Ethanol Exposure During the Intravenous Administration of Chemotherapeutic Drugs: An Analysis of Clinical Practice and a Literature Review

2022 ◽  
Author(s):  
Quentin Hiver ◽  
Héloïse Henry ◽  
Michèle Vasseur ◽  
Elodie Cuvelier ◽  
Émilie Le Rhun ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Supportive Care ◽  
Medical Center ◽  
Ethanol Exposure ◽  
Routine Clinical Practice ◽  
Drug Formulation ◽  
European Medicines Agency ◽  
Antineoplastic Drugs ◽  
Chemotherapeutic Drugs ◽  
Chemical Code

PURPOSE: Injectable cytotoxics may be formulated with ethanol. This study sought to quantify the amount of ethanol exposure during chemotherapy infusions. MATERIALS AND METHODS: We first reviewed the antineoplastic drugs (Anatomical Therapeutic and Chemical code L01) and oncologic supportive care drugs (eg, antiemetics) currently available in France, to identify preparations containing ethanol. The amount of ethanol in the final chemotherapy preparation was calculated. Next, we performed a 2-year, single-center, retrospective analysis of injectable antineoplastic drug compounding in routine clinical practice in a French university medical center. Finally, we reviewed our results with regard to the literature data. RESULTS: Ten of the 60 cytotoxic products on the market contained ethanol at concentrations of up to 790 mg/mL, depending on the drug, formulation, and supplier. Several final preparations contained more than 3 g of ethanol per infusion (the maximum recommended by the European Medicines Agency); this was notably the case for gemcitabine, paclitaxel (up to 20 g ethanol per injection, for both), and etoposide (up to 50 g ethanol per infusion). The analysis of our compounding activity showed that 3,172 (4.99%) of the 63,613 chemotherapy preparations (notably paclitaxel) contained more than 3 g of ethanol. None of the oncologic supportive care drugs contained ethanol. CONCLUSION: Patients are exposed to ethanol during the infusion of antineoplastic drugs. With a view to better patient care, physicians and pharmacists should carefully evaluate the risk of ethanol exposure throughout the course of cytotoxic drug treatment.

scholarly journals Implementation of a cloud-based electronic patient-reported outcome (ePRO) platform in patients with advanced cancer

2021 ◽  
Vol 5 (1) ◽  
Author(s):  
Olga Generalova ◽  
Mohana Roy ◽  
Evan Hall ◽  
Sumit A. Shah ◽  
Kristen Cunanan ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Supportive Care ◽  
Healthcare Utilization ◽  
Advanced Cancer ◽  
Data Privacy ◽  
Medical Center ◽  
Academic Medical Center ◽  
Ease Of Use ◽  
Cancer Center ◽  
Patient Reported

Abstract Background Patient reported outcomes (PROs) have been associated with improved symptom management and quality of life in patients with cancer. However, the implementation of PROs in an academic clinical practice has not been thoroughly described. Here we report on the execution, feasibility and healthcare utilization outcomes of an electronic PRO (ePRO) application for cancer patients at an academic medical center. Methods We conducted a randomized trial comparing an experimental ePRO arm to standard of care in patients with advanced cancer in the thoracic, gastrointestinal, and genitourinary oncology groups at Stanford Cancer Center from March 2018 to November 2019. We describe the pre-implementation, implementation, and post-implementation phases of the ePRO arm, technological barriers, electronic health record (EHR) integration, clinician burden, and patient data privacy and security. Feasibility was pre-specified to be at least 70% completion of all questionnaires. Acceptability was based on patient and clinician feedback. Ambulatory healthcare utilization was assessed by reviewing numbers of phone messages, electronic portal messages, and referrals for supportive care. Results Of 617 ePRO questionnaires sent to 72 patients, 445 (72%) were completed. Most clinicians (87.5%) and patients (93%) felt neutral or positive about the ePRO tool’s ease of use. Exposure to ePRO did not cause a measurable change in ambulatory healthcare utilization, with a median of less than two phone messages and supportive care referrals, and 5–6 portal messages. Conclusions Web-based ePRO tools for patients with advanced cancer are feasible and acceptable without increasing clinical burden. Key lessons include the importance of pilot testing, engagement of stakeholders at all levels, and the need for customization by disease group. Future directions for this work include completion of EHR integration, expansion to other centers, and development of integrated workflows for routine clinical practice.

