DSpace Collection:
https://hdl.handle.net/10171/22958
2024-03-28T13:15:50Z
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Linezolid-induced haematological toxicity
https://hdl.handle.net/10171/40295
Title: Linezolid-induced haematological toxicity
Abstract: Objetivo: determinar la incidencia de toxicidad hematológica
por linezolid. Estudiar la influencia del aclaramiento renal en
su aparición y la efectividad de la piridoxina en su prevención.
Método: estudio observacional retrospectivo de todos los pacientes
tratados con linezolid en un hospital universitario en
seis meses. Se consideró toxicidad hematológica a la disminución
del 25% de la hemoglobina, del 25% de las plaquetas y/o
del 50% de neutrófilos al final respecto al inicio del tratamiento.
Se comparó en los pacientes con y sin fallo renal (aclaramiento
de creatinina inferior a 50 mL/min), con más o menos
de 30 mL/min, y con o sin piridoxina, la incidencia de toxicidad
hematológica mediante Chi-Cuadrado y la disminución en el
porcentaje de variables analíticas hematológicas mediante U
Mann-Whitney.
Resultados: se evaluaron 38 pacientes. Dieciséis (42%) presentaron
toxicidad hematológica (2 por disminución de hemoglobina,
9 de plaquetas y 8 de neutrófilos). En 2 pacientes (5%) se
suspendió el tratamiento por plaquetopenia. La incidencia de
toxicidad fue similar en pacientes con y sin insuficiencia renal,
42% vs. 42%, p = 0,970, con más o menos de 30 mL/min,
67% vs. 40%, p = 0,369, con piridoxina o sin ella, 47,8% vs.
33%, p = 0,376. Los pacientes con fallo renal presentaron una
reducción significativamente mayor de plaquetas, p = 0,0185.
Conclusiones: un 42% de los pacientes presentó toxicidad hematológica,
más frecuentemente disminución de plaquetas y
neutrófilos. Esta no fue significativamente mayor en los pacientes
con fallo renal, ni en aquellos sin piridoxina. Se halló
mayor reducción de plaquetas en los pacientes con insuficiencia
renal.; Objective: to determine the incidence of linezolid-induced haematological
toxicity and study the influence of renal clearance
on its appearance and the preventive effect of pyridoxine.
Methods: a retrospective observational study was conducted.
Every patient treated with linezolid in a university hospital during
6 months was included. Haematological toxicity was defined
as a decrease of 25% in hemoglobin, of 25% in platelets
and/or 50% in neutrophils from baseline. The incidence of
haematological toxicity and the percentage decrease in analytical
variables were compared in patients with and without renal
failure (creatinine clearance lower than 50 mL/min), using the
30 mL/min threshold, and with or without pyridoxine; using
Chi -Square and U Mann-Whitney tests, respectively.
Results: thirty-eight patients were evaluated. Sixteen (42%)
presented haematological toxicity (2 due to a decrease in haemoglobin,
9 in platelets and 8 in neutrophils). Two patients
(5%) discontinued treatment due to thrombocytopenia. Toxicity
incidence was similar in patients with and without renal
failure, 42% vs 42%, p = 0.970, with more or less than 30 ml/min,
67% vs 40%, p = 0.369, or with or without pyridoxine, 47.8%
vs 33%, p = 0.376. Patients with renal failure had a significantly
greater reduction in platelet count, p = 0.0185.
Conclusion: forty-two percent of patients had haematological
toxicity, being more frequent platelets and neutrophils reduction.
This was not significantly higher in patients with renal
failure or in those without pyridoxine. Greater reduction in platelet
count was observed in patients with renal failure.
2015-01-01T00:00:00Z
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Economic evaluation in collaborative hospital drug evaluation reports
https://hdl.handle.net/10171/40160
Title: Economic evaluation in collaborative hospital drug evaluation reports
Abstract: Abstract
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; Resumen
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.
2015-01-01T00:00:00Z
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Comparaciones indirectas en los informes de evaluación de medicamentos en la web del grupo GENESIS de la SEFH
https://hdl.handle.net/10171/22957
Title: Comparaciones indirectas en los informes de evaluación de medicamentos en la web del grupo GENESIS de la SEFH
Abstract: 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.
© 2011 SEFH. Published
2012-01-01T00:00:00Z
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Caracterización y variabilidad de los informes de evaluación de medicamentos en la página web del grupo GENESIS de la SEFH
https://hdl.handle.net/10171/22444
Title: Caracterización y variabilidad de los informes de evaluación de medicamentos en la página web del grupo GENESIS de la SEFH
Abstract: 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.
2011-01-01T00:00:00Z