gms | German Medical Science

Background: Adverse drug events (ADEs) are a common cause of emergency department visits and occur frequently during hospitalisation. A systematic review and meta-analysis on in-hospital ADEs reported a cumulative incidence of 16.88%, with incidence rates up to 60.74% measured on a German geriatric ward [1], [2]. Likewise, approximately 5 to 10% of all hospital admissions are attributable to ADEs [3]. Such ADEs impose a significant burden on patients, as they are a common cause of morbidity and mortality, and are estimated to increase the length of hospital stay by 3 days [4], [5]. In addition to health consequences, they also pose an economic challenge to the health care system [5]. Taking into consideration that ADEs occurring at hospital admission and during inpatient stay vary in their relevance, depending on their frequency, severity, and preventability [6], [7], [8], a screening tool with focus on the most relevant ADEs could lead to a more targeted and efficient use of limited resources in both clinical practice and research.

Therefore, the aim of the present study was to identify a set of prioritised adverse events (AEs) as a basis for defining medication safety measures for applications in clinical practice (e.g. decision support), quality improvement and research.

Materials and Methods: The study design is a two-round expert consensus process based on the RAND Appropriateness Method (RAM), a modified Delphi survey, combining scientific evidence and expert opinion. We conducted two RAM consensus processes in order to prioritise adverse events (AEs) for two clinical settings: (1) at hospital admission and (2) during hospital stay. Panel 1 and panel 2 consisted of 13 and 12 members from 11 and 9 German university sites, respectively. The panelists were asked to assess the overall importance of 65 AEs and 63 AEs, respectively, which were identified by a systematic review of studies investigating adverse drug events (ADEs) in Germany. For each item, panelists were asked to rate “In a patient with this AE: How important is it to conduct a medication review as a strategy to prevent further or repeated harm from this AE?” on a four-point Likert scale (1=lowest to 4=highest priority). All ratings were placed in confidence. In each panel, the distribution of first-round ratings were discussed in a virtual meeting of all panelists followed by second-round ratings. AEs with a median rating of ≥3 without disagreement were a priori defined as „prioritised“. Disagreement was defined as follows: for items with a median of ≥3 consistent with prioritisation at least 30% of expert ratings were 1 or 2 or for items with a median of <2 inconsistent with prioritisation at least 30% were 3 or 4.

Results: Finally, 38 out of 65 AEs in panel 1 and 34 out of 63 AEs in panel 2 were prioritised according to their overall importance rating. 29 AEs were prioritised in both panels, 4 AEs were prioritised only in panel 1, 9 AEs only in panel 2. The highest rated events were acute renal failure and hypoglycaemia (both panels), as well as Stevens-Johnson syndrome in panel 1 and rhabdomyolysis in panel 2.

Conclusion: The present RAND survey led to a set of prioritised adverse events (AEs) providing a focus for further research and practice. In order to achieve our aim to detect adverse drug events (ADEs) at hospital admission and during hospital stay, the next step will be to create drug-event pairs combining the prioritised AEs with potentially causative drugs through a second RAM process. As this modified RAND consensus process is embedded in the Medical Informatics Initiative (MI-I) overarching use case POLAR (POLypharmacy, drug interActions, Risks), the developed indicators will be operationalised and implemented in routine hospital data in university hospitals throughout Germany. Ultimately, they will be used to determine the prevalence of potential ADEs at hospital admission and to develop automated risk models for the prediction of adverse drug events in hospitals.

Annotation: Anna Böhmer and Annette Härdtlein share first authorship. Tobias Dreischulte and Ulrich Jaehde share senior authorship.