Multifaceted pharmacist-led interventions in secondary care settings between countries of various income levels: a scoping review protocol.

INTRODUCTION: Clinical pharmacy services often involve multifaceted pharmacist-led interventions. However, current pharmacy practice models vary across different countries. Despite the documented benefits of clinical pharmacy services, the characteristics of pharmacist-led interventions in different countries have not yet been adequately explored and described. Therefore, this protocol outlines the methodology for a proposed scoping review aiming to investigate various types of multifaceted pharmacist-led interventions and the outcomes used to evaluate their effectiveness within secondary care settings. Additionally, the scoping review will map the current evidence surrounding the characteristics of interventions and outcomes reported across various countries of socioeconomic status. METHODS AND ANALYSIS: The scoping review will be conducted according to the JBI Methodology for Scoping Reviews and reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) Extension for Scoping Reviews. We will systematically search the following electronic databases: MEDLINE (Ovid), CINAHL (EbscoHost), Embase (embase.com), Scopus (scopus.com), Cochrane Library (cochranelibrary.com) and APA PsycInfo (Ovid). Additionally, the reference lists of identified reviews and included full texts will be searched for relevant papers. Grey literature sources, such as International Pharmaceutical Abstracts and the International Pharmaceutical Federation (FIP) website, will be searched. We will include primary studies published in the English language from January 2013 to December 2023, involving secondary care multifaceted pharmacist-led interventions. Two independent reviewers will screen studies against eligibility criteria and use a piloted data extraction form to extract relevant information. We will extract relevant data, complete a tabular summary from each included publication and analyse it. ETHICS AND DISSEMINATION: Ethical approval is not required as we will be using data from publicly available literature sources. Findings will be disseminated in publications and presentations with relevant stakeholders. We aim to map available evidence across the breadth of studies that have reported multifaceted pharmacist-led interventions and their outcomes.

Acuerdo de riesgo compartido basado en resultados de salud para el tratamiento de psoriasis moderada-grave con certolizumab pegol / Risk-sharing agreement based on health outcomes for the treatment of moderate-severe psoriasis with certolizumab pegol

Objetivo: aportar evidencia de la efectividad de certolizumab pegol (CZP) en la práctica clínica real en pacientes adultos afectados por psoriasis (PsO) en placas moderada-grave, dentro del contexto de un acuerdo de riesgo compartido (ARC). Métodos: estudio observacional retrospectivo a partir de las variables recogidas en un ARC en los pacientes adultos con PsO en placas moderada-grave tratados con CZP. Participaron 10 hospitales españoles donde se estableció el ARC. Se evaluó el porcentaje de pacientes que alcanzaron la respuesta clínica objetivo del ARC en la visita de seguimiento (semana 16): valor de Psoriasis Area and Severity Index (PASI) absoluto ≤3 para la población naive a biológicos, y ≤5 ante el fracaso previo a un único fármaco biológico. Además, se analizó la mejora en la puntuación de otras escalas: Body Surface Area (BSA), Dermatology Life Quality Index (DLQI), Physician’s Global Assesment (PGA) y Nail Psoriasis Severity Index (NAPSI). Se realizó un análisis descriptivo del total de la población y por subgrupos de pacientes (naive vs. no naive a biológico, hombre vs. mujer, y con vs. sin interrupción). Resultados: se incluyeron 66 pacientes, 12 hombres y 54 mujeres. El 90,9% alcanzaron la respuesta clínica objetivo, con una reducción media de 8 (−78,4%) puntos de PASI absoluto. Se observó una mejora en BSA, PGA, NAPSI y DLQI, con una reducción de 11,3 (−80,6%), 1,9 (−65,5%), 3,3 (−30,7%) y 9,0 (−66,4%) puntos del valor absoluto, respectivamente. Pese a no alcanzar el objetivo terapéutico establecido en el ARC en 6 pacientes (9%) (el coste del fármaco fue asumido por el laboratorio), solo 2 (3%) interrumpieron el tratamiento. Conclusión: nuestro estudio muestra que CZP resulta efectivo en la práctica clínica real en los pacientes con PsO en placas moderada-grave con una mejora de PASI absoluto y DLQI, así como de otras escalas, tanto para el total de la población como en los subgrupos analizados...(AU)

