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: Health-care 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 on the basis of 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 HSs; 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 HS 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 health-care professionals manage to secure optimal antimicrobial treatment for patients using available IT and human resources.
Highlights
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
The hospitals included in this study represented a broad spectrum of large (H-AT and H-BE) and smaller hospitals (H-CR, H-GR, H-SP, and H-SR) in number of hospital beds, physicians, hospital pharmacists, and pharmacy technicians (Table 1)
In H-AT and H-BE, this assessment is informed by their respective official national shortage websites
Summary
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. Following medicine shortages, providing a suitable, clinically appropriate and safe alternative medicine to a patient is a priority to every health-care professional [3, 4]. Many risks may occur when substituting medicines including reducing the treatment effectiveness and threatening patient safety [5]. These risks include, among others, incorrectly comparing the alternative medicine’s administration patterns to the initial treatment, miscommunicating them to health-care professionals, and underestimating the potential for new drug–drug interactions [5]. A survey conducted by the ISMP revealed that medicine shortages pose a challenge to health-care professionals to provide safe medication treatment and avoid life-threatening medication errors, compromising the health-care process and affecting patient safety [5]. The World Health Organization (WHO) Medication Without Harm initiative considers that the aforementioned errors and malpractice could be avoided through ensuring safer processes encompassing the prescription of the medicine, as well as its dispensing, preparation, and administration [6]
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
