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INTRODUCTION: Oral folic acid supplementation is essential for patients treated with pemetrexed, to prevent the risk of severe hematologic toxicity. In case of intestinal absorption disorder, no recommendations exist for intravenous folic acid supplementation. CASE REPORT: We describe a 74-year-old patient with multimetastatic non-small-cell lung adenocarcinoma, receiving first-line chemotherapy with carboplatin AUC5, pemetrexed 500â mg/m2 and pembrolizumab 200â mg intravenously every 3 weeks. The patient presented neglected celiac disease, resulting in malabsorption syndrome with iron and folic acid deficiency. The question was how to administer folic acid supplementation during the pemetrexed-based chemotherapy. MANAGEMENT AND OUTCOMES: Intravenous injection of 200â mg levoleucovorin on day 1 of cycle 1 of pemetrexed-based chemotherapy was administered and well tolerated. During the second cycle, the levoleucovorin perfusion was not renewed by omission. The patient was hospitalized for 7 days because of febrile aplasia. Piperacillin-tazobactam was started, and then switched to amoxicillin-clavulanate plus ciprofloxacin. After this episode of post-chemotherapy febrile aplasia, it was decided to systematically supplement the patient with intravenous levoleucovorin, with blood folate concentration monitoring at each cycle. At 16 months after start of treatment, the patient was in complete remission, indicating that the immune-chemotherapy was effective, with no further febrile neutropenia. DISCUSSION/CONCLUSION: This case report highlights intravenous levoleucovorin supplementation as an alternative to oral folic acid if needed during pemetrexed-antifolate-based chemotherapy.
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Adenocarcinoma , Carcinoma Pulmonar de Células não Pequenas , Doença Celíaca , Neoplasias Pulmonares , Humanos , Idoso , Pemetrexede/uso terapêutico , Carcinoma Pulmonar de Células não Pequenas/tratamento farmacológico , Carcinoma Pulmonar de Células não Pequenas/patologia , Neoplasias Pulmonares/tratamento farmacológico , Neoplasias Pulmonares/patologia , Injeções Intravenosas , Levoleucovorina , Doença Celíaca/tratamento farmacológico , Doença Celíaca/etiologia , Ácido Fólico/uso terapêutico , Suplementos Nutricionais , Adenocarcinoma/tratamento farmacológico , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêuticoRESUMO
INTRODUCTION: Recent advances in technology have made it possible to develop robots for preparing injectable anticancer drugs. This study aims to compare characteristics between robots available in the European market in 2022 and to help future pharmacy users in their choices. METHODS: Three sources of data were used: (1) a review of published articles in the MEDLINE database from November 2017 to end of June 2021 on chemotherapy-compounding robots used in hospital; (2) all manufacturers' documentation, and (3) demonstrations of robot operations in real hospital conditions and discussions with users and manufacturers. Robot characteristics included number of robots installed, general technical characteristics, type of injectable chemotherapy produced and compatible materials, productivity data, preparation control methods, residual manual tasks, chemical and microbiological risk management, cleaning method, software, and implementation time. RESULTS: Seven robots commercialized were studied. Several technical characteristics have to be taken into account in selecting the robot whose match the specific needs of a particular hospital, and which often require rethinking the current production workflow as well as the organization of the pharmacy unit. In addition to increasing productivity, the robots improve the quality of production thanks to better traceability, reproducibility, and precision of sampling. They also improve user protection against chemical risk, musculoskeletal disorders, and needle wounds. Nevertheless, when robotization is being planned, there are still numerous residual manual tasks to keep in mind. CONCLUSION: Robotization of the production of injectable anticancer drugs is booming within anticancer chemotherapy preparation pharmacy units. Feedback from this experience needs to be further shared with the pharmacy community regarding this significant investment.
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Antineoplásicos , Serviço de Farmácia Hospitalar , Farmácia , Robótica , Humanos , Robótica/métodos , Reprodutibilidade dos Testes , Serviço de Farmácia Hospitalar/métodosRESUMO
BACKGROUND: European 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. OBJECTIVE: The 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. METHODS: A 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. RESULTS: In 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. CONCLUSIONS: This 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.
