Association between anticholinergic activity and xerostomia and/ or xerophthalmia in the elderly: systematic review.

PURPOSE: The aim of this work was to investigate the association between anticholinergic burden or anticholinergic drug use and xerostomia and/or xerophtalmia in elderly through a systematic review of the published literature. METHODS: A search was carried out in 3 databases (CINAHL, Embase and Pubmed). Studies conducted in people ≥65 years of age, who took anticholinergic medications, and measured the association between the anticholinergic burden or the use of these medications with the prevalence of xerostomia and / or xerophthalmia, published up to August 2022, were selected. Studies published in languages other than Spanish and/or English were excluded. RESULTS: One thousand two hundred eleven articles were identified, 10 were selected for this review: six cross-sectional studies, two cohorts, one case-control and one randomized controlled clinical trial. A total of 3535 patients included in the different studies were studied. The most used scales were the Anticholinergic Drug Scale (ADS) and the Anticholinergic Risk Scale (ARS). Four articles studied the relationship between the use of anticholinergic medication and the prevalence of xerostomia and / or xerophthalmia, finding a positive relationship with xerostomia in all of them. Another 6 measured the relationship between anticholinergic burden and xerostomia and / or xerophthalmia. Four found a positive relationship between anticholinergic burden and xerostomia and/or xerophthalmia. CONCLUSIONS: Our findings suggest a clear relationship between the use of anticholinergic drugs or anticholinergic burden and the presence of xerostomia. This relationship was less conclusive in the case of xerophthalmia.

Respuesta: Comentarios sobre la herramienta web Anticholinergic Burden Calculator / Reply: Comments on the Anticholinergic Burden Calculator Web Tool

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Assessment of new drugs in a tertiary hospital using a standardized tool.

OBJECTIVE: To describe the profile of new drugs evaluated by the Pharmacy and Therapeutics committee in a tertiary hospital using a standardized tool, the Guideline for the Introduction of New Drugs in the Formulary (GINF form), as main objective. MATERIALS AND METHODS: Retrospective observational study of drugs was assessed during 2008-2011. Variables related to the drug, the request, and the result of the evaluation were collected based on information contained in the GINF form and in the assessment reports. RESULTS: 63 of 75 assessed drugs (84%) were included in the hospital formulary. Only one drug (1%) was included without any restrictions. The rest of them were included as therapeutic equivalents (23%) or under specific recommendations (61%). Half of the drugs (6) not included had insufficient evidence of effectiveness compared with current treatments. Haematology and Medical Oncology were found to be the most active medical services in the application process. There was a high prevalence of drugs that had more than one advanced clinical trial (phase III and/or phase IV). Furthermore, 28% of assessed drugs were associated with a financial burden of more than ?10,000 per year for our hospital. Highquality information was provided by applicants to the P&T committee for drugs that were finally included. However, the relationship between the information provided to the P&T committee and its decision was not statistical significance. CONCLUSION: The requests received were primarily related to drugs intended for parenteral use and most of them were antineoplastic drugs. The medical departments most heavily represented were Haematology and Oncology.

Objetivo: Describir las características de los nuevos fármacos evaluados por la Comisión de Farmacia y Terapéutica (CFyT) en un hospital terciario mediante el empleo de una herramienta normalizada, la Guía para la valoración de Inclusión de Nuevos Fármacos, como objetivo principal. Material y métodos: Estudio observacional retrospectivo de aquellos fármacos evaluados en el periodo 2008-11. Fueron recogidas variables relativas al fármaco, a la solicitud y al resultado final de la evaluación mediante la información contenida en las guías GINF y en los informes finales de evaluación. Resultados: De los 75 medicamentos evaluados, 63 (84%) fueron incluidos en la Guía Farmacoterapéutica del Hospital. Únicamente 1 (1,3%) lo fue sin ningún tipo de restricción. El resto fueron incluidos como equivalentes terapéuticos (21,3%) o bajo recomendaciones específicas (61,3%). La mitad de los fármacos no incluidos (6) presentaban insuficiente evidencia respecto a su eficacia frente a los tratamientos habituales. Hematología y Oncología Médica se encontraron entre los servicios médicos más activos en la solicitud. Se observó un alto porcentaje de fármacos que disponían de más de un ensayo clínico en fase avanzada (III y/o IV). Por otra parte, el 28% de los fármacos evaluados se relacionaron con un impacto financiero superior 10.000 ??anuales. Las guías GINF proporcionadas por los solicitantes a la CFyT se caracterizaron por la alta calidad de la información contenida en ellas. Sin embargo, la relación entre la información proporcionada a la CFyT y la decisión final de la misma no fue estadísticamente significativa. Conclusiones: Las solicitudes recibidas pertenecieron principalmente a fármacos de administración parenteral, siendo la mayor parte de ellos antineoplásicos. Los servicios médicos más intensamente representados fueron Hematología y Oncología.