Objective: To provide evidence of the effectiveness of certolizumab pegol (CZP) in real clinical practice in adult patients with moderate-to-severe plaque psoriasis (PsO) in the context of a risk-sharing agreement (RSA). Methods: Retrospective observational study based on variables collected in the RSA for treatment with CZP of adult patients with moderate-severe plaque PsO. Ten Spanish hospitals where the RSA was implemented participated. The percentage of patients who achieved the target clinical response of the RSA at the follow-up visit (week 16) was evaluated: absolute Psoriasis Area and Severity Index (PASI) value ≤3 for biologic naïve population, and ≤5 in case of previous failure to a single biologic drug. In addition, the improvement in the scores of other scales included in the study was analyzed: Body Surface Area (BSA), Dermatology Life Quality Index (DLQI), Physician's Global Assessment (PGA), and Nail Psoriasis Severity Index (NAPSI). A descriptive analysis was performed for the total population and by patient subgroups (naive vs. non-naive to biologic, male vs. female, and with vs. without discontinuation). Results: Sixty-six patients were included, 12 men and 54 women. 90.9% achieved the target clinical response, with a mean reduction of 8 (−78.4%) absolute PASI points. Improvement was observed in BSA, PGA, NAPSI and DLQI, with a reduction of 11.3 (−80.6%), 1.9 (−65.5%), 3.3 (−30.7%) and 9.0 (−66.4%) absolute value points, respectively. Despite not achieving the therapeutic target set in the RSA in six patients (9%) (the cost of the drug was assumed by the laboratory), only two (3%) discontinued treatment. Conclusion: Our study shows that CZP is effective in real clinical practice in patients with moderate-severe plaque PsO, with an improvement in absolute PASI and DLQI, as well as other scales, both for the total population and in the subgroups analyzed. Nearly 91% of patients reached the therapeutic target fixed in the RSA...(AU)

Risk-sharing agreement based on health outcomes for the treatment of moderate–severe psoriasis with certolizumab pegol / Acuerdo de riesgo compartido basado en resultados de salud para el tratamiento de psoriasis moderada-grave con certolizumab pegol

Objetivo: aportar evidencia de la efectividad de certolizumab pegol (CZP) en la práctica clínica real en pacientes adultos afectados por psoriasis (PsO) en placas moderada-grave, dentro del contexto de un acuerdo de riesgo compartido (ARC). Métodos: estudio observacional retrospectivo a partir de las variables recogidas en un ARC en los pacientes adultos con PsO en placas moderada-grave tratados con CZP. Participaron 10 hospitales españoles donde se estableció el ARC. Se evaluó el porcentaje de pacientes que alcanzaron la respuesta clínica objetivo del ARC en la visita de seguimiento (semana 16): valor de Psoriasis Area and Severity Index (PASI) absoluto ≤3 para la población naive a biológicos, y ≤5 ante el fracaso previo a un único fármaco biológico. Además, se analizó la mejora en la puntuación de otras escalas: Body Surface Area (BSA), Dermatology Life Quality Index (DLQI), Physician’s Global Assesment (PGA) y Nail Psoriasis Severity Index (NAPSI). Se realizó un análisis descriptivo del total de la población y por subgrupos de pacientes (naive vs. no naive a biológico, hombre vs. mujer, y con vs. sin interrupción). Resultados: se incluyeron 66 pacientes, 12 hombres y 54 mujeres. El 90,9% alcanzaron la respuesta clínica objetivo, con una reducción media de 8 (−78,4%) puntos de PASI absoluto. Se observó una mejora en BSA, PGA, NAPSI y DLQI, con una reducción de 11,3 (−80,6%), 1,9 (−65,5%), 3,3 (−30,7%) y 9,0 (−66,4%) puntos del valor absoluto, respectivamente. Pese a no alcanzar el objetivo terapéutico establecido en el ARC en 6 pacientes (9%) (el coste del fármaco fue asumido por el laboratorio), solo 2 (3%) interrumpieron el tratamiento. Conclusión: nuestro estudio muestra que CZP resulta efectivo en la práctica clínica real en los pacientes con PsO en placas moderada-grave con una mejora de PASI absoluto y DLQI, así como de otras escalas, tanto para el total de la población como en los subgrupos analizados...(AU)

Objective: To provide evidence of the effectiveness of certolizumab pegol (CZP) in real clinical practice in adult patients with moderate-to-severe plaque psoriasis (PsO) in the context of a risk-sharing agreement (RSA). Methods: Retrospective observational study based on variables collected in the RSA for treatment with CZP of adult patients with moderate-severe plaque PsO. Ten Spanish hospitals where the RSA was implemented participated. The percentage of patients who achieved the target clinical response of the RSA at the follow-up visit (week 16) was evaluated: absolute Psoriasis Area and Severity Index (PASI) value ≤3 for biologic naïve population, and ≤5 in case of previous failure to a single biologic drug. In addition, the improvement in the scores of other scales included in the study was analyzed: Body Surface Area (BSA), Dermatology Life Quality Index (DLQI), Physician's Global Assessment (PGA), and Nail Psoriasis Severity Index (NAPSI). A descriptive analysis was performed for the total population and by patient subgroups (naive vs. non-naive to biologic, male vs. female, and with vs. without discontinuation). Results: Sixty-six patients were included, 12 men and 54 women. 90.9% achieved the target clinical response, with a mean reduction of 8 (−78.4%) absolute PASI points. Improvement was observed in BSA, PGA, NAPSI and DLQI, with a reduction of 11.3 (−80.6%), 1.9 (−65.5%), 3.3 (−30.7%) and 9.0 (−66.4%) absolute value points, respectively. Despite not achieving the therapeutic target set in the RSA in six patients (9%) (the cost of the drug was assumed by the laboratory), only two (3%) discontinued treatment. Conclusion: Our study shows that CZP is effective in real clinical practice in patients with moderate-severe plaque PsO, with an improvement in absolute PASI and DLQI, as well as other scales, both for the total population and in the subgroups analyzed. Nearly 91% of patients reached the therapeutic target fixed in the RSA...(AU)

