Foro de debate: seguridad de las alternativas a la transfusión alogénica en el paciente quirúrgico y/o crítico / Forum for debate: Safety of allogeneic blood transfusion alternatives in the surgical/critically ill patient

Estos últimos años han aparecido alertas de seguridad, no siempre bien sustentadas, que cuestionan el uso de algunas alternativas farmacológicas a la transfusión de sangre alogénica y/o lo restringen en indicaciones establecidas. Asistimos también a la preconización de otras alternativas, incluyendo productos hemáticos y fármacos antifibrinolíticos, sin que haya una base científica sólida que lo justifique. Por iniciativa del Grupo de Estudios Multidisciplinares sobre Autotransfusión y del Anemia Working Group España se reunió a un panel multidisciplinar de 23 expertos del área de cuidados de la salud en un foro de debate para: 1) analizar las diferentes alertas de seguridad en torno a ciertas alternativas a la transfusión; 2) estudiar los antecedentes que las han propiciado, la evidencia que las sustentan y las consecuencias que conllevan para la práctica clínica, y 3) emitir una valoración argumentada de la seguridad de cada alternativa a la transfusión cuestionada, según el uso clínico de la misma. Los integrantes del foro mantuvieron contactos por vía telemática y una reunión presencial en la que presentaron y discutieron las conclusiones sobre cada uno de los elementos examinados. Se elaboró un primer documento que fue sometido a 4 rondas de revisión y actualización hasta alcanzar un consenso, unánime en la mayoría de los casos. Presentamos la versión final del documento, aprobada por todos los miembros del panel, esperando sea de utilidad para nuestros colegas

In recent years, several safety alerts have questioned or restricted the use of some pharmacological alternatives to allogeneic blood transfusion in established indications. In contrast, there seems to be a promotion of other alternatives, based on blood products and/or antifibrinolytic drugs, which lack a solid scientific basis. The Multidisciplinary Autotransfusion Study Group and the Anemia Working Group España convened a multidisciplinary panel of 23 experts belonging to different healthcare areas in a forum for debate to: 1) analyze the different safety alerts referred to certain transfusion alternatives; 2) study the background leading to such alternatives, the evidence supporting them, and their consequences for everyday clinical practice, and 3) issue a weighted statement on the safety of each questioned transfusion alternative, according to its clinical use. The members of the forum maintained telematics contact for the exchange of information and the distribution of tasks, and a joint meeting was held where the conclusions on each of the items examined were presented and discussed. A first version of the document was drafted, and subjected to 4 rounds of review and updating until consensus was reached (unanimously in most cases). We present the final version of the document, approved by all panel members, and hope it will be useful for our colleagues

Forum for debate: Safety of allogeneic blood transfusion alternatives in the surgical/critically ill patient.

In recent years, several safety alerts have questioned or restricted the use of some pharmacological alternatives to allogeneic blood transfusion in established indications. In contrast, there seems to be a promotion of other alternatives, based on blood products and/or antifibrinolytic drugs, which lack a solid scientific basis. The Multidisciplinary Autotransfusion Study Group and the Anemia Working Group España convened a multidisciplinary panel of 23 experts belonging to different healthcare areas in a forum for debate to: 1) analyze the different safety alerts referred to certain transfusion alternatives; 2) study the background leading to such alternatives, the evidence supporting them, and their consequences for everyday clinical practice, and 3) issue a weighted statement on the safety of each questioned transfusion alternative, according to its clinical use. The members of the forum maintained telematics contact for the exchange of information and the distribution of tasks, and a joint meeting was held where the conclusions on each of the items examined were presented and discussed. A first version of the document was drafted, and subjected to 4 rounds of review and updating until consensus was reached (unanimously in most cases). We present the final version of the document, approved by all panel members, and hope it will be useful for our colleagues.

