Formulación magistral en la atención farmacéutica del paciente oncopediátrico / Drug Compounding in Pharmaceutical Care of Oncopediatric Patients

Introducción: El tratamiento farmacológico del paciente oncopediátrico supone una dificultad para el equipo asistencial ya que muchos medicamen-tos registrados por la administración sanitaria no están indicados en población pediátrica, creándo-se un vacío terapéutico en el tratamiento que es cubierto a través de la formulación magistral (FM). El objetivo del estudio es analizar la elaboración de medicamentos individualizados para oncopediatría en los últimos tres años en el Servicio de Farmacia de un hospital de tercer nivel.Métodos: Estudio descriptivo, observacional, retrospectivo de las FM que se elaboraron para el Servicio de Oncopediatría en el periodo 2019-2021. Para cada FM se detalló su indicación y aplicación clínica. En la descripción cuantitativa se especificó número de fórmulas elaboradas y porcentaje. En la descripción cualitativa se detalló principio activo y concentración, procedimiento para elaborar la for-mulación, dosis de principio activo y de excipientes; condiciones de conservación y fecha de caducidad.Resultados: En el periodo de estudio, se elaboraron 3730 FM para el Servicio de Oncopediatría. Las 4 fórmulas magistrales con mayor peso en la prepa-ración son las de los principios activos: etopósido, fenofibrato, ondansetrón y mercaptopurina. El 57,4% de las FM fueron soluciones orales y el 26,5% suspensiones. La aplicación clínica del 71% de las FM preparadas fue el tratamiento de las patologías onco-hematológicas.Conclusiones: En el paciente oncopediátrico, se acentúa la necesidad de una farmacoterapia más individualizada para asegurar una correcta dosifi-cación y adherencia al tratamiento, siendo la FM la herramienta que solventaría sus necesidades terapéuticas (AU)

Introduction: The pharmacological treatment of the oncopediatric patient represents a difficulty for the health care team, since many drugs registered by the health administration are not indicated in the pediatric population, creating a therapeutic gap in the treatment that is covered through the drug compounding (DC). The aim of this study is to analyze the preparation of individualized drugs for oncopediatrics in the last three years in the Phar-macy Service of a tertiary hospital.Methods: It was carried out a descriptive, observa-tional and retrospective study of the DCs that were prepared for the Oncopediatric Service in the period 2019-2021. For each DC, its indication and clinical application were detailed. In the quantitative de-scription, the number of DC elaborated and percent-age were specified. In the qualitative description, active ingredient and concentration, procedure to prepare the formulation, dose of active ingredient, excipients, storage conditions and expiration date were detailed.Results: During the study period, 3730 DC were prepared for the Oncopediatric Service. It is import-ant to note that the 4 formulations with the greatest weight in the preparation were those of the active ingredients: etoposide, fenofibrate, ondansetron and mercaptopurine. Oral solutions and suspen-sions accounted for 57.4% and 26.5% of the DC. The clinical application of 71% of the DC prepared was the treatment of onco-hematological patholo-gies.Conclusions: In the oncopediatric patient, the need for a more individualized pharmacotherapy is accentuated to ensure a correct dosage and adher-ence to treatment, being the DC the tool that would solve its therapeutic needs (AU)

Effectiveness and safety of nab-paclitaxel/gemcitabine in locally advanced or metastatic pancreatic adenocarcinoma.

