Search results for "Vigilance"
showing 10 items of 154 documents
Adverse drug reactions in some African herbal medicine: literature review and stakeholders’ interview
2014
International audience; Background: In view of the large consumption of herbal medicine in Africa countries, it is likely that many adverse drugs reactions go unrecorded with either patients failing to present to health services, or no pharmacovigilance analysis being made, or the analysis not being reported centrally. This problem is of interest especially for those who are working in the general area of adverse drug reactions or stakeholders in the domain of herbal medicine for considering safety issues. Methods: We are particularly interested in the way that the use of very wellknown and highly valued plants is linked to the observation of adverse drug reactions in African countries. We …
SP0027 Biosimilars: Potential Clinical Differences and European Regulatory Aspects
2014
Although successful drugs, the use of anti-TNFs is limited by their high cost, and in the present climate of economic difficulty, there is pressure to find alternatives that reproduce their effects at a lower price. Due to their large molecular size and structural complexity, anti-TNFs are impossible to duplicate, unlike smaller, chemically-generated compounds, which can be copied. However, unlike generics, biosimilars are similar rather than identical to the original drugs. Determining the level of similarity that guarantees a comparable efficacy and safety represents a new test for the pharmacological market. Biosimilars of smaller biological molecules, such as somatotropin, EPO and GCSF …
Therapeutic drug monitoring for antidepressant drug treatment.
2012
The aim of antidepressant drug treatment is to produce remission without causing adverse effects during the acute phase of the illness and to prevent relapses or recurrences during continuation or maintenance therapy. To achieve these goals, drug choice and dosage must be optimized for each patient individually. Therapeutic drug monitoring (TDM), which is based on the assumption that clinical effects correlate better with blood levels than doses, can be helpful. When using tricyclic antidepressant drugs TDM enhances safety and efficacy. For newer antidepressant drugs, however, it is a matter of debate to which extend TDM can have beneficial effects. For many antidepressants there exist care…
Herbal hepatotoxicity: a hidden epidemic
2011
Complementary and alternative therapies, including herbal products, have become increasingly popular in the general population and among patients and physicians. Regulations and pharmacovigilance regarding herbal drugs are still incomplete and need to be improved. In fact, herbals are commonly marketed on the Internet, and in many countries they are sold as food supplements, which are beyond the control of drug regulatory agencies. In Europe and the U.S., reports of hepatotoxicity from these products, including those advertised for liver diseases, are accumulating. Many herbal drugs are also commonly used in children, and in women during pregnancy and lactation, because they are believed to…
Monitoring of Plasma Concentrations of Psychotropic Drugs in Pharmacovigilance
2015
The primary aims of pharmacovigilance are supervision and prevention of medication-related problems under everyday conditions. Pharmacovigilance is an indication for monitoring plasma concentrations, i.e. conducting therapeutic drug monitoring (TDM). Using TDM, it can be clarified if observed unwanted drug effects may be attributed to abnormally high or low drug concentrations. Utmost benefits from TDM are obtained for pharmacovigilance when the method is adequately integrated into the clinical treatment process. How to do this is described in consensus guidelines for TDM in psychiatry. During the last 20 years, TDM was very successful for detection of multiple pharmacokinetic drug-drug int…
Pharmacotherapy, drug-drug interactions and potentially inappropriate medication in depressive disorders.
2021
Introduction The aim of this study was to describe the number and type of drugs used to treat depressive disorders in inpatient psychiatry and to analyse the determinants of potential drug-drug interactions (pDDI) and potentially inappropriate medication (PIM). Methods Our study was part of a larger pharmacovigilance project funded by the German Innovation Funds. It included all inpatients with a main diagnosis in the group of depressive episodes (F32, ICD-10) or recurrent depressive disorders (F33) discharged from eight psychiatric hospitals in Germany between 1 October 2017 and 30 September 2018 or between 1 January and 31 December 2019. Results The study included 14,418 inpatient cases.…
The relationship between online vigilance and affective well-being in everyday life: Combining smartphone logging with experience sampling
2021
Contains fulltext : 220301.pdf (Publisher’s version ) (Open Access) Through communication technology, users find themselves constantly connected to others to such an extent that they routinely develop a mindset of connectedness. This mindset has been defined as online vigilance. Although there is a large body of research on media use and well-being, the question of how online vigilance impacts well-being remains unanswered. In this preregistered study, we combine experience sampling and smartphone logging to address the relation of online vigilance and affective well-being in everyday life. Seventy-five Android users answered eight daily surveys over five days (N = 1615) whilst having their…
Work strain in midlife and 28-year work ability trajectories
2011
We investigated the 28-year development trajectories of work ability among initially middle-aged male and female municipal employees and the association of perceived mental and physical work strain in midlife by work ability trajectory groups.The baseline data of the Finnish longitudinal study of municipal employees (FLAME) were collected in 1981 (N=6257) with follow-ups in 1985, 1992, 1997, and 2009. Work ability was assessed in all the waves as present perceived work ability relative to lifetime best. Altogether, N=2690 had work ability data in 1981 and 2009, and at least for one wave in between these years, and were included in group-based semi-parametric mixture modeling trajectory anal…
Individual Differences in Dispositional Mindfulness Predict Attentional Networks and Vigilance Performance
2022
Acknowledgements The authors wish to thank Tao Coll-Martín, Fernando G. Luna, and Miguel A. Vadillo for the kind and helpful input provided during the development of this research project.
Adverse reactions to human papillomavirus vaccine in the Valencian Community (2007-2011)
2014
Resumen: Introducción: En 2009, 2 casos de convulsiones en adolescentes tras la administración de la vacuna tetravalente frente al virus del papiloma humano (VPH) generaron impacto mediático y afectaron negativamente la confianza del público en esta vacuna.Nuestros objetivos fueron describir las sospechas de reacciones adversas (SRA) notificadas al Centro Autonómico de Farmacovigilancia de la Comunidad Valenciana (CAFCV) tras la administración de la vacuna frente al VPH y comparar la tasa de notificación de síncope y convulsiones de esta vacuna con la de otras vacunas administradas en adolescentes. Material y métodos: Estudio descriptivo de las notificaciones de SRA relacionadas con esta va…