Presence of metallic components in transdermal drug delivery systems and risk of skin burns. / [Artículo traducido] Presencia de partículas metálicas en parches transdérmicos de medicamentos y riesgo de quemaduras.

OBJECTIVE: 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. METHOD: For each presentation, the summary of product characteristics was reviewed. If the information was not provided, manufacturers were contacted. RESULTS: 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. CONCLUSION: 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.

Treatment with Rasburicase in Hospitalized Patients with Cardiorenal Syndrome: Old Treatment, New Scenario.

Cardiorenal syndrome (CRS) involves joint dysfunction of the heart and kidney. Acute forms share biochemical alterations like hyperuricaemia (HU) with tumour lysis syndrome (TLS). The mainstay treatment of acute CRS with systemic overload is diuretics, but rasburicase is used in TLS to prevent and treat hyperuricaemia. An observational, retrospective study was performed to assess the effectiveness and safety of a single dose of rasburicase in hospitalized patients with cardiorenal syndrome, worsening renal function and uric acid levels above 9 mg/dL. Rasburicase improved diuresis and systemic congestion in the 35 patients included. A total of 86% of patients did not need to undergo RRT, and early withdrawal was possible in the remaining five. Creatinine (Cr) decreased after treatment with rasburicase from a peak of 3.6 ± 1.27 to 1.79 ± 0.83 mg/dL, and the estimated glomerular filtration rate (eGFR) improved from 17 ± 8 to 41 ± 20 mL/min/1.73 m2 (p = 0.0001). The levels of N-terminal type B Brain Natriuretic Peptide (Nt-ProBNP) and C-reactive protein (CRP) were also significantly reduced. No relevant adverse events were detected. Our results show that early treatment with a dose of rasburicase in patients with CRS and severe HU is effective to improve renal function and systemic congestion, avoiding the need for sustained extrarenal clearance, regardless of comorbidities and ventricular function.

Blood gene expression biomarkers of response to anti-TNF drugs in pediatric inflammatory bowel diseases before initiation of treatment.

BACKGROUND/AIMS: Changes in gene expression profiles among individuals with inflammatory bowel diseases (IBDs) could potentially influence the responsiveness to anti-TNF treatment. The aim of this study was to identify genes that could serve as predictors of early response to anti-TNF therapies in pediatric IBD patients prior to the initiation of treatment. METHODS: We conducted a prospective, longitudinal, and multicenter study, enrolling 24 pediatric IBD patients aged less than 18 years who were initiating treatment with either infliximab or adalimumab. RNA-seq from blood samples was analyzed using the DESeq2 library by comparing responders and non-responders to anti-TNF drugs. RESULTS: Bioinformatic analyses unveiled 102 differentially expressed genes, with 99 genes exhibiting higher expression in responders compared to non-responders prior to the initiation of anti-TNF therapy. Functional enrichment analyses highlighted defense response to Gram-negative bacteria (FDR = 2.3 ×10-7) as the most significant biological processes, and hemoglobin binding (FDR = 0.002), as the most significant molecular function. Gene Set Enrichment Analysis (GSEA) revealed notable enrichment in transcriptional misregulation in cancer (FDR = 0.016). Notably, 13 genes (CEACAM8, CEACAM6, CILP2, COL17A1, OLFM4, INHBA, LCN2, LTF, MMP8, DEFA4, PRTN3, AZU1, and ELANE) were selected for validation, and a consistent trend of increased expression in responders prior to drug administration was observed for most of these genes, with findings for 4 of them being statistically significant (CEACAM8, LCN2, LTF2, and PRTN3). CONCLUSIONS: We identified 102 differentially expressed genes involved in the response to anti-TNF drugs in children with IBDs and validated CEACAM8, LCN2, LTF2, and PRTN3. Genes participating in defense response to Gram-negative bacterium, serine-type endopeptidase activity, and transcriptional misregulation in cancer are good candidates for anticipating the response to anti-TNF drugs in children with IBDs.

Detection and reduction of errors in parenteral nutrition compounding through gravimetric and product control.