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Inteligência Artificial , Armazenamento e Recuperação da Informação , Humanos , Sistema de Registros , Hospitais , Big DataRESUMO
OBJECTIVES: In the context of the SARS-CoV-2 pandemic, hospital pharmacists supported the implementation of recommendations and ensured the safety of patient medication management. The aim of this study is to establish the interest of the involvement of the hospital pharmacist in this context by describing and comparing the activities carried out with patients with COVID-19 and those without. METHODS: During the study period, data on clinical pharmacy activities with hospitalized patients were collected and analyzed: pharmaceutical analysis of prescriptions, participation in multi-professional consultation meetings (RCP) dedicated to COVID-19, and monitoring of adverse events. RESULTS: The activities concerned 1483 patients, including 444 with COVID-19, resulting in 575 pharmaceutical interventions (PI). The main problems identified were overdoses, untreated indications, and drug-drug interactions (DDI). AMIs were significantly more common in patients with COVID-19, with 73.3% involving disease-specific therapies. Eleven PIs had a life-threatening impact, 189 a major impact. During the PCRs, 36 PIs were performed for 59% of the patients presented. A pharmacovigilance report was performed for a quarter of patients treated with hydroxychloroquine and 33% of patients treated with lopinavir/ritonavir. CONCLUSIONS: This study demonstrates the value of involving hospital pharmacists in the drug management of patients with COVID-19, particularly with the evolution of available therapies and the implementation of vaccination, in order to reduce the spread of SARS-COV2 and limit the appearance of resistance.
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COVID-19 , SARS-CoV-2 , Humanos , Farmacêuticos , Pandemias , RNA Viral , Assistência ao Paciente , HospitaisRESUMO
BACKGROUND: Cancer patients are being exposed to antineoplastic drugs more frequently and for longer periods, resulting in a higher risk of hypersensitivity reactions. The aim of this study was to assess the pharmaceutical time and direct cost of drug allergy explorations following immediate hypersensitivity reactions to antineoplastic agents. METHODS: A micro-costing method was used to collect data on consumption of human and material resources for allergy exploration preparations. The monetisation was carried out on the basis of prices and hourly wage costs applied in 2018. The number and type of allergy explorations prepared by the pharmacy as well as nature of antineoplastic drugs tested, and the number of culprit drugs reintroductions were collected. RESULTS: Almost 1.5â h is required to realise allergy tests for one patient including pharmacist time for prescription analysis and pharmacy technician's time for tests preparation. The mean manufacturing cost of these tests is estimated at 62.87 (57.82-65.49) per culprit drug for one patient. Programming patients according to culprit drugs tested allows rationalising healthcare provider time and increasing efficiency. From January 2010 to December 2018, 277 patients were tested and 490 allergy explorations were performed, corresponding to more than 5000 preparations. Mostly, the culprit drug could be reintroduced (n = 383, 78.2%) allowing patients to receive the best possible treatment. CONCLUSION: Management of hypersensitivity reactions is constantly progressing, as it contributes to improving patient care in oncology. This activity is time-consuming for the pharmacy team but allows patients with previous hypersensitivity reaction to continue effective treatment.
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Antineoplásicos , Hipersensibilidade a Drogas , Hipersensibilidade Imediata , Farmácia , Antineoplásicos/efeitos adversos , Hipersensibilidade a Drogas/etiologia , Hipersensibilidade a Drogas/terapia , Humanos , Hipersensibilidade Imediata/induzido quimicamente , Testes CutâneosRESUMO
This study aims to evaluate the impact of implementing a specialized clinical pharmacy program in patients with allogeneic hematopoietic stem cell transplant (HSCT) on their adherence to the immunosuppression treatment after discharge. A prospective open interventional design using a retrospective control group was used. The intervention was based on pharmaceutical consultations: the first was performed the day before discharge of HSCT unit and the next consultations during day-care follow-up (weeks 2 and 4 after discharge). Proactive medication reconciliation was implemented with a complete list of medications before the discharge prescription. The discharge prescription summarized on a personalized drug schedule was explained to the patient. The importance of optimal adherence and the potential problems related to self-medication were explained to the patient. Immunosuppression drug adherence was assessed by a direct method using serum levels of calcineurin inhibitors. The potential impact on acute GvHD, and infection was investigated. Twenty-six patients were included in the specialized clinical pharmacy program and 35 patients were in the control group. Seventy-nine pharmaceutical consultations were conducted in the intervention group, lasting a mean 25 min and 16 min for the first and following consultations, respectively. Serum levels in the therapeutic target range were higher in the intervention group (61.5% versus 53.0%, p = 0.07), with greater intra-individual variation (p = 0.005). There was no significant intergroup difference in acute GvHD (53.8% versus 50.3%, p = 0.85) or infection (26.9 versus 22.8%, p = 0.72). The implementation of a specialized clinical pharmacy program for patients who have received allogeneic HSCT seems to be beneficial for immunosuppression drug adherence; this now needs to be confirmed in a multicenter study involving a larger number of patients.
