Sécurisation du circuit des chimiothérapies (évolution de l'organisation et des pratiques de préparation suite au passage d'un fonctionnement sous poste de sécurité microbiologique à isolateur)

La PUI du CHU d'Angers prépare des chimiothérapies au sein d'une ZAC dédiée. Cette ZAC a évolué suite à la mise en place d'une nouvelle URCC utilisant des isolateurs en remplacement des PSM. L'URCC avec les PSM utilise des poches semi-rigides, des aiguilles et des prises d'air pour les différentes étapes de reconstitution et préparation. Dans le cadre de l'amélioration de la sécurisation du circuit des chimiothérapies, ce travail présente les évolutions au niveau de la préparation. Afin de valider le procédé de fabrication et le personnel manipulateur sous les isolateurs, un test de remplissage aseptique est mis en place. Dans le but d'améliorer l'ergonomie et la sécurité du travail, de nouvelles références de poches souples munies d'une valve bidirectionnelle ou d'un dispositif annexe de sécurisation sont recherchées, testées puis choisies. De manière à diminuer le risque de piqûre des manipulateurs et réduire le risque de contamination chimique des systèmes de prélèvement sans aiguille pour flacon à petit et grand col sont recherchés, testés puis choisis. Les poches souples Freeflex® muni d'un dispositif de sécurisation annexe (CareFusion®), les dispositifs de prélèvement de chez Codan® et CairLGL® ont été retenus suite à ce travail. Les étapes de préparation des poches sont mieux sécurisées mais d'autres préparations ne le sont pas encore (seringues par exemple). De même, la sécurisation de l'administration n'a pas encore été entreprise avec notamment la problématique de la mise en place d'une tubulure purgée et du rinçage.ANGERS-BU Médecine-Pharmacie (490072105) / SudocSudocFranceF

Drug-Induced Acute Kidney Injury: A Study from the French Medical Administrative and the French National Pharmacovigilance Databases Using Capture-Recapture Method

Background: Acute kidney injury (AKI) is a public health concern. Among the pathological situations leading to AKI, drugs are preventable factors but are still under-notified. We aimed to provide an overview of drug-induced AKI (DIAKI) using pharmacovigilance and medical administrative databases Methods: A query of the PMSI database (French Medical Information System Program) of adult inpatient hospital stays between 1 January 2017 and 31 December 2018 was performed using ICD-10 (International Classification of Diseases 10th revision) codes to identify AKI cases which were reviewed by a nephrologist and a pharmacovigilance expert to identify DIAKI cases. In parallel, DIAKIs notified in the French Pharmacovigilance Database (FPVDB) were collected. A capture-recapture method was performed to estimate the total number of DIAKIs. Results: The estimated total number of DIAKIs was 521 (95%CI 480; 563), representing 20.0% of all AKIs. The notification was at a rate of 12.9% (95%CI 10.0; 15.8). According to the KDIGO classification, 50.2% of the DIAKI cases were stage 1 and 49.8% stage 2 and 3. The mortality rate was 11.1% and 9.6% required hemodialysis. Conclusion: This study showed that drugs are involved in a significant proportion of patients developing AKI during a hospital stay and emphasizes the severity of DIAKI cases

Suspicion of Fenofibrate-related Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) Syndrome: a Case Report

We describe a DRESS syndrome induced by fenofibrate. This side effect, rarely described with fenofibrate, should be known by clinicians to stop it immediately and avoid serious complications

High Incidence of Amoxicillin-Induced Crystal Nephropathy in Patients Receiving High Dose of Intravenous Amoxicillin

International audienceBackground: Amoxicillin (AMX)-induced crystal nephropathy (AICN) is considered as a rare complication of high dose intravenous (IV) AMX administration. However, recently, its incidence seems to be increasing based on French pharmacovigilance centers. Occurrence of AICN has been observed mainly with IV administration of AMX and mostly under doses over 8 g/day. Given that pharmacovigilance data are based on declaration, the real incidence of AICN may be underestimated. Thus, the primary objective of the present study was to determine the incidence of AICN in the current practice. Materials and Methods: We conducted a retrospective study between 1 January 2015 and 31 December 2017 in Angers University Hospital. Inclusion criteria were age over 18 years-old and IV AMX administration of at least 8 g/day for more than 24 h. Patients admitted directly into the intensive care units were excluded. Medical records of patients that developed Kidney Disease:Improving Global Outcome (KDIGO) stage 2–3 acute kidney injury (AKI) were reviewed by a nephrologist and a specialist in pharmacovigilance. AICN was retained if temporality analysis was conclusive, after exclusion of other causes of AKI, in absence of other nephrotoxic drug administration. Results: A total of 1303 patients received IV AMX for at least 24 h. Among them, 358 (27.5%) were exposed to AMX doses of at least 8 g/day and were included. Patients were predominantly males (68.2%) with a mean age of 69.1 years-old. AMX was administered for a medical reason in 78.5% of cases. Patients received a median dose of AMX of 12 g/day (152.0 mg/kg/day). Seventy-three patients (20.4%) developed AKI, 42 (56.8%) of which were KDIGO stage 2 or 3. Among the latter, AICN diagnosis was retained in 16 (38.1%) patients, representing an incidence of 4.47% of total patients exposed to high IV AMX doses. Only female gender was associated with an increased risk of AICN. AMX dose was not significantly associated with AICN development. Conclusion: This study suggests a high incidence of AICN in patients receiving high IV AMX doses, representing one third of AKI causes in our study. Female gender appeared as the sole risk factor for AICN in this study

Adverse Drug Reaction-Related to Drug Shortage: A Retrospective Study on the French National Pharmacovigilance Database

International audienceAIM: Drug shortage is a growing global health issue. The aim of the study was to evaluate the consequences of drug shortages on patient safety based on data recorded in the French Pharmacovigilance Database. METHODS: All cases involving drug shortages reported from 1985 to the end of 2019 were extracted from the database. RESULTS: Following the selection process, 462 cases were included. The number of cases increased significantly from 2004 to 2019. Cases mainly involved drugs from the nervous system (22.1%, CI95[17.5;27.0]), the cardiovascular system (16.4%, CI95[11.9;21.4]), and anti-infectives for systemic use (14.3%, CI95[9.7;19.2]) ATC classes. Most of the cases reported an adverse drug reaction (ADR) belonging to the SOC nervous system (21%, CI95[18;24]), skin and subcutaneous (14%, CI95[11;17]), general (13%, CI95[10;17]), and gastrointestinal (8%, CI95[5;11]) disorders. Disease worsening was observed in 15.9% of the cases, mostly related to a lack of efficacy of the replacement drug. Half of the cases were considered as serious. Evolution was favourable in 79.4% of the cases. Death and/or life-threatening situations were reported in 5.8% of the cases. Medication errors (ME) were identified in 51 cases (11%), mostly occurring at the administration step and involving a human factor. CONCLUSION: This study emphasises the clinical impact of drug shortage in terms of ADRs, ME and inefficiency. These observations underline the importance of a global health policy programme to limit the occurrence of drug shortages and to reinforce the information provided to patients and health care professionals in this context to limit risk