Detection and reduction of errors in parenteral nutrition compounding through gravimetric and product control. / [Artículo traducido] Detección y reducción de errores en la elaboración de la nutrición parenteral mediante control gravimétrico y de producto.

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 nutrition 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 < 0.05) 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 < 0.05). 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.

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.

Cost-Effectiveness Analysis of Abrocitinib Compared with Other Systemic Treatments for Severe Atopic Dermatitis in Spain.

INTRODUCTION: Atopic dermatitis (AD) is a chronic, inflammatory skin disease characterized by itchy, painful, and dry skin. Despite the great number of available therapies, economic evaluations are still needed to provide evidence on their cost efficiency. This research aimed to evaluate the cost effectiveness of the Janus kinase (JAK) inhibitor abrocitinib (200 mg) compared with dupilumab (300 mg), tralokinumab (300 mg), baricitinib (2 and 4 mg), and upadacitinib (15 and 30 mg) for the treatment of patients with severe AD from the Spanish National Health System (NHS) perspective. METHODS: A hybrid model consisting of a decision tree linked to a Markov model was developed to estimate costs, quality-adjusted life-years (QALYs), total years in response and incremental cost-per-QALY gained (willingness-to-pay [WTP] threshold: €25,000/QALY). Adults with severe AD entered the decision tree and response (75% reduction in baseline Eczema Area and Severity Index score, EASI-75) was considered at 16 and 52 weeks. After this time, patients entered the Markov model (remainder of the 10-year time horizon), which consisted of three health states: maintenance with active therapy, subsequent treatment, or death. All costs were presented in 2022 euros (€). Additionally, cost per number-needed-to-treat (NNT) was calculated for abrocitinib and dupilumab based on a head-to-head post-hoc analysis. RESULTS: Abrocitinib 200 mg was dominant (i.e., lower incremental costs and higher incremental benefit) compared with all studied alternatives (dupilumab 300 mg, tralokinumab 300 mg, baricitinib 2 and 4 mg, upadacitinib 15 and 30 mg) with a QALYs gain of 0.49, 0.60, 0.64, 0.43, 0.45, and 0.08, respectively, and per-person costs savings of €22,097, €24,140, €14,825, €7,116, €12,805, and €45,189, respectively. Considering the WTP threshold, abrocitinib was dominant or cost effective compared with all alternatives for most simulations. Additionally, abrocitinib was dominant compared with all alternatives when evaluating the cost effectiveness over a 5-year time horizon. NNT showed that abrocitinib was dominant versus dupilumab. CONCLUSIONS: The results of the study show that abrocitinib is a cost-effective therapy compared with other JAK inhibitors and biological therapies from the Spanish NHS perspective.

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.

Consensus of Spanish Society of Hospital Pharmacy on optimal medication therapy management of atopic dermatitis / Consenso de la Sociedad Española de Farmacia Hospitalaria en manejo fármacoterapéutico óptimo de la dermatitis atópica

Aim: This study's aims are: 1) To use the Delphi method to determine the level of consensus among hospital pharmacists (HPs) as regards the factors involved in the current approach to patients with atopic dermatitis (AD); 2) To identify potential areas for improvement in hospital pharmacy in terms of dealing with patients with severe AD; and 3) To contribute to adequate pharmaceutical care for patients with AD by drawing up recommendations. Methods: A two-round Delphi survey with participation from HPs from all over Spain. Three theme-based blocks were set out: 1) AD; 2) Management of patients with severe AD in the Hospital Pharmacy setting; and 3) Unmet needs (pathology, patient, treatment and management). Results: The 42 HPs participating reached a consensus in recognising the impact of severe AD on the patients suffering from it, the need to encourage adherence and the recommendations to use scales that take into account the patient's quality of life and indicators of the patient's experience. It has also been demonstrated that it is worthwhile evaluating the results in real clinical practice in consensus with other specialists from the multidisciplinary team. Finally, it is advisable to use drugs that have demonstrated long-term effectiveness and safety for patients with severe AD, given the disease's chronic nature. Conclusions: This Delphi consensus highlights the impact of severe AD on patients, the importance of a multidisciplinary and holistic approach, in which HP play a major role. It also highlights the importance of increased access to new drugs to improve health outcomes. (AU)

