[Analysis of the evolution of outpatient pharmaceutical care in hospital pharmacy services in Spain after the implementation and development of the MAPEX initiative]. / Analisis de la evolución de la atención farmacéutica al paciente externo en los servicios de farmacia hospitalaria en España tras la puesta en marcha y desarrollo de la iniciativa MAPEX.

INTRODUCTION AND OBJECTIVE: In 2015, the Spanish Society of Hospital Pharmacy (SEFH) launched the Strategic Map for Outpatient Pharmaceutical Care (MAPEX), with the purpose of adapting the activity offered in Hospital Pharmacy outpatient clinics to the new healthcare context. The aim of the present study was to analyse the evolution of outpatient pharmaceutical care in Hospital Pharmacy Services in Spain in the period 2016-2021 after the implementation and development of the MAPEX initiative. MATERIAL AND METHOD: The implementation and development of the project was carried out by a group of experts from SEFH and consisted of five phases: creation of the structure, consensus conference, situation analysis, development of strategic initiatives and evolutionary analysis. To analyse the evolutionary development, a specific 43-item questionnaire was developed that addressed aspects related to structure, context, integration, processes, outcomes and research and was answered in 2016 and 2021 (in the latter case by adding 3 additional questions). RESULTS: 141 hospitals participated in the status survey in 2016 and 138 in 2021. Significant differences were found in all dimensions analysed. None of the aspects assessed suffered a setback in this period. The most highly rated aspects at the general level were the improvement of the care model (65.0%) and at the local level, the incorporation of non-face-to-face pharmaceutical care (42.8%). Further progress in the coming years in the expansion and practical application of the methodology proposed in the project was considered a priority. CONCLUSIONS: The implementation and development of the MAPEX initiative has had a positive impact in terms of quality of care for outpatient pharmaceutical care in Hospital Pharmacy services in Spain.

[Status of the structure, process and outcoms of pharmaceutical care to HIV patient in Spain. Origen study]. / Situación actual de la estructura, procesos y resultados de la Atención Farmacéutica al paciente VIH en España. Proyecto ORIGEN.

OBJECTIVES: To describe the structure, process and outcomes with which hospital pharmacist performs health care activity, teaching and research about Pharmaceutical Care (PC) in HIV patients in Spain. METHODS: Observational, cross-sectional and multicenter study carried out between November 2011-February 2012 in spanish hospitals. The inclusion criteria were: hospitals pharmacy services that dispensed antiretroviral medication to HIV patients. The questionnaire had 41 questions structured in 9 groups: hospital type and person conducting the survey, structure and resources, health care activities, interventions, communication with the rest of the multidisciplinary team, adherence, and quality records, management and pharmacoeconomy and teaching and research. Descriptive analysis was performed. To analyze the existence of statistically significant relationships, we applied fisher test, chi-square or logistic regression. RESULTS: 86 hospitals completed the survey. In 93%, PC consultation was not classified by pathologies. 27.9% provided continuing PC to all patients. Adherence was determined regularly or when pharmacist suspected poor adherence (57.5 %). 20% of hospital s teaching had a program that allowed a high level of training in PC to HIV patient. 52,3% of participating centers had published scientific articles related to HIV. CONCLUSIONS: Pharmaceutical care to HIV patients in Spain need to adapt to a new situation. For this, hospital pharmacists have to consider several issues such as chronicity, comorbidity, incorporation of new technologies and the stratification of patients in order to make it more efficient.

Objetivos: Describir la estructura, proceso y resultados con la que se lleva a cabo la actividad asistencial, docente e investigadora en torno a la Atención Farmacéutica (AF) al paciente VIH en los hospitales españoles. Material y métodos: Estudio observacional, transversal, pragmático y multicéntrico realizado entre Noviembre 2011-Febrero 2012. Participaron servicios de farmacia de hospitales españoles que dispensaran medicación antirretroviral para pacientes VIH. El cuestionario presentaba 41 preguntas estructuradas en 9 bloques: tipo de hospital y persona que realiza la encuesta, estructura y recursos disponibles, actividad asistencial, intervenciones, comunicación con el resto del equipo multidisciplinar, adherencia, registros y calidad, gestión y farmacoeconomía y docencia e investigación. Se realizó un análisis descriptivo y se aplicó la prueba de fisher, Chi cuadrado o regresión logística para analizar la existencia de relaciones estadísticamente significativas. Resultados: 86 hospitales cumplimentaron la encuesta. En el 93%, la consulta de AF era compartida con el resto de patologías. El 27,9% proporcionaba AF continuada a todos los pacientes. El 57,5% determinaban la adherencia periódicamente o en casos de sospecha de mala adhesión. El 20% de los hospitales docentes tenían un programa que permitía un alto nivel de formación en AF al paciente VIH. El 52,3% de los hospitales no habían publicado artículos científicos relacionados con el VIH. Conclusiones: La AF al paciente VIH+ en España debe adaptarse a un nuevo escenario donde se han de considerar aspectos como la cronicidad, la pluripatología, la incorporación de nuevas tecnologías y la necesidad de estratificación de los pacientes para hacerla más eficiente.

