Análisis 2016-2021 del desarrollo del proyecto de atención farmacéutica al paciente externo MAPEX por Comunidades Autónomas / Analysis 2016-2021 of the development of the MAPEX outpatient pharmaceutical care Project by regions in Spain

Objetivo: analizar la evolución del proyecto «Mapa Estratégico de Atención Farmacéutica al Paciente Externo» (MAPEX) por comunidades autónomas en España, a través del análisis de los resultados de la encuesta de situación comparativa entre los años 2016 y 2021. Métodos: un comité de expertos nacionales pertenecientes a la Sociedad Española de Farmacia Hospitalaria elaboró la Encuesta MAPEX sobre la situación de las unidades de pacientes externos, que constó de 43 preguntas específicas de aspectos relacionados con estructura, contexto, integración, procesos, resultados y formación, docencia e investigación. Se llevó a cabo en 2 periodos, uno en 2016 y otro en 2021 (con 3 preguntas adicionales en 2021, relacionadas con los avances de la iniciativa MAPEX y las líneas prioritarias a seguir). Se realizó un análisis comparativo de resultados a nivel nacional y por comunidad autónoma. Resultados: participaron 141 hospitales en 2016 y 138 en 2021, con representación de las 17 comunidades autónomas. El análisis de los resultados mostró mejoras significativas en todas las dimensiones de la encuesta, con variabilidad entre las diferentes regiones. De entre las mejoras más importantes, destacó el desarrollo y consolidación de la telefarmacia, la mayor especialización del farmacéutico por áreas de conocimiento y su integración en equipos multidisciplinares. La mejora del modelo asistencial se consideró el mayor avance a nivel general (65%) y la atención farmacéutica no presencial a nivel de centro (48,2%). Se consideraron líneas prioritarias de trabajo la expansión y aplicación práctica de la metodología de atención farmacéutica (66,4%), la investigación (58,4%) y la formación en todas las iniciativas MAPEX (53,3%). Conclusiones: la implantación y desarrollo de las iniciativas MAPEX ha supuesto un impacto positivo en la evolución en todos los ámbitos asistenciales de la atención farmacéutica al paciente externo. La encuesta permite identificar...(AU)

Objective: Analyse the evolution of the MAPEX Project (Strategic Map of Pharmaceutical Care for Outpatients) by regions in Spain, through the results of the comparative situation survey between the years 2016 and 2021. Methods: A committee of national experts belonging to the Spanish Society of Hospital Pharmacy prepared the MAPEX Survey on the situation of Outpatient Units, which consisted of 43 specific questions on aspects related to structure, context, integration, processes, results and training, teaching and investigation. It was carried out in two periods, one in 2016 and another in 2021 (with 3 additional questions in 2021, related to the progress of the MAPEX initiative and the priority lines to follow). A comparative analysis of results was carried out at the national level and by regions in Spain. Results: 141 hospitals participated in 2016 and 138 in 2021, with representation from the 17 autonomous communities. The analysis of the results shows significant improvements in all the dimensions of the survey, with variability between the different regions. Among the most important improvements, the development and consolidation of telepharmacy stood out, the greater specialization of pharmacists by areas of knowledge and their integration into multidisciplinary teams. The improvement of the healthcare model was considered the greatest advance at a general level (65%), and remote pharmaceutical care at the hospital level (48.2%). Priority lines of work were considered the expansion and practical application of the pharmaceutical care methodology (66.4%), research (58.4%), and training in all MAPEX initiatives (53.3%). Conclusions: The implementation and development of the MAPEX initiatives has had a positive impact on the evolution in all healthcare areas of pharmaceutical care for outpatients. The situation survey makes it possible to identify by regions the significant points for improvement...(AU)

Analysis 2016-2021 of the development of the MAPEX outpatient pharmaceutical care Project by Regions in Spain / Análisis 2016-2021 del desarrollo del Proyecto de atención farmacéutica al paciente externo MAPEX por Comunidades Autónomas en España

Objetivo: analizar la evolución del proyecto «Mapa Estratégico de Atención Farmacéutica al Paciente Externo» (MAPEX) por comunidades autónomas en España, a través del análisis de los resultados de la encuesta de situación comparativa entre los años 2016 y 2021. Métodos: un comité de expertos nacionales pertenecientes a la Sociedad Española de Farmacia Hospitalaria elaboró la Encuesta MAPEX sobre la situación de las unidades de pacientes externos, que constó de 43 preguntas específicas de aspectos relacionados con estructura, contexto, integración, procesos, resultados y formación, docencia e investigación. Se llevó a cabo en 2 periodos, uno en 2016 y otro en 2021 (con 3 preguntas adicionales en 2021, relacionadas con los avances de la iniciativa MAPEX y las líneas prioritarias a seguir). Se realizó un análisis comparativo de resultados a nivel nacional y por comunidad autónoma. Resultados: participaron 141 hospitales en 2016 y 138 en 2021, con representación de las 17 comunidades autónomas. El análisis de los resultados mostró mejoras significativas en todas las dimensiones de la encuesta, con variabilidad entre las diferentes regiones. De entre las mejoras más importantes, destacó el desarrollo y consolidación de la telefarmacia, la mayor especialización del farmacéutico por áreas de conocimiento y su integración en equipos multidisciplinares. La mejora del modelo asistencial se consideró el mayor avance a nivel general (65%) y la atención farmacéutica no presencial a nivel de centro (48,2%). Se consideraron líneas prioritarias de trabajo la expansión y aplicación práctica de la metodología de atención farmacéutica (66,4%), la investigación (58,4%) y la formación en todas las iniciativas MAPEX (53,3%). Conclusiones: la implantación y desarrollo de las iniciativas MAPEX ha supuesto un impacto positivo en la evolución en todos los ámbitos asistenciales de la atención farmacéutica al paciente externo. La encuesta permite identificar...(AU)