Objetivos: Los objetivos de este estudio son: 1) Determinar, mediante el método Delphi, el grado de consenso existente entre los farmacéuticos de hospital (FH) en cuanto a los factores que intervienen en el abordaje actual de los pacientes con dermatitis atópica (DA); 2) Identificar posibles áreas de mejora en la farmacia hospitalaria en cuanto al abordaje de los pacientes con DA grave; y 3) Contribuir a una adecuada atención farmacéutica a los pacientes con DA mediante la elaboración de recomendaciones. Método: Una encuesta Delphi con participación de FHs de toda España. Se establecieron tres bloques temáticos: 1) DA; 2) Manejo de pacientes con DA grave desde Farmacia Hospitalaria; y 3) Necesidades no cubiertas (patología, paciente, tratamiento y manejo). Resultados: Los 42 FHs participantes llegaron a un consenso en el reconocimiento del impacto de la DA grave en los pacientes, la necesidad de fomentar la adherencia y las recomendaciones de utilizar escalas que tengan en cuenta la calidad de vida del paciente e indicadores de la experiencia. También se muestra la conveniencia de evaluar los resultados en la práctica clínica real en consenso con otros especialistas del equipo multidisciplinar. Por último, es aconsejable utilizar fármacos que hayan demostrado eficacia y seguridad a largo plazo para los pacientes con DA grave, dado el carácter crónico de la enfermedad. Conclusiones: Este consenso Delphi pone de manifiesto el impacto de la DA grave en los pacientes, la importancia del abordaje multidisciplinar y holístico, en el que el FH juega un papel de gran importancia. También se resalta la importancia de un mayor acceso a nuevos fármacos que permitan mejorar resultados en salud. (AU)

Consensus of Spanish Society of Hospital Pharmacy on optimal medication therapy management of atopic dermatitis. / [Artículo traducido] Consenso de la Sociedad Española de Farmacia Hospitalaria sobre el manejo fármacoterapéutico óptimo de la dermatitis atópica.

AIM: This study's aims are: 1) To use the Delphi method to determine the level of consensus among HPs as regards the factors involved in the current approach to patients with AD; 2) To identify potential areas for improvement in hospital pharmacy in terms of dealing with patients with severe AD; and 3) To contribute to adequate pharmaceutical care for patients with AD by drawing up recommendations. METHODS: A two-round Delphi survey with participation from HPs from all over Spain. Three theme-based blocks were set out: 1) AD; 2) Management of patients with severe AD in the Hospital Pharmacy setting; and 3) Unmet needs (pathology, patient, treatment and management). RESULTS: The 42 HPs participating reached a consensus in recognizing the impact of severe AD on the patients suffering from it, the need to encourage adherence and the recommendations to use scales that take into account the patient's quality of life and indicators of the patient's experience. It has also been demonstrated that it is worthwhile evaluating the results in real clinical practice in consensus with other specialists from the multidisciplinary team. Finally, it is advisable to use drugs that have demonstrated long-term effectiveness and safety for patients with severe AD, given the disease´s chronic nature. CONCLUSIONS: This Delphi consensus highlights the impact of severe AD on patients, the importance of a multidisciplinary and holistic approach, in which HP play a major role. It also highlights the importance of increased access to new drugs to improve health outcomes.

Implementation of a parenteral nutrition home care programme in a tertiary hospital / Implementación de un programa de atención domiciliaria de nutrición parenteral en un hospital de tercer nivel

Aim: the objective of this study was to describe the results of the implementation of a home parenteral nutrition (HPN) care programme (Nutrihome©) in a cohort of patients treated at a tertiary hospital. Methods: retrospective study of the patients included in Nutrihome© at Hospital General Universitario Gregorio Marañón, Madrid, Spain. Nutrihome consists of different modules including pre-discharge nursing hospital visits and nursing home visits, deliveries of the infusion pump, consumables and parenteral nutrition bags, patient training, weekly scheduled nursing home visits, scheduled nursing phone calls, stock control phone calls and 24-hour on-call line manned by the nurses. Results: the study included 8 (75 % women) and 10 (70 % women) patients in the Nutrihome© pilot and Nutrihome© programme, respectively. A total 37 adverse events were reported during Nutrihome© pilot, 26 of which were technical, 9 clinical, 1 was catheter-related and 1 other event. Nutrihome© programme registered a total of 107 adverse events reported, 57 of which were technical, 21 clinical, 16 were catheter-related and 13 were other events. A total of 99 % of these events were solved by Nutrihome© via phone calls or home visits. Conclusions: Nutrihome© programme has been extremely useful during this pandemic, facilitaing both the start of HPN and training at the patient home without the need for hospitalisation. Additionally, the adverse events reported and solved by Nutrihome© not only reduced the physicians’ burden during those tough times and the patients´ stress of being hospitalised during a pandemic, but supported the entire healthcare system. (AU)

