ABSTRACT
Objetivos: Determinar la presencia de neurotoxicidad asociada a oxaliplatino en la práctica clínica asistencial, la gravedad de la misma y el manejo clínico relacionado con este efecto adverso. Método Estudio observacional retrospectivo que incluyó pacientes diagnosticados de cáncer colorrectal y que iniciaron un esquema de quimioterapia basada en oxaliplatino durante el año 2008 en un hospital de segundo nivel. Los datos se obtuvieron del programa de prescripción de Onco-Hematología propio del hospital y de las historias clínicas informatizadas. Se recogieron variables relacionadas con las características clínicas de los pacientes, con el tratamiento antineoplásico, con la neurotoxicidad asociada a oxaliplatino, así como con su manejo clínico. Resultados Se incluyó un total de 64 pacientes. La presencia de neurotoxicidad se situó en un 65,6%, presentándose mayoritariamente de forma leve o moderada. Alrededor de una tercera parte de los pacientes que presentaron este efecto adverso requirió un cambio en la prescripción de oxaliplatino. Se determinó una relación estadísticamente significativa (p=0,0004) entre dosis acumuladas de oxaliplatino y presencia de toxicidad neurológica. Conclusiones La presencia de neurotoxicidad asociada a oxaliplatino y su distribución en función de su gravedad, es similar a la descrita en literatura médica. El número de pacientes que requiere un cambio en la prescripción de oxaliplatino podría justificar la necesidad de diseñar estudios que valoren las consecuencias clínicas asociadas a estas modificaciones. Consideramos que es necesario el desarrollo de estrategias neuroprotectoras efectivas que garanticen la seguridad y calidad de vida de estos pacientes (AU)
Objectives: To evaluate the presence and severity of oxaliplatin-associated neurotoxicity inclinical practice and the clinical management of this adverse side effect. Method: Observational retrospective study including patients diagnosed with colorectal cancer that started an oxaliplatin-based chemotherapy regimen during 2008 at a secondary hospital. Data were obtained from an onco-haematological prescription programme at the hospital and from digital clinical histories. We compiled variables related to the clinical characteristics of the patients, antineoplastic treatment, neurotoxicity associated with oxaliplatin, and clinical management of this issue. Results: Our study included a total of 64 patients. Neurotoxicity was recorded in 65.6% of cases, usually in mild or moderate forms. In approximately one third of patients who developed this adverse effect, the oxaliplatin prescription had to be modified. We observed a statistically significant relationship between cumulative oxaliplatin doses and the presence of neurological toxicity (P=.0004).Conclusions: The presence of oxaliplatin-associated neurotoxicity and its distribution based onits severity was similar to rates published in the literature. The number of patients requiring a change in the oxaliplatin prescription could justify the need for studies that assess the clinical consequences of these modifications. We believe that effective strategies for neurological protection need to be developed in order to guarantee the safety and quality of life in these patients (AU)
Subject(s)
Humans , Colorectal Neoplasms/drug therapy , Antineoplastic Agents/adverse effects , Neurotoxicity Syndromes/epidemiology , Retrospective Studies , Cisplatin/adverse effects , Cytostatic Agents/adverse effectsABSTRACT
Objetivo: Cuantificar el uso de comparaciones indirectas (CI) en los informes de evaluación de medicamentos publicados en internet por el Grupo de Evaluación de Novedades, Estandarización e Investigación en Selección de Medicamentos (GENESIS).Método Estudio retrospectivo de los informes redactados en 2008-2009. Registro de la existencia de comparadores y características de los estudios comparativos directos e indirectos incluidos. Resultados En el 95% de los 337 informes analizados existe un comparador activo, en el 50% hay un estudio frente a éste. En 114 informes (34%), se referencia una CI, el 69% elaborada por el autor del informe. La mayoría fueron CI narrativas, ninguna ajustada. En los casos sin CI podría haberse realizado en el 16% y era dudoso en el 24%.ConclusionesMuchos medicamentos tienen comparador pero no estudios directos frente a éste, las CI deberían incorporarse en los informes en mayor medida y con criterios de calidad. (AU)
Objective: Quantify use of indirect comparisons (IC) in drug evaluation reports published on the GENESIS Group web page for new drug assessment, standardisation, and drug selection research. Method: Retrospective study of drug reports written between 2008 and 2009. Data collected: presence of an active comparator and details from any direct and indirect comparative studies included. Results: An active comparator was present in 95% of the 337 analysed reports; 50% included a direct comparative study vs comparator. In 114 reports (34%), an IC was used; 69% of the ICs were made by the report author. Most ICs were narrative and none were adjusted. An IC could have been made in an additional 16% of the cases and possibly in 24% more. Conclusions: Most evaluated drugs have an active comparator but studies comparing them directly are not as common. ICs could be included in more reports along with quality control criteria (AU)
Subject(s)
Humans , Drugs, Investigational/therapeutic use , Drug Evaluation/methods , Interchange of Drugs , Bioequivalent Drugs , Drug CompoundingABSTRACT
OBJECTIVE: Quantify use of indirect comparisons (IC) in drug evaluation reports published on the GENESIS Group web page for new drug assessment, standardisation, and drug selection research. METHOD: Retrospective study of drug reports written between 2008 and 2009. DATA COLLECTED: presence of an active comparator and details from any direct and indirect comparative studies included. RESULTS: An active comparator was present in 95% of the 337 analysed reports; 50% included a direct comparative study vs comparator. In 114 reports (34%), an IC was used; 69% of the ICs were made by the report author. Most ICs were narrative and none were adjusted. An IC could have been made in an additional 16% of the cases and possibly in 24% more. CONCLUSIONS: Most evaluated drugs have an active comparator but studies comparing them directly are not as common. ICs could be included in more reports along with quality control criteria.
