Sequential administration of paricalcitol followed by IL-17 blockade for progressive refractory IgA nephropathy patients.

There is no established treatment for progressive IgA nephropathy refractory to steroids and immunosuppressant drugs (r-IgAN). Interleukin 17 (IL-17) blockade has garnered interest in immune-mediated diseases involving the gut-kidney axis. However, single IL-17A inhibition induced paradoxical effects in patients with Crohn's disease and some cases of de novo glomerulonephritis, possibly due to the complete Th1 cell response, along with the concomitant downregulation of regulatory T cells (Tregs). Seven r-IgAN patients were treated with at least six months of oral paricalcitol, followed by the addition of subcutaneous anti-IL-17A (secukinumab). After a mean follow-up of 28 months, proteinuria decreased by 71% (95% CI: 56-87), P < 0.001. One patient started dialysis, while the annual eGFR decline in the remaining patients [mean (95% CI)] was reduced by 4.9 mL/min/1.73 m2 (95% CI: 0.1-9.7), P = 0.046. Circulating Th1, Th17, and Treg cells remained stable, but Th2 cells decreased, modifying the Th1/Th2 ratio. Intriguingly, accumulation of circulating Th17.1 cells was observed. This novel sequential therapy appears to optimize renal advantages in patients with r-IgAN and elicit alterations in potentially pathogenic T helper cells.

Influence of the COVID-19 pandemic on patients receiving oral anticoagulants for the treatment of non-valvular atrial fibrillation.

Background: Frequent monitoring of patients declined during the COVID-19 pandemic, harming patients with chronic diseases who critically needed correct monitoring. We evaluated the impact of the COVID-19 pandemic in patients with non-valvular atrial fibrillation (NVAF) receiving treatment with vitamin K antagonists (VKA) or non-vitamin K antagonist oral anticoagulants (NOAC) in clinical practice in Spain. Methods: This observational, retrospective study analyzed prevalent patients treated with NOAC/VKA on 14/03/2019 (pre-COVID-19 period) and 14/03/2020 (COVID-19 period), who were followed up to 12 months. The study also considered incident patients who started treatment with NOAC/VKA between 15/03/2019 and 13/03/2020 (pre-COVID-19 period) and from 15/03/2020 to 13/03/2021 (COVID-19 period). Demographic characteristics, comorbidities, effectiveness, treatment patterns, and healthcare resource utilization were considered. Results: Prevalent patients amounted to 12,336 and 13,342 patients, whereas 1,612 and 1,602 incident patients were included in the pre-COVID-19 and COVID-19 periods, respectively. Prevalent patients treated with VKA had more strokes, thromboembolism, and major bleeding compared to those receiving NOAC, particularly during the COVID-19 period. NOAC patients had a 12 % lower risk of death than those on treatment with VKA (Hazard ratio = 0.88 [95 % CI: 0.81 - 0.95], p = 0.033). In addition, VKA patients were less persistent after 12 months than NOAC patients (pre-COVID-19 period: 52.1 % vs. 78.9 %, p < 0.001; COVID-19 period: 49.2 % vs. 80.3 %, p < 0.001), and required more healthcare visits and hospitalizations than those on treatment with NOAC. Conclusion: Compared to VKA, NOAC seems to have reduced the incidence of severe events and the use of healthcare resources for NVAF, particularly during the pandemic.

Defining a standard set of health outcomes for patients with relapsing-remitting multiple sclerosis.

BACKGROUND: Standardizing health outcomes is challenging in clinical management, but it also holds the potential for creating a healthcare system that is both more effective and efficient. The aim of the present study is to define a standardized set of health outcomes for managing Relapsing-Remitting Multiple Sclerosis (RRMS). METHODS: The project was led and coordinated by a multidisciplinary scientific committee (SC), which included a literature review, a patient-focused group, three nominal group meetings, and two SC meetings. RESULTS: 36 outcome variables were included in the standard set: 24 clinical (including weight, smoking habit, comorbidities, disability, mobility, diagnosis of secondary progressive multiple sclerosis, relapsed-related variables, radiological variables, cognitive status and disease-related symptoms), nine treatment-related (pharmacological and non-pharmacological information), and 3 related to the impact of RRMS on the patient's life (quality of life, pregnancy desire, work-related difficulties). In addition, experts also agreed to collect 10 case-mix variables that may affect but cannot be controlled as part of the management of the condition: 4 sociodemographic (age, sex, race, and employment status) and 6 clinical (height, date of diagnosis and first episode, serological status, early symptoms, and number of relapses pre-diagnosis). CONCLUSION: The information provided through the present standard set of outcome variables can improve the management of RRMS and promote patient-centred quality care.

