Expresiones y criterios mejorables en la redacción de informes de evaluación y posicionamiento terapéutico / Expressions and criteria that could be improved in the writing of reports for drug evaluation and therapeutic positioning

En la revisión de borradores de informes para evaluación y posicionamiento de nuevos fármacos en un entorno multidisciplinar, se observan determinados errores de expresión o criterio que se repiten con frecuencia. Principalmente, están relacionados con la consideración de “diferencias” o tendencias no significativas, abuso de la reducción relativa del riesgo, errores en la valoración de resultados por subgrupos sin calcular la interacción estadística, confusiones en la interpretación de las comparaciones indirectas, sobrevaloración de la relevancia clínica con variables subclínicas y afirmaciones sesgadas en el apartado de seguridad, entre otros. También se observa a menudo ambigüedad o inhibición en el posicionamiento, especialmente en situaciones de precariedad en la evidencia disponible. El presente trabajo expone de forma sintética tales errores, aclara algunos términos comunes y propone expresiones o criterios alternativos que se consideran preferibles, con el fin de ofrecer una evaluación para la toma de decisiones en beneficio de los pacientes. (AU)

In the review of reports for evaluation and positioning of new drugs in a multidisciplinary setting, some usual errors of expression or criteria are observed. Most of them are related to the consideration of «differences» or non-significant trends, abuse of the relative risk reduction, errors in the assessment of results by subgroups without calculating the statistical interaction, misinterpretation of indirect comparisons, excess in the assessment of clinical relevance with subclinical variables and biased statements in the safety section, among others. Ambiguity or inhibition in positioning is also often observed, especially in situations of precariousness in the available evidence. This work summarizes such errors, clarifies some common terms and proposes alternative expressions or criteria that are considered preferable, in order to offer evaluations for decision-making focused on the benefit of patients. (AU)

Comparaciones indirectas, respuesta de los autores / Indirect comparisons, author response

No disponible

Comparaciones indirectas en los informes de evaluación de medicamentos en la web del grupo GENESIS de la SEFH / Indirect comparisons in drug assessment reports on the GENESIS group (SEFH) webpage

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)

[Indirect comparisons in drug assessment reports on the GENESIS group (SEFH) webpage]. / Comparaciones indirectas en los informes de evaluación de medicamentos en la web del grupo GENESIS de la SEFH.

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.

Variabilidad en la actividad y los resultados de la evaluación de nuevos medicamentos por las comisiones de farmacia y terapéutica de los hospitales en España / Variability in Activity and Results From Drug Assessments by Pharmacy and Therapeutics Committees in Spanish Hospitals

Objetivo Cuantificar la actividad de las Comisiones de Farmacia y Terapéutica (CFyT) con relación a la evaluación y selección de medicamentos, y describir la variabilidad en las decisiones de incorporación de los mismos. Método Estudio descriptivo transversal basado en un cuestionario dirigido a los 513 hospitales españoles con más de 75 camas. Se incluyeron preguntas referidas a las resoluciones de la CFyT, el posicionamiento terapéutico y los informes de evaluación. El reclutamiento se realizó entre noviembre de 2007 y enero de 2008. La variabilidad en las conclusiones de las CFyT se expresa en 5 categorías o grados de coincidencia. Resultados Participaron 175 hospitales, tasa de respuesta del 34% (54% de las camas). El número medio (DE) de medicamentos-indicación evaluados por hospital en 2006 fue 10,35 (7,45). La proporción de evaluaciones que concluyen en inclusión o rechazo del fármaco fue del 75,3 y 21,4%, respectivamente. En el 16,2% se concluyó en equivalencia terapéutica. Se establecieron condiciones de uso en un 64%, y se incluyeron en una guía clínica en un 33%. En cuanto a la variabilidad, en el 81,0% de las evaluaciones se coincide en la conclusión de incluir o de rechazar el medicamento, en el 19,0% se ha tomado la decisión opuesta a la mayoritaria. Conclusiones La actividad de evaluación y selección de medicamentos en los hospitales es considerable. La proporción de medicamentos aprobados es similar en los diferentes tipos de hospital. La variabilidad en la decisión de inclusión es amplia y similar a estudios realizados en otros países. Indican la conveniencia de estandarización de la metodología (AU)

