Identification and prioritisation of risks in a hospital pharmacy using healthcare failure mode and effect analysis

Vida, María Ángeles Castro; Plata, Juan Enrique Martínez de la; Morales-Molina, José Antonio; Lázaro, Juan José Pérez; Robles, P Acosta

doi:10.1136/ejhpharm-2017-001242

Cited by 8 publications

(5 citation statements)

References 13 publications

(4 reference statements)

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“…Several studies have recognized the importance that HFMEA has when it comes to identifying failure modes (FMs), its causes and consequences in a variety of health-care processes, such as distribution and the administration of medicines, parenteral nutrition, and chemotherapy (31)(32)(33)(34)(35)(36)(37)(38)(39). As recently demonstrated in a study by Castro Vida et al (40), the HFMEA has been conducted in all processes and sub-processes in hospital pharmacies except for medicine-shortage management (40).…”

Section: Introductionmentioning

confidence: 99%

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

et al. 2020

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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 Miljković et al. HFMEA of European Medicine Shortages 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.

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Section: Introductionmentioning

confidence: 99%

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

et al. 2020

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“…For risk assessment and decision making, it is necessary to have complete information on the internal and external environment and risk carriers [9]. In accordance with this, we conducted a content analysis [6,8,[10][11][12][13][14], which allowed us to identify the main sources of risk, to identify them, and to classify them by the degree of consequences ( Fig. 1).…”

Section: Resultsmentioning

confidence: 99%

Research of the Main Components of Risk Management in Pharmacy

Євтушенко¹,

Жирова²,

Spichak³

2019

Proceedings of the 1st International Symposium Innovations in Life Sciences (ISILS 2019)

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A market economy characterized by existing of uncertainty and the possibility of choosing one or more development directions for the pharmaceutical market subjects causes risk situations. The reasons for their occurrence are usually the company affiliation, its size, form of ownership, legal status, technological integrity and degree of subordination, strategy, principles of the company, capital structure, resources and their use, quality and level of marketing, etc. Thus, the creation of an effective health care management system, and in particular of pharmacy, is impossible without the monitoring, accounting, assessment and management of risk situations arising from the practice. In connection with the above mentioned, the purpose of our study was to study the features of risk management in pharmacy.The structure of risk factors in the activity of the pharmaceutical organization with its division into internal and external ones has been developed, which will allow timely determinate the possibility of occurrence of adverse situations and introduce measures for their prevention or minimization. The list of these entities is the basis for developing risk management standards in a pharmaceutical company.

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“…To reduce the criticality, corrective actions have been proposed—mainly, the instauration of the double-checking before delivery. In the study of Castro Vida et al , 99 failures were identified, including 50 failures associated with medicine management and inpatient pharmaceutical care processes, with 11 failures considered as critical 29. The large number of failure modes identified in their study can be explained by more diversified pharmaceutical activities in comparison with our activity: pharmacotechnics and drug compounding, pharmacokinetics, nutrition and research.…”

Section: Discussionmentioning

confidence: 99%

Failure mode and effect analysis applied to improve the medication management process in a pharmacy of a teaching hospital and a proposal for a simplified rating system

2022

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BackgroundHealthcare is not as safe as it should be and medication error remains a significant source of preventable morbidity and mortality among patients.ObjectivesTo present a failure mode and effect analysis (FMEA) of the medication management process in the pharmacy of the largest teaching hospital in Tunisia. Secondly, to examine the validity of a proposed simplified risk rating method by comparing the degree of concordance with the FMEA rating system in classifying failure modes related to the studied process.MethodsThe FMEA method was applied to the medication management process in the pharmacy for 5 months from January 2020. For the traditional FMEA rating system, failure modes were prioritised according to the risk priority number, which considers severity, occurrence and non-detectability. Failure modes were classified for the traditional method considering three categories: accepted, requiring control and critical. The proposed rating system was based on two indices: the number of parts, which reflected severity, and the number of causes according to the 5M method (manpower, machines, material, methods and medium), which reflected occurrence. Failure modes were classified for the proposed method considering three categories: low, medium and high. Failure modes were independently analysed to determine the degree of agreement in ranking of risk between the two studied methods. Prioritised failure modes were targeted by decisions and solutions aiming to reduce risk and enhance safety.ResultsTwenty-four failure modes were identified for the six-step process of medication management in a pharmacy (overall criticality=2607). The most critical failure modes were: data error in drugs reception (risk priority number (RPN)=432), break in the cold chain (RPN=320) and non-optimal pharmaceutical analysis (RPN=280). A good agreement was found between the classic FMEA and the proposed rating methods (κ=0.795). A high correlation was shown between the two scorings (r=0.785). Three failure modes were underestimated by the proposed rating method.ConclusionsAn FMEA study on the medication management process in a teaching pharmacy showed that FMEA is an effective, proactive risk assessment that enables a better understanding of the studied process. The proposed risk scoring permits a good concordance with the classic method, with the advantage of being fast. Targeting the identified risks will allow integration into a continuous process of improvement and increase patient safety.

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Identification and prioritisation of risks in a hospital pharmacy using healthcare failure mode and effect analysis

Cited by 8 publications

References 13 publications

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

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

Research of the Main Components of Risk Management in Pharmacy

Failure mode and effect analysis applied to improve the medication management process in a pharmacy of a teaching hospital and a proposal for a simplified rating system

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