Objective: Analyse the evolution of the MAPEX Project (Strategic Map of Pharmaceutical Care for Outpatients) by regions in Spain, through the results of the comparative situation survey between the years 2016 and 2021. Methods: A committee of national experts belonging to the Spanish Society of Hospital Pharmacy prepared the MAPEX Survey on the situation of Outpatient Units, which consisted of 43 specific questions on aspects related to structure, context, integration, processes, results and training, teaching and investigation. It was carried out in two periods, one in 2016 and another in 2021 (with 3 additional questions in 2021, related to the progress of the MAPEX initiative and the priority lines to follow). A comparative analysis of results was carried out at the national level and by regions in Spain. Results: 141 hospitals participated in 2016 and 138 in 2021, with representation from the 17 autonomous communities. The analysis of the results shows significant improvements in all the dimensions of the survey, with variability between the different regions. Among the most important improvements, the development and consolidation of telepharmacy stood out, the greater specialization of pharmacists by areas of knowledge and their integration into multidisciplinary teams. The improvement of the healthcare model was considered the greatest advance at a general level (65%), and remote pharmaceutical care at the hospital level (48.2%). Priority lines of work were considered the expansion and practical application of the pharmaceutical care methodology (66.4%), research (58.4%), and training in all MAPEX initiatives (53.3%). Conclusions: The implementation and development of the MAPEX initiatives has had a positive impact on the evolution in all healthcare areas of pharmaceutical care for outpatients. The situation survey makes it possible to identify by regions the significant points for improvement...(AU)

Analysis 2016-2021 of the development of the MAPEX outpatient pharmaceutical care Project by regions in Spain. / Análisis 2016-2021 del desarrollo del proyecto de atención farmacéutica al paciente externo MAPEX por Comunidades Autónomas.

OBJECTIVE: Analyse the evolution of the MAPEX Project (Strategic Map of Pharmaceutical Care for Outpatients) by regions in Spain, through the results of the comparative situation survey between the years 2016 and 2021. METHODS: A committee of national experts belonging to the Spanish Society of Hospital Pharmacy prepared the MAPEX Survey on the situation of Outpatient Units, which consisted of 43 specific questions on aspects related to structure, context, integration, processes, results and training, teaching and investigation. It was carried out in two periods, one in 2016 and another in 2021 (with 3 additional questions in 2021, related to the progress of the MAPEX initiative and the priority lines to follow). A comparative analysis of results was carried out at the national level and by regions in Spain. RESULTS: 141 hospitals participated in 2016 and 138 in 2021, with representation from the 17 autonomous communities. The analysis of the results shows significant improvements in all the dimensions of the survey, with variability between the different regions. Among the most important improvements, the development and consolidation of telepharmacy stood out, the greater specialization of pharmacists by areas of knowledge and their integration into multidisciplinary teams. The improvement of the healthcare model was considered the greatest advance at a general level (65%), and remote pharmaceutical care at the hospital level (48.2%). Priority lines of work were considered the expansion and practical application of the pharmaceutical care methodology (66.4%), research (58.4%), and training in all MAPEX initiatives (53.3%). CONCLUSIONS: The implementation and development of the MAPEX initiatives has had a positive impact on the evolution in all healthcare areas of pharmaceutical care for outpatients. The situation survey makes it possible to identify by regions the significant points for improvement, as well as those areas to be developed through strengthening and corrective actions. The expansion of the project in the coming years will mean progress towards excellence in care and in the improvement of health results.

[Translated article] Biological and immunosuppressive medications in pregnancy, breastfeeding and fertility in immune mediated diseases.

