Effect and associated factors of a clinical pharmacy model in the incidence of medication errors in the hospital Pablo Tobón Uribe eacpharmodel study: stepped wedge randomized controlled Trial (NCT03338725).

Background The World Health Organization considers medication errors to be an issue that requires attention at all levels of care, to reduce the severe and preventable harm related to drug therapy. Different standards for clinical pharmaceutical practices have been proposed by various organizations across the world, where the pharmacist, as part of the multidisciplinary health team, can help improve patient safety. Objective To assess the impact of the introduction of a clinical pharmacy practice model on medication error in patients of a university hospital. Setting The study was conducted in a tertiary care hospital, Medellín, Colombia. Methods A randomized, controlled cluster-wedge staggered trial with a duration of 14 months was conducted to compare the clinical pharmacy practice model with the usual care process in the hospital. Five hospital health care units were included, which were initially assigned to the control group, and after an observation period of 2 months, they were randomly assigned to the intervention group. The trial protocol was registered in ClinicalTrials.gov (identifier NCT03338725). Main outcome measure The incidence of medication errors in hospitalized patients was the main outcome measure. Results The incidence of medication error was 13.3% and 22.8% for the intervention group and control group, respectively. The probability of presenting a medication error was 48% lower when the patient was in the intervention group (RR 0.52; 95% CI: 0.34-0.79). The probability of presenting a medication error over time was 44% lower in the intervention group (p = 0.0005); meanwhile, the resolution of a medication error over time was 70% higher in the intervention group (p = 0. 0029). Conclusion The clinical pharmacy practice model, made up of strategies focused on reducing medication errors, significantly reduces medication errors in patients during hospitalization compared with usual practice. This work assessed the effect of a clinical pharmacy model on the incidence of medication errors and demonstrated its effectiveness in reducing these errors in hospitalized patients. Trial registration ClinicalTrials.gov, NCT03338725. Registered on 9 November 2017. First patient randomized on February 2, 2018.

Errores de medicación en pacientes pediátricos en un hospital universitario en Medellín Colombia, un estudio de corte transversal / Medication errors in pediatric patients in an academic hospital in Medellin Colombia. A cross-sectional study

Resumen Introducción: Una tercera parte de los Errores en la atención en salud se ha relacionado a Errores de medicación; con una incidencia 3 veces mayor en pediatría con respecto a los pacientes adultos. Una estrategia recomendada para mejorar la gestión describe adoptar un sistema de notificación que permita la detección, identificación de causas e implementación de acciones enfocadas a la prevención. Objetivo: Determinar la prevalencia y caracterizar los errores de medicación en el servicio de pediatría reportados en el Sistema de notificación y gestión de riesgo clínico de un hospital universitario entre el 2017 y 2018. Metodología: Estudio de corte transversal. Se cuantificó la proporción de errores de medicación en el servicio de pediatría a partir de un informe del Sistema de notificación de riesgo clínico entre el año 2017 y 2018. Los errores de medicación se clasificaron por proceso de ocurrencia, tipo de error, subgrupo y gravedad. Para el análisis se utilizó estadística descriptiva. Resultados: Se generaron 669 reportes de eventos adversos, 376 (56,20%) estaban relacionados con medicamentos. La tasa calculada de errores fue 7,71 por cada 1000 paciente-días. La mayoría de los errores de medicación se clasificaron como Error sin daño (categoría B y C), 176 ambas subcategorías (352 total) para un 93,62% del total de errores. El proceso de prescripción reportó la mayoría de los errores 59,84%. Conclusiones: La mayoría de los errores de medicación reportados se relacionaron con la prescripción, clasificándose principalmente como errores sin daño. MÉD.UIS.2020;33(2):33-40.

Abstract Introduction: A third of medical errors has been related to medication errors. In the pediatric population, an incidence of medication errors 3 times higher compared to adults has been described. A recommended strategy to improve medication errors risk management describes the adoption of a notification system that allows detection, identification of causes and the implementation of activities focused on prevention. Objective: To determine the prevalence and to characterize medication errors in the pediatric service reported in the clinical risk management and notification system of an academic hospital in 2017 and 2018. Methodology: Cross-sectional study. The proportion of medication errors in the pediatric department was quantified from a report of the Clinical Risk notification System for 2017 and 2018. Medication errors were grouped according to process, type of error, subgroup and gravity. Descriptive statistics were used for the analysis. Outcomes: 669 reports of adverse events were generated in the pediatric service, 376 (56,20%) were related to medications. The error rate was 7,71 per-1000 patient days. Most of the errors were classified as Error without damage (category B and C), 176 both subcategories (total 352), representing 93,62 % of the total of errors. The prescription process was the one that most reported errors 59,84%. Conclusions: Most of the reported medication errors were related to the prescription. The main were classified in the errors without damage category. MÉD.UIS.2020;33(2):33-40.

