Spontaneous reporting of adverse drug reactions in a pediatric population in a tertiary hospital

The pediatric population is a vulnerable group for adverse drug reactions (ADRs), and data on spontaneous reporting of ADRs in the hospital setting are scarce. We conducted a retrospective analysis of ADRs in pediatric patients spontaneously reported by health care professionals to a Pharmacovigilance Program in a tertiary hospital between 2010 and 2020, and we compared characteristics of ADRs between pediatric age subgroups. From 1787 spontaneously reported ADRs in an 11-year period, 103 (5.85%) were pediatric ADRs. The median age of patients with ADRs was 8.4 years (range 1 day-17 years) and 57.3% were male. The most frequent ADRs reported were nervous system disorders (13.6%) and the most frequently involved drugs were antineoplastics and immunodulators (32.4%). A 59.2% of the ADRs were serious and 55.3% were classified as being type B reactions. Medication errors were involved in 7.8% of the ADRs and 11.9% of the suspected drugs were used off-label. Spontaneous reports of ADRs in newborns, infants, and toddlers were more serious and less often described in the product data sheet than in children and adolescents (p < 0.001 and p = 0.004 respectively). Medication errors were more frequent in patients under two years of age. These results should be interpreted with caution due to under-reporting and biases in spontaneous reporting of ADRs

SUINBELL: suport infermer a Bellvitge. Una experiència d'Aprenentatge-Servei a l'Escola d'Infermeria de la Universitat de Barcelona: alguns reptes a contemplar

Podeu consultar la Vuitena trobada de professorat de Ciències de la Salut completa a: http://hdl.handle.net/2445/66524Introducció: La comunicació descriurà una experiència d’Aprenentatge – Servei (ApSU) en el nostre Campus, des de l’Escola d’Infermeria UB i en el barri de Bellvitge. Parteix de la finalització de l’assignatura optativa Pèrdues i Dol en el Cicle Vital de les Persones en la Diplomatura d’Infermeria (curs 2007-08), quan un grup d’estudiants demana al professorat continuïtat periòdica de trobades. Amb aquesta finalitat, la intuïció del professorat, l’Espai Europeu d’Educació Superior, en procés construcció i la responsabilitat social de la Universitat, orienten estructurar una activitat d’Aprenentatge – Servei (ApS-U). Objectius: - Donar resposta a la demanda dels estudiants, a partir d’afavorir el creixement personal grupal, per mitjà d’una experiència ApS-U, (aprenentatge experiencial situat i avaluat). - Proporcionar suport psicosocial a persones sanes o sense malaltia greu, en situació de pèrdua i dol des de un voluntariat infermer en formació. Metodologia: Es va comptar amb agenda de trobades periòdiques amb els estudiants, establiment i selecció de continguts reglats de l’àrea psicosocial (cures infermeres estandarditzades) i graella per a registres de visites i posterior avaluació amb el grup i el professorat. Implementació: trets generals La estructura de implementació va comptar amb suport institucional i amb la col·laboració de l’Àrea Bàsica de Salut de Bellvitge, on la treballadora social era la font de subministrament de possibles receptors beneficiaris del servei. L’aprenentatge a partir de la experiència pot orientar alguns reptes a contemplar a l’hora de programar aquest tipus d’activitats, que en cas contrari, poden actuar com a detractors i dificultar el procés. Conclusions: Excel·lent experiència. Motivadora per al creixement personal, grupal (d’estudiants i professorat) i un altra mirada del coneixement psicosocial en salut, contextualitzat socialment

Experiència de flexibilitat metodològica en el procés d'ensenyament-aprenentatge. El cas de l'assignatura del grau de Farmàcia 'Biomembranes: estudis fisicoquímics'

Es descriu l'experiència realitzada en l'assignatura optativa Biomembranes: estudis fisicoquímics del Grau de Farmàcia de la UB. Aquest aspecte comporta formar un grup no molt nombrós d'estudiants i permet realitzar experiències metodològiques noves introduint aspectes de flexibilitat per a estudiants i professors. Es van establir els objectius competencials i es va dissenyar un programa flexible respecte a continguts, a activitats i dimensió espai-temps amb resultats satisfactoris

Flipped Classroom i satisfacció de l'alumnat: una alternativa a les classes magistrals

