Effectiveness and safety of pembrolizumab as first-line treatment for non-small cell lung cancer in real clinical practice.

INTRODUCTION: Pembrolizumab is currently the drug for the first-line treatment of stage-IV non-small cell lung cancer. The objective of this study is to measure the effectiveness of pembrolizumab as a first-line treatment and to analyze its safety in real clinical practice. METHODS: This was a retrospective study that included patients with metastatic non-small cell lung cancer who had received pembrolizumab as a first-line treatment between 1 June 2018 and 31 January 2021. Variables related to the patients, treatment, and drug's efficacy and safety were collected. RESULTS: A total of 50 patients were analyzed. The median real-world progression-free survival and real-world overall survival of those who received pembrolizumab in monotherapy were 10.5 months (95% CI: 2.3-18.6) and 18.9 months (95% CI: 16.9-20.8), respectively. The median real-world progression-free survival and real-world overall survival of those who received the drug with chemotherapy was 7.9 months (95% CI: 4.1-11.7) and 13.3 months (95% CI: 0.0-27), respectively. Mostly digestive (48.3%) and endocrine (41.4%) immune-related adverse events were detected among the patients who received pembrolizumab in monotherapy, whereas mostly digestive immune-related adverse events (85.7%) and hematological toxicities (71.5%) were observed in those treated with pembrolizumab plus chemotherapy. CONCLUSION: Pembrolizumab has proven its effectiveness in terms of increasing real-world progression-free survival and real-world overall survival in real clinical practice. The main adverse events were digestive toxicities with pembrolizumab in monotherapy and with chemotherapy.

Switching between reference adalimumab and biosimilars in chronic immune-mediated inflammatory diseases: A systematic literature review.

AIMS: Adalimumab is a biological therapy used to treat different chronic inflammatory diseases. At present, there is an increasing number of adalimumab biosimilars. To assume the acceptability of interchangeability between reference adalimumab and biosimilars, there should be evidence about efficacy and safety of this switching. Regulation of this practice falls under the authority of individual European Union Member States. The aim of this study is to systematically review the evidence on the efficacy, safety and immunogenicity of switching between reference adalimumab and biosimilars in different chronic immune-mediated inflammatory diseases. METHODS: Studies presenting data about switching between reference adalimumab and biosimilars were identified by sensitive search strategies in Medline and EMBASE from 1 January 2004 to 30 June 2021. RESULTS: A total of 471 references were obtained and 21 finally included in the analysis (total number of patients switching: 2802). Eight different adalimumab biosimilars were tested after receiving reference adalimumab. Eight articles included rheumatoid arthritis (RA), one miscellaneous rheumatic disease, six psoriasis (PSO) and six inflammatory bowel disease (IBD) patients. Overall, the efficacy results in the switching groups were comparable to those obtained in the arms of continuous biosimilar and continuous reference adalimumab. There were no significant differences in treatment emergent adverse events, anti-drug or neutralising antibodies among the three groups. CONCLUSIONS: Switching between reference adalimumab and biosimilars has no impact on efficacy, safety and immunogenicity in patients with RA, PSO and IBD. This finding was consistent for the different adalimumab biosimilars analysed. These conclusions could probably be extended to other rheumatic diseases such as psoriatic arthritis and ankylosing spondylitis.

Direct costs in patients with chronic inflammatory arthropathies on biological therapy: a real-world data study.

OBJECTIVES: The aim of the study was to assess the direct costs for the Spanish Health System of patients with chronic inflammatory arthropathies treated with biological therapies in daily clinical practice and to establish possible factors associated with lower costs. METHODS: A descriptive, observational and retrospective study was conducted. Patients with rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis who started a biological therapy between 1 January 2009 and 31 December 2016 were included. Variables related to socioeconomic status, disease and biological therapy were included. The annual cost of biological treatment and other direct medical costs were calculated for each disease. The analysis of costs was based on the National Health Service perspective. The time horizon comprised the 8-year long study period. RESULTS: A total of 422 biological therapy lines were analysed. The annual biological therapy cost per patient was €12,494±3,865 for rheumatoid arthritis, €11,248±2,763 for ankylosing spondylitis and €12,263±35,155 for psoriatic arthritis (p=0.008). The cost of biological therapies entailed about 80% of the total cost of these diseases. Hospital admission was a factor which contributed to an increasing cost in all these conditions. A longer duration of the biological therapy was associated with lower cost in all the diseases. CONCLUSIONS: The cost of ankylosing spondylitis is lower than that of rheumatoid arthritis and psoriatic arthritis. The biological therapy is the factor with the highest impact on the overall cost of these diseases. Preventing hospital admissions and a higher persistence to the biological therapy can contribute to lower costs for the system.