OBJECTIVE: The objective of this review is to gather the available evidence on the different drugs used in immune-mediated inflammatory diseases in pregnancy, lactation, their influence on female and male fertility, advice on discontinuation before conception and to help in routine clinical practice for better patient advice on family planning. METHODS: A bibliographic search was carried out, where published articles (review studies, observational studies and case series) in English or Spanish until April 2020 that analyzed the management of pregnancy, lactation and/or fertility in patients on treatment in immune-mediated diseases were selected. RESULTS: A total of 95 references were selected and the information on each drug was synthesized in tables. Drugs contraindicated in pregnancy are topical retinoids, pimecrolimus, cyclooxygenase 2 inhibitors, methotrexate, mycophenolate mofetil, leflunomide, acitretin, and thiopurines. The lack of data advises against the use of apremilast, tofacitinib, baricitinib, anakinra, abatacept, tocilizumab and the new biologicals. Topical salicylates, paracetamol, ultraviolet therapy and hydroxychloroquine treatment are safe, and anti-TNF biological therapy are considered low risk, with certolizumab being the drug of choice throughout pregnancy and lactation. Most are compatible with paternal exposure except for sulfasalazine, mycophenolate and leflunomide, for which suspension of treatment prior to conception is recommended, and cyclosporine with dose requirements of less than 2 mg/kg/day. CONCLUSIONS: In this context of chronic treatments with teratogenic potential, it is necessary to highlight the importance of pregnancy planning to select the safest drug. Given the quality of the available data, it is still necessary to continuously update the information, as well as to promote observational studies of cohorts of pregnant patients and men of childbearing age, including prospective studies, in order to generate more scientific evidence.

Biological and immunosuppressive medications in pregnancy, breastfeeding and fertility in immune mediated diseases. / Medicamentos inmunosupresores y biológicos en el embarazo, la lactancia y la fertilidad en enfermedades inmunomediadas.

OBJECTIVE: The objective of this review is to gather the available evidence on the different drugs used in immune-mediated inflammatory diseases in pregnancy, lactation, their influence on female and male fertility, advice on discontinuation before conception and to help in routine clinical practice for better patient advice on family planning. METHODS: A bibliographic search was carried out, where published articles (review studies, observational studies and case series) in English or Spanish until April 2020 that analyzed the management of pregnancy, lactation and/or fertility in patients on treatment in immune-mediated diseases were selected. RESULTS: A total of 95 references were selected and the information on each drug was synthesized in tables. Drugs contraindicated in pregnancy are topical retinoids, pimecrolimus, cyclooxygenase 2 inhibitors, methotrexate, mycophenolate mofetil, leflunomide, acitretin, and thiopurines. The lack of data advises against the use of apremilast, tofacitinib, baricitinib, anakinra, abatacept, tocilizumab and the new biologicals. Topical salicylates, paracetamol, ultraviolet therapy and hydroxychloroquine treatment are safe, and anti-TNF biological therapy are considered low risk, with certolizumab being the drug of choice throughout pregnancy and lactation. Most are compatible with paternal exposure except for sulfasalazine, mycophenolate and leflunomide, for which suspension of treatment prior to conception is recommended, and cyclosporine with dose requirements of less than 2mg/kg/day. CONCLUSIONS: In this context of chronic treatments with teratogenic potential, it is necessary to highlight the importance of pregnancy planning to select the safest drug. Given the quality of the available data, it is still necessary to continuously update the information, as well as to promote observational studies of cohorts of pregnant patients and men of childbearing age, including prospective studies, in order to generate more scientific evidence.

Medicamentos inmunosupresores y biológicos en el embarazo, la lactancia y la fertilidad en enfermedades inmunomediadas / Biological and immunosuppressive medications in pregnancy, breastfeeding and fertility in immune mediated diseases

Objetivo: El objetivo de esta revisión es reunir la evidencia disponible de los diferentes medicamentos utilizados en las enfermedades inflamatorias inmunomediadas en la gestación y lactancia, su influencia en la fertilidad femenina y masculina, consejos sobre su suspensión antes de la concepción y servir de ayuda en la práctica clínica habitual para un mejor consejo al paciente en la planificación familiar.Métodose realizó una búsqueda bibliográfica, donde se seleccionaron los artículos publicados (estudios de revisión, observacionales y series de casos) en lengua inglesa o española hasta abril de 2020 que analizaban el manejo del embarazo, la lactancia y/o la fertilidad en pacientes con tratamientos utilizados en las enfermedades inflamatorias inmunomediadas de dermatología, reumatología y digestivas.Resultadosse seleccionaron un total de 95 referencias y se sintetizó la información de cada medicamento en tablas. Los fármacos contraindicados en el embarazo son los retinoides tópicos, pimecrolimus, inhibidores de la ciclooxigenasa 2, metotrexato, micofenolato de mofetilo, leflunomida, acitretina y tiopurinas. La falta de datos desaconseja el uso de apremilast, tofacitinib, baricitinib, anakinra, abatacept, tocilizumab y los nuevos biológicos. Mientras que son seguros los salicilatos y los emolientes tópicos, el paracetamol, la terapia ultravioleta, la hidroxicloroquina y en la terapia biológica los anti-TNF se consideran de bajo riesgo, siendo el certolizumab el de elección durante todo el embarazo y la lactancia. La mayoría son compatibles con la exposición paterna, excepto algunos como la sulfasalazina, micofenolato y leflunomida, que se recomienda la suspensión del tratamiento previa a la concepción, y la ciclosporina con requerimientos de dosis inferiores a 2 mg/kg/día. (AU)

