Atención farmacéutica al paciente ingresado en una unidad multidisciplinar de paciente crónico complejo / Pharmaceutical care for the patients admitted to a multidisciplinary complex chronic patient unit

Objetivo: evaluar la contribución del farmacéutico mediante el análisis de la prescripción potencialmente inapropiada y la conciliación del tratamiento domiciliario en la unidad de pacientes crónicos complejos de un hospital terciario. Métodos: estudio observacional, prospectivo y multidisciplinar de los pacientes de la unidad de pacientes crónicos complejos de un hospital durante febrero de 2019 - junio de 2020. El equipo multidisciplinar del crónico complejo elaboró un checklist con una selección de fármacos no recomendados basado en los criterios STOPP/START, Beers y PRISCUS y fármacos susceptibles de desprescripción según los criterios LESS-CHRON. El farmacéutico aplicaba el checklist diariamente en los pacientes que ingresaban en la unidad, además de realizar la conciliación del tratamiento domiciliario revisando el tratamiento prescrito con el detallado en la receta electrónica domiciliaria. Por eso, se recogieron las siguientes variables: edad, sexo y número de fármacos al ingreso como variables independientes, y variables dependientes: número de fármacos al alta, tipo de prescripción potencialmente inapropiada, motivos de conciliación, fármacos implicados y grado de aceptación de la recomendación por parte del médico prescriptor para evaluar la contribución farmacéutica. El análisis estadístico se realizó con IBM® SPSS® Statistics22. Resultados : se revisaron 621 pacientes con una mediana de edad de 84 años (56,4% mujeres), y se intervino en 218 (35,1%). La mediana del número de fármacos fue de 11 (2-26) al ingreso y de 10 (0-25) al alta. Se realizaron 373 intervenciones: 235 por conciliación de la medicación (78,3% aceptadas), 71 por medicamentos no recomendados (57,7% aceptadas), 42 por desprescripción (61,9% aceptadas) y 25 por otros motivos. ... (AU)

Objective: To assess the pharmacist’s contributions by analysing potentially inappropriate prescription and home treatment reconciliation in the complex chronic patient unit of a tertiary hospital.MethodObservational, prospective, multidisciplinary study of patients in the complex chronic patient unit of a hospital during February 2019 - June 2020. Multidisciplinary team of the complex chronic developed a checklist with a selection of non-recommended drugs based on STOPP/START, Beers and PRISCUS criteria, and drugs susceptible to deprescription according to LESS-CHRON criteria. The pharmacist applied the checklist daily in patients admitted to the unit, in addition to reconciling home treatment by reviewing the prescribed treatment with that detailed in the electronic home prescription. Therefore, the following variables were collected: age, sex and number of drugs on admission as independent variables, and dependent variables: number of drugs at discharge, type of potentially inappropriate prescription, reasons for reconciliation, drugs involved and degree of acceptance of the recommendation by the prescribing physician to assess the pharmaceutical contribution. The statistical analysis was performed with IBM® SPSS® Statistics22.Results: We reviewed 621 patients with a median age of 84 years (56.4% women), and intervention was performed in 218 (35.1%). The median number of drugs was 11 (2-26) at admission and 10 (0-25) at discharge 373 interventions were performed: 235 for medication reconciliation (78.3% accepted), 71 for non-recommended drugs (57.7% accepted), 42 for deprescription (61.9% accepted) and 25 for other reasons. Statistically significant differences were observed between the number of drugs at discharge and at admission in both intervention patients (n = 218) and complex chronic patients (n = 114) (p < 0.001 in both cases). ...(AU)

Pharmaceutical care for the patients admitted to a multidisciplinary complex chronic patient unit. / [Artículo traducido] Atención farmacéutica al paciente ingresado en una unidad multidisciplinar de paciente crónico complejo.