Real-world prevalence and consequences of potential drug-drug interactions in the first-wave COVID-19 treatments.

WHAT IS KNOWN AND OBJECTIVE: Initial treatment recommendations of COVID-19 were based on the use of antimicrobial drugs and immunomodulators. Although information on drug interactions was available for other pathologies, there was little evidence in the treatment of COVID-19. The objective of this study was to analyse the potential drug-drug interactions (pDDIs) derived from the medication used in COVID-19 patients in the first pandemic wave and to evaluate the real consequences of such interactions in clinical practice. METHODS: Cohort, retrospective and single-centre study carried out in a third-level hospital. Adult patients, admitted with suspected COVID-19, that received at least one dose of hydroxychloroquine, lopinavir/ritonavir, interferon beta 1-b or tocilizumab and with any pDDIs according to "Liverpool Drug Interaction Group" between March and May 2020 were included. The possible consequences of pDDIs at the QTc interval level or any other adverse event according to the patient's medical record were analysed. A descriptive analysis was carried out to assess possible factors that may affect the QTc interval prolongation. RESULTS AND DISCUSSION: Two hundred and eighteen (62.3%) patients of a total of 350 patients admitted with COVID-19 had at least one pDDI. There were 598 pDDIs. Thirty-eight pDDIs (6.3%) were categorized as not recommended or contraindicated. The mean value difference between baseline and pDDI posterior ECG was 412.3 ms ± 25.8 ms vs. 426.3 ms ± 26.7 ms; p < 0.001. Seven patients (5.7%) had a clinically significant alteration of QTc. A total of 44 non-cardiological events (7.3%) with a possible connection to a pDDI were detected. WHAT IS NEW AND CONCLUSION: The number of pDDIs in patients admitted for COVID-19 in the first pandemic wave was remarkably high. However, clinical consequences occurred in a low percentage of patients. Interactions involving medications that would be contraindicated for concomitant administration are rare. Knowledge of these pDDIs and their consequences could help to establish appropriate therapeutic strategies in patients with COVID-19 or other diseases with these treatments.

Predicted concentrations of antineoplastic drugs in the aquatic environment: The case of Ría de Vigo (NW, Spain).

The European Medicines Agency (EMA) mandates Environmental Risk Assessments (ERAs) since 2006 to determine potential risks of new marketed medicines. Drugs with a Predicted Environmental Concentration (PEC) in inland surface waters exceeding 0.01 µg L-1 require further environmental risk assessment. PEC may be refined based on prevalence data and/or based on the treatment regimen. In this study, based on EMA regulations, refined PEC of 108 antineoplastic drugs in coastal waters were determined based on the consumption in a coastal health area during 2021, identifying six drugs with potential environmental risk in surface waters (hydroxyurea, capecitabine, abiraterone, ibrutinib, imatinib and 5-fluorouracil) and two in marine ecosystem (hydroxyurea and capecitabine). Comparison of these refined PECs with data from marketing laboratories revealed significant disparities, suggesting the need for regular updates, especially with changes in drug indications or financing. Notably, the identified drugs are not yet on the main reference lists of emerging contaminants.

Optical Microscopy as a Tool for Assessing Parenteral Nutrition Solution Stability: A Proof of Concept.

Background/Objectives: Parenteral nutrition (PN) is used when enteral feeding is not possible. It is a complex mixture of nutrients that must meet a patient's needs but can face stability issues, such as lipid emulsion destabilisation and precipitate formation. Stability studies are complex, and the methodologies used are very varied in the literature. In addition, many studies are outdated and use outdated components. This study conducts a stability analysis of PN solutions using optical microscopy. Methods: Samples were prepared according to clinical practice standards and previous studies. We used a counting chamber for optical microscopic observations and different storage conditions (RT, 4 °C 1-14 days). Results: Precipitates larger than 5 µm were found in 8 out of 14 samples after 14 days of storage at room temperature, and none were observed in refrigerated samples. More lipid globules larger than 5 µm were detected in samples stored at room temperature than in those stored in a refrigerator after 14 days. Additionally, the number of large globules generally increased from day 1 to day 14 in most samples. Conclusions: The observed precipitates were probably calcium oxalate crystals, the formation of which is possible in PN but is not expected under the usual storage conditions in a hospital environment. Prolonged storage time and storage at room temperature increases the formation of these precipitates. These findings highlight the importance of using filters during both the preparation and administration of PN to prevent large particles from reaching patients.

Physicochemical Stability of Hospital Parenteral Nutrition Solutions: Effect of Changes in Composition and Storage Protocol.