A Multifactorial Approach in Type 2 Diabetes Over 3 Years Decelerates Progression of Subclinical Arterial Disease in Routine Clinical Practice

Angiology ◽  
2021 ◽  
pp. 000331972110106
Author(s):  
George Konstantonis ◽  
Aikaterini Arida ◽  
Evaggelia Aissopou ◽  
Athanasios Protogerou ◽  
Nikolaοs Tentolouris ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Clinical Practice ◽  
Randomized Clinical Trials ◽  
Medical Center ◽  
Routine Clinical Practice ◽  
Vascular Pathology ◽  
Lipid Lowering ◽  
Multifactorial Approach ◽  
The Impact

The beneficial effect of multifactorial treatment of cardiovascular (CV) risk factors (RFs) in type 2 diabetes (T2D) is well established from randomized clinical trials. We prospectively evaluated the impact of such treatment in a real-world setting, on the development of subclinical arterial damage (SAD), as determined by structural/functional noninvasive biomarkers of vascular pathology (atheromatosis, carotid hypertrophy, arteriosclerosis). We prospectively studied 116 persons with T2D, treated with a multifactorial approach for CV RFs at a tertiary medical center, and 324 individuals without diabetes, for 3.2 years. The primary outcome was changes in vascular biomarkers related to SAD. At baseline, participants in the diabetes group had higher prevalence of SAD. At study end, the changes in clinical, biochemical, and lifestyle characteristics, as well as antihypertensive and lipid-lowering treatments, were comparable between the 2 groups. During follow-up, classical CV RFs (smoking, blood pressure, low-density lipoprotein-cholesterol, triglycerides) and behavioral features were significantly improved in both groups. Multivariate analysis, after adjusting for all classic CV RFs and use of antihypertensive/lipid-lowering therapies, demonstrated that all evaluated SAD biomarkers were similarly changed in the 2 groups. In conclusion, implementation of a multimodality approach of T2D treatment is feasible and efficacious in decelerating progression of SAD in routine clinical practice.

scholarly journals The challenge of managing severe delirium: an observational study of the effects of pharmacological and supportive care on delirium duration and resolution in 602 patients

2019 ◽  
Author(s):  
Carl Moritz Zipser ◽  
Peter Hayoz ◽  
Silvana Knöpfel ◽  
Peter Peyk ◽  
Maria Schubert ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Supportive Care ◽  
Proportional Hazards ◽  
Dual Therapy ◽  
Estimating Equation ◽  
Cox Proportional Hazards ◽  
Routine Clinical Practice ◽  
Hospitalised Patients ◽  
Observational Cohort ◽  
Management Approaches

Abstract Background: Delirium is the most common neuropsychiatric disorder seen in hospitalised patients. Current guidelines recommend only using antipsychotics with distressed patients. Nonetheless, in routine clinical practice, multiple psychotropics are commonly administered. More evidence on the short-term benefits of various management approaches in patients with delirium is required. Methods: In this observational cohort study, 602 delirious patients were followed for twenty days. Supportive care was provided to all patients in addition to either no psychotropic therapy, monotherapy, dual therapy, or polytherapy defined as three or more psychotropic drugs. The effectiveness of interventions regarding delirium resolution and symptom severity was determined by Cox proportional hazards regression and generalized estimating equation models. Results: Psychotropics were commonly used to manage delirium. In total, 12.1% of patients received polytherapy, 37.2% dual therapy, 37.7% monotherapy, and 12.1% supportive care alone (i.e., almost half of the patients received ≥ two psychotropics). Patients who received polytherapy had higher initial baseline delirium severity and exposed the mixed subtype more often; with the latter delirium lasted longer and recovery was less frequent than in mild delirium. Providing supportive care alone in mild delirium was superior to all psychotropic approaches. Conclusions: In routine clinical practice, the use of multiple psychotropics is common. In our study, however, despite combined supportive management and polypharmacy, patients with severe delirium suffer longer from delirium and have lower resolution rates. For the management of patients with mild delirium supportive care alone can be considered. When psychotropics are considered, single psychotropics and dose optimisation are recommended. These findings underline the challenge of managing severe delirium.