Objective: The objective of this review is to gather the available evidence on the different drugs used in immune-mediated inflammatory diseases in pregnancy, lactation, their influence on female and male fertility, advice on discontinuation before conception and to help in routine clinical practice for better patient advice on family planning.MethodsA bibliographic search was carried out, where published articles (review studies, observational studies and case series) in English or Spanish until April 2020 that analyzed the management of pregnancy, lactation and/or fertility in patients on treatment in immune-mediated diseases were selected.ResultsA total of 95 references were selected and the information on each drug was synthesized in tables. Drugs contraindicated in pregnancy are topical retinoids, pimecrolimus, cyclooxygenase 2 inhibitors, methotrexate, mycophenolate mofetil, leflunomide, acitretin, and thiopurines. The lack of data advises against the use of apremilast, tofacitinib, baricitinib, anakinra, abatacept, tocilizumab and the new biologicals. Topical salicylates, paracetamol, ultraviolet therapy and hydroxychloroquine treatment are safe, and anti-TNF biological therapy are considered low risk, with certolizumab being the drug of choice throughout pregnancy and lactation.Most are compatible with paternal exposure except for sulfasalazine, mycophenolate and leflunomide, for which suspension of treatment prior to conception is recommended, and cyclosporine with dose requirements of less than 2mg/kg/day. (AU)

Telepharmacy scorecard: Activity and quality indicators for the pharmaceutical care in a hospital pharmacy service.

OBJECTIVE: Telepharmacy, as a complementary activity to face-to-face pharmaceutical care in a Hospital pharmacy service, must have specific activity, effectiveness and quality indicators. The objectives of the  project were to design a scorecard of activity, effectiveness and quality  indicators that will make it possible to assess the situation and progress of Telepharmacy and enable continuous improvement. A tool is also provided to measure the indicators, and some recommendations are given for its  implementation. METHOD: The project, led by a panel of expert pharmacists, was developed in  2021 in four phases: a literature review, preliminary identification of quality  criteria and indicators, evaluation of indicators, adjustment of the proposal and definition of priority indicators, and drafting of descriptive files, as well as the  development and validation of a scorecard. The indicators were prioritized  based on their appropriateness, usefulness, relevance and feasibility. Finally,  the scorecard was submitted for evaluation by the members and Patient  Committee of the Spanish Hospital Pharmacy Society. RESULTS: The resulting scorecard consists of 50 indicators grouped into five  areas: General aspects (18); pharmacotherapeutic follow-up (12); home drug  delivery (15); patient information and education (2); and coordination with the  care team (3). A total of 31 were considered priority or essential  indicators, which are initially recommended for the implementation of a  Telepharmacy program. In contrast, 15 are general indicators, including  measurement of patient and professional satisfaction; 6 indicators refer to  pharmacotherapeutic follow-up; 1 is related to patient information and  education, and 2 correspond to care team coordination. CONCLUSIONS: The scorecard developed is a management tool for the implementation and evaluation of Telepharmacy in the Hospital pharmacy service. This tool enables assessing the initial situation, monitoring  implementation progress, measuring quality and performance, facilitating  decision-making and establishing an improvement plan.

OBJETIVO: La Telefarmacia, como actividad complementaria de la atención farmacéutica presencial en un servicio de farmacia de hospital, debe disponer de indicadores de calidad, actividad y efectividad específicos. Los objetivos del proyecto fueron definir los indicadores de calidad, actividad y efectividad de un cuadro de mando que permitan conocer la  situación y evolución de la Telefarmacia y ayuden a la toma de decisiones de mejora continua, además de diseñar una herramienta que permita medir los indicadores y establecer recomendaciones para su implantación.Método: El proyecto liderado por un grupo de expertos farmacéuticos se desarrolló durante el año 2021 en cuatro fases: revisión bibliográfica,  elaboración preliminar de criterios de calidad e indicadores, valoración de los indicadores y definición de indicadores prioritarios, la elaboración de fichas descriptivas, y el desarrollo y validación de una herramienta de cuadro de mando. Los indicadores se priorizaron en función de su adecuación, utilidad, pertinencia y factibilidad. Finalmente, el cuadro de mando fue sometido a la evaluación de los socios y del Comité de Pacientes de la Sociedad Española de Farmacia Hospitalaria. RESULTADOS: El cuadro de mando consta de 50 indicadores agrupados en cinco ámbitos: 18 de ellos sobre aspectos generales, 12 en el ámbito del  seguimiento farmacoterapéutico, 15 relacionados con la dispensación y entrega informada de medicamentos a distancia, 2 sobre formación e información a los  pacientes y 3 en relación con la coordinación con el equipo asistencial. Se  consideraron 31 de ellos prioritarios, siendo los recomendados inicialmente en  la implantación de un programa de Telefarmacia. De ellos, 15 son generales  (incluyendo la medida de satisfacción del paciente y el profesional), 6 son  indicadores de seguimiento, 1 de formación e información y 2 de coordinación  asistencial. CONCLUSIONES: El cuadro de mando desarrollado es una herramienta de  gestión para implantar y evaluar la Telefarmacia en los servicios de farmacia  hospitalaria, que permite conocer la situación inicial, monitorizar la  implantación, medir la calidad y el desempeño, facilitar la toma de decisiones y  establecer un plan de mejora.

