Abstract

ObjectiveAdverse drug events (ADEs) during hospital stays are a significant problem of healthcare systems. Established monitoring systems lack completeness or are cost intensive. Routinely assigned International Statistical Classification of Diseases and Related Health Problems (ICD) codes could complement existing systems for ADE identification. To analyze the potential of using routine data for ADE detection, the validity of a set of ICD codes was determined focusing on hospital-acquired events.Material and methodsThe study utilized routine data from four German hospitals covering the years 2014 and 2015. A set of ICD, 10th Revision, German Modification (ICD-10-GM) diagnoses coded most frequently in the routine data and identified as codes indicating ADEs was analyzed. Data from psychiatric and psychotherapeutic departments were excluded. Retrospective chart review was performed to calculate positive predictive values (PPV) and sensitivity.ResultsOf 807 reviewed ADE codes, 91.2% (95%-confidence interval: 89.0, 93.1) were identified as disease in the medical records and 65.1% (61.7, 68.3) were confirmed as ADE. For code groups being predominantly hospital-acquired, 78.5% (73.7, 82.9) were confirmed as ADE, ranging from 68.5% to 94.4% dependent on the ICD code. However, sensitivity of inpatient ADEs was relatively low. 49.7% (45.2, 54.2) of 495 identified hospital-acquired ADEs were coded as disease in the routine data, from which a subgroup of 12.1% (9.4, 15.3) was coded as drug-associated disease.ConclusionsICD codes from routine data can provide an important contribution to the development and improvement of ADE monitoring systems. Documentation quality is crucial to further increase the PPV, and actions against under-reporting of ADEs in routine data need to be taken.

Highlights

  • Adverse drug events (ADEs) are frequently occurring complications in the community and during inpatient treatment. [1] They pose a significant burden on the patient’s recovery and to financial resources of healthcare systems. [2, 3] A prompt identification of such events is a prerequisite in order to avert further damage to third parties by optimizing clinical processes and by increasing the knowledge about specific drugs

  • ICD codes from routine data can provide an important contribution to the development and improvement of ADE monitoring systems

  • Vigilance systems for spontaneous reporting of adverse drug events are established in hospital environments such as Critical Incident Reporting Systems (CIRS), they suffer from under-reporting in daily hospital care. [4, 5] Structured chart review is more efficient in identifying ADEs but time and cost intensive

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Summary

Introduction

Adverse drug events (ADEs) are frequently occurring complications in the community and during inpatient treatment. [1] They pose a significant burden on the patient’s recovery and to financial resources of healthcare systems. [2, 3] A prompt identification of such events is a prerequisite in order to avert further damage to third parties by optimizing clinical processes and by increasing the knowledge about specific drugs. Adverse drug events (ADEs) are frequently occurring complications in the community and during inpatient treatment. Vigilance systems for spontaneous reporting of adverse drug events are established in hospital environments such as Critical Incident Reporting Systems (CIRS), they suffer from under-reporting in daily hospital care. The utilization of routinely collected diagnoses coded by the International Statistical Classification of Diseases and Related Health Problems (ICD) could usefully complement the existing systems in terms of timely detection, accuracy, and completeness, especially when combined with other computerized surveillance systems such as laboratory value triggers or Computerized Physician Order Entry systems. Diagnoses of inpatients in Germany are coded by the ICD-10-German Modification (ICD10-GM) system. Applying the ICD system for the coding of diagnoses is internationally established and other studies have shown the potential of using ICD codes for the identification of ADEs. Applying the ICD system for the coding of diagnoses is internationally established and other studies have shown the potential of using ICD codes for the identification of ADEs. [6, 7]

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