OBJECTIVE: To assess the pharmacist's contributions by analysing potentially inappropriate prescription and home treatment reconciliation in the complex chronic patient unit of a tertiary hospital. METHOD: Observational, prospective, multidisciplinary study of patients in the complex chronic patient unit of a hospital during February 2019 - June 2020. Multidisciplinary team of the complex chronic developed a checklist with a selection of non-recommended drugs based on STOPP/START, Beers and PRISCUS criteria, and drugs susceptible to deprescription according to LESS-CHRON criteria. The pharmacist applied the checklist daily in patients admitted to the unit, in addition to reconciling home treatment by reviewing the prescribed treatment with that detailed in the electronic home prescription. Therefore, the following variables were collected: age, sex and number of drugs on admission as independent variables, and dependent variables: number of drugs at discharge, type of potentially inappropriate prescription, reasons for reconciliation, drugs involved and degree of acceptance of the recommendation by the prescribing physician to assess the pharmaceutical contribution. The statistical analysis was performed with IBM® SPSS® Statistics22. RESULTS: We reviewed 621 patients with a median age of 84 years (56.4% women), and intervention was performed in 218 (35.1%). The median number of drugs was 11 (2-26) at admission and 10 (0-25) at discharge 373 interventions were performed: 235 for medication reconciliation (78.3% accepted), 71 for non-recommended drugs (57.7% accepted), 42 for deprescription (61.9% accepted) and 25 for other reasons. Statistically significant differences were observed between the number of drugs at discharge and at admission in both intervention patients (n = 218) and complex chronic patients (n = 114) (p < 0.001 in both cases). Moreover, statistically significant differences were observed in the number of drugs at admission between patients included in the complex chronic programme and those not included (p = 0.001), and in the number of drugs at discharge (p = 0.006). CONCLUSIONS: The integration of the pharmacist in the multidisciplinary team of the complex chronic patient unit improves patient safety and quality of care. The selected criteria were useful for detecting inappropriate drugs in this population and favoured deprescription.

Pharmaceutical care for the patients admitted to a multidisciplinary complex chronic patient unit.

OBJECTIVE: To assess the pharmacist's contributions by analyzing potentially inappropriate prescription and home treatment reconciliation in the complex chronic patient unit of a tertiary hospital. METHOD: Observational, prospective, multidisciplinary study of patients in the complex chronic patient unit of a hospital during February 2019-June 2020. Multidisciplinary team of the complex chronic developed a checklist with a selection of non-recommended drugs based on STOPP/START, Beers and Priscus criteria, and drugs susceptible to deprescription according to LESS-CHRON criteria. The pharmacist applied the checklist daily in patients admitted to the unit, in addition to reconciling home treatment by reviewing the prescribed treatment with that detailed in the electronic home prescription. Therefore, the following variables were collected: age, sex and number of drugs on admission as independent variables, and dependent variables: number of drugs at discharge, type of potentially inappropriate prescription, reasons for reconciliation, drugs involved and degree of acceptance of the recommendation by the prescribing physician to assess the pharmaceutical contribution. The statistical analysis was performed with IBM® SPSS® Statistics22. RESULTS: We reviewed 621 patients with a median age of 84 years (56.4% women), and intervention was performed in 218 (35.1%). The median number of drugs was 11 (2-26) at admission and 10 (0-25) at discharge. 373 interventions were performed: 235 for medication reconciliation (78.3% accepted), 71 for non-recommended drugs (57.7% accepted), 42 for deprescription (61.9% accepted) and 25 for other reasons. Statistically significant differences were observed between the number of drugs at discharge and at admission in both intervention patients (n = 218) and complex chronic patients (n = 114) (p < 0.001 in both cases). Moreover, statistically significant differences were observed in the number of drugs at admission between patients included in the complex chronic programme and those not included (p = 0.001), and in the number of drugs at discharge (p = 0.006). CONCLUSIONS: The integration of the pharmacist in the multidisciplinary team of the complex chronic patient unit improves patient safety and quality of care. The selected criteria were useful for detecting inappropriate drugs in this population and favored deprescription.

The contribution of fenfluramine to the treatment of Dravet syndrome in Spain through Multi-Criteria Decision Analysis.

