Protocolization of Analgesia and Sedation Through Smart Technology in Intensive Care: Improving Patient Safety.

BACKGROUND: The risk of medication errors in intensive care units is high, primarily in the drug administration phase. LOCAL PROBLEM: Management of high-alert medications within intensive care units in the study institution varied widely. The aim of this quality improvement project was to protocolize and centralize the management of high-alert medications in acute care settings and to implement smart intravenous infusion pump technology in intensive care units. METHODS: The project was conducted in 4 phases: (1) protocolization and standardization of intravenous mixtures, (2) centralization of intravenous mixture preparation in the Pharmacy Department, (3) programming of the smart pumps, and (4) dissemination and staged implementation of intravenous mixture protocols. Smart pumps (Alaris, CareFusion) were used to deliver the medicines, and the manufacturer's software (Alaris Guardrails, CareFusion) was used to analyze data regarding adherence to the drug library and the number of programming errors detected. RESULTS: Morphine, remifentanil, fentanyl, midazolam, dexmedetomidine, and propofol were included. After implementation of the smart pumps, 3283 infusions were started; of these, 2198 were programmed through the drug library, indicating 67% compliance with the safety software. The pumps intercepted 398 infusion-related programming errors that led to cancellation or reprogramming of drug infusions. CONCLUSIONS: Protocolization and centralization of the preparation of high-alert sedative and analgesic medications for critically ill patients and the administration of these drugs using smart pump technology decrease variability of clinical practice and intercept potentially serious medication errors.

Real-world effectiveness and factors associated with increased mortality in non-critically ill patients with COVID-19 pneumonia receiving remdesivir.

OBJECTIVES: Evidence on the effectiveness of remdesivir when used in real-life clinical practice is controversial. This study aims to analyse its effectiveness and the factors associated with increased mortality in non-critically ill patients with COVID-19 pneumonia who require supplemental low-flow oxygen and received remdesivir. METHODS: A retrospective cohort study was conducted at Ramón y Cajal University Hospital (Madrid, Spain) which included all patients treated with remdesivir in our institution during the second pandemic breakout in Spain, from August to November 2020. Treatment with remdesivir was limited to non-critically ill patients with COVID-19 pneumonia requiring low-flow supplemental oxygen, with a treatment duration of 5 days. RESULTS: A total of 1757 patients were admitted with COVID-19 pneumonia during the study period, of which 281 non-critically ill patients were treated with remdesivir and included in the analysis. Mortality at 28 days after initiation of treatment was 17.1%. The median (IQR) time to recovery was 9 days (6-15). 104 (37.0%) patients had complications during hospitalisation, with renal failure being the most frequent (31 patients; 36.5%). After adjustment for confounding factors, high-flow oxygen therapy was associated with increased 28-day mortality (HR 2.77; 95% CI 1.39 to 5.53; p=0.004) and decreased 28-day clinical improvement (HR 0.54; 95% CI 0.35 to 0.85; p=0.008). A significant difference in survival and clinical improvement was identified between patients treated with high and low-flow oxygen. CONCLUSION: The 28-day mortality rate in patients treated with remdesivir needing low-flow oxygen therapy was higher than that published in clinical trials. Age and increased oxygen therapy needed after the beginning of treatment were the main risk factors associated with mortality.

Cost-utility analysis of venetoclax in combination with obinutuzumab as first-line treatment of chronic lymphocytic leukaemia in Spain.

OBJECTIVE: Venetoclax in combination with obinutuzumab has significantly improved efficacy versus immunochemotherapy (progression-free survival) in patients with chronic lymphocytic leukaemia who have not  received prior treatment. The objective of this study was to evaluate its efficiency in Spain using a cost-utility analysis. METHOD: Using a partitioned-survival analysis model adapted to the Spanish  context and based on three health states (progression-free survival, survival  after progression, and death), a simulation of the evolution of patients who  were candidates for initiating first-line treatment was conducted for a lifetime  time horizon. Venetoclax in combination with obinutuzumab was compared to  the most commonly used therapeutic options for these patients at the time of  study design: chlorambucil in combination with obinutuzumab, ibrutinib,  fludarabine in combination with cyclophosphamide and rituximab, and  bendamustine in combination with rituximab. In order to estimate survival  curves, efficacy data were derived from the CLL14 trial and a network meta- analysis. The  analysis was conducted from the perspective of the Spanish  National Healthcare System and included direct healthcare costs (i.e.  pharmacological costs and their administration), and those associated with the management of the disease and adverse events. The resource use was validated by an expert group. Quality of life data were used to estimate the  quality-adjusted life years obtained for each alternative. A threshold of  €25,000/quality-adjusted life years was used. The robustness of the model was evaluated using deterministic and probabilistic sensitivity analyses. RESULTS: Venetoclax in combination with obinutuzumab was shown to be a  dominant alternative compared to the rest of the treatment alternatives, with a  lower cost per patient (€-67,869 compared to chlorambucil in combination  with obinutuzumab, €-375,952 compared to ibrutinib, €-61,996 compared to  fludarabine in combination with cyclophosphamide and rituximab, and €- 77,398 compared to bendamustine in combination with rituximab). It also had  a greater gain in quality-adjusted life years (0.551 quality-adjusted life years  gained compared to chlorambucil in combination with obinutuzumab and  ibrutinib, 1.639 quality-adjusted life years gained compared to fludarabine in  combination with cyclophosphamide and rituximab, and 1.186 quality-adjusted  life years gained compared to bendamustine in combination with  rituximab). Between 68% and 85% of the simulations performed in the  sensitivity analysis showed that venetoclax in combination with obinutuzumab  had lower costs and more quality-adjusted life years gained. CONCLUSIONS: Venetoclax in combination with obinutuzumab is an efficient and  dominant alternative for treating previously untreated patients with chronic lymphocytic leukaemia compared to the available  alternatives and from the perspective of the Spanish National Health System.