Desarrollo y validación de un modelo predictivo para la identificación de pacientes infectados por el VIH con problemas relacionados con los medicamentos. Estudio predictor / Development and validation of a prediction model to identify HIV+ patients with drug-related problems. A prediction study

Objetivo: Desarrollar y validar un modelo predictivo para la detección de problemas relacionados con los medicamentos (PRM) en pacientes con tratamiento antirretroviral (TAR), durante su seguimiento periódico en consultas de atención farmacéutica (AF) y previamente a la dispensación. Método Para encontrar factores pronósticos de PRM, se realizó un modelo de regresión logística binaria tras un análisis univariante, el cual identificó variables independientes relacionadas con PRM que fueron introducidas en el modelo multivariante para la selección final. La validez del modelo se determinó por el método Shrinkage y la capacidad discriminatoria por el estadístico C-Harrell. Estudio multicéntrico, abierto, prospectivo. Se incluyeron pacientes infectados por el VIH con y sin PRM. Para el diseño del modelo se incluyeron variables demográficas, clínicas y farmacoterapéuticas (relacionadas o no con el TAR).Resultados Se incluyeron 733 pacientes. Las variables «adherencia», «prescripción de fármacos con necesidad de ajuste posológico» y «número de medicamentos totales prescritos (al margen del TAR)» se relacionaban de manera independiente con la aparición de PRM. Las probabilidades predichas por el modelo, personalizando los coeficientes por el método shrinkage uniforme mostraron un valor R2=0,962 para la muestra de construcción y R2=0,872 para la de validación. La capacidad discriminatoria del modelo fue de 0,816 para la muestra de construcción y 0,779 para la de validación. Conclusiones El modelo predictivo desarrollado y validado permite la detección de pacientes con tratamiento antirretroviral y con mayor riesgo de sufrir un PRM. Las variables predictoras utilizadas se corresponden con las manejadas habitualmente en la historia farmacoterapéutica del paciente, permitiendo su empleo sistemático en la práctica asistencial (AU)

Objective: To develop and validate a prediction model for the detection of drug-related problems (DRP) in patients on antiretroviral treatment during their regular monitoring in Pharmaceutical Care Clinics before dispensing drugs. Method: Open multicentre prospective study. HIV patients with and without DRP were included. Demographic, clinical and pharmacotherapy variables (related and unrelated to antiretroviral treatment) were included in the model design. To find prognostic factors for DRP, a binary logistic regression model was created after performing a univariate analysis that identified independent variables related to DRP these variables were introduced in the multivariate model for the final selection. Model validity was determined by the shrinkage method and the discriminatory power by Harrell’s C-index. Results: 733 patients were included. The variables ‘‘adherence’’, ‘‘prescription of drugs needing dosage adjustment’’, and ‘‘total number of drugs prescribed (apart from the antiretroviral treatment)’’ were independently related to the appearance of DRP. Probabilities predicted by the model, customising the coefficients using the uniform shrinkage method, showed aR2= 0.962 for the construction sample and a R2= 0.872 for the validation sample. The discriminatory capacity of the model was 0.816 for the construction sample and 0.779 for the validationsample. Conclusions: The developed and validated model enables detection of patients on antiretroviral treatment who are at a higher risk for experiencing a DRP. The prediction variables employed are commonly used in patient’s pharmacotherapy record, allowing the model to be used in routine clinical practice (AU)

[Development and validation of a prediction model to identify HIV+ patients with drug-related problems. A prediction study]. / Desarrollo y validación de un modelo predictivo para la identificación de pacientes infectados por el VIH con problemas relacionados con los medicamentos. Estudio predictor.

