Real-world outcomes of abiraterone and enzalutamide in first-line treatment of metastatic castration-resistant prostate cancer: which patients benefit most?

OBJECTIVES: Abiraterone and enzalutamide are two oral novel androgen receptor axis-targeted agents approved for the treatment of castration-resistant prostate cancer (mCRPC). Despite the availability of multiple treatments, there is a need to improve the knowledge and management of these drugs in the real-world setting, especially in patient groups under-represented in clinical trials. Our aim was to review the outcome of patients with chemotherapy-naïve mCRPC treated with abiraterone or enzalutamide in routine clinical practice in order to identify factors that are predictive for response. METHODS: This observational retrospective study was performed in a Spanish tertiary hospital and included men with chemotherapy-naïve mCPRC who started treatment with abiraterone or enzalutamide between September 2012 and November 2018. The study end date was 30 October 2020. RESULTS: Ninety patients with mCRPC were included, 57 with abiraterone and 33 with enzalutamide. Median overall survival (OS) was 26.87 months (95% CI 19.68 to 34.05), with no difference found between the two treatment groups. Nine variables were related to increased OS in the univariate analysis: Eastern Cooperative Oncology Group (ECOG) performance status (0-1 vs 2), pain (need of opioids for cancer pain), visceral disease, ≥3 bone lesions, exclusively lymph node metastases, baseline prostate specific antigen (PSA) (<50 vs ≥50 ng/dL and <20 vs ≥20 ng/dL), haemoglobin (<12 vs ≥12 g/dL) and alkaline phosphatase (≤116 vs >116 IU/L). A PSA response >50% was observed in 65 patients (76.5%). In the multivariate analysis, ECOG performance status, pain, visceral disease and alkaline phosphatase provided independent prognostic information. Median OS by Kaplan-Meier analysis was significantly longer for patients with a PSA response (32.1 vs 17.9 months; HR 0.46, 95% CI 0.27 to 0.78; p=0.003). CONCLUSIONS: This study assessed the efficacy of abiraterone and enzalutamide in a real-world setting, including patients under-represented in pivotal studies. Some clinical factors were correlated with improved OS in chemotherapy-naïve men with mCPRC treated with these drugs.

[Medication reconciliation errors according to patient risk and type of physician prescriber identified by prescribing tool used]. / Perfil de riesgo y análisis comparativo de los errores de conciliación de medicamentos según el médico prescriptor y la herramienta de prescripción.

OBJECTIVES: To study the frequency of medication reconciliation errors (MREs) in hospitalized patients and explore the profiles of patients at greater risk. To compare the rates of errors in prescriptions written by emergency physicians and ward physicians, who each used a different prescribing tool. MATERIAL AND METHODS: Prospective cross-sectional study of a convenience sample of patients admitted to medical, geriatric, and oncology wards over a period of 6 months. A pharmacist undertook the medication reconciliation report, and data were analyzed for possible associations with risk factors or prescriber type (emergency vs ward physician). RESULTS: A total of 148 patients were studied. Emergency physicians had prescribed for 68 (45.9%) and ward physicians for 80 (54.1%). A total of 303 MREs were detected; 113 (76.4%) patients had at least 1 error. No statistically significant differences were found between prescriber types. Factors that conferred risk for a medication error were use polypharmacy (odds ratio [OR], 3.4; 95% CI, 1.2-9.0; P=.016) and multiple chronic conditions in patients under the age of 80 years (OR, 3.9; 95% CI, 1.1-14.7; P=.039). CONCLUSION: The incidence of MREs is high regardless of whether the prescriber is an emergency or ward physician. The patients who are most at risk are those taking several medications and those under the age of 80 years who have multiple chronic conditions.