OBJETIVO: Venetoclax en combinación con obinutuzumab ha mostrado frente a  la inmunoquimioterapia mejoras significativas en términos de eficacia (supervivencia libre de progresión) en pacientes con leucemia  infocítica crónica que no han recibido tratamiento previo. El objetivo de este  estudio fue evaluar su eficiencia en España a partir de un análisis de coste- utilidad.Método: A partir de un modelo de análisis de la supervivencia adaptado al  contexto español y basado en tres estados de salud (supervivencia libre de  progresión, supervivencia tras progresión y muerte), se llevó a cabo una  simulación de la evolución de los pacientes candidatos a iniciar una primera  línea de tratamiento para un horizonte temporal de toda la vida. Venetoclax en  combinación con obinutuzumab se comparó frente a las opciones terapéuticas  más utilizadas para estos pacientes en el momento del diseño del estudio:  clorambucilo en combinación con obinutuzumab, ibrutinib, fludarabina en  combinación con ciclofosfamida y rituximab, y bendamustina en combinación  con rituximab. Los datos de eficacia para estimar las curvas de supervivencia  fueron derivados del estudio CLL14 y de un metaanálisis en red. El análisis  consideró la perspectiva del Sistema Nacional de Salud incluyendo los costes  sanitarios directos, en concreto los farmacológicos y su administración, y los  asociados al manejo de la enfermedad y acontecimientos adversos. El uso de  recursos fue validado por un grupo de expertos. Se emplearon datos de calidad  de vida para estimar los años de vida ajustados por calidad obtenidos  para cada alternativa. Se consideró un umbral de 25.000 €/años de vida  ajustados por calidad. La robustez del modelo se evaluó mediante análisis de  sensibilidad determinísticos y probabilísticos. RESULTADOS: Venetoclax en combinación con obinutuzumab se mostró como  una alternativa dominante frente al resto de alternativas de tratamiento, con  un menor coste por paciente (­67.869 € frente a clorambucilo en combinación  con obinutuzumab, ­375.952 € frente a ibrutinib, ­61.996 € frente a  ludarabina en combinación con ciclofosfamida y rituximab, y ­77.398 € frente  a bendamustina en combinación con rituximab) y una mayor ganancia en años  de vida ajustados por calidad (0,551 años de vida ajustados por calidad  ganados frente a clorambucilo en combinación con obinutuzumab e ibrutinib,  1,639 años de vida ajustados por calidad ganados frente a fludarabina en  combinación con ciclofosfamida y rituximab, y 1,186 años de vida ajustados  por calidad ganados frente a bendamustina en combinación con rituximab).  Entre el 68% y el 85% de las simulaciones realizadas en el análisis de  sensibilidad mostraban a venetoclax en combinación con obinutuzumab con un  menor coste y un mayor número de años de vida ajustados por calidad  ganados. CONCLUSIONES: Venetoclax en combinación con obinutuzumab se muestra como una alternativa eficiente y dominante como tratamiento de  pacientes con leucemia linfocítica crónica no tratados previamente frente a las  alternativas disponibles y desde la perspectiva del Sistema Nacional de Salud.