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)

Perfil de seguridad de nirmatrelvir-ritonavir: evidencia de eventos adversos por interacciones farmacológicas / Safety profile of nirmatrelvir-ritonavir: Evidence of adverse events due to drug-drug interactions

Objetivo: evaluar el perfil de seguridad de nirmatrelvir-ritonavir (NMV-r) en la práctica clínica real y analizar la relevancia clínica de las interacciones farmacológicas en el desarrollo de eventos adversos. Material y métodos: estudio observacional, retrospectivo en el que se evaluaron los datos de seguridad de pacientes tratados con NMV-r entre abril y julio de 2022. Se recopilaron datos demográficos y analíticos antes de comenzar el tratamiento. La duración del seguimiento fue de 28 días y se evaluó el número reacciones adversas reportadas, así como si fueron manejadas de forma ambulatoria o precisaron de asistencia sanitaria especializada y la presencia de deterioro de la función renal y hepática. Se revisó el tratamiento concomitante, identificando interacciones farmacológicas teóricas (IFT) cuya gravedad fue definida mediante la clasificación Lexi-interact. Resultados: el estudio incluyó 146 pacientes, 82 (56,16 %) eran mujeres, cuya mediana de edad fue de 65 años (22-95). El número de IFT detectadas y mantenidas durante el tratamiento con NMV-r fue de 164, siendo el porcentaje de pacientes con al menos una interacción de 62,33%. La mediana de IFT por paciente fue de uno (0-5). En 18 pacientes (11,84%) se reportó al menos un evento adverso (EA). Once EA se relacionaron potencialmente con alguna IFT, 7 pacientes requirieron contacto con asistencia hospitalaria para el manejo del EA, 8 pacientes presentaron deterioro de la función renal y 2 de la función hepática a los 28 días. Los principales grupos de fármacos implicados en la aparición de algún EA fueron los anticoagulantes orales, así como los calcio-antagonistas. Conclusiones: nuestros resultados muestran un elevado número de IFT detectadas entre NMV-r y otros fármacos, aunque la frecuencia de EA asociados fue baja. Este estudio proporciona un mayor conocimiento de los fármacos implicados en dichas interacciones y su potencial relación con la aparición de EA.(AU)

Objective: The aim of the study was to evaluate the safety profile of nirmatrelvir-ritonavir (NMV-r) in real clinical practice and to analyze the clinical relevance of drug-drug interactions in the development of adverse events. Methods: Observational, retrospective study in which safety data of patients treated with NMV-r between April and July 2022 in an outpatient setting were evaluated. The duration of follow-up was 28 days and the number of adverse reactions reported, as well as whether they were managed on an outpatient basis or required health care, and the presence of renal and hepatic function impairment were assessed. Concomitant treatment was reviewed, identifying theoretical drug-drug interactions (TDDIs) whose severity was defined using the Lexi-interact classification. Results: The study included 146 patients, 82 (56,16%) were women, whose median age was 65 years (22-95). The number of TDDIs detected and maintained during treatment with NMV-r was 164, with the percentage of patients with at least one interaction being 62,33%. The median number of TDDIs per patient was 1 (0-5). At least 1 adverse event (AE) was reported in 18 patients (11,84%). Eleven AEs were potentially related to any TDDI. Seven patients required contact with hospital assistance for AE management. Eight patients had impaired renal function and 2 had impaired liver function at 28 days. The main groups of drugs implicated in the occurrence of an AE were oral anticoagulants and calcium antagonists. Conclusions: Our results show a high number of TDDIs detected were detected between NMV-r and other drugs. This study provides greater knowledge of the drugs involved in such interactions and their potential relationship with the occurrence of adverse events.(AU)

Safety profile of nirmatrelvir-ritonavir: Evidence of adverse events due to DDIs / Perfil de seguridad de nirmatrelvir-ritonavir: evidencia de eventos adversos por interacciones farmacológicas