(1) Background: Parenteral nutrition (PN) is a technique used for the administration of nutrients to patients for whom traditional routes cannot be used. It is performed using solutions with extremely complex compositions, which can give rise to a large number of interactions. These interactions can impact their stability and put the patient's life at risk. The aim of this study is to determine how changes in composition and storage protocol affect the stability of NP solutions. (2) Methods: Twenty-three samples were prepared according to routine clinical practice, with modifications to the concentration of some components. The samples were stored at room temperature (RT) and refrigerated (4 °C). Measurements of the droplet diameter, pH, density and viscosity were performed for both storage protocols on days 1, 3, 10 and 14. (3) Results: The samples with the lowest concentration of lipids (PN13-17) and proteins (PN18-22) showed a larger droplet diameter than the rest of the samples throughout the experiments. The USP limits were exceeded for some of the measurements of these sample groups. The pH density and viscosity remained relatively constant under the conditions studied. (4) Conclusions: The PN samples were considered stable and safe for administration under real-world conditions, but the samples with the lowest concentrations of lipids and proteins showed a tendency towards emulsion instability.

Electron Microscopy for the Stability Assessment of Parenteral Nutrition Admixtures: Focus on Precipitation.

(1) Background: parenteral nutrition (PN) is indispensable for patients unable to receive oral or enteral feeding. However, the complexity of PN solutions presents challenges regarding stability and compatibility. Precipitation reactions may occur. The most frequent is the formation of calcium phosphate (Ca-P). The different factors influencing these reactions must be considered to ensure patient safety. (2) Methods: eight paediatric PN solutions were prepared, following standard protocols. Samples were stored at room temperature and in a refrigerator. Electron microscopy, coupled with energy dispersive X-ray spectroscopy (EDS), was employed. Precipitates were analysed for composition and morphology. (3) Results: precipitates were observed in all samples, even at day 0. Crystalline structures, predominantly composed of calcium or magnesium, sometimes associated with chlorine or phosphorus, were detected. Additionally, amorphous precipitates, contained heterogeneous compositions, including unexpected elements, were identified. (4) Conclusions: various precipitates, primarily calcium- or magnesium-based, can form in PN solutions, although it is not expected that they can form under the real conditions of use. Calcium oxalate precipitation has been characterised, but the use of organic calcium and phosphate salts appears to mitigate calcium phosphate precipitation. Electron microscopy provides interesting results on NP precipitation, but sample preparation may present technical limitations that affect the interpretation of the results.

Evaluation of the Stability of Newborn Hospital Parenteral Nutrition Solutions.

(1) Background: parenteral nutrition (PN) solutions are an extremely complex mixture. It is composed of a multitude of chemical elements that can give rise to a large number of interactions that condition its stability and safety. The aim of this study was to evaluate the stability of PN solutions for preterm infants. (2) Methods: eight samples were prepared according to the protocol for prescribing PN in preterm infants. Samples PN1-PN7 had the normal progression of macronutrients and standard amounts of micronutrients for a 1 kg preterm infant. The PN8 sample had a high concentration of electrolytes, with the idea of forcing stability limits. Samples were stored both at room temperature and under refrigeration. Measurements of globule size, pH, density, and viscosity were performed in both storage protocols on different days after processing. (3) Results: the changes in the composition of the samples did not affect the evolution of the stability at the different measurement times and temperatures. Viscosity was affected by the compositional changes made in the PN samples, but no alterations due to time or temperature were observed. Density and pH remained stable, without significant changes due to time, storage temperature, or different composition. (4) Conclusion: all samples remained stable during the study period and did not undergo significant alterations due to compositional changes or different experimental conditions.

Telemedicine informatics application for nutritional support surveillance of instutionalized persons in nursing homes from a hospital pharmacy service.