Podeu consultar la Vuitena trobada de professorat de Ciències de la Salut completa a: http://hdl.handle.net/2445/66524En la classe invertida o flipped classroom bona part de la responsabilitat de l’ensenyament-aprenentatge recau en l’alumnat . El professorat elabora el material d’estudi que haurà de preparar l’alumnat abans de classe. En el nostre cas, posteriorment, a l’aula es treballa en petits grups, per contrastar el treball individual, resoldre dubtes, avaluacio per parells i en general, construir l’aprenentatge a partir d’un seguit d’estratègies protocol•litzades, que comporten quantitat de treball i un grau important de satisfaccio tant per a l'alumne com per al professorat

Competencia trabajo en equipo (CTE): modelo GIOTEI. Una representación gráfica

El Grupo de Innovación Docente Consolidado (GIDC) GIOTEI (Grup Infermeria Orientat a Tècniques Educatives Innovadores) trabaja en una línea sobre la CTE (competencia trabajo en equipo) (tercer proyecto PMID2014PID-UB/053). Se pretende implementar un cuestionario de evaluación de la CTE elaborado anteriormente y vincularlo al desarrollo de una rúbrica, adecuándola a los cuatro cursos del Grado de Enfermería

Competencia trabajo en equipo (CTE): modelo GIOTEI una representación gráfica (Comunicación)

Podeu consultar la Vuitena trobada de professorat de Ciències de la Salut completa a: http://hdl.handle.net/2445/66524El Grupo de Innovación Docente Consolidado (GIDC) GIOTEI (Grup Infermeria Orientat a Tècniques Educatives Innovadores) trabaja en una línea sobre la CTE (competencia trabajo en equipo) (tercer proyecto PMID2014PID-UB/053). Se pretende implementar un cuestionario de evaluación de la CTE elaborado anteriormente y vincularlo al desarrollo de una rúbrica, adecuándola a los cuatro cursos del Grado de Enfermería. El trabajo en equipo se investiga desde los años setenta, sin embargo, las investigaciones sobre la CTE son mucho más recientes y escasas sus publicaciones. Ello dificulta la identificación de un modelo teórico afín a las dimensiones de dicha competencia propuestas por nuestro grupo. La consideración de la multidimensionalidad y la perspectiva sistémica del trabajo en equipo parecen ofrecer pocas dudas. Sin embargo, no hay acuerdo en la conceptualización de las dimensiones que configuran la CTE. Además, las divergencias terminológicas empleadas en la categorización de contenidos (uso indiferenciado de categorías, funciones, capacidades) dificultan identificar su especificidad. Por ello se escoge el modelo híbrido de representación jerárquica (Rousseau et al. 2006) al que ajustamos nuestra propuesta a partir de las categorías: 1) Comportamientos del trabajo en equipo: 1a) Regulación de la actuación del equipo 1b) Gestión del mantenimiento del equipo. En estas dos clasificaciones se integran las dimensiones que componen nuestro modelo: 1) Planificación de tareas 2) Gestión del tiempo 3) Colaboración 4) Comunicación 5

Effectiveness and Safety of the Sequential Use of a Second and Third Anti-TNF Agent in Patients with Inflammatory Bowel Disease: Results from the Eneida Registry

Background: The effectiveness of the switch to another anti-tumor necrosis factor (anti-TNF) agent is not known. The aim of this study was to analyze the effectiveness and safety of treatment with a second and third anti-TNF drug after intolerance to or failure of a previous anti-TNF agent in inflammatory bowel disease (IBD) patients. Methods: We included patients diagnosed with IBD from the ENEIDA registry who received another anti-TNF after intolerance to or failure of a prior anti-TNF agent. Results: A total of 1122 patients were included. In the short term, remission was achieved in 55% of the patients with the second anti-TNF. The incidence of loss of response was 19% per patient-year with the second anti-TNF. Combination therapy (hazard ratio [HR], 2.4; 95% confidence interval [CI], 1.8-3; P < 0.0001) and ulcerative colitis vs Crohn''s disease (HR, 1.6; 95% CI, 1.1-2.1; P = 0.005) were associated with a higher probability of loss of response. Fifteen percent of the patients had adverse events, and 10% had to discontinue the second anti-TNF. Of the 71 patients who received a third anti-TNF, 55% achieved remission. The incidence of loss of response was 22% per patient-year with a third anti-TNF. Adverse events occurred in 7 patients (11%), but only 1 stopped the drug. Conclusions: Approximately half of the patients who received a second anti-TNF achieved remission; nevertheless, a significant proportion of them subsequently lost response. Combination therapy and type of IBD were associated with loss of response. Remission was achieved in almost 50% of patients who received a third anti-TNF; nevertheless, a significant proportion of them subsequently lost response