Subject(s)
Drug Evaluation , Internet , Humans , Research Design , Retrospective Studies , Treatment OutcomeABSTRACT
OBJECTIVES: To evaluate the presence and severity of oxaliplatin-associated neurotoxicity in clinical practice and the clinical management of this adverse side effect. METHOD: Observational retrospective study including patients diagnosed with colorectal cancer that started an oxaliplatin-based chemotherapy regimen during 2008 at a secondary hospital. Data were obtained from an onco-haematological prescription programme at the hospital and from digital clinical histories. We compiled variables related to the clinical characteristics of the patients, antineoplastic treatment, neurotoxicity associated with oxaliplatin, and clinical management of this issue. RESULTS: Our study included a total of 64 patients. Neurotoxicity was recorded in 65.6% of cases, usually in mild or moderate forms. In approximately one third of patients who developed this adverse effect, the oxaliplatin prescription had to be modified. We observed a statistically significant relationship between cumulative oxaliplatin doses and the presence of neurological toxicity (P=.0004). CONCLUSIONS: The presence of oxaliplatin-associated neurotoxicity and its distribution based on its severity was similar to rates published in the literature. The number of patients requiring a change in the oxaliplatin prescription could justify the need for studies that assess the clinical consequences of these modifications. We believe that effective strategies for neurological protection need to be developed in order to guarantee the safety and quality of life in these patients.
Subject(s)
Antineoplastic Agents/adverse effects , Neurotoxicity Syndromes/psychology , Organoplatinum Compounds/adverse effects , Adult , Aged , Aged, 80 and over , Antineoplastic Agents/therapeutic use , Colonic Neoplasms/complications , Colonic Neoplasms/drug therapy , Dose-Response Relationship, Drug , Female , Humans , Male , Middle Aged , Organoplatinum Compounds/therapeutic use , Oxaliplatin , Rectal Neoplasms/complications , Rectal Neoplasms/drug therapy , Retrospective StudiesABSTRACT
Objetivo Analizar los informes de evaluación publicados en la página de Internet del Grupo de Evaluación de Novedades, Estandarización e Investigación en Selección de Medicamentos (GENESIS) y la variabilidad de sus propuestas sobre incorporación de medicamentos en la Guía Farmacoterapéutica. Métodos Se analizaron los informes publicados por hospitales en la página web de GENESIS y elaborados de 2004 a 2007. Se recogió el medicamento e indicación, el grupo terapéutico, la publicación en abierto o con clave, el hospital y la fecha de realización. Se elaboró un cuestionario que medía la inclusión en el informe de los 9 apartados recomendados por GENESIS. De aquellos medicamentos con 2 o más informes se analizó si coincidían en la recomendación y la posible causa de discordancia. Resultados Se analizaron 416 informes correspondientes a 185 medicamentos-indicaciones diferentes. El 93% incluían 6 o más de los apartados recomendados, número que incrementó con el tiempo. Se incluían con más frecuencia (porcentajes de 2007) las indicaciones aprobadas (92%), el mecanismo de acción (95%) o la bibliografía (86%). Apartados cumplimentados en un porcentaje creciente aunque más bajo son características diferenciales (60%), método de búsqueda bibliográfica (40%) o conclusiones con resumen de eficacia, seguridad y coste (52%); un 73% tenían recomendaciones concretas. En 42 de los 67 medicamentos con más de un informe con recomendación, ésta coincidía. Conclusiones La actividad del grupo GENESIS ha contribuido a que los hospitales españoles compartan sus informes de evaluación de medicamentos y a que éstos sean más completos aunque existen aspectos mejorables (AU)
Objective To analyse the assessment reports published on the GENESIS webpage (Group for Innovation, Assessment, Standardisation and Research in the Selection of Drugs) and assess the variability of the group's proposals to include drugs in the Formulary. Method We analysed reports published by hospitals on the GENESIS webpage between 2004 and 2007. Data were collected on drugs and indications, ATC group, open or restricted access publications, hospital, and publication date. We drafted a questionnaire that would measure to what extent to what extent the 9-section model recomended by GENESIS was included in each report. For drugs with two or more reports, we analysed whether the recommendation coincided and the possible cause in the event of conflict. Results We analysed 416 reports corresponding to 185 different drug indications. 