New legal framework for the eradication of falsified medicines: the new safety devices

Introducción: Los medicamentos falsificados son un problema emergente en la sociedad actual. Una de las principales estrategias para poder combatirlos es el empleo del Derecho. Por ello se promulgó, por parte de las instituciones europeas legalmente competentes para ello, el Reglamento Delegado de la Unión Europea 2016/161 de la Comisión de 2 de octubre de 2015, que completa la Directiva 2001/83/CE del Parlamento Europeo y del Consejo estableciendo disposiciones detalladas relativas a los dispositivos de seguridad que figuran en el envase de los medicamentos de uso humano (de fabricación industrial). Método: Se realizó una revisión bibliográfica de esta nueva normativa, promulgada por diversas instituciones comunitarias, con el objetivo de analizar las novedades existentes en el ámbito del medicamento. Resultados: La norma comunitaria, objeto de nuestro estudio, establece las directrices para verificar aquellos medicamentos con mayor riesgo de falsificación, mediante unos dispositivos de seguridad compuestos de dos partes. Un dispositivo anti-manipulación que permite visualizar que el envase no ha sido alterado y un código identificador único, que será reconocido en todos los países comunitarios y que posee información sobre el medicamento. Desde las oficinas de farmacia se autentifica cada medicamento mediante la verificación y desactivación del código identificador en el momento de la dispensación del mismo. Conclusiones: Esta nueva normativa pretende evitar la posible entrada de medicamentos falsificados en la cadena de suministro legal de medicamentos. Sus principales ventajas son, garantizar al paciente la veracidad del medicamento dispensado en las oficinas de farmacia y mejorar la trazabilidad de los mismos.Introduction: Falsified medicines are an emerging problem in today’s society. One of the main strategies to combat them is the use of law. That is why the Commission Delegated Regulation (EU) 2016/161 of 2 October 2015 was enacted by the relevant European institutions, which supplements Directive 2001/83/ EC of the European Parliament and of the Council by laying down detailed provisions relating to safety features appearing on the external packaging of medicinal products for human use (industrial manufacturing). Method: A literature review of this new legislation enacted by various Community institutions has been carried out with the aim of analyzing developments in the scope of the medicinal product. Results: The Community regulation sets out the guidelines for verifying those medicinal products which have an increased risk of been falsified, using safety features consist of two parts: an anti-tampering device that allows to view that the packaging has not been altered, and a unique identifier code, which will be recognized in all Community countries and it has information on the medicinal product. Each drug is authenticated from the Pharmacies by verifying and deactivating the identifier code at the time of dispensing it. Conclusions: This new regulation aims to avoid the possible entry of falsified medicines into the legal supply chain of medicinal products. Its main advantages are ensuring to the patient the veracity of the drugs dispensed in the Pharmacy and improving the traceability of them

PELIGROSIDAD A LOS MOVIMIENTOS DE LADERA EN LA VERTIENTE MERIDIONAL DE SIERRA NEVADA (GRANADA) A PARTIR DE LA ESTIMACIÓN MULTI-TÉCNICA DE LA ACTIVIDAD

El presente trabajo aborda la cartografía de la susceptibilidad y la peligrosidad a los movimientos de ladera, en un ambiente montañoso, con información limitada sobre su actividad. El análisis y validación de la susceptibilidad se realizada mediante un modelo elaborado a partir del ModelBuilder™ de ArcGIS basado en el Método de la Matriz en un SIG. Dicho modelo necesita una cartografía previa de los movimientos, un MDE y un análisis discriminante de los factores determinantes de la estabilidad. Los datos del análisis reflejan que el 15% de la zona estudiada muestra una susceptibilidad a los movimientos de moderada a muy alta que, a su vez, coincide con lugares donde se encuentran la mayoría de las infraestructuras públicas de la región. Además, los valores registrados en la validación mediante el grado de ajuste están por encima del 83% para las zonas de susceptibilidad alta y muy alta. Estas zonas que presentan un mayor grado de susceptibilidad y, por tanto, una mayor exposición potencial al riesgo, son las seleccionadas para el análisis detallado de la peligrosidad. El principal problema, que, por otra parte, suele ser generalizado en este tipo de áreas para la estimación de la frecuencia con la que se suceden movimientos de ladera, es la falta de información sobre su ocurrencia. Por tanto, y con el objetivo de obtener la mayor información posible, los datos relativos a la actividad de los movimientos se extraen de diversas fuentes y técnicas, de forma que interactivamente solventen sus correspondientes limitaciones. Estos datos se extraen de una documentación previa, tanto en prensa como bibliografía específica, donde se presentan trabajos sobre DInSAR, fotogrametría aérea y LIDAR, y TLS. Además, se realiza de forma específica un análisis dendrogeomorfológico de árboles en movimientos de ladera y se revisa la ortofotografía aérea histórica de la zona de estudio. Posteriormente, con los datos de actividad, se realiza un análisis de los factores desencadenantes, que refleja que los movimientos de ladera están relacionados con episodios de precipitaciones intensas y prolongadas, y no tanto con la actividad sísmica del área. Por último, de forma indirecta, se estima la peligrosidad de la zona de estudio a los movimientos de ladera, asociando los resultados obtenidos de actividad con los factores desencadenantes; esto es, con periodos de precipitaciones intensas. Así, se establece un periodo de retorno que se extrapola a toda el área, con la asunción de que los grandes deslizamientos se generan o reactivan, conjuntamente con movimientos superficiales, tras periodos lluviosos intensos y prolongados, y que las lluvias torrenciales generan movimientos de ladera superficiales tipo flujo y desprendimientos. Los resultados obtenidos indican que la frecuencia con la que se generan los movimientos es de 5 años para los flujos superficiales y desprendimientos (F=0,2), y de 18 años para los deslizamientos y movimientos complejos (F=0,06). La zona, en términos generales, presenta determinados sectores con susceptibilidad moderada a muy alta, sin embargo la peligrosidad a los movimientos de ladera es de moderada a muy baja. En términos de probabilidad temporal, los flujos y desprendimientos son los movimientos con mayor peligrosidad

