A Qualitative Tool to Guide in the Interpretation of the Numerical Rating Scale for Pruritus Intensity in Patients with Atopic Dermatitis.

Atopic dermatitis is a cutaneous inflammatory disease characterized by intense pruritus, which is often underestimated despite its direct impact on patients' health-related quality of life and the high burden it poses. The authors' goal was to design a qualitative tool to guide patients and healthcare professionals in their assessment and interpretation of pruritus intensity using a numerical rating scale. The draft of this tool, henceforth "guideline", was developed based on a systematic literature review and focus groups comprising patients and a scientific committee. This draft was validated with an independent group of patients and the final version was designed following their feedback. According to the results of the systematic review, pruritus impacts 6 health-related quality of life domains: sleep quality; emotional status; overall health-related quality of life; physical function; social/sexual activity; productivity, particularly affecting sleep quality and the emotional domain. Patients considered that physical function was the most strongly affected domain, followed by sleep quality and emotional well-being, establishing that a minimum pruritus intensity of 4 and 7 points impacts moderately and severely, respectively, on the different domains of patients' health- related quality of life. The guideline may help patients and healthcare professionals to interpret and assess pruritus intensity using a numerical rating scale and to understand the impact of pruritus on patients' health-related quality of life.

Elevating the Standard of Care for Patients with Psoriatic Arthritis: 'Calls to Action' from a Multistakeholder Pan-European Initiative.

INTRODUCTION: Psoriatic arthritis (PsA) is a complex, progressive, and often debilitating disease. Despite recent advances in treatment, numerous unmet needs in patient care persist. Rheumacensus is a multistakeholder, pan-European initiative designed to identify ways to elevate the standard of care (SoC) and treatment ambition for patients with PsA, using the perspectives of three key stakeholder groups: patients, healthcare professionals (HCPs) and payors. METHODS: Rheumacensus followed three phases: an insights-gathering workshop to identify current unmet needs in PsA and an area of focus for the project, a modified Delphi process to gain consensus on improvements within the agreed area of focus, and a Consensus Council (CC) meeting which used consensus statements as inspiration to generate 'Calls to Action' (CTA)-practical measures which, if implemented, could elevate the SoC for patients with PsA. RESULTS: The Rheumacensus CC consisted of four patient representatives, four HCPs and four payors. All 12 members completed all three Delphi e-consultations. The shared area of focus that informed the Delphi process was "patient empowerment through education on the disease and treatment options available, to enable patient involvement in management". Four key themes emerged from the Delphi process: patient empowerment, patient knowledge and sources of education, patient-HCP consultations, and optimal initial treatment. Statements within these themes informed 12 overarching CTA, which focus on the need for a multistakeholder approach to implementing a paradigm shift towards patient-centred care and improved outcomes for patients with PsA. CONCLUSION: Rheumacensus has identified shortcomings in the current SoC for patients with PsA and provides a foundation for change through practical CTA. It is hoped that all stakeholders will now take practical steps towards implementing these CTA across Europe to elevate the SoC for patients with PsA.

Inequalities in the care patients with psoriatic arthritis (PsA) receive can be mainly explained by poorly coordinated management due to a lack of disease and treatment knowledge. This report is about a programme called Rheumacensus which has the overall aim of improving the standard of care (SoC) for patients with PsA. Rheumacensus brings together the points of view of three key groups involved in the care of people with PsA: patients, payors and healthcare professionals (HCPs) from across Europe. Together, these three groups agreed to focus on patient empowerment through education on the disease and treatment options as a way to raise the SoC. Through a series of exercises­to agree on the current SoC and what needs to be improved­and group discussions, four themes were established which were used by the groups to help them suggest 'Calls to action' (CTA). The CTAs were ideas of how improvements could be made or what needs to be done to improve the care patients receive. The four themes were (1) patient empowerment, (2) patient knowledge, (3) patient­HCP consultation and (4) optimal initial treatment. In total, 12 CTAs were developed across these themes that provide direction and practical next steps which patients, payors and HCPs could take to drive change and make a real difference to patients by improving their care.

Telematic interview in telepharmacy: consensus document for farmacotherapeutic monitoring and informed drug delivery.

Telepharmacy is defined as the practice of remote pharmaceutical care, using information and communication technologies. Given its growing importance in outpatient pharmaceutical care, the Spanish Society of Hospital Pharmacy developed a consensus document, "Guía de entrevista telemática en atención farmacéutica," as part of its strategy for the development and expansion of telepharmacy, with key recommendations for effective pharmacotherapeutic monitoring and informed dispensing and delivery of medications through telematic interviews. The document was developed by a working group of hospital pharmacists with experience in the field. It highlights the benefits of telematic interviewing for patients, hospital pharmacy professionals, and the healthcare system as a whole, reviews the various tools for conducting telematic interviews, and provides recommendations for each phase of the interview. These recommendations cover aspects such as tool/platform selection, patient selection, obtaining authorization and consent, assessing technological skills, defining objectives and structure, scheduling appointments, reviewing medical records, and ensuring humane treatment. Telematic interview is a valuable complement to face-to-face consultations but its novelty requires a strategic and formal framework that this consensus document aims to cover. The use of appropriate communication tools and compliance with recommended procedures ensure patient safety and satisfaction. By implementing telematic interviews, healthcare institutions can improve patient care, optimize the use of resources and promote continuity of care.