Recommendations for the future management of thrombocytopenia in patients with liver cirrhosis: A modified RAND/UCLA appropriateness method / Recomendaciones para el futuro manejo de la trombocitopenia en pacientes con cirrosis hepática: una versión modificada de la Metodología RAND/UCLA

Objective The lack of consensus and specific guidelines, and the introduction of new treatments in thrombocytopenia management in liver cirrhosis patients, required a series of recommendations by experts to improve knowledge on this disease. This study's aim was to improve the knowledge around thrombocytopenia in liver cirrhosis patients, in order to contribute to the generation of future evidence to improve the management of this disease. Patients and methods A modified version of the RAND/UCLA appropriateness method was used. The scientific committee, a multidisciplinary team of 7 experts in managing thrombocytopenia in liver cirrhosis patients, identified the expert panel, and participated in elaborating the questionnaire. Thirty experts from different Spanish institutions were invited to answer a 48-item questionnaire covering 6 areas on a nine-point Likert scale. Two rounds were voted. The consensus was obtained if >77.7% of panelists reached agreement or disagreement. Results A total of 48 statements were developed by the scientific committee and then voted by the experts, resulting in 28 defined as appropriate and completely necessary, relating to evidence generation (10), care circuit, (8), hemorrhagic risk assessment, decision-making and diagnostic tests (14), professionals’ role and multidisciplinary coordination (9) and patient education (7). Conclusions This is the first consensus in Spain on the management of thrombocytopenia in liver cirrhosis patients. Experts indicated several recommendations to be carried out in different areas that could help physicians make better decisions in their clinical practice (AU)

Objetivo La falta de consenso y guías específicas, y la introducción de nuevos tratamientos para el manejo de la trombocitopenia en pacientes con cirrosis hepática, requerían recomendaciones expertas para mejorar el conocimiento sobre dicha patología. El objetivo de este estudio es mejorar el conocimiento sobre la trombocitopenia en pacientes con cirrosis hepática de cara a contribuir en la generación de futuras evidencias que mejoren el manejo de esta patología. Metodología Ae utilizó una versión modificada de la metodología Delphi RAND/UCLA. El comité científico, formado por 7 expertos en el manejo de la trombocitopenia en pacientes con cirrosis hepática, identificó un panel de expertos y participó en la elaboración del cuestionario de recomendaciones. Treinta expertos de diferentes hospitales españoles fueron invitados a responder al cuestionario. Los expertos respondieron a 48 ítems divididos en 6 áreas en una escala Likert de 9 puntos. La votación tuvo lugar en 2 rondas, en las que se obtuvo consenso siempre y cuando >77,7% de los panelistas alcanzasen acuerdo o desacuerdo. Resultados Cuarenta y ocho recomendaciones fueron elaboradas por el comité científico para su votación por parte del panel de expertos. Finalmente 28 recomendaciones fueron consideradas apropiadas y completamente necesarias: 10 de ellas relativas a la generación de evidencia; 8 al circuito de cuidados; 14 a la evaluación de riesgo hemorrágico, la toma de decisiones y los test diagnósticos; 9 al papel de los profesionales y la coordinación multidisciplinar, y 7 a la educación de los pacientes. Conclusiones Se trata del primer consenso español en el manejo de la trombocitopenia en pacientes con cirrosis hepática. Los expertos definieron un amplio número de recomendaciones que podrían contribuir a la toma de decisiones clínicas y a la mejora en el manejo de estos pacientes en la práctica clínica real (AU)

Recommendations for the future management of thrombocytopenia in patients with liver cirrhosis: A modified RAND/UCLA appropriateness method.

