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The most common symptom in heart failure (HF) is congestion, which can be refractory to diuretic treatment. To verify whether, in patients with advanced HF and diuretic resistance, subcutaneous furosemide or furosemide in an oral solution can improve the clinical-analytical status. From 2018 to 2020, 27 consecutive outpatients with diuretic resistance, not candidates for other alternatives, were recruited. Patients were treated either with subcutaneous furosemide in elastomeric pump (n: 10) or with oral solution (n: 17) for 5 days. The functional status (NYHA) improved with subcutaneous administration (predose: 3.8 ± 0.5 vs. postdose: 3.1 ± 0.7; p: 0.02) and oral solution (predose: 3.7 ± 0.3 vs. postdose: 2.5 ± 0.7; p: 0.0001). Weight loss was greater with the oral solution (predose: 85.5 ± 19.5 vs. postdose: 81.3 ± 18.8Kg; p: 0.0001) than subcutaneous (predose: 81.6 ± 15.9 vs. postdose: 80.4 ± 15.1kg; p: 0.16). Creatinine showed a non-significant increase in both groups. The number of hospital visits showed no difference between both options. The administration of furosemide, both subcutaneously by elastomeric pump or drinking the oral solution, is effective for the treatment of congestion in advanced HF refractory to diuretic treatment.

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.

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.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.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.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.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.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.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.

Background People living with human immunodeficiency virus (HIV) require specific pharmaceutical care (PC). Although the 2017 Capacity-Motivation-Opportunity (CMO) PC model allows a multidisciplinary approach that focuses on patient needs, it is too complex and presents room for improvement. Objective The aim of this study is to simplify and adapt the previous 2017 PC tool through a multidimensional approach to improve HIV patient care, to prove the validity of the model in real-life patients. Methods The new PC tool was generated by keeping some of the variables of the 2017 document and conducting a literature search. Content validity was determined by a 2-round Delphi methodology with an expert panel of 42 pharmacists. Consensus for the first and second rounds was defined as ≥70% agreement. The tool generated was validated in 407 real-life patients. Results Thirty-seven experts completed the first round of the Delphi survey and 36 the second. No consensus was reached for 3 variables, any of the frequency options and 4 interventions, while the experts agreed not to include 1 intervention in round 1. Consensus to include them was found for all but 1 variable and 1 intervention in round 2. The final tool obtained to select and stratify HIV-positive patients was composed of 9 dimensions divided into 17 variables. The new tool was validated with real-life patients and 3 priority levels were defined. Conclusions and relevance We created a new pyramid of score thresholds to classify patients into priority levels. The new tool simplifies the 2017 model and improves its utility to help HIV-positive patients, owing to its multidimensional approach.

Resumen: La evolución de Internet y de la tecnología digital en la sociedad y en los sectores productivos ha planteado en los sistemas sanitarios la necesidad de una transformación digital que aporte mejoras en calidad y eficiencia. A pesar de los avances tecnológicos y de la creciente demanda social para incorporarlos en la práctica clínica diaria, el grado de implementación de la innovación digital en el sector sanitario es todavía escaso y lento, en parte debido a la brecha digital. Por ello, resulta imprescindible que todos los agentes de salud incorporen ciertos conocimientos y habilidades específicas relacionadas con el entorno digital y la transformación que conlleva. Se presentan una serie de nuevas competencias que pueden facilitar esta transición a los profesionales de la salud y ayudarles a mejorar su desempeño profesional con la ayuda de Internet y las tecnologías asociadas. Como profesionales de la información y del conocimiento, los sanitarios no debemos vivir ajenos a esta transformación, ya que la salud digital supone una oportunidad para la mejora continua en áreas tan transversales e importantes como la gestión de la información, la comunicación, la investigación, la innovación, la docencia y la publicación científica. Abstract: The evolution of the Internet and digital technology in society and in all productive sectors has led to health systems establishing the need for changing to digital/computerised systems that can provide improvements in quality and efficiency. Despite technological advances and growth of social demand to incorporate them into daily clinical practice, the level of implementation of digital innovation in the healthcare sector is still limited and slow, partly due to the digital divide. This is why it is essential that accurate knowledge and skills related to the digital environment are acquired by all health workers, as well as patients. This article presents a series of digital skills for different health workers in order to facilitate this transition and improve their professional performance with the help of the Internet and associated technologies. We must not remain outside this transformation, since digital healthcare is a great opportunity for continuous improvement in such wide and important areas as information management, communication, research, innovation, teaching and scientific publication.