OBJECTIVE: To develop and validate a prediction model for the detection of drug-related problems (DRP) in patients on antiretroviral treatment during their regular monitoring in Pharmaceutical Care Clinics before dispensing drugs. MEHOD: Open multicentre prospective study. HIV patients with and without DRP were included. Demographic, clinical and pharmacotherapy variables (related and unrelated to antiretroviral treatment) were included in the model design. To find prognostic factors for DRP, a binary logistic regression model was created after performing a univariate analysis that identified independent variables related to DRP these variables were introduced in the multivariate model for the final selection. Model validity was determined by the shrinkage method and the discriminatory power by Harrell's C-index. RESULTS: 733 patients were included. The variables "adherence", "prescription of drugs needing dosage adjustment", and "total number of drugs prescribed (apart from the antiretroviral treatment)" were independently related to the appearance of DRP. Probabilities predicted by the model, customising the coefficients using the uniform shrinkage method, showed a R(2)=0.962 for the construction sample and a R(2)=0.872 for the validation sample. The discriminatory capacity of the model was 0.816 for the construction sample and 0.779 for the validation sample. CONCLUSIONS: The developed and validated model enables detection of patients on antiretroviral treatment who are at a higher risk for experiencing a DRP. The prediction variables employed are commonly used in patient's pharmacotherapy record, allowing the model to be used in routine clinical practice.

Adherencia subóptima al tratamiento en la esclerosis múltiple / Adherence to treatment in multiple sclerosis

Objetivo Conocer la adherencia al tratamiento con interferón beta y acetato de glatirámero de pacientes con esclerosis múltiple, así como el porcentaje de discontinuación y sus causas. Método Estudio observacional, longitudinal prospectivo y multicéntrico de ámbito nacional en el que se seleccionaron pacientes con esclerosis múltiple que acudieron a los servicios de farmacia hospitalarios para recoger medicación. La variable principal de valoración fue el porcentaje de adherencia durante un año, medido como la relación entre las dosis de fármaco dispensadas y las necesarias. Secundariamente se midieron las discontinuaciones de tratamiento y sus causas. Resultados Se incluyeron, durante un periodo de seis meses, 543 pacientes en 39 servicios de farmacia. El tiempo medio de exposición a los fármacos durante el estudio fue de 312 días y la adherencia media en ese periodo del 61,5% (IC 95%: 59,4-63,5). De los 543 participantes en el estudio, 34 (6,26%) discontinuaron el tratamiento, en la mayoría de los casos por criterio médico. Conclusiones La adherencia terapéutica durante un año en los pacientes con esclerosis múltiple ha sido inferior a la óptima. Es necesario analizar las causas y establecer medidas correctoras (AU)

Objective To find out if patients with multiple sclerosis adhere to treatment with beta interferons and glatiramer acetate, the percentage of withdrawal and its causes. Methods Observational, longitudinal, prospective, national, multicentre study which selected multiple sclerosis patients who attended the hospital pharmacy department to collect their medication. The main variable was the adherence percentage during a year, measured as the relationship between the dose of the dispensed and necessary drug. Treatment withdrawals and their causes were then measured. Results Over a six-month period, 543 patients from 39 pharmacy departments were included. The average time exposed to the drugs during the study period was 312 days and the average adherence in this period was 61.5% (95% CI: 59.4-63.5). Thirty-four (6.26%) of the 543 study participants withdrew treatment, which for most cases was decided by the doctor. Conclusions Multiple sclerosis patients’ treatment adherence during a period of one year has been lower than the ideal. The causes should therefore be analysed and corrective measures established (AU)

Adherence to treatment in multiple sclerosis.

OBJECTIVE: To find out if patients with multiple sclerosis adhere to treatment with beta interferons and glatiramer acetate, the percentage of withdrawal and its causes. METHODS: Observational, longitudinal, prospective, national, multicentre study which selected multiple sclerosis patients who attended the hospital pharmacy department to collect their medication. The main variable was the adherence percentage during a year, measured as the relationship between the dose of the dispensed and necessary drug. Treatment withdrawals and their causes were then measured. RESULTS: Over a six-month period, 543 patients from 39 pharmacy departments were included. The average time exposed to the drugs during the study period was 312 days and the average adherence in this period was 61.5% (95% CI: 59.4-63.5). Thirty-four (6.26%) of the 543 study participants withdrew treatment, which for most cases was decided by the doctor. CONCLUSIONS: Multiple sclerosis patients' treatment adherence during a period of one year has been lower than the ideal. The causes should therefore be analysed and corrective measures established.

