Evaluation of Electronic Healthcare Databases for Post-Marketing Drug Safety Surveillance and Pharmacoepidemiology in China
Sign Up to like & getrecommendations! Published in 2017 at "Drug Safety"
DOI: 10.1007/s40264-017-0589-z
Abstract: IntroductionElectronic healthcare databases (EHDs) are used increasingly for post-marketing drug safety surveillance and pharmacoepidemiology in Europe and North America. However, few studies have examined the potential of these data sources in China.MethodsThree major types of… read more here.
Keywords: drug; core variables; drug safety; safety surveillance ... See more keywords
Active Safety Surveillance in Africa: Pragmatism and Agility
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DOI: 10.1007/s40264-018-0677-8
Abstract: In this issue of Drug Safety, Ndagije et al. [1] reports on an active follow-up study to establish the burden of adverse drug reactions (ADRs) due to artemisinin-based antimalarial treatment in selected urban and rural… read more here.
Keywords: health; drug safety; safety; safety surveillance ... See more keywords
Rapid assessment of enhanced safety surveillance for influenza vaccine.
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DOI: 10.1016/j.puhe.2018.12.013
Abstract: OBJECTIVES The enhanced safety surveillance for seasonal influenza vaccines established by the European Medicines Agency is required each season. Therefore, a registry capable of rapidly detecting and evaluating potential new safety concerns is needed. The… read more here.
Keywords: influenza vaccine; safety surveillance; safety; enhanced safety ... See more keywords
Efficacy of m-Health for the detection of adverse events following immunization - The stimulated telephone assisted rapid safety surveillance (STARSS) randomised control trial.
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DOI: 10.1016/j.vaccine.2020.11.056
Abstract: INTRODUCTION Passive surveillance is recommended globally for the detection of adverse events following immunisation (AEFI) but this has significant challenges. Use of Mobile health for vaccine safety surveillance enables a consumer-centred approach to reporting. The… read more here.
Keywords: detection; safety surveillance; surveillance; control ... See more keywords
Enhanced safety surveillance of STAMARIL® yellow fever vaccine provided under the expanded access investigational new drug program in the United States.
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DOI: 10.1093/jtm/taad037
Abstract: BACKGROUND YF-VAX® (Sanofi, Swiftwater, PA), a live attenuated vaccine based on strain 17D-204, is the only yellow fever (YF) vaccine licensed in the USA. Manufacturing disruption of YF-VAX® and anticipated depletion of the US supply… read more here.
Keywords: safety; enhanced safety; yellow fever; vaccine ... See more keywords
Enhanced passive safety surveillance of high‐dose and standard‐dose quadrivalent inactivated split‐virion influenza vaccines in Germany and Finland during the influenza season 2021/22
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DOI: 10.1111/irv.13071
Abstract: Enhanced passive safety surveillance (EPSS) was conducted for quadrivalent inactivated split‐virion influenza vaccines (IIV4) in Germany (high dose [HD], aged ≥60 years) and in Finland (standard dose [SD], aged ≥6 months) at the beginning of the… read more here.
Keywords: quadrivalent inactivated; inactivated split; enhanced passive; influenza ... See more keywords
Post-authorisation passive enhanced safety surveillance of seasonal influenza vaccines: protocol of a pilot study in England
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DOI: 10.1136/bmjopen-2016-015469
Abstract: Aim To pilot enhanced safety surveillance of seasonal influenza vaccine meeting the European Medicines Agency (EMA) requirement to rapidly detect a significant increase in the frequency or severity of adverse events of interest (AEIs), which… read more here.
Keywords: safety surveillance; surveillance; study; seasonal influenza ... See more keywords