Inhaled aztreonam lysine in the management of Pseudomonas aeruginosa in patients with cystic fibrosis: real-life effectiveness.

BACKGROUND: Inhaled antibiotics have achieved or stabilised the clinical condition of patients with cystic fibrosis (CF) and chronic Pseudomonas aeruginosa infection. We aimed to determine the effectiveness of aztreonam lysine inhaled solution (AZLI) in patients with CF and chronic P. aeruginosa infection. METHODS: A retrospective observational study was conducted on patients with CF and chronic P. aeruginosa infection who received AZLI between July 2012 and September 2018 inclusive in three Spanish hospitals in a routine clinical practice setting. The primary endpoint was the absolute change in the percentage of predicted forced expiratory volume in 1 second (FEV1) compared with the previous 12 months, at the start of AZLI treatment and 12 months after starting the drug. Other variables analysed were exacerbations, hospitalisations, type and route of antibiotics prescribed, weight and body mass index (BMI) and adverse drug reactions. RESULTS: In a cohort of 52 patients, AZLI treatment led to stabilisation of FEV1, changing from a mean (SD) value of 55.60 (21.3)% at the start of treatment to 56.8 (20.4)% after 12 months of treatment (p=0.5296) in patients who had not previously received the drug. In addition, it significantly reduced exacerbations from a median (P25; P75) of 2.0 (1.0; 3.0) in the 12 months prior to AZLI to 1.0 (1.0; 2.0) in the 12 months after treatment initiation (p=0.0350). AZLI also reduced the need for other antibiotics and prevented a decrease in BMI, with an adequate safety profile. CONCLUSIONS: AZLI achieved stabilisation of lung function measured by FEV1 in patients with CF and chronic P. aeruginosa infection, along with an adequate safety profile.

Lista de comprobación para la atención farmacéutica del paciente con enfermedad pulmonar intersticial (CheckEPID): un consenso basado en el método Delphi / Checklist for Pharmaceutical Care of the Patient with interstitial lung disease (CheckEPID): A Delphi-based consensus

Objetivo desarrollar una lista de comprobación para facilitar la atención farmacéutica al paciente con enfermedad pulmonar intersticial que requieren o están en tratamiento con antifibróticos. Método 5 especialistas en farmacia hospitalaria desarrollaron un listado inicial de 37 ítems divididos en 4 bloques: 1) primera visita del paciente, que incluía datos generales del paciente y datos del primer tratamiento; 2) visitas de seguimiento, valorando aspectos del seguimiento del tratamiento con nintedanib o pirfenidona; 3) telefarmacia, consistente en la evaluación de la inclusión de pacientes en un programa de este tipo, evolución de la enfermedad e identificación del contacto con el servicio de farmacia y 4) tratamiento no farmacológico e información al paciente. Para decidir su potencial inclusión en el listado de comprobación se realizaron 2 rondas del Delphi en las que los panelistas tenían que valorar de cada ítem propuesto su grado de acuerdo con su «utilidad», que fue el criterio determinante para su inclusión y su «aplicabilidad». Resultados se contactó con 48 farmacéuticos hospitalarios, 30 (63%) aceptaron por escrito participar, 28 (58%) completaron la primera ronda del Delphi y 27 (56%) completaron la segunda ronda. Después de la primera ronda el cuestionario se modificó y quedó constituido por 40 ítems. De los 40 ítems evaluados tras las 2 rondas del Delphi, hubo 2 que, basados en la utilidad, los participantes del Delphi no alcanzaron el consenso para su inclusión en el listado: el referido a «Antecedentes de intervención quirúrgica, específicamente cirugía abdominal en las últimas 4 semanas» (finalmente mantenido en el listado por su implicación en la indicación de nintedanib) y el de realizar recomendaciones sobre «Relajación». En 2 de los ítems no se alcanzó consenso sobre su aplicabilidad: «Estratificación del paciente según el modelo del paciente crónico de la SEFH» y «Recogida de resultados comunicados por el paciente». Conclusiones... (AU)

Objective To develop a checklist to facilitate pharmaceutical care for patients with interstitial lung disease who require or are undergoing treatment with antifibrotic drugs. Method Five hospital pharmacists developed an initial list of 37 items divided into 4 blocks: 1) First visit, which included general patient data and data from the first treatment; 2) Follow-up visits, assessing aspects of the follow-up of the treatment with nintedanib or pirfenidone; 3) Telepharmacy, consisting of the evaluation of the inclusion of patients in a program of this type, course of the disease, and identification of the contact with the pharmacy service; 4) Non-pharmacological treatment and patient information. To decide its potential inclusion in the checklist, two rounds of the Delphi were carried out in which the panelists had to assess the degree of agreement of each proposed item according to its “utility”, which was the determining criterion for its inclusion, and its “applicability”. Results 48 hospital pharmacists were contacted, 30 (63%) agreed in writing to participate, 28 (58%) completed the first round of the Delphi, and 27 (56%) completed the second round. After the first round of the Delphi the questionnaire was amended and comprised 40 items. Of the 40 items evaluated after the two rounds of the Delphi, there were two that, based on utility, the participants did not reach consensus for inclusion in the checklist: The one referring to “History of surgical intervention, specifically abdominal surgery in the last 4 weeks” (finally kept on the checklist due to its involvement in the indication of nintedanib) and to make recommendations on “Relaxation”. No consensus was reached on their applicability for two of the items: “Patient stratification according to the Spanish Society of Hospital Pharmacy (SEFH) chronic patient model” and “Collection of Results Reported by the Patient”. Conclusions ... (AU)

Patient-reported outcome measures in severe asthma: an expert consensus.