OBJECTIVE: The lack of consensus and specific guidelines, and the introduction of new treatments in thrombocytopenia management in liver cirrhosis patients, required a series of recommendations by experts to improve knowledge on this disease. This study's aim was to improve the knowledge around thrombocytopenia in liver cirrhosis patients, in order to contribute to the generation of future evidence to improve the management of this disease. PATIENTS AND METHODS: A modified version of the RAND/UCLA appropriateness method was used. The scientific committee, a multidisciplinary team of 7 experts in managing thrombocytopenia in liver cirrhosis patients, identified the expert panel, and participated in elaborating the questionnaire. Thirty experts from different Spanish institutions were invited to answer a 48-item questionnaire covering 6 areas on a nine-point Likert scale. Two rounds were voted. The consensus was obtained if >77.7% of panelists reached agreement or disagreement. RESULTS: A total of 48 statements were developed by the scientific committee and then voted by the experts, resulting in 28 defined as appropriate and completely necessary, relating to evidence generation (10), care circuit, (8), hemorrhagic risk assessment, decision-making and diagnostic tests (14), professionals' role and multidisciplinary coordination (9) and patient education (7). CONCLUSIONS: This is the first consensus in Spain on the management of thrombocytopenia in liver cirrhosis patients. Experts indicated several recommendations to be carried out in different areas that could help physicians make better decisions in their clinical practice.

An international comparative analysis and roadmap to sustainable biosimilar markets.

Background: Although biosimilar uptake has increased (at a variable pace) in many countries, there have been recent concerns about the long-term sustainability of biosimilar markets. The aim of this manuscript is to assess the sustainability of policies across the biosimilar life cycle in selected countries with a view to propose recommendations for supporting biosimilar sustainability. Methods: The study conducted a comparative analysis across 17 countries from North America, South America, Asia-Pacific, Europe and the Gulf Cooperation Council. Biosimilar policies were identified and their sustainability was assessed based on country-specific reviews of the scientific and grey literature, validation by industry experts and 23 international and local non-industry experts, and two advisory board meetings with these non-industry experts. Results: Given that European countries tend to have more experience with biosimilars and more developed policy frameworks, they generally have higher sustainability scores than the other selected countries. Existing approaches to biosimilar manufacturing and R&D, policies guaranteeing safe and high-quality biosimilars, exemption from the requirement to apply health technology assessment to biosimilars, and initiatives counteracting biosimilar misconceptions are considered sustainable. However, biosimilar contracting approaches, biosimilar education and understanding can be ameliorated in all selected countries. Also, similar policies are sometimes perceived to be sustainable in some markets, but not in others. More generally, the sustainability of the biosimilar landscape depends on the nature of the healthcare system and existing pharmaceutical market access policies, the experience with biosimilar use and policies. This suggests that a general biosimilar policy toolkit that ensures sustainability does not exist, but varies from country to country. Conclusion: This study proposes a set of elements that should underpin sustainable biosimilar policy development over time in a country. At first, biosimilar policies should guarantee the safety and quality of biosimilars, healthy levels of supply and a level of cost savings. As a country gains experience with biosimilars, policies need to optimise uptake and combat any misconceptions about biosimilars. Finally, a country should implement biosimilar policies that foster competition, expand treatment options and ensure a sustainable market environment.

Evaluation of Patient Experience With A Model of Coordinated Telematic Pharmaceutical Care Between Hospital and Rural Pharmacies in Spain: A Proof of Concept.

Purpose: To determine the usefulness of a coordinated pharmaceutical care model between the specialized hospital setting and the rural community care setting, based on the incorporation of telepharmacy based on Capacity-Motivation-Opportunity (CMO) methodology to improve patient experience with hospital medication prescriptions. Patients and Methods: Prospective cohort study in outpatients receiving telepharmacy based on CMO-based pharmaceutical care in rural areas in Spain between January and November 2021, conducted by the pharmacy department of four hospitals and 29 rural communities' pharmacy. Each patient was followed for 48 weeks on both face-to-face and telematic visits, scheduled and unscheduled at the patients' request. Patient experience (IEXPAC questionnaire), and satisfaction (EVASAF) were determined. Secondary variables included pharmaceutical care interventions, care coordination and clinical variables (compliance with pharmacotherapeutic objectives according to the clinical conditions of each patient), additionally measurement of individual holistic results (EQ5D-5L score) was evaluated. Results: A new telepharmacy tool (called Telemaco) was developed for a multidisciplinary healthcare team (available at: https://inteligeniapps.com/telemaco/) that includes seven different functionalities. We evaluated the first 20 patients (50% women) were included. Their median age was 66.0 years (IQR=14). A total of 215 visits were made (adding 150 video calls). A total of 64 visits were unscheduled (29.7%). The patient´s experience showed improvement (7.4 vs 9.5, p<0.005). The results of the EVASAF questionnaire were also higher (44 vs 48, p<0.001). Overall, 573 pharmaceutical interventions were performed. A difference was observed in patients who achieved the intended pharmacotherapeutic objectives: 48.5 vs 88.2 (p< 0.001). The mean EQ-5D-5L score was 74.7 ± 3.3 at baseline and 80.6 ± 3.6 points at the end (p>0.05). Conclusion: Telepharmacy based on the CMO-PC model, using the "Telemaco" tool, has improved the patient experience, satisfaction, and offered other advantages over the traditional model, including more pharmaceutical interventions adapted to the needs of each patient.

