Hospital Environment as a Source of Azole-Resistant Aspergillus fumigatus Strains with TR34/L98H and G448S Cyp51A Mutations.

Azole-resistant Aspergillus fumigatus is an emerging worldwide problem with increasing reports of therapy failure cases produced by resistant isolates. A case of azole-resistant A. fumigatus hospital colonization in a patient is reported here. Investigations of the hospital environment led to the recovery of A. fumigatus strains harboring the TR34/L98H and the G448S Cyp51A azole resistance mechanisms. Isolate genotyping showed that one strain from the environment was isogenic with the patient strains. These are the first environmental A. fumigatus azole resistant strains collected in a hospital in Spain; it supports the idea of the hospital environment as a source of dissemination and colonization/infection by azole resistant A. fumigatus in patients. The isolation of an azole-resistant strain from an azole-naïve patient is an interesting finding, suggesting that an effective analysis of clinical and environmental sources must be done to detect azole resistance in A. fumigatus. The emergence and spread of these resistance mechanisms in A. fumigatus is of major concern because it confers high resistance to voriconazole and is associated with treatment failure in patients with invasive aspergillosis.

Incidentes y eventos adversos en la Unidad de Cuidados Paliativos de un hospital de agudos geriátricos / Incidents and adverse events in the palliative care unit of an acute geriatric hospital

OBJETIVOS: Mejorar la seguridad del paciente es necesario en las unidades de cuidados paliativos donde no hay datos de incidentes y eventos adversos. Se analizaron los tipos de incidentes/eventos adversos, su frecuencia y gravedad en la Unidad de Cuidados Paliativos de un hospital de agudos geriátrico con el objetivo de introducir medidas que pudieran reducir su incidencia. MATERIAL Y MÉTODOS: Estudio retrospectivo de 6 años utilizando un sistema de notificación voluntaria, un sistema de notificación obligatoria para las caídas de los pacientes y la herramienta Global Trigger Tool. Se llevó a cabo en un hospital geriátrico universitario español de 200 camas (27 camas en la Unidad de Cuidados Paliativos). Se incluyeron todos los pacientes ingresados en la Unidad (1.854). La severidad del daño se calculó por el Index of the National Coordinating Council for Medication Error Reporting and Prevention. RESULTADOS: Se identificaron 743 incidentes/eventos adversos, de los cuales 518 (69,7%) eran incidentes (categorías A-D de la clasificación del National Coordinating Council for Medication Error Reporting and Prevention) y 201 eventos adversos (categorías E-I). Los cuidados generales (51,5%) y los errores de medicación (45,2%) fueron los más frecuentes. De estos últimos, los más comunes eran las omisiones de dosis/medicamentos (43,5%). Tanto los antihipertensivos-IECA, antibióticos, antiepilépticos y neurolépticos presentaban tasas de error por encima de la media (5,2), cuando se calcularon los cocientes de incidentes/dispensación. CONCLUSIONES: Este estudio revela un nivel de eventos adversos nada desdeñable dada la conocida falta de sensibilidad de los métodos de detección de eventos adversos, lo que implica la necesidad de desarrollar marcadores de alarma específicos de cuidados paliativos

OBJECTIVES: Improving patient safety is necessary in palliative care units where data on incidents and adverse events are lacking. An analysis was performed on the types of incidents/adverse events, their frequency and severity in the Palliative Care Unit of an Acute Geriatric Hospital with the aim of introducing measures that might lower their incidence. MATERIAL AND METHODS: A 6 year retrospective study was conducted using a voluntary reporting system, a compulsory reporting system for patient falls, and the Global Trigger Tool in a Spanish urban geriatric teaching hospital of 200 beds (27 beds in the Palliative Care Unit). All patients (1,854) admitted to the Unit were included. The Index of the National Coordinating Council for Medication Error Reporting and Prevention was used to evaluate severity. RESULTS: A total of 743 incidents/adverse events were identified, of which 518 (69.7%) were incidents (categories A-D of the National Coordinating Council for Medication Error Reporting and Prevention classification), and 201 were adverse events (categories E-I). General care (51.5%) and medication errors (45.2%) were the most frequent. Of the latter, missing doses/drugs were most common (43.5%). Antihypertensives-ACEIs, antibiotics, antiepileptics, and neuroleptics showed mistake rates above the mean (5.2) when the incident-adverse events/dispensation ratios were calculated. CONCLUSIONS: This study reveals a negligible level of adverse events, given the known low sensitivity of the detection methods of incidents/adverse events, which implies the need to develop specific alarms in Palliative Care

Economic evaluation in collaborative hospital drug evaluation reports.