Análisis coste-utilidad de venetoclaxen combinación con obinutuzumab comotratamiento de primera línea de la leucemia linfocítica crónica en España / Cost-utility analysis of venetoclax in combination with obinutuzumab as first-line treatment of chronic lymphocytic leukaemia in Spain

Objetivo: Venetoclax en combinación con obinutuzumab ha mostradofrente a la inmunoquimioterapia mejoras significativas en términos de eficacia(supervivencia libre de progresión) en pacientes con leucemia linfocíticacrónica que no han recibido tratamiento previo. El objetivo de este estudiofue evaluar su eficiencia en España a partir de un análisis de coste-utilidad.Método: A partir de un modelo de análisis de la supervivencia adaptadoal contexto español y basado en tres estados de salud (supervivencia librede progresión, supervivencia tras progresión y muerte), se llevó a cabouna simulación de la evolución de los pacientes candidatos a iniciar unaprimera línea de tratamiento para un horizonte temporal de toda la vida. Venetoclax en combinación con obinutuzumab se comparó frente a lasopciones terapéuticas más utilizadas para estos pacientes en el momentodel diseño del estudio: clorambucilo en combinación con binutuzumab,ibrutinib, fludarabina en combinación con ciclofosfamida y rituximab, ybendamustina en combinación con rituximab. Los datos de eficacia paraestimar las curvas de supervivencia fueron derivados del estudio CLL14 y de un metaanálisis en red. El análisis consideró la perspectiva del Sistema Nacional de Salud incluyendo los costes sanitarios directos, en concreto losfarmacológicos y su administración, y los asociados al manejo de la enfermedady acontecimientos adversos. El uso de recursos fue validado por ungrupo de expertos. Se emplearon datos de calidad de vida para estimarlos años de vida ajustados por calidad obtenidos para cada alternativa.Se consideró un umbral de 25.000 €/años de vida ajustados por calidad. La robustez del modelo se evaluó mediante análisis de sensibilidad determinísticosy probabilísticos.

Objective: Venetoclax in combination with obinutuzumab has significantlyimproved efficacy versus immunochemotherapy (progression-freesurvival) in patients with chronic lymphocytic leukaemia who have notreceived prior treatment. The objective of this study was to evaluate itsefficiency in Spain using a cost-utility analysis.Method: Using a partitioned-survival analysis model adapted to theSpanish context and based on three health states (progression-free urvival,survival after progression, and death), a simulation of the evolutionof patients who were candidates for initiating first-line treatment wasconducted for a lifetime time horizon. Venetoclax in combination withobinutuzumab was compared to the most commonly used therapeuticoptions for these patients at the time of study design: chlorambucil incombination with obinutuzumab, ibrutinib, fludarabine in combinationwith cyclophosphamide and rituximab, and bendamustine in combinationwith rituximab. In order to estimate survival curves, efficacy datawere derived from the CLL14 trial and a network meta-analysis. The analysis was conducted from the perspective of the Spanish NationalHealthcare System and included direct healthcare costs (i.e. pharmacologicalcosts and their administration), and those associated with themanagement of the disease and adverse events. The resource use wasvalidated by an expert group. Quality of life data were used to estimatethe quality-adjusted life years obtained for each alternative. A thresholdof €25,000/quality-adjusted life years was used. The robustness of themodel was evaluated using deterministic and probabilistic sensitivityanalyses.

Healthcare failure mode and effect analysis in the chemotherapy preparation process.

PURPOSE: To conduct a Health Care Failure Mode and Effects Analysis (HFMEA) of the chemotherapy preparation process to identify the steps with the potential to cause errors, and to develop further strategies to improve the process and thus minimize the risk of errors. METHODS: An HFMEA was conducted to identify and reduce preparation errors during the chemotherapy preparation process. A multidisciplinary team mapped the preparation process, formally identified all the steps, and then conducted a brainstorming session to determine potential failure modes and their potential effects. A severity and probability score for each failure mode, a hazard score (HS) and a total HS were calculated. A hazard analysis was conducted for each HS equal to or more than 8. Finally, an action plan was identified for each failure mode. After the action plan was implemented, failure modes were revaluated and a new HS score was calculated as well as the percentage decrease in risk. RESULTS: The team identified five main steps in the chemotherapy preparation process and nine potential failure modes. After implementing the control measures, all the HSs decreased. The total HS associated with the chemotherapy preparation process decreased from 54 to 26 (-52%). This reduction in the total HS was mainly achieved by updating the Standard Operating Procedures (SOPs) and implementing bar code and gravimetric control system. CONCLUSION: The application of HFMEA to the chemotherapy preparation process in centralized chemotherapy units can be very useful in identifying actions aimed at reducing errors in the healthcare setting.

