Introducción: La Nutrición Parenteral Domiciliaria (NPD) es una práctica en continuo crecimiento por las importantes ventajas que presenta para el paciente y el sistema sanitario. En la investigación ...de los resultados en salud resulta hoy en día fundamental evaluar el punto de vista del paciente. Dentro de las medidas centradas en el paciente con NPD se han realizado varios estudios sobre la calidad de vida, pero no se ha evaluado el grado de satisfacción con esta modalidad de tratamiento. Objetivos: Evaluar el grado de satisfacción de los pacientes que reciben NPD y sus cuidadores con los médicos, farmacéuticos y enfermeros de hospital. Métodos: Se repartió una encuesta anónima y que constaba de 48 preguntas cerradas a los pacientes que recibían NPD y a sus cuidadores, los cuales contestaron de forma voluntaria. Con las respuestas recogidas se creó una base de datos en el programa SPSS con las siguientes variables: datos personales, socioculturales, clínicos y relacionados con la NPD y valoración del personal sanitario implicado (área de nutrición del Servicio de Farmacia y Unidades Médica y de Enfermería de Nutrición) y de las instalaciones del hospital relacionadas con la NPD. También se incluyó un apartado de sugerencias con respuesta abierta. Resultados: Se repartieron 24 encuestas, 12 a pacientes y 12 a cuidadores. La tasa de respuesta fue un 91,7% en el caso de los pacientes y un 58,3% en los cuidadores. El 63,6% de los pacientes y el 42,9% de los cuidadores eran mujeres. La media de edad fue, respectivamente, 46,1 años (DE: 13,7) y 47,0 años (DE: 3,6). La mayoría de los pacientes (54,5%) y de los cuidadores (42,9%) tenían estudios secundarios y eran pensionistas (72,7% y 71,4%, respectivamente). Las enfermedades de base de los pacientes fueron: enteritis rádica (27,3%), obstrucción intestinal (18,2%), carcinomatosis intestinal (45,5%) y enfermedad de Crohn (9,1%). Con respecto a los ítems que evaluaban la satisfacción con médicos, enfermeros y farmacéuticos, en general tanto pacientes como cuidadores estuvieron satisfechos. Las sugerencias recogidas fueron: mayor amplitud del horario de entrega de la NPD e inclusión de información audiovisual. Conclusiones: El grado de satisfacción de los pacientes que reciben NPD y sus cuidadores con el servicio dado por médicos, enfermeros y farmacéuticos es adecuado, aunque se pueden introducir mejoras para optimizar la calidad de todo el proceso.
To evaluate the association between starting early treatment with anti-TNF and effectiveness as well as the possibility of applying therapeutic spacing in daily practice in patients with rheumatoid ...arthritis (RA).
Observational, retrospective study conducted in two universitary hospitals in Spain. RA patients who received the first anti-TNF (adalimumab: ADA, etanercept: ETN or infliximab: IFX) during the study period (October 2006-2010) were included. Demographic data, time since diagnosis, disease activity (DAS28-ESR) and anti-TNF dosage were analyzed. Therapeutic objective was defined as DAS28 DAS28 < 2.6. Also the response related to criteria of the European League Against Rheumatism (EULAR) was evaluated. Therapeutic spacing was defined as the use of a lower dose or a higher interval according to label doses. The main endpoint was to assess the association between the effectiveness and the moment when the anti-TNF therapy begins. The secondary target was to evaluate the association between RA activity at the beginning of treatment with anti-TNF and dose used. Results. 82 patients were included. The prescription profile was: ADA (48.8%), ETN (31.7%) and IFX (19.5%). 71.4% of patients treated with anti-TNF during the first year since diagnosis, 57.1% of those who started after 1-5 years and 30.6% of patients who started after 5 years were in remission when the study ended. De-escalation strategy was performed in 25.6% of patients: ETN (38.5%), ADA (20.0%) and IFX (18.8%). The patients treated with a higher dose according to label doses were: IFX (81%), ADA, (12.5%) and ETN (7.7%).
Results suggest that early treatment with anti-TNF can achieve a higher percentage of remissions. Therapeutic spacing is established as a strategy that improves the efficiency in those patients in remission, being the ETN the anti-TNF most susceptible for spacing, although a relation between the early beginning with anti-TNF and the used dose was not found.