OBJECTIVE: To analyze the errors in the preparation of parenteral nutrition in a Pharmacy Service, detected through an already consolidated gravimetric and product quality control, and compare them with those detected during the initial years of implementing this quality control. METHODS: All errors detected through quality control in the compounding of pediatric and adult parenteral nutritions between 2019 and 2021 were prospectively analyzed. This quality control consisted of 3 sequential processes: a visual check, a gravimetric control, and a product control. Errors were classified as gravimetric, when the nutrition had a deviation of more than 5% from the theoretical weight, or as product errors when a qualitative or quantitative error was detected upon reviewing the remainder of the components used. These errors were analyzed in terms of type and the component involved. A comparison was made with the errors detected during the implementation phase of this quality control from 2016 to 2018. RESULTS: A total of 41,809 parenteral nutritions were reviewed, and 345 errors were detected (0.83% of the preparations); of these, 59 errors were found in pediatric nutritions (0.68% of them), and 286 in adult nutritions (0.86% of them). Among these errors, 193 were of gravimetric nature, while 152 were detected through product control. The main components involved in product errors were electrolytes, primarily due to the addition of excessive volumes and the use of incorrect components. A significant absolute reduction of 0.71% (P < .05) in the total number of errors was observed when compared to the implementation phase. This reduction was consistent in both gravimetric errors (-0.59%) and product-related errors (-0.12%) (P < .05). CONCLUSIONS: Comprehensive quality control of parenteral nutrition preparation is an easily implementable tool that effectively detected and prevented significant errors. Furthermore, its widespread adoption contributed to a reduction in the overall error count.

Presence of metallic components in transdermal drug delivery systems and risk of skin burns.

OBJECTIVE: 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. METHOD: For each pharmaceutical form, the summary of product characteristics was reviewed. If the information was not provided, manufacturers were contacted. RESULTS: 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. CONCLUSION: 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.

Changes in the Expression of TGF-Beta Regulatory Pathway Genes Induced by Vitamin D in Patients with Relapsing-Remitting Multiple Sclerosis.

Vitamin D is an environmental factor related to multiple sclerosis that plays a significant role in immune regulation. TGF-ß is a superfamily of cytokines with an important dual effect on the immune system. TGF-ß inhibits the Th1 response while facilitating the preservation of regulatory T cells (FOXP3+) in an immunoregulatory capacity. However, when IL-6 is present, it stimulates the Th17 response. Our aim was to analyze the regulatory effect of vitamin D on the in vivo TGF-ß signaling pathway in patients with relapsing-remitting multiple sclerosis (RRMS). A total of 21 patients with vitamin D levels < 30 ng/mL were recruited and supplemented with oral vitamin D. All patients were receiving disease-modifying therapy, with the majority being on natalizumab. Expression of SMAD7, ERK1, ZMIZ1, BMP2, BMPRII, BMP4, and BMP5 was measured in CD4+ lymphocytes isolated from peripheral blood at baseline and one and six months after supplementation. SMAD7 was overexpressed at six months with respect to baseline and month one. ERK1 was overexpressed at six months with respect to month one of treatment. No significant differences in expression were observed for the remaining genes. No direct correlation was found with serum vitamin D levels. BMPRII expression changed differentially in non-natalizumab- versus natalizumab-treated patients. Changes were observed in the expression of ERK1, BMP2, and BMP5 based on disease activity measured using the Rio-Score, BMP2 in patients who had relapses, and BMP5 in those whose EDSS worsened. Our results suggest indirect regulation of vitamin D in TGF-ß pathway genes in patients with RRMS.

Remdesivir and SARS-CoV-2 monoclonal antibodies to prevent COVID-19 progression in hematological patients: an observational study.