INTRODUCTION: Institutionalized patients who require nutrition support regularly visit the Unit of Nutrition Support of the Hospital Pharmacy  Service. During these visits, prior to establishing a nutrition regime and  followup scheme, an initial nutritional status assessment is performed.  Telemedicine and Telepharmacy have expanded in recent years for remote  monitoring of institutionalized persons. OBJECTIVE: To evaluate the implementation of a Telemedicine informatics application for nutritional support surveillance of instutionalized  persons in nursing homes from a hospital pharmacy service. Method: A multidisciplinary team led by the Hospital Pharmacy Service was  created. Data of institutionalized persons in nursing homes needing artificial  nutritional support was extracted from the SILICON prescription system and  the internal ecords of the hospital pharmacy service. Nursing homes were  selected on the basis of their previous experience using the Telemedicine  informatics application TELEA. The following nutritional  support variables were  assessed: score on Mini-Nutritional Assessment questionnaire; a 24-h  food record; pressure ulcer control; and laboratory parameters. The existing  information flow between nursing homes and hospital specialists was analyzed.  The functionalities available on TELEA were considered. RESULTS: In 2021, over 300 institutionalized persons from 28 nursing homes  were incluided for nutritional support surveillance program of the hospital  pharmacy service. The project was implemented in two nursing homes serving  38 patients, although only 13 were involved in the nutrition surveillance  program of the Nutrition Support Unit. Nutritional status assessment and  nutritional support surveillance reports were adapted to the Telemedicine  informatics application. Paper reports were replaced  with electronic data or  online questionnaires available on the informatics application. An information  flow protocol was established. An instantaneous messaging and alert system  was activated, which allowed continuous communication. Some Telepharmacy  requests were categorized as preferential when the clinical status of the patient  so required. All the information generated during the nutritional status  assessment and nutritional support surveillance process was integrated into  the electronic medical history of each patient. CONCLUSIONS: TELEA-based nutritional support surveillance facilitates the  continuum of care by enabling direct communication between nursing homes  and secondary care for institutionalized persons. This model makes it possible  to record nutrition-related data on the electronic medical history of patients  through a Telepharmacy process. This model also eliminates paper  prescriptions and medical reports, and unnecessary travels. A nutritional status  profile should also be made available to facilitate nutrition surveillance in institutionalized persons with chronic diseases. That  would be the first step for a new integrated healthcare informatics application  for frail/polymorbid elderly patients.

Introducción: Los pacientes institucionalizados que requieren soporte  nutricional artificial acuden de forma periódica a las consultas de la Unidad de  Soporte Nutricional del Servicio de Farmacia. En ellas se realiza una  valoración nutricional inicial, a partir de la cual se establece la pauta nutricional  y el plan de seguimiento. La Telemedicina y la Telefarmacia se han  expandido en los últimos años para la monitorización remota de personas  institucionalizadas. OBJETIVO: Evaluar la implementación de una aplicación informática de Telemedicina para la vigilancia del soporte nutricional de personas  nstitucionalizadas en residencias de ancianos desde un servicio de farmacia hospitalaria.Método: Se formó un equipo multidisciplinar liderado por el Servicio de Farmacia. Los datos de pacientes institucionalizados que requieren soporte nutricional artificial se obtuvieron del programa SILICON y de los  registros internos del Servicio de Farmacia. Se eligieron las primeras  residencias candidatas según la experiencia previa en el manejo de la  aplicación informática de asistencia domiciliaria. Se analizaron llas variables de  soporte nutricional necesarias para el seguimiento nutricional: Mini  Nutritional Assessment, recordatorio de ingestas de las últimas 24 horas,  control de úlceras por presión y parámetros analíticos. Se analizó el flujo de  información existente entre las residencias sociosanitarias y la atención  hospitalaria y se valoraron las opciones disponibles a través de la plataforma  tecnológica de asistencia domiciliaria. RESULTADOS: El Servicio de Farmacia realizó seguimiento nutricional a más de  300 pacientes institucionalizados en 28 residencias sociosanitarias en el año  2021. El proyecto se implantó en dos residencias sociosanitarias que cuentan  con 38 pacientes institucionalizados, aunque solo 13 pacientes estaban en  seguimiento por la Unidad de Soporte Nutricional. Todos los registros  generados en la valoración y seguimiento nutricional se adecuaron a la  aplicación informática de asistencia domiciliaria, se cambiaron los registros en  papel por información incluida en la plataforma o cuestionarios online  facilitados a través de la misma. Además, se protocolizó el flujo de información  generada y se activó un sistema de mensajería con alertas que  permite una comunicación continua. En caso de que la situación clínica  del  paciente lo requiera se puede programar una teleconsulta preferente.Toda la  información generada en el proceso de valoración y seguimientonutricional de  cada paciente se integró en la historia clínica electrónica. CONCLUSIONES: El seguimiento nutricional a través de la aplicación informática de asistencia domiciliaria facilita la continuidad asistencial por el establecimiento de una comunicación directa entre las residencias  sociosanitarias y la atención hospitalaria, permitiendo la integración de la  información nutricional de los pacientes en la historia clínica electrónica  mediante un proceso de Telefarmacia. Se han eliminado las prescripciones en  papel, informes clínicos impresos y los desplazamientos innecesarios. El  desarrollo de este perfil podría ser extensible al seguimiento nutricional de  pacientes con patologías crónicas, y ser el precedente de un nuevo programa  de cuidado integral del paciente anciano frágil o pluripatológico.

