Impact of a multidisciplinary medication reconciliation program on clinical outcomes: A pre-post intervention study in surgical patients.

BACKGROUND: Previous studies have evaluated the effects of medication reconciliation (MR) and suggest that it is effective in decreasing medication discrepancies. Nevertheless, a recent overview of systematic reviews concluded that there is no clear evidence in favor of MR in patient-related outcomes and healthcare utilization, and further research about it is needed. OBJECTIVE: To evaluate the impact of a multidisciplinary MR program on clinical outcomes in patients with colorectal cancer presenting other chronic diseases, undergoing elective colorectal surgery. METHODS: We performed a pre-post study. Adult patients scheduled for elective colorectal cancer surgery were included if they presented at least one "high-risk" criteria. The MR program was developed by internists, pharmacists and surgeons, and ended with the obtention of the patient's pre-admission medication list and follow-up care until discharge. The primary outcome was the length of stay (LOS). Secondly, we evaluated mortality, preventable surgery cancellations and risk factors for complications. RESULTS: Three hundred and eight patients were enrolled. Only one patient in the pre-intervention group suffered a preventable surgery cancellation (p = 0.317). The mean LOS was 13 ± 12 vs. 11 ± 5 days in the pre-intervention and the intervention cohort, respectively (p = 0.435). A difference in favor of the intervention group in patients with cardiovascular disease (p = 0.038) and those >75 years old (p = 0.043) was observed. No difference was detected in the mortality rate (p = 0.999) neither most of the indicators of risk factors for complications. However, the management of preoperative systolic blood pressure of hypertensive patients (p = 0.004) and insulin reconciliation in patients with treated diabetes (p = 0.003) were statistically better in the intervention group. CONCLUSIONS: No statistically significant change was observed in the mean global LOS. A statistically significant positive effect on LOS was observed in vulnerable populations: patients >75 years old and those with cardiovascular disease, who presented a 5-day reduction in the mean LOS.

Impact of medication reconciliation on health outcomes: An overview of systematic reviews.

BACKGROUND: Recent systematic reviews and meta-analyses suggest that medication reconciliation (MR) is effective in decreasing the risk of medication discrepancies. Nevertheless, the association between MR and subsequent improved healthcare outcomes is not well established. OBJECTIVES: This systematic review of reviews set out to identify published systematic reviews on the impact of MR programs on health outcomes and to describe key components of the intervention, the health outcomes assessed and any associations between MR and health outcomes. METHODS: PubMed, EMBASE, Cochrane Library, Cumulative Index to Nursing and Allied Health Literature (CINAHL) and SCOPUS were searched from inception to May 2019. Systematic reviews of all study designs, populations, intervention providers and settings that measured patient-related outcomes or healthcare utilization were considered. Methodological quality was assessed using A Measurement Tool to Assess Systematic Reviews 2 (AMSTAR 2). Two investigators performed study selection, quality assessment and data collection independently. RESULTS: Five systematic reviews met the inclusion criteria: 2 were rated as low quality and 3 as critically low quality. Reviews included primary studies in different settings (hospitals, the community and residential aged care facilities) that reported the impact of MR on mortality, length of stay, Emergency Department (ED) visits, readmissions, physician visits and healthcare utilization. Only one review reported results on mortality. However, healthcare utilization, which usually included ED visits and readmissions, was communicated in all reviews. Meta-analyses were conducted in all reviews except one. Medication reconciliation was not consistently found to be associated with improvements in health outcomes. CONCLUSIONS: Few systematic reviews support the value of MR in achieving good patient-related outcomes and healthcare utilization improvements. The quality of the systematic reviews was low and the primary studies included commonly involved additional activities related to MR. There was no clear evidence in favor of intervention in mortality, length of stay, ED visits, unplanned readmissions, physician visits and healthcare utilization.