OBJECTIVE: The study aimed to reach a consensus on the most relevant patient-reported outcomes (PROs), the corresponding measures (PROMs), and measurement frequency during severe asthma patient follow-up. METHODS: Two Delphi rounds were conducted. The questionnaire was developed based on a systematic literature review, a focus group with patients, and a nominal group with experts. It assessed PROs' relevance and the appropriateness (A) and feasibility (F) of PROMs using a Likert scale (1=totally agree; 9=totally disagree). The consensus was established when ≥75% of participants agreed (1-3) or disagreed (7-9). RESULTS: Sixty-three professionals (25 hospital pharmacists, 14 allergists, 13 pulmonologists, and 11 nurses) and 5 patients answered the Delphi questionnaire. A consensus was reached on all PROs regarding their relevance. Experts agreed on the use of ACT (A:95.24%; F:95.24%), mini AQLQ (A:93.65; F:79.37%), mMRC dyspnea scale (A:85.71%; F:85.71%), TAI (A:92.06%; F:85.71%), MMAS (A:75.40%; F:82%), and the dispensing register (A:96.83%; F:92.06%). Also considered suitable were: SNOT-22 (A:90.48%; F:73.80%), PSQI (A:82.54; F:63.90%), HADS (A:82.54; F:64%), WPAI (A:77.78%; F:49.20%), TSQM-9 (A:79.37; F:70.50%) and knowledge of asthma questionnaire (A:77%; F:68.80%); however, their use in clinical practice was considered unfeasible. Panelists also agreed on the appropriateness of EQ-5D, which was finally included despite being considered unfeasible (A: 84.13%; F:67.20%) in clinical practice. Agreement was reached on using ACT, TAI, mMRC, and a dispensing register every three months; mini-AQLQ and MMAS every six months; and EQ-5D every twelve months. CONCLUSION: This consensus paves the way toward patient-centered care, promoting the development of strategies supporting routine assessment of PROs in severe asthma management.

[Translated article] Checklist for the pharmaceutical care of patients with interstitial lung disease (CheckEPID): A Delphi-based consensus.

OBJECTIVE: To develop a checklist to facilitate pharmaceutical care for patients with interstitial lung disease who require or are undergoing treatment with antifibrotic drugs. METHOD: Five hospital pharmacists developed an initial list of 37 items divided into 4 blocks: (1) First visit, which included general patient data and data from the first treatment; (2) follow-up visits, assessing aspects of the follow-up of the treatment with nintedanib or pirfenidone; (3) telepharmacy, consisting of the evaluation of the inclusion of patients in a program of this type, course of the disease, and identification of the contact with the pharmacy service; (4) non-pharmacological treatment and patient information. To decide its potential inclusion in the checklist, 2 rounds of the Delphi were carried out in which the panelists had to assess the degree of agreement of each proposed item according to its "utility", which was the determining criterion for its inclusion, and its "applicability". RESULTS: Forty-eight hospital pharmacists were contacted, 30 (63%) agreed in writing to participate, 28 (58%) completed the first round of the Delphi, and 27 (56%) completed the second round. After the first round of the Delphi, the questionnaire was amended and comprised 40 items. Of the 40 items evaluated after the 2 rounds of the Delphi, there were 2 that, based on utility, the participants did not reach consensus for inclusion in the checklist: the one referring to "History of surgical intervention, specifically abdominal surgery in the last 4 weeks" (finally kept on the checklist due to its involvement in the indication of nintedanib) and to make recommendations on "Relaxation". No consensus was reached on their applicability for 2 of the items: "Patient stratification according to the Spanish Society of Hospital Pharmacy (SEFH) chronic patient model" and "Collection of Results Reported by the Patient". CONCLUSIONS: The management of patients with ILD and/or pulmonary fibrosis is complex and requires a multidisciplinary approach where the hospital pharmacist plays a key role, especially, although not only, in monitoring drug treatment. We believe that this checklist can contribute from pharmaceutical care to improving the integrated care of patients with ILD who require or are undergoing treatment with antifibrotic drugs.

Consensus statement on the use of biosimilar drugs in immune-mediated diseases in Spain.