La depresión infantojuvenil: prevención en un Instituto de Enseñanza Secundaria

La infancia se acorta por la actividad a que los adultos someten a los niños/as, y la adolescencia se prolonga artificialmente, porque el período de dependencia económica y psicosocial no coincide con el de autonomía física que se consolida en la pubertad. La sociedad, las familias, la escolaridad, las circunstancias... en muchas ocasiones hacen que los niños/as y adolescentes tengan dificultades de adaptación que se manifiestan en conductas de depresión, que se prolongan o surgen en la adultez. Se proponen las bases de un Programa de (Intervención desde la) Prevención, en un Instituto de Enseñanza Secundaria, desde el Departamento de Orientación, con la colaboración de los tutores del centro, las familias, y con la implicación de toda la comunidad educativa.Childhood is shortened by the activity that adults subject children and adolescence is extended artificially, because the period of psychological and economic dependency does not coincide with the physical autonomy which is consolidated at puberty. The society, families, schooling, the circumstances... on many occasions make that children and adolescents have difficulties of adaptation that is manifested in behavior of depression, which extend or arise in adulthood. We propose the bases of a program of (intervention from the) prevention, in an Institute of secondary education, from the guidance Department, with the collaboration of the Center, families, tutors and with the involvement of the entire educational communityEste trabajo pretende dar a conocer la importancia de la prevención de la depresión infantojuvenil en un Instituto de Enseñanza Secundaria, mediante la elaboración de las bases de un Programa de intervención desde el Departamento de Orientación, con la colaboración de los tutores del centro, las familias, y con la implicación de toda la comunidad educativa

Nicotianamine Synthase 2 Is Required for Symbiotic Nitrogen Fixation in Medicago truncatula Nodules

Symbiotic nitrogen fixation carried out by the interaction between legumes and diazotrophic bacteria known as rhizobia requires relatively large levels of transition metals. These elements are cofactors of many key enzymes involved in this process. Metallic micronutrients are obtained from soil by the roots and directed to sink organs by the vasculature, in a process mediated by a number of metal transporters and small organic molecules that facilitate metal delivery in the plant fluids. Among the later, nicotianamine is one of the most important. Synthesized by nicotianamine synthases (NAS), this molecule forms metal complexes participating in intracellular metal homeostasis and long-distance metal trafficking. Here we characterized the NAS2 gene from model legume Medicago truncatula. MtNAS2 is located in the root vasculature and in all nodule tissues in the infection and fixation zones. Symbiotic nitrogen fixation requires of MtNAS2 function, as indicated by the loss of nitrogenase activity in the insertional mutant nas2-1, phenotype reverted by reintroduction of a wild-type copy of MtNAS2. This would result from the altered iron distribution in nas2-1 nodules shown with X-ray fluorescence. Moreover, iron speciation is also affected in these nodules. These data suggest a role of nicotianamine in iron delivery for symbiotic nitrogen fixation

The Effect of a Physical Activity Program on the Total Number of Primary Care Visits in Inactive Patients: A 15-Month Randomized Controlled Trial