Haemophagocytic syndrome and paradoxical reaction to tuberculostatics after treatment with infliximab.

CASE: A 44-year-old man was diagnosed with ankylosing spondylitis, on treatment with infliximab. After three doses, he was admitted to hospital with fever, fatigue and nausea. A bone marrow biopsy confirmed haemophagocytic syndrome. He was treated with immunoglobulin, cyclosporine and corticosteroids. CT scan revealed tuberculosis. Tuberculostatic treatment was started 26 days after admission. One month later, he was transferred intensive care with septic shock and acute respiratory distress syndrome. After improvement, he was transferred to the medical ward and later discharged. Two weeks after discharge, he was readmitted with a suspected paradoxical reaction (PR) to tuberculostatics and treated with prednisone. He was discharged 15 days later. CONCLUSIONS: In patients treated with anti-TNF therapy it may be advisable to monitor the signs and symptoms of tuberculosis. HPS is a rare complication of rheumatic diseases. The possibility of developing a PR in immunosuppressed patients treated with antituberculous should be considered.

LEAN methodology: design and assessment of a standardized medication storage model.

OBJECTIVE: The objective of this study was to assess the results of applying  Lean Methodology in the design of a standardized medication storage model in  hospitalization departments. METHOD: Descriptive and retrospective study conducted between September 2017 and January 2019 in a tertiary level hospital. The Pharmacy Service led the creation of a multidisciplinary team. Lean Methodology was used to establish the components and organization and  identification criteria that made up the standardized medication storage model.  The stocks of each hospitalization department were reviewed and quantified, the final amount of stock needed was agreed with the supervisor of each department, and the economic impact of the implementation of the  standardized medication model was assessed. A questionnaire was designed and sent to nursing staff to determine their level of satisfaction with the new model. RESULTS: The standardized medication storage model was scaled up to 20  nursing departments, leading to an overall reduction of 56.72% in the number of pharmaceutical dosage forms available (5,688 vs 2,462). The number of high-risk drugs was reduced by 40.73% (631 vs 374). This elimination of wastage  achieved a saving of €25,357.98. A total of 58 nurses returned the  questionnaires (20.70% of the total): 22.40% worked a fixed shift and 77.60%  worked a rotating shift. The mean score on overall satisfaction was 5.79 ± 3.61  (scores ranged from 1 to 10). CONCLUSIONS: The application of Lean Methodology is very useful for the  management of medication stocks in hospitalization departments. The implementation of a standardized medication storage model leads to  economic savings and a marked reduction in the number of active ingredients and high-risk medications. The nursing staff were satisfied with the  implementation of the model, suggesting that we should continue to pursue this effective line of action.

Objetivo: El objetivo del estudio es evaluar los resultados de la aplicación de la  metodología Lean en el diseño de un modelo estandarizado de almacenaje de  medicación en las unidades de hospitalización. Método: Estudio descriptivo y  retrospectivo desarrollado entre septiembre de  2017 y enero de 2019 en un  hospital de tercer nivel. Se creó un  equipo multidisciplinar liderado por el  Servicio de Farmacia. Se empleó la  metodología Lean para establecer los  elementos y criterios de organización e identificación que conformaron el modelo estandarizado de almacenaje de  medicación. Se revisaron y cuantificaron los stocks de cada unidad de hospitalización, se consensuó la medicación con la supervisora de cada unidad y se estimó el impacto económico de la implantación del modelo estandarizado. Se diseñó y envió una encuesta para evaluar la  satisfacción de enfermería con el nuevo modelo.Resultados: El modelo estandarizado de almacenaje se aplicó en 20 unidades de enfermería y supuso una reducción global del 56,72% en el número  de presentaciones de principios activos disponibles (5.688 versus 2.462). Se disminuyó el número de presentaciones de principios activos  de medicamentos de alto riesgo en un 40,73% (631 versus 374). La eliminación de este despilfarro supuso un ahorro económico de 25.357,98 €. Se recibieron 58 respuestas a la encuesta de satisfacción del personal de enfermería (20,70%  del total de encuestas enviadas), de las que un 22,40% correspondieron al turno fijo y 77,60% al turno rotativo. La media de la satisfacción global (valorada  entre 1 y 10) fue de 5,79 ± 3,61.Conclusiones: La aplicación de la metodología Lean es útil para la gestión de  stocks de medicación de las unidades de hospitalización. La implantación del  modelo estandarizado de almacenaje conlleva un ahorro económico y una  reducción del número de presentaciones de principios activos y de  medicamentos de alto riesgo. El personal de enfermería está conforme con la  implantación del modelo, lo que nos plantea seguir en esta línea de mejora.

