A New Methodology to Estimate Drug Cost Avoidance in Clinical Trials: Development and Application.

Background: Oncology clinical trials can lead to relevant financial savings in drug acquisition for healthcare providers. Considerable methodological heterogeneity is observed among previous studies estimating these savings. Methods: We developed a methodology to estimate the economic benefit obtained from the enrollment of patients into clinical trials through the analysis of drug cost avoidance. We designed a decision algorithm to determine if a clinical trial is associated with drug cost avoidance. This algorithm is based on five scenarios according to the availability or not of standard treatment, the presence or absence of a control arm (placebo or active treatment), and the provider of the medication. We considered as reference the cost of the standard treatment that the patient would have received in routine clinical practice. We standardized drug doses and treatment durations according to the literature. Costs were considered from a National Health System perspective. We applied this methodology at a single, research-active University Hospital in 2019. A cost avoidance analysis per trial and patient was carried out on cancer patients. Results: We analyzed 140 trials in which 198 patients were recruited. Drug cost avoidance was found in 120 trials (85.7%). The estimated total drug cost avoidance amounted to over €3,200,000. Melanoma and genitourinary tumors were the tumor types associated with the highest cost avoidance. The average drug cost avoidance per patient was €16,245. Conclusion: We describe a standardized method to estimate drug cost avoidance in clinical trials. We have applied it to all ongoing oncology clinical trials in our center. This methodology could be valuable for other centers to analyze the potential saving of clinical trials.

Use of the EFQM excellence model to improve hospital pharmacy performance.

BACKGROUND: Quality management systems are widely used to improve the quality and efficiency of healthcare services. However, evidence regarding the value of the European Foundation for Quality Management (EFQM) model in improving the performance of hospital departments is lacking. OBJECTIVE: To describe the value of the EFQM model as a quality framework for improving the performance of a hospital pharmacy department (PD). DESIGN: A case study describing the development of the Enablers' criteria of the model and the results achieved. SETTING: PD in a tertiary-care teaching hospital of the Madrid Public Health Service (Spain). INTERVENTIONS: Four self-assessments were conducted using the questionnaire "Perfil" during the period 2008-2017. A quality improvement plan was developed on the basis of the results of each self-assessment. A balanced scorecard was used to track progress. Improvement in quality management was externally evaluated by the Spanish Management Excellence Club in 2010, 2013, and 2017. MAIN OUTCOME MEASURES: Change in the scores obtained in the external assessments, the quality improvement initiatives implemented for each Enabler's criteria, and the results of key performance indicators. RESULTS: The EFQM was a useful framework for self-assessment and a good system for identifying improvement initiatives. The model progressively improved the services provided for patients, the safety and efficiency of pharmacotherapy, productivity of the PD, and customer and staff satisfaction. The external assessment scores exceeded 300 points in 2010, 400 points in 2013, and 500 points in 2017. Scores for all of the criteria progressively improved, particularly in 'people'. CONCLUSIONS: The EFQM was a practical tool for improvement of PD performance, especially in areas such as strategic planning, people management, and innovation. The main difficulties were the lack of decision-making capacity in relevant areas and benchmarking with other PDs.

Differences between a probable and proven BCG infection following intravesical instillations: 16 years experience in a tertiary care hospital.

BACKGROUND: Intravesical instillation of Bacillus Calmette-Guérin (BCG) is an efficient immunotherapy for superficial bladder cancer. BCG infection represents a major yet uncommon adverse event that occurs in 5-10% of the patients treated with BCG instillations, though the pathogenesis of this entity is not clear. METHODS: We report two cases of patients presented at our institution with BCG infection after instillation: one with microbiological BCG isolate and another without, and review all the medical records of patients instilled with BCG in our institution from 1996 until 2012, comparing patients with probable and proven BCG infection. RESULTS: During the study period, a total of 786 patients received BCG intravesical instillations. Of them, 31 (4%) patients had to suspend treatment because of adverse events and, specifically, 11 (1.3%) patients had to interrupt treatment because of suspected BCG infection. The incidence of BCG infection during our study period was 0.87 episodes per 1,000 instilled patients/year and 140 cases per 10,000 instilled patients. Of the 11 patients with suspected BCG infection, 7 (64%) had a probable BCG infection, while 4 (36%) patients had a proven BCG infection. All patients with a proven infection had a previous underlying condition, compared to a high proportion of patients with probable infection (57%) that did not present with underlying diseases. Common findings between both groups of patients were abnormal imaging studies and laboratory tests. Regarding treatment, 8 (73%) of the 11 patients with BCG infection received at least two first line drugs active against M. bovis (isoniazid, rifampicin or ethambutol), four patients (36%) received steroids as part of the treatment and curation was obtained in 10 (91%) patients, while 1 patient with a proven infection had a death related to BCG infection. CONCLUSIONS: We can conclude that BCG infection after intravesical instillations has a low incidence in our institution. Patients with previous underlying conditions seem to have more proven infections. A high proportion of patients do not yield positive microbiological tests; in those cases the diagnosis relies in clinical, radiological and laboratory findings. Treatment for BCG infection should include at least two active drugs against M. bovis and coadjuvant steroid treatment for systemic BCG infections.