Evolución de la adherencia al tratamiento antirretoviral del 2000 al 2008 / Evolution of antiretroviral treatment adherence from 2000 to 2008

Objetivos Evaluar la adherencia al tratamiento antirretroviral en la cohorte de pacientes VIH de nuestro hospital y ver su evolución a lo largo de 9 años; así como conocer el patrón individual de la adherencia con el tiempo. Métodos Estudio descriptivo de la evolución de la adherencia media anual y el porcentaje anual de pacientes con adherencias superiores al 95%, desde el 2000 al 2008. Se analizó el patrón individual de adherencia con el tiempo y se clasificó a los pacientes en adherentes consistentes, no adherentes consistentes y fluctuantes. Resultados En el análisis de 577 pacientes, la adherencia basal fue significativamente mayor en los pacientes naive respecto a los pretratados. La adherencia media anual aumentó ligeramente y se mantuvo en valores cercanos al 95%. Al igual que el porcentaje de pacientes con adherencia superior al 95%, que aumentó desde el 64% en el 2000 al 79% en 2008.En cuanto al patrón individual de adherencia con el tiempo, de los 468 pacientes analizados, la mayoría (59%) fueron adherentes consistentes, un 4% no adherente y el resto (37%) presentaban fluctuaciones en su adherencia. Conclusiones En nuestra cohorte los valores de adherencia global se mantienen con el tiempo e incluso presentan una tendencia positiva; resultado de una monitorización sistemática de la adherencia e implantación de estrategias dirigidas a mantener la adherencia (AU)

Objectives To evaluate antiretroviral treatment adherence in the HIV patient cohort of our hospital and observe their evolution over a 9-year period; also to determine the individual pattern of adherence over time. Methods Descriptive study of the evolution of average annual adherence and the annual percentage of adherent patients greater than 95% from 2000 to 2008. We analysed the individual pattern of adherence over time and patients were classified into consistently adherent, consistently non-adherent, and fluctuating. Results In the analysis of 577 patients, baseline adherence was significantly greater in naïve patients with respect to those who were pre-treated. Average annual adherence increased slightly and stayed at values around 95%. As with the percentage of patients with adherence greater than 95%, which increased from 64% in 2000 to 79% in 2008.In terms of the individual pattern of adherence over time, of the 468 patients analysed, the majority (59%) were consistently adherent, 4% non-adherent, and the rest (37%) fluctuated in their adherence. Conclusions In our cohort the overall adherence values maintained themselves over time and even show a positive trend, likely the result of systematic monitoring of adherence and implementation strategies to maintain adherence (AU)

Papel del farmacéutico de hospital en la prevención, identificación y manejo de los efectos adversos asociados al tratamiento antirretroviral / The role of the hospital pharmacist in the prevention, treatment and management of the side effects associated with antiretroviral treatment

Resumen En la actualidad los efectos adversos asociados al tratamiento antirretroviral es la principal causa de discontinuación de este tipo de terapia, tanto en ensayos clínicos como en la práctica clínica habitual. Por otro lado, debido al cambio de orientación que nuestra profesión ha sufrido en los últimos años, nos enfrentamos a la necesidad de establecer una relación totalmente diferente con el paciente, realizando atención farmacéutica de manera directa y eficaz, en un marco asistencial de corresponsabilidad en los resultados terapéuticos. Las intervenciones farmacéuticas deben estar dirigidas a mejorar la calidad de vida de los pacientes, lo que solo puede conseguirse con un abordaje multidisciplinar e individualizado y ajustada a los nuevos patrones de toxicidad de los fármacos actualmente utilizados. El farmacéutico que realiza esta labor debe saber interpretar estos efectos adversos, dar una información precisa al paciente tanto del tratamiento farmacológico como no farmacológico del mismo y realizar un seguimiento farmacoterapéutico correcto donde se establezcan claramente los criterios de derivación a las consultas médicas. El objetivo de este documento es establecer las líneas básicas para que el farmacéutico de hospital realice una labor uniforme y clara en la prevención, identificación y manejo de los principales efectos adversos: gastrointestinales, cardiovasculares, dermatológicos, a nivel del sistema nervioso central y renales, asociados al tratamiento antirretroviral (AU)

Abstract At present, the side effects associated with antiretroviral treatment are the main reasons for discontinuation of this kind of therapy, both in clinical trials and in regular clinical practise. On the other hand, due to the change of direction that our profession has suffered in recent years, we face the need to establish a different relationship with the patient, achieving direct and effective Pharmaceutical Care within a framework of shared responsibility for therapeutic results. Pharmacist interventions should be aimed at improving the quality of life of patients, which can only be achieved with a multidisciplinary approach and individualised and adjusted to new patterns of toxicity of the drugs currently used. The pharmacist who does this work must know how to interpret these side effects, giving accurate information to the patient about both pharmacological and non-pharmacological treatment and correct pharmaceutical follow-up which clearly sets forth the criteria for referral to medical appointments. The aim of this paper is to establish baselines so that the hospital pharmacist can perform clearly and uniformly in the prevention, identification and management of major side effects: gastrointestinal, cardiovascular, dermatological, at the central nervous system and kidney level, associated with antiretroviral therapy (AU)