Biological therapy safety in chronic inflammatory arthropathy patients.

OBJECTIVE: The marketing of biological therapies transformed the treatment of rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis. But there is still concern about patient safety and management in daily clinical practice. The aim of this study was to estimate risk factors of the adverse effects in a cohort of Spanish patients with rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis. METHODS: A single institution, descriptive, retrospective, cohort study was developed from January 2009 to December 2016. Patients diagnosed with rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis on biological therapies were included. Undesirable events affecting patients during biological therapy, their clinical implications and the use of health resources related to adverse effects were collected. RESULTS: Three hundred and sixty-two patients corresponding to 478 biological therapy lines were analysed. It implied 1192 years of monitoring. There were 57 adverse effects per 100 biological patient- years and 4.8 serious adverse effects per 100 biological patient-years. The only significant factor for a likely serious adverse effect was having a Charlson Index ≥10, OR of 6.2 (CI 95%: 3.4-11.1, p<0.001). Around 15 % of patients with adverse effects were admitted to hospital and 25% received attention at the Emergency Department. CONCLUSION: Over half of the patients with arthropathies on biological therapy can suffer adverse effect during treatment but only 8.5% of these effects are serious. Special vigilance must be paid to patients with a higher number of comorbidities because they are more likely to experience serious adverse effects.

Biological therapy safety in chronic inflammatory arthropathy patients.

OBJECTIVE: The marketing of biological therapies transformed the treatment of rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis. But there is still concern about patient safety and management in daily clinical practice. The aim of this study was to estimate risk factors of the adverse effects in a cohort of Spanish patients with rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis. METHODS: A single institution, descriptive, retrospective, cohort study was developed from January 2009 to December 2016. Patients diagnosed with rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis on biological therapies were included. Undesirable events affecting patients during biological therapy, their clinical implications and the use of health resources related to adverse effects were collected. RESULTS: Three hundred and sixty-two patients corresponding to 478 biological therapy lines were analysed. It implied 1192 years of monitoring. There were 57 adverse effects per 100 biological patient-years and 4.8 serious adverse effects per 100 biological patient-years. The only significant factor for a likely serious adverse effect was having a Charlson Index ≥10, OR of 6.2 (CI 95%: 3.4-11.1, p<0.001). Around 15 % of patients with adverse effects were admitted to hospital and 25% received attention at the Emergency Department. CONCLUSION: Over half of the patients with arthropathies on biological therapy can suffer adverse effect during treatment but only 8.5% of these effects are serious. Special vigilance must be paid to patients with a higher number of comorbidities because they are more likely to experience serious adverse effects.

Content analysis of Twitter in relation to biological treatments for chronic inflammatory arthropathies: an exploratory study.

OBJECTIVE: To analyse the volume and content of tweets in relation to biological treatments for chronic inflammatory arthropathies. METHODS: A Twitter analysis was carried out during one month using the following keywords: 'rheumatoid arthritis', 'ankylosing spondylitis', 'psoriatic arthritis' and their biological therapies: 'abatacept', 'adalimumab', 'certolizumab', 'etanercept', 'golimumab', 'infliximab' and 'tocilizumab'. Tweets were hand-coded and filtered for content. RESULTS: 25 441 tweets contained at least one of the keywords. After filtering, 2480 tweets were included in the analysis. Regarding the 983 tweets about therapies, the most frequently mentioned biologics were 'adalimumab' (n=359), 'infliximab' (n= 278) and 'etanercept' (n= 205). In the 1497 tweets about diseases, the term 'rheumatoid arthritis' (n= 1109) was used more frequently than 'psoriatic arthritis' (n= 233) and 'ankylosing spondylitis' (n= 155). The most commonly addressed subjects in the tweets in relation to biological therapies were related to safety/adverse events (136 of 983 (13.8%)) and to administration, particularly drug infusion (60 of 983 (6.1%)) and self-administration (57 of 983 (5.8%)). Regarding diseases, the most commonly addressed subjects were non-pharmacological recommendations such as alternative therapies (145 of 1497 (9.7%)), nutrition (128 of 1497 (8.5%)) and exercise (91 of 1497 (6.1%)). CONCLUSIONS: Twitter is widely used to search for information about biological treatments for chronic athropathies. Learning more about the subjects dealt with in the tweets will enable us to improve our understanding of the areas of greater interest and concern among patients. This could help hospital pharmacists establish patient-focused strategies addressing the needs of the patients.

Adherence to biological therapies in patients with chronic inflammatory arthropathies.