OBJETIVO: Estudiar la frecuencia y el perfil de los pacientes ingresados que tienen mayor riesgo de errores de conciliación (EC) y si las prescripciones originadas por los médicos de urgencias (MU), mediante una herramienta de prescripción electrónica de texto libre, presentan más EC que las realizadas por los médicos responsables de la planta de hospitalización (MPH) con un programa de prescripción electrónica asistida. METODO: Estudio de una serie de casos prospectivos con análisis transversal que incluyó por oportunidad a los pacientes ingresados en plantas de hospitalización convencional de los servicios de medicina interna, geriatría y oncología durante un periodo de 6 meses. Los EC detectados por un farmacéutico se analizaron en función de los factores de riesgo teóricos y del responsable de la prescripción (MU frente a MPH). RESULTADOS: Se incluyeron 148 pacientes, 68 (45,9%) con prescripción de los MU y 80 (54,1%) de los MPH. El farmacéutico detectó 303 EC y 113 pacientes (76,4%) presentaron al menos un EC. No hubo diferencias significativas según el responsable de la prescripción conciliada. Los EC se asociaron a la polimedicación [OR 3,4 (IC 95%:1,2-9,0; p = 0,016)] y el tener pluripatología en el grupo de pacientes menores de 80 años [OR 3,9 (IC95%:1,1-14,7; pinteracción = 0,039)]. CONCLUSIONES: La frecuencia de EC es elevada indistintamente de si el responsable de la prescripción fue el MU o el MPH. Los pacientes con mayor riesgo de EC fueron los polimedicados y los menores de 80 años con pluripatología.

Perfil de riesgo y análisis comparativo de los errores de conciliación de medicamentos según el médico prescriptor y la herramienta de prescripción / Medication reconciliation errors according to patient risk and type of physician prescriber identified by prescribing tool used

Objetivo. Estudiar la frecuencia y el perfil de los pacientes ingresados que tienen mayor riesgo de errores de conciliación (EC) y si las prescripciones originadas por los médicos de urgencias (MU), mediante una herramienta de prescripción electrónica de texto libre, presentan más EC que las realizadas por los médicos responsables de la planta de hospitalización (MPH) con un programa de prescripción electrónica asistida. Método. Estudio de una serie de casos prospectivos con análisis transversal que incluyo por oportunidad a los pacientes ingresados en plantas de hospitalización convencional de los servicios de medicina interna, geriatría y oncología durante un periodo de 6 meses. Los EC detectados por un farmacéutico se analizaron en función de los factores de riesgo teóricos y del responsable de la prescripción (MU frente a MPH). Resultados. Se incluyeron 148 pacientes, 68 (45,9%) con prescripción de los MU y 80 (54,1%) de los MPH. El farmacéutico detecto 303 EC y 113 pacientes (76,4%) presentaron al menos un EC. No hubo diferencias significativas según el responsable de la prescripción conciliada. Los EC se asociaron a la polimedicación [OR 3,4 (IC 95%:1,2-9,0; p = 0,016)] y el tener pluripatología en el grupo de pacientes menores de 80 anos [OR 3,9 (IC95%:1,1-14,7; pinteracción = 0,039)]. Conclusiones. La frecuencia de EC es elevada indistintamente de si el responsable de la prescripción fue el MU o el MPH. Los pacientes con mayor riesgo de EC fueron los polimedicados y los menores de 80 años con pluripatología (AU)

Objectives. To study the frequency of medication reconciliation errors (MREs) in hospitalized patients and explore the profiles of patients at greater risk. To compare the rates of errors in prescriptions written by emergency physicians and ward physicians, who each used a different prescribing tool. Methods. Prospective cross-sectional study of a convenience sample of patients admitted to medical, geriatric, and oncology wards over a period of 6 months. A pharmacist undertook the medication reconciliation report, and data were analyzed for possible associations with risk factors or prescriber type (emergency vs ward physician). Results. A total of 148 patients were studied. Emergency physicians had prescribed for 68 (45.9%) and ward physicians for 80 (54.1%). A total of 303 MREs were detected; 113 (76.4%) patients had at least 1 error. No statistically significant differences were found between prescriber types. Factors that conferred risk for a medication error were use polypharmacy (odds ratio [OR], 3.4; 95% CI, 1.2-9.0; P=.016) and multiple chronic conditions in patients under the age of 80 years (OR, 3.9; 95% CI, 1.1-14.7; P=.039). Conclusion. The incidence of MREs is high regardless of whether the prescriber is an emergency or ward physician. The patients who are most at risk are those taking several medications and those under the age of 80 years who have multiple chronic conditions (AU)