Cuadro de mando de Telefarmacia: Indicadores deactividad y calidad de la atención farmacéuticade un servicio de farmacia de hospital / Telepharmacy scorecard: Activity and quality indicators for the pharmaceutical care in a hospital pharmacy service

Objetivo: La Telefarmacia, como actividad complementaria de la atención farmacéutica presencial en un servicio de farmacia de hospital, debedisponer de indicadores de calidad, actividad y efectividad específicos.Los objetivos del proyecto fueron definir los indicadores de calidad, actividad y efectividad de un cuadro de mando que permitan conocer la situación y evolución de la Telefarmacia y ayuden a la toma de decisiones demejora continua, además de diseñar una herramienta que permita medirlos indicadores y establecer recomendaciones para su implantación.Método: El proyecto liderado por un grupo de expertos farmacéuticos sedesarrolló durante el año 2021 en cuatro fases: revisión bibliográfica, elaboración preliminar de criterios de calidad e indicadores, valoración de losindicadores y definición de indicadores prioritarios, la elaboración de fichasdescriptivas, y el desarrollo y validación de una herramienta de cuadrode mando. Los indicadores se priorizaron en función de su adecuación,utilidad, pertinencia y factibilidad. Finalmente, el cuadro de mando fuesometido a la evaluación de los socios y del Comité de Pacientes de laSociedad Española de Farmacia Hospitalaria. Resultados: El cuadro de mando consta de 50 indicadores agrupadosen cinco ámbitos: 18 de ellos sobre aspectos generales, 12 en el ámbitodel seguimiento farmacoterapéutico, 15 relacionados con la dispensacióny entrega informada de medicamentos a distancia, 2 sobre formación einformación a los pacientes y 3 en relación con la coordinación con elequipo asistencial. Se consideraron 31 de ellos prioritarios, siendo losrecomendados inicialmente en la implantación de un programa de Telefarmacia. De ellos, 15 son generales (incluyendo la medida de satisfaccióndel paciente y el profesional), 6 son indicadores de seguimiento, 1 deformación e información y 2 de coordinación asistencial. (AU)

Objective: Telepharmacy, as a complementary activity to face-to-facepharmaceutical care in a Hospital pharmacy service, must have specificactivity, effectiveness and quality indicators. The objectives of the projectwere to design a scorecard of activity, effectiveness and quality indicators that will make it possible to assess the situation and progress ofTelepharmacy and enable continuous improvement. A tool is also provided to measure the indicators, and some recommendations are given forits implementation.Method: The project, led by a panel of expert pharmacists, was developed in 2021 in four phases: a literature review, preliminary identificationof quality criteria and indicators, evaluation of indicators, adjustment ofthe proposal and definition of priority indicators, and drafting of descriptive files, as well as the development and validation of a scorecard. Theindicators were prioritized based on their appropriateness, usefulness,relevance and feasibility. Finally, the scorecard was submitted for evaluation by the members and Patient Committee of the Spanish HospitalPharmacy Society Results: The resulting scorecard consists of 50 indicators grouped intofive areas: General aspects (18); pharmacotherapeutic follow-up (12);home drug delivery (15); patient information and education (2); and coordination with the care team (3). A total of 31 were considered priorityor essential indicators, which are initially recommended for the implementation of a Telepharmacy program. In contrast, 15 are general indicators, including measurement of patient and professional satisfaction;6 indicators refer to pharmacotherapeutic follow-up; 1 is related to patientinformation and education, and 2 correspond to care team coordination. (AU)

Implementation of a pharmacy e-interconsultation integrated in patient medical record.

OBJECTIVE: To describe the phases of development and the success of implementation of the pharmacist non-face-to-face consultation in primary and hospital setting. METHOD: A descriptive and retrospective study was conducted to implement pharmacist non-face-to-face consultation with the clinician, integrated in the patient medical record. A working group was created to define content of the consultation, time of answer and the pharmacist appointment schedule integrated in the patient record. The number and type of consultations and pharmacist documentations were measure during the study period. RESULTS: 530 non-face-to-face consultations were collected from April 2018 to September 2019, principally from hospital setting, but also from primary care. The main motive of consultation was high cost drugs application. The pharmacist documentations in medical record increased after non-face-to-face consultation implementation from 98 in the prior period to 375 afterwards. As a conclusion, pharmacist non-face-to-face consultation has been successfully implemented in our health area, enhancing pharmacist presence in patient medical record and improving the communication between the pharmacists and the physicians.