To analyze knowledge, perceptions, attitude, barriers and facilitators of biosimilars uptake across physicians managing immune diseases and hospital pharmacists.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.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.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.

The introduction of direct-acting antivirals (DAA) and the implementation of the National Strategic Plan has extended the spectrum of patients suitable for treatment to include practically all affected individuals. There has been a change in patient profile. Most patients are previously untreated, with lesser awareness of the disease, and taking polymedication, and are often under treatment with opioid replacement therapy, are active drug users or have psychiatric comorbidities. This article reviews the most important factors determining the degree of treatment adherence, in particular, drug therapy complexity, the adverse effects of DAA, demographic factors (age, ethnic group, sex, educational level, marital status) and psychosocial factors (beliefs, motivation to take therapy and negative attitude to therapy), as well as the doctor-patient relationship, knowledge/awareness of the disease, and finally comorbidities and drug abuse or abuse of other substances such as alcohol. Supplement information: This article is part of a supplement entitled "The value of simplicity in hepatitis C treatment", which is sponsored by Gilead. © 2019 Elsevier Espana, S.L.U. All rights reserved.

Background Respiratory syncytial virus (RSV) can cause severe respiratory infection and is a risk factor for development of bronchiolitis obliterans syndrome (BOS) in patients who have undergone lung transplantation (LT). The treatment options are limited in this population. We assessed the efficacy of oral administration for the treatment of RSV infection after LT. Methods A retrospective case-control was conducted in LT patients who documented RSV infection. Demographic, clinical, and efficacy variables (resolution infection, recovery of lung function, incidence of BOS, mortality) was compared between the oral ribavirin (RBV) group and the control group. Results Thirty-six LT patients were included (19 RBV group, 17 control group). Significant differences were found for age, sex and coinfections. However, no differences of immunosuppressive level and baseline forced expiratory volume in the first second of expiration (FEV1) were found. RSV clearance was evident in 5 patients (26.3%) of the RBV group vs 2 patients (11.8%) in the control group (odds ratio [OR], 0.37; P = .282). At 3 months, FEV1 remained stable in 12 patients (80%) of the RBV group vs 13 patients (81.3%) of the control group (OR, 0.92; P = .321). At 6 months, FEV1 remained stable in 11 patients (73.3%) of the RBV group and 12 patients (75%) of the control group (OR, 1.25; P = .779), and BOS appeared in 6 patients (31.6%) vs 4 patients (23.5%) of the control group (OR, 1.50; P = .591). Mortality rates were 26% (5 patients) in the RBV group vs 29.4% (5 patients) in the control group (OR, 1.40; P = .637). Conclusions No significant differences in efficacy parameters were found between groups; however, stabilization without worsening of respiratory function was observed at 3 and 6 months. Because of the variability in the treatment regimen and the heterogeneity of groups, a protocol was developed to standardize and evaluate the use of oral RBV as treatment for RSV in LT.

Background and importance The protease inhibitor (PI)/enhancer combination, more than 20 years after its appearance, continues to be the antiretroviral therapy (ART) of choice in certain circumstances due to its high genetic barrier. Ritonavir (RTV) acts as an enhancer and has a higher potential for drug interactions. Aim and objectives To analyse the profile of pharmacological interactions with RTV as an enhancer of PIs and their severity. Material and methods A retrospective observational study was conducted where patients undergoing treatment for HIV-1 infection with PI boosted with RTV before 2018 were reviewed. Patients who had been treated with RTV as an enhancer for at least 6 months were selected. Those that presented some interaction with PI/enhancer were reviewed. Data were collected on age, sex, drug interactions and their severity, and medical action/decision. The data were obtained from the drug dispensing register of the outpatient pharmaceutical care unit and the electronic clinical record. Interactions and their severity were reviewed using www.hiv-druginteractions.org/checker. Results 210 patients were reviewed, of whom 5 patients (2.38%) had interactions that motivated treatment modification, reflected in the clinical history, with a mean age of 52 years (SD 5). RTV–triazolam: avoid co–administration. RTV can increase triazolam concentrations resulting in prolonged sedation or respiratory depression. Decision: ART modification. RTV–sildenafil: potential interaction. Co–administration of darunavir/RTV (400/100 mg twice daily) and a single dose of sildenafil resulted in fourfold greater exposure. Decision: use sildenafil single dose at a maximum 25 mg every 48 hours. RTV–quetiapine: avoid co–administration. Concomitant administration of RTV and quetiapine is contraindicated because it can increase the toxicity related to quetiapine due to its metabolism mainly by CYP3A4, which RTV inhibits. Decision: reduce quetiapine dose to one–sixth if administered jointly. RTV–atorvastatin: very low evidence interaction. Co–administration may increase atorvastatin concentrations and increase the risk of myopathy. Decision: exchange for pravastatin. RTV–anti–VHC (ombitasvir+paritaprevir/RTV): avoid co–administration. Co–administration with additional ritonavir is not recommended. Optional decision: modification of ART until the end of anti–HCV treatment. Conclusion and relevance Interactions related to ART based on PI/enhancer can be easily managed to avoid causing harm to the patient. It is necessary to review the complete treatment in ART patients whenever they start a new drug. References and/or acknowledgements Conflict of interest No conflict of interest