Abstract Background: Effective promotion of exercise could result in substantial savings in healthcare cost expenses in terms of direct medical costs, such as the number of medical appointments. However, this is hampered by our limited knowledge of how to achieve sustained increases in physical activity. Objectives: To assess the effectiveness of a Primary Health Care (PHC) based physical activity program in reducing the total number of visits to the healthcare center among inactive patients, over a 15-month period. Research Design: Randomized controlled trial. Subjects: Three hundred and sixty-two (n = 362) inactive patients suffering from at least one chronic condition were included. One hundred and eighty-three patients (n = 183; mean (SD); 68.3 (8.8) years; 118 women) were randomly allocated to the physical activity program (IG). One hundred and seventy-nine patients (n = 179; 67.2 (9.1) years; 106 women) were allocated to the control group (CG). The IG went through a three-month standardized physical activity program led by physical activity specialists and linked to community resources. Measures: The total number of medical appointments to the PHC, during twelve months before and after the program, was registered. Self-reported health status (SF-12 version 2) was assessed at baseline (month 0), at the end of the intervention (month 3), and at 12 months follow-up after the end of the intervention (month 15). Results: The IG had a significantly reduced number of visits during the 12 months after the intervention: 14.8 (8.5). The CG remained about the same: 18.2 (11.1) (P = .002). Conclusions: Our findings indicate that a 3-month physical activity program linked to community resources is a shortduration, effective and sustainable intervention in inactive patients to decrease rates of PHC visits. Trial Registration: ClinicalTrials.gov NCT0071483

Consensus document on allergic conjunctivitis (DECA)

Allergic conjunctivitis (AC) is an inflammatory disease of the conjunctiva caused mainly by an IgE-mediated mechanism. It is the most common type of ocular allergy. Despite being the most benign form of conjunctivitis, AC has a considerable effect on patient quality of life, reduces work productivity, and increases health care costs. No consensus has been reached on its classification, diagnosis, or treatment. Consequently, the literature provides little information on its natural history, epidemiological data are scarce, and it is often difficult to ascertain its true morbidity. The main objective of the Consensus Document on Allergic Conjunctivitis (Documento dE Consenso sobre Conjuntivitis Alérgica [DECA]), which was drafted by an expert panel from the Spanish Society of Allergology and Spanish Society of Ophthalmology, was to reach agreement on basic criteria that could prove useful for both specialists and primary care physicians and facilitate the diagnosis, classification, and treatment of AC. This document is the first of its kind to describe and analyze aspects of AC that could make it possible to control symptoms

Metabolic and Functional Profile of Premenopausal Women With Metabolic Syndrome After Training With Elastics as Compared to Free Weights

The aim of this study was to compare the effects of a strength training program (STP) using free weights (FW) versus elastic tubing (ET) in 62 premenopausal, sedentary women diagnosed with metabolic syndrome (MS). Participants were randomly assigned to the FW or ET experimental group (EG) or a control group whose members remained sedentary. Members of each EG followed their assigned STP for 12 weeks, and biomarkers (BMs) related to MS and motor function (MF) parameters were evaluated. Both EGs showed a significant reduction in C-reactive protein level and a positive trend in the other BMs. Almost all MF parameters increased significantly in both EGs. No positive changes were found in the CG. These results indicate that the implementation of an STP, with either FW or ET, improves both metabolic health and MF and should be considered part of the basic approach to health care in women

Advancing Key Gaps in the Knowledge of Plasmodium vivax Cryptic Infections Using Humanized Mouse Models and Organs-on-Chips

Plasmodium vivax is the most widely distributed human malaria parasite representing 36.3% of disease burden in the South-East Asia region and the most predominant species in the region of the Americas. Recent estimates indicate that 3.3 billion of people are under risk of infection with circa 7 million clinical cases reported each year. This burden is certainly underestimated as the vast majority of chronic infections are asymptomatic. For centuries, it has been widely accepted that the only source of cryptic parasites is the liver dormant stages known as hypnozoites. However, recent evidence indicates that niches outside the liver, in particular in the spleen and the bone marrow, can represent a major source of cryptic chronic erythrocytic infections. The origin of such chronic infections is highly controversial as many key knowledge gaps remain unanswered. Yet, as parasites in these niches seem to be sheltered from immune response and antimalarial drugs, research on this area should be reinforced if elimination of malaria is to be achieved. Due to ethical and technical considerations, working with the liver, bone marrow and spleen from natural infections is very difficult. Recent advances in the development of humanized mouse models and organs-on-a-chip models, offer novel technological frontiers to study human diseases, vaccine validation and drug discovery. Here, we review current data of these frontier technologies in malaria, highlighting major challenges ahead to study P. vivax cryptic niches, which perpetuate transmission and burden