Caracterización organoléptica, nutricional, microbiológica y digestibilidad in vitro de ensilados con diferentes niveles de inclusión de desperdicios de alimentos / Organoleptic, nutritional, microbiological characterization and in vitro digestibility of silage with different levels of inclusion of food waste

RESUMEN Objetivo: caracterización organoléptica, nutricional, microbiológica y digestibilidad in vitro de ensilados de desperdicios de alimentos recolectados en un restaurante de un centro de estudios técnicos y tecnológicos con subproductos de cosecha. Metodología: se realizó un análisis organoléptico, microbiológico, proximal de la composición y digestibilidad in vitro de ensilajes con diferentes niveles de inclusión de desperdicios de alimentos. Resultados: se evidencian características de olor, color y textura óptimas para su palatabilidad, valores nutricionales favorables para el 30, 35 y 40% de inclusión de desperdicios, bajos promedios de proteína, pero con niveles de energía superiores a los del maíz, sorgo y soya. La digestibilidad in vitro de la materia seca (DIVMS) fue mejor para el 35% de inclusión. Así mismo, la Unidad Formadora de Colonias UFC/g para el día 21 fue 1 x10 (Escherichia coli), que se ajusta a las normas para alimentos de animales. Conclusiones: la utilización de ensilados con un 35% de inclusión de desperdicios de alimento puede ser una importante herramienta de suplementación para la alimentación porcina.

ABSTRACT Aim: characterize organoleptic, nutritional, microbiological and in vitro digestibility of food waste silage collected in a restaurant of a technical and technological studies center with harvest by-products. Metodology: it has been make organoleptic analysis, microbiologic, proximal composition, in vitro digestibility of silages with different levels of inclusion of food waste. Results: it is evidenced characteristics of smell, color and texture optimal so as to palatability, favorable nutritional values for 30, 35 and 40% inclusion of waste, low protein levels, but with hight energy levels superior to corn, sorghum and soybeans. The dry mater in vitro digestibility in vitro de la materia seca (DIVMS) was better for 35% inclusión. Moreover, In addition, the UFC/g colony forming units for 21th day was 1 X101 (Escherichia coli), that conforms to the standards for animal feed. Conclusions: to use silages with 35% inclusion of food waste may be one important tool of supplementation for swine feeding.

[Patients' competences and health literacy assessment questionnaire]. / Valoración de las competencias en salud de los pacientes: Instrumento VACS.

OBJECTIVE: To design a questionnaire to identify patients with difficulties to obtain, understand and use health information. MATERIAL AND METHOD: Qualitative study through semi-structured interviews and a consensus technique. A review of the literature on health literacy was carried out. Five semi-structured interviews were conducted with experts in the field. A 12-item instrument was designed. Content validity was determined using the Health Consensus technique. Participants were health professionals and patient representatives (5 semi-structured interviews and 60 Health Consensus). An instrument to measure the level of skills and literacy in patients' health was developed. The measures were 7categories on the health competencies and literacy construct: Ability to search for information, ability to understand the information, ability to communicate with health professionals, capacity for operational understanding, competence in decision making, ability to move and navigate through the health system, and competencies in self-care. RESULTS: A 12-item questionnaire was designed. The median scores obtained in the Health Consensus ranged between 6.08 (1.43) and 7.22 (1.52), with an agreement level of between 73.87% to 84.19%. Finally, a 5-item instrument was obtained to assess the patients' health competencies. CONCLUSIONS: The questionnaire is a useful tool to detect those at risk of having difficulties in obtaining, understanding and using health information. This would allow professionals to focus their attention on the type of information patients need and better adapt it to their needs.

[Effects of hypotherapy on the motor function of persons with Down's syndrome: a systematic review]. / Efectos de la hipoterapia sobre la funcion motora en personas con sindrome de Down: revision sistematica.