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The rapid emergence of expensive anticancer therapies is leading to exponential growth in healthcare expenses. In clinical trials, most investigational drugs are provided free of charge by industrial and academic sponsors. This results in drug cost savings for healthcare payers, who are no longer charged with the cost of the standard-of-care treatment, which would have been administered outside the trial. This study aims to estimate drug cost savings resulting from patient enrolment in hematological oncology clinical trials, from a public payer perspective. Retrospective screening identified all patients with hematological malignancies included from 2011 to 2016 in a phase III trial and having received at least one sponsor-provided cycle. Drug cost savings were defined as the standard treatment costs not charged to the payer due to sponsor provision of treatment. For each patient, cost savings were determined by the number of cycles received in the trial and the cost of standard (control arm) treatment. Of the 345 patients included in eligible trials during study period, 272 received sponsor-provided drugs. Drug cost savings could be estimated for 177 patients (65.1%) included in 27 trials. Total cost savings were 5218 million (US$ 6804 million) for 1720 sponsor-provided cycles. Mean cost saving per patient was 19 182.7 ± 29 865.7 ($25 015.24 ± 39 478.25). Most cost-saving trials were industry-sponsored (77.8%), although academic trials generated 40.15% of total cost savings. Enrolling patients in clinical trials, whether industry-sponsored or academic, leads to substantial drug cost savings for payers. Implications are significant for public payers facing increasing financial constraints, as savings can be reallocated to patient care.
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Protocolos de Quimioterapia Combinada Antineoplásica/economia , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Redução de Custos , Análise Custo-Benefício , Neoplasias Hematológicas/tratamento farmacológico , Neoplasias Hematológicas/economia , Hospitais Universitários/economia , Humanos , Prognóstico , Estudos RetrospectivosRESUMO
Two autologous anti-CD19 chimeric antigen receptors (CAR) T cells (axicabtagene ciloleucel [axi-cel] and tisagenlecleucel [tisa-cel]) are commercially approved in Europe for relapsed/refractory (R/R) diffuse large B cell lymphoma (DLBCL). We performed a retrospective study to evaluate patterns of use, efficacy and safety for axi-cel and tisa-cel. Data from 70 patients who underwent apheresis for commercial CAR T cells between January 2018 and November 2019 in our institution were retrospectively collected. Sixty-one patients were infused. The median age at infusion was 59 years old (range 27-75 years). The median number of prior therapies was 3 (range, 2-6). The overall response rates (ORRs) at 1 month and 3 months were 63% and 45%, respectively, with 48% and 39% achieving a complete response (CR), respectively. After a median follow-up after infusion of 5.7 months, the median progression-free survival (PFS) was 3.0 months (95% CI, 2.8-8.8 months), and the median overall survival (OS) was 11.8 months (95% CI, 6.0-12.6 months). In multivariate analysis, factors associated with poor PFS were the number of previous lines of treatment before CAR T cells (≥4) (P = .010) and a C reactive protein (CRP) value >30 mg/L at the time of lymphodepletion (P < .001). Likewise, the only factor associated with a shorter OS was CRP >30 mg/L (P = .009). Cytokine release syndrome (CRS) of any grade occurred in 85% of patients, including 8% of patients with CRS of grade 3 or higher. Immune cell-associated neurotoxicity syndrome (ICANS) of any grade occurred in 28% of patients, including 10% of patients with ICANS of grade 3 or higher. Regarding efficacy and safety, no significant difference was found between axi-cel and tisa-cel. This analysis describes one of the largest real-life cohorts of patients treated with axi-cel and tisa-cel for R/R aggressive B cell lymphoma in Europe.
