The Real-World Effectiveness, Persistence, Adherence, and Safety of Janus Kinase Inhibitor Baricitinib in Rheumatoid Arthritis: A Long-Term Study.

Background/Aim: Baricitinib (BAR) is the first oral selective Janus kinase inhibitor approved in Europe for rheumatoid arthritis (RA). Real-world data are still needed to clarify its long-term benefits/risk profile. This study aimed to evaluate the effectiveness, persistence, adherence, and safety of BAR in a real-world setting. Methods: An ambispective study was conducted between October 2017 and December 2021 in RA patients starting BAR. The effectiveness was evaluated, assessing changes from the baseline of the Disease Activity Score using 28-joint counts-C reactive protein (DAS28CRP), and the achievement of low disease activity/remission. Drug persistence was evaluated using Kaplan-Meier analysis. Adherence was estimated using the medication possession ratio (MPR) and the 5-item Compliance Questionnaire for Rheumatology. Safety was assessed determining global incidence proportion and adverse event adjusted incidence rates. Results: In total, 61/64 recruited patients were finally analyzed, 83.6% were female, 78.7% were seropositive, the mean age was 58.1 (15.4) years, and the disease duration was 13.9 (8.3) years. A total of 32.8% of patients were naïve to biologics and 16.4% received BAR as monotherapy. The median exposure to BAR was 12.4 (6.6-31.2) months (range 3.1-51.4). A significant change in DAS28CRP was observed after treatment (difference -1.2, p = 0.000). 70.5% and 60.7% of patients achieved low disease activity or remission, respectively, and 50.8% (31/61) remained on BAR throughout the follow-up, with a median persistence of 31.2 (9.3-53.1) months. The average MPR was 0.96 (0.08) and all patients exhibited "good adherence" according to the questionnaire. In total, 21.3% of patients discontinued baricitinib due to toxicity. Conclusions: In our real-world practice, BAR demonstrated effectiveness, large persistence, high adherence to treatment, and an acceptable safety profile.

Anti-interleukin-17 therapies for moderate/severe psoriasis in clinical practice: effectiveness, safety and association with clinical patient factors.

OBJECTIVES: Interleukin-17 (IL-17) contributes to the pathogenesis of psoriasis. Secukinumab, ixekizumab, and brodalumab are monoclonal antibodies anti-IL-17 antibodies, approved for the treatment of moderate/severe plaque psoriasis.The aim of the study was to describe the effectiveness and safety of anti-IL-17 agents in moderate/severe plaque psoriasis in clinical practice. We also analysed anti-IL-17 therapies' survival, dose adjustment, and clinical patients' factors associated with their effectiveness and safety. METHODS: A retrospective, longitudinal study was conducted at a tertiary hospital. We included patients with moderate/severe psoriasis treated with anti-IL-17 agents. The effectiveness was evaluated with Psoriasis Area and Severity Index (PASI) score and safety through the adverse drug reactions (ADRs) collected. RESULTS: 38 patients were studied (median age=47.4 years, 71.0% male). The mean number of biological therapies that patients received was 2.6, and anti-IL-17 therapy was the first biological therapy for 36.8% of patients. The median years in treatment were 2.5 (95% CI 1.95 to 2.98) for secukinumab, 1.2 (95% CI 0.36 to 1.47) for ixekizumab, and 0.7 (IQR 0.71) for brodalumab. The median PASI score after 6 months of treatment was 0 (IQR 0) and 85.3% of patients achieved a PASI of 90 (84.0% with secukinumab, 87.5% with ixekizumab, and 100% with brodalumab). Dose adjustment was associated with the line of treatment (p=0.034 for naïve patients), age (p=0.044 for younger patients), and concomitant pathologies (p=0.015 without more diseases).24 patients suffered from ADRs, mainly infections of the upper respiratory tract, and there were no statistically significant differences between the three therapies. CONCLUSIONS: Anti-IL-17 agents constitute an effective treatment for patients with moderate/severe plaque psoriasis and for longer. Dose reductions were associated with fewer lines of treatment, younger patients and absence of concomitant pathologies. ADR were minor and similar among the anti-IL-17.