INTRODUCTION: Dravet Syndrome (DS) is a severe, developmental epileptic encephalopathy (DEE) that begins in infancy and is characterized by pharmaco-resistant epilepsy and neurodevelopmental delay. Despite available antiseizure medications (ASMs), there is a need for new therapeutic options with greater efficacy in reducing seizure frequency and with adequate safety and tolerability profiles. Fenfluramine is a new ASM for the treatment of seizures associated with DS as add-on therapy to other ASMs for patients aged 2 years and older. Fenfluramine decreases seizure frequency, prolongs periods of seizure freedom potentially helping to reduce risk of Sudden Unexpected Death in Epilepsy (SUDEP) and improves patient cognitive abilities positively impacting on patients' Quality of Life (QoL). Reflective Multi-Criteria Decision Analysis (MCDA) methodology allows to determine what represents value in a given indication considering all relevant criteria for healthcare decision-making in a transparent and systematic manner from the perspective of relevant stakeholders. The aim of this study was to determine the relative value contribution of fenfluramine for the treatment of DS in Spain using MCDA. METHOD: A literature review was performed to populate an adapted a MCDA framework for orphan-drug evaluation in Spain. A panel of ten Spanish experts, including neurologists, hospital pharmacists, patient representatives and decision-makers, scored four comparative evidence matrices. Results were analyzed and discussed in a group meeting through reflective MCDA discussion methodology. RESULTS: Dravet syndrome is considered a severe, rare disease with significant unmet needs. Fenfluramine is perceived to have a higher efficacy profile than all available alternatives, with a better safety profile than stiripentol and topiramate and to provide improved QoL versus studied alternatives. Fenfluramine results in lower other medical costs in comparison with stiripentol and clobazam. Participants perceived that fenfluramine could lead to indirect costs savings compared to available alternatives due to its efficacy in controlling seizures. Overall, fenfluramine's therapeutic impact on patients with DS is considered high and supported by high-quality evidence. CONCLUSIONS: Based on reflective MCDA, fenfluramine is considered to add greater benefit in terms of efficacy, safety and QoL when compared with available ASMs.

Impact of the subcutaneous formulations of trastuzumab and rituximab on efficiency and resource optimization in Spanish hospitals: H-Excelencia study.

BACKGROUND: Subcutaneous (SC) versus intravenous (IV) administration is advantageous in terms of patient convenience and hospital efficiency. This study aimed to compare the effect of optimizing the processes involved in SC versus IV administration of rituximab and trastuzumab on hospital capacity and service quality. METHODS: This cross-sectional resource utilization study interviewed oncologists, hematologists, nurses, and pharmacists from 10 hospitals in Spain to estimate changes in processes associated with conversion from IV to SC rituximab and trastuzumab, based on clinical experience and healthcare use from administrative databases. RESULTS: Efficient use of SC formulations increased the monthly capacity for parenteral administration by 3.35% (potentially increasable by 5.75% with maximum possible conversion according to the product label). The weekly capacity for hospital pharmacy treatment preparation increased by 7.13% due to conversion to SC formulation and by 9.33% due to transferring SC preparation to the cancer treatment unit (potentially increasable by 12.16 and 14.10%, respectively). Monthly hospital time decreased by 33% with trastuzumab and 47% with rituximab. In a hypothetical hospital, in which all processes for efficient use of SC rituximab and/or trastuzumab were implemented and all eligible patients received SC formulations, the estimated monthly capacity for preparation and administration increased by 23.1% and estimated hospital times were reduced by 60-66%. CONCLUSIONS: Conversion of trastuzumab and rituximab to SC administration could improve the efficiency of hospitals and optimize internal resource management processes, potentially increasing care capacity and improving the quality of care by reducing time spent by patients at hospitals.

Evaluación de la seguridad de los anticoagulantes orales de acción directa / Safety assessment of new oral anticoagulants