Introduction Individual pharmacokinetic (PK) profiling in hemophilia A (HA) helps to individualize prophylaxis using population PK models (popPK). A specific popPK model for plasma-derived factor VIII containing von-Willebrand Factor (pdFVIII/VWF) was developed. Aim To compare standard versus PK-driven prophylaxis, using a generic or a specific popPK model for pdFVIII/VWF. Materials and methods A prospective study conducted in HA patients in prophylaxis with pdFVIII/VWF (Fanhdi®) comparing three one-year study periods: (1) standard prophylaxis, (2) PK-guided prophylaxis using a generic pdFVIII popPK model which described FVIII activity irrespective of FVIII concentrate, and (3) PK-guided prophylaxis with specific pdFVIII/VWF popPK model. PK parameters analyzed were half-life, trough levels (TL) at 24, 48 and 72 h, and time to reach FVIII levels of 1, 2, 5% (T5%). Clinical outcomes were dose/kg, FVIII consumption, annualized bleeding rate (ABR), annualized joint bleeding rate (AJBR), spontaneous and traumatic bleeds. Results Of the 30 analyzed patients, 28 had severe HA and the median age was 31.2. Fifteen patient's prophylaxis doses were PK-adjusted. After the generic PK-guided prophylaxis period, younger patients showed more joint bleeds, a shorter half-life, and lower TL48, TL72 and T5%. Using the specific pdFVIII/VWF popPK model compared with standard prophylaxis, a lower spontaneous AJBR was observed in the entire cohort and in patients aged >15 years. Additionally, lower spontaneous ABR was reported in patients aged ≤15 years comparing specific and generic models. Conclusions PK-guided prophylaxis with a specific pdFVIII/VWF popPK model allowed treatment individualization and improved bleeding control in routine clinical practice, especially in younger patients with short pdFVIII/VWF half-lives.

The introduction of direct-acting antivirals (DAA) and the implementation of the National Strategic Plan has extended the spectrum of patients suitable for treatment to include practically all affected individuals. There has been a change in patient profile. Most patients are previously untreated, with lesser awareness of the disease, and taking polymedication, and are often under treatment with opioid replacement therapy, are active drug users or have psychiatric comorbidities. This article reviews the most important factors determining the degree of treatment adherence, in particular, drug therapy complexity, the adverse effects of DAA, demographic factors (age, ethnic group, sex, educational level, marital status) and psychosocial factors (beliefs, motivation to take therapy and negative attitude to therapy), as well as the doctor-patient relationship, knowledge/awareness of the disease, and finally comorbidities and drug abuse or abuse of other substances such as alcohol. Supplement information: This article is part of a supplement entitled "The value of simplicity in hepatitis C treatment", which is sponsored by Gilead. © 2019 Elsevier España, S.L.U. All rights reserved.

