categories).Ethics and disseminationEthical approval is not required. The results will be disseminated via publication in peer-reviewed journals, scientific networks and relevant conferences.

Background Staff observations are the most common source of data for driving improvements in care. However, the patient perspective should also be considered, and healthcare complaints offer concrete details that health organizations might otherwise overlook and that can highlight areas for learning and improvement in the healthcare system. However, because of the diverse nature of patient complaints, systematic analyses can be challenging. This study aimed to identify and prioritize areas for improvement using a data-driven approach to analysing patient complaints. Methods The Danish version of the Healthcare Complaints Analysis Tool was used to categorize the content of complaint letters. All complaints managed by the national complaints authority, compensation claims to the Patient Compensation Association, and locally managed complaints that were filed directly at Odense University Hospital from 2017 to 2021 were included. Proportional reporting ratios (PRRs) were used to measure and display the top five signals of disproportionality and rank them by excess complaints at the hospital level and when divided into department types. Results The study included 6366 complaints containing 13 156 problems (on average, 2.1 problems mentioned per complaint letter). Surgical departments had the highest number of complaints (3818), followed by medical (1059), service (439), and emergency departments (239). Signal 1 of disproportionality, relating to quality problems during ward procedures, had the highest excess reporting of 1043 complaints at the hospital level, a PRR of 1.61, and was present in all department types. Signal 2, relating to safety problems during the examination and diagnosis stage, had excess reporting of 699 problems, a PRR of 1.86, and was also present in all department types. Signal 3, relating to institutional problems during admission, had the highest PRR of 3.54 and was found in most department types. Signals 4 and 5, relating to environmental problems during ward procedures and care on the ward, respectively, had PRRs of 1.5 and 1.84 and were present in most department types. Conclusion The study found that analysing patient complaints can identify potential areas for hospital improvement. The study identified recurring issues in multiple departments, including quality problems during ward procedures, safety problems during the examination, institutional problems during admission, and environmental problems on the ward. The study highlights disproportionality analysis of complaints as a valuable tool to monitor patient concerns systematically.