Application of failure mode and effects analysis (FMEA) to improve medication safety in the dispensing process – a study at a teaching hospital, Sri Lanka

Abstract Background Failure mode and effects analysis (FMEA) is a prospective, team based, structured process used to identify system failures of high risk processes before they occur. Medication dispensing is a risky process that should be analysed for its inherent risks using FMEA. The objective of this study was to identify possible failure modes, their effects, and causes in the dispensing process of a selected tertiary care hospital using FMEA. Methods Two independent teams (Team A and Team B) of pharmacists conducted the FMEA for two months in the Department of Pharmacy of a selected teaching hospital, Colombo, Sri Lanka. Each team had five meetings of two hours each, where the dispensing process and sub processes were mapped, and possible failure modes, their effects, and causes, were identified. A score for potential severity (S), frequency (F) and detectability (D) was assigned for each failure mode. Risk Priority Numbers (RPNs) were calculated (RPN=SxFxD), and identified failure modes were prioritised. Results Team A identified 48 failure modes while Team B identified 42. Among all 90 failure modes, 69 were common to both teams. Team A prioritised 36 failure modes, while Team B prioritised 30 failure modes for corrective action using the scores. Both teams identified overcrowded dispensing counters as a cause for 57 failure modes. Redesigning of dispensing tables, dispensing labels, the dispensing and medication re-packing processes, and establishing a patient counseling unit, were the major suggestions for correction. Conclusion FMEA was successfully used to identify and prioritise possible failure modes of the dispensing process through the active involvement of pharmacists