title: Use of failure mode, effect and criticality analysis to improve safety in the medication administration process.
abstract: OBJECTIVE
  To critically evaluate the causes of preventable adverse drug events during the nurse medication administration process in inpatient units with computerized prescription order entry and profiled automated dispensing cabinets in order to prioritize interventions that need to be implemented and to evaluate the impact of specific interventions on the criticality index.
  
  
  METHODS
  This is a failure mode, effects and criticality analysis (FMECA) study. A multidisciplinary consensus committee composed of pharmacists, nurses and doctors evaluated the process of administering medications in a hospital setting in Spain. By analysing the process, all failure modes were identified and criticality was determined by rating severity, frequency and likelihood of failure detection on a scale of 1 to 10, using adapted versions of already published scales. Safety strategies were identified and prioritized.
  
  
  RESULTS
  Through consensus, the committee identified eight processes and 40 failure modes, of which 20 were classified as high risk. The sum of the criticality indices was 5254. For the potential high-risk failure modes, 21 different potential causes were found resulting in 24 recommendations. Thirteen recommendations were prioritized and developed over a 24-month period, reducing total criticality from 5254 to 3572 (a 32.0% reduction). The recommendations with a greater impact on criticality were the development of an electronic medication administration record (-582) and the standardization of intravenous drug compounding in the unit (-168). Other improvements, such as barcode medication administration technology (-1033), were scheduled for a longer period of time because of lower feasibility.
  
  
  CONCLUSIONS
  FMECA is a useful approach that can improve the medication administration process.
authors.affiliation: Pharmacy Department, Hospital General Universitario Gregorio Marañón, Instituto de Investigación Sanitaria del Hospital Gregorio Marañón, Madrid, Spain.
authors.forename: Carmen Guadalupe
authors.initials: CG
authors.lastname: Rodriguez-Gonzalez
authors.affiliation: Pharmacy Department, Hospital General Universitario Gregorio Marañón, Instituto de Investigación Sanitaria del Hospital Gregorio Marañón, Madrid, Spain.
authors.forename: Maria Luisa
authors.initials: ML
authors.lastname: Martin-Barbero
authors.affiliation: Pharmacy Department, Hospital General Universitario Gregorio Marañón, Instituto de Investigación Sanitaria del Hospital Gregorio Marañón, Madrid, Spain.
authors.forename: Ana
authors.initials: A
authors.lastname: Herranz-Alonso
authors.affiliation: Gastroenterology Department, Hospital General Universitario Gregorio Marañón, Madrid, Spain.
authors.forename: Maria Isabel
authors.initials: MI
authors.lastname: Durango-Limarquez
authors.affiliation: Gastroenterology Department, Hospital General Universitario Gregorio Marañón, Madrid, Spain.
authors.forename: Paloma
authors.initials: P
authors.lastname: Hernandez-Sampelayo
authors.affiliation: Hospital General Universitario Gregorio Marañón, Instituto de Investigación Sanitaria del Hospital Gregorio Marañón, Madrid, Spain.
authors.forename: Maria
authors.initials: M
authors.lastname: Sanjurjo-Saez
mesh_terms: D005762:Gastroenterology; D006302:Health Services Research; D006801:Humans; D008508:Medication Errors / Q000517:prevention & control*; D008510:Medication Systems, Hospital / Q000458:organization & administration*; D009741:Nursing Staff, Hospital / Q000458:organization & administration*; D017064:Process Assessment, Health Care; D058996:Quality Improvement; D017751:Safety Management / Q000592:standards*; D013030:Spain
keywords: FMECA, computerized prescription order entry; automated medication dispensing cabinet; drug administration; failure mode; failure mode and effects analysis