Objetivo: Comparar la incidencia de hemorragias entre los anticoagulantes orales (ACO) y analizar los factores que influyen en la aparición de hemorragias. Material y métodos: Estudio observacional, retrospectivo unicéntrico. Tras estudiar la población total en tratamiento con ACO, se analizó a los pacientes en tratamiento con un ACO del sector II de Zaragoza que acudieron al Servicio de Urgencias de Hospital Universitario Miguel Servet de julio a diciembre de 2015 por presentar algún evento. Se registraron datos demográficos, variables clínicas y características del evento hemorrágico. Como factores independientes en la aparición de hemorragias se valoró la dosis, fármacos, el sexo y la edad. Resultados: Había 9.452 pacientes en tratamiento con ACO, de los cuales 371 presentaron un evento hemorrágico (3,9%). La frecuencia por ACO fue 4,1% (311) en pacientes tratados con antagonistas de la vitamina K (AVK), 3,8% (33) con rivaroxaban, 3,3% (19) con dabigatran y, por último, con apixaban 2,1% (8) (p<0,05). En el análisis multivariante solo obtuvieron una influencia estadísticamente significativa la selección del anticoagulante y el sexo, en concreto, la dosis de apixaban 2,5mg y ser mujer presentaban menor riesgo de hemorragia (OR=0,1; IC=0,014-0,71 y OR=0,688; IC=0,55-0,85, respectivamente). Conclusión: Según los datos obtenidos, las mujeres y los pacientes en tratamiento con apixaban presentaban menor riesgo hemorrágico, si bien existen dudas de si este mejor perfil de seguridad está relacionado con una infradosificación, que podría influir en su efectividad. Por lo tanto, estos resultados deben ser analizados con prudencia y se deben realizar más estudios para confirmar estos datos

Objective: To compare the occurrence of haemorrhages among the different oral anticoagulants (OAC) and to analyse factors that influence it. Material and methods: Single-centre, observational, retrospective study. After studying the total population treated with OAC, patients who were treated with an OAC from July 2015 to December 2015 in the II Sector of the Zaragoza Hospital, who consulted the Emergency Department of the Miguel Servet University Hospital and presented a haemorrhagic event, were analysed. Patients' demographic data, clinical variables and data on the haemorrhagic event characteristics were gathered. Results: There were 9,452 patients treated with an OAC, 371 (3.9%) of which presented a haemorrhagic event. The frequency per OAC was; 4.1% (311) in patients treated with vitamin K antagonists, 3.8% (33) with rivaroxaban, 3.3% (19) with dabigatran and 2.1% (8) with apixaban. In the multivariate analysis, only the choice of anticoagulant and sex had a statistically significant influence of a lower risk of haemorrhage, in particular the dose of apixaban at 2.5mg and being female. (OR=0.1, CI=0.014-0.71 and OR=0.688, CI=0.55-0.85, respectively). Conclusion: According to the results obtained, females and patients undergoing treatment with apixaban presented lower haemorrhagic risk, although there are doubts about whether this better safety profile is related to underdosing, which could influence its effectiveness. Therefore, these results should be analysed with caution and further studies are needed to confirm this data

Safety assessment of new oral anticoagulants. / Evaluación de la seguridad de los anticoagulantes orales de acción directa.

OBJECTIVE: To compare the occurrence of haemorrhages among the different oral anticoagulants (OAC) and to analyse factors that influence it. MATERIAL AND METHODS: Single-centre, observational, retrospective study. After studying the total population treated with OAC, patients who were treated with an OAC from July 2015 to December 2015 in the II Sector of the Zaragoza Hospital, who consulted the Emergency Department of the Miguel Servet University Hospital and presented a haemorrhagic event, were analysed. Patients' demographic data, clinical variables and data on the haemorrhagic event characteristics were gathered. RESULTS: There were 9,452 patients treated with an OAC, 371 (3.9%) of which presented a haemorrhagic event. The frequency per OAC was; 4.1% (311) in patients treated with vitamin K antagonists, 3.8% (33) with rivaroxaban, 3.3% (19) with dabigatran and 2.1% (8) with apixaban. In the multivariate analysis, only the choice of anticoagulant and sex had a statistically significant influence of a lower risk of haemorrhage, in particular the dose of apixaban at 2.5mg and being female. (OR=0.1, CI=0.014-0.71 and OR=0.688, CI=0.55-0.85, respectively). CONCLUSION: According to the results obtained, females and patients undergoing treatment with apixaban presented lower haemorrhagic risk, although there are doubts about whether this better safety profile is related to underdosing, which could influence its effectiveness. Therefore, these results should be analysed with caution and further studies are needed to confirm this data.

Effectiveness and security of chronic hepatitis C treatment in coinfected patients in real-world.