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Antígenos CD19/sangue , Antígenos de Neoplasias/sangue , Imunoterapia Adotiva , Linfoma Difuso de Grandes Células B , Adulto , Idoso , Intervalo Livre de Doença , Feminino , França/epidemiologia , Humanos , Linfoma Difuso de Grandes Células B/sangue , Linfoma Difuso de Grandes Células B/mortalidade , Linfoma Difuso de Grandes Células B/terapia , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Taxa de SobrevidaRESUMO
PURPOSE: Medication reconciliation can reduce drug-related iatrogenesis by facilitating exhaustive information transmission at care transition points. Given the vulnerability of cancer patients to adverse drug events, medication reconciliation could provide a significant clinical benefit in cancer care. This review aims to synthesize existing evidence on medication reconciliation in cancer patients. METHODS: A comprehensive search was performed in the PubMed/Medline, Scopus, and Web of Science databases, associating the keywords "medication reconciliation" and "cancer" or "oncology." RESULTS: Fourteen studies met the selection criteria. Various medication reconciliation practices were reported: performed at admission or discharge, for hospitalized or ambulatory patients treated with oral or parenteral anticancer drugs. In one randomized controlled trial, medication reconciliation decreased clinically significant medication errors by 26%. Although most studies were non-comparative, they highlighted that medication reconciliation led to identification of discrepancies and other drug-related problems in up to 88% and 94.7% of patients, respectively. The impact on post-discharge healthcare utilization remains under-evaluated and mostly inconclusive, despite a trend toward reduction. No comparative economic evaluations were available but one study estimated the benefit:cost ratio of medication reconciliation to be 2.31:1, suggesting its benefits largely outweigh its costs. Several studies also underlined the extended pharmacist time required for the intervention, highlighting the need for further cost analysis. CONCLUSION: Medication reconciliation can reduce adverse drug events in cancer patients. More robust and economic evaluations are still required to support its development in everyday practice.
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Reconciliação de Medicamentos/métodos , Neoplasias/tratamento farmacológico , Neoplasias/economia , Antineoplásicos/administração & dosagem , Antineoplásicos/efeitos adversos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/prevenção & controle , Humanos , Reconciliação de Medicamentos/economia , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
The aim of this retrospective cohort study was to investigate the incidence of delayed methotrexate elimination in patients treated with high-dose methotrexate (≥1 g/m2 ) for haematological malignancy and to identify the impact of interacting drugs, especially proton-pump inhibitors (PPIs) and ranitidine. All patients treated with high-dose methotrexate over a 6 year period in the haematology department of the Lyon Sud University Hospital (Hospices Civils de Lyon, France) were included. Potential risk factors for delayed methotrexate elimination were tested in a generalized linear model by univariate analysis: patient age, gender, methotrexate dose, administration of PPI or ranitidine, and concomitant nephrotoxic drugs. A total of 412 cycles of methotrexate were administered to 179 patients. Proton-pump inhibitors were co-administered with methotrexate in 127 cycles and ranitidine in 192 cycles. Ninety-three cycles included no antacid drugs. A total of 918 plasma methotrexate assays were performed. Methotrexate concentrations were checked at 24 hours in 92% of cycles. Delayed methotrexate elimination was observed in 20.9% of cycles. A total of 63 cycles with delayed methotrexate elimination were only identified on plasma methotrexate measures at 72 hours: ie, plasma methotrexate was in the normal range at 24 and 48 hour post injection. Use of PPI/ranitidine or no antacid drugs did not increase risk of delayed elimination, with respectively delayed methotrexate elimination in 20.5%, 21.9%, and 19.4% of cycles (P = .89). Impaired baseline creatinine clearance showed significant association in univariate analysis. Fifteen patients showed grade 1 acute kidney injury, 1 grade 2, 2 grade 3, and none grade 4. For half of these cases, delayed methotrexate elimination was observed and the 2 grade 3 events appeared in patients treated with PPIs. This retrospective study suggests that there is no association between concomitant use of proton-pump inhibitors (pantoprazole and esomeprazole) or ranitidine and delayed methotrexate elimination.