INTRODUCTION: Down's syndrome is the main cause of intellectual disability and the most common human genetic alteration. Motor impairments are among the most important alterations presented by Down's syndrome subjects. Hippotherapy is a treatment on and with a horse, and it is currently being used as a therapy to correct those dysfunctions. AIM: To review published research literature on the effect exerted by hippotherapy on the gross motor function of people with Down's syndrome. SUBJECTS AND METHODS: The bibliography in the following databases has been widely searched: CINAHL, Medline, The Cochrane Library, PEDro, Scopus, and Web of Science. The journals Fisioterapia and Cuestiones de Fisioterapia have also been consulted. The electronic literature search strategy was addressed in two thematic fields: Down's syndrome and hippotherapy. Studies selection was carried out following inclusion and exclusion criteria and rejecting duplicate papers. That search included articles published between 2000 and 2016. RESULTS: For this work, 23 articles were found, 15 of which were discarded for different reasons, leaving 8 valid ones. CONCLUSIONS: There is no strong evidence on the improvement of gross motor function in people with Down's syndrome after treatment with hippotherapy. More studies with higher methodological quality, are needed to verify the effectiveness of hippotherapy in the treatment of gross motor function in subjects with Down's syndrome.

TITLE: Efectos de la hipoterapia sobre la funcion motora en personas con sindrome de Down: revision sistematica.Introduccion. El sindrome de Down es la principal causa de discapacidad intelectual y la alteracion genetica humana mas comun. Entre las alteraciones mas importantes que se presentan se encuentran las deficiencias motoras. La hipoterapia es un tratamiento sobre el caballo y con el caballo, y se usa en la actualidad como terapia en la correccion de dichas disfunciones. Objetivo. Analizar las evidencias cientificas existentes sobre el efecto que la hipoterapia ejerce en la funcion motora de personas con sindrome de Down. Sujetos y metodos. Se efectuo una amplia busqueda de la bibliografia en las siguientes bases de datos: CINAHL, Medline, The Cochrane Library, PEDro, Scopus y Web of Science. Ademas, se consultaron las revistas Fisioterapia y Cuestiones de Fisioterapia. Las busquedas se realizaron incluyendo los articulos publicados entre los años 2000 y 2016. La estrategia de busqueda electronica se planteo en dos bloques tematicos: sindrome de Down e hipoterapia. La seleccion de articulos se llevo a cabo siguiendo unos criterios de inclusion y exclusion, y se eliminaron los articulos duplicados. Resultados. En la busqueda realizada para esta investigacion se encontraron 23 articulos, y quedaron como validos ocho despues de excluir el resto por diferentes motivos. Conclusiones. No existen evidencias solidas sobre la mejora o no de la funcion motora en personas con sindrome de Down tras el tratamiento con hipoterapia. Son necesarios mas estudios, y de mayor calidad metodologica, para poder constatar la efectividad de la hipoterapia en el tratamiento de la funcion motora gruesa en sujetos con sindrome de Down.

[Failure mode effect analysis applied to preparation of intravenous cytostatics]. / Análisis modal de fallos y efectos aplicado a la elaboración de citostáticos intravenosos.

OBJECTIVE: To proactively identify risks in the preparation of intravenous cytostatic drugs, and to prioritise and establish measures to improve safety procedures. MATERIAL AND METHODS: Failure Mode Effect Analysis methodology was used. A multidisciplinary team identified potential failure modes of the procedure through a brainstorming session. The impact associated with each failure mode was assessed with the Risk Priority Number (RPN), which involves three variables: occurrence, severity, and detectability. Improvement measures were established for all identified failure modes, with those with RPN>100 considered critical. The final RPN (theoretical) that would result from the proposed measures was also calculated and the process was redesigned. RESULTS: A total of 34 failure modes were identified. The initial accumulated RPN was 3022 (range: 3-252), and after recommended actions the final RPN was 1292 (range: 3-189). RPN scores >100 were obtained in 13 failure modes; only the dispensing sub-process was free of critical points (RPN>100). A final reduction of RPN>50% was achieved in 9 failure modes. CONCLUSIONS: This prospective risk analysis methodology allows the weaknesses of the procedure to be prioritised, optimize use of resources, and a substantial improvement in the safety of the preparation of cytostatic drugs through the introduction of double checking and intermediate product labelling.

Quality of cancer care in Spain: recommendations of a patients' jury.