Background HIV-HCV coinfection produces high morbi-mortality. Direct-acting antivirals (DAAs) have shown high efficacy, although special attention should be paid to the risk of drug interactions. However, due to the lack of representativeness of coinfected patients in clinical trials, it is important to know real-world results. Objective To evaluate DAA treatment effectiveness in coinfected patients. We also analyse safety profile of DAA treatment and drug interactions between HCV and HIV therapy. Setting Descriptive study carried in a tertiary hospital of Spain Method HIV-HCV coinfected patients treated with DAAs between November 2014 and June 2016 were included. Main outcome measure Efficacy was measured in terms of sustained virologic response at week 12 after the end of therapy. Adverse events that led to treatment discontinuation were registered to evaluate the safety profile, and also drug interactions between DAAs and antiretroviral treatment were evaluated. Results Main HCV genotypes were 1a (34.9%) and 4 (24.5%). 51.9% were HCV previously treated, 54.7% had grade 4 liver fibrosis. SVR12 was reported in 90.6%. HCV treatment was well tolerated and there were no discontinuations because of adverse events. 30.2% of HIV treatments had to be modified before DAA treatment was started due to interactions, HIV suppression was not compromised. Conclusion DAA treatment in coinfected patients seems to be highly effective and secure. Evaluation of drug interactions must be a priority in order to maximize effectiveness and avoid toxicity.

Errores de medicación en un servicio de urgencias hospitalario: estudio de situación para mejorar la seguridad de los pacientes / Medication errors in a hospital emergency department: study of the current situation and critical points for improving patient safety

Objetivos. Conocer la tasa total de errores de medicación (EM) y de incidencias en el proceso de utilización de los medicamentos en el servicio de urgencias hospitalario (SUH) de un hospital terciario que se producen e identificar los puntos críticos asociados para implantar medidas de mejora. Método. Estudio prospectivo por observación directa para detectar EM entre los meses de junio y julio de 2016. Resultados. La tasa de EM total fue del 23,7%, y los EM más frecuentes fueron los referentes al proceso de administración (10,9%). Se detectaron 1.532 incidencias, el 53,6% en días laborales (p = 0,001), 43,1% en turno de tarde (p = 0,004) y 43,1% en salas de observación (p = 0,004). Conclusiones. La tasa de EM fue significativa, en su mayoría en el turno de tarde y en la sala de observación, así como la de las incidencias. Las más frecuentes lo fueron en relación con la administración de los medicamentos (AU)

Objectives. To determine the frequency of medication errors and incident types in a tertiary-care hospital emergency department. To quantify and classify medication errors and identify critical points where measures should be implemented to improve patient safety. Method. Prospective direct-observation study to detect errors made in June and July 2016. Results. The overall error rate was 23.7%. The most common errors were made while medications were administered (10.9%). We detected 1532 incidents: 53.6% on workdays (P=.001), 43.1% during the afternoon/evening shift (P=.004), and 43.1% in observation areas (P=.004). Conclusions. The medication error rate was significant. Most errors and incidents occurred during the afternoon/evening shift and in the observation area. Most errors were related to administration of medications (AU)

Trastuzumab, non-pegylated liposomal-encapsulated doxorubicin and paclitaxel in the neoadjuvant setting of HER-2 positive breast cancer.

BACKGROUD: Neoadjuvant treatment based on the combination of trastuzumab plus chemotherapy is the standard of care in patients with HER2-positive early or locally advanced breast cancer. The concurrent use of trastuzumab, anthracyclines and taxanes is frequently used in this setting despite the potential cardiotoxicity of both anthracyclines and trastuzumab. However, not much information is available about this chemotherapy scheme. OBJECTIVE: We wanted to evaluate the efficacy and safety profile of the combination of trastuzumab, liposome-encapsulated doxorubicin and paclitaxel as neoadjuvant scheme. We also tried to establish predictive factors of pathologic complete response. SETTING: The study was carried out in a tertiary University Hospital of Spain. METHOD: This is a descriptive study of the clinical practice performed in our hospital. MAIN OUTCOME MEASURE: Efficacy was measured in terms of pathologic complete response, which was defined as the absence of invasive cancer cells in the breast and the axilla after neoadjuvant treatment. RESULTS: Thirty patients were included, the median age was 48. Seventeen (56.7 %) were hormonal receptor (HR) positive, 14 (46.6 %) had IIIa-b clinical stage and one of them had inflammatory breast cancer. 12 patients (40 %) achieved pCR. Patients with HR-negative BC achieved a higher pCR rate than those ones with HR-positive BC (61.5 % and 23.5 %, respectively; p value = 0.035). 21 patients (70 %) underwent breast conservative surgery. The treatment was in general well tolerated, most frequent grade 3-4 adverse events were neutropenia (20 %), asthenia and liver enzyme alteration (10 %) and febrile neutropenia (6.7 %). No patient developed heart failure, but one (3.3 %) presented a 10 % asymptomatic absolute reduction in left ventricular fraction ejection. CONCLUSIONS: The studied treatment for the neoadjuvant setting of HER2 positive breast cancer seems to be an effective therapeutic option. Despite the expected high rate of cardiotoxicity of this regimen, the study results shows that this treatment regimen appears to be safe. The combination of trastuzumab, non-pegylated liposomal-encapsulated doxorubicin and paclitaxel should be considered for the treatment of HER2-overexpressing breast cancer.