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Metotrexato/farmacocinética , Inibidores da Bomba de Prótons/farmacologia , Ranitidina/farmacologia , Adulto , Idoso , Antiulcerosos/administração & dosagem , Antiulcerosos/farmacologia , Antimetabólitos Antineoplásicos/administração & dosagem , Antimetabólitos Antineoplásicos/farmacocinética , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Interações Medicamentosas , Feminino , Neoplasias Hematológicas/tratamento farmacológico , Neoplasias Hematológicas/metabolismo , Humanos , Masculino , Metotrexato/administração & dosagem , Pessoa de Meia-Idade , Inibidores da Bomba de Prótons/administração & dosagem , Ranitidina/administração & dosagem , Estudos Retrospectivos , Fatores de TempoRESUMO
Rituximab is used as a standard of care for follicular lymphoma and is usually administered intravenously. A novel subcutaneous formulation recently showed non-inferior efficacy with similar pharmacokinetic and safety profiles compared to intravenous rituximab in patients with follicular lymphoma. This new approach is promising in terms of comfort for patients and time-saving for hospital staff. To evaluate the real-life economic impact of subcutaneous rituximab as maintenance therapy in patients with follicular lymphoma in real life, we conducted a cost-consequence analysis from the hospital's point of view in three French teaching hospitals. Health-related quality of life (EQ-5D-3L) was investigated as well as patients' and nurses' perception. Compared to intravenous rituximab, subcutaneous administration showed an estimated cost-saving of 109.20 per patient per cycle (p < 0.001), 78.6% of which could be attributed to the rituximab cost. Health-related quality of life showed no significant difference between the two groups despite tendencies for greater pain in the subcutaneous group and greater anxiety in the intravenous group. Thus, subcutaneous rituximab had a favorable pharmacoeconomic profile, with clinical efficacy similar to that of intravenous rituximab. The subcutaneous form was preferred by almost all patients, but further consideration should be given to improve the patients' experience: a dedicated day unit with trained medical, nursing, and pharmaceutical staff could be helpful.
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Linfoma Folicular/tratamento farmacológico , Linfoma Folicular/economia , Rituximab/administração & dosagem , Rituximab/economia , Administração Intravenosa , Adulto , Idoso , Idoso de 80 Anos ou mais , Análise Custo-Benefício , Estudos Transversais , Custos de Medicamentos , Feminino , França/epidemiologia , Hospitais de Ensino , Humanos , Injeções Subcutâneas , Linfoma Folicular/epidemiologia , Linfoma Folicular/metabolismo , Masculino , Pessoa de Meia-Idade , Preferência do Paciente/economia , Preferência do Paciente/estatística & dados numéricos , Qualidade de Vida , Rituximab/farmacocinéticaRESUMO
After 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 < 60 mL/min) and 2 severe (creatinine clearance < 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 [≤1 mg/kg]) needs to be investigated in randomized controlled trials.
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Antivirais/uso terapêutico , Cistite/terapia , Citosina/análogos & derivados , Neoplasias Hematológicas/terapia , Hemorragia/terapia , Organofosfonatos/uso terapêutico , Infecções por Polyomavirus/terapia , Infecções Tumorais por Vírus/terapia , Adulto , Vírus BK/efeitos dos fármacos , Vírus BK/fisiologia , Cidofovir , Cistite/etiologia , Cistite/imunologia , Cistite/mortalidade , Citosina/uso terapêutico , Esquema de Medicação , Feminino , Taxa de Filtração Glomerular , Sobrevivência de Enxerto , Neoplasias Hematológicas/imunologia , Neoplasias Hematológicas/mortalidade , Neoplasias Hematológicas/patologia , Transplante de Células-Tronco Hematopoéticas/efeitos adversos , Transplante de Células-Tronco Hematopoéticas/métodos , Hemorragia/etiologia , Hemorragia/imunologia , Hemorragia/mortalidade , Humanos , Masculino , Pessoa de Meia-Idade , Agonistas Mieloablativos/uso terapêutico , Infecções por Polyomavirus/etiologia , Infecções por Polyomavirus/imunologia , Infecções por Polyomavirus/mortalidade , Estudos Retrospectivos , Análise de Sobrevida , Condicionamento Pré-Transplante , Transplante Homólogo , Infecções Tumorais por Vírus/etiologia , Infecções Tumorais por Vírus/imunologia , Infecções Tumorais por Vírus/mortalidade , Carga Viral/efeitos dos fármacosRESUMO
OBJECTIVE: To assess the impact of investigational drug labels on the risk of medication error in drug dispensing. DESIGN: A simulation-based learning program focusing on investigational drug dispensing was conducted. SETTING: The study was undertaken in an Investigational Drugs Dispensing Unit of a University Hospital of Lyon, France. PARTICIPANTS: Sixty-three pharmacy workers (pharmacists, residents, technicians or students) were enrolled. INTERVENTION: Ten risk factors were selected concerning label information or the risk of confusion with another clinical trial. Each risk factor was scored independently out of 5: the higher the score, the greater the risk of error. From 400 labels analyzed, two groups were selected for the dispensing simulation: 27 labels with high risk (score ≥3) and 27 with low risk (score ≤2). Each question in the learning program was displayed as a simulated clinical trial prescription. MAIN OUTCOME MEASURE: Medication error was defined as at least one erroneous answer (i.e. error in drug dispensing). For each question, response times were collected. RESULTS: High-risk investigational drug labels correlated with medication error and slower response time. Error rates were significantly 5.5-fold higher for high-risk series. Error frequency was not significantly affected by occupational category or experience in clinical trials. CONCLUSIONS: SIMME-CT is the first simulation-based learning tool to focus on investigational drug labels as a risk factor for medication error. SIMME-CT was also used as a training tool for staff involved in clinical research, to develop medication error risk awareness and to validate competence in continuing medical education.