Real-world outcomes of abiraterone and enzalutamide in first-line treatment of metastatic castration-resistant prostate cancer: which patients benefit most?

OBJECTIVES: Abiraterone and enzalutamide are two oral novel androgen receptor axis-targeted agents approved for the treatment of castration-resistant prostate cancer (mCRPC). Despite the availability of multiple treatments, there is a need to improve the knowledge and management of these drugs in the real-world setting, especially in patient groups under-represented in clinical trials. Our aim was to review the outcome of patients with chemotherapy-naïve mCRPC treated with abiraterone or enzalutamide in routine clinical practice in order to identify factors that are predictive for response. METHODS: This observational retrospective study was performed in a Spanish tertiary hospital and included men with chemotherapy-naïve mCPRC who started treatment with abiraterone or enzalutamide between September 2012 and November 2018. The study end date was 30 October 2020. RESULTS: Ninety patients with mCRPC were included, 57 with abiraterone and 33 with enzalutamide. Median overall survival (OS) was 26.87 months (95% CI 19.68 to 34.05), with no difference found between the two treatment groups. Nine variables were related to increased OS in the univariate analysis: Eastern Cooperative Oncology Group (ECOG) performance status (0-1 vs 2), pain (need of opioids for cancer pain), visceral disease, ≥3 bone lesions, exclusively lymph node metastases, baseline prostate specific antigen (PSA) (<50 vs ≥50 ng/dL and <20 vs ≥20 ng/dL), haemoglobin (<12 vs ≥12 g/dL) and alkaline phosphatase (≤116 vs >116 IU/L). A PSA response >50% was observed in 65 patients (76.5%). In the multivariate analysis, ECOG performance status, pain, visceral disease and alkaline phosphatase provided independent prognostic information. Median OS by Kaplan-Meier analysis was significantly longer for patients with a PSA response (32.1 vs 17.9 months; HR 0.46, 95% CI 0.27 to 0.78; p=0.003). CONCLUSIONS: This study assessed the efficacy of abiraterone and enzalutamide in a real-world setting, including patients under-represented in pivotal studies. Some clinical factors were correlated with improved OS in chemotherapy-naïve men with mCPRC treated with these drugs.

Development of a telematic pharmaceutical care app (Haemoassist) for multidisciplinary follow-up of patients with congenital coagulopathies.

BACKGROUND: Guidelines for congenital coagulopathies recommend that patients record treatment administrations and bleeding episodes to help healthcare professionals monitor the disease. RESEARCH DESIGN AND METHODS: We studied over two years which patient profiles (age, treatment regimen, treatment compliance) were most likely to accept the use of an app to collect this information. We validated the quality of patient-reported data by comparing it with data obtained from hospital electronic records, pharmacy dispensing records and patient interview, collected in an access database used as a reference. Patient and professional opinions were solicited through open-ended interviews. RESULTS: The app was used by 52% of 315 patients studied. Younger patients were the most frequent users. Patients with better treatment compliance used the app more, although data collection was incomplete for most patients. The best rated by patients were the reminders of days of administration and the minimum stock alerts at home. Healthcare professionals rated the app positively. CONCLUSIONS: Healthcare professionals valued the app as useful for managing treatment of congenital coagulopathies. Patients need support and time to use the app and improve the quality of the data entered. Patients who used the app rated it positively. The treatment compliance improved.

Intervention by a clinical pharmacist carried out at discharge of elderly patients admitted to the internal medicine department: influence on readmissions and costs.