Calidad de la recogida de la medicación domiciliaria en urgencias: discrepancias en la conciliación / Quality of Home Medication Collection in the Emergency Department: Reconciliation Discrepancies

Introducción El objetivo del estudio fue valorar la calidad de la recogida de información de la medicación domiciliaria en el servicio de Urgencias de un hospital de tercer nivel, e identificar si las posibles deficiencias en esta recogida se tradujeron en errores de conciliación al ingreso, analizar estos y clasificarlos, así como identificar los grupos farmacológicos implicados. Métodos Se realizó un estudio observacional prospectivo en el que se analizó la información farmacoterapéutica recogida en el servicio de Urgencias. Se incluyeron los pacientes que ingresaron en la Unidad de Neumología y de Medicina Interna del Hospital Universitario Miguel Servet de Zaragoza. Se elaboró un listado con la medicación domiciliaria del paciente antes del ingreso, y se valoró si las deficiencias de calidad en la información recogida en urgencias se tradujeron en errores de conciliación al ingreso. Se tuvieron en cuenta las discrepancias no justificadas y se clasificaron siguiendo los criterios del Documento de consenso sobre terminología, clasificación y evaluación de los programas de Conciliación de la Medicación 2009.ResultadosSe incluyeron 136 pacientes, hallando errores de conciliación en el 86,8%. El número total de errores de conciliación encontrados fue 519. Siendo los subtipos más frecuentes: omisión de algún medicamento, falta de dosis y falta de frecuencia de administración. Cerca de un 40% de los errores de conciliación encontrados en el servicio de Medicina Interna no fueron resueltos, el doble de los encontrados en el servicio de Neumología. El grupo farmacológico en el que se encontraron más discrepancias fue el de aparato digestivo y metabolismo, con un 24%.ConclusionesEl porcentaje de pacientes con errores de conciliación es elevado (86%), observándose una importante oportunidad de mejora al ingreso de los pacientes en el servicio de Urgencias (AU)

Introduction The objective of the study was to assess home medication data collected at the emergency department in a tertiary hospital. It also aimed to identify whether any possible deficiencies in this collection were translated as reconciliation errors on admission, to analyse and classify these data and identify the pharmacological groups involved. Methods A prospective observational study was carried out which analysed the pharmacotherapeutic data collected at the emergency department. Patients who were admitted to the Pneumology and Internal Medicine wards at the Miguel Servet University Hospital in Zaragoza were included. A list of the home drugs taken before the hospital stay was compiled, assessing whether the quality deficiencies in data collected in the emergency department translated as reconciliation errors at admission. Unjustified discrepancies were considered and classified in line with the criteria of the consensus document on terminology, classification and assessment of the drug reconciliation programmes for 2009.ResultsWe included 136 patients, finding reconciliation errors in 86.8%. The total number of reconciliation errors found was 519. The most frequent types were: omitting a drug, missing dose information, missing administration frequency information. Almost 40% of the reconciliation errors found in the Internal Medicine ward were not resolved, which was double to that of the Pneumology ward. Most discrepancies were found for the Digestive System and Metabolism group (24%).Conclusions The percentage of patients that experienced reconciliation errors was high (86%), observing an important opportunity to improve at patient admission to the emergency department (AU)

[Quality of home medication collection in the Emergency Department: reconciliation discrepancies]. / Calidad de la recogida de la medicación domiciliaria en urgencias: discrepancias en la conciliación.

INTRODUCTION: The objective of the study was to assess home medication data collected at the Emergency Department in a tertiary hospital. It also aimed to identify whether any possible deficiencies in this collection were translated as reconciliation errors on admission, to analyse and classify these data and identify the pharmacological groups involved. METHOD: A prospective observational study was carried out which analysed the pharmacotherapeutic data collected at the Emergency Department. Patients who were admitted to the Pneumology and Internal Medicine wards at the Miguel Servet University Hospital in Zaragoza were included. A list of the home drugs taken before the hospital stay was compiled, assessing whether the quality deficiencies in data collected in the emergency department translated as reconciliation errors at admission. Unjustified discrepancies were considered and classified in line with the criteria of the consensus document on terminology, classification and assessment of the drug reconciliation programmes for 2009. RESULTS: We included 136 patients, finding reconciliation errors in 86.8%. The total number of reconciliation errors found was 519. The most frequent types were: omitting a drug, missing dose information, missing administration frequency information. Almost 40% of the reconciliation errors found in the Internal Medicine ward were not resolved, which was double that of the Pneumology ward. Most discrepancies were found for the Digestive System and Metabolism group (24%). CONCLUSIONS: The percentage of patients that experienced reconciliation errors was high (86%), observing an important opportunity to improve at patient admission to the Emergency Department.