The social value of a PASI 90 or PASI 100 response in patients with moderate-to-severe plaque psoriasis in Spain.

Introduction: Psoriasis is a chronic disease involving the skin, which significantly impacts the quality of life. Disease severity and treatment efficacy (i.e., response) are assessed through the Psoriasis Area and Severity Index (PASI). A PASI 75 response, i.e., an improvement of at least 75% with respect to the baseline PASI score, has traditionally been used as a therapeutic benchmark in clinical trials. Therapeutic advances have made PASI 90 or PASI 100 responses possible in most patients treated with some biologics. A greater response may generate social value beyond clinical outcomes that would benefit both patients and society. Methods: A 1-year economic model was applied to estimate the impact of having a PASI 75, PASI 90, or PASI 100 response in four areas of analysis (quality of life, activities of daily living, work productivity, and out-of-pocket expenditures) and the social value of having a PASI 90 or PASI 100 response in comparison with a PASI 75 response. A mixed-methods approach based on the scientific literature, a focus group with patient, and an advisory committee with psoriasis stakeholders was used. The model included three different scenarios: having a PASI 90 vs a PASI 75 response; a PASI 100 vs a PASI 90 response; and a PASI 100 vs a PASI 75 response. A sensitivity analysis was included. Results: The annual economic impact per patient with moderate-to-severe plaque psoriasis having a PASI 75 response was estimated at L 6,139, mainly related to labour productivity losses and quality of life reductions. Having a PASI 90 or a PASI 100 response would reduce this impact to €3,956 or €1,353, respectively. Accordingly, the social value of having a PASI 90 instead of a PASI 75 response was estimated at €2,183, and €4,786 with a PASI 100 response. Discussion: A PASI 90 or PASI 100 response would have a lower economic impact and a greater social value than a PASI 75 response for patients with moderate-to-severe plaque psoriasis.

Efficacy and Safety of Inhaled Ethanol in Early-Stage SARS-CoV-2 Infection in Older Adults: A Phase II Randomized Clinical Trial.

BACKGROUND: Inhaled ethanol in the early stages of SARS-CoV-2 infection may reduce the viral load, decreasing progression and improving prognosis. The ALCOVID-19 trial was designed to study the efficacy and safety of inhaled ethanol in older adults at initial phases of infection. METHODS: Randomized, triple-blind, placebo-controlled phase II clinical trial. Experimental group (n = 38) inhaled 65° ethanol through an oxygen flow, while in the control group (n = 37), water for injection was used. General endpoint was to evaluate disease progression according to the modified World Health Organization (WHO) Clinical Progression Scale. Specific effectiveness endpoints were body temperature, oxygen saturation, viral load assessed by cycle threshold (Ct) on real-time polymerase chain reaction (RT-PCR), analytical biomarkers and use of antibiotics or corticosteroids. Specific safety outcomes were the absence of ethanol in plasma, electrographic, analytical, or respiratory alterations. RESULTS: In the intention-to-treat population, no differences were found regarding disease progression. Mean Ct values increased over time in both groups, being numerically higher in the ethanol group, reaching a value above 33 only in the ethanol group on day 14, a value above which patients are considered non-infective. No differences were found in the other specific effectiveness endpoints. Inhaled ethanol was proven to be safe as no plasma ethanol was detected, and there were no electrocardiographic, analytical, or respiratory alterations. CONCLUSIONS: The efficacy of inhaled ethanol in terms of the progression of SARS-CoV-2 infection was not demonstrated in the present trial. However, it is positioned as a safe treatment for elderly patients with early-stage COVID-19.

Assessing patient experience with a Telepharmacy model coordinated in the hospital and rural pharmacy setting: The TELEMACO project.

