Preventable adverse drug events and their causes and contributing factors: the analysis of register data

Abstract

Objective

To identify the causes and contributing factors of adverse drug events (ADEs) from the information management point of view.

Design

Retrospective study. Official register data were used to analyse preventable ADEs. The data were retrieved from the National Supervisory Authority for Welfare and Health and were analysed using qualitative content analysis, which was mainly based on the classification of ADEs.

Setting

National health care system.

Participants

Patient complaints (n = 16) and official statements about causality of injuries or deaths (n = 41) in which ADEs were present from the years 2001–07. A total of 57 statements were reviewed, and the 67 ADEs that occurred in the statements were analysed.

Interventions

None.

Main Outcome Measures

Causes, contributing factors, types of errors.

Results

The majority of ADEs (81%) occurred in inpatients in general health care units (n = 26), in specialized health care units (n = 19) or in nursing homes (n = 10). ADEs occurring in the prescription, transcription (n = 23) and administration (n = 21) stages were the most frequent, and human factors were the leading class of underlying cause followed by the use of data. Error types relating to information management (n = 26) occurred in every phase of the medication use process. The majority of information management errors were related to documentation, copying data or contraindicated prescriptions, and they mainly occurred in the prescription and transcription (n = 11), and admission phases (n = 8).

Conclusion

Information management processes need to be improved to improve medication safety.

adverse drug events, patient complaints, spontaneous reporting, information management