Assessment of new drugs in a tertiary hospital using a standardized tool

OBJECTIVE: To describe the profile of new drugs evaluated by the Pharmacy and Therapeutics committee in a tertiary hospital using a standardized tool, the Guideline for the Introduction of New Drugs in the Formulary (GINF form), as main objective. MATERIALS AND METHODS: Retrospective observational study of drugs was assessed during 2008-2011. Variables related to the drug, the request, and the result of the evaluation were collected based on information contained in the GINF form and in the assessment reports. RESULTS: 63 of 75 assessed drugs (84%) were included in the hospital formulary. Only one drug (1%) was included without any restrictions. The rest of them were included as therapeutic equivalents (23%) or under specific recommendations (61%). Half of the drugs (6) not included had insufficient evidence of effectiveness compared with current treatments. Haematology and Medical Oncology were found to be the most active medical services in the application process. There was a high prevalence of drugs that had more than one advanced clinical trial (phase III and/or phase IV). Furthermore, 28% of assessed drugs were associated with a financial burden of more than €10,000 per year for our hospital. High-quality information was provided by applicants to the P&T committee for drugs that were finally included. However, the relationship between the information provided to the P&T committee and its decision was not statistical significance. CONCLUSION: The requests received were primarily related to drugs intended for parenteral use and most of them were antineoplastic drugs. The medical departments most heavily represented were Haematology and Oncology

OBJETIVO: Describir las características de los nuevos fármacos evaluados por la Comisión de Farmacia y Terapéutica (CFyT) en un hospital terciario mediante el empleo de una herramienta normalizada, la Guía para la valoración de Inclusión de Nuevos Fármacos, como objetivo principal. MATERIAL Y MÉTODOS: Estudio observacional retrospectivo de aquellos fármacos evaluados en el periodo 2008-11. Fueron recogidas variables relativas al fármaco, a la solicitud y al resultado final de la evaluación mediante la información contenida en las guías GINF y en los informes finales de evaluación. RESULTADOS: De los 75 medicamentos evaluados, 63 (84%) fueron incluidos en la Guía Farmacoterapéutica del Hospital. Únicamente 1 (1,3%) lo fue sin ningún tipo de restricción. El resto fueron incluidos como equivalentes terapéuticos (21,3%) o bajo recomendaciones específicas (61,3%). La mitad de los fármacos no incluidos (6) presentaban insuficiente evidencia respecto a su eficacia frente a los tratamientos habituales. Hematología y Oncología Médica se encontraron entre los servicios médicos más activos en la solicitud. Se observó un alto porcentaje de fármacos que disponían de más de un ensayo clínico en fase avanzada (III y/o IV). Por otra parte, el 28% de los fármacos evaluados se relacionaron con un impacto financiero superior 10.000 € anuales. Las guías GINF proporcionadas por los solicitantes a la CFyT se caracterizaron por la alta calidad de la información contenida en ellas. Sin embargo, la relación entre la información proporcionada a la CFyT y la decisión final de la misma no fue estadísticamente significativa. CONCLUSIONES: Las solicitudes recibidas pertenecieron principalmente a fármacos de administración parenteral, siendo la mayor parte de ellos antineoplásicos. Los servicios médicos más intensamente representados fueron Hematología y Oncología

Biological treatments for moderate-to-severe psoriasis: indirect comparison.