Objetivo: el objetivo de este estudio fue describir los resultados de la implementación de un programa de cuidados de nutrición parenteral domiciliaria (NPD) (Nutrihome©) en una cohorte de pacientes atendidos en un hospital terciario. Métodos: estudio retrospectivo de los pacientes incluidos en Nutrihome© en el Hospital General Universitario Gregorio Marañón de Madrid (España). Nutrihome consta de diferentes módulos que incluyen visitas de enfermería previas al alta y visitas al domicilio, entregas de la bomba de infusión, consumibles y bolsas de nutrición parenteral, formación del paciente, visitas semanales al domicilio programadas, llamadas telefónicas de enfermería programadas, llamadas telefónicas de control de existencias y atención telefónica de enfermería las 24 horas al día. Resultados: el estudio incluyó a 8 (75 % mujeres) y 10 (70 % mujeres) pacientes en el piloto Nutrihome© y en el programa Nutrihome©, respectivamente. Durante el piloto, se registraron un total de 37 eventos adversos, de los cuales 26 fueron técnicos, 9 clínicos, 1 relacionado con el catéter y 1 otro evento. Durante el programa Nutrihome©, se registró un total de 107 eventos adversos, de los cuales 57 fueron técnicos, 21 clínicos, 16 relacionados con el catéter y 13 otros eventos. El 99 % de estos eventos fueron resueltos por Nutrihome© por teléfono o mediante visitas a domicilio. Conclusiones: el programa Nutrihome© ha sido de gran utilidad durante esta pandemia, posibilitando tanto el inicio de la NPD como la formación en el domicilio del paciente sin necesidad de hospitalización. Además, los eventos adversos descritos y resueltos por Nutrihome© no solo redujeron la carga de los médicos durante esos tiempos difíciles y el estrés de los pacientes derivado de estar hospitalizados durante la pandemia, sino que fue un apoyo para todo el sistema de salud. (AU)

Implementation of a parenteral nutrition home care programme in a tertiary hospital.

Introduction: Aim: the objective of this study was to describe the results of the implementation of a home parenteral nutrition (HPN) care programme (Nutrihome©) in a cohort of patients treated at a tertiary hospital. Methods: retrospective study of the patients included in Nutrihome© at Hospital General Universitario Gregorio Marañón, Madrid, Spain. Nutrihome consists of different modules including pre-discharge nursing hospital visits and nursing home visits, deliveries of the infusion pump, consumables and parenteral nutrition bags, patient training, weekly scheduled nursing home visits, scheduled nursing phone calls, stock control phone calls and 24-hour on-call line manned by the nurses. Results: the study included 8 (75 % women) and 10 (70 % women) patients in the Nutrihome© pilot and Nutrihome© programme, respectively. A total 37 adverse events were reported during Nutrihome© pilot, 26 of which were technical, 9 clinical, 1 was catheter-related and 1 other event. Nutrihome© programme registered a total of 107 adverse events reported, 57 of which were technical, 21 clinical, 16 were catheter-related and 13 were other events. A total of 99 % of these events were solved by Nutrihome© via phone calls or home visits. Conclusions: Nutrihome© programme has been extremely useful during this pandemic, facilitaing both the start of HPN and training at the patient home without the need for hospitalisation. Additionally, the adverse events reported and solved by Nutrihome© not only reduced the physicians' burden during those tough times and the patients´ stress of being hospitalised during a pandemic, but supported the entire healthcare system.

Introducción: Objetivo: el objetivo de este estudio fue describir los resultados de la implementación de un programa de cuidados de nutrición parenteral domiciliaria (NPD) (Nutrihome©) en una cohorte de pacientes atendidos en un hospital terciario. Métodos: estudio retrospectivo de los pacientes incluidos en Nutrihome© en el Hospital General Universitario Gregorio Marañón de Madrid (España). Nutrihome consta de diferentes módulos que incluyen visitas de enfermería previas al alta y visitas al domicilio, entregas de la bomba de infusión, consumibles y bolsas de nutrición parenteral, formación del paciente, visitas semanales al domicilio programadas, llamadas telefónicas de enfermería programadas, llamadas telefónicas de control de existencias y atención telefónica de enfermería las 24 horas al día. Resultados: el estudio incluyó a 8 (75 % mujeres) y 10 (70 % mujeres) pacientes en el piloto Nutrihome© y en el programa Nutrihome©, respectivamente. Durante el piloto, se registraron un total de 37 eventos adversos, de los cuales 26 fueron técnicos, 9 clínicos, 1 relacionado con el catéter y 1 otro evento. Durante el programa Nutrihome©, se registró un total de 107 eventos adversos, de los cuales 57 fueron técnicos, 21 clínicos, 16 relacionados con el catéter y 13 otros eventos. El 99 % de estos eventos fueron resueltos por Nutrihome© por teléfono o mediante visitas a domicilio. Conclusiones: el programa Nutrihome© ha sido de gran utilidad durante esta pandemia, posibilitando tanto el inicio de la NPD como la formación en el domicilio del paciente sin necesidad de hospitalización. Además, los eventos adversos descritos y resueltos por Nutrihome© no solo redujeron la carga de los médicos durante esos tiempos difíciles y el estrés de los pacientes derivado de estar hospitalizados durante la pandemia, sino que fue un apoyo para todo el sistema de salud.

Consensus of Spanish Society of Hospital Pharmacy on optimal medication therapy management of atopic dermatitis.