INTRODUCTION: The aims of the study were to quantify adherence, determine the factors that can  predict adherence and identify the consequences of poorer adherence in patients with chronic  inflammatory arthropathies treated with biological therapies in daily clinical practice. METHOD: A descriptive, observational and retrospective study was carried out. Patients with  rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis who started a biologic therapy  between 1 January 2009 and 31 December 2016 were included. Variables related to socioeconomic  status, the disease, the biological therapy and hospital resources were included. Adherence was  calculated by using the medication possession ratio. RESULTS: Three hundred and sixty-two patients and 423 lines of biological therapy were included.  Mean age ± standard deviation was 50.3 ± 13.9 years, and 228 (53.9%) were women. The  percentage of adherent patients was 187 out of 216 (87%) in rheumatoid arthritis, 91 out of 107  (85%) in ankylosing spondylitis and 84 out of 100 (84%) in psoriatic arthritis. Greater adherence was  associated with more frequent visits to the pharmacy service (odds ratio 1.2, 95% confidence  interval: 1.1-1.3 [p = 0.001]) and poorer adherence with a failure to attend scheduled appointments  at the rheumatology clinic (odds ratio 0.2, 95% confidence interval: 0.1-0.9 [p = 0.030]). There were  no differences between  adherent and non-adherent patients in terms of the number of hospital resources used. CONCLUSIONS: There are no differences in adherence to biological therapies among patients with  chronic inflammatory arthropathies. Adherence correlates with attendance at outpatient  appointments, but this does not imply an increase in the use of hospital resources.

Objetivo: Los objetivos del estudio fueron cuantificar la adherencia, determinar los factores  predictivos y conocer las consecuencias de una menor adherencia, en la práctica clínica diaria, en  pacientes con artropatías inflamatorias crónicas tratados con terapias biológicas. Método: Estudio descriptivo, observacional y retrospectivo. Se incluyeron pacientes con artritis  reumatoide, espondilitis anquilosante y artritis psoriásica que iniciaron una terapia biológica entre el 1  de enero de 2009 y el 31 de diciembre de 2016. Se recogieron variables sociodemográficas, relacionadas con la enfermedad, sobre las terapias biológicas y los recursos  hospitalarios. La adherencia se calculó mediante la ratio media de posesión.Resultados: Se incluyeron 362 pacientes y 423 líneas de terapia biológica. La media de edad ±  desviación estándar fue de 50,3 ± 13,9 años; 228 (53,9%) fueron mujeres. El porcentaje de  adherentes fue de 187 de 216 (87%) en artritis reumatoide, 91 de 107 (85%) en espondilitis  anquilosante y 84 de 100 (84%) en artritis psoriásica. La adherencia se relacionó con acudir con más  frecuencia a la consulta del servicio de farmacia(odds ratio de 1,2; intervalo de confianza 95%: 1,1- 1,3 [p = 0,001]) e inversamente con no acudir a las consultas de reumatología en la fecha prevista (odds ratio de 0,2; intervalo de confianza 95%: 0,1-0,9 [p = 0,030]). No hubo diferencias en  el número de recursos hospitalarios utilizados por pacientes adherentes y no adherentes.Conclusiones: La adherencia a las terapias biológicas entre las artropatías inflamatorias crónicas es  similar. Dicha adherencia se correlaciona con la frecuentación a consultas externas, pero no implica  un aumento del consumo de recursos.

Spanish Society of Hospital Pharmacy position paper on biosimilar medicines.

Biological medicines nowadays have a great impact, as they offer treatment for  diverse diseases and suppose a high cost for health system. Biosimilar medicines contain a version of an active substance already authorized as an original  biotechnological medicine, whose patent has expired, and they comply with the  guidelines published by the European Medicines Agency. These guidelines, where biosimilarity criteria are established, guarantee comparability between biosimilar product and reference one. Biosimilars' authorization is carried out through a  centralized procedure based on clinical, non-clinical and quality studies. These  studies allow the extrapolation of indications, frequently, without carrying out additional analyses. In several European countries, switching between  original and biosimilar medicine is considered safe. In Spain, Pharmacy and Therapeutic Committee of hospitals, as consensus bodies among health professionals, are the most suitable bodies to establish the  interchangeability criteria in each center. Biosimilar drugs contribute to  sustainability and to improvement of the accessibility to medicines. Faced with  this situation, Spanish Society of Hospital Pharmacy considers interesting to  express its position about biosimilar medicines' strategies. Spanish Society of  Hospital Pharmacy, in September 2015, published an information note about biosimilar medicines, in which its role as medicines similar in quality,  safety and efficacy to the originals, but at lower cost, was highlighted. Likewise, it was stressed the role of hospital pharmacists within the Pharmacy  and Therapeutic Committee of hospitals, where their knowledge for the  selection, evaluation and use of medicines could be useful, in coordination and permanent collaboration with other units or clinical services of hospitals.