WHAT IS KNOWN AND OBJECTIVE: Psoriasis is a chronic skin disease for which there is an increasing range of treatment options. Biological agents (ustekinumab, adalimumab, infliximab and etanercept) are indicated for moderate-to-severe plaque-type psoriasis in adults who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporine, methotrexate and PUVA Unfortunately, with new drugs, the pivotal trials leading to their licensing are often placebo-controlled trials rather than comparative trials vs. established therapies. Therefore, inference on comparative effectiveness of the newer agents must be derived indirectly, through estimation of effects of the new agents vs. a common comparator. The objective of this study is to compare the relative efficacy of the biological agents through a systematic review of the indirect clinical trial evidence. METHODS: A systematic literature search was performed for clinical trials of biological agents in psoriasis. Pivotal, randomized, double-blind, controlled (placebo) trials using intention-to-treat analysis were selected for detailed analysis. Trials must include PASI 75 as a primary end point. The indirect comparison was performed using the method of Bucher adjusted with the ITC calculator (Indirect Treatment Comparisons of the Canadian Agency for Drugs and Technologies in Health), etanercept being the reference drug. We defined delta value for therapeutic equivalence as a difference in the efficacy of 25% among the different treatment options. RESULTS AND DISCUSSION: Fourteen studies (four for ustekinumab, three for adalimumab, three for infliximab and four for etanercept) were included. The indirect comparison results reveal that ustekinumab, adalimumab and infliximab were statistically superior to etanercept with an absolute risk difference for PASI 75 of 12% (95% CI = 5·9-18%), 11% (95% CI = 5·3-16·7%) and 24% (29·7-18·3%) respectively. However, in all situations, the 95% confidence interval does not achieve clinical relevance as no delta exceeds the previously set value (25%). WHAT IS NEW AND CONCLUSION: Ustekinumab, adalimumab, infliximab and etanercept can be regarded as clinical equivalents for the treatment of psoriasis. Choice between these agents therefore depends on their relative safety profiles, individual contra-indications and cost effectiveness.

Reliability of a questionnaire for pharmacological treatment appropriateness in patients with multiple chronic conditions.

BACKGROUND: The original Medication Appropriateness Index was validated for elderly and polymedicated patients, both in hospital and outpatient contexts. However, no studies have applied this questionnaire in patients with multiple chronic conditions. The objective of this study is to assess the reliability of a modified Medication Appropriateness Index questionnaire in a population of patients with multiple chronic conditions. METHODS: We selected patients with multiple chronic conditions who were included in an integrated care project conducted at the Hospital Universitario Virgen del Rocío. To determine inter-observer reliability, each professional (internist or hospital pharmacy specialist) applied the questionnaire under the same conditions and with the same resources. To determine intra-observer reliability, each physician applied the tool at baseline and two months later. We measured inter- and intra-observer reliability using the kappa coefficient. The proportion of overall agreement was also determined. RESULTS: We obtained a weak overall kappa (k=0.38) for inter-observer reliability and moderate (k=0.52) and very good (k=0.84) values for intra-observer reliability of the internist and specialist in hospital pharmacy, respectively. The proportion of overall agreement is very high in all three situations: 96%, 98%, and 99%, respectively. CONCLUSIONS: Despite its limitations, the Medication Appropriateness Index questionnaire modified by our group can be used, as a reliable method, to assess the appropriateness of pharmacotherapy in patients with multiple chronic conditions.