scholarly journals A European Observational Study to Evaluate the Safety and the Effectiveness of Safinamide in Routine Clinical Practice: The SYNAPSES Trial

2020 ◽  
pp. 1-12
Author(s):  
Giovanni Abbruzzese ◽  
Jaime Kulisevsky ◽  
Bruno Bergmans ◽  
Juan C. Gomez-Esteban ◽  
Georg Kägi ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Adverse Events ◽  
Real Life ◽  
Routine Clinical Practice ◽  
European Medicines Agency ◽  
Serious Adverse Events ◽  
Positive Effects ◽  
Special Groups ◽  
Psychiatric Conditions ◽  
Clinically Significant

Background: Safinamide modulates both dopaminergic and glutamatergic systems with positive effects on motor and non-motor symptoms of Parkinson’s disease (PD). The drug utilization study SYNAPSES was designed to investigate the use of safinamide in routine clinical practice, as recommended by the European Medicines Agency. Objective: To describe the occurrence of adverse events in PD patients treated with safinamide in real-life conditions. Methods: The SYNAPSES trial is an observational, European, multicenter, retrospective-prospective cohort study. Patients were followed up to 12 months with analyses performed in the overall population and in patients aged >75 years, with relevant comorbidities and with psychiatric conditions. Results: Of the 1610 patients included, 82.4% were evaluable after 12 months with 25.1% of patients >75 years, 70.8% with relevant comorbidities and 42.4% with psychiatric conditions. During observation 45.8% patients experienced adverse events, 27.7% patients had adverse drug reactions and 9.2% patients had serious adverse events. The adverse events were those already described in the patients’ information leaflet. The majority were mild or moderate and completely resolved and no differences were detected between the subgroup of patients. Clinically significant improvements were seen in the UPDRS motor score and in the UPDRS total score in ≥40% of patients, according to the criteria developed by Shulman et al. Conclusion: The SYNAPSES study confirms the good safety profile of safinamide even in special groups of patients. Motor complications and motor scores improved with clinically significant results in the UPDRS scale maintained in the long-term.

Diagnosis and Management of Cardiomyopathies – A Focus on Genetics, Cardiac Magnetic Resonance and Clinical Features

2011 ◽  
Vol 7 (3) ◽  
pp. 225
Author(s):  
Gianfranco Sinagra ◽  
Michele Moretti ◽  
Giancarlo Vitrella ◽  
Marco Merlo ◽  
Rossana Bussani ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Cardiac Magnetic Resonance ◽  
Magnetic Resonance ◽  
Imaging Techniques ◽  
Molecular Genetic ◽  
Molecular Genetic Analysis ◽  
Routine Clinical Practice ◽  
Clinical Approach ◽  
Diagnosis And Management ◽  
Made In

In recent years, outstanding progress has been made in the diagnosis and treatment of cardiomyopathies. Genetics is emerging as a primary point in the diagnosis and management of these diseases. However, molecular genetic analyses are not yet included in routine clinical practice, mainly because of their elevated costs and execution time. A patient-based and patient-oriented clinical approach, coupled with new imaging techniques such as cardiac magnetic resonance, can be of great help in selecting patients for molecular genetic analysis and is crucial for a better characterisation of these diseases. This article will specifically address clinical, magnetic resonance and genetic aspects of the diagnosis and management of cardiomyopathies.

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