Objetivo: evaluar el perfil de seguridad de nirmatrelvir-ritonavir (NMV-r) en la práctica clínica real y analizar la relevancia clínica de las interacciones farmacológicas en el desarrollo de eventos adversos. Material y métodos: estudio observacional, retrospectivo en el que se evaluaron los datos de seguridad de pacientes tratados con NMV-r entre abril y julio de 2022. Se recopilaron datos demográficos y analíticos antes de comenzar el tratamiento. La duración del seguimiento fue de 28 días y se evaluó el número reacciones adversas reportadas, así como si fueron manejadas de forma ambulatoria o precisaron de asistencia sanitaria especializada y la presencia de deterioro de la función renal y hepática. Se revisó el tratamiento concomitante, identificando interacciones farmacológicas teóricas (IFT) cuya gravedad fue definida mediante la clasificación Lexi-interact. Resultados: el estudio incluyó 146 pacientes, 82 (56,16 %) eran mujeres, cuya mediana de edad fue de 65 años (22-95). El número de IFT detectadas y mantenidas durante el tratamiento con NMV-r fue de 164, siendo el porcentaje de pacientes con al menos una interacción de 62,33%. La mediana de IFT por paciente fue de uno (0-5). En 18 pacientes (11,84%) se reportó al menos un evento adverso (EA). Once EA se relacionaron potencialmente con alguna IFT, 7 pacientes requirieron contacto con asistencia hospitalaria para el manejo del EA, 8 pacientes presentaron deterioro de la función renal y 2 de la función hepática a los 28 días. Los principales grupos de fármacos implicados en la aparición de algún EA fueron los anticoagulantes orales, así como los calcio-antagonistas. Conclusiones: nuestros resultados muestran un elevado número de IFT detectadas entre NMV-r y otros fármacos, aunque la frecuencia de EA asociados fue baja. Este estudio proporciona un mayor conocimiento de los fármacos implicados en dichas interacciones y su potencial relación con la aparición de EA.(AU)

Objective: The aim of the study was to evaluate the safety profile of nirmatrelvir-ritonavir (NMV-r) in real clinical practice and to analyze the clinical relevance of drug-drug interactions in the development of adverse events. Methods: Observational, retrospective study in which safety data of patients treated with NMV-r between April and July 2022 in an outpatient setting were evaluated. The duration of follow-up was 28 days and the number of adverse reactions reported, as well as whether they were managed on an outpatient basis or required health care, and the presence of renal and hepatic function impairment were assessed. Concomitant treatment was reviewed, identifying theoretical drug-drug interactions (TDDIs) whose severity was defined using the Lexi-interact classification. Results: The study included 146 patients, 82 (56,16%) were women, whose median age was 65 years (22-95). The number of TDDIs detected and maintained during treatment with NMV-r was 164, with the percentage of patients with at least one interaction being 62,33%. The median number of TDDIs per patient was 1 (0-5). At least 1 adverse event (AE) was reported in 18 patients (11,84%). Eleven AEs were potentially related to any TDDI. Seven patients required contact with hospital assistance for AE management. Eight patients had impaired renal function and 2 had impaired liver function at 28 days. The main groups of drugs implicated in the occurrence of an AE were oral anticoagulants and calcium antagonists. Conclusions: Our results show a high number of TDDIs detected were detected between NMV-r and other drugs. This study provides greater knowledge of the drugs involved in such interactions and their potential relationship with the occurrence of adverse events.(AU)

Abemaciclib as adjuvant treatment for high-risk early breast cancer / Abemaciclib en adyuvancia para el tratamiento del cáncer de mama precoz de alto riesgo

Objective: To adapt the GHEMA report of abemaciclib, an inhibitor of cyclin-dependent kinases 4 and 6. European Medicines Agency authorization (April 2022) includes, in combination with endocrine therapy, the adjuvant treatment of adult patients with hormone receptor positive, human epidermal growth factor receptor 2 negative, node-positive, early breast cancer at high risk of recurrence. Method: The efficacy and safety of abemaciclib were evaluated in a randomized, open-label, and multicenter phase III study. A total of 5637 patients diagnosed with early breast cancer with hormone receptor positive, human epidermal growth factor receptor 2 negative, node positive, and high risk of recurrence were included. High risk was defined as patients with 4 or more positive axillary lymph nodes, or 1–3 positive axillary lymph nodes and at least one of the following: tumor size ≥5 cm, histologic grade 3, or Ki-67≥20%. Patients were randomized (1:1) to receive adjuvant abemaciclib+endocrine therapy (n = 2808) or endocrine therapy alone (n = 2829) for 2 years, with endocrine therapy prescribed for at least 5 years. Results: With a median follow-up of 15.5 months, abemaciclib+endocrine therapy demonstrated a statistically significant improvement in invasive disease-free survival versus endocrine therapy alone [HR = 0.747 (95% CI 0.598–0.932), P = 0.0096]; achieving an absolute improvement of 3.5% invasive disease-free survival rate at 2-years. These results were maintained, with a median follow-up of 27.7 months: absolute improvement of 2.7% and 5.4% in invasive disease-free survival rate at 2 and 3 years, respectively. All-causality grade 3 or 4 adverse events were 45.9% for abemaciclib and 12.9% for endocrine therapy, and included neutropenia (19.6% vs. 0.8%), leukopenia (11.4% vs. 0.4%), and diarrhea (7.8% vs. 0.2%). Conclusions: The results of the pivotal trial are sufficient to consider abemaciclib as adjuvant treatment for...(AU)