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Rotulagem de Medicamentos/estatística & dados numéricos , Drogas em Investigação/administração & dosagem , Erros de Medicação/estatística & dados numéricos , Sistemas de Medicação no Hospital/organização & administração , Sistemas de Medicação no Hospital/estatística & dados numéricos , Simulação por Computador , França , Hospitais Universitários , Humanos , Sistemas de Medicação no Hospital/normas , Farmacêuticos/estatística & dados numéricos , Residências em Farmácia/estatística & dados numéricos , Técnicos em Farmácia/estatística & dados numéricos , Fatores de Risco , Estudantes de Farmácia/estatística & dados numéricos , Fatores de TempoRESUMO
INTRODUCTION: The development of oral anticancer agents (OAA) has profoundly changed cancer care, leading patients to manage their chemotherapy treatment on an outpatient basis. The prevention of iatrogenic effects of OAA remains a major concern, especially since their side effects are not less serious than those of intravenous chemotherapy. The ONCORAL programme was set up to secure the management of OAA in cancer patients followed at the Lyon University Hospital. This multidisciplinary programme involves hospital pharmacists, nurses, oncologists, and haematologists, as well as community health professionals. Given the economic stakes that this programme entails for the health system, a medico-economic study was designed. METHODS AND ANALYSIS: This is a prospective controlled study, with individual open-label randomisation. A total of 216 outpatients treated with OAA and at risk of developing a drug-related iatrogenic event, will be randomised (2:1) to undergo follow-up in the ONCORAL programme or usual care. The primary outcome will be the estimation of the incremental cost-effectiveness ratio (difference in total costs per quality adjusted life years gained) at 12 months between the two groups. The secondary outcomes will be evaluation of OAA management consequences (relative-dose intensity, adherence, adverse drug events, drug-drug interactions, and proven medication errors), evaluation of overall survival and cancer-related quality of life, and patient-reported outcomes in relation to the treatment. A budget impact analysis will be implemented. Patient and health professional satisfaction regarding the ONCORAL programme will be measured. ETHICS AND DISSEMINATION: Approval to conduct this study was obtained from an Ethics Committee (Comité de Protection des Personnes Ile-de-France VI) in October 2019, and from the French data protection agency (Commission Nationale de l'Informatique et des Libertés), according to the French Law. Trial results will be disseminated at clinical conferences and published in peer-reviewed journals. TRIAL REGISTRATION: NCT03660670.