Utilización de fármacos específicos para la enfermedad de Alzheimer / Use of specific drugs for Alzheimer's disease

Objetivo. Analizar la evolución y repercusiones económicas del consumo de fármacos específicos para la enfermedad de Alzheimer (EA) en Aragón, conocer su patrón de utilización y estimar la proporción de pacientes en tratamiento específico. Métodos. Estudio descriptivo del consumo extrahospitalario de inhibidores de colinesterasa y memantina (1996-2004) a través de los envases facturados por oficinas de farmacia al Sistema Nacional de Salud. A partir de las dosis diarias definidas (DDD) e importe se calcularon: DDD por cada 1.000 habitantes (DHD), DDD por cada 1.000 habitantes mayores de 64 años (DHD65), incremento primer-último año (%), consumo proporcional por fármaco, coste por habitante y año y coste-tratamiento- día (CTD). Para la estimar la proporción de pacientes tratados se compararon las DHD65 con la prevalencia de EA. Resultados. Las DHD del conjunto han evolucionado de 0,026 (1996) a 3,235 (2004). El donepezilo se consolida como el más prescrito, aunque su peso disminuye ante la rápida penetración de nuevas alternativas. Las DHD consumidas en 2004 supusieron un coste cercano a 6 millones de euros. El CTD disminuyó un 30% en el período estudiado, mientras que el coste total se multiplicó por 90 (por 60 cuando se utilizaron euros constantes de 2004). Se estima que en 2004 el 34% de pacientes con EA recibió tratamiento específico. Conclusiones. Se observa un importante ascenso en el uso y la carga económica que suponen estos fármacos, cuyo coste-efectividad ha sido discutido en algunos estudios. Son necesarios trabajos con datos más específicos por paciente que permitan identificar sus características y valorar la adecuación de los tratamientos

Objetive. To evaluate the consumption evolution and financial impact of specific treatments for Alzheimer's disease (AD) in Aragon (Spain), analyzing consumption patterns and trends, and to estimate the proportion of AD patients treated with these drugs. Methods. Descriptive study of outpatient utilization of cholinesterase inhibitors and memantine (1996-2004), obtained from the drug packages dispensed by community pharmacists through prescriptions charged to the National Health Service. According to the defined daily doses (DDD) and expenditure data available, data were expressed in DDD per 1,000 inhabitants per day (DHD), DDD per 1,000 inhabitants older than 64 (DHD65), firstlast year increase (%), drug consumption pattern, annual cost per inhabitant and daily treatment cost (DTC). To estimate the proportion of treated patients we compared the DHD65 data with the estimated AD prevalence. Results. Overall consumption of these drugs has increased from 0.026 DHD (1996) to 3.235 DHD (2004). Donepezil remains as the most prescribed, though it is proportionally decreasing as a result of the quick introduction of newer alternatives. Overall cost of the DHD dispensed in 2004 reached nearly 6 million euros. DTC decreased about 30% over the study period, but the total cost increased ninety-fold (sixty-fold when non-variable euros from 2004 were considered). According to our estimates, 34 % of people with AD were receiving specific treatment. Conclusions. There is a significant increase in the consumption and economical burden of these drugs, whose cost-effectiveness has been questioned in some studies. More studies including specific patient data are needed in order to identify individual characteristics and evaluate treatment appropriateness

[Use of specific drugs for Alzheimer's disease]. / Utilización de fármacos específicos para la enfermedad de Alzheimer.