OBJECTIVE: To improve knowledge about biosimilar medicines and to generate a consensus framework on their use. METHODS: Qualitative study. A multidisciplinary group of experts in biosimilar medicines was established (1dermatologist, 1hospital pharmacist, 1rheumatologist, and 1gastroenterologist) who defined the sections and topics of the document. A narrative literature review was performed in Medline to identify articles on biosimilar medicines. Systematic reviews, controlled, pre-clinical, clinical, and real-life studies were selected. Based on the results of the review, several general principles and recommendations were generated. The level of agreement was tested in a Delphi that was extended to 66 health professionals who voted from 1 (totally disagree) to 10 (totally agree). Agreement was defined if at least 70% of the participants voted ≥7. RESULTS: The literature review included 555 articles. A total of 10 general principles and recommendations were voted upon. All reached the level of agreement established. The document includes data on the main characteristics of biosimilar medicines (definition, development, approval, indication extrapolation, interchangeability, financing, and traceability); published evidence (biosimilarity, efficacy, effectiveness, safety, immunogenicity, efficiency, switch); barriers and facilitators to its use; and data on information for patients. CONCLUSIONS: Authorized biosimilar medicines meet all the characteristics of quality, efficacy, and safety. They also significantly help improve patient access to biological therapies and contribute to health system sustainability.

Documento de consenso sobre los medicamentos biosimilares en enfermedades inmunomediadas en España / Consensus statement on the use of biosimilar drugs in immune-mediated diseases in Spain

Objetivo: Mejorar el nivel de conocimiento sobre los medicamentos biosimilares y generar un marco consensuado sobre su uso. Métodos: Estudio cualitativo. Se seleccionó un grupo multidisciplinar de expertos en medicamentos biosimilares (una dermatóloga, un farmacéutico de hospital, un reumatólogo y un gastroenterólogo) que definieron los apartados y los temas del documento. Se realizó una revisión narrativa de la literatura en Medline para identificar artículos sobre los medicamentos biosimilares. Se seleccionaron revisiones sistemáticas de la literatura, estudios controlados pre-clínicos, clínicos y en vida real. Con esta información se generaron varios principios generales y recomendaciones. El grado de acuerdo con los mismos se estableció mediante un Delphi que se extendió a 66 profesionales de la salud que votaron de 1 (totalmente en desacuerdo) a 10 (totalmente de acuerdo). Se definió acuerdo si al menos el 70% de los participantes votaron ≥7. Resultados: La revisión de la literatura incluyó 555 artículos. Se votaron un total de 10 principios generales y recomendaciones. Todos alcanzaron el nivel de acuerdo establecido en el Delphi. El documento incluye datos sobre las características principales de los medicamentos biosimilares (definición, desarrollo, aprobación, extrapolación de indicaciones, intercambiabilidad, financiación y trazabilidad); sobre la evidencia publicada (biosimilitud, eficacia, efectividad, seguridad, inmunogenicidad, eficiencia, switch); sobre barreras y facilitadores a su uso, y datos sobre la información para pacientes. Conclusiones: Los medicamentos biosimilares autorizados reúnen todas las características de calidad, eficacia y seguridad. Además, ayudan significativamente a mejorar el acceso de los pacientes a las terapias biológicas y contribuyen a la sostenibilidad de los sistemas sanitarios. (AU)

Objective: To improve knowledge about biosimilar medicines and to generate a consensus framework on their use. Methods: Qualitative study. A multidisciplinary group of experts in biosimilar medicines was established (1dermatologist, 1hospital pharmacist, 1rheumatologist, and 1gastroenterologist) who defined the sections and topics of the document. A narrative literature review was performed in Medline to identify articles on biosimilar medicines. Systematic reviews, controlled, pre-clinical, clinical, and real-life studies were selected. Based on the results of the review, several general principles and recommendations were generated. The level of agreement was tested in a Delphi that was extended to 66 health professionals who voted from 1 (totally disagree) to 10 (totally agree). Agreement was defined if at least 70% of the participants voted ≥7. Results: The literature review included 555 articles. A total of 10 general principles and recommendations were voted upon. All reached the level of agreement established. The document includes data on the main characteristics of biosimilar medicines (definition, development, approval, indication extrapolation, interchangeability, financing, and traceability); published evidence (biosimilarity, efficacy, effectiveness, safety, immunogenicity, efficiency, switch); barriers and facilitators to its use; and data on information for patients. Conclusions: Authorized biosimilar medicines meet all the characteristics of quality, efficacy, and safety. They also significantly help improve patient access to biological therapies and contribute to health system sustainability. (AU)

Checklist for Pharmaceutical Care of the Patient with interstitial lung disease (CheckEPID): A Delphi-based consensus. / Lista de comprobación para la atención farmacéutica del paciente con enfermedad pulmonar intersticial (CheckEPID): un consenso basado en el método Delphi.

