Introduction and evaluation of pharmacovigilance for beginners

Drugs safety profile monitoring is an essential element for the effective use of medicines and for high quality medical care. Pharmacovigilance (PV), is the pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products. The PV comes in picture after elixir sulfanilamide tragedy of 1937 and in the late 1950s and early 1960s, more than 10,000 children in 46 countries were born with deformities such as phocomelia as a consequence of thalidomide use has opened the eyes of drug regulators as well as consumers to establish a way to ensure drug safety. The hospitalization due to adverse drug reaction (ADR) in USA is about or more than 10%. In addition, it is estimates that 15-20% of the hospital inpatient suffers from ADRs. Now the pharmacovigilance system is globalised, strengthen and systematized after the establishment of World Health Organization (WHO) Programme for International Drug Monitoring. The patient safety is now becoming the priority area of pharmaceuticals. In this article, we are describing brief history and introduction of PV that will help to understand PV for beginners

Bioética, saber narrativo y sentido de vida

Introducción: Humanismo y vida continúan en proceso de reconfiguración en el ágora digital. En las últimas décadas, se ha consolidado un "movimiento narrativo" con presencia de la bioética en esta ola. El presente artículo se orienta a plantear que el mundo de la vida y su sentido podrían encontrar en el saber narrativo elementos para fortalecer una bioética en crisis en su camino hacia los 50 años. Metodología: Artículo de reflexión con base en una revisión narrativa focalizada en las categorías bioética, saber narrativo, hermenéutica, vida, en bases de datos internacionales y autores representativos. Resultados: El saber narrativo con su poder performativo, su fuerza configuradora de realidad, sentido e identidad y su dimensión hermenéutica podrían fortalecer los procesos de la bioética. La estructura del relato, forma privilegiada del saber narrativo, posibilita plantear implicaciones y provocaciones para la bioética. Conclusiones: La bioética podría caminar de analizar principios a reconfigurar sus propuestas mediante la hermenéutica de la vida misma y su sentido, con la mediación del saber narrativo.

Introduction. Humanism and life continue in a remaking process in the digital agora. In the last years, it has been consolidated a narrative wave whit bioethics participation. This paper evidence that the life environment and its sense could find in narrative knowledge elements for strengthen a bioethics on the way to his 50 years. Methodology. Perspective, opinnion and commentary paper based on a narrative review focused on the categories of bioethics, narrative knowledge, hermeneutics and life, based on international database searches and outstandig authors. Results. The narrative knowledge with if performative power, reality-shaping force, sense and identity and its hermeneutic dimension, could strengthen bioetics process. The structure of the story, privileged form of narrative knowledge, it allows implications and provocations for bioethics. The bioethics could change from analyze axioms to reconfigurate proposals through hermeneutics of life itself and his sense, whit the mediation of narrative knowledge.

Introdução: O humanismo e a vida continuam o processo de reconfiguração na ágora digital. Nas últimas décadas, tem sido consolidado um "movimento narrativo" com presença da bioética neste movimento. O presente artigo, orienta-se a considerar que o mundo da vida e seu sentido podem-se encontrar no saber narrativo, assim os elementos para fortalecer uma bioética em crises em seu caminho para cinquenta. Metodologia: Artigo de reflexão em base de uma revisão narrativa focalizada nas categorias bioética, saber narrativo, hermenêutica, vida, em base de dados internacionais e autores representativos. Resultados: O saber narrativo com seu poder performativo, sua força configuradora de realidade, sentido e identidade, sua dimensão hermenêutica pode fortalecer os processos da bioética. A estrutura do relato, forma privilegiada do saber narrativo, possibilita considerar-se implicações e provocações para a bioética. Conclusões: A bioética poderia caminhar e analisar os princípios a reconfigurar suas propostas por meio da hermenêutica da vida mesma e seu sentido, com a mediação do saber narrativo.

Research Progress of Individual Case Safety Report and Periodic Safety Update Reports / 沈阳医学院学报

In our country,pharmacovigilance evolved from the adverse drug reaction surveillance system,as increase awareness of which value, pharmacovigilance developed rapidly in recent years. Individual case safety report (ICSR) and periodic Safety Update Reports (PSUR) are key tasks of pharmacovigilance,this paper focused on discussing the new progress of these two parts.