OBJECTIVE: To evaluate the consumption evolution and financial impact of specific treatments for Alzheimer's disease (AD) in Aragon (Spain), analyzing consumption patterns and trends, and to estimate the proportion of AD patients treated with these drugs. METHODS: Descriptive study of outpatient utilization of cholinesterase inhibitors and memantine (1996-2004), obtained from the drug packages dispensed by community pharmacists through prescriptions charged to the National Health Service. According to the defined daily doses (DDD) and expenditure data available, data were expressed in DDD per 1,000 inhabitants per day (DHD), DDD per 1,000 inhabitants older than 64 (DHD65), first-last year increase (%), drug consumption pattern, annual cost per inhabitant and daily treatment cost (DTC). To estimate the proportion of treated patients we compared the DHD65 data with the estimated AD prevalence. RESULTS: Overall consumption of these drugs has increased from 0.026 DHD (1996) to 3.235 DHD (2004). Donepezil remains as the most prescribed, though it is proportionally decreasing as a result of the quick introduction of newer alternatives. Overall cost of the DHD dispensed in 2004 reached nearly 6 million euros. DTC decreased about 30% over the study period, but the total cost increased ninety-fold (sixty-fold when non-variable euros from 2004 were considered). According to our estimates, 34% of people with AD were receiving specific treatment. CONCLUSIONS: There is a significant increase in the consumption and economical burden of these drugs, whose cost-effectiveness has been questioned in some studies. More studies including specific patient data are needed in order to identify individual characteristics and evaluate treatment appropriateness.

[Perioperative anaemia in geriatric patients with hip fracture]. / Efectividad de distintas pautas de tratamiento de la anemia perioperatoria en pacientes ancianos con fractura de cadera.

OBJECTIVE: To describe and study the effectiveness of the perioperative anaemia treatment patterns for patients older than 64 with hip fracture. METHOD: Three groups of patients were compared: Group 1: Oral iron or without iron therapy. Group 2: low doses of intravenous iron. Group 3: treated according to a blood saving programme including intravenous iron, alpha epoetin and restrictive transfusional criteria. The homogeneity of gender, age, type of fracture, ASA, preoperative period and perisurgical bleeding affecting drug consumption within the groups was analyzed. The effectiveness of the treatments was determined by means of transfusional rate, postoperative haemoglobin levels, and postoperative length of stay and infection rate. RESULTS: 329 patients were checked. Patients were comparable. Patients included in Group 3 were transfused less than the rest (36.5 of patients in group 3 vs. 52.0% in group 1 and 67.6% in group 3, p = 0.002). Decreases in the infection rate and mean postoperative stay in group 3 were not significant. Haemoglobin levels at 48 hours post surgery were higher in group 1 but haemoglobin levels at the seventh day post surgery were similar for the three groups. CONCLUSIONS: The above mentioned blood saving programme has been observed to be effective in decreasing transfusional requirements without increasing morbidity. However, further prospective studies are needed in order to define the cost-effectiveness of this programme and to determine its role in the reduction of posttransfusional infections and postoperative length of stay.

Efectividad de distintas pautas de tratamiento de la anemia perioperatoria en pacientes ancianos con fractura de cadera / Perioperative anaemia in geriatric patients with hip fracture

Objetivo: Analizar la efectividad de distintas pautas de tratamientode la anemia perioperatoria en pacientes mayores de 64años con fractura de cadera.Método: Se compararon tres grupos de pacientes: Grupo 1:sin ferroterapia o con hierro oral. Grupo 2: con hierro intravenosoa bajas dosis. Grupo 3: tratados según protocolo de ahorro desangre con criterios transfusionales restrictivos, hierro intravenosoy epoetina alfa. Se estudió si los grupos eran homogéneos ensexo, edad, tipo de fractura, ASA, tiempo prequirúrgico y consumode fármacos que pueden afectar al sangrado. La efectividad delos tratamientos se determinó mediante el porcentaje de pacientestransfundidos, los valores de hemoglobina postoperatorios, laestancia postoperatoria y la presencia de infección hospitalaria.Resultados: Se estudiaron 329 pacientes, que se consideraroncomparables en las variables estudiadas. Los pacientes delgrupo 3 se transfundieron significativamente menos que el resto(el 36,5 de los pacientes frente al 52,0% de los del grupo 1 y el67,6% de los del grupo 2, p = 0,002). El porcentaje de pacientescon infección hospitalaria y la estancia postoperatoria media fuemenor en el grupo 3 que en el resto de grupos aunque no alcanzósignificación. Los valores de hemoglobina a las 48 h tras la intervenciónfueron mayores en el grupo 1 pero los niveles a los sietedías fueron similares en los tres grupos. Conclusiones: El protocolo de ahorro de sangre se ha mostradoefectivo en disminuir las necesidades transfusionales sinaumentar la morbilidad. Sin embargo son necesarios estudios másamplios, de carácter prospectivo, que establezcan su papel en ladisminución de las infecciones postransfusionales, en la disminuciónde la estancia hospitalaria y que definan el coste-efectividaddel programa