Estudio piloto para desarrollar y validar un cuestionario basado en el índice de síntomas de VIH / Pilot study to develop and validate a questionnaire based on HIV symptoms index

Objetivo: El objetivo principal es validar el cuestionario de Índice de Síntomas de VIH en población española, en cuanto a comprensión y aceptabilidad. Objetivos secundarios: describir síntomas referidos por el paciente, tolerancia y calidad de vida. Método: Fase piloto de un estudio observacional y multicéntrico no comparativo, para la validación del cuestionario de Índice de Síntomas de VIH en población española. Se incluyeron pacientes mayores de 18 años, diagnosticados de infección por el VIH en tratamiento. Se calculó el índice de síntomas, la adherencia según los registros de dispensación y la calidad de vida con el cuestionario MOS-HIV. Los cálculos estadísticos se realizaron en el SAP System V9.2. Resultados: Se aplicó el cuestionario de Índice de Síntomas de VIH en 75 pacientes, durante los años 2013 y 2014. El 95% consideró el cuestionario como de fácil aplicación y comprensión. La mediana de la puntuación total del cuestionario fue de nueve síntomas (RIQ 1-18); y los síntomas más frecuentes fueron: nervios o ansiedad (45%), hinchazón, dolor o gas en el estómago (40%), dificultad para dormir (39%) y cansancio o falta de energía (37%). La presencia de síntomas se relacionó con un peor resultado en el cuestionario MOS-HIV. Según la escala visual analógica, cuanto mayor era la puntuación en el cuestionario, menor era el nivel de tolerancia (R = -0,51; p < 0,0001) y mayor el número de días con síntomas (R = 0,51; p < 0,0001). Conclusiones: La aplicación del cuestionario fue sencilla. Se constata un nivel de tolerancia alto; y una correlación consistente y significativa con el MOS-HIV, así como con la escala visual analógica

Objective: The primary endpoint is to validate the HIV Symptoms Index Questionnaire in a Spanish population, in terms of comprehension and accep tability. The secondary endpoints are to describe symptoms reported by patients, tolerance, and quality of life. Method: The pilot trial of an observational and multicenter non-comparative study, for the validation of the HIV Symptoms Index Questionnaire in a Spanish population. Patients over the age of 18 diagnosed with HIV infection and receiving treatment were included. The symptoms index, treatment adherence based on pharmacy dispensing records, and quality of life with MOS-HIV questionnaire were calculated. Statistical analyses were conducted with the SAP System V9.2. Results: Between 2013 and 2014, the HIV Symptoms Index Questionnaire was applied to 75 patients; 95% of these patients considered the questionnaire was easy to apply and understand. The total median score of the questionnaire was nine symptoms (IQR 1-18); and the most frequent symptoms were nerves or anxiety (45%), stomach swelling, pain or gas (40%), sleep problems (39%), and fatigue or lack of energy (37%). Presence of symptoms was associated with a worse outcome in the MOS-HIV questionnaire. According to the Visual Analogue Scale, the higher the score in the questionnaire, the lower the tolerance level (R = -0.51; p < 0.0001), and the higher number of days with symptoms (R = 0.51; p < 0.0001). Conclusions: The questionnaire was easy to apply. A high tolerance level was confirmed, as well as a consistent and significant correlation with the MOS-HIV and the Visual Analogue Scale

Pilot study to develop and validate a questionnaire based on HIV symptoms index.

OBJECTIVE: The primary endpoint is to validate the HIV Symptoms Index Questionnaire in a Spanish  population, in terms of comprehension and acceptability. The secondary endpoints are to describe  symptoms reported by patients, tolerance, and quality of life. METHOD: The pilot trial of an observational and multicenter non-comparative study, for the validation  of the HIV Symptoms Index Questionnaire in a Spanish population. Patients over the age of 18  diagnosed with HIV infection and receiving treatment were included. The symptoms index, treatment  adherence based on pharmacy dispensing records, and quality of life with MOS-HIV questionnaire  were calculated. Statistical analyses were conducted with the SAP System V9.2. RESULTS: Between 2013 and 2014, the HIV Symptoms Index Questionnaire was applied to 75  patients; 95% of these patients considered the questionnaire was easy to apply and understand. The  total median score of the questionnaire was nine symptoms (IQR 1-18); and the most frequent symptoms were nerves or anxiety (45%), stomach swelling, pain or gas (40%), sleep  problems (39%), and fatigue or lack of energy (37%). Presence of symptoms was associated with a  worse outcome in the MOS-HIV questionnaire. According to the Visual Analogue Scale, the higher the  score in the questionnaire, the lower the tolerance level (R = -0.51; p < 0.0001), and the higher  number of days with symptoms (R = 0.51; p < 0.0001). CONCLUSIONS: The questionnaire was easy to apply. A high tolerance level was confirmed, as well as a  consistent and significant correlation with the MOS-HIV and the Visual Analogue Scale.