Hospital Pharmacy Service (HPS) in Spain have been impacted by the health crisis caused by the COVID-19 pandemic. Thus, the outbreak has forced HPSs to adapt their outpatient consultation services to Telepharmacy to optimize clinical outcomes and reduce the risk of contagion. The purpose of this article is to describe and analyze the experience of HPSs with outpatient Telepharmacy during the COVID-19 pandemic and expose the lessons learned. Measures have been adopted in on-site outpatient pharmacy clinics to prevent exposure of patients and professionals to the virus. These measures are based on national and international recommendations on social distancing and hygiene. With regard to remote outpatient pharmacy services, teleconsultation with drug dispensing has been promoted based on five basic procedures, each with its advantages and limitations: home drug delivery from HPSs, with the advantage of universal access and the limitation of entailing a substantial investment in resources; HPS coordination with primary care pharmacists, which requires no investments but with limited access to some geographic areas; HPS coordination with community pharmacists based on a large network of pharmacies, which requires the patient to go to the pharmacy, without confidentiality being guaranteed for any patient; geolocation and hospital-based medication dispensing, which provides universal access and direct traceability, but entails investment in human resources; and HPS coordination with associations of patients, which does not entail any additional cost but limits the information available on the diseases of society members. Three main lessons have been learned during the pandemic: the satisfactory capacity of HPS to provide outpatient pharmacy consultation services in the setting of a public health crisis; the usefulness of Telepharmacy for the clinical follow-up, healthcare coordination, outpatient counseling, and informed dispensing and delivery of medication (with a high level of satisfaction among patients); and the need to foster Telepharmacy as a complementary tool through a mixed model of outpatient pharmacy consultation service that incorporates the advantages of each procedure and adapts to the individual needs of each patient in a context of humanized healthcare.Los servicios de farmacia hospitalaria (SFH) en España se han visto afectados por la crisis sanitaria provocada por SARS-CoV-2 y han tenido que adoptar sus procedimientos de atención farmacéutica (AF) al paciente externo (PE) mediante estrategias de Telefarmacia, con los objetivos de maximizar los resultados en salud y reducir el riesgo de contagio. El objetivo de ese artículo es describir y analizar los procedimientos AFPE durante la pandemia SARS-CoV-2 y comunicar las lecciones aprendidas en los SFH. En relación con las consultas externas de AF presenciales, se han adoptado medidas para minimizar el contagio viral de pacientes y profesionales, siguiendo las recomendaciones nacionales e internacionales de referencia de distanciamiento temporal, espacial y recomendaciones higiénicas. En cuanto a las consultas externas de AF no presenciales, se han potenciado las teleconsultas con dispensación del tratamiento en base a cinco procedimientos básicos, cada uno de ellos con sus ventajas y limitaciones: dispensación domiciliaria desde SFH que presenta las ventajas de la universalidad de acceso, pero requiere una elevada inversión en recursos; coordinación del SHF con farmacéuticos de atención primaria, que conlleva una nula inversión en recursos, pero limita el acceso a determinadas zonas geográficas; coordinación del SFH con farmacéuticos comunitarios, que utiliza una amplia red de oficinas de farmacia, pero exige el desplazamiento del paciente sin garantías de confidencialidad para todos los casos; geolocalización y dispensación hospitalaria, que permite un acceso universal y trazabilidad directa, pero requiere un incremento en recursos humanos; y coordinación del SFH con asociaciones de pacientes, que no requiere inversión económica, pero limita el acceso a las patologías de los asociados. Destacamos finalmente tres lecciones aprendidas: la capacidad de AFPE de SFH españoles ante una crisis sanitaria; la utilidad de la Telefarmacia para el seguimiento clínico, la coordinación asistencial, información al PE, dispensación y entrega informada (con elevada satisfacción de los pacientes); y la necesidad de potenciar la Telefarmacia como herramienta complementaria, en un modelo mixto de AFPE que incorpore las ventajas de cada uno de los procedimientos adaptándose a las necesidades individuales de los pacientes en un entorno de humanización de la asistencia sanitaria.

What is known and objectives Most of the clotting factor (CF) dispensations to haemophiliac patients are centralized in a few haemophilia treatment centres, necessitating frequent visits and long travel distances. The aim was to evaluate the home delivery programme developed by the Outpatient Pharmaceutical Care Unit (OPCU) through the association of patients (ASHECOVA). MethodsResults and discussionA specific software programme was designed to communicate the individual CF requirements. Dispensations were prepared in advance, and an ASHECOVA member collected and delivered to patients' homes in optimal conditions. Data regarding the programme were analysed from December 2011 to December 2017. An electronic satisfaction survey with 34 questions was conducted, asking about organizational aspects, education and communication, use of apps and satisfaction level. Forty-nine patients were included and 2464 home deliveries were made, without any reported incident related to dispensation errors, drug preservation, communication or confidentiality problems. This system avoids 11.4 annual dispensation visits per patient to OCPU, and a mean travel distance, time and cost of 1189.1km, 945.3minutes and 373.5euros, respectively. Overall satisfaction with home delivery was 9.7, without any change suggested in the current system. Ninety-five per cent of individuals believed that the programme improves adherence and all patients would recommend it to other patients. The most common benefits reported were less frequent visits to hospital, reducing time and cost spent on transportation. What is new and conclusionThe home delivery programme guarantees a proper follow-up of treatments with full patient satisfaction. This programme allows OPCU to achieve better pharmaceutical care, traceability of the process and optimization of working times and CF stock management.