93% included 6 or more of the recommended sections, a number which increased over time. The most frequently included sections were: approved indications (92%), mechanism of action (95%), and references (86%) (percentages from 2007). Sections which had an increasing but lower percentage were: differential characteristics (60%), literature search method (40%) and conclusions with a summary of efficacy, safety and cost data (52%). 73% of which had definite recommendations, which coincided for 42 out of the 67 drugs with more than one recommendation report. Conclusions The work carried out by the GENESIS group has enabled Spanish hospitals to share their drug assessment reports and making them more complete, although there are still some aspects that can be improved(AU)
Subject(s)
Humans , Drug Evaluation/standards , Research Report/standards , Pharmacy Service, Hospital/organization & administration , Forms and Records Control/standards , Webcasts as TopicABSTRACT
OBJECTIVE: To analyse the assessment reports published on the GENESIS webpage (Group for Innovation, Assessment, Standardisation and Research in the Selection of Drugs) and assess the variability of the group's proposals to include drugs in the Formulary. METHOD: We analysed reports published by hospitals on the GENESIS webpage between 2004 and 2007. Data were collected on drugs and indications, ATC group, open or restricted access publications, hospital, and publication date. We drafted a questionnaire that would measure to what extent to what extent the 9-section model recommended by GENESIS was included in each report. For drugs with two or more reports, we analysed whether the recommendation coincided and the possible cause in the event of conflict. RESULTS: We analysed 416 reports corresponding to 185 different drug indications. 93% included 6 or more of the recommended sections, a number which increased over time. The most frequently included sections were: approved indications (92%), mechanism of action (95%), and references (86%) (percentages from 2007). Sections which had an increasing but lower percentage were: differential characteristics (60%), literature search method (40%) and conclusions with a summary of efficacy, safety and cost data (52%). 73% of which had definite recommendations, which coincided for 42 out of the 67 drugs with more than one recommendation report. CONCLUSIONS: The work carried out by the GENESIS group has enabled Spanish hospitals to share their drug assessment reports and making them more complete, although there are still some aspects that can be improved.
Subject(s)
Clinical Pharmacy Information Systems , Internet , Pharmacy Service, Hospital , Research Report , Evaluation Studies as Topic , Research Report/standardsABSTRACT
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Subject(s)
Humans , Scientific Misconduct/ethics , Publishing/ethics , PlagiarismABSTRACT
OBJECTIVE: Electronic prescribing is considered a basic measure for the prevention and reduction of medications errors. The goal of this survey was to assess the incidence of errors occurring with electronic versus standard prescription. METHOD: A prospective, sequential, open-label study to assess errors with electronic prescribing as compared to traditional manual prescribing in two public hospitals in Balearic Islands. Errors regarding medication, diet and/or nursing orders were assesses along four process stages: medical prescription, pharmacy transcription/validation, nursing transcription, and dispensation. RESULTS: With manual prescription 1,576 errors/18,539 therapy orders (8.50%) were identified, whereas with electronic prescription 827 errors/18,885 therapy orders (4.38%) were detected, which represents a relative risk reduction by 48% and an absolute risk reduction by 4.12% (p < 0.0001). Pharmacy transcription/validation errors decreased (1.73 vs. 0.13%, p < 0.0001), as did nursing transcription errors (2.54 vs. 0.81%, p < 0.0001) and dispensation errors (2.13 vs. 0.96%, p < 0.0001); however, the number of prescription errors increased (2.10 vs. 2.40%, p = 0.0401). CONCLUSIONS: Electronic prescription is a powerful tool, and one that in this work was shown to decrease medication-, diet-, and nursing care-related errors in a highly significant way; however, it should be developed and maintained in order to achieve safety and effectiveness as required by drug usage.