Los medicamentos biológicos actualmente presentan un gran impacto, ya que ofrecen tratamiento para diversas enfermedades y suponen un elevado  coste para el sistema sanitario. Los medicamentos biosimilares contienen una  versión de una sustancia activa ya autorizada como medicamento biotecnológico original, cuya patente ha caducado, y cumplen con las guías publicadas por la European Medicines Agency, que establecen los criterios de biosimilitud para garantizar la comparabilidad entre el producto biosimilar y el de referencia.  La autorización de los biosimilares se realiza mediante un procedimiento  centralizado, a través de estudios comparativos clínicos, no-clínicos y de calidad, que permiten la extrapolación de indicaciones, frecuentemente sin realizar  estudios adicionales. Algunos países europeos consideran seguro el intercambio  entre medicamento original y biosimilar. En España, las Comisiones de Farmacia y Terapéutica hospitalarias, como órganos de consenso entre  profesionales sanitarios, se consideran las más adecuadas para establecer los  criterios de intercambiabilidad en cada centro. Los biosimilares contribuyen a la  sostenibilidad y a la accesibilidad a los medicamentos. Ante esta situación, la  Sociedad Española de Farmacia Hospitalaria considera de interés expresar su  posicionamiento sobre las estrategias relacionadas con los medicamentos  biosimilares. La Sociedad Española de Farmacia Hospitalaria, en septiembre de  2015, publicó una nota informativa sobre los medicamentos biosimilares, en la  que destacó su similitud en calidad, seguridad y eficacia respecto a los  originales, pero con menor coste. Igualmente, se recalcó el papel del  farmacéutico hospitalario en las Comisiones de Farmacia y Terapéutica  hospitalarias, donde sus conocimientos son útiles para la selección, evaluación y  empleo de los medicamentos, en coordinación y colaboración permanente con  los demás servicios clínicos del hospital.

Factors associated with patient satisfaction in an outpatient hospital pharmacy.

OBJECTIVE: To analyse the factors leading to greater satisfaction among patients attending the outpatient hospital pharmacy (OPh). METHODS: A cross-sectional study was conducted of patients attending the OPh of a 1250-bed university hospital. A self-administered questionnaire for measuring outpatients' satisfaction was developed. Global satisfaction was measured on a scale of 1 to 10. Indices of perceived quality for accessibility, interpersonal professional-patient relationship and the convenience of the process were modelled through a principal component analysis using varimax rotation. The relationship between the principal components and overall satisfaction was evaluated using regression analysis. RESULTS: A questionnaire-based survey was conducted between May and June 2015. A total of 509 valid responses (86.9% response rate) were collected from the OPh. The overall satisfaction score was 7.81 (95% CI 7.59 to 8.04). The principal component analysis produced two components that explained 62.1% of the variance. The first component (CP1) contained questions related to the adequacy of the resources and services. The second component (CP2) contained questions about interpersonal professional-patient relationship. An additional unit in the CP2 was associated with a 3.23 increased risk of having higher satisfaction scores, while an increase of an additional unit in CP1 was associated with a 1.93 increased risk of having higher satisfaction scores. CONCLUSIONS: Our study shows that the factor which predicts the satisfaction of patients who come to the OPh is the quality of care provided by pharmacists-in particular, information provided, resolution of doubts, personal attention and time devoted to the patient.

[Pharmaceutical care strategies to prevent medication errors]. / Estrategias de atención farmacéutica para prevenir errores de medicación.

OBJECTIVE: To evaluate the impact of implementing new programs to improve the quality of the pharmaceutical care and unit-dose distribution system for in-patients. MATERIAL AND METHODS: An observational and prospective study was carried out in a general hospital during two different six-monthly period. Transcription and dispensation errors were evaluated in twelve wards during the first six months. Then, two new measures were introduced: the first- reference ward-pharmacist and the second-a new protocol for checking medication on the ward. Results were evaluated by SPSS v. 14 program. RESULTS: In the transcription evaluation, units without a ward pharmacist did not improve. Transcription errors significantly decreased in three units: gynaecology-urology (3.24% vs. 0.52%), orthopaedic (2% vs. 1.69%) and neurology-pneumology (2.81% vs. 2.02%). In dispensing, only units with the new protocol decreased their medication errors (1.77% vs. 1.24%). CONCLUSIONS: The participation of pharmacists in multidisciplinary teams and exhaustive protocols for dispensing medication were effective in detecting and decreasing medication errors in patients.