OBJECTIVE: To determine variation in patient experience with a model of Telepharmacy coordinated in the specialist hospital and rural pharmacy setting. METHOD: A pre-post experimental analytical study. A set of common essential  pharmacy tasks based on the capacity-motivation-opportunity method will be  performed in each participating site. A a Telepharmacy software will be  designed to include the following functionalities: history of patient  pharmaceutical profiling and prioritization; scheduled appointment book;  unscheduled visit record; generic participant communication wall; patient- professional instantaneous messaging chat; video calls; monitoring of  treatment adherence; and evaluation of patient-reported outcomes. Inclusion  criteria: age older than 18 years; being on regular hospital pharmacy follow-up for the last 6 months; using a stable drug therapy (without treatment changes  in the last 6 months); using a chronic hospital outpatient prescription (any  prescription valid for at least 6 months); living in any of the municipalities  served by the participating pharmacies or using the services of a participating  pharmacy located near the usual place of residence; granting informed consent prior to inclusion in the study. A 48-week follow-up will be performed of each  patient. The primary endpoint will be variation in patient experience, as  assessed using the "Instrumento de Evaluación de la eXperiencia del PAciente  Crónico" scale at baseline and at the end of the follow-up period. CONCLUSIONS: The incorporation, development and implementation of a  coordinated Telepharmacy care model will help us determine whether this  model is useful in improving patient follow-up and communication with pharmacy professionals at different levels of healthcare.

OBJETIVO: Determinar la variación en la experiencia del paciente con un modelo de atención farmacéutica coordinada entre farmacia hospitalaria y  farmacia rural especializado y el rural de atención comunitaria, basado en la  incorporación de la Telefarmacia.Método: Estudio analítico experimental de intervención antes-después. Para desarrollar el proyecto se realizarán una serie de procedimientos comunes e indispensables, basados en la metodología capacidad-motivación- oportunidad, en cada uno de los centros. Se diseñará una aplicacion  informática de Telefarmacia que contemplará, entre otras, las siguientes  funcionalidades: historial de caracterización y priorización farmacoterapéutica  de los pacientes; agenda de visitas programadas y registro de visitas no  programadas; muro de comunicación genérica entre participantes; chat de  mensajería instantánea entre pacientes y profesionales; videollamadas;  onitorización de la adherencia a la medicación y valoración de cuestionarios de  resultados reportados por pacientes. Se incluirán: pacientes mayores de 18  años; en seguimiento habitual en consultas externas de farmacia hospitalaria  durante más de 6 meses previo al inicio del estudio; que se encuentren en  situación estable desde el punto de vista farmacoterapéutico (sin cambios de  tratamientos en los últimos 6 meses); que tengan prescrito, al menos, un  tratamiento crónico de dispensación en oficina de farmacia (prescripción con  una vigencia de más de 6 meses de cualquier fármaco); que residan  habitualmente en las localidades de las oficinas de farmacia participantes en el  estudio o que acudan a las mismas por cercanía a su lugar de residencia  habitual; y que otorguen su consentimiento informado de participación. Cada  paciente tendrá un seguimiento de 48 semanas. La variable principal será la  diferencia en la experiencia del paciente, valorada mediante la escala  Instrumento de Evaluación de la eXperiencia del PAciente Crónico", desde el  inicio hasta el final de seguimiento. CONCLUSIONES: La puesta en marcha, desarrollo e implementación de la metodología de atención farmacéutica coordinada, basada en la  Telefarmacia, permitirá identificar, a partir de su medición, si esta metodología consigue llevar a cabo un seguimiento más oportuno de los  pacientes incluidos, y si proporciona una mejor experiencia de los mismos en  su relación con los profesionales farmacéuticos que les atienden en los  diferentes niveles de atención sanitaria.