Autorización de usos de medicamentos fuera de indicación en un hospital de tercer nivel / Off-label approval of drug use in a tertiary hospital

Fundamento y objetivo. Comisión de Farmacia y Terapéutica (CFT) evalúa peticiones de usos fuera de indicación con un modelo de informe abreviado. El objetivo fue realizar un análisis descriptivo de esta actividad y estudiar la tasa de autorizaciones. Material y métodos. Estudio descriptivo de los informes de la CFT del hospital entre septiembre de 2009 y abril de 2011. Se analizó tipo de fármaco por grupo terapéutico y por tipo de dispensación, indicación y servicio peticionario. Además, se estudió la decisión final adoptada como variable principal y porcentaje de solicitudes aprobadas según características del medicamento evaluado, indicación solicitada, alternativas usadas, evidencia y coste, como resultados secundarios. Resultados. De un total de 51 solicitudes analizadas, un 60,8% fueron medicamentos de uso hospitalario y un 54,9% citostáticos. Destacaron las indicaciones oncohematológicas (43,2%) y autoinmunes (35,3%). Los servicios con más peticiones fueron Hematología (11 peticiones aprobándose el 72,7%), Oncología y Pediatría (10 peticiones aprobándose el 50% para ambas). Se aprobaron el 60,8% de las peticiones. De las no autorizadas, 11 no agotaron las alternativas terapéuticas y 8 no presentaban evidencia suficiente para ser aceptadas. El 47,1% de los medicamentos solicitados tenían un coste/paciente entre 10.000-100.000 euros aprobándose el 58,3% (coste por tratamiento completo si tenía duración definida o coste por año en tratamientos crónicos). Conclusión. Hay una gran actividad de la CFT que crece con los años. La mayoría de las solicitudes son de fármacos de uso hospitalario, sobre todo de citostáticos por Oncohematología. Existe una alta tasa de autorización con una alta variabilidad según servicio y tipo de evidencia. La diferencia, entre aprobados y no aprobados respecto al coste sigue una lógica de coste-efectividad(AU)

Background and objective. The Pharmacy and Therapeutics Committee (PTC) evaluates the requests for off-label uses with an abbreviated report format. The aim of this study is to perform a descriptive analysis of this activity and to study the rate of approvals. Material and Methods. A descriptive study was performed on the PTC reports in a tertiary hospital between September 2009 and April 2011. The type of drug by treatment group and by type of dispensing, indication and requesting department was analysed. The final decision adopted was studied as the primary outcome, and the percentage of requests approved according to the characteristics of the drug evaluated, indication requested, alternatives used, evidence and cost, as secondary outcomes. Results. A total of 51 applications were analysed, of which 60.8% were drugs for hospital use and 54.9% cytostatic. The most requested indications were the onco-haematological (43.2%) and autoimmune (35.3%). Haematology was the department that made most requests (11 requests with 72.7% approved), Oncology and Paediatrics (both with 10 requests, with 50% approved). Almost two-thirds (60.8%) of the requests were approved. Of those that were not approved, 11 had not used up the therapeutic alternatives, and 8 had no evidence. Just under half (47.1%) of the drugs requested had a cost/patient between 10,000-100,000 euros,of which 58.3% were approved (cost per course of treatment if it had a defined period, or cost of treatment per year for chronic treatment). Conclusion. There is an increase in the activity of the PTC that is growing over the years. Most applications focus on drugs for hospital use and cytostatic drugs by Onco-haematology. There is a high rate of approval by the PTC, and high variability in the percentage of approval depending on the department and the evidence of use. The difference between approved and unapproved requests followed a logic of cost-effectiveness(AU)

[Off-label approval of drug use in a tertiary hospital]. / Autorización de usos de medicamentos fuera de indicación en un hospital de tercer nivel.