The aim of the study was to evaluate quality of cancer care in Spain through patient's views, experiences and perceptions; with the purpose of making recommendations to improve cancer care. A modified citizen's jury was organised with the participation of 30 members and four experts as witnesses. For 1 day jurors representing 13 of 17 Spanish Autonomous Communities were met to make recommendations for improving the quality of cancer care in Spain. Concerns were identified regarding care fragmentation, test delays, duplications and poor social and emotional support. Some recommendations highlighted the need to improve the access to psycho-oncology care as well as support in social care and counselling, addressing patients to specific care. Some strategies proposed by the jury included a 24-h call centre, continuity in palliative care and appropriate follow-up and support after the end of therapy. In conclusion, the experience of cancer should include access to multiple specialists, effective coordination of care, accurate information about the disease and treatment options, and timely attention to symptoms and psychosocial needs.

[Prevalence and factors associated with peripheral artery disease in patients with type 2 diabetes mellitus in Primary Care]. / Prevalencia y factores asociados a la enfermedad arterial periférica en pacientes con diabetes mellitus tipo 2 en Atención Primaria.

INTRODUCTION: Peripheral artery disease in the lower limbs (PAD) is a prevalent condition that entails high morbidity in diabetic patients; this study assesses PAD in these patients and its socio-demographic and clinic associated variables. MATERIAL AND METHODS: Descriptive study in a systematic sample of diabetic patients (DM2) aged 50-80 years, in Primary Care settings. The dependent variable was the presence of PAD diagnosed by ankle-brachial index (ABI) ≤ 0.9; independent variables: socio-demographic, clinical and laboratory. STATISTICS: bivariate and multiple logistic regression analyses were performed to determine the variables associated with low ABI. RESULTS: A sample of 251 patients, 52.6% women; mean age: 68.5 ±8.5. A low ABI was detected in 18.3% (95% Confidence Interval (95% CI):13.3-23.3%), with 6 subjets (2.4%) previously diagnosed as suffering PAD. Age (OR=1.07; 95% CI: 1.02-1.12) and retinopathy (OR=2.69; 95% CI: 1.06-6.81) were associated (multiple logistic regression analysis) with ABI. CONCLUSIONS: The percentage of patients diagnosed with PAD is very low, although PAD prevalence is high among DM2 patients attending Primary Care clinics, especially in older patients and those with retinopathy. We emphasize the recommendation of performing the ABI test in this population at risk.

[Conflicts of interests in clinical research in primary health care]. / Conflictos de intereses en investigación clínica en el área de atención primaria de salud.

Conflicts of interests between professionals and patients in biomedical research, is an ethical problem. None of the laws in Spain mention whether the clinical researcher has to clarify to participants the reasons why it proposes them to participate in a clinical trial. In this article, conflicts of interests in research are discussed in the context of primary healthcare. In this area conflicts of interests might alter the confidence between patients and healthcare professionals. Finally, we suggest some practical strategies that can help participants make the decision to participate in a clinical trial more willingly and freely.

[Visa at a tertiary hospital]. / El visado en un hospital de tercer nivel.

OBJECTIVE: To analyze the visa application process and his activity at a tertiary hosipital. MATERIAL AND METHODS: Descriptive study of the drug s visa activity during the period April 2011-April 2012. We designed a database and defined categories on the study variables: patients and recipes. For patients admitted to the Visa Unit, issues detected were recorded based on a previously established classification. RESULTS: 6738 patients were included. They involved the visa of 8,465 recipes. The visa was applied to 170 drugs and nutrition products different, being the majority Tacrolimus. During this period, we detected a total of 420 incidents being the most frequent «No clinical document¼ (46.67%) and the «Formal completion errors¼ (28.57%). CONCLUSIONS: This work has allowed a more detailed analysis of the activity, the types of incidents and the identification of areas for improvement.

Objetivo: Analizar el procedimiento de visado y su actividad en un hospital de tercer nivel. Material y métodos: Estudio descriptivo del procedimiento de visado durante el período abril 2011-abril 2012. Se diseñó una base de datos y se definieron categorías relativas a las variables de estudio: pacientes y recetas. Para los pacientes atendidos en la Unidad de Visado se registraron las incidencias detectadas en base a una clasificación previamente establecida. Resultados: Se incluyeron 6.738 pacientes (8.465 recetas visadas). Se visaron 170 medicamentos y productos de nutrición diferentes, siendo el mayoritario Tacrolimus. Se detectaron un total de 420 incidencias, siendo las más frecuentes la «Ausencia de documento clínico¼ (46,67 %) y los «Errores formales de cumplimentación¼ (28,57%). Conclusiones: El presente trabajo ha permitido un conocimiento más pormenorizado de la actividad, los tipos de incidencias y la identificación de áreas de mejora.