OBJECTIVE: To develop a checklist to facilitate pharmaceutical care for patients with interstitial lung disease who require or are undergoing treatment with antifibrotic drugs. METHOD: Five hospital pharmacists developed an initial list of 37 items divided into 4 blocks: 1) First visit, which included general patient data and data from the first treatment; 2) Follow-up visits, assessing aspects of the follow-up of the treatment with nintedanib or pirfenidone; 3) Telepharmacy, consisting of the evaluation of the inclusion of patients in a program of this type, course of the disease, and identification of the contact with the pharmacy service; 4) Non-pharmacological treatment and patient information. To decide its potential inclusion in the checklist, two rounds of the Delphi were carried out in which the panelists had to assess the degree of agreement of each proposed item according to its "utility", which was the determining criterion for its inclusion, and its "applicability". RESULTS: 48 hospital pharmacists were contacted, 30 (63%) agreed in writing to participate, 28 (58%) completed the first round of the Delphi, and 27 (56%) completed the second round. After the first round of the Delphi the questionnaire was amended and comprised 40 items. Of the 40 items evaluated after the two rounds of the Delphi, there were two that, based on utility, the participants did not reach consensus for inclusion in the checklist: The one referring to "History of surgical intervention, specifically abdominal surgery in the last 4 weeks" (finally kept on the checklist due to its involvement in the indication of nintedanib) and to make recommendations on "Relaxation". No consensus was reached on their applicability for two of the items: "Patient stratification according to the Spanish Society of Hospital Pharmacy (SEFH) chronic patient model" and "Collection of Results Reported by the Patient". CONCLUSIONS: The management of patients with ILD and/or pulmonary fibrosis is complex and requires a multidisciplinary approach where the hospital pharmacist plays a key role, especially, although not only, in monitoring drug treatment. We believe that this checklist can contribute from pharmaceutical care to improving the integrated care of patients with ILD who require or are undergoing treatment with antifibrotic drugs.

Actualización 2022 de los indicadores para la calidad asistencial y la atención farmacéutica a las personas que viven con el virus de la inmunodeficiencia humana / 2022 update of the indicators for quality of care and pharmaceutical care for people living with human immunodeficiency virus

Objetivo: actualizar y definir los indicadores para la mejora de la calidad asistencial y la atención farmacéutica a las personas que viven con infección por VIH en España. Método: el presente proyecto, que actualiza la versión anterior del documento de 2013, se desarrolló en 4 fases de trabajo realizadas entre enero y junio de 2022.En la fase 1, de organización, se creó un grupo de trabajo conformado por 7 especialistas en farmacia hospitalaria con amplia experiencia en atención farmacéutica y procedentes de distintos servicios del territorio nacional. Adicionalmente otros 34 especialistas, participaron en la valoración de los indicadores a través de 2 rondas de evaluación online para generación del consenso.Para la fase 2, inicialmente, se llevó a cabo una revisión bibliográfica con el objetivo de establecer una base a partir de la cual poder definir una propuesta de criterios de calidad e indicadores. A continuación, se realizó una propuesta preliminar de criterios y se establecieron revisiones para su ajuste en varias reuniones de trabajo telemáticas.En la fase 3 se estableció el consenso basado en la metodología de consenso Delphi-Rand/UCLA.Adicionalmente todos los indicadores clasificados como adecuados y necesarios fueron agrupados según 2 niveles de recomendación de monitorización, de manera que pueda orientar a los servicios en la prioridad de su medición: claves y avanzados.Por último, en la fase 4 se elaboró el documento final del proyecto, junto con las fichas descriptivas correspondientes para cada indicador con la finalidad de facilitar su medición y evaluación por parte de los servicios de farmacia hospitalaria. Resultados: se obtuvo un listado consensuado de ítems conformado por 79 indicadores adecuados y necesarios que permiten establecer un seguimiento y monitorización de la calidad y actividad de la atención farmacéutica a las personas que viven con VIH. De los mismos, 60 fueron establecidos como clave y 19 avanzados. Conclusiones: (AU)

Objective: To update and define indicators for improving the quality of care and pharmaceutical care for people living with HIV infection in Spain. Method: The present project, which updates the previous version of the 2013 document, was developed in four work phases carried out between January and June 2022.In phase 1, the organization phase, a working group was created, made up of seven hospital pharmacy specialists with extensive experience in pharmaceutical care and from different SFHs in Spain. In addition, another 34 specialists participated in the evaluation of the indicators through two rounds of online evaluation to generate consensus.For phase 2, initially, a review of the identified reference literature was carried out with the aim of establishing a basis from which to define a proposal for quality criteria and indicators. Then, a preliminary proposal of criteria was made and revisions were established for their adjustment in several telematic work meetings.In phase 3, consensus was established based on the Delphi-Rand/UCLA consensus methodology.In addition, all the indicators classified as appropriate and necessary were grouped according to two levels of monitoring recommendation, so as to guide the hospital pharmacy services in the priority of their measurement: key and advanced.Finally, in phase 4, the final project document was prepared, along with the corresponding descriptive sheets for each indicator in order to facilitate the measurement and evaluation of the indicators by the hospital pharmacy services. Results: Following the consensus methodology used, a list of items made up of 79 appropriate and necessary indicators was drawn up to establish a follow-up and monitoring of the quality and activity of pharmaceutical care for people living with HIV. Of these, 60 were established as key and 19 advanced. Conclusions ... (AU)

[Translated article] 2022 update of the indicators for quality of care and pharmaceutical care for people living with human immunodeficiency virus.

