Clinical and economic burden of adverse drug reactions.
TLDR
Overall, pharmacovigilance is aimed at identifying drug safety signals as early as possible, thus minimizing potential clinical and economic consequences of ADRs, and reducing healthcare costs in the process.Abstract:
Adverse drug reactions (ADRs) are unwanted drug effects that have considerable economic as well as clinical costs as they often lead to hospital admission, prolongation of hospital stay and emergency department visits. Randomized controlled trials (RCTs) are the main premarketing methods used to detect and quantify ADRs but these have several limitations, such as limited study sample size and limited heterogeneity due to the exclusion of the frailest patients. In addition, ADRs due to inappropriate medication use occur often in the real world of clinical practice but not in RCTs. Postmarketing drug safety monitoring through pharmacovigilance activities, including mining of spontaneous reporting and carrying out observational prospective cohort or retrospective database studies, allow longer follow-up periods of patients with a much wider range of characteristics, providing valuable means for ADR detection, quantification and where possible reduction, reducing healthcare costs in the process. Overall, pharmacovigilance is aimed at identifying drug safety signals as early as possible, thus minimizing potential clinical and economic consequences of ADRs. The goal of this review is to explore the epidemiology and the costs of ADRs in routine care.read more
Citations
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Pharmacovigilance from social media: mining adverse drug reaction mentions using sequence labeling with word embedding cluster features.
TL;DR: A machine learning-based approach to extract mentions of adverse drug reactions (ADRs) from highly informal text in social media, suitable for social media mining, as it relies on large volumes of unlabeled data, thus diminishing the need for large, annotated training data sets.
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Deep learning for pharmacovigilance: recurrent neural network architectures for labeling adverse drug reactions in Twitter posts.
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References
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Journal ArticleDOI
Adverse drug reactions as cause of admission to hospital: prospective analysis of 18 820 patients
Munir Pirmohamed,Sally James,Shaun Meakin,Chris D. Green,A Scott,Tom Walley,Keith Farrar,B. Kevin Park,Alasdair Breckenridge +8 more
TL;DR: The burden ofADRs on the NHS is high, accounting for considerable morbidity, mortality, and extra costs, and measures need to be put into place to reduce the burden of ADRs and thereby further improve the benefit:harm ratio of the drugs.
Journal ArticleDOI
External validity of randomised controlled trials: “To whom do the results of this trial apply?”
TL;DR: In this paper, the authors present a checklist for clinicians to consider external validity in the design and reporting of RCTs and make recommendations for greater consideration of external validity for clinical trials.
Journal ArticleDOI
The costs of adverse drug events in hospitalized patients
David W. Bates,Nathan Spell,David J. Cullen,Elisabeth Burdick,Nan M. Laird,Laura A. Petersen,Stephen D. Small,Bobbie Jean Sweitzer,Lucian L. Leape +8 more
TL;DR: The substantial costs of ADEs to hospitals justify investment in efforts to prevent these events, and estimates of annual costs attributable to all ADEs and preventable ADEs for a 700-bed teaching hospital are $5.6 million and $2.8 million are conservative because they do not include the costs of injuries to patients or malpractice costs.
Journal ArticleDOI
Adverse drug events in hospitalized patients : Excess length of stay, extra costs, and attributable mortality.
TL;DR: The attributable lengths of stay and costs of hospitalization for ADEs are substantial and an ADE is associated with a significantly prolonged length of stay, increased economic burden, and an almost 2-fold increased risk of death.
Journal ArticleDOI
Why we need observational studies to evaluate the effectiveness of health care
TL;DR: The view is widely held that experimental methods (randomised controlled trials) are the "gold standard" for evaluation and that observational methods have little or no value, but this ignores the limitations of randomised trials.
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