BACKGROUND: Patient education on pharmacological treatment could reduce readmissions. Our objective was to carry out a pharmacist intervention focused on providing information about high-risk medications to chronic patients and to analyse its influence on readmissions and costs. METHODS: A single-centre study with an intervention group and a retrospective control group was conducted. The intervention was carried out in all polymedicated patients ≥ 65 years who were admitted to internal medicine and signed the informed consent between June 2017 and February 2018. Patients discharged to nursing homes or long-term hospitals were excluded. The control group were all the patients who were admitted during the same months of 2014 who met the same inclusion criteria. The patients were classified according to the HOSPITAL score as having a low, intermediate, or high risk of potentially avoidable readmission. Outcome measures were 30-day readmission and cost data. To analyse the effect of the intervention on readmission, a logistic regression was performed. RESULTS: The study included 589 patients (286 intervention group; 303 control group). The readmission rate decreased from 20.13% to 16.43% in the intervention group [OR = 0.760 95% CI (0.495-1.166); p = 0.209)]. The incremental cost for the intervention to prevent one readmission was €3,091.19, and the net cost saving was €1,301.26. In the intermediate- and high-risk groups, readmissions were reduced 10.91% and 10.00%, and the net cost savings were €3,3143.15 and €3,248.71, respectively. CONCLUSIONS: The pharmacist intervention achieved savings in the number of readmissions, and the net cost savings were greater in patients with intermediate and high risks of potentially avoidable readmission according to the HOSPITAL score.

Safety and effectiveness of a four-factor prothrombin complex concentrate for vitamin K antagonist reversal following a fixed-dose strategy.

OBJECTIVES: Early reversal of anticoagulation improves outcomes in major bleeding and emergency surgery. To reverse vitamin K antagonists (VKA), vitamin K in addition to prothrombin complex concentrate (PCC) is recommended. Dosing recommendations for VKA reversal provided by the manufacturer are 25-50 IU/kg depending on the baseline international normalised ratio (INR). Nevertheless, we recommend an initial fixed dose of 1000 IU, and additional 500 IU doses evaluated on a case-by-case basis. As there is a paucity of clinical data demonstrating the efficacy and safety of this strategy, we designed this study to assess the effectiveness and safety of a four-factor (4F)-PCC for VKA reversal following a fixed-dose strategy. METHODS: This was a retrospective study of adult patients who received 4F-PCC for VKA reversal. The primary outcome was INR correction. INR correction was achieved if the first INR draw after 4F-PCC was ≤1.5. Safety outcome was any confirmed thromboembolic event within 3 months after 4F-PCC. Secondary outcomes included activated partial thromboplastin time (aPTT) correction, as well as haemostatic effectiveness for bleeding patients. RESULTS: A total of 145 patients were included: 106 (73.1%) in the bleeding group and 39 (26.9%) in the emergency surgery group. The INR target was reached in 102 (70.3%) patients (p<0.0001). In one case, a thromboembolic complication was possibly related to 4F-PCC. The aPTT ratio target was reached in 113 (77.9%) patients (p<0.0001), and 79 of the 106 (74.5%) patients reversed for bleeding achieved haemostatic effectiveness. CONCLUSIONS: After 4F-PCC, the majority of patients achieved the target INR, meaning 4F-PCC is a useful modality for rapid INR reduction. The safety profile may be considered acceptable. Fixed-dose 4F-PCC was able to restore haemostasis rapidly while minimising the risk of adverse events and optimising available resources.

Factores asociados a la persistencia a largo plazo de rituximab en artritis reumatoide en la práctica clínica: Estudio RITAR / Factors associated with long-term persistence of rituximab in rheumatoid arthritis In clinical practice: RITAR Study