Introducción: En el proceso de elaboración de nutrición parenteral se debe garantizar que el personal de enfermería utiliza una técnica aséptica adecuada. En el capítulo 797 de la United States ...Pharmacopeia se clasifican los niveles de riesgo de las preparaciones estériles y se definen los requerimientos que se deben cumplir en la elaboración. Objetivo: Describir el desarrollo de un procedimiento de validación de la técnica aséptica utilizada por el personal de enfermería que elabora nutriciones parenterales en el área de elaboración del Servicio de Farmacia según las recomendaciones del capítulo 797 de la United States Pharmacopeia. Métodos: Se revisó el capítulo 797 de la United States Pharmacopeia y se clasificaron las nutriciones parenterales como preparaciones de riesgo medio de contaminación microbiológica. Resultados: Se adaptaron las recomendaciones de la United States Pharmacopeia para mezclas de riesgo medio y se estableció un procedimiento de validación de la técnica aséptica para la elaboración de las nutriciones parenterales. Discusión: El procedimiento de validación de la técnica aséptica permite validar la calidad del manejo aséptico del personal de enfermería. El procedimiento se ha incorporado a la práctica habitual, realizándose de forma mensual por el personal de enfermería del área de nutrición.
Skin burns are associated with the presence of metallic components in transdermal drug delivery systems during Magnetic Resonance Imaging, cardioversion, or defibrillation procedures.
The aim of the ...study was to review the presence of metallic components in marketed products of transdermal drug delivery systems in Spain.
For each pharmaceutical form, the summary of product characteristics was reviewed. If the information was not provided, manufacturers were contacted.
We identified 59 marketed products of transdermal drug delivery systems of 12 different active substances.
59.3% of patches contained metallic components or their presence could not be ruled out. Information regarding the need to remove the patch was only included in 8 summaries of product characteristics (13.6%)
A table was elaborated and included the following aspects: product, active substance, manufacturer, need to remove the patch before the exposure to magnetic or electric fields, and references.
More than a half of the patches at the time of the study contained metals or their absence could not be confirmed by the manufacturer. However, this information was only included in 13.6% of summaries of product characteristics.
La presencia de partículas metálicas en los parches transdérmicos de medicamentos se ha asociado con riesgo de quemaduras en la piel cuando los pacientes son sometidos a una resonancia magnética, cardioversión eléctrica o desfibrilación.
Por este motivo, el objetivo del trabajo fue analizar la presencia de partículas metálicas en los parches transdérmicos de medicamentos comercializados en España.
De cada presentación comercial, se revisó la ficha técnica para comprobar la presencia de estas partículas en su composición. Si no constaba, entonces se contactó con el laboratorio fabricante.
Se identificaron 59 presentaciones comerciales de 12 principios activos diferentes. Un 59,3% contenía partículas metálicas o la presencia de las mismas no se pudo descartar. Únicamente, en 8 fichas técnicas (13,6%) constaba la advertencia de retirar el parche cuando el paciente es sometido a alguno de estos procedimientos.
Se elaboró una tabla que incluyó los siguientes aspectos: principio activo, presentación comercial, laboratorio fabricante, necesidad de retirar el parche cuando el paciente es sometido a la exposición de un campo magnético o eléctrico y referencias.
Más de la mitad de los parches comercializados contenían compuestos metálicos o su presencia no pudo descartarse por el laboratorio fabricante. Sin embargo, esta información sólo constaba en un 13,6% de las fichas técnicas.
la presencia de partículas metálicas en los parches transdérmicos de medicamentos se ha asociado con riesgo de quemaduras en la piel cuando a los pacientes se les realiza una resonancia magnética, ...cardioversión eléctrica o desfibrilación.
Por este motivo, el objetivo del trabajo fue analizar la presencia de partículas metálicas en los parches transdérmicos de medicamentos comercializados en España.
de cada presentación comercial se revisó la ficha técnica para comprobar la presencia de estas partículas en su composición. Si no constaba, entonces se contactó con el laboratorio fabricante.
se identificaron 59 presentaciones comerciales de 12 principios activos diferentes. Un 59,3% contenía partículas metálicas o la presencia de las mismas no se pudo descartar. Únicamente en 8 fichas técnicas (13,6%) constaba la advertencia de retirar el parche cuando el paciente recibe alguno de estos procedimientos.