Genetic analysis of haematological and plasma biochemical parameters in the Spanish purebred horse exercised on a treadmill.

The novel aim of this study was to describe the reference values of different haematological and biochemical parameters in the Spanish purebred horse (Andalusian, SPB) in each of the stages of a programmed exercise on a treadmill system, and to establish heritability and genetic correlations for these haematological and biochemical parameters. For this, 94 young SPB male horses (4.22 ± 2.27 years old) were used. An increasing intensity exercise test at 4, 5, 6 and 7 m/s was carried out on a treadmill (6% inclination). Total red blood cells, total white blood cells, neutrophils and lymphocytes counts; haematocrit, haemoglobin, lactate, uric acid, creatinine and total plasma proteins concentrations and aspartate transaminase, lactate dehydrogenase, creatine-quinase activities were determined. To conclude: (i) the reference values for each parameter were determined for each of the exercise test stages (ii) all the parameters analysed manifested a medium-high heritability and a high repeatability. These results will, in the near future, determine the measuring guidelines for improving the SPB horse's athletic ability on an objective treadmill system and for selecting these animals in response to those parameters.

On health literacy and health outcomes: background, impact, and future directions.

This article presents an overview of an emerging area of research called health literacy. It draws attention to the undisputed relationship between literacy levels of the population, the complexity of health systems and health outcomes. Authors believe that instead of focusing on improving individual skills, health institutions and health care settings should concentrate their efforts on making their physical and social environment more accessible and easy to navigate for their users. A more balanced approach to health literacy action includes improving the quality and accessibility of information, professionals' communication skills, and eliminating structural barriers to healthful action.

[ISMP-Spain questionnaire and strategy for improving good medication practices in the Andalusian health system]. / Cuestionario ISMP-España y estrategia de mejora en el uso seguro del medicamento dentro del Servicio Andaluz de Salud.

OBJECTIVE: To describe the strategy employed by Andalusian public health service hospitals to foster safe medication use. The self-evaluation questionnaire on drug system safety in hospitals, adapted by the Spanish Institute for Safe Medication Practices was used as a fundamental tool to that end. MATERIAL AND METHOD: The strategy is developed in several phases. We analyse the report evaluating drug system safety in Andalusian public hospitals published by the Spanish Ministry of Health and Consumption in 2008 and establish a grading system to assess safe medication practices in Andalusian hospitals and prioritise areas needing improvement. We developed a catalogue of best practices available in the web environment belonging to the Andalusian health care quality agency's patient safety observatory. We publicised the strategy through training seminars and implemented a system allowing hospitals to evaluate the degree of compliance for each of the best practices, and based on that system, we were able to draw up a map of centres of reference. RESULTS: We found areas for improvement among several of the questionnaire's fundamental criteria. These areas for improvement were related to normal medication procedures in daily clinical practice. We therefore wrote 7 best practice guides that provide a cross-section of the assessment components of the questionnaire related to the clinical process needing improvement. CONCLUSIONS: The self-evaluation questionnaire adapted by ISMP-Spain is a good tool for designing a systematic, rational intervention to promote safe medication practices and intended for a group of hospitals that share the same values.

Utility of the discriminant analysis to categorize untrained Spanish Pure Bred horses on the basis of biochemical and muscle variables before and after a standardized exercise test.