ANTECEDENTES Y OBJETIVO: El tratamiento de la artritis reumatoide con rituximab (RTX) requiere ciclos repetidos y no existe una pauta bien establecida en dosis y frecuencia de retratamiento. El objetivo fue analizar la persistencia del tratamiento con RTX y los factores que influyen en condiciones de práctica clínica habitual. MATERIALES Y MÉTODOS: RITuximab en Artritis Reumatoide (Estudio RITAR) es un estudio observacional, retrospectivo que analiza la persistencia de RTX en una cohorte desde 2003 hasta 2015. La persistencia se calculó por análisis de Kaplan-Meier, las curvas se compararon con el test del Log-Rank. Para cuantificar el riesgo de suspensión se utilizó la regresión de Cox, se realizaron análisis multivariables para determinar los factores asociados a la persistencia del tratamiento. RESULTADOS: Se incluyeon 454 ciclos de RTX pertenecientes a 114 pacientes. La mediana de supervivencia fue 10 años y la tasa de incidencia de suspensión 7,7 por cada 100 pacientes-año. Los factores asociados a la persistencia fueron la seropositividad, el uso de RTX combinado con FAMEsc. No estuvieron asociados sexo, edad, n.° de comorbilidades, tiempo de evolución, n.° de complicaciones, DAS28 basal, HAQ basal, número de líneas de tratamiento, pauta de retratamiento fijo o a demanda, año de inicio de RTX. Los modelos multivariables confirmaron la relación entre seropositividad, uso en monoterapia y persistencia de RTX. CONCLUSIONES: La persistencia de RTX en la práctica clínica es elevada en pacientes seropositivos y en aquellos que están tratados con RTX asociado a un FAMEsc. La dosis por ciclo y la frecuencia de retratamiento no tienen un papel determinante en la persistencia

BACKGROUND AND OBJECTIVE: Treatment of rheumatoid arthritis with rituximab (RTX) requires repeated cycles, but there is no well-established retreatment regimen in dose and frequency. The objective was to analyse the persistence of RTX treatment and factors that influence in terms of routine clinical practice. METHODS: Rituximab in Rheumatoid Arthritis (RITAR Study) is an observational, retrospective study that analyses the persistence of RTX in a cohort from 2003 to 2015. Persistence was calculated by the Kaplan-Meier analysis; curves were compared with the Log-Rank test. Cox regression was used to quantify the risk of discontinuation and multivariate analyses were conducted to determine the factors associated with the persistence of the treatment. RESULTS: 454 cycles of RTX in 114 patients were included. Median survival was 10.0 years and incidence rate of discontinuation was 7.7 per 100 patients/year. Factors associated with persistence were autoantibody positivity and use of RTX in combination with csDMARDs. Sex, age, number of comorbidities, rheumatoid arthritis evolution, number of complications, basal DAS28, basal HAQ, number of lines of treatment, fixed or on demand retreatment and year of RTX starting were not associated. Multivariable models confirmed the relationship between autoantibody positivity, monotherapy and persistence of RTX. CONCLUSIONS: The persistence of RTX in clinical practice is higher in seropositive patients and in those who are treated with RTX associated with a csDMARD. Dose per cycle and retreatment frequency do not have a decisive role in rituximab persistence

Off-Label and Unlicensed Drugs in Pediatric Palliative Care: A Prospective Observational Study.

CONTEXT: Off-label and unlicensed use of drugs is a widespread practice in pediatric care because of the lack of specific efficacy and safety data and the absence of formulations adapted to the needs of these individuals. Pediatric patients with a life-limiting illness frequently receive drugs under these conditions, although no studies have established the prevalence of this practice. OBJECTIVES: To describe the prevalence, indications, and most common uses of off-label and unlicensed drugs in a pediatric palliative care unit (PPCU). METHODS: A prospective cross-sectional observational study carried out between January and October 2019. RESULTS: About 85 patients involving 1198 prescriptions were analyzed. A total of 39.6% were off label, and 12.9% were unlicensed. All received at least one off-label drug, with a median of five per patient (interquartile range 3-7), and 81.2% received at least one unlicensed drug. A total of 36.1% of the prescriptions were considered off label because of indication, 33.8% because of dosage, and 26.6% because of age. The main drugs used off label were oral morphine, oral levetiracetam, inhaled albuterol, sublingual ondansetron, oral tizanidine, sublingual fentanyl, and oral diazepam. The main symptoms treated with off-label drugs were dyspnea, pain, and nausea/vomiting. CONCLUSION: More than half of the prescriptions in this PPCU were off label or unlicensed. Treatment indication was one of the main reasons for off-label use. Administration of compounded preparations was common in patients with a life-limiting illness.