OBJECTIVE: economic evaluation is a fundamental criterion when deciding a drug's place in therapy. The MADRE method (Method for Assistance in making Decisions and Writing Drug Evaluation Reports) is widely used for drug evaluation. This method was developed by the GENESIS group of the Spanish Society of Hospital Pharmacy (SEFH), including economic evaluation. We intend to improve the economic aspects of this method. As for the direction to take, we have to first analyze our previous experiences with the current methodology and propose necessary improvements. METHOD: economic evaluation sections in collaboratively conducted drug evaluation reports (as the scientific society, SEFH) with the MADRE method were reviewed retrospectively. RESULTS: thirty-two reports were reviewed, 87.5% of them included an economic evaluation conducted by authors and 65.6% contained published economic evaluations. In 90.6% of the reports, a Budget impact analysis was conducted. The cost per life year gained or per Quality Adjusted Life Year gained was present in 14 reports. Twenty-three reports received public comments regarding the need to improve the economic aspect. Main difficulties: low quality evidence in the target population, no comparative studies with a relevant comparator, non-final outcomes evaluated, no quality of life data, no fixed drug price available, dosing uncertainty, and different prices for the same drug. CONCLUSIONS: proposed improvements: incorporating different forms of aid for non-drug costs, survival estimation and adapting published economic evaluations; establishing criteria for drug price selection, decision-making in conditions of uncertainty and poor quality evidence, dose calculation and cost-effectiveness thresholds depending on different situations.

Objetivo: la evaluación económica es un criterio fundamental en el posicionamiento de medicamentos. El método MADRE (Método de Ayuda para la toma de Decisiones y la Realización de Evaluaciones de medicamentos) es ampliamente utilizado en la evaluación de medicamentos. Fue desarrollado por el grupo GENESIS de la Sociedad Española de Farmacia Hospitalaria (SEFH), e incluye una evaluación económica. Con objeto de mejorar los aspectos económicos de este método, analizaremos la experiencia previa con esta metodología y propondremos mejoras. Método: revisión retrospectiva de las evaluaciones económicas en los informes de evaluación de medicamentos realizados de forma colaborativa (como SEFH) con el método MADRE. Resultados: se revisaron 32 informes, el 87,5% incluían una evaluación económica realizada por los autores y un 65,6% una publicada. El 90,6% incluían un análisis de impacto presupuestario. 14 informes incluían el coste por año de vida o por año de vida ganado ajustado por calidad. 23 informes recibieron alegaciones relacionadas con la evaluación económica. Las principales dificultades fueron: baja calidad de la evidencia en la población diana, falta de estudios comparativos con el comparador relevante, resultados finales no evaluados, falta de datos de calidad de vida, precio del medicamento no fijado, incertidumbre en la dosis y diferentes precios del medicamento. Conclusiones: mejoras propuestas: incorporar ayudas para inclusión de costes no farmacológicos, estimación de la supervivencia y adaptación de evaluaciones económicas publicadas; establecer criterios para: selección de precios, toma de decisiones en condiciones de incertidumbre o evidencia pobre, cálculo de dosis y umbrales de coste-efectividad en diferentes situaciones.