We hypothesized that the information obtained from a discriminant analysis could be used to objectively discriminate horses untrained from early ages, in agreement with certain physiological characteristics. In the biopsies of 24 Spanish Pure Bred horses (1.5-3 years old) before and after a standardized exercise test (SET; 4-7 m/s with a change of velocity of 1m/s every 2 min) muscle enzymes, substrate and metabolites were determined. Also, diverse plasma and blood parameters were considered. Three pre-exercise groups (A1: six horses; A2: seven horses and A3: eleven horses) and two post-exercise groups (B1: sixteen horses; B2: eight horses) were defined from a correspondence analysis. Forward stepwise discriminant analysis selected 11 variables which differentiated the groups between each other both pre- and post-exercise. The results of the present study suggested the utility of a discriminant analysis to categorize horses in agreement with certain physiological variables. It could be used for establishing different types of training in each group by expert trainers.

[Pharmacogenetic analysis of the absorption kinetics of cyclosporine in a population of Spanish cardiac transplant patients]. / Análisis farmacogenético de la cinética de absorción de ciclosporina en una población española de pacientes trasplantados cardíacos.

OBJECTIVE: To determine how single nucleotide polymorphisms located on genes MDR1, CYP3A4 and CYP3A5 affect the absorption kinetics of cyclosporine in cardiac transplant patients. METHOD: We selected a sample of 30 adult patients having previously undergone a primary cardiac transplant and who had received cyclosporine as an immunosuppressant. During the first month after the transplant, we performed a pharmacokinetic study of each patient to determine values in the cyclosporine concentration area under the 12-hour curve, steady-state cyclosporine concentration, maximum cyclosporine concentration, and time to reach that concentration. Single nucleotide polymorphisms were genotyped in all patients: MDR1 3435C > T, CYP3A4-390A > G and CYP3A5 6986A > G. RESULTS: Being a carrier of the T-allele for polymorphism MDR1 3435C > T is associated with higher values in the cyclosporine concentration area under the 12-hour curve (p = 0.01) and in steady-state cyclosporine concentration (p = 0.05), compared with those from patients who do not carry that allele. DISCUSSION: Our results show that genotype differences in MDR1 3435C > T can explain part of the variability in cyclosporine absorption among individuals in the population of Spanish cardiac transplant recipients.

[Work of a multidisciplinary team in the control of the prescription of ertapenem]. / Actuación de un equipo multidisplinario en el control de la prescripción de ertapenem.

OBJECTIVE: To determine the effectiveness of the intervention of a multidiscipline antimicrobial control group in the correct prescription of Ertapenem. METHOD: A four-month long, prospective study into prescriptions for Ertapenem was carried out in a third-level hospital. Assessment into the degree of suitability of each prescription according to the infections commission usage criteria. In the situation where prescriptions were not suitable, recommendations were given and acceptance of this was recorded. The effectiveness of the antimicrobial treatment used was assessed and treatment was considered effective when there was remission of the signs and symptoms of the infection when the treatment was completed. The treatment was considered to have failed when the signs and symptoms of infection persisted or progressed, requiring the addition of another antimicrobial agent, changing antibiotics or the prolongation of the treatment for longer than 2 weeks. Lastly, the differences in the average length of stay and the duration of the antibiotic treatment between groups were analysed. RESULTS: Forty-eight prescriptions were assessed. The usage criterion was adequate in 48 % of cases, with 78 % effectiveness in this group. In the cases where the prescription was not adequate, but a change in prescription was accepted, the effectiveness was 92 %, with 55.5 % of those cases not accepting recommendation for change. The average stay was higher in this last group (p = 0.07). The duration of the antibiotic treatment in the patients who accepted the change in prescription was significantly less than in those who did not accept it (2 vs 7.4 days, p < 0.0001). CONCLUSIONS: The control of Ertapenem prescriptions by a multidisciplinary team was effective.

[Assessment of safety practices for medication-use systems in Spanish hospitals (2007)]. / Evaluación de las prácticas de seguridad de los sistemas de utilización de medicamentos en los hospitales españoles (2007).