Factors associated with long-term persistence of rituximab in rheumatoid arthritis In clinical practice: RITAR Study. / Factores asociados a la persistencia a largo plazo de rituximab en artritis reumatoide en la práctica clínica: Estudio RITAR.

BACKGROUND AND OBJECTIVE: Treatment of rheumatoid arthritis with rituximab (RTX) requires repeated cycles, but there is no well-established retreatment regimen in dose and frequency. The objective was to analyse the persistence of RTX treatment and factors that influence in terms of routine clinical practice. METHODS: Rituximab in Rheumatoid Arthritis (RITAR Study) is an observational, retrospective study that analyses the persistence of RTX in a cohort from 2003 to 2015. Persistence was calculated by the Kaplan-Meier analysis; curves were compared with the Log-Rank test. Cox regression was used to quantify the risk of discontinuation and multivariate analyses were conducted to determine the factors associated with the persistence of the treatment. RESULTS: 454 cycles of RTX in 114 patients were included. Median survival was 10.0 years and incidence rate of discontinuation was 7.7 per 100 patients/year. Factors associated with persistence were autoantibody positivity and use of RTX in combination with csDMARDs. Sex, age, number of comorbidities, rheumatoid arthritis evolution, number of complications, basal DAS28, basal HAQ, number of lines of treatment, fixed or on demand retreatment and year of RTX starting were not associated. Multivariable models confirmed the relationship between autoantibody positivity, monotherapy and persistence of RTX. CONCLUSIONS: The persistence of RTX in clinical practice is higher in seropositive patients and in those who are treated with RTX associated with a csDMARD. Dose per cycle and retreatment frequency do not have a decisive role in rituximab persistence.

Impacto de la protocolización de mezclas intravenosas de fármacos vasoactivos en el coste del tratamiento del paciente crítico / Impact of the implementation of vasoactive drug protocols on costs in the treatment of critically ill patients

Objetivo: Evaluar la eficiencia de la protocolización y centralización de la elaboración de mezclas intravenosas de fármacos vasoactivos en el tratamiento del paciente crítico. Método: Se realizó un estudio prospectivo, de intervención (julio 2012-diciembre 2014) para medir el impacto de la protocolización de mezclas intravenosas en el coste del tratamiento del paciente crítico. Para realizar el análisis económico se compararon los costes directos (fijos y variables) de la preparación de mezclas intravenosas de fármacos vasoactivos en el Servicio de Farmacia versus preparación en planta. Se midieron las variables tiempo y coste de elaboración de una mezcla intravenosa. Para la determinación del coste final de elaboración se incluyeron medicamento, diluyente, material fungible, personal y utilización de las cabinas de flujo laminar. Los costes se midieron en euros. Resultados: La diferencia encontrada en los tiempos de elaboración entre el Servicio de Farmacia y la Unidad de Enfermería (2,10 versus 2,86 minutos) fue estadísticamente significativa y favorable a la elaboración centralizada en el Servicio de Farmacia. El coste medio de elaboración por mezcla fue 5,24 ± 1,45 euros en el Servicio de Farmacia y 5,62 ± 1,55 euros en planta, aunque la diferencia encontrada no alcanzó la significación estadística. Al incluir en el análisis el coste de las mezclas intravenosas caducadas antes de su utilización, la preparación centralizada en el Servicio de Farmacia supuso un coste superior (2.174 euros/año). Conclusiones: La elaboración en el Servicio de Farmacia supone un ahorro significativo de tiempo en comparación con la preparación en planta. La diferencia de coste de esta alternativa, debida principalmente al impacto de las mezclas intravenosas caducadas, se eliminaría al optimizar la producción en la Unidad de Mezclas Intravenosas y al minimizar las pérdidas por caducidad (AU)