Implantación de un robot para la elaboración de antineoplásicos / Implementation of a robot for the preparation of antineoplastic drugs in the Pharmacy Service

Objetivo: Describir la implantación de un robot para la elaboración de antineoplásicos en el Servicio de Farmacia y evaluar el valor añadido al proceso farmacoterapéutico. Método: La implantación se llevó a cabo en Junio 2012 en un hospital de tercer nivel, realizándose en dos períodos: 1-Período de pruebas con la instalación del robot, configuración técnica del equipo, validación de 29 principios activos e integración con el software de prescripción electrónica (9 meses); 2-Período de utilización (22 meses). Se impartieron cursos de formación a farmacéuticos y personal de enfermería. Para su funcionamiento el robot emplea reconocimiento fotográfico, identificación por código de barras y controles gravimétricos, que proporcionaron datos de error cometido por preparación, tolerando ±10% y restringiéndolo, tras un estudio piloto, a un intervalo de tolerancia de ±4%. El robot fue programado para reconocer bolsas, infusores, jeringas y viales. El valor añadido se evaluó durante 31 meses con la identificación de los errores de preparación. Resultados: Se realizaron 11.865 preparaciones en el robot, que correspondieron al 40% del global de antineoplásicos elaborados, de 29 principios activos diferentes. Se identificaron y evitaron errores de dosificación en el 1,12% (n=133) de las preparaciones, que no alcanzaron al paciente al ser identificadas por el robot como preparaciones con desviación negativa (-4%) y ser corregidas manualmente. Conclusiones: La implantación de un robot en la elaboración de antineoplásicos permite identificar los errores de elaboración y evitar que lleguen al paciente, promoviendo la seguridad y calidad del proceso farmacoterapéutico de antineoplásicos y reduciendo la exposición del manipulador a los mismos (AU)

Objective: To describe the implementation of a robot for the preparation of antineoplastic drugs in the Pharmacy Service and to be able to analyze the added value to pharmacotherapy. Methods: The implementation was carried out in June 2012 at a tertiary level Hospital, taking place in two periods: 1- test period with the installation of the robot, with technical configuration of the equipment and validation of 29 active ingredients and the integration of electronic prescribing software with the robot application (9 months). 2- Usage period (22 months). On the other hand, training was given to pharmacists and nurses. The robot uses image recognition, barcode identification and gravimetric controls for proper operation. These checks provide information about the error ratio in the preparation, with a margin of ± 10%, which after a pilot study was restricted to a range of ±4%. The robot was programmed to recognize bags, infusion pumps, syringes and vials. The added value was assessed for 31 months by identifying preparation´s errors. Results: 11,865 preparations were made by the robot, which meant approximately 40% of all antineoplastic prepared from 29 different active ingredients. 1.12% (n=133) of the errors were identified by the robot and therefore didn´t reach the patient (negative desviation - 4%). These errors were corrected manually. Conclusion: The implementation of a robot in the preparation of antineoplastic drugs allows to identify errors therefore preventing them to arrive to the patient. This promotes safety and quality of the process, reducing the exposure to cytotoxic drugs from the manipulator (AU)

[Implementation of a robot for the preparation of antineoplastic drugs in the Pharmacy Service]. / Implantación de un robot para la elaboración de antineoplásicos.