BACKGROUND: Patients with hematological malignancies (HM) are at high risk of COVID-19 progression. Hence, early treatments to prevent progression are needed. The aim of our work was to evaluate the effectiveness and safety of remdesivir (RDV) and SARS-CoV-2 monoclonal antibodies (mAb) in patients with HM and mild-to-moderate disease in real clinical practice. METHODS: We conducted a prospective study in a tertiary hospital in 55 HM patients with mild-to-moderate SARS-CoV-2 disease diagnosed between August 2021 and July 2022 and who received RDV or mAb to prevent COVID-19 progression (related death or hospitalization). The primary endpoint was COVID-19 progression on day 28. Other outcomes were COVID-19 progression beyond day 28 and viral load evolution. RESULTS: RDV was administered to 44 (80.0%) patients and mAb to 11 (20.0%) patients. Death occurred in 1 (1.8%) patient and hospitalization in 9 (16.4%) patients by day 28, respectively; 3 patients (5.5%) required intensive care and 8 (14.5%), oxygen support. Of note, 5 additional patients [15, (27.3%) in total] died or required hospitalization after day 28. Two hazard Cox regression models yielded the absence of anti-SARS-CoV-2 antibodies, age over 65 years, and ECOG-performance status ≥ 2 as the main risk factors for COVID-19-related death or hospitalization. CONCLUSION: Our results from clinical practice suggest that RDV and SARS-CoV-2 mAb therapies elicit worse outcomes in hematological patients than those reported for high-risk population in clinical trials.

Polymorphisms indicating risk of inflammatory bowel disease or antigenicity to anti-TNF drugs as biomarkers of response in children.

Few genetic polymorphisms predict early response to anti-TNF drugs in inflammatory bowel disease (IBD), and even fewer have been identified in the pediatric population. However, it would be of considerable clinical interest to identify and validate genetic biomarkers of long-term response. Therefore, the aim of the study was to analyze the usefulness of biomarkers of response to anti-TNFs in pediatric IBD (pIBD) as long-term biomarkers and to find differences by type of IBD and type of anti-TNF drug. The study population comprised 340 children diagnosed with IBD who were treated with infliximab or adalimumab. Genotyping of 9 selected SNPs for their association with early response and/or immunogenicity to anti-TNFs was performed using real-time PCR. Variants C rs10508884 (CXCL12), A rs2241880 (ATG16L1), and T rs6100556 (PHACTR3) (p value 0.049; p value 0.03; p value 0.031) were associated with worse long-term response to anti-TNFs in pIBD. DNA variants specific to disease type and anti-TNF type were identified in the pediatric population. Genotyping of these genetic variants before initiation of anti-TNFs would enable, if validated in a prospective cohort, the identification of pediatric patients who are long-term responders to this therapy.

Anti-interleukin-17 therapies for moderate/severe psoriasis in clinical practice: effectiveness, safety and association with clinical patient factors.

OBJECTIVES: Interleukin-17 (IL-17) contributes to the pathogenesis of psoriasis. Secukinumab, ixekizumab, and brodalumab are monoclonal antibodies anti-IL-17 antibodies, approved for the treatment of moderate/severe plaque psoriasis.The aim of the study was to describe the effectiveness and safety of anti-IL-17 agents in moderate/severe plaque psoriasis in clinical practice. We also analysed anti-IL-17 therapies' survival, dose adjustment, and clinical patients' factors associated with their effectiveness and safety. METHODS: A retrospective, longitudinal study was conducted at a tertiary hospital. We included patients with moderate/severe psoriasis treated with anti-IL-17 agents. The effectiveness was evaluated with Psoriasis Area and Severity Index (PASI) score and safety through the adverse drug reactions (ADRs) collected. RESULTS: 38 patients were studied (median age=47.4 years, 71.0% male). The mean number of biological therapies that patients received was 2.6, and anti-IL-17 therapy was the first biological therapy for 36.8% of patients. The median years in treatment were 2.5 (95% CI 1.95 to 2.98) for secukinumab, 1.2 (95% CI 0.36 to 1.47) for ixekizumab, and 0.7 (IQR 0.71) for brodalumab. The median PASI score after 6 months of treatment was 0 (IQR 0) and 85.3% of patients achieved a PASI of 90 (84.0% with secukinumab, 87.5% with ixekizumab, and 100% with brodalumab). Dose adjustment was associated with the line of treatment (p=0.034 for naïve patients), age (p=0.044 for younger patients), and concomitant pathologies (p=0.015 without more diseases).24 patients suffered from ADRs, mainly infections of the upper respiratory tract, and there were no statistically significant differences between the three therapies. CONCLUSIONS: Anti-IL-17 agents constitute an effective treatment for patients with moderate/severe plaque psoriasis and for longer. Dose reductions were associated with fewer lines of treatment, younger patients and absence of concomitant pathologies. ADR were minor and similar among the anti-IL-17.