Objective: To evaluate the efficiency of the protocolization and centralization of the preparation of intravenous vasoactive drug mixtures in the treatment of critically ill patients. Method: A prospective interventional study (July 2012-December 2014) was conducted to measure the impact of different vasoactive drug protocols on costs in the treatment of critically ill patients. The economic impact was measured by comparing the direct costs (fixed and variable) of the preparation of intravenous vasoactive drug mixtures in the Pharmacy Department with their traditional preparation in hospital care units. The variables time and cost of preparation of an intravenous mixture were measured. Costs included pharmaceutical product, diluent, medical supplies, cost of manpower, and use of laminar flow cabinets in the Pharmacy Department. Costs were measured in Euros. Results: A statistically significant difference was found between processing times in the Pharmacy Department and those in the hospital care unit (2.10 vs 2.86 minutes). Centralized preparation in the Pharmacy Department was more efficient. The average cost of preparation was euros5.24±1.45 in the Pharmacy Department and euros5.62±1.55 in the hospital care unit, although this difference did not reach statistical significance. If the analysis had included the cost of intravenous mixtures that had expired prior to their use, the centralized preparation of the mixtures in the Pharmacy Department would have entailed a higher cost (euros2174/y). Conclusions: The centralized preparation of intravenous mixtures in the Pharmacy Department entails significant time savings compared with their preparation in the hospital care unit. The increased cost of their preparation in the Pharmacy Department would be prevented by optimizing production in this department and reducing losses due to expired intravenous mixtures (AU)

Impact of the implementation of vasoactive drug protocols on costs in the treatment of critically ill patients.

OBJECTIVE: To evaluate the efficiency of the protocolization and centralization of  the preparation of intravenous vasoactive drug mixtures in the treatment of  critically ill patients. METHOD: A prospective interventional study (July 2012-December 2014) was  conducted to measure the impact of different vasoactive drug protocols on costs  in the treatment of critically ill patients. The economic impact was measured by  comparing the direct costs (fixed and variable) of the preparation of intravenous  vasoactive drug mixtures in the Pharmacy Department with their traditional  preparation in hospital care units. The variables time and cost of preparation of  an intravenous mixture were measured. Costs included pharmaceutical product,  diluent, medical supplies, cost of manpower, and use of laminar flow cabinets in  the Pharmacy Department. Costs were measured in Euros. RESULTS: A statistically significant difference was found between processing times in the Pharmacy Department and those in the hospital care unit (2.10 vs 2.86 minutes). Centralized preparation in the Pharmacy Department  was more efficient. The average cost of preparation was €5.24±1.45 in the  Pharmacy Department and €5.62±1.55 in the hospital care unit, although this  difference did not reach statistical significance. If the analysis had included the  cost of intravenous mixtures that had expired prior to their use, the centralized  preparation of the mixtures in the Pharmacy Department would have entailed a  higher cost (€2 174/y). CONCLUSIONS: The centralized preparation of intravenous mixtures in the Pharmacy Department entails significant time savings compared with their preparation in the hospital care unit.

Objetivo: Evaluar la eficiencia de la protocolización y centralización de la  elaboración de mezclas intravenosas de fármacos vasoactivos en el tratamiento  del paciente crítico.Método: Se realizó un estudio prospectivo, de intervención (julio 2012- diciembre 2014) para medir el impacto de la protocolización de mezclas  intravenosas en el coste del tratamiento del paciente crítico. Para realizar el  análisis económico se compararon los costes directos (fijos y variables) de la  preparación de mezclas intravenosas de fármacos vasoactivos en el Servicio de  Farmacia versus preparación en planta. Se midieron las variables tiempo y coste de elaboración de una mezcla intravenosa. Para la determinación del coste final  de elaboración se incluyeron medicamento, diluyente, material fungible,  personal y utilización de las cabinas de flujo laminar. Los costes se midieron en  euros.Resultados: La diferencia encontrada en los tiempos de elaboración entre el  Servicio de Farmacia y la Unidad de Enfermería (2,10 versus 2,86 minutos) fue  estadísticamente significativa y favorable a la elaboración centralizada en el  Servicio de Farmacia. El coste medio de elaboración por mezcla fue 5,24 ± 1,45  euros en el Servicio de Farmacia y 5,62 ± 1,55 euros en planta, aunque la  diferencia encontrada no alcanzó la significación estadística. Al incluir en el  análisis el coste de las mezclas intravenosas caducadas antes de su utilización,  la preparación centralizada en el Servicio de Farmacia supuso un coste superior  (2.174 euros/año).Conclusiones: La elaboración en el Servicio de Farmacia supone un ahorro  significativo de tiempo en comparación con la preparación en planta. La  diferencia de coste de esta alternativa, debida principalmente al impacto de las  mezclas intravenosas caducadas, se eliminaría al optimizar la producción en la  Unidad de Mezclas Intravenosas y al minimizar las pérdidas por caducidad.

