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Application of Failure Mode and Effect Analysis (FMEA) to improve medication safety: a systematic review
  1. Jayaweera A Lakshika Anjalee1,
  2. Victoria Rutter2,
  3. Nithushi R Samaranayake3
  1. 1 Department of Pharmacy, Colombo South Teaching Hospital, Dehiwala, Sri Lanka
  2. 2 Commonwealth Pharmacists Association, London, UK
  3. 3 Department of Pharmacy and Pharmaceutical Sciences, Faculty of Allied Health Sciences, University of Sri Jayewardenepura, Nugegoda, Sri Lanka
  1. Correspondence to Nithushi R Samaranayake, Department of Pharmacy and Pharmaceutical Sciences, Faculty of Allied Health Sciences, University of Sri Jayewardenepura, Nugegoda, Sri Lanka; nithushi{at}


Medication safety is a phenomenon of interest in most healthcare settings worldwide. Failure Mode and Effect Analysis (FMEA) is a prospective method to identify failures. We systematically reviewed the application of FMEA in improving medication safety in the medication use process. Electronic databases were searched using keywords ((failure mode and effect analysis) AND (pharmacy OR hospital)). Articles that fulfilled prespecified inclusion criteria were selected and were then screened independently by two researchers. Studies fulfilling the inclusion criteria and cited in articles selected for the study were also included. Selected articles were then analysed according to specified objectives. Among 27€706 articles obtained initially, only 29 matched the inclusion criteria. After adding four cited articles, a total of 33 articles were analysed. FMEA was used to analyse both existing systems and new policies before implementing. All participants of FMEA reported that this process was an effective group activity to identify errors in the system, although time-consuming and subjective.

  • Clinical pharmacology
  • health services administration & management
  • health & safety
  • quality in health care

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  • Contributors JALA and NRS carried out the systematic review being reviewer 1 and reviewer 2. VR assisted in conducting the review. JALA wrote the manuscript in consultation with NRS and VR. All three authors discussed and contributed to fine-tune the final version of the manuscript. VR did the language editing.

  • Funding This study was funded by the University Research Grants (Ref No: ASP/01/RE/MED/2017/37) of University of Sri Jayewardenepura, Sri Lanka.

  • Competing interests None declared.

  • Patient consent for publication Not required.

  • Provenance and peer review Not commissioned; internally peer reviewed.

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.

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