Chemotherapeutic errors in hospitalised cancer patients: attributable damage and extra costs

<p>Abstract</p> <p>Background</p> <p>In spite of increasing efforts to enhance patient safety, medication errors in hospitalised patients are still relatively common, but with potentially severe consequences. This study aimed to assess antineoplastic medication errors in both affected patients and intercepted cases in terms of frequency, severity for patients, and costs.</p> <p>Methods</p> <p>A 1-year prospective study was conducted in order to identify the medication errors that occurred during chemotherapy treatment of cancer patients at a French university hospital. The severity and potential consequences of intercepted errors were independently assessed by two physicians. A cost analysis was performed using a simulation of potential hospital stays, with estimations based on the costs of diagnosis-related groups.</p> <p>Results</p> <p>Among the 6, 607 antineoplastic prescriptions, 341 (5.2%) contained at least one error, corresponding to a total of 449 medication errors. However, most errors (n = 436) were intercepted before medication was administered to the patients. Prescription errors represented 91% of errors, followed by pharmaceutical (8%) and administration errors (1%). According to an independent estimation, 13.4% of avoided errors would have resulted in temporary injury and 2.6% in permanent damage, while 2.6% would have compromised the vital prognosis of the patient, with four to eight deaths thus being avoided. Overall, 13 medication errors reached the patient without causing damage, although two patients required enhanced monitoring. If the intercepted errors had not been discovered, they would have resulted in 216 additional days of hospitalisation and cost an estimated annual total of 92, 907€, comprising 69, 248€ (74%) in hospital stays and 23, 658€ (26%) in additional drugs.</p> <p>Conclusion</p> <p>Our findings point to the very small number of chemotherapy errors that actually reach patients, although problems in the chemotherapy ordering process are frequent, with the potential for being dangerous and costly.</p

Systemic approach to medication risk in cancerology

L’iatrogénie induite par les erreurs médicamenteuses est un problème majeur de santé publique. Ce travail a pour objectif de développer une approche systémique visant à réduire leur occurrence en cancérologie. L’étude est menée aux Hospices Civils de Lyon au sein du Groupement Hospitalier Sud. L’analyse des erreurs médicamenteuses interceptées, sur une période de 5 ans, révèle que 4 prescriptions de chimiothérapie sur 100 présentent au moins une erreur médicamenteuse, dont plus de la moitié sont des erreurs de dose. Les facteurs de risque d’erreurs de prescription identifiés sont la prescription par un interne, l’hospitalisation conventionnelle, le patient ayant une surface corporelle supérieure à 2 m², les protocoles de plus de trois médicaments anticancéreux, comprenant du carboplatine ou nécessitant une modification par le prescripteur. L’évaluation de la gravité clinique potentielle des erreurs médicamenteuses montre que 13,4% d’entre elles auraient causé un préjudice temporaire et 2,6% un préjudice permanent. Le pronostic vital aurait été engagé dans 2,6% des cas conduisant au décès pour 6 patients sur une période d’un an. L’évaluation médico-économique permet d’estimer le coût pour l’assurance maladie d’une erreur médicamenteuse en cancérologie avec conséquences cliniques à 1 523€ associé à 3,5 journées d’hospitalisation supplémentaires. Cette approche systémique conduit au développement de revues d’erreurs médicamenteuses et de morbi-mortalité, socle de l’analyse collective indispensable à la prévention du risque médicamenteux en cancérologieMedication errors are a major public health problem. This work aims to develop a systemic approach to reduce their occurrence in oncology. The study was conducted in Groupement Hospitalier Sud (Hospices Civils de Lyon). The analysis of intercepted medication errors, over a period of five years, reveals that four out of 100 prescriptions of chemotherapy include at least one medication error, which over half are dose errors. Risk factors of prescribing errors identified are prescription by a resident physician, inpatient care, patient with a body surface area greater than 2 m², protocol with more that three anticancer drugs, protocol involving carboplatin or protocol requiring at least one modification by the physician. 13.4% of avoided errors would have resulted in temporary injury and 2.6% in permanent damage. The vital prognosis of the patient would have been compromised in 2.6% of cases leading to death for six patients over a period of one year. The cost of one medication error with clinical consequences was estimated at € 1 523 associated to 3.5 additional days of hospitalisation. This approach led to the development of systematic medication errors reviews and morbi-mortality conferences that allow a collective and multidisciplinary analysis to enhance the patient’s safet

Impact médico-économique de la prévention des erreurs médicamenteuses en cancérologie (étude prospective d'un an au Groupement Hospitalier Sud, Hospices Civils de Lyon)