OBJECTIVE: To update and define indicators for improving the quality of care and Pharmaceutical Care for people living with HIV infection in Spain. METHOD: The present project, which updates the previous version of the 2013 document, was developed in four work phases carried out between January and June 2022. In phase 1, the organization phase, a working group was created, made up of seven hospital pharmacy specialists with extensive experience in pharmaceutical care and from different SFHs in Spain. In addition, another 34 specialists participated in the evaluation of the indicators through two rounds of online evaluation to generate consensus. For phase 2, initially, a review of the identified reference literature was carried out with the aim of establishing a basis from which to define a proposal for quality criteria and indicators. Then, a preliminary proposal of criteria was made and revisions were established for their adjustment in several telematic work meetings. In phase 3, consensus was established based on the Delphi-Rand/UCLA consensus methodology. In addition, all the indicators classified as appropriate and necessary were grouped according to two levels of monitoring recommendation, so as to guide the hospital pharmacy services in the priority of their measurement: key and advanced. Finally, in phase 4, the final project document was prepared, along with the corresponding descriptive sheets for each indicator in order to facilitate the measurement and evaluation of the indicators by the hospital pharmacy services. RESULTS: Following the consensus methodology used, a list of items made up of 79 appropriate and necessary indicators was drawn up to establish a follow-up and monitoring of the quality and activity of Pharmaceutical Care for people living with HIV. Of these, 60 were established as key and 19 advanced. CONCLUSIONS: The indicators defined and updated, since the previous version of 2013, are intended to be a tool for professionals to guide decision-making and facilitate the measurement and assessment of the most relevant aspects of the quality and pharmaceutical care of people living with HIV.

2022 update of the indicators for quality of care and pharmaceutical care for people living with human immunodeficiency virus. / Actualización 2022 de los indicadores para la calidad asistencial y la atención farmacéutica a las personas que viven con el virus de la inmunodeficiencia humana.

OBJECTIVE: To update and define indicators for improving the quality of care and pharmaceutical care for people living with HIV infection in Spain. METHOD: The present project, which updates the previous version of the 2013 document, was developed in four work phases carried out between January and June 2022. In phase 1, the organization phase, a working group was created, made up of seven hospital pharmacy specialists with extensive experience in pharmaceutical care and from different SFHs in Spain. In addition, another 34 specialists participated in the evaluation of the indicators through two rounds of online evaluation to generate consensus. For phase 2, initially, a review of the identified reference literature was carried out with the aim of establishing a basis from which to define a proposal for quality criteria and indicators. Then, a preliminary proposal of criteria was made and revisions were established for their adjustment in several telematic work meetings. In phase 3, consensus was established based on the Delphi-Rand/UCLA consensus methodology. In addition, all the indicators classified as appropriate and necessary were grouped according to two levels of monitoring recommendation, so as to guide the hospital pharmacy services in the priority of their measurement: key and advanced. Finally, in phase 4, the final project document was prepared, along with the corresponding descriptive sheets for each indicator in order to facilitate the measurement and evaluation of the indicators by the hospital pharmacy services. RESULTS: Following the consensus methodology used, a list of items made up of 79 appropriate and necessary indicators was drawn up to establish a follow-up and monitoring of the quality and activity of pharmaceutical care for people living with HIV. Of these, 60 were established as key and 19 advanced. CONCLUSIONS: The indicators defined and updated, since the previous version of 2013, are intended to be a tool for professionals to guide decision-making and facilitate the measurement and assessment of the most relevant aspects of the quality and pharmaceutical care of people living with HIV.

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.

The Telepharmacy patient prioritisation model of the Spanish Society of Hospital Pharmacy.

The Spanish Society of Hospital Pharmacy Position Paper on Telepharmacy states that the inclusion of patients should take into account  ethical considerations and, therefore, be based on the concept of equity. Thus, it establishes that Telepharmacy should not be limited to specific  pathologies or medicines, but should be based on the individual needs of each patient: it also highlights the need to rely on selection or prioritisation models to help identify patients who can benefit from  Telepharmacy. The aim of this article is to present the Spanish Society of  Hospital Pharmacy Telepharmacy Patient Prioritisation Model, which establishes  key recommendations and a reference prioritisation model to guide  hospital pharmacists in the identification and prioritisation of patients  who are candidates for inclusion in Telepharmacy programmes. This model was  developed based on the experience of a group of experts in their clinical  practice as well as on a review of the main reference documents available in  this field. It comprises 25 criteria, grouped into 8 minimum inclusion criteria, 5 continuity criteria, and 12 recommended criteria. The latter criteria are divided  into high, medium, and low priority criteria. Patients are prioritised according  to their scores on meeting the recommended criteria, such that those with the  highest scores are given the highest priority. As stated in the Spanish Society  of Hospital Pharmacy Position Paper on Telepharmacy, pharmacotherapeutic  monitoring can be conducted via remote consultation without sending  medication, but not vice versa; thus, the 25 criteria defined apply to  Telepharmacy programmes in the area of the remote dispensing and informed  delivery of medicines, but only 19 of them apply to pharmacotherapeutic  monitoring programmes. The model presented is intended to be a reference  guide and should be adapted to the particular characteristics and  circumstances of each pharmacy service, depending on demand and available  resources.