AIM: This study's aims are: 1) To use the Delphi method to determine the level of consensus among hospital pharmacists (HPs) as regards the factors involved in the current approach to patients with atopic dermatitis (AD); 2) To identify potential areas for improvement in hospital pharmacy in terms of dealing with patients with severe AD; and 3) To contribute to adequate pharmaceutical care for patients with AD by drawing up recommendations. METHODS: A two-round Delphi survey with participation from HPs from all over Spain. Three theme-based blocks were set out: 1) AD; 2) Management of patients with severe AD in the Hospital Pharmacy setting; and 3) Unmet needs (pathology, patient, treatment and management). RESULTS: The 42 HPs participating reached a consensus in recognising the impact of severe AD on the patients suffering from it, the need to encourage adherence and the recommendations to use scales that take into account the patient's quality of life and indicators of the patient's experience. It has also been demonstrated that it is worthwhile evaluating the results in real clinical practice in consensus with other specialists from the multidisciplinary team. Finally, it is advisable to use drugs that have demonstrated long-term effectiveness and safety for patients with severe AD, given the disease's chronic nature. CONCLUSIONS: This Delphi consensus highlights the impact of severe AD on patients, the importance of a multidisciplinary and holistic approach, in which HP play a major role. It also highlights the importance of increased access to new drugs to improve health outcomes.

Information and Communication Technologies in Patients With Immune-Mediated Inflammatory Diseases: Cross-sectional Survey.

BACKGROUND: Information and communication technologies (ICTs) are changing the traditional health care model and redefining personalized health. ICTs offer effective communication and real-time monitoring of patients and provide additional data to support clinical decision-making, improve the quality of care, and contribute to the empowerment of patients. However, evidence on the use of ICTs and digital preferences of immune-mediated inflammatory disease (IMID) patients is scarce. OBJECTIVE: The aim of this study is to describe the degree of use of ICTs in patients with IMIDs (including rheumatic diseases, inflammatory bowel diseases, and psoriasis), identify their needs, and analyze their interest in the use of apps as tools for better management of their disease. METHODS: A questionnaire was created by a multidisciplinary team including pharmacists, rheumatologists, gastroenterologists, dermatologists, and nurses with experience in ICTs applied to the field of IMID. The survey included 27 questions organized into 3 blocks: (1) sociodemographic characteristics, (2) ICT use for health-related information, and (3) patient expectations about mobile health. RESULTS: A total of 472 questionnaires were analyzed. Overall, 52.9% (250/472) of patients were diagnosed with a rheumatologic disease, 39.4% (186/472) with inflammatory bowel disease, and 12.3% (58/472) with psoriasis. The state of health was considered good by 45.6% (215/472) of patients. Patients were interested in staying informed about health issues in 86.9% (410/427) of cases and sought health-related information mainly from the internet (334/472, 70.8%) and health care professionals (318/472, 67.4%). Overall, 13.6% (64/472) did not trust the health information they found in internet. Of the patients, 42.8% (202/472) had a health app, and 42.2% (199/472) had found it on their own. Patients would like a health app to help mainly to manage appointments (281/472, 59.5%), obtain information about their diseases and treatments (274/472, 58.1%), and get in contact with health professionals (250/472, 53.0%). Overall, 90.0% (425/472) of patients reported they would use an app to manage their IMID if their health professional recommended it, and 58.0% (274/472) would pay or probably be willing to pay for it. CONCLUSIONS: IMID patients were very interested in finding health-related information via ICTs, especially using smartphones and apps recommended by health professionals. Appointment management, advice on disease and treatment management, and personalized communication with health professionals were the most desired app features identified. Health professionals should play an essential role in recommending and validating these tools to ensure they are of high quality.

Evaluation of the hospital care quality perceived by patients with immune-mediated inflammatory diseases from the pharmacy service. SACVINFA study.

WHAT IS KNOWN AND OBJECTIVE: Immune-mediated inflammatory diseases (IMIDs) are a group of chronic and highly disabling diseases. The objective is to evaluate the satisfaction with the health care received by patients with the most prevalent IMIDs in Spain: inflammatory bowel disease (IBD), psoriasis (Ps) psoriatic arthritis (PsA), rheumatoid arthritis (RA) and spondyloarthropathies (SpAs), and to determine the factors that influence patient satisfaction. METHODS: This was an observational, cross-sectional, multicentre study in a real-world evidence context conducted in the Pharmacy Service in four hospital centres of the Community of Madrid that belong to the National Health System. The study included adult patients diagnosed with an IMID who had attended the Pharmacy Service at least three times. The patients were grouped according to the main IMID. Health care satisfaction was evaluated using the chronic patient experience assessment (IEXPAC) questionnaire. The responses to IEXPAC are grouped into three factors: productive interactions, new relational model and patient self-management, with a total score from 0 (worst) to 10 (best experience). Health-related quality of life (HRQoL) was also evaluated using the EQ-5D-5L questionnaire, and pharmacological adherence was evaluated through the Morisky-Green test. RESULTS AND DISCUSSION: A total of 578 patients were analysed (IBD = 25.3%; Ps = 19.7%; SpAs = 18.7%; RA = 18.5%; PsA = 17.8%). The mean age (SD) was 49.8 (12.3) years and 50.7% were male. The average score (SD) for the total IEXPAC sample was 6.6 (1.9). RA was the IMID with the lowest score, at 5.83 (2.0), significantly lower than the scores of Ps (SD) [7.01 (1.7); p = 0.003], IBD [6.83 (1, 9); p = 0.012] and SpAs [6.80 (1.6); p = 0.001]. Productive interactions (SD) [8.5 (1.8)] and patient self-management (SD) [7.3 (2.3)] were the factors with the highest scores, and the new relational model had the lowest score (SD) [3.2 (2.7)]. Male gender, a longer time interval between medication administrations and a higher HRQoL were correlated with better patient satisfaction. Current biological therapy (according to the Anatomical Chemical classification system) also had a significant influence; patients treated with tumour necrosis factor inhibitors and interleukin inhibitors showed greater satisfaction than those treated with selective immunosuppressants. WHAT IS NEW AND CONCLUSION: The IEXPAC results show high general satisfaction with care quality reported by patients with IMIDs treated in the Pharmacy Service. However, there are areas of improvement in care quality specially health professional-patient communication, such as increasing access to information, and promoting and facilitating relationships with patients in similar conditions.