BACKGROUND AND OBJECTIVE: The Pharmacy and Therapeutics Committee (PTC) evaluates the requests for off-label uses with an abbreviated report format. The aim of this study is to perform a descriptive analysis of this activity and to study the rate of approvals. MATERIAL AND METHODS: A descriptive study was performed on the PTC reports in a tertiary hospital between September 2009 and April 2011. The type of drug by treatment group and by type of dispensing, indication and requesting department was analysed. The final decision adopted was studied as the primary outcome, and the percentage of requests approved according to the characteristics of the drug evaluated, indication requested, alternatives used, evidence and cost, as secondary outcomes. RESULTS: A total of 51 applications were analysed, of which 60.8% were drugs for hospital use and 54.9% cytostatic. The most requested indications were the onco-haematological (43.2%) and autoimmune (35.3%). Haematology was the department that made most requests (11 requests with 72.7% approved), Oncology and Paediatrics (both with 10 requests, with 50% approved). Almost two-thirds (60.8%) of the requests were approved. Of those that were not approved, 11 had not used up the therapeutic alternatives, and 8 had no evidence. Just under half (47.1%) of the drugs requested had a cost/patient between 10,000-100,000 euros,of which 58.3% were approved (cost per course of treatment if it had a defined period, or cost of treatment per year for chronic treatment). CONCLUSION: There is an increase in the activity of the PTC that is growing over the years. Most applications focus on drugs for hospital use and cytostatic drugs by Onco-haematology. There is a high rate of approval by the PTC, and high variability in the percentage of approval depending on the department and the evidence of use. The difference between approved and unapproved requests followed a logic of cost-effectiveness.

Modelos de atención al paciente pluripatológico y el papel de la farmacia hospitalaria / Health care models for patients with multiple chronic conditions and the role of the hospital pharmacy

Introducción: La atención a los pacientes crónicos constituye actualmente el principal reto que afrontan los sistemas sanitarios. Dentro de estos pacientes, los pacientes pluripatológicos son aquellos que presentan una mayor tendencia a la discapacidad y a la muerte, y consumen mayores recursos. Se caracterizan por la coexistencia de dos o más enfermedades crónicas que duran un año o más y que precisan asistencia médica continuada y/o limitan las actividades diarias. Son los pacientes crónicos que más se pueden beneficiar de una atención farmacéutica, por lo que deberían ser objetivo prioritario de la farmacia hospitalaria. Objetivo: Dar a conocer la importancia de este colectivo de pacientes y las características de los principales modelos de atención y enfoques propuestos, así como resaltar la conveniencia de que el farmacéutico de hospital se integre con prontitud en estos modelos y exponer algunas actividades que debería desempeñar en el seno de los mismos. Resultados: Existen numerosos modelos en el panorama internacional, fundamentalmente el Chronic Care Model y la pirá - mide de riesgos de Kaiser Permanente. En nuestro país hay un desarrollo creciente de iniciativas que han culminado en la reciente Declaración de Sevilla. Para la farmacia hospitalaria la atención a crónicos en un modelo multiprofesional, cooperativo, integral y centrado en el paciente es todo un desafío. Los servicios de farmacia y la SEFH deberán reorientar sus estrategias de atención farmacéutica, la formación y la investigación. En especial, cobran interés las actividades dirigidas a mejorar la adherencia, la adecuación y la continuidad de los tratamientos, con énfasis en la participación activa del paciente (AU)

Introduction: Managing care for patients with chronic conditions currently represents one of the greatest challenges to health care systems. As a subgroup of these patients, those with multiple chronic conditions are at greater risk for death or disability, and they consume more resources. They are characterized by the coexistence of two or more chronic illnesses lasting a year or longer which require ongoing medical attention and/or interfere with their daily activities. For these polypathological patients pharmaceutical care would be of special benefit, thus, their needs should be a priority objective for hospital pharmacy. Objective: To increase awareness of this type of patients and the characteristics of the principal approaches and health care models proposed to improve chronic disease management, as well as to emphasize the urgency for hospital pharmacists to join these models, and to present various activities that pharmacists might carry out as an integral part of these approaches. Results: Numerous models exist internationally, including the Chronic Care Model and the Kaiser Permanente pyramid of risks. In our country a growing number of initiatives has culminated in the recent Seville Declaration. For the hospital pharmacy, caring for the chronically ill patient following a model that is multi-professional, cooperative, integral, and patient centered, is an enormous task. Pharmacy departments and the Spanish Society of Hospital Pharmacy should reorient their strategies for pharmaceutical care, training, and research. Of special interest are those activities designed to improve adherence, adequacy, and continuity in treatments, all the while emphasizing active patient participation (AU)

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

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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.

[Health care models for patients with multiple chronic conditions and the role of the hospital pharmacy/the hospital pharmacist]. / Modelos de atención al paciente pluripatológico y el papel de la farmacia hospitalaria.