Evaluación de la experiencia del paciente conun modelo de atención farmacéutica telemática coordinada entre farmacia hospitalaria y farmaciarural. Proyecto TELÉMACO / Assessing patient experience with a Telepharmacy model coordinated in the hospital and rural pharmacy setting: The TELEMACO project

Objetivo: Determinar la variación en la experiencia del paciente con unmodelo de atención farmacéutica coordinada entre farmacia hospitalariay farmacia rural especializado y el rural de atención comunitaria, basadoen la incorporación de la Telefarmacia.Método: Estudio analítico experimental de intervención antes-después. Paradesarrollar el proyecto se realizarán una serie de procedimientos comunes eindispensables, basados en la metodología capacidad-motivación-oportunidad, en cada uno de los centros.Se diseñará una aplicacion informática de Telefarmacia que contemplará,entre otras, las siguientes funcionalidades: historial de caracterización y priorización farmacoterapéutica de los pacientes; agenda de visitas programadasy registro de visitas no programadas; muro de comunicación genérica entreparticipantes; chat de mensajería instantánea entre pacientes y profesionales;videollamadas; monitorización de la adherencia a la medicación y valoración de cuestionarios de resultados reportados por pacientes.Se incluirán: pacientes mayores de 18 años; en seguimiento habitual en consultas externas de farmacia hospitalaria durante más de 6 meses previo al inicio del estudio; que se encuentren en situación estable desde el punto de vistafarmacoterapéutico (sin cambios de tratamientos en los últimos 6 meses). (AU)

Objective: To determine variation in patient experience with a model ofTelepharmacy coordinated in the specialist hospital and rural pharmacysetting.Method: A pre-post experimental analytical study. A set of commonessential pharmacy tasks based on the capacity-motivation-opportunitymethod will be performed in each participating site.A a Telepharmacy software will be designed to include the followingfunctionalities: history of patient pharmaceutical profiling and prioritization; scheduled appointment book; unscheduled visit record; generic participant communication wall; patient-professional instantaneous messagingchat; video calls; monitoring of treatment adherence; and evaluation ofpatient-reported outcomes.Inclusion criteria: age older than 18 years; being on regular hospital pharmacy follow-up for the last 6 months; using a stable drug therapy (withouttreatment changes in the last 6 months); using a chronic hospital outpatientprescription (any prescription valid for at least 6 months); living in any ofthe municipalities served by the participating pharmacies or using theservices of a participating pharmacy located near the usual place ofresidence; granting informed consent prior to inclusion in the study. A48-week follow-up will be performed of each patient. The primary endpoint will be variation in patient experience, as assessedusing the “Instrumento de Evaluación de la eXperiencia del PAciente Crónico” scale at baseline and at the end of the follow-up period.Conclusions: The incorporation, development and implementation ofa coordinated Telepharmacy care model will help us determine whetherthis model is useful in improving patient follow-up and communication withpharmacy professionals at different levels of healthcare. (AU)

Assessing the value contribution of bimekizumab for the treatment of moderate-to-severe psoriasis using a multidisciplinary reflective multi-criteria decision analysis.

BACKGROUND: Multi-criteria decision analysis (MCDA) was proposed to surmount arbitrary clinical decisions in the field of biological therapies for psoriatic patients. At the same time, MCDA may further highlight the potential of bimekizumab for the treatment of moderate-to-severe psoriasis, compared to placebo, adalimumab, ustekinumab, secukinumab, and even ixekizumab and risankizumab. RESEARCH DESIGN AND METHODS: The EVIDEM framework was adapted to reflect relevant criteria for the assessment. Estimated values were obtained by means of an additive linear model combining weights and scores assigned by a multidisciplinary committee of 12 experts. Consistency and replicability were evaluated through an alternative weighting method and a re-test. RESULTS: Bimekizumab was assessed by the committee as an intervention with a positive value contribution for the treatment of moderate-to-severe psoriasis in comparison to any of the alternatives. The drug provides a substantial therapeutical benefits and improves the health results reported by the patients, as it combines a higher level of clearance, rapidity, and persistence with a similar safety and tolerability profile. CONCLUSIONS: Under a methodology with increasing use in the health field, bimekizumab was evaluated as a drug with a high added value for the treatment of moderate-to-severe psoriasis when compared to six different alternatives.

Unmet Needs in the Management of Moderate-to-Severe Psoriasis in Spain: A Multidimensional Evaluation.

Psoriasis is a chronic, systemic inflammatory disease that affects the skin, with a high impact on patients' quality of life. The aim of this study was to identify and determine the relative importance of unmet needs in the management of moderate-to-severe psoriasis in Spain, from a multi-stakeholder perspective. A mixed method-approach was used to collect information, design a questionnaire and a discrete-choice exercise, and elicit the unmet needs through a multidisciplinary committee composed of 12 experts. A total of 65 unmet needs were identified and categorized into 4 areas: clinical, patient-related, decision-making process, and social. Decision-making process unmet needs were perceived as the most pressing ones, followed by social, clinical and patient-related. Individually, the need to incorporate outcomes that are important to the patients and to have treatments that achieve total clearance with a rapid onset of action and long-term persistence were the most important unmet needs.