Objective To quantify the Spanish Pharmacy and Therapeutics Commission (P&TC) activity with regard to assessing and selecting drugs and describing variability in decisions made to include them. Method Descriptive, cross-sectional study based on a questionnaire aimed at 513 hospitals with more than 75 beds. We included questions referring to the P&TC resolutions, the therapeutic positioning and assessment reports. Recruitment was carried out between November 2007 and January 2008. Variability among P&TC conclusions was presented in five categories or levels of coincidence. Results One hundred and seventy-five hospitals participated, with a response rate of 34% (54% of beds). The mean number of drug-indications assessed per hospital was 10.35 (7.45). The proportion of assessments that conclude with drug inclusion or rejection was 75.3% and 21.4%, respectively. 16.2% concluded with therapeutic equivalence. Conditions for use were established for 64% of them, and 33% were included in a clinical guide. With regard to variability, 81.0% of assessments coincided with the conclusion to include or reject the drug. A contradictory decision was made for 19.0%.ConclusionsDrug assessment and selection in hospitals are considerable. The proportion of drugs approved is similar in different types of hospitals. There is extensive variability as regards deciding upon inclusion and is similar to studies conducted in other countries. They indicate that a standardising methodology would be recommendable (AU)

Caracterización y variabilidad de los informes de evaluación de medicamentos en la página web del grupo GENESIS de la SEFH / Classification and variability of drug assessment reports on the GENESIS group (SEFH) webpage

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)

[Classification and variability of drug assessment reports on the GENESIS group (SEFH) webpage]. / Caracterización y variabilidad de los informes de evaluación de medicamentos en la página web del grupo GENESIS de la SEFH.

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.

Variability in activity and results from drug assessments by pharmacy and therapeutics committees in Spanish hospitals.

OBJECTIVE: To quantify the Spanish Pharmacy and Therapeutics Committees (P&TC) activity with regard to assessing and selecting drugs and describing variability in decisions made to include them. METHOD: Descriptive, cross-sectional study based on a questionnaire aimed to 513 hospitals with more than 75 beds. We included questions referring to the P&TC resolutions, the therapeutic positioning and assessment reports. Recruitment was carried out between November 2007 and January 2008. Variability among P&TC conclusions were presented in five categories or levels of coincidence. RESULTS: One hundred and seventy-five hospitals participated, with a response rate of 34% (54% of beds). The mean (SD) number of drug-indications assessed per hospital was 10.35 (7.45). The proportion of assessments that conclude with drug inclusion or rejection was 75.3 and 21.4%, respectively. 16.2% concluded with therapeutic equivalence. Conditions for use were established for 64% of them, and 33% were included in a clinical guide. With regard to variability, 81.0% of assessments coincided with the conclusion to include or reject the drug. A contradictory decision was made for 19.0%. CONCLUSIONS: Drug assessment and selection activity in hospitals involve an amount of work. The proportion of drugs approved is similar in different types of hospitals. There is extensive variability as regards deciding upon inclusion and is similar to studies conducted in other countries. They indicate that a standardising methodology would be recommendable.

[Clinical and economic impact of the pharmacy resident incorporation into the healthcare team]. / Impacto clínico y económico de la incorporación del farmacéutico residente en el equipo asistencial.

OBJECTIVE: To quantify the impact of the incorporation of a hospital pharmacy resident into a healthcare team. To describe the work schedule followed. METHOD: The resident was integrated for 8 months in Medical Oncology, Intensive Care Unit, and Oncology Day Hospital. Interventions were recorded and evaluated using Atefarm software. Problem characteristics, type, and severity were recorded, as were acceptance, and costs avoided by interventions. RESULTS: In all, 2,415 drug-related problems were detected (10 per day, and 3.6 per patient), and 2,545 interventions for 672 patients were carried out. Most common problems were inadequate treatment duration, and conversion to oral route. Sixty-one percent of errors were prevented. Sixty-five percent of interventions influenced safety, 35% efficiency, and 25% effectiveness. Ninety-four percent of interventions were accepted. Costs avoided by the pharmacist amounted to 3,133 euro per month. CONCLUSIONS: The integration of a pharmacist in the healthcare teams optimizes therapy, reduces costs, prevents adverse events, and offers healthcare education.

Impacto clínico y económico de la incorporación del farmacéutico residente en el equipo asistencial / No disponible

Objetivo: Cuantificar el impacto de la integración de un residentede Farmacia Hospitalaria en el equipo asistencial. Describirla sistemática de trabajo seguida.Método: El residente se integró durante 8 meses en oncologíamédica, unidad de cuidados intensivos y hospital de día de oncología.Las intervenciones se registraron y evaluaron mediante elprograma informático Atefarm®. Se registraron las características,tipo y gravedad de los problemas y la aceptación y coste evitadode las intervenciones.Resultados: Se detectaron 2.415 problemas relacionadoscon los medicamentos (10 por día y 3,6 por paciente) y se realizaron2.545 intervenciones sobre 672 pacientes. Los más frecuentesfueron la inadecuada duración de los tratamientos y la conversióna vía oral. El 61% de los errores fueron prevenidos. Un 65%de las intervenciones tuvo impacto sobre seguridad, 35% sobreeficiencia y 25% sobre efectividad. El 94% de las intervencionesfueron aceptadas. El coste evitado por farmacéutico/mes ascendióa 3.133 €.Conclusiones: El farmacéutico integrado en los equipos asistencialesoptimiza la terapia, reduce costes, previene efectosadversos y ofrece educación sanitaria