Design and implementation of a mobile app for the pharmacotherapeutic follow-up of patients diagnosed with immune-mediated inflammatory diseases: eMidCare.

Background: Pharmacotherapeutic management of immune-mediated inflammatory diseases (IMID) has become more complex due to the development of new treatments, such as biological therapies. Mobile health, especially apps, can provide IMID patients with greater autonomy and facilitate communication with healthcare professionals. Our objective was to design and implement an app for remote monitoring and communication with IMID patients. Methods: A multidisciplinary group was created to design and develop an app for IMID patients in a tertiary hospital. The app functionalities were identified through a focus group with IMID patients and through an observational, descriptive study of available apps for IMID patients at App Store and Play Store platforms. Once the app was designed and developed, we offered the app to IMID patients who initiated a new biological therapy. The inclusion period was from December 2020 to August 2021. We performed an observational, longitudinal study to assess the app's impact on medication safety, communication, satisfaction, and usability. Results: We designed an app (eMidCare®) with the following modules: My Medication, My Questionnaires, Adverse Events, Useful Information, Messages, and Patient Profile. A total of 85 patients were installed with the app. The median (range) follow-up time for app use was 123 (5-270) days. In the My Medication module, 100% of patients registered their biological therapy and 25.9% also used this module to record each dose of medication administered. A total of 82 adverse events (AEs) were registered. Thirty-two percent of the patients registered at least 1 AE. The most frequent AEs were fatigue, injection site reaction, headache, and nausea. Fifty-two percent of patients used the Messages module to communicate with healthcare professionals. The most frequent messages concerned doubts about managing AEs (26.2%) and drug interactions (18.9%). The satisfaction survey yielded a median (range) score of 9.1 (7-10) out of 10. Conclusions: We developed an app, eMidCare®, which reminds patients to take their medication, enables them to record AEs, and helps them communicate with healthcare professionals. Approximately one-third of the patients registered the administration of the biological therapies and registered at least 1 AE. The most used and most satisfactory functionality was communication with health professionals.

The Characteristics and Functionalities of Mobile Apps Aimed at Patients Diagnosed With Immune-Mediated Inflammatory Diseases: Systematic App Search.

BACKGROUND: Immune-mediated inflammatory diseases (IMIDs) are systemic conditions associated with a high social and health impact. New treatments have changed the prognosis of IMIDs and have increased patient autonomy in disease management. Mobile apps have enormous potential to improve health outcomes in patients with IMIDs. Although a large number of IMID apps are available, the app market is not regulated, and functionality and reliability remain uncertain. OBJECTIVE: Our aims are to review available apps for patients with IMIDs or caregivers and to describe the main characteristics and functionalities of these apps. METHODS: We performed an observational, cross-sectional, descriptive study of all apps for patients with IMIDs. Between April 5 and 14, 2021, we conducted a search of the App Store (iOS) and Play Store (Android) platforms. We used the names of the different IMIDs as search terms. The inclusion criteria were as follows: content related to IMIDs, English or Spanish language, and user population consisting of patients and health care consumers, including family and caregivers. The variables analyzed were as follows: app name, type of IMID, platform (Android or iOS), country of origin, language, category of the app, cost, date of the last update, size, downloads, author affiliation, and functionalities. RESULTS: We identified 713 apps in the initial search, and 243 apps met the criteria and were analyzed. Of these, 37% (n=90) were on Android, 27.2% (n=66) on iOS, and 35.8% (n=87) on both platforms. The most frequent categories were health and well-being/fitness apps (n=188, 48.5%) and medicine (n=82, 37.9%). A total of 211 (82.3%) apps were free. The mean time between the date of the analysis and the date of the most recent update was 18.5 (SD 19.3) months. Health care professionals were involved in the development of 100 (41.1%) apps. We found differences between Android and iOS in the mean time since the last update (16.2, SD 14.7 months vs 30.3, SD 25.7 months) and free apps (85.6% vs 75.8%; respectively). The functionalities were as follows: general information about lifestyles, nutrition, or exercises (n=135, 55.6%); specific information about the disease or treatment (n=102, 42%); recording of symptoms or adverse events (n=51, 21%); agenda/calendar (n=44, 18.1%); reminder medication (n=41, 16.9%); and recording of patient-reported outcomes (n=41, 16.9%). A total of 147 (60.5%) apps had more than one functionality. CONCLUSIONS: IMID-related apps are heterogeneous in terms of functionality and reliability. Apps may be a useful complement to IMID care, especially inpatient education (their most frequent functionality). However, more than half of the IMID apps had not been developed by health care professionals or updated in the last year.

