Application of Failure Mode Effect Analysis (FMEA) to Improve Medication Safety in the Dispensing Process – A Study at A Teaching Hospital, Sri Lanka

Abstract

Background: Failure Mode Effect 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. Objectives: 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) to prioritise identified failure modes. Results: Team A identified 48 failure modes while Team B identified 42. Among all 90 failure modes, 69 were common to both teams. Using the RPN, Team A prioritised one failure mode, while Team B prioritised three (having identical RPNs). 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 active involvement of pharmacists.

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

“…At the first meeting the researcher introduced the FMEA process to team members with illustrations [ 13 , 41 ] and re-emphasised on the importance of a safety culture. To ensure that all were knowledgeable about the concept of a safety culture in the hospital, all the team members previously (Five months prior to this FMEA) attended a workshop on medication safety organised by the research team where various aspects of medication safety were emphasised [ 42 ]. This effort indicated that members of both teams were knowledgeable on medication safety and safety culture before engaging in FMEA.…”