Development and Characterization of Inhaled Ethanol as a Novel Pharmacological Strategy Currently Evaluated in a Phase II Clinical Trial for Early-Stage SARS-CoV-2 Infection.

Inhaled administration of ethanol in the early stages of COVID-19 would favor its location on the initial replication sites, being able to reduce the progression of the disease and improving its prognosis. Before evaluating the efficacy and safety of this novel therapeutic strategy in humans, its characterization is required. The developed 65° ethanol formulation is stable at room temperature and protected from light for 15 days, maintaining its physicochemical and microbiological properties. Two oxygen flows have been tested for its administration (2 and 3 L/min) using an automated headspace gas chromatographic analysis technique (HS-GC-MS), with that of 2 L/min being the most appropriate one, ensuring the inhalation of an ethanol daily dose of 33.6 ± 3.6 mg/min and achieving more stable concentrations during the entire treatment (45 min). Under these conditions of administration, the formulation has proven to be safe, based on histological studies of the respiratory tracts and lungs of rats. On the other hand, these results are accompanied by the first preclinical molecular imaging study with radiolabeled ethanol administered by this route. The current ethanol formulation has received approval from the Spanish Agency of Medicines and Medical Devices for a phase II clinical trial for early-stage COVID-19 patients, which is currently in the recruitment phase (ALCOVID-19; EudraCT number: 2020-001760-29).

Monitorización de las superficies de trabajo de medicamentos peligrosos en los Servicios de Farmacia. Documento de consenso. Guía de práctica farmacéutica de la Sociedad Española de Farmacia Hospitalaria (SEFH) / Monitoring contamination of hazardous drug compounding surfaces at hospital pharmacy departments. A consensus Statement. Practice guidelines of the Spanish Society of Hospital Pharmacists (SEFH)

Objetivo: Establecer unas recomendaciones, en base a la evidencia disponible, para la monitorización de la contaminación de superficies en las áreasde elaboración de medicamentos peligrosos de los Servicios de Farmacia.Método: A partir de una revisión bibliográfica en las bases de datosMedline y Embase desde enero de 2009 a julio de 2019, así como de laconsulta de documentos de estándares y recomendaciones de organizaciones sanitarias, un comité de expertos de la Sociedad Española de FarmaciaHospitalaria ha definido una serie de prácticas seguras sobre manipulaciónde medicamentos peligrosos y monitorización de superficies de trabajo. Lasdecisiones de recomendación se tomaron por consenso entre el grupo deexpertos teniendo en cuenta las recomendaciones encontradas, la situaciónen nuestro entorno y los costes asociados a la monitorización.Resultados: Se han definido 10 recomendaciones estructuradas enocho secciones. Se incluyen aspectos relacionados con los medicamentos a monitorizar; localizaciones a monitorizar; momento de la toma demuestras; determinación del riesgo y plan de muestreo; técnicas analíticas;umbrales de contaminación; plan de acción según los resultados del muestreo y descontaminación. (AU)

Objective: To establish a series of recommendations based on available evidence for monitoring surface contamination in the areas devoted tocompounding hazardous drugs in pharmacy departments.Method: Based on a literature search in the Medline and Embase databases (search period: January 2009 to July 2019), as well as on a reviewof standards and recommendations issued by different healthcare organizations, a committee of experts from the Spanish Society of Hospital Pharmacists defined a series of safe practices for handling hazardous drugsand monitoring compounding work surfaces. Recommendation decisionswere adopted by consensus among the members of the expert group,considering the recommendations reviewed, the monitoring situation inSpanish hospital departments, and the associated costs.Results: Ten recommendations were formulated, structured into eight sections. They include aspects related to the drugs to be monitored; the areasto be monitored; when samples should be taken; risk determination andpreparation of a sampling protocol; analytical techniques; contaminationthresholds; and design of an action plan based on the sampling anddecontamination results obtained. (AU)

Monitoring contamination of hazardous drug compounding surfaces at hospital pharmacy departments. A consensus Statement. Practice guidelines of the Spanish Society of Hospital Pharmacists (SEFH).