Evolution after Anti-TNF Discontinuation in Patients with Inflammatory Bowel Disease: A Multicenter Long-Term Follow-Up Study

OBJECTIVES:The aims of this study were to assess the risk of relapse after discontinuation of anti-tumor necrosis factor (anti-TNF) drugs in patients with inflammatory bowel disease (IBD), to identify the factors associated with relapse, and to evaluate the overcome after retreatment with the same anti-TNF in those who relapsed.METHODS:This was a retrospective, observational, multicenter study. IBD patients who had been treated with anti-TNFs and in whom these drugs were discontinued after clinical remission was achieved were included.RESULTS:A total of 1, 055 patients were included. The incidence rate of relapse was 19% and 17% per patient-year in Crohn''s disease and ulcerative colitis patients, respectively. In both Crohn''s disease and ulcerative colitis patients in deep remission, the incidence rate of relapse was 19% per patient-year. The treatment with adalimumab vs. infliximab (hazard ratio (HR)=1.29; 95% confidence interval (CI)=1.01-1.66), elective discontinuation of anti-TNFs (HR=1.90; 95% CI=1.07-3.37) or discontinuation because of adverse events (HR=2.33; 95% CI=1.27-2.02) vs. a top-down strategy, colonic localization (HR=1.51; 95% CI=1.13-2.02) vs. ileal, and stricturing behavior (HR=1.5; 95% CI=1.09-2.05) vs. inflammatory were associated with a higher risk of relapse in Crohn''s disease patients, whereas treatment with immunomodulators after discontinuation (HR=0.67; 95% CI=0.51-0.87) and age (HR=0.98; 95% CI=0.97-0.99) were protective factors. None of the factors were predictive in ulcerative colitis patients. Retreatment of relapse with the same anti-TNF was effective (80% responded) and safe.CONCLUSIONS:The incidence rate of inflammatory bowel disease relapse after anti-TNF discontinuation is relevant. Some predictive factors of relapse after anti-TNF withdrawal have been identified. Retreatment with the same anti-TNF drug was effective and safe

Effects of Salt Stress on Three Ecologically Distinct Plantago Species

Comparative studies on the responses to salt stress of taxonomically related taxa should help to elucidate relevant mechanisms of stress tolerance in plants. We have applied this strategy to three Plantago species adapted to different natural habitats, P. crassifolia and P. coronopus both halophytes and P. major, considered as salt-sensitive since it is never found in natural saline habitats. Growth inhibition measurements in controlled salt treatments indicated, however, that P. major is quite resistant to salt stress, although less than its halophytic congeners. The contents of monovalent ions and specific osmolytes were determined in plant leaves after four-week salt treatments. Salt-treated plants of the three taxa accumulated Na+ and Cl- in response to increasing external NaCl concentrations, to a lesser extent in P. major than in the halophytes; the latter species also showed higher ion contents in the non-stressed plants. In the halophytes, K+ concentration decreased at moderate salinity levels, to increase again under high salt conditions, whereas in P. major K+ contents were reduced only above 400 mM NaCl. Sorbitol contents augmented in all plants, roughly in parallel with increasing salinity, but the relative increments and the absolute values reached did not differ much in the three taxa. On the contrary, a strong (relative) accumulation of proline in response to high salt concentrations (600 800 mM NaCl) was observed in the halophytes, but not in P. major. These results indicate that the responses to salt stress triggered specifically in the halophytes, and therefore the most relevant for tolerance in the genus Plantago are: a higher efficiency in the transport of toxic ions to the leaves, the capacity to use inorganic ions as osmotica, even under low salinity conditions, and the activation, in response to very high salt concentrations, of proline accumulation and K+ transport to the leaves of the plants.MAH was a recipient of an Erasmus Mundus pre-doctoral scholarship financed by the European Commission (Welcome Consortium). AP acknowledges the Erasmus mobility programme for funding her stay in Valencia to carry out her Master Thesis.Al Hassan, M.; Pacurar, AM.; López Gresa, MP.; Donat Torres, MDP.; Llinares Palacios, JV.; Boscaiu Neagu, MT.; Vicente Meana, Ó. (2016). Effects of Salt Stress on Three Ecologically Distinct Plantago Species. PLoS ONE. 11(8):1-21. doi:10.1371/journal.pone.0160236S12111

Correction to: Cluster identification, selection, and description in Cluster randomized crossover trials: the PREP-IT trials

An amendment to this paper has been published and can be accessed via the original article