Errores de medicación asociados al sistema de distribución de medicamentos en dosis unitarias. Concordancia entre observadores / No disponible

Objetivo: Evaluar la calidad del proceso de distribución de medicamentos en dosis unitarias (SDMDU) mediante cuantificación de errores y valoración de la concordancia entre observadores en suclasificación. Material y método: Estudio observacional para evaluar errores de llenado y de transcripción. Se analizaron 6 unidades médicas, 5días por semana, en semanas diferentes, con selección al azar de la planta revisada el primer día. Dos observadores (A y B) clasificaron los errores de transcripción según la taxonomía del GrupoRuiz-Jarabo 2000 modificada y valoraron la concordancia mediante el índice kappa. Resultados: Se detectó un 1,9% de errores de llenado y el 12,01% de errores de transcripción. El 74,2% de los fármacoserróneos se utilizaban para tratar afecciones del sistema nervioso, el aparato digestivo y el sistema cardiovascular. Los profesionalesrelacionados con mayor frecuencia con los errores fueron el farmacéutico y el enfermero ( = 0,793) y la transcripción fue laetapa de mayor trascendencia ( = 0,766). Los tipos de incidentes más frecuentes para A y B fueron omisión de dosis o medicamento (el 29,6 y el 31,2%), el intervalo posológico incorrecto (el 25 y el 22,6%) y la duración no acorde con la orden médica (el 21,5 y el 27,8%) ( = 0,701). La causas fueron los factores humanos(el 71,2 y el 96,3%) y los problemas de interpretación dela prescripción (el 26,5 y el 2,3%) ( = 0,55).Conclusiones: Medir los indicadores ha permitido valorar la calidad del trabajo y servirá de referencia para futuras evaluaciones. Los factores humanos son la principal causa de los errores que se producenen el proceso de transcripción, y es necesario introducir estrategias, como la prescripción electrónica, que han demostrado su efectividad en la disminución de errores

Objective: To evaluate the quality of the unit-dose drug distribution system by quantifying errors and evaluating concordance between observers in their classification.Material and method: We performed an observational study to evaluate filling and transcription errors. Six medical units were analyzed 5 days per week, in different weeks, with random selection ofthe unit evaluated on the first day. Two observers (A and B) classified transcription errors according to the taxonomy of the modifiedRuiz-Jarabo group classification 2000. Concordance was assessed using the Kappa index.Results: A total of 1.9% filling errors and 12.01% transcription errors were detected. Among the errors, 74.2% of the drugs were used in the nervous system, digestive tract and cardiovascular diseases.The professionals most frequently involved in errors werepharmacists and nurses ( = 0.793), and the most critical phase was transcription ( = 0.766). The commonest errors for A and B were dose or drug omission (29.6%, 31.2%), incorrect dosage interval(25.0%, 22.6%) and incorrect duration of therapy according to the original medical prescription (21.5%, 27.8%) ( = 0.701). The main causes of error were human factors (71.2%, 96.3%) and incorrect interpretation of the medical prescription (26.5%, 2.3%)( = 0.55). Conclusions: The indicators used allowed the quality of the activityof the pharmacy service to be evaluated, and will serve as a reference for future evaluations. Human factors were the main cause of errors made during transcription. Consequently, new strategies withdemonstrated effectiveness in reducing this kind of error, such as electronic prescription, should be introduced