Errores de medicación en quimioterapia antes y después de la implantación de un sistema de prescripción electrónica asistida / Chemotherapy medication errors before and after the implementation of an electronically assisted prescription system

Identificar, cuantificar y comparar los errores de medicación (EM) de antineoplásicos que se producen con un sistema de prescripción manual y con un sistema de prescripción electrónica asistida (PEA). Estudio observacional, descriptivo, prospectivo, realizado en pacientes ingresados en una unidad de Hematología. Se analizaron los EM producidos antes y después de la implantación de la PEA. Se detectaron 184 EM y 53 de identificación de pacientes. La RRR fue del 92,03% y la RAR del 40,02%. Las disminuciones de los errores en las categorías de falta de prescripción de un medicamento necesario, dosis mayor, error de preparación/manipulación, vía de administración y velocidad de administración fueron estadísticamente significativas. La PEA de antineoplásicos disminuye el número de EM. Evita errores derivados de la omisión de información y disminuye los relacionados con la dosis y la estabilidad de las mezclas (AU)

To identify, quantify and compare medication errors (ME) of antineoplastic agents produced with manual prescriptions and with electronically assisted prescriptions (EAP). An observational, descriptive, prospective study in a haematological hospitalisation unit. Antineoplastic agents ME were determined before and after implementation of EAP. 184 ME and 53 identification errors were detected. A RRR of 92,03% and an AAR of 40,02% were obtained. Non-prescription medication errors, higher dose errors, wrong preparation or handling errors, administration route errors and rate of administration errors were significantly lower with EAP. Antineoplastic agents ME have decreased since computerising the prescription process. The decrease of omission errors, dosage-related errors and those related to the stability of the mixtures stands out (AU)

Estudio de Utilización de Dabigatrán Etexilato en Pacientes Hospitalizados / Utilization Study of Dabigatran Etexilate in Hospitalized Patients

Se ha definido el perfil de utilización de dabigatrán etexilato en pacientes hospitalizados, en un estudio de utilización de tipo prescripción-indicación, observacional, prospectivo, de cuatro meses de duración, realizado en un hospital general. Los datos se obtuvieron, a partir de los tratamientos farmacológicos del programa de prescripción electrónica, las analíticas y la historia clínica de los pacientes. Se revisó la adaptación a la ficha técnica del medicamento y al protocolo de utilización del hospital, teniendo en cuenta que la prescripción está restringida a los Servicios de Traumatología y Geriatría para la prevención primaria de episodios tromboembólicos tras cirugía programada de reemplazo total de cadera o rodilla. Se registró la incidencia de reacciones adversas al medicamento. Se utilizaron 138 pacientes, que iniciaron el tratamiento con dabigatrán etexilato, de los cuales el 97,10% ingresó en el servicio de Traumatología. En un 89,13% de los pacientes, se prescribió el dabigatrán para la indicación aprobada en ficha técnica, mientras que en un 10,87%, se utilizó para otras indicaciones. El 57,24% de las prescripciones, se adaptaron al protocolo del hospital y a la ficha técnica. La reacción adversa más frecuente fue manchado en el lugar de la herida (7,97%). La utilización de dabigatrán ha sido la adecuada para la mayoría de los pacientes(AU)