Objetivo: Adaptar el informe GHEMA de abemaciclib, un inhibidor de quinasas dependientes de ciclinas 4 y 6, con autorización de la Agencia Europea del Medicamento en abril de 2022 para el tratamiento adyuvante de pacientes adultos con cáncer de mama precoz, receptor hormonal positivo, receptor del factor de crecimiento epidérmico negativo, con afectación ganglionar y riesgo elevado de recaída; en combinación con hormonoterapia. Método: La eficacia y seguridad de abemaciclib se evaluó en un estudio fase III multicéntrico, aleatorizado y abierto. Se incluyeron 5.637 pacientes diagnosticados de cáncer de mama precoz con ganglios positivos, receptor hormonal positivo, receptor del factor de crecimiento epidérmico negativo y alto riesgo de recaída. El criterio de alto riesgo se definió como la presencia de ≥ 4 ganglios positivos, o de 1–3 ganglios y al menos una de las siguientes características: tamaño del tumor ≥5 cm, grado histológico 3 o Ki-67 ≥ 20%. Los pacientes fueron aleatorizados (1:1) a recibir durante 2 años abemaciclib + hormonoterapia (n = 2.808) u hormonoterapia sola (n = 2.829). En ambos brazos el tratamiento con hormonoterapia se mantuvo mínimo 5 años. Resultados: Con una mediana de seguimiento de 15,5 meses, abemaciclib + hormonoterapia mostró beneficio significativo frente a la hormonoterapia sola [HR = 0,747 (IC95% 0,598-0,932), p = 0,0096], con una mejora absoluta del 3,5% en la tasa de supervivencia libre de enfermedad invasiva a 2 los años. Este beneficio se mantuvo con una mediana de seguimiento de 27,7 meses, logrando una mejora en la tasa de supervivencia libre de enfermedad invasiva del 2,7% y del 5,4% a los 2 y 3 años, respectivamente. La incidencia de efectos adversos grado 3–4 fue superior en el brazo de abemaciclib (45,9% vs. 12,9%); e incluía neutropenia (19,6% vs. 0,8%), leucopenia (11,4% vs. 0,4%) y diarrea (7,8% vs. 0,2%). Conclusiones: Los resultados del ensayo pivotal son suficientes para considerar abemaciclib como...(AU)

Abemaciclib en adyuvancia para el tratamiento del cáncer de mama precoz de alto riesgo / Abemaciclib as adjuvant treatment for high-risk early breast cancer

Objective: To adapt the GHEMA report of abemaciclib, an inhibitor of cyclin-dependent kinases 4 and 6. European Medicines Agency authorization (April 2022) includes, in combination with endocrine therapy, the adjuvant treatment of adult patients with hormone receptor positive, human epidermal growth factor receptor 2 negative, node-positive, early breast cancer at high risk of recurrence. Method: The efficacy and safety of abemaciclib were evaluated in a randomized, open-label, and multicenter phase III study. A total of 5637 patients diagnosed with early breast cancer with hormone receptor positive, human epidermal growth factor receptor 2 negative, node positive, and high risk of recurrence were included. High risk was defined as patients with 4 or more positive axillary lymph nodes, or 1–3 positive axillary lymph nodes and at least one of the following: tumor size ≥5 cm, histologic grade 3, or Ki-67≥20%. Patients were randomized (1:1) to receive adjuvant abemaciclib+endocrine therapy (n = 2808) or endocrine therapy alone (n = 2829) for 2 years, with endocrine therapy prescribed for at least 5 years. Results: With a median follow-up of 15.5 months, abemaciclib+endocrine therapy demonstrated a statistically significant improvement in invasive disease-free survival versus endocrine therapy alone [HR = 0.747 (95% CI 0.598–0.932), P = 0.0096]; achieving an absolute improvement of 3.5% invasive disease-free survival rate at 2-years. These results were maintained, with a median follow-up of 27.7 months: absolute improvement of 2.7% and 5.4% in invasive disease-free survival rate at 2 and 3 years, respectively. All-causality grade 3 or 4 adverse events were 45.9% for abemaciclib and 12.9% for endocrine therapy, and included neutropenia (19.6% vs. 0.8%), leukopenia (11.4% vs. 0.4%), and diarrhea (7.8% vs. 0.2%). Conclusions: The results of the pivotal trial are sufficient to consider abemaciclib as adjuvant treatment for...(AU)

Objetivo: Adaptar el informe GHEMA de abemaciclib, un inhibidor de quinasas dependientes de ciclinas 4 y 6, con autorización de la Agencia Europea del Medicamento en abril de 2022 para el tratamiento adyuvante de pacientes adultos con cáncer de mama precoz, receptor hormonal positivo, receptor del factor de crecimiento epidérmico negativo, con afectación ganglionar y riesgo elevado de recaída; en combinación con hormonoterapia. Método: La eficacia y seguridad de abemaciclib se evaluó en un estudio fase III multicéntrico, aleatorizado y abierto. Se incluyeron 5.637 pacientes diagnosticados de cáncer de mama precoz con ganglios positivos, receptor hormonal positivo, receptor del factor de crecimiento epidérmico negativo y alto riesgo de recaída. El criterio de alto riesgo se definió como la presencia de ≥ 4 ganglios positivos, o de 1–3 ganglios y al menos una de las siguientes características: tamaño del tumor ≥5 cm, grado histológico 3 o Ki-67 ≥ 20%. Los pacientes fueron aleatorizados (1:1) a recibir durante 2 años abemaciclib + hormonoterapia (n = 2.808) u hormonoterapia sola (n = 2.829). En ambos brazos el tratamiento con hormonoterapia se mantuvo mínimo 5 años. Resultados: Con una mediana de seguimiento de 15,5 meses, abemaciclib + hormonoterapia mostró beneficio significativo frente a la hormonoterapia sola [HR = 0,747 (IC95% 0,598-0,932), p = 0,0096], con una mejora absoluta del 3,5% en la tasa de supervivencia libre de enfermedad invasiva a 2 los años. Este beneficio se mantuvo con una mediana de seguimiento de 27,7 meses, logrando una mejora en la tasa de supervivencia libre de enfermedad invasiva del 2,7% y del 5,4% a los 2 y 3 años, respectivamente. La incidencia de efectos adversos grado 3–4 fue superior en el brazo de abemaciclib (45,9% vs. 12,9%); e incluía neutropenia (19,6% vs. 0,8%), leucopenia (11,4% vs. 0,4%) y diarrea (7,8% vs. 0,2%). Conclusiones: Los resultados del ensayo pivotal son suficientes para considerar abemaciclib como...(AU)