LYON1-BU Santé (693882101) / SudocSudocFranceF

Expériences médicamenteuses et expériences du cancer. L'appropriation des anticancéreux oraux par les patients

International audienc

Physico-Chemical Stability of Sodium Thiosulfate Infusion Solutions in Polyolefin Bags at Room Temperature over a Period of 24 Hours

Many publications described sodium thiosulfate used to prevent the renal toxicity induced by cisplatin hyperthermic intraperitoneal chemotherapy. After around 60 or 90 minutes of hyperthermic chemotherapy, cisplatin was drained and then, sodium thiosulfate was infused by intravenous route. Sodium thiosulfate is used in two steps: a first step, at 9 g/m2 in 250 mL of 0.9 % sodium chloride over 10 minutes followed by a second step, at 12 g/m2 in 1000 mL of 0.9 % sodium chloride over 6 hours. The purpose of this work was to study the stability of sodium thiosulfate at 16 mg/mL in 0.9 % sodium chloride polyolefin bags 1000 mL and at 72 mg/mL in 0.9 % sodium chloride polyolefin bags 250 mL, at 25 °C, protected or unprotected from light

Ovarian cancer in the older patient: where are we now? What to do next?

In recent years, major advances have been made toward the individualization of epithelial ovarian cancer care, leading to an overall improvement of patient outcomes. However, real-life data indicate that the oldest populations do not benefit from this, due to aspects related to cancer (more aggressive histopathological features), treatment (i.e. frequently suboptimal), and the host (increased toxicities in patients with lower physiological reserve). A specific risk–benefit perspective should therefore be taken when considering surgery, chemotherapy, and maintenance treatments: the decision for cytoreductive surgery should include geriatric vulnerability and surgical complexity, neo-adjuvant chemotherapy being an option when primary surgery appears at high risk; carboplatin paclitaxel association remains the standard even in vulnerable older patients; and bevacizumab and poly(ADP-ribose) polymerase inhibitors maintenance are interesting options provided they are prescribed according to their indications with a close monitoring of their toxicities. Future studies should aim to individualize care without limiting access of older patients to innovation. A specific focus is needed on age-specific translational analyses (focusing on tumor mutational burden and impaired biological pathways), a better patient stratification according to geriatric parameters, an adaptation of both oncological treatment and geriatric interventions, and treatment adaptations not a priori but according to formal pharmacokinetic data

Development of Indirect Health Data Linkage on Health Product Use and Care Trajectories in France: Systematic Review

BackgroundEuropean national disparities in the integration of data linkage (ie, being able to match patient data between databases) into routine public health activities were recently highlighted. In France, the claims database covers almost the whole population from birth to death, offering a great research potential for data linkage. As the use of a common unique identifier to directly link personal data is often limited, linkage with a set of indirect key identifiers has been developed, which is associated with the linkage quality challenge to minimize errors in linked data. ObjectiveThe aim of this systematic review is to analyze the type and quality of research publications on indirect data linkage on health product use and care trajectories in France. MethodsA comprehensive search for all papers published in PubMed/Medline and Embase databases up to December 31, 2022, involving linked French database focusing on health products use or care trajectories was realized. Only studies based on the use of indirect identifiers were included (ie, without a unique personal identifier available to easily link the databases). A descriptive analysis of data linkage with quality indicators and adherence to the Bohensky framework for evaluating data linkage studies was also realized. ResultsIn total, 16 papers were selected. Data linkage was performed at the national level in 7 (43.8%) cases or at the local level in 9 (56.2%) studies. The number of patients included in the different databases and resulting from data linkage varied greatly, respectively, from 713 to 75,000 patients and from 210 to 31,000 linked patients. The diseases studied were mainly chronic diseases and infections. The objectives of the data linkage were multiple: to estimate the risk of adverse drug reactions (ADRs; n=6, 37.5%), to reconstruct the patient’s care trajectory (n=5, 31.3%), to describe therapeutic uses (n=2, 12.5%), to evaluate the benefits of treatments (n=2, 12.5%), and to evaluate treatment adherence (n=1, 6.3%). Registries are the most frequently linked databases with French claims data. No studies have looked at linking with a hospital data warehouse, a clinical trial database, or patient self-reported databases. The linkage approach was deterministic in 7 (43.8%) studies, probabilistic in 4 (25.0%) studies, and not specified in 5 (31.3%) studies. The linkage rate was mainly from 80% to 90% (reported in 11/15, 73.3%, studies). Adherence to the Bohensky framework for evaluating data linkage studies showed that the description of the source databases for the linkage was always performed but that the completion rate and accuracy of the variables to be linked were not systematically described. ConclusionsThis review highlights the growing interest in health data linkage in France. Nevertheless, regulatory, technical, and human constraints remain major obstacles to their deployment. The volume, variety, and validity of the data represent a real challenge, and advanced expertise and skills in statistical analysis and artificial intelligence are required to treat these big data