The dabigatran etexilate therapy will help to define its safety profile in hospitalized patients. A four-month prospective, observational, prescription-indication utilization study. Data were obtained through review of drug therapy in electronic prescription, laboratory parameters and medical history. The recommendations of product information and hospital protocol were reviewed and it was considered that dabigatran is a restricted drug in the hospital for primary prevention of venous thromboembolic events in adult patients who have undergone elective total hip or total knee replacement surgery. The incidence of adverse drug events was recorded. 138 patients started treatment with dabigatran etexilate; 97,10% were admitted in the traumatology hospitalisation unit. In most patients (89,13%), dabigatran was prescribed for the authorized indication but it was also used for other indications (10,87%). A 57,24% of prescriptions were adapted to the recommendations. The most commonly reported adverse event was bleeding in surgical wound (7,97%). Use of dabigatran etexilate was adequate for most patients(AU)

Cytotoxic activity of Alfa-humulene and transcaryophyllene from Salvia officinalis in animal and human tumor cells / Actividad citotóxica del Alfa-humuleno y del tras-cariofileno de Salvia officinalis en dos líneas celulares tumorales animal y humana

Background: The purpose of the present work is two-fold: the fractionationof Salvia officinalis essential oil and the cytotoxic study ofthis oil with its fractions ¡°in vitro¡± tumor cell lines. Materials andMethods: S. officinalis essential oil was obtained by hydrodistillationand fractionated with column chromatography; the essential oil andits fractions were analyzed by gas chromatography (GC) coupled tomass spectrometry (MS). The cytotoxic activity was evaluated incellular lines of breast cancer MCF-7, colon cancer HCT-116, andmurine macrophage RAW264.7 cell lines by the MTT assay. Results:the sub-subfraction F1.1.1 of S. officinalis essential oil containing ¦Á-humulene present highest activity on RAW264.7 and HCT-116 withIC50 values of 41.9 and 77.3 ¦Ìg/ml, respectively. The sub-subfractionF1.2.1 of S. officinalis essential oil with trans-caryophyllene showedless activity on RAW246.7 and HCT-116 with IC50 values of 90.5 and145.8 ¦Ìg/ml. Conclusion: This paper suggests that the ¦Á-humulene andtrans-caryophyllene extracted from S.officinalis essential oil inhibit tumorcell growth (AU)

Antecedentes: Este trabajo tiene dos objetivos: el fraccionamiento del aceite esencial de la especie Salvia officinalis y la determinación de la citotoxicidad del mencionado aceite esencial con sus fracciones en líneas celulares tumorales “in vitro”. Material y Métodos: El aceite esencial de Salvia officinalis fue obtenido por hidrodestilación y fraccionado mediante cromatografía en columna; el aceite esencial y sus fracciones fueron analizadas mediante cromatografía de gases (GC) acoplada a espectrometría de masas (MS). La actividad citotóxica fue evaluada en líneas celulares de cáncer de mama MCF-7; cáncer de colon HCT-116 y en macrófago murino. RAW264.7 con el ensayo MTT. Resultados: La sub-subfracción F1.1.1 del aceite esencial de Salvia officinalis que contiene alfa-humuleno presenta la actividad mas acusada frente a las líneas celulares RAW264.7 y HCT-116, con valores de IC50 de 41,9 y de 77,3 μg/ml respectivamente. La sub-subfracción F1.2.1 del aceite esencial de Salvia officinalis con trans-cariofileno, muestra menor actividad sobre células RAW246.7 y HCT-116 con valores de IC50 de 90,5 y 145,8 μg/ml respectivamente. Conclusión: Estos resultados sugieren que el alfa-humuleno y el trans-cariofileno de los extractos del aceite esencial de Salvia officinalis inhiben el crecimiento de células tumorales (AU)