Ortega-Eslava, A. (Ana)
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- Linezolid-induced haematological toxicity(Aula Médica Ediciones, 2015) Leache, L. (Leire); Ortega-Eslava, A. (Ana); Aquerreta, I. (Irene); Moraza, L. (Libe)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.
- A systematic review of drug allergy alert systems(Elsevier, 2022) Luri-Fernández-de-Manzanos, M. (Marta); Gastaminza, G. (Gabriel); Leache, L. (Leire); Ortega-Eslava, A. (Ana); Idoate, A. (Antonio)Background and objective: Drug allergy alert systems (DAAS), have been considered an effective strategy to reduce preventable adverse drug events (ADEs), improving patient’s safety. To date, no review has been conducted analyzing characteristics of DAAS in the hospital setting. Therefore, the aim of this study is to identify, describe and summarize the DAAS used in hospitals. The secondary objectives are to analyse drug allergy alerts (DAA) characteristics, the override rate (OvR) and the clinical consequences of alert overrides. Methods: Searches were conducted in Medline and Cochrane Library to identify studies describing DAAS. Systems characteristics, generated alerts, DAA, OvR, and its clinical consequences were extracted and analyzed. Results: Twenty-eight articles were included in the review. Seventeen different electronic DAAS were identified, of which 53% were commercially available. Systems differed in drug allergy information and rules for generating alerts. DAA were generally interruptive, triggered by non-exact match at drug prescribing and when ignored, an override reason was mandatory. The OvR ranged from 43.7% to 97%. The main override reason given by pro- viders was that ‘patient had previously tolerated or had taken the drug without allergic reaction’. Clinical consequences of overriding DAA were only analyzed in four studies, with an ADE incidence between 0% and 6%. Conclusions: Different DAAS are used in hospitals with some degree of heterogeneity. Accurate and updated drug allergy information is important to generate only high value alerts. A regular review of DAAS and a standard- ization of alert rules, alert information and override reasons are necessary to optimize systems. Future studies should evaluate the impact of the DAAS aspects on preventing ADEs.
- Effectiveness of pharmacokinetic / pharmacodynamic-guided meropenem treatment in critically ill patients: A comparative cohort study(Wolters Kluwer, 2021) Aldaz, A. (Azucena); Ortega-Eslava, A. (Ana); Monedero, P. (Pablo); Idoate-Grijalba, A. I. (Ana Isabel); Aquerreta, I. (Irene)Background: The proper dosage of antibiotics is a key element in the effective treatment of infection, especially in critically ill patients. This study aimed to evaluate the efficacy of optimized meropenem regimens based on pharmacokinetic/pharmacodynamic criteria in patients admitted to the intensive care unit. Methods: This observational, naturalistic, retrospective, unicentric cohort study was performed between May 2011 and December 2017. The clinical and bacteriologic responses of 77 control intensive care unit patients receiving meropenem were compared with those of 77 propensity score-balanced patients who received meropenem dose adjusted by therapeutic drug monitoring. The primary end point of clinical response was a reduction at the end of treatment of at least 80% of the maximum procalcitonin (PCT) value recorded during the meropenem treatment. Results: The primary end point was met by 55 patients (71.4%) in the adjusted group compared with 41 (53.3%) patients in the control group (mean difference 18.1%, P = 0.02). Fifty-one patients (66.2%) in the adjusted group required a meropenem dose adjustment, being necessary in 46 of them (90.2%) to decrease the dose. The reduction of PCT was the greatest in the adjusted group compared with the unadjusted group (93% versus 85%, P = 0.004); a greater percentage of patients reached a PCT level < 0.5 ng/mL (63.6% versus 41.6%, P = 0.006), and there was a trend toward an improved bacteriologic response (relative risk = 1.27; 95% confidence interval: 0.92-1.56). There were no differences in early mortality or safety between groups. Conclusions: Adjustment of meropenem therapy by monitoring is a useful strategy for improving meropenem effectiveness in the treatment of infection in critically ill patients, with no impact on safety.
- Caracterización y variabilidad de los informes de evaluación de medicamentos en la página web del grupo GENESIS de la SEFH(Elsevier, 2011) Ortega-Eslava, A. (Ana); Puigventos, F. (Francesc); Santos-Ramos, B. (B.); Calderon-Hernaz, B. (B.); Vilanova-Bolto, M. (M.)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.
- Economic evaluation in collaborative hospital drug evaluation reports(Aula Médica Ediciones, 2015) Marin-Gil, R. (Roberto); Ortega-Eslava, A. (Ana); Puigventos, F. (Francesc); Lopez-Briz, E. (Eduardo); Fraga-Fuentes, M.D. (M.D.); Dranitsaris, G. (George)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
- Comparaciones indirectas(Elsevier, 2012) Ortega-Eslava, A. (Ana); Fraga-Fuentes, M.D. (M.D.); Ventayol-Bosch, P. (P.); Alegre-del-Rey, E.J. (E.J.)
- Información de medicamentos a la población desde el Servicio de Farmacia a través de Internet(Elsevier España, 2003) Lacasa, C. (Carlos); Aldaz, A. (Azucena); Morales-de-Alava, I. (Isabel); Ortega-Eslava, A. (Ana); Idoate, A. (Antonio); Conchillo, A. (Ana); Giraldez, J. (J.); Aquerreta, I. (Irene); Yuste, J.R. (José Ramón); Garcia, N. (Nicolás); Beorlegui, B. (Blanca)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.
- Comparaciones indirectas en los informes de evaluación de medicamentos en la web del grupo GENESIS de la SEFH(Elsevier, 2012) Ortega-Eslava, A. (Ana); Puigventos, F. (Francesc); Clopes-Estela, A. (A.); Fraga-Fuentes, M.D. (M.D.); Santos-Ramos, B. (B.); Vilanova-Bolto, M. (M.)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
- Usefulness of drug allergy alert systems: present and future(Springer, 2023) Luri-Fernández-de-Manzanos, M. (Marta); Sánchez-Fernández, S. (Sergio); Gastaminza, G. (Gabriel); Ortega-Eslava, A. (Ana); Quan, P.L. (Paola Leonor); Parrado-Gil, L. (Lucía); Calvo-Alonso, A. (Alfonso); Bodero-Sánchez, J.M. (José Miguel)Purpose of Review The goal of this paper is to review drug allergy alert systems (DAAS), to summarise their key components, and to overview potential benefts and challenges associated with these tools. Methods for validation of their effects on patient safety, alternative uses, and strategies to streamline DAAS’ functions and reduce system fatigue are discussed. Recent Findings DAAS are clinical decision support systems (CDSS) that focus on preventing drug adverse events within healthcare settings. The advent of electronic medical records has facilitated the development of digital DAAS. Existing versions use different methods to document diagnosed allergies, and rely on distinct rules and matching strategies for the generation of real-time alerts. DAAS promote the automation of several processes, facilitate prompt patient referral, and may be customised. Information overload, alert overrides by clinicians, and the development of “alert fatigue” may interfere with their usefulness. The newest strategies to streamline the function of DAAS include the use of artifcial intelligence (AI) and other predictive techniques. Summary The rising prevalence of drug allergies underscores the importance of effective DAAS. Further research is needed to evaluate their usefulness, to optimise their performance, to explore different algorithms and data sources, and to enhance the standardised integration of these systems into clinical practice.