Objective: To describe and study the effectiveness of the perioperativeanaemia treatment patterns for patients older than 64with hip fracture.Method: Three groups of patients were compared: Group 1:Oral iron or without iron therapy. Group 2: low doses of intravenousiron. Group 3: treated according to a blood saving programmeincluding intravenous iron, alfa epoetin and restrictivetransfusional criteria. The homogeneity of gender, age, type offracture, ASA, preoperative period and perisurgical bleedingaffecting drug consumption within the groups was analyzed. Theeffectiveness of the treatments was determined by means of transfusionalrate, postoperative haemoglobin levels, and postoperativelength of stay and infection rate.Results: 329 patients were checked. Patients were comparable.Patients included in Group 3 were transfused less than the rest (36.5of patients in group 3 vs. 52.0% in group 1 and 67.6% in group 3, p= 0.002). Decreases in the infection rate and mean postoperativestay in group 3 were not significant. Haemoglobin levels at 48 hourspost surgery were higher in group 1 but haemoglobin levels at theseventh day post surgery were similar for the three groups.Conclusions: The above mentioned blood saving programmehas been observed to be effective in decreasing transfusionalrequirements without increasing morbidity. However, furtherprospective studies are needed in order to define the cost-effectivenessof this programme and to determine its role in the reduction ofpostransfusional infections and postoperative length of stay

Influencia del género en investigación clínica / No disponible

Objetivo: Analizar desde la perspectiva de género los ensayos clínicos llevados a cabo en nuestro medio en los tres últimos años. Material y métodos: Estudio retrospectivo sobre una muestra de 101 ensayos realizados con la participación del servicio de farmacia de un hospital universitario de 1.240 camas. Fuentes de datos: protocolos e informes-resumen elaborados por el servicio de farmacia, programa informático Gecos®, fichas de seguimiento de ensayos, registro de recepción, dispensación y devolución de muestras e informes anuales.Resultados: 17 ensayos analizados incluían exclusivamente mujeres, 13 sólo hombres y 71 pacientes de ambos sexos. En ensayos de participación exclusivamente femenina la patología más estudiada fue cáncer de mama (70,6%), las fases de ensayo más frecuentes la III (47,1%) y la II (41,2%) y los medicamentos más investigados docetaxel (17,7%) y trastuzumab (11,8%).En ensayos de participación exclusivamente masculina disfunción eréctil fue la patología más estudiada (92,3%), la fase III lamás frecuente (76,9%) y tadalafilo (38,5%) y vardenafilo (30,8%)los fármacos más implicados. En ensayos sin criterios de inclusión según género las patologíasmás estudiadas fueron cáncer de colon (11,3%) y pulmón (11,3%) einsuficiencia renal (9,9%), la fase más repetida la III (57,7%) y losmedicamentos más ensayados interferón alfa 2a, gemcitabina y riba-virina. El porcentaje de participación global fue 62,3% para hombresy 37,7% para mujeres.Conclusiones:a) la patología más estudiada, sin considera-ción de género, ha sido el cáncer, en ensayos de mujeres cáncerde mama y disfunción eréctil en los de hombres; b) en los ensayossin criterios de inclusión según género se observa que la participa-ción de hombres y mujeres está en una relación de 2 a 1; y c) lafase III ha sido la más frecuente en todos los ensayos, destacandola fase II en los de mujeres de acuerdo con las directrices quepotencian su inclusión en fases tempranas del ensayo (AU)