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Antineoplásicos , Pacientes Ambulatoriais , Humanos , Qualidade de Vida , Análise Custo-Benefício , Estudos Prospectivos , Antineoplásicos/efeitos adversos , Doença Iatrogênica , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
BACKGROUND: Hospital admission and discharge are at high risk of drug-related problems (DRPs) in older patients with cancer. This study aimed to assess the clinical and economic impact of a comprehensive pharmaceutical care intervention (RECAP) to optimize drug therapy in patients with cancer ≥75 years admitted to oncology or geriatric wards. METHOD: RECAP intervention was defined as follows: at admission and discharge, hospital pharmacists conducted comprehensive medication reconciliation and review, identified relevant DRPs and provided optimization recommendations to prescribers; at discharge, pharmacists also provided patient education and shared information with primary care providers. The impact of the intervention was assessed by the rate of implementation of recommendations by the prescribers and the evolution of polypharmacy rate; a peer review of the clinical significance of DRPs was performed by an expert panel of geriatric oncologists and pharmacists. A cost saving analysis compared cost avoided through resolution of DRPs to cost of pharmacist's time. RESULTS: From January 2019 and August 2020, 201 patients were included (median age 80 [75-97] years), 68.7% with solid tumors. DRPs requiring optimization were identified in 70.9% of patients at admission (mean 1.7 DRP/patient) and 47.7% at discharge (0.9 DRP/patient). Most pharmacist recommendations (70.8%) were followed by prescribers, allowing the correction of 1.2 DRP/patient at admission and 0.7 DRP/patient at discharge. Half of resolved DRPs were rated as clinically significant. However, polypharmacy rate was not reduced at discharge. Cost comparison showed $7.2 avoided for $1 invested, with an estimated total net benefit of $354,822 (mean $1766 per patient). CONCLUSIONS: The RECAP model significantly reduces DRPs in hospitalized older patients with cancer. The model was cost saving, confirming the value of implementing it in routine practice.
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Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Neoplasias , Serviço de Farmácia Hospitalar , Humanos , Idoso , Idoso de 80 Anos ou mais , Erros de Medicação , Reconciliação de Medicamentos , Farmacêuticos , Neoplasias/tratamento farmacológicoRESUMO
BACKGROUND: Cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (HIPEC) is an effective treatment for peritoneal metastases. However, HIPEC with cisplatin is associated with renal toxicity. Sodium thiosulfate (ST) has been shown to prevent cisplatin-induced toxicity. METHODS: A retrospective, single-center analysis of patients treated curatively for peritoneal surface malignancy, who underwent cytoreductive surgery with cisplatin-based HIPEC between 2015 and 2020. Patients were categorized into three groups based on the management of cisplatin-induced renal toxicity: preoperative hyperhydration alone (PHH), preoperative hyperhydration with ST (PHH + ST), and ST alone. Renal function and complications, in terms of Acute (AKI) and chronic kidney injury (CKI), were monitored and analyzed during 3 postoperative months. RESULTS: This study included 220 consecutive patients. Mean serum creatinine levels were 95, 57 and 61 mmol/L, for PHH, PHH + ST and ST groups, respectively (p < 0.001). Glomerular Filtration Rate (GFR) were 96, 94 and 78 ml/min/1.73 m2, respectively (p < 0.001). AKI and CKI are respectively for PHH, PHH + ST and ST groups were 21 % (n = 46), 1 % (n = 2) and 0 % vs 19 % (n = 42), 0 % and 0 % (p < 0.001), for pairwise analysis did not show any difference between PHH + ST and ST alone combination, regarding nephrological outcomes. All patients were followed 3 months postoperatively. CONCLUSION: There is no need for preoperative hyperhydration when sodium-thiosulfate is used to prevent cisplatin-induced nephrotoxicity in patients undergoing cytoreductive surgery with HIPEC. These findings have implications for improving and simplifying the management of patients with peritoneal metastases undergoing HIPEC with cisplatin.
Assuntos
Injúria Renal Aguda , Antineoplásicos , Hipertermia Induzida , Neoplasias Peritoneais , Intoxicação por Água , Humanos , Cisplatino , Antineoplásicos/uso terapêutico , Tiossulfatos/uso terapêutico , Quimioterapia Intraperitoneal Hipertérmica/efeitos adversos , Estudos Retrospectivos , Neoplasias Peritoneais/tratamento farmacológico , Neoplasias Peritoneais/secundário , Intoxicação por Água/induzido quimicamente , Intoxicação por Água/complicações , Hipertermia Induzida/efeitos adversos , Injúria Renal Aguda/induzido quimicamente , Injúria Renal Aguda/prevenção & controle , Procedimentos Cirúrgicos de Citorredução/efeitos adversos , Terapia Combinada , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Taxa de SobrevidaRESUMO
BACKGROUND: To reduce the occurrence of medication errors, a systemic approach was developed combining anti-neoplastic medication error reviews and morbidity and mortality conferences (M&MCs). We report the first experience of implementing this strategy in oncology. METHODS: The case reports submitted to combined reviews were prepared by physicians and pharmacists, and medication error(s) were described and chronological and root-cause analyses were performed. RESULTS: Ten combined reviews were conducted, which involved the departments of haematology, medical oncology, pneumology, gastroenterology and clinical oncology pharmacy. A total of 91 errors were analysed, of which 3 had reached the patient. Thirty-four corrective actions were proposed; 53% consisted of changes in practice, 35% in procedural reminders and 12% in on-ward education sessions. CONCLUSIONS: The combination of medication error reviews and M&MCs appears to be an efficient means of improving cancer patient safety and personnel proficiency. This multidisciplinary work is indispensable to improve future patient management through the critical analysis of past medical errors.