Appropriateness of Empirical Antibiotic Therapy for Cervicitis and Urethritis Prescribed in the Emergency Department.

Objectives: Sexually transmitted infections are a prevalent global health care problem. Treatment guidelines have recently been updated as a result of antimicrobial resistance and public health trends. The aim of the study was to assess the appropriateness of empirical antibiotic therapy prescribed for cervicitis and urethritis in the emergency department. Methods: We designed a retrospective observational cohort study. We included adult patients with suspected cervicitis or urethritis who attended the emergency department of a tertiary hospital in 2020. We excluded patients with suspected pelvic inflammatory disease, pregnancy or prostatitis and those requiring admission to hospital. Appropriateness of empirical antibiotic therapy was evaluated taking into account 4 aspects: indication, dosing, duration of therapy, and route of administration. Data were obtained from the electronic medical record, the electronic prescription program, and the discharge summary. Results: The study population comprised 176 patients; mean age was 28.9 years (SD = 7.7), and 90.9% were men. The most prescribed treatment was the combination of ceftriaxone and azithromycin (83.0%). Treatment was inappropriate in 71.6% of patients. A total of 159 drug errors were recorded. The most frequent cause was undertreatment (36.4%) related to underdosing (46.5%), particularly with regard to ceftriaxone. The percentage of errors was 11.9% for indication, 84.9% for dosing, 3.1% for duration, and 0% for route of administration. Conclusions: A high percentage of patients who attended the emergency department for suspected cervicitis or urethritis received an inappropriate empirical antibiotic regimen. The main reason was undertreatment due to underdosing.

Achieving excellence in the pharmaceutical care of the surgical patient. / Hacia la excelencia en la atención farmacéutica al paciente quirúrgico.

The perioperative setting is one of the hospital areas with the highest prevalence of medication errors. Despite the wide experience of hospital pharmacists in developing medication safety programs and improvement initiatives, the surgical environment has remained one of the areas in which there is less experience. Clinical pharmacist should be integrated into the multidisciplinary care teams so that they can be involved in the different surgical phases of care, which include from the preoperative assessment to inpatient stay, and finally discharge from hospital. Their work will consist of coordinating and implementing strategies that have been demonstrated to reduce medication errors throughout the perioperative process. The aim of this paper is to introduce a specialized pharmaceutical care program to achieve excellence in the pharmaceutical care of surgical patients. This program is especially aimed at promoting the figure of the clinical pharmacist in the perioperative setting to guarantee the highest quality and safety in pharmacotherapeutic care throughout all the surgical phases of care.

Association between HLA DNA Variants and Long-Term Response to Anti-TNF Drugs in a Spanish Pediatric Inflammatory Bowel Disease Cohort.

The genetic polymorphisms rs2395185 and rs2097432 in HLA genes have been associated with the response to anti-TNF treatment in inflammatory bowel disease (IBD). The aim was to analyze the association between these variants and the long-term response to anti-TNF drugs in pediatric IBD. We performed an observational, multicenter, ambispective study in which we selected 340 IBD patients under 18 years of age diagnosed with IBD and treated with anti-TNF drugs from a network of Spanish hospitals. Genotypes and failure of anti-TNF drugs were analyzed using Kaplan-Meier curves and Cox logistic regression. The homozygous G allele of rs2395185 and the C allele of rs2097432 were associated with impaired long-term response to anti-TNF drugs in children with IBD after 3 and 9 years of follow-up. Being a carrier of both polymorphisms increased the risk of anti-TNF failure. The SNP rs2395185 but not rs2097432 was associated with response to infliximab in adults with CD treated with infliximab but not in children after 3 or 9 years of follow-up. Conclusions: SNPs rs2395185 and rs2097432 were associated with a long-term response to anti-TNFs in IBD in Spanish children. Differences between adults and children were observed in patients diagnosed with CD and treated with infliximab.