Subject(s)
Drug Prescriptions/standards , Medical Order Entry Systems/standards , Medication Errors/statistics & numerical data , Humans , Medication Errors/classification , Prospective StudiesABSTRACT
Objetivo: Evaluar la incidencia de errores que se producencon la prescripción electrónica comparada con la prescripciónmanual.Método: Estudio prospectivo, secuencial y abierto para valorarlos errores con prescripción electrónica comparándola con laprescripción manual tradicional en dos hospitales públicos de lasIslas Baleares. Se han valorado los errores de medicación, dietay/u órdenes de enfermería en cuatro fases del proceso: prescripciónmédica, transcripción/validación en farmacia, transcripciónde enfermería y dispensación.Resultados: Con la prescripción manual se detectaron 1.576errores/18.539 órdenes de tratamiento (8,50%), y con la prescripciónelectrónica 827 errores/18.885 órdenes de tratamiento(4,38%), lo que supone una reducción relativa del riesgo del 48%y una reducción absoluta del riesgo de 4,12% (p < 0,0001). Existeuna disminución de errores de transcripción/validación en farmacia(1,73 vs. 0,13%, p < 0,0001), transcripción de enfermería(2,54 vs. 0,81%, p < 0,0001) y dispensación (2,13 vs. 0,96%, p < 0,0001); sin embargo, en la prescripción se observa un aumentodel número de errores (2,10 vs. 2,40%, p = 0,0401).Conclusiones: La prescripción electrónica es una herramientamuy poderosa que ha mostrado en este trabajo disminuir deforma muy significativa los errores de medicación, dieta y cuidadosde enfermería, pero que hay que desarrollar y mantener paraconseguir la seguridad y efectividad que se pretende en la utilizaciónde medicamentos
Objective: Electronic prescribing is considered a basic measurefor the prevention and reduction of medications errors. Thegoal of this survey was to assess the incidence of errors occurringwith electronic versus standard prescription.Method: A prospective, sequential, open-label study to assesserrors with electronic prescribing as compared to traditional manualprescribing in two public hospitals in Balearic Islands. Errorsregarding medication, diet and/or nursing orders were assessesalong four process stages: medical prescription, pharmacy transcription/validation, nursing transcription, and dispensation.Results: With manual prescription 1,576 errors/18,539 therapyorders (8.50%) were identified, whereas with electronic prescription827 errors/18,885 therapy orders (4.38%) were detected,which represents a relative risk reduction by 48% and an absoluterisk reduction by 4.12% (p < 0.0001). Pharmacy transcription/validationerrors decreased (1.73 vs. 0.13%, p < 0.0001), as did nursingtranscription errors (2.54 vs. 0.81%, p < 0.0001) and dispensationerrors (2.13 vs. 0.96%, p < 0.0001); however, the number ofprescription errors increased (2.10 vs. 2.40%, p = 0.0401).Conclusions: Electronic prescription is a powerful tool, andone that in this work was shown to decrease medication-, diet-,and nursing care-related errors in a highly significant way; however,it should be developed and maintained in order to achieve safetyand effectiveness as required by drug usage
Subject(s)
Humans , Drug Prescriptions/statistics & numerical data , Electronics, Medical , Medication Systems, Hospital/statistics & numerical data , Medication Errors/methods , Medication Errors/statistics & numerical data , Drug Therapy, Computer-Assisted , Prospective Studies , Hospitals, Public , SpainABSTRACT
INTRODUCTION: Ten years of publications (1984-1993) about drug compliance in spanish hypertensive patients are presented. MATERIAL AND METHODS: A bibliography search of Medline (EBSCO CD-ROM ver 104.1, act Jul 1995), Indice Médico Español (CSIC CD-ROM, act Oct 1993) and other sources has been made. RESULTS: 39 articles have been located and 23 investigational publications have been analysed. All the publications, but one, have evaluated the compliance by an indirect method, mainly patient selfdeclaration. The degree of patient compliance determined by interviews, questionnaires or inquiries is 55.5% (IC 95%: 52.7-58.3). The patient compliance in the publications that use methods based in pill counts is 46.4% (IC 95%: 41.6-51.2). The treatment dropout is present in the 18.5% of the patients (IC 95%: 20.5-16.5). CONCLUSIONS: The drug compliance degree in Spanish patients with hypertension is low.