Assuntos
Antineoplásicos/efeitos adversos , Congressos como Assunto/organização & administração , Erros de Medicação/estatística & dados numéricos , Neoplasias/tratamento farmacológico , Antineoplásicos/uso terapêutico , Hospitais Universitários , Humanos , Comunicação Interdisciplinar , Erros de Medicação/prevenção & controle , Assistência ao Paciente/normasRESUMO
OBJECTIVE: Artificial Intelligence (AI) offers potential opportunities to optimize clinical pharmacy services in community or hospital settings. The objective of this systematic literature review was to identify and analyse quantitative studies using or integrating AI for clinical pharmacy services. MATERIALS AND METHODS: A systematic review was conducted using PubMed/Medline and Web of Science databases, including all articles published from 2000 to December 2021. Included studies had to involve pharmacists in the development or use of AI-powered apps and tools.. RESULTS: 19 studies using AI for clinical pharmacy services were included in this review. 12 out of 19 articles (63.1%) were published in 2020 or 2021. Various methodologies of AI were used, mainly machine learning techniques and subsets (natural language processing and deep learning). The datasets used to train the models were mainly extracted from electronic medical records (6 studies, 32%). Among clinical pharmacy services, medication order review was the service most targeted by AI-powered apps and tools (9 studies), followed by health product dispensing (4 studies), pharmaceutical interviews and therapeutic education (2 studies). The development of these tools mainly involved hospital pharmacists (12/19 studies). DISCUSSION AND CONCLUSION: The development of AI-powered apps and tools for clinical pharmacy services is just beginning. Pharmacists need to keep abreast of these developments in order to position themselves optimally while maintaining their human relationships with healthcare teams and patients. Significant efforts have to be made, in collaboration with data scientists, to better assess whether AI-powered apps and tools bring value to clinical pharmacy services in real practice.
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Serviços Comunitários de Farmácia , Serviço de Farmácia Hospitalar , Médicos , Humanos , Inteligência Artificial , Farmacêuticos , HospitaisRESUMO
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.
RESUMO
INTRODUCTION: Optimizing medication use is a major issue in older patients with cancer and pharmacists are increasingly involved in their multidisciplinary care. The implementation of pharmaceutical care interventions must be supported by impact evaluations to enable their development and funding. This systematic review aims to synthesize evidence on the impact of pharmaceutical care interventions in older patients with cancer. MATERIALS AND METHODS: A comprehensive search was performed in the PubMed/Medline, Embase, and Web of Science databases, for articles reporting evaluations of pharmaceutical care interventions for patients with cancer aged 65 years or older. RESULTS: Eleven studies met the selection criteria. Most pharmacists were part of multidisciplinary geriatric oncology teams. Whether in outpatient or inpatient settings, interventions had common components, including patient interview, medication reconciliation, and comprehensive medication review to assess drug-related problems (DRPs). DRPs were identified in 95% of patients with 1.7 to 3 DRPs on average. Pharmacist recommendations resulted in a 20-40% reduction in the total number of DRPs and a 20-25% decrease in the prevalence of DRP. Prevalence of potentially inappropriate or omitted medications and their subsequent deprescribing or addition varied greatly between studies, notably depending on detection tools used. Clinical impact was insufficiently evaluated. Only one study reported a reduction of anticancer treatment toxicities following a joint pharmaceutical and geriatric assessment. A single economic evaluation calculated a potential net benefit of $3,864.23 per patient resulting from the intervention. DISCUSSION: These encouraging results must be confirmed by more robust evaluations to support the involvement of pharmacists in multidisciplinary care of older patients with cancer.