[Recommendations for using oral antineoplastic and immunomodulating agents in oncohematology by enteral tube administration]. / Recomendaciones para la administración de antineoplásicos e inmunomoduladores orales por sonda enteral en oncohematología.

INTRODUCTION: Introduction and objective: in recent years, the number of oral antineoplastic and immunomodulating drugs in oncohematology has increased enormously. Often, these drugs must be administered to patients with enteral tube feeding or swallowing disorders, which causes safety problems when handling these drugs (many of them are classified as hazardous drugs). In addition, it is important to note that the administration of these drugs can also interact with enteral nutrition (EN). The objective of this study was to review and update the recommendations for the administration and handling of oral antineoplastic and immunomodulating drugs. Methods: a Working Group made up of pharmacists from the Pharmacy Group of The Spanish Society of Clinical Nutrition and Metabolism (SENPE) and the Clinical Nutrition Group of The Spanish Society of Hospital Pharmacy (SEFH) was created. A bibliographic review was carried out between 2015 and 2020 on the administration and handling of oral antineoplastic and immunomodulating drugs in oncohematology. The information about pharmaceutical specialties, dosage, presentation, brand names, instructions for oral or enteral tube administration, interactions with EN, precautions, and remarks for handling and administration was analyzed. Results: a total of 77 active principles and 84 pharmaceutical forms were included. Recommendations and instructions for oral, nasogastric tube, and gastrostomy administration, handling of the antineoplastic and immunomodulating drugs, and interactions with EN were described. Conclusions: the handling and administration information about the oral antineoplastic and immunomodulating drugs currently used in oncohematology for people with enteral accesses or swallowing disorders is limited. It is important to perform post-marketing studies to ensure a safe and effective administration of these drugs.

INTRODUCCIÓN: Introducción y objetivo: en los últimos años, el número de fármacos antineoplásicos e inmunomoduladores orales (ANIO) ha crecido enormemente. Con frecuencia, estos fármacos deben administrarse por sonda enteral (SE) o a pacientes con problemas de deglución, planteando un problema respecto a su manipulación (muchos pertenecen al grupo de medicamentos peligrosos). Además, también pueden presentar interacciones cuando se administran con la nutrición enteral (NE). El objetivo ha sido analizar y actualizar las recomendaciones de administración y manipulación de los ANIO. Métodos: se creó un Grupo de Trabajo formado por farmacéuticos del Grupo de Farmacia de la Sociedad Española de Nutrición Clínica y Metabolismo (SENPE) y del Grupo de Nutrición Clínica de la Sociedad Española de Farmacia Hospitalaria (SEFH). Se realizó una revisión bibliográfica entre 2015 y 2020 de las condiciones de manipulación y administración de los ANIO en oncohematología, elaborando una tabla que recoge especialidades farmacéuticas, dosis, presentación, nombre comercial, instrucciones para la administración oral y por SE, interacciones con la NE, precauciones y observaciones para su manipulación y administración. Resultados: se elaboró una tabla con 77 principios activos y 84 formas farmacéuticas, recogiendo recomendaciones e instrucciones para su administración por vía oral, sonda nasogástrica y gastrostomía, para la correcta manipulación y para la administración junto a la NE. Conclusiones: la información sobre cómo administrar y manipular los ANIO en personas con accesos enterales o problemas de deglución es escasa. Consideramos importante incluir en los estudios poscomercialización una investigación dirigida a responder a estas cuestiones para garantizar una administración segura y eficaz de los medicamentos a estos pacientes.

Clinical course of severe patients with COVID-19 treated with tocilizumab: report from a cohort study in Spain.

Background: We report the long-term outcomes, changes in laboratory parameters, the incidence of secondary nosocomial infections and treatment cost of a Spanish cohort of patients with severe COVID-19 that received tocilizumab (TCZ).Methods: Retrospective cohort of PCR confirmed adult patients who received TCZ from March 1 to 24, 2020 in a tertiary hospital was analyzed. Patients were followed up until 10 May 2020.Results: We included 162 patients (median age 64 years; 70.4% male). At time of TCZ administration, 48.1% of patients were on invasive mechanical ventilation (IMV). Over a median follow-up of 53 days, 46.9% of patients were discharge in good conditions and 19.8% were still hospitalized. The overall mortality was 33.3%, being higher in patients on IMV than those who did not (46.2% vs 26.7%, P < 0.001). A significant improvement in the lymphocyte count, C-reactive protein, lactate dehydrogenase, and D-dimer was observed. Overall, 43.2% patients presented nosocomial infections, causing death in 8%. Infections were more prevalent in ICU units (63.0% vs 17.1%, P < 0.001). The total cost of TCZ was €371,784.Conclusions: Among the patients who used TCZ, one third died, regardless the improvement in some inflammatory biomarkers. The incidence of secondary nosocomial infections was high.

