[Risk analysis applied to the monitoring of immunosuppressor concentrations in lung transplant recipients]

Ann Pharm Fr. 2025 Jan;83(1):153-162. doi: 10.1016/j.pharma.2024.09.010. Epub 2024 Sep 29.
[Article in French]

Abstract

Mastering and monitoring immunosuppressant concentrations is central to the care of lung transplant patients and involves multiple stakeholders. The objective is to conduct a risk analysis to evaluate the impact of various actions taken. The lung transplantation team was convened to carry out a failure mode effect analysis. The process was divided into stages where different risks were identified. The risk priority number (RPN) (severity, frequency, detectability) and risk level of criticality (frequency, severity) were established before implementation of actions (before 2009) and then after (in 2022) to classify risks according to four levels of criticality. The implemented actions included the establishment of a quality assurance process, computerization of monitoring, and double analysis by a physician/pharmacist pair. Thirty-two risks were identified during the four stages of the process: biological sampling (n=13), reception (n=3), analysis and treatment of levels (n=5), transmission of information/prescriptions to the patient (n=11). The total raw RPN (before 2009) was 839, with 12 major risks. The current total RPN (in 2022) was 452 (a decrease of 46.1%), with 7 major risks identified. The analysis enabled the objective evaluation of the effectiveness of the actions taken. The most secure stage of the process is the reception of residual level results. Efforts should focus on empowering and involving patients, as well as engaging local stakeholders in collaboration with the specialized transplantation team.

Keywords: Analyse des modes de défaillance et de leurs effets en soin de santé; Drug monitoring; Healthcare failure mode and effect analysis; Immunosuppresseurs; Immunosuppressive agents; Index thérapeutique; Lung transplantation; Surveillance des médicaments; Therapeutic index; Transplantation pulmonaire.

Publication types

  • English Abstract

MeSH terms

  • Drug Monitoring* / methods
  • Healthcare Failure Mode and Effect Analysis
  • Humans
  • Immunosuppressive Agents* / therapeutic use
  • Lung Transplantation*
  • Risk Assessment
  • Transplant Recipients

Substances

  • Immunosuppressive Agents