Economic evaluation in collaborative hospital drug evaluation reports / Evaluación económica en los informes de medicamentos realizados de forma colaborativa

Objective: economic evaluation is a fundamental criterion when deciding a drug’s place in therapy. The MADRE method (Method for Assistance in making Decisions and Writing Drug Evaluation Reports) is widely used for drug evaluation. This method was developed by the GENESIS group of the Spanish Society of Hospital Pharmacy (SEFH), including economic evaluation. We intend to improve the economic aspects of this method. As for the direction to take, we have to first analyze our previous experiences with the current methodology and propose necessary improvements. Method: economic evaluation sections in collaboratively conducted drug evaluation reports (as the scientific society, SEFH) with the MADRE method were reviewed retrospectively. Results: thirty-two reports were reviewed, 87.5% of them included an economic evaluation conducted by authors and 65.6% contained published economic evaluations. In 90.6% of the reports, a Budget impact analysis was conducted. The cost per life year gained or per Quality Adjusted Life Year gained was present in 14 reports. Twenty-three reports received public comments regarding the need to improve the economic aspect. Main difficulties: low quality evidence in the target population, no comparative studies with a relevant comparator, non-final outcomes evaluated, no quality of life data, no fixed drug price available, dosing uncertainty, and different prices for the same drug. Conclusions: proposed improvements: incorporating different forms of aid for non-drug costs, survival estimation and adapting published economic evaluations; establishing criteria for drug price selection, decision-making in conditions of uncertainty and poor quality evidence, dose calculation and cost-effectiveness thresholds depending on different situations (AU)

Objetivo: la evaluación económica es un criterio fundamental en el posicionamiento de medicamentos. El método MADRE (Método de Ayuda para la toma de Decisiones y la Realización de Evaluaciones de medicamentos) es ampliamente utilizado en la evaluación de medicamentos. Fue desarrollado por el grupo GENESIS de la Sociedad Española de Farmacia Hospitalaria (SEFH), e incluye una evaluación económica. Con objeto de mejorar los aspectos económicos de este método, analizaremos la experiencia previa con esta metodología y propondremos mejoras. Método: revisión retrospectiva de las evaluaciones económicas en los informes de evaluación de medicamentos realizados de forma colaborativa (como SEFH) con el método MADRE. Resultados: se revisaron 32 informes, el 87,5% incluían una evaluación económica realizada por los autores y un 65,6% una publicada. El 90,6% incluían un análisis de impacto presupuestario. 14 informes incluían el coste por año de vida o por año de vida ganado ajustado por calidad. 23 informes recibieron alegaciones relacionadas con la evaluación económica. Las principales dificultades fueron: baja calidad de la evidencia en la población diana, falta de estudios comparativos con el comparador relevante, resultados finales no evaluados, falta de datos de calidad de vida, precio del medicamento no fijado, incertidumbre en la dosis y diferentes precios del medicamento. Conclusiones: mejoras propuestas: incorporar ayudas para inclusión de costes no farmacológicos, estimación de la supervivencia y adaptación de evaluaciones económicas publicadas; establecer criterios para: selección de precios, toma de decisiones en condiciones de incertidumbre o evidencia pobre, cálculo de dosis y umbrales de coste-efectividad en diferentes situaciones (AU)

Drug tolerability in assisted reproduction techniques: a longitudinal study.

A longitudinal, observational prospective panel cohort study of 61 patients lasting one year was undertaken. Explanatory variables included sociodemographic factors along with factors related to the underlying pathology as well as the protocol used and the type of treatment received. These variables were analyzed both individually and in combination to account for confounding effects and model interactions. A generalized estimating equation (GEE) model was constructed for each adverse effect. Associations were calculated as odds ratios (OR). Confounding variables related to drug tolerability were identified. Follitropin-alpha and cetrorelix exhibited the poorest safety profile. With respect to local adverse drug reactions (ADEs), the results obtained in our study point to statistically significant tolerability improvements for menotropin when administered in insemination. For gastrointestinal ADEs, ganirelix was the drug that showed the highest tolerability in in vitro treatments whereas follitropin-alpha showed the lowest tolerability in insemination treatments. Diverse factors related to assisted reproduction techniques (ART) influence the incidence of adverse effects. Each drug has a different safety profile with possible interactions depending on the type of assisted reproduction therapy used.