Application of Failure Mode and Effect Analysis (FMEA) to improve medication safety: a systematic review

Anjalee, J. A. L.; Rutter, Victoria; Samaranayake, NR

doi:10.1136/postgradmedj-2019-137484

Cited by 35 publications

(30 citation statements)

References 38 publications

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“…PubMed, JSTOR, Emerald, SAGE, Wiley online, Oxford journals, Web of science, Scopus and Cochrane library databases were searched for relevant studies from January 2006 to December 2017 (27). During this review, we found a number of studies using FMEA in areas such as chemotherapy (11)(12)(13)(14), parenteral nutrition (28), medication management (2,29,30), medication administration (31,32), medication use process (one or more steps from prescribing to dispensing) among in-patients (18,33,34) and paediatrics (12,(15)(16)(17)23).…”

Section: Discussionmentioning

confidence: 99%

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

Anjalee

Rutter²,

Samaranayake

2021

Preprint

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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.

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Section: Discussionmentioning

confidence: 99%

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

Anjalee

Rutter²,

Samaranayake

2021

Preprint

Self Cite

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“…In a 2021 systematic review of 33 articles about medication safety, 31 had corrective actions recommended. 21 Anjalee et al 21 found that 6 articles reported a reduction in errors. In addition, the perceptions of FMEA participants about its advantages were reported; these included the ability to gather the collective knowledge of the team, analyze complex processes, increase clinicians' awareness of health care risks, and promote safety.…”

Section: Discussionmentioning

confidence: 99%

“…Several drawbacks were listed as well, such as being a time-consuming process, subjective in nature, and having a single-institution focus. 21 …”

Section: Discussionmentioning

confidence: 99%

Using a Patient Safety Analysis to Guide Infusion Therapy for Patients With COVID-19

Hagle

Snyder

Janicek

et al. 2021

Journal of Infusion Nursing

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In the United States, during the Coronavirus Disease 2019 (COVID-19) pandemic, patients with COVID-19 overwhelmed available intensive care beds, staffing levels were unpredictable, and personal protective equipment was limited. The safety of situating electronic infusion pumps outside patient rooms was evaluated using an internal risk assessment. Based on a low level of risk, a procedure was developed to direct clinicians as to when this process is appropriate during a national crisis. A standardized analysis, Healthcare Failure Mode and Effects Analysis, was conducted to identify all potential risks and implement actions that would eliminate or control the risk. No adverse events were reported. Safe systems and preparation can protect patients.

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“…Accordingly, it is of vital importance to reduce risk proactively. Failure Mode and Effect Analysis (FMEA), a valuable prospective analysis that incorporates methods for identifying failure modes, and their causes and effects ( 22 ), was first used in the aerospace industry in the mid-1960 s ( 23 ). It has since been revised and applied to healthcare by the Joint Commission on Accreditation of Healthcare Organizations in 2001, which has been renamed the Healthcare Failure Mode and Effect Analysis (HFMEA) ( 23 ).…”

Section: Introductionmentioning

confidence: 99%

Use of failure mode and effect analysis to reduce patient safety risks in purchasing prescription drugs from online pharmacies in China

et al. 2022

Front. Med.

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BackgroundOnline pharmacies have gradually penetrated the market, but pose risks to patients' health. Failure Mode and Effect Analysis (FMEA) is an effective and reliable method for reducing pharmacy and medication risks. The purpose of this study was to conduct a prospective risk analysis of the process of purchasing prescription drugs from online pharmacies in China to guarantee drug quality and patient safety.MethodsThe FMEA was performed at Sichuan University, China. A multidisciplinary team was assembled comprising a leader, four regulators, four pharmacists, two experts, etc. The process was composed of eight subprocesses: searching for prescription drugs, submitting medication requirements, completing patient information forms, dispensing, delivering, etc. Brainstorming was used to identify and prioritize failure modes, propose corrective actions, and reduce risks. Risk priority numbers were the main criterion and were obtained by multiplying three scores: severity, occurrence and detectability, which were scored by the team The team proposed corrective actions for each selected failure mode.ResultsA total of forty-one potential failure modes were identified, and the causes, effects, and corrective actions of the 30 top failure modes were analyzed. The highest risk value was assigned to “photocopies of paper prescriptions uploaded were reused by patients.” Three failure modes for the S value of 5 were: “drugs are eroded and polluted by moisture or insects in the process of transportation,” “the qualification information of the pharmacies were absent or fake,” and “pharmacists fail to check prescriptions in accordance with Prescription Administrative Regulation.” Of the top failure modes, 36.67% were from Step 5, delivering the drug. After taking corrective measures to control risks, the risks reduced by 69.26%.ConclusionThe results of this study proves that the FMEA is a valuable tool for identifying and prioritizing the risks inherent in online pharmacies. This study shows that there are many potential risks in the process of purchasing prescription drugs from online pharmacies, especially in the drug delivery stage. Enhanced training and the introduction of smart devices may minimize risks. Online pharmacies and Chinese regulators should consider these findings for risk mitigation and the improvement of regulations pertaining to online pharmacies.

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Application of Failure Mode and Effect Analysis (FMEA) to improve medication safety: a systematic review

Cited by 35 publications

References 38 publications

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

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

Using a Patient Safety Analysis to Guide Infusion Therapy for Patients With COVID-19

Use of failure mode and effect analysis to reduce patient safety risks in purchasing prescription drugs from online pharmacies in China

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