AUTHOR=Miljković Nenad , Godman Brian , van Overbeeke Eline , Kovačević Milena , Tsiakitzis Karyofyllis , Apatsidou Athina , Nikopoulou Anna , Yubero Cristina Garcia , Portillo Horcajada Laura , Stemer Gunar , Kuruc-Poje Darija , De Rijdt Thomas , Bochenek Tomasz , Huys Isabelle , Miljković Branislava 

TITLE=Risks in Antibiotic Substitution Following Medicine Shortage: A Health-Care Failure Mode and Effect Analysis of Six European Hospitals

JOURNAL=Frontiers in Medicine

VOLUME=Volume 7 - 2020

YEAR=2020

URL=https://www.frontiersin.org/journals/medicine/articles/10.3389/fmed.2020.00157

DOI=10.3389/fmed.2020.00157

ISSN=2296-858X

ABSTRACT=Introduction
Medicine shortages result in great risk for the continuity of patient care especially for antimicrobial treatment potentially enhancing resistance rates and having a higher economic impact. This study aims to identify, describe, assess and assign risk priority levels to potential failures following substitution of antimicrobial treatment due to shortages among European hospitals. Furthermore, the study investigated the impact of corrective actions on risk reduction so as to provide guidance and improve future patient care.
Methods
Healthcare Failure Mode and Effect Analysis (HFMEA) was applied to hospitals in Austria (H-AT), Belgium (H-BE), Croatia (H-CR), Greece (H-GR), Spain (H-SP) and Serbia (H-SR). Multidisciplinary teams identified processes, failure modes, causes, and corrective actions related to antibiotic substitution following medicine shortages. Characteristics of study hospitals as well as severity, probability and hazard scores (HSs) of failure modes/causes were analyzed using Microsoft Office Excel 2010 and IBM SPSS Statistics® via descriptive and inferential statistics.
Results
Through HFMEA, 74 failure modes were identified, with 53 of these scoring 8 or above based on assigned severity and probability for a failure. Severity of failure modes differed before and after corrective actions in H-CR; H-GR and H-SR (p<0.005). Their probability differed in all study hospitals (p<0.005) when compared before and after corrective actions aimed to be implemented. The highest number of failure-mode causes was detected in H-CR (46) and the lowest in H-SP (16). Corrective actions can address failure modes and lower hazard scores; therein all teams proposed the following: structuring communication among stakeholders, introducing electronic prescribing, strengthening pharmacists’ involvement and increasing effectiveness of the ward stock assessment. These proposed actions led to hazard score reductions up to 83%.
Conclusion
There is a lack of structure in addressing risks associated with antibiotic substitution following shortages. Furthermore, lack of communication, data scarcity on availability of antibiotics, non-supportive Information Technology (IT) systems, and lack of internal substitution protocols hinder quick assessment of alternatives addressing patient needs. Nevertheless, the study shows that healthcare professionals manage to secure optimal antimicrobial treatment for patients using available IT and human resources.