Se elaboró una tabla que incluyó los siguientes aspectos: principio activo, presentación comercial, laboratorio fabricante, necesidad de retirar el parche cuando el paciente es expuesto a un campo magnético o eléctrico y referencias.
más de la mitad de los parches comercializados contenían compuestos metálicos o su presencia no pudo descartarse por el laboratorio fabricante. Sin embargo, esta información solo constaba en un 13,6% de las fichas técnicas.
Skin burns are associated with the presence of metallic components in transdermal drug delivery systems during Magnetic Resonance Imaging, cardioversion or defibrillation procedures.
The aim of the study was to review the presence of metallic components in marketed products of transdermal drug delivery systems in Spain.
For each presentation, the summary of product characteristics was reviewed. If the information was not provided, manufacturers were contacted.
We identified 59 marketed products of transdermal drug delivery systems of 12 different active substances.
59.3% of patches contained metallic components or their presence could not be ruled out. Information regarding the need to remove the patch was only included in 8 summaries of product characteristics (13.6%).
A table was elaborated and included the following aspects: product, active substance, manufacturer, need to remove the patch before the exposure to magnetic or electric fields and references.
More than a half of the patches at the time of the study contained metals or their absence could not be confirmed by the manufacturer. However, this information was only included in 13.6% of summaries of product characteristics.
This study aims to analyze the impact of the eOncosalud app on the management and follow-up of adverse effects (AE) in patients receiving oral antineoplastic agents.
We performed an observational, ...prospective study of cancer outpatients treated with oral antineoplastic agents (OAA), monitored by the eOncosalud app between August 2017 and October 2021. Safety variables were collected from eOncosalud: the number of AE; severity of the AE according to CTCAE, version 4.03; timelapse from app installation to first recorded AE; automatic recommendations issued; and the patient's acceptance of the recommendations made. To assess the impact of the recommendations generated by the algorithm, we calculated the positive predictive value (PPV) as the number of recommendations accepted out of the total number of recommendations generated. Safety-related patient messages were also analyzed (AE, drug-drug interactions, drug administration).
The app was downloaded and used by 186 patients (58.0% women), with a mean age of 59.0 years. A total of 1,368 AE were recorded, the most frequent being fatigue (19.37%), diarrhea (18.20%), and skin changes (9.21%). Regarding the recommendations issued by the app algorithm, 102 patients received 344 information brochures, 39 patients received 51 recommendations for supportive care to control AE, 60 patients received 240 recommendations to visit their primary care doctor, 14 patients received 16 recommendations to contact their specialist pharmacist or oncologist-hematologist, and 34 patients received 73 recommendations to go to the emergency room. The suggestion to go to the emergency room and contact the specialist pharmacist or oncologist-hematologist had a PPV of 0.51 and 0.35, respectively. Half of the patients (50.4%) used the messaging module. A total of 1,668 messages were sent. Of these, 47.8% were related to treatment safety: AE, 22.7%; drug-drug interactions, 20.6%; drug administration, 3.6%; and missing a dose, 1.0%.
The eOncosalud app enables close, real-time monitoring of patients treated with OAA. The automatic recommendations through the app's algorithm have optimized available healthcare resources. The app facilitated early detection of AE, thus enabling patients themselves to improve the safety of their treatment.
Background: The variant rs34983651 (UGT1A1*28) and its genotyping are used to prevent irinotecan-induced toxicity. Several variants are in close linkage disequilibrium. Our objective was to evaluate ...the potential correlation of genotyping UGT1A1*80 instead of UGT1A1*28 in different populations. Methods: We studied SNPs in linkage disequilibrium with UGT1A1*28 in several populations and selected rs887829 to develop an inexpensive and rapid genotyping method and compare it with the one we currently use for UGT1A1*28 genotyping. Samples from cancer patients (n = 701) already tested using PCR and electrophoresis prior to treatment with irinotecan for rs34983651 (UGT1A1*28) in a Spanish hospital were genotyped for rs887829 (UGT1A1*80) using real-time PCR with a TaqMan probe. Results: We observed a complete match for both genotypes, except in one sample. This method was 100% efficient in correctly genotyping *28/*28 patients, 99.68% efficient for *1/*28, and 100% efficient for *1/*1. Linkage disequilibrium between populations showed the Iberian population to be the most suitable for the clinical use of UGT1A1*80. This method is less expensive and the time to decision is shorter. Conclusion: Genotyping of rs887829 using the proposed method may be used to substitute genotyping of rs34983651 as a pharmacogenetics test in cancer patients prior to starting irinotecan-based treatments, mainly in the Iberian population. In addition, it is less expensive than other conventional methods and easy to implement, with a shorter time to decision than UGT1A1*28.