BACKGROUND: Treatment based on nab-paclitaxel plus gemcitabine is one of the standard treatments for locally advanced or metastatic pancreatic adenocarcinoma. Not much information is available about its use in clinical practice. Looking for prognostic markers may aid in improving treatment plans for patients. OBJECTIVE: To describe the effectiveness and safety profile of nab-paclitaxel/gemcitabine in locally advanced or metastatic pancreatic adenocarcinoma. We also tried to evaluate prognostic markers of response to treatment. SETTING: Retrospective descriptive study carried out in a tertiary hospital of Spain. METHOD: Patients with locally advanced or metastatic pancreatic adenocarcinoma treated with nab-paclitaxel/gemcitabina between January 2014 and December 2017 were included in the analyses. MAIN OUTCOME MEASURE: Effectiveness was measured in terms of overall survival, progression-free survival and response rate. To evaluate the safety profile, every adverse event from the start of the treatment and up to 10 days after its completion was registered. RESULTS: Fifty patients were included. Thirty-three (66%) had metastatic disease. Median overall survival was 8.8 months (95%CI: 5.1-12.5) and the median progression-free survival was 5.6 months (95%CI: 4.3-6.9). Relevance of carbohydrate antigen 19-9 baseline levels as prognostic response marker was confirmed, while neutrophil-to-lymphocyte ratio did not show conclusive results for overall survival. Safety profile was similar to that observed in clinical trials, with a single case of treatment discontinuation due to grade 3 neuropathy. CONCLUSION: The studied schedule for locally advanced or metastatic pancreatic adenocarcinoma seems to be an effective therapeutic option, with an easy to manage toxicity profile, similar to other schedules used in pancreatic adenocarcinoma.

Obinutuzumab induces depletion of NK cells in patients with chronic lymphocytic leukemia.

AIM: Obinutuzumab induces NK cell antibody-dependent cell-mediated cytotoxicity. OBJECTIVE: Investigate the effects on the human immune system after obinutuzumab monotherapy treatment in patients with chronic lymphocytic leukemia (CLL). METHOD: To evaluate these effects, we analyzed the distribution of CD4+ and CD8+ T cells, B cells and NK cells in the peripheral blood of eight CLL patients who were treated with obinutuzumab in monotherapy. The distribution of peripheral blood lymphocytes was examined prior to each dose of obinutuzumab and 24-72 h after the first 1000 mg complete dose (cycle 1 day 2). We also repeated measurements 3 months after the last obinutuzumab dose. In total we obtained ten samples of each patient. Analyses were performed by flow cytometry with monoclonal antibodies against CD3, CD4, CD8, CD19 and CD56+. RESULTS: After the first 1000 mg obinutuzumab infusion (cycle 1 day 2), CD4+ T cells and CD8+ T cells were significantly decreased in peripheral blood compared with prior to therapy. This reduction in the CD4+ T cells persisted after six cycles of obinutuzumab (1235 cells/µl basal vs 662 cells/µl after six cycles, p ≤ 0.05), but not in CD8+ T cells (987 cells/µl basal vs 837 cells/µl after six cycles). Interestingly, we also observed significant differences in the NK cell compartment after the first 1000 mg drug infusion (490 cells/µl basal vs 23 cells/µl postinfusion, p ≤ 0.05), and after cycle 6 (490 cells/µl basal vs 149 cells/µl after six cycles, p ≤ 0.05). CONCLUSION: Obinutuzumab induces depletion of NK cells in CLL.

Prevalencia de prescripción de fármacos anticolinérgicos en pacientes mayores con VIH / Prevalence of the consumption of anticholinergic drugs in HIV patients

Objetivo: Analizar el consumo de fármacos con efecto anticolinérgico en pacientes con VIH ≥ 50 años. Determinar el riesgo anticolinérgico mediante las escalas ACB y ARS. Determinar si consumen alguna benzodiacepina. Método: Estudio observacional descriptivo de 256 pacientes con VIH cuya edad era ≥ 50 años. Resultados: El 73,1% eran hombres. La media de edad fue de 56 ± 5,9 años. El 55,9% de los pacientes estaban coinfectados por el VHC. El consumo medio de fármacos por paciente, sin incluir los fármacos para el VIH, fue de 2,9 ± 2,9. Según la escala ACB y ARS, el 26,2% y el 17,2% de los pacientes, respectivamente, tomaba un fármaco con efecto anticolinérgico. El 43,3% presentaba alto riesgo anticolinérgico con la escala ACB y el 36,4% alto riesgo según la escala ARS. El 30,5% de los pacientes consumía alguna benzodiacepina. Conclusiones: El porcentaje de pacientes con VIH ≥ 50 años que toma fármacos con efecto anticolinérgico es mayor utilizando la escala ACB que utilizando la escala ARS, obteniendo una diferencia estadística-mente significativa. No hay estudios disponibles en población con VIH con los que comparar nuestros resultados, pero sí una evidencia de que este grupo de fármacos puede afectar a la población anciana (AU)