Effect of a Mobile App for the Pharmacotherapeutic Follow-Up of Patients With Cancer on Their Health Outcomes: Quasi-Experimental Study.

BACKGROUND: Oral antineoplastic agents (OAAs) have revolutionized cancer management. However, they have been reported with adverse side effects and drug-drug interactions. Moreover, patient adherence to OAA treatment is critical. Mobile apps can enable remote and real-time pharmacotherapeutic monitoring of patients, while also promoting patient autonomy in their health care. OBJECTIVE: The primary objective was to analyze the effect of using a mobile app for the follow-up of patients with oncohematological malignancies undergoing treatment with OAAs on their health outcomes. The secondary objectives were to analyze the role of the app in communication with health care professionals and patient satisfaction with the app. METHODS: We performed a comparative, quasi-experimental study based on a prepost intervention with 101 patients (control group, n=51, traditional pharmacotherapeutic follow-up vs intervention group, n=50, follow-up through e-OncoSalud, a custom-designed app that promotes follow-up at home and the safety of patients receiving OAAs). The effect of this app on drug safety, adherence to treatment, and quality of life was evaluated. RESULTS: With regard to drug safety, 73% (37/51) of the patients in the control group and 70% (35/50) of the patients in the intervention group (P=.01) presented with drug-related problems. The probability of detecting an insufficiently treated health problem in the intervention group was significantly higher than that in the control group (P=.04). The proportion of patients who presented with side effects in the intervention group was significantly lower than that in the control group (P>.99). In the control group, 49% (25/51) of the patients consumed some health resources during the first 6 months of treatment compared with 36% (18/50) of the patients in the intervention group (P=.76). Adherence to treatment was 97.6% (SD 7.9) in the intervention group, which was significantly higher than that in the control group (92.9% [SD 10.0]; P=.02). The EuroQol-5D in the intervention group yielded a mean (SD) index of 0.875 (0.156), which was significantly higher than that in the control group (0.741 [0.177]; P<.001). Approximately 60% (29/50) of the patients used the messaging module to communicate with pharmacists. The most frequent types of messages were acknowledgments (77/283, 27.2%), doubts about contraindications and interactions with OAAs (70/283, 24.7%), and consultations for adverse reactions to treatment (39/283, 13.8%). The satisfaction with the app survey conducted in the intervention group yielded an overall mean (SD) score of 9.1 (0.4) out of 10. CONCLUSIONS: Use of e-OncoSalud for the real-time follow-up of patients receiving OAAs facilitated the optimization of some health outcomes. The intervention group had significantly higher health-related quality of life and adherence to treatment than the control group. Further, the probability of the intervention group presenting with side effects was significantly lower than that of the control group.

Control de calidad de la elaboración de nutriciones parenterales: control gravimétrico y de productos utilizados / Quality control of parenteral nutrition compounding: gravimetric and component verification control

INTRODUCCIÓN: la elaboración de nutriciones parenterales (NP) es un proceso complejo y con alta probabilidad de aparición de errores. OBJETIVO: analizar los errores detectados en el control gravimétrico (CG) y de productos (CP) utilizados realizado en las NP elaboradas. MÉTODOS: se realizó un análisis prospectivo en el que durante tres años (enero de 2016 a diciembre de 2018) se pesaron las NP elaboradas. Se utilizó el programa informático MedicalOne Parenteral®, que calcula el peso teórico teniendo en cuenta la densidad y el volumen. Cada NP elaborada se pesaba para obtener el peso real. El error gravimétrico (%) (EG = (peso real - peso teórico) X 100 / peso teórico) se consideró correcto dentro del intervalo de ± 5 %. El CP consistía en la comprobación de los productos y los volúmenes utilizados con la hoja de elaboración. RESULTADOS: se realizó el control de 28.761 NP. Se pesaron 20.612 NP de adultos (NPA), siendo incorrectas 124 (0,6 %). De las 1203 NP de pacientes pediátricos no neonatos (NPP), 15 (1,25 %) fueron incorrectas, y de las 6946 de neonatos (NPN), 164 (2,96 %). Respecto al CP se detectaron 71 errores en las NPA (0,70 %), 6 (1,34 %) en las NPP y 5 (0,21 %) en las NPN. Los errores fueron: añadir más volumen de un componente [38 (46,34 %)], añadir menos volumen [17(20,73 %)] y producto erróneo [27 (32,93 %)]. CONCLUSIONES: el control de calidad realizado permitió detectar errores producidos durante la elaboración y evitó que llegaran al paciente. Se detectaron en el CG más NP incorrectas entre las NPN. Con el CP, el error mayoritario fue añadir más volumen de un componente