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Preventing severe irinotecan-induced adverse reactions would allow us to offer better treatment and improve patients’ quality of life. Transporters, metabolizing enzymes, and genes ...involved in the folate pathway have been associated with irinotecan-induced toxicity. We analyzed 12 polymorphisms in UGT1A1, ABCB1, ABCG2, ABCC4, ABCC5, and MTHFR in 158 patients with metastatic colorectal cancer treated with irinotecan and studied the association with grade >2 adverse reactions (CTCAE). Among the most frequent ADRs, the SNPs rs1128503, rs2032582, and rs1045642 in ABCB1 and rs1801133 in MTHFR were associated with hematological toxicity and overall toxicity. The SNP rs11568678 in ABCC4 was also associated with overall toxicity. After correction of P values using a false discovery rate, only ABCB1 variants remained statistically significant. Haplotype analysis in ABCB1 showed an 11.3-fold and 4.6-fold increased risk of hematological toxicity (95% CI, 1.459–88.622) and overall toxicity (95% CI, 2.283–9.386), respectively. Consequently, genotyping of the three SNPs in ABCB1 can predict overall toxicity and hematological toxicity with a diagnostic odds ratio of 4.40 and 9.94, respectively. Genotyping of ABCB1 variants can help to prevent severe adverse reactions to irinotecan-based treatments in colorectal cancer.
Background: Evidence about the use of dolutegravir (DTG) and rilpivirine (RPV) as an antiretroviral therapy (ART) in treatment-experienced patients is scarce. Objective: To explore the effectiveness, ...safety, and costs of switching to a DTG plus RPV regimen in this population. Methods: This observational, prospective study included all treatment-experienced patients who switched to DTG plus RPV between November 2014 and July 2016. Patients were excluded if resistance mutations to integrase inhibitors or RPV were found. The effectiveness endpoint was the proportion of patients who achieved virological suppression (viral load VL <50 copies/mL) at week 48 (W48). Safety (incidence of adverse events leading to discontinuation and laboratory abnormalities), adherence, and costs were analyzed. Results: A total of 35 patients were included, and 91.4% were virologically suppressed at baseline. Patients were treated with ART for a median of 14 years (interquartile range = 7-20). At W48, 91.4% of patients were virologically suppressed (95% CI = 77.0-98.2). Two of the 3 patients not suppressed at baseline achieved undetectable VL at W48, and 2 patients discontinued DTG plus RPV (intolerance and a drug-drug interaction). None of the virologically suppressed patients at baseline showed virological rebound through W48. There were no significant changes in lipid, liver, and renal profiles. The proportion of patients with an ART adherence >90% increased from 65.6% to 93.8% (P = 0.004). The annual per-patient ART costs dropped by €665 (P = 0.265). Conclusions: Switching to DTG plus RPV seems to be an effective and safe strategy. Significant improvements in patients’ adherence and costs were achieved.
Severe, life-threatening adverse reactions to capecitabine sometimes occur in the treatment of solid tumors. Screening for dihydropyrimidine dehydrogenase (DPYD) deficiency is encouraged before start ...of treatment, but the genetic variants that are commonly analyzed often fail to explain toxicities seen in clinical practice. Here we describe the case of a 79-year-old Caucasian female with breast cancer who presented with life-threatening, rapidly increasing toxicity after 1 week of treatment with capecitabine and for whom routine genetic
test resulted negative.
exon sequencing found variant c.2242+1G>T at the donor splicing site of exon 19. This variant is responsible for skipping of exon 19 and subsequent generation of a non-functional DPYD enzyme. This variant has not been described previously but was found in three other members of the patient's family. With this case, we show that exon sequencing of
in patients who experience marked toxicity to fluoropyrimidines and test negative for commonly evaluated variants can prove extremely useful for identifying new genetic variants and better explain adverse reactions causality.
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