Objective: To analyse anticholinergic agent consumption in HIV patients 50 years or older; to determine anticholinergic risk using the ACB and ARS scales; and to determine if these patients use any type of benzodiazepine. Method: A descriptive observational study of 256 HIV patients 50 years or older. Results: 73.1% were men. Mean age was 56 ± 5.9 years. 55.9% of the patients were coinfected with HCV. Excluding HIV drugs, mean drug consumption was 2.9 ± 2.9 drugs per patient. The ACB and ARS scales showed that 26.2% and 17.2% of the patients took an anticholinergic agent, and that 43.3% and 36.4% presented high anticholinergic risk, respectively. 30.5% of patients consumed benzodiazepines. Conclusions: The percentage of HIV patients aged 50 years or older who were taking anticholinergic agents was statistically significantly higher on the ACB scale than on the ARS scale. No studies are available on the HIV population with which to compare our results, but there is evidence that this group of drugs can affect older adult (AU)

Prevalence of the consumption of anticholinergic drugs in HIV patients.

OBJECTIVE: To analyse anticholinergic agent consumption in HIV patients 50  years or older; to determine anticholinergic risk using the ACB and ARS scales;  and to determine if these patients use any type of benzodiazepine. METHOD: A descriptive observational study of 256 HIV patients 50 years or  older. RESULTS: 73.1% were men. Mean age was 56 ± 5.9 years. 55.9% of the  patients were coinfected with HCV. Excluding HIV drugs, mean drug consumption was 2.9 ± 2.9 drugs per patient. The ACB and ARS scales showed that 26.2% and 17.2% of the patients took an anticholinergic agent, and that 43.3% and 36.4% presented high anticholinergic  risk, respectively. 30.5% of patients consumed benzodiazepines. CONCLUSIONS: The percentage of HIV patients aged 50 years or older who were  taking anticholinergic agents was statistically significantly higher on the ACB  scale than on the ARS scale. No studies are available on the HIV population with  which to compare our results, but there is evidence that this group of drugs can  affect older adults.

Objetivo: Analizar el consumo de fármacos con efecto anticolinérgico en  pacientes con VIH ≥ 50 años. Determinar el riesgo anticolinérgico mediante las  escalas ACB y ARS. Determinar si consumen alguna benzodiacepina.Método: Estudio observacional descriptivo de 256 pacientes con VIH cuya edad  era ≥ 50 años.Resultados: El 73,1% eran hombres. La media de edad fue de 56 ± 5,9 años.  El 55,9% de los pacientes estaban coinfectados por el VHC. El consumo medio  de fármacos por paciente, sin incluir los fármacos para el VIH, fue de 2,9 ± 2,9.  Según la escala ACB y ARS, el 26,2% y el 17,2% de los pacientes,  respectivamente, tomaba un fármaco con efecto anticolinérgico. El 43,3%  presentaba alto riesgo anticolinérgico con la escala ACB y el 36,4% alto riesgo  según la escala ARS. El 30,5% de los pacientes consumía alguna  benzodiacepina.Conclusión: El porcentaje de pacientes con VIH ≥ 50 años que toma fármacos  con efecto anticolinérgico es mayor utilizando la escala ACB que utilizando la  escala ARS, obteniendo una diferencia estadísticamente significativa). No hay  estudios disponibles en población con VIH con los que comparar nuestros  resultados, pero sí una evidencia de que este grupo de fármacos puede afectar a  la población anciana.