Background: Little is known about the association between the pharmacokinetic features of adalimumab (ADL) and disease outcome in patients with inflammatory bowel disease (IBD). Aims: To assess the association between random serum ADL levels and clinical or biochemical remission with clinical decision making in daily practice according to these levels; and to determine the cutoff value for successful dose reduction in patients with IBD treated with ADL. Methods: We conducted a prospective observational study of patients with IBD who received long-term maintenance therapy with ADL. Results: Data were available for 157 serum samples from 87 patients. Serum ADL levels were associated with clinical remission: median 9.2 versus 6.0 mu g/mL for patients with Crohn's disease with active disease (P = 0.009) and 14.4 versus 5.2 mg/mL in patients with ulcerative colitis with active disease (P = 0.002). Serum ADL levels were 9.2 mg/mL for patients with a normal C-reactive protein value (

Background Adherence to disease-modifying drugs (DMDs) is one of the key factors for achieving optimal clinical outcomes. Rebismart® is an injection device for subcutaneous administration of interferon beta-1a (INF β-1a) that is also able to monitor adherence objectively. The aim of this study was to describe adherence to INF β-1a using the said electronic autoinjection device and to explore the relationship between adherence and relapses in a Spanish cohort. Methods This is a retrospective observational study in which 110 Spanish patients self-administered INF β-1a subcutaneously using an electronic autoinjection device between June 2010 and June 2015. The primary end point was the percentage of adherence measured by Rebismart® to subcutaneous INF β-1a injections calculated as number of injections received in time period versus number of injections scheduled in time period. Other variables recorded were demographic and clinical data. Statistical analysis was performed using SPSS 19.0 software. Results Median adherence for the total study period was 96.5% (interquartile range [IQR]: 91.1-99.1). Similar values were observed during the first 6 months: 98.7% (IQR: 91.3-100), and the last 6 months: 97.6% (IQR: 91.1-99.8). Median duration of treatment was 979 days (IQR: 613.8-1,266.8). During the entire treatment period, 77.3% of patients were relapse free and mean annualized relapse rate was 0.14 (standard deviation: 0.33). Increased adherence was associated with better clinical outcomes, leading to lower relapse risk (odds ratio: 0.953; 95% confidence interval: 0.912-0.995). Specifically, every percentage unit increase in adherence resulted in a 4.7% decrease in relapse. Conclusion Patients with multiple sclerosis who self-injected INF β-1a with Rebismart® had excellent adherence, correlating with a high proportion of relapse-free patients and very low annualized relapse rate.

Background: The absence of therapy adherence is a public health problem and leads to negative consequences in inflammatory chronic diseases. The measurement of therapy adherence has demonstrated effectiveness on the improvement of compliance, but it is difficult to estimate because it is based on indirect measurements. With high probability there will be discrepancies between different measurements. Objectives: To estimate the discrepancies between therapy adherence controlled by prescription of medication, Morisky-Green test and self-perception adherence patients under biological subcutaneous treatment or under JAKinhibs oral treatment. Methods: Observational study including inflammatory chronic disease patients under biological subcutaneous treatment or under JAKinhibs oral treatment, selected consecutively. We performed a preliminary stage where patients were contacted by telephone and after that the questionnarie was sent to the email address they provided. The questionnaire included Morisky-Green test and a self-perception adherence scale (0-10). Data about dispensation of medication was collected from the pharmacy service. We defined as “adherent patient” a dispensation rate over 80%. Results: 54 patients were contacted, and 37 of them full-filled the questionnaire. 28 full-filled the online questionnaire but the other 9 preferred the paper format. The patients from the online format questionnaire had a mean age of 50.86 years (range 22-74), and patients of paper format questionnaire had a mean age of 61.38 years (38-71). We observed a high proportion of patients with university studies among those who preferred the online format. 21 of the patients surveyed had rheumatoid arthritis, 7 psoriatic arthritis, 7 ankylosing spondylitis and 1 juvenile idiopathic arthritis. 21 were under subcutaneous biological therapies and 16 under oral JAKinhibitor therapies. From the 37 patients, 64.8% took 2 or more pills daily. among the 37 surveyed patients a discrepancy between therapy adherence controlled by dispensation of medication and adherence by Morisky-Green was observed (94.6% vs 72.97%, P among the analyzed factors which may affect the therapy adherence, the oral route of administration showed more adherence rate controlled by dispensation of medication (P=0.019) and with Morisky-Green adherence rate (P=0.016). No other association with other factors as age, gender or time of disease evolution was observed. Conclusion: Younger patients and those with university studies preferred to full-fill the online questionnaire. A discrepancy between therapy adherence controlled by dispensation of medication and adherence by Morisky-Green was observed. Moreover oral route of treatment showed more therapy adherence than subcutaneous route of treatment. Even if the patients are no self-considered as 100% adherents (Morisky-Green), a tendency of collect the medication on a regular basis was observed. This seems to indicate that instead of the controlled dispensation of medication by Pharmacy, patients with lower therapy adherence will collect all the medication. Disclosure of Interests: None declared