[Causes of the emergency department visits in cancer patients: postchemotherapy toxicity]. / Análisis descriptivo de los motivos que originan visitas a urgencias en pacientes oncológicos: toxicidad postquimioterapia.

PURPOSE: to assess the causes of the Emergency Department visits in cancer patients treated with antineoplastics. The secondary objective is to analyse the use of growth stimulating factors in febrile neutropenia. METHODS: a retrospective observational study was conducted during six months of 2012. The adult patients diagnosed with solid tumour that visited the Emergency Department and whose physician was an oncologist, were included. RESULTS: a total of 83 patients fulfilled the inclusion criteria. The causes of visits were: 63% due to the tumour, 31% due to the chemotherapy toxicity and 6% due to other causes. In patients with chemotherapy toxicity, 65% had fever or infection, 50% pain and 42% febrile neutropenia. The treatment and prophylaxis with filgrastim followed the recommendations. CONCLUSIONS: in cancer patients, most of emergencies are due to the tumour. The management of the pain, the fever and the neutropenia is important.

Objetivo: cuantificar y analizar las causas por las que los pacientes oncológicos acuden al Servicio de Urgencias y analizar el uso de factores estimulantes de colonias para la profilaxis o el tratamiento de la neutropenia febril. Método: estudio retrospectivo de seis meses del año 2012. Se incluyeron pacientes adultos con tumor sólido y tratamiento activo atendidos por oncólogos en el Servicio de Urgencias. Resultados: se incluyeron 83 pacientes. Respecto al motivo de consulta: en el 63% es causa tumoral, 31% toxicidad postquimioterapia y 6% otras causas. En los que acuden por toxicidad, el 65% presentaron fiebre o síntomas de infección, el 50% dolor y el 42% neutropenia febril. La profilaxis y el tratamiento de la neutropenia febril con filgrastim siguieron las recomendaciones. Conclusiones: la mayor parte de los episodios oncológicos en Urgencias son debidos al propio proceso tumoral. Algunos problemas importantes son el manejo del dolor, la fiebre y la neutropenia.

Análisis descriptivo de los motivos que originan visitas a urgencias en pacientes oncológicos: toxicidad postquimioterapia / Causes of the emergency department visits in cancer patients: post-chemotherapy toxicity

Objetivo: cuantificar y analizar las causas por las que los pacientes oncológicos acuden al Servicio de Urgencias y analizar el uso de factores estimulantes de colonias para la profilaxis o el tratamiento de la neutropenia febril. Método: estudio retrospectivo de seis meses del año 2012. Se incluyeron pacientes adultos con tumor sólido y tratamiento activo atendidos por oncólogos en el Servicio de Urgencias. Resultados: se incluyeron 83 pacientes. Respecto al motivo de consulta: en el 63% es causa tumoral, 31% toxicidad postquimioterapia y 6% otras causas. En los que acuden por toxicidad, el 65% presentaron fiebre o síntomas de infección, el 50% dolor y el 42% neutropenia febril. La profilaxis y el tratamiento de la neutropenia febril con filgrastim siguieron las recomendaciones. Conclusiones: la mayor parte de los episodios oncológicos en Urgencias son debidos al propio proceso tumoral. Algunos problemas importantes son el manejo del dolor, la fiebre y la neutropenia (AU)

Purpose: to assess the causes of the Emergency Department visits in cancer patients treated with antineoplastics. The secondary objective is to analyse the use of growth stimulating factors in febrile neutropenia. Methods: a retrospective observational study was conducted during six months of 2012. The adult patients diagnosed with solid tumour that visited the Emergency Department and whose physician was an oncologist, were included. Results: a total of 83 patients fulfilled the inclusion criteria. The causes of visits were: 63% due to the tumour, 31% due to the chemotherapy toxicity and 6% due to other causes. In patients with chemotherapy toxicity, 65% had fever or infection, 50% pain and 42% febrile neutropenia. The treatment and prophylaxis with filgrastim followed the recommendations. Conclusions: in cancer patients, most of emergencies are due to the tumour. The management of the pain, the fever and the neutropenia is important (AU)