Evaluación de la adherencia y de los resultados en salud en trasplante alogénico de progenitores hematopoyéticos / Evaluation of adherence and clinical outcomes in patients undergoing allogeneic haematopoietic stem cell transplantation

OBJETIVO: Medir la adherencia a la profilaxis del fallo secundario del implante (ciclosporina, tacrolimus, sirolimus), de la enfermedad injerto contra receptor (ciclosporina, tacrolimus, sirolimus, micofenolato) y de las infecciones (posaconazol, voriconazol, valganciclovir) en el paciente sometido a trasplante alogénico de progenitores hematopoyéticos. Compa-rar la incidencia de complicaciones agudas en función de la adherencia.MÉTODO: Estudio observacional retrospectivo en pacientes sometidos a trasplante alogénico de progenitores hematopoyéticos desde mayo de 2017 hasta mayo de 2018, entre el día 0 y +100 postrasplante. La adherencia a micofenolato, tacrolimus, sirolimus, posaconazol, voriconazol y valganciclovir se evaluó mediante los registros de dispensación del servicio de farmacia, siempre que fuera posible. Se definió como paciente adherente aquel con un porcentaje de adherencia igual o superior al 95%. La evaluación de la adherencia a ciclosporina se realizó mediante medida de los niveles plasmáticos. Se definió como paciente no adherente aquel cuyos niveles plasmáticos de ciclosporina fueran inferiores a 100 ng/ml en alguna medida entre los días 0 y +100, en ausencia de factores asociados que lo justificaran. La asociación entre adherencia e incidencia de complicaciones agudas (fallo secundario del implante, enfermedad injerto contra receptor aguda e infección) se estimó mediante la odds ratio y su intervalo de confianza del 95%. RESULTADOS: Se incluyó a 46 pacientes. Todos comenzaron profilaxis inmunosupresora con ciclosporina; en el 8,7% se cambió a tacrolimus o sirolimus por toxicidad. Todos los pacientes recibieron ciclosporina para la profilaxis de la enfermedad injerto contra receptor. En el 41,3% de los casos también se administró micofenolato. El 82,6% fueron adherentes a la profilaxis del fallo de injerto. En cuanto a la profilaxis de enfermedad injerto contra receptor, resultó adherente el 80,4%. Todos los pacientes resultaron adherentes a la profilaxis infecciosa. La incidencia de enfermedad injerto contra receptor aguda de los pacientes adherentes a la profilaxis fue del 45,9% frente al 55,6% en los no adherentes (odds ratio 0,68; intervalo de confianza del 95% 0,157-2,943; p = 0,718). CONCLUSIONES: Los pacientes sometidos a trasplante alogénico de progenitores hematopoyéticos presentan una aceptable adherencia a la profilaxis de complicaciones agudas, pero existe un considerable porcentaje de pacientes que no toman su tratamiento adecuadamente. La correcta adherencia a los inmunosupresores parece disminuir el riesgo de sufrir enfermedad injerto contra receptor aguda

OBJECTIVE: To measure adherence to cyclosporine, tacrolimus and siroli-mus prophylaxis against secondary graft failure; cyclosporine, tacrolimus, sirolimus and mycophenolate prophylaxis against graft-versus-host disease; and posaconazole, voriconazole, valganciclovir prophylaxis against infec-tion in patients undergo to transplantation of haematopoietic stem cells; and to analise the incidence of acute complications based on adherence.METHOD: Retrospective observational study of patients who underwent allo-geneic haematopoietic stem cell transplantation between May 2017 and May 2018. Analyses were carried out between 0 and +100 days post-engraftment.Whenever possible, adherence to mycophenolate, tacrolimus, sirolimus, posaconazole, voriconazole and valganciclovir was evaluated by means of the dispensation records of the Pharmacy Department of our hospital. To be considered adherent, patients should have proved an adherence rate equal to or higher than 95%. Adherence to cyclosporine was determi-ned based on serum levels. Patients were considered to be non-adherent if their cyclosporine serum concentrations dropped below 100 ng/mL at any time between days 0 and +100, in the absence of any specific justifying circumstances. The association between adherence and the incidence of acute complications (secondary graft failure, acute graft-versus-host disease and infection) was determined by means of the odds ratio (confidence interval: 95%). RESULTS: The study sample was made up by 46 patients, all of whom were started on immunosuppressive cyclosporine prophylaxis; 8.7% needed to be switched to tacrolimus or sirolimus due to toxicity issues. All the pa-tients received cyclosporine as prophylaxis against graft-versus-host disea-se. Mycophenolate was also administered in 41.3% of cases. A total of 82.6% patients were found to be adherent to their prophylaxis treatment against graft failure and 80.4% were found to be adherent to prophylaxis against graft-versus-host disease. All patients were adherent to anti-infection prophylaxis. The incidence of acute graft-versus-host disease in prophylaxis-adherent patients was 45.9%, compared with 55.6% for non-adherent pa-tients (odds ratio 0.68; confidence interval: 95% 0.157-2.943; p = 0.718). CONCLUSIONS: Patients undergoing allogeneic haematopoietic stem cell transplantation demonstrated acceptable adherence to prophylaxis aga-inst acute complications, although a considerable percentage of patients was found not to take their medication as prescribed. Correct adherence to immunosuppressants seems to reduce the risk of developing acute graft-versus-host disease

Evaluation of adherence and clinical outcomes in patients undergoing allogeneic haematopoietic stem cell transplantation.