Objective: To quantify the impact of the incorporation of ahospital pharmacy resident into a healthcare team. To describethe work schedule followed.Method: The resident was integrated for 8 months in MedicalOncology, Intensive Care Unit, and Oncology Day Hospital. Interventionswere recorded and evaluated using Atefarm®‚ software.Problem characteristics, type, and severity were recorded, as wereacceptance, and costs avoided by interventions.Results: In all, 2,415 drug-related problems were detected(10 per day, and 3.6 per patient), and 2,545 interventions for672 patients were carried out. Most common problems wereinadequate treatment duration, and conversion to oral route. Sixty-one percent of errors were prevented. Sixty-five percent ofinterventions influenced safety, 35% efficiency, and 25% effectiveness.Ninety-four percent of interventions were accepted.Costs avoided by the pharmacist amounted to 3,133 per month.Conclusions: The integration of a pharmacist in the healthcareteams optimizes therapy, reduces costs, prevents adverseevents, and offers healthcare education

Información de medicamentos a la población desde el Servicio de Farmacia a través de Internet / Drug information mada available to the population via Internet from a Pharmacy Department

Objetivos: Describir y analizar la labor del Servicio de Farmacia en el portal sanitario www.viatusalud.com Métodos: El Servicio de Farmacia trabaja en la creación y actualización de un vademécum de medicamentos y en la respuesta a las consultas que los usuarios demandan del farmacéutico a través del portal. Resultados: A fecha de 31 de diciembre de 2002, se ofrecen más de 750 fichas diferentes de medicamentos y se han respondido 3.030 consultas. Conclusiones: Con este servicio de información sobre medicamentos y de respuesta a consultas on-line, el Servicio de Farmacia contribuye a satisfacer la demanda de información sanitaria originada por la sociedad y por pacientes que han sido atendidos en la Clínica Universitaria anteriormente. Además, permite identificar puntos de mejora en la información que se puede ofrecer a los pacientes desde el Servicio de Farmacia y supone una fuente terciaria de información a profesionales de la salud (AU)

Posibilidad de generalizar los resultados de una evaluación económica / Possibility of generalizing the results os an economic evaluation

No disponible

[Drug information made available to the population via Internet from a Pharmacy Department]. / Información de medicamentos a la población desde el Servicio de Farmacia a través de Internet.

OBJECTIVES: To describe and discuss the work of a Pharmacy Department for the health-care portal www.viatusalud.com. METHODS: Using a web portal, a Pharmacy Department develops and updates a vademecum on drugs, and answers enquiries by end-users. RESULTS: On December 31, 2002 more than 750 records on drugs were available, and 3030 enquiries had been answered. CONCLUSIONS: With this drug information and online enquiry service, our Pharmacy Department helps meet the demand of health-care information posed by the community and by patients previously seen at Clínica Universitaria. In addition, it allows areas of improvement to be detected in the information to be offered to patients fron a Pharmacy Department, and represents a tertiary source of information for health-care professionals.

Encuesta de opinión a los pacientes sobre el medicamento en el hospital y la atención en el servicio de farmacia / Survey of patient opinion of hospital medication and the pharmacy service

El objetivo del estudio fue valorar la opinión del paciente sobre el medicamento en el hospital y la atención en el servicio de farmacia y diseñar una herramienta para medir la calidad percibida por el usuario. Se realizó un estudio transversal multicéntrico encuestando a 337 pacientes ingresados y 179 ambulatorios. El 93 por ciento de los ingresados están satisfechos en general y el 94 por ciento de los ambulatorios lo está con la información que recibe. Pocos pacientes ingresados tienen contacto directo con el farmacéutico (2 por ciento). Al 77 por ciento de los ingresados les informan sobre los medicamentos y sólo el 37 por ciento conoce los efectos secundarios de éstos. En cuanto a los pacientes ambulatorios, su satisfacción aumenta si se les da información escrita, se les atiende en un lugar separado y se les ofrece la posibilidad de llamar. En definitiva, los pacientes están satisfechos, aunque la información al paciente ofrece al farmacéutico oportunidades de mejora (AU)