Investigación de la eficacia y criterios de aprobación de los tratamientos con medicamentos para pacientes con cáncer: una revisión / Research of effectiveness and approval criteria for treatments with medications for patients with cancer: a review

RESUMEN Los diversos trastornos malignos de los tejidos humanos afectan a una gran proporción de personas de Colombia y el mundo, lo que ha llevado al incremento de los tratamientos farmacológicos para estas enfermedades, sin que se tenga claro el real beneficio para los pacientes que los reciben. Además, se tienen dudas sobre la calidad de la evidencia en la que se basan las instituciones que avalan los tratamientos anti-cáncer con medicamentos, como son la Food and Drug Administration (FDA) y la European Medicines Agency (EMA). Este trabajo tuvo como objetivo conocer cómo se realizan los estudios de eficacia y la forma en que se aprueban los tratamientos con medicamentos que se ofrecen a las personas con cáncer; se realizó una revisión narrativa, que se basó en la formulación de preguntas que guiaron el desarrollo de los temas que se incluyeron en ella. Se hizo la búsqueda de la información en Pubmed de una forma estructurada, no sistemática. Se incluyeron artículos publicados en inglés y español, sin restricción por fecha de publicación.

SUMMARY Several malignant disorders of human tissues affect a large proportion of people in Colombia and worldwide, which has led to an increase in pharmacological treatments for these diseases, without the real benefit being clear to the patients who receive them. Furthermore, there are doubts about the quality of the evidence on which the institutions that support anticancer treatments with medications are based, such as the Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Our objective was to know how efficacy studies are carried out and how treatments with medications offered to people with cancer are approved. A narrative review was carried out, which was based on the formulation of questions that guided the development of the topics that were included. The search strategy was done in PubMed in a structured but non-systematic way. Articles published in english and spanish were included, without restriction by publication date.

Amphotericin B deoxycholate versus liposomal amphotericin B: effects on kidney function.

BACKGROUND: The incidence of invasive fungal infections has increased globally as a result of several factors. Conventional amphotericin B (sodium deoxycholate) has been used as standard therapy for the treatment of invasive fungal infections; however, it is associated with adverse drug reactions, including acute kidney injury (AKI). New formulations of amphotericin B have aimed to improve the safety profile of the conventional formulation. OBJECTIVES: This review aimed to assess the effects of amphotericin B deoxycholate versus liposomal amphotericin B on kidney function. SEARCH METHODS: We searched Cochrane Kidney and Transplant's Specialised Register to 10 March 2015 through contact with the Trials' Search Co-ordinator using search terms relevant to this review. SELECTION CRITERIA: We included randomised controlled trials (RCTs) that compared amphotericin B sodium deoxycholate with liposomal amphotericin B. DATA COLLECTION AND ANALYSIS: Two authors independently assessed studies for eligibility and conducted risk of bias evaluation. MAIN RESULTS: We included 12 studies (2298 participants) in this review. Of these, 10 were meta-analysed (2172 participants). Liposomal amphotericin B was found to be significantly safer than conventional amphotericin B in terms of serum creatinine increase (RR 0.49, 95% CI 0.40 to 0.59). There was significant decrease in all infusion-related reactions in the liposomal group compared with the conventional group: fever (4 studies, 1092 participants): RR 0.39, 95% CI 0.28 to 0.55; I(2) = 32%); chills and/or rigours (5 studies, 1081 participants): RR 0.27, 95% CI 0.15 to 0.48; I(2) = 75%); fever and/or rigours (2 studies, 720 participants): RR 0.68, 95% CI 0.52 to 0.90; I(2) = 58%); nausea (6 studies, 1187 participants): RR 0.50, 95% CI 0.35 to 0.72; I(2) = 0%); and vomiting (3 studies, 1019 participants): RR 0.51, 95% CI 0.27 to 0.95; I(2) = 61%). Overall, risk of bias in included studies was low or unclear for most domains. However, blinding of participants and personnel, blinding of outcome assessment and other bias (funding) tended to have a high risk of bias. The sensitivity analysis performed did not change the significance of difference in favour of the liposomal formulation. Assessment for publication bias found that review results were robust. AUTHORS' CONCLUSIONS: Current evidence suggests that liposomal amphotericin B is less nephrotoxic than conventional amphotericin B (when the effect on kidney function is measured as an increase in serum creatinine level equal to or greater than two-fold from the baseline level). We also found that there were fewer infusion-related reactions associated with the liposomal formulation.