OBJECTIVE: To establish a series of recommendations based on available evidence for monitoring surface contamination in the areas devoted to compounding hazardous drugs in pharmacy departments. METHOD: Based on a literature search in the Medline and Embase databases (search period: January 2009 to July 2019), as well as on a review of standards and recommendations issued by different healthcare organizations, a committee of experts from the Spanish Society of Hospital Pharmacists defined a series of safe practices for handling hazardous drugs and monitoring compounding work surfaces. Recommendation decisions were adopted by consensus among the members of the expert group, considering the recommendations reviewed, the monitoring situation in Spanish hospital departments, and the associated costs. RESULTS: Ten recommendations were formulated, structured into eight sections. They include aspects related to the drugs to be monitored; the  areas to be monitored; when samples should be taken; risk determination and preparation of a sampling protocol; analytical techniques; contamination thresholds; and design of an action plan based on the sampling and decontamination results obtained. CONCLUSIONS: Surface monitoring allows hazardous drugs detection and evaluation of the effectiveness of current protocols for the safe handling of such drugs in hospital pharmacy departments. The evaluation should include an analysis of the efficacy of engineering controls, work practices and cleaning and decontamination processes.

Objetivo: Establecer unas recomendaciones, en base a la evidencia disponible, para la monitorización de la contaminación de superficies en las áreas de elaboración de medicamentos peligrosos de los Servicios de Farmacia.Método:A partir de una revisión bibliográfica en las bases de datos Medline y Embase desde enero de 2009 a julio de 2019, así como de la consulta de documentos de estándares y recomendaciones de organizaciones sanitarias, un comité de expertos de la Sociedad Española de Farmacia Hospitalaria ha definido una serie de prácticas seguras sobre manipulación de medicamentos peligrosos y monitorización de superficies de trabajo. Las decisiones de recomendación se tomaron por consenso entre el grupo de expertos teniendo en cuenta las recomendaciones encontradas, la situación en nuestro entorno y los costes asociados a la monitorización.Resultados: Se han definido 10 recomendaciones estructuradas en ocho secciones. Se incluyen aspectos relacionados con los medicamentos a  monitorizar; localizaciones a monitorizar; momento de la toma de muestras; determinación del riesgo y plan de muestreo; técnicas analíticas; umbrales de contaminación; plan de acción según los resultados del muestreo y descontaminación.Conclusiones: La monitorización de superficies permite determinar la presencia de medicamentos peligrosos y evaluar la eficacia del programa de manejo seguro de los mismos en los Servicios de Farmacia. La  evaluación debería incluir un estudio de la eficacia de los controles de  ingeniería, de las prácticas laborales y de los procesos de limpieza y descontaminación.

Thermolabile drug storage in an ambulatory setting.

More thermolabile drugs are becoming available, and in most cases, these medications are dispensed to ambulatory patients. However, there is no regulation once medications are dispensed to patients and little is known with regard to what happens during transport and home storage. Previous studies suggest that these drugs are improperly stored. The present study was designed to determine the storage conditions of thermolabile drugs once they are dispensed to the patient in the Hospital Pharmacy Department. This is a prospective observational study to assess the temperature profile of 7 thermolabile drugs once they are dispensed to ambulatory patients at a tertiary care hospital. A data logger was added to the medication packaging. Temperature was considered inappropriate if one of the following circumstances were met: any temperature record less than or equal to 0 °C or over 25 °C; temperatures between 0-2 or 8-25 °C for a continuous period over 30 min. The time series of temperature measurements obtained from each data logger were analyzed as statistically independent variables. The data shown did not undergo any statistical treatment and must be considered directly related to thermal measurements. One hundred and fourteen patients were included and 107 patients were available for the analysis. On the whole, a mean of 50.6 days (SD 18.3) were measured and the mean temperature was 6.88 °C (SD 2.93). Three data loggers (2.8%) maintained all the measurements between 2 and 8 °C with less than 3 continuous data (< 30 min) out of this range but no data over 25 °C or below or equal to 0 °C. 28 (26.2%) data loggers had at least one measurement below zero, 1 data logger had a measurement greater than 25 °C and 75 (70.1%) were between 0 and 2 °C and/or between 8 and 25 °C for more than 30 min. In conclusion, once dispensed to patients, most thermolabile drugs are improperly stored. Future studies should focus on clinical consequences and possible solutions.