Using Prospective Risk Analysis Tools to Improve Safety in Pharmacy Settings: A Systematic Review and Critical Appraisal

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This study aimed to review and critically appraise the published literature on 2 selected prospective risk analysis tools, Failure Mode and Effects Analysis and Socio-Technical Probabilistic Risk Assessment, as applied to the dispensing of medicines in both inpatient and outpatient pharmacy settings.


A comprehensive search of electronic databases (PubMed and Scopus) was conducted (January 1990–March 2016), supplemented by hand search of reference lists. Eligible articles were assessed for data sources used for the risk analysis, uniformity of the risk quantification framework, and whether the analysis teams assembled were multidisciplinary.


Of 1011 records identified, 11 articles met our inclusion criteria. These studies were mainly focused on dispensing of high-alert medications, and most were conducted in inpatient settings. The main risks identified were transcription, preparation, and selection errors, whereas the most common corrective actions included electronic transmission of prescriptions to the pharmacy, use of barcode, and medication safety training. Significant risk reduction was demonstrated by implementing corrective measures in both inpatient and outpatient pharmacy settings. The main Failure Mode and Effects Analysis limitations were its subjectivity and the lack of common risk quantification criteria.


The prospective risk analysis methods included in this review revealed relevant safety issues and hold significant potential for risk reduction. They were deemed suitable for application in both inpatient and outpatient pharmacy settings and should form an integral part of any patient safety improvement strategy.

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