Eficacia del aprepitant para la prevención de la náusea y el vómito postoperatorios. revisión sistemática y metaanálisis de ensayos clínicos / Efficacy of aprepitant for prevention of postoperative nausea and vomiting. systematic review and meta-analysis of randomized clinical trials / Eficácia do aprepitanto (emend) para a prevenção da náusea e vómito pós-operatórios. revisão sistemática e meta-análises de ensaios clínicos

Objetivo: evaluar la eficacia del aprepitant, comparada con la de otros antieméticos, para la prevención de la náusea y el vómito postoperatorios en adultos que recibieron anestesia general. Métodos: revisión sistemática de ensayos clínicos con asignación aleatoria que evaluaron comparativamente la eficacia del aprepitant con la de otros antieméticos para la prevención de la náusea y el vómito postoperatorios, el uso de antiemético de rescate y los efectos adversos. La búsqueda se hizo en The Cochrane Library, EBSCO, Embase, LILACS, OVID, PubMed, SciELO, ScienceDirect, Scopus y Google Scholar. Se definió la heterogeneidad con la Q de Cochran y el estadístico I2, se usó el modelo de efectos fijos y aleatorios, se empleó el método de Mantel- Haenszel con el riesgo relativo de cada desenlace y su respectivo intervalo de confianza al 95%. Resultados: se encontró diferencia significativa a favor del aprepitant para la prevención del vómito a las 24 (RR 0,52; IC 95%: 0,38-0,7) y a las 48 horas (RR 0,51; IC 95%: 0,39-0,67), pero no de la náusea a las 24 horas (RR 1,16; IC 95%: 0,85-1,6). Conclusiones: el aprepitant previene el vómito postoperatorio, pero no la náusea, a las 24 y 48 horas.

Objective: To evaluate the efficacy of aprepitant compared with other antiemetics for the prevention of postoperative nausea and vomiting in adults who underwent general anesthesia. Methods: Systematic review of randomized clinical trials with meta-analysis, that evaluated the efficacy of aprepitant in comparison with other antiemetics for the prevention of postoperative nausea and vomiting, antiemetic rescue and adverse effects. The search was done in The Cochrane Library, EBSCO, EMBASE, LILACS, OVID, PubMed, SciELO, ScienceDirect, Scopus and Google Scholar. Heterogeneity was defined with the Cochran Q and I2 statistic; the model of fixed and random effects, and the Mantel-Haenszel method for relative risk of each outcome and its respective confidence interval 95% were used. Results: There was significant difference in favor of aprepitant for the prevention of vomiting at 24 (RR 0.52; 95% CI: 0.38-0.7) and at 48 hours (RR 0.51; 95% CI: 0.39 to 0.67), but not for nausea at 24 hours (RR 1.16; 95% CI: 0.85-1.6). Conclusions: Aprepitant prevents postoperative vomiting, but not nausea, at 24 and 48 hours.

Objetivo: avaliar a eficácia do aprepitanto, comparada com a de outros antieméticos, para a prevenção da náusea e vómito pós-operatórios em adultos que receberam anestesia geral. Métodos: revisão sistemática de ensaios clínicos com atribuição aleatória que avaliaram comparativamente a eficácia do aprepitanto com a de outros antieméticos para a prevenção da náusea e vómito pós-operatórios, o uso de antiemético de resgate e os efeitos adversos. A busca se fez em The Cochrane Library, EBSCO, Embase, LILACS, OVID, PubMed, SciELO, ScienceDirect, Scopus e Google Scholar. Definiu-se a heterogeneidade com o Q de Cochran e o estatístico I2, usou-se o modelo de efeitos fixos e aleatórios, empregou- se o método de Mantel-Haenszel com o risco relativo de cada desenlace e seu respectivo intervalo de confiança a 95%. Resultados: encontrou-se diferença significativa a favor do aprepitanto para a prevenção do vómito às 24 (RR 0,52; IC 95%: 0,38-0,7) e às 48 horas (RR 0,51; IC 95%: 0,39-0,67), mas não da náusea às 24 horas (RR 1,16; IC 95%: 0,85-1,6). Conclusões: o aprepitanto previne o vómito pós -operatório, mas não a náusea, às 24 e 48 horas.