Objective: To analyze clinical trials performed in our setting for the past three years from a gender-related standpoint.Material and methods: A retrospective study of 101 trials in which the pharmacy department of a 1,240-bed university hospital took part.Data sources: protocols and summary reports by the pharmacy department, Gecos® software program, trial follow-up cards,reception records, sample dispensation and returns, and yearly reports.Results: 17 trials included women only, 13 trials included men only, and 71 trials included patients of both genders.In female-only trials the most commonly studied condition was breast cancer (70.6%), the most common phases were phase III(47.1%) and II (41.2%) and the most commonly studied drugs were docetaxel (17.7%) and trastuzumab (11.8%).In male-only trials the most commonly studied condition was erectile dysfunction (92.3%), the most common phase was phaseIII (76.9%) and the most commonly studied drugs were tadalafil(38.5%) and vardenafil (30.8%).In trials without gender-related inclusion criteria the most commonly studied conditions included colon cancer (11.3%), lung cancer(11.3%), and renal failure (9.9%); the most common phase was phase III (57.7%) and the most frequently assayed drugs were interferon alpha-2a, gemcitabine and ribavirin. Overall participation rate was 62.3% for males and 37.7% for females.Conclusions: a) Regardless of gender, the most commonly studied condition was cancer, with breast cancer being most common in female-only trials and erectile dysfunction in male-only trials; b)male and female participation followed a 2:1 ratio in trials without gender-related inclusion criteria; and c) phase III was most commonamongst all trials considered, with phase II having a relevant role inwomen-only trials as per guidelines favoring inclusion in early trials (AU)

[Cross-hypersensitivity syndrome between antiepileptic drugs: report of a case]. / Síndrome de hipersensibilidad cruzado entre antiepilépticos: a propósito de un caso.

Antiepileptic hypersensitivity syndrome (SHA) is a rare (1/1.000 to 1/10.000 in new exposures) but potentially life-threatening syndrome that occurs after exposure to an anticonvulsant, most commonly the aromatic ones such as phenytoin, carbamazepine or phenobarbital. Clinical features of this syndrome include cutaneous reactions, fever, lymphadenopaties, eosinophilia and internal organ involvement (mainly liver, but also kidney, CNS, heart or lung). We present a case report of a 61-year-old woman treated with phenobarbital who developed a cutaneous eruption attributed to this drug. Treatment was changed to phenytoin and after 17 days the patient developed cutaneous rash, eosinophilia and an increase in transaminase levels. The high rate of cross-sensitivity between aromatic anticonvulsants (40-80%) suggests a link between a hypersensitivity reaction to phenytoin and the previous reaction to phenobarbital.

[Influence of gender on clinical research]. / Influencia del género en investigación ckínica.

OBJECTIVE: To analyze clinical trials performed in our setting for the past three years from a gender-related standpoint. MATERIAL AND METHODS: A retrospective study of 101 trials in which the pharmacy department of a 1,240-bed university hospital took part. DATA SOURCES: protocols and summary reports by the pharmacy department, Gecos software program, trial follow-up cards, reception records, sample dispensation and returns, and yearly reports. RESULTS: 17 trials included women only, 13 trials included men only, and 71 trials included patients of both genders. In female-only trials the most commonly studied condition was breast cancer (70.6%), the most common phases were phase III (47.1%) and II (41.2%) and the most commonly studied drugs were docetaxel (17.7%) and trastuzumab (11.8%). In male-only trials the most commonly studied condition was erectile dysfunction (92.3%), the most common phase was phase III (76.9%) and the most commonly studied drugs were tadalafil (38.5%) and vardenafil (30.8%). In trials without gender-related inclusion criteria the most commonly studied conditions included colon cancer (11.3%), lung cancer (11.3%), and renal failure (9.9%); the most common phase was phase III (57.7%) and the most frequently assayed drugs were interferon alpha-2a, gemcitabine and ribavirin. Overall participation rate was 62.3% for males and 37.7% for females. CONCLUSIONS: a) Regardless of gender, the most commonly studied condition was cancer, with breast cancer being most common in female-only trials and erectile dysfunction in male-only trials; b) male and female participation followed a 2:1 ratio in trials without gender-related inclusion criteria; and c) phase III was most common amongst all trials considered, with phase II having a relevant role in women-only trials as per guidelines favoring inclusion in early trials.