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.

BACKGROUND: Healthcare is not as safe as it should be and medication error remains a significant source of preventable morbidity and mortality among patients. OBJECTIVES: To 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. METHODS: The 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. RESULTS: Twenty-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. CONCLUSIONS: An 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.

Cirrhotic cardiomyopathy.

The presence of cardiocirculatory dysfunction in liver cirrhosis has been described since 1960 and it was exclusively attributed to alcoholic cardiomyopathie. Only in the last two decades, the term of cirrhotic cardiomyopathy (CCM) was introduced to describe cardiac dysfunction in patients with cirrhosis. This entity is currently underdiagnosed because the disease is usually latent and manifests when the patient is under stress. However, overt cardiac failure has been described after transjugular intrahepatic portosystemic shun and liver transplantation. The diagnosis of CCM is still difficult to determine because of the lack of specific diagnosis tools. CCM is characterized by systolic dysfunction, diastolic dysfunction and electrophysiological abnormalities. At present, there is no specific treatment outside liver transplantation in the light of increased mortality and postoperative complications.Our review provides an overview of CCM, its definition, prevalence, pathogenic mechanisms, clinical presentation, various explorations and management in light of the most recent published literature.