La Sociedad Española de Farmacia Hospitalaria, en su Documento de  osicionamiento sobre Telefarmacia, establece que la inclusión de pacientes debe tener en cuenta consideraciones éticas y, por tanto, estar  basada en el concepto de equidad. Por ello, establece que la Telefarmacia no  debe restringirse por patologías ni medicamentos, sino en función de las  necesidades individuales de cada paciente, y destaca la necesidad de apoyarse en modelos de selección o priorización que ayuden en la  identificación de los pacientes que puedan beneficiarse de la Telefarmacia. El  objetivo de este artículo es presentar el "Modelo de priorización de pacientes  en Telefarmacia de la Sociedad Española de Farmacia Hospitalaria", que pretende establecer recomendaciones clave y un modelo de priorización de referencia que sirva de orientación a los farmacéuticos especialistas en farmacia hospitalaria para la identificación y priorización de pacientes candidatos a ser incluidos en programas de Telefarmacia. El modelo  a sido desarrollado en base a la experiencia de un grupo de expertos en su práctica clínica y a la revisión de los principales documentos de referencia disponibles en este ámbito y está conformado por un total de 25  criterios, agrupados en 8 criterios mínimos de inclusión, 5 criterios de  continuidad y 12 criterios recomendables. Estos últimos se dividen en criterios  de alta, media y baja prioridad. En función de las puntuaciones obtenidas del  cumplimiento de los criterios recomendables, se establece el orden de  prioridad de pacientes, de modo que aquellos que mayor puntuación obtengan  serán los más prioritarios. Tal como recoge el "Documento de Posicionamiento sobre Telefarmacia de la Sociedad Española de Farmacia Hospitalaria", puede  haber seguimiento farmacoterapéutico por teleconsulta sin envío de medicación, pero no al contrario, por lo que los 25 criterios definidos aplican a  programas de Telefarmacia en el ámbito de la dispensación y entrega informada de medicamentos a distancia, pero solamente 19 de ellos aplican para los programas de seguimiento farmacoterapéutico. El modelo que se  presenta ha sido concebido como un marco de referencia y deberá adaptarse a las características y circunstancias particulares de cada servicio de farmacia,  en función de la demanda y de los recursos disponibles.

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)

Modelo de priorización de pacientes en Telefarmacia de la Sociedad Española de Farmacia Hospitalaria / The Telepharmacy patient prioritisation model of the Spanish Society of Hospital Pharmacy

La Sociedad Española de Farmacia Hospitalaria, en su Documento de Posicionamiento sobre Telefarmacia, establece que la inclusión de pacientesdebe tener en cuenta consideraciones éticas y, por tanto, estar basada enel concepto de equidad. Por ello, establece que la Telefarmacia no deberestringirse por patologías ni medicamentos, sino en función de las necesidades individuales de cada paciente, y destaca la necesidad de apoyarseen modelos de selección o priorización que ayuden en la identificaciónde los pacientes que puedan beneficiarse de la Telefarmacia. El objetivode este artículo es presentar el “Modelo de priorización de pacientes enTelefarmacia de la Sociedad Española de Farmacia Hospitalaria”, quepretende establecer recomendaciones clave y un modelo de priorizaciónde referencia que sirva de orientación a los farmacéuticos especialistas enfarmacia hospitalaria para la identificación y priorización de pacientescandidatos a ser incluidos en programas de Telefarmacia. El modelo hasido desarrollado en base a la experiencia de un grupo de expertos en supráctica clínica y a la revisión de los principales documentos de referenciadisponibles en este ámbito y está conformado por un total de 25 criterios,agrupados en 8 criterios mínimos de inclusión, 5 criterios de continuidad y 12 criterios recomendables. Estos últimos se dividen en criterios de alta,media y baja prioridad. En función de las puntuaciones obtenidas del cumplimiento de los criterios recomendables, se establece el orden de prioridadde pacientes, de modo que aquellos que mayor puntuación obtengan seránlos más prioritarios. (AU)

The Spanish Society of Hospital Pharmacy Position Paper on Telepharmacy states that the inclusion of patients should take into account ethicalconsiderations and, therefore, be based on the concept of equity. Thus,it establishes that Telepharmacy should not be limited to specific pathologies or medicines, but should be based on the individual needs of eachpatient: it also highlights the need to rely on selection or prioritisationmodels to help identify patients who can benefit from Telepharmacy. Theaim of this article is to present the Spanish Society of Hospital PharmacyTelepharmacy Patient Prioritisation Model, which establishes key recommendations and a reference prioritisation model to guide hospital pharmacists in the identification and prioritisation of patients who are candidatesfor inclusion in Telepharmacy programmes. This model was developedbased on the experience of a group of experts in their clinical practiceas well as on a review of the main reference documents available in thisfield. It comprises 25 criteria, grouped into 8 minimum inclusion criteria,5 continuity criteria, and 12 recommended criteria. The latter criteria aredivided into high, medium, and low priority criteria. Patients are prioritisedaccording to their scores on meeting the recommended criteria, such that those with the highest scores are given the highest priority. (AU)

Observational study to evaluate discontinuation of monotherapy with cobicistat-boosted darunavir in patients with human immunodeficiency virus.