Resumen Objetivo Evaluar la influencia del peso de los pacientes en el coste de tratamiento de la artritis reumatoide con farmacos biologicos indicados en primera linea tras respuesta inadecuada a metotrexato. Pacientes y metodo Se incluyeron costes farmacologicos y de administracion considerando no optimizacion y optimizacion de viales de los farmacos intravenosos. Los datos de posologias y peso de pacientes se obtuvieron de forma retrospectiva de 66 pacientes atendidos en un servicio de Reumatologia Clinica de un hospital terciario en Espana. El horizonte temporal del estudio fue de 2 anos. Los costes se expresaron en euros de 2013. Resultados En un paciente promedio de 69 kg de peso, abatacept subcutaneo (ABA SC) fue el farmaco de menor coste (21.028,09 €) sin optimizacion de viales, e infliximab (IFX) (20.779,29 €) con optimizacion de viales. Considerando el peso de los pacientes, sin optimizacion de viales, IFX fue menos costoso en pacientes de 45-49 kg, ABA intravenoso en pacientes de 50-60 kg y ABA SC en pacientes ≥ 60 kg. Con optimizacion de viales IFX seria menos costoso en pacientes Conclusiones Suponiendo efectividad comparable de farmacos biologicos, el peso de los pacientes es una variable relevante, pudiendo alcanzarse ahorros potenciales superiores a 20.000 € en pacientes de mas de 100 kg de peso en 2 anos de tratamiento.

Objective The objective was to assess the influence of patients’ weight in the cost of rheumatoid arthritis treatment with biologic drugs used in first line after non-adequate response to methotrexate. Patients and method Pharmaceutical and administration costs were calculated in two scenarios: non-optimization and optimization of intravenous (IV) vials. The retrospective analysis of 66 patients from a Spanish 1000 beds-hospital Rheumatology Clinic Service was used to obtain posology and weight data. The study time horizon was two years. Costs were expressed in 2013 euros. Results For an average 69 kg-weighted patient the lowest cost corresponded to abatacept subcutaneous (SC ABA) (€21,028.09) in the scenario without IV vials optimization and infliximab (IFX) (€20,779.29) with optimization. Considering patients’ weight in the scenario without IV vials optimization infliximab (IFX) was the least expensive drug in patients ranged 45–49 kg, IV ABA in 50–59 kg and SC ABA in patients over 60 kg. With IV vials optimization IFX was the least expensive drug in patients under 69 kg and SC ABA over 70 kg. Conclusions Assuming comparable effectiveness of biological drugs, patient's weight is a variable to consider, potentials savings could reach €20,000 in two years.