[Translated article] Achieving excellence in the pharmaceutical care of the surgical patient.

The perioperative setting is one of the hospital areas with the highest prevalence of medication errors. Despite the wide experience of hospital pharmacists in developing medication safety programs and improvement initiatives, the perioperative setting has remained one of the areas in which there is less experience. Clinical pharmacist should be integrated into the multidisciplinary care team so that they can be involved in the different surgical phases of care, which include from the preoperative assessment to inpatient stay, and finally discharge from hospital. Their work will consist of coordinating and implementing strategies that have been demonstrated to reduce medication errors during the perioperative process. The aim of this paper is to introduce a specialized pharmaceutical care program to achieve excellence in the pharmaceutical care of surgical patients. This program is especially aimed at promoting the figure of the clinical pharmacist in the perioperative setting to guarantee the highest quality and safety in pharmacotherapeutic care throughout all the surgical phases of care.

Hacia la excelencia en la atención farmacéutica al paciente quirúrgico / Achieving excellence in the pharmaceutical care of the surgical patient

El proceso quirúrgico es una de las áreas del hospital con más prevalencia de errores de medicación. A pesar de la amplia experiencia del farmacéutico en el desarrollo de prácticas seguras de utilización de los medicamentos, el bloque quirúrgico ha sido una de las áreas en las que menos experiencia existe.El farmacéutico especialista debe integrarse en el equipo multidisciplinar, de tal forma que pueda estar presente en todas las etapas de atención al enfermo (prehospitalización, precirugía, intracirugía, postcirugía y alta). Su función será coordinar y diseñar la puesta en marcha de diferentes estrategias que han demostrado reducir el riesgo de errores de medicación durante todo el proceso perioperatorio.El objetivo del presente trabajo es presentar un programa de atención farmacéutica especializada para alcanzar la excelencia en la atención farmacéutica del paciente quirúrgico. Este programa está dirigido especialmente a visibilizar la figura del farmacéutico en el entorno perioperatorio, para que pueda colaborar en garantizar una atención farmacoterapéutica de máxima calidad y seguridad en todas las etapas. (AU)

The perioperative setting is one of the hospital areas with the highest prevalence of medication errors. Despite the wide experience of hospital pharmacists in developing medication safety programs and improvement initiatives, the surgical environment has remained one of the areas in which there is less experience.Clinical pharmacist should be integrated into the multidisciplinary care teams so that they can be involved in the different surgical phases of care, which include from the preoperative assessment to inpatient stay, and finally discharge from hospital. Their work will consist of coordinating and implementing strategies that have been demonstrated to reduce medication errors throughout the perioperative process.The aim of this paper is to introduce a specialized pharmaceutical care program to achieve excellence in the pharmaceutical care of surgical patients. This program is especially aimed at promoting the figure of the clinical pharmacist in the perioperative setting to guarantee the highest quality and safety in pharmacotherapeutic care throughout all the surgical phases of care. (AU)

Standardisation of intravenous infusion therapy for paediatrics: big challenges for the little patients.

BACKGROUND: Worldwide organisations advocate standardising the management of intravenous drugs as an essential strategy to increase safety in paediatric healthcare settings. Intravenous administration is a route associated with some potential complications. Many adverse events are related to the use of intravenous medications, and the great variability in their handling and preparation represents an added risk that jeopardises the safety of children. PURPOSE: To standardise the dilutions of intravenous drugs most commonly administered to Spanish hospitalised paediatric and neonatal patients. METHODS: The process leading to the standardisation of concentrations was undertaken following a two-round modified Delphi procedure. The consensus included the most common drugs administered by continuous or intermittent intravenous infusion to hospitalised and/or critically ill paediatric patients. RESULTS: For paediatric patients, the proposal included a total of 102 drugs (45 continuous infusion and 59 intermittent infusion), with 192 concentrations to be standardised. The final consensus included 101 drugs (99%), of which 44 were continuous infusion and 59 intermittent infusion; 160 concentrations were standardised (72.7%). For neonates, the initial proposal included 80 drugs (38 continuous infusion and 43 intermittent infusion), with 189 concentrations to be standardised. The final consensus included 80 drugs (100%), of which 38 were continuous infusion and 43 were intermittent infusion; 120 concentrations were standardised (49.2%). CONCLUSIONS: This proposal showed that standardisation is a feasible approach that can be reached by other healthcare institutions. It can be used in other centres and contribute in the future to unifying paediatric clinical practice.