BACKGROUND AND OBJECTIVE: To examine the current status of safety practices for medication-use systems in Spanish hospitals and to identify major areas of risk. MATERIAL AND METHOD: Those hospitals that completed the "Medication use-system safety self-assessment for hospitals" between June 1 and July 15, 2007, were included in the study. The survey contained 232 items for evaluation grouped into 20 core characteristics. RESULTS: A total of 105 hospitals from the 17 autonomous communities in Spain participated in the study. The average aggregate score for the survey of all the participating hospitals was 612.7 (39.7% of the maximum possible score) and there were no differences found with regard to number of beds, training activity or type of hospital. When core characteristics were analyzed, there were 3 criteria with the lowest values (< 25%), associated with professional training, skills, and the establishment of a system for reporting errors. Another 9 criteria, with percentages between 25% and 50%, reflected practices related to: access to information regarding patients and medications; communication of medication orders; prevention of errors due to naming, labeling, and packaging problems; standardization of medication delivery devices; restriction of medications in patient care units; and safety culture and double-checking procedures. CONCLUSIONS: Many opportunities for improvement have been identified, particularly in areas related to training, risk management, incorporating new technologies and patient participation. The information obtained may prove useful for prioritizing practices when establishing patient safety strategies, and as a baseline for successfully monitoring the effectiveness of the initiatives and programs consequently set into motion.

[Stability and in vitro activity of voriconazole eyedrops at a concentration of 3 microg/mL]. / La estabilidad y actividad in vitro de voriconazol en colirio a una concentración de 3 microg/mL.

OBJECTIVE: To assess the stability and activity of voriconazole 3 microg/mL eyedrops as prepared for use against amphotericin B- and fluconazole-resistant fungal endophthalmitis. METHOD: Stability (concentration using UV-spectrophotometry; pH, osmolarity, and particle formation) and sterility were analyzed under various preservation conditions--room temperature (22-24 degrees C) or refrigerated (2-8 degrees C). The preparation's in vitro efficacy was analyzed using the standard National Committee for Clinical Laboratory Standards method for 30 days. RESULTS: Voriconazole concentrations were found to be within limits allowed by the United Stated Pharmacopeia (90-115%). pH (room temperature: 6.96-7.60; refrigerated: 6.84-7.21) and osmolarity (room temperature: 265-284 mOsm/l; refrigerated: 270-285 mOsm/l) remained within eye physiological ranges throughout the study under the analyzed conditions. The preparation s antifungal activity remained stable during the first three weeks. CONCLUSIONS: The voriconazole 3 microg/mL eyewash preparation remained stable, sterile and with full antifungal activity for 21 days when stored both at room temperature and under refrigeration conditions.

[Tacrolimus blood levels and incidence of graft rejection in heart transplantation]. / Relación entre los niveles de tacrolimus en sangre y la incidencia de rechazo en enfermos trasplantados de corazón.

OBJECTIVE: To determine the relationship between pharmacokinetic parameters and clinical outcomes after heart transplantation and to determine the range of tacrolimus blood levels which provides the most effective protection against graft rejection. To study other factors that predict graft rejection. METHOD: We retrospectively analyzed the clinical outcomes of all adult patients who received a heart transplant between January 2000 and October 2003 and had routine monitoring of tacrolimus trough levels at the time of scheduled endomyocardial biopsy. Rejection was defined as Grade = 3, based on the International Society for Heart and Lung Transplantation (ISHLT) criteria. The follow-up period was 1 year. All patients were on a triple therapy regimen of Tacrolimus (TAC), Corticosteroids and Azatioprine/Micophenolate Mofetil. Data were analyzed by Student s t-test, univariate logistic regression and ROC curve. RESULTS: Tacrolimus blood levels measured at day +5 postransplant were the strongest predictor of acute graft rejection over a 1-year follow-up period (rejection 5.76 +/- 3.4 ng/ml vs no rejection 9.66 +/- 2.73 ng/ml, p = 0.016). A decrease of one unit in TAC trough level values at day +5 postransplant implied a 1.58 greater risk of rejection (p = 0.05). Overall incidence of treated acute rejection was lower for patients with trough levels higher than 8 ng/ml on day +5 postransplant (33 vs 80%, p = 0.055, Fisher s exact test). CONCLUSIONS: Data suggest that in heart transplant patients it may be crucial to achieve tacrolimus levels of at least 8 ng/ml during the first days postsurgery to avoid rejection.