OBJECTIVE: To measure adherence to cyclosporine, tacrolimus and  sirolimus prophylaxis against secondary graft failure; cyclosporine,  tacrolimus, sirolimus and mycophenolate prophylaxis against graft- versus-host disease; and posaconazole, voriconazole, valganciclovir  prophylaxis against infection in patients undergo to transplantation of  haematopoietic stem cells; and to analise the incidence of acute  complications based on adherence. METHOD: Retrospective observational study of patients who underwent  allogeneic haematopoietic stem cell transplantation between May 2017  and May 2018. Analyses were carried out between 0 and +100 days  post-engraftment. Whenever possible, adherence to mycophenolate,  tacrolimus, sirolimus, posaconazole, voriconazole and valganciclovir was  evaluated by means of the dispensation records of the Pharmacy  Department of our hospital. To be considered adherent, patients should  have proved an adherence rate equal to or higher than 95%. Adherence  to cyclosporine was determined based on serum levels.  Patients were considered to be non-adherent if their cyclosporine serum  concentrations dropped below 100 ng/mL at any time between days 0  and +100, in the absence of any specific justifying circumstances. The  association between adherence and the inci dence of acute  complications (secondary graft failure, acute graft-versushost disease  and infection) was determined by means of the odds ratio (confidence  interval: 95%). RESULTS: The study sample was made up by 46 patients, all of whom were started on immunosuppressive cyclosporine prophylaxis; 8.7%   needed to be switched to tacrolimus or sirolimus due to toxicity issues.   All the patients received cyclosporine as prophylaxis against graft-  versus-host disease. Mycophenolate was also administered in 41.3% of  cases. A total of 82.6% patients were found to be adherent to their  prophylaxis treatment against graft failure and 80.4% were found to be  adherent to prophylaxis against graft-versus-host disease. All patients  were adherent to anti-infection prophylaxis. The incidence of acute  graft-versus-host disease in prophylaxisadherent patients was 45.9%,  compared with 55.6% for non-adherent patients (odds ratio 0.68;  confidence interval: 95% 0.157-2.943; p = 0.718). CONCLUSIONS: Patients undergoing allogeneic haematopoietic stem cell transplantation demonstrated acceptable adherence to prophylaxis  against acute complications, although a considerable percentage of  patients was found not to take their medication as prescribed. Correct  adherence to immunosuppressants seems to reduce the risk of  developing acute graftversus- host disease.

Objetivo: Medir la adherencia a la profilaxis del fallo secundario del implante (ciclosporina, tacrolimus, sirolimus), de la enfermedad  injerto contra receptor (ciclosporina, tacrolimus, sirolimus,  micofenolato) y de las infecciones (posaconazol, voriconazol,  valganciclovir) en el paciente sometido a trasplante alogénico de  progenitores hematopoyéticos. Comparar la incidencia de  complicaciones agudas en función de la adherencia.Método: Estudio observacional retrospectivo en pacientes sometidos a trasplante alogénico de progenitores hematopoyéticos desde mayo de 2017 hasta mayo de 2018, entre el día 0 y +100 postrasplante. La adherencia a micofenolato, tacrolimus, sirolimus, posaconazol,  voriconazol y valganciclovir se evaluó mediante los registros de  dispensación del servicio de farmacia, siempre que fuera posible. Se  definió como paciente adherente aquel con un porcentaje de adherencia  igual o superior al 95%. La evaluación de la adherencia a ciclosporina se  realizó mediante medida de los niveles plasmáticos. Se definió como  paciente no adherente aquel cuyos niveles plasmáticos de ciclosporina  fueran inferiores a 100 ng/ml en alguna medida entre los días 0 y +100,  en ausencia de factores asociados que lo justificaran. La  asociación entre adherencia e incidencia de complicaciones agudas (fallo  secundario del implante, enfermedad injerto contra receptor  aguda e infección) se estimó mediante la odds ratio y su intervalo de  confianza del 95%.Resultados: Se incluyó a 46 pacientes. Todos comenzaron rofilaxis inmunosupresora con ciclosporina; en el 8,7% se cambió a  tacrolimus o sirolimus por toxicidad. Todos los pacientes recibieron  ciclosporina para la profilaxis de la enfermedad injerto contra receptor.  En el 41,3% de los casos también se administró micofenolato. El 82,6%  fueron adherentes a la profilaxis del fallo de injerto. En cuanto a la  profilaxis de enfermedad injerto contra receptor, resultó adherente el  80,4%. Todos los pacientes resultaron adherentes a la profilaxis  infecciosa. La incidencia de enfermedad injerto contra receptor aguda de  los pacientes adherentes a la profilaxis fue del 45,9% frente al  55,6% en los no adherentes (odds ratio 0,68; intervalo de confianza del  95% 0,157-2,943; p = 0,718). Conclusiones: Los pacientes sometidos a trasplante alogénico de  progenitores hematopoyéticos presentan una aceptable adherencia a la  profilaxis de complicaciones agudas, pero existe un considerable  porcentaje de pacientes que no toman su tratamiento adecuadamente.  La correcta adherencia a los inmunosupresores parece disminuir el  riesgo de sufrir enfermedad injerto contra receptor aguda.