INTRODUCTION: Managing care for patients with chronic conditions currently represents one of the greatest challenges to health care systems. As a subgroup of these patients, those with multiple chronic conditions are at greater risk for death or disability, and they consume more resources. They are characterized by the coexistence of two or more chronic illnesses lasting a year or longer which require ongoing medical attention and/or interfere with their daily activities. For these polypathological patients pharmaceutical care would be of special benefit, thus, their needs should be a priority objective for hospital pharmacy. OBJECTIVE: To increase awareness of this type of patients and the characteristics of the principal approaches and health care models proposed to improve chronic disease management, as well as to emphasize the urgency for hospital pharmacists to join these models, and to present various activities that pharmacists might carry out as an integral part of these approaches. RESULTS: Numerous models exist internationally, including the Chronic Care Model and the Kaiser Permanente pyramid of risks. In our country a growing number of initiatives has culminated in the recent Seville Declaration. For the hospital pharmacy, caring for the chronically ill patient following a model that is multi-professional, cooperative, integral, and patient centered, is an enormous task. Pharmacy departments and the Spanish Society of Hospital Pharmacy should reorient their strategies for pharmaceutical care, training, and research. Of special interest are those activities designed to improve adherence, adequacy, and continuity in treatments, all the while emphasizing active patient participation.

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)

Consensus method to update the GINF formulary request form

Objective: To update the Guideline for the Introduction of New Drugs in the Formulary (GINF form) using the RAND/UCLA appropriateness method, which combines the best available evidence and an expert panel’s judgement. Study Design/Methods: Two procedures were employed to detect where improvements could be made to the former versions of the request form and to transform them into concrete scenarios, found from a telephone survey with GINF form users, and a structured review of the scientific literature. The list of scenarios was later assessed by an expert panel. In a series of successive rounds, the rest of the research team critically assessed the expert panel’s result, applying a score. Results: A total of 52 improvement proposals were registered; 31 of them dealt with the form structure and the remaining 21 referred to the form process. Six formulary request forms were selected from the literature review. The final version included 24 assessed scenarios mainly addressing clinical trials’ validity, qualitative assessment and local implications of the requested drug. Conclusions: A new version of the GINF form has been developed. Much improvement has been made based on the guide users’ opinion, available evidence and similar experiences that have been carried out internationally. The whole process has been subject to the experts’ opinion following a contrasted, consensus methodology: RAND/UCLA appropriateness method (AU)

Objetivo: Diseñar una nueva versión de la Guía para la Introducción de Nuevos Fármacos (GINF), ˜utilizando para ello la metodología RAND/UCLA sobre el uso adecuado, que combina la mejor evidencia disponible con el juicio de un panel de expertos. Diseño del estudio/métodos: ˜ Se emplearon 2 procedimientos para detectar oportunidades de mejora de las versiones anteriores de la guía, que fueron transformadas en escenarios concretos: una encuesta telefónica a usuarios de la GINF, y una revisión estructurada de la literatura científica. Esta lista de escenarios fue evaluada por un panel de expertos mediante rondas sucesivas. El resto del equipo de investigación evaluó críticamente el resultado del panel de expertos. Resultados: Se registraron 52 propuestas de mejora, 31 de ellas se refieren a la estructura de la guía y las 21 restantes se refieren al procedimiento de utilización de la guía. En cuanto a la búsqueda bibliográfica, 6 de las guías de inclusión de nuevos medicamentos fueron seleccionadas. La versión final incluyó 24 de los escenarios propuestos orientados principalmente a la validez del ensayo clínico, la evaluación cualitativa y las consecuencias locales del fármaco solicitado. Conclusiones: La nueva versión de la guía GINF llevada a cabo incluye muchas mejoras extraídas tanto de la opinión de los usuarios de guía como de la mejor evidencia disponible y las experiencias similares que se han llevado a cabo a nivel internacional. Todo el proceso ha sido sometido a la opinión de los expertos tal como indica la metodología de consenso RAND/UCLA (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.