Economic impact of clinical pharmaceutical activities in hospital wards: A systematic review

International audienceThe positive impact of clinical pharmacy services (CPS) in improving clinical outcomes such as reduction of drug related problems is well demonstrated. Despite these results, the deployment of these activities is not systematically observed in the hospital setting.Objectives: This systematic review first aimed to describe existing evidence regarding economic evaluation of ward-based CPS focusing on the entire treatment of a patient in a hospital setting. Secondly, the quality of economic evaluations of existing evidence was assessed.Methods: A comprehensive literature search was performed in PubMed/Medline, Science Direct and the NHS Economic Evaluation databases from January 2000 to March 2019. English or French language articles describing an economic evaluation of ward-based CPS on inpatients in hospital settings were included. Articles not describing a single study, dealing with a CPS not considering the entire medication regimen of the patient or presenting both inpatient and outpatient CPS were excluded. Selected articles were analyzed according to Drummond's check-list for assessing economic evaluations.Results: Forty-one studies were included. About one third were American publications. CPS implemented in ICU represented about half of the selected articles. Pharmacist-to-bed ratios varied according to countries and care unit type with the most favorable ratios in ICU and in American studies. Cost-avoidance was mostly used to express economic impact and ranged from €1579 to €3,089 328. Studies yielding the greater economic impact were conducted in the USA with implementation of full-time equivalents pharmacists or establishing of collaborative practice agreements. Only 6 articles dealt correctly with at least 7 of the 10 Drummond's checklist assessment criteria.Conclusion: This review suggests that the existing evidence is not sufficient to conclude to a positive economic impact of CPS conducted according to clinical pharmacy guidelines. Funding resources, remuneration of clinical pharmacy activities and provision of standardized national clinical and economic databases appear to be essential evolutions to improve CPS development

Cidofovir in the Treatment of BK Virus-Associated Hemorrhagic Cystitis after Allogeneic Hematopoietic Stem Cell Transplantation

International audienceAfter allogeneic hematopoietic stem cell transplantation (HSCT), BK virus-associated hemorrhagic cystitis (BKV-HC) is a common complication. Although supportive measures have been the standard of care for many years, several studies suggested the efficacy of cidofovir. The aim of this study was to assess the safety profile and efficacy of cidofovir. A retrospective study was conducted on all patients treated with cidofovir in our HSCT unit between March 2011 and May 2013. Data for efficacy (partial [PR] or complete response [CR]), prescription (dose, frequency, number of doses, and administration route), and toxicity were collected from published reports and medical files. Renal toxicity was evaluated using creatinine clearance calculated with the Cockcroft and Gault formula. A parallel literature search using PubMed (last search, May 2015) was performed. From March 2011 to June 2013, 27 of 181 patients undergoing allogeneic HSCT in our department received cidofovir for BKV-HC: 24 (88.9%) intravenously, 1 intravesically, and 2 via both routes. Mean dose was 5 mg/kg per administration, for a median of 4 injections (range, 1 to 11), from twice a week to once every 2 weeks. CR was achieved in 22 patients (81.5%), PR in 2, and no response in 2 patients. Eight patients presented renal failure (29.6%): 6 moderate (creatinine clearance \\textless 60 mL/min) and 2 severe (creatinine clearance \\textless 30 mLmin). Mean decrease in creatinine clearance after cidofovir was 27% (35 mL/min; range, 2 to 159). In 3 cases renal insufficiency and hematologic toxicity led to discontinuation of treatment or switch to intravesical instillation. For 3 patients cidofovir dose was reduced because of nephrotoxicity. Thirteen studies have reported on the use of cidofovir for BKV-HC (204 patients) since 2005. Intravenous cidofovir was used for 91.3% of patients, with doses ranging from .5 to 5 mg/kg. The main toxicity reported was renal failure (9% to 50% in 9 studies). Between 60% and 100% of CRs were observed independently of cidofovir dose or administration route. Cidofovir is an effective therapy for BKV-HC but requires very precise renal function management to avoid toxicity. Cidofovir treatment modalities (high dose, intravesical instillation, or low dose