Chemotherapy Near the End of Life in Onco-Hematological Adult Patients.

OBJECTIVE: The use of chemotherapy near the end of life is not advisable. There are scarce data in Europe but shows signs of aggressiveness. We designed this study to analyze the proportion of onco-hematological patients receiving chemotherapy within their last 2 weeks of life as well as starting a new chemotherapy regimen in the 30 days prior to death. METHODS: A retrospective observational study was conducted in a tertiary hospital. Adults who died of an onco-hematological neoplasia while hospitalized between April 2017 and March 2018 were included. We assessed the use of chemotherapy over the course of the last 14 days of life, defined as the administration of at least one dose of chemotherapy. We also examined the proportion of patients starting a new chemotherapy regimen in the last 30 days of life. RESULTS: A total of 298 inpatients died in the Hematology and Oncology units. During the last 14 days, 28.2% (n = 11) of hematological and 26.3% (n = 68) of oncological patients received chemotherapy; the overall rate was 26.5% (n = 79). Furthermore, the proportion of patients starting a new chemotherapy regimen in the last 30 days of life was high (20.5% and 20.8%, respectively). Female gender (odds ratio [OR] = 1.99, 95% confidence interval [CI] = 1.18-3.35) and age <45 (OR = 2.68, 95% CI = 1.05-6.88) were associated with higher rates of chemotherapy. CONCLUSION: The proportion of patients receiving chemotherapy in the last 14 days of life was high, as well as the proportion of patients starting a new regimen in their last 30 days. This was indicative of excessive aggressiveness at the end-of-life care.

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.

[Adherence to entecavir for chronic hepatitis B and correlation with effectiveness]. / Relación entre adherencia a entecavir y efectividad en pacientes con hepatitis B crónica.

PURPOSE: to evaluate adherence of patients with chronic hepatitis B initiated on entecavir as first-line treatment and to correlate adherence with effectiveness. METHODS: observational retrospective study performed between January 2007 and June 2013. Patients treated with entecavir for at least one year were included. A patient was considered to be adherent if median adherence was ≥ 95%. Virological response (HBV DNA < 20UI/ml by Polymerase Chain Reaction), biochemical response (normalized level of alanine amino transferase [AAT]) and serological response (loss of hepatitis B surface antigen [HBsAg]) was assessed at month 12. RESULTS: 85 patients were included. The median adherence rate was 94.2 (SD 12.8)%. 85.7% of the adherent patients achieved a virological response in contrast with 71.4% of the nonadherent patients (OR:2,40; IC95%:0,60-9,54;p = 0,19). 87.9% of the adherent patients and 85.7% of the nonadherent patients showed normalized level of AAT (OR:1,21; IC95%:0,22- 6,60;p = 0,56). Two adherent patients showed clearance of hepatitis B surface antigen. CONCLUSION: the median adherence is not high. Nonadherent patients have a trend towards a higher rate of virological failure so it is necessary to promote improved adherence to treatment.