OBJECTIVE: To describe the implementation of a robot for the preparation of antineoplastic drugs in the Pharmacy Service and to be able to analyze the added value to pharmacotherapy. METHODS: The implementation was carried out in June 2012 at a tertiary level Hospital, taking place in two periods: 1- test period with the installation of the robot, with technical configuration of the equipment and validation of 29 active ingredients and the integration of electronic prescribing software with the robot application (9 months). 2- Usage period (22 months). On the other hand, training was given to pharmacists and nurses. The robot uses image recognition, barcode identification and gravimetric controls for proper operation. These checks provide information about the error ratio in the preparation, with a margin of ± 10%, which after a pilot study was restricted to a range of ±4%. The robot was programmed to recognize bags, infusion pumps, syringes and vials. The added value was assessed for 31 months by identifying preparation's errors. RESULTS: 11,865 preparations were made by the robot, which meant approximately 40% of all antineoplastic prepared from 29 different active ingredients. 1.12% (n=133) of the errors were identified by the robot and therefore didn't reach the patient (negative desviation - 4%). These errors were corrected manually. CONCLUSION: The implementation of a robot in the preparation of antineoplastic drugs allows to identify errors therefore preventing them to arrive to the patient. This promotes safety and quality of the process, reducing the exposure to cytotoxic drugs from the manipulator.

Objetivo: Describir la implantación de un robot para la elaboración de antineoplásicos en el Servicio de Farmacia y evaluar el valor añadido al proceso farmacoterapéutico. Método: La implantación se llevó a cabo en Junio 2012 en un hospital de tercer nivel, realizándose en dos períodos: 1-Período de pruebas con la instalación del robot, configuración técnica del equipo, validación de 29 principios activos e integración con el software de prescripción electrónica (9 meses); 2-Período de utilización (22 meses). Se impartieron cursos de formación a farmacéuticos y personal de enfermería. Para su funcionamiento el robot emplea reconocimiento fotográfico, identificación por código de barras y controles gravimétricos, que proporcionaron datos de error cometido por preparación, tolerando ±10% y restringiéndolo, tras un estudio piloto, a un intervalo de tolerancia de ±4%. El robot fue programado para reconocer bolsas, infusores, jeringas y viales. El valor añadido se evaluó durante 31 meses con la identificación de los errores de preparación. Resultados: Se realizaron 11.865 preparaciones en el robot, que correspondieron al 40% del global de antineoplásicos elaborados, de 29 principios activos diferentes. Se identificaron y evitaron errores de dosificación en el 1,12% (n=133) de las preparaciones, que no alcanzaron al paciente al ser identificadas por el robot como preparaciones con desviación negativa (-4%) y ser corregidas manualmente. Conclusiones: La implantación de un robot en la elaboración de antineoplásicos permite identificar los errores de elaboración y evitar que lleguen al paciente, promoviendo la seguridad y calidad del proceso farmacoterapéutico de antineoplásicos y reduciendo la exposición del manipulador a los mismos.

How to read fetal heart rate tracings in labor: a comparison between ACOG and NICE guidelines.

The aim of this study was to assess reproducibility and clinical relevance of current guidelines on fetal heart rate interpretation in labor. Two obstetricians with comparable experience analyzed one hundred fetal heart rate tracings. One doctor made a first analysis using American College of Obstetricians and Gynecologists (ACOG) 2009 guideline's criteria; the other used National Institute for Health and Clinical Excellence (NICE) 2007 guideline's criteria; subsequently they repeated the evaluation crossing the guidelines used. The primary outcome of this experiment was to determine the time spent to evaluate the tracings, secondary outcomes were: the intraobserver concordance (concordance of the evaluation with the two systems for each investigator), the interobserver concordance (concordance between the interpretation given by each investigator) and. the concordance between operators' grading and actual outcome of labor. The interpretation of fetal heart rate tracings was longer using ACOG criteria. The intraobserver agreement was significant. The interobserver agreement was better using NICE guidelines. The same trend showed for the concordance between investigators' grading and actual outcomes There was more discordance in worse outcomes. Both guidelines are interesting and useful, but NICE seems easier to handle than ACOG.