Validated medication deprescribing instruments for patients with palliative care needs: a systematic review / Instrumentos validados de desprescripción de medicamentos para los pacientes que reciben cuidados paliativos: una revisión sistemática

Objectives: Patients with life-limiting illnesses are prone to unnecessary polypharmacy. Deprescribing tools may contribute to minimizing negative outcomes. Thus, the aims of the study were to identify validated instruments for deprescribing inappropriate medications for patients with palliative care needs and to assess the impact on clinical, humanistic, and economic outcomes. Methods: A systematic review was conducted in LILACS, PUBMED, EMBASE, COCHRANE, and WEB OF SCIENCE databases (until May 2021). A manual search was performed in the references of enrolled articles. The screening, eligibility, extraction, and bias risk assessment were carried out by 2 independent researchers. Experimental and observational studies were eligible for inclusion. Results: Out of the 5791 studies retrieved, after excluding duplicates (n = 1050), conducting title/abstract screening (n = 4741), and full reading (n = 41), only 1 study met the inclusion criteria. In this included study, a randomized controlled trial was conducted, which showed a high level of bias risk overall. Adults 75 years or older (n = 130) with limited life expectancy and polypharmacy were allocated to 2 groups [intervention arm (deprescribing); and control arm (usual care)]. Deprescribing was performed with the aid of the STOPPFrail tool. The mean number of inappropriate medications and monthly medication costs were significantly lower in the intervention arm. No statistically significant differences were found in terms of unscheduled hospital presentations, falls, fractures, mortality, and quality of life. Conclusions: Despite the availability of several instruments to support deprescribing in patients with palliative care needs, only 1 of them has undergone validation and robust assessment for effectiveness in clinical practice. The STOPPFrail tool appears to reduce the number of inappropriate medications for older people with limited life expectancy (and probably palliative care needs)...(AU)

Objetivo: Los pacientes con enfermedades terminales son propensos a la polifarmacia innecesaria. Las herramientas de desprescripción pueden contribuir a minimizar los resultados negativos. Por lo tanto, los objetivos del estudio fueron identificar instrumentos validados para la desprescripción de medicamentos inapropiados en pacientes con necesidades de cuidados paliativos y evaluar el impacto en los resultados clínicos, humanísticos y económicos. Métodos: Se realizó una revisión sistemática en las bases de datos LILACS, PUBMED, EMBASE, COCHRANE y WEB OF SCIENCE (hasta mayo de 2021). Se realizó una búsqueda manual en las referencias de los artículos incluidos. La selección, elegibilidad, extracción y evaluación del riesgo de sesgo se llevaron a cabo por dos investigadores independientes. Se aceptó la inclusión de estudios observacionales y experimentales. Resultados: De los 5791 estudios recuperados, después de excluir duplicados (n = 1050), realizar la selección de títulos/resúmenes (n = 4741) y la lectura completa (n = 41), solo un estudio cumplió con los criterios de inclusión. En este estudio incluido, se realizó un ensayo controlado aleatorizado, que mostró un alto nivel de riesgo de sesgo en general. A los adultos de 75 años o más (n = 130) con esperanza de vida limitada y polifarmacia se les asignaron dos grupos [grupo de intervención (desprescripción) y grupo de control (atención habitual)]. Se realizó la desprescripción con la ayuda de la herramienta STOPPFrail. El número promedio de medicamentos inapropiados y los costos mensuales de los medicamentos fueron significativamente más bajos en el grupo de intervención. No se encontraron diferencias estadísticamente significativas en términos de presentaciones hospitalarias no programadas, caídas, fracturas, mortalidad y calidad de vida. Conclusiones: A pesar de la disponibilidad de varias herramientas para apoyar la deprescripción en pacientes con necesidades de cuidados paliativos...(AU)

Instrumentos validados de desprescripción de medicamentos para los pacientes que reciben cuidados paliativos: una revisión sistemática / Validated medication deprescribing instruments for patients with palliative care needs: a systematic review