Objetivo: evaluar la adherencia de pacientes con hepatitis B cronica que inician tratamiento con entecavir como primera linea, y relacionarla con la efectividad. Métodos: estudio observacional retrospectivo realizado entre enero de 2007 y junio de 2013. Se incluyeron pacientes tratados con entecavir al menos durante un ano. Se considero un paciente adherente si la adherencia media era ≥ 95%. Se evaluo la respuesta virologica (ADN VHB < 20UI/ml mediante la reaccion en cadena de la polimerasa), bioquimica (normalizacion de alanina aminotranferasa [AAT]) y serologica (perdida del antigeno de superficie [HBsAg]) a los 12 meses. Resultados: se incluyeron 85 pacientes. La adherencia media fue 94,2 (DE 12,8)%. El 85,7% de los pacientes adherentes lograron respuesta virologica vs. el 71,4% de los de no adherentes (OR:2,40; IC95%:0,60­9,54; p=0,19). El 87,9% de los pacientes adherentes y el 85,7% de los no adherentes normalizaron niveles de AAT (OR:1,21; IC95%:0,22- 6,60; p=0,56). Solo dos pacientes adherentes mostraron perdida del HBsAg. Conclusión: la adherencia media no es alta. Los pacientes sin adherencia presentan una mayor tendencia al fracaso virologico, por lo que es necesario fomentar una mejora en la adherencia a los tratamientos.

Relación entre adherencia a entecavir y efectividad en pacientes con hepatitis B crónica / Adherence to entecavir for chronic hepatitis B and correlation with effectiveness

Objetivo: evaluar la adherencia de pacientes con hepatitis B crónica que inician tratamiento con entecavir como primera línea, y relacionarla con la efectividad. Métodos: estudio observacional retrospectivo realizado entre enero de 2007 y junio de 2013. Se incluyeron pacientes tratados con entecavir al menos durante un año. Se consideró un paciente adherente si la adherencia media era ≥ 95%. Se evaluó la respuesta virológica (ADN VHB < 20UI/ml mediante la reacción en cadena de la polimerasa), bioquímica (normalización de alanina aminotranferasa [AAT]) y serológica (pérdida del antígeno de superficie [HBsAg]) a los 12 meses. Resultados: se incluyeron 85 pacientes. La adherencia media fue 94,2 (DE 12,8)%. El 85,7% de los pacientes adherentes lograron respuesta virológica vs. el 71,4% de los de no adherentes (OR:2,40; IC95%:0,60–9,54; p=0,19). El 87,9% de los pacientes adherentes y el 85,7% de los no adherentes normalizaron niveles de AAT (OR:1,21; IC95%:0,22- 6,60; p=0,56). Solo dos pacientes adherentes mostraron pérdida del HBsAg. Conclusión: la adherencia media no es alta. Los pacientes sin adherencia presentan una mayor tendencia al fracaso virológico, por lo que es necesario fomentar una mejora en la adherencia a los tratamientos (AU)

Purpose: to evaluate adherence of patients with chronic hepatitis B initiated on entecavir as first-line treatment and to correlate adherence with effectiveness. Methods: observational retrospective study performed between January 2007 and June 2013. Patients treated with entecavir for at least one year were included. A patient was considered to be adherent if median adherence was ≥ 95%. Virological response (HBV DNA < 20UI/ml by Polymerase Chain Reaction), biochemical response (normalized level of alanine amino transferase [AAT]) and serological response (loss of hepatitis B surface antigen [HBsAg]) was assessed at month 12. Results: 85 patients were included. The median adherence rate was 94.2 (SD 12.8)%. 85.7% of the adherent patients achieved a virological response in contrast with 71.4% of the nonadherent patients (OR:2,40; IC95%:0,60–9,54;p = 0,19). 87.9% of the adherent patients and 85.7% of the nonadherent patients showed normalized level of AAT (OR:1,21; IC95%:0,22- 6,60;p = 0,56). Two adherent patients showed clearance of hepatitis B surface antigen. Conclusion: the median adherence is not high. Nonadherent patients have a trend towards a higher rate of virological failure so it is necessary to promote improved adherence to treatment (AU)

Diseño de un programa informático para la gestión de medicamentos en situaciones especiales en un servicio de farmacia hospitalaria / Design of a computer program for the management of drugs in special situations in a hospital pharmacy department

Objetivo: describir las funcionalidades de un programa informático para gestión de medicamentos en situaciones especiales en un Servicio de Farmacia Hospitalaria (SFH). Describir la metodología seguida para su implantación en los Servicios Médicos. Evaluar su uso tras 2 años de utilización. Método: el diseño se realizó por farmacéuticos del SFH. Las etapas del proceso fueron: selección de una empresa de desarrollo informático, constitución de un grupo de trabajo, selección de una plataforma de desarrollo, diseño de un visor interactivo, definición de funcionalidades y de datos a procesar, creación de las bases de datos, conexión, instalación y configuración, pilotaje de la aplicación y realización de mejoras. Para la implantación en los servicios médicos se empleó una estrategia secuencial dirigida. Se evaluó la utilidad y experiencia de la aplicación tras 2 años. Resultados: se constituyó un grupo de trabajo multidisciplinar y se desarrolló Pk_Usos®. El programa trabaja en entorno web con un visor común para todos los usuarios que permite consultar la situación del expediente en tiempo real y se adapta al procedimiento de la CFT de gestión de medicamentos en situaciones especiales. Pk_Usos® se implantó en primer lugar en el Servicio de Oncología Médica, con 15 oncólogos como usuarios del programa. En dos años se realizaron 384 solicitudes en 343 pacientes, de las cuales se autorizaron 363. Conclusiones: PK_Usos® es el primer software diseñado para la gestión de los medicamentos en situaciones especiales en el SFH. Es una herramienta eficiente y dinámica, que permite la optimización de tiempos a todos los profesionales implicados en el proceso (AU)