Background Adherence to disease-modifying drugs (DMDs) is one of the key factors for achieving optimal clinical outcomes. Rebismart® is an injection device for subcutaneous administration of interferon beta-1a (INF β-1a) that is also able to monitor adherence objectively. The aim of this study was to describe adherence to INF β-1a using the said electronic autoinjection device and to explore the relationship between adherence and relapses in a Spanish cohort. Methods This is a retrospective observational study in which 110 Spanish patients self-administered INF β-1a subcutaneously using an electronic autoinjection device between June 2010 and June 2015. The primary end point was the percentage of adherence measured by Rebismart® to subcutaneous INF β-1a injections calculated as number of injections received in time period versus number of injections scheduled in time period. Other variables recorded were demographic and clinical data. Statistical analysis was performed using SPSS 19.0 software. Results Median adherence for the total study period was 96.5% (interquartile range [IQR]: 91.1–99.1). Similar values were observed during the first 6 months: 98.7% (IQR: 91.3–100), and the last 6 months: 97.6% (IQR: 91.1–99.8). Median duration of treatment was 979 days (IQR: 613.8–1,266.8). During the entire treatment period, 77.3% of patients were relapse free and mean annualized relapse rate was 0.14 (standard deviation: 0.33). Increased adherence was associated with better clinical outcomes, leading to lower relapse risk (odds ratio: 0.953; 95% confidence interval: 0.912–0.995). Specifically, every percentage unit increase in adherence resulted in a 4.7% decrease in relapse. Conclusion Patients with multiple sclerosis who self-injected INF β-1a with Rebismart® had excellent adherence, correlating with a high proportion of relapse-free patients and very low annualized relapse rate.

Objectives To assess the cost-effectiveness of methoxy polyethylene glycol-epoetin β (CERA) used in routine clinical practice for maintenance of Hb levels in patients with chronic kidney disease in predialysis and previous stabilised treatment with conventional epoetin. As secondary objective, we analyse the use of CERA in clinical practice. Methods Retrospective observational study including all patients receiving conventional epoetin who were switched to CERA over a period of 2 years. Demographic, clinical and therapeutic variables were collected. The main effectiveness outcome chosen was the difference between the haemoglobin level with conventional epoetin versus CERA after 24 weeks of treatment. Economic analysis was performed taking into account only the direct drug acquisition cost, the main cost outcome was the difference of patient/month cost with conventional epoetin versus CERA. Results Sixty-nine patients with a mean age of 68 years (35% male) were enrolled in the study. In 92.8% of cases, the starting dose used was lower than that recommended in the summary of product characteristics. Mean haemoglobin at 0 and 24 weeks was 11.9 and 11.7 g/dL, with no statistically significant difference (−0.2, 95% CI −0.6 to 0.1). With CERA, a lower proportion of patients exceeded the haemoglobin limit of 13 g/dL. The patient/month cost was 159.6€ and 169.9€ at weeks 0 and 24, with a difference of 10.3€ (95% CI −6.8 to 27.5). Conclusions CERA was as effective as conventional epoetin for the maintenance of haemoglobin levels after 24 weeks of follow-up. Conversion to CERA has led to an increase of 10.3€ the patient/month cost.

Objective To assess unmet needs at hospital pharmacies and treatment adherence of patients with multiple sclerosis (MS) treated with disease-modifying therapies (DMTs). Methods A non-interventional and multicentre study involving 24 pharmacies that included 237 patients with relapsing-remitting MS (RRMS) or secondary progressive MS (SPMS) treated with DMTs. Pharmacists completed a questionnaire on management and needs. Adherence was assessed using the Morisky-Green test. Results The mean age of patients was 40.1±9.4 years (65.8% women). The average time from diagnosis was 7.5±5.6 years, 95.4% had RRMS and 61.2% had no relapses during the last year. Most patients (62.4%) had Expanded Disability Status Scale grade 0–2.5. Overall adherence was 77.1%. Treatment adherence was significantly higher among patients with no relapses (82.9% vs 67.4%, p Conclusions It is necessary to improve educational materials and operational protocols regarding workload at hospital pharmacies to provide adequate follow-up and to ensure adherence by Spanish patients with MS.

Indications for linezolid use are nosocomial or community-acquired pneumonia and skin infections or soft tissue infection caused by gram-positive microorganisms, but new recommendations may emerge. It is important to balance benefits with risks because severe adverse events have been described in patients taking linezolid treatment. Accordingly, we evaluated the suitability of linezolid prescription according to approval of indication by evaluating the presence of drug-related problems (DRP) in a University hospital. DRP were identified in 36 patients (50.0%). In most cases, they were related to known or established indications (15 patients, 20.8%), to safety (5 patients, 6.9%), and to both in others (16 patients, 22.2%). No DRP were recorded, which modified linezolid efficacy. DRP were significantly higher in the patients treated by an approved indication in Spain (63.3%) than in those treated by an unapproved indication in Spain (28.6%). We concluded that new studies about extending linezolid indications may be necessary.