Implementation and evaluation of a home pharmaceutical care model through Telepharmacy.

OBJECTIVE: To describe the impact of a Specialized Pharmaceutical Care model  that includes pharmacotherapeutic monitoring of patients through an  Telepharmacy platform and home medication dispensing. METHOD: A descriptive and retrospective study conducted in the Pharmacy Service of a tertiary hospital, between 23 March 2020 and 31  December 2021. A new pharmaceutical care model for chronic ambulatory  patients was developed, including: (i) definition of criteria for selecting  Telepharmacy candidate patients; (ii) stratification of patients by risk level; (iii)  definition of individualized pharmacotherapeutic monitoring; (iv)  adaptation of the Pharmacy Service app platform to ensure continuous pharmacotherapeutic monitoring and patient monitoring (e- Oncohealth, e-Midcare and farMcuida), (v) implementation of an appointment  system; and (vi) development of a software module for the management of  home medication delivery. The impact of this pharmaceutical care model was assessed by analyzing indicators of activity, safety, adherence and  perceived quality. Moreover, an additional study on the impact of COVID­19 was developed in order to assess the accessibility of medical care  and continuity of treatment through a survey conducted on a random sample of 100 patients. RESULTS: During the study period, 2,737 patients benefited from the new  remote pharmaceutical care model. A total of 7,758 Telepharmacy consultations were performed. Pharmacotherapeutic monitoring  prevented 1,043 adverse drug reactions, which affected 10.4% of patients  (3.6 adverse drug reactions/patient). Mean adherence to treatment  was 95.2%. Overall satisfaction with the new model was 9.8/10. All patients would recommend this model to other patients. CONCLUSIONS: The new Pharmaceutical care model increases patient safety and  improves treatment adherence, with a high perceived quality. Patient  stratification and individualized follow-up via an Telepharmacy platform were  crucial to the development of this model.

OBJETIVO: Describir el impacto de un modelo de atención farmacéutica especializada que incluye el seguimiento farmacoterapéutico de  los pacientes mediante una plataforma de Telefarmacia y la dispensación de  la medicación en el domicilio.Método: Estudio descriptivo, retrospectivo, llevado a cabo en un servicio de  farmacia de un hospital terciario entre el 23 marzo de 2020 y el 31 de  diciembre de 2021. Se desarrolló un nuevo modelo de atención farmacéutica para la atención de los pacientes crónicos ambulatorios, que incluye: i) definición de los criterios de selección de los pacientes  candidatos a Telefarmacia, ii) estratificación de los pacientes según el nivel de riesgo, iii) definición del seguimiento farmacoterapéutico individualizado, iv)  adaptación de la plataforma de apps del servicio de  farmacia para garantizar el seguimiento farmacoterapéutico continuo y la  monitorización de los pacientes (e-Oncosalud, e-Midcare y farMcuida), v)  implantación de un sistema de citación, y vi) el desarrollo de un módulo  informático para la gestión de la dispensación y entrega de la medicación en el  domicilio. El impacto de este modelo de atención se evaluó mediante el análisis  de indicadores de actividad, seguridad, adherencia y calidad percibida.  Asimismo, se incluyó un estudio adicional sobre el impacto de la  COVID­19 en  la accesibilidad de la atención médica y la continuidad de los  tratamientos, mediante una encuesta a una muestra aleatoria de 100  pacientes. RESULTADOS: Durante el periodo de estudio, 2.737 pacientes se han beneficiado del nuevo modelo de atención farmacéutica a distancia. El número de consultas de Telefarmacia realizadas fue 7.758. El seguimiento  farmacoterapéutico evitó 1.043 eventos adversos asociados a la  medicación, que afectaron al 10,4% de los pacientes atendidos (3,6 eventos  adversos asociados a la medicación/paciente). La adherencia media al  tratamiento de los pacientes fue del 95,2%. La satisfacción global con el nuevo  modelo de atención farmacéutica fue de 9,8/10. El 100% de los  pacientes lo recomendaría a otros pacientes. CONCLUSIONES: Este nuevo modelo de atención farmacéutica aumenta la  seguridad del paciente y mejora su adherencia al tratamiento, con unos índices  de calidad percibida elevados. La estratificación de pacientes y el  seguimiento personalizado mediante la plataforma Telefarmacia resultaron clave en su desarrollo.

