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Using Healthcare Failure Mode and Effect Analysis in prospective medication safety risk management in secondary care inpatient wards


Objectives The evaluation and improvement of medication management processes is an essential part of preventive medication risk management strategies in hospitals. The aim of the present study was to identify and analyse risks of a new electronic medication management process and to suggest improvements to manage the identified risks in a secondary care hospital.

Methods The electronic medication management process of four wards at the Lapland Central Hospital, Finland was evaluated by Healthcare Failure Mode and Effect Analysis (HFMEA). The multidisciplinary HFMEA team consisted of five experts who identified the failure modes and rated their hazard scores (scale of 1–16). In addition, the patient safety incident reports of the hospital were used for identification of failure modes. Safety recommendations were identified, prioritised and implemented with a follow-up evaluation.

Results The team identified five phases in the electronic medication management process. Altogether, 35 potential failure modes were found, with eight being classified as the most severe (hazard score >8). The given recommendations (n=15) concerned improvements to the electronic medical record (EMR) (n=8) and to the work processes of the wards (n=7). Only two of the recommendations were fully implemented, and five were under development or partly implemented after a 15-month follow-up period.

Conclusions For identifying risks associated with electronic medication management and for compiling related safety recommendations, triangulation of different risk identification methodologies is recommended. When implementing electronic medication management, appropriate patient identification in medication administration should be ensured together with EMR development. Systematic efforts should be made for the effective implementation of the safety recommendations. Further research is warranted to explore barriers to implementing safety improvements, especially in small healthcare units in rural areas.

  • safety
  • quality of health care
  • pharmacy administration
  • medical informatics
  • documentation

Data availability statement

Data are available upon reasonable request.

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