Objectives: Patients with life-limiting illnesses are prone to unnecessary polypharmacy. Deprescribing tools may contribute to minimizing negative outcomes. Thus, the aims of the study were to identify validated instruments for deprescribing inappropriate medications for patients with palliative care needs and to assess the impact on clinical, humanistic, and economic outcomes. Methods: A systematic review was conducted in LILACS, PUBMED, EMBASE, COCHRANE, and WEB OF SCIENCE databases (until May 2021). A manual search was performed in the references of enrolled articles. The screening, eligibility, extraction, and bias risk assessment were carried out by 2 independent researchers. Experimental and observational studies were eligible for inclusion. Results: Out of the 5791 studies retrieved, after excluding duplicates (n = 1050), conducting title/abstract screening (n = 4741), and full reading (n = 41), only 1 study met the inclusion criteria. In this included study, a randomized controlled trial was conducted, which showed a high level of bias risk overall. Adults 75 years or older (n = 130) with limited life expectancy and polypharmacy were allocated to 2 groups [intervention arm (deprescribing); and control arm (usual care)]. Deprescribing was performed with the aid of the STOPPFrail tool. The mean number of inappropriate medications and monthly medication costs were significantly lower in the intervention arm. No statistically significant differences were found in terms of unscheduled hospital presentations, falls, fractures, mortality, and quality of life. Conclusions: Despite the availability of several instruments to support deprescribing in patients with palliative care needs, only 1 of them has undergone validation and robust assessment for effectiveness in clinical practice. The STOPPFrail tool appears to reduce the number of inappropriate medications for older people with limited life expectancy (and probably palliative care needs)...(AU)

Objetivo: Los pacientes con enfermedades terminales son propensos a la polifarmacia innecesaria. Las herramientas de desprescripción pueden contribuir a minimizar los resultados negativos. Por lo tanto, los objetivos del estudio fueron identificar instrumentos validados para la desprescripción de medicamentos inapropiados en pacientes con necesidades de cuidados paliativos y evaluar el impacto en los resultados clínicos, humanísticos y económicos. Métodos: Se realizó una revisión sistemática en las bases de datos LILACS, PUBMED, EMBASE, COCHRANE y WEB OF SCIENCE (hasta mayo de 2021). Se realizó una búsqueda manual en las referencias de los artículos incluidos. La selección, elegibilidad, extracción y evaluación del riesgo de sesgo se llevaron a cabo por dos investigadores independientes. Se aceptó la inclusión de estudios observacionales y experimentales. Resultados: De los 5791 estudios recuperados, después de excluir duplicados (n = 1050), realizar la selección de títulos/resúmenes (n = 4741) y la lectura completa (n = 41), solo un estudio cumplió con los criterios de inclusión. En este estudio incluido, se realizó un ensayo controlado aleatorizado, que mostró un alto nivel de riesgo de sesgo en general. A los adultos de 75 años o más (n = 130) con esperanza de vida limitada y polifarmacia se les asignaron dos grupos [grupo de intervención (desprescripción) y grupo de control (atención habitual)]. Se realizó la desprescripción con la ayuda de la herramienta STOPPFrail. El número promedio de medicamentos inapropiados y los costos mensuales de los medicamentos fueron significativamente más bajos en el grupo de intervención. No se encontraron diferencias estadísticamente significativas en términos de presentaciones hospitalarias no programadas, caídas, fracturas, mortalidad y calidad de vida. Conclusiones: A pesar de la disponibilidad de varias herramientas para apoyar la deprescripción en pacientes con necesidades de cuidados paliativos...(AU)

How Should We Draw on Pharmacists' Expertise to Manage Drug Shortages in Hospitals?

This article argues that drug shortages should be addressed as crises that exacerbate already compromised US health care infrastructure. Clinicians, especially pharmacists, can help limit threats that shortages pose to patients. For example, pharmacists can canvass procurement options, consolidate inventory, and prepare medications to prevent need for some clinical interventions. This article describes how pharmacists' preparation and training equip them to help clinical teams navigate shortages by equitably rationing limited medicines, suggesting appropriate therapeutic alternatives, modifying drug administration routes, or delaying interventions. Pharmacists' roles can be key, since good management of supplies during drug shortages can mitigate risk of worse-than-usual clinical outcomes, mitigate risk of medication errors, and reduce some financial burdens on the overall health care system.

Intelligent supervision of PIVAS drug dispensing based on image recognition technology.

Pharmacy Intravenous Admixture Services (PIVAS) are places dedicated to the centralized dispensing of intravenous drugs, usually managed and operated by professional pharmacists and pharmacy technicians, and are an integral part of modern healthcare. However, the workflow of PIVAS has some problems, such as low efficiency and error-prone. This study aims to improve the efficiency of drug dispensing, reduce the rate of manual misjudgment, and minimize drug errors by conducting an in-depth study of the entire workflow of PIVAS and applying image recognition technology to the drug checking and dispensing process. Firstly, through experimental comparison, a target detection model suitable for drug category recognition is selected in the drug-checking process of PIVAS, and it is improved to improve the recognition accuracy and speed of intravenous drug categories. Secondly, a corner detection model for drug dosage recognition was studied in the drug dispensing stage to further increase drug dispensing accuracy. Then the PIVAS drug category recognition system and PIVAS drug dosage recognition system were designed and implemented.