A smartphone app to improve the safety of patients undergoing treatment with oral antineoplastic agents: 4 years of experience in a university hospital.

Objective: 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. Material and methods: 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). Result: 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%. Conclusions: 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.

Implantación y evaluación de un modelo de atención farmacéutica domiciliaria mediante Telefarmacia / Implementation and evaluation of a home pharmaceutical care model through Telepharmacy

Objetivo: Describir el impacto de un modelo de atención farmacéutica especializada que incluye el seguimiento farmacoterapéutico de lospacientes mediante una plataforma de Telefarmacia y la dispensación dela medicación en el domicilio.Método: Estudio descriptivo, retrospectivo, llevado a cabo en un serviciode farmacia de un hospital terciario entre el 23 marzo de 2020 y el 31de diciembre de 2021. Se desarrolló un nuevo modelo de atención farmacéutica para la atención de los pacientes crónicos ambulatorios, queincluye: i) definición de los criterios de selección de los pacientes candidatos a Telefarmacia, ii) estratificación de los pacientes según el nivel deriesgo, iii) definición del seguimiento farmacoterapéutico individualizado,iv) adaptación de la plataforma de apps del servicio de farmacia paragarantizar el seguimiento farmacoterapéutico continuo y la monitorizaciónde los pacientes (e-Oncosalud, e-Midcare y farMcuida), v) implantación deun sistema de citación, y vi) el desarrollo de un módulo informático para lagestión de la dispensación y entrega de la medicación en el domicilio. Elimpacto de este modelo de atención se evaluó mediante el análisis deindicadores de actividad, seguridad, adherencia y calidad percibida. Asimismo, se incluyó un estudio adicional sobre el impacto de la COVID-19 en la accesibilidad de la atención médica y la continuidad de los tratamientos,mediante una encuesta a una muestra aleatoria de 100 pacientes.Resultados: Durante el periodo de estudio, 2.737 pacientes se hanbeneficiado del nuevo modelo de atención farmacéutica a distancia. Elnúmero de consultas de Telefarmacia realizadas fue 7.758. (AU)

Objective: To describe the impact of a Specialized PharmaceuticalCare model that includes pharmacotherapeutic monitoring of patientsthrough an Telepharmacy platform and home medication dispensing.Method: A descriptive and retrospective study conducted in the Pharmacy Service of a tertiary hospital, between 23 March 2020 and31 December 2021. A new pharmaceutical care model for chronicambulatory patients was developed, including: (i) definition of criteria forselecting Telepharmacy candidate patients; (ii) stratification of patients byrisk level; (iii) definition of individualized pharmacotherapeutic monitoring;(iv) adaptation of the Pharmacy Service app platform to ensure continuouspharmacotherapeutic monitoring and patient monitoring (e-Oncohealth,e-Midcare and farMcuida), (v) implementation of an appointment system;and (vi) development of a software module for the management of homemedication delivery. The impact of this pharmaceutical care model wasassessed by analyzing indicators of activity, safety, adherence and perceived quality. Moreover, an additional study on the impact of COVID-19was developed in order to assess the accessibility of medical care andcontinuity of treatment through a survey conducted on a random sampleof 100 patients. Results: During the study period, 2,737 patients benefited from thenew remote pharmaceutical care model. A total of 7,758 Telepharmacyconsultations were performed. Pharmacotherapeutic monitoring prevented 1,043 adverse drug reactions, which affected 10.4% of patients(3.6 adverse drug reactions/patient). Mean adherence to treatment was95.2%. Overall satisfaction with the new model was 9.8/10. (AU)

Genotyping of UGT1A1*80 as an Alternative to UGT1A1*28 Genotyping in Spain.

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.