To evaluate the reasons for changing to monotherapy with protease inhibitors, together with the proportion and reasons for the interruption to treatment, in patients who have been treated at some point with cobicistat-boosted darunavir (DRV/c). Outpatients in a tertiary hospital. Observational retrospective study to evaluate monotherapy with DRV/c (800 mg/150 mg) in adult patients with human immunodeficiency virus infection, from December 2014 to July 2022. Demographic variables, viral load, cluster of differentiation 4 lymphocyte lymphocyte count, and antiretroviral therapy were assessed. 42 patients were included. 36% of the patients were undergoing monotherapy at the time of the analysis. The main reason for discontinuation was poor adherence. At time of analysis, 80% of the patients in monotherapy had an undetectable viral load. Antiretroviral therapy recommendations advise against exposing the patient to functional monotherapy with a single drug due to the high risk of virological failure and the onset of resistance to a single drug. Following the analysis of the results, DRV/c in monotherapy is not an effective strategy in the medium and long term due to factors such as lack of adherence or virological failure, although it can be maintained in specific circumstances. Therefore, patients undergoing monotherapy require close monitoring.

Knowledge, perceptions, attitude, barriers and facilitators of biosimilars use across specialty physicians and hospital pharmacists: A national survey.

OBJECTIVE: To analyze knowledge, perceptions, attitude, barriers and facilitators of biosimilars uptake across physicians managing immune diseases and hospital pharmacists. METHOD: Two structured and closed anonymous online surveys were designed and sent to 41 physicians (rheumatologists, dermatologists, gastroenterologists) and 32 hospital pharmacists.  Sociodemographic and clinical practice related variables were collected. We also gathered information about biosimilars knowledge and importance,  access, attitude in clinical practice and perceptions, barriers and facilitators to biosimilars uptake. A descriptive analysis was performed. RESULTS: Surveys response rate was 100% (hospital pharmacists) and 96% (physicians). We found certain lack of biosimilars knowledge  about key aspects including switching, extrapolation, interchangeability or  substitution. There was a great variability in the types and brands of  biosimilars depending on the hospital. We observed several organization  preferences, policies, and practices regarding biosimilars. General  perception and attitude to biosimilars was positive. If used, biosimilars  were predominantly prescribed in biologic treatment-naive patients (this  indication was considered adequate and participants felt comfortable with  it). Reluctance to switch in clinical practice was common. The main  barriers to biosimilars uptake were the lack of confidence and knowledge.  The main facilitators were the development of recommendations from  professional associations and societies and the demonstration of  interchangeability efficacy. We gathered concerns about biosimilar long  term efficacy and safety, lack of real-life data, lack of biosimilars  traceability or the risk of biologic reference medicines stock shortages. CONCLUSIONS: Biosimilar education and more evidence filling current gaps  might help increase prescriber knowledge, comfort and use of biosimilars.

Objetivo: Analizar el conocimiento, las percepciones, la actitud, las barreras y los facilitadores sobre el uso de los biosimilares entre los  médicos que manejan enfermedades inmunológicas y los farmacéuticos de hospital.Método: Se diseñaron dos encuestas online anónimas, estructuradas y  cerradas que se enviaron a 41 médicos (reumatólogos, dermatólogos y  gastroenterólogos) y 32 farmacéuticos de hospital. Se recogieron variables sociodemográficas y relacionadas con la práctica clínica. También  información sobre el nivel de conocimiento e importancia de los  biosimilares, el acceso a los mismos, la actitud en la práctica clínica, y las  percepciones, barreras y facilitadores con el uso de los mismos. Se realizó  un análisis descriptivo.Resultados: La tasa de respuesta fue del 100% (farmacéuticos de  hospital) y del 96% (médicos). Encontramos cierta falta de conocimiento  sobre los biosimilares en aspectos clave como el cambio de un biológico de referencia a un biosimilar, la extrapolación de indicaciones, la  intercambiabilidad o la sustitución. Hubo una gran variabilidad en los tipos  y marcas comerciales de biosimilares entre hospitales. Observamos  distintas preferencias, políticas y prácticas en los hospitales en relación  con el uso de biosimilares. La percepción y actitud general hacia los  biosimilares fue positiva. Los biosimilares se prescribían  predominantemente en pacientes sin tratamiento bioló gico previo (esta  indicación se consideraba adecuada y los participantes se sentían cómodos con ella). La reticencia al cambio en la práctica clínica fue común. Los  principales obstáculos para el uso de biosimilares fueron la falta de  confianza y de conocimientos. Los principales facilitadores el desarrollo de recomendaciones de asociaciones y sociedades científicas y la  demostración de la eficacia de la intercambiabilidad. Se recogieron  preocupaciones sobre la eficacia y seguridad a largo plazo de los  biosimilares, la falta de datos en vida real, la falta de trazabilidad de los  biosimilares o el riesgo de escasez de existencias de medicamentos  biológicos de referencia.Conclusiones: Actividades formativas en biosimilares y una mayor  evidencia podrían ayudar a aumentar el conocimiento, comodidad y el uso de los biosimilares por parte de los prescriptores.