The aim of this study was to establish guidelines for the optimization of biologic therapies for health professionals involved in the management of patients with RA, AS and PsA. Recommendations were established via consensus by a panel of experts in rheumatology and hospital pharmacy, based on analysis of available scientific evidence obtained from four systematic reviews and on the clinical experience of panellists. The Delphi method was used to evaluate these recommendations, both between panellists and among a wider group of rheumatologists. Previous concepts concerning better management of RA, AS and PsA were reviewed and, more specifically, guidelines for the optimization of biologic therapies used to treat these diseases were formulated. Recommendations were made with the aim of establishing a plan for when and how to taper biologic treatment in patients with these diseases. The recommendations established herein aim not only to provide advice on how to improve the risk:benefit ratio and efficiency of such treatments, but also to reduce variability in daily clinical practice in the use of biologic therapies for rheumatic diseases Sociedad Española de Reumatología 4.524 JCR (2015) Q1, 6/32 Rheumatology UEM

Objective: To report a case of fetal exposure to pyridostigmine and 3,4-diaminopyridine (3,4-DAP) in a pregnant woman with congenital myasthenia syndrome (CMS). Case Summary: A 31-year-old woman with postsynaptic CMS, not genetically characterized, was being treated with pyridostigmine and 3,4-DAP. She decided to become pregnant, despite having been informed about the paucity of available information on the possible risks of these drugs for the fetus. The dose of pyridostigmine remained stable throughout the pregnancy (60 mg every 8 h), and the 3,4-DAP dose was adjusted according to the patient's level of fatigue (20 mg/day, with occasional additional doses of 5 mg). At 25 weeks' gestation, ultrasonography confirmed the presence of only one umbilical artery. The results of other tests were normal. At 38 weeks' gestation, a healthy male neonate was born. His APGAR scores were 9 and 10 at 1 and 5 minutes, respectively. Five months later, the infant was healthy and his pediatric progress had been uneventful. Discussion: It was difficult to find information about the possible congenital defects related to the use of 3,4-DAP because it is a rarely used drug. This case attracted our interest because it is an uncommon disease, and we found no reports on the use of 3,4-DAP during pregnancy. To our knowledge, as of this writing, this is the first published report of the use of 3,4-DAP during pregnancy. Conclusions: A successful pregnancy with a healthy infant was achieved after fetal exposure to 3,4-DAP and pyridostigmine.

Canavan disease is a rare autosomal recessive leukodystrophy characterized by abnormal accumulation of N-acetyl aspartate (NAA) in brain white matter. Currently, there is no cure for this disease, and management of patients consists mainly of treating symptoms. We describe a 3-month-old girl who was hospitalized for poor head control and decreased muscle tone. A battery of laboratory and genetic (homozygous mutation p.C218X) analysis revealed the presence of Canavan disease. Lithium citrate was initiated at a dosage of 45 mg/kg per day after diagnosis. Periodic controls of thyroid and liver function, and lithium levels in blood showed that this drug was sure and well tolerated. After 1 year of treatment, NAA levels decreased by approximately 20% in the brain region, urinary NAA levels showed a reduction of 80%, and patient improved alertness and visual tracking but continued with no heat support, axial hypotonia, and spastic diplegia. In our patient, the results obtained after drug administration are important with respect to the decrease in NAA and more discreet in clinical improvement. However, given the absence of adverse effects and limited treatment options, lithium citrate may be a good alternative to stop the progression of the disease and improve the quality of life of patients.

Indications for linezolid use are nosocomial or community-acquired pneumonia and skin infections or soft tissue infection caused by gram-positive microorganisms, but new recommendations may emerge. It is important to balance benefits with risks because severe adverse events have been described in patients taking linezolid treatment. Accordingly, we evaluated the suitability of linezolid prescription according to approval of indication by evaluating the presence of drug-related problems (DRP) in a University hospital. DRP were identified in 36 patients (50.0%). In most cases, they were related to known or established indications (15 patients, 20.8%), to safety (5 patients, 6.9%), and to both in others (16 patients, 22.2%). No DRP were recorded, which modified linezolid efficacy. DRP were significantly higher in the patients treated by an approved indication in Spain (63.3%) than in those treated by an unapproved indication in Spain (28.6%). We concluded that new studies about extending linezolid indications may be necessary.