Pharmacist-led medication reconciliation service for patients after discharge from tertiary hospitals to primary care in Singapore: a qualitative study.

BACKGROUND: Medication discrepancies commonly occur when patients are transferred between care settings. Despite the presence of medication reconciliation services (MRS), medication discrepancies are still prevalent, which has clinical costs and implications. This study aimed to explore the perspectives of various stakeholders on how the MRS can be optimized in Singapore. METHODS: This is a descriptive qualitative study. Semi-structured interviews with 30 participants from the National Healthcare Group, including family physicians (N = 10), pharmacists (N = 10), patients recently discharged from restructured hospitals (N = 7) and their caregivers (N = 3) were conducted. All transcribed interviews were coded independently by three coders and inductive thematic analysis approach was used. RESULTS: Five core themes were identified. (1) The MRS enhanced healthcare services in various aspects including efficiency and health literacy; (2) There were several challenges in delivering the MRS covering processes, technology and training; (3) Issues with suitable patient selection and follow-up; (4) Barriers to scaling up of MRS that involve various stakeholders, cross-sector integration and environmental restrictions; and finally (5) Role definition of the pharmacist to all the stakeholders. CONCLUSION: This study identified the role of MRS in enhancing healthcare services and explored the challenges encountered in the provision of MRS from family physicians, pharmacists, patients and their caregivers. These findings supported the need for a shift of MRS towards a more comprehensive medication review model. Future improvement work to the MRS can be conducted based on the findings.

A clinical-pharmaceutical medication reconciliation with patient interview for a medication review to identify drug-related problems in elective patients during hospital admission.

Background and aim: Drug-related problems (DRPs), e.g.drug-drug interactions (DDI), can lead to adversedrug reactions (ADRs) and thus complications during hospitalization. For this reason, such DRP, DDI and ADR should be identified and characterized as early as possible during hospital admission. We aimed to perform a clinical-pharmaceutical medication reconciliation in which patient-related information was collected and compared to drug-related information in a medication review. Investigations: During a 24-week-period, we consecutively invited patients electively admitted to Urology, Otolaryngology, Oral and Maxillofacial Surgery, General and Visceral Surgery, and Oncology Departments of a 300-bed hospital. A clinical pharmacist performed a patient interview asking for medication, ADR, and adherence. The medication reconciliation considered packages for a brown-bag analysis, medication lists, and data from the clinical information-system (CIS). In a medication review, we matched patient-related information to drug-related information from the drug label, guidelines, drug-databases and websites to identify DRPs. Results: In the study, 356 patients (median age: 58 years) taking 1,712 drugs participated. Of all patients, 7.3% reported ADR and 10.7% missing adherence. 5.3% brought packages that enabled a brown-bag analysis and 21.1% a medication list. In 76.7% of patients, information from CIS was incomplete or not up-to-date. Among the most frequently identified DRPs were "Medication without diagnosis" (31.2%) and "Inappropriate timing of administration" (11.5%). The proportion of patients affected by severe DDI ranged from 0.8%-16.6%, depending on the drug information source. Conclusions: Incomplete patient data, frequently identified DRPs and inconsistent drug-based information make pharmaceutical involvement in medication reconciliation on admission a necessity.

Financial impact of medication reviews by clinical pharmacists to reduce in-hospital adverse drug events: a return-on-investment analysis.

BACKGROUND: Adverse drug events contribute to rising health care costs. Clinical pharmacists can reduce their risks by identifying and solving drug-related problems (DRPs) through medication review. AIM: To develop an economic model to determine whether medication reviews performed by clinical pharmacists could lead to a reduction in health care costs associated with the prevention of potential adverse drug events. METHOD: Two pharmacists performed medication reviews during ward rounds in an internal medicine setting over one year. Avoided costs were estimated by monetizing five categories of DRPs (improper drug selection, drug interactions, untreated indications, inadequate dosages, and drug use without an indication). An expert panel assessed potential adverse drug events and their probabilities of occurrence for 20 randomly selected DRPs in each category. The costs of adverse drug events were extracted from internal hospital financial data. A partial economic study from a hospital perspective then estimated the annual costs avoided by resolving DRPs identified by 3 part-time clinical pharmacists (0.9 full-time equivalent) from 2019 to 2020. The return on investment (ROI) of medication review was calculated. RESULTS: The estimated annual avoided costs associated with the potential adverse drug events induced by 676 DRPs detected was € 304,170. The cost of a 0.9 full-time equivalent clinical pharmacist was € 112,408. Extrapolated to 1 full-time equivalent, the annual net savings was € 213,069 or an ROI of 1-1.71. Sensitivity analyses showed that the economic model was robust. CONCLUSION: This economic model revealed the positive financial impact and favorable return on investment of a medication review intervention performed by clinical pharmacists. These findings should encourage the future deployment of a pharmacist-led adverse drug events prevention program.