Objective: to describe the features of a computer program for management of drugs in special situations (off-label and compassionate use) in a Department of Hospital Pharmacy (PD). To describe the methodology followed for its implementation in the Medical Services. To evaluate their use after 2 years of practice. Method: the design was carried out by pharmacists of the PD. The stages of the process were: selection of a software development company, establishment of a working group, selection of a development platform, design of an interactive Viewer, definition of functionality and data processing, creation of databases, connection, installation and configuration, application testing and improvements development. A directed sequential strategy was used for implementation in the Medical Services. The program’s utility and experience of use were evaluated after 2 years. Results: a multidisciplinary working group was formed and developed Pk_Usos®. The program works in web environment with a common viewer for all users enabling real time checking of the request files’ status and that adapts to the management of medications in special situations procedure. Pk_Usos® was introduced first in the Oncology Department, with 15 oncologists as users of the program. 343 patients had 384 treatment requests managed, of which 363 are authorized throughout two years. Conclusions: PK_Usos® is the first software designed for the management of drugs in special situations in the PD. It is a dynamic and efficient tool for all professionals involved in the process by optimization of times (AU)

[Designing a software for drug management in special situations at a hospital's drug administration service]. / Diseño de un programa informático para la gestión de medicamentos en situaciones especiales en un servicio de farmacia hospitalaria.

OBJECTIVE: to describe the features of a computer program for management of drugs in special situations (off-label and compassionate use) in a Department of Hospital Pharmacy (PD). To describe the methodology followed for its implementation in the Medical Services. To evaluate their use after 2 years of practice. METHOD: the design was carried out by pharmacists of the PD. The stages of the process were: selection of a software development company, establishment of a working group, selection of a development platform, design of an interactive Viewer, definition of functionality and data processing, creation of databases, connection, installation and configuration, application testing and improvements development. A directed sequential strategy was used for implementation in the Medical Services. The program's utility and experience of use were evaluated after 2 years. RESULTS: a multidisciplinary working group was formed and developed Pk_Usos®. The program works in web environment with a common viewer for all users enabling real time checking of the request files' status and that adapts to the management of medications in special situations procedure. Pk_Usos® was introduced first in the Oncology Department, with 15 oncologists as users of the program. 343 patients had 384 treatment requests managed, of which 363 are authorized throughout two years. CONCLUSIONS: PK_Usos® is the first software designed for the management of drugs in special situations in the PD. It is a dynamic and efficient tool for all professionals involved in the process by optimization of times.

Objetivo: describir las funcionalidades de un programa informático para gestión de medicamentos en situaciones especiales en un Servicio de Farmacia Hospitalaria (SFH). Describir la metodología seguida para su implantación en los Servicios Médicos. Evaluar su uso tras 2 años de utilización. Método: el diseño se realizó por farmacéuticos del SFH. Las etapas del proceso fueron: selección de una empresa de desarrollo informático, constitución de un grupo de trabajo, selección de una plataforma de desarrollo, diseño de un visor interactivo, definición de funcionalidades y de datos a procesar, creación de las bases de datos, conexión, instalación y configuración, pilotaje de la aplicación y realización de mejoras. Para la implantación en los servicios médicos se empleó una estrategia secuencial dirigida. Se evaluó la utilidad y experiencia de la aplicación tras 2 años. Resultados: se constituyó un grupo de trabajo multidisciplinar y se desarrolló Pk_Usos®. El programa trabaja en entorno web con un visor común para todos los usuarios que permite consultar la situación del expediente en tiempo real y se adapta al procedimiento de la CFT de gestión de medicamentos en situaciones especiales. Pk_Usos® se implantó en primer lugar en el Servicio de Oncología Médica, con 15 oncólogos como usuarios del programa. En dos años se realizaron 384 solicitudes en 343 pacientes, de las cuales se autorizaron 363. Conclusiones: PK_Usos® es el primer software diseñado para la gestión de los medicamentos en situaciones especiales en el SFH. Es una herramienta eficiente y dinámica, que permite la optimización de tiempos a todos los profesionales implicados en el proceso.