INTRODUCTION: parenteral nutrition (PN) compounding is a process with a high probability of errors. OBJECTIVE: to analyze PN compounding errors detected using a gravimetric control (GC) and a component verification control (CVC). METHODS: a prospective analysis was carried out during a three-year period (January 2016 to December 2018). The MedicalOne Parenteral® software program was used to calculate the theoretical weight of each PN based on density and volume. Each elaborated PN was weighed to obtain the real weight. Gravimetric error (%) ((real weight - theoretical weight) X 100 / theoretical weight) was considered correct if within the ± 5 % interval. The CVC consisted of checking that the correct ingredients and volumes were added according to the PN order. RESULTS: during the study period a total number of 28,761 PNs were checked out; 20,612 adult PNs (APN) were weighed and 124 were considered incorrect (0.60 %). Of the 1,203 non-neonatal pediatric PNs (NPPN), 15 (1.25 %) were incorrect, and of the 6,946 neonatal PNs (NPN), 164 (2.96 %) were incorrect. Regarding the CVC, 71 errors were detected in the APN (0.70 %), 6 (1.34 %) in the NPPN, and 5 (0.21 %) in the NPN group. The total number of errors included: adding more volume of one component [38 (46.34 %)], adding a wrong component [27 (32.93 %)], and absent volume of one component [17 (20.73 %)]. CONCLUSIONS: the quality control carried out allowed to detect errors during the preparation of PNs and prevented them from reaching the patient. More incorrect NPNs were detected through GC. The main error detected with CVC was adding more volume of a component

[Quality control of parenteral nutrition compounding: gravimetric and component verification control]. / Control de calidad de la elaboración de nutriciones parenterales: control gravimétrico y de productos utilizados.

INTRODUCTION: Introduction: parenteral nutrition (PN) compounding is a process with a high probability of errors. Objective: to analyze PN compounding errors detected using a gravimetric control (GC) and a component verification control (CVC). Methods: a prospective analysis was carried out during a three-year period (January 2016 to December 2018). The MedicalOne Parenteral® software program was used to calculate the theoretical weight of each PN based on density and volume. Each elaborated PN was weighed to obtain the real weight. Gravimetric error (%) ((real weight - theoretical weight) x 100 / theoretical weight) was considered correct if within the ± 5 % interval. The CVC consisted of checking that the correct ingredients and volumes were added according to the PN order. Results: during the study period a total number of 28,761 PNs were checked out; 20,612 adult PNs (APN) were weighed and 124 were considered incorrect (0.60 %). Of the 1,203 non-neonatal pediatric PNs (NPPN), 15 (1.25 %) were incorrect, and of the 6,946 neonatal PNs (NPN), 164 (2.96 %) were incorrect. Regarding the CVC, 71 errors were detected in the APN (0.70 %), 6 (1.34 %) in the NPPN, and 5 (0.21 %) in the NPN group. The total number of errors included: adding more volume of one component [38 (46.34 %)], adding a wrong component [27 (32.93 %)], and absent volume of one component [17 (20.73 %)]. Conclusions: the quality control carried out allowed to detect errors during the preparation of PNs and prevented them from reaching the patient. More incorrect NPNs were detected through GC. The main error detected with CVC was adding more volume of a component.

INTRODUCCIÓN: Introducción: la elaboración de nutriciones parenterales (NP) es un proceso complejo y con alta probabilidad de aparición de errores. Objetivo: analizar los errores detectados en el control gravimétrico (CG) y de productos (CP) utilizados realizado en las NP elaboradas. Métodos: se realizó un análisis prospectivo en el que durante tres años (enero de 2016 a diciembre de 2018) se pesaron las NP elaboradas. Se utilizó el programa informático MedicalOne Parenteral®, que calcula el peso teórico teniendo en cuenta la densidad y el volumen. Cada NP elaborada se pesaba para obtener el peso real. El error gravimétrico (%) (EG = (peso real - peso teórico) x 100 / peso teórico) se consideró correcto dentro del intervalo de ± 5 %. El CP consistía en la comprobación de los productos y los volúmenes utilizados con la hoja de elaboración. Resultados: se realizó el control de 28.761 NP. Se pesaron 20.612 NP de adultos (NPA), siendo incorrectas 124 (0,6 %). De las 1203 NP de pacientes pediátricos no neonatos (NPP), 15 (1,25 %) fueron incorrectas, y de las 6946 de neonatos (NPN), 164 (2,96 %). Respecto al CP se detectaron 71 errores en las NPA (0,70 %), 6 (1,34 %) en las NPP y 5 (0,21 %) en las NPN. Los errores fueron: añadir más volumen de un componente [38 (46,34 %)], añadir menos volumen [17(20,73 %)] y producto erróneo [27 (32,93 %)]. Conclusiones: el control de calidad realizado permitió detectar errores producidos durante la elaboración y evitó que llegaran al paciente. Se detectaron en el CG más NP incorrectas entre las NPN. Con el CP, el error mayoritario fue añadir más volumen de un componente.