Objetivo: El objetivo principal es validar el cuestionario de Índice de Síntomas de VIH en población  española, en cuanto a comprensión y aceptabilidad. Objetivos secundarios: describir síntomas  referidos por el paciente, tolerancia y calidad de vida.Método: Fase piloto de un estudio observacional y multicéntrico no comparativo, para la validación  del cuestionario de Índice de Síntomas de VIH en población española. Se incluyeron pacientes  mayores de 18 años, diagnosticados de infección por el VIH en tratamiento. Se calculó el índice de  síntomas, la adherencia según los registros de dispensación y la calidad de vida con el cuestionario  MOS-HIV. Los cálculos estadísticos se realizaron en el SAP System V9.2.Resultados: Se aplicó el cuestionario de Índice de Síntomas de VIH en 75 pacientes, durante los  años 2013 y 2014. El 95% consideró el cuestionario como de fácil aplicación y comprensión. La  mediana de la puntuación total del cuestionario fue de nueve síntomas (RIQ 1-18); y los síntomas  más frecuentes fueron: nervios o ansiedad (45%), hinchazón, dolor o gas en el estómago (40%),  dificultad para dormir (39%) y cansancio o falta de energía (37%). La presencia de síntomas se  relacionó con un peor resultado en el cuestionario MOS-HIV. Según la escala visual analógica, cuanto  mayor era la puntuación en el cuestionario, menor era el nivel de tolerancia (R = ­0,51; p < 0,0001)  y mayor el número de días con síntomas (R = 0,51; p < 0,0001).Conclusiones: La aplicación del cuestionario fue sencilla. Se constata un nivel de tolerancia alto; y  una correlación consistente y significativa con el MOS-HIV, así como con la escala visual analógica.

Adherencia en pacientes en tratamiento crónico: resultados del 'Día de la Adherencia' del 2013 / Adherence in patients with chronic treatment: data of 'Adherence Day 2013'

Objetivo: Conocer el nivel de adherencia en pacientes en tratamiento crónico que acudieron al hospital el 15 de noviembre del 2013 en el marco del 'día de la adherencia' Métodos: Estudio trasversal, observacional, multicéntrico, realizado en 43 hospitales nacionales, para conocer el nivel de adherencia utilizando los cuestionarios de Haynes- Sackett y Morisky- Green, además de una escala analógica visual y preguntas relacionadas con la complejidad del tratamiento y la adherencia selectiva. Se realizó un análisis descriptivo y se calculó la concordancia entre los distintos métodos. Resultados: Se recogieron 723 encuestas principalmente en el área de pacientes externos, siendo el 43% de las encuestadas mujeres, con una mediana de edad de 51 años y tomando 3 medicamentos al día. Según el test de Haynes- Sackett, el 10,8% de los pacientes refirieron tener dificultades para tomar su tratamiento. En cambio, un 56,4% de los pacientes fueron cumplidores totales según el cuestionario de Morisky- Green, aunque al considerar únicamente la pregunta relacionada con la omisión de la toma, eran adherentes un 77% de los pacientes. Al aplicar la escala analógica visual, el 71% de los pacientes consideró su adherencia como buena, superior al 80%. Y un 11% de los pacientes presentaron una adherencia selectiva, refiriendo no tomar por igual todos los fármacos. El test de concordancia entre los distintos cuestionarios, considerando el cuestionario de Morisky- Green como Gold estándar, fue débil. Conclusión: En nuestro estudio solamente un 56% de los pacientes en tratamiento crónico presentaron un nivel de adherencia total o perfecto (AU)

Objetive: The primary objective of this study was to evaluate the adherence level in chronic conditions patients during 'The Adherence Day' celebrated on November 15, 2013. Methods: We performed a transversal, observational and multicenter study at 43 Spanish hospitals, in order to estimate adherence in chronic treatments. We used the validated questionnaires Haynes- Sackett and Morisky- Green to measure medication adherence; but also a visual analogue scale and questions related with treatment complexity and selective adherence were applied. We performed a descriptive analysis and the closeness of agreement between questionnaires results. Results: A total of 723 surveys were collected especially among outpatients. 43% of the participants were women, with a median age of 51 and taking 3 drugs per day. 10.8% of the patients reported to have difficulty taking their pills according to Haynes- Sackett test. However, depending on Morisky- Green questionnaire, 56.4% of the participants were totally compliant; but considering only the question about forgetfulness, more were adherents (77%). 71% of the patients considered their compliance level as good (more than 8) according to visual analogue scale. And 11% presented a selective adherence, no taking equally well all the medications. The closeness of agreement between questionnaires and Morisky- Green test, as gold standard, was poor for Haynes- Sackett and weak for visual analogue scale. Conclusions: In our study only 56% of the patients with chronic treatment had a perfect adherence (AU)

[Adherence in patients with chronic treatment: data of "adherence day 2013"]. / Adherencia en pacientes en tratamiento crónico: resultados del "Día de la Adherencia" del 2013.

OBJETIVE: The primary objective of this study was to evaluate the adherence level in chronic conditions patients during "The Adherence Day" celebrated on November 15, 2013. METHODS: We performed a transversal, observational and multicenter study at 43 Spanish hospitals, in order to estimate adherence in chronic treatments. We used the validated questionnaires Haynes- Sackett and Morisky- Green to measure medication adherence; but also a visual analogue scale and questions related with treatment complexity and selective adherence were applied. We performed a descriptive analysis and the closeness of agreement between questionnaires results. RESULTS: A total of 723 surveys were collected especially among outpatients. 43% of the participants were women, with a median age of 51 and taking 3 drugs per day. 10.8% of the patients reported to have difficulty taking their pills according to Haynes- Sackett test. However, depending on Morisky- Green questionnaire, 56.4% of the participants were totally compliant; but considering only the question about forgetfulness, more were adherents (77%). 71% of the patients considered their compliance level as good (more than 8) according to visual analogue scale. And 11% presented a selective adherence, no taking equally well all the medications. The closeness of agreement between questionnaires and Morisky- Green test, as gold standard, was poor for Haynes- Sackett and weak for visual analogue scale. CONCLUSIONS: In our study only 56% of the patients with chronic treatment had a perfect adherence.

Objetivo: Conocer el nivel de adherencia en pacientes en tratamiento crónico que acudieron al hospital el 15 de noviembre del 2013 en el marco del "día de la adherencia" Métodos: Estudio trasversal, observacional, multicéntrico, realizado en 43 hospitales nacionales, para conocer el nivel de adherencia utilizando los cuestionarios de Haynes- Sackett y Morisky- Green, además de una escala analógica visual y preguntas relacionadas con la complejidad del tratamiento y la adherencia selectiva. Se realizó un análisis descriptivo y se calculó la concordancia entre los distintos métodos. Resultados: Se recogieron 723 encuestas principalmente en el área de pacientes externos, siendo el 43% de las encuestadas mujeres, con una mediana de edad de 51 años y tomando 3 medicamentos al día. Según el test de Haynes- Sackett, el 10,8% de los pacientes refirieron tener dificultades para tomar su tratamiento. En cambio, un 56,4% de los pacientes fueron cumplidores totales según el cuestionario de Morisky- Green, aunque al considerar únicamente la pregunta relacionada con la omisión de la toma, eran adherentes un 77% de los pacientes. Al aplicar la escala analógica visual, el 71% de los pacientes consideró su adherencia como buena, superior al 80%. Y un 11% de los pacientes presentaron una adherencia selectiva, refiriendo no tomar por igual todos los fármacos. El test de concordancia entre los distintos cuestionarios, considerando el cuestionario de Morisky- Green como Gold estándar, fue débil. Conclusión: En nuestro estudio solamente un 56% de los pacientes en tratamiento crónico presentaron un nivel de adherencia total o perfecto.

Spanish Rheumatology Society and Hospital Pharmacy Society Consensus on recommendations for biologics optimization in patients with rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis.

OBJECTIVE: The aim of this study was to establish guidelines for the optimization of biologic therapies for health professionals involved in the management of patients with RA, AS and PsA. METHODS: Recommendations were established via consensus by a panel of experts in rheumatology and hospital pharmacy, based on analysis of available scientific evidence obtained from four systematic reviews and on the clinical experience of panellists. The Delphi method was used to evaluate these recommendations, both between panellists and among a wider group of rheumatologists. RESULTS: Previous concepts concerning better management of RA, AS and PsA were reviewed and, more specifically, guidelines for the optimization of biologic therapies used to treat these diseases were formulated. Recommendations were made with the aim of establishing a plan for when and how to taper biologic treatment in patients with these diseases. CONCLUSION: The recommendations established herein aim not only to provide advice on how to improve the risk:benefit ratio and efficiency of such treatments, but also to reduce variability in daily clinical practice in the use of biologic therapies for rheumatic diseases.

Effect of concomitant use of montelukast and efavirenz on neuropsychiatric adverse events.

OBJECTIVE: To report the case of an HIV patient who developed neuropsychiatric disturbances when montelukast was added to her therapy containing efavirenz. CASE SUMMARY: A 41-year-old woman with HIV infection had been on treatment with efavirenz, emtricitabine, and tenofovir disoproxil fumarate since 2007 with good tolerance. In November 2011, montelukast was started for asthma and shortly thereafter neuropsychiatric symptoms appeared, consisting of disturbed sleep, vivid dreams, irritability, confusion, and concentration difficulties. In January 2012, 2 months after the introduction of montelukast, she continued to report unbearable symptoms without any improvement; so, montelukast was withdrawn and the psychiatric symptoms completely disappeared. DISCUSSION: The combination of efavirenz and montelukast has not previously been associated with any pharmacokinetic interactions or worsening of neuropsychiatric symptoms. This case report indicates the possibility of adverse effects developing when the 2 drugs are used together. These symptoms might either be related to a drug-drug interaction or increased by the similar side effect profiles of the 2 drugs. The higher score on the Karch-Lasagna scale suggests that an adverse effect is the more likely explanation. We cannot, however, rule out a drug interaction, given that efavirenz inhibits the CYP 2C9, 2C19, and 3A4 isoenzymes and CYP 3A4, 2C9, and 2C8 are involved in the metabolism of montelukast. CONCLUSIONS: Considering that efavirenz is frequently used in antiretroviral therapy and that neuropsychiatric symptoms can limit its use, clinicians should consider the possibility of